Weekly Legislative & Regulatory Round-up
Week of August 15 - 21
| GAO reports |
No relevant notices.
| OIG reports |
Review of Duplicate Capitation Payments to Medicare Advantage Organizations and Programs of All-Inclusive Care for the Elderly Organizations (A-07-08-01052)
| Bills introduced |
Congress in recess.
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological Products Advisory Committee;
ACTION: Notice of public meeting
Name of Committee: Vaccines and Related Biological Products
Advisory Committee.
DATE: The meeting will be held on September 9, 2009, from
8 a.m. to approximately 5 p.m.
ADDRESS: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Board of Scientific Counselors, National Center for Public Health
Informatics (BSC, NCPHI)
ACTION: Notice of public meeting
DATE: 8:30 a.m.-5 p.m., September 2, 2009.
ADDRESS: Hyatt Regency, 265 Peachtree Street NE., Atlanta, Georgia,
30303 Tel: (404) 577-1234, Fax: (404) 588-4137.
Food and Drug Administration
Development of Antiviral Products for Treatment of Smallpox and
Related Poxvirus Infections; Public Workshop
ACTION: Notice of public workshop.
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop regarding scientific issues in clinical development of
antiviral drug products for treatment of smallpox and related poxvirus
infections. This public workshop is intended to provide information for
and gain perspective from health care providers, academia, and industry
on various aspects of antiviral product development for smallpox and
related poxvirus infections.
DATES: The public workshop will be held on September 1,
2009, from 8:30 a.m. to 5:30 p.m. and on September 2, 2009, from 8 a.m.
to 4 p.m.
ADDRESS: The public workshop will be held at the Crowne Plaza
Silver Spring, 8777 Georgia Ave., Silver Spring, MD 20910.
Office of the Secretary
Notice of Interest Rate on Overdue Debts
ACTION: Notice
Section 30.18 of the Department of Health and Human Services'
claims collection regulations (45 CFR Part 30) provides that the
Secretary shall charge an annual rate of interest as fixed by the
Secretary of the Treasury after taking into consideration private
consumer rates of interest prevailing on the date that HHS becomes
entitled to recovery. The rate generally cannot be lower than the
Department of Treasury's current value of funds rate or the applicable
rate determined from the ``Schedule of Certified Interest Rates with
Range of Maturities.'' This rate may be revised quarterly by the
Secretary of the Treasury and shall be published quarterly by the
Department of Health and Human Services in the Federal Register.
The Secretary of the Treasury has certified a rate of 11\1/4% for
the quarter ended June 30, 2009. This interest rate will remain in
effect until such time as the Secretary of the Treasury notifies HHS of
any change.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
AHRQ Intent To Publish Grant and Contract Solicitations for
Comparative Effectiveness Research (CER) Projects With Funds From the
American Recovery and Reinvestment Act (ARRA)
ACTION: Notice of Intent.
SUMMARY: AHRQ is announcing the Agency's intention to support new CER
projects, with funding from the American Recovery and Reinvestment Act
(ARRA).
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 Quality Measures for Children's
Healthcare in Medicaid and Children's Health Insurance Programs
ACTION: Notice of public meeting.
SUMMARY: In accordance with section 10(a) of the Federal Advisory
Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the
National Advisory Council for Healthcare Research and Quality
Subcommittee on Quality Measures for Children's Healthcare in Medicaid
and Children's Health Insurance Programs (CHIP).
DATES: The meeting will be held on Thursday, September 17, 2009, from 8
a.m. to 5 p.m. and Friday, September 18, 2009 from 8 a.m. to 12 p.m.
ADDRESSES: Holiday Inn Capitol, 550 C Street, SW., Washington, DC
20024.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Device Reporting: Electronic Submission Requirements
ACTION: Proposed rule.
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its postmarket medical device reporting regulation to require that
manufacturers, importers, and user facilities submit mandatory reports
of individual medical device adverse events, also known as medical
device reports (MDRs) to the agency in an electronic format that FDA
can process, review, and archive. Mandatory electronic reporting would
improve the agency's process for collecting and analyzing postmarket
medical device adverse event information. The proposed regulatory
changes would provide the agency with a more efficient data entry
process that would allow for timely access to medical device adverse
event information and identification of emerging public health issues.
Elsewhere in this issue of the Federal Register, FDA is also announcing
a draft guidance document that provides recommendations on how to
prepare and submit electronic MDRs to FDA in a manner that satisfies
the requirements of this proposed regulation. The proposal also includes modifications
to the regulations specifying the content of required MDRs to better
track information already solicited on the FDA Form 3500A.
DATES: November 19, 2009. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 (the PRA) by September
21, 2009, (see the ``Paperwork Reduction Act of 1995'' section of this
document).
ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0393 and/or RIN number 0910-AF86, electronically or written.
Electronic Submissions: Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Written Submissions: Submit written submissions in the following ways:
FAX: 301-827-6870. or Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Postmarketing Safety Reports for Human Drug and Biological
Products; Electronic Submission Requirements
ACTION: Proposed rule.
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its postmarketing safety reporting regulations for human drug and
biological products to require that persons subject to mandatory
reporting requirements submit safety reports in an electronic format
that FDA can process, review, and archive. FDA is taking this action to
improve the agency's systems for collecting and analyzing postmarketing
safety reports. The proposed change would help the agency to more
rapidly review postmarketing safety reports, identify emerging safety
problems, and disseminate safety information in support of FDA's public
health mission. In addition, the proposed amendments would be a key
element in harmonizing FDA's postmarketing safety reporting regulations
with international standards for the electronic submission of safety
information.
DATES: Submit written or electronic comments on the proposed rule by
November 19, 2009. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 by September 21, 2009, (see
section ``VII. Paperwork Reduction Act of 1995'' of this document). See
section III.G of this document for the proposed effective date of a
final rule based on this proposed rule.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0334 and/or RIN number 0910-AF96, electronically or in writing.
Electronic Submissions: Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Written Submissions: FAX: 301-827-6870 or Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.