Weekly Legislative & Regulatory Round-up

State and Local Pandemic Influenza Preparedness: Medical Surge (OEI-02-08-00210)

Local Pandemic Influenza Preparedness: Vaccine and Antiviral Drug Distribution and Dispensing (OEI-04-08-00260)

September 21

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

 Agency for Healthcare Research and Quality

Patient Safety Organizations: A Compliance Self-Assessment Guide

ACTION: Notice of Availability--Patient Safety Organizations: A

Compliance Self-Assessment Guide.

SUMMARY: AHRQ is announcing the availability of a document entitled:

``Patient Safety Organizations: A Compliance Self-Assessment Guide.''

The Patient Safety and Quality Improvement Act of 2005, Public Law 109-

41, 42 U.S.C. 299-b21--b-26 (Patient Safety Act) provides for the

formation of Patient Safety Organizations (PSOs), which collect,

aggregate, and analyze confidential information regarding the quality

and safety of healthcare delivery. The Patient Safety and Quality

Improvement Final Rule (Patient Safety Rule) (42 CFR part 3) authorizes

AHRQ, on behalf of the Secretary of HHS, to: list as a PSO an entity

that attests that it meets the statutory and regulatory requirements

for listing; and request additional information and conduct reviews

(including announced or unannounced site visits) to assess PSO

compliance. To assist PSOs in making the required attestations and

preparing for a compliance review, AHRQ developed the sample questions

in this guide to encourage each PSO to take a thorough and systematic

approach to compliance. The guide recognizes that each PSO's approach

to compliance may be different based upon the specific mission it has

chosen, the specific activities and expertise it offers to healthcare

providers, and its size and mode of operation. Thus, these questions

are merely illustrative; some questions will not be applicable or even

appropriate for every PSO. The guide does not establish new standards

or requirements beyond those that are established by the Patient Safety

Rule.

Centers for Disease Control and Prevention

Proposed Enhancements to Occupational Health Surveillance Data

Collection Through the Healthcare Personnel Safety (HPS) Component of

the National Healthcare Safety Network (NHSN)

ACTION: Notice of public meeting and availability for public comment.

SUMMARY: The National Institute for Occupational Safety and Health

(NIOSH) of the Centers for Disease Control and Prevention (CDC)

announces the following meeting and request for public comment on

proposed enhancements to occupational health surveillance data

collection through the Healthcare Personnel Safety (HPS) Component of

the National Healthcare Safety Network (NHSN).

Public Comment Period: Comments must be received by October 21,

2009.

Centers for Disease Control and Prevention

Office of Blood, Organ and Other Tissue Safety, Division of

Healthcare Quality Promotion, Center for Preparedness, Detection, and

Control of Infectious Diseases

Request for Information Regarding Development and Operation of a

Transplantation Sentinel Network

ACTION: Request for information notice.

SUMMARY: The Centers for Disease Control and Prevention (CDC) is

seeking information on development and operation of a national

transplantation sentinel network (TSN) for the United States, including

resources needed for management of such a system. The purpose of the

network is to detect and prevent disease transmission from organ and

tissue allografts recovered for transplantation.

Food and Drug Administration

Guidance for Industry on End-of-Phase 2A Meetings; Availability

ACTION:  Notice.

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

availability of a guidance for industry entitled ``End-of-Phase 2A

Meetings.'' This guidance provides information on end-of-phase 2A

(EOP2A) meetings for sponsors of investigational new drug applications

(INDs).

Food and Drug Administration

Promotion of Food and Drug Administration-Regulated Medical

Products Using the Internet and Social Media Tools; Notice of Public

Hearing

ACTION:  Notice of public hearing; request for comments.

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

Evaluation and Research (CDER), in collaboration with FDA's Center for

Biologics Evaluation and Research (CBER), Center for Veterinary

Medicine (CVM), and Center for Devices and Radiological Health (CDRH),

is announcing a public hearing to discuss issues related to the

promotion of FDA-regulated medical products (including prescription

drugs for humans and animals, prescription biologics, and medical

devices) using the Internet and social media tools.

Dates and Times: The public hearing will be held on November 12 and

13, 2009, from 8 a.m. to 5 p.m. each day. Submit written or electronic

registration by close of business on October 9, 2009. Written and

electronic comments will be accepted until February 28, 2010.

September 22

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

Agency Information Collection Activities: Proposed Collection:

Comment Request

Proposed Project: Drug Pricing Program Reporting Requirements (OMB No.

0915-0176)--[Extension]

September 23

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Current Good Manufacturing Practice Requirements for Combination

Products

ACTION:  Proposed rule.

SUMMARY:  The Food and Drug Administration (FDA or agency) proposes to

codify the current good manufacturing practice (cGMP) requirements

applicable to combination products. This proposed rule is intended to

promote the public health by clarifying which cGMP requirements apply

when drugs, devices, and biological products are combined to create a

combination product. In addition, the proposed rule sets forth a

transparent and streamlined regulatory framework for firms to use when

demonstrating compliance with cGMP requirements for ``single-entity''

and ``co-packaged'' combination products.

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

December 22, 2009. See section IX of this document for the proposed

effective date of a final rule based on this document.

September 24

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Request for Notification From Industry Organizations Interested

in Participating in the Selection Process for a Nonvoting Industry

Representative on the Tobacco Products Scientific Advisory Committee

and Request for Nominations for Nonvoting Industry Representatives on

the Tobacco Products Scientific Advisory Committee; Amendment of Notice

ACTION: Notice.

September 25

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

Medicare Program; Prospective Payment System and Consolidated

Billing for Skilled Nursing Facilities; Correction

ACTION: Final rule; correction.

SUMMARY: This document corrects technical errors that appeared in the

final rule published in the Federal Register (74 FR 40288) on August

11, 2009 entitled, ''Medicare Program; Prospective Payment System and

Consolidated Billing for Skilled Nursing Facilities for FY 2010;

Minimum Data Set, Version 3.0 for Skilled Nursing Facilities and

Medicaid Nursing Facilities.''

DATES: Effective Date: This correction is effective October 1, 2009.

Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid

Services (CMS), Department of Health and Human Services, is publishing

the following summary of proposed collections for public comment.

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

approved collection; Title of Information Collection: Children's Health

Insurance Program (CHIP) Report on Payables and Receivables.

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

approved collection; Title of Information Collection: Medicaid Report

on Payables and Receivables

3. Type of Information Collection Request: Reinstatement without

change of a previously approved collection; Title of Information

Collection: Information Collection Requirements in 42 CFR 478.18,

478.34, 478.36, 478.42, QIO Reconsiderations and Appeals.

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

approved collection; Title of Information Collection: Medicare

Advantage and Prescription Drug Program: Final Marketing Provisions CFR

422.111(a)(3) and 423.128 (a)(3).

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

approved collection; Title of Information Collection: Medicaid and

Children's Health Insurance (CHIP) Managed Care.

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs; Application by the American

Osteopathic Association for Continued Deeming Authority for Ambulatory

Surgical Centers

ACTION: Final notice.

SUMMARY: This final notice announces our decision to approve the

American Osteopathic Association (AOA) for continued recognition as a

national accreditation program for ambulatory surgical centers (ASCs)

seeking to participate in the Medicare or Medicaid programs.

DATES: Effective Date: This final notice is effective on October 23,

2009 through October 23, 2013.

Centers for Medicare & Medicaid Services

Medicare and Medicaid Programs; Quarterly Listing of Program

Issuances--April through June 2009

ACTION: Notice.

SUMMARY: This notice lists CMS manual instructions, substantive and

interpretive regulations, and other Federal Register notices that were

published from April 2009 through June 2009, relating to the Medicare

and Medicaid programs.

Centers for Medicare & Medicaid Services

Medicare Program; Medicare Appeals; Adjustment to the Amount in

Controversy Threshold Amounts for Calendar Year 2010

ACTION: Notice.

SUMMARY: This notice announces the annual adjustment in the amount in

controversy (AIC) threshold amounts for Administrative Law Judge (ALJ)

hearings and judicial review under the Medicare appeals process. The

adjustment to the AIC threshold amounts will be effective for requests

for ALJ hearings and judicial review filed on or after January 1, 2010.

The 2010 AIC threshold amounts are $130 for ALJ hearings and $1,260 for

judicial review.

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

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Advisory Panel on Medicare

Education, October 20, 2009

ACTION: Notice of meeting.

DATES: Meeting Date: October 20, 2009 from 8:30 a.m. to 3 p.m., eastern

daylight time (e.d.t.).

ADDRESSES: Meeting Location: Hilton Washington Hotel Embassy Row, 2015

Massachusetts Avenue, NW., Washington, DC 20036, (202) 265-6800.

Centers for Medicare & Medicaid Services

Medicare Program; Meeting of the Medicare Evidence Development

and Coverage Advisory Committee--November 18, 2009

ACTION: Notice of meeting.

DATES: Meeting date: The public meeting will be held on Wednesday,

November 18, 2009 from 7:30 a.m. until 4:30 p.m., Eastern Standard Time

(EST).

ADDRESSES: Meeting Location: The meeting will be held in the main

auditorium of the Centers for Medicare & Medicaid Services, 7500

Security Boulevard, Baltimore, MD 21244.

Centers for Medicare & Medicaid Services

Medicare Program; Listening Session Regarding: Defining an

Episode Logic for the Medicare Physician Resource Use Measurement

Program; November 10, 2009

ACTION: Notice of meeting.

SUMMARY: This notice announces a listening session being conducted as

part of the proposal to further the Medicare program's ability to

assess the relative resources used for beneficiary care using episodes

of care as the unit of measurement.

DATES: Meeting Date: The listening session will be held on November 10,

2009 from 9 a.m. until 1 p.m. Eastern standard time (e.s.t.).

ADDRESSES: Meeting Location: The listening session will be held in the

main auditorium of the Central Building of the Centers for Medicare &

Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

Centers for Medicare & Medicaid Services

Medicare Program; Medicare Provider Feedback Group Town Hall

Meeting--October 29, 2009

ACTION: Notice.

SUMMARY: This notice announces the annual Medicare Provider Feedback

Group (MPFG) Town Hall meeting. This meeting is open to all Medicare

Fee-for-Service (FFS) providers and suppliers that participate in the

Medicare program, including physicians, hospitals, home health

agencies, third-party billers, and interested parties, to present their

individual views and opinions on selected FFS Medicare topics. In

addition, we will be soliciting input on how we can improve

communications to better serve the Medicare providers and suppliers.

DATES: Meeting Date: The Town Hall meeting announced in this notice

will be held on Thursday, October 29, 2009 from 2 p.m. to 4 p.m.

Eastern Daylight Time (EDT).

ADDRESSES: Meeting Location: The Town Hall meeting will be held in the

main auditorium of the central building of the Centers for Medicare and

Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244. The

meeting will also be available by teleconference.

Centers for Medicare & Medicaid Services

Medicare Program; Request for Nominations for Members for the

Medicare Evidence Development & Coverage Advisory Committee

ACTION: Notice.

SUMMARY: This notice announces the request for nominations for

consideration for membership on the Medicare Evidence Development &

Coverage Advisory Committee (MEDCAC).

DATES: Nominations will be considered if postmarked by Monday, October

26, 2009 and mailed to the address specified in the ADDRESSES section

of this notice.

Food and Drug Administration

Enforcement of General Tobacco Standard Special Rule for

Cigarettes

ACTION:  Notice.

SUMMARY:  The Federal Food, Drug, and Cosmetic Act (the act), as

amended by the Family Smoking Prevention and Tobacco Control Act

(FSPTCA), establishes a tobacco standard special rule for cigarettes.

DATES:  Effective September 22, 2009.