Weekly Legislative & Regulatory Round-up
Week of September 5 - September 11
| GAO reports |
Recovery Act: States' and Localities' Current and Planned Uses of Funds While Facing Fiscal Stresses GAO-09-908T
Ryan White CARE Act: Program Changes Affecting Minority AIDS Initiative and Part D Grantees GAO-09-1027T
| OIG reports |
Medicare Hospice Care for Beneficiaries in Nursing Facilities: Compliance With Medicare Coverage Requirements (OEI-02-06-00221)
Medicare Hospice Care: Services Provided to Beneficiaries Residing in Nursing Facilities (OEI-02-06-00223)
Medicare Part D Reconciliation Payments for 2006 and 2007 (OEI-02-08-00460)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description |
H. Res. 727 |
9/9/09 |
STEVE ISRAEL (D-NY) |
A resolution supporting the goals and ideals of National Ovarian Cancer Awareness Month; to the Committee on Oversight and Government Reform. |
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 022
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 022'' (Recognition List Number: 022), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit written or electronic comments concerning this document
at any time. See section VII of this document for the effective date of
the recognition of standards announced in this document.
Food and Drug Administration
2009 Parenteral Drug Association and Food and Drug Administration
Joint Regulatory Conference
ACTION: Notice of meeting.
SUMMARY: The Food and Drug Administration (FDA) in co-sponsorship with
the Parenteral Drug Association (PDA), is announcing a conference
entitled ``Securing the Future of Medical Product Quality: A 2020
Vision.'' The workshop helps to achieve objectives set forth in the FDA
Modernization Act of 1997, which include working closely with
stakeholders and maximizing the availability and clarity of information
to stakeholders and the public.
Date and Time: The conference will be held on Monday, September 14,
2009 from 8 a.m. to 6 p.m.; Tuesday, September 15, 2009 from 7:15 a.m.
to 5:45 p.m.; and Wednesday, September 16 from 7:15 a.m. to 1:15 p.m.
Location: The public workshop will be held at the Renaissance
Hotel, 999 9th St., Washington, D.C., 20001; 1-202-898-9000; FAX: 1-
202-289-0947.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
Emergency Clearance: Public Information Collection Requirements
Submitted to the Office of Management and Budget (OMB)
Type of Information Collection Request: New collection; Title of
Information Collection: Recovery Act--Reporting Requirements for States
Under FMAP Increase and TMA Provisions.
Food and Drug Administration
Draft Guidance for Industry and Food and Drug Administration
Staff; Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for the Detection or Detection and Differentiation
of Human Papillomaviruses; Availability
ACTION: Notice.
Food and Drug Administration
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for a Pool of Nonvoting
Industry Representatives for the Risk Communication Advisory Committee
and Request for Nominations for Nonvoting Industry Representatives for
the Risk Communication Advisory Committee
ACTION: Notice.
Food and Drug Administration
Request for Notification from Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives on Medical Device Advisory Committee Panels and Request
for Nonvoting Industry Representatives on Medical Device Advisory
Committee Panels
ACTION: Notice.
Food and Drug Administration
Request for Nominations for Voting and Nonvoting Consumer
Representative Members on Public Advisory Committees and Panels
ACTION: Notice.
The Food and Drug Administration (FDA) is requesting
nominations for voting and nonvoting consumer representatives to serve
on the National Mammography Quality Assurance Advisory Committee
(NMQAAC) and certain devices panels of the Medical Devices Advisory
Committee in the Center for Devices and Radiological Health (CDRH).
DATES: Nominations will be accepted for current vacancies and for those
that will or may occur through October 31, 2010. Because vacancies
occur on various dates throughout the year, there is no cutoff date for the receipt of
nominations.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Notice of Amendment--Public Meeting of the AHRQ National Advisory
Council for Healthcare Research and Quality Subcommittee On Quality
Measures for Children's Healthcare in Medicaid and Children's Health
Insurance Programs
SUMMARY: With this correction notice, the Agency for Healthcare Research and
Quality (AHRQ) informs public of an Amendment made to the notice
subject mentioned above which was published on August 20, 2009, Vol.
74, No. 160, pages 42079-42080, The amendment is to add at the end of
section SUPPLEMENTARY INFORMATION, the following: ``As previously
noted, the meeting is open to the public and can also be joined via
Webcast. The link to online registration for Webcast is http://
www.ConnectLive.com/events/AHRQ2009.''
Food and Drug Administration
Medical Devices: Neurological Devices; Electroconvulsive Therapy
Device; Establishing a Public Docket
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a public docket to receive information and comments
regarding the current classification process related to
electroconvulsive therapy devices (ECT).
Office of the Secretary, Office of Public Health and Science
Meeting of the National Vaccine Advisory Committee
ACTION: Notice; amendment.
SUMMARY: A notice was published in the Federal Register on Wednesday,
August 26, 2009, Vol. 74, No. 164, to announce that a meeting of the
National Vaccine Advisory Committee will be held on September 15 and
16, 2009. The meeting is open to the public. The meeting proceedings
also will be Webcast; the Webcast can be viewed at http://
Office of the Secretary of Health and Human Services
Secretarial Review and Publication of the Annual Report to
Congress Submitted by the Contracted Consensus-Based Entity Regarding
Performance Measurement
ACTION: Notice.
SUMMARY: This notice acknowledges the Department of Health and Human
Services' (HHS) receipt and review of the annual report submitted to
the Secretary and Congress by the contracted consensus-based entity
regarding performance measurement as mandated by section 183 of the
Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).
The statute requires HHS to publish not later than six months after
receiving the annual report to Congress in the Federal Register
together with any Secretarial comments.
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.
Interested persons are invited to send comments regarding this burden
estimate or any other aspect of this collection of information.
1. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Matching Grants to States for the Operation of High Risk Pools;
2. Type of Information Collection Request: New Collection; Title of
Information Collection: State Plan Pre-Print to Implement Required
Dental Benefits Pursuant of Children's Health Insurance Program
Reauthorizing Act (CHIPRA) 2009;
3. Type of Information Collection Request: New Collection; Title of
Information Collection: Optional Dental-only Supplemental Coverage
State Plan Amendment Template;
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: The Medicare
Contractor Provider Satisfaction Survey (MCPSS).
Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection;
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS) is publishing the following summary of proposed
collections for public comment. Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information.
1. Type of Information Collection Request: Extension without change
of a currently approved collection;
2. Type of Information Collection Request: New Collection; Title of
Information Collection: State Medicaid HIT Plan and Templates for
Implementation of Section 4201 of ARRA.