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

Results 51 - 100 of 296
Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
Document Number: 2017-13296
Type: Notice
Date: 2017-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements associated with extralabel drug use in animals.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-13288
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2017-13252
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals
Document Number: 2017-13248
Type: Notice
Date: 2017-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Reporting for Custom Device Exemption
Document Number: 2017-13245
Type: Notice
Date: 2017-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-13240
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2017-13236
Type: Notice
Date: 2017-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. 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 award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that Brineura (cerliponase alfa) manufactured by Biomarin Pharmaceuticals Inc., meets the criteria for a priority review voucher.
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2017-13221
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-13220
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2017-13219
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-13218
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2017-13217
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2017-13216
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health Notice of Closed Meeting
Document Number: 2017-13215
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2017-13214
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-13213
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-13212
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs: Approval of an Application From the Center for Improvement in Healthcare Quality for Continued CMS Approval of Its Hospital Accreditation Program
Document Number: 2017-13207
Type: Notice
Date: 2017-06-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the Center for Improvement in Healthcare Quality (CIHQ) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2017-13203
Type: Notice
Date: 2017-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-13198
Type: Notice
Date: 2017-06-26
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 (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.
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-13070
Type: Notice
Date: 2017-06-22
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.
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2017-13054
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2017-13051
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity; Comment Request
Document Number: 2017-13033
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Revision of a Currently Approved Collection (ICR Rev); National Survey of Older Americans Act Participants (NSOAAP)
Document Number: 2017-13030
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) 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 as required under the Paperwork Reduction Act of 1995 (the PRA). This 30-Day notice collects comments on the information collection requirements related to a Revision of a Currently Approved Collection (ICR Rev) (OMB approval number 0985-0023).
National Committee on Vital and Health Statistics: Meeting
Document Number: 2017-13023
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services
Agency Information Collection Activities: Submission to OMB for Review and Approval; Information Collection Request Title: Rural Health Network Development Planning Performance Improvement and Measurement System Database, OMB No. 0915-0384-Extension
Document Number: 2017-13019
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form
Document Number: 2017-13018
Type: Notice
Date: 2017-06-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-13017
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services, Administration for Children and Families
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2017-12981
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2017-12980
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-12979
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-12978
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-12977
Type: Notice
Date: 2017-06-22
Agency: Department of Health and Human Services, National Institutes of Health
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