Department of Health and Human Services February 2017 – Federal Register Recent Federal Regulation Documents

Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03902
Type: Notice
Date: 2017-02-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-03901
Type: Notice
Date: 2017-02-28
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2017-03897
Type: Notice
Date: 2017-02-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-03896
Type: Notice
Date: 2017-02-28
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2017-03895
Type: Notice
Date: 2017-02-28
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: http://www.dhhs.gov/ ohrp/sachrp-committee/meetings/index.html.
Statement of Delegation of Authority
Document Number: 2017-03867
Type: Notice
Date: 2017-02-28
Agency: Department of Health and Human Services, National Institutes of Health
Use of Ozone-Depleting Substances
Document Number: 2017-03866
Type: Rule
Date: 2017-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
In accordance with a determination by the Director of the Office of Management and Budget (OMB) that the direct final rule (``Use of Ozone Depleting Substances'') published on October 26, 2016, is excluded from the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action confirms the effective date of February 23, 2017, for the direct final rule.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2017-03856
Type: Notice
Date: 2017-02-28
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 the Public Health Service (PHS) Act, as amended. While the Secretary of HHS 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.
Prospective Grant of Exclusive Patent License: The Development of an Anti-Mesothelin Recombinant Immunotoxin (RIT) for the Treatment of Human Cancers.
Document Number: 2017-03823
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Selecta Biosciences (``Selecta'') located in Watertown, Massachusetts to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2017-03822
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2017-03821
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-03820
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2017-03819
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03818
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2017-03817
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-03816
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2017-03815
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2017-03814
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-03809
Type: Notice
Date: 2017-02-27
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 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 State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa; Public Workshop
Document Number: 2017-03751
Type: Notice
Date: 2017-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop regarding the current state and further development of animal models for serious infections caused by Acinetobacter baumannii and Pseudomonas aeruginosa. FDA is conducting this workshop in order to facilitate the development of narrow-spectrum antibacterial drugs, such as those that are active against only a single species of bacteria that may not occur frequently. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, academic experts, contract research organizations, and industry on various aspects of development efforts pertaining to animal models of serious infections. The input from this public workshop will also help FDA in developing topics for future discussion.
Draft Chapter: Analysis of Carbon Nanotubes and Nanofibers on Filters by Transmission Electron Microscopy; Request for Comments
Document Number: 2017-03738
Type: Notice
Date: 2017-02-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft chapter to be published in the NIOSH Manual of Analytical Methods entitled, ``Analysis of Carbon Nanotubes and Nanofibers on Filters by Transmission Electron Microscopy,'' for public comment. The document and instructions for submitting comments can be found at www.regulations.gov.
Personal Protective Equipment Information (PPE-Info) Database
Document Number: 2017-03737
Type: Notice
Date: 2017-02-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention announces the availability of a draft web-based database entitled PPE-Info for public comment. To view the notice and related materials, visit www.regulations.gov and enter CDC-2017-0001 in the search field and click ``Search.''
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2017-03717
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-03716
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Meeting
Document Number: 2017-03708
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03707
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2017-03706
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-03705
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2017-03704
Type: Notice
Date: 2017-02-27
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: 2017-03703
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 2017-03702
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 2017-03701
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meetings
Document Number: 2017-03700
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 2017-03699
Type: Notice
Date: 2017-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03693
Type: Notice
Date: 2017-02-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-03692
Type: Notice
Date: 2017-02-24
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
Document Number: 2017-03678
Type: Rule
Date: 2017-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) at the sponsor's request because the product is no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address
Document Number: 2017-03677
Type: Rule
Date: 2017-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or 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 September and October 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 changes of sponsorship of several applications and a change of a sponsor's address.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2017-03676
Type: Notice
Date: 2017-02-24
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Pantex Plant in Amarillo, Texas, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2017-03675
Type: Notice
Date: 2017-02-24
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Area IV of the Santa Susana Field Laboratory in Ventura County, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Decision To Evaluate a Petition To Designate a Class of Employees From Santa Susana Field Laboratory in Eastern Ventura County, California, To Be Included in the Special Exposure Cohort
Document Number: 2017-03674
Type: Notice
Date: 2017-02-24
Agency: Department of Health and Human Services
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from Area IV of the Santa Susana Field Laboratory in eastern Ventura County, California, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-03647
Type: Notice
Date: 2017-02-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-03629
Type: Notice
Date: 2017-02-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-03628
Type: Notice
Date: 2017-02-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-State, Tribal, Local and Territorial (STLT) Subcommittee
Document Number: 2017-03626
Type: Notice
Date: 2017-02-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Health Insurance MarketplaceSM
Document Number: 2017-03598
Type: Notice
Date: 2017-02-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the next meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace\SM\,\1\ Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
Document Number: 2017-03596
Type: Rule
Date: 2017-02-24
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 approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the- counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative.
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Document Number: 2017-03595
Type: Rule
Date: 2017-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of 18 new animal drug applications (NADAs) and 2 abbreviated new animal drug applications (ANADAs). These withdrawals of approval of NADAs and ANADAs for antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed are being made because the products are no longer manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine's initiative for the Judicious Use of Antimicrobials.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-03593
Type: Notice
Date: 2017-02-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services