Department of Health and Human Services August 2019 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Proposed Collection; Comment Request; State Program Report
Document Number: 2019-18842
Type: Notice
Date: 2019-08-30
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 Proposed Revision for the information collection requirements related to State Program Report.
Proposed Collection; 30 Day Comment Request; The Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research (Clinical Center)
Document Number: 2019-18840
Type: Notice
Date: 2019-08-30
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Determination of Regulatory Review Period for Purposes of Patent Extension; NERLYNX
Document Number: 2019-18816
Type: Notice
Date: 2019-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NERLYNX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; MACI
Document Number: 2019-18805
Type: Notice
Date: 2019-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MACI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-18802
Type: Notice
Date: 2019-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.'' This guidance document describes FDA's current approach to considering uncertainty in making benefit-risk determinations to support certain FDA premarket decisions for medical devicespremarket approval applications (PMAs), De Novo requests, and humanitarian device exemption applications. This guidance document elaborates on the consideration of uncertainty as part of our overarching approach to a benefit-risk based framework that is intended to assure greater predictability, consistency, and efficiency through the application of least burdensome principles. This guidance also provides examples of how the principles for considering uncertainty could be applied in the context of clinical evidence and circumstances where greater uncertainty could be appropriate in premarket decisions, balanced by postmarket controlsPMAs for Breakthrough Devices and PMAs for devices for small patient populations.
Determination of Regulatory Review Period for Purposes of Patent Extension; BEVYXXA
Document Number: 2019-18788
Type: Notice
Date: 2019-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BEVYXXA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program; Reopening of Submission Period
Document Number: 2019-18771
Type: Notice
Date: 2019-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the submission period for the notice entitled ``Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program'' that published in the Federal Register of June 29, 2018. The Agency is taking this action to allow interested persons additional time to participate in the program.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2019-18769
Type: Notice
Date: 2019-08-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.
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: 2019-18766
Type: Notice
Date: 2019-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) and the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. This annual notice is also in accordance with the 21st Century Cures Act, which requires the Secretary of Health and Human Services (the Secretary) to provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel 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.
Notice of Closed Meeting
Document Number: 2019-18746
Type: Notice
Date: 2019-08-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 2019-18745
Type: Notice
Date: 2019-08-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 250 people. The public is also welcome to view the meeting by webcast. Check the CLIAC website on the day of the meeting for the webcast link www.cdc.gov/cliac.
Advisory Committee on Immunization Practices (ACIP); Notice of Meeting and Request for Comment
Document Number: 2019-18744
Type: Notice
Date: 2019-08-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public, limited only by room seating. The meeting room accommodates 216 for public seating. Room 245, adjacent to the meeting room, will be available once the meeting room reaches capacity, providing up to 18 additional seats. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for meeting registration and more information on ACIP please visit the ACIP website: https://www.cdc.gov/vaccines/acip/ index.html.
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2019-18743
Type: Notice
Date: 2019-08-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry; Availability; Correction
Document Number: 2019-18730
Type: Notice
Date: 2019-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Pediatric Rare DiseasesA Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of December 7, 2017. The document announced the availability of a draft guidance focusing on drug development for pediatric patients with Gaucher disease. The document was published with the incorrect docket number. This document corrects that error.
National Biodefense Science Board: Public Meeting
Document Number: 2019-18612
Type: Notice
Date: 2019-08-30
Agency: Department of Health and Human Services
The HHS Office of the Secretary is hosting the National Biodefense Science Board (NBSB) Public Meeting in Washington, DC, on September 11, 2019. The purpose of the meeting is to gather information to develop expert advice provided by NBSB and guidance to the Secretary on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate.
Meeting of the President's Council on Sports, Fitness, and Nutrition
Document Number: 2019-18726
Type: Notice
Date: 2019-08-29
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Sports, Fitness, and Nutrition (PCSFN) will hold its annual meeting. The meeting will be open to the public.
Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products; Guidance for Industry; Availability
Document Number: 2019-18715
Type: Notice
Date: 2019-08-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products.'' This guidance provides recommendations to industry about using placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products to treat hematologic malignancies and oncologic diseases regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance finalizes the draft guidance entitled ``Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development'' issued August 24, 2018.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Dronabinol (delta-9 tetrahydrocannabinol) and Its Stereoisomers; Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical Preparations of Cannabis; Reopening of the Comment Period
Document Number: 2019-18714
Type: Notice
Date: 2019-08-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled ``International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Dronabinol (delta-9 tetrahydrocannabinol) and its Stereoisomers; Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical Preparations of Cannabis'' that appeared in the Federal Register of March 1, 2019. The Agency is taking this action to allow interested persons additional time to submit comments.
Horizontal Approaches to Food Standards of Identity Modernization; Public Meeting; Request for Comments
Document Number: 2019-18713
Type: Notice
Date: 2019-08-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``Horizontal Approaches to Food Standards of Identity Modernization.'' The purpose of the public meeting is to give interested persons an opportunity to discuss FDA's effort to modernize food standards of identity (SOI) and provide information about changes we could make to existing SOI, particularly changes that could be made across categories of standardized foods (i.e., horizontal changes), to provide flexibility for the development of healthier foods. We are also interested in discussing horizontal changes that would better facilitate innovation. This effort is part of the FDA's comprehensive, multiyear Nutrition Innovation Strategy (NIS) designed to improve healthy dietary behavior and help reduce preventable death and disease related to poor nutrition by, among other things, providing incentives for food manufacturers to produce products that have more healthful attributes.
Proposed Update of the CDC's 2006 Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings
Document Number: 2019-18659
Type: Notice
Date: 2019-08-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is seeking public comment for updating the following guideline: Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings (2006). The purpose of this notice is to solicit feedback on best approaches on HIV screening in clinical settings and prompt linkage to treatment and care. CDC will update this guideline to ensure that HIV testing providers, public health agencies, and other stakeholders have access to up-to-date and consistent information about new evidence, current approaches, and resources for HIV testing in clinical settings.
Prospective Grant of an Exclusive Patent License: Genetically-Modified Lymphocytes for Cancer Therapy
Document Number: 2019-18648
Type: Notice
Date: 2019-08-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Intima Bioscience, Inc. (``Intima''), headquartered in New York, NY.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Information Collection Request Title: Forms for Use With Applications to the Maternal and Child Health Bureau Research and Training Grants, New
Document Number: 2019-18646
Type: Notice
Date: 2019-08-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of 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.
National Institute of Dental & Craniofacial Research; Amended Notice of Meeting
Document Number: 2019-18644
Type: Notice
Date: 2019-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-18643
Type: Notice
Date: 2019-08-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2019-18642
Type: Notice
Date: 2019-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Laboratory Animal Welfare: Report on Reducing Administrative Burden for Researchers: Animal Care and Use in Research
Document Number: 2019-18611
Type: Notice
Date: 2019-08-28
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) is announcing the publication of Reducing Administrative Burden for Researchers: Animal Care and Use in Research, a report by the NIH, the United States Department of Agriculture (USDA), and the Food and Drug Administration (FDA). The report describes the recommendations of the 21st Century Cures Act, Section 2034(d), Working Group and decisions of the agencies.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-18580
Type: Notice
Date: 2019-08-28
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-18570
Type: Notice
Date: 2019-08-28
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.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of Meeting
Document Number: 2019-18546
Type: Notice
Date: 2019-08-28
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2019-18545
Type: Notice
Date: 2019-08-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-18539
Type: Notice
Date: 2019-08-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-18536
Type: Notice
Date: 2019-08-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-18533
Type: Notice
Date: 2019-08-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-18530
Type: Notice
Date: 2019-08-28
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Evaluation of the National Human Trafficking Hotline Program (New Collection)
Document Number: 2019-18515
Type: Notice
Date: 2019-08-28
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE) is proposing a data collection activity as part of the Evaluation of the National Human Trafficking Hotline (NHTH) Program. This data collection activity will examine the experiences of individuals who seek assistance from the NHTH after their interactions with the NHTH. The study will collect information via voluntary phone and Web-based surveys at two time pointsimmediately after an individual has contacted the NHTH by phone, text, or live online chat, and two weeks later.
Proposed Information Collection Activity; ACF's Generic Clearance for Reviewer Recruitment Forms (OMB #0970-0477)
Document Number: 2019-18514
Type: Notice
Date: 2019-08-28
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) proposes to revise the existing overarching generic clearance for Grant Reviewer Recruitment (GRR) forms to expand the focus from recruiting just grant reviewers to recruiting expert reviewers in general.
Meeting of the Advisory Committee on Interdisciplinary, Community-Based Linkages
Document Number: 2019-18502
Type: Notice
Date: 2019-08-28
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) has scheduled a public meeting. Information about ACICBL and the agenda for this meeting can be found on the ACICBL website at: https://www.hrsa.gov/advisory-committees/ interdisciplinary-community-linkages/.
National Advisory Council on the National Health Service Corps Meeting Cancellation
Document Number: 2019-18483
Type: Notice
Date: 2019-08-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
This is to notify the public that the meeting of the National Advisory Council on the National Health Service Corps (NACNHSC), previously scheduled for September 17, 2019, through September 18, 2019, is cancelled. This meeting was announced in the Federal Register, Vol. 84, No. 87 on Monday, February 25, 2019 (FR Doc. 2019-03180 Filed 2-22-19). Future meetings will occur in calendar year 2020 and be announced through the Federal Register at a later date.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-18469
Type: Notice
Date: 2019-08-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; 30-Day Comment Request Introduction to Cancer Research Careers (ICRC) Application (NCI)
Document Number: 2019-18426
Type: Notice
Date: 2019-08-27
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Delta States Rural Development Network Grant Program; OMB No. 0915-0386-Extension
Document Number: 2019-18425
Type: Notice
Date: 2019-08-27
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: Submission for OMB Review; Comment Request
Document Number: 2019-18415
Type: Notice
Date: 2019-08-27
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2019-18410
Type: Notice
Date: 2019-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public. Members will participate via teleconference.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Evidence-Based Telehealth Network Program Measures, OMB No. 0906-xxxx-NEW
Document Number: 2019-18388
Type: Notice
Date: 2019-08-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of 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.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-18383
Type: Notice
Date: 2019-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Reallotment of Fiscal Year 2018 Funds for the Low Income Home Energy Assistance Program (LIHEAP)
Document Number: 2019-18374
Type: Notice
Date: 2019-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
Notice is hereby given of a preliminary determination that funds from the fiscal year (FY) 2018 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to States, Territories, Tribes, and Tribal Organizations that received FY 2019 direct LIHEAP grants. No subgrantees or other entities may apply for these funds.
Male Breast Cancer: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2019-18363
Type: Notice
Date: 2019-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Male Breast Cancer: Developing Drugs for Treatment.'' This draft guidance provides recommendations regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of male patients with breast cancer. Specifically, this draft guidance recommends the inclusion of male patients in clinical trials of breast cancer drugs and provides recommendations on clinical development when males have either not been included in clinical trials for drugs to treat breast cancer or when inclusion of males in those trials is very limited. The development of drugs for male breast cancer may provide clinical data and additional FDA-approved treatment options to improve the clinical management of breast cancer in male patients.
Request for Information: Regarding Revisions to the PHS Guideline for Reducing Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Organ Transplantation
Document Number: 2019-17759
Type: Notice
Date: 2019-08-27
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health in the Department of Health and Human Services (HHS) seeks public comment regarding proposed revisions to the 2013 PHS Guideline for Reducing Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Organ Transplantation.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: HIV Quality Measures (HIVQM) Module, OMB No. 0906-0022-Revision
Document Number: 2019-18332
Type: Notice
Date: 2019-08-26
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.
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