{"description":"Documents matching 'entitlement information disclosed include social'","count":9622,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=entitlement+information+disclosed+include+social&format=json&page=2","results":[{"title":"Privacy Act of 1974; Matching Program","type":"Notice","abstract":"In accordance with the provisions of the Privacy Act, as amended, this notice announces a new matching program with the United States Department of Health and Human Services, Administration for Children and Families, Office of Child Support Services (OCSS). Under this matching program, OCSS will disclose quarterly wage (QW) information to SSA to establish or verify eligibility, continuing entitlement, or payment amounts, or all of the above, of individuals under Title II Disability Insurance (DI) program of the Social Security Act (Act).","document_number":"2025-20488","html_url":"https://www.federalregister.gov/documents/2025/11/21/2025-20488/privacy-act-of-1974-matching-program","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-21/pdf/2025-20488.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20488.pdf?1763646310","publication_date":"2025-11-21","agencies":[{"raw_name":"Social Security Administration","name":"Social Security Administration","id":470,"url":"https://www.federalregister.gov/agencies/social-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/470","parent_id":null,"slug":"social-security-administration"}],"excerpts":"state that your comments refer to Docket No. SSA-2025-0027 so that we may associate your comments with the correct regulation. \n \n Caution: \n You should be careful to include in your comments only information that you wish to make publicly available. We strongly urge you not to include in your comments any personal information, such as Social Security numbers or medical information.\n \n \n 1. \n Internet: \n We strongly recommend that you submit your comments via the internet. Please visit the Federal eRulemaking portal at \n https://www.regulations.gov"},{"title":"Privacy Act of 1974; System of Records","type":"Notice","abstract":"In accordance with the Privacy Act of 1974, we are issuing public notice of our intent to modify an existing system of records entitled, Master Files of Social Security Number (SSN) Holders and SSN Applications (60-0058), last published on February 20, 2025. This notice publishes details of the modified system as set forth below under the caption, SUPPLEMENTARY INFORMATION.","document_number":"2025-19849","html_url":"https://www.federalregister.gov/documents/2025/11/12/2025-19849/privacy-act-of-1974-system-of-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-12/pdf/2025-19849.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19849.pdf?1762782306","publication_date":"2025-11-12","agencies":[{"raw_name":"Social Security Administration","name":"Social Security Administration","id":470,"url":"https://www.federalregister.gov/agencies/social-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/470","parent_id":null,"slug":"social-security-administration"}],"excerpts":"about present or alternative Social Security programs; are of importance to the Social Security program or the Social Security beneficiaries; or are for an epidemiological project that relates to the Social Security program or beneficiaries. We will disclose information under this routine use pursuant only to a written agreement with us. \n 36. To State and Territory MVA officials (or agents or contractors on their behalf) and State and Territory chief election officials, under the provisions of section 205(r)(8) of the Social Security Act (42 U.S.C."},{"title":"Privacy Act of 1974; Matching Program","type":"Notice","abstract":"In accordance with the provisions of the Privacy Act, as amended, this notice announces a new matching program with the United States Department of the Treasury, Internal Revenue Service (IRS). Under this matching program, the IRS will disclose to SSA certain tax return information for the purpose of establishing the correct amount of Medicare Part B premium subsidy adjustments and Medicare Part D premium increases provided under the Social Security Act (Act), the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Medicare Modernization Act), and the Affordable Care Act of 2010 (ACA).","document_number":"2025-15152","html_url":"https://www.federalregister.gov/documents/2025/08/11/2025-15152/privacy-act-of-1974-matching-program","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-08-11/pdf/2025-15152.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-15152.pdf?1754657147","publication_date":"2025-08-11","agencies":[{"raw_name":"Social Security Administration","name":"Social Security Administration","id":470,"url":"https://www.federalregister.gov/agencies/social-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/470","parent_id":null,"slug":"social-security-administration"}],"excerpts":"state that your comments refer to Docket No. SSA-2025-0004 so that we may associate your comments with the correct regulation. \n \n Caution: \n You should be careful to include in your comments only information that you wish to make publicly available. We strongly urge you not to include in your comments any personal information, such as Social Security numbers or medical information.\n \n \n 1. \n Internet: \n We strongly recommend that you submit your comments via the internet. Please visit the Federal eRulemaking portal at \n https://www.regulations.gov"},{"title":"Privacy Act of 1974; System of Records","type":"Notice","abstract":"RRB-1, Social Security Benefit Vouchering System is used to administer, certify, and voucher Social Security benefit payments.","document_number":"2025-22051","html_url":"https://www.federalregister.gov/documents/2025/12/05/2025-22051/privacy-act-of-1974-system-of-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-05/pdf/2025-22051.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-22051.pdf?1764855923","publication_date":"2025-12-05","agencies":[{"raw_name":"RAILROAD RETIREMENT BOARD","name":"Railroad Retirement Board","id":444,"url":"https://www.federalregister.gov/agencies/railroad-retirement-board","json_url":"https://www.federalregister.gov/api/v1/agencies/444","parent_id":null,"slug":"railroad-retirement-board"}],"excerpts":"2904 and 2906. \n g. Disclosure of non-medical information in this system of records may be made to the attorney representing such individuals upon receipt of a written letter or declaration stating the fact of representation, if that individual would not be denied access to the information. Medical information may be released to an attorney when such records are requested for the purpose of contesting a determination either administratively or judicially. \n h. Benefit rate information may be disclosed to primary beneficiaries regarding secondary"},{"title":"QTc Information in Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"QTc Information in Human Prescription Drug and Biological Product Labeling.\" This guidance is intended to assist applicants with incorporating heart rate-corrected QT (QTc) interval prolongation-related information into the labeling of non-antiarrhythmic human prescription drug and biological products. The guidance provides recommendations on how and where to appropriately include the clinically relevant information on QTc interval prolongation in the labeling, in accordance with regulatory requirements for the content and format of human prescription drug labeling. This guidance finalizes the draft guidance of the same title issued on August 8, 2023.","document_number":"2025-21798","html_url":"https://www.federalregister.gov/documents/2025/12/03/2025-21798/qtc-information-in-human-prescription-drug-and-biological-product-labeling-guidance-for-industry","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-03/pdf/2025-21798.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-21798.pdf?1764683111","publication_date":"2025-12-03","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on \n https://www.regulations.gov. \n \n • If you want to submit a comment with confidential information that you do not wish to"},{"title":"Information Collection: NRCareers (Monster Government Solutions)","type":"Notice","abstract":"The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, \"NRCareers (Monster Government Solutions).\"","document_number":"2026-05770","html_url":"https://www.federalregister.gov/documents/2026/03/25/2026-05770/information-collection-nrcareers-monster-government-solutions","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-25/pdf/2026-05770.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05770.pdf?1774356312","publication_date":"2026-03-25","agencies":[{"raw_name":"NUCLEAR REGULATORY COMMISSION","name":"Nuclear Regulatory Commission","id":383,"url":"https://www.federalregister.gov/agencies/nuclear-regulatory-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/383","parent_id":null,"slug":"nuclear-regulatory-commission"}],"excerpts":"listed in the \n For Further Information Contact \n section of this document.\n \n \n • \n Mail comments to: \n Heather Dempsey, Office of the Chief Information Officer, Mail Stop: T-6 A10M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.\n \n \n For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the \n SUPPLEMENTARY INFORMATION \n section of this document.\n \n \n \n FOR FURTHER INFORMATION CONTACT: \n \n Heather Dempsey, Office of the Chief Information Officer, U.S. Nuclear"},{"title":"Privacy Act of 1974; System of Records","type":"Notice","abstract":"In accordance with the Privacy Act of 1974, we are issuing public notice of our intent to modify an existing system of records entitled, Master Files of Social Security Number (SSN) Holders and SSN Applications (60-0058), last published on January 4, 2022. This notice publishes details of the modified system as set forth below under the caption, SUPPLEMENTARY INFORMATION.","document_number":"2024-31131","html_url":"https://www.federalregister.gov/documents/2024/12/31/2024-31131/privacy-act-of-1974-system-of-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-12-31/pdf/2024-31131.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-31131.pdf?1735566312","publication_date":"2024-12-31","agencies":[{"raw_name":"Social Security Administration","name":"Social Security Administration","id":470,"url":"https://www.federalregister.gov/agencies/social-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/470","parent_id":null,"slug":"social-security-administration"}],"excerpts":"about present or alternative Social Security programs; are of importance to the Social Security program or the Social Security beneficiaries; or are for an epidemiological project that relates to the Social Security program or beneficiaries. We will disclose information under this routine use pursuant only to a written agreement with us. \n 36. To State and Territory MVA officials (or agents or contractors on their behalf) and State and Territory chief election officials, under the provisions of section 205(r)(8) of the Social Security Act (42 U.S.C."},{"title":"Drug Repurposing for Unmet Medical Needs; Request for Information; Extension of Comment Period","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the notice entitled \"Drug Repurposing for Unmet Medical Needs; Request for Information\" that appeared in the Federal Register of May 12, 2026 (91 FR 25897). In the notice, FDA requested comments to solicit input on FDA's efforts with respect to drug repurposing to address unmet medical needs. The Agency is taking this action to allow interested persons additional time to submit comments.","document_number":"2026-11691","html_url":"https://www.federalregister.gov/documents/2026/06/11/2026-11691/drug-repurposing-for-unmet-medical-needs-request-for-information-extension-of-comment-period","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11691.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11691.pdf?1781095514","publication_date":"2026-06-11","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on \n https://www.regulations.gov. \n \n • If you want to submit a comment with confidential information that you do not wish to"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Social Impact Partnerships To Pay for Results Act (SIPPRA) Program Review","type":"Notice","abstract":"The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to comment on the proposed information collections listed below, in accordance with the Paperwork Reduction Act of 1995. Treasury has completed two rounds of funding for the SIPPRA program through two releases of a Notice of Funding Opportunity (NOFO). Treasury invites comments on the revisions to the FY26 NOFO to improve the efficacy and efficiency of the application review process.","document_number":"2026-04685","html_url":"https://www.federalregister.gov/documents/2026/03/10/2026-04685/agency-information-collection-activities-proposed-collection-comment-request-social-impact","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-10/pdf/2026-04685.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04685.pdf?1773060316","publication_date":"2026-03-10","agencies":[{"raw_name":"DEPARTMENT OF THE TREASURY","name":"Treasury Department","id":497,"url":"https://www.federalregister.gov/agencies/treasury-department","json_url":"https://www.federalregister.gov/api/v1/agencies/497","parent_id":null,"slug":"treasury-department"}],"excerpts":"SIPPRA Program Director, Office of Economic Policy, at \n SIPPRA@treasury.gov. \n \n \n \n FOR FURTHER INFORMATION CONTACT: \n \n Copies of the submissions may be obtained from Matthew Cook by emailing \n SIPPRA@treasury.gov, \n calling (202) 927-5331, or viewing the entire information collection request at \n www.reginfo.gov. \n \n \n \n \n SUPPLEMENTARY INFORMATION: \n \n \n Title: \n Agency Information Collection Activities; Proposed Collection; Comment Request; Social Impact Partnerships to Pay for Results Act (SIPPRA) Program Review.\n \n \n OMB Control Number: \n 1505-0260"},{"title":"Privacy Act of 1974; System of Records; Correction","type":"Notice","abstract":"We published a document in the Federal Register revisiting our rules on December 31, 2024. In accordance with the Privacy Act of 1974 and the Executive Order 14168, Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, we are re-issuing public notice of our intent to modify an existing system of records entitled, Master Files of Social Security Number (SSN) Holders and SSN Applications (60-0058). This notice publishes details of the modified system as set forth below under the caption, SUPPLEMENTARY INFORMATION.","document_number":"2025-02850","html_url":"https://www.federalregister.gov/documents/2025/02/20/2025-02850/privacy-act-of-1974-system-of-records-correction","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-02-20/pdf/2025-02850.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-02850.pdf?1739972711","publication_date":"2025-02-20","agencies":[{"raw_name":"Social Security Administration","name":"Social Security Administration","id":470,"url":"https://www.federalregister.gov/agencies/social-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/470","parent_id":null,"slug":"social-security-administration"}],"excerpts":"about present or alternative Social Security programs; are of importance to the Social Security program or the Social Security beneficiaries; or are for an epidemiological project that relates to the Social Security program or beneficiaries. We will disclose information under this routine use pursuant only to a written agreement with us. \n 36. To State and Territory MVA officials (or agents or contractors on their behalf) and State and Territory chief election officials, under the provisions of section 205(r)(8) of the Social Security Act (42 U.S.C."},{"title":"Privacy Act of 1974; System of Records","type":"Notice","abstract":"In accordance with the Privacy Act of 1974, we are issuing public notice of our intent to modify an existing system of records entitled, Electronic Disability Claim File (60-0320), hereinafter referred to as the eDIB Claim File, last published on June 24, 2020. This notice publishes details of the modified system as set forth below under the caption, SUPPLEMENTARY INFORMATION.","document_number":"2026-07300","html_url":"https://www.federalregister.gov/documents/2026/04/15/2026-07300/privacy-act-of-1974-system-of-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-15/pdf/2026-07300.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07300.pdf?1776170719","publication_date":"2026-04-15","agencies":[{"raw_name":"Social Security Administration","name":"Social Security Administration","id":470,"url":"https://www.federalregister.gov/agencies/social-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/470","parent_id":null,"slug":"social-security-administration"}],"excerpts":"for the maintenance of the system to include sections 702 and 1633 of the Social Security Act, as amended. We are expanding the purposes for which we may use the information in this system to include tracking opt-in and opt-out of electronic messaging selections. We are deleting vendor information from medical examiners or providers from the categories of records, as it is duplicative. We are also expanding the categories of records to include opt-in and opt-out of electronic messaging selections; information about a medical examiner or provider"},{"title":"Privacy Act of 1974; Matching Program","type":"Notice","abstract":"In accordance with the provisions of the Privacy Act, as amended, this notice announces a new matching program with the Department of Labor (DOL). Under this matching program, DOL will disclose the DOL-administered Part C Black Lung (BL) benefit data to SSA. SSA will match DOL's Part C BL data with SSA's records of persons receiving Social Security disability benefits to verify that Part C BL beneficiaries are receiving the correct amount of Social Security disability benefits.","document_number":"2024-22768","html_url":"https://www.federalregister.gov/documents/2024/10/03/2024-22768/privacy-act-of-1974-matching-program","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-10-03/pdf/2024-22768.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-22768.pdf?1727873125","publication_date":"2024-10-03","agencies":[{"raw_name":"Social Security Administration","name":"Social Security Administration","id":470,"url":"https://www.federalregister.gov/agencies/social-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/470","parent_id":null,"slug":"social-security-administration"}],"excerpts":"please state that your comments refer to Docket No. SSA-2024-0004 so that we may associate your comments with the correct regulation. CAUTION: You \n \n should be careful to include in your comments only information that you wish to make publicly available. We strongly urge you not to include in your comments any personal information, such as Social Security numbers or medical information.\n \n \n 1. \n internet: \n We strongly recommend that you submit your comments via the internet. Please visit the Federal eRulemaking portal at \n https://www.regulations.gov"},{"title":"Privacy Act of 1974; System of Records","type":"Notice","abstract":"In accordance with the Privacy Act of 1974, we are issuing public notice of our intent to modify an existing system of records entitled, Hearings and Appeals Case Control System (60-0009), last published on October 13, 1982. This notice publishes details of the modified system as set forth under the caption, SUPPLEMENTARY INFORMATION.","document_number":"2026-00132","html_url":"https://www.federalregister.gov/documents/2026/01/08/2026-00132/privacy-act-of-1974-system-of-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-01-08/pdf/2026-00132.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-00132.pdf?1767793510","publication_date":"2026-01-08","agencies":[{"raw_name":"Social Security Administration","name":"Social Security Administration","id":470,"url":"https://www.federalregister.gov/agencies/social-security-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/470","parent_id":null,"slug":"social-security-administration"}],"excerpts":"is expected to have, information relating to the individual's capability to manage their benefits or payments, or their eligibility for or entitlement to benefits or eligibility for payments, under the Social Security program;\n \n • third party contacts, where necessary, to establish or verify information provided by a representative payee or representative payee applicant; \n • a Social Security beneficiary or claimant, when a claim is filed by an individual on the same record that is adverse to the beneficiary, only information concerning the facts"},{"title":"Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.\" This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements. In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. This guidance finalizes the draft guidance for industry of the same title issued on August 23, 2021.","document_number":"2026-10703","html_url":"https://www.federalregister.gov/documents/2026/05/29/2026-10703/bioequivalence-studies-with-pharmacokinetic-endpoints-for-drugs-submitted-under-an-abbreviated-new","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-29/pdf/2026-10703.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10703.pdf?1779972316","publication_date":"2026-05-29","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on \n https://www.regulations.gov. \n \n • If you want to submit a comment with confidential information that you do not wish to"},{"title":"Privacy Act of 1974; System of Records","type":"Notice","abstract":"In accordance with the Privacy Act of 1974, as amended, the U.S. Department of Education (Department) publishes this notice of a modified system of records entitled the \"National Student Loan Data System (NSLDS)\" (18-11-06). The information contained in this system is maintained for various purposes relating to aid applicants and recipients. These include determining aid applicants' and recipients' eligibility for Federal student financial assistance under the programs authorized by title IV of the Higher Education Act of 1965, as amended (HEA); assisting institutions of higher education participating in and administering the title IV, HEA programs by verifying the eligibility of aid recipients for, and tracking, Federal student loans; and assisting the Department's oversight and administration of the title IV, HEA programs, including evaluating their effectiveness.","document_number":"2026-07817","html_url":"https://www.federalregister.gov/documents/2026/04/22/2026-07817/privacy-act-of-1974-system-of-records","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-22/pdf/2026-07817.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07817.pdf?1776775514","publication_date":"2026-04-22","agencies":[{"raw_name":"DEPARTMENT OF EDUCATION","name":"Education Department","id":126,"url":"https://www.federalregister.gov/agencies/education-department","json_url":"https://www.federalregister.gov/api/v1/agencies/126","parent_id":null,"slug":"education-department"}],"excerpts":"to the student; \n (6) aggregated income information on completers and non-completers of a particular educational program, and the median loan debt incurred by students enrolled in those education programs; \n (7) student demographic information, such as dependency status, citizenship, veteran status, marital status, gender, income and asset information (including income and asset information on the student's spouse, if married), and expected family contribution or Student Aid Index (SAI); \n (8) information on the parent(s) of a dependent aid applicant"},{"title":"AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled \"AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information\" that appeared in the Federal Register of April 29, 2026. In the notice, FDA requested comments to solicit input on a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision- making in early phase clinical trials. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.","document_number":"2026-10602","html_url":"https://www.federalregister.gov/documents/2026/05/28/2026-10602/ai-enabled-optimization-of-early-phase-clinical-trials-pilot-program-request-for-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-28/pdf/2026-10602.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10602.pdf?1779885915","publication_date":"2026-05-28","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or \n \n anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on \n https://www.regulations.gov. \n \n • If you want to submit a comment with confidential information that you do not wish"},{"title":"Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act.\" This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug that FDA determines should be included in the labeling of the drug. This guidance is being updated and reissued in draft to, among other things, include the addition of information related to Congress' 2018 changes to the definition of adverse drug experience regarding reduced effectiveness and make other changes to reflect current Agency processes and procedures regarding safety labeling changes. This draft guidance revises and, when finalized, will replace the guidance for industry entitled \"Safety Labeling Changes--Implementation of Section 505(o)(4) of the FD&C Act\" issued in July 2013.","document_number":"2025-18152","html_url":"https://www.federalregister.gov/documents/2025/09/19/2025-18152/safety-labeling-changes-implementation-of-section-505o4-of-the-federal-food-drug-and-cosmetic-act","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-19/pdf/2025-18152.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18152.pdf?1758199513","publication_date":"2025-09-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on \n https://www.regulations.gov \n .\n \n • If you want to submit a comment with confidential information that you do not wish to"},{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Required Warnings for Cigarette Packages and Advertisements","type":"Notice","abstract":"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 collection of information entitled, \"Required Warnings for Cigarette Packages and Advertisements.\"","document_number":"2025-23474","html_url":"https://www.federalregister.gov/documents/2025/12/19/2025-23474/agency-information-collection-activities-proposed-collection-comment-request-required-warnings-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-19/pdf/2025-23474.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23474.pdf?1766065529","publication_date":"2025-12-19","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on \n https://www.regulations.gov. \n \n • If you want to submit a comment with confidential information that you do not wish to"},{"title":"New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers.\" This draft guidance is intended to assist applicants requesting New Clinical Investigation exclusivity (also referred to as 3-year exclusivity) for a new drug application (NDA) or NDA supplement. The guidance discusses the statutory and regulatory criteria for eligibility for 3-year exclusivity and provides recommendations on the content and format of requests for 3-year exclusivity in the form of questions and answers (Q&As). FDA intends to update this draft guidance document to include additional Q&As as appropriate.","document_number":"2026-04291","html_url":"https://www.federalregister.gov/documents/2026/03/04/2026-04291/new-clinical-investigation-exclusivity-3-year-exclusivity-for-drug-products-questions-and-answers","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-04/pdf/2026-04291.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04291.pdf?1772545524","publication_date":"2026-03-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on \n https://www.regulations.gov. \n \n • If you want to submit a comment with confidential information that you do not wish to"},{"title":"E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.\" The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance updates the 2003 guidance titled \"E2D Post- Approval Safety Data Management: Definitions and Standards for Expedited Reporting,\" by clarifying the use of new or increasingly used data sources (e.g., social media, market research programs, patient support programs). This final guidance clarifies the use of new postapproval safety sources and update terminology and standards for postapproval adverse event reporting. The guidance replaces the draft guidance \"E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports\" issued on March 14, 2024, and the final guidance issued September 15, 2003.","document_number":"2026-04252","html_url":"https://www.federalregister.gov/documents/2026/03/04/2026-04252/e2dr1-postapproval-safety-data-definitions-and-standards-for-management-and-reporting-of-individual","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-04/pdf/2026-04252.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04252.pdf?1772545516","publication_date":"2026-03-04","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on \n https://www.regulations.gov. \n \n \n • If you want to submit a comment with confidential information that you do not wish to"}]}