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

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Announcing the Domestic Violence Awareness Month YouTube Challenge; CFDA Number: 93.592
Document Number: 2016-23853
Type: Notice
Date: 2016-09-30
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (FVPSA), announces a Domestic Violence Awareness Month YouTube Challenge. This Challenge is open to individuals and organizations that support children and youth exposed to domestic violence and their abused parents. The goal is to bring attention to the most innovative and inclusive approaches, practices, policies, programs, safe spaces, activities, and strategies that the public is using to improve safety, promote healing, and provide support for this special population.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-23722
Type: Notice
Date: 2016-09-30
Agency: Department of Health and Human Services, Administration for Children and Families
State Health Departments Coordinating Center of the Jurisdictional Approach To Curing Hepatitis C Among HIV/HCV Coinfected People of Color Demonstration Project Supported by the Secretary's Minority AIDS Initiative Fund
Document Number: 2016-23693
Type: Notice
Date: 2016-09-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA's HIV/AIDS Bureau (HAB) awarded a non-competitive single source cooperative agreement to National Alliance of State and Territorial AIDS Directors (NASTAD) for approximately $977,400 in the Secretary's Minority AIDS Initiative Funds (SMAIF) as authorized under the Consolidated Appropriations Act, 2016 (Pub L. 114-113), Division H, Title II. Subject to the availability of funds and NASTAD's satisfactory performance, HAB will also issue non-competitive, single- source awards of approximately $750,000 each in fiscal years (FY) 2017 and 2018. This will allow NASTAD to facilitate the participation of up to two Ryan White HIV/AIDS Program Part B recipients in the Jurisdictional Approach to Curing Hepatitis C among HIV/HCV Coinfected People of Color demonstration project over its 3-year project period.
Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate
Document Number: 2016-23671
Type: Rule
Date: 2016-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete swine feeds. This action is in response to a food additive petition filed by BASF Corp.
BASF Corp.; Filing of Food Additive Petition (Animal Use)
Document Number: 2016-23645
Type: Proposed Rule
Date: 2016-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that BASF Corp., as a part of their petition (FAP 2286) proposing that the food additive regulations be amended to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete swine feeds, also proposed that FDA amend the animal food additive regulations for formic acid and ammonium formate to limit formic acid and formate salts from all added sources.
Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device
Document Number: 2016-23633
Type: Rule
Date: 2016-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying the Evoked Photon Image Capture Device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Submission for OMB Review; Comment Request
Document Number: 2016-23628
Type: Notice
Date: 2016-09-30
Agency: Department of Health and Human Services, Administration for Children and Families
Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2017
Document Number: 2016-23624
Type: Notice
Date: 2016-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the sponsors of rare pediatric disease product applications that meet all of the requirements of this program, are submitted 90 days or more after July 9, 2012, and upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2017 and outlines the payment procedures for such fees.
Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2017
Document Number: 2016-23623
Type: Notice
Date: 2016-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a tropical disease priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2017.
Agency Information Collection Activities; Proposed Collection; Comment Request; Donor Risk Assessment Questionnaire for the Food and Drug Administration/National Heart, Lung, and Blood Institute-Sponsored Transfusion-Transmissible Infections Monitoring System-Risk Factor Elicitation
Document Number: 2016-23622
Type: Notice
Date: 2016-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on an information collection request regarding risk factors associated with transfusion-transmissible infections (TTI) in blood donors.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-23619
Type: Notice
Date: 2016-09-30
Agency: Department of Health and Human Services, Office of the Secretary
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 the ICR to OMB, OS seeks comments from the public regarding the burden estimate below or any other aspect of the ICR.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23605
Type: Notice
Date: 2016-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-23604
Type: Notice
Date: 2016-09-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-23603
Type: Notice
Date: 2016-09-30
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
Document Number: 2016-23230
Type: Rule
Date: 2016-09-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address.
Child Care and Development Fund (CCDF) Program
Document Number: 2016-22986
Type: Rule
Date: 2016-09-30
Agency: Department of Health and Human Services, Administration for Children and Families
This final rule makes regulatory changes to the Child Care and Development Fund (CCDF) based on the Child Care and Development Block Grant Act of 2014. These changes strengthen requirements to protect the health and safety of children in child care; help parents make informed consumer choices and access information to support child development; provide equal access to stable, high-quality child care for low-income children; and enhance the quality of child care and the early childhood workforce.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2016-23585
Type: Notice
Date: 2016-09-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS (the Secretary) is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-23537
Type: Notice
Date: 2016-09-29
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 (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: 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.
Biosimilar User Fee Act; Public Meeting; Correction
Document Number: 2016-23523
Type: Notice
Date: 2016-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Biosimilar User Fee Act; Public Meeting'' that appeared in the Federal Register of September 19, 2016 (81 FR 64171). The document announced a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. The document was published with the incorrect date of the closure of the docket and incorrect transcript information. This document corrects those errors.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
Document Number: 2016-23521
Type: Notice
Date: 2016-09-29
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 FDA's regulations regarding current good manufacturing practice (CGMP) for dietary supplements.
Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Correction
Document Number: 2016-23514
Type: Notice
Date: 2016-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is correcting a notice that appeared in the Federal Register of Tuesday, September 13, 2016 (81 FR 62910). The document announced the availability of a guidance for industry entitled ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The document was published with incorrect information of a comment period due date. This document corrects that error.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-23506
Type: Notice
Date: 2016-09-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; University Centers for Excellence in Developmental Disabilities Education, Research, and Service-Annual Report
Document Number: 2016-23488
Type: Notice
Date: 2016-09-29
Agency: Department of Health and Human Services
The Administration on Intellectual and Developmental Disabilities (AIDD), now part of the Administration for Community Living, 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.
National Eye Institute; Notice of Closed Meeting
Document Number: 2016-23453
Type: Notice
Date: 2016-09-29
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2016-23452
Type: Notice
Date: 2016-09-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meetings
Document Number: 2016-23451
Type: Notice
Date: 2016-09-29
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of Requirements and Registration for “The Simple Extensible Sampling Tool Challenge”
Document Number: 2016-23124
Type: Notice
Date: 2016-09-29
Agency: Department of Health and Human Services, Office of Inspector General
The Simple Extensible Sampling Tool Challenge (Challenge) is an HHS/OIG Challenge under the ``America COMPETES'' (Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science) Reauthorization Act of 2010 (Pub. L. 111-358). The objective of this Challenge is to construct a sampling tool to replace the current version of RAT-STATS software.
The National Heart, Lung, and Blood Institute (NHLBI) COPD National Action Plan; Request for Public Comments
Document Number: 2016-23392
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
NHLBI, with input from federal and nonfederal partners, is developing the COPD National Action Plan to help guide stakeholders nationwide in their efforts to reduce the burden of Chronic Obstructive Pulmonary Disease (COPD). The purpose of this notice is to seek public input on the current draft of the COPD National Action Plan.
Notice of Listing of Members of the National Institutes of Health's Senior Executive Service 2016 Performance Review Board (PRB)
Document Number: 2016-23391
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health's Senior Executive Service 2016 Performance Review Board.
Use of the Term “Healthy” in the Labeling of Human Food Products: Guidance for Industry; Availability
Document Number: 2016-23367
Type: Rule
Date: 2016-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry.'' The guidance advises manufacturers who wish to use the implied nutrient content claim ``healthy'' to label their food products as provided by our regulations. More specifically, the guidance advises food manufacturers of our intent to exercise enforcement discretion with respect to the implied nutrient content claim ``healthy'' on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of ``low fat'', or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.
Use of the Term “Healthy” in the Labeling of Human Food Products; Request for Information and Comments
Document Number: 2016-23365
Type: Proposed Rule
Date: 2016-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive information and comments on the use of the term ``healthy'' in the labeling of human food products. This action is consistent with our recently released 2016-2025 Foods and Veterinary Medicine (FVM) Program's strategic plan with specific goals for nutrition and other planned and recent activity including the issuance of final rules updating certain of our nutrition labeling regulations. In addition, we received a citizen petition asking that we update, among other things, our nutrient content claim regulations to be consistent with current federal dietary guidance. In particular, the petitioners request that FDA amend the regulation defining the nutrient content claim ``healthy'' with respect to total fat intake and amend the regulation to emphasize whole foods and dietary patterns rather than specific nutrients. We invite public comment on the term ``healthy'', generally, and as a nutrient content claim in the context of food labeling and on specific questions contained in this document.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-23340
Type: Notice
Date: 2016-09-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; IONSYS
Document Number: 2016-23330
Type: Notice
Date: 2016-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for IONSYS 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 the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2016-23315
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting
Document Number: 2016-23314
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 2016-23313
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2016-23312
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-23311
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection: Public Comment Request; The Division of Independent Review Grant Reviewer Recruitment Form
Document Number: 2016-23306
Type: Notice
Date: 2016-09-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
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), 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.
Meeting of the 2018 Physical Activity Guidelines Advisory Committee
Document Number: 2016-23280
Type: Notice
Date: 2016-09-27
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS) is hereby giving notice that a meeting of the 2018 Physical Activity Guidelines Advisory Committee (2018 PAGAC or Committee) will be held. This meeting will be open to the public.
Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements
Document Number: 2016-23277
Type: Rule
Date: 2016-09-27
Agency: Department of Health and Human Services
This final rule outlines annual reporting requirements for practitioners who are authorized to treat up to 275 patients with covered medications in an office-based setting. This final rule will require practitioners to provide information on their annual caseload of patients by month, the number of patients provided behavioral health services and referred to behavioral health services, and the features of the practitioner's diversion control plan. These reporting requirements will help the Department of Health and Human Services (HHS) ensure compliance with the requirements of the final rule, ``Medication Assisted Treatment for Opioid Use Disorders,'' published in the Federal Register on July 8, 2016.
Proposed Information Collection Activity; Comment Request Proposed Projects:
Document Number: 2016-23274
Type: Notice
Date: 2016-09-27
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-23252
Type: Notice
Date: 2016-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-23213
Type: Notice
Date: 2016-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-23212
Type: Notice
Date: 2016-09-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-23181
Type: Notice
Date: 2016-09-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-23171
Type: Notice
Date: 2016-09-27
Agency: Department of Health and Human Services, Office of the Secretary
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 an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0001, which expires on December 31, 2016. Prior to submitting the 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
Document Number: 2016-23157
Type: Notice
Date: 2016-09-26
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 (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.
National Institute of Neurological Disorders and Stroke
Document Number: 2016-23143
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23142
Type: Notice
Date: 2016-09-26
Agency: Department of Health and Human Services, National Institutes of Health