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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.'' For purposes of implementing the Generic Drug User Fee Amendments of 2022 (GDUFA III), the Pre-Submission Facility Correspondence (PFC) process was revised as part of the performance goals and program enhancements agreed to by FDA and industry, as described in the GDUFA Reauthorization Performance Goals and Program Enhancements, Fiscal Years 2023 through 2027 (GDUFA III commitment letter). FDA assesses facility information submitted in a PFC to inform the Agency's decision regarding the need for facility inspections that support assessment of the abbreviated new drug application (ANDA). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned ANDA submission for priority ANDAs, allowing the Agency more time to make preapproval inspection decisions. A PFC meeting the conditions outlined in the revised draft guidance will qualify the ANDA for a shorter, 8- month priority review goal. This revised draft guidance describes the content, timing, and assessment of a complete and accurate PFC for purposes of GDUFA III. Additionally, this revised draft guidance provides information on the Agency's rationale for and current approach to assessing a PFC and replaces the previous draft guidance for industry, ``ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence),'' issued in November 2017.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to add additional data collection activities as part of the rigorous evaluation of the Procedural Justice-Informed Alternatives to Contempt (PJAC) Demonstration. The proposed revision to conduct additional data collection is part of a research supplement that builds on the PJAC study to understand the role of bias in child support program enforcement actions.

This notice announces a $688.00 calendar year (CY) 2023 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, 2023 and on or before December 31, 2023.

The Department of Health and Human Services (HHS or ``the Department'') is issuing this notice of proposed rulemaking (NPRM) to solicit public comment on its proposal to modify its regulations to implement section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

The Secretary of Health and Human Services delegates to the National Institutes of Health (NIH) Director and the Food and Drug Administration (FDA) Commissioner the authorities vested in the Secretary of Health and Human Services under Section 3 of the Accelerating Access to Critical Therapies for ALS Act, as amended, to establish and implement a Public-Private Partnership for rare neurodegenerative diseases. These authorities may be redelegated. Exercise of this authority shall be in accordance with established policies, procedures, guidelines, and regulations as prescribed by the Secretary. The Secretary retains the authority to submit reports to Congress and promulgate regulations.

The Administration for Children and Families (ACF) is requesting approval of the ACF Congressionally Directed Community ProjectsUniversal Project Description (CDCP-UPD). This new information collection is proposed to collect information from recipients of ACF Congressionally Directed funds. A Congressional Directive is an authorization act or appropriations act that requires ACF to make an award(s) to a named recipient(s) for a particular program, project, activity, or geographic area(s).

In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the National Advisory Council on Nurse Education and Practice (NACNEP) has been rechartered. The effective date of the recharter is November 30, 2022.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces fees for vessel sanitation inspections for Fiscal Year (FY) 2023. These inspections are conducted by HHS/CDC's Vessel Sanitation Program (VSP). VSP helps the cruise ship industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly unannounced operations inspections and, when necessary, reinspection.

The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 019832 for SULFAMYLON[supreg] (Mafenide Acetate, USP) Powder for 5% Topical Solution, held by Mylan Institutional, Inc., a Viatris company (Mylan). Mylan has voluntarily requested withdrawal of this application and has waived its opportunity for a hearing.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 Information Collection (IC) Revision solicits comments on the information collection requirements relating to the Developmental Disabilities State Plan OMB control number 0985-0029.

The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule entitled ``Food Labeling: Nutrient Content Claims; Definition of Term `Healthy' '' that appeared in the Federal Register of September 29, 2022. We are taking this action in response to a request from stakeholders to extend the comment period to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridioides difficile Infection Not Responsive to Standard Therapies; Guidance for Industry.'' The guidance document informs members of the medical and scientific community and other interested persons notice that, at this time, we intend to exercise enforcement discretion with respect to the investigational new drug application (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat Clostridioides difficile (C. difficile) infection not responding to standard therapies under limited circumstances described in the guidance. The guidance announced in this notice finalizes the draft guidance entitled ``Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies'' dated March 2016, and supersedes the guidance entitled ``Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies'' dated July 2013.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jennings Ryan Staley for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Staley was convicted of one felony count under Federal law for Importation Contrary to Law. The factual basis supporting Mr. Staley's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Staley was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. Mr. Staley provided notice to FDA that he acquiesced to the debarment; FDA received that notice on October 6, 2022. As such, his debarment commenced on the date FDA was notified of acquiescence.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. This annual notice is also in accordance with the 21st Century Cures Act, which requires the Secretary of Health and Human Services (the Secretary) to provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore, encourages nominations of appropriately qualified candidates from these groups.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Respiratory Protective Devices42 CFR part 84Regulation. The purpose of the data collection is to enable 42 CFR part 84 respirator approval certification activities.

Notice is hereby given of a change in the solicitation of nominations for appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP-STAC). The solicitation notice is being amended to extend the deadline for submission of nominations from November 14, 2022, in the original Federal Register notice, to December 30, 2022.

In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (the Act), the Federal anti-kickback statute, as well as developing new OIG Special Fraud Alerts.