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

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Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12606
Type: Notice
Date: 2019-06-14
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Systematic Review Data Repository.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection.
Solicitation of Nominations for Membership To Serve on the National Advisory Council on Migrant Health
Document Number: 2019-12592
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the National Advisory Council on Migrant Health (NACMH/Council). The NACMH consults with and makes recommendations to the HHS Secretary concerning the organization, operation, selection, and funding of migrant health centers (MHC) and other entities, under grants and contracts under the Public Health Service (PHS) Act. HRSA is seeking nominations to fill up to five positions on the NACMH with individuals served by nominating health centers.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2019-12566
Type: Notice
Date: 2019-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. 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.
Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Cellular, Tissue, and Gene Therapies Advisory Committee
Document Number: 2019-12565
Type: Notice
Date: 2019-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a non-voting industry representative(s) to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee Blood Products Advisory Committee. A nominee may either be self- nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry; Availability
Document Number: 2019-12564
Type: Notice
Date: 2019-06-14
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 document entitled ``Testing for Biotin Interference in In Vitro Diagnostic Devices; Draft Guidance for Industry.'' The draft guidance document provides FDA's recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). The draft guidance is intended to help device developers and clinicians understand how FDA recommends biotin interference testing should be performed and how the results of the testing should be communicated to end users, including clinical laboratories and clinicians. FDA also recommends that manufacturers of currently marketed devices consider these draft recommendations.
Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications
Document Number: 2019-12560
Type: Notice
Date: 2019-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-12559
Type: Notice
Date: 2019-06-14
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 FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-12558
Type: Notice
Date: 2019-06-14
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 Psychopharmacologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2019-12528
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-12527
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2019-12526
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2019-12525
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Nondiscrimination in Health and Health Education Programs or Activities
Document Number: 2019-11512
Type: Proposed Rule
Date: 2019-06-14
Agency: Department of Health and Human Services, Office of the Secretary, Centers for Medicare and Medicaid Services
The Department of Health and Human Services (``the Department'') is committed to ensuring the civil rights of all individuals who access or seek to access health programs or activities of covered entities under Section 1557 of the Patient Protection and Affordable Care Act. The Department proposes to revise its Section 1557 regulation in order to better comply with the mandates of Congress, address legal concerns, relieve billions of dollars in undue regulatory burdens, further substantive compliance, reduce confusion, and clarify the scope of Section 1557 in keeping with pre-existing civil rights statutes and regulations prohibiting discrimination on the basis of race, color, national origin, sex, age, and disability.
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
Document Number: 2019-11484
Type: Notice
Date: 2019-06-14
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Secretary of Health and Human Services (Secretary) announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The ISMICC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12489
Type: Notice
Date: 2019-06-13
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.
Meeting of the Pain Management Best Practices Inter-Agency Task Force; Correction
Document Number: 2019-12482
Type: Notice
Date: 2019-06-13
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health published a document in the Federal Register of June 3, 2019, announcing the Pain Management Best Practices Inter-Agency Task Force's virtual public meeting. This document is announcing a change in the meeting date.
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Extension of Comment Period
Document Number: 2019-12478
Type: Proposed Rule
Date: 2019-06-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of April 2, 2019. The Agency is taking this action in response to requests for an extension to allow interested parties additional time to submit comments.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-12474
Type: Notice
Date: 2019-06-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
Document Number: 2019-12472
Type: Notice
Date: 2019-06-13
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 information collection ``Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act.''
Mouse Embryo Assay for Assisted Reproduction Technology Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-12430
Type: Notice
Date: 2019-06-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Mouse Embryo Assay for Assisted Reproduction Technology Devices.'' This draft guidance document provides recommendations on conducting the Mouse Embryo Assay (MEA) to support premarket submissions and lot release of assisted reproduction technology devices. This draft guidance is not final nor is it in effect at this time.
Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Guidance for Industry; Availability
Document Number: 2019-12389
Type: Rule
Date: 2019-06-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, Guidance for Industry.'' Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This guidance is intended to assist applicants to prepare PMTAs for ENDS products.
Proposed Collection; 60-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: 2019-12387
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Clinical Center, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2019-12369
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2019-12368
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-12367
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2019-12366
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-12365
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-12348
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review: Notice of Closed Meeting
Document Number: 2019-12345
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12340
Type: Notice
Date: 2019-06-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Members
Document Number: 2019-12323
Type: Notice
Date: 2019-06-12
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The National Advisory Council for Healthcare Research and Quality (the Council) is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) with respect to activities proposed or undertaken to carry out AHRQ's statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven current members' terms will expire in November 2019.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of United States Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products
Document Number: 2019-12321
Type: Notice
Date: 2019-06-12
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; Reporting Associated With Designated New Animal Drugs for Minor Use and Minor Species
Document Number: 2019-12316
Type: Notice
Date: 2019-06-12
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 associated with designation under the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act).
Determination of Regulatory Review Period for Purposes of Patent Extension; ALUNBRIG
Document Number: 2019-12320
Type: Notice
Date: 2019-06-11
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 ALUNBRIG 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 drug product.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12312
Type: Notice
Date: 2019-06-11
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on March 19, 2019, and allowed 60 days for public comment. AHRQ did not receive substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Determination That NIZORAL (Ketoconazole) Topical Cream, 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-12308
Type: Notice
Date: 2019-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) has determined that NIZORAL (ketoconazole) topical cream, 2%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12306
Type: Notice
Date: 2019-06-11
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``The AHRQ Safety Program for Improving Antibiotic Use.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 1, 2019 and allowed 60 days for public comment. AHRQ did not receive substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Determination of Regulatory Review Period for Purposes of Patent Extension; KISQALI
Document Number: 2019-12305
Type: Notice
Date: 2019-06-11
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 KISQALI 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 patents which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; BAXDELA TABLETS-NDA 208610
Document Number: 2019-12299
Type: Notice
Date: 2019-06-11
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 BAXDELA TABLETS under NDA 208610 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; BAXDELA IV INJECTION-NDA 208611
Document Number: 2019-12298
Type: Notice
Date: 2019-06-11
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 BAXDELA IV INJECTION under new drug application (NDA) 208611 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12293
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability; Reopening of Comment Period
Document Number: 2019-12292
Type: Notice
Date: 2019-06-11
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 ``Quality Considerations for Continuous Manufacturing; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of February 27, 2019. The Agency is taking this action to allow interested persons additional time to submit comments.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-12291
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration
Document Number: 2019-12288
Type: Notice
Date: 2019-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) 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.
Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications
Document Number: 2019-12287
Type: Notice
Date: 2019-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of six abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2019-12278
Type: Notice
Date: 2019-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
Document Number: 2019-12266
Type: Notice
Date: 2019-06-11
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 investigational device exemptions reports and records.
Development of Best Practices in Physiologically Based Pharmacokinetic Modeling To Support Clinical Pharmacology Regulatory Decision-Making; Public Workshop
Document Number: 2019-12256
Type: Notice
Date: 2019-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), is announcing a public workshop entitled ``Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making.'' The purpose of this public workshop is to discuss best practices and evidentiary criteria in the use of physiologically based pharmacokinetic (PBPK) modeling approaches to support regulatory decision-making; share experiences and cases where applying PBPK modeling and simulation highlight the opportunities and limitations of this approach; obtain input from stakeholders on when, where, how, and with what limitations PBPK modeling and simulation may be applied in regulatory decision-making; and discuss the knowledge gaps and research needed to advance PBPK modeling sciences in drug development to support regulatory decisions. This public workshop is also being conducted to satisfy one of FDA's performance goals included in the sixth reauthorization of the Prescription Drug User Fee Amendments (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), to hold a series of workshops related to model-informed drug development (MIDD).
Opportunity To Collaborate on National Youth Sports Initiative To Increase Youth Sports Participation; Correction
Document Number: 2019-12251
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services
The Department of Health and Human Services published a document in the Federal Register of June 3, 2019, concerning the opportunity to collaborate on National Youth Sports Initiative to increase youth sports participation with the President's Council on Sports, Fitness & Nutrition (PCSFN). The document contained an incorrect date.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2019-12227
Type: Notice
Date: 2019-06-11
Agency: Department of Health and Human Services, National Institutes of Health