The Federal Register

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Draft Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Standards for Securing the Drug Supply ChainStandardized Numerical Identification for Prescription Drug Packages.'' This draft guidance is being issued under the Federal Food, Drug, and Cosmetic Act (the act), which requires FDA to develop standardized numerical identifiers for prescription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requesting responses from interested stakeholders to questions posed in this Federal Register notice related to the draft guidance.

Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of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 The draft guidance document provides establishments that manufacture HCT[sol]Ps with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Draft Guidance for Industry: Submission of Laboratory Packages by Accredited Laboratories; Availability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).

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Jan 16 2009 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6395960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3956974. Written comments should be received within 30 days of this notice. Proposed Project

Sexually Transmitted Disease (STD) Morbidity SurveillanceNew National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description

The CDC is responsible for the reporting and dissemination of nationally notifiable STD morbidity information for prevention and control purposes in collaboration with state and lo

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.

Center for Scientific Review; Notice of Closed Meetings

Fri, Jan 16 2009 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: Center for Scientific Review Special Emphasis Panel; Trafficking and Signaling.

Date: January 26, 2009.

Time: 1:30 p.m. to 2:30 p.m.

Agenda: To review and evaluate grant applications,

Place: National Institutes of Health, 6701 Rockledge Drive Bethesda, MD 20892 (Telephone Conference Call).

Contact Person: Deborah L. Lewis, PhD, Scientific R

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Jan 16 2009 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046395960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collecte

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.

Center for Scientific Review; Notice of Closed Meetings

Fri, Jan 16 2009 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflicts: Prevention and Behavioral Intervention.

Date: January 15, 2009.

Time: 3 p.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

Contact Person: Karen Lec

Proposed Data Collections Submitted for Public Comment and Recommendations

Fri, Jan 16 2009 11:00:00 GMT

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.''

National Library of Medicine; Notice of Meeting

Fri, Jan 16 2009 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, Lister Hill National Center for Biomedical Communications.

The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Library of Medicine, including consideration of personnel
qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clear

Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Centers for Agricultural Disease

Fri, Jan 16 2009 11:00:00 GMT

In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting:

Time and Date:

7 p.m.5 p.m., February 10, 2009 (Closed).

7 p.m.5 p.m., February 11, 2009 (Closed).

7 p.m.5 p.m., February 12, 2009 (Closed).

Place: Renaissance Columbus, 50 North 3rd Street, Columbus, Ohio 43215, telephone: (614) 2285050.

Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92463.

Matters to be Discussed: The meeting will include the review, discussion, and evaluation of applications received in response to ``Centers for Agricultural Disease and Injury Research, Education and Prevention, PAR06057.''

Contact Person for More Information: Stephen Olenchock, PhD, Scientific Review Adm

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.

Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH)

Fri, Jan 16 2009 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the following Meeting of the aforementioned committee:

Times and Dates:
8 a.m.5 p.m., February 17, 2009.

8 a.m.5 p.m., February 18, 2009.

Place: Embassy Suites Hotel, 1900 Diagonal Road, Alexandria, Virginia 22314, telephone (703)6845900, fax (703) 6841403.

Status:
Closed 8 a.m.5 p.m., February 17, 2009.

Closed 8 a.m.5 p.m., February 18, 2009.

Purpose: The Safety and Occupational Health Study Section will review, discuss, and evaluate grant application(s) received in response to the Institute's standard grants review and funding cycles pertaining to research issues in occupational safety and health, and allied areas.

It is the intent of NIOSH to support broadbased research endeavors in keeping with the Institute's program goals. This will lead to improved understanding and appreciation for the magnitude of the aggregate he

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.

Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics

Fri, Jan 16 2009 11:00:00 GMT

This interim final rule with comment period implements certain provisions of section 154 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) related to the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) Competitive Acquisition Program. Specifically, this rule: Implements certain MIPPA provisions that delay implementation of Round 1 of the program; requires CMS to conduct a second Round 1 competition (the ``Round 1 rebid'') in 2009; and mandates certain changes for both the Round 1 rebid and subsequent rounds of the program, including a process for providing feedback to suppliers regarding missing financial documentation and requiring contractors to disclose to CMS information regarding subcontracting relationships.

Medicare Program: Medicare Advantage and Prescription Drug Programs MIPPA Drug Formulary & Protected Classes Policies

Fri, Jan 16 2009 11:00:00 GMT

This interim final rule with comment period revises the regulations governing the Medicare prescription drug benefit program (Part D). This regulation makes conforming changes to reflect revisions to the rules governing Part D that were made as a result of provisions in the Medicare Improvements for Patients and Providers Act (MIPPA), which became law on July 15, 2008. These MIPPA provisions change the definition of a covered Part D drug, and add new requirements that apply to Part D formularies.

Medicare, Medicaid, and Clinical Laboratory Improvement Amendments of 1988 (CLIA) Program; Cytology Proficiency

Fri, Jan 16 2009 11:00:00 GMT

This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations for cytology proficiency testing (PT), to reflect changes in cytology laboratory operations and practices. The proposed changes are based on recommendations received from the Clinical Laboratory Improvement Advisory Committee (CLIAC), input from the professional community, and government experience with the implementation of cytology PT. The proposed changes would amend certain definitions, lengthen the testing interval, require validation of cytology challenges before use in testing, increase the minimum number of cytology challenges per testing event, change the grading scheme, and allow flexibility to accommodate new technologies (for example, digital images, as they are implemented in cytology laboratory practice).

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Jan 16 2009 11:00:00 GMT

Medicare Program; Meeting of the Medicare Evidence Development & Coverage Advisory Committee--March 18, 2009

Fri, Jan 16 2009 11:00:00 GMT

This notice announces that a public meeting of the Medicare [[Page 3052]]
Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, March 18, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of Bayesian statistics to interpret evidence in making coverage decisions. The meeting will introduce Bayesian concepts, contrast Bayesian approaches with frequentist approaches, and provide some examples of using Bayesian techniques for metaanalyses. Bayesian analysis is a statistical technique in which prior evidence is used to update or to newly infer the probability that a hypothesis may be true. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

Statement of Mission, Organization, Functions, and Delegations of Authority

Fri, Jan 16 2009 11:00:00 GMT

This notice amends Part K of the Statement of Mission, Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), as follows: Chapter KE, Administration for Native Americans (ANA), as last amended in 60 FR 1708485, 04/04/95. This notice establishes the Division of Policy, Planning and Evaluation and moves the support staff function to the Office of the Commissioner. The changes are as follows:

I. Chapter KE. Administration for Native Americans

A. Delete KE. 00 Mission in its entirety and replace with the following:

KE. 00 Mission. The mission of the Administration for Native Americans is to promote the goal of selfsufficiency and cultural preservation for Native Americans by providing social and economic development opportunities through financial assistance, training, and technical assistance to eligible Tribes and Native American communities, including American Indians, Alaska Natives,

Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic

Fri, Jan 16 2009 11:00:00 GMT

This final rule adopts updated versions of the standards for electronic transactions originally adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This final rule also adopts a transaction standard for Medicaid pharmacy subrogation. In addition, this final rule adopts two standards for billing retail pharmacy supplies and professional services, and clarifies who the ``senders'' and ``receivers'' are in the descriptions of certain transactions.

HIPAA Administrative Simplification: Modifications to Medical Data Code Set Standards To Adopt ICD-10-CM and

Fri, Jan 16 2009 11:00:00 GMT

This final rule adopts modifications to two of the code set standards adopted in the Transactions and Code Sets final rule published in the Federal Register pursuant to certain provisions of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Specifically, this final rule modifies the standard medical data code sets (hereinafter ``code sets'') for coding diagnoses and inpatient hospital procedures by concurrently adopting the International Classification of Diseases, 10th Revision, Clinical Modification (ICD10CM) for diagnosis coding, including the Official ICD10CM Guidelines for Coding and Reporting, as maintained and distributed by the U.S. Department of Health and Human Services (HHS), hereinafter referred to as ICD10CM, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD10PCS) for inpatient hospital procedure coding, including the Official ICD10PCS Guidelines for Coding and Reporting

Office of Global Health Affairs: Regulation on the Organizational Integrity of Entities That Are Implementing Programs

Fri, Jan 16 2009 11:00:00 GMT

This document corrects technical errors that appeared in the final rule published in the Federal Register on December 24, 2008, entitled ``Regulation on the Organizational Integrity of Entities That Are Implementing Programs and Activities Under the Leadership Act'' (73 FR 78997).

Agency Information Collection Activities: Proposed Collection: Comment Request

Fri, Jan 16 2009 11:00:00 GMT

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 10413), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, e mail paperwork@hrsa.gov or call the HRSA Reports Clearance Officer on (301) 4431129.

Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the agency; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to