Department of Health and Human Services June 2008 – Federal Register Recent Federal Regulation Documents

Results 301 - 304 of 304
Medical Devices; Hearing Aids; Technical Data Amendments
Document Number: E8-11910
Type: Rule
Date: 2008-06-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations governing hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids. We are amending the regulations to require that manufacturers may use state-of-the-art methods to provide technical data in hearing aid labeling. FDA is also amending the regulations to update an address and remove an outdated requirement. FDA is amending the regulations in accordance with its direct final rule procedures. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedures for notice and comment rulemaking to provide a procedural framework to finalize the rule in the event we receive a significant adverse comment and withdraw this direct final rule.
Medical Devices; Hearing Aids; Technical Data Amendments
Document Number: E8-11909
Type: Proposed Rule
Date: 2008-06-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its regulations governing hearing aid labeling to reference the most recent version of the consensus standard used to determine the technical data to be included in labeling for hearing aids. We are proposing to amend the regulations to require manufacturers to use state-of-the-art methods to provide technical data in hearing aid labeling. FDA is also proposing to amend the regulations to update an address and remove an outdated requirement. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-11790
Type: Notice
Date: 2008-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Designation of Medically Underserved Populations and Health Professional Shortage Areas
Document Number: 08-1314
Type: Proposed Rule
Date: 2008-06-02
Agency: Department of Health and Human Services
On April 21, 2008, HHS published a 30-day extension to the public comment period and provided clarification on the notice of proposed rulemaking, ``Designation of Medically Underserved Populations and Health Professional Shortage Areas'' (73 FR 21300). HHS and the Health Resources and Services Administration (HRSA) have received requests for a further extension to the comment period. In consideration of these requests, HHS is extending the comment period an additional 30 days, with a new closing date of June 30, 2008.