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

Advice About Eating Fish: For Those Who Might Become or Are Pregnant or Breastfeeding and Children Ages 1-11 Years, From the Environmental Protection Agency and Food and Drug Administration; Revised Fish Advice; Availability
Document Number: 2021-23666
Type: Notice
Date: 2021-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of revised fish advice entitled ``Advice About Eating Fish: For Those Who Might Become or Are Pregnant or Breastfeeding and Children Ages 1-11 Years.'' The revised advice updates advice that FDA and the U.S. Environmental Protection Agency (EPA) jointly issued in January 2017 and subsequently revised in July 2019. The advice is intended to help those who might become or are pregnant or breastfeeding, and parents and caregivers of children make informed choices about fish that are nutritious and safe to eat. We are revising the advice in accordance with a recent directive from Congress.
Submission for OMB Review; Office of Child Care Data Collection for ACF-218: FFY 2021 Quality Progress Report (QPR) (OMB #0970-0517)
Document Number: 2021-23644
Type: Notice
Date: 2021-10-29
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Care (OCC) is requesting a 1-year extension of the form ACF-218: Quality Progress Report (QPR) (OMB #0970-0517, expiration 9/30/2021). There are minor changes requested to the form related to COVID-19 pandemic supplemental funding increases.
Request for Public Comment: 30-Day Notice for Extension of the Indian Health Service Loan Repayment Program (LRP)
Document Number: 2021-23629
Type: Notice
Date: 2021-10-29
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995 (PRA), 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 0917-0014, titled, ``IHS Loan Repayment Program (LRP).'' The IHS is requesting OMB to approve an extension for this collection, which expires on November 30, 2021. Notice regarding the information collection was last published in the Federal Register (86 FR 43257) on August 6, 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-23587
Type: Notice
Date: 2021-10-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-23585
Type: Notice
Date: 2021-10-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-23556
Type: Notice
Date: 2021-10-29
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 Application for Training, which supports the management and evaluation of online training and professional development opportunities for public health and health care professionals.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-23555
Type: Notice
Date: 2021-10-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-23554
Type: Notice
Date: 2021-10-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Generic Drug User Fee Amendments; Public Meeting; Request for Comments
Document Number: 2021-23499
Type: Notice
Date: 2021-10-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2023 through 2027. GDUFA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to assess and collect fees to support human generic drug activities. The current legislative authority for GDUFA expires at the end of September 2022. At that time, new legislation will be required for FDA to continue to assess and collect generic drug user fees for future fiscal years. The FD&C Act directs FDA, following negotiations with the regulated industry and periodic consultations with other stakeholders, to present recommendations for reauthorization of the GDUFA program to the relevant Congressional committees, publish the recommendations in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.
Securing Updated and Necessary Statutory Evaluations Timely; Proposal To Withdraw or Repeal
Document Number: 2021-23472
Type: Proposed Rule
Date: 2021-10-29
Agency: Food and Drug Administration, Department of Health and Human Services, Public Health Service, Office of the Secretary, Administration for Children and Families, Centers for Medicare and Medicaid Services, Office of the Inspector General
The Department of Health and Human Services (HHS or Department) is proposing to withdraw or repeal a final rule entitled ``Securing Updated and Necessary Statutory Evaluations Timely'' (SUNSET final rule) and published in the Federal Register of January 19, 2021. The SUNSET final rule was originally scheduled to take effect on March 22, 2021. However, after a lawsuit was filed on March 9, 2021, seeking to overturn the SUNSET final rule, HHS issued an administrative delay of effective date that extended the effective date of the SUNSET final rule until March 22, 2022. HHS is now proposing to withdraw or repeal the SUNSET final rule.
Temporary Extension and Modification of Framework for Conditional Sailing Order (CSO) for Cruise Ships Operating or Intending To Operate in U.S. Waters
Document Number: 2021-23573
Type: Notice
Date: 2021-10-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces a temporary extension and modification of the Framework for Conditional Sailing Order (CSO).
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-23509
Type: Notice
Date: 2021-10-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-23508
Type: Notice
Date: 2021-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Targeted Mechanism of Action Presentations in Prescription Drug Promotion
Document Number: 2021-23507
Type: Notice
Date: 2021-10-28
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 a proposed study entitled ``Targeted Mechanism of Action Presentations in Prescription Drug Promotion.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2021-23504
Type: Notice
Date: 2021-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
Document Number: 2021-23501
Type: Notice
Date: 2021-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad, and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA's website from the links indicated.
Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Document Number: 2021-23500
Type: Notice
Date: 2021-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Life Technologies Corporation (a part of Thermo Fisher Scientific, Inc.) (Thermo Fisher) for the TaqPath COVID-19 MS2 Combo Kit 2.0. FDA revoked this Authorization on September 27, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.
Updated HRSA-Supported Women's Preventive Services Guidelines: Contraception and Screening for HIV Infection
Document Number: 2021-23498
Type: Notice
Date: 2021-10-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice seeks comments on two updated draft recommendations for (1) providing contraception and (2) screening for human immunodeficiency virus (HIV) infection, as part of the HRSA- supported Women's Preventive Services Guidelines (Guidelines). These updated draft recommendations have been developed through a national cooperative agreement, the Women's Preventive Services Initiative (WPSI), by the American College of Obstetricians and Gynecologists (ACOG). Under applicable law, non-grandfathered group health plans and health insurance issuers offering non-grandfathered group and individual health insurance coverage must include coverage, without cost sharing, for certain preventive services, including those provided for in the HRSA-supported Women's Preventive Services Guidelines (Guidelines). The Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury have previously issued regulations, which describe how group health plans and health insurance issuers apply the coverage requirements, including the use of reasonable medical management. (See 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR 147.130).
Supplemental Evidence and Data Request on Nutrition as Prevention for Improved Cancer Outcomes
Document Number: 2021-23456
Type: Notice
Date: 2021-10-28
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 Nutrition as Prevention for Improved Cancer Outcomes, 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.
Exemption of Certain Categories of Biological Products From Certain Reporting Requirements Under the Federal Food, Drug, and Cosmetic Act
Document Number: 2021-23396
Type: Notice
Date: 2021-10-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is proposing to exempt certain categories of biological products from certain reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Specifically, each person who registers with FDA with regard to a drug is required to report annually to FDA on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution; however, certain biological products or categories of biological products may be exempted by order from these reporting requirements if FDA determines that applying such reporting requirements is not necessary to protect the public health. FDA is proposing to exempt the two categories of biological products from these reporting requirements because the Agency has determined that applying such requirements is not necessary to protect the public health.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Document Number: 2021-23395
Type: Notice
Date: 2021-10-27
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.
Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2022 Proposed Guidance Development
Document Number: 2021-23392
Type: Notice
Date: 2021-10-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in fiscal year (FY) 2022. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholders' needs.
Determination of Regulatory Review Period for Purposes of Patent Extension; INREBIC
Document Number: 2021-23388
Type: Notice
Date: 2021-10-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for INREBIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; XENLETA Tablets New Drug Application 211672
Document Number: 2021-23387
Type: Notice
Date: 2021-10-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XENLETA tablets and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; XENLETA Injection New Drug Application 211673
Document Number: 2021-23386
Type: Notice
Date: 2021-10-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XENLETA injection new drug application (NDA) 211673 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-23384
Type: Notice
Date: 2021-10-27
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 Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-23383
Type: Notice
Date: 2021-10-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-23382
Type: Notice
Date: 2021-10-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2021-23371
Type: Notice
Date: 2021-10-27
Agency: Department of Health and Human Services, National Institutes of Health
Record of Decision; Acquisition of Site for Development of a Replacement Underground Safety Research Program Facility for the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) in Mace, West Virginia
Document Number: 2021-23341
Type: Notice
Date: 2021-10-27
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), in cooperation with the General Services Administration (GSA), announces the availability of the Record of Decision (ROD) for the acquisition of a Site in Mace, West Virginia, and the development of this Site into a replacement for the National Institute for Occupational Safety and Health (NIOSH) Underground Safety Research Program facility (Proposed Action). The acquisition and development will replace the former Lake Lynn Experimental Mine in Fayette County, Pennsylvania, and will support research programs focused on miner health and safety issues. The site to be acquired and developed includes 461.35 acres located off U.S. Route 219 in Randolph and Pocahontas Counties near Mace, West Virginia (Site).
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2021-23336
Type: Notice
Date: 2021-10-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that RETHYMIC (allogeneic processed thymus tissue-agdc), manufactured by Enzyvant Therapeutics, GmbH, meets the criteria for a priority review voucher.
Request for Information and Notice of Listening Session on Efforts To Advance Health Equity Among Native Hawaiian and Pacific Islander Populations
Document Number: 2021-23200
Type: Notice
Date: 2021-10-26
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) seeks input from Native Hawaiian and Pacific Islander (NHPI) communities, NHPI-serving organizations, and other interested parties regarding efforts of the new Center for Indigenous Innovation and Health Equity (Center). The Center is tasked with supporting education, service and policy development, and research related to advancing sustainable solutions, to address health disparities and advance health equity among NHPI and American Indian/ Alaska Native (AI/AN) populations. This is NOT a solicitation for proposals or proposal abstracts. Please Note: This RFI and notice of a listening session is for planning purposes only. It is not a notice for a proposal and does not commit the federal government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the federal government and will not be returned. All responses will become part of the public record and will not be held confidential. The federal government reserves the right to use the information provided by respondents for purposes deemed necessary and legally appropriate. Respondents are advised that the federal government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents concerning any information submitted. Responses will not be accepted after the due date.
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2021-23334
Type: Notice
Date: 2021-10-26
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 Neurological 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.
National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting
Document Number: 2021-23318
Type: Notice
Date: 2021-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and Commercialization of CRISPR-Engineered T Cell Therapies for the Treatment of Cancer
Document Number: 2021-23289
Type: Notice
Date: 2021-10-26
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Neogene Therapeutics, Inc. (``Neogene''), headquartered in Santa Monica, CA.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-23284
Type: Notice
Date: 2021-10-26
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.
Expedited OMB Review and Public Comment: Office of Community Services Data Collection for the Low Income Household Water Assistance Program Reports (New Collection)
Document Number: 2021-23271
Type: Notice
Date: 2021-10-26
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Community Services, Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) and inviting public comment on the proposed collection. The proposed forms are necessary to provide data to the Administration and Congress in its oversight of recipients' performance in administering the Low Income Household Water Assistance Program (LIHWAP) program. The information collection is essential to the mission of the agency for this emergency assistance effort and the use of normal clearance procedures is reasonably likely to disrupt and prevent the collection of information.
Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2021-23223
Type: Notice
Date: 2021-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, limited only by the number of audio conference lines and internet conference accesses available, which is 200 combined. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining a teleconference line and/or computer connection (information below).
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-23192
Type: Notice
Date: 2021-10-25
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Secretary; Notice of Meeting
Document Number: 2021-23191
Type: Notice
Date: 2021-10-25
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-23187
Type: Notice
Date: 2021-10-25
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 ``Maritime Illness Database and Reporting System (MIDRS).'' The purpose of this data collection is to provide U.S.-bound passenger vessel operators an electronic reporting system to assist with their legal requirement to notify CDC of the number of passengers and crew members onboard their ship who have reportable acute gastroenteritis (AGE) as defined by federal quarantine regulations.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-23186
Type: Notice
Date: 2021-10-25
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 to take this opportunity to comment on proposed information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Research Data Center (RDC) Proposal for Access to Confidential Data for the National Center for Health Statistics (NCHS). The proposed collection will be used to assess researcher's requests for access to confidential NCHS data for their research projects.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-23185
Type: Notice
Date: 2021-10-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-23182
Type: Notice
Date: 2021-10-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2022
Document Number: 2021-23143
Type: Notice
Date: 2021-10-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a $631.00 calendar year (CY) 2022 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2022 and on or before December 31, 2022.
National Library of Medicine; Notice of Closed Meetings
Document Number: 2021-23134
Type: Notice
Date: 2021-10-25
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2021-23222
Type: Notice
Date: 2021-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-23107
Type: Notice
Date: 2021-10-22
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.
Prospective Grant of Exclusive Patent Commercialization License: CD28H Domain-Containing Chimeric Antigen Receptors and Methods of Use
Document Number: 2021-23092
Type: Notice
Date: 2021-10-22
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Ankarys Therapeutics Inc., located at 110 Cumberland Street, Suite 520, M5R 3V5, Toronto, Ontario, Canada, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2021-23091
Type: Notice
Date: 2021-10-22
Agency: Department of Health and Human Services, National Institutes of Health