Weekly Legislative & Regulatory Round-up
Week of February 13 - 19, 2010
| GAO reports |
Electronic Personal Health Information Exchange: Health Care Entities' Reported Disclosure Practices and Effects on Quality of Care GAO-10-361
Recovery Act: Project Selection and Starts Are Influenced by Certain Federal Requirements and Other Factors GAO-10-383
| OIG reports |
No relevant reports.
| Bills introduced |
No bills introduced.
| Federal Register notices |
No relevant notices
No relevant notices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Agreement for Shipment of Devices for Sterilization
ACTION: Notice.
Food and Drug Administration
Agency Information Collection Activities; Proposed Collection;
Comment Request; Exception From General Requirements for Informed
Consent
ACTION: Notice.
Food and Drug Administration
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Humanitarian Device Exemption Holders, Institutional Review Boards,
Clinical Investigators, and Food and Drug Administration Staff:
Humanitarian Device Exemption Regulation: Questions and Answers;
Availability
ACTION: Notice.
Food and Drug Administration
Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
ACTION: Notice.
Date and Time: The meeting will be held on March 18 and 19, 2010,
from 8 a.m. to 6 p.m.
Location: College Park Holiday Inn, Grand Ballroom, 10000 Baltimore
Ave., College Park, MD.
Food and Drug Administration
Pediatric Advisory Committee; Notice of Meeting
ACTION: Notice.
Date and Time: The meeting will be held on Monday, March 22, 2010,
from 8 a.m. to 6 p.m.
Location: Bethesda Marriott Hotel, 5151 Pooks Hill Rd., Bethesda,
MD., 20814.
Office of the Secretary, HHS.
Agency Information Collection Request; 60-Day Public Comment
Proposed Project: Evaluation of Medicare Personal Health Records
Choice Pilot--OMB No. 0990-NEW--Office of the Assistant Secretary for
Planning and Evaluation.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Reporting Information Regarding Falsification of Data
ACTION: Proposed rule.
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations to require sponsors to report information indicating
that any person has, or may have, engaged in the falsification of data
in the course of reporting study results, or in the course of
proposing, designing, performing, recording, supervising, or reviewing
studies that involve human subjects or animal subjects conducted by or
on behalf of a sponsor or relied on by a sponsor. A sponsor would be
required to report this information to the appropriate FDA center
promptly, but no later than 45 calendar days after the sponsor becomes
aware of the information. This proposal is necessary because ambiguity
in the current reporting scheme has caused confusion among sponsors.
The proposed rule is intended to help ensure the validity of data that
the agency receives in support of applications and petitions for FDA
product approvals and authorization of certain labeling claims and to
protect research subjects.
Food and Drug Administration
Office of the Commissioner Reorganization; Statement of
Organizations, Functions, and Delegations of Authority
ACTION: Notice.
Office of the Secretary, Office of Public Health and Science
Meeting of the Secretary's Advisory Committee on Human Research
Protections
ACTION: Notice.
SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee
Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's
Advisory Committee on Human Research Protections (SACHRP) will hold its
twenty-second meeting. The meeting will be open to the public.
DATE: The meeting will be held on Tuesday, March 9, 2010 from 8:30 a.m.
until 5 p.m. and Wednesday, March 10, 2010 from 8:30 a.m. until 5 p.m.
ADDRESSES: U.S. Department of Health & Human Services, 200 Independence
Avenue, SW., Hubert H. Humphrey Building, Room 800, Washington, DC
20201.
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Proposed Project: The Health Education Assistance Loan (HEAL) Program
Regulations (OMB No. 0915-0108) Extension