The Federal Register

Determination That NUBAIN (Nalbuphine Hydrochloride) Injection, 10 and 20 Milligrams/Milliliter, Was Not Withdrawn

Fri, Nov 21 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing its determination that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 milligrams/milliliter (mg/ml), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nalbuphine hydrochloride injection, 10 and 20 mg/ml, if all other legal and regulatory requirements are met.

Oncologic Drugs Advisory Committee; Notice of Meeting

Fri, Nov 21 2008 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: Oncologic 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 December 16, 2008, from 8 a.m. to 4 p.m.

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

Contact Person: Nicole Vesely, 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, 3018276793, fax: 3018276776, email: nicole.vesely@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512542. Please call

Oral Dosage Form New Animal Drugs; Amprolium; Correction

Thu, Nov 20 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) that appeared in the Federal Register of August 6, 2008 (73 FR 45610). FDA is correcting a paragraph designating the sponsors of approved applications for oral dosage forms of amprolium. This correction is being made to improve the accuracy of the animal drug regulations.

Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)

Wed, Nov 19 2008 11:00:00 GMT

The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is amending FDA's regulation on the use of ozonedepleting substances (ODSs) in self pressurized containers to remove the essentialuse designation for epinephrine used in oral pressurized metereddose inhalers (MDIs). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDAregulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs, and therefore epinephrine would no longer be an essential use of ODSs as of December 31, 2011. Epinephrine MDIs containing an ODS cannot be marketed after this date.

Global Harmonization Task Force, Study Group 1; Proposed and Final Documents; Availability

Wed, Nov 19 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of proposed and final documents that have been prepared by Study Group 1 of the Global Harmonization Task Force (GHTF). These documents represent a harmonized proposal and recommendation from the GHTF Study Group that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacture of products in the United States.

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Tue, Nov 18 2008 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: Orthopaedic and Rehabilitation 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 December 9, 2008, 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: Ronald P. Jean, Center for Devices and Radiological Health (HFZ410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 2402763676, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512521. Please call the Information Line for uptodate information on this meeting. A notice in the Federal Register about last minute modifica

Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile; Technical

Tue, Nov 18 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the biologics regulations to reincorporate a regulation that was inadvertently removed. This action is being taken to correct the regulations.

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

Tue, Nov 18 2008 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.

Draft Guidance for Industry on Process Validation: General Principles and Practices; Availability

Tue, Nov 18 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Process Validation: General Principles and Practices.'' FDA is revising its guidance for industry entitled ``Guideline on General Principles of Process Validation,'' which issued in May 1987 (the 1987 guidance). The revised draft guidance promotes a ``lifecycle'' approach to process validation that includes scientifically sound design practices, robust qualification, and process verification. When finalized, this draft guidance will replace the 1987 guidance.

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

Mon, Nov 17 2008 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 reprocessed singleuse device labeling.

Determination of Regulatory Review Period for Purposes of Patent Extension; SOMATULINE DEPOT

Mon, Nov 17 2008 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for SOMATULINE DEPOT 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.

Pediatric Advisory Committee; Notice of Meeting

Fri, Nov 14 2008 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: Pediatric Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues. The committee also advises and makes recommendations to the Secretary of Health and Human Services under 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services (DHHS), when that research is also regulated by the FDA.

Date and Time: The meeting will be held on Tuesday, December 9, 2008, from 3:30 p.m. to 6 p.m.

Location: The Legacy Hotel & Meeting Centre, 1775 Rockville Pike, Rockville, MD 20852.

Contact Person: Carlos Pe[ntilde]a, Office of Science and Health Coordination, Office of the Commissioner (HF33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm

Pediatric Ethics Subcommittee; Notice of Meeting

Fri, Nov 14 2008 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: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the Pediatric Advisory Committee on FDA, and certain Department of Health and Human Services (DHHS) regulatory issues.

Date and Time: The meeting will be held on Tuesday, December 9, 2008, from 9 a.m. to 3 p.m.

Location: The Legacy Hotel & Meeting Centre, 1775 Rockville Pike, Rockville, MD 20852.

Contact Person: Carlos Pe[ntilde]a, Office of Science and Health Coordination, Office of the Commissioner (HF33), Food and Drug Administration, 5600 Fishers Lane (for express delivery, rm. 14B08), Rockville, MD 20857, 3018273340, or by email:
carlos.pe[ntilde]a@fda.hhs.gov or FDA Advisory Committee Information Line, 18007418138 (301

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal

Thu, Nov 13 2008 11:00:00 GMT

Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans; Availability

Thu, Nov 13 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans.'' The interim safety/risk assessment evaluated exposure to melamine and its analogues (cyanuric acid, ammelide and ammeline) in infant formula and other foods to identify, where possible, a level of exposure that would not raise public health concerns. FDA is seeking public comment on the interim safety/risk assessment.

Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Thu, Nov 13 2008 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: Anesthesiology and Respiratory Therapy 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 December 5, 2008, 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: Neel J. Patel, Center for Devices and Radiological Health (HFZ480), Food and Drug Administration, 9200 Corporate Blvd., 2402763700, or FDA Advisory Committee Information Line, 1800741 8138 (3014430572 in the Washington, DC area), code 3014512624. Please call the Information Line for uptodate information on this meeting. A notice in the Federal Register about last minute modifications that imp

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

Thu, Nov 13 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CBER's public advisory committees. A nominee may either be selfnominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for upcoming vacancies effective with this notice.

Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis

Wed, Nov 12 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, September 29, 2008 (73 FR 56477). The final rule was published with an inadvertent error in the ``Analysis of Economic Impacts'' section. This document corrects that error.

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

Wed, Nov 12 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing a new regulation to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within our jurisdiction. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended. The last adjustment was published in the Federal Register of July 20, 2004 (69 FR 43299), and the FCPIAA requires Federal agencies to adjust their civil money penalties at least once every 4 years. This rule does not adjust the civil money provisions enacted by the Food and Drug Administration Amendments Act of 2007 (FDAAA). We are using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. In the proposed rule section of this issue of the Federal Register, we are concurrently proposing and soliciting comments on this rule. If significant adverse comments are received, we will withdraw this final r

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

Wed, Nov 12 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend our regulations to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within our jurisdiction. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended. The last adjustment was published in the Federal Register of July 20, 2004 (69 FR 43299), and the FCPIAA requires Federal agencies to adjust their civil money penalties at least once every 4 years. This proposed rule does not adjust the civil money provisions
[[Page 66812]]
enacted by the Food and Drug Administration Amendments Act of 2007 (FDAAA).

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

Wed, Nov 12 2008 11:00:00 GMT

Notice of Approval of Original Abbreviated New Animal Drug Application; Phenylbutazone Tablets

Wed, Nov 12 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice that it has approved an original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for veterinary prescription use of phenylbutazone tablets in horses for the relief of inflammatory conditions associated with the
musculoskeletal system.

Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex

Mon, Nov 10 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.'' The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.

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

Mon, Nov 10 2008 11:00:00 GMT

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

Mon, Nov 10 2008 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for IXEMPRA 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.

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

Mon, Nov 10 2008 11:00:00 GMT

The Food and Drug Administration (FDA) has determined the regulatory review period for TYKERB 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.

Draft Compliance Policy Guide; ``Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and

Fri, Nov 7 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft Compliance Policy Guide (CPG) entitled ``Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The draft CPG provides written guidance to FDA's and Customs and Border Protection's (CBP's) staff on enforcement of section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulations, which require prior notice for food imported or offered for import into the United States. The final rule entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' is published elsewhere in this issue of the Federal Register.

Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act;

Thu, Nov 6 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on adding additional diseases to the list of tropical diseases recognized under the Food and Drug Administration Amendments Act (FDAAA), which adds a new section to the Federal Food, Drug, and Cosmetic Act (the act). The new section authorizes FDA to award priority review vouchers to sponsors of certain tropical disease product applications that meet the criteria specified by the act. The new section lists diseases considered to be ``tropical diseases'' for the purposes of this legislation, and provides for expansion of the list to include diseases meeting certain criteria. This public meeting is being held to obtain comments from the public on the criteria that should be used to determine whether an infectious disease should be added to the list, and to elicit suggestions for adding specific diseases.

Antiviral Drugs Advisory Committee; Notice of Meeting

Tue, Nov 4 2008 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: Antiviral 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 December 2, 2008, 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: Paul Tran, 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: paul.tran@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 301451

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

Tue, Nov 4 2008 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: Immunology 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 December 3, 2008, from 8:30 a.m. to 5 p.m.

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

Contact Person: Dai J. Li, Center for Devices and Radiological Health (HFZ440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 2402760997, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512516. Please call the Information Line for uptodate information on this meeting. A notice in the Federal Register about last minute modifications that impact a previou

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Tue, Nov 4 2008 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: Orthopaedic and Rehabilitation 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 November 14, 2008, from 8:30 a.m. to 5 p.m.

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

Contact Person: Ronald P. Jean, Center for Devices and Radiological Health (HFZ410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD, 20850, 2402763676, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code
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3014512521. Please call the Information Line for uptodate information on this meeting. A notice in the Federal Register about l

Agency Emergency Processing Under Office of Management and Budget Review; Implementation of the Animal Generic Drug

Mon, Nov 3 2008 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 for the Animal Generic Drug User Fee Cover Sheet, Form FDA 3728 and the timeframe requirement under the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (21 U.S.C. 379j21) for implementing the new user fee cover sheet Form FDA 3728.

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal

Mon, Nov 3 2008 11:00:00 GMT

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Mon, Nov 3 2008 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee
[[Page 65387]]
of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.

Name of Committee: Vaccines and Related Biological 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 November 20, 2008, from 1 p.m. to approximately 4 p.m.

Location: National Institutes of Health, Building 29B, Conference Room C. This meeting will be held by teleconference. The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the Internet at

Oral Dosage Form New Animal Drugs; Firocoxib Tablets

Fri, Oct 31 2008 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 Merial Ltd. The supplemental NADA provides for veterinary prescription use of firocoxib chewable tablets in dogs for the control of postoperative pain and inflammation associated with orthopedic surgery.

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

Fri, Oct 31 2008 11:00:00 GMT

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

Food Additives Permitted in Feed and Drinking Water of Animals; Methyl Esters of Conjugated Linoleic Acid (Cis-9,

Wed, Oct 29 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of methyl esters of conjugated linoleic acid (cis9, trans11 and trans10, cis12 octadecadienoic acids) as a source of fatty acids in swine diets. This action is in response to a food additive petition filed by BASF Corp. (BASF), 100 Campus Dr., Florham Park, NJ.

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

Wed, Oct 29 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act'' 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; Waiver of In Vivo Demonstration of

Wed, Oct 29 2008 11:00:00 GMT

Memorandum of Understanding With the National Heart, Lung, and Blood Institute, a Part of the National Institutes of

Wed, Oct 29 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA's Center for Biologics Evaluation and Research (CBER) and the National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health (NIH). This MOU outlines the terms of collaboration between CBER and NHLBI in areas of mutual concern for protecting and improving the public health. Specifically this MOU provides for the implementation of a plan for promoting better communication and understanding of regulations, policies, and statutory responsibilities, and to serve as a forum for discussion of scientific and clinical topics, questions, and problems that may arise. This MOU also provides the framework for sharing of information.

Memorandum of Understanding With the U.S. Army Medical Research Institute of Infectious Diseases

Wed, Oct 29 2008 11:00:00 GMT

SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) with the U.S. Army Research Institute of Infectious Diseases (USAMRIID). This MOU identifies the terms of collaboration between FDA and USAMRIID in the area of emergency preparedness. Specifically this MOU provides for the sharing of information and collaborative activities related to biological threat agents and diagnostics to detect such biological threat agents in order to assist both parties in more efficiently preparing for and responding to emergencies in which such diagnostic tests may be used.

Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products

Tue, Oct 28 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing a final rule that confirms the interim final rule entitled ``TollFree Number for Reporting Adverse Events on Labeling for Human Drug Products'' (73 FR 402, January 3, 2008) (interim final rule) and responds to comments submitted in response to the request for comments in the proposed rule of the same title (69 FR 21778, April 22, 2004) (proposed rule). This final rule affirms the interim final rule's requirement for the addition of a statement to the labeling for certain human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (the act). The statement includes a toll free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice (the side effects statement). This final rule also affirms the interim final rule's addition of new part 209 to the regulations requiring distribution of the side effects statement. This final rule i

Label Requirement for Food That Has Been Refused Admission Into the United States; Correction

Mon, Oct 27 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of Thursday, September 18, 2008 (73 FR 54106). The document issued a proposed rule that would require owners or consignees to label imported food that is refused entry into the United States. The preamble to the proposed rule inadvertently omitted a reference. This document corrects that error.

Intrapartum Electronic Fetal Monitoring With Computer Assisted Diagnosis Workshop--Exploring Methods of Evaluation

Mon, Oct 27 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Intrapartum Electronic Fetal Monitoring (EFM) With Computer Assisted Diagnosis (CAD)Exploring Methods of Evaluation.'' The objectives of this workshop are to gather ideas on how to identify and differentiate categories of EFM/CAD devices and the corresponding levels of evidence needed to validate these devices. Workshop participants will also discuss how currently available databases might be used to verify/validate intrapartum EFM/CAD algorithms.

Date and Time: The workshop will be held on November 10, 2008, from 8 a.m. to 5 p.m. Registrations will be accepted through October 31, 2008. Participants are encouraged to arrive early to ensure time for parking, security screening, and registration before the meeting. Security screening will begin at 7 a.m. and registration will begin at 7:30 a.m. See Registration Information section of this document for registration details.

Location: The workshop will be h

Agency Information Collection Activities; Proposed Collection; Comment Request; Survey to Evaluate the Effectiveness

Fri, Oct 24 2008 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 a voluntary consumer survey of fishing and fish consumption habits in the Mississippi Delta.

Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

Fri, Oct 24 2008 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: Dermatologic and Ophthalmic 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 December 5, 2008, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC/Rockville, Plaza Ballrooms, 1750 Rockville Pike, Rockville, MD. The hotel phone number is 3014681100.

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: 3018276778, email: yvette.waples@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512534.

Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting

Fri, Oct 24 2008 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: Peripheral and Central Nervous System 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 January 7 and 8, 2009, from 8 a.m. to 5 p.m.

Location: Hilton Washington DC/Rockville, The Ballrooms, 1750 Rockville Pike, Rockville, MD. The hotel telephone number is 301468 1100.

Contact Person: DiemKieu Ngo, 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: diem.ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 30145

Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee,

Fri, Oct 24 2008 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: PulmonaryAllergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and the Pediatric 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 December 10 and 11, 2008, from 8:30 a.m. to 5 p.m.

Location: Hilton Washington DC/Rockville, Plaza Ballrooms, 1750 Rockville Pike, Rockville, MD. The hotel phone number is 3014681100.

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 Comm

Opportunity for Hearing on a Proposal to Withdraw Approval of Prescription Polyethylene Glycol 3350 Abbreviated New

Fri, Oct 24 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to withdraw approval of the following abbreviated new drug applications (ANDAs) for drug products containing polyethylene glycol 3350 (PEG 3350) labeled for prescription only use: ANDA 76652 held by Schwarz Pharma, Inc.; ANDA 77736 held by Kali Laboratories, Inc.; ANDA 77706 held by Nexgen Pharma Inc. (formerly known as Anabolic Laboratories, Inc.); ANDA 77893 held by Coastal Pharmaceuticals, Inc.; and ANDA 77 445 held by Teva Pharmaceutical Industries, Ltd. (collectively, the PEG 3350 ANDAs). The proposal is based on the switch of MiraLax from prescription only (``Rx only'') to overthecounter (OTC) use. This switch was pursuant to the submission of a new drug application (NDA) for MiraLax (NDA 22015), which was approved by the agency on October 6, 2006, establishing that PEG 3350 may be used safely and effectively without the supervision of a licensed healthcare professional. The Federal Food, Drug, and Cosmetic Act (the act) does not permit b

Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Final Rule;

Fri, Oct 24 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, September 8, 2008 (73 FR 51919). The final rule was published with an inadvertent error in the ``Analysis of Impacts'' section. This document corrects that error.

Substances Prohibited From Use in Animal Food or Feed; Correction

Thu, Oct 23 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 25, 2008 (73 FR 22720). The document amended the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE). The document was inadvertently published with incorrect dollar amounts in two separate areas: The summary of economic impacts and the paperwork burden table. This document corrects those errors.

Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Data Collection Using

Thu, Oct 23 2008 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 use of MedWatch\Plus\ Portal and Rational Questionnaire to collect electronically all adverse event, consumer complaint/product problem and medication use error data submitted to FDA.

Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the

Thu, Oct 23 2008 11:00:00 GMT

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

Thu, Oct 23 2008 11:00:00 GMT

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

Tue, Oct 21 2008 11:00:00 GMT

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

Authorization of Emergency Use of Doxycycline Hyclate Tablet Emergency Kits for Eligible United States Postal Service

Tue, Oct 21 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for doxycycline hyclate tablet emergency kits for eligible United States Postal Service (USPS) participants in the Cities Readiness Initiative (CRI) and their household members. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, HHS. The Authorization contains, among other things, conditions on the emergency use of doxycycline hyclate tablet emergency kits. The Authorization follows the determination by the Secretary of the Department of Homeland Security that there is a significant potential for a domestic emergency, involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracis. On the basis of su

Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting; Amendment of

Tue, Oct 21 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an amendment to the public meeting notice entitled ``Preparation for ICH meetings in Brussels, Belgium.'' This meeting was announced in the Federal Register of September 16, 2008 (73 FR 53428). The amendment is being made to reflect changes in the Location portion of the document. There are no other changes.

Draft Guidance for Industry on Tropical Disease Priority Review Vouchers; Availability

Mon, Oct 20 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Tropical Disease Priority Review Vouchers.'' There has been significant outside interest in FDA's interpretation of section 1102 of the Food and Drug Administration Amendments Act (FDAAA), which adds a new section 524 to the Federal Food, Drug, and Cosmetic Act (the act). Section 524 makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease product applications that meet the criteria specified by the act. This draft guidance explains to internal and external stakeholders how FDA intends to implement the provisions of section 524.

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

Fri, Oct 17 2008 11:00:00 GMT

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

FDA-Regulated Products that Contain Bisphenol-A; Request for Information

Wed, Oct 15 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting assistance in the identification of types of FDAregulated products that contain Bisphenol A (BPA), whether as a component of the product or its packaging, and any information relating to the leaching of BPA from the packaging to the product and/or from the product from the product following human administration.

Anti-Infective Drugs Advisory Committee; Notice of Meeting

Wed, Oct 15 2008 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 November 18, 2008, from 8 a.m. to 5 p.m., November 19, 2008, from 8 a.m. to 5:30 p.m. and on November 20, 2008, from 8 a.m. to 12 noon.

Location: Holiday Inn/College Park, The Ballroom, 10000 Baltimore Ave., College Park, MD. The hotel telephone number is 3013456700.

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, 18

Arthritis Advisory Committee; Notice of Meeting

Wed, Oct 15 2008 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: Arthritis 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 24, 2008, from 8:30 a.m. to 4:30 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: Nicole Vesely, 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, 3018276793, FAX: 3018276776, email:
nicole.vesely@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code
3014512532. Please ca

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

Wed, Oct 15 2008 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration
[[Page 61138]]

(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 November 20, 2008, from 8 a.m. to 5:30 p.m.

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

Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Wed, Oct 15 2008 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: Obstetrics and Gynecology 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 December 11, 2008, from 8 a.m. to 5:30 p.m.

Location: Gaithersburg Holiday Inn, Walker/Whetstone Salons, Two Montgomery Village Ave., Gaithersburg, MD.

Contact Person: Michael Bailey, Center for Devices and Radiological Health (HFZ470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 2402764100, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512524. Please call the Information Line for uptodate information on this meeting. A notice in the Federal Register about last minute modific

Pediatric Advisory Committee; Notice of Meeting

Wed, Oct 15 2008 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: Pediatric Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues. The committee also advises and makes recommendations to the Secretary under 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services, when that research is also regulated by FDA.

Date and Time: The meeting will be held on Tuesday, November 18, 2008, from 8 a.m. to 5 p.m.

Location: Holiday Inn Gaithersburg, 2 Montgomery Village Rd., Gaithersburg, MD 20877.

Contact Person: Carlos Pe[ntilde]a, Office of Science and Health Coordination, Office of the Commissioner (HF33), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, rm. 14B08), Rockville, MD 20857, 3018273340

Request for Nominations for Voting Members on Public Advisory Panels or Committees

Wed, Oct 15 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2009.

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.

International Drug Scheduling; Convention of Psychotropic Substances; Single Convention on Narcotic Drugs;

Tue, Oct 14 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is reopening until October 20, 2008, the comment period for the notice on ``International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs,'' published in the Federal Register of September 5, 2008 (73 FR 51823), requesting comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drug substances. FDA is taking this action in response to a request for a reopening of the comment period to allow interested persons additional time to review the notice and submit comments.
[[Page 60706]]

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

Tue, Oct 14 2008 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 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 November 13 and 14, 2008, from 8 a.m. to 4:30 p.m.

Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD. The hotel phone number is 3019488900.

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 I

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

Fri, Oct 10 2008 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 December 10, 2008, 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.

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, 301 8277001, FAX: 3018276776, email: elaine.ferguson@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Fri, Oct 10 2008 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: General and Plastic Surgery 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 November 18, 2008, from 8:30 a.m. to 5 p.m., and November 19, 2008, from 8 a.m. to 12:30 p.m.

Location: Marriott Gaithersburg Washingtonian Center, Salons C and D, 9751 Washingtonian Blvd., Gaithersburg, MD.

Contact Person: Lisa M. Lim, Center for Devices and Radiological Health (HFZ410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 2402763555, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512519. Please call the Information Line for uptodate information on this meeting. A no

Anti-Infective Drugs Advisory Committee; Notice of Meeting

Fri, Oct 10 2008 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 December 3, 2008, from 8 a.m. to 5 p.m.

Location: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.

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.

Distribution of Certain Drug Products by Registered Blood Establishments and Comprehensive Hemophilia Diagnostic

Thu, Oct 9 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is amending its regulations to allow certain registered blood establishments and comprehensive hemophilia diagnostic treatment centers that are also health care entities to distribute certain drug products. The final rule amends limited provisions of the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA). These regulations, among other things, restrict the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs purchased by hospitals and other health care entities.

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

Thu, Oct 9 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics'' 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;

Thu, Oct 9 2008 11:00:00 GMT

Science Board to the Food and Drug Administration; Notice of Meeting

Thu, Oct 9 2008 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: Science Board to the Food and Drug Administration (Science Board).

General Function of the Committee: The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community in industry and academia. Additionally, the Science Board provides advice to the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science, on formulating an appropriate research agenda, and on upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs.

Date and Time: The meeting will be held on Friday, Octob

Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability

Thu, Oct 9 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products'' dated October 2008. The draft guidance document provides manufacturers of cellular and gene therapy (CGT) products with recommendations for developing tests to measure potency. The recommendations are intended to clarify the potency information needed to support an Investigational New Drug Application (IND) or a Biologics License Application (BLA).

Implantation or Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid

Wed, Oct 8 2008 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 Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for veterinarian prescription use of ceftiofur crystalline free acid injectable suspension for the treatment
[[Page 58872]]
of bovine foot rot (interdigital necrobacillosis).

Implantation or Injectable Dosage Form New Animal Drugs; Tulathromycin

Wed, Oct 8 2008 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 Pfizer, Inc. The supplemental NADA provides for veterinarian prescription use of tulathromycin injectable solution for the treatment of bovine foot rot (interdigital necrobacillosis) in beef and nonlactating dairy cattle.

Medical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date

Wed, Oct 8 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is confirming the effective date of October 15, 2008, for the final rule that appeared in the Federal Register of June 2, 2008 (73 FR 31358). The direct final rule amends the hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids. This document confirms the effective date of the direct final rule.

New Animal Drugs for Use in Animal Feeds; Fenbendazole

Wed, Oct 8 2008 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 Intervet Inc. The supplemental NADA provides for use of a fenbendazole free choice, liquid Type C medicated feed in dairy and beef cattle for the removal and control of various internal parasites.

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors:

Wed, Oct 8 2008 11:00:00 GMT

Anitox; Filing of Food Additive Petition (Animal Use); Formaldehyde

Tue, Oct 7 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that Anitox has filed a petition proposing that the food additive regulations be amended to provide for the safe use of formaldehyde to retard the growth of Clostridium perfringens in animal feeds.

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Correction

Tue, Oct 7 2008 11:00:00 GMT

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of September 24, 2008 (73 FR 55114). The document announced a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). A portion of the meeting will be closed to the public. This document corrects the error.