Department of Health and Human Services May 13, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Joslyn Manufacturing and Supply Company in Fort Wayne, Indiana, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH GL51); Guidance for Industry on Statistical Evaluation of Stability Data; Availability
The Food and Drug Administration (FDA) is announcing the availability of guidance for industry (GFI 219) entitled ``Guidance for Industry on Statistical Evaluation of Stability Data, VICH GL51.'' This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guidance entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products, GL3(R)'' to propose a retest period or shelf life in a registration application.
Determination of Regulatory Review Period for Purposes of Patent Extension; IMPROVEST
The Food and Drug Administration (FDA) has determined the regulatory review period for IMPROVEST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; TRADJENTA
The Food and Drug Administration (FDA) has determined the regulatory review period for TRADJENTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Proposed Collection; 60-Day Comment Request Return: Chimpanzee Research Use Form (OD)
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 Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), 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 to address 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) Ways 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: The Division of Program Coordination, Planning, and Strategic Initiatives, OD, NIH, Building 1, Room 260, 1 Center Drive, Bethesda, MD 20892; or call non-toll-free number 301-402-9852; or email your request, including your address, to dpcpsi@od.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Chimpanzee Research Use Form, 0925-NEW, Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this form is to obtain information needed by the NIH to assess whether the proposed research triggers consideration by the Chimpanzee Research Use Panel (CRUP) and the NIH Council of Councils (Council), and if so, whether the research satisfies the agency's policy for research involving chimpanzees. The CRUP is a working group of the Council that has been charged with considering whether research proposing to use chimpanzees is consistent with principles and criteria for research involving chimpanzees, as discussed in the 2011 Institute of Medicine report, Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity, and as implemented through agency policy. The NIH, the CRUP, and/or the Council, will consider the information submitted through this form prior to the agency making funding decisions or otherwise allowing the research to begin. Completion of this form is a mandatory step toward receiving NIH support or approval for research involving chimpanzees. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours is 40.
Immune Responses to Enzyme Replacement Therapies: Role of Immune Tolerance Induction; Public Workshop
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the National Organization for Rare Disorders (NORD), is announcing a 1-day public workshop entitled ``Immune Responses to Enzyme Replacement Therapies: Role of Immune Tolerance Induction.'' Partners and stakeholders planning the workshop also include representatives from academia, industry, and patients. The purpose of this workshop is to provide a forum to discuss the role of immune tolerance induction in patients receiving replacement biological products.
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.'' FDA developed this draft document to provide guidance about the appropriate use of national and international voluntary consensus standards in the preparation and evaluation of premarket submissions for medical devices. This document also discusses procedures for the appropriate use of consensus standards, both recognized and non- recognized, limitations on the use of consensus standards, and the content of a Declaration of Conformity to FDA-recognized consensus standards. This draft guidance is not final nor is it in effect at this time.
Determination of Regulatory Review Period for Purposes of Patent Extension; SURFAXIN
The Food and Drug Administration (FDA) has determined the regulatory review period for SURFAXIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Request for Information: The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods Requests the Nomination of Reference Chemicals
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests the nomination of reference chemicals, with supporting data, to be used to validate in vitro metabolizing systems with the potential to interact with estrogen receptors (ERs) or androgen receptors (ARs). Specifically, a list of chemicals is needed to characterize the usefulness and limitations of in vitro metabolizing systems for use in conjunction with ER and AR transactivation tests.
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