Department of Health and Human Services June 23, 2017 – Federal Register Recent Federal Regulation Documents

Submission of Proposed Recommendations for Industry on Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing; Establishment of a Public Docket
Document Number: 2017-13195
Type: Notice
Date: 2017-06-23
Agency: Food and Drug Administration, Department of Health and Human Services
In connection with promoting the use of innovative technologies, the Food and Drug Administration (FDA or Agency) is establishing a public docket to invite discussion of issues related to the adoption of continuous manufacturing by the pharmaceutical industry.
Patient-Focused Drug Development for Alopecia Areata; Public Meeting; Request for Comments
Document Number: 2017-13194
Type: Notice
Date: 2017-06-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting and an opportunity for public comment on ``Patient-Focused Drug Development for Alopecia Areata.'' Patient- Focused Drug Development is part of FDA's performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of alopecia areata, including on daily life. FDA is also seeking patients' views on treatment approaches and decision factors taken into account when selecting a treatment.
Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee
Document Number: 2017-13182
Type: Notice
Date: 2017-06-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health. In accordance with the 21st Century Cures Act, this notice provides an annual opportunity for patients, representatives of patients, and sponsors of medical device submissions to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Federal Tort Claims Act (FTCA) Program Deeming Applications for Free Clinics, OMB No. 0915-0293-Extension
Document Number: 2017-13178
Type: Notice
Date: 2017-06-23
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 of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Federal Tort Claims Act (FTCA) Program Deeming Applications for Health Centers, OMB No. 0906-XXXX-New
Document Number: 2017-13176
Type: Notice
Date: 2017-06-23
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 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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Federal Tort Claims Act (FTCA) Program Deeming Applications for Health Center Volunteer Health Professionals
Document Number: 2017-13172
Type: Notice
Date: 2017-06-23
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, 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.
Draft Report on Carcinogens Monograph on Haloacetic Acids Found as Water Disinfection By-Products; Availability of Document; Request for Comments; Notice of Peer-Review Meeting
Document Number: 2017-13159
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces a meeting to peer review the Draft Report on Carcinogens (RoC) Monograph on Haloacetic Acids Found as Water Disinfection By-Products. The monograph was prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). The peer review meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration is available at https:// ntp.niehs.nih.gov/go/38853.
Announcement of the Award of 43 Single-Source Low-Cost Extension Supplement Grants Within the Office of Refugee Resettlement's Unaccompanied Alien Children's (UAC) Program
Document Number: 2017-13081
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR, announces the award of 43 single-source low-cost extension supplement grants for a total of $34,847,803 under the Unaccompanied Alien Children's (UAC) Program.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2017-13080
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2017-13079
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2017-13078
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-13077
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2017-13076
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2017-13075
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Advisory Committee on Minority Health
Document Number: 2017-13072
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meetings and/or participate in the public comment session should email OMH-ACMH@hhs.gov.
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