Weekly Legislative & Regulatory Round-up
Week of April 4 - 10
| GAO reports |
No relevant reports
| OIG reports |
New HHS Recovery Act Fund Oversight Section
Exclusions and Reinstatements Occurring in the Month of March 2009
Civil Monetary Penalty Enforcement Actions Update
March 2009 Criminal and Civil Enforcement Report
| Bills introduced |
Congress in recess
| Federal Register notices |
No relevant reports
No relevant reports
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
Request for Information on Carbon Nanotubes (CNTs) Including
Single-Walled Carbon Nanotubes (SWCNTs) and Multi-Walled Carbon
Nanotubes (MWCNTs)
ACTION: Notice of public comment period.
SUMMARY: The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC) intends
to evaluate the scientific data on carbon nanotubes (CNTs) and develop
appropriate communication documents, such as an Alert and/or Current
Intelligence Bulletin, which will convey the potential health risks and
recommend measures for the safe handling of these materials. NIOSH has
developed guidelines for managing the potential health concerns
associated with occupational exposures to engineered nanoparticles
[see: http://www.cdc.gov/niosh/topics/nanotech/safenano/] which will
provide the framework for developing specific recommendations for CNTs.
Public Comment Period: Comments must be received by May 15, 2009.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Devices; Order for Certain Class III Devices; Submission
of Safety and Effectiveness Information
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
requiring manufacturers of remaining preamendments class III devices
for which regulations requiring submission of premarket approval
applications (PMAs) have not been issued to submit to FDA a summary of,
and a citation to, any information known or otherwise available to them
respecting such devices, including adverse safety or effectiveness
information concerning the devices which has not been submitted under
the Federal Food, Drug, and Cosmetic Act (the act). FDA is requiring
the submission of this information in order to determine, for each
device, whether the classification of the device should be revised to
require the submission of a PMA or a notice of completion of a Product
Development Protocol (PDP), or whether the device should be
reclassified into class I or II.
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of 1995:
Proposed Project: Uncompensated Services Assurance Report (OMB No.
0915-0077)--[Extension]
Under the Hill-Burton Act, the government provides grants and loans
for construction or renovation of health care facilities. As a
condition of receiving this construction assistance, facilities are
required to provide services to persons unable to pay. A condition of
receiving this assistance requires facilities to provide assurances
periodically that the required level of uncompensated care is being
provided, and that certain notification and record keeping procedures
are being followed. These requirements are referred to as the
uncompensated services assurance.
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)
ACTION: Solicits nominations for new members of USPSTF.
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) invites
nominations of individuals qualified to serve as members of the U.S.
Preventive Services Task Force (USPSTF).
The USPSTF, a standing, panel of outside experts that makes
evidence-based recommendations to the health care community and the
public regarding the provision of clinical preventive services, is
composed of members appointed to serve for four year terms with an
option for reappointment. New members are selected each year to replace
approximately one fourth of the USPSTF members, i.e., those who are
completing their appointments. Individuals nominated but not appointed
in previous years, as well as those newly nominated, are considered in
the annual selection process.
To obtain a diversity of perspectives, and enhance opportunities,
AHRQ particularly encourages nominations of women, members of minority
populations, and persons with disabilities. Interested individuals can
self nominate. Organizations and individuals may nominate one or more
persons qualified for membership on the USPSTF.