Department of Health and Human Services August 2021 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 237
National Cancer Institute; Notice of Closed Meetings
Document Number: 2021-18399
Type: Notice
Date: 2021-08-26
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee; Nonprescription Drugs Advisory Committee; Renewal
Document Number: 2021-18396
Type: Notice
Date: 2021-08-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the renewal of the Nonprescription Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Nonprescription Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the August 27, 2023, expiration date.
Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine; Request for Comments; Extension of Comment Period
Document Number: 2021-18395
Type: Notice
Date: 2021-08-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the request for comments that appeared in the Federal Register of June 15, 2021. In that notice, FDA requested comments on the use of study data exchange standards from persons involved in study conduct, data collection, data management, and submission of animal study data intended to support the approval of new animal drug applications (NDAs), abbreviated new animal drug applications (ANDAs), or applications for conditional approval. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2021-18394
Type: Notice
Date: 2021-08-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Submission for OMB Review; 30-Day Comment Request Electronic Individual Development Plan (eIDP) (National Eye Institute)
Document Number: 2021-18393
Type: Notice
Date: 2021-08-26
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.
Meeting of the Advisory Committee on Infant Mortality
Document Number: 2021-18378
Type: Notice
Date: 2021-08-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Infant Mortality (ACIM or Committee) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https://www.hrsa.gov/advisory-committees/infant-mortality/ind ex.html.
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 or Programmed Cell Death-Ligand 1 Blocking Antibodies for Treatment of Patients With Cancer; Draft Guidance for Industry; Availability
Document Number: 2021-18317
Type: Notice
Date: 2021-08-26
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 draft guidance for industry entitled ``Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer.'' This draft guidance provides recommendations for sponsors of investigational new drug applications (INDs) and biologics license applications (BLAs) on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies. This draft guidance is based on accumulated scientific and regulatory experience for PD-1 and PD-L1 drugs, and as such, does not address development of alternative dosing regimens for any other drugs or biologics, changes in route of administration, or novel formulations of previously approved PD-1/PD-L1 products.
Notice of Award of a Single-Source Cooperative Agreement to Fund the Association of University Centers on Disability
Document Number: 2021-18324
Type: Notice
Date: 2021-08-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the award of approximately $3,190,000 in coronavirus disease 2019 (COVID- 19) funding in response to an unsolicited application that has been submitted by the Association of University Centers on Disability (AUCD) to address vaccine hesitancy among people with disabilities, their families and direct support professionals.
Submission for OMB Review; Refugee Support Services (RSS) and RSS Set Aside Sub-Agency List (0970-0556)
Document Number: 2021-18307
Type: Notice
Date: 2021-08-25
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) seeks approval for a revision to an existing information collection, requesting Refugee Support Services (RSS) grantees and RSS Set Aside grantees to provide the agency name, city, state, website, and funding amount for each contracted sub-grantee. Additionally, ORR seeks approval to have the option to make this information public. This would enhance the accessibility of refugee service provider information to eligible clients in support of the service referral responsibilities of the State Refugee Coordinators. Similar information for ORR's discretionary grants is currently made public.
Electronic Common Technical Document; Data Standards; Specifications for the Electronic Common Technical Document Validation Criteria
Document Number: 2021-18303
Type: Notice
Date: 2021-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the date that FDA will begin rejecting submissions which fail Electronic Common Technical Document (eCTD) validations 1306 or 1323 that have been raised to high validation errors as described in the ``Specifications for eCTD Validation Criteria.''
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-18245
Type: Notice
Date: 2021-08-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations
Document Number: 2021-18239
Type: Notice
Date: 2021-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 ``Environmental Impact Considerations.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment and Operation of Clinical Trial Data Monitoring Committees
Document Number: 2021-18235
Type: Notice
Date: 2021-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, 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.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-18203
Type: Notice
Date: 2021-08-24
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2021-18201
Type: Notice
Date: 2021-08-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2021-18170
Type: Notice
Date: 2021-08-24
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 Request. 60-Day Public Comment Request
Document Number: 2021-18168
Type: Notice
Date: 2021-08-24
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.
National Institute on Minority Health and Health Disparities; Amended Notice of Meeting
Document Number: 2021-18162
Type: Notice
Date: 2021-08-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-18161
Type: Notice
Date: 2021-08-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Black Lung Clinics Program Performance Measures, OMB No. 0915-0292-Revision
Document Number: 2021-18152
Type: Notice
Date: 2021-08-24
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-18126
Type: Notice
Date: 2021-08-24
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 renewal of the information collection project ``Medical Office Survey on Patient Safety Culture Database.'' This proposed information collection was previously published in the Federal Register on May 3rd, 2021 and allowed 60 days for public comment. AHRQ did not receive any substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Supplemental Evidence and Data Request on Schedule of Visits and Use of Telemedicine for Routine Antenatal Care
Document Number: 2021-18125
Type: Notice
Date: 2021-08-24
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 Schedule of Visits and Use of Telemedicine for Routine Antenatal Care, 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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-18112
Type: Notice
Date: 2021-08-24
Agency: Department of Health and Human Services, National Institutes of Health
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-18107
Type: Notice
Date: 2021-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. Members will participate via teleconference. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document.
Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2021-18094
Type: Notice
Date: 2021-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is hosting a virtual public meeting entitled ``Reauthorization of the Prescription Drug User Fee Act.'' The purpose of the public meeting is to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027. PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations, as necessary.
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Draft Guidance for Industry; Availability
Document Number: 2021-18073
Type: Notice
Date: 2021-08-23
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 revised draft guidance for industry entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.'' This revised draft supersedes the draft guidance entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for Drug Products Submitted Under an ANDA,'' which was announced in the Federal Register on December 5, 2013. This revised draft guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2021-18072
Type: Notice
Date: 2021-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-18051
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2021-18050
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2021-18049
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director; National Institutes of Health Notice of Meeting
Document Number: 2021-18048
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2021-18047
Type: Notice
Date: 2021-08-23
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: 2021-18041
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-18040
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-18039
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-18038
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, National Institutes of Health
Health Information Technology Advisory Committee 2021 Schedule of Meetings
Document Number: 2021-18019
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services
The Health Information Technology Advisory Committee (HITAC) was established in accordance with 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 2021. See list of public meetings below.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: COVID-19 Provider Relief Programs Application and Attestation Portal, and Claims Reimbursement Submission Activities
Document Number: 2021-18018
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2021-17996
Type: Notice
Date: 2021-08-23
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.
Determination That ORTHO-CEPT (Desogestrel-Ethinyl Estradiol) 21- and 28-Day Oral Tablets, 0.15 Milligram/0.03 Milligram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-17990
Type: Notice
Date: 2021-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) has determined that ORTHO-CEPT (desogestrel-ethinyl estradiol) 21- and 28- day oral tablets, 0.15 milligram (mg)/0.03 mg, were 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.
Office of the Director; Notice of Charter Renewal
Document Number: 2021-17989
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-17988
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2021-17930
Type: Notice
Date: 2021-08-23
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-17908
Type: Notice
Date: 2021-08-20
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.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-17896
Type: Notice
Date: 2021-08-20
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2021-17895
Type: Notice
Date: 2021-08-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-17880
Type: Notice
Date: 2021-08-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-17877
Type: Notice
Date: 2021-08-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting
Document Number: 2021-17876
Type: Notice
Date: 2021-08-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2021-17875
Type: Notice
Date: 2021-08-20
Agency: Department of Health and Human Services, National Institutes of Health