Department of Health and Human Services June 17, 2015 – Federal Register Recent Federal Regulation Documents
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Submission for OMB Review; 30-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-3rd Wave (NIDA)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 11, 2015, pages 7619-7620 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute on Drug Abuse (NIDA), National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_Submission@omb.eop.gov or by fax to (202) 395-6974, Attention: NIH Desk Officer.
Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
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; Regulations Under the Federal Import Milk 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Irradiation in the Production, Processing, and Handling of Food
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.
Naming of Drug Products Containing Salt Drug Substances; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Naming of Drug Products Containing Salt Drug Substances'' which replaces the draft guidance of the same title that published on December 26, 2013. This guidance describes the United States Pharmacopeia's (USP's) ``Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations,'' which became official on May 1, 2013, and how the Center for Drug Evaluation and Research (CDER) is implementing it.
Final Determination Regarding Partially Hydrogenated Oils
Based on the available scientific evidence and the findings of expert scientific panels, the Food and Drug Administration (FDA or we) has made a final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially-produced trans fatty acids (IP-TFA) are generally recognized as safe (GRAS) for any use in human food. This action responds, in part, to citizen petitions we received, and we base our determination on available scientific evidence and the findings of expert scientific panels establishing the health risks associated with the consumption of trans fat.
Content and Format of Abbreviated 510(k)s for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices.'' This guidance provides industry and Agency staff with recommendations for the suggested format and content of an abbreviated 510(k) submission for EGR1 gene FISH test system for specimen characterization devices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Ads
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; Announcement of Office of Management and Budget Approval; Food and Cosmetic Export Certificate Applications Process
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ``Food and Cosmetic Export Certificate Applications Process'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). 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.
Announcement of the Award of Single-Source Expansion Supplement Grants to Seven Personal Responsibility Education Program Innovative Strategies (PREIS) Grantees
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS), announces the award of single-source expansion supplement grants to seven PREIS grantees for the purpose of expanding retention and follow-up efforts for program participants. The funds will allow grantees to collect the increased data necessary to determine the program effectiveness and for the manualization of a validated curriculum and supporting documents.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a revision to several of the information collections pertaining to the importation of dogs as outlined in the currently approved information collection entitled ``Foreign Quarantine Regulations (42 CFR part 71)''.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This proposed rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. The proposed rule sets forth the calculation of the ceiling price and application of civil monetary penalties.
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