Weekly Legislative & Regulatory Round-up
Week of February 6 - 12, 2010
| GAO reports |
No relevant reports.
| OIG reports |
Average Sales Prices: Manufacturer Reporting and CMS Oversight (OEI-03-08-00480)
| Bills introduced |
|
Number/ Title |
Date Introduced | Sponsor | Description | S. 3011 |
2/11/10 |
KRISTEN GILLIBRAND (D-NY) |
A bill to address HIV/AIDS in the African-American community, and for other purposes; to the Committee on Health, Education, Labor, and Pensions. |
| Federal Register notices |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Guidance for Industry and Food and Drug Administration; Guidance
for the Use of Bayesian Statistics in Medical Device Clinical Trials;
Availability
ACTION: Notice.
Food and Drug Administration
Guidance for Industry on the Contents of a Complete Submission
for the Evaluation of Proprietary Names; Availability
ACTION: Notice.
National Institutes of Health
Proposed Collection; Comment Request
Title: Web Based Training for Pain Management Providers.
Type of Information Collection Request: New.
National Institutes of Health
Prospective Grant of Exclusive License: Purified Inactivated
Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion
in the 3'-UTR of Dengue Types 1,2,3, and 4
ACTION: Notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
National Center for Health Statistics (NCHS), Classifications and
Public Health Data Standards Staff, announces the following meeting:
Name: ICD-9-CM Coordination and Maintenance Committee meeting.
Time and Date: 9 a.m.-4:30 p.m., March 9-10, 2010.
Place: Centers for Medicare and Medicaid Services (CMS) Auditorium,
7500 Security Boulevard, Baltimore, Maryland.
Status: Open to the public.
Food and Drug Administration
Medical Devices Regulated by the Center for Biologics Evaluation
and Research; Availability of Summaries of Safety and Effectiveness
Data for Premarket Approval Applications
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved by the
Center for Biologics Evaluation and Research (CBER). This list is
intended to inform the public of the availability through the Internet
and FDA's Division of Dockets Management of summaries of safety and
effectiveness data of approved PMAs.
Food and Drug Administration
Regulatory Site Visit Training Program
ACTION: Notice.
SUMMARY: The Food and Drug Administration's (FDA's) Center for
Biologics Evaluation and Research (CBER) is announcing an invitation
for participation in its Regulatory Site Visit Training Program (RSVP).
This training program is intended to give CBER regulatory review,
compliance, and other relevant staff an opportunity to visit biologics
facilities. These visits are intended to allow CBER staff to directly
observe routine manufacturing practices and to give CBER staff a better
understanding of the biologics industry, including its challenges and
operations. The purpose of this notice is to invite biologics
facilities to contact CBER for more information if they are interested
in participating in this program.
Office of the National Coordinator for Health Information
Technology
HIT Policy Committee's Adoption/Certification Workgroup
Meeting
ACTION: Notice of meeting.
Date and Time: The meeting will be held on February 25, 2010,
from 10 a.m. to 3 p.m./Eastern Time.
Location: OMNI Shoreham Hotel, 2500 Calvert Street, NW.,
Washington, DC 20008.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Expert Meeting on Measurement Criteria for Children's Health
Insurance Program; Reauthorization Act Pediatric Quality Measures
ACTION: Notice of public meeting.
DATES: The meeting will be held on Wednesday, February 24, 2010, from
10 a.m. to 5 p.m. and Thursday, February 25, 2010, from 8 a.m. to 4
p.m.
ADDRESSES: Agency for Healthcare Research and Quality Eisenberg
Building, 540 Gaither Rd., Rockville, MD 20850 and by public webcast.
No relevant notices
No relevant notices.