Department of Health and Human Services February 2014 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 344
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership 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 the FDA Safety Communication Readership Survey.
Draft Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of the draft guidance entitled ``Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.'' The draft guidance, when finalized, will describe our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to nonexempt infant formulas.
Draft Guidance for Industry: Demonstration of the Quality Factor Requirements for “Eligible” Infant Formulas; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Demonstration of the Quality Factor Requirements for `Eligible' Infant Formulas.'' The draft guidance, when finalized, will describe our current thinking on the quality factor requirements for eligible infant formulas, the record requirements for eligible infant formulas, and the submission of citizen petitions for eligible infant formulas.
Lohmann Animal Health GMBH; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA) is announcing that Lohmann Animal Health GMBH has filed a petition proposing that the food additive regulations be amended to provide for the safe use of the enzyme phytase from bioengineered Pichia pastoris yeast in animal feed.
Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula
The Food and Drug Administration (FDA, the Agency, or we) is revising our infant formula regulations to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDA's quality control procedures, notification, and record and reporting requirements for infant formula. FDA is taking this action to improve the protection of infants who consume infant formula products.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
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: 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.
Agency Information Collection Activities: Submission for OMB Review
The Centers for Medicare and Medicaid Services published a document in the Federal Register on January 27, 2014, concerning the submission of an information collection request for OMB review and a request for public comments. The document was published in error.
Guidance for Industry; Providing Regulatory Submissions in Electronic Format-Receipt Date; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatReceipt Date.'' This guidance describes how FDA will assign receipt dates to certain submissions provided in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This document finalizes the guidance of the same name, which was issued in June 2007.
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). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Correction
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Pulmonary Arterial Hypertension Public Meeting on Patient-Focused Drug Development
The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for pulmonary arterial hypertension. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of pulmonary arterial hypertension on daily life, as well as their perspectives on the available therapies for pulmonary arterial hypertension.
Scientific Information Request on Public Reporting of Cost Measures in Health
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on public reporting of cost measures in health. Scientific information is being solicited to inform our technical brief on Public Reporting of Cost Measures in Health, which is currently being conducted by the Evidence- based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on public reporting of cost measures in health will improve the quality of this technical brief. AHRQ is conducting this technical brief pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
Proposed Information Collection; 60-day Comment Request: Population Assessment of Tobacco and Health (PATH) Study
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) The approaches used to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Draft Guidance for Industry on Analgesic Indications: Developing Drug and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Analgesic Indications: Developing Drug and Biological Products.'' This guidance provides recommendations to sponsors on the development of prescription drugs for the management of acute and chronic pain, as well as the management of breakthrough pain. Specifically, this guidance focuses on drug development and trial design issues and chemistry, manufacturing, and controls concerns that are unique to the study of acute, chronic, and breakthrough pain and the labeling considerations for analgesic drugs.
Revised Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Standardized Study Data; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data.'' The draft guidance announced in this notice is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on that topic. The draft guidance describes how FDA plans to implement the requirements for the electronic submission of standardized study data contained in certain submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) and is being issued for public comment. This document supersedes the guidance entitled ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data'' that was issued in February 2012.
Study Data Technical Conformance Guide and Data Standards Catalog; Availability
The Food and Drug Administration (FDA) is announcing the availability of a Study Data Technical Conformance Guide and an update to the Data Standards Catalog (formerly the Study Data Standards Catalog). The Study Data Technical Conformance Guide supplements the revised draft guidance for industry ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data'' and provides specifications, recommendations, and general considerations on submitting standardized study data using FDA supported data standards specified in the Data Standards Catalog.
Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatSubmissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance announced in this notice sets forth FDA's interpretation of the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and the Public Health Service Act be submitted in electronic format specified by FDA, beginning no earlier than 24 months after publication of a final version of the draft guidance. This guidance describes how FDA interprets and plans to implement the electronic submission requirements.
Advancing the Development of Pediatric Therapeutics: Pediatric Bone Health; Public Workshop
The Food and Drug Administration's (FDA) Pediatric and Maternal Health Staff in the Center for Drug Evaluation and Research and the Office of Pediatric Therapeutics are announcing a 1-day public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health.'' The purpose of this initial workshop is to provide a forum to consider issues related to advancing pediatric regulatory science in the evaluation of bone health in pediatric patients. Date and Time: The public workshop will be held on March 4, 2014, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held in the Pooks Hill Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814. The hotel's telephone number is 301-897-9400. Contact: Denise Pica-Branco, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1732, Fax: 301-796-9858, email: denise.picabranco@fda.hhs.gov.
Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Reopening of the Comment Period
The Food and Drug Administration (FDA or we) is reopening the comment period for the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled ``Investigational New Drug Applications (INDs)Determining whether Human Research Studies can be Conducted without an IND,'' published in the Federal Register of September 10, 2013 (78 FR 55262). We are reopening the comment period only with respect to those subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements).
NIOSH Center for Motor Vehicle Safety: Research and Guidance Strategic Plan 2014-2018
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft document entitled NIOSH Center for Motor Vehicle Safety: Research and Guidance Strategic Plan 2014-2018 for public comment. To view the notice and related materials, visit https:// www.regulations.gov and enter CDC-2013-0024 in the search field and click ``Search.'' Public comment period: Comments must be received within 30 days from publication of the Federal Register Notice.
Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping
The Food and Drug Administration (FDA or we) 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 the information collection provisions of FDA's regulations governing batch certification of color additives manufactured for use in foods, drugs, cosmetics, or medical devices in the United States.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Cosmetic Registration Program
The Food and Drug Administration (FDA or we) 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 invites comments on the collection of information associated with our Voluntary Cosmetic Registration Program (VCRP).
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Pharmacogenomic Data Submissions
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 the information collection resulting from the submission to the Agency of pharmacogenomic data during the drug development process.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Temporary Assistance for Needy Families (TANF) Program, State Reporting On Policies and Practices to Prevent Use of TANF Funds in Electronic Benefit Transfer Transactions in Specified Locations
The Administration for Children and Families (ACF) proposes to amend the Temporary Assistance for Needy Families (TANF) regulations to require states, subject to penalty, to maintain policies and practices that prevent TANF funded assistance from being used in any electronic benefit transfer transaction in specified locations. This responds to provisions in the Middle Class Tax Relief and Job Creation Act of 2012 requiring states receiving TANF grants to maintain policies and practices as necessary to prevent assistance provided under the program from being used in any electronic benefit transfer transaction in any liquor store; any casino, gambling casino, or gaming establishment; or any retail establishment that provides adult-oriented entertainment in which performers disrobe or perform in an unclothed state for entertainment.
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