The Federal Register

Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning

Fri, Nov 20 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow for public comment in response to the notice. This notice solicits comments on requirements for recordkeeping and reports concerning experience with approved new animal drugs, specifically on new data elements to be used in revised versions of Forms FDA 1932 and 1932a. The information contained in the reports required by this regulation enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy.

Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of

Wed, Nov 18 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the reporting of biological product deviations (BPDs) and human cells, tissues, and cellular and tissuebased product (HCT/P) deviations, and Form FDA 3486 and Addendum 3486A.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Nov 18 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Nutrition Facts

Wed, Nov 18 2009 11:00:00 GMT

Memorandum of Understanding Between the Food and Drug Administration and Waterfront Media

Wed, Nov 18 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Waterfront Media. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product recalls.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Nov 18 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; ``Real Time'' Surveys of Consumers'

Wed, Nov 18 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Nov 17 2009 11:00:00 GMT

New Animal Drugs in Genetically Engineered Animals

Thu, Nov 12 2009 11:00:00 GMT

CFR Correction

In Title 21 of the Code of Federal Regulations, Parts 500599, revised as of April 1, 2009, on page 359, the heading for part 528 is corrected to read ``NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS''.
[FR Doc. E927305 Filed 111009; 8:45 am]
BILLING CODE 150501D

Current Good Manufacturing Practice Requirements for Combination Products; Extension of Comment Period

Tue, Nov 10 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is extending to February 5, 2010, the comment period for the proposed rule that appeared in the Federal Register of September 23, 2009. In the proposed rule, FDA requested comments on current good manufacturing practice (CGMP) requirements applicable to combination products. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of

Fri, Nov 6 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Bar Code Label Requirement for Human

Fri, Nov 6 2009 11:00:00 GMT

Amendment to Memorandum of Understanding Between the Food and Drug Administration and WebMD, LLC

Thu, Nov 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of an amendment to a memorandum of understanding (MOU) between FDA's Office of External Relations and WebMD, LLC.

Food and Drug Administration's Safe Use Initiative; Availability of Information

Thu, Nov 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the launch of its Safe Use Initiative with the release of a report titled ``FDA's Safe Use InitiativeCollaborating to Reduce Preventable Harm from Medicines.'' FDA is opening a docket to enable the public to comment on the report and the initiative. In addition, a safe use Web site has been created to facilitate transparency as the initiative moves forward. The initiative proposes a series of next steps, including working with interested partnerspatients, consumers, caretakers, healthcare practitioners, pharmacists, healthcare systems, health insurers, drug manufacturers, and other Federal agenciesto select specific candidate cases of preventable, drugrelated harm for analysis, intervention proposals, and evaluation metrics. The report identifies some specific areas of concern that could benefit from Safe Use Initiative partnerships.

Draft Guidance for Industry on Listing of Ingredients in Tobacco Products; Availability

Tue, Nov 3 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Listing of Ingredients in Tobacco Products.'' The draft guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by section 904 of the Federal Food, Drug, and Cosmetic Act (the act) as added by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug

Mon, Nov 2 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Mon, Nov 2 2009 11:00:00 GMT

Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information;

Mon, Nov 2 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for peramivir 200 milligrams (mg)/20 milliliter (mL) (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst) for intravenous (IV) administration in certain adult and pediatric patients. Peramivir is a drug that is not approved by FDA. FDA is issuing the Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of peramivir. The Authorization follows the determination by then Acting Secretary of the U.S. Department of Health and Human Services Charles E. Johnson (then Acting Secretary) that a public health emergency exists involving Swine Influenza A (now known as ``2009H1N1 Influenza'') that affects, or has the significant potential to affect, national security. The determination

Investigational New Drug Applications; Technical Amendment

Thu, Oct 29 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that are intended to support abbreviated new drug applications (ANDAs) should be sent directly to the
[[Page 55771]]
Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency's regulations.

Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License

Wed, Oct 28 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Oct 28 2009 11:00:00 GMT

Prescription Drug User Fee Rates for Fiscal Year 2010; Correction

Tue, Oct 27 2009 11:00:00 GMT

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2009 (74 FR 38451). The document announced the fiscal year 2010 fee rates for the Prescription Drug User Fee Act. The document was published with errors. This document corrects those errors.

Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Standard for Flavored

Mon, Oct 26 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug

Mon, Oct 26 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection;

Fri, Oct 23 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection;

Fri, Oct 23 2009 11:00:00 GMT

New Animal Drug Applications

Fri, Oct 23 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the regulations regarding new animal drug applications (NADAs). Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility needed to address the development of all types of new animal drug products. This amendment will allow the agency to appropriately review safety and effectiveness data submitted to support the approval of new animal drug products. FDA is amending the regulations in accordance with its direct final rule procedures.

Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedure for noticeand comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adve

New Animal Drug Applications

Fri, Oct 23 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to amend the regulations regarding new animal drug applications (NADAs). Specifically, this proposed rule is being issued to provide that NADAs shall be submitted in the form and containing the information described, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility needed to address the development of all types of new animal drug products. This amendment will allow the agency to appropriately review safety and effectiveness data submitted to support the approval of new animal drug products. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

Agency Information Collection Activities; Proposed Collection;

Fri, Oct 23 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements of FDA's regulations that require records on FDAregulated human food, including dietary supplements, and cosmetics that are manufactured from, processed with, or otherwise contain, material derived from cattle.

Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons

Thu, Oct 22 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and

Tue, Oct 20 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Oct 20 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Recommendations for Clinical

Tue, Oct 20 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension, of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on collections of information associated with the guidance issued January 30, 2008, and titled ``Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices''.

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent For In

Tue, Oct 20 2009 11:00:00 GMT

Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2010 Proposed Guidance Development

Tue, Oct 20 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the Web location where it will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.

Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned

Fri, Oct 16 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning

Thu, Oct 15 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements for recordkeeping and reports concerning experience with approved new animal drugs. The information contained in the reports required by the regulation enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy.

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet;

Thu, Oct 15 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Form FDA 3601 entitled ``Medical Device User Fee Cover Sheet,'' which must be submitted along with certain medical device product applications, supplements, and fee payment of those applications.
[[Page 52966]]

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of

Tue, Oct 13 2009 11:00:00 GMT

Agency Emergency Processing Under Office of Management and Budget Review; Tobacco Product Establishment Registration

Tue, Oct 13 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is reopening until October 26, 2009, the comment period for the notice published in the Federal Register of September 1, 2009 (74 FR 45219). The document announced the proposed collection of information concerning the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and health related documents, as required by The Family Smoking Prevention and Tobacco Control Act (FSPTCA). The agency is reopening the comment period because FDA has reevaluated the expected launch date of the electronic portal and to allow interested persons additional time to review the proposed collection of information and submit comments.

Regulation of Tobacco Products; Extension of Comment Period; Correction

Wed, Oct 7 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a notice; extension of comment period that appeared in the Federal Register of October 1, 2009 (74 FR 50810). The notice; extension of comment period announced that FDA is extending to December 28, 2009, the comment period for a notice that originally published in the Federal Register of July 1, 2009 (74 FR 31457). The notice; extension of comment period published with an inadvertent error in the DATES section. This document corrects that error.

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions

Tue, Oct 6 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Oct 6 2009 11:00:00 GMT

Current Good Manufacturing Practice Requirements for Combination Products; Correction

Mon, Oct 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of September 23, 2009 (74 FR 48423). The document proposed to codify the current good manufacturing practice requirements applicable to combination products. The document published with an incorrect docket number. This document corrects that error.

Draft Guidance for Industry on Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS

Thu, Oct 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the act) giving FDA the authority to require REMS. The draft guidance describes the format and content of a proposed risk evaluation and mitigation strategy, including REMS supporting documentation, the content of assessments and proposed modifications of approved REMS, what identifiers to use on REMS documents, and how to communicate with FDA about a REMS.

National Mammography Quality Assurance Advisory Committee; Notice of Meeting

Thu, Oct 1 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: National Mammography Quality Assurance Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on November 2, 2009, from 9 a.m. to 5 p.m.

Location: Holiday Inn, WalkerWhetstone Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.

Contact Person: Normica Facey, Center for Devices and Radiological Health (White Oak, Bldg. 66, rm. 4652), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 3017965914, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512397. Please call the Information Line for uptodate information on this meeting. A notice in the Federal Register about last minute modifications tha

Pilot Program To Evaluate Proposed Proprietary Name Submissions; Procedures To Register for Participation and Submit

Thu, Oct 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the opportunity for pharmaceutical firms (applicants) to participate in a voluntary 2year pilot program for the evaluation of proposed proprietary names to be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The pilot program will enable participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated from those evaluations to FDA for review, as outlined in the FDA concept paper entitled ``PDUFA Pilot Project Proprietary Name Review.'' This document describes procedures to register and submit data for applicants who wish to have their proposed proprietary names evaluated under the pilot program.

Regulation of Tobacco Products; Extension of Comment Period

Thu, Oct 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is extending to December 28, 2009, the comment period for the notice that appeared in the Federal Register of July 1, 2009 (74 FR 31457). In the notice, FDA requested comments on the implementation of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Act). The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Postmarketing Safety Reporting for Combination Products

Thu, Oct 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) proposes to amend the combination product regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, the rule will clarify the postmarketing safety reporting requirements that apply when regulated articles (drugs, devices, and biological products) are combined to create a combination product. The proposed rule is intended to promote and protect the public health by clarifying requirements for postmarketing safety reporting for combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products.

Determination of Regulatory Review Period for Purposes of Patent Extension; CLEVIPREX

Thu, Oct 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for CLEVIPREX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Sep 30 2009 11:00:00 GMT

Enforcement of General Tobacco Standard Special Rule for Cigarettes

Fri, Sep 25 2009 11:00:00 GMT

The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), establishes a tobacco standard special rule for cigarettes. This special rule for cigarettes prohibits a cigarette or any of its component parts (including the tobacco, filter, or paper) from containing, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. The Food and Drug Administration (FDA) is providing this notice to remind regulated industry that as of the effective date identified in the FSPTCA, cigarettes that contain certain characterizing flavors are considered adulterated under the act. FDA is also providing in this notice contact information to which individuals

Current Good Manufacturing Practice Requirements for Combination Products

Wed, Sep 23 2009 11:00:00 GMT

The Food and Drug Administration (FDA or agency) proposes to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for ``singleentity'' and ``copackaged'' combination products.

Draft Guidance for Industry on Microbiological Data for Systemic Antibacterial Drug Products--Development, Analysis, and

Thu, Sep 17 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled
``Microbiological Data for Systemic Antibacterial Drug Products Development, Analysis, and Presentation.'' The draft guidance informs industry of FDA's current thinking regarding the types of
microbiological studies, assessments, and clinical trials needed to support an investigational new drug application (IND) and a new drug application (NDA) for a systemic antibacterial drug product. Recommendations in this guidance cover microbiological considerations in the three major areas of conducting general nonclinical studies; conducting animal and human studies and clinical trials; and establishing and updating in vitro susceptibility test methods, quality control (QC) parameters, and interpretive criteria. This guidance also recommends the content and format for presentation of microbiological data for antibacterial drug products in the Microbiology subsection of labeling.

National Fisheries Institute; Filing of Food Additive Petition; Amendment

Wed, Sep 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the [[Page 47593]]
filing notice for a food additive petition filed by the National Fisheries Institute, to provide for the safe use of ionizing radiation for control of foodborne pathogens in crustaceans and processed crustaceans.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Sep 15 2009 11:00:00 GMT

Agency Emergency Processing Under the Office of Management and Budget Review; Tobacco Product Establishment

Tue, Sep 15 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 1, 2009 (74 FR 45219). The document announced the proposed collection of information concerning the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and health related documents, as required by the Family Smoking Prevention and Tobacco Control Act. The document was published with an incorrect date for submitting written or electronic comments on the proposed collection. This document corrects that error.

Memorandum of Understanding With Duke University

Mon, Sep 14 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and Duke University. The purpose of this MOU is to establish a framework for collaboration between the Parties and for pursuing specific collaborative projects. This collaboration between the Parties shall be known as the Cardiac Safety Research Consortium.

Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations

Wed, Sep 9 2009 11:00:00 GMT

Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and

Wed, Sep 9 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting nominations for voting and nonvoting consumer representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain devices panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health (CDRH).

FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Sep 4 2009 11:00:00 GMT

Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments;

Fri, Sep 4 2009 11:00:00 GMT

Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon, by holders of approved drug and biological products. This is the agency's report on the status of the studies and clinical trials that applicants have agreed to or are required to conduct.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Sep 1 2009 11:00:00 GMT

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Importer's Entry

Tue, Sep 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Importer's Entry Notice'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Emergency Processing Under Office of Management and Budget Review; Tobacco Product Establishment Registration

Tue, Sep 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the submission of tobacco product establishment registration and submission of certain health information, including ingredient listing and health related documents, as required by The Family Smoking Prevention and Tobacco Control Act (FSPTCA).

Egg Safety; Final Rule for Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and

Mon, Aug 31 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing two public meetings to discuss the final rule concerning the prevention of Salmonella Enteritidis (SE) in shell eggs during production, storage, and transportation. The purpose of the public meetings is to explain the requirements of the rule and how to comply with it, and to provide the public an opportunity to ask questions.
Dates, Times, and Locations: See ``How to Participate in the Meetings'' in the SUPPLEMENTARY INFORMATION section of this document for dates and times of the meetings, closing dates for advance registration, requesting special accommodations due to disability, and other information regarding meeting participation.
Contact Person: For general questions about the meetings or for special accommodations due to a disability, contact Juanita Yates, Center for Food Safety and Applied Nutrition (HFS009), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301 4361731, email:

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for

Mon, Aug 31 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Memorandum of Understanding Between the Food and Drug Administration, National Center for Toxicological Research, and

Thu, Aug 27 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Air Force Research Laboratory. This Memorandum of Understanding (MOU) between the Food and Drug Administration, National Center for Toxicological Research (NCTR), and the Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate, Biosciences and Protection Division, Applied Biotechnology Branch (711 HPW/RHPB) (hereinafter referred to as ``the Parties''), sets forth the agreement of the Parties to facilitate information sharing in the area of toxicogenomic and computational toxicology research. Through the exchange of information, the Parties intend to coordinate research efforts so as to identify and expedite research and development of new tools and technologies that can be implemented that promote new understanding of the mechanisms of biological responses to environmental stressors, including toxic injury, and to identify biomarkers of exposu

Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a

Wed, Aug 26 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Tobacco Products Scientific Advisory Committee notify FDA in writing. A nominee may either be selfnominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents announcing the establishment of the committee and the request for nomination of the Tobacco Products Scientific Advisory Committee.

Defining ``Small Number of Animals'' for Minor Use Designation

Wed, Aug 26 2009 11:00:00 GMT

The designation provision of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to animal drug sponsors to encourage drug development and approval for minor species and for minor uses in major animal species. Congress provided a statutory definition of ``minor use'' that relied on the phrase ``small number of animals'' to characterize such use. At this time, the Food and Drug Administration (FDA) is amending the implementing regulations of the MUMS Act. In response to Congress' charge to the agency to further define minor use, this amendment establishes a specific ``small number of animals'' for each of the seven major animal species to be used in determining whether any particular intended use in a major species is a minor use.

Advisory Committee; Tobacco Products Scientific Advisory Committee; Establishment

Wed, Aug 26 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the Establishment of the Tobacco Products Scientific Advisory Committee. These actions are needed to implement the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act. Elsewhere in this issue of the Federal Register, FDA is publishing two separate documents requesting nominations for voting and nonvoting membership on this committee. This document also amends the agency's regulations to add the Tobacco Products Scientific Advisory Committee (the committee) to the agency's list of standing advisory committees.

Acrylamide in Food; Request for Comments and for Scientific Data and Information

Wed, Aug 26 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting comments and scientific data and information on acrylamide in food. Acrylamide is a chemical that can form in some foods during certain types of high temperature cooking. FDA is seeking information on practices that manufacturers have used to reduce acrylamide in food and the reductions they have been able to achieve in acrylamide levels. FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products.

Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Recruitment

Tue, Aug 25 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Mental Models Study of Recruitment and Retention of Pregnant Women into an Asthma Pregnancy Registry. Pregnancy registries are a common source of safety information about medications used during pregnancy. Together with other information being collected, FDA will use the results from this study to better understand how pregnant women and their health care providers make decisions about participation in pregnancy exposure registries. FDA will use this new knowledge to develop and recommend effective ways to support the involvement

Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of

Tue, Aug 25 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Public Health Notification

Mon, Aug 24 2009 11:00:00 GMT

Agency Information Collection Activities: Proposed Collection; Comment Request; Internet Survey on Barriers to Food

Mon, Aug 24 2009 11:00:00 GMT

Revision of the Requirements for Publication of License Revocation; Confirmation of Effective Date

Fri, Aug 21 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is confirming the effective date of September 17, 2009, for the direct final rule that appeared in the Federal Register of May 5, 2009 (74 FR 20583). The direct final rule amends the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license. The rule provides that FDA will publish a notice in the Federal Register following revocation of a biologics license under FDA regulations and will include a statement of the specific grounds for the revocation. This document confirms the effective date of the direct final rule.

Clinical Investigator Training Course

Fri, Aug 21 2009 11:00:00 GMT

The Food and Drug Administration's (FDA's) Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI) are cosponsoring a 3day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This training course is intended to provide investigators with expertise in the design, conduct, and analysis of clinical trials; improve the quality of clinical trials; and enhance the safety of trial participants. Senior FDA staff will communicate directly with clinical investigators on issues of greatest importance for successful clinical research.

Prescription Drug User Fee Act IV Information Technology Assessment

Fri, Aug 21 2009 11:00:00 GMT

In the last decade, the Food and Drug Adminstration (FDA) has achieved great success in reforming and modernizing its regulatory processes and responsibilities as a result of changes and improvements driven by the requirements of the Prescription Drug User Fee Act (PDUFA), the 1997 FDA Modernization Act (FDAMA), and other legislation. PDUFA was reauthorized by the Food and Drug Administration Amendments Act of 2007, Title I, Prescription Drug User Fee Amendments of 2007 (PDUFA IV). FDA plans to make even greater progress during the PDUFA IV timeframe (Fiscal Years 2008 through 2012), building on the foundation established in previous years. The additional resources provided by user fees, when combined with appropriations, have enabled the FDA to modernize its information technology infrastructure and begin a monumental transformation from a paperbased to an electronic work environment.

As part of the PDUFA IV commitment, FDA published the PDUFA IV Information Technology (IT) Plan for commen

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational New

Thu, Aug 20 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Investigational New Drug Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; MedWatch: Food and

Thu, Aug 20 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``MedWatch: Food and Drug Administration Medical Products Reporting Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Aug 18 2009 11:00:00 GMT

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recommendations for

Tue, Aug 18 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recommendations for Early Food Safety Evaluation of New NonPesticidal Proteins Produced by New Plant Varieties Intended for Food Use'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Irradiation in the

Tue, Aug 18 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Irradiation in the Production, Processing, and Handling of Food'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Mental Models Study

Tue, Aug 18 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Financial Disclosure

Tue, Aug 18 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Financial Disclosure by Clinical Investigators'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2010; Correction

Tue, Aug 18 2009 11:00:00 GMT

The Food and Drug Administration is correcting a notice entitled that appeared in the Federal Register of August 3, 2009 (74 FR 38429). The document announced the Fiscal Year 2010 fee rates for the Animal Drug User Fee Act. The document was published with a typographical error. This document corrects that error.

Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority

Tue, Aug 18 2009 11:00:00 GMT

The Food and Drug Administration (FDA) has reorganized the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the realignment of four Deputy level offices within the Office of the Commissioner: the Office of the Chief Scientist; the Office of Administration (formerly titled the Office of Operations); the Office of Foods; and the Office of Policy, Planning and Budget (formerly titled the Office of Policy, Planning and Preparedness).

International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial

Fri, Aug 14 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 10: Polyacrylamide Gel Electrophoresis General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Polyacrylamide Gel Electrophoresis General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding re

Review of Post-Inspection Responses

Tue, Aug 11 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a program to support public health protection by facilitating the timely issuance of warning letters. The program establishes a timeframe for the submission and agency review of postinspection responses to inspectional
[[Page 40212]]
observations that are communicated to a firm through issuance of a form FDA 483, list of inspectional observations.

Use of Ozone-Depleting Substances; Epinephrine

Tue, Aug 11 2009 11:00:00 GMT

CFR Correction

In Title 21 of the Code of Federal Regulations, parts 1 to 99, revised as of Apr. 1, 2009, on page 66, Sec. 2.125(e)(2)(v) is reinstated as follows:
Sec. 2.125 Use of ozonedepleting substances in foods, drugs, devices, or cosmetics.
* * * * *
(e) * * *
(2) * * *
(v) Epinephrine.
* * * * *
[FR Doc. E919297 Filed 81009; 8:45 am]
BILLING CODE 150501D

Guidance for Industry on Pharmaceutical Components at Risk for Melamine Contamination; Availability

Fri, Aug 7 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Pharmaceutical Components at Risk for Melamine Contamination.'' This guidance provides recommendations that will help pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug compounding avoid the use of components that are at risk for melamine contamination. As of the date of this announcement, FDA is not aware of any pharmaceutical components that are contaminated with melamine.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adverse Event

Tue, Aug 4 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability

Tue, Aug 4 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the
Authorizations), one of which was amended, for certain in vitro diagnostic devices. FDA is issuing the Authorizations under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostics. The Authorizations follow the determination by the Acting Secretary of the Department of Health and Human Services, Charles E. Johnson (the Acting Secretary), that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain in vitro diagnostics, accompanie

Authorization of Emergency Use of Certain Personal Respiratory Protection Devices; Availability

Tue, Aug 4 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization), as amended, for certain personal respiratory protection devices.\1\ FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized personal respiratory protection devices. The Authorization follows the determination by the Acting Secretary of the Department of Health and Human Services, Charles E. Johnson (the Acting Secretary), that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain disposable Nation

Cooperative Agreement Between the Food and Drug Administration and the Dauphin Island Sea Lab

Tue, Aug 4 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 (FY09) to the Dauphin Island Sea Lab (DISL). The goal of the DISL is marine science education, basic and applied marine science research, coastal zone management policy and educating the general public.

Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2010

Mon, Aug 3 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2010 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Drug User Fee Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees for certain animal drug applications and supplements, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2010.

Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2010

Mon, Aug 3 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2010 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2010.

For FY 2010, the generic animal drug user fee rates are: $75,000 for each abbreviated application for a generic new animal drug; $3,255 for each generic new animal drug product; $54,050 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $40,537 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $27,025 for a generic new anim

Medical Device User Fee Rates for Fiscal Year 2010

Mon, Aug 3 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the [[Page 38445]]
fee rates and payment procedures for medical device user fees for fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), and the Medical Device User Fee Amendments of 2007 (title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device submissions, and annual fees both for certain periodic reports and for certain establishments subject to registration. The FY 2010 fee rates are provided in this document. These fees apply from October 1, 2009, through September 30, 2010. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your app

Prescription Drug User Fee Rates for Fiscal Year 2010

Mon, Aug 3 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Prescription Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA IV, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that onethird of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This notice establishes fee rates for FY 2010 for application fees for an application requiring clinical data ($1,405,500), for an application not requiring clin

Seafood Hazard Analysis and Critical Control Points Alliance for Education and Training (U18)

Mon, Aug 3 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 (FY09) to the University of Florida for the support of the Seafood Hazard Analysis and Critical Control Points (HACCP) Alliance for Education and Training. The goal of the Seafood HACCP Alliance for Education and Training is to provide partial support, periodic clerical assistance, and personnel travel to national and international events and committee meetings.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Jul 31 2009 11:00:00 GMT

International Conference on Harmonisation; Draft Guidance on E16 Genomic Biomarkers Related to Drug Response:

Thu, Jul 30 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers. The draft guidance is intended to foster consistency of applications across regions and facilitate joint discussions with and among regulatory authorities.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Jul 29 2009 11:00:00 GMT

Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting

Tue, Jul 28 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. We are taking this action as part of our implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General

Fri, Jul 24 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

New Animal Drugs; Change of Sponsor

Wed, Jul 22 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Notice of

Wed, Jul 22 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Notice of Participation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for

Wed, Jul 22 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export of Food

Wed, Jul 22 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Export of Food and Drug Administration Regulated Products: Export Certificates'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Contact

Wed, Jul 22 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Contact Substances Notification System'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Jul 22 2009 11:00:00 GMT

Advisory Committee; Risk Communication Advisory Committee; Termination and Recharter

Tue, Jul 21 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the termination and the recharter of the Risk Communication Advisory Committee (the committee). These actions are needed to implement the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Amendments Act of 2007, to change the committee from a discretionary to a statutory committee. This document also amends the agency's regulations which list advisory committees to reflect that the Risk Communication Advisory Committee has been rechartered and to revise the function statement.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Record Retention

Mon, Jul 20 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Record Retention Requirements for the Soy Protein and Coronary Heart Disease Health Claim'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Regulations

Wed, Jul 15 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions in FDA's food labeling regulations and on Form FDA 3570, ``Model Small Business Nutrition Labeling Exemption Notice,'' which small businesses may use to claim the small business exemption from nutrition labeling.

Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in

Fri, Jul 10 2009 11:00:00 GMT

Guidance for Industry on Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug

Thu, Jul 2 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. This guidance describes how FDA will comply with the FDAAA requirement and procedures for application holders to update the labeling of antibacterial drug products and antimicrobial susceptibility testing (AST) devices.

Regulation of Tobacco Products; Request for Comments

Wed, Jul 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is establishing a public docket to obtain information on the implementation of the Family Smoking Prevention and Tobacco Control Act. FDA is establishing this docket in order to provide an opportunity for all interested parties to provide information and share views on the implementation of the new law.

Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human

Tue, Jun 30 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 29, 2009. The document requires important new organspecific warnings and related labeling for overthecounter (OTC) internal analgesic, antipyretic, and antirheumatic drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal antiinflammatory drugs (NSAIDs). The document was published with an incorrect Analysis of Impacts section and omitted a reference from the reference section of the final rule. The document was also published with an error in the codified text regarding the introductory sentence to the stomach bleeding warning for NSAIDs. This document replaces the incorrect Analysis of Impacts section with the correct Analysis of Impacts section, adds a reference to the reference section of the final rule, and corrects the codified text.

Draft Guidance for Industry on Measures to Address the Risk for Contamination by Salmonella Species in Food

Mon, Jun 29 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a PistachioDerived Product as an Ingredient'' (draft guidance). The draft guidance, when finalized, is intended to clarify for manufacturers who produce foods containing a pistachioderived product as an ingredient that there is a risk that Salmonella species may be present in the incoming pistachioderived product, and to recommend measures to address that risk.

Beverages: Bottled Water; Correction

Thu, Jun 25 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Friday, May 29, 2009 (74 FR 25651). The final rule was published with an inadvertent error in the ``Analysis of Impacts'' section. This document corrects that error.

Convener of Active Medical Product Surveillance Discussion (U13)

Wed, Jun 24 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a neutral, independent institution and/or organization that proposes appropriate methods and processes for convening a broad range of stakeholders with relevant expertise to manage and support conferences and meetings. The focus of the conferences and meetings is to explore and address methodological, data development, technical, and communication issues related to active medical product surveillance. The awardee would be expected to synthesize, summarize, and communicate findings from these conferences and meetings to a broad range of organizations and individuals who have the capability to use the information to further develop and create active medical product surveillance methods and systems.

Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Presentation of

Mon, Jun 22 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Directto Consumer (DTC) Television and Print Advertisements for Prescription Drugs. This study is designed to communicate quantitative information about product benefits in DTC print and television ads.

Clinical Trials Transformation Initiative (U19)

Fri, Jun 19 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of grant funds to support the Clinical Trials Transformation Initiative (CTTI). The goal of CTTI is to support modernization of the clinical trial enterprise by identifying practices that will enhance human subject protection, boost the quality of information derived from clinical trials, and make the research process more efficient.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Jun 17 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Thu, Jun 11 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397

Mon, Jun 8 2009 11:00:00 GMT

Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations;

Mon, Jun 8 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft productspecific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' explaining the process that would be used to make product specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of final product specific BE recommendations.

Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability

Mon, Jun 8 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of final productspecific bioequivalence (BE)
recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' explaining the process that would be used to make productspecific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of additional draft and revised draft productspecific BE recommendations.

Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining a List

Thu, Jun 4 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealers

Tue, Jun 2 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification

Tue, Jun 2 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the regulation requiring manufacturers, packers, and distributors of dietary supplements to notify FDA that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the act).

Cooperative Agreement to Support the Illinois Institute of Technology's National Center for Food Safety and

Tue, Jun 2 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 (FY09) to the Illinois Institute of Technology (IIT) to support the National Center for Food Safety and Technology (NCFST). The estimated amount of support in FY09 will be for up to $7 million (direct plus indirect costs), with the possibility of 4 additional years of support for up to $28 million, subject to the availability of funds. This award will improve public health by continued support of an applied research, education, and outreach program related to the safety of food processing technologies and processed foods.

Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Nutrition

Mon, Jun 1 2009 11:00:00 GMT

Beverages: Bottled Water

Fri, May 29 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its bottled water regulations to require that bottled water manufacturers test source water for total coliform, as is required for finished bottled water products, and to require, if any coliform organisms are detected in source water, that bottled water manufacturers determine whether any of the coliform organisms are Escherichia coli (E. coli), an indicator of fecal contamination. FDA also is amending its bottled water regulations to require, if any coliform organisms are detected in finished bottled water products, that bottled water manufacturers determine whether any of the coliform organisms are E. coli. FDA also is amending the adulteration provision of the bottled water standard to reflect the possibility of adulteration caused by the presence of filth. Bottled water containing E. coli will be considered adulterated, and source water containing E. coli will not be considered to be of a safe, sanitary quality and will be prohibited from

Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for

Fri, May 29 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information provisions of the final rule, ``Beverages: Bottled Water,'' published elsewhere in this issue of the Federal Register, which requires both domestic and foreign bottled water manufacturers that sell bottled water in the United States to maintain records of Escherichia coli testing and corrective measures, in addition to existing recordkeeping requirements.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Thu, May 28 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Thu, May 21 2009 11:00:00 GMT

Temporary Deferment of Activities Relating to Medical Device Submissions

Thu, May 21 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that the Center for Devices and Radiological Health (CDRH) will be moving from various Rockville, Maryland locations to Building 66 at 10903 New Hampshire Avenue in Silver Spring, Maryland from approximately mid May 2009 until the beginning of August 2009. Offices will progressively move over weekends during this period. Specifically, moves will occur on Friday, Saturday, and Sunday except on holiday weekends. During the period required for relocation of files, equipment, and agency personnel, the Center for Devices and Radiological Health will not officially receive premarket submissions on the Friday of a move weekend and the Monday after a move weekend.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, May 20 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, May 19 2009 11:00:00 GMT

Request for Nominations for Voting Consumer Representative Members on Public Advisory Committees

Fri, May 15 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting nominations for voting consumer representatives to serve on the Food Advisory Committee. This advisory committee is under the purview of the Center for Food Safety and Applied Nutrition (CFSAN).

FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on its advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

Compliance Guidance for Small Business Entities on Labeling Over- the-Counter Human Drug Products; Availability

Wed, May 13 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a compliance guidance for small business entities entitled ``Labeling OTC Human Drug Products; Small Entity Compliance Guide.'' FDA has prepared this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand and comply with the agency's over thecounter (OTC) labeling requirements and to prepare new labeling. This compliance guidance finalizes the draft compliance guidance published on December 9, 2004.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Mon, May 11 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, May 8 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, May 8 2009 11:00:00 GMT

Availability of Information Related to the Sentinel Initiative

Thu, May 7 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the opening of a docket to receive and to make available to the public reports and other relevant information received by FDA related to the Sentinel Initiative. The goal of the Sentinel Initiative is to develop a system that will ultimately enable FDA to actively monitor the safety of marketed regulated products. The information that will be made available is being developed primarily, but not exclusively, as a result of a series of contracts awarded by FDA to inform the development of the system. The information will be made available in the docket under the docket number at the top of this notice, as well as on FDA's Sentinel Initiative Web page (Sentinel Web page) at http:// www.fda.gov/oc/initiatives/advance/sentinel/. FDA welcomes interested parties, including individuals, to submit to this

New Animal Drugs; Change of Sponsor's Name

Tue, May 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from IVX Animal Health, Inc., to Teva Animal Health, Inc.

Revision of the Requirements for Publication of License Revocation

Tue, May 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is clarifying the regulatory procedures for notifying the public about the revocation of a biologics license to be consistent with current practices. FDA is amending the regulations in accordance with the agency's direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment rulemaking to provide a procedural framework to finalize the rule in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

Revision of the Requirements for Publication of License Revocation; Companion Document to Direct Final Rule

Tue, May 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license to be consistent with current practices. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

Pediatric Device Consortia Grant Program

Mon, May 4 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia Grant Program (PDCGP). The goal of the PDCGP is to promote pediatric device development by providing grants to nonprofit consortia whose business model and approach to device development will either result in, or substantially contribute to, market approval of medical devices designed specifically for use in children. Although administered by the OOPD, this grant program is intended to encompass devices that could be used in all pediatric conditions or diseases, not just rare diseases. The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment.

Draft Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

Fri, May 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Label Comprehension Studies for Nonprescription Drug Products.'' The draft guidance provides recommendations on the design of label comprehension studies, which can be used to assess the extent to which consumers understand the information conveyed by proposed nonprescription drug product labeling and then apply that information when making hypothetical drug product use decisions.

Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human

Wed, Apr 29 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing this final rule to require important new organspecific warnings and related labeling for overthecounter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal antiinflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA).

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Apr 28 2009 11:00:00 GMT

Intramammary Dosage Forms; Change of Sponsor

Mon, Apr 27 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application (NADA) from Merial Ltd. to Cross Vetpharm Group Ltd.

Draft Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen, Jet, and

Mon, Apr 27 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.'' The draft guidance document provides technical and scientific information for sponsors to consider in developing information to support a marketing application for a pen, jet, or related injector device intended for use with drugs or biological products. The marketing application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA) application for the injector alone. For a combination product that includes the injector, the marketing application would typically be a new drug application (NDA) or a biological licensing application (BLA).

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal

Mon, Apr 27 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (185) entitled ``Target Animal Safety for Veterinary Pharmaceutical Products,'' VICH GL43. The purpose of this harmonized guidance is to provide recommendations regarding target animal safety (TAS) evaluation for regulatory submission of an Investigational Veterinary Pharmaceutical Product (IVPP), which is appropriate for determining the safety of an IVPP in the target animal. The guidance includes recommendations on including identification of target organs, where possible, and confirmation of margin of safety, using the minimum number of animals appropriate for the studies.

Computational Modeling for Cardiovascular Devices; Public Workshop

Mon, Apr 27 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Computational Modeling for Cardiovascular Devices.'' FDA is cosponsoring the conference with the National Heart, Blood and Lung Institute of the National Institutes of Health and the National Science Foundation. The purpose of the public workshop is to facilitate discussion among FDA and other interested parties on the use of computational modeling in the design, development, and evaluation of cardiovascular medical devices.

Date and Time: The public workshop will be held on June 1 and 2, 2009, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Hilton Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852.

Contact Person: Donna R. Lochner, Center for Devices and Radiological Health (HFZ450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 2402764043, email:
donna.lochner@fda.h

Small Entity Compliance Guide on Prior Notice of Imported Food; Availability

Fri, Apr 24 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide (SECG) for the final rule on prior notice of imported food. The final rule issued under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and it was published in the Federal Register of November 7, 2008. The SECG is entitled ``What You Need to Know About Prior Notice of Imported Food ShipmentsA Small Entity Compliance Guide,'' and it is intended to help all entities, especially small businesses, better understand the prior notice regulation.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Apr 22 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance, Emergency Use

Mon, Apr 20 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Apr 17 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing [[Page 17869]]
that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good

Fri, Apr 17 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and `Lookback''' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for

Fri, Apr 17 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Substances Prohibited From Use in Animal Food or Feed; Final Rule: Proposed Delay of Effective Date

Thu, Apr 9 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is seeking public comment on a contemplated delay of 60 days in the effective date of the rule entitled ``Substances Prohibited From Use in Animal Food or Feed,'' published in the Federal Register on
[[Page 16161]]
April 25, 2008 (73 FR 22720). That rule established measures to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE). FDA has become aware that some affected persons, particularly those in the rendering industry, are experiencing difficulties modifying their operations to comply with the new requirements contained in the April 25, 2008 final rule and, therefore, may not be in full compliance by the April 27, 2009, effective date. Accordingly, the FDA is proposing this action to delay the effective date of the April 25, 2008, final rule for 60 days until June 26, 2009. FDA is providing 7 days for public comment solely on the question of whether to delay the effective date.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary

Wed, Apr 8 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary Cosmetic Registration Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Enforcement

Wed, Apr 8 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Enforcement Notifications'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for

Wed, Apr 8 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4B: Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the
int

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for

Wed, Apr 8 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4C: Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory region

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for

Wed, Apr 8 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 4A: Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the
interchangeabilit

International Conference on Harmonisation; Guidance on Q10 Pharmaceutical Quality System; Availability

Wed, Apr 8 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q10 Pharmaceutical Quality System.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on ``Q8 Pharmaceutical Development'' and ``Q9 Quality Risk Management.''

Propylthiouracyl (PTU)-Related Liver Toxicity; Public Workshop

Wed, Apr 8 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a 1-day public workshop, cosponsored with the American Thyroid Association (ATA), entitled ``Propylthiouracyl (PTU)Related Liver Toxicity.'' This public workshop is intended to provide a public forum for discussion of the clinical, scientific, and regulatory issues pertaining to PTU induced hepatitis to seek constructive input from academia, regulatory scientists, and other interested parties on the topic of PTUinduced hepatitis. The input from this public workshop will help the ATA to develop guidelines for the management of hyperthyroidism and help inform FDA about necessary changes to prescription drug labeling for PTU.

Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Tue, Apr 7 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on April 23, 2009, from 8:30 a.m. to 5:30 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD.

Contact Person: James Swink, Center for Devices and Radiological Health (HFZ450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 2402764050, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512625. Please call the Information Line for uptodate information on this meeting. A notice in the Federal Register about last minute modifications that

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

Tue, Apr 7 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Gastrointestinal Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on May 19, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301589 5200.

Contact Person: Kristine T. Khuc, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5630 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001; FAX: 3018276776, email: Kristine.Khuc@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512538. Please

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

Tue, Apr 7 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Gastrointestinal Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on May 20, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301589 5200.

Contact Person: Kristine T. Khuc, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5630 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email: Kristine.Khuc@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512538. Please

Sodium Shale Oil Sulfonate Eligibility for Inclusion in Monograph; Over-the-Counter Dandruff, Seborrheic Dermatitis,

Tue, Apr 7 2009 11:00:00 GMT

As part of our ongoing review of over-the-counter (OTC) drug products, we (Food and Drug Administration (FDA)) are announcing a callfordata for safety and effectiveness information for sodium shale oil sulfonate (SSOS), 0.5 to 2.0 percent, as a rinseoff treatment for dandruff. We have reviewed a time and extent application (TEA) for SSOS and determined that it is eligible for consideration in our OTC drug monograph system. We will evaluate the submitted data and information to determine whether SSOS can be generally recognized as safe and effective (GRASE) as an OTC rinseoff treatment for dandruff.

Generic New Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009

Tue, Apr 7 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2009 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for certain abbreviated applications for a generic new animal drug, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2009.

For FY 2009, the generic new animal drug user fee rates are: $41,400 for each abbreviated application for a generic new animal drug; $3,005 for each generic new animal drug product; $56,350 for each generic new animal drug sponsor paying 100 percent of the sponsor fee; $42,265 for each generic new animal drug sponsor paying 75 percent of the sponsor fee; and $28,175 for a generic new

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Mon, Apr 6 2009 11:00:00 GMT

Economically Motivated Adulteration; Public Meeting; Request for Comment

Mon, Apr 6 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public meeting pertaining to economically motivated adulteration (EMA). The purpose of the meeting is to stimulate and focus a discussion about ways in which the food (including dietary supplements and animal food), drug, medical device, and cosmetic industries, regulatory agencies, and other parties can better predict and prevent economically motivated adulteration with a focus on situations that pose the greatest public health risk. FDA invites interested individuals, organizations, and other stakeholders, including industry representatives, to present information pertaining to predicting and preventing EMA of food (including dietary supplements and animal food), drugs, medical devices, and cosmetics. The agency also requests interested parties to submit comments on this issue to the public docket.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Apr 3 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Apr 3 2009 11:00:00 GMT

Draft Guidance for Industry: Somatic Cell Therapy for Cardiac Disease; Availability

Thu, Apr 2 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Somatic Cell Therapy for Cardiac Disease'' dated March 2009. The draft guidance document provides sponsors of cellular therapies for the treatment of cardiac disease with recommendations on the design of preclinical and clinical studies, and information that should be submitted about the product delivery system. This guidance also provides recommendations on the chemistry, manufacturing and controls information to include in an investigational new drug application (IND) for cardiac cellular therapy.

Revision of Organization and Conforming Changes to Regulations

Wed, Apr 1 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organizational changes in the agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.

Medical Devices; Technical Amendment

Tue, Mar 31 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending a medical device regulation to correct a statutory reference to reflect the current citation and to ensure accuracy and clarity in the agency's regulations.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Mon, Mar 30 2009 11:00:00 GMT

Change of Addresses and Names; Technical Amendment

Thu, Mar 26 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its regulations to reflect a change of address for the Center for Drug Evaluation and Research's (CDER's) Central Document Room in Beltsville, MD; the relocation of certain CDER offices to the White Oak campus in Silver Spring, MD; and changes of the names of certain CDER organizational units. This action is editorial in nature and is intended to ensure the accuracy and clarity of the agency's regulations.

New Animal Drugs for Use in Animal Feeds

Thu, Mar 26 2009 11:00:00 GMT

CFR Correction

In title 21 of the Code of Federal Regulations, part 558, revised as of April 1, 2008, on page 410, in Sec. 558.58 (e)(1)(iii), the entry for Bambermycins 1 to 3, in the column under ``Limitations'' remove ``057926'' and in its place add ``016592''; in the column under ``Sponsors'', add ``016592''.
[FR Doc. E96810 Filed 32509; 8:45 am]
BILLING CODE 150501D

Agency Emergency Processing Under Office of Management and Budget Review; Guidance for Industry: Animal Generic Drug

Thu, Mar 26 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the burden hours required to implement the new statutory requirements for the user fees and fee waivers reductions provisions of the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Federal Food, Drug, and Cosmetic Act (the act)).

Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Source Plasma Establishments

Thu, Mar 26 2009 11:00:00 GMT

The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation to participate in a pilot evaluation program for CBER's eSubmitter Program (eSubmitter). CBER's eSubmitter has been customized as an automated biologics license application (BLA) and BLA supplement (BLS) submission system for blood and blood components. Participation in the pilot program is open to blood establishments that collect Source Plasma. The pilot program is intended to provide industry and CBER regulatory review staff the opportunity to evaluate the eSubmitter system and determine if it facilitates the BLA/BLS submission process. The purpose of this notice is to invite blood establishments that collect Source Plasma to submit a request to CBER if they are interested in participating in this pilot program.
[[Page 13211]]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Mar 24 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of

Tue, Mar 24 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an [[Page 12366]]
opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA) (Public Law 100 293).

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Mar 20 2009 11:00:00 GMT

Implantation or Injectable Dosage Form New Animal Drugs; Tylosin

Thu, Mar 19 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for tylosin injectable solution.

[Docket Nos. FDA-2008-M-0535, FDA-2008-M-0547, FDA-2008-M-0536, FDA- 2008-M-0563, FDA-2008-M-0593, FDA-2008-M-0601,

Thu, Mar 19 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

Blood Products Advisory Committee; Notice of Meeting

Tue, Mar 17 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.

Name of Committee: Blood Products Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on April 1, 2009, from 8 a.m. to 6 p.m. and on April 2, 2009, from 8 a.m. to 4:45 p.m.

Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877, 3019778900.

Contact Person: William Freas or Pearline K. Muckelvene, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike (HFM71), Rockville, MD 20852, 3018270314, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014519516. Please call the Information Line for uptodate information on this meeting

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Mon, Mar 16 2009 11:00:00 GMT

Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability

Mon, Mar 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 197 entitled ``Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files.'' The purpose of this draft guidance is to simplify the preparation and evaluation of submissions in support of new animal drug applications by providing a uniform system for documenting statistical analysis programs and data files.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Mon, Mar 16 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Mar 13 2009 11:00:00 GMT

Determination of Regulatory Review Period for Purposes of Patent Extension; PROFENDER

Thu, Mar 12 2009 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for PROFENDER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.

Anti-Infective Drugs Advisory Committee; Notice of Meeting

Thu, Mar 12 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: AntiInfective Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on June 3, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd, Silver Spring, MD. The hotel telephone number is 301 5895200.

Contact Person: Janie Kim, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301827 7001, FAX: 3018276776, email: janie.kim@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington DC area), code 3014512530. Please call the Inform

Anti-Infective Drugs Advisory Committee; Notice of Meeting

Thu, Mar 12 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: AntiInfective Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on June 2, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel telephone number is 301 5895200.

Contact Person: Janie Kim, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301827 7001, FAX: 3018276776, email: Janie.kim@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington DC area), code 3014512530. Please call the Infor

Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Thu, Mar 12 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on March 27, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD.

Contact Person: James Swink, Center for Devices and Radiological Health (HFZ450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 2402764050, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512396. Please call the Information Line for uptodate information on this meeting. A notice in the Federal Register about last minute modifications that impact a previ

Agency Information Collection Activities; Proposed Collection; Comment Request; Implementation of the Animal Generic

Wed, Mar 11 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Mar 10 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Mar 10 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Mon, Mar 9 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of Potential Data Sources

Mon, Mar 9 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed information collection through a survey designed to identify potential data sources and/or data environments that could participate in the Sentinel Initiative to create a national, electronic distributed system, strengthening FDA's ability to monitor the postmarket performance of a medical product.

Astringent Drug Products That Produce Aluminum Acetate; Skin Protectant Drug Products for Over-the-Counter Human Use;

Fri, Mar 6 2009 11:00:00 GMT

We (Food and Drug Administration (FDA)) are amending the final monograph (FM) for overthecounter (OTC) skin protectant astringent drug products. This amendment clarifies that aluminum acetate solutions, produced by dissolving aluminum sulfate tetradecahydrate and calcium acetate monohydrate in powder or tablet form in water, are generally recognized as safe and effective (GRASE) and not misbranded as astringent drug products. The amendment also describes how manufacturers should relabel these products to comply with the FM. We are issuing this amendment in response to a citizen petition (CP) that we received from a manufacturer of OTC astringent drug products. This final rule is part of our ongoing review of OTC drug products.

New Drug Applications and Abbreviated New Drug Applications; Technical Amendment

Fri, Mar 6 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA) regulations to update agency contacts for patent information and patent notifications and to correct an inaccurate crossreference. This action is being taken to ensure accuracy and clarity in the agency's regulations.

Agency Information Collection Activities; Proposed Collection; Comment Request; Request for Samples and Protocols

Fri, Mar 6 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Gluten-Free Labeling of Food Products

Fri, Mar 6 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Thu, Mar 5 2009 11:00:00 GMT

Determination of Regulatory Review Period for Purposes of Patent Extension; SOLIRIS

Wed, Mar 4 2009 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for SOLIRIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

Wed, Mar 4 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

[[Page 9407]]

Name of Committee: Psychopharmacologic Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on April 7 and 8, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd, Silver Spring, MD. The hotel phone number is 301589 5200.

Contact Person: Yvette Waples, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, fax: 3018276776, email: yvette.waples@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), cod

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Mar 3 2009 11:00:00 GMT

Draft Guidance for Industry on the Clinical Pharmacology Section of Labeling for Human Prescription Drug and

Tue, Mar 3 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This draft guidance is one of a series of guidance documents intended to assist applicants in complying with new FDA regulations on the content and format of labeling for human prescription drug and biological products. The draft guidance describes the recommended information to include in the Clinical pharmacology section of labeling that pertains to the safe and effective use of human prescription drug and biological products.

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and

Mon, Mar 2 2009 11:00:00 GMT

Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin

Mon, Mar 2 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a 1percent ivermectin solution by subcutaneous injection.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Thu, Feb 26 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Importer's Entry Notice

Wed, Feb 25 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting:

Wed, Feb 25 2009 11:00:00 GMT

Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act;

Tue, Feb 24 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is confirming the effective date of March 27, 2009, for the direct final rule that appeared in the Federal Register of November 12, 2008 (73 FR 66750). The direct final rule amends the agency's regulations to update the statutory citations regarding the new civil monetary penalties prescribed by the Food and Drug Administration Amendments Act of 2007 (FDAAA), amends the regulations to include the new FDAAA penalties, and adjusts the preceding maximum civil penalty amounts for inflation as prescribed by the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA). This document confirms the effective date of the direct final rule.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Feb 24 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. Elsewhere in this issue of the Federal Register, FDA is announcing that a proposed collection of information regarding labeling requirements for nonprescription human drugs marketed without an approved application has been submitted to OMB for review.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Feb 24 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). Elsewhere in this issue of the Federal Register, FDA is announcing that a proposed collection of information regarding dietary supplement labeling requirements and recommendations has been submitted for OMB review.

Arthritis Advisory Committee; Notice of Postponement of Meeting

Tue, Feb 24 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is postponing the meeting of the Arthritis Advisory Committee scheduled for March 5, 2009. This meeting was announced in the Federal Register of January 29, 2009 (74 FR 5165). The postponement is due to the need to complete the review of additional data submitted by the applicant. Future meeting dates will be announced in the Federal Register.

Clinical Trial Design for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia; Public Workshop

Tue, Feb 24 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), the American College of Chest Physicians (ACCP), the Society of Critical Care Medicine (SCCM), and the American Thoracic Society (ATS) regarding scientific issues in clinical trial design for hospital acquired pneumonia (HAP) and ventilatorassociated pneumonia (VAP). This public workshop is intended to provide information about, and gain perspective from, health care providers, academia, and industry on various aspects of antimicrobial drug development for HAP and VAP, including diagnosis of HAP and VAP, effect of antimicrobial treatment for HAP and VAP, endpoints for trials of HAP and VAP, and statistical issues in analysis of results of trials in HAP and VAP. The input from this public workshop will help in developing topics for further discussion.

Date and Time: The public workshop will be held on March 31, 2009, from 8 a.m. to 6 p.m. and on April 1,

International Conference on Harmonisation; Draft Guidance on S9 Nonclinical Evaluation for Anticancer Pharmaceuticals;

Tue, Feb 17 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides recommendations for nonclinical studies for the development of pharmaceuticals, including both drugs and biotechnologyderived products, intended to treat patients with advanced cancer. The recommendations describe the type and timing of nonclinical studies to support an investigational new drug application (IND) and the submission of a new drug application (NDA) or biologics license application (BLA). The draft guidance is intended to provide information on internationally accepted recommendations for nonclinical studies to facilitate the development of anticancer pharmaceuticals.

International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts

Tue, Feb 17 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 6: Uniformity of Dosage Units General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Uniformity of Dosage Units General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the
Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a co

International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts

Tue, Feb 17 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Dissolution Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding
[[Page 7448]]
redundant testing in favor of a common t

International Conference on Harmonisation; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts

Tue, Feb 17 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 8: Sterility Test General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Sterility Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in

Phonetic Orthographic Computer Analysis Software Program for Review of Proprietary Drug and Biologic Names; Availability

Tue, Feb 17 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the source code and supporting technical documentation for the Phonetic Orthographic Computer Analysis (POCA) software program. POCA is an analytic tool designed to help identify drug and biologic names and medical terminology that are phonetically and orthographically similar to one another. POCA is one analytic tool that FDA uses to review proposed proprietary drug and biologic names.

Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production,

Fri, Feb 13 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's requirements for food irradiation processors. This notice also notifies the public of and solicits comments on FDA's proposal to transfer the collection of information and associated burden hours from the Office of Management and Budget (OMB) control number 09100549 to the subject collection of information (OMB control number 09100186).

Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

Thu, Feb 12 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in dairy cattle for control of pyrexia associated with acute bovine mastitis.

Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications

Wed, Feb 11 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is withdrawing approval of 103 new drug applications (NDAs) and 35 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Determination of Regulatory Review Period for Purposes of Patent Extension; MACROPLASTIQUE IMPLANTS

Wed, Feb 11 2009 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for MACROPLASTIQUE IMPLANTS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that medical device.

Guidance for Industry: Referral Program From the Food and Drug Administration to the National Oceanic and Atmospheric

Wed, Feb 11 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance document entitled ``Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association.'' The revised guidance only changes the date on which FDA intends to stop issuing export certificates for fish or fishery products that are to be shipped to the European Union (EU) and the European Free Trade Association (EFTA). The date FDA now intends to stop issuing EU Export Certificates is June 17, 2009.

Improving Endpoints, Improving Care: Alpha-1 Antitrypsin Augmentation Therapy and Clinical Trials; Public Workshop

Wed, Feb 11 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public workshop entitled: Improving Endpoints, Improving Care: Alpha1 Antitrypsin Augmentation Therapy and Clinical Trials. The purpose of the public workshop is to identify the most useful clinical trial endpoints and surrogate markers for Alpha1 antitrypsin (AAT) augmentation therapy. FDA, Alpha1 Foundation, and the Department of Health and Human Services, Office of Public Health and Science are convening this workshop to facilitate the design of future clinical trials intended to establish clinical efficacy of AAT products. The public workshop will feature presentations and panel discussions led by experts from academic institutions, government, and industry.

Date and Time: The public workshop will be held on March 23, 2009, from 8:30 a.m. to 5:30 p.m. and March 24, 2009, from 8:30 a.m. to 5 p.m.

Location: The public workshop will be held at the Lister Hill Center Auditorium, Bldg. 38A, National Institutes of Health, 8800 Rockville Pike, B

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

Wed, Feb 11 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Cardiovascular and Renal Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on March 18, 2009, from 8 a.m. to 5 p.m.

[[Page 6904]]

Location: Marriott Conference Centers, UMUC Inn and Conference Center, 3501 University Blvd. East, Adelphi, MD. The hotel telephone number is 3019857385.

Contact Person: Elaine Ferguson, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email:
elaine.ferguson@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, D

Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committee and Panels

Wed, Feb 11 2009 11:00:00 GMT

New Animal Drugs; Bc6 Recombinant Deoxyribonucleic Acid Construct

Wed, Feb 11 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by GTC Biotherapeutics, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) construct in a lineage of genetically engineered (GE) goats expressing recombinant human antithrombin in their milk. The subsequently purified antithrombin is a biological product for human therapeutic use. In a separate action, a biologics license application (BLA) has been approved by FDA for use of this antithrombin in humans.

Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Regulations

Wed, Feb 11 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe:

Wed, Feb 11 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Feb 11 2009 11:00:00 GMT

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Tue, Feb 10 2009 11:00:00 GMT

Food Labeling Workshop; Public Workshop

Tue, Feb 10 2009 11:00:00 GMT

The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas, is announcing a public workshop entitled ``Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups.

Date and Time: This public workshop will be held on April 21, 2009, from 8 a.m. to 5 p.m., and on April 22, 2009, from 8 a.m. to 4 p.m.

Location: The public workshop will be held at the Continuing Education Center, Two East Center St., Fayetteville, AR (located downtown).

Contact: David Arvelo, Small Business Representative, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 2142534952, FAX: 214253 4970, or email: david.arvelo@fda.hhs.gov.

For

Food Protection; Public Workshop

Tue, Feb 10 2009 11:00:00 GMT

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in cosponsorship with the University of Arkansas Institute of Food
[[Page 6642]]
Science and Engineering (IFSE), is announcing a public workshop entitled ``Food Protection Workshop.'' This public workshop is intended to provide information about food safety, food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and other subjects related to the Food Protection Plan as it relates to food facilities such as farms, manufacturers, processors, distributors, retailers, and restaurants.

Date and Time: This public workshop will be held on May 19 and 20, 2009, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Continuing Education Center, Two East Center St., Fayetteville, AR (located downtown).

Contact Person: Regarding information on accommodation options: Steven C. Seideman,

[Docket Nos. FDA-2008-M-0522, FDA-2008-M-0425, FDA-2008-M-0426, FDA- 2008-M-0478, FDA-2008-M-0402, FDA-2008-M-0437,

Tue, Feb 10 2009 11:00:00 GMT

Request for Nominations for Voting Members on Public Advisory Committees

Thu, Jan 29 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Allergenic Products Advisory Committee;Blood Products Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Transmissible Spongiform Encephalopathies Advisory Committee; and the Vaccines and Related Biological Products Advisory Committee. Nominations will be accepted for current vacancies and those that will or may occur through September 30, 2009.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for

Wed, Jan 28 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Compliance Policy Guide Sec. 540.370--Fish and Fishery Products-- Decomposition; Availability

Thu, Jan 22 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the [[Page 4040]]
availability of Compliance Policy Guide Sec. 540.370Fish and Fishery ProductsDecomposition (the CPG). The CPG provides guidance for FDA staff on decomposition in fish and fishery products.

Draft Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the

Wed, Jan 21 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the act) addressing the agency's treatment of certain citizen petitions and petitions for stay of agency action (collectively, petitions), as well as related applications. The draft guidance describes how FDA will determine if the new provisions apply to a particular petition and how FDA will determine if a petition would delay approval of a pending abbreviated new drug application (ANDA) or 505(b)(2) application. The draft guidance also describes how FDA will interpret the requirements that such petitions include a certification and that supplemental information or comments to such petitions include a verification. The draft guida

Report of Quantitative Risk and Benefit Assessment of Commercial Fish Consumption, Focusing on Fetal

Wed, Jan 21 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of two draft documents. The first is entitled ``Report of Quantitative Risk and Benefit Assessment of Commercial Fish Consumption, Focusing on Fetal Neurodevelopmental Effects (Measured by Verbal Development in Children) and on Coronary Heart Disease and Stroke in the General Population'' (draft risk and benefit assessment report). The draft risk and benefit assessment report describes an analysis done by FDA that results in quantitative estimates of the net effect on fetal neurodevelopment in children of maternal consumption of commercial fish, as measured by verbal development and the net effect of eating commercial fish on coronary heart disease and stroke in the general population. Effects with respect to each of these health endpoints has been associated in the scientific literature with methylmercury exposure (which primarily occurs through fish consumption) and with the consumption of fish and of omega3 fatty acids,

Risk Assessment of the Public Health Impact From Foodborne Listeria monocytogenes in Some Ready-to-Eat Foods Sliced,

Wed, Jan 21 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting [[Page 3618]]
comments and scientific data and information that would assist the agency in its plans to conduct a risk assessment of the public health impact of foodborne Listeria monocytogenes in some readytoeat foods sliced, prepared, and/or packaged in retail facilities. The purpose of the risk assessment is to ascertain the impact on public health of current practices and potential interventions that reduce or prevent L. monocytogenes contamination in readytoeat food.

Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of

Fri, Jan 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and TissueBased Products (HCT[sol]Ps)'' dated January 2009. The draft guidance document provides establishments that manufacture HCT[sol]Ps with
recommendations for complying with CGTP requirements.

Draft Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories; Availability

Fri, Jan 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories.'' The draft guidance document provides information and recommendations about accreditation standards for laboratories and the quality and type of data that accredited laboratories produce to support testing results submitted to FDA about the admissibility of detained articles offered for import. We are taking this action under a recommendation made by the President's Interagency Working Group on Import Safety (Working Group).

Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA

Fri, Jan 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA or the agency) is announcing the availability of a guidance for industry 187 entitled ``Regulation of Genetically Engineered Animals Containing Heritable recombinant DNA Constructs.'' This guidance is intended to clarify FDA's requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. The guidance describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the act) apply with respect to GE animals, including FDA's intent to exercise enforcement discretion regarding requirements for certain GE animals.

Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds; Availability

Fri, Jan 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Voluntary Third Party Certification Programs for Foods and Feeds.'' This guidance describes the general attributes FDA believes a voluntary thirdparty certification program should have in order to help ensure its certification is a reliable reflection that the foods and feeds (hereinafter foods) from certified establishments meet applicable FDA requirements, as well as other certification criteria.

Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims

Fri, Jan 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Guidance for Industry: EvidenceBased Review System for the Scientific Evaluation of Health Claims.'' This guidance outlines the agency's approach to the review of the scientific evidence for health claims that meet the significant scientific agreement standard (SSA) and qualified health claims. Elsewhere in this issue of the Federal Register, FDA is announcing the withdrawal of the guidance documents entitled ``Guidance for Industry and FDA: Interim EvidenceBased Ranking System for Scientific Data'' and ``Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements.''

Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and

Fri, Jan 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance entitled ``Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements,'' that was issued December 1999.

Release of Task Force Report; Guidance for Industry and FDA: Interim Evidence-Based Ranking System for Scientific

Fri, Jan 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the withdrawal of the guidance entitled ``Guidance for Industry and FDA: Interim EvidenceBased Ranking System for Scientific Data'' that was issued on July 10, 2003.

Requirements for Submission of Bioequivalence Data; Final Rule

Fri, Jan 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its regulations on the submission of bioequivalence data to require an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA, but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product meets these criteria. FDA is amending the regulation because we now believe that data from additional BE studies may be important in our determination of whether the proposed formulation is bioequivalent to the reference listed drug (RLD), and are relevant to our evaluation of ANDAs in general. In addition, such data will increase our understanding of how changes in components, composition,

Draft Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification

Fri, Jan 16 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Standards for Securing the Drug Supply ChainStandardized Numerical Identification for Prescription Drug Packages.'' This draft guidance is being issued under the Federal Food, Drug, and Cosmetic Act (the act), which requires FDA to develop standardized numerical identifiers for prescription drugs. We are also requesting responses from interested stakeholders to questions posed in this Federal Register notice related to the draft guidance.

Institutional Review Boards; Registration Requirements

Thu, Jan 15 2009 11:00:00 GMT

The Food and Drug Administration (FDA, we) is issuing a final rule to require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). The registration information includes contact information (such as addresses and telephone numbers), the number of active protocols involving FDAregulated products reviewed during the preceding 12 months, and a description of the types of FDAregulated products involved in the protocols reviewed. The IRB registration requirements will make it easier for FDA to inspect IRBs and to convey information to IRBs.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Waiver

Thu, Jan 15 2009 11:00:00 GMT

Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Adverse Event Reporting--Improving

Thu, Jan 15 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Adverse Event ReportingImproving Human Subject Protection.'' This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to institutional review boards (IRBs). FDA developed this guidance in response to concerns raised by the IRB community that increasingly large volumes of individual, unanalyzed adverse event reports are inhibiting, rather than enhancing, the ability of IRBs to adequately protect human subjects. The guidance provides recommendations to IRBs, sponsors, and investigators on improving the usefulness of the adverse event information submitted to IRBs. Elsewhere in this issue of the Federal Register, FDA is issuing the final rule entitled ``Institutional Review Boards; Registration Requirements.''

Secure Supply Chain Pilot Program; Notice of Pilot Program

Thu, Jan 15 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for sponsors and foreign manufacturers of finished drug products and active pharmaceutical ingredients (APIs) intended for human use imported by a secure supply chain to apply to participate in a voluntary Secure Supply Chain (SSC) pilot program to be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Office of Regulatory Affairs (ORA). The goal of the pilot program is to allow FDA to determine the practicality of developing a secure supply chain program. The information obtained from this pilot program will assist FDA in its determination. A Secure Supply Chain program would assist the agency in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the agency to focus its resources on imported drugs outside the program that may pose such risks. Such a program would increase the likelihood of expedited entry for specific finished drug products and APIs imported into the United S

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Wed, Jan 14 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Filing Objections and Requests for a

Wed, Jan 14 2009 11:00:00 GMT

Advisory Committees; Tentative Schedule of Meetings for 2009

Tue, Jan 13 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2009. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM's recommendation.

Draft Guidance for Industry on Good Importer Practices; Availability

Tue, Jan 13 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing on behalf of several members of the Interagency Working Group on Import Safety (agencies) the availability of a draft guidance for industry entitled ``Good Importer Practices.'' This draft guidance document provides general recommendations to importers on possible practices and procedures they may follow to increase the likelihood the products they import are in
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compliance with applicable U.S. safety and security requirements. The recommendations provided here are intended to promote and facilitate an assessment by importers of a product's life cycle so the importer may make sound decisions about how best to address the product's potential to cause harm and to facilitate compliance with U.S. requirements.

Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or

Tue, Jan 13 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.'' The guidance provides drug, biologics, and device manufacturers with the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses for FDA approved drugs or biologics or FDAapproved or cleared medical devices to healthcare professionals and healthcare entities.

Participation of Certain Population Subsets in Clinical Drug Trials; Request for Comment

Tue, Jan 13 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is seeking information and comments on issues related to the enrollment of certain populations in clinical drug trials. Particularly, we are requesting information and comments from medical product manufacturers, institutional review boards (IRBs), patient groups, universities, researchers, community groups, and other interested parties. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA) section 901, which requires recommendations be included in a report to Congress addressing best practice approaches on increasing the participation of elderly populations, children, racially and ethnically diverse communities, and medically underserved populations in clinical drug trials. FDA requests that those with information on possible approaches to increase participation of these groups in clinical drug trials submit comments.

Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets and Boluses

Mon, Jan 12 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by First Priority, Inc. The supplemental application provides for revising the description of a 1gram oral dosage form of phenylbutazone from tablet to bolus.

Meeting To Discuss Women's Health

Mon, Jan 12 2009 11:00:00 GMT

The Food and Drug Administration (FDA), Office of Women's Health is announcing the following meeting: ``Women's Health Dialogue.'' The meeting is intended for directors of national organizations interested in discussing women's health research and educational out reach.

Date and Time: The meeting will be held on February 9, 2009, from 8:30 a.m. to 11:30 a.m.

Location: The meeting will be held at HMA Associates, Inc., 1101 17th St., NW., suite 1102, Washington, DC 20036.

Contact: Deborah Kallgren, FDA Office of Women's Health (HF8), Food and Drug Administration, 5600 Fishers Lane, rm. 1665, Rockville, MD 20857, 3018270350, FAX: 3018279194, email:
deborah.kallgren@fda.hhs.gov.

Registration: There is no registration fee, but preregistration is required. Send registration information (including name, title, firm name, address, telephone, and fax number) to Deborah Kallgren. Seating is limited to 15 participants (1 person per organiz

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Jan 9 2009 11:00:00 GMT

Agency Information Collection Activities; Proposed Collection; Comment Request; Recommendations for the Early Food

Fri, Jan 9 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on
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the information collection provisions of the guidance document entitled ``Recommendations for the Early Food Safety Evaluation of New Non Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.''

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for

Fri, Jan 9 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Test for Extractable Volume of Parenteral Preparations General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the
interchangeability between the local regional pharmacopoeias, thus av

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for

Fri, Jan 9 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Test for Particulate Contamination: Subvisible Particles General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Thu, Jan 8 2009 11:00:00 GMT

Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management

Mon, Jan 5 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committees: Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

General Function of the Committees: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on January 30, 2009, from 8 a.m. to 4:30 p.m.

Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy, Gaithersburg, MD. The hotel phone number is 301977 8900.

Contact Person: Kalyani Bhatt, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, fax: 3018276776, email: Kalyani.Bhatt@fda.hhs.gov, or FDA Advisory Committee Information Line, 1

Training Program for Regulatory Project Managers; Information Available to Industry

Mon, Jan 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.

Listing of Color Additives Exempt From Certification; Food, Drug, and Cosmetic Labeling: Cochineal Extract and

Mon, Jan 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is revising its requirements for cochineal extract and carmine by requiring their declaration by name on the label of all food and cosmetic products that contain these color additives. This final rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract containing food and carminecontaining food and cosmetics and will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. This action also responds to a citizen petition submitted by the Center for Science in the Public Interest (CSPI).

Draft Guidance for Industry and Food and Drug Administration Staff; Assay Migration Studies for In Vitro Diagnostic

Mon, Jan 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Assay Migration Studies for In Vitro Diagnostic Devices.'' This draft guidance presents a least burdensome regulatory approach to gaining FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved assay is migrating (i.e., transitioning) to a New System for which the assay has not been previously approved or licensed.

Guidance for Industry on Labeling Over-the-Counter Human Drug Products--Questions and Answers; Availability

Mon, Jan 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling OTC Human Drug ProductsQuestions and Answers.'' This guidance is intended to assist manufacturers, packers, and distributors of overthecounter (OTC) drug products in complying with the agency's regulation on standardized content and format requirements for the labeling of OTC drug products. This guidance primarily discusses labeling questions that have been frequently asked by manufacturers, packers, and distributors relating to these requirements. The labeling examples in this guidance show various format and content features and suggest how OTC drug monograph labeling information finalized before the new requirements can be converted to the new format. This guidance finalizes the draft guidance of the same name published January 13, 2005 (70 FR 2415).

``Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal

Mon, Jan 5 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.'' The guidance describes the amount, type, and quality of evidence that FDA recommends a manufacturer have to substantiate a claim under this section of the Federal Food, Drug, and Cosmetic Act (the act).

Medical Devices; Immunology and Microbiology Devices; Classification of Enterovirus Nucleic Acid Assay

Fri, Jan 2 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is classifying enterovirus nucleic acid assay into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA'' (ribonucleic acid). The agency is classifying the device into class II (special controls) in order to provide a
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reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.

Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic

Fri, Jan 2 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA.'' This guidance document describes a means by which an enterovirus nucleic acid assay may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule codifying the classification of the enterovirus nucleic acid assays into class II (special controls). This guidance document is immediately in effect as the special control for an enterovirus nucleic acid assay, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

Blood Products Advisory Committee; Notice of Meeting; Amendment

Fri, Jan 2 2009 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an amendment to the notice of the Blood Products Advisory Committee. This meeting was announced in the Federal Register of December 9, 2008 (73 FR 74725). The amendment is being made to reflect a change in the Agenda portion of the document.

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

Fri, Jan 2 2009 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Cardiovascular and Renal Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on February 3, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC/Silver Spring, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301 5895200.