Weekly Legislative & Regulatory Round-up
Week of April 11 - 17
| GAO reports |
No relevant reports
| OIG reports |
Potential Improper Medicaid Payments for Outpatient Clinical Diagnostic Laboratory Services for Dual-Eligible Beneficiaries (PDF) (OEI-04-07-00340)
| Bills introduced |
Congress in recess
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Presidential Documents
Executive Order 13507 of April 8, 2009
Establishment of the White House Office of Health Reform
Office of the Secretary
Solicitation of Written Comments on Draft National Vaccine
Advisory Committee Vaccine Safety Working Group Recommendations to the
Immunization Safety Office
ACTION: Notice.
SUMMARY: The National Vaccine Program Office (NVPO) is soliciting
public comment on the National Vaccine Advisory Committee (NVAC)
Vaccine Safety Working Group draft Recommendations to the Centers for
Disease Control and Prevention's Immunization Safety Office (ISO).
DATES: Comments on the NVAC Vaccine Safety Working Group draft report
should be received no later than 5 p.m. on May 13, 2009.
Office of the Secretary
Meeting of the Advisory Committee on Blood Safety and
Availability
ACTION: Notice.
SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S.
Department of Health and Human Services is hereby giving notice that
the Advisory Committee on Blood Safety and Availability (ACBSA) will
hold a meeting. The meeting will be open to the public.
DATES: The meeting will take place Thursday, April 30 and Friday, May
1, 2009 from 9 a.m. to 5 p.m.
ADDRESSES: The Universities at Shady Grove, 9630 Gudelsky Drive,
Rockville, MD 20850, Phone: 301-738-6000.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Determination That ZOMETA (Zoledronic Acid for Injection),
Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for
Injection, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) has determined that
ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams
(mg) base/vial, lyophilized powder for injection, was not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
zoledronic acid lyophilized powder for injection, 4-mg base/vial.
National Institutes of Health
Government-Owned Inventions; Availability for Licensing: Methods
for Improvements and Enhancements of Diffusion Tensor MRI
ACTION: Notice.
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of Federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
ACTION: Notice.
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of Federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
National Institutes of Health
The Best Pharmaceuticals for Children Act (BPCA) Priority List of
Needs in Pediatric Therapeutics
ACTION: Notice.
SUMMARY: In this notice, we will summarize past efforts to prioritize off-patent
drugs that need further study as mandated by the BPCA 2002 and describe
the plans for identifying needs in pediatric therapeutics as authorized
by the BPCA 2007.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Preparation for International Conference on Harmonisation
Meetings in Yokohama, Japan; Public Meeting
ACTION: Notice of public meeting.
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Preparation for ICH meetings in Yokohama, Japan'' to
provide information and receive comments on the International
Conference on Harmonisation (ICH) as well as the upcoming meetings in
Yokohama, Japan. The topics to be discussed are the topics for
discussion at the forthcoming ICH Steering Committee Meeting. The
purpose of the meeting is to solicit public input prior to the next
Steering Committee and Expert Working Groups meetings in Yokohama,
Japan, scheduled for June 6 through 11, 2009, at which discussion of
the topics underway and the future of ICH will continue, as well as
provide comprehensive updates of the various ICH topics.
Date and Time: The meeting will be held on May 6, 2009, from 2:30
p.m. to 5 p.m.
Location: The meeting will be held in the Washington Room at the
Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750
Rockville Pike, Rockville, MD 20852. For security reasons, all
attendees are asked to arrive no later than 2:15 p.m.
No relevant notices.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Solicitation for Nominations for Members of the U.S. Preventive
Services Task Force (USPSTF)
In notice document E9-8040 beginning on page 16408 in the issue of
Friday, April 10, 2009, make the following corrections:
1. On page 16409, in the first column, in the fifth line from the
top, ``indMduals'' should read ``individuals''.
2. On the same page, in the ADDRESSES section, in the eighth and
ninth lines, ``http://dreamless.keenspot.com/comic.rss'' should read
``uspstaskforce@ahrq.hhs.gov''.
3. On the same page, in the FOR FURTHER INFORMATION CONTACT
section, in the second line, ``uspstaskforce@ahrg.hhs.gov'' should read
``uspstaskforce@ahrq.hhs.gov''.
4. On the same page, in the last full paragraph, in the second line
from the bottom, ``http://preventiveservices.ahrg.gov'' should read
``http://preventiveservices.ahrq.gov''.
Food and Drug Administration
Draft Guidance for Industry and Food and Drug Administration
Staff; Investigational Device Exemption Guidance for Retinal
Prostheses; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Investigational Device
Exemption (IDE) Guidance for Retinal Prostheses.'' This draft guidance
document provides recommendations to industry about developing pre-
clinical and clinical tests of retinal prosthetic devices for
submission to FDA in an IDE application. This draft guidance is not
final nor is it in effect at this time.
Food and Drug Administration
Draft Guidance for Industry on the Submission of Summary
Bioequivalence Data for Abbreviated New Drug Applications; Availability
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Submission of Summary Bioequivalence Data for ANDAs.'' The draft guidance is intended to assist abbreviated new drug application (ANDA) applicants in complying with the new requirements in the final rule on the submission of bioequivalence data published in the Federal Register in January 2009.