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

Results 201 - 245 of 245
Premarket Tobacco Product Applications and Recordkeeping Requirements
Document Number: 2021-21011
Type: Rule
Date: 2021-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, us, or we) is issuing a final rule that sets forth requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule will help ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product. The rule codifies the general procedures FDA will follow when evaluating PMTAs and creates postmarket reporting requirements for applicants that receive marketing granted orders. The rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.
Applications for Premarket Review of New Tobacco Products; Draft Guidance for Industry; Withdrawal
Document Number: 2021-21010
Type: Notice
Date: 2021-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the withdrawal of a draft guidance for industry entitled ``Applications for Premarket Review of New Tobacco Products.'' We are withdrawing this guidance because the topics discussed in the draft guidance are addressed in the final rule entitled ``Premarket Tobacco Product Applications and Recordkeeping Requirements.''
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
Document Number: 2021-21009
Type: Rule
Date: 2021-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to provide additional information on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (SE Reports). The final rule also establishes the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report. The final rule will provide applicants with more certainty and clarity related to preparing and submitting SE Reports.
Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19; Correction
Document Number: 2021-21652
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, Office of the Secretary
This document clarifies a term that appeared in the ``Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19,'' including in the final notice published in the Federal Register on September 14, 2021, entitled ``Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19.'' Specifically, this document supplements the references to the Advisory Committee on Immunization Practices (ACIP) with references to the Centers for Disease Control and Prevention (CDC). This change is being made to clarify that what are commonly referred to as ``ACIP recommendations'' and ``ACIP standard immunization schedules'' are in fact recommendations and schedules made by the CDC after consultation with ACIP. The addition of ``CDC'' is also intended to recognize coverage of recommendations issued directly by the CDC. This clarification also applies to related guidance and opinions.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-21561
Type: Notice
Date: 2021-10-04
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: 2021-21560
Type: Notice
Date: 2021-10-04
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: 2021-21558
Type: Notice
Date: 2021-10-04
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.
Medicare Program; Fiscal Year (FY) 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022); Correction
Document Number: 2021-21546
Type: Rule
Date: 2021-10-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule published in the Federal Register on August 4, 2021 entitled ``Medicare Program; FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022)''.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21538
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21536
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21535
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21534
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2021-21531
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21530
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-21529
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-21524
Type: Notice
Date: 2021-10-04
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 Study to Explore Early Development (SEED) Follow-up Studies. This follow-up study will allow CDC to better understand the developmental trajectory of children with autism spectrum disorder, their health outcomes and co-occurring conditions at older ages, and the associated early predictors of these outcomes, including intellectual abilities.
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2021-21523
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-21521
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-21519
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2021-21513
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2021-21468
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-21467
Type: Notice
Date: 2021-10-04
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: 2021-21466
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2021-21461
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the October 25, 2021 meeting the Advisory Council will hear presentations about ways to support and strengthen the long-term services and supports direct care workforce, both paid and unpaid, to support access to care, improve the quality of caregiving, and meet the growing demand for long-term care dementia services. The Advisory Council will also hear about a recent workshop on the behavioral and social research and clinical practice implications of preclinical diagnosis of AD/ADRD, as well as the AD/ ADRD decadal study conducted by the National Academies of Sciences, Engineering, and Medicine. Federal representatives will provide updates on work towards the goals of the National Plan to Address Alzheimer's Disease in the last quarter.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-21459
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2021-21454
Type: Notice
Date: 2021-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Implementation of Executive Order on Access to Affordable Life-Saving Medications; Rescission of Regulation
Document Number: 2021-21457
Type: Rule
Date: 2021-10-01
Agency: Department of Health and Human Services
HHS is rescinding the final rule entitled ``Implementation of Executive Order on Access to Affordable Life-Saving Medications,'' published in the December 23, 2020, Federal Register (2020 Rule). HHS is rescinding the 2020 Rule due to the excessive administrative costs and burdens that implementation would have imposed on health centers. In particular, the 2020 Rule required health centers to create and maintain new practices necessary to determine patients' eligibility to receive certain drugs at or below the discounted price paid by the health center or subgrantees plus a minimal administration fee. HHS finds the 2020 Rule's implementation would have resulted in reduced resources available to support critical services to health center patientsincluding those who use insulin and injectable epinephrine. HHS's consideration of the 2020 Rule's impact was informed, in part, by the demands on health centers resulting from the COVID-19 pandemic. As Executive Order 13937 remains in effect, HHS is exploring non- regulatory options to implement the Executive Order.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms
Document Number: 2021-21421
Type: Notice
Date: 2021-10-01
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.
Announcement of Intent To Award Supplement to El Pajaro Community Development Corporation, in Watsonville, CA
Document Number: 2021-21420
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, Administration for Children and Families
The ACF, OCS, Division of Discretionary Programs announces the intent to award a supplement in the amount of $196,633 to the El Pajaro Community Development Corporation (EPCDC), in Watsonville, CA, to support the renovation of a building, into a shared commercial kitchen and a food packing facility.
Announcement of the Intent To Award Four Single-Source Grants
Document Number: 2021-21418
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, Administration for Children and Families
The ACF, OHSEPR announces the intent to award four single- source grants in the amount of up to $300,000 to the following recipients: United Way Worldwide, Alexandria, VA; National Association of Social Workers, Washington, DC; American Public Human Services Association, Arlington, VA; and National Association of County Human Services Administrators, Washington, DC. The purpose of these awards is to facilitate the coordination of human services to U.S. Citizens and their dependents evacuating to the United States from Afghanistan. These organizations are key players in the leadership, coordination, or direct provision of human services after an emergency and have direct access to their constituencies and networks. U.S. citizens and their dependents (repatriates) eligible for temporary assistance under the U.S. Repatriation Program can receive up to 90 days of temporary assistance which includes transportation, food, medical care, cash assistance, temporary lodging, and case management. These awards will ensure appropriate training and technical assistance, coordination, and subject matter expertise as repatriates connect to human services entities.
Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments; Extension of Comment Period
Document Number: 2021-21403
Type: Notice
Date: 2021-10-01
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 notice entitled ``Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments'' that appeared in the Federal Register of August 9, 2021. The Agency is taking this action to allow interested persons additional time to submit comments.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
Document Number: 2021-21402
Type: Notice
Date: 2021-10-01
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 (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2021-21397
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2021-21396
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2021-21386
Type: Notice
Date: 2021-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
Document Number: 2021-21382
Type: Notice
Date: 2021-10-01
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 requests comments on the information collection associated with FDA research in obtaining information from pharmacists and other management at outsourcing facilities and related human prescription drug compounding businesses. The research supports a comprehensive analysis of the outsourcing facility sector that informs ongoing FDA work in this area.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-21381
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2021-21380
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, National Institutes of Health
Sitesh Bansi Patel: Final Debarment Order
Document Number: 2021-21375
Type: Notice
Date: 2021-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Sitesh Bansi Patel for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Patel was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Patel was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 8, 2021 (30 days after receipt of the notice), Mr. Patel has not responded. Mr. Patel's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Watson Laboratories, Inc., et al.; Withdrawal of Approval of 36 Abbreviated New Drug Applications; Correction
Document Number: 2021-21371
Type: Notice
Date: 2021-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 25, 2021. The document announced the withdrawal of approval of 36 abbreviated new drug applications (ANDAs) from multiple applicants as of July 26, 2021. The document indicated that FDA was withdrawing approval of the following ANDA, after receiving a withdrawal request from Yung Shin Pharmaceutical Ind. Co. Ltd., authorized U.S. agent, Carlsbad Technology, Inc./Simon Law, 5922 Farnsworth Ct., Suite 101, Carlsbad, CA 92008: ANDA 065152, Cephalexin Capsules, Equivalent to (EQ) 250 milligrams (mg) base and EQ 500 mg base. Before FDA withdrew the approval of this ANDA, Yung Shin Pharmaceutical Ind. Co. Ltd. informed FDA that it did not want the approval of the ANDA withdrawn. Because Yung Shin Pharmaceutical Ind. Co. Ltd. timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 065152 is still in effect.
Public/Private Refugee Cash Assistance Inflationary Increase
Document Number: 2021-21369
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, Office of Refugee Resettlement
In accordance with ORR regulations, the Director of ORR is announcing an inflationary increase to the public/private Refugee Cash Assistance (RCA) program's monthly payment ceilings, effective October 1, 2021. The current payment ceilings have remained fixed since March 22, 2000, despite inflation. The new payment ceilings accommodate that inflation and will provide arriving ORR-eligible populations greater economic stability as they transition to self-sufficiency.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety; Federal-State Food Regulatory Program Standards
Document Number: 2021-21367
Type: Notice
Date: 2021-10-01
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.
Request for Public Comment: 60 Day Notice for Extension of Fast Track Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery: IHS Customer Service Satisfaction and Similar Surveys
Document Number: 2021-21350
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0036, ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.'' This notice announces our intent to submit this previously approved information collection, which expires January 31, 2022, to OMB for approval of an extension and solicit comments on specific aspects for the proposed information collection.
Center for Indigenous Innovation and Health Equity Tribal Advisory Committee; Solicitation of Nominations for Delegates
Document Number: 2021-21253
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) hereby gives notice that OMH is establishing a Center for Indigenous Innovation and Health Equity Tribal Advisory Committee (CIIHE TAC) and accepting nominations of qualified candidates to serve as primary and alternate delegates for the CIIHE TAC, in alignment with the 12 geographic areas served by the Indian Health Service (IHS).
Final Policy: Updates to Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement
Document Number: 2021-21241
Type: Notice
Date: 2021-10-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Ryan White HIV/AIDS Program (RWHAP) statute of the Public Health Services Act requires that RWHAP Part A, B, and C recipients expend not less than 75 percent of Parts A, B, and C grant funds on core medical services for individuals with HIV/AIDS identified and eligible under the statute, after reserving statutory permissible amounts for administrative and clinical quality management (CQM) costs. The statute also grants the Secretary of HHS authority to waive this requirement if certain requirements are met. HRSA has simplified the process for RWHAP Part A, B, and C recipients to request a waiver of the core medical services expenditure amount requirement by replacing HRSA Policy Number 13-07, ``Uniform Standard for Waiver of Core Medical Services Requirement for Grantees Under Parts, A, B, and C'' with Policy Notice 21-01, ``Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement.''