Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

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Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2017
Document Number: 2016-17801
Type: Notice
Date: 2016-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. This document establishes the fee rates for FY 2017.
Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-17750
Type: Notice
Date: 2016-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices.'' FDA is issuing this draft guidance to clarify how we evaluate real- world data (RWD) to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in regulatory decisionmaking for medical devices. This guidance also clarifies when an investigational device exemption (IDE) may be needed to prospectively collect and use RWD for purposes of determining the safety and effectiveness of a device. This draft guidance is not final nor is it in effect at this time.
Statement of Organization, Functions, and Delegations of Authority: Office of the Deputy Assistant Secretary for Administration; Office of the Assistant Secretary
Document Number: 2016-17737
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Office of the Deputy Assistant Secretary for Administration (ODASA). This reorganization moves the Office of Information Services from ODASA and establishes it as the new Office of the Chief Information Officer, which reports directly to the Assistant Secretary for Children and Families.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2016-17729
Type: Notice
Date: 2016-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public to attend in person at the FDA White Oak campus in Silver Spring, MD. Members will participate via teleconference.
Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: 2016-17724
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-17720
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-17716
Type: Notice
Date: 2016-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-17656
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2016-17655
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2016-17654
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, National Institutes of Health
Adaptive Designs for Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-17651
Type: Notice
Date: 2016-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Adaptive Designs for Medical Device Clinical Studies.'' This guidance provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial's integrity and validity. Adaptive designs, when properly implemented, can reduce resource requirements and/or increase the chance of study success.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-17643
Type: Notice
Date: 2016-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-17642
Type: Notice
Date: 2016-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
Document Number: 2016-17620
Type: Notice
Date: 2016-07-26
Agency: Department of Health and Human Services
The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twenty-sixth meeting on August 31, 2016. At this meeting, the Commission will reflect on the past, present, and future impact of national bioethics advisory bodies. Topics will include the history of national bioethics advisory bodies and their contributions to health policy, perspectives about similar bodies elsewhere, and discussion about what the future holds for groups like the Commission.
Submission for OMB Review; Comment Request
Document Number: 2016-17618
Type: Notice
Date: 2016-07-26
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-17611
Type: Notice
Date: 2016-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort 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 the National Health Interview Survey (NHIS). The annual National Health Interview Survey is a major source of general statistics on the health of the U.S. population.
Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes
Document Number: 2016-17609
Type: Rule
Date: 2016-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-17604
Type: Notice
Date: 2016-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-17603
Type: Notice
Date: 2016-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 ``National Network of Sexually Transmitted Diseases Clinical Prevention Training Centers (NNPTC): Evaluation''. The purpose of this study is to improve sexually transmitted disease care in the United States.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-17602
Type: Notice
Date: 2016-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 the Well- Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Reporting System. The WISEWOMAN program aims to reduce cardiovascular disease in women ages 40-64 by providing screening services, referrals to medical care, and lifestyle intervention programs.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-17601
Type: Notice
Date: 2016-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 accompanies a Notice of Proposed Rulemaking and invites comment on the information collection request Airline and Vessel and Traveler Information Collection. This information collection request pertains to CDC's activities with regard to requirements at proposed Sec. 71.4 and Sec. 71.5 that airlines and vessels arriving to the United States from foreign countries send passenger, crew, and conveyance information (aka manifests) to CDC in the event that a communicable disease of public health concern is suspected or confirmed in a person aboard who poses a potential public health risk to other travelers and their communities after arriving in the United States. This information also pertains to current activities with regard to the collection of manifests from domestic flights within the United States, as well as the collection of traveler information using the Passenger Locator Form (PLF) on both international and domestic flights.
Agency Information Collection Activities; Proposed Collection; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
Document Number: 2016-17571
Type: Notice
Date: 2016-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collection provisions of our regulations requiring reporting and recordkeeping for processors and importers of fish and fishery products.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 044
Document Number: 2016-17570
Type: Notice
Date: 2016-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled Modifications to the List of Recognized Standards, Recognition List Number: 044 (Recognition List Number: 044), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
Document Number: 2016-17569
Type: Notice
Date: 2016-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
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.
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2016-17561
Type: Notice
Date: 2016-07-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-17560
Type: Notice
Date: 2016-07-26
Agency: Department of Health and Human Services, National Institutes of Health
Unique Device Identification System: Form and Content of the Unique Device Identifier; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments
Document Number: 2016-17554
Type: Notice
Date: 2016-07-26
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 for industry and FDA staff entitled ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).'' When finalized, this draft document will define the expected content and forms of the unique device identifier (UDI), to assist both labelers and FDA-accredited issuing agencies better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the unique device identification system rule (UDI Rule). This draft guidance is not the final version of the guidance nor is it in effect at this time.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-17548
Type: Notice
Date: 2016-07-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2016-17547
Type: Notice
Date: 2016-07-26
Agency: Department of Health and Human Services, National Institutes of Health
Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements
Document Number: 2016-17532
Type: Notice
Date: 2016-07-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public listening session on August 2, 2016, to solicit comments regarding the supplemental notice of proposed rulemaking, ``Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements.'' The session will be held in Rockville, MD, to obtain direct public input from stakeholders on the proposed reporting requirements.
New Animal Drugs; Change of Sponsor
Document Number: 2016-17501
Type: Rule
Date: 2016-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc.
Health Center Program
Document Number: 2016-17497
Type: Notice
Date: 2016-07-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Bureau of Primary Health Care (BPHC) is awarding funds to health centers transitioning to value-based models of care, improving the use of information in decision making, and increasing engagement in delivery system transformation.
Findings of Research Misconduct
Document Number: 2016-17495
Type: Notice
Date: 2016-07-25
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Zhiyu Li, Ph.D., Mount Sinai School of Medicine: Based upon the evidence and findings of an investigation report by the Mount Sinai School of Medicine (MSSM) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Zhiyu Li, former Postdoctoral Fellow, MSSM, engaged in research misconduct in research that was supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R21 CA120017. ORI found that falsified and/or fabricated data were included in the following published papers, submitted manuscript, poster presentation, and grant applications:
Request for Public Comment: 60 Day Proposed Information Collection: Environmental Health Assessment of Tribal Child Care Centers in the Pacific Northwest
Document Number: 2016-17494
Type: Notice
Date: 2016-07-25
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995 which requires 60 days advance opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Proposed Collection: Title: 0917-NEW, ``Indian Health Service Environmental Health Assessment of Tribal Child Care Centers in the Pacific Northwest.'' Type of Information Collection Request: Three year approval of this new information collection, 0917- NEW, ``Indian Health Service Environmental Health Assessment of Tribal Child Care Centers in the Pacific Northwest.'' Form(s): Child Care Center Director Questionnaire and Pesticide Applicator Questionnaire.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-17478
Type: Notice
Date: 2016-07-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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: the necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2016-17441
Type: Notice
Date: 2016-07-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.samhsa.gov/workplace.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Notice of Closed Meeting
Document Number: 2016-17423
Type: Notice
Date: 2016-07-25
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: 2016-17422
Type: Notice
Date: 2016-07-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-17421
Type: Notice
Date: 2016-07-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2016-17420
Type: Notice
Date: 2016-07-25
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-17419
Type: Notice
Date: 2016-07-25
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development 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 and/or co-development.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-17411
Type: Notice
Date: 2016-07-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for OMB Review; Comment Request
Document Number: 2016-17403
Type: Notice
Date: 2016-07-25
Agency: Department of Health and Human Services, Administration for Children and Families
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
Document Number: 2016-17385
Type: Notice
Date: 2016-07-22
Agency: Department of Health and Human Services
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). This meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: http:// www.surgeongeneral.gov/priorities/prevention/advisorygrp/advi sory- group-meetings.html.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-17376
Type: Notice
Date: 2016-07-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Submission for OMB Review; Comment Request
Document Number: 2016-17359
Type: Notice
Date: 2016-07-22
Agency: Department of Health and Human Services, Administration for Children and Families
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2016-17346
Type: Notice
Date: 2016-07-22
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2016-17298
Type: Notice
Date: 2016-07-22
Agency: Department of Health and Human Services, National Institutes of Health