Department of Health and Human Services February 2022 – Federal Register Recent Federal Regulation Documents

Center for Scientific Review; Notice of Closed Meetings
Document Number: 2022-04127
Type: Notice
Date: 2022-02-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2022-04126
Type: Notice
Date: 2022-02-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2022-04065
Type: Notice
Date: 2022-02-28
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Commission on Childhood Vaccines Meeting Cancellation
Document Number: 2022-04105
Type: Notice
Date: 2022-02-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
This is to notify the public that the March 3, 2022, meeting of the Advisory Commission on Childhood Vaccines (ACCV) is canceled and will be rescheduled. This meeting was announced in the Federal Register, Vol. 87, No. 20 on Monday, January 31, 2022 (FR Doc. 2022- 01848 Filed 1-28-22). Future meetings will occur in June, September, and December of calendar year 2022 and were announced through the same Federal Register notice.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2022-04102
Type: Notice
Date: 2022-02-28
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 ``AHRQ's National Nursing Home COVID-19 Coordinating Center.'' This proposed information collection was previously published in the Federal Register on December 8th, 2021 and allowed 60 days for public comment. AHRQ did not receive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Conduct of Persons and Traffic on the National Institutes of Health Federal Enclave
Document Number: 2022-02859
Type: Proposed Rule
Date: 2022-02-28
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), proposes to amend the existing regulation for the conduct of persons and traffic on the NIH enclave in Bethesda, Maryland, in order to update certain provisions of the regulation.
Submission for OMB Review; Annual Report on Households Assisted by the Low Income Home Energy Assistance Program (LIHEAP)
Document Number: 2022-04085
Type: Notice
Date: 2022-02-28
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Community Services (OCS), Division of Energy Assistance, is requesting a 3-year extension of the Household Report Form (OMB #0970-0060, expiration 02/28/2022). Submission of the completed report is one requirement for LIHEAP grant recipients applying for federal LIHEAP block grant funds. OCS proposes minor changes related to reporting of supplemental funding and to update reporting dates and number of respondents.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2022-04161
Type: Notice
Date: 2022-02-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2022-04158
Type: Notice
Date: 2022-02-28
Agency: Department of Health and Human Services, National Institutes of Health
Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications
Document Number: 2022-04153
Type: Notice
Date: 2022-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Patient-Focused Drug Development: Methods To Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability
Document Number: 2022-04152
Type: Notice
Date: 2022-02-28
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 industry, FDA staff, and other stakeholders entitled ``Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.'' This guidance (Guidance 2) is the second in a series of four methodological guidance documents that FDA committed to develop to describe how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision making. This guidance finalizes the draft guidance of the same title issued on October 1, 2019.
Office of the Director, National Institutes of Health; Notice of Closed Meeting
Document Number: 2022-04162
Type: Notice
Date: 2022-02-28
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs; Withdrawal of Approval of New Animal Drug Application
Document Number: 2022-03539
Type: Notice
Date: 2022-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) at the sponsor's request because the product is no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor
Document Number: 2022-03538
Type: Rule
Date: 2022-02-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and a conditionally approved new animal drug application (cNADA) during July, August, and September 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy of the regulations.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2022-04001
Type: Notice
Date: 2022-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; ACF-801: Child Care and Development Fund (CCDF) Quarterly Case-Level Report, (OMB #0970-0167)
Document Number: 2022-04000
Type: Notice
Date: 2022-02-25
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Care (OCC), Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF- 801: CCDF Quarterly Case-Level Report (OMB #0970-0167, expiration 2/28/ 2022). OCC proposes minor changes to the response categories under the following three data elements: Child's gender, ethnicity, and race.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission
Document Number: 2022-03994
Type: Notice
Date: 2022-02-25
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 associated with the tobacco health document submission.
Agency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products
Document Number: 2022-03992
Type: Notice
Date: 2022-02-25
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 exemptions from substantial equivalence requirements for tobacco products.
Submission for OMB Review; Administration for Native Americans Annual Data Report (ADR)
Document Number: 2022-03991
Type: Notice
Date: 2022-02-25
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families' (ACF) Administration for Native Americans (ANA) is requesting a 2-year extension to the following information collection: Annual Data Report (ADR) (OMB# 0970-0475; expiration date: 2/28/2022). There are no changes requested to the form.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2022-04005
Type: Notice
Date: 2022-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2022-04004
Type: Notice
Date: 2022-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2022-04003
Type: Notice
Date: 2022-02-25
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Meeting
Document Number: 2022-04002
Type: Notice
Date: 2022-02-25
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Correction
Document Number: 2022-03966
Type: Proposed Rule
Date: 2022-02-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the proposed rule published in the Federal Register on January 12, 2022 entitled ``Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs.''
Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act; Public Meeting; Request for Comments
Document Number: 2022-03926
Type: Notice
Date: 2022-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act (BsUFA)'' (the Program) and an opportunity for public comment. The topics to be discussed are the final assessment and public stakeholder views of the Program.
Agency Information Collection Activities; Proposed Collection; Comment Request; Sanitary Transportation of Human and Animal Food
Document Number: 2022-03916
Type: Notice
Date: 2022-02-24
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements associated with the sanitary transportation of human and animal food.
Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising From the COVID-19 Pandemic; Guidance for Industry; Availability
Document Number: 2022-03915
Type: Notice
Date: 2022-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic.'' The COVID-19 pandemic has resulted in a significant reduction in the supply of nonhuman primates (NHPs) available for conducting toxicology studies for new pharmaceuticals. This has the potential to significantly delay the development of new medications for the treatment of diseases currently without effective treatment options. This guidance provides FDA's recommendations to industry to help mitigate the NHP supply issue by reducing the demand for NHPs during the COVID-19 pandemic. Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2022-03936
Type: Notice
Date: 2022-02-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low- burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS- 10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.
Clinical Center; Notice of Closed Meeting
Document Number: 2022-03946
Type: Notice
Date: 2022-02-24
Agency: Department of Health and Human Services, National Institutes of Health
Lead Exposure and Prevention Advisory Committee (LEPAC); Notice of Recharter
Document Number: 2022-03865
Type: Notice
Date: 2022-02-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Lead Exposure and Prevention Advisory Committee (LEPAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through January 17, 2024.
Notice of Closed Meeting
Document Number: 2022-03870
Type: Notice
Date: 2022-02-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR); Meeting
Document Number: 2022-03869
Type: Notice
Date: 2022-02-24
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, Center for Preparedness and Response, (BSC, CPR). This is a virtual meeting that is open to the public, limited only by the number of internet conference accesses available, which is 500. Time will be available for public comment. Pre-registration is required by accessing the link in the addresses section.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2022-03888
Type: Notice
Date: 2022-02-24
Agency: Department of Health and Human Services, National Institutes of Health
Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Rabies Section
Document Number: 2022-03768
Type: Notice
Date: 2022-02-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Rabies Section (Draft Guideline: Rabies Section). The Draft Guideline: Rabies Section updates the Rabies section of the Guideline for infection control in health care personnel, 1998 (1998 Guideline), Part E: Epidemiology and Control of Selected Infections Transmitted Among Health Care Personnel and Patients and its corresponding recommendations in Part II of the 1998 Guideline: ``14. Rabies.'' The updated recommendations in the Draft Guideline: Rabies Section are intended for use by the leaders and staff of occupational health services. These updated recommendations will help facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) who have been exposed or infected and may be contagious to others in the workplace.
Request for Public Comment: 30-Day Proposed Information Collection: Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions
Document Number: 2022-03823
Type: Notice
Date: 2022-02-23
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 titled, ``Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions,'' Office of Management and Budget (OMB) Control Number 0917-0028. The IHS is requesting OMB to approve an extension for this collection, which expires on February 28, 2022. Notice regarding the information collection was last published in the Federal Register on December 13, 2021, and allowed 60 days for public comment. The purpose of this notice is to announce the IHS' intent to submit this collection to OMB and to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID: IHS_FRDOC_0001).
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2022-03822
Type: Notice
Date: 2022-02-23
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: 2022-03821
Type: Notice
Date: 2022-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2022-03820
Type: Notice
Date: 2022-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2022-03799
Type: Notice
Date: 2022-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2022-03798
Type: Notice
Date: 2022-02-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2022-03796
Type: Notice
Date: 2022-02-23
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Quality System Regulation Amendments
Document Number: 2022-03227
Type: Proposed Rule
Date: 2022-02-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). We propose to do so through incorporating by reference an international standard specific for device quality management systems set by the International Organization for Standardization (ISO), the 2016 edition of ISO 13485 (ISO 13485). Through this rulemaking we also propose additional requirements to align with existing requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, and make conforming edits to the Code of Federal Regulations (CFR) to clarify the device CGMP requirements for combination products. This action, if finalized, will continue our efforts to align our regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high- quality devices for patients.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2022-03666
Type: Notice
Date: 2022-02-22
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: 2022-03665
Type: Notice
Date: 2022-02-22
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Meeting
Document Number: 2022-03616
Type: Notice
Date: 2022-02-22
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice of Award of a Single-Source Cooperative Agreement To Fund Cote d'Ivoire Ministry of Health and Public Hygiene and Universal Health Coverage (MSHPCMU)
Document Number: 2022-03631
Type: Notice
Date: 2022-02-22
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 $3,000,000 for Year 1 of funding to the (MSHPCMU). The award will strengthen the capacities of the Ministry of Health (MOH) at the central and decentralized levels for HIV/TB infection control interventions. Funding amounts for years 2-5 will be set at continuation.
Notice of Award of a Single-Source Grant To Fund the International Agency for Research on Cancer
Document Number: 2022-03630
Type: Notice
Date: 2022-02-22
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 $200,000, with an expected total funding of approximately $1,000,000 over a five-year period to the International Agency for Research on Cancer (IARC). The award will support the IARC Handbooks on Cancer Prevention program which provide comprehensive reviews and consensus evaluations evidence on the effectiveness of preventive interventions that may reduce cancer incidence or mortality in the United States and other countries.
Notice of Award of a Single-Source Cooperative Agreement To Fund the Kazakhstan Scientific Center for Dermatology and Infectious Diseases (KSCDID)
Document Number: 2022-03629
Type: Notice
Date: 2022-02-22
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 $500,000, for Year 1 of funding to the Kazakhstan Scientific Center for Dermatology and Infectious Diseases (KSCDID). The award will reduce new HIV infections and AIDS deaths in Kazakhstan through rapidly expanding prevention, testing, care, and effective treatment services to people living with HIV (PLHIV). Funding amounts for years 2-5 will be set at continuation.
Notice of Award of a Single-Source Cooperative Agreement To Fund the Ho Chi Minh City Department of Health (HCMC DOH), Vietnam
Document Number: 2022-03628
Type: Notice
Date: 2022-02-22
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 $2,000,000 for Year 1 of funding to the Ho Chi Minh City Department of Health (HCMC DOH). The award will strengthen the capacity of the HCMC DOH to provide sustainable evidence-based effective HIV prevention, care and treatment services. As Ho Chi Minh City contributes to 22.6% of the HIV burden, HCMC DOH remains critical to the success of HIV program in Vietnam. This NOFO will contribute directly to the national HIV prevention, care and treatment goals by supporting direct services and will support long-term sustainability of the HIV response through capacity building and technical assistance (TA). Funding amounts for years 2-5 will be set at continuation.
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