Department of Health and Human Services December 4, 2013 – Federal Register Recent Federal Regulation Documents

National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2013-29020
Type: Notice
Date: 2013-12-04
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act
Document Number: 2013-29010
Type: Notice
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-29008
Type: Notice
Date: 2013-12-04
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-28991
Type: Notice
Date: 2013-12-04
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
Document Number: 2013-28990
Type: Notice
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Tissue Intended for Transplantation
Document Number: 2013-28989
Type: Notice
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations
Document Number: 2013-28980
Type: Proposed Rule
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is preparing to develop a list of drug products that present demonstrable difficulties for compounding (difficult-to-compound list). To identify candidates for this list, FDA is encouraging interested groups and individuals to nominate specific drug products or categories of drug products and is describing the information that should be provided to the Agency in support of each nomination.
List of Bulk Drug Substances That May Be Used in Pharmacy Compounding; Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act
Document Number: 2013-28979
Type: Proposed Rule
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing the proposed rule to list bulk drug substances used in pharmacy compounding and preparing to develop a list of bulk drug substances (bulk drugs) that may be used to compound drug products, although they are neither the subject of a United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA- approved drugs. To identify candidates for this bulk drugs list, interested groups and individuals may nominate specific bulk drug substances, and FDA is describing the information that should be provided to the Agency in support of each nomination.
Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act, Concerning Outsourcing Facilities; Request for Nominations
Document Number: 2013-28978
Type: Proposed Rule
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is preparing to develop a list of bulk drug substances (bulk drugs) that may be used to compound drug products in accordance with section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), concerning outsourcing facilities. To identify candidates for this bulk drugs list, interested groups and individuals may nominate specific bulk drug substances, and FDA is describing the information that should be provided to the Agency in support of each nomination.
Draft Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidances
Document Number: 2013-28963
Type: Notice
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance entitled ``Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act''. The draft guidance announces the Agency's intention with regard to enforcement of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to regulate entities that compound drugs, now that the FD&C Act has been amended by the Drug Quality and Security Act. When final, the guidance will reflect the Agency's current thinking on the issues addressed by the guidance. The Agency is also announcing the withdrawal of a guidance entitled, ``Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act,'' which was issued in November 1998, and the withdrawal of CPG Section 460.200 of the Compliance Program Guidance (CPG) Manual entitled, ``Pharmacy Compounding,'' which was issued in May 2002. These guidances are being withdrawn because they are no longer consistent with the Agency's current thinking on the issues they address.
Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2013-28962
Type: Notice
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). The draft guidance is intended to assist human drug compounders that choose to register as outsourcing facilities (outsourcing facilities) in registering with FDA. The draft guidance provides information on how an outsourcing facility should submit facility registration information electronically.
Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability
Document Number: 2013-28961
Type: Notice
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions.'' This guidance provides information in response to questions that FDA has received regarding the issuance of civil money penalties for violations of regulations issued under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) relating to tobacco products in retail outlets.
Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2013-28960
Type: Notice
Date: 2013-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA), and sets forth an interim electronic submission method for human drug compounders that choose to register as outsourcing facilities (outsourcing facilities).
Findings of Research Misconduct
Document Number: 2013-28887
Type: Notice
Date: 2013-12-04
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Timothy Sheehy, B.A., BSc., SAIC-Frederick, Inc.