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

The Agency for Healthcare Research and Quality (AHRQ), on behalf of the Department of Health and Human Services (HHS), seeks public comment about advancing patient and healthcare workforce safety through the development of a National Healthcare System Action Alliance to Advance Patient Safety (Action Alliance) in partnership with healthcare systems, patients, families and caregivers, HHS and other Federal agencies, and other stakeholders to support sustained improvements in patient safety. Specifically, the RFI seeks input on how the Action Alliance can be most effective. In addition, the RFI seeks comments about innovative models of care, approaches, promising strategies, and solutions for overcoming some of the common impediments to safety being experienced in healthcare today. This request for information will inform HHS's work and more specifically the work of the Action Alliance.

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 Healthcare System Level Strategies to Address Racial/Ethnic and Related Disparities in Health and Healthcare, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Department of Health and Human Services (HHS) gives notice of a determination concerning a petition to add a class of employees from the Reduction Pilot Plant in Huntington, West Virginia to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to replace its current annual reporting requirement for investigational new drug applications (INDs) with a new requirement: the annual FDA development safety update report (FDA DSUR). The proposed annual FDA DSUR is intended to be consistent with the format and content of the DSUR that is supported by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which is described in FDA's ICH guidance for industry entitled ``E2F Development Safety Update Report'' (E2F DSUR) (August 2011). The proposed annual FDA DSUR regulation, if finalized, would require an annual report that is more comprehensive and informative than the IND annual report currently required under FDA regulations.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations on investigational new drug applications (INDs) to exempt from the IND requirements certain clinical investigations of lawfully marketed foods for human consumption (including both conventional foods and dietary supplements) and cosmetics when the product is to be studied to evaluate its use as a drug. Under the proposal, clinical studies to evaluate a drug use of such products would not have to be conducted under an IND when, among other things, the study is not intended to support a drug development plan or a labeling change that would cause the lawfully marketed product to become an unlawfully marketed drug, and the study does not present a potential for significant risk to the health, safety, or welfare of subjects. Though exempt from the IND requirements, such investigations would still be subject to other regulations designed to protect the rights and safety of subjects, including requirements for informed consent and review by institutional review boards (IRBs). By exempting from the IND requirements certain clinical investigations of products lawfully marketed as a food or cosmetic, the proposed provisions are intended to reduce the regulatory burden of conducting such studies while retaining protections for human subjects.

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.

The Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR), located within the Department of Health and Human Services (HHS) announces the availability of the final Guidelines for Examining Unusual Patterns of Cancer and Environmental Concerns (2022 Guidelines). The 2022 Guidelines provide updates to the 2013 publication, Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from the CDC and the Council of State and Territorial Epidemiologists (CSTE). The updates provide state, tribal, local, and territorial health departments guidance for a revised and expanded approach to evaluating concerns about unusual patterns of cancer in communities, including those associated with local environmental concerns. The 2022 Guidelines finalize the draft guidelines issued on May 25, 2022.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 35 new drug applications (NDAs) 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.

The National Advisory Committee on Children and Disasters (NACCD or the Committee) is required by section 2811A of the PHS Act, as amended by the Pandemic and All Hazards Preparedness and Advancing Innovation Act (PAHPAIA) and governed by the provisions of the Federal Advisory Committee Act (FACA). The NACCD shall evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS and ASPR to support and enhance all-hazards public health and medical preparedness, response, and recovery aimed at meeting the unique needs of children and their families across the entire spectrum of their wellbeing. The Secretary of HHS has formally delegated authority to operate the NACCD to ASPR.

The purpose of this Request for Information (RFI) is to solicit public input on a proposed revised framework for evaluating and scoring peer review criteria for National Institutes of Health (NIH) research project grant (RPG) applications. NIH is proposing a revised simplified framework that will reorganize five major regulatory criteria under three scored categories and reduce the number of non- score driving review considerations that reviewers evaluate in judging the scientific merit of RPG applications. The proposed changes pertain to those RPGs with standard review criteria. All the factors required by regulation will continue to be evaluated. NIH is not proposing to revise the regulatory criteria. Rather, NIH is proposing to revise its policy of how peer reviewers score the criteria, and how NIH organizes the criteria for review purposes. NIH believes that these changes will allow peer reviewers to refocus on the critical task of judging scientific merit and will improve those judgements by reducing bias.

The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. 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 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 issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that IMJUDO (tremelimumab), approved October 23, 2022, meets the criteria for redeeming a priority review voucher.

This proposed notice acknowledges the receipt of an application from the Center for Improvement in Healthcare Quality (CIHQ) for initial recognition as a national accrediting organization for critical access hospitals (CAHs) that wish to participate in the Medicare or Medicaid programs.

This notice announces the cancellation of the December 7, 2022 virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') that was published in the October 11, 2022 Federal Register. This notice also announces a virtual public meeting of the MEDCAC Committee on Monday, February 13 and Tuesday, February 14, 2023. National Coverage Determinations resulting in coverage with evidence development (CED) can expedite earlier Medicare beneficiary access to innovative technology while ensuring that systematic patient safeguards are in place to reduce the risks inherent to new technologies, or to new applications of older technologies. This meeting will examine the general requirements for clinical studies submitted for CMS coverage requiring CED. The MEDCAC will evaluate the CED criteria to assure that CED studies are evaluated with consistent, feasible, transparent and methodologically rigorous criteria and advise CMS on whether the criteria are appropriate to ensure that CED-approved studies will produce reliable evidence that CMS can rely on to help determine whether a particular item or service is reasonable and necessary. This meeting is open to the public in accordance with the Federal Advisory Committee Act.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials.'' The final guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The guidance revises the draft guidance for industry entitled ``E19 Optimisation of Safety Data Collection'' issued in June 2019. The final guidance provides recommendations regarding appropriate use of a selective approach to safety data collection in some late-stage pre- or post-marketing studies of drugs where the safety profile, with respect to commonly occurring adverse events, is well understood and documented. The final guidance is intended to advance important clinical research questions through the conduct of clinical investigations that collect relevant patient data, which will enable an adequate benefit-risk assessment of the drug for its intended use, while reducing the burden to patients from unnecessary tests that may yield limited additional information.

The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs 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 Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the September 1, 2024, expiration date.

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.

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 (the 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 Proposed Extension of a Currently Approved Collection (ICR Ext) solicits comments on the information collection requirements related to the State Plan for Independent Living under the Rehabilitation Act of 1973, as amended.

As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020. The new effective date is November 6, 2023.

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.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2023 based on our continuing experience with these systems. We describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program; the ASC Quality Reporting (ASCQR) Program; and the Rural Emergency Hospital Quality Reporting (REH) Program. We also make updates to the requirements for Organ Acquisition, REHs, Prior Authorization, and Overall Hospital Quality Star Rating. We are establishing a new provider type for REHs, and we are finalizing proposals regarding payment policy, quality measures, and enrollment policy for REHs. In addition, we are finalizing the Conditions of Participation that REHs must meet in order to participate in the Medicare and Medicaid programs. This rule also finalizes changes to the Critical Access Hospitals (CAH) CoPs for the location and distance requirements, patient's rights requirements, and flexibilities for CAHs that are part of a larger health system. Finally, we are finalizing as implemented a number of provisions included in the COVID-19 interim final rules with comment period (IFCs).

The Food and Drug Administration (FDA or Agency) is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies two bulk drug substances that FDA has considered and proposes to include on the 503B Bulks List to compound three categories of compounded drug products: arginine hydrochloride (HCl) for oral use, lysine HCl for oral use, and lysine HCl for intravenous use in combination with FDA-approved, single-ingredient arginine HCl for intravenous use. This notice identifies three bulk drug substances that FDA has considered and proposes not to include on the 503B Bulks List: etomidate, furosemide, and rocuronium bromide. Additional bulk drug substances nominated for inclusion on this list are under consideration and may be the subject of future notices.

OCS, Division of Energy Assistance, is requesting a substantial change of the Household Report Office of Management and Budget (OMB) #0970-0060, expiration May 31, 2025). Grant recipients complete the Household Report on an annual basis, completing either the Long Form or the Short Form version of the report. Submission of the completed report is one requirement for the Low Income Home Energy Assistance Program (LIHEAP) grant recipients applying for Federal LIHEAP block grant funds. OCS proposes substantive changes, including the addition of reporting requirements for assisted applicants and household member demographic characteristics on the Household Report Long Form and Short Form, and the removal of reporting requirements collecting counts of applicant households by assistance type and poverty interval on the Household Report Long Form.

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.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's investigation of how youth and young adults process tobacco education messaging and to identify effective tobacco prevention and education message strategies.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services, 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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Assessing Knowledge, Attitudes, and Practices (KAPs) of Hispanic/Latina Women of Reproductive Age about Folic Acid Fortification and Supplementation. The data collection will involve focus groups of Hispanic/Latina populations to understand knowledge, awareness, and practices about use of folic acid and fortified food for neural tube defect (NTD) prevention.

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 proposed new recommendations for perinatal hepatitis C virus (HCV) infection testing to identify infants who may go on to develop chronic hepatitis C. Recommendations include: HCV testing of all perinatally exposed infants at age 2-6 months with a Nucleic Acid Test (NAT) for detection of HCV ribonucleic acid (RNA); and referral of infants with detectable HCV RNA to a healthcare provider with expertise in pediatric hepatitis C management. CDC also announces an Informational Webinar to explain the public comment process.

HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Infant and Maternal Mortality (ACIMM or Committee). ACIMM advises the Secretary of HHS (Secretary) on department activities, partnerships, policies, and programs directed at reducing infant mortality, maternal mortality and severe maternal morbidity, and improving the health status of infants and women before, during, and after pregnancy. HRSA is seeking nominations of qualified candidates to fill open positions on the ACIMM.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACF Program Instruction Children's Justice Act (Office of Management and Budget (OMB) #0970- 0425, expiration 6/30/2023). There are no changes proposed to the Program Instruction.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), announces the availability of the CDC Clinical Practice Guideline for Prescribing Opioids for PainUnited States, 2022 (2022 Clinical Practice Guideline). The 2022 Clinical Practice Guideline updates and expands the CDC Guideline for Prescribing Opioids for Chronic PainUnited States, 2016 (2016 Guideline) and provides evidence-based recommendations for clinicians who provide pain care, including those prescribing opioids, for outpatients age 18 years and older with: acute pain (duration less than 1 month), subacute pain (duration of 1-3 months), or chronic pain (duration of more than 3 months). The recommendations in the 2022 Clinical Practice Guideline do not apply to pain management related to sickle cell disease, cancer-related pain treatment, palliative care, or end-of-life care. The 2022 Clinical Practice Guideline finalizes the draft clinical practice guideline issued on February 10, 2022.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID). This virtual meeting is open to the public via Zoom, limited only by the number of web conference lines available (500 lines). Pre-registration is required by accessing the link below in the addresses section.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 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.

The Administration for Children and Families (ACF) proposes to extend approval of the existing overarching generic clearance for Reviewer Recruitment Forms (Office of Management and Budget (OMB) #0970-0477). No changes are proposed to the terms of the overarching generic.

This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare and Medicaid provider enrollment policies, including for skilled nursing facilities; updates to conditions of payment for DMEPOS suppliers; HCPCS Level II coding and payment for wound care management products; electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (SUPPORT Act); updates to the Medicare Ground Ambulance Data Collection System; provisions under the Infrastructure Investment and Jobs Act; and finalizes the CY 2022 Methadone Payment Exception for Opioid Treatment Programs IFC. We are also finalizing, as implemented, a few provisions included in the COVID-19 interim final rules with comment period.

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.

The Food and Drug Administration (FDA, the Agency, or we) is hosting a virtual public meeting entitled ``Draft Amended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada.'' The purpose of the public meeting is to obtain public input on a draft amended environmental assessment (EA) prepared by FDA in support of an approved new animal drug application (NADA 141-454) concerning AquAdvantage Salmon (AAS), in response to an order by the U.S. District Court, Northern District of California.

In the July 11, 2022 issue of the Federal Register, we published a final rule that updated proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. The effective date was August 10, 2022, except for the amendments in amendatory instructions 2 and 5 through 21, which are effective July 11, 2024. This document corrects one technical error identified in the July 11, 2022 final rule.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the Record of Decision (ROD) for the Final Supplemental Environmental Impact Statement (SEIS) for CDC's Roybal Campus in Atlanta, Georgia.

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 National Notifiable Diseases Surveillance System. The purpose of this data collection is to provide the official source of statistics in the United States for nationally notifiable conditions.

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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era (MIC-DROP). This project is a prospective cohort study to understand men who have sex with men's (MSM) strategies to prevent HIV and sexually transmitted infections (STIs), including pre-exposure prophylaxis (PrEP) use and adherence, condom use, sexual risk-taking behavior and substance-using behaviors.

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.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services is proposing additional information collection activities to assess the implementation of LifeSet, a program that provides services and supports to young adults ages 17 to 21 with previous child welfare involvement. Current data collection activities are approved under this same Office of Management and Budget (OMB) #: 0970-0577.

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), is providing notice of a re-established matching program between HHS/ACF/OCSE and state workforce agencies (SWA) administering the Unemployment Compensation benefits program (UC). The matching program compares SWA records with new hire and quarterly wage information maintained in the National Directory of New Hires (NDNH), the outcomes that help SWAs administer their UC programs.

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE) is providing notice of a re-established matching program between HHS/ ACF/OCSE and state agencies administering the Temporary Assistance for Needy Families (TANF) program. The matching program compares state TANF agency records with new hire, quarterly wage, and unemployment insurance information maintained in the National Directory of New Hires (NDNH). The outcomes of the comparisons help state agencies to establish and verify eligibility for applicants and recipients of TANF benefits, reduce TANF benefit errors, and maintain program integrity.

The Centers for Medicare & Medicaid Services (CMS) is requesting nominations to fill vacancies on the Advisory Panel (the Panel) on Hospital Outpatient Payment (HOP). The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (the Administrator) on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, supervision of hospital outpatient therapeutic services, and hospital outpatient prospective payment system (OPPS) OPPS APC rates for covered ambulatory surgical centers (ASC) procedures.