Department of Health and Human Services February 19, 2013 – Federal Register Recent Federal Regulation Documents

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Period for Information Collection Provisions
Document Number: 2013-03778
Type: Proposed Rule
Date: 2013-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or ``we'') is extending the comment period for the information collection provisions of the proposed rule on ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' that appeared in the Federal Register of January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the information collection provisions associated with the rule.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: 2013-03737
Type: Notice
Date: 2013-02-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Period for Information Collection Provisions
Document Number: 2013-03732
Type: Proposed Rule
Date: 2013-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or ``we'') is extending the comment period for the information collection related to the proposed rule on ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' that appeared in the Federal Register of January 16, 2013. In the preamble to the proposed rule, FDA requested comments on the information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the information collection provisions associated with the rule.
Request for Information: Main Study Design for the National Children's Study
Document Number: 2013-03716
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, National Institutes of Health
The Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD), National Institutes of Health (NIH), is issuing a Request for Information (RFI) as part of the National Children's Study's (NCS) effort to engage communities and receive public input on specific design questions for incorporation into the Main Study Design of the NCS. The information obtained from RFI responses will be used to guide the construction of decision points or parameters for the Main Study design over the next 12-18 months. This RFI was preceded by a workshop with the National Academy of Sciences which posed similar questions. For background information on this workshop, please visit: http://www.nationalchildrensstudy.gov/research/ workshops/Pages/nationalacademyofsciencesworkshop.aspx.
Advisory Committee on Organ Transplantation; Notice of Meeting
Document Number: 2013-03713
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards
Document Number: 2013-03707
Type: Notice
Date: 2013-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
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 ``Manufactured Food Regulatory Program Standards.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act
Document Number: 2013-03705
Type: Notice
Date: 2013-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection involving interviews of pharmaceutical manufacturers who submit new molecular entity (NME) new drug applications (NDAs) and original biologics license applications (BLAs) to FDA under the Program for Enhanced Review Transparency and Communication (``the Program'') during fiscal years (FYs) 2013-2017. The Program is part of the FDA performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA), which allows FDA to collect user fees for the review of human drug and biologics applications for FYs 2013-2017.
Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act; Availability
Document Number: 2013-03652
Type: Notice
Date: 2013-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time.
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure
Document Number: 2013-03647
Type: Proposed Rule
Date: 2013-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 1, 2010, along with a companion direct final rule. The proposed rule proposed to amend the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. The Agency received significant adverse comment and withdrew the direct final rule. The Agency is issuing this supplemental notice of proposed rulemaking re-proposing the amendments reflecting comments received.
Clinical Center; Notice of Closed Meeting
Document Number: 2013-03643
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-03642
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meeting
Document Number: 2013-03641
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-03640
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging And Bioengineering; Notice of Closed Meeting
Document Number: 2013-03639
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute Of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-03638
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2013-03637
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2013-03636
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2013-03635
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2013-03634
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2013-03624
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-03622
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-03621
Type: Notice
Date: 2013-02-19
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Neonatal Subcommittee of the Pediatric Advisory Committee; Notice of Meeting
Document Number: 2013-03613
Type: Notice
Date: 2013-02-19
Agency: Food and Drug Administration, Department of Health and Human Services
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2013-03612
Type: Notice
Date: 2013-02-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
Document Number: 2013-03610
Type: Notice
Date: 2013-02-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services