Department of Health and Human Services August 22, 2012 – Federal Register Recent Federal Regulation Documents
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Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agencies, and Organizations
This final rule makes technical changes that will update a requirement that many of the written agreements and memoranda of understanding (MOUs) between the Food and Drug Administration (FDA) and other departments, Agencies, and organizations be published in the Federal Register. Because we already post and will continue to post our ongoing agreements and MOUs with other departments, Agencies, and organizations on our Web site upon their completion, this requirement is no longer necessary. This final rule, accordingly, eliminates it. We are making these technical changes to conserve Agency time and resources, reduce government paperwork, and eliminate unnecessary Federal Register printing costs while continuing to afford public access to these documents.
Animal Drugs, Feeds, and Related Products; Regulation of Carcinogenic Compounds in Food-Producing Animals
The Food and Drug Administration (FDA) is amending its regulations regarding compounds of carcinogenic concern used in food- producing animals. Specifically, the Agency is clarifying the definition of ``So'' and revising the definition of ``Sm'' so that it conforms to the clarified definition of So. Other clarifying and conforming changes are also being made.
Cardiovascular and Renal Drugs Advisory Committee; Cancellation
The meeting of the Cardiovascular and Renal Drugs Advisory Committee scheduled for September 14, 2012, is cancelled. The meeting is no longer needed. This meeting was announced in the Federal Register of July 23, 2012 (77 FR 43093).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Ranbaxy Laboratories Limited; Withdrawal of Approval of 27 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) held by Ranbaxy Laboratories Ltd., c/o Ranbaxy Inc. (Ranbaxy), 600 College Rd. East, Princeton, NJ 08540. The drug products are no longer marketed, and Ranbaxy has requested that the approval of the applications be withdrawn.
Request for Information (RFI): Guidance on Data Streamlining and Reducing Undue Reporting Burden for HHS-Funded HIV Prevention, Treatment, and Care Services Grantees
The Department of Health and Human Services (HHS) seeks assistance from key stakeholders to identify and address grant-related data flow challenges and offer specific solutions for streamlining data collection and reducing undue burden among HHS grantees funded to provide HIV prevention, treatment, and care services.
Request for Information on Quality Measurement Enabled by Health IT-Extension Date for Responses
The Agency for Healthcare Research and Quality (AHRQ) requests information from the Public, including diversified stakeholders (health information technology (IT) system developers, including vendors; payers, quality measure developers, end-users, clinicians, health care consumers) regarding current successful strategies and challenges regarding quality measurement enabled by health IT. Quality measurementthe assessment of the timeliness, completeness and appropriateness of preventive services, diagnostic services, and treatment provided in health carehas been most generally conducted via paper chart information capture, manual chart abstraction, and the analysis of administrative claims data. Through this notice, the comment period has been extended. The subject matter content remains unchanged from the original notice which was previously published on July 20, 2012 (www.GPO.gov/fdsys/PKG/FR-2012-07-20/html/2012-17530.htm)
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