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

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Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Sickle Cell Disease Treatment Demonstration Regional Collaborative Program, OMB No. 0906-xxxx-New
Document Number: 2020-14612
Type: Notice
Date: 2020-07-07
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. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention to Participate
Document Number: 2020-14585
Type: Notice
Date: 2020-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholdersincluding patient and consumer advocacy groups, healthcare professionals, and scientific and academic expertsnotify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Notice of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Change in Information Contact, Removal of Chloroquine Phosphate and Hydroxychloroquine HCl; Correction
Document Number: 2020-14525
Type: Notice
Date: 2020-07-07
Agency: Department of Health and Human Services, Office of the Secretary
This document updates the March 30, 2020, Federal Register Notice entitled ``Notice of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures,'' by replacing the named contact and updating the ``Notice of Designation of Scarce Materials or Threatened Materials'' section.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Data to Support Cross-Center Collaboration for Social Behavioral Sciences Associated With Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of Food and Drug Administration Regulated Products
Document Number: 2020-14517
Type: Notice
Date: 2020-07-07
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a new collection of information to collect entitled ``Generic Clearance for Data to Support Cross-Center Collaboration for Social Behavioral Sciences Associated with Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of FDA Regulated Products.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health Care Providers' Understanding of Opioid Analgesic Abuse Deterrent Formulations
Document Number: 2020-14516
Type: Notice
Date: 2020-07-07
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 (PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials
Document Number: 2020-14514
Type: Notice
Date: 2020-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled, ``Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials.''
Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.7 Implementation Guide 3.3 and for Define-Extensible Markup Language Version 2.1; Requirement Ends for Study Data Tabulation Model Version 1.3 Implementation Guide 3.1.3
Document Number: 2020-14512
Type: Notice
Date: 2020-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the dates that support and requirement will begin for version 1.7 of the Clinical Data Interchange Standards Consortium (CDISC) for Study Data Tabulation Model (SDTM) Implementation Guide (IG) 3.3, as well as for version 2.1 of the Define-Extensible Markup Language (Define-XML). CBER and CDER are also announcing the date that support and requirement will end for version 1.3 of the CDISC SDTM IG 3.1.3. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes.
National Cancer Institute; Notice of Closed Meeting
Document Number: 2020-14480
Type: Notice
Date: 2020-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2020-14479
Type: Notice
Date: 2020-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2020-14478
Type: Notice
Date: 2020-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC); Amended Notice of Meeting
Document Number: 2020-14447
Type: Notice
Date: 2020-07-06
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 Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC). This meeting is partially open and partially closed to the public. The open session is limited only by the ports available. There will be 2,000 telephone ports available. There will also be 55 minutes allotted for oral public comments at the end of the open session from 12:20 p.m. to 1:15 p.m., EDT on July 22, 2020. In addition, written comments may also be submitted for the meeting record. Written comments should be emailed to NCIPCBSC@cdc.gov and will be accepted until July 28, 2020, 5:00 p.m., EDT. The public is encouraged to register to participate by telephone and/or provide oral public comment using the registration form available at the link provided: https://www.surveymonkey.com/r/NVV9XM2. Individuals registered to provide oral public comment will be called upon to speak based on the order of registration. After persons who have registered have spoken, any remaining time in the oral public comment period will be used for members of the public who have not registered to speak but wish to offer comment. Individuals making oral public comment during the meeting will have a 2-minute speaking limit to allow for as many comments as possible.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2020-14431
Type: Notice
Date: 2020-07-06
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP, the full meeting agenda, and instructions for linking to public access will be posted on the SACHRP website at http://www.dhhs.gov/ohrp/sachrp-committee/meetings/ index.html.
Request for Information Concerning Personnel and the Retention of Next Generation Sequencing Data in Clinical and Public Health Laboratories; Extension of Comment Period
Document Number: 2020-14417
Type: Notice
Date: 2020-07-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On May 15, 2020, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) published a notice in the Federal Register requesting public comment on the Request for Information Concerning Personnel and the Retention of Next Generation Sequencing Data in Clinical and Public Health Laboratories (85 FR 29456). Written and electronic comments were to be received on or before July 14, 2020. HHS/CDC has received a request asking for a 60-day extension of the comment period. In consideration of this request, HHS/CDC is extending the comment period to September 14, 2020.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Healthcare Provider Perception of Boxed Warning Information Survey
Document Number: 2020-14377
Type: Notice
Date: 2020-07-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Multiple Indications in Direct-to-Consumer Television Advertisements
Document Number: 2020-14375
Type: Notice
Date: 2020-07-06
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled ``Study of Multiple Indications in Direct-to-Consumer Television Advertisements.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Disclosures to Health Care Providers Regarding Data that Do Not Support Unapproved Use of an Approved Prescription Drug
Document Number: 2020-14372
Type: Notice
Date: 2020-07-06
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Study of Disclosures to Health Care Providers Regarding Data that Do Not Support Unapproved Use of an Approved Prescription Drug.''
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-14369
Type: Notice
Date: 2020-07-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-14368
Type: Notice
Date: 2020-07-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-14367
Type: Notice
Date: 2020-07-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
Document Number: 2020-14365
Type: Notice
Date: 2020-07-06
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 (PRA).
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2020-14364
Type: Notice
Date: 2020-07-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2020-14363
Type: Notice
Date: 2020-07-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-14362
Type: Notice
Date: 2020-07-06
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 2020-14336
Type: Notice
Date: 2020-07-06
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-14330
Type: Notice
Date: 2020-07-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Practitioner Data Bank Continues Temporary Waiver of User Fees for Eligible Entities
Document Number: 2020-14291
Type: Notice
Date: 2020-07-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
Pursuant to its authority under Federal regulations for the National Practitioner Data Bank (NPDB), HRSA's Division of Practitioner Data Bank announces a continuation of its temporary waiver of user fees for NPDB queries from March 1, 2020, through September 30, 2020, to support our eligible entities in making credentialing, hiring, privileging, and licensing decisions in combatting the COVID-19 pandemic. The waiver includes all one-time queries and continuous queries during the waiver time period. Fees for self-queries will not be waived. The NPDB is a confidential information clearinghouse created by Congress and is intended to facilitate a comprehensive review of the professional credentials of health care practitioners, entities, providers, and suppliers. In response to President Trump's declaration of a national emergency and associated emergency declarations by all states, the Federal Government, state governments, and many health care entities have taken unprecedented steps regarding licensure portability and the deployment of health workforce resources, including the expansion of telemedicine and granting of disaster privileges. HRSA's NPDB is in a unique position to temporarily waive fees, granting NPDB access to the nation's hospitals, health centers, health plans, state licensing boards, Federal agencies, and other eligible health care entities in support of their efforts to mobilize and appropriately deploy health workforce professionals.
Promoting the Rule of Law Through Improved Agency Guidance Documents
Document Number: 2020-14433
Type: Notice
Date: 2020-07-02
Agency: Department of Health and Human Services, Office of the Secretary
On October 9, 2019, the President issued Executive Order (E.O.) 13891: Promoting the Rule of Law Through Improved Agency Guidance Documents. This E.O. requires all Federal agencies to establish an on-line guidance portal and to rescind any guidance documents that are no longer active or valid.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-14332
Type: Notice
Date: 2020-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Oral Health Basic Screening Survey for Children. The project provides state-specific data on dental caries (tooth decay) and dental sealants from a state-representative sample of elementary school children or children enrolled in Head Start programs and has been used by states to monitor oral health status of children and evaluate public health programs and policies.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-14331
Type: Notice
Date: 2020-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Formative Research on Community-Level Factors that Promote the Primary Prevention of Adverse Childhood Experiences (ACEs) and Opioid Misuse Among Children, Youth, and Families in Tribal American Indian and Alaska Native (AI/AN) Communities.'' The proposed collection is designed to conduct formative qualitative studies to identify community-level protective factors and primary prevention strategies across a range of Tribal communities to prevent adverse childhood experiences (ACEs) and opioid misuse.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-14329
Type: Notice
Date: 2020-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Teva Branded Pharmaceutical Products R&D, Inc.; Withdrawal of Approval of a New Drug Application for ZECUITY (Sumatriptan Iontophoretic Transdermal System)
Document Number: 2020-14284
Type: Notice
Date: 2020-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ZECUITY (sumatriptan iontophoretic transdermal system) held by Teva Branded Pharmaceutical Products R&D, Inc. (Teva), 41 Moores Rd., P.O. Box 4011, Frazer, PA 19355. Teva requested withdrawal of this application and has waived its opportunity for a hearing.
Determination That ZOVIRAX (Acyclovir) Oral Capsules, 200 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2020-14269
Type: Notice
Date: 2020-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that ZOVIRAX (acyclovir) oral capsules, 200 milligrams (mg), 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 also 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; Exceptions or Alternatives To Labeling Requirements for Products Held by the Strategic National Stockpile
Document Number: 2020-14267
Type: Notice
Date: 2020-07-02
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 related to the exceptions or alternatives to labeling requirements for products held by the Strategic National Stockpile (SNS).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees
Document Number: 2020-14263
Type: Notice
Date: 2020-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
Document Number: 2020-14262
Type: Notice
Date: 2020-07-02
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.
Supplemental Evidence and Data Request on Breast Reconstruction After Mastectomy
Document Number: 2020-14237
Type: Notice
Date: 2020-07-02
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Breast Reconstruction after Mastectomy, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-October 2019 Through March 2020
Document Number: 2020-14203
Type: Notice
Date: 2020-07-01
Agency: Department of Health and Human Services
This notice lists the OMHA Case Processing Manual (OCPM) instructions that were published from October 2019 through March 2020. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
Infectious Diseases and Circumstances Relevant to Notification Requirements: Definition of Emergency Response Employee
Document Number: 2020-14201
Type: Notice
Date: 2020-07-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), has added a definition of the term ``emergency response employees'' to the definitions section of the document entitled ``Implementation of Section 2695 (42 U.S.C. 300ff-131) Public Law 111-87: Infectious Diseases and Circumstances Relevant to Notification Requirements.'' This list of potentially life-threatening infectious diseases to which emergency response employees may be exposed and companion guidelines has been re-published by the National Institute for Occupational Safety and Health (NIOSH) and is available on the NIOSH website.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2020-14167
Type: Notice
Date: 2020-07-01
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-14165
Type: Notice
Date: 2020-07-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2020-14163
Type: Notice
Date: 2020-07-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2020-14162
Type: Notice
Date: 2020-07-01
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Request
Document Number: 2020-14156
Type: Notice
Date: 2020-07-01
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
For the ``Opioid Management in Older Adults'' project, AHRQ is seeking to identify innovative approaches to managing opioid medications for chronic pain that are particularly relevant for older adults. Use of long-term opioid therapy in older adults can be especially problematic because of increased risks such as delirium, falls, and dementia. Through this notice, the comment period has been extended to August 30, 2020. The subject matter content remains unchanged from the original notice which was previously published on March 18, 2020.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-14088
Type: Notice
Date: 2020-07-01
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-14087
Type: Notice
Date: 2020-07-01
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.
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2020-14082
Type: Rule
Date: 2020-07-01
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 guidance entitled ``Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.'' This guidance revises the guidance by the same title issued November 5, 2018, and describes FDA's intention with respect to the enforcement of unique device identification (UDI) requirements for class I and unclassified devices, other than implantable, life-sustaining, or life- supporting (I/LS/LS) devices. In this revised guidance, FDA clarifies that, at this time, in light of the considerations described in the guidance, it does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements for these devices before September 24, 2022. The guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
Development of Anti-Infective Drug Products for the Pediatric Population; Draft Guidance for Industry; Availability
Document Number: 2020-14085
Type: Notice
Date: 2020-06-30
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 draft guidance for industry entitled ``Development of Anti-Infective Drug Products for the Pediatric Population.'' The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for pediatric patients. The guidance addresses initiation of pediatric clinical studies, enrollment strategies, extrapolation of efficacy, and other considerations to help facilitate pediatric anti-infective drug product development.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-14059
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-14058
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30 Day Comment Request Application Process for Clinical Research Training and Medical Education at the Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness (Clinical Center)
Document Number: 2020-14057
Type: Notice
Date: 2020-06-30
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.