Weekly Legislative & Regulatory Round-up

National Institutes of Health–Internal Control Review of the Process for Awarding American Recovery and Reinvestment Act Funds (A-05-09-00064)

September 28

No relevant notices.

September 29

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare Programs; End-Stage Renal Disease Prospective Payment

System

ACTION: Proposed rule.

SUMMARY: This proposed rule would implement a case-mix adjusted bundled

prospective payment system (PPS) for Medicare outpatient end-stage

renal disease (ESRD) dialysis facilities beginning January 1, 2011, in

compliance with the statutory requirement of the Medicare Improvements

for Patients and Providers Act (MIPPA), enacted July 15, 2008. The

proposed ESRD PPS would replace the current basic case-mix adjusted

composite payment system and the methodologies for the reimbursement of

separately billable outpatient ESRD services.

DATES: To be assured consideration, comments must be received at one of

the addresses provided below, no later than 5 p.m. on November 16,

2009.

Centers for Medicare & Medicaid Services

Medicare Program; Town Hall Meeting on End-Stage Renal Disease

Prospective Payment System

ACTION: Notice.

SUMMARY: This notice announces the date, time, and location of the town

hall meeting to discuss the Medicare End-Stage Renal Disease (ESRD)

Prospective Payment System (PPS) proposed rule. This meeting provides a

forum for interested parties including, but not limited to

beneficiaries, caregivers, providers, and other industry

representatives to make oral statements in response to the ESRD PPS

proposed rule. The meeting is open to the public, but registration is

required and attendance is limited to space available.

DATES: Meeting Date: The town hall meeting will be held on Wednesday,

October 23, 2009, from 9 a.m. to 12 p.m., eastern daylight time

(e.d.t.).

Office of the National Coordinator for Health Information

Technology; HIT Standards Committee Advisory Meeting; Notice of Meeting

ACTION: Notice of meeting.

Name of Committee: HIT Standards Committee.

Date and Time: The meeting will be held on October 14, 2009,

from 9 a.m. to 3 p.m./Eastern Time.

Location: The Omni Shoreham Hotel, 2500 Calvert Street, NW.,

Washington, DC. The hotel telephone number is 202-234-0700.

President's Advisory Council for Faith-Based and Neighborhood

Partnerships

Name: President's Advisory Council for Faith-based and

Neighborhood Partnerships Council Meeting.

Time and Date: Tuesday, October 13th, 9 a.m.-1 p.m. and 2 p.m.-6

p.m. Eastern.

Place: Meetings will be held in person. Location TBD.

Status: Open to the public, limited only by the space available.

Conference call line will be available.

September 30

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the National Coordinator for Health Information

Technology

HIT Policy Committee Advisory Meeting; Notice of Two-Day Meeting

ACTION: Notice of meeting.

Name of Committee: HIT Policy Committee.

Date and Time: The two-day meeting will be held on October 27 and

October 28, 2009, from 10 a.m. to 5:15 p.m./Eastern Time on October

27th, and 8:30 a.m. to 3 p.m./Eastern Time on October 28th.

Location: The Omni Shoreham Hotel, 2500 Calvert Street, NW.,

Washington, DC. The hotel telephone number is 202-234-0700.

October 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare Program; Inpatient Rehabilitation Facility Prospective

Payment System for Federal Fiscal Year 2010; Correction

ACTION: Correction of final rule.

SUMMARY: This document corrects technical errors that appeared in the

final rule published in the Federal Register on August 7, 2009 entitled

``Inpatient Rehabilitation Facility Prospective Payment System for

Federal Fiscal Year 2010'' (74 FR 39762).

DATES: Effective Date. The correction to the average length of stay

value for CMG 0501, tier 2, in Table 1 on page 39768 of the final rule

(74 FR 39762) is effective October 1, 2009. The correction to the

preamble text at the top of the middle column of page 39791 of the

final rule (74 FR 39762) is effective January 1, 2010.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

1. Type of Information Collection Request: Revision of a currently

approved collection; Title of Information Collection: Medicare

Advantage Applications-Part C.

2. Type of Information Collection Request: Revision of a currently

approved collection; Title of Information Collection: Application for

Prescription Drug Plans (PDP); Application for Medicare Advantage

Prescription Drug (MA-PD); Application for Cost Plans to Offer

Qualified Prescription Drug Coverage; Application for Employer Group

Waiver Plans to Offer Prescription Drug Coverage; Service Area

Expansion Application for Prescription Drug Coverage.

Food and Drug Administration

Postmarketing Safety Reporting for Combination Products

ACTION: Proposed rule.

SUMMARY: 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.

DATES: Submit written or electronic comments on the proposed rule by

December 30, 2009. Submit comments on information collection issues

under the Paperwork Reduction Act of 1995 by November 2, 2009, (see the

``Paperwork Reduction Act of 1995'' section of this document).

Food and Drug Administration

Determination of Regulatory Review Period for Purposes of Patent

Extension; CLEVIPREX

ACTION: Notice.

Food and Drug Administration

Draft Guidance for Industry on Format and Content of Proposed

Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and

Proposed REMS Modifications; Availability

ACTION: Notice.

Food and Drug Administration

National Mammography Quality Assurance Advisory Committee; Notice

of Meeting

ACTION:  Notice.

Name of Committee: National Mammography Quality Assurance Advisory

Committee.

Date and Time: The meeting will be held on November 2, 2009, from 9

a.m. to 5 p.m.

Location: Holiday Inn, Walker-Whetstone Ballroom, Two Montgomery

Village Ave., Gaithersburg, MD.

Food and Drug Administration

Pilot Program To Evaluate Proposed Proprietary Name Submissions;

Procedures To Register for Participation and Submit Data

ACTION: Notice.

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

opportunity for pharmaceutical firms (applicants) to participate in a

voluntary 2-year 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.

DATES: FDA will begin accepting requests to register for the voluntary

pilot program on October 1, 2009.

October 2

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Meeting of the AHRQ National Advisory Council for Healthcare

Research and Quality Subcommittee on Patient Safety and Medical

Liability Reform Demonstrations

ACTION: Notice of public meeting.

SUMMARY: This notice announces a meeting of the National Advisory

Council for Healthcare Research and Quality Subcommittee on Patient

Safety and Medical Liability Reform Demonstrations.

DATES: The meeting will be held in October; specific information will

be available on the AHRQ Web site at http://www.AHRQ.gov.

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Proposed Collection;

Comment Request

1. Type of Information Collection Request: New Collection; Title of

Information Collection: State Plan Amendment Template for the Option to

Cover Certain Children and Pregnant Women Lawfully residing in U.S.

HHS Office of the Secretary

Declaration Under the Public Readiness and Emergency Preparedness

Act

September 28, 2009.

ACTION: Notice.

SUMMARY: Declaration pursuant to section 319F-3 of the Public Health

Service Act (42 U.S.C. 247d-6d) to provide targeted liability

protections for pandemic countermeasures based on the Secretary's

finding under the Act that the 2009-H1N1 virus strain and the resulting

disease, 2009-H1N1 influenza, constitutes a public health emergency.

DATES: This notice and the attached declaration are effective as of the

date of signature of the declaration.