Department of Health and Human Services September 30, 2016 – Federal Register Recent Federal Regulation Documents

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.