Department of Health and Human Services March 7, 2008 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry and Review Staff on Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route.'' The draft guidance provides recommendations concerning development of safety profiles to support approval of reformulated drug products and products proposed for use by a route of administration for which the product was not previously approved.
Outcome of Meeting of the International Cooperation on Cosmetic Regulation, September 26-28, 2007; Availability
The Food and Drug Administration (FDA) is announcing the availability of the International Cooperation on Cosmetic Regulation (ICCR) Outcome of Meeting, September 26-28, 2007. This notice is in keeping with an FDA/ICCR commitment to transparency as well as providing opportunity for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Collection of Data Relating to the Prevention of Medical Gas Mix-ups at Health Care Facilities-Survey
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on measures, taken by certain health care medical facilities that use medical oxygen, to present mix- ups with other gases.
Intramammary Dosage Forms; Cephapirin Benzathine
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 Fort Dodge Animal Health, Division of Wyeth. The supplemental NADA provides for a revision to the labeling of cephapirin benzathine intramammary infusion administered to dairy cows entering their dry period for the treatment of mastitis.
Revision of the Requirements for Live Vaccine Processing; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of March 18, 2008, for the direct final rule that appeared in the Federal Register of October 18, 2007 (72 FR 59000). The direct final rule amends the biologics regulations by providing options to the existing requirements for the processing of live vaccines. This document confirms the effective date of the direct final rule.
Determination That RELAFEN (Nabumetone) Tablets and Three Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the four drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
State Systems Advance Planning Document (APD) Process
The Advance Planning Document (APD) process governs the procedure by which States obtain approval for Federal financial participation in the cost of acquiring automated data processing equipment and services. This NPRM reduces the submission requirements for lower-risk information technology (IT) projects and procurements and increases oversight over higher-risk IT projects and procurements by making technical changes, conforming changes and substantive revisions in the documentation required to be submitted by States, counties, and territories for approval of their Information Technology plans and acquisition documents.
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