Department of Health and Human Services September 2021 – Federal Register Recent Federal Regulation Documents
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Fee Rate for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2022
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to sponsors of rare pediatric disease product applications that meet all the requirements of this program and are submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2022 and outlines the payment procedures for such fees.
Fee Rate for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2022
The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for review of drug and biological products when those applications use a tropical disease priority review voucher. These vouchers are awarded to the sponsors of certain tropical disease product applications submitted after September 27, 2007, the enactment date of FDAAA, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each fiscal year based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the tropical disease priority review fee rate for FY 2022 and outlines the payment procedures for such fees.
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.'' The guidance document provides FDA's current thinking on certain criteria that help determine sameness of human gene therapy products for the purpose of orphan-drug designation and orphan-drug exclusivity. The guidance is intended to assist stakeholders, including industry and academic sponsors who seek orphan-drug designation and orphan-drug exclusivity, in the development of gene therapies for rare diseases. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2020.
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early Phase Clinical Trial; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial; Draft Guidance for Industry.'' The draft guidance document provides recommendations to sponsors interested in studying multiple versions of a cellular or gene therapy product in an early phase clinical trial for a single disease. Sponsors have expressed interest in gathering preliminary evidence of safety and activity using multiple versions of a cellular or gene therapy product in a single clinical trial, where each version is a distinct product that should be submitted to FDA in a separate investigational new drug application (IND). The draft guidance describes the regulatory framework for conducting such studies, including recommendations on how to organize and structure the INDs, submit new information, and report adverse events.
Request for Information on Research Opportunities and Operational Activities Related to the NIH Strategic Plan To Advance Research on the Health and Well-Being of Sexual & Gender Minorities Fiscal Years 2021-2025
Through this Request for Information (RFI), the Sexual & Gender Minority Research Office (SGMRO) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), invites feedback from stakeholders throughout the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal NIH stakeholders, and other interested constituents on research opportunities and operational activities related to the NIH Strategic Plan to Advance Research on the Health and Well-Being of Sexual and Gender Minorities fiscal years (FY) 2021-2025. The goal of this request for information is to provide SGM focused organizations, researchers, non-profits, and community members an opportunity to identify potential research opportunities and operational activities related to the NIH mission.
Fee Rate for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2022
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2022. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the sponsors of material threat MCM applications that meet all the requirements of this program and upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2022 and outlines the payment procedures for such fees.
Investigator Responsibilities-Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Investigator ResponsibilitiesSafety Reporting for Investigational Drugs and Devices.'' The draft guidance provides recommendations to help clinical investigators comply with the safety reporting requirements of investigational new drug application (IND) studies and investigational device exemption (IDE) studies. The guidance is intended to help clinical investigators of drugs identify safety information that is considered an unanticipated problem involving risk to human subjects or others and that therefore requires prompt reporting to institutional review boards (IRBs) and to help clinical investigators of devices identify safety information that meets the requirements for reporting unanticipated adverse device effects (UADEs) to sponsors and to IRBs.
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.'' FDA is issuing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision making. This draft guidance is intended to provide sponsors, researchers, and other interested stakeholders with considerations when proposing to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
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.
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2022
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2022. The calendar year 2022 AIC threshold amounts are $180 for ALJ hearings and $1,760 for judicial review.
Submission for OMB Review; Services Provided to Unaccompanied Children (0970-0553)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on revisions to an approved information collection. The request consists of several forms that allow the Unaccompanied Children (UC) Program to provide services to UC as required by statute and ORR policy.
Submission for OMB Review; Release of Unaccompanied Children From ORR Custody (OMB #0970-0552)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on revisions to an approved information collection. The request consists of several forms that allow the Unaccompanied Children (UC) Program to process release of UC from ORR custody and provide services after release.
Submission for OMB Review; Mental Health Care Services for Unaccompanied Children (New Collection)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on the proposed collection. The request consists of several forms that allow the Unaccompanied Children (UC) Program to provide mental health care services to UC.
Charter Renewal for the Advisory Committee on Infant and Maternal Mortality (Formerly the Advisory Committee on Infant Mortality)
In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the Advisory Committee on Infant Mortality has been renamed the Advisory Committee on Infant and Maternal Mortality (ACIMM) and has been renewed.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 72nd full Council meeting utilizing virtual technology on Monday, November, 15 and Wednesday, November, 17, 2021 from 1:00- 5:00 p.m. (ET) on both days. The meeting will be open to the public; a public comment session will be held during the meeting. Pre- registration is required to provide public comment during the meeting. To pre-register to attend or to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Monday, November 8, 2021. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing PACHA@hhs.gov by close of business Wednesday, November 24, 2021. The meeting agenda will be posted on the PACHA page on HIV.gov at https://www.hiv.gov/federal-response/pacha/about-pacha prior to the meeting.
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Microbiological Quality Considerations in Non-Sterile Drug Manufacturing.'' The purpose of this guidance is to assist manufacturers in assuring the microbiological quality of their non- sterile drugs (NSDs). This guidance discusses product development considerations, risk assessments, and certain current good manufacturing practice (CGMP) requirements that are particularly relevant to microbiological control in a manufacturing operation for an NSD.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The HRSA Community-Based Outreach Reporting Module, OMB #0906-0064, Revision
HRSA at the U.S. Department of Health and Human Services (HHS) requests a revision to the data collection for the Community- Based Workforce for COVID-19 Vaccine Outreach Programs (CBO Programs) (OMB # 0906-0064). 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.
Benefit-Risk Assessment for New Drug and Biological Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Benefit- Risk Assessment for New Drug and Biological Products.'' FDA has developed this guidance document in accordance with commitments associated with the Prescription Drug User Fee Act of 2017 (PDUFA VI) under the FDA Reauthorization Act of 2017 and requirements under the 21st Century Cures Act (Cures Act). The intent of this guidance is to provide drug sponsors and other stakeholders with a clearer understanding of how considerations about a drug's benefits, risks, and risk management options factor into certain FDA pre- and postmarket regulatory decisions about new drug applications (NDAs) submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and biologics license applications (BLAs).
Submission for OMB Review; The Study of Disability Services Coordinators and Inclusion in Head Start (New Collection)
This is a primary data collection request for the Study of Disability Services Coordinators and Inclusion in Head Start (New Collection). The study aims to provide a nationally representative picture of the Early Head Start (EHS) and Head Start (HS) Disability Services Coordinator (DSC) workforce, as well as services provided to children with disabilities and their families within these programs and how EHS/HS collaborates with services in the community, including health providers, Local Education Agencies, and Part C. This is the first study of the HS/EHS DSC workforce and will contain three Phases of data collection using surveys and qualitative interviews.
Submission for OMB Review; Child and Family Services Reviews (OMB #0970-0214)
The Administration for Children and Families (ACF) is requesting reinstatement of the activities associated with the Child and Family Services Reviews (CFSR) collection (OMB #0970-0214). Revisions have been made to the forms to clarify instructions and incorporate new guidance. The activities associated with the Title IV-E Foster Care Eligibility Reviews and Anti-Discrimination Enforcement Corrective Action Plans were removed from this collection.
Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Electronic Submission Template for Medical Device 510(k) Submissions.'' FDA is issuing this draft guidance to introduce submitters of premarket notification (510(k)) submissions to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed to support 510(k) electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it in effect at this time.
Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC).
Patient Safety Organizations: Voluntary Relinquishment for the Chicago Breast Cancer Quality Consortium
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the Chicago Breast Cancer Quality Consortium, PSO number P0074, of its status as a PSO, and has delisted the PSO accordingly.
Public Workshop: Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients From Birth to Less Than Two Years of Age
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age.'' The purpose of the public workshop is to discuss the state of science, data gaps, and challenges in drug development for drugs intended to treat acute pain in patients less than 2 years of age.
Rescission of Humanitarian Exemption for All Afghan Evacuees Subject to CDC's Global Testing Order
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces rescission of the temporary humanitarian exemption to the agency's Requirement for Negative Pre-Departure COVID-19 Test Result, which was previously granted for individuals relocating to the United States from Afghanistan (``Afghan Evacuees''), including U.S. citizens, lawful permanent residents (LPRs), third country nationals, and Afghans at risk, including Afghan Special Immigrant Visa (SIV) applicants.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Medicare Program: Application by the Association of Diabetes Care and Education Specialists (ADCES) for Continued CMS Approval of Its Diabetes Outpatient Self-Management Training Program
This final notice announces our decision to approve the Association of Diabetes Care and Education Specialists (ADCES) application for continued recognition as a national accrediting organization (AO) for accrediting entities that wish to furnish diabetes outpatient self-management training services to Medicare beneficiaries.
Health and Human Services Grants Regulation
The U.S. District Court for the District of Columbia in Facing Foster Care et al. v. HHS, 21-cv-00308 (D.D.C. Feb. 2, 2021), has postponed the effective date of portions of the final rule making amendments to the Uniform Administrative Requirements, promulgated on January 12, 2021.
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