Department of Health and Human Services July 2023 – Federal Register Recent Federal Regulation Documents

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is proposing to collect data from grantee agencies participating in the Voluntary Agencies Matching Grant Program. Client data collected will include enrollment information, demographics, and program outcomes.

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: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections (``Draft Guideline: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections''). The Draft Guideline: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections updates 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: ``8. Measles;'' ``10. Mumps;'' ``15. Rubella;'' and ``21. Varicella.'' The updated recommendations in the Draft Guideline: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections are intended for use by the leaders and staff of healthcare facilities and systems' Occupational Health Services (OHS), as further provided herein. 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.

This notice acknowledges the receipt of an application from The Joint Commission (TJC) for continued recognition as a national accrediting organization providing home infusion therapy (HIT) services that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This notice extends the comment period for a 60-day notice request for proposed information collection request associated with the notice [Document Identifier: CMS-576 and CMS-576A] entitled ``Organ Procurement Organization (OPO) Request for Designation as an OPO, Health Insurance Benefits Agreement, and Supporting Regulations'' that was published in the June 13, 2023 Federal Register. The comment period for the information collection request, which would have ended on August 14, 2023, is extended to August 28, 2023.

The Indian Health Service (IHS or Service) administers the Catastrophic Health Emergency Fund (CHEF) pursuant to section 202 of the Indian Health Care Improvement Act (IHCIA). The purpose of the CHEF is to meet the extraordinary medical costs associated with the treatment of victims of disasters or catastrophic illnesses who are within the responsibility of the Service. This notice proposes regulations governing the administration of the CHEF.

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.

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Social Security Administration (SSA), ``Determining Enrollment or Eligibility for Insurance Affordability Programs Under the Patient Protection and Affordable Care Act.''

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 ELEVIDYS (delandistrogene moxeparvovec-rokl), manufactured by Sarepta Therapeutics, Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry.'' The management of manufacturing changes presents many challenges for human cellular therapy or gene therapy (CGT) products due to the complexity of these products. The draft guidance provides sponsors of Investigational New Drug Applications (INDs) and applicants of Biologics License Applications (BLAs) for CGT products, with recommendations regarding product comparability and the management of manufacturing changes for investigational and licensed CGT products. The purpose of this draft guidance is to provide FDA's current thinking on management and reporting of manufacturing changes for CGT products based on a life-cycle approach, and comparability studies to assess the effect of manufacturing changes on product quality.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act.'' The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to require certain postmarketing studies and clinical trials for prescription drugs at the time of approval or after approval if FDA becomes aware of new safety information. This draft guidance describes the factors FDA considers when determining whether an applicant has demonstrated good cause for failure to comply with the timetable for completion of studies or clinical trials required under the provisions. This draft guidance also provides information on relevant procedures, including how an applicant should communicate with FDA regarding compliance with these required studies and trials and describes actions FDA may take for noncompliance with the requirements.

The Food and Drug Administration (FDA or Agency) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Drug Evaluation and Research (CDER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CDER's public advisory committees. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

The Food and Drug Administration (FDA) is announcing the renewal of the National Mammography Quality Assurance Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the National Mammography Quality Assurance Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the July 7, 2025, expiration date.

In accordance with the Public Health Service Act and the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) scheduled a public meeting to be held Thursday, August 10, 2023, and Friday, August 11, 2023. Information about ACHDNC and the agenda for this meeting can be found on ACHDNC's website at https:// www.hrsa.gov/advisory-committees/heritable-disorders/index.ht ml.

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 Shigella Hypothesis Generating Questionnaire (SHGQ). The SHGQ supports shigellosis cluster and outbreak investigations. CDC will collect state and local health department furnished shigellosis case data.

OCSS proposes to provide temporary relief to states from certain child support program performance requirements and penalties during natural disasters and other calamities which have a negative impact on state child support program operations. The proposed rule would provide ACF with ongoing authority to modify performance measure requirements when states are affected by natural disasters and other calamities that have resulted, or are expected to result, in the failure of state child support programs to achieve performance standards for paternity establishment, support order establishment, and current collections. The proposed rule will enable states to avoid the imposition of penalties due to adverse data reliability audit findings during, and subsequent to, natural disasters and other calamities, including pandemics and declared public health emergencies.

The Department of Health and Human Services, Administration for Children and Families proposes to amend the Child Care and Development Fund (CCDF) regulations. This notice of proposed rulemaking (NPRM) proposes changes to lower families' child care costs, which can be a significant financial strain for families and disincentivize work, training, and education. It proposes changes to improve child care provider payment rates and practices to increase parent choice for child care arrangements and help stabilize operations for participating providers. It also proposes ways for CCDF Lead Agencies to streamline eligibility and enrollment processes so families can receive child care assistance faster and so program bureaucracy is less likely to disrupt parent employment, training, and education and impede access to child care. The NPRM also includes technical and other changes to improve clarity and program implementation.