Weekly Legislative & Regulatory Round-up

Top HHS Management and Performance Challenges: FY 2009 (PDF)

December 7

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Office of the Secretary

ACTION: Semiannual Regulatory Agenda.

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order

(EO) 12866 requires the semi-annual issuance of an inventory of

rulemaking actions under development throughout the Department with a

view to offering summarized information about forthcoming regulatory

actions for public review.

December 8

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Office of the Secretary

Implementation of Section 5001 of the American Recovery and

Reinvestment Act of 2009 for Adjustments to the Third and Fourth

Quarters of Fiscal Year 2009 Federal Medical Assistance Percentage

Rates for Federal Matching Shares for Medicaid and Title IV-E Foster

Care, Adoption Assistance and Guardianship Assistance Programs

ACTION: Notice

SUMMARY: This notice finalizes the methodology for calculating the

higher Federal matching funding that is made available under Section

5001 of the American Recovery and Reinvestment Act of 2009 (ARRA), and

provides the final calculation of the adjusted Federal Medical

Assistance Percentage (FMAP) rates for the third and fourth quarters of

Fiscal Year 2009 (FY09). Section 5001 of the ARRA provides for

temporary increases in the FMAP rates to provide fiscal relief to

States and to protect and maintain State Medicaid and certain other

assistance programs in a period of economic downturn. The increased

FMAP rates apply during a recession adjustment period that is defined

as the period beginning October 1, 2008 and ending December 31, 2010.

DATES: Effective Date: The percentages listed are for the third quarter

of FY09 beginning April 1, 2009 and ending June 30, 2009 and for the

fourth quarter of FY09 beginning July 1, 2009 and ending September 30,

2009.

December 9

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Centers for Medicare & Medicaid Services

Medicare Program; Application of Certain Appeals Provisions to

the Medicare Prescription Drug Appeals Process

ACTION: Final rule.

SUMMARY: This final rule will implement the procedures that the

Department of Health and Human Services will follow at the

Administrative Law Judge and Medicare Appeals Council levels in

deciding appeals brought by individuals who have enrolled in the

Medicare prescription drug benefit program. In addition, it will

implement the reopening procedures that will be followed at all levels

of appeal.

DATES: Effective date: This final rule is effective on January 8, 2010.

Centers for Medicare & Medicaid Services

Medicare Program: Changes to the Medicare Claims Appeal

Procedures

ACTION: Final rule.

SUMMARY: Under the procedures in this final rule, Medicare

beneficiaries and, under certain circumstances, providers and suppliers

of health care services can appeal adverse determinations regarding

claims for benefits under Medicare Part A and Part B pursuant to

sections 1869 and 1879 of the Social Security Act (the Act). Section

521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and

Protection Act of 2000 (BIPA) amended section 1869 of the Act to

provide for significant changes to the Medicare claims appeal

procedures. After publication of a proposed rule implementing the

section 521 changes, additional new statutory requirements for the

appeals process were enacted in Title IX of the Medicare Prescription

Drug, Improvement, and Modernization Act of 2003 (MMA). In March 2005,

we published an interim final rule with comment period to implement

these statutory changes. This final rule responds to comments on the

interim final rule regarding changes to these appeal procedures, makes

revisions where warranted, establishes the final implementing

regulations, and explains how the new procedures will be put into

practice.

DATES: Effective Date: These regulations are effective on January 8,

2010.

Food and Drug Administration

Guidance for Industry on Patient-Reported Outcome Measures: Use

in Medical Product Development to Support Labeling Claims; Availability

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of a guidance for industry entitled ``Patient-Reported

Outcome Measures: Use in Medical Product Development to Support

Labeling Claims.'' This guidance describes how FDA reviews and

evaluates patient-reported outcome (PRO) instruments used to measure

treatment benefit in medical product clinical trials. It also provides

recommendations on how sponsors can use study results measured by PRO

instruments to support claims in approved medical product labeling.

This guidance finalizes the draft guidance published on February 3,

2006.

DATES: Submit written or electronic comments on agency guidances at any

time.

December 10

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Centers for Medicare & Medicaid Services

Medicare Program; Payment Policies Under the Physician Fee

Schedule and Other Revisions to Part B for CY 2010; Corrections

ACTION: Final rule; correction.

SUMMARY: This document corrects several technical and typographical

errors in the final rule with comment period that appeared in the

November 25, 2009, Federal Register entitled ``Medicare Program;

Payment Policies Under the Physician Fee Schedule and Other Revisions

to Part B for CY 2010''.

DATES: Effective Date: This correction is effective January 1, 2010.

Food and Drug Administration

Current Good Manufacturing Practice for Positron Emission

Tomography Drugs

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is issuing regulations

on current good manufacturing practice (CGMP) for positron emission

tomography (PET) drugs. The regulations are intended to ensure that PET

drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act

(the act) regarding safety, identity, strength, quality, and purity.

DATES: This regulation is effective December 12, 2011. The

incorporation by reference of a certain publication listed in the rule

is approved by the Director of the Federal Register as of December 12,

2011.

Food and Drug Administration

Guidance on Current Good Manufacturing Practice for Positron

Emission Tomography Drugs; Availability

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of a guidance entitled ``PET Drugs--Current Good

Manufacturing Practice (CGMP).'' Elsewhere in this issue of the Federal

Register, we are issuing final regulations on CGMPs for positron

emission tomography (PET) drugs. We are issuing the guidance to help

PET drug producers better understand FDA's thinking concerning

compliance with the PET CGMP regulations.

DATES: Submit written or electronic comments on agency guidances at any

time.

Food and Drug Administration

Electronic Margin of Safety and NonClinical Toxicology Study Data

Submission; Notice of Pilot Project

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration's (FDA's) Center for

Veterinary Medicine (CVM) is seeking sponsors interested in

participating in a pilot project to test the electronic submission of

margin of safety and nonclinical toxicology study data using the

Standard for Exchange of Nonclinical Data (SEND), a new electronic data

standard format which is used to support review activity. FDA

anticipates that a successful pilot will enable CVM to accept margin of

safety and nonclinical toxicology study data related to investigational

new animal drug (INAD) files and new animal drug applications (NADA's)

electronically in SEND format.

DATES:  Submit electronic or written requests to participate in the

pilot project by March 10, 2010. General comments on the pilot project

are welcome at any time.

December 11

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Food and Drug Administration

Postmarketing Safety Reporting for Combination Products;

Extension of Comment Period

ACTION: Proposed rule; extension of comment period.

SUMMARY:  The Food and Drug Administration (FDA) is extending to

January 29, 2009, the comment period for the proposed rule that

appeared in the Federal Register of October 1, 2009. In the proposed

rule, FDA requested comments on postmarketing safety reporting

requirements for combination products. The agency is taking this action

in response to requests for an extension to allow interested persons

additional time to submit comments.

DATES:  The comment period for the proposed rule published October 1,

2009 (74 FR 50744), is extended. Submit written or electronic comments

by January 29, 2010.

Food and Drug Administration

Postmarketing Safety Reporting for Combination Products;

Extension of Comment Period

ACTION: Proposed rule; extension of comment period.

SUMMARY:  The Food and Drug Administration (FDA) is extending to

January 29, 2009, the comment period for the proposed rule that

appeared in the Federal Register of October 1, 2009. In the proposed

rule, FDA requested comments on postmarketing safety reporting

requirements for combination products. The agency is taking this action

in response to requests for an extension to allow interested persons

additional time to submit comments.

DATES:  The comment period for the proposed rule published October 1,

2009 (74 FR 50744), is extended. Submit written or electronic comments

by January 29, 2010.