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

Results 201 - 250 of 29,744
Notice of a HRSA-Initiated Supplemental Award to Recipients in the Reaching Practicing Maternal and Child Health (MCH) Professionals in Underserved Areas Through Education and Training Program
Document Number: 2019-08877
Type: Notice
Date: 2019-05-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces the award of a supplement of $705,246 for the Reaching Practicing MCH Professionals in Underserved Areas through Education and Training Program (hereafter Program) recipients. The supplement will allow the current four recipients, during the period of June 1, 2019-May 31, 2020, to continue supporting the development and implementation of in-depth training tailored to the specific needs of MCH public health professionals practicing in underserved communities, including rural and frontier areas and Indian reservations.
Notice of a HRSA-Initiated Supplemental Award to the University of Nebraska Medical Center/Board of Regents of the University of Nebraska for the Partnership for Urban Maternal and Child Health (MCH) Leadership Community Cooperative Agreement
Document Number: 2019-08876
Type: Notice
Date: 2019-05-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces the award of a supplement for $700,000 to the University of Nebraska Medical Center/Board of Regents of the University of Nebraska for the Partnership for Urban MCH Leadership Community Cooperative Agreement. The supplement will allow the current recipient, during the period of May 1, 2019-April 30, 2020, to assess the outcomes and impact of its collective impact learning collaborative with urban health departments.
Proposed Collection; 60-Day Comment Request; NIH Information Collection Forms To Support Genomic Data Sharing for Research Purposes (OD)
Document Number: 2019-08855
Type: Notice
Date: 2019-05-01
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 National Institutes of Health Office of the Director (OD) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
Document Number: 2019-08845
Type: Notice
Date: 2019-05-01
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; Mammography Quality Standards Act Requirements
Document Number: 2019-08784
Type: Notice
Date: 2019-05-01
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 estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-08780
Type: Notice
Date: 2019-05-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2019-08775
Type: Notice
Date: 2019-05-01
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-08766
Type: Notice
Date: 2019-05-01
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 ``Safety Program in Perinatal Care (SPPC)-II Demonstration Project.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-08765
Type: Notice
Date: 2019-05-01
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 updates to the currently approved information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component.''
Agency for Healthcare Research and Quality Notice of Meetings
Document Number: 2019-08764
Type: Notice
Date: 2019-05-01
Agency: Department of Health and Human Services
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.
Health Information Technology Advisory Committee 2019 Schedule
Document Number: 2019-08727
Type: Notice
Date: 2019-04-30
Agency: Department of Health and Human Services
The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2019. See list of public meetings below.
Medicare and Medicaid Programs; Risk Adjustment Data Validation
Document Number: 2019-08691
Type: Proposed Rule
Date: 2019-04-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document extends the comment period for the Risk Adjustment Data Validation (RADV) provisions of the proposed rule titled ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021'' that was published in the November 1, 2018 Federal Register. The comment period for the RADV provision of this proposed rule, which would end on April 30, 2019, is extended by 120 days until August 28, 2019. This document also announces that CMS will be releasing additional data underlying the FFS Adjuster Study released October 26, 2018.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-08683
Type: Notice
Date: 2019-04-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2019-08651
Type: Notice
Date: 2019-04-30
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-08644
Type: Notice
Date: 2019-04-30
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.
Administration for Community Living; Notice of Intent To Award a Sole Source Supplement to the Christopher and Dana Reeve Foundation
Document Number: 2019-08635
Type: Notice
Date: 2019-04-30
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing the award of single-source supplement for the National Paralysis Resource Center (PRC) that was included in the 2019 Congressional budget appropriations. The National Paralysis Resource Center is operated by the Christopher and Dana Reeve Foundation, which offers important programmatic opportunities for persons with disabilities and older adults. The PRC provides comprehensive information for people living with spinal cord injury, paralysis, and mobility-related disabilities and their families. Resources include information and referral by phone and email in multiple languages; a peer and family support mentoring program; a military and veterans program; multicultural outreach services; multiple quality of life grants; and a national website. The administrative supplement for FY2019 will be in the amount of $1,000,000, bring the total award for FY 19 to $7,761,661. Program Name: National Paralysis Resource Center. Recipient: Christopher and Dana Reeve Foundation. Period of Performance: The supplement award will be issued for the second year of a three year project a project period, July 1, 2019 through June 30, 2020. Award Amount: $1,000,000. Award Type: Cooperative Agreement. Statutory Authority: This program is authorized under Section 317 of the Public Health Service Act (42 U.S.C. 247(b-4)); Consolidated and Further Continuing Appropriations Act, 2016, Public Law 114-113 (Dec. 18, 2015). CFDA Number: 93.325 Discretionary Projects.
Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties
Document Number: 2019-08530
Type: Rule
Date: 2019-04-30
Agency: Department of Health and Human Services
This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies HHS regulations concerning the assessment of Civil Money Penalties (CMPs) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as such provision was amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act. Current HHS regulations apply the same cumulative annual CMP limit across four categories of violations based on the level of culpability. As a matter of enforcement discretion, and pending further rulemaking, HHS will apply a different cumulative annual CMP limit for each of the four penalties tiers in the HITECH Act.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2019
Document Number: 2019-08640
Type: Notice
Date: 2019-04-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2019, relating to the Medicare and Medicaid programs and other programs administered by CMS.
National Institute of Biomedical Imaging and Bioengineering; Amended Notice of Meeting
Document Number: 2019-08623
Type: Notice
Date: 2019-04-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2019-08622
Type: Notice
Date: 2019-04-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2019-08621
Type: Notice
Date: 2019-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Secretary; Notice of Meeting
Document Number: 2019-08618
Type: Notice
Date: 2019-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-08617
Type: Notice
Date: 2019-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-08610
Type: Notice
Date: 2019-04-29
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 Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committees 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; YESCARTA
Document Number: 2019-08609
Type: Notice
Date: 2019-04-29
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 YESCARTA 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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2019-08607
Type: Notice
Date: 2019-04-29
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; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices
Document Number: 2019-08558
Type: Notice
Date: 2019-04-29
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.
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: 2019-08534
Type: Notice
Date: 2019-04-29
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 http:// www.samhsa.gov/workplace.
National Institute of Mental Health; Notice of Workshop
Document Number: 2019-08501
Type: Notice
Date: 2019-04-29
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-08499
Type: Notice
Date: 2019-04-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2019-08498
Type: Notice
Date: 2019-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Unique Device Identification: Convenience Kits; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-08472
Type: Notice
Date: 2019-04-26
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 ``Unique Device Identification: Convenience Kits; Guidance for Industry and Food and Drug Administration Staff.'' The unique device identification system regulations require that the label and device package of a device must bear a unique device identifier (UDI), unless an exception or alternative applies. An exception is provided for devices packaged within the immediate container of a convenience kit, if the label of the convenience kit bears a UDI. This guidance document describes FDA's interpretation of the definition of ``convenience kit.'' This guidance does not apply to in vitro diagnostic (IVD) devices that are subject to IVD labeling requirements nor does it apply to combination products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification
Document Number: 2019-08471
Type: Notice
Date: 2019-04-26
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; Agreement for Shipment of Devices for Sterilization
Document Number: 2019-08470
Type: Notice
Date: 2019-04-26
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 information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-08466
Type: Notice
Date: 2019-04-26
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 ``Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.'' FDA has developed this document to describe relevant information that should be included in test report summaries, test protocols, and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests).
Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-08465
Type: Notice
Date: 2019-04-26
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 ``Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.'' The guidance identifies the types of UHMWPE commonly in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions for such devices.
Final Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
Document Number: 2019-08462
Type: Notice
Date: 2019-04-26
Agency: Department of Health and Human Services, National Institutes of Health
This notice sets forth final changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within the existing regulatory framework, as initially outlined by the NIH Office of Science Policy (OSP) in a Federal Register notice issued on August 17, 2018. Following the solicitation of public comment on its original proposal, the NIH is amending the NIH Guidelines to: (A) Delete the NIH protocol registration submission and reporting requirements under Appendix M of the NIH Guidelines, and (B) modify the roles and responsibilities of entities that involve human gene transfer and the Recombinant DNA Advisory Committee (RAC).
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2019-08446
Type: Notice
Date: 2019-04-26
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.
Solicitation of Nominations for Appointment to the Board of Scientific Counselors, National Center for Injury Prevention and Control BSC, NCIPC
Document Number: 2019-08442
Type: Notice
Date: 2019-04-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the BSC, NCIPC. The BSC, NCIPC consists of 18 experts in fields associated with surveillance, basic epidemiologic research, intervention research, and implementation, dissemination, and evaluation of promising and evidence-based strategies for the prevention of injury and violence. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of pertinent disciplines involved in injury and violence prevention, including, but not limited to, epidemiology, statistics, trauma surgery, rehabilitation medicine, behavioral science/psychology, health economics, program evaluation, political science, law, criminology, informatics and other aspects of injury management. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of BSC, NCIPC objectives https:// www.cdc.gov/injury/bsc/.
Office of Urban Indian Health Programs; 4-in-1 Grant Programs
Document Number: 2019-08414
Type: Notice
Date: 2019-04-26
Agency: Department of Health and Human Services, Indian Health Service
Office of Urban Indian Health Programs; Urban Indian Education and Research Program
Document Number: 2019-08413
Type: Notice
Date: 2019-04-26
Agency: Department of Health and Human Services, Indian Health Service
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Environmental Information Documentation, OMB No. 0915-0324-Revision
Document Number: 2019-08383
Type: Notice
Date: 2019-04-26
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 Vaccine Injury Compensation Program: List of Petitions Received
Document Number: 2019-08381
Type: Notice
Date: 2019-04-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Child Support Program Technical Corrections Notice of Proposed Rulemaking; Correction
Document Number: 2019-08299
Type: Proposed Rule
Date: 2019-04-26
Agency: Department of Health and Human Services, Administration for Children and Families
This document corrects the regulatory identification number (RIN) that appeared in the heading of a notice of proposed rulemaking published in the Federal Register of December 18, 2018. Through that document, OCSE proposed to eliminate regulations rendered outdated or unnecessary and make technical amendments to the Flexibility, Efficiency, and Modernization in Child Support Enforcement final rule, published on December 20, 2016, including proposing to amend the compliance date for review and adjustment of child support orders.
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics With Continuous Outcomes; Draft Guidance for Industry; Availability
Document Number: 2019-08353
Type: Notice
Date: 2019-04-25
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 ``Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes.'' The draft guidance, when finalized, will represent the current thinking of FDA on adjusting for covariates in randomized clinical trials for drugs and biologics, focusing on randomized clinical trials with continuous endpoints.
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles; Guidance for Government Public Health and Emergency Response Stakeholders; Availability
Document Number: 2019-08349
Type: Notice
Date: 2019-04-25
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 government public health and emergency response stakeholders entitled ``Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.'' This document provides guidance to government stakeholders on testing to extend the expiration dateunder the Federal Food, Drug, and Cosmetic Act (FD&C Act)of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This guidance has been prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturer's labeled expiration date so the replacement of stockpiled product could be deferred. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other nonemergency purpose. This guidance finalizes the draft guidance issued in April 2017.
Notice of Closed Meeting
Document Number: 2019-08339
Type: Notice
Date: 2019-04-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2019-08338
Type: Notice
Date: 2019-04-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2019-08337
Type: Notice
Date: 2019-04-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2019-08322
Type: Notice
Date: 2019-04-25
Agency: Department of Health and Human Services, Administration for Children and Families