Meeting of the Secretary's Advisory Committee on Human Research Protections
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.
Use of Ozone-Depleting Substances
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
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.
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
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
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
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
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.''
New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
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
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
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
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
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.
Health Insurance MarketplaceSM
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
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
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.