{"description":"Documents matching 'must include information demonstrating these'","count":10000,"total_pages":50,"next_page_url":"https://www.federalregister.gov/api/v1/documents?conditions%5Bterm%5D=must+include+information+demonstrating+these&format=json&page=2","results":[{"title":"Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled \"Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein.\" The guidance provides information for manufacturers and contract laboratories that perform PER studies to assist in designing, conducting, evaluating, and reporting PER studies. The guidance explains \"appropriate modifications\" of AOAC Official Method 960.48 (the AOAC Method) with the aim of supporting industry in successfully conducting PER studies that demonstrate that a new infant formula meets the quality factor of sufficient biological quality of protein when fed as the sole source of nutrition. The guidance finalizes the approach presented in the draft guidance issued in 2023.","document_number":"2026-10284","html_url":"https://www.federalregister.gov/documents/2026/05/22/2026-10284/protein-efficiency-ratio-rat-bioassay-studies-to-demonstrate-that-a-new-infant-formula-supports-the","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-22/pdf/2026-10284.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10284.pdf?1779367512","publication_date":"2026-05-22","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":"Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry titled \"Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.\" FDA has revised and is reissuing this draft guidance in response to public comments and to changes in drug development by focusing on generating rigorous scientific evidence in the most efficient manner. Advances in our understanding of biological processes and the increasing availability of high-quality data have transformed the evidentiary landscape for drug development. Given these advances, the draft guidance discusses the many factors that can impact the strength of evidence of effectiveness for a drug and clarifies how sponsors can rely on one adequate and well-controlled clinical investigation with confirmatory evidence to satisfy the substantial evidence of effectiveness standard. When final, this guidance will replace the 1998 guidance titled \"Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.\"","document_number":"2026-12622","html_url":"https://www.federalregister.gov/documents/2026/06/24/2026-12622/demonstrating-substantial-evidence-of-effectiveness-for-human-drug-and-biological-products-revised","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-24/pdf/2026-12622.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12622.pdf?1782141309","publication_date":"2026-06-24","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":"Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.\" This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application under the Public Health Service Act (PHS Act).","document_number":"2025-20380","html_url":"https://www.federalregister.gov/documents/2025/11/20/2025-20380/scientific-considerations-in-demonstrating-biosimilarity-to-a-reference-product-updated","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-11-20/pdf/2025-20380.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-20380.pdf?1763559916","publication_date":"2025-11-20","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; Suspensions Pending Appeal and Bonding","type":"Notice","abstract":"In accordance with the Paperwork Reduction Act of 1995 (PRA), ONRR is proposing to renew an information collection. Through this Information Collection Request renewal (ICR), ONRR seeks renewed authority to collect information related to the paperwork requirements necessary to post a surety or bond or demonstrate financial solvency.","document_number":"2026-07750","html_url":"https://www.federalregister.gov/documents/2026/04/21/2026-07750/agency-information-collection-activities-suspensions-pending-appeal-and-bonding","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-21/pdf/2026-07750.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07750.pdf?1776689115","publication_date":"2026-04-21","agencies":[{"raw_name":"DEPARTMENT OF THE INTERIOR","name":"Interior Department","id":253,"url":"https://www.federalregister.gov/agencies/interior-department","json_url":"https://www.federalregister.gov/api/v1/agencies/253","parent_id":null,"slug":"interior-department"},{"raw_name":"Office of Natural Resources Revenue","name":"Natural Resources Revenue Office","id":586,"url":"https://www.federalregister.gov/agencies/natural-resources-revenue-office","json_url":"https://www.federalregister.gov/api/v1/agencies/586","parent_id":253,"slug":"natural-resources-revenue-office"}],"excerpts":" Notice of information collection; request for comment. \n \n \n SUMMARY: \n In accordance with the Paperwork Reduction Act of 1995 (PRA), ONRR is proposing to renew an information collection. Through this Information Collection Request renewal (ICR), ONRR seeks renewed authority to collect information related to the paperwork requirements necessary to post a surety or bond or demonstrate financial solvency. \n \n \n DATES: \n Your written comments must be received on or before May 21, 2026. \n \n \n ADDRESSES: \n \n All comment submissions must (1) reference"},{"title":"Agency Information Collection Activities; Notice and Request for Comment; 49 CFR 583-Automobile Parts Content Labeling","type":"Notice","abstract":"NHTSA invites public comments about our intention to request approval from the Office of Management and Budget (OMB) for a reinstatement with modification of a previously approved information collection. Before a Federal Agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal Agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes a collection of information for which NHTSA intends to seek OMB approval on Labeling and Reporting Requirements for 49 CFR part 583--Automobile Parts Content Labeling Under the American Automobile Labeling Act. This request for reinstatement includes a modification to the number of manufacturers that increases the total annual burden hours.","document_number":"2026-11652","html_url":"https://www.federalregister.gov/documents/2026/06/11/2026-11652/agency-information-collection-activities-notice-and-request-for-comment-49-cfr-583-automobile-parts","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11652.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11652.pdf?1781095509","publication_date":"2026-06-11","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"National Highway Traffic Safety Administration","name":"National Highway Traffic Safety Administration","id":345,"url":"https://www.federalregister.gov/agencies/national-highway-traffic-safety-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/345","parent_id":492,"slug":"national-highway-traffic-safety-administration"}],"excerpts":"approved information collection. \n \n \n SUMMARY: \n NHTSA invites public comments about our intention to request approval from the Office of Management and Budget (OMB) for a reinstatement with modification of a previously approved information collection. Before a Federal Agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal Agencies must solicit public comment on proposed collections of information, including"},{"title":"Considerations in Demonstrating Interchangeability With a Reference Product: Update; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Considerations in Demonstrating Interchangeability With a Reference Product: Update.\" This draft guidance describes considerations regarding a switching study or studies intended to support a demonstration that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act (PHS Act). After considering any comments received in the docket for this draft guidance, we intend to revise the final guidance for industry entitled \"Considerations in Demonstrating Interchangeability With a Reference Product\" issued on May 14, 2019, to amend sections in that document regarding the subject addressed in this draft guidance.","document_number":"2024-13429","html_url":"https://www.federalregister.gov/documents/2024/06/21/2024-13429/considerations-in-demonstrating-interchangeability-with-a-reference-product-update-draft-guidance","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-21/pdf/2024-13429.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13429.pdf?1718887516","publication_date":"2024-06-21","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 \n \n 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":"Medicaid Program; Community Engagement Requirement for Certain Individuals","type":"Rule","abstract":"This interim final rule with comment period (IFC) interprets and implements the community engagement requirement in Medicaid under section 1902(xx) of the Social Security Act. States are required to implement the new requirement no later than January 1, 2027. This IFC specifies the requirements and expectations for States, including the Medicaid applicants and beneficiaries who must demonstrate community engagement as a condition of their eligibility, the types of qualifying activities that satisfy the community engagement requirement, the criteria to meet an exception from the requirement (that is, be deemed compliant), and the criteria to meet a specified exclusion from the requirement. It also specifies requirements for verification of qualifying activities, outreach to affected populations, steps States must take if they determine individuals are noncompliant, and additional operational considerations for States. Finally, this IFC specifies implementation timing and establishes new State reporting requirements.","document_number":"2026-11094","html_url":"https://www.federalregister.gov/documents/2026/06/03/2026-11094/medicaid-program-community-engagement-requirement-for-certain-individuals","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-03/pdf/2026-11094.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11094.pdf?1780346707","publication_date":"2026-06-03","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":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Security Boulevard, Baltimore, MD 21244-1850.\n \n \n For information on viewing public comments, see the beginning of the \n SUPPLEMENTARY INFORMATION \n section.\n \n \n \n FOR FURTHER INFORMATION CONTACT: \n \n CMS Medicaid Works, \n Medicaidworks@cms.hhs.gov. \n \n \n \n \n SUPPLEMENTARY INFORMATION: \n \n \n Inspection of Public Comments: \n All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments"},{"title":"Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Human Space Flight Requirements for Crew/Space Flight Participants","type":"Notice","abstract":"In accordance with the Paperwork Reduction Act of 1995, FAA invites public to make public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The information for this collection is mandatory. The collection involves information demonstrating that a launch or reentry operation involving human participants will meet the risk criteria and requirement to ensure public safety. The FAA has established requirements for human space flight crew and space flight participants as required by the Commercial Space Launch Amendments Act of 2004. On December 15, 2006, the FAA published a final rule (71 FR 75616) which established requirements for crew qualifications, training and notification, and training and informed consent requirements for space flight participants. The requirements were designed to achieve public safety and to notify participants of the risks they face from launch or reentry.","document_number":"2026-05638","html_url":"https://www.federalregister.gov/documents/2026/03/23/2026-05638/agency-information-collection-activities-requests-for-comments-clearance-of-renewed-approval-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-23/pdf/2026-05638.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05638.pdf?1774010720","publication_date":"2026-03-23","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"Federal Aviation Administration","name":"Federal Aviation Administration","id":159,"url":"https://www.federalregister.gov/agencies/federal-aviation-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/159","parent_id":492,"slug":"federal-aviation-administration"}],"excerpts":"SE, Washington, DC 20591.\n \n \n \n \n FOR FURTHER INFORMATION CONTACT: \n \n Charles Huet by email at: \n charles.huet@faa.gov \n or phone: (202) 267-7427\n \n \n \n \n SUPPLEMENTARY INFORMATION: \n \n \n Public Comments Invited: \n You are asked to comment on any aspect of this information collection, including (a) Whether the proposed collection of information is necessary for FAA's performance; (b) the accuracy of the estimated burden; (c) ways for FAA to enhance the quality, utility and clarity of the information collection; and (d) ways that the burden could"},{"title":"Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Human Space Flight Requirements for Crew/Space Flight Participants","type":"Notice","abstract":"In accordance with the Paperwork Reduction Act of 1995, FAA invites public to make public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on March 23, 2026. The information for this collection is mandatory. The collection involves information demonstrating that a launch or reentry operation involving human participants will meet the risk criteria and requirement to ensure public safety. The FAA has established requirements for human space flight crew and space flight participants as required by the Commercial Space Launch Amendments Act of 2004. On December 15, 2006, the FAA published a final rule (71 FR 75616) which established requirements for crew qualifications, training and notification, and training and informed consent requirements for space flight participants. The requirements were designed to achieve public safety and to notify participants of the risks they face from launch or reentry.","document_number":"2026-12693","html_url":"https://www.federalregister.gov/documents/2026/06/24/2026-12693/agency-information-collection-activities-requests-for-comments-clearance-of-renewed-approval-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-24/pdf/2026-12693.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12693.pdf?1782218717","publication_date":"2026-06-24","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"Federal Aviation Administration","name":"Federal Aviation Administration","id":159,"url":"https://www.federalregister.gov/agencies/federal-aviation-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/159","parent_id":492,"slug":"federal-aviation-administration"}],"excerpts":"FAA invites public to make public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The \n Federal Register \n Notice with a 60-day comment period soliciting comments on the following collection of information was published on March 23, 2026. The information for this collection is mandatory. The collection involves information demonstrating that a launch or reentry operation involving human participants will meet the risk criteria and requirement to ensure public safety. The"},{"title":"Visibility Protection: Regional Haze State Plan Requirements Rule Revision","type":"Proposed Rule","abstract":"The Environmental Protection Agency (EPA or Agency) is soliciting information and requesting comment to assist in the development of regulatory changes pertaining to the restructuring of the Regional Haze Rule (RHR). Under the current RHR, states must submit state implementation plans (SIPs) to protect visibility in mandatory Class I Federal areas (Class I areas) to demonstrate reasonable progress towards the national visibility goal. The Agency is seeking input regarding how the EPA can meaningfully revise the RHR to streamline regulatory requirements impacting states' visibility improvement obligations under the Clean Air Act (CAA).","document_number":"2025-19280","html_url":"https://www.federalregister.gov/documents/2025/10/02/2025-19280/visibility-protection-regional-haze-state-plan-requirements-rule-revision","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-10-02/pdf/2025-19280.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-19280.pdf?1759322720","publication_date":"2025-10-02","agencies":[{"raw_name":"ENVIRONMENTAL PROTECTION AGENCY","name":"Environmental Protection Agency","id":145,"url":"https://www.federalregister.gov/agencies/environmental-protection-agency","json_url":"https://www.federalregister.gov/api/v1/agencies/145","parent_id":null,"slug":"environmental-protection-agency"}],"excerpts":"a header before providing a response. Do not submit to EPA's docket at \n https://www.regulations.gov \n any information you consider to be Confidential Business Information (CBI), Proprietary Business Information (PBI), or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents"},{"title":"Agency Information Collection Activities; Notice and Request for Comment; Petitions for Exemption From the Vehicle Theft Prevention Standard","type":"Notice","abstract":"NHTSA invites public comments about our intention to request approval from the Office of Management and Budget (OMB) to reinstate with a change previously approved information collection. Before a Federal agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes a collection of information for which NHTSA intends to seek OMB approval: Petitions for Exemption from the Vehicle Theft Prevention Standard, 49 CFR part 543. This is a reinstatement with change because it decreases the estimated burden hours. The previously approved information collection estimated 2,094 annual burden hours and this reinstatement estimates 1,828 annual burden hours due to a decrease of the estimated number of exemptions per year.","document_number":"2026-11651","html_url":"https://www.federalregister.gov/documents/2026/06/11/2026-11651/agency-information-collection-activities-notice-and-request-for-comment-petitions-for-exemption-from","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11651.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-11651.pdf?1781095509","publication_date":"2026-06-11","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"National Highway Traffic Safety Administration","name":"National Highway Traffic Safety Administration","id":345,"url":"https://www.federalregister.gov/agencies/national-highway-traffic-safety-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/345","parent_id":492,"slug":"national-highway-traffic-safety-administration"}],"excerpts":"previously approved information collection. \n \n \n SUMMARY: \n NHTSA invites public comments about our intention to request approval from the Office of Management and Budget (OMB) to reinstate with a change previously approved information collection. Before a Federal agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions"},{"title":"Unaccompanied Children Program Foundational Rule; Sponsor Assessment Update To Include Proof of Identity, Background Check, Placement, and Income Verification Standards","type":"Proposed Rule","abstract":"This notice of proposed rulemaking (NPRM, or proposed rule) would establish certain additional requirements for sponsor suitability assessments related to proof of identity, proof of income, and other information required for background checks to promote the safe placement of unaccompanied alien children (UAC). This NPRM proposes acceptable documentation for proof of identity and would require proof of income from potential sponsors of UAC in ORR custody by reason of their immigration status, as described in the Homeland Security Act of 2002 (HSA) and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA). This NPRM also proposes amendments to background check requirements for sponsor suitability assessments and the conduct of examinations of UAC related to considerations of UAC dangerousness to self or others that align with the One Big Beautiful Bill Act. Finally, this NPRM proposes certain administrative updates to align numbering and terminology between proposals and existing regulations. The docket on https://www.regulations.gov will include a plain language summary of the NPRM.","document_number":"2026-12946","html_url":"https://www.federalregister.gov/documents/2026/06/26/2026-12946/unaccompanied-children-program-foundational-rule-sponsor-assessment-update-to-include-proof-of","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12946.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12946.pdf?1782391518","publication_date":"2026-06-26","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":"Administration for Children and Families","name":"Children and Families Administration","id":49,"url":"https://www.federalregister.gov/agencies/children-and-families-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/49","parent_id":221,"slug":"children-and-families-administration"}],"excerpts":"RIN 0970-AD26 in the subject line of the message.\n \n \n Instructions: \n All submissions received must include the agency name and docket number or RIN for this rulemaking. For detailed instructions on submitting comments and additional information on the rulemaking process, see the “Public Participation” heading of the \n SUPPLEMENTARY INFORMATION \n section of this document.\n \n \n \n FOR FURTHER INFORMATION CONTACT: \n \n Toby Biswas, Assistant Deputy Director-Policy, Unaccompanied Alien Children Bureau, Office of Refugee Resettlement, Administration for"},{"title":"Agency Information Collection Activities: Proposed Collection; Comment Request-The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) Breastfeeding Award of Excellence","type":"Notice","abstract":"In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a revision of a currently approved collection for awarding local agencies for excellence in WIC breastfeeding services and support. The Child Nutrition Act of 1966 at 42 U.S. Code Sec. 1786(h)(4)(B), requires that the Department of Agriculture (USDA) establish a program to recognize WIC local agencies and clinics that demonstrate exemplary breastfeeding promotion and support activities.","document_number":"2026-04773","html_url":"https://www.federalregister.gov/documents/2026/03/11/2026-04773/agency-information-collection-activities-proposed-collection-comment-request-the-special","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-11/pdf/2026-04773.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-04773.pdf?1773146716","publication_date":"2026-03-11","agencies":[{"raw_name":"DEPARTMENT OF AGRICULTURE","name":"Agriculture Department","id":12,"url":"https://www.federalregister.gov/agencies/agriculture-department","json_url":"https://www.federalregister.gov/api/v1/agencies/12","parent_id":null,"slug":"agriculture-department"},{"raw_name":"Food and Nutrition Service","name":"Food and Nutrition Service","id":200,"url":"https://www.federalregister.gov/agencies/food-and-nutrition-service","json_url":"https://www.federalregister.gov/api/v1/agencies/200","parent_id":12,"slug":"food-and-nutrition-service"}],"excerpts":"public record. \n \n \n FOR FURTHER INFORMATION CONTACT: \n \n Requests for additional information or copies of this information collection should be directed to Valery Soto, Chief, Nutrition Services and Promotion Branch, Food Safety and Nutrition Division, Supplemental Nutrition and Safety Programs, FNS, USDA, 1320 Braddock Pl, Alexandria, VA 22314. Email: \n Valery.Soto@usda.gov, \n Telephone: (703) 305-2742.\n \n \n \n \n SUPPLEMENTARY INFORMATION: \n Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance"},{"title":"Agency Information Collection Activities: Submission for OMB Review; Comment Request","type":"Notice","abstract":"We have submitted a request to the Office of Management and Budget (OMB) for approval to reinstate a previously-approved information collection that expired in July 2025. This information collection will be used to connect veterans and Schedule A-eligible applicants with an opportunity for noncompetitive employment. Information will be collected from people who are interested in these opportunities to consider them for the positions and match them with possible jobs. The collection includes approval of a form, NA Form 3102, NARA Employment Interest Questionnaire. We invite you to comment on these information collections.","document_number":"2026-13879","html_url":"https://www.federalregister.gov/documents/2026/07/09/2026-13879/agency-information-collection-activities-submission-for-omb-review-comment-request","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-09/pdf/2026-13879.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-13879.pdf?1783514715","publication_date":"2026-07-09","agencies":[{"raw_name":"NATIONAL ARCHIVES AND RECORDS ADMINISTRATION","name":"National Archives and Records Administration","id":304,"url":"https://www.federalregister.gov/agencies/national-archives-and-records-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/304","parent_id":null,"slug":"national-archives-and-records-administration"}],"excerpts":"previously-approved information collection that expired in July 2025. This information collection will be used to connect veterans and Schedule A-eligible applicants with an opportunity for noncompetitive employment. Information will be collected from people who are interested in these opportunities to consider them for the positions and match them with possible jobs. The collection includes approval of a form, NA Form 3102, NARA Employment Interest Questionnaire. We invite you to comment on these information collections. \n \n \n DATES: \n OMB must receive written"},{"title":"Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; 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 (GFI) #279 entitled \"Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting.\" This final guidance describes an approach to satisfy the requirements for the completion of the Bioequivalence technical section for generic Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active pharmaceutical ingredients (APIs) that have little to no systemic absorption, and for which blood level studies are not considered appropriate to demonstrate product bioequivalence. The suggested approach described in this guidance uses a combination of in vitro and in vivo data to support a determination of bioequivalence to address the unique challenges associated with demonstrating bioequivalence of TAMAs containing poorly soluble, locally acting APIs that have little to no systemic absorption.","document_number":"2024-13690","html_url":"https://www.federalregister.gov/documents/2024/06/21/2024-13690/demonstrating-bioequivalence-for-type-a-medicated-articles-containing-active-pharmaceutical","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-21/pdf/2024-13690.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-13690.pdf?1718887546","publication_date":"2024-06-21","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; Notice and Request for Comment; Event Data Recorders","type":"Notice","abstract":"NHTSA invites public comments about our intention to request approval from the Office of Management and Budget (OMB) for an extension of a currently-approved information collection. Before a Federal agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatements of previously approved collections. This document describes a collection of information for which NHTSA intends to seek OMB approval on Part 563, Event Data Recorders (EDRs).","document_number":"2025-13720","html_url":"https://www.federalregister.gov/documents/2025/07/22/2025-13720/agency-information-collection-activities-notice-and-request-for-comment-event-data-recorders","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-07-22/pdf/2025-13720.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-13720.pdf?1753101911","publication_date":"2025-07-22","agencies":[{"raw_name":"DEPARTMENT OF TRANSPORTATION","name":"Transportation Department","id":492,"url":"https://www.federalregister.gov/agencies/transportation-department","json_url":"https://www.federalregister.gov/api/v1/agencies/492","parent_id":null,"slug":"transportation-department"},{"raw_name":"National Highway Traffic Safety Administration","name":"National Highway Traffic Safety Administration","id":345,"url":"https://www.federalregister.gov/agencies/national-highway-traffic-safety-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/345","parent_id":492,"slug":"national-highway-traffic-safety-administration"}],"excerpts":"currently approved information collection. \n \n \n SUMMARY: \n NHTSA invites public comments about our intention to request approval from the Office of Management and Budget (OMB) for an extension of a currently-approved information collection. Before a Federal agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions"},{"title":"Agency Information Collection Activities; Proposals, Submissions, and Approvals; Schedule A and Veterans Recruitment Initiative","type":"Notice","abstract":"We have submitted a request to the Office of Management and Budget (OMB) for approval to reinstate a previously-approved information collection that expired in July 2025. This information collection will be used to connect veterans and Schedule A-eligible applicants with an opportunity for noncompetitive employment. Information will be collected from people who are interested in these opportunities to consider them for the positions and match them with possible jobs. The collection includes approval of a form, NA Form 3102, NARA Employment Interest Questionnaire. We invite you to comment on these information collections.","document_number":"2026-09153","html_url":"https://www.federalregister.gov/documents/2026/05/08/2026-09153/agency-information-collection-activities-proposals-submissions-and-approvals-schedule-a-and-veterans","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-08/pdf/2026-09153.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-09153.pdf?1778157914","publication_date":"2026-05-08","agencies":[{"raw_name":"NATIONAL ARCHIVES AND RECORDS ADMINISTRATION","name":"National Archives and Records Administration","id":304,"url":"https://www.federalregister.gov/agencies/national-archives-and-records-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/304","parent_id":null,"slug":"national-archives-and-records-administration"}],"excerpts":"Questionnaire. We invite you to comment on these information collections. \n \n \n DATES: \n We must receive written comments on or before July 7, 2026. \n \n \n ADDRESSES: \n \n Send comments to \n surveys@nara.gov. \n \n \n \n FOR FURTHER INFORMATION CONTACT: \n \n Ben Jordi, Paperwork Reduction Act Officer, by email at \n ben.jordi@nara.gov \n or by telephone at 304-726-7865 with requests for additional information or copies of the proposed information collection and supporting statement.\n \n \n \n \n \n SUPPLEMENTARY INFORMATION: \n Pursuant to the Paperwork Reduction Act"},{"title":"Agency Information Collection Activities; Proposed Renewal; Comment Request; Renewal Without Change on Information Sharing Between Government Agencies and Financial Institutions","type":"Notice","abstract":"As part of its continuing efforts to reduce paperwork and respondent burden, FinCEN invites comments on the proposed renewal, without change, of existing information collection requirements found in Bank Secrecy Act (BSA) regulations concerning information sharing between government agencies and financial institutions. Specifically, the regulations require that, upon receiving an information request from FinCEN, a financial institution must search its records to determine whether it maintains or has maintained any account or engaged in any transaction with an individual, entity, or organization named in the request. If a financial institution identifies an account or transaction named in the request, it must report such information to FinCEN in the manner and timeframe specified in the request. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995.","document_number":"2025-18928","html_url":"https://www.federalregister.gov/documents/2025/09/30/2025-18928/agency-information-collection-activities-proposed-renewal-comment-request-renewal-without-change-on","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-09-30/pdf/2025-18928.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-18928.pdf?1759149912","publication_date":"2025-09-30","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"},{"raw_name":"Financial Crimes Enforcement Network","name":"Financial Crimes Enforcement Network","id":194,"url":"https://www.federalregister.gov/agencies/financial-crimes-enforcement-network","json_url":"https://www.federalregister.gov/api/v1/agencies/194","parent_id":497,"slug":"financial-crimes-enforcement-network"}],"excerpts":"regulations and guidance. Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments are public records; they are publicly displayed exactly as received, and will not be deleted, modified, or redacted. Comments may be submitted anonymously. \n \n \n FOR FURTHER INFORMATION CONTACT: \n \n FinCEN's Regulatory Support Section at \n www.fincen.gov/contact. \n \n \n \n \n SUPPLEMENTARY INFORMATION: \n I. Statutory and Regulatory"},{"title":"Publication or Submission of Quotations Without Specified Information","type":"Proposed Rule","abstract":"The Securities and Exchange Commission (\"Commission\") is proposing amendments to revise a rule that governs certain information gathering and review requirements that brokers and dealers must satisfy before initiating (or resuming) any quotation for a security in a quotation medium other than a national securities exchange. The proposed amendments would revise the rule to refer to only equity securities.","document_number":"2026-05401","html_url":"https://www.federalregister.gov/documents/2026/03/19/2026-05401/publication-or-submission-of-quotations-without-specified-information","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-03-19/pdf/2026-05401.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-05401.pdf?1773837917","publication_date":"2026-03-19","agencies":[{"raw_name":"SECURITIES AND EXCHANGE COMMISSION","name":"Securities and Exchange Commission","id":466,"url":"https://www.federalregister.gov/agencies/securities-and-exchange-commission","json_url":"https://www.federalregister.gov/api/v1/agencies/466","parent_id":null,"slug":"securities-and-exchange-commission"}],"excerpts":"annual report or statement, or periodic or current report) \n 76 \n \n or other documents and information,\n 77 \n \n depending on the regulatory status of the issuer of the security that is the subject of a broker's, dealer's, or QIDQS's review. Certain paragraph (b) information currently includes the term \n \n “security.” The proposal, therefore, includes conforming amendments to paragraph (b) to specify that documents and information regarding only equity securities must be gathered and reviewed. The Commission is proposing to replace the term “security”"},{"title":"Notice of Solicitation of Proposals for the Department of Defense University Consortium for Cybersecurity Support Center","type":"Notice","abstract":"The Secretary of Defense has determined the need for a Support Center (Center) for the University Consortium for Cybersecurity (UC2). The Center will provide, during a two-year term, administrative support for the academic research and engagement activities of UC2. To be eligible, interested institutions must have been designated as National Centers of Academic Excellence (NCAE) in cybersecurity for at least 24 months from the date of the publication of this notice and, further, must demonstrate an understanding of cybersecurity research, be eligible for access to classified material, and demonstrate commitment to the UC2 mission of a closer collaboration between academia and the DoD.","document_number":"2024-20652","html_url":"https://www.federalregister.gov/documents/2024/09/12/2024-20652/notice-of-solicitation-of-proposals-for-the-department-of-defense-university-consortium-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-09-12/pdf/2024-20652.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-20652.pdf?1726058734","publication_date":"2024-09-12","agencies":[{"raw_name":"DEPARTMENT OF DEFENSE","name":"Defense Department","id":103,"url":"https://www.federalregister.gov/agencies/defense-department","json_url":"https://www.federalregister.gov/api/v1/agencies/103","parent_id":null,"slug":"defense-department"},{"raw_name":"Office of the Secretary"}],"excerpts":"Gwyneth Sutherlin, 202-685-2080. The application shall include a cover page, labeled “PROPOSAL UC2 Support Center,” that includes the prospective proposer's administrative point of contact, to include a telephone number and email address. The application must be limited to three (3) pages, single-sided, and must include: a certificate of NCAE designation status for 24 months, a statement of experience and understanding with cybersecurity research, evidence of eligibility to access to classified material, a narrative description of potential contribution"}]}