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

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 Fiber Intake and Laxation 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.

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) 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.

This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias (ADRD) on people with the disease and their caregivers. During the meeting on April 29 and April 30, 2024, the Advisory Council will hear updates from federal agencies on activities during the last quarter and from panels organized by the clinical care and long-term services and supports subcommittees. On the first day, presenters will discuss care and navigation across healthcare settings from post-diagnosis through advanced disease. The panels on the second day will focus on challenges with long-term services and supports for people with young-onset dementia and their care partners/families, as well as challenges with dementia among aging populations experiencing homelessness or incarceration.

The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled ``Reporting and Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).

The Food and Drug Administration (FDA, the Agency, or we) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA has determined these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This proposal follows a court decision vacating a prior ban and amendment to the Federal Food, Drug, and Cosmetic Act clarifying our authority to ban a device for one or more intended uses. This action, if finalized, will mean ESDs for SIB and AB are adulterated and not legally marketed.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) for LYNPARZA (olaparib) Capsules, 50 milligrams (mg) held by AstraZeneca Pharmaceuticals LP (AZ), 1800 Concord Pike, Wilmington, DE 19803. AZ has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the 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 notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Tuesday, May 21, 2024. The MEDCAC panel will consider which health outcomes in studies of devices for self- management of Type 1 and insulin-dependent Type 2 diabetes should be of interest to CMS. Given the increased emphasis on new and innovative medical products for difficult to manage conditions, some studies of new medical technologies have focused on short-term data with greater reliance on intermediate outcomes and surrogate endpoints. As a result, assessments of new medical technologies have more frequent evidence gaps with respect to clinically meaningful health outcomes for CMS beneficiaries. The MEDCAC panel will examine the growing challenges associated with the decreased level of evidence of certain new and innovative technologies. By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS about the ideal health outcomes in research studies of devices for diabetes self-management, appropriate measurement instruments and adequate follow-up durations to help to provide clarity and transparency in future National Coverage Analyses (NCAs). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces 6 separate awards to fund White Mountain Apache Tribe (WMAT), San Carlos Apache Tribe (SCAT), Gila River Indian Community (GRIC), Navajo Nation (NN), Hopi Tribe and Tohono O'odham Nation (TON). Funding amounts will be determined on disease burden during 2010-2020. The total 5 year period amount for the (6) recipients is $1,800,000.00 The awards will address Rocky Mountain Spotted Fever (RMSF) prevention activities, including but not limited to vector control, outreach, and education, and RMSF prevention support services.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award up to $675,000 per year for up to five (5) years to the Community-Based, Advocacy-Focused, Data-Driven, Coalition-Building Association (CADCA). The purpose of the award is to leverage existing resources to expand SAMHSA's scope and prevention capacity; provide training and technical assistance to state and community prevention leaders, including members of anti-drug community coalitions from around the country who are committed to addressing the evolving needs of the behavioral health field; and to promote prevention workforce development. The training and workforce development activities supported through this cooperative agreement include SAMHSA's Prevention Day and SAMHSA's participation in the annual National Leadership Forum, the annual Mid-Year Training Institute of CADCA, and developing youth leaders across the three conferences/events listed above.

The Administration for Community Living (ACL) seeks information on recommended area(s) and or issue(s) for which elder justice stakeholders believe the Elder Justice Coordinating Council (Council) can be the most beneficial to promoting elder justice and have the greatest positive impact for survivors of elder abuse, neglect, and exploitation and their communities.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the Independent Living Services (ILS) Program Performance Report (PPR) OMB 0985-0043.

The Division of Program Innovation, Office of Child Support Services (OCSS), Administration for Children and Families (ACF) is requesting a 3-year extension of the Access and Visitation Survey: Annual Report (Office of Management and Budget #: 0970-0204, expiration 6/30/2024). There are no changes requested to the form.

HHS published a document in the Federal Register of March 12, 2024, announcing the Presidential Advisory Council on HIV/AIDS (PACHA) 80th full council meeting. Due to unforeseen circumstances, there has been an update in meeting location.

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 The National Firefighter Registry (NFR) for Cancer. In accordance with the Firefighter Cancer Registry Act of 2018, the NFR will maintain a voluntary registry of firefighters to collect relevant health and occupational information of such firefighters for purposes of determining cancer incidence.

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 Poolbeg Pharma (UK) Limited, incorporated in the United Kingdom.

The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for two chapters of a multichapter draft guidance entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry,'' which were announced in the Federal Register of September 27, 2023. The relevant draft chapters are entitled ``Chapter 11 Food Allergen Program'' and ``Chapter 16Acidified Foods.'' We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments before FDA begins work on the final guidance.

The Administration for Children and Families (ACF) is requesting a 3-year extension with proposed revisions to the Interstate Administrative Subpoena and Notice of Lien forms (Office of Management and Budget #0970-0152, expiration 6/30/2024). The forms are updated to reflect the name change of the Federal child support program office from the Office of Child Support Enforcement to the Office of Child Support Services.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Willis Reed from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Reed was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Reed was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of February 10, 2024 (30 days after receipt of the notice), Mr. Reed has not responded. Mr. Reed's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA, the 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 the information collections associated with Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of SARAFEM (fluoxetine hydrochloride (HCl)) capsules, equivalent to (EQ) 10 milligrams (mg) base and EQ 20 mg base, including the premenstrual dysphoric disorder (PMDD) indication, approved under new drug application (NDA) 018936. This NDA is held by Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 (Lilly). Lilly notified the Agency in writing that SARAFEM (fluoxetine HCl) capsules, EQ 10 mg base and EQ 20 mg base, indicated for the treatment of PMDD, was no longer marketed and requested that the approval of SARAFEM (fluoxetine HCl) capsules, including the PMDD indication, be withdrawn.

The Food and Drug Administration is proposing to establish criteria for the lists of drug products or categories of drug products that present demonstrable difficulties for compounding (Demonstrable Difficulties for Compounding Lists or DDC Lists) under certain sections of the Federal Food, Drug, and Cosmetic Act. Additionally, the Agency is proposing to identify the first three categories of drug products on both DDC Lists. Drug products or categories of drug products that appear on the DDC Lists cannot qualify for certain statutory exemptions, and therefore may not be compounded under, either section 503A or section 503B, respectively.

CDC has modified its structure. This notice announces the reorganization of the Office of Safety, Security and Asset Management (OSSAM). OSSAM retitled a component.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) 205864 and the new animal drug application (NADA) 141-395 for the designated medical gas Helium, USP held by Air Products and Chemicals, Inc., 1940 Air Products Blvd., Allentown, PA 18106-5500 (Air Products). Air Products notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award(s) of approximately $10,000,000, for Year 1 funding to MISAU. The(se) award(s) will support the GRM through MISAU to continue to address Tuberculosis (TB) and human immunodeficiency virus (HIV) as a public health problem through the expansion of access to quality HIV prevention, care, and treatment services to reduce remaining gaps among children, adolescents, key populations (KP) and men. Funding amounts for years 2-5 will be set at continuation.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $17,500,000, for Year 1 funding to RBC. The award will support a sustainable, affordable, integrated, and country- led HIV/AIDS clinical and public health program in Rwanda. Funding amounts for years 2-5 will be set at continuation.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $20,000,000, for Year 1 funding to WHO. This award will support the development of global guidelines and provide technical assistance through WHO to aid PEPFAR-supported countries to meet the 95-95-95 targets and achieve program sustainability by 2030. Funding amounts for years 2-5 will be set at continuation.

The Office of Family Assistance (OFA), Administration for Children and Families (ACF) is requesting a three-year extension of the form ACF-4125: Annual Report on Children in Foster Homes and Children in Families Receiving Payment in Excess of the Poverty Income Level from a State Program Funded Under Part A of Title IV of the Social Security Act (Office of Management and Budget #: 0970-0004, expiration 6/30/2024). There are no changes requested to the form.

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 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.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.

Prioritizing and directing resources to American Indian and Alaskan Native (AI/AN) programs to implement, expand, and/or enhance their Head Start services to tribal children and families is critical for meeting federal trust responsibility; preserving, and promoting Native language, culture, and traditions; and addressing the impact of historical trauma on Native Americans. As part of the Administration for Children and Families' (ACF) commitment to partnering with tribal nations to provide high-quality Head Start programming, in addition to regular tribal consultations, the Office of Head Start (OHS) invites public comment on the rules, regulations, and available training and technical assistance (TTA) supports impacting the AI/AN Head Start community. This Request for Information (RFI) seeks input on topics including eligibility; program options; quality environments; child health and safety; tribal language preservation, maintenance, revitalization, and restoration; family and community engagement; workforce; training and technical assistance; partnerships with state systems; facilities; fiscal operations; early childhood systems; and others, to improve the quality of Head Start services in areas of great need and affirm the federal government's commitment to protect Native communities.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #285 entitled ``Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.'' This draft guidance is intended to provide recommendations for the primary batches of drug product manufactured to support the approval or conditional approval of new animal drug products. This guidance is applicable to all original new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs), and their associated investigational new animal drug files (INADs) and generic investigational new animal drug files, respectively, as well as applications for conditional approval of new animal drugs (CNADAs).

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 or Agency) has determined that NUCYNTA (tapentadol hydrochloride) solution, equivalent (eq) 20 milligrams (mg) base/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for tapentadol hydrochloride solution, eq 20 mg base/mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or Agency) has determined that DUEXIS (ibuprofen and famotidine) tablet, 800 milligrams (mg) ibuprofen and 26.6 mg famotidine, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or we) is revoking the standard of identity and the standard of quality for frozen cherry pie. This action, in part, responds to a citizen petition submitted by the American Bakers Association (ABA). We conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. Revocation of the standards of identity and quality for frozen cherry pie will provide greater flexibility in the product's manufacture, consistent with comparable, nonstandardized foods available in the marketplace.

The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to update a citation for information collection and conform the regulatory provisions to the Federal Food, Drug, and Cosmetics Act (FD&C Act). The rule does not impose any new requirements on affected parties. This action is editorial in nature to correct errors and to ensure accuracy and clarity in the Agency's regulations.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on December 18, 2023. The document announced the withdrawal of approval of two new drug applications (NDA), withdrawn as of January 17, 2024. The document indicated that FDA was withdrawing approval of NDA 022424, FLOWTUSS (guaifenesin 200 milligrams (mg)/5 milliliters (mL) and hydrocodone bitartrate 2.5 mg/5 mL) Oral Solution held by Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 10920. Before FDA withdrew the approval of this NDA, Chartwell RX Sciences, LLC informed FDA that it did not want the approval of the NDA withdrawn. Because Chartwell RX Sciences, LLC timely requested that approval of NDA 022424 not be withdrawn, the approval is still in effect. This notice corrects that error.

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, Improving Customer Experience (OMB Circular A-11, Section 280 Implementation).

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VTAMA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance updates the existing E2D guidance entitled ``E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting,'' published in 2003. The draft guidance is intended is to clarify the use of new or increasingly used data sources (e.g., social media, market research programs, patient support programs) and update terminology and standards for postmarket adverse event reporting.

The Food and Drug Administration (FDA or Agency) has determined that Romidepsin Injection, 10 milligrams (mg)/2 milliliters (mL) (5 mg/mL) and 27.5 mg/5.5 mL (5 mg/mL), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for romidepsin solution, 10 mg/2 mL (5 mg/mL) and 27.5 mg/5.5 mL (5 mg/mL), that refer to these drugs as long as they meet relevant legal and regulatory requirements.

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 the Proposed Small Dispensers Assessment under the Drug Supply Chain Security Act (DSCSA).

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 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.

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Infant and Maternal Mortality (ACIMM or Committee) has scheduled a public meeting. Information about ACIMM and the agenda for this meeting can be found on the ACIMM website at https://www.hrsa.gov/advisory-committees/infant- mortality/.

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 convene the 80th full council meeting on Wednesday, March 27-Thursday, March 28, 2024. The meeting will be open to the public and there will be a public comment session during the meeting; pre-registration is required to provide public comment. To pre-register to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Monday, March 18, 2024. 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 Thursday, April 4, 2024. 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Early Alzheimer's Disease: Developing Drugs for Treatment.'' This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer's disease (AD) that occur before the onset of overt dementia. This draft guidance revises the previous draft guidance for industry of the same name issued on February 16, 2018.

The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Pharmaceutical Science and Clinical Pharmacology 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 Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the January 22, 2026, expiration date.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements in the Agency's regulations relating to establishment registration and product listing for manufacturers of human blood and blood products and licensed devices.

The Food and Drug Administration (FDA, Agency, 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.

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) is correcting a notice that appeared in the Federal Register on February 22, 2024. The document announced the availability of a final guidance for industry entitled ``Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.'' The document was published with an incorrect docket number. This document corrects that error.

In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

CDC has modified its structure. This notice announces the reorganization of the World Trade Center (WTC) Health Program within the National Institute for Occupational Safety and Health (NIOSH). The WTC Health Program has established three branches.

The Food and Drug Administration (FDA or Agency) is announcing the availability of final guidances for industry entitled ``Q2(R2) Validation of Analytical Procedures'' and ``Q14 Analytical Procedure Development.'' The guidances were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance entitled ``Q2(R2) Validation of Analytical Procedures'' provides a general framework for the principles of analytical procedure validation, including validation principles that cover the analytical use of spectroscopic data. The guidance entitled ``Q14 Analytical Procedure Development'' provides harmonized guidance on scientific approaches for analytical procedure development and describes principles to facilitate more efficient, science-based, and risk-based postapproval change management. The guidances are intended to facilitate regulatory evaluations and potential flexibility in postapproval change management of analytical procedures when scientifically justified. The guidances replace the draft guidances ``Q2(R2) Validation of Analytical Procedures'' and'' Q14 Analytical Procedure Development'' issued on August 29, 2022.

The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Gastrointestinal 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 Gastrointestinal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the March 3, 2026, expiration date.

This document corrects technical and typographical errors in the final rule entitled, ``Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing'' that was published in the Federal Register on January 9, 2024, and has a stated effective of February 8, 2024.

As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats or formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of Common Formats for SurveillanceHospital Version 1.0 for public review and comment.