Change Requests

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Payment of Indemnity and Compensation for Highly Pathogenic Avian Influenza

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Abstract

Interim final rule amending regulations related to conditions for payment of indemnity and compensation for highly pathogenic avian influenza claims. Amendments include new activities related to biosecurity audits and instrument for conducting same, and reconsideration process for audit results.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 107 - 171 10401-18	View Law

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Unaccompanied Alien Children Sponsor Application Packet

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Abstract

The Administration for Children and Families (ACF) requests emergency review and approval of this information collection by the Office of Management and Budget (OMB), as authorized under 5 CFR 1320.13. The proposed revisions to the Authorization for Release of Information (Form SAP-2) and Sponsor Application (Form SAP-3) align the PDF and digital sponsor applications used by the Office of Refugee Resettlement (ORR). Under the October 30, 2026, court order in Angelica S. v. HHS, ORR must make the OMB-approved PDF application available as the exclusive sponsorship application if OMB has not approved the online application by November 30, 2026. The information collected is essential to the mission of the agency. Children’s safety and well-being are central to the sponsorship process. ORR must obtain sufficient information to evaluate prospective sponsors, assess household conditions, identify potential safety concerns, and support safe and timely placement decisions. The revised forms organize this information and related conditional follow-up questions to support consistent collection and review throughout the sponsorship process. The use of normal PRA clearance procedures is reasonably likely to delay approval beyond November 30, 2026, and disrupt information collection by requiring ORR to transition to exclusive use of the approved PDF application. This transition will likely substantially increase manual processing of sponsor applications by Federal staff, draw out the sponsorship process by requiring Federal staff to read out and have sponsors respond to lengthy interviews through Sponsor Assessment questions, increase records management burden, and could compromise the security of significant sensitive information of sponsors, their households, and unaccompanied alien children. Operationally, such a transition would result in a significant delay for sponsor assessments and release and unification of unaccompanied alien children with their vetted family member. ACF therefore requests emergency approval by November 3, 2026, to support continued use of the online application, avoid processing delays, and maintain essential safeguards for children throughout the sponsorship and release process.Emergency Justfication:ACF requests OMB’s emergency review and approval of the digital sponsor application and corresponding revisions to the Authorization for Release of Information (Form SAP-2) and Sponsor Application (Form SAP-3), under OMB Control No. 0970-0278, as authorized under 5 CFR 1320.13. ACF requests approval as soon as possible and before November 30 to avoid substantial disruption to ORR’s sponsor intake and assessment process while meeting the court’s minute order in Angelica S. v. U.S. Department of Health and Human Services (Case No. 1:25-cv-01405). On October 30, 2026, the court ordered that, if the online sponsorship application is not approved by OMB by November 30, 2026, the OMB-approved PDF version must be made available as the exclusive sponsorship application. Emergency approval would permit ORR to maintain its current online intake process while implementing aligned, OMB-approved digital and PDF instruments. This information collection is essential to ACF’s and ORR’s responsibilities to protect the care, safety, and well-being of unaccompanied alien children and support their safe placement with suitable sponsors. Given the court’s November 30, 2026, requirement, the use of normal clearance procedures under the Paperwork Reduction Act is reasonably likely to necessitate a transition to universal PDF intake, increasing government costs for manual processing, document handling, and records management. Diverting staff from substantive sponsor assessments would necessarily delay safe placement decisions, prolong the time unaccompanied alien children remain in ORR custody in congregate care settings, and increase federal expenditures for their continued care. Prolonged stays in Federal custody and congregate care settings present significant child welfare concerns and litigation risk for ORR. Requiring universal PDF intake would substantially change ORR’s current operations, increase handling of sensitive personal information outside the secure application system, and expand manual processing and records management work beyond available staffing resources. Essential to Mission This collection is essential to the agency’s mission (as described in 5 CFR 1320.13(a)(1)(ii)) because Forms SAP-2 and SAP-3 are necessary for ACF and ORR to carry out their responsibilities for the care, safety, and well-being of children. These forms collect and document information ORR needs to assess prospective sponsors and determine whether a child can be safely released from federal custody. They support required sponsor suitability assessments while helping ORR avoid unnecessary delays in placing children with suitable sponsors. The forms enable ORR to carry out its responsibilities under the Homeland Security Act, 6 U.S.C. Section 279, which assigns ORR responsibility for the care and placement of unaccompanied alien children and requires consideration of children’s interests in decisions concerning their care and custody.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

8 USC 1232	View Law

Pub.L. 119 - 21 87001(b)(1)	View Law

Pub.L. 113 - 4 1101(c)	View Law

6 USC 279	View Law

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NMDP Patient Support Center Survey

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NMDP provides navigation services, education resources, and support to people in need of an allogeneic hematopoietic cell transplant (allo-HCT). NMDP is required to conduct surveys to evaluate patient satisfaction with the services provided. As such, NMDP will elicit feedback from all HCT patients, caregivers, and family members who had contact with the NMDP Patient Support Center (PSC) for service and support (advocacy). Survey results will be used to inform program development and resource allocation decisions.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 111 - 264 3	View Law

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Health Professions Student Loan (HPSL) Program and Nursing Student Loan (NSL) Program: Administrative Requirements (Regulations & Policy)

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The Health Professions Student Loan (HPSL) Program, authorized by Public Health Service (PHS) Act sections 721-722 and 725-735, is a grant program where recipients provide long-term, low-interest loans to students attending schools of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine, and pharmacy. The Loans for Disadvantaged Students (LDS) Program, authorized by PHS Act sections 721-722 and 724-735, is a grant program where recipients provide long-term, low interest loans to certain students attending schools of allopathic medicine, osteopathic medicine, podiatric medicine, dentistry, optometry, pharmacy, and veterinary medicine. The Primary Care Loan (PCL), authorized by PHS Act sections 721-723 and 725-735, is a grant program where recipients provide long-term, low interest loans to students attending schools of allopathic medicine and osteopathic medicine to practice primary health care. The Nursing Student Loan (NSL) Program, authorized by PHS Act sections 835-842, is a grant program where recipients provide long-term, low-interest loans to students who attend eligible schools of nursing in programs leading to a diploma degree, an associate degree, a baccalaureate degree, or a graduate degree in nursing. These programs have a number of recordkeeping and reporting requirements for academic institutions and loan applicants. The applicable program regulations are found in 42 C.F.R. §§ 57.201-218 and 57.301-318.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 292t	View Law

42 USC 292s	View Law

42 USC 292q-292y	View Law

42 USC 297a-297i	View Law

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Premarket Notification Submission 510(k), Subpart E

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This ICR collects information from persons who intend to market a medical device. Based on the information provided in the premarket notification (510(k)) submission, FDA determines whether a new device provides reasonable assurance of the safety and effectiveness of the device through substantial equivalence to a legally marketed device and whether the device can, therefore, be allowed to enter the U.S. market. Because the review of 510(k) submissions confirms that the new device is as safe and as effective as legally marketed predicate devices, potentially unsafe and/or ineffective devices, including those with fraudulent claims, are prevented from entering the U.S. market.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

21 USC 510(k)	View Law

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Prison Education Program Application

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Prison Education Programs (PEP) is authorized under section 484(t) of the Higher Education Act of 1965, as amended (HEA) with the requirements for participation outlined in 34 CFR 668, Subpart P. These are the regulatory requirements for a school to offer a PEP to confined or incarcerated students. This is a request for an extension without change for the application form from institutions that wish to participate in PEP under the regulations in 668, Subpart P. There have been no changes to the regulations.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

20 USC 1091	View Law

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Tobacco Product Establishment Registration and Submission of Certain Health Information

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The Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by the Tobacco Control Act of 2009, grants FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 905 of the FD&C Act requires the annual registration of any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products. Section 904 of the FD&C Act requires that each tobacco product manufacturer or importer submit a listing of all ingredients and additives that are added by the manufacturer to each tobacco product by brand and by quantity in each brand and sub brand. Section 904 also requires that a tobacco product manufacturer advise the FDA in writing prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive. It also requires that a tobacco product manufacturer advise the FDA in writing prior to eliminating or decreasing an existing additive, or adding or increasing an additive designated by the FDA as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

21 USC 905	View Law

21 USC 904	View Law

Pub.L. 111 - 111 31	View Law

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Almonds Grown in California (7 CFR Part 981)

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Information is needed to administer a mandatory program to reduce the potential for Salmonella bacteria in almonds through outgoing quality control requirements. The information will assist in verifying that the almonds are treated in accordance with the outgoing quality control requirements specified in the order.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

7 USC 601-674	View Law

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Pre-Claim Review Demonstration For Home Health Services (CMS-10599)

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The Centers for Medicare & Medicaid Services (CMS) is requesting the Office of Management and Budget (OMB) approval for the Pre-Claim Review Demonstration for Home Health Services. This demonstration would help assure that payments for home health services are appropriate before the claims are paid, thereby preventing fraud, waste, and abuse. CMS proposes performing prior authorization before processing claims for home health services in: Florida, Texas, Illinois, Michigan, and Massachusetts.Emergency Justfication:Please see the attached emergency justification.

Authorizing Statutes

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Subpart C Research Certification Form

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The Office for Human Research Protections (OHRP) is requesting a three-year extension, without changes, for the currently approved collection for the OMB No. 0990-0473, HHS Subpart C Certification Form. The current form is approved through October 31, 2026. The purpose of the form is to provide a simplified, standardized procedure for institutions to electronically submit subpart C research certifications to OHRP in order to meet the regulatory requirements for including prisoners in non-exempt human subjects research that is conducted or supported by HHS. The form also simplifies the internal process used by OHRP to review and record such certifications, resulting in faster processing while reducing unnecessary and burdensome staff time. Respondents for this collection are institutions or organizations operating Institutional Review Boards (IRBs) that have enrolled or are planning to enroll prisoners in human subjects research conducted or supported by HHS.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC Section 289	View Law

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Generic Information Collection Request for Health Resources and Services Administration Hotlines, Chatlines, and Online Portals

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This is a request for a new umbrella information collection (ICR) which will collect information about the operation of HRSA hotlines, chatlines, and online portals. HRSA hotlines, chatlines, and online portals are one way that HRSA can respond to customer questions and concerns on HRSA programs (e.g., Health Centers, Loan and Scholarship Programs, and Ryan White HIV/AIDS Program). HRSA also has hotlines and chatlines where members of the public can get assistance on specific medical issues (e.g., National Clinician Consultation Centers hotline/warmlines, and National Maternal Mental Health Hotline). HRSA hotlines, chatlines, and online portals are operated by HRSA or a contractor acting on HRSA’s behalf. Because these forms will be used to provide high-quality services to HRSA grantees and stakeholders, it is authorized by Executive Order 14058, “Setting Customer Service Standards.” The specific statutes authorizing these collections cannot be identified in advance but will be included as part of each submission request to OMB. HRSA would only request OMB approval for collections under this umbrella-collection if the collection is voluntary, low-burden, and uncontroversial. As part of this umbrella ICR, HRSA requests that OMB provide a response on individual generic collections within 5 business days. If no response is received and the request meets the purposes, uses and scope outlined in this document, HRSA would then move forward with the proposed information collection. HRSA believes this fast-track process should apply to this information collection, since these information collections will focus on the awareness, understanding, attitudes, preferences, or experiences of HRSA customers or other stakeholders (e.g., funding recipients and their delivery partners, and potential funding applicants) relating to existing or future services, products, or communication materials. The individual IC template is included under Supporting Documents.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

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NASA Small Business Supplier Development Program

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This information collection supports the application for a Mentor‑Protégé Agreement under the NASA Small Business Supplier Development Program and NASA’s subsequent administration of those Agreements. Mentor-Protégé Agreements are designed to build supplier capacity to fulfill NASA requirements and support a strong, dynamic, and resilient industrial base, which is critical to the health of our nation’s economy and to America’s effort to lead in space.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

48 USC 48 CFR Subpart 1819.72	View Law

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Terms of Credit Card Plans Survey

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Terms of Credit Card Plans Survey The Terms of Credit Card Plans (TCCP) Survey was implemented in February 1990 as required by Section 5 of the Fair Credit and Charge Card Disclosure Act (FCCCA) of 1988. Each respondent provides information about its credit card plan with the largest outstanding number of cards. The FCCCA required the Federal Reserve to collect this information semiannually from the largest 25 issuers of credit cards and at least 125 additional institutions in a manner that ensured both an equitable geographic distribution within the sample and representation of a wide spectrum of institutions. The Federal Reserve was further directed to make the credit card price information for each institution available to the public upon request and to report the information semiannually to Congress. Consumer Credit Card Agreement Quarterly Submission On July 21, 2011, the Bureau assumed responsibility under the CARD Act for the quarterly collecting of credit card agreements in a publicly available database. Pursuant to 12 CFR 1026.58 and 15 U.S.C. 1632(d)(2)–(3), collection is mandated for all issuers (subject to de minimis exceptions), and the scope of the mandate may require submission of multiple different agreements for each issuer. See 15 U.S.C. 1632(d)(2) (“Each creditor shall provide to the Bureau, in electronic format, the consumer credit card agreements that it publishes . . . .”) (emphasis added); id. at 1632(d)(3) (“The Bureau shall establish and maintain on its publicly available Internet site a central repository of the consumer credit card agreements received from creditors pursuant to this subsection, and such agreements shall be easily accessible and retrievable by the public.”) (emphasis added). College Credit Card Agreement Annual Submission This collection is made pursuant to the CARD Act requirement, codified at 12 CFR 1026.57(d); 15 U.S.C. 1637(r). Every year, the CARD Act requires the Bureau to collect agreements in place between credit card issuers and institutions of higher education, as well as certain summary data about the credit cards offered pursuant to these agreements. See 15 U.S.C. 1637(r)(2)(A) (“Each creditor shall submit an annual report to the Bureau containing the terms and conditions of all business, marketing, and promotional agreements and college affinity card agreements with an institution of higher education, or an alumni organization or foundation affiliated with or related to such institution, with respect to any college student credit card issued to a college student at such institution.”). The CARD Act requires the Bureau to submit to Congress, and to make available to the public, an annual report that lists information submitted to the Bureau concerning agreements between credit card issuers and institutions of higher education or certain affiliated organizations. See id. 1637(r)(3) (“The Bureau shall submit to the Congress, and make available to the public, an annual report . . . .”). Affiliated organizations include fraternities, sororities, alumni associations, or foundations affiliated with or related to an institution of higher education. The Bureau provides this centralized repository on its website and also submits to Congress and publishes an annual report each year based upon the submitted data.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 111 - 203 1100A	View Law

15 USC 1646(b)	View Law

Pub.L. 100 - 583 5	View Law

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Medicare Part C and Part D Data Validation (42 CFR 422.516(g) and 423.514(g)) (CMS-10305)

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CMS' regulatory authority to require data validation is described in 42 CFR 422.516(g) and 423.514(g). Organizations contracted to offer Medicare Part C and Part D benefits are required to report data to CMS on a variety of measures. In order for the data to be useful for monitoring and performance measurement, the data must be reliable, valid, complete, and comparable among sponsoring organizations. To meet this goal, CMS has developed reporting standards and data validation specifications with respect to the Part C and Part D reporting requirements. These standards provide a review process for Medicare Advantage Organizations (MAOs), Cost Plans, and Part D sponsors to use to conduct independent data validation checks on their reported Part C and Part D data to determine their reliability, validity, completeness, and comparability in accordance with specifications developed by CMS.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

18 Stat. 1857

18 Stat. 1860

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Generic Clearance for NIH Citizen Science and Crowdsourcing Projects (OD)

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This is a revision of a currently approved generic clearance to comply with the Administrations goals and priorities and to extend for an additional three years. The revision will continue to allow the continuation of projects for Agency researchers and program staff to test ideas more quickly, respond to the project’s needs as they evolve, and incorporate feedback from participants for flexible, innovative research methods. Any collection under this umbrella is expected to be low in burden.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 114 - 329 402	View Law

42 USC 285	View Law

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Negotiation Program Drug Selection for Initial Price Applicability Year 20XX under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) - (CMS-10844)

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The Centers for Medicare & Medicaid Services (CMS) is requesting review and approval of a revision to an existing data collection related to the Inflation Reduction Act of 2022 (P.L. 117-169) (the Act). Sections 1193 and 1194 of the Act requires drug manufacturers to submit data to the Secretary of the Department of Health and Human Services, in a form and manner specified by the Secretary; information on the non-Federal average manufacturer price; and information that the Secretary requires to carry out the negotiation or renegotiation process. The Act establishes a Drug Price Negotiation Program for certain selected drugs covered under Medicare Part B and Part D. The Secretary is required to negotiate maximum fair prices (MFPs) with drug manufacturers for 15 Part B and Part D drugs in 2028, 20 Part B and Part D drugs for 2029 and each following year. The Secretary is required to renegotiate MFPs with drug manufacturers of selected drugs that are eligible and selected for renegotiation for 2028 and each following year. Additionally, this information collection request describes the information collection that may occur if the Primary Manufacturer chooses to develop and submit a written counteroffer to CMS’ written initial offer for initial negotiation or renegotiation of the MFP, as applicable to a selected drug, during initial price applicability year 2028 under the Medicare Drug Price Negotiation Program (under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (P.L. 117-169), codified in sections 1191 through 1198 of the Social Security Act

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Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

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This information collection provides for documenting procedures and maintaining records pertaining to the production of dietary supplements. Products that do not meet CGMP requirements may be deemed to be in violation of the Federal Food, Drug, and Cosmetic Act. The information collection also covers regulations pertaining to exemptions from testing requirements applicable to these products and how petitions should be filed with FDA.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

21 USC 342(g)	View Law

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Current Good Manufacturing Practice Regulations For Type A Medicated Articles and Medicated Feeds

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This ICR concerns the recordkeeping requirements of FDA’s current good manufacturing practice (cGMP) regulations for medicated feeds and for Type A medicated articles. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease, or growth promotion and feed efficiency. A manufacturer is required to establish, maintain, and retain records for a medicated feed, including records to document procedures required during the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (i.e. batch and stability testing), labels, and product distribution. A Type A medicated article is a feed product containing a concentrated drug diluted with a feed carrier substance. A Type A medicated article is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease or for growth promotion and feed efficiency. Under part 226, a manufacturer is required to establish, maintain, and retain records for Type A medicated articles, including records to document procedures required under the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (i.e. batch and stability testing), and product distribution. These records are subject to FDA review during an inspection. Medicated feeds that are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

21 USC 351	View Law

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Consumer Price Index Commodities and Services Survey

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Abstract

The Consumer Price Index (CPI) is a measure of the average change over time in the prices paid by consumers for a market basket of consumer goods and services. Each month, BLS data collectors called economic assistants, visit or call thousands of retail stores, service establishments, rental units, and doctors' offices, all over the United States to obtain information on the prices of the thousands of items used to track and measure price changes in the CPI. The collection of price data from retail establishments is essential for the timely and accurate calculation of the commodities and services component of the CPI. The CPI is then widely used as a measure of inflation, indicator of the effectiveness of government economic policy, deflator for other economic series, and as a means of adjusting dollar values.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

29 USC Section 2, Chapter 1, Sub 1	View Law

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Generic Clearance for the Collection of Customer Participation and Performance Management with NIH Programs, Processes, Products, and Services (NIH)

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Abstract

This is a revision of a currently approved generic clearance to comply with the Administrations goals and priorities and to extend for an additional three years. The purpose of the “Generic Clearance for the Collection of Customer Participation and Satisfaction with NIH Programs, Processes, Products, and Services” is to continue to provide a flexible and timely approval framework that facilitates the collection of information needed to measure and improve the performance of NIH programs, processes, products, or services.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

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Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act

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Abstract

This collection requires each tobacco product manufacturer or importer, or an agent, to report to FDA "all constituents, including smoke constituents, identified by [FDA] as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product." These entities must also provide similar information at least 90 days prior to introducing the product into interstate commerce.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 111 - 111 31	View Law

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