Department of Health and Human Services June 2014 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 337
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
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.
Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products'' dated June 2014. The draft guidance document provides investigational new drug application (IND) sponsors and applicants for a biologics license application (BLA), or a supplement to a BLA, with recommendations on considerations when assessing whether to submit an Environmental Assessment (EA) for gene therapies, vectored vaccines, and related recombinant viral or microbial products (GTVVs). The guidance also contains recommendations as to what information should be included in an EA and what sponsors and applicants can expect once an EA is filed. The guidance, when finalized, will supplement the guidance entitled ``Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications,'' dated July 1998 (1998 Guidance) and will also supersede those recommendations for GTVVs in section IV.B.1 Assessing Toxicity to Environmental Organisms'' of the guidance.
Canned Tuna Deviating From Identity Standard; Temporary Permit for Market Testing
The Food and Drug Administration (FDA or we) received applications for temporary permits from Bumble Bee Foods, LLC; Chicken of the Sea International; and StarKist Seafood Company (the applicants). We are announcing that we have issued temporary permits to the applicants to market test products (designated as ``canned tuna'' products) that deviate from the U.S. standard of identity for canned tuna. The purpose of the temporary permits is to market test the product throughout the United States and the Commonwealth of Puerto Rico. The permits will allow the applicants to measure consumer acceptance of the products and assess the commercial feasibility of the products.
Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy and Accountability, Division of Acquisition; Public Availability of the Department of Health and Human Services FY 2013 Service Contract Inventory
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), Department of Health and Human Services (HHS) is publishing this notice to advise the public of the availability of its FY 2013 Service Contract Inventory. This inventory provides information on service contract actions over $25,000 that were made in FY 2013. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 and December 19, 2011 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at https://www.whitehouse.gov/ sites/default/files/omb/procurement/memo/service-contract-inv entories- guidance-11052010.pdf. HHS has posted its inventory and a summary of the inventory on the HHS homepage at the following link: https:// www.hhs.gov/grants/servicecontracts.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; OAA Title III-E Evaluation
The Administration for Community Living (formerly the Administration on Aging (AoA)) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Draft Guidance for Industry on Uncomplicated Gonorrhea: Developing Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Uncomplicated Gonorrhea: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the development of new antibacterial drugs for the treatment of uncomplicated gonorrhea.
Request for Information: The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods Requests Data and Information on Devices and/or Technologies Used for Identifying Potential Inhalation Hazards
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on devices and/or technologies currently used for identifying potential inhalation hazards. Submitted information will be used to assess the state of the science and determine the technical needs for a dynamic nonanimal system to assess the potential toxicity of inhaled chemicals and nanomaterials.
Symposium on Assessing Exposures and Health Effects Related to Indoor Biomass Fuel Burning; Notice of Meeting and Registration Information
The National Toxicology Program (NTP) announces a symposium on ``Assessing Exposures and Health Effects Related to Indoor Biomass Fuel Burning.'' The symposium will bring together researchers working in the area of indoor biomass fuel burning emissions and health effects to discuss the latest science, policy, and future directions. The meeting is open to the public. Registration is requested for attendance and required to access the webcast. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/41613.
Aurobindo Pharma Ltd. et al.; Withdrawal of Approval of Eighty-Six Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 86 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Proposed Collection; 60-Day Comment Request; Cancer Epidemiology Descriptive Cohort Database (NCI)
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 Cancer Institute (NCI), 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) Ways to enhance 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: Seminara, Daniela, Senior Scientist and Cohort and Consortia Coordination Team Lead, Epidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, 9609 Medical Center Drive, Rockville, MD 20892 or call non-toll-free number 240-276-6748 or Email your request, including your address to: seminard@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
Proposed Collection; 30-Day Comment Request-the Hispanic Community Health Study/Study of Latinos (HCHS/SOL)
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 March 25, 2014 (Vol. 79, No. 57, pages 16345-16347). 3 comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Heart, Lung and Blood Institute (NHLBI), 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; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products, Exemptions From Substantial Equivalence Requirements
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; Adverse Event Program for Medical Devices (Medical Product Safety Network)
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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.
Draft Guidance for Industry on Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Internet/ Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.'' This draft guidance responds to (among other things) stakeholder requests for specific guidance and describes FDA's current thinking on how manufacturers, packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical devices for human use (devices), including biological products, should respond, if they choose to respond, to misinformation related to a firm's own FDA-approved or cleared products when that information is created or disseminated by independent third parties. This draft guidance updates and clarifies FDA's policies on the correction of misinformation created or disseminated by independent third parties on the Internet or through social media platforms, regardless of whether that misinformation appears on a firm's own forum or an independent third-party forum or Web site. The draft guidance represents FDA's current thinking on specific aspects of FDA's evolving consideration of social media platforms and other Internet-related matters. FDA continues actively to review, analyze, and develop approaches to a variety of topics related to the labeling and advertising of medical products, including the development of this and other guidance addressing the use of social media platforms and the Internet.
Draft Guidance for Industry on Internet/Social Media Platforms With Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Internet/ Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.'' This draft guidance responds to, among other things, stakeholder requests for specific guidance and describes FDA's current thinking on how manufacturers, packers, and distributors (firms) of prescription human and animal drugs (drugs) and medical devices for human use (devices), including biological products, that choose to present benefit information should present both benefit and risk information within advertising and promotional labeling of their FDA- regulated medical products on electronic/digital platforms that are associated with character space limitations, specifically on the Internet and through social media or other technological venues (Internet/social media). The draft guidance represents FDA's current thinking on specific aspects of FDA's evolving consideration of social media platforms and other Internet-related matters. FDA continues actively to review, analyze, and develop approaches to a variety of topics related to the labeling and advertising of medical products, including the development of this and other guidance addressing the use of social media platforms and the Internet.
Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant
The Food and Drug Administration (FDA) is issuing a final order to reclassify the blade-form endosseous dental implant, a preamendments class III device, into class II (special controls). On its own initiative, based on new information, FDA is revising the classification of blade-form endosseous dental implants.
Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator
The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for a wheelchair elevator device commonly known as a manually operated portable wheelchair lift. This device is used to provide a means for a disabled person to move a wheelchair from one level to another. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Implementation of the Food and Drug Administration Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act; Reopening of Comment Period
The Food and Drug Administration (FDA or we) is reopening the comment period for the advance notice of proposed rulemaking that appeared in the Federal Register of March 26, 2014. In the advance notice of proposed rulemaking, FDA solicited comments, data, and information to assist the Agency in implementing the FDA Food Safety Modernization Act (FSMA), which added new provisions to the Reportable Food Registry (RFR) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, U.S. Department of Health and Human Services has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
National Preparedness and Response Science Board (previously known as the “National Biodefense Science Board”) Call for Nominees
The deadline for all application submissions to the National Preparedness and Response Science Board (NPRSB), previously known as the National Biodefense Science Board, is extended from June 15, 2014, to June 29, 2014, at 11:59 p.m.. The Office of the Secretary is accepting application submissions from qualified individuals who wish to be considered for membership on the NPRSB; seven members have membership expiration dates of December 31, 2014; therefore, seven new voting members will be selected for the Board. Nominees are being accepted in the following categories: Industry, academia, practicing health care, pediatrics, and organizations representing other appropriate stakeholders. Please visit the NPRSB Web site at www.phe.gov/nprsb for all application submission information and instructions. All members of the public are encouraged to apply.
Scientific Information Request on Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/ CFS), 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 will improve the quality of this review. AHRQ is conducting this systematic review 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 Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the Educating the Educator (EtE) Workshop.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on March 28th, 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``The Agency for Healthcare Research and Quality (AHRQ) Health Care Innovations Exchange Innovator Interview and Innovator Email Submission Guidelines.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on March 28th, 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2014. To fill these positions, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.
Medicare Program; Additional Extension of the Payment Adjustment for Low-Volume Hospitals and the Medicare-Dependent Hospital (MDH) Program Under the Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals for Fiscal Year 2014
This document announces changes to the payment adjustment for low-volume hospitals and to the Medicare-dependent hospital (MDH) program under the hospital inpatient prospective payment systems (IPPS) for the second half of FY 2014 (April 1, 2014 through September 30, 2014) in accordance with sections 105 and 106, respectively, of the Protecting Access to Medicare Act of 2014 (PAMA).
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