Department of Health and Human Services April 17, 2009 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Summary Bioequivalence Data for ANDAs.'' The draft guidance is intended to assist abbreviated new drug application (ANDA) applicants in complying with the new requirements in the final rule on the submission of bioequivalence data published in the Federal Register in January 2009. The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The draft guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs, and is applicable to BE studies conducted during both preapproval and postapproval periods.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting, to be held by teleconference. This meeting will be equivalent to an in-person meeting and will be open to the public. Pre- registration is required for both public attendance by phone as well as public comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail nvpo@hhs.gov.
Oral Dosage Form New Animal Drugs; Fenbendazole Suspension
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA provides for a revised human food safety warning for use of fenbendazole suspension in horses.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Retraction
On Friday, March 6, 2009 (74 FR 9820), the Centers for Medicare & Medicaid Services (CMS) published a Notice document titled ``Agency Information Collection Activities; Proposed Collection; Comment Request''. That notice invited public comments on one information collection. Through the publication of this document, CMS is retracting that notice requesting public comment on the Information Collection Requirement titled ``Electronic Health Records (EHR) Demonstration Web Enabled Application for Phase II'', form number CMS- 10165 (OMB 0938-0965).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and `Lookback''' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device Exemption Guidance for Retinal Prostheses; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Investigational Device Exemption (IDE) Guidance for Retinal Prostheses.'' This draft guidance document provides recommendations to industry about developing pre- clinical and clinical tests of retinal prosthetic devices for submission to FDA in an IDE application. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
