Background

FSIS is responsible for ensuring that meat, poultry, and egg products are safe, wholesome, and properly labeled. The Agency administers a regulatory program for meat products under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq. ), for poultry products under the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq. ), and for egg products under the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq. ). FSIS also provides voluntary reimbursable inspection services under the Agricultural Marketing Act (AMA) (7 U.S.C. 1622 and 1624) for eligible products not requiring mandatory inspection under the FMIA, PPIA, and EPIA.

Under the FMIA, PPIA, and EPIA, any meat, poultry, or egg product is misbranded if its labeling is false or misleading (21 U.S.C. 601(n)(1); 21 U.S.C. 453(h)(1); 21 U.S.C. 1036(b)). In particular, no product or any of its wrappers, packaging, or other containers shall bear any false or misleading marking, label, or other labeling; and no statement, word, picture, design, or device which conveys any false impression or gives any false indication of origin or quality or is otherwise false or misleading shall appear in any marking or other labeling (9 CFR 317.8(a)), 381.129(b), 590.411(f)(1)). FSIS has similar authority under the AMA concerning the false or misleading labeling of products receiving voluntary inspection services (7 U.S.C. 1622(h)(1)).

On March 18, 2024, FSIS published the final rule, Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims (89 FR 19470). The final rule amended FSIS labeling regulations to allow two specific voluntary U.S.-origin label claims, “Product of USA” and “Made in the USA,” to be generically approved  1 for use on single ingredient FSIS-regulated products ( i.e., products produced under FSIS mandatory or voluntary inspection services) derived from animals born, raised, slaughtered, and processed in the United States. Under the final rule, the two voluntary label claims “Product of USA” and “Made in the USA” are also generically approved for use on multi-ingredient FSIS-regulated products if: (1) All FSIS-regulated products in the multi-ingredient product are derived from animals born, raised, slaughtered, and processed in the United States; (2) all other ingredients, other than spices and flavorings, are of domestic origin; and (3) the preparation and processing steps for the multi-ingredient product have occurred in the United States. Also under the final rule, label claims other than “Product of USA” or “Made in the USA” that indicate that a preparation or processing step of an FSIS-regulated product is of U.S. origin are generically approved for use, but such claims will need to include the preparation and processing steps that occurred in the United States upon which the claim is made. 2

On March 18, 2024, FSIS also announced the availability of the revised FSIS Guideline on Label Approval (89 FR 19470). FSIS published the revised guideline to help establishments meet the new requirements for use of voluntary U.S.-origin label claims on FSIS-regulated products and to provide examples of claims and the types of documentation that establishments may maintain to support use of the claims. FSIS requested comments on the guideline, and the Agency received three comments within the scope of the guideline updates during the 60-day comment period. On April 30 and May 15, 2024, FSIS hosted public webinars to provide an overview of the final rule and information about related labeling guidance. 3 During the webinars, FSIS received several participant comments on the guideline. Since publication of the final rule, FSIS also has received several questions about the guideline through askFSIS, the Agency's Web-based and telephone-based application for addressing technical and policy-related questions. 4

After review and consideration of all comments, FSIS has made changes to the guideline to clarify and update information on the use of voluntary U.S.-origin label claims. These changes to the guideline are summarized below and are discussed in more detail in FSIS' responses to comments. The revised guideline is available at the FSIS guideline web page at: https://www.fsis.usda.gov/policy/fsis-guidelines. Although comments will no longer be accepted on this guideline through www.regulations.gov, FSIS will update the document as necessary if new information becomes available.

For purposes of voluntary U.S.-origin label claims under FSIS regulations,

• FSIS is clarifying that the meaning of “raised” is “from birth to slaughter.”

• FSIS is clarifying that the term “harvested” may be used to mean “slaughtered.”

• FSIS is clarifying that for purposes of meeting the requirements for use of the voluntary U.S.-origin label claims “Product of USA” or “Made in the USA” on multi-ingredient products, the requirement that “all other ingredients other than spices and flavorings” in the product must be of domestic origin does not include sub-ingredients of an ingredient ( e.g., the soybean or wheat sub-ingredient in a soy sauce ingredient).

• FSIS is clarifying the definitions of “spices” and “flavorings.”

• FSIS is clarifying that multi-ingredient products made with edible natural casings that are processed ( e.g., cleaned) outside the United States are eligible for use of the voluntary U.S.-origin label claims “Product of USA” or “Made in the USA,” provided that the product meets all other requirements under the rule.

• FSIS is clarifying that “Product of North America” is allowed as a voluntary label claim on products if the claim is truthful and not misleading and complies with the FSIS requirements in 9 CFR 317.8(b)(1) and 9 CFR 381.129(b)(2) for use of label terms having geographical significance ( i.e., the animal from which the product was derived was born, raised, slaughtered, and processed in North America).

• FSIS is clarifying that a voluntary multi-country origin label claim that includes the United States and a foreign country ( e.g., “Product of USA and Canada”) is allowed on products, provided (1) the animal from which the product was derived was born, raised, slaughtered, and processed in either the United States or the listed foreign country; (2) in the case of a multi-ingredient product, all other ingredients (other than spices and flavorings) are of the origin of either the United States or the listed foreign country; and (3) the claim is accompanied by qualifying language describing the preparation and processing steps that occurred in the United States ( e.g., “Product of USA and Canada, Packaged in the USA”).

• FSIS is clarifying that, as with the claims “processed” and “manufactured,” the term “produced” may not be used as a stand-alone label claim to describe the preparation and processing steps of a product that occurred in the United States, as this term does not provide meaningful consumer information about the actual preparation and processing steps of the product that occurred in the United States.

• FSIS is providing additional examples of voluntary U.S.-origin label claims that may be used to describe the preparation and processing steps of a product that occurred in the United States ( e.g., “Cooked in the U.S.A.”).

• FSIS is clarifying the final rule's effect on the label display of certain U.S. State endorsement program logos.

• FSIS is clarifying that, under the final rule at the amended subsections 9 CFR 317.8(b)(1) and 9 CFR 381.129(b)(2), statements, words, pictures, designs, or devices depicting the United States, or a U.S. State or territory, may be used on the labels of products without a qualifying statement only if the animal from which the meat or poultry product was derived was born, raised, slaughtered, and processed in the United States, or U.S. State or territory. If the product does not meet these requirements, the depiction must be accompanied by a qualifying statement.

• FSIS is providing additional examples of the types of documentation that may be maintained to support a voluntary U.S.-origin label claim.

• FSIS is making a few editorial changes throughout the guideline for readability and clarity.

During the comment period for the guideline announced in the Federal Register , FSIS received three comments on the updated label approval guideline from one U.S. trade association representing the meat industry, one foreign trade association representing the meat industry, and one foreign country. Other comments were outside the scope of the updated guideline and discussed general opposition to the final rule by restating specific concerns included in the comments they submitted in response to the proposed rule. FSIS is not addressing those comments here. After the end of the comment period, FSIS also received from the public several askFSIS questions on the updated guideline. Finally, FSIS received several participant questions during the Agency's April and May 2024 public webinars on the final rule and updated label guideline. 5 A summary of the relevant issues raised by these comments and questions and the Agency's responses follows.

Comment: One foreign country and a few askFSIS submitters asked FSIS to clarify the definition of “raised” under the final rule for the purposes of determining whether an animal from which an FSIS-regulated product was derived was “raised” in the United States.

Response: FSIS has updated the guideline to clarify that “raised” means “raised from birth to slaughter” for the purposes of meeting the requirement for use of the voluntary U.S.-origin label claims “Product of USA” and “Made in the USA” under 9 CFR 412.3(a) and (b). Therefore, a claim of “raised” or “born and raised” is allowed under 9 CFR 412.3(c) as a voluntary U.S.-origin label claim other than “Product of USA” and “Made in the USA” when the animal from which the product was derived was raised in the United States for the entirety of its life ( i.e., from birth to slaughter). When the animal was raised in the United States for a period less than from birth to slaughter, the claim must be accompanied by a truthful description of the length of time the animal was raised in the United States ( e.g., the label claim “raised for at least 30 days in the USA” on a single ingredient beef chuck roast.)

Comment: A few askFSIS submitters asked whether FSIS will accept use of the term “harvested” to mean “slaughtered” to describe the preparation and processing steps of an FSIS-regulated product to accompany voluntary U.S.-origin label claims.

Response: FSIS has updated the guideline to clarify that the term “harvested” may be used to mean “slaughtered” for the purposes of meeting the requirements for use of voluntary U.S.-origin label claims.

Comment: A few askFSIS submitters asked whether the sub-ingredients of ingredients in FSIS-regulated multi-ingredient products must be of domestic origin for such products to be eligible for the voluntary U.S.-origin label claims, “Product of USA” and “Made in the USA.”

Response: FSIS has updated the guideline to clarify that for purposes of meeting the requirements under 9 CFR 412.3(b) for use of the voluntary label claims “Product of USA” and “Made in the USA” on multi-ingredient products, the requirement that “all other ingredients other than spices and flavorings” in the product must be of domestic origin does not include sub-ingredients of an ingredient. For example, if a pork sausage product labeled with the claim “Made in the USA” contains the ingredient soy sauce, the soy sauce needs to be of domestic origin, but the “sub-ingredients” of the soy sauce ( e.g., soybeans or wheat), need not be of domestic origin. FSIS is making this change because the source of sub-ingredients may not be available to establishments using the U.S.-origin label claim or to FSIS inspectors verifying the claim meets labeling requirements.

Comment: One trade association, a few askFSIS submitters, and a few webinar participants asked FSIS to clarify the definitions of “spices” and “flavorings” for the purpose of meeting the final rule requirements that all other ingredients ( i.e., ingredients that are not FSIS-regulated products), other than spices and flavorings, must be of domestic origin for an FSIS-regulated multi-ingredient product label to bear the voluntary claims “Product of USA” or “Made in the USA”.

Response: The terms “spices” and “flavorings” are defined in 9 CFR 317.2(f)(i)(A) and (B) and 381.118(c)(1) and (2). FSIS is using these definitions for the purposes of meeting the final rule requirements for the labeling of multi-ingredient FSIS-regulated products with the voluntary claims “Product of USA” or “Made in the USA”, as well as compliance with other FSIS regulations that use these terms. FSIS has updated the guideline to clarify the definitions and provide citations to these regulations.

Comment: A few webinar participants and askFSIS submitters asked whether the Agency will consider an edible natural casing to be an ingredient for the purposes of meeting the requirement under 9 CFR 412.3(b) that all other ingredients ( i.e., ingredients that are not FSIS-regulated products) in a multi-ingredient product, other than spices and flavorings, must be of domestic origin for the product label to bear the voluntary U.S.-origin claims “Product of USA” or “Made in the USA.”

Response: Under the final rule, edible natural casings from animals born, raised, slaughtered, and processed in the United States are considered to be of domestic origin for purposes of meeting the final rule requirements for use of the voluntary U.S.-origin claims “Product of USA” and “Made in the USA” on FSIS-regulated multi-ingredient products. However, FSIS recognizes that most edible natural casings produced in the United States are exported to foreign countries to be processed ( e.g., cleaned), then imported back to the United States for use as an ingredient in multi-ingredient meat products. Therefore, FSIS has updated the guideline to clarify that multi-ingredient FSIS-regulated products made with edible natural casings that are processed outside the United States are eligible for label use of the voluntary U.S.-origin claims “Product of USA” or “Made in the USA,” provided that the product meets all other requirements under 9 CFR 412.3(b) for use of such claims. For example, a multi-ingredient pork sausage product may be labeled with the voluntary claim “Product of USA” if the product's edible natural casing was produced by an animal born, raised, processed, and slaughtered in the United States, but the casing was sent outside the U.S. to be processed ( e.g., for further cleaning), provided that all other FSIS-regulated ingredients are derived from animals born, raised, slaughtered, and processed exclusively in the United States; all other ingredients, other than spices and flavorings, are of domestic origin; and the preparation and processing steps for the product occurred in the United States.

Comment: A few askFSIS submitters asked whether under the final rule “Product of North America” is allowed as a voluntary label claim on an FSIS-regulated product when the animal from which the product was derived was born, raised, and slaughtered in North America, all product ingredients are of North America origin, and all processing steps occurred in North America. A few askFSIS submitters also asked whether multi-country claims that include the United States are allowed as voluntary label claims on FSIS-regulated products.

Response: FSIS has updated the guideline to clarify that, while it is not a U.S.-origin claim, “Product of North America” is allowed as a voluntary label claim on FSIS-regulated products if it is truthful and not misleading and complies with the FSIS labeling requirements in 9 CFR 317.8(b)(1) and 9 CFR 381.129(b)(2) ( e.g., all animals from which the product was derived were born, raised, slaughtered, and processed in North America).

FSIS also has updated the guideline to clarify that voluntary multi-country label claims that include the United States are allowed for use on FSIS-regulated products, provided (1) the animal from which the product was derived was born, raised, slaughtered, and processed in the United States or the foreign country, and (2) the claim includes a qualifying statement describing all the preparation and processing steps that occurred in the United States. For example, a single ingredient pork product derived from an animal born, raised, and slaughtered in the United States and Canada, and the meat then processed in the United States or Canada, may bear the label claim “Product of USA and Canada,” provided the claim is accompanied by qualifying language describing the preparation and processing steps that occurred in the U.S ( e.g., “Product of USA and Canada, packaged in the United States”).

Comment: A few askFSIS submitters asked whether “Produced in the USA” is allowed under the final rule. One foreign country asked for confirmation whether “Processed in the United States” is allowed as a voluntary U.S.-origin claim.

Response: The final rule allows for the use of voluntary U.S.-origin label claims other than “Product of USA” or “Made in the USA,” provided that the claim includes a description to indicate which preparation and processing steps occurred in the United States (9 CFR 412.3(c)). As stated in the final rule, this description needs to provide consumers meaningful information about the U.S.-origin components of the product's preparation and processing (89 FR 19470, 19475). Also as stated in both the final rule and draft guideline published in March 2024, the generalized claims “Processed in the United States” and “Manufactured in the United States” are so broad as to not provide consumers meaningful information about what preparation and processing steps occurred in the United States (89 FR 19470, 19475). FSIS has updated the guideline to add “Produced in the United States” as a claim that is so broad as to not provide consumers meaningful information about which preparation and processing steps occurred in the United States. Therefore, “Produced in the United States” and “Processed in the United States” are not approved for use as standalone voluntary U.S.-origin label claims.

FSIS also notes that if a label claim is so broad as to not provide meaningful information about what preparation and processing steps of a product occurred in the United States ( e.g., “Processed in the United States,” “Manufactured in the United States,” or “Produced in the Unites States”), the claim is not approved, even if the claim is combined with a claim that does provide meaningful preparation and processing information. For example, “Processed and Packaged in the USA” would not be approved for use as a voluntary label claim on an FSIS-regulated product; however, “Sliced and Packaged in the USA” would be approved as a voluntary U.S.-origin label claim.

Comment: One trade association asked FSIS to provide in the guideline additional examples of voluntary U.S.-origin label claims other than “Product of USA” and “Made in the USA” that may be used to indicate the preparation and processing steps of an FSIS-regulated product that occurred in the United States. Specifically, the commenter asked FSIS to clarify whether the voluntary label claim “Cooked (in the United States)” is allowed under the final rule.

Response: As discussed in the final rule, voluntary U.S.-origin label claims other than “Product of USA” or “Made in the USA” may be used on FSIS-regulated products, provided they include descriptions that provide meaningful consumer information about which preparation and processing steps occurred in the United States (89 FR 19470, 19475; see 9 CFR 412.3(c)). FSIS has updated the guideline to include additional examples of descriptions that provide consumers meaningful information about the U.S. preparation and processing steps of FSIS-regulated products, including “cooked.”

Comment: One trade association and several askFSIS submitters requested clarification on the final rule's effect on U.S. State agriculture endorsement program (“State endorsement program”) logos. The trade association specifically stated that FSIS should exempt such program logos ( e.g., “Go Texan”) from the new requirements for use of voluntary U.S.-origin label claims. The commenter argued that the State endorsement program logo labeling option is essential to address the burden of the final rule's requirements for voluntary “Product of USA” and “Made in the USA” label claims.

Response: Under the requirements at 9 CFR 412.3(a), (b), and (d) for the use of the voluntary claims “Product of (U.S. State)” or “Made in (U.S. State),” if a State endorsement program logo includes the statement “Product of (U.S. State)” or “Made in (U.S. State),” the product must meet the final rule requirements for the label use of the voluntary claims “Product of (U.S. State)” or “Made in (U.S. State).” For example, a single ingredient poultry product labeled with a State endorsement program logo that includes the statement “Product of (U.S. State)” must be derived from an animal born, raised, slaughtered, and processed in that State.

Further, if a State endorsement program logo includes the image of the State's flag, the logo may be used on the label of an FSIS-regulated product without a qualifying statement only if the product meets the final rule requirements for label display of the U.S. flag, or a U.S. State or territory flag. Specifically, under 9 CFR 412.3(e), the standalone label use of a State endorsement program logo that includes the image of the State's flag will need to meet the requirements for use of voluntary “Product of (U.S. State)” and “Made in (U.S. State)” label claims. However, if the product does not meet all requirements under 9 CFR 412.3(e), a State endorsement program logo that includes the State's flag image may be used to designate the State origin of components of an FSIS-regulated product's preparation and processing as long as the logo is accompanied by a description of the preparation and processing steps that occurred in the State upon which the claim is being made. For example, a beef product that does not meet all requirements for a voluntary “Product of (U.S. State)” claim may be labeled with a State endorsement program logo that includes the image of the State's flag, but the logo must be accompanied by a description of the preparation and processing steps that occurred in the state ( e.g., “beef harvested and packaged in (U.S. State).”

Finally, if a State endorsement program logo does not include the statement “Product of (U.S. State)” or “Made in (U.S. State),” and does not include an image of the State flag or other geographic emblematic design, the logo may be used on the label of an FSIS-regulated product if the establishment maintains supporting documentation for use of the logo. The guideline provides information about what kinds of documentation are sufficient to support the logo use. The final rule concerns voluntary U.S.-origin label claims. Establishments can choose to use a voluntary U.S.-origin label claim for which a particular product is eligible or not make any type of U.S.-origin label claim (see 89 FR 19470, 19478).

Comment: A few askFSIS submitters commented generally about the effect of the final rule on various types of geographic depictions of the United States, or a U.S. State or territory, on the labels of FSIS-regulated products ( e.g., the display of the map of the Commonwealth of Virginia on a label of a poultry product).

Response: FSIS has updated the guideline to clarify that, under the final rule at the amended subsections 9 CFR 317.8(b)(1) and 9 CFR 381.129(b)(2), statements, words, pictures, designs, or devices depicting the United States, or a U.S. State or territory, may be used on the labels of FSIS-regulated products only if the animal from which the meat or poultry product was derived was born, raised, slaughtered, and processed in the depicted geographical location. For the purposes of using statements, words, pictures, designs, or devices depicting the United States, or a U.S. State or territory, on a multi-ingredient FSIS-regulated product, under 9 CFR 317.8(b)(1) and 381.129(b)(2), other ingredients in the product need not be of domestic origin. If the product does not meet these requirements, the depiction must be accompanied by a qualifying statement describing the preparation and processing steps of the animal from which the product was derived that occurred in the United States, or U.S. State or territory. For example, a label for a multi-ingredient poultry patty product derived from an animal that was born, raised, slaughtered, and partially processed in North Carolina, then packaged in Arizona, that includes the outline of the State of Arizona must be accompanied by a qualifying statement describing the preparation and processing steps that occurred in Arizona ( e.g., “Packaged in Arizona”).

Comment: One trade association asked about the use of the voluntary “Product of USA” label claim to meet requirements for products exported from the United States. Specifically, the commenter asked the Agency to clarify whether pressure-sensitive labels or stamps are acceptable under the final rule for the purpose of meeting export requirements. The commenter further stated that it is unclear whether the “Product of USA” statement may be used on labels intended for use on both products for the U.S. market and exported products.

Response: As explained in the final rule, the regulatory requirements for voluntary U.S.-origin label claims do not apply to products intended for export from the United States (89 FR 19470, 19478). Additional export requirements maintained by foreign countries that have been officially communicated to FSIS by the importing country can be accessed in the FSIS Export Library. 6 All products intended for the domestic market must meet the requirements under the final rule for use of voluntary U.S.-origin label claims, including “Product of USA.” As with all FSIS-regulated products labeled either for the domestic market or export from the United States, manufacturers may use pressure sensitive stickers on existing labeling material to cover inaccurate and/or misleading labeling information with corrected text. 7

Comment: One trade association argued that the guideline describes recordkeeping and traceability requirements that are nearly unattainable for establishments that choose to use a voluntary U.S.-origin label claim. Specifically, the commenter stated that maintaining documented traceability of products from derived animals' U.S. birth, raising, slaughter, and processing are unreasonable in the absence of a mandatory animal identification system and an effective traceability program.

Response: The final rule established general recordkeeping requirements that provide flexibility for establishments that choose to use a voluntary U.S.-origin label claim on FSIS-regulated products. The final rule includes examples of the types of documentation that may be maintained to support a voluntary U.S.-origin label claim (9 CFR 412.3(f)). Establishments may choose which types of documentation to maintain, based on the particular U.S.-origin claim they seek to use and other considerations relevant to the product (89 FR 19470, 19483). As published with the final rule, the label guideline also provided examples of the types of documentation that may be maintained to support a voluntary U.S.-origin label claim. In response to the comment, FSIS has updated the guideline to provide an additional example of supporting documentation.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication online through the FSIS web page located at: http://www.fsis.usda.gov/federal-register. FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS can provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

In accordance with Federal civil rights law and USDA civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information ( e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the State or local Agency that administers the program or contact USDA through the Telecommunications Relay Service at 711 (voice and TTY). Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at How to File a Program Discrimination Complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by: (1) mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Mail Stop 9410, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) email: program.intake@usda.gov.

USDA is an equal opportunity provider, employer, and lender.

This request is for a revision and extension of an existing information collection. This survey updates the 2023 survey to remove a question regarding identity in underserved groups and provide multiple choice answer options for two questions that were previously open-ended in order to reduce response time.

This collection is sponsored by the Northwest Fisheries Science Center (NWFSC), National Oceanic and Atmospheric Administration. The overall purpose of collecting these data is to develop stakeholder-based societal inputs relative to fisheries participation, but these survey data will also increase the capacity of NOAA to respond effectively to relevant mandates and executive orders that guide social science activities within the National Marine Fisheries Service (NEPA, MFCMA and its National Standard 8, and Executive Order (E.O.) 12898).

Fishing livelihoods are both centrally dependent on ecosystems and part of the forces acting on these ecosystems, including resident marine species. Alongside social factors like economics and management, fisheries population fluctuations shape fishing livelihoods. However, the decisions fishermen make regarding which fisheries to access and when to access them are not fully understood, particularly within the food web frameworks offered up by ecosystem-based approaches to research and management. An understanding and predictive capacity for these movements of fishermen across fisheries in the context of ecological and social variability presents a significant gap in management-oriented knowledge. Managing fisheries in a way that enhances their socioeconomic value, mitigates risks to ecosystems and livelihoods, and facilitates sustainable adaptation, requires this fundamental knowledge.

For this reason, the NWFSC seeks to conduct a follow-up U.S. mail survey, replicating the surveys administered during 2017, 2020, and 2023. This survey updates the 2023 survey to remove a question regarding identity in underserved groups and provide multiple choice answer options for two questions that were previously open-ended in order to reduce response time. The survey will be voluntary, and contacted individuals may decline to participate. Respondents will be asked to answer questions about their motivations for fishing and factors that affect participation in the suite of West Coast commercial fisheries. Fishing and non-fishing employment information will also be collected. This survey is essential because data on smaller scale fishing practices, values, participation decisions and fishing livelihoods are sparse; yet they are critical to the development of fishery ecosystem models that account for non-pecuniary fishing benefits, as well as the ways in which fishing practices shape individual and community well-being.

The information described in the survey will be collected primarily through the use of completed paper surveys sent via U.S. mail, with an option for web-based input available to mail survey recipients. NWFSC staff will contract a private research survey firm to mail out the survey via U.S. mail, and NWFSC scientists will be responsible for analyzing the data and disseminating the findings generated by the survey. This approach has demonstrated effective response and minimal burden in 2017, 2020, and 2023.

OMB Control Number: 0648-0749.

Form Number(s): None.

Type of Review: Regular submission [revision and extension of a current information collection].

Affected Public: Individuals or households.

Estimated Number of Respondents: 908.

Estimated Time per Response: 15 minutes.

Estimated Total Annual Burden Hours: 227.

Estimated Total Annual Cost to Public: $0.

Respondent's Obligation: Voluntary.

Legal Authority: National Marine Fisheries Service (NEPA, MFCMA and its National Standard 8, and Executive Order (E.O.) 12898.

We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this information collection request. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

The Infrastructure Investment and Jobs Act, 2021 (Infrastructure Act), which was adopted on November 15, 2021, provided $65 billion of funding for programs to close the digital divide and ensure that all Americans have access to affordable, reliable, high-speed internet. NTIA administers multiple broadband connectivity grant programs funded by the Infrastructure Act. Under the Native Entities Grant Program (NEGP), which brings together the set-asides authorized under 47 U.S.C. 1723(i) (Digital Equity Capacity Grant Program) and 1724(j) (Digital Equity Competitive Grant Program), NTIA is required to reserve not less than five percent (5%) of total program funds for Indian Tribes, Alaska Native entities, and Native Hawaiian organizations (collectively referred to as “Native Entities”). These set-asides ensure that Native communities have direct access to funding to advance broadband adoption, digital skills development, and access to devices and public connectivity resources.

Likewise, the Tribal Broadband Connectivity Program (TBCP), authorized by the Consolidated Appropriations Act, 2021, adopted on December 27, 2020, (CAA) as amended by the Infrastructure Act, Division F, Title II, Section 60201, Public Law 117-58, 135 Stat. 429 (Nov. 15, 2021), provides new federal funding for grants to eligible entities to expand access to and adoption of: (i) Broadband service on Tribal Land; or (ii) for programs that promote the use of broadband to access remote learning, telework, or telehealth resources.

NTIA intends to release Notice of Funding Opportunities (NOFOs) in spring 2026 for both NEGP and TBCP to support Tribal broadband access. NTIA is working on reforms across these programs to reduce red tape for Tribal governments, promote flexibility, and align NTIA's grant opportunities to better serve Tribal connectivity. These reforms will be reflected in the forthcoming NOFOs.

NTIA will use the information collected from each applicant to effectively review the proposed applications and budgets from Indian Tribes, Alaska Native Entities, and Native Hawaiian organizations for NEGP, and from Tribal Governments, Tribal Colleges or Universities, Tribal organizations, or Alaska Native Corporations for TBCP.

NTIA will collect data through both electronic and mail submission.

OMB Control Number: 0660-XXXX.

Form Number(s): TBD.

Type of Review: Regular submission for a new information collection.

Affected Public (NEGP): Indian Tribes, Alaska Native Entities, and Native Hawaiian organizations.

Affected Public (TBCP): Tribal Governments, Tribal Colleges or Universities, Tribal organizations, or Alaska Native Corporations.

Estimated Number of Respondents: 700.

Estimated Time per Response: 10 hours for applicants.

Estimated Total Annual Burden Hours: 7,000 hours.

Estimated Total Annual Cost to Public: $321,426.00.

Respondent's Obligation: Mandatory.

Legal Authority: Section 60305 of the Infrastructure Investment and Jobs Act of 2021 (IIJA), Public Law 117-58, 135 Stat. 429 (November 15, 2021); Consolidated Appropriations Act, 2021, Division N, Title IX, Section 905(c), Public Law 116-260, 134 Stat. 1182 (Dec. 27, 2020) (Act), as amended by the IIJA.

We are soliciting public comments to permit the Department/Bureau to:

(a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility.

(b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.

(c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected.

(d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this Information Collection Request. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

35 U.S.C. 156 generally provides that the term of a patent may be extended for a period of up to five years, if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review. 35 U.S.C. 156(d)(5) generally provides that the term of such a patent may be extended for no more than five interim periods of up to one year each, if the approval phase of the regulatory review period (RRP) is reasonably expected to extend beyond the expiration date of the patent.

On December 1, 2025, Hoffman-La Roche, Inc., the patent owner of record of the '099 patent, timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of the '099 patent. The '099 patent claims the human drug product Bitopertin (GlyT1 inhibitor) oral tablets. The application indicates that the approval phase for the regulatory period, as described in 35 U.S.C. 156(g)(1)(B)(ii), for NDA 220707 for the human drug product Bitopertin (GlyT1 inhibitor) oral tablets is ongoing before the Food and Drug Administration for permission to market and use the product commercially.

Review of the patent term extension application indicates that, except for permission to market or use the product commercially, the '099 patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B).

Because it appears reasonable to expect the approval phase of the RRP to continue beyond the expiration date of the patent, i.e., December 17, 2025, interim extension of the '099 patent's term under 35 U.S.C. 156(d)(5) is appropriate.

An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 7,319,099 is granted for a period of one year from the original expiration date of the patent.

Title of Collection: Home Mortgage Disclosure Act (Regulation C).

OMB Control Number: 3170-0008.

Type of Review: Extension of an information collection.

Affected Public: Individuals and households.

Estimated Number of Respondents: 136.

Estimated Total Annual Burden Hours: 1,510,960.

Abstract: The Home Mortgage Disclosure Act (HMDA) requires certain depository institutions and for-profit, non-depository institutions to collect, report, and disclose data about originations and purchases of mortgage loans. Additionally, these institutions must report mortgage loan applications that do not result in originations (for example, applications that are denied or withdrawn). The Bureau's Regulation C (12 CFR part 1003) implements HMDA. The purpose of the information collection is:

• To help determine whether financial institutions are serving the housing needs of their communities;

• To assist public officials in distributing public-sector investment so as to attract private investment to areas where it is needed; and

• To assist in identifying possible discriminatory lending patterns and enforcing antidiscrimination statutes.

Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the CFPB, including whether the information will have practical utility; (b) The accuracy of the CFPB's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB's approval. All comments will become a matter of public record.

Title of Collection: Registration of Mortgage Loan Originators (Regulation G).

OMB Control Number: 3170-0005.

Type of Review: Extension of an information collection.

Affected Public: Private sector: Businesses or other for-profits.

Estimated Number of Respondents: 261,638.

Estimated Total Annual Burden Hours: 249,628.

Abstract: Regulation G (12 CFR part 1007 et seq. ) implements the Secure and Fair Enforcement for Mortgage Licensing Act (the S.A.F.E. Act, 12 U.S.C. 5101 et seq. ) which contains the Federal registration requirement with respect to any covered financial institutions and their employees who act as residential mortgage loan originators (MLOs). Regulation G requires covered institutions to register with the Nationwide Mortgage Licensing System and Registry, to obtain a unique identifier, to maintain this registration, and to disclose to consumers the unique identifier. Regulation G also requires the covered financial institutions employing these MLOs to adopt and to follow written policies and procedures ensuring their employees comply with these requirements and disclose the unique identifiers of their MLOs.

Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the CFPB, including whether the information will have practical utility; (b) The accuracy of the CFPB's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB's approval. All comments will become a matter of public record.

Title of Collection: Truth in Savings (Regulation DD).

OMB Control Number: 3170-0004.

Type of Review: Extension of an information collection.

Affected Public: Private sector: Businesses or other for-profits.

Estimated Number of Respondents: 171.

Estimated Total Annual Burden Hours: 561,632.

Abstract: The Truth in Savings Act (TISA), 12 U.S.C. 4301 et seq., was enacted to enhance economic stability, improve competition between depository institutions, and strengthen consumer ability to make informed decisions regarding deposit accounts by requiring uniformity in the disclosure of interest rates and fees. TISA assists consumers in comparing deposit accounts offered by depository institutions, principally through the disclosure of fees, the annual percentage yield, the interest rate, and other account terms. TISA and Regulation DD require depository institutions to disclose yields, fees, and other terms concerning deposit accounts to consumers at account opening, upon request, and when changes in terms occur. Depository institutions that provide periodic statements are required to include information about fees imposed, interest earned, and the annual percentage yield earned during those statement periods. TISA and Regulation DD mandate the methods by which institutions determine the account balance on which interest is calculated. They also contain rules about advertising deposit accounts and overdraft services. Regulation DD requires depository institutions subject to TISA to retain evidence of compliance with the regulation. These recordkeeping requirements ensure that records that might contain evidence of violations of TISA remain available to Federal enforcement agencies, as well as to private litigants.

Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the CFPB, including whether the information will have practical utility; (b) The accuracy of the CFPB's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB's approval. All comments will become a matter of public record.

Table A—2025-2026 Award Year Deadline Dates by Which a Student Must Submit the FAFSA Form, by Which the Institution Must Receive the Student's Institutional Student Information Record (ISIR) or FAFSA Submission Summary, and by Which the Institution Must Submit Verification Outcomes for Certain Students.

Table A provides information and deadline dates for receipt of the FAFSA form, corrections to and signatures for the FAFSA form, ISIRs, and FAFSA Submission Summary, and verification documents.

The deadline date for the receipt of a FAFSA form by the Department's FAFSA Processing System (FPS) is June 30, 2026, regardless of the method that the applicant uses to submit the FAFSA form. The deadline date for the receipt of corrections, notices of change of address or institution, or requests for a duplicate FAFSA Submission Summary is September 12, 2026.

For all title IV, HEA programs, an ISIR or FAFSA Submission Summary for the student must be received by the institution no later than the student's last date of enrollment for the 2025-2026 award year or September 19, 2026, whichever is earlier. Note that a FAFSA form must be submitted and an ISIR or FAFSA Submission Summary received for the dependent student for whom a parent is applying for a Direct PLUS Loan.

Except for students selected for Verification Tracking Groups V4 and V5, verification documents must be received by the institution no later than 120 days after the student's last date of enrollment for the 2025-2026 award year or September 19, 2026, whichever is earlier. For students selected for Verification Tracking Groups V4 and V5, institutions must submit identity verification results no later than 60 days following the institution's first request to the student to submit the documentation or October 28, 2025 (60 days after the release of the Verification of Identity functionality in the FAFSA Partner Portal) for the 2025-2026 Award Year, whichever is later.

For all title IV, HEA programs except for (1) Direct PLUS Loans that will be made to parent borrowers, and (2) Direct Unsubsidized Loans that will be made to dependent students who have been determined by the institution, pursuant to section 479A(a) of the HEA, to be eligible for such a loan without providing parental information on the FAFSA, the ISIR or FAFSA Submission Summary must have an official Student Aid Index (SAI) and the ISIR or FAFSA Submission Summary must be received by the institution no later than the earlier of the student's last date of enrollment for the 2025-2026 award year or September 19, 2026. For the two exceptions mentioned above, the ISIR or FAFSA Submission Summary must be received by the institution by the same dates noted in this paragraph, but the ISIR or FAFSA Submission Summary is not required to have an official SAI.

For a student who is requesting aid through the Pell Grant, FSEOG, or FWS programs or for a student requesting Direct Subsidized Loans, who does not meet the conditions for a late disbursement under 34 CFR 668.164(j), a valid ISIR or valid FAFSA Submission Summary must be received by the institution by the student's last date of enrollment for the 2025-2026 award year or September 19, 2026, whichever is earlier.

In accordance with 34 CFR 668.164(j)(4)(i), an institution may not make a late disbursement of title IV, HEA program funds later than 180 days after the date of the institution's determination that the student was no longer enrolled. Table A provides that, to make a late disbursement of title IV, HEA program funds, an institution must receive a valid ISIR or valid FAFSA Submission Summary no later than 180 days after its determination that the student was no longer enrolled, but not later than September 19, 2026.

Table B—2025-2026 Award Year Deadline Dates by Which an Institution Must Submit Disbursement Information for the Pell Grant, Direct Loan, and TEACH Grant Programs.

For the Pell Grant, Direct Loan, and TEACH Grant programs, Table B provides the earliest disbursement date, the earliest dates for institutions to submit disbursement records to the Department's Common Origination and Disbursement (COD) System, and deadline dates by which institutions must submit disbursement and origination records.

For the 2025-2026 Award Year, an institution must submit Pell Grant, Direct Loan, and TEACH Grant disbursement records to COD, no later than November 30, 2026 or 15 days after making the disbursement or becoming aware of the need to adjust a previously reported disbursement, whichever is later. In accordance with 34 CFR 668.164(a), title IV, HEA program funds are disbursed on the date that the institution: (a) credits those funds to a student's account in the institution's general ledger or any subledger of the general ledger; or (b) pays those funds to a student directly. Title IV, HEA program funds are disbursed even if an institution uses its own funds in advance of receiving program funds from the Department.

An institution's failure to submit disbursement records within the required timeframe may result in the Department rejecting all or part of the reported disbursement. Such failure may also result in an audit or program review finding or the initiation of an adverse action, such as a fine or other penalty for such failure, in accordance with subpart G of the General Provisions regulations in 34 CFR part 668.

Deadline Dates for Enrollment Reporting by Institutions.

In accordance with 34 CFR 674.19(f), 682.610(c), 685.309(b), and 690.83(b)(2), upon receipt of an enrollment report from the Secretary, institutions must update all information included in the report and return the report to the Secretary in a manner and format prescribed by the Secretary and within the timeframe prescribed by the Secretary. Consistent with the National Student Loan Data System (NSLDS) Enrollment Reporting Guide, the Secretary has determined that institutions must report at least every two months. Institutions may find the NSLDS Enrollment Reporting Guide in the “Knowledge Center” via Federal Student Aid's (FSA) Partner Connect website at: https://fsapartners.ed.gov/knowledge-center.

Other Sources for Detailed Information.

We publish a detailed discussion of the FAFSA application process in the Application and Verification Guide volume of the 2025-2026 Federal Student Aid Handbook and in Volume 6 of the 2025-2026 FAFSA Specifications Guide.

Information on the institutional reporting requirements for the Pell Grant, Direct Loan, Federal Work-Study, and TEACH Grant programs is included in the 2025-2026 Common Origination and Disbursement (COD) Technical Reference. Also, see the NSLDS Enrollment Reporting Guide.

You may access these publications by visiting the “Knowledge Center” via FSA's Partner Connect website at: https://fsapartners.ed.gov/knowledge-center.

Additionally, the 2025-2026 award year reporting deadline dates for the Federal Perkins Loan, FWS, and FSEOG programs were published in the Federal Register on May 22, 2025 (90 FR 21909).

Applicable Regulations: The following regulations apply:

(1) Student Assistance General Provisions, 34 CFR part 668.

(2) Federal Pell Grant Program, 34 CFR part 690.

(3) William D. Ford Direct Loan Program, 34 CFR part 685.

(4) Teacher Education Assistance for College and Higher Education Grant Program, 34 CFR part 686.

(5) Federal Work-Study Programs, 34 CFR part 675.

(6) Federal Supplemental Education Opportunity Grant Program, 34 CFR part 676.

Accessible Format: On request to the program contact person listed under FOR FURTHER INFORMATION CONTACT , individuals with disabilities can obtain this document in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov. At this site you can view this document, as well as all other Department documents published in the Federal Register , in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access Department documents published in the Federal Register by using the article search feature at www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Program Authority: 20 U.S.C. 1070a, 1070b-1070b-4, 1070g, 1070h, 1087a-1087j, 1087aa-1087ii, and 1087-51-1087-58.

The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: DC School Choice Incentive Program.

OMB Control Number: 1810-0774.

Type of Review: An extension without change of a currently approved ICR.

Respondents/Affected Public: Individuals and Households.

Total Estimated Number of Annual Responses: 3,000.

Total Estimated Number of Annual Burden Hours: 1,000.

Abstract: The DC Opportunity Scholarship Program (OSP) is currently authorized under the Scholarships for Opportunity and Results Act (SOAR). Under the SOAR Act, the US Department of Education awards a grant to a non-profit to administer scholarships to students who reside in the District of Columbia and come from households whose incomes do not exceed 185% of the poverty line (300% of the poverty line for returning students). The current administrator of the OSP is Serving Our Children (SOC). Under the law, priority is given to siblings of students in the program, and students who are currently attending low-performing schools, as defined by Title I. To assist in the student selection and assignment process, the information collected is used to determine the eligibility of those students who are interested in the available scholarships.

The Federal Register Notices published for DC School Choice Incentive Program included incorrect information. The incorrect 60-day Federal Register Notice (90 FR 56138) was published on December 5, 2025. A new 60-day Federal Register Notice is also being published in this issue of the Federal Register to replace the incorrect notice.

Purpose of the Board: The purpose of the Board is to provide advice and recommendations concerning the following EM site-specific issues: clean-up activities and environmental restoration; waste and nuclear materials management and disposition; excess facilities; future land use and long-term stewardship. The Board may also be asked to provide advice and recommendations on other EM program components. The Board also provides an avenue to fulfill public participation requirements outlined in the National Environmental Policy Act (NEPA), the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the Resource Conservation and Recovery Act (RCRA), Federal Facility Agreements, Consent Orders, Consent Decrees and Settlement Agreements.

Tentative Agenda: (agenda topics are subject to change; please contact Juanita Campbell at juanita.campbell@srs.gov for the most current agenda)

Public Participation: The meeting is open to the public and public comment can be given orally or in writing. Fifteen minutes are allocated during the meeting for public comment and those wishing to make oral comment will be given a minimum of two minutes to speak. Written comments received at least two working days prior to the meeting will be provided to the members and included in the meeting minutes. Written comments received within two working days after the meeting will be included in the minutes. For additional information on public comment and to submit written comment, please contact srscitizensadvisoryboard@srs.gov. The EM SSAB, Savannah River Site, welcomes the attendance of the public at its meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact srscitizensadvisoryboard@srs.gov at least seven days in advance of the meeting.

Meeting conduct: The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Questioning of board members or presenters by the public is not permitted.

Minutes: Minutes will be available at the following website: www.cab.srs.gov.

Signing Authority: This document of the Department of Energy was signed on December 8, 2025, by David Borak, Committee Management Officer, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Comments are invited on: (a) Whether the extended collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

This information collection request contains:

(1) OMB No.: 1910-NEW;

(2) Information Collection Request Title: EERE Small Businesses and Startups Impact Evaluation Data Collection;

(3) Type of Request: new;

(4) Purpose: The information collected through this effort is needed as an input to an evaluation study that will produce an analysis of the impact EERE's funding has had on small businesses between 2008 and 2024. The results of this evaluation study will be used by DOE leadership to understand the impact to date and opportunities for improvement in financial awards provided to small businesses. Respondents to this data collection effort will small businesses and startup companies that have applied for financial assistance, SBIR/STTR grants and prize funding from EERE between 2008 and 2024, and will include both award recipients and applicants who did not receive funding. This is planned to be a one-time data collection effort.

(5) Annual Estimated Number of Respondents: 9,000;

(6) Annual Estimated Number of Total Responses: 9,000;

(7) Annual Estimated Number of Burden Hours: 13,500;

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: $751,275.

Statutory Authority: Foundations for Evidence-based Policymaking Act of 2018 (Pub. L. 115-435; Jan. 14, 2019).

This document of the Department of Energy was signed on November 19, 2025, by Audrey Robertson, Assistant Secretary of Energy, Office of Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

OMB Control Number: 3060-1211.

Title: Sections 96.17; 96.21; 96.23; 96.25; 96.33; 96.35; 96.39; 96.41; 96.43; 96.45; 96.51; 96.57; 96.59; 96.61; 96.63; 96.67, Commercial Operations in the 3550-3650 MHz Band.

Form Number: N/A.

Type of Review: Extension of a currently approved information collection.

Respondents: Business or other for-profit entities, state, local, or tribal government and not for profit institutions.

Number of Respondents: 110,782 respondents; 226,099 responses.

Estimated Time per Response: .25 to 1 hour.

Frequency of Response: One-time and on occasion reporting requirements; other reporting requirements—as-needed basis for equipment safety certification that is no longer in use, and consistently (likely daily) responses automated via the device.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for, these collections are contained in 47 U.S.C. 151, 152, 154(i), 154(j), 155(c), 302(a), 303, 304, 307(e), and 316 of the Communications Act of 1934.

Total Annual Burden: 64,561 hours.

Total Annual Cost: $13,213,975.

Needs and Uses: The FCC adopted an Order on Reconsideration and Second Report and Order, FCC 16-55, that amends rules established in the First Report and Order, FCC 15-47, for commercial use of 150 megahertz in the 3550-3700 MHz (3.5 GHz) band and a new Citizens Broadband Radio Service, on April 28, 2016, published at 81 FR 49023 (July 26, 2016). The rule changes and information requirements contained in the First Report and Order are also approved under this Office of Management and Budget (OMB) control number and have not changed since they were last approved by OMB.

The Commission also received approval from OMB for the information collection requirements contained in FCC 16-55. The amendments contained in the Second Report and Order create additional capacity for wireless broadband by adopting a new approach to spectrum management to facilitate more intensive spectrum sharing between commercial and federal users and among multiple tiers of commercial users. The Spectrum Access System (SAS) will use the information to authorize and coordinate spectrum use for Citizen Broadband Radio Service Devices (CBSDs). The Commission will use the information to coordinate among the spectrum tiers and determine Protection Areas for Priority Access Licensees (PALs).

The following is a description of the information collection requirements for is approved under this collection:

Section 96.25(c)(1)(i) requires PALs to inform the SAS if a CBSD is no longer in use.

Section 96.25(c)(2)(i) creates a default protection contour for any CBSD at the outer limit of the PAL Protection Area, but allows a PAL to self-report a contour smaller than that established by the SAS. These rules which contain information collection requirements are designed to provide for flexible use of this spectrum, while managing three tiers of users in the band, and create a low-cost entry point for a wide array of users. The rules will encourage innovation and investment in mobile broadband use in this spectrum while protecting incumbent users. Without this information, the Commission would not be able to carry out its statutory responsibilities.

OMB Control Number: 3060-1199.

Title: Section 15.407(j), U-NII Operator Filing Requirement.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Businesses or other for-profit.

Number of Respondents and Responses: 5 respondents; 5 responses.

Estimated Time per Response: 32 hours.

Frequency of Response: On occasion, one-time reporting requirement, recordkeeping and third-party disclosure requirements.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this Information collection is contained in 47 U.S.C. 154(i), 302, 303, 303(r), and 307.

Total Annual Burden: 160 hours.

Total Annual Cost: No cost.

Needs and Uses: The Commission will submit this information collection to the Office of Management and Budget (OMB) after this 60-day comment period in order to obtain the full year three-year clearance from them.

The Commission's Rules to Permit Unlicensed National Information Infrastructure (U-NII) in the 5 GHz Band, Section 15.407(j) of the FCC rules, established filing requirements for U-NII operators that deploy a collection of more than one thousand outdoor access points with the 5.15-5.25 GHz band. Subsequentially, parties must submit a letter to the Commission acknowledging that, should harmful interference to licensed services in this band occur, they will be required to take corrective action. Corrective actions may include reducing power, turning off devices, changing frequency bands, and/or further reducing power radiated in the vertical direction. This material shall be submitted to Laboratory Division, Office of Engineering and Technology, Federal Communications Commission, 7435 Oakland Mills Road, Columbia, MD 21046 Attn: U-NII Coordination, or via website at https://www.fcc.gov/labhelp with the SUBJECT LINE: “U-NII-1 Filing”.

Pursuant to section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule § 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of 30 days. The following Analysis of Proposed Agreement Containing Consent Orders to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC website at this web address: https://www.ftc.gov/news-events/commission-actions.

The public is invited to submit comments on this document. For the Commission to consider your comment, we must receive it on or before January 9, 2026. Write “Boeing and Spirit AeroSystems; File No. 241 0098” on your comment. Your comment—including your name and your State—will be placed on the public record of this proceeding, including, to the extent practicable, on the https://www.regulations.gov website.

Because of the agency's heightened security screening, postal mail addressed to the Commission will be delayed. We strongly encourage you to submit your comments online through the https://www.regulations.gov website. If you prefer to file your comment on paper, write “Boeing and Spirit AeroSystems; File No. 241 0098” on your comment and on the envelope, and mail your comment by overnight service to: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Mail Stop H-144 (Annex A), Washington, DC 20580.

Because your comment will be placed on the publicly accessible website at https://www.regulations.gov, you are solely responsible for making sure your comment does not include any sensitive or confidential information. In particular, your comment should not include sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other State identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure your comment does not include sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “trade secret or any commercial or financial information which . . . is privileged or confidential”—as provided by section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule § 4.10(a)(2), 16 CFR 4.10(a)(2)—including competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule § 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule § 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on https://www.regulations.gov —as legally required by FTC Rule § 4.9(b)—we cannot redact or remove your comment from that website, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule § 4.9(c), and the General Counsel grants that request.

Visit the FTC website at https://www.ftc.gov to read this document and the news release describing this matter. The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments it receives on or before January 9, 2026. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Orders (“Consent Agreement”) designed to remedy the anticompetitive effects resulting from The Boeing Company's (“Boeing”) proposed acquisition of Spirit AeroSystems Holdings, Inc. (“Spirit”). Pursuant to an Agreement and Plan of Merger, dated June 30, 2024, Boeing will acquire all the outstanding voting shares of Spirit in exchange for shares of Boeing common stock representing an equity value of approximately $4.7 billion (the “Acquisition”). The total value of the Acquisition is approximately $8.3 billion, including the assumption of Spirit's debt.

The Commission's Complaint alleges that the Acquisition, if consummated, would violate section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and section 5 of the FTC Act, as amended, 15 U.S.C. 45, by substantially lessening competition in: (1) the worldwide market for large commercial aircraft and (2) the United States market for military aircraft. In each relevant market, the Acquisition would provide Boeing with the ability and incentive to limit competing aircraft manufacturers' access to critically important Spirit-supplied aerostructures.

The proposed Decision and Order (“Order”) will remedy the Acquisition's likely anticompetitive effects in the large commercial aircraft market by requiring Boeing and Spirit (collectively, the “Respondents”) to divest (1) Spirit's business operations primarily relating to supplying Airbus SE (“Airbus”) with aerostructures, wherever located (the “Airbus Assets”), to Airbus, and (2) Spirit's Subang, Malaysia aerostructures business that currently supplies aerostructures to, among others, Boeing and Airbus, to Composites Technology Research Malaysia Sdn. Bhd. (“CTRM”) (the “CTRM Assets”).

The Order will remedy the alleged violations in the military aircraft market by requiring Boeing to (1) act as a non-discriminatory merchant supplier of Spirit aerostructures rather than favor its own military aircraft business by both continuing to support Spirit's current non-Boeing defense customers and by offering to supply Spirit aerostructures to rival military aircraft manufacturers for future military aircraft, and (2) protect competitors' competitively sensitive information from improper use or disclosure.

The Consent Agreement has been placed on the public record for 30 days for receipt of comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again evaluate the Consent Agreement, along with the comments received, to make a final decision as to whether it should withdraw from the Consent Agreement, modify it, or make final the Order.

Boeing is a Delaware corporation with its principal place of business in Arlington, Virginia. Boeing is a leading global aerospace and defense company that designs, develops, manufactures, sells, and services commercial jetliners, as well as numerous high-priority programs for the United States Department of War (“DoW”) and other U.S. Government agencies, including military aircraft, weapon systems, spacecraft, space launch systems, and human space flight systems.

Spirit is a Delaware corporation with its principal place of business in Wichita, Kansas. Spirit is the largest independent supplier of aerostructures in the world. The company designs, develops, and manufactures large complex aerostructures, including fuselages and integrated fuselage sections, wings and wing components, nacelles, and pylons. Spirit supplies these aerostructures, which are custom designed for specific aircraft, to manufacturers of large commercial aircraft, military aircraft, and business/regional jets. Spirit primarily supplies aerostructures for large commercial aircraft. It currently supplies products for Boeing's 737, 767, 777, and 787 as well as Airbus' A220, A320/321, and A350 families of large commercial aircraft. Spirit also designs and builds aerostructures for military aircraft, including Boeing's KC-46A, P-8A Poseidon, and B-52 bomber, Lockheed Martin's CH-53K King Stallion, and Northrop Grumman's B-21 Raider, as well as multiple classified development programs.

Boeing and its chief rival, Airbus, are the only two significant suppliers of large commercial aircraft in the world. Large commercial aircraft are jet engine-powered airplanes used to transport passengers and/or cargo over long distances. These aircraft are designed to carry 100 or more passengers for distances of more than 2,000 nautical miles. Customers, including commercial airlines, air cargo carriers, and aircraft leasing companies, do not have any close substitute for large commercial aircraft. Boeing and Airbus together account for over 95 percent of large commercial aircraft delivered annually worldwide.

Military aircraft have specialized, high-performance designs and employ advanced military-specific technologies that enable these aircraft to perform specialized functions and unique missions that no other aircraft can perform. The DoW relies on multiple types of military aircraft for essential national defense capabilities, including fighters, bombers, attack aircraft, support aircraft, and reconnaissance and surveillance aircraft. Each type of military aircraft purchased by DoW has unique capabilities and is designed specifically to perform its given mission(s).

Boeing is one of only three U.S. companies with the relevant design, development, and manufacturing experience and capability to provide most types of military aircraft, and national security considerations and other factors limit DoW's ability to procure military aircraft from foreign suppliers. Boeing is developing, supplying or supporting multiple U.S. military aircraft, including the F-47, F/A-18EF Super Hornet, F-15EX, B-1, B-52, P-8A Poseidon, KC-46A Pegasus, VC-25, T-7A Red Hawk, C-17 Globemaster, MQ-25, MQ-28, CH-47 Chinook, MH-139A Grey Wolf, AH-64E Apache, and AH-6 Little Bird.

New entry into the two markets at issue would not be timely, likely, or sufficient in magnitude, character, and scope to deter or counteract the anticompetitive effects of the Acquisition. There are significant barriers to entry into the development, manufacture, certification, and sale of both large commercial and military aircraft. It would be extremely difficult and costly for a new entrant to establish the technological expertise and specialized facilities necessary to compete successfully in either of these markets.

The Acquisition would give Boeing the ability and incentive to raise the cost or otherwise degrade rivals' access to competitively significant inputs for their competing aircraft. Spirit currently supplies essential aerostructures to multiple competitors of Boeing, including Airbus, Northrop Grumman, and Lockheed Martin. Aerostructures are critical inputs for all aircraft, as their design and manufacture impact the performance and overall cost of the aircraft. Depending on the significance of the structure provided, it can also account for a material proportion of the total production cost of the aircraft. Once an aircraft manufacturer has selected a supplier to design and build a large or complex aerostructure, switching suppliers would be extremely time-consuming, impose significant costs, and create significant risks. Moreover, Spirit is differentiated from most other potential suppliers of aerostructures, especially other U.S. suppliers of classified defense aerostructures, in terms of its scale, experience, and capabilities.

Absent the protections of the Consent Agreement, after the Acquisition, Boeing would have the ability and incentive to disadvantage competing aircraft manufacturers by denying or limiting their access to Spirit's aerostructure products and technologies, which would lessen the ability of Boeing's rivals to compete successfully. Boeing could also gain access to proprietary competitively sensitive information relating to its competitors and exploit it to its own advantage.

The Order and the Order to Maintain Assets effectively remedy the competitive concerns raised by the Acquisition in both markets at issue.

Pursuant to the Order, the Respondents are required to divest to Airbus the Airbus Assets, which, except for specified Excluded Assets (including certain retained intellectual property (“IP”) and certain real property), include all property and assets that Airbus requires to manufacture the products that Spirit currently supplies to Airbus, including (1) Spirit's Kinston business, (2) Spirit's St. Nazaire business, (3) Spirit's Morocco business, (4) Spirit's Prestwick business, (5) Spirit's A220 pylon production line, and (6) the Airbus portion of Spirit's Belfast business. Furthermore, the Order requires the Respondents to divest Spirit's assets relating to its Subang, Malaysia operations, which currently supplies Airbus and Boeing with aerostructures, to CTRM.

Both Airbus and CTRM have extensive experience and knowledge relating to the respective businesses they will acquire and possess the requisite financial resources, expertise, and capabilities to seamlessly transfer and operate the divested assets in a competitive manner. The Respondents must accomplish these divestitures no later than ten days after the Acquisition is consummated. The Order further allows the Commission to appoint a divestiture trustee in the event the parties fail to divest the Airbus Assets or the CTRM Assets.

The Order contains several provisions to help ensure that the divestitures are successful. The Order requires Boeing to provide required transitional services to Airbus and CTRM to assist them in manufacturing various products during the transitional period. Also, under the Order and the Order to Maintain Assets, the Commission has appointed ALCIS Advisers GmbH (“ALCIS”) as the Monitor to oversee these divestitures and to ensure that the Respondents comply with all the provisions of the Order relating to commercial aerostructures. ALCIS has significant experience acting as a monitor in other complex transactions in the United States and Europe. The Commission issued an Order to Maintain Assets that requires Respondents to operate and maintain the Airbus Assets in the normal course of business for the brief transition period until the Commission approves the final Order.

The Order will remedy the alleged violations in the military aircraft market by requiring: (1) Boeing to provide continued support to non-Boeing military aircraft prime contractors that Spirit is currently supplying with Defense Aerostructures; (2) Spirit Defense Aerostructure Business to respond to any commercially reasonable requests for follow-on work related to current Spirit third-party prime contractor programs; (3) Boeing, whenever it has taken steps to compete to be the prime contractor for a competitive military aircraft program, to make Spirit's Defense Aerostructure Services available on a non-discriminatory basis to third-party competing prime contractors on commercially fair and reasonable price terms; (4) Boeing to maintain the financial viability and competitiveness of Spirit's non-Boeing Defense Aerostructure Business; and (5) Boeing to establish firewalls to ensure that any confidential information that Spirit's Defense Aerostructure Business receives from third-party military aircraft prime contractors is not shared in a manner that harms competition.

The Order also provides that the Under Secretary of War for Acquisition and Sustainment shall appoint a compliance officer to oversee Boeing's compliance with the military aircraft-related aspects of the Order. The compliance officer will have all the necessary investigative powers to perform his or her duties, including the right to interview Respondents' personnel, inspect Respondents' facilities, and require Respondents to provide documents, data, and other information. The compliance officer has the authority to retain third-party advisors, at Respondents' expense, as appropriate to perform his or her duties. Access to these resources will ensure that the compliance officer is fully capable of overseeing the implementation of, and compliance with, the Order. The Order also requires Boeing to establish and operate a compliance program and develop written procedures and protocols to comply with the requirements of the Order and requires that the Respondents shall bear all the costs of monitoring, complying, and enforcing the Consent Order. Finally, the Order specifies that it will terminate ten years from the date it is issued.

The purpose of this analysis is to facilitate public comment on the proposed Consent Agreement, and it is not intended to constitute an official interpretation of the proposed Consent Agreement or to modify its terms in any way.

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ).

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Coverage of Certain Preventive Services Under the Affordable Care Act: Data Submission Requirements to Receive the Federally-facilitated Exchange User Fee Adjustment; Use: The Patient Protection and Affordable Care Act, Public Law 111-148, enacted on March 23, 2010, and the Health Care and Education Reconciliation Act, Public Law 111-152, enacted on March 30, 2010 [collectively, the “Affordable Care Act” (ACA)], provides the authority for the U.S. Department of Health and Human Services (HHS) to charge user fees to issuers participating in Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). Additionally, section 2713 of the Public Health Service Act (PHS Act) requires coverage without cost sharing of certain preventive health services, including certain contraceptive services, in non-exempt, non-grandfathered group health plans and health insurance coverage, including issuers participating in the FFEs and SBE-FPs. The final rule “Coverage of Certain Preventive Services Under the Affordable Care Act” (78 FR 39870) set forth regulations regarding coverage for certain preventive services under section 2713 of the PHS Act. The final regulations (78 FR 39870) establish rules under which the third party administrator (TPA) of a self-insured group health plan will provide or arrange for a third party to provide separate contraceptive coverage to plan participants and beneficiaries without cost sharing, premium, fee, or other charge to plan participants or beneficiaries or to the eligible organization or its plan under a process to accommodate qualifying objections to contraceptive coverage.

The final rules (78 FR 39870) also require the submission of certain information to HHS and the adjustment of user fees to compensate issuers, as well as standards to fund the payments for the contraceptive services that are provided for participants and beneficiaries in self-insured plans of eligible organizations under the accommodation described previously, through an adjustment to the user fees payable by issuers. HHS requires this information to ensure that these FFE (or SBE-FP) user fee adjustments reflect payments for contraceptive services provided under this accommodation and that the adjustment is applied to the appropriate participating issuer.

This document describes the data collection requirements related to this adjustment, collected via a webform. This revision includes a decrease in burden, with the total estimated issuer and TPA burden and associated costs decreasing based on past years of experience with the program demonstrating a decreasing number of participants. Form Number: CMS-10492 (OMB Control Number: 0938-1285); Frequency: Annually; Affected Public: Private Sector, Business or other for-profit and not-for-profit institutions; Number of Respondents: 235; Number of Responses: 315; Total Annual Hours: 1,340. (For policy questions regarding this collection, contact Mohinee Mukherjee at 404-562-0151.)

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product, FILSUVEZ (birch triterpenes), indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older. Subsequent to this approval, the USPTO received patent term restoration applications for FILSUVEZ (U.S. Patent Nos. 8,828,444; 9,352,041; and 9,827,214) from Amaryt Pharmaceuticals Designated Activity Company and the USPTO requested FDA's assistance in determining these patents' eligibility for patent term restoration. In a letter dated June 27, 2025, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of FILSUVEZ represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for FILSUVEZ is 1,929 days. Of this time, 935 days occurred during the testing phase of the regulatory review period, while 994 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: September 8, 2018. The applicant claims September 5, 2018, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was September 8, 2018, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: March 30, 2021. FDA has verified the applicant's claim that the new drug application (NDA) for FILSUVEZ (NDA 215064) was initially submitted on March 30, 2021.

3. The date the application was approved: December 18, 2023. FDA has verified the applicant's claim that NDA 215064 was approved on December 18, 2023.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application(s) for patent extension, this applicant seeks 1,463 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product, GRAFAPEX (treosulfan), indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). Subsequent to this approval, the USPTO received a patent term restoration application for GRAFAPEX (U.S. Patent No. 7,199,162) from Medac Gesellschaft fur Klinische Spezialpraparate mbH and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated June 27, 2025, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of GRAFAPEX represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for GRAFAPEX is 9,906 days. Of this time, 8,281 days occurred during the testing phase of the regulatory review period, while 1,625 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: December 10, 1997. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on December 10, 1997.

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: August 11, 2020. FDA has verified the applicant's claim that the new drug application (NDA) for GRAFAPEX (NDA 214759) was initially submitted on August 11, 2020.

3. The date the application was approved: January 21, 2025. FDA has verified the applicant's claim that NDA 214759 was approved on January 21, 2025.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application(s) for patent extension, this applicant seeks 5 years of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FDA is announcing the availability of a guidance for industry entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers.” This guidance addresses questions firms may have when developing FDA-regulated promotional communications for prescription reference products licensed under section 351(a) of the PHS Act (42 U.S.C. 262(a)) and prescription biosimilar products, including interchangeable biosimilar products, licensed under section 351(k) of the PHS Act.

Section 351(k) of the PHS Act provides an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference product. Section 351(i) of the PHS Act defines biosimilarity to mean “that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” To meet the standard for interchangeability, an applicant must provide sufficient information to demonstrate biosimilarity and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch (section 351(k)(4) of the PHS Act). Interchangeable biosimilar products may be substituted for the reference product without the intervention of the prescribing healthcare provider (section 351(i)(3) of the PHS Act). Decisions regarding pharmacy-level substitution are subject to State pharmacy law.

The guidance discusses considerations for presenting data and information about reference products or biosimilar products, including interchangeable biosimilar products, in promotional communications to help ensure that they are accurate, truthful, and non-misleading. The guidance includes information about general requirements for the content of FDA-regulated promotional communications that apply to reference products and biosimilar products and includes more specific considerations for developing these promotional communications for reference products and biosimilar products, such as:

The guidance also provides examples to illustrate some of the considerations outlined in the guidance.

This guidance finalizes the revised draft guidance of the same title issued on April 25, 2024 (89 FR 31757) (2024 draft guidance). FDA considered comments received on the 2024 draft guidance as the guidance was finalized.

Changes from the 2024 draft guidance to the final guidance include:

• Clarification that the recommendations in the guidance apply regardless of the medium of communication ( e.g., paper, digital)

• Further discussion related to the considerations that firms should take into account when comparing biosimilar products and reference products

• Editorial changes for consistency, readability, and clarity

In conjunction with the enactment of the Biosimilar User Fee Amendments of 2022 (BsUFA III), FDA agreed to work toward publishing a final guidance on promotional labeling and advertising considerations for interchangeable biosimilar products within 18 months after the close of the public comment period on the draft guidance, as described in the document titled “Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027.”

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

FDA considered the applicability of Executive Order 14192, per OMB guidance in M-25-20, and finds this action to be deregulatory in nature.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 314, Form FDA 2253 (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use), and the guidance for industry entitled “Providing Regulatory Submissions in Electronic and Non-Electronic Format: Promotional Labeling and Advertising Materials for Human Prescription Drugs” have been approved under OMB control number 0910-0001. The collections of information in 21 CFR 601.12 have been approved under OMB control number 0910-0338. The collections of information in 21 CFR 202.1 and in the guidance for industry entitled “Medical Product Communications That Are Consistent With the Food and Drug Administration Required Labeling: Questions and Answers” have been approved under OMB control number 0910-0686. The collections of information in 21 CFR part 11 relating to electronic records and signatures have been approved under OMB control number 0910-0303. The collections of information relating to the submission of biosimilar and interchangeable product applications under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) have been approved under OMB control number 0910-0718.

Persons with access to the internet may obtain the guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov .

When submitting comments or requesting information, please include the ICR title for reference.

Information Collection Request Title: Health Resources and Services Administration (HRSA) Uniform Data System (UDS), OMB No. 0915-0193 − Revision

Abstract: The Health Center Program, administered by HRSA, is authorized under section 330 of the Public Health Service (PHS) Act (42 U.S.C. 254b). Health centers are community-based and patient-directed organizations that deliver affordable, accessible, quality, and cost-effective primary health care services to patients regardless of their ability to pay. Nearly 1,400 funded health centers operate more than 16,200 service delivery sites that provide primary health care to more than 32 million people in every U.S. state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin.

HRSA uses the UDS for annual reporting of program-specific data by Health Center Program awardees (those funded under section 330 of the PHS Act), Health Center Program look-alikes (entities meeting requirements of, but not funded under, section 330 of the PHS Act), and Nurse Education, Practice, Quality and Retention (NEPQR) and Advanced Nursing Education (ANE) Program awardees (specifically those funded under the practice priority areas of sections 831(b) and 811 of the PHS Act).

Some NEPQR and ANE Program awardees establish and expand nursing practice arrangements in non-institutional settings to demonstrate methods for improving access to primary health care in medically underserved communities. Nursing grantees implementing nursing practice arrangements have historically used the same data collection system as the Health Center Program.

Need and Proposed Use of the Information: HRSA requires the collection of information through UDS to monitor and evaluate the performance of health centers under section 330 and select NEPQR and ANE recipients under sections 831(b) and 811. These data support program compliance, inform quality improvement initiatives, guide the delivery of technical assistance, and shape federal health program decisions. To keep this instrument relevant and responsive to the Health Center Program's needs and Administration priorities, periodic updates are essential. HRSA proposes to make the following updates for the performance year 2026 UDS data collection:

• Managed Care Utilization—UDS measures associated with managed care member months, Capitated Member Months, Fee-for-Service Member Months, and Total Member Months (Lines 13a-13c) will be removed to reduce the reporting burden, given variations in payer structures and payment arrangements across health centers.

• Various Clinical Measures —Clinical measures associated with various diagnoses and selected services rendered are being removed from Table 6A to streamline reporting, reduce burden, and eliminate potential redundancies where similar information is captured elsewhere in the UDS. These updates align with the Administration and HRSA's priorities to simplify data collection and focus reporting on measures that provide the greatest programmatic value. The specific measures proposed for removal are indicated below:

• Type I Diabetes —A new measure is being added as line 9a to identify the number of patients with Type 1 Diabetes. This addition will help address key data gaps and improve HRSA's understanding of the distinct care and resource needs of patients with Type 1 Diabetes.

• Intellectual and Developmental Disabilities —A new measure is being added as line 20g to capture the number of patients with intellectual and developmental disabilities. Available data indicate that this population may experience lower rates of access to preventive and chronic care, including fewer screenings, lower dental care utilization, and higher rates of undiagnosed or unmanaged conditions. Capturing this information will improve understanding of the prevalence of persons with intellectual and developmental disabilities in the Health Center Program and support efforts to enhance health care access and quality of care for individuals requiring complex coordinated services.

• Autism Spectrum Disorder Screening —A new measure is being added as line 26g to capture the number of patients screened for autism spectrum disorder. This measure, in alignment with Administration priorities, will help assess the extent to which health centers are implementing recommended developmental screening practices and connecting children and families to needed support services.

• Patient Support Services —Four new measures are being added as lines 35-38 to capture the number of patients receiving case management, eligibility assistance, transportation, and language assistance services to better understand the range of non-clinical services that facilitate access to care and contribute to improved patient outcomes.

• Health-Related Needs —Four new measures are being added as lines 39-42, transitioning from Appendix D to the UDS core tables, to identify the number of patients who are screened for, and who receive, services addressing health-related needs. These or similar measures are now being elevated to the core reporting set to support standardized data collection. Integrating these measures within the core tables will enhance the ability to monitor how health centers identify and address patients' access to and utilization of services.

• Clinical Quality Measures —Tables 6B and 7 collect UDS clinical quality measures, and where applicable, clinical quality measures will be updated in alignment with specifications of the issued performance year 2026 electronic clinical quality measures. These specifications were released by the Centers for Medicare & Medicaid Services on May 8, 2025, for use by eligible providers. Aligning clinical performance measures across national programs promotes data standardization, quality, and transparency, and decreases the reporting burden for providers and organizations participating in multiple federal programs.

• Allocation of Facility and Non-Clinical Support Services —Allocation of Facility and Non-Clinical Support Services, Column b, and the requirement to report overhead costs on Table 8A will be removed.

• Enabling Services —Details for Cost of Enabling Services, Lines 11a, 11b, 11c, 11d, 11e, 11f, and 11h will be removed. These costs will be consolidated into a single line to reflect all Patient Support Services costs (previously known as Enabling Services).

• Donations —Line 18, Value of Donated Facilities, Services, and Supplies (specify __), will be removed.

These updates are being made to reduce the reporting burden, aligning with the Administration and HRSA's priorities and Health Center Program stakeholder feedback.

• Retroactive Settlements, Receipts, and Paybacks —measures associated with Columns c1—c4 for classification of collections will be removed:

• Payer Category —Managed care lines have been consolidated as part of total payor revenue. Total Medicaid (Line 3), Total Medicare (Line 6), Total Other Public (specify) (Line 9), and Total Private (Line 12) will be reported, and the following lines will be removed as a result:

These updates are being made to reduce the reporting burden, aligning with the Administration and HRSA's priorities and stakeholder feedback.

• Net Patient Services Revenue —A new column will be added for Net Patient Services Revenue (charges less adjustments) (Line 16, Column g).

• Pharmacy Net Patient Service Revenue —A new line will be added to reflect all Pharmacy Net Patient Service Revenue (Line 17, Column g).

• Third-Party Incentive Revenue —A new line will be added for Third-Party Incentive Revenue (Line 18, Column g).

These updates are being made to reduce reporting burden and to better assess financials in alignment with generally accepted accounting principles.

• HRSA's Bureau of Primary Health Care (BPHC) Grants —Health Center Program grant funding sources (formerly Lines 1a-1e) and other BPHC funding detail lines (formerly Lines 1o-1q) will be removed. Grants with active funding will be aggregated and reported on the Total Health Center BPHC Grants line (Line 1), while those no longer receiving funding will be excluded from reporting.

• Other Federal Grants —Other federal grant funding sources (formerly Lines 2 and 3) will be removed.

These updates are being made to align with supplemental funding being rolled into the base Health Center Program funding, as well as to remove outdated supplemental funding lines and reduce the reporting burden.

• Appendix D: Health IT Capabilities —Several questions specific to Electronic Health Records implementation (Questions 1a, 1a2, 1a3, 1c, 1c1, and 10) will be removed from Appendix D.

• Appendix D: Health IT Capabilities —Health-related needs screening questions (Questions 11, 11a, 12, 12a, and 12b) will be removed from Appendix D.

• Appendix E: Other Data Elements —Appendix E will be removed, and certain data elements will be combined with Appendix D. Outreach and enrollment assists (formerly Appendix E, Question 3) will be removed (aspects will be incorporated in the Table 6A Patient Support Services addition).

These updates are being made to reduce the reporting burden, aligning with the Administration and HRSA's priorities and stakeholder feedback.

• Appendix D: Health IT Capabilities —Three questions on Alternative Payment Models (APM) will be added to Appendix D (Questions 17-19), to include:

• What payor arrangements do you have for value-based purchasing contracts?

• Please list the types of APMs your health center is involved in.

• What percentage of your health center's revenue during the year is tied to value-based payment contracts?

These additional data elements are being proposed to capture health centers' participation in APMs to improve understanding of the evolving payment landscape within the Health Center Program. As health centers increasingly engage in payment arrangements that emphasize value, care coordination, and outcomes rather than volume of services, collecting information on APM participation will provide valuable insight into the range and scope of these models.

Likely Respondents: Respondents will include Health Center Program award recipients and Health Center Program look-alikes carrying out programs under section 330 of the PHS Act and NEPQR and ANE award recipients funded under the practice priority areas of section 831(b) and 811 of the PHS Act.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

Total Estimated Annualized Burden Hours:

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.

Title: Arrival and Departure Record (Form I-94) and Electronic System for Travel Authorization (ESTA).

OMB Number: 1651-0111.

Form Number: I-94.

Current Actions: Revision.

Type of Review: Revision.

Affected Public: Individuals.

Abstract: CBP invites the public to comment on the following changes listed below, that were submitted to and approved by OMB through an emergency clearance, with the justification of an unanticipated event and reasons to believe following the normal PRA process would result in public harm.

1. Voluntary Self-Reported Exit (VSRE) Pilot and I-94 Automation: CBP is implementing a new functionality within the CBP Home mobile application, or any successor mobile application, to allow aliens who are subject to I-94 requirements and who are departing the United States, to voluntarily provide biographic data from their passports or other travel documents, facial images, and geolocation to provide evidence of that departure. Note that while the use of this functionality is optional, submitting a facial image is a required part of this functionality. This collection of data is a part of CBP's critical efforts to fulfill DHS's statutory mandate to collect biometric information from departing aliens and CBP's plans to fully automate I-94 information collection. This capability will close the information gap on alien entries and exits by making it easier for aliens subject to I-94 requirements to report their exit to CBP after their departure from the United States. It will also create a biometrically confirmed, and thereby more accurate, exit record for such aliens leaving the United States.

CBP will use geolocation services to confirm that the traveler reporting their departure is outside the United States, as well as, run “liveness detection” software to determine that the selfie photo is a live photo, as opposed to a previously uploaded photo. The mobile application will then compare the facial image submitted to facial images for that person already retained by CBP to confirm the exit biometrically. CBP will use this information to help reconcile a traveler's exit with that traveler's last arrival. The report of exit will be recorded as a confirmed departure in the Arrival and Departure Information System (ADIS) maintained by CBP. Aliens can use this information as proof of departure, which is most relevant in the land border environment, but may be used for departures via air and sea if a traveler desires. This is also beneficial for the alien, as having proof of an exit via a CBP mobile application provides travelers with evidence for Officers to consider in the event that the Officer is unsure whether a nonimmigrant complied with I-94 requirements during their previous entry.

2. Photo Upload for ESTA Website and Mobile: CBP intends to update the ESTA application website to require applicants to provide a photograph of their face, or “selfie”, in addition to the photo of the passport biographical page. In addition, CBP intends to update the mobile application and require third party submissions to include a “selfie” or photograph of the applicant's face. These photos would be used to better ensure that the applicant is the rightful possessor of the document being used to obtain an ESTA authorization.

Currently, applicants are allowed to have a third party apply for an ESTA on their behalf. While this update would not remove that option, third parties, such as travel agents or family members, would be required to provide a photograph of the ESTA applicant.

As noted previously, the ESTA Mobile application currently requires applicants to take a live photograph of their face, which is compared to the passport photo collected during the ESTA Mobile application process. This change will better align the application processes and requirements for ESTA website and ESTA Mobile applicants.

3. VWP Burden of Information Collection Increase: CBP has calculated the estimated burden for this information collection to account for additional countries added into the VWP over the next three years. As an ESTA is required for any travel to the United States under the VWP, the collection is being updated to include travelers from current VWP designated countries and travelers from potentially added designated countries over the next three years.

Additionally, CBP recently revised the collection to add Qatar into the VWP. CBP invites the public to comment on the PRA burden of the Visa Waiver Program Designation (VWP) changes.

CBP also invites the public to comment on the newly proposed changes listed below:

1. ESTA Website Decommission: CBP will decommission the ESTA website Application process to establish the ESTA Mobile application as the sole platform to apply for a new ESTA.

CBP intends to require applicants to submit ESTA applications solely via the ESTA Mobile application; consequently, travelers would no longer be permitted to submit ESTA applications using the existing ESTA website. CBP believes that moving to a mobile-only approach for ESTA submissions will both enhance security and improve efficiency. The ESTA website would remain available as a resource for information about the ESTA program, as well as allow applicants to check the status of their ESTA applications but will not be used to collect information from applicants.

Currently, applicants can apply for an ESTA via the ESTA website or the ESTA Mobile application. However, poor quality image uploads to the ESTA website have resulted in applicants bypassing the facial comparison screening. A case study from the National Targeting Center (NTC) Traveler Application Security Unit (TASU) of a poor-quality passport photo submission demonstrates the increased accuracy of live mobile image capture over web-based uploads. NTC TASU identified over 2,400 poor quality passport biographical page uploads and over 8,000 invalid passport photos that led to negative or failed photo comparison screenings. CBP believes that travelers are aware of this vulnerability and have begun to exploit it by purposely uploading poor quality images to avoid detection.

Additionally, CBP continues to struggle with fraudulent third-party websites. Third-party fraudulent websites charge travelers exorbitant fees to process an application, where many of these applications may never be processed by CBP, resulting in a traveler being unable to board a U.S. bound plane.

Lastly, unlike ESTA Mobile, the ESTA website is unable to validate the authenticity of the passport through the certificates embedded on the electronic chip (e-Chip). Bad actors exploit this vulnerability to apply for an ESTA. NTC TASU has discovered hundreds of fraudulent ESTAs created by facilitators to support visa applications. These facilitators uploaded fraudulent passport bio pages to obtain approved ESTAs. travelers then presented official ESTA printouts, falsely claiming the ESTA holder was a spouse, to strengthen their visa applications.

The ESTA Mobile application provides superior identity verification methods, including liveness detection, facial recognition and Near Field Communication (NFC)-based passport scanning/electronic chip verification. Applying for an ESTA on the website does not allow NFC verification of an ePassport, unlike when using the mobile app. The current ESTA Mobile submission process includes retrieving biographic information and portrait photo from the e-Chip, matching the portrait with a live selfie via the CBP Traveler Verification Service (TVS), and auto-denying applications that fail Country Signing Certificate validation from the Traveler Document Authentication System.

While transitioning to a mobile-only ESTA system may present some initial challenges, the long-term benefits, including enhanced security and fraud reduction, make the transition a viable national security decision. CBP believes the continued evolution of mobile technology will further streamline and secure the traveler authentication process, paving the way for future advancements in contactless verification and biometric authentication.

2. Romania Removal from Visa Waiver Program (VWP): Due to the removal of Romania from the approved list of countries under the VWP, CBP is updating relevant collections to reflect this removal. The public can refer to https://www.dhs.gov/visa-waiver-program for the list of approved countries under the VWP.

3. Mandatory Social Media: In order to comply with the January 2025 Executive Order 14161 (Protecting the United States From Foreign Terrorists and Other National Security and Public Safety Threats), CBP is adding social media as a mandatory data element for an ESTA application. The data element will require ESTA applicants to provide their social media from the last 5 years.

4. High Value Data Elements: To comply with the January 2025 E.O. (14161), and the April 4, 2025, Memorandum Updating All Forms to Collect Baseline Biographic Data, CBP will add several “high value data fields” to the ESTA application, when feasible. This is in addition to the information already collected in the ESTA application.

The high value data fields include:

a. Telephone numbers used in the last five years;

b. Email addresses used in the last ten years;

c. IP addresses and metadata from electronically submitted photos;

d. Family member names (parents, spouse, siblings, children);

e. Family number telephone numbers used in the last five years;

f. Family member dates of birth;

g. Family member places of birth;

h. Family member residencies;

i. Biometrics—face, fingerprint, DNA, and iris;

j. Business telephone numbers used in the last five years;

k. Business email addresses used in the last ten years.

CBP invites the public to comment on both the previously approved emergency changes and the newly proposed changes.

Type of Information Collection: Paper I-94.

Estimated Number of Respondents: 865,639.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Number of Total Annual Responses: 865,639.

Estimated Time per Response: 8 minutes.

Estimated Total Annual Burden Hours: 115,418.

Type of Information Collection: I-94 website.

Estimated Number of Respondents: 2,278,054.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Number of Total Annual Responses: 2,278,054.

Estimated Time per Response: 4 minutes.

Estimated Total Annual Burden Hours: 151,870.

Type of Information Collection: ESTA Mobile Application.

Estimated Number of Respondents: 14,484,073.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Number of Total Annual Responses: 14,484,073.

Estimated Time per Response: 22 minutes.

Estimated Total Annual Burden Hours: 5,310,827.

Type of Information Collection: CBP Home.

Estimated Number of Respondents: 600,000.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Number of Total Annual Responses: 600,000.

Estimated Time per Response: 2 minutes.

Estimated Total Annual Burden Hours: 20,000.

CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). This proposed information collection was previously published in the Federal Register (89 FR 3299) on January 18, 2024, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.

Title: Guam-CNMI Visa Waiver Information (Form I-736).

OMB Number: 1651-0109.

Form Number: I-736.

Current Actions: Revision.

Type of Review: Revision.

Affected Public: Individuals.

Abstract: Public Law 110-229 provides for certain aliens to be exempt from the nonimmigrant visa requirement if seeking entry into Guam or the Commonwealth of the Northern Mariana Islands (CNMI) as a visitor for a maximum stay of 45 days, provided that no potential threat exists to the welfare, safety, or security of the United States, or its territories, and other criteria are met. At the Secretary's discretion, passport holders of the People's Republic of China who are not in possession of a visitors' visa may be allowed to enter CNMI for up to 14 days under the discretionary parole authority. Upon arrival at the Guam or CNMI Ports-of-Entry, each applicant for admission presents a completed paper Form I-736 to CBP, which collects information about the applicant's identity and travel documents. CBP Form I-736 is provided for by 8 CFR 212.1(q).

Please note that certain items on the new version remains identical to those in the original version. However, updates are necessary to be able to transition to automating Form I-736, Guam-CNMI Visa Waiver Information that is used in compliance with the Guam-CNMI Visa Waiver Program. The automation will facilitate CBP to gather information on travelers from Guam-CNMI Visa Waiver Program countries to determine their admissibility to enter Guam or the CNMI. In addition, CBP intends to migrate from paper I-736 to a mandatory automated environment; therefore, the collection of a paper form will no longer be acceptable. However, after the regulation implementing mandatory automation is published, CBP will grant a transition period of three months to facilitate travelers adjusting to the new collection method. At the end of the transition period, the paper I-736 form will become obsolete and travelers must input and submit in advance their personal information and respond to the eligibility questions using the new electronic format. The travelers' information is pre-screened or vetted against law enforcement databases. Based on the results of the pre-screening, the application is approve or denied. The system generates a board or no board status message to the carrier indicating a denied or approved authorization to board before the flight. The applicant also receives a message with the application status: approved, denied, canceled or pending. All information will be saved in the newly created Guam-CNMI Visa Waiver Program database.

In a recent approval, several data elements were added to the Form I-736: the foreign passport type (mandatory), social media identifier (optional), valid email address (mandatory), and social media provider/platform (optional). Adding these data elements enhances the existing vetting process and provides CBP with additional information to determine travelers' admissibility to enter Guam or the CNMI under the Guam-CNMI Visa Waiver Program. CBP intends to migrate from the paper Form I-736 process to a mandatory automated process via rulemaking.

As part of the regulatory updates for the Interim Final Rule (IFR) which fully automates the collection of Form I-736 and requires that travelers under the G-CNMI VWP submit this information in advance of arrival. The rule also creates a new system, CNMI EVS-TAP, wherein travelers from the PRC to the CNMI can submit advance information to CBP so they may be vetted for a 14-day visa free admissibility period. These travelers will also need to complete an additional set of vetting questions.

Type of Information Collection: Form I-736.

Estimated Number of Respondents: 1,370,000.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Number of Total Annual Responses: 1,370,000.

Estimated Time per Response: 21 minutes.

Estimated Total Annual Burden Hours: 479,500.

Type of Information Collection: CNMI EVS-TAP.

Estimated Number of Respondents: 230,000.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Number of Total Annual Responses: 230,000.

Estimated Time per Response: 26 minutes.

Estimated Total Annual Burden Hours: 99,667.

Important mission requirements of the Department of Homeland Security (“DHS”) include border security and the detection and prevention of illegal entry into the United States. Border security is critical to the nation's national security. Recognizing the critical importance of border security, Congress has mandated DHS to achieve and maintain operational control of the international land border. Secure Fence Act of 2006, Public Law 109-367, section 2, 120 Stat. 2638 (Oct. 26, 2006) (8 U.S.C. 1701 note). Congress defined “operational control” as the prevention of all unlawful entries into the United States, including entries by terrorists, other unlawful aliens, instruments of terrorism, narcotics, and other contraband. Id. Consistent with that mandate, the President's Executive Order on Securing Our Borders directs that I take all appropriate action to deploy and construct physical barriers to ensure complete operational control of the southern border of the United States. Executive Order 14165, section 3 (Jan. 20, 2025).

Congress has provided to the Secretary of Homeland Security a number of authorities necessary to carry out DHS's border security mission. One of those authorities is found at section 102 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996, as amended (“IIRIRA”). Public Law 104-208, Div. C, 110 Stat. 3009-546, 3009-554 (Sept. 30, 1996) (8 U.S.C 1103 note), as amended by the REAL ID Act of 2005, Public Law 109-13, Div. B, 119 Stat. 231, 302, 306 (May 11, 2005) (8 U.S.C. 1103 note), as amended by the Secure Fence Act of 2006, Public Law 109-367, section 3, 120 Stat. 2638 (Oct. 26, 2006) (8 U.S.C. 1103 note), as amended by the Department of Homeland Security Appropriations Act, 2008, Public Law 110-161, Div. E, Title V, section 564, 121 Stat. 2090 (Dec. 26, 2007). In section 102(a) of IIRIRA, Congress provided that the Secretary of Homeland Security shall take such actions as may be necessary to install additional physical barriers and roads (including the removal of obstacles to detection of illegal entrants) in the vicinity of the United States border to deter illegal crossings in areas of high illegal entry into the United States. In section 102(b) of IIRIRA, Congress mandated that in carrying out the authority of section 102(a), I provide for the installation of additional fencing, barriers, roads, lighting, cameras, and sensors to achieve and maintain operational control of the border. Finally, in section 102(c) of IIRIRA, Congress granted to the Secretary of Homeland Security the authority to waive all legal requirements that I, in my sole discretion, determine necessary to ensure the expeditious construction of barriers and roads authorized by section 102 of IIRIRA.

The United States Border Patrol Laredo Sector is an area of high illegal entry. Between fiscal year 2021 and fiscal year 2025, Border Patrol apprehended over 310,390 illegal aliens attempting to enter the United States between border crossings in the Laredo Sector. In that same time period Border Patrol seized over 44,188 pounds of marijuana, over 576 pounds of cocaine, over 104 pounds of heroin, over 1,246 pounds of methamphetamine, and over 14 pounds of fentanyl.

Since the President took office, DHS has delivered the most secure border in history. More can and must be done, however. As the statistics cited above demonstrate, the Laredo Sector is an area of high illegal entry where illegal aliens regularly attempt to enter the United States and smuggle illicit drugs, and given my mandate to achieve and maintain operational control of the border, I must use my authority under section 102 of IIRIRA to install additional barriers and roads in the Laredo Sector. Therefore, DHS will take immediate action to construct additional barriers and roads in a segment of the border in the Laredo Sector. The segment where such construction will occur is referred to herein as the “project area,” which is more specifically described in Section 2 below.

I determine that the following area in the vicinity of the United States border, located in the state of Texas within the U. S. Border Patrol Laredo Sector, is an area of high illegal entry (the “project area”): Starting at approximately GPS point 28.028853, -100.008143 and generally following the Rio Grande River south and east to approximately GPS point 26.571855,-99.169240.

There is presently an acute and immediate need to construct additional physical barriers and roads in the vicinity of the border of the United States in order to prevent unlawful entries into the United States in the project area pursuant to section 102(a) and 102(b) of IIRIRA. In order to ensure the expeditious construction of additional physical barriers and roads in the project area, I have determined that it is necessary that I exercise the authority that is vested in me by section 102(c) of IIRIRA.

Accordingly, pursuant to section 102(c) of IIRIRA, I hereby waive in their entirety, with respect to the construction of physical barriers and roads (including, but not limited to, accessing the project areas, creating and using staging areas, the conduct of earthwork, excavation, fill, and site preparation, and installation and upkeep of physical barriers, roads, supporting elements, drainage, erosion controls, safety features, lighting, cameras, and sensors) in the project area, all of the following statutes, including all federal, state, or other laws, regulations, and legal requirements of, deriving from, or related to the subject of, the following statutes, as amended: The National Environmental Policy Act (Pub. L. 91-190, 83 Stat. 852 (Jan. 1, 1970) (42 U.S.C. 4321 et seq. )); the Endangered Species Act (Pub. L. 93-205, 87 Stat. 884 (Dec. 28, 1973) (16 U.S.C. 1531 et seq. )); the Federal Water Pollution Control Act (commonly referred to as the Clean Water Act (33 U.S.C. 1251 et seq. )); the National Historic Preservation Act (Pub. L. 89-665, 80 Stat. 915 (Oct. 15, 1966), as amended, repealed, or replaced by Pub. L. 113-287 (Dec. 19, 2014) (formerly codified at 16 U.S.C. 470 et seq., now codified at 54 U.S.C. 100101 note and 54 U.S.C. 300101 et seq. )); the Migratory Bird Treaty Act (16 U.S.C. 703 et seq. ); the Migratory Bird Conservation Act (16 U.S.C. 715 et seq. ); the Clean Air Act (42 U.S.C. 7401 et seq. ); the Archeological Resources Protection Act (Pub. L. 96-95 (16 U.S.C. 470aa et seq. )); the Paleontological Resources Preservation Act (16 U.S.C. 470aaa et seq. ); the Federal Cave Resources Protection Act of 1988 (16 U.S.C. 4301 et seq. ); the National Trails System Act (16 U.S.C. 1241 et seq. ), the Safe Drinking Water Act (42 U.S.C. 300f et seq. ); the Noise Control Act (42 U.S.C. 4901 et seq. ); the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act (42 U.S.C. 6901 et seq. ); the Comprehensive Environmental Response, Compensation, and Liability Act (42 U.S.C. 9601 et seq. ); the Archaeological and Historic Preservation Act (Pub. L. 86-523, as amended, repealed, or replaced by Pub. L. 113-287 (Dec. 19, 2014) (formerly codified at 16 U.S.C. 469 et seq., now codified at 54 U.S.C. 312502 et seq. )); the Antiquities Act (formerly codified at 16 U.S.C. 431 et seq. and 16 U.S.C. 431a et seq., now codified 54 U.S.C. 320301 et seq. ); the Historic Sites, Buildings, and Antiquities Act (formerly codified at 16 U.S.C. 461 et seq., now codified at 54 U.S.C. 320301-320303 & 320101-320106); the Eagle Protection Act (16 U.S.C. 668 et seq. ); the Native American Graves Protection and Repatriation Act (25 U.S.C. 3001 et seq. ); the Administrative Procedure Act (5 U.S.C. 551 et seq. ); Section 438 of the Energy Independence and Security Act (42 U.S.C. 17094); the National Fish and Wildlife Act of 1956 (Pub. L. 84-1024 (16 U.S.C. 742a, et seq. )); the Fish and Wildlife Coordination Act (Pub. L. 73-121 (16 U.S.C. 661 et seq. )); the Farmland Protection Policy Act (7 U.S.C. 4201 et seq. ); the Wild Horse and Burro Act (16 U.S.C. 1331 et seq. ); 43 U.S.C. 387; the Wild and Scenic Rivers Act (Pub. L. 90-542 (16 U.S.C. 1281 et seq. ); the Rivers and Harbors Act of 1899 (33 U.S.C. 403 et seq. ); the Federal Insecticide, Fungicide, and Rodenticide Act, (16 U.S.C. 136-136y); and the Marine Mammal Protection Act (16 U.S.C. 1361-1421h).

This waiver does not revoke or supersede any other waiver determination made pursuant to section 102(c) of IIRIRA. Such waivers shall remain in full force and effect in accordance with their terms. I reserve the authority to execute further waivers from time to time as I may determine to be necessary under section 102 of IIRIRA.

TSA published a Federal Register notice, with a 60-day comment period soliciting comments, of the following collection of information on August 1, 2025, 90 FR 36171. TSA did not receive any comments on the notice.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The ICR documentation will be available at https://www.reginfo.gov upon its submission to OMB. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to:

(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Title: Secure Flight Program.

Type of Request: Revision of a currently approved collection.

OMB Control Number: 1652-0046.

Forms(s): N/A.

Affected Public: Aircraft operators, airport operators.

Abstract: TSA collects information from covered aircraft operators, including foreign air carriers, in order to prescreen passengers under the Secure Flight Program. The information collected under the Secure Flight Program is used for watch list-matching, for matching against lists of known travelers, and to assess passenger risk ( e.g., to identify passengers who present lower risk and may be eligible for expedited screening). The collection covers:

(1) Secure Flight Passenger Data (SFPD) for passengers of covered domestic and international flights within, to, from, or over the continental United States, as well as flights between two foreign locations when operated by a covered U.S. aircraft operator.

(2) SFPD for passengers of charter operators and lessors of aircraft with a maximum takeoff weight of over 12,500 pounds (Twelve-Five operators).

(3) Certain identifying information for non-traveling individuals that covered aircraft operators, airport operators or airport operator points of contact seek to authorize to enter a sterile area at a U.S. airport ( e.g., to patronize a restaurant, to escort a minor or a passenger with disabilities, or for another approved purpose). TSA is revising the collection for non-traveling individuals to also request authorization to enter a sterile area at a U.S. airport directly from TSA, and TSA will issue a visitor pass for the non-traveler to enter the sterile area.

(4) Registration information critical to deployment of Secure Flight, such as contact information, data format, or the mechanism the covered aircraft operators use to transmit SFPD and other data.

(5) Lists of low-risk individuals who are eligible for expedited screening provided by federal and non-federal entities. Through TSA PreCheck®, TSA implemented expedited screening of known low-risk travelers. Some federal and non-federal entities maintain lists of eligible individuals pursuant to agreements with DHS and TSA, and provide TSA with a list of eligible low-risk individuals to be used as part of Secure Flight processes. Secure Flight identifies individuals who should receive expedited screening and transmits the appropriate boarding pass printing result to the aircraft operators.

Estimated Annual Number of Respondents: 300,919. 1

Estimated Annual Number of Burden Hours: 43,636.

On October 2, 2025, HUD published in the Federal Register an RFI entitled “Future of the HECM and HMBS Programs and Opportunities for Innovation in Accessing Home Equity.” The RFI provided for a 60-day comment period, which ended on December 1, 2025. However, due to the Federal government shutdown that occurred on October 1, 2025, HUD has decided to re-open the comment period until January 5, 2026, to give commenters additional time to provide market feedback on opportunities to enhance the HECM and HMBS programs and the appropriate role of these programs in facilitating access to home equity for senior homeowners.

Background. —In July 2023, the Commission determined that an industry in the United States was materially injured by reason of imports of certain freight rail couplers and parts thereof from China that were sold in the United States at less than fair value and subsidized by the government of China. Certain Freight Rail Couplers and Parts Thereof from China, Inv. Nos. 701-TA-682 and 731-TA-1592 (Final), USITC Pub. No. 5438 (July 2023). Respondents Strato, Inc. and Wabtec Corporation contested the Commission's determinations regarding China before the U.S. Court of International Trade (“CIT”). The CIT remanded “for the Commission's reconsideration or further explanation of its decision not to exclude Amsted from the domestic industry.” Wabtec v. United States, Court No. 22-00157, Slip Op. 25-134.

Participation in the Remand Proceedings. —Only those persons who were interested parties that participated in the investigations ( i.e., persons listed on the Commission Secretary's service list) and also parties to the appeal may participate in the remand proceedings. Such persons need not file any additional appearances with the Commission to participate in the remand proceedings, unless they are adding new individuals to the list of persons entitled to receive business proprietary information (“BPI”) under administrative protective order. BPI referred to during the remand proceedings will be governed, as appropriate, by the administrative protective order issued in the investigations. The Secretary will maintain a service list containing the names and addresses of all persons or their representatives who are parties to the remand proceedings, and the Secretary will maintain a separate list of those authorized to receive BPI under the administrative protective order during the remand proceedings.

Written submissions. —The Commission is not reopening the record and will not accept the submission of new factual information for the record. The Commission will permit the parties to file comments concerning how the Commission could best comply with the court's remand instructions.

The comments must be based solely on the information in the Commission's record. The Commission will reject submissions containing additional factual information or arguments pertaining to issues other than the issue on which the court has remanded this matter. The deadline for filing comments is January 2, 2026. Comments must be limited to no more than ten (10) double-spaced and single-sided pages of textual material, inclusive of attachments and exhibits.

Parties are advised to consult with the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subpart A (19 CFR part 207) for provisions of general applicability concerning written submissions to the Commission. All written submissions must conform to the provisions of section 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission's rules. Please note the Secretary's Office will accept only electronic filings at this time. Filings must be made through the Commission's Electronic Document Information System (EDIS, https://edis.usitc.gov ). No in-person paper-based filings or paper copies of any electronic filings will be accepted until further notice. The Commission's Handbook on E-Filing, available on the Commission's website at http://edis.usitc.gov, elaborates upon the Commission's rules with respect to electronic filing.

Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, will not be accepted unless good cause is shown for accepting such submissions or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.

In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the investigation must be served on all other parties to the investigation (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.

The Commission instituted this investigation on March 27, 2025, based on a complaint filed by AX Wireless, LLC of Austin, Texas (“Complainant”). 90 FR 13879-80 (Mar. 27, 2025). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain video game consoles, routers and gateways, and components thereof by reason of the infringement of certain claims of U.S. Patent Nos. 10,917,272; 11,646,927; 11,777,776; and 12,063,134. Id. The complaint further alleges that a domestic industry exists. Id. The Commission's notice of investigation names four respondents, including: Sony Interactive Entertainment Inc. of Tokyo, Japan and Sony Interactive Entertainment LLC of San Mateo, California (collectively, “Sony”); Vantiva SA of Paris, France; and Vantiva USA, LLC of Norcross, Georgia. Id. The Office of Unfair Import Investigations (“OUII”) is participating in the investigation. Id.

The Commission previously terminated Vantiva SA and Vantiva USA, LLC based on settlement. Order No. 20 (Aug. 28, 2025), unreviewed by Comm'n Notice (Sept. 18, 2025).

On September 25, 2025, Complainant filed an unopposed motion for termination of this investigation in its entirety based on a settlement agreement between Complainant and Sony. On September 26, 2025, Complainant filed a corrected version of its motion that attached the settlement, which was inadvertently not attached to the original motion. On September 29, 2025, OUII filed a response in support of the motion. No other responses to the motion were filed.

On September 29, 2025, the presiding ALJ issued the subject ID granting the unopposed motion to terminate the investigation in its entirety. See Order No. 24 (Sept. 29, 2025). The subject ID finds that the motion complies with Commission Rule 210.21(b)(1) (19 CFR 210.21(b)) and that no extraordinary circumstances prevent granting the motion. The subject ID also finds that termination based on settlement would not be contrary to the public interest.

No party petitioned for review of the subject ID.

The Commission has determined not to review the subject ID (Order No. 24). The investigation is terminated.

The Commission vote for this determination took place on December 5, 2025.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

Notice is hereby given that the Advisory Committee on Actuarial Examinations will meet by teleconference on Monday, January 12, 2026, from 10:00 a.m. to 5:00 p.m. (ET), and Tuesday, January 13, 2026, from 10:00 a.m. to 3:00 p.m. (ET).

The purpose of the meeting is to discuss topics and questions that may be recommended for inclusion on future Joint Board examinations in actuarial mathematics and methodology referred to in 29 U.S.C. 1242(a)(1)(B) and to review the November 2025 Pension (EA-2F) Examination in order to make recommendations relative thereto, including the minimum acceptable pass score. Topics for inclusion on the syllabus for the Joint Board's examination program for the May 2026 Basic (EA-1) Examination and the May 2026 Pension (EA-2L) Examination also will be discussed.

A determination has been made as required by section 10(d) of the Federal Advisory Committee Act, 5 U.S.C. 1009(d), that the portions of the meeting dealing with the discussion of questions that may appear on the Joint Board's examinations and the review of the November 2025 Pension (EA-2F) Examination fall within the exceptions to the open meeting requirement set forth in 5 U.S.C. 552b(c)(9)(B), and that the public interest requires that such portions be closed to public participation.

The open portion of the meeting dealing with the discussion of the other topics will commence at 12:00 p.m. (ET) on January 12, 2026, and will continue for as long as necessary to complete the discussion, but not beyond 1:00 p.m. (ET). Time permitting, after the close of this discussion by Advisory Committee members, interested persons may make statements germane to this subject. Persons wishing to make oral statements should contact the Designated Federal Officer at NHQJBEA@irs.gov and include the written text or outline of comments they propose to make orally. Such comments will be limited to 10 minutes in length. Persons who wish to attend the public session should contact the Designated Federal Officer at NHQJBEA@irs.gov to obtain teleconference access instructions. Notifications of intent to make an oral statement or to attend the meeting must be sent electronically to the Designated Federal Officer by no later than January 5, 2026. In addition, any interested person may file a written statement for consideration by the Joint Board and the Advisory Committee by sending it to NHQJBEA@irs.gov.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3) Evaluate whether and if so, how the quality, utility, and clarity of the information to be collected can be enhanced; and

(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

1. Type of Information Collection: Extension of a currently approved collection.

2. Title of the Form/Collection: Financial Capability Form.

3. Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection: Form Number: 1122-0030. U.S. Department of Justice, Office on Violence Against Women.

4. Affected public who will be asked or required to respond, as well as a brief abstract: The affected public includes non-governmental applicants to OVW grant programs that do not currently (or within the last 3 years) have funding from OVW. In accordance with 2 CFR 200.206 the information is required for assessing the financial risk of an applicant's ability to administer federal funds. The form includes a mix of check box and narrative questions related to the organization's financial systems, policies and procedures.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply: It is estimated that it will take approximately 40 respondents (non-governmental applicants of OVW grant programs) approximately 4 hours to complete an online assessment form.

6. An estimate of the total public burden (in hours) associated with the collection: The total annual hour burden to complete the data collection forms is 160 hours, that is 40 applicants completing a form once as a new applicant with an estimated completion time for the form being 4 hours.

7. An estimate of the total annual cost burden associated with the collection, if applicable: The annualized cost to the Federal Government resulting from OVW staff review of the forms is estimated to be $9,275.

If additional information is required contact: Darwin Arceo, Department Clearance Officer, United States Department of Justice, Justice Management Division, Enterprise Portfolio Management, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC.

In this document, the Department is taking initial steps to learn more about the needs of faith organizations who are interested in helping advance DOL's mission of fostering, promoting, and developing the welfare of wage earners, job seekers, and retirees. Faith organizations have a long history of providing critical services, such as job training, education, career counseling, and community support in a culturally competent and compassionate manner. This RFI solicits input from stakeholders, including faith organizations and program participants, to identify barriers to participation in DOL-funded or regulated programs, suggest potential reasonable religious accommodations, and propose strategies to improve outreach to and engagement with faith organizations.

The Department administers programs and funding to support workforce development, job training, unemployment insurance, and wage earner protections. Faith organizations have a long history of providing critical services, such as job training, education, career counseling, and community support in a culturally competent and compassionate manner.

Executive Order 14291 issued by President Donald Trump on May 1, 2025, declares: “The Founders envisioned a Nation in which religious voices and views are integral to a vibrant public square and human flourishing and in which religious people and institutions are free to practice their faith without fear of discrimination or hostility from the Government.” The Executive Order further states that it will be “the policy of the executive branch to vigorously enforce the historic and robust protections for religious liberty enshrined in Federal law.”

Executive Order 14205, issued by President Donald Trump in February 2025, is aimed at assisting faith-based entities and houses of worship in their efforts to strengthen American families, promote work and self-sufficiency, and protect religious liberty. As part of the executive order, a White House Faith Office was established, with each agency creating a Center for Faith with a faith director. DOL has a Center for Faith, a faith director, and a staff of appointees to carry out this work at the agency.

Consistent with the principles outlined in these Executive Orders, DOL believes faith groups and houses of worship, to the fullest extent permitted by law, should be able to compete on a level playing field for grants, contracts, and other federal funding opportunities. DOL seeks to ensure its regulations, policies, and practices align with these principles and facilitate the participation of qualified faith organizations.

In this Section III, the Department solicits responses to questions primarily for the purpose of considering whether additional guidance or regulatory changes would be helpful to facilitate faith organizations' participation in DOL programs and funding opportunities.

1. What, if any, specific DOL regulations, guidance, or policies, explicitly or implicitly restrict or discourage faith-based organizations from participating in DOL-funded programs ( e.g., job training, workforce development, or employment services)?

2. If applicable, provide examples of how these barriers impact your faith organization's ability to deliver services.

3. What, if any, changes to regulations or procedures do you recommend in order to address these issues?

4. What accommodations, policies, or tools could DOL develop to ensure faith organizations receive reasonable accommodations for their religious beliefs and practices while participating in DOL programs?

5. Can you provide examples of specific accommodations you believe would enhance the participation of faith organizations in DOL-funded programs?

6. What platforms or strategies should DOL use to ensure outreach to faith organizations is effective and they are aware of funding opportunities and program requirements?

7. In what ways do you believe faith organizations contribute to DOL's mission of improving employment outcomes and wage earner welfare?

8. What do you believe the impact on communities would be if faith organizations were unable to participate in DOL programs or access federal funding?

9. What metrics or data should DOL collect to assess the effectiveness of faith organizations in delivering DOL-funded services?

10. Are there ways DOL can support the work of faith organizations on current or future workforce development, apprenticeships, and job training other than by providing federal funding (for instance, by providing technical assistance)?

11. What other resources can DOL provide that would be helpful for faith organizations? How else can DOL help faith organizations engage with workforce-related issues?

This document was prepared under the direction of Lori Chavez-DeRemer, Secretary of Labor.

Please refer to Docket ID NRC-2025-0045 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2025-0045. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC-2025-0045 on this website.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin ADAMS Public Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to PDR.Resource@nrc.gov. A copy of the NRC Forms 541 and 541A and related instructions may be obtained without charge by accessing ADAMS Accession Nos. ML25164A040, and ML25164A041, respectively and ML20178A433 (NUREG-BR-0204, Revision 3). The supporting statement is available in ADAMS under Accession No. ML25164A037.

• NRC's PDR: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.

• NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Acting Clearance Officer, Heather Dempsey, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0856 email: Infocollects.Resource@nrc.gov.

The NRC encourages electronic comment submission through the Federal rulemaking website ( https://www.regulations.gov ). Please include Docket ID NRC-2025-0045, in your comment submission.

The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at https://www.regulations.gov and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized as follows.

1. The title of the information collection: NRC Forms 541 and 541A, “Uniform Low-Level Radioactive Waste Manifest Container and Waste Description and Continuation Page.”

2. OMB approval number: 3150-0166.

3. Type of submission: Extension.

4. The form number, if applicable: NRC Forms 541 and 541A.

5. How often the collection is required or requested: NRC Form 541 and 541A, or the Agreement State equivalent forms are required when low-level radioactive waste (LLRW) is transferred by any waste generator, waste collector, or waste processor licensee, who ships LLRW either directly, or indirectly through a waste collector or waste processor, for ultimate disposal at a licensed LLRW disposal facility.

6. Who will be required or asked to respond: NRC Form 541 and continuation Form 541A are completed by waste generators, waste collectors, and waste processors who ship LLRW intended for ultimate disposal at a licensed LLRW land disposal facility.

7. The estimated number of annual responses: 4,616.

8. The estimated number of annual respondents: 712.

9. The estimated number of hours needed annually to comply with the information collection requirement or request: 15,233.

10. Abstract: The NRC regulations in section 20.2006 of title 10 of the Code of Federal Regulations (10 CFR), “Transfer for Disposal and Manifest” and 10 CFR part 20, appendix G, “Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests,” established requirements for a nationwide system to ensure the safe and efficient transportation and disposal of LLRW. The Uniform LLRW Manifest system is implemented by the utilization of specific NRC Forms to document the information required by 10 CFR 20.2006 and 10 CFR part 20, appendix G. The NRC Forms 541/541A, “Uniform LLRW Manifest Container and Waste Description and Continuation Page,” combined with NRC Forms 540/540A, “Uniform LLRW Manifest (Shipping Paper) and Continuation Page” and, if necessary, NRC Forms 542/542A, “Uniform LLRW Manifest Index and Regional Compact Tabulation,” are collectively referred to as the Uniform LLRW Manifest Forms. The forms were originally developed by the NRC at the request of low-level waste industry groups, and Federal and State agencies. These forms assist in providing a standardized nationwide framework for collecting and transmitting LLRW related information from generation to disposal.

The NRC Forms 541 and 541A or Agreement State equivalent forms are used on a nationwide basis to reflect the minimum safety-related information for an LLRW shipment as required by Federal and State reporting requirements for the safe transportation and disposal of LLRW. The Uniform LLRW Manifest Form 541/541A is completed by shippers of LLRW intended for disposal at a licensed LLRW land disposal facility. These NRC forms include information regarding the disposal container description, waste description for each waste type in the container (physical and chemical description of the waste, and the radiological description (radionuclides and activity)) and the classification of the waste in accordance with 10 CFR part 61.55 “Waste Classification.” The Uniform LLRW Manifest Forms 541/541A are not required to physically accompany the shipment. Upon agreement between the shipper and consignee, NRC Form 541/541A are (1) mailed or electronically transferred to the intended consignee prior to the shipment arriving at the consignee; or (2) delivered with the waste to the consignee. The NUREG/BR-0204, Revision 3, contains instructions for completing NRC Uniform LLRW Manifest Forms.

As stated in 10 CFR part 20, appendix G, “Licensees need not use originals of these NRC forms as long as any substitute forms are equivalent to the original documentation in respect to content, clarity, size, and location of information . . .” The NRC previously noticed the availability of revisions to the Uniform LLRW Manifest Forms in the Federal Register on November 23, 2022 (87 FR 71694). The information collection contained in the current extension request does not include any changes to the forms.

The NRC is seeking comments that address the following questions:

1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? Please explain your answer.

2. Is the estimate of the burden of the information collection accurate? Please explain your answer.

3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?

4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?

Please refer to Docket ID NRC-2025-0043 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2025-0043.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin ADAMS Public Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to PDR.Resource@nrc.gov. A copy of the NRC Forms 540 and 540A and related instructions may be obtained without charge by accessing ADAMS Accession Nos. ML25163A284, and ML25163A285, respectively and ML20178A433 (NUREG-BR-0204, Revision 3). The supporting statement is available in ADAMS under Accession ML25163A281.

• NRC's PDR: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.

• NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Acting Clearance Officer, Heather Dempsey, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0856 email: Infocollects.Resource@nrc.gov.

The NRC encourages electronic comment submission through the Federal rulemaking website ( https://www.regulations.gov ). Please include Docket ID NRC-2025-0043, in your comment submission.

The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at https://www.regulations.gov and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized as follows.

1. The title of the information collection: NRC Forms 540 and 540A, “Uniform Low-Level Radioactive Waste Manifest (Shipping Paper) and Continuation Page.”

2. OMB approval number: 3150-0164.

3. Type of submission: Extension.

4. The form number, if applicable: NRC Forms 540 and 540A.

5. How often the collection is required or requested: NRC Form 540 and 540A, or the Agreement State equivalent forms are required when low-level radioactive waste (LLRW) is transferred by any waste generator, waste collector, or waste processor licensee, who ships LLRW either directly, or indirectly through a waste collector or waste processor, for ultimate disposal at a licensed LLRW disposal facility.

6. Who will be required or asked to respond: NRC Form 540 and continuation Form 540A are completed by waste generators, waste collectors, and waste processors who ship LLRW intended for ultimate disposal at a licensed LLRW land disposal facility.

7. The estimated number of annual responses: 4,616.

8. The estimated number of annual respondents: 712.

9. The estimated number of hours needed annually to comply with the information collection requirement or request: 3,462 (3,116 reporting and 346 recordkeeping).

10. Abstract: The NRC regulations in section 20.2006 of title 10 in the Code of Federal Regulations (10 CFR), “Transfer for Disposal and Manifest” and 10 CFR part 20, appendix G, “Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests,” established requirements for a nationwide system to ensure the safe and efficient transportation and disposal of LLRW. The Uniform LLRW Manifest system utilizes specific NRC forms to document the information required by 10 CFR 20.2006 and 10 CFR part 20, appendix G. The NRC Forms 540/540A, “Uniform Low-Level Radioactive Waste Manifest (Shipping Paper) and Continuation Page,” combined with NRC Forms 541/541A, “Uniform Low-Level Radioactive Waste Manifest Container and Waste Description and Continuation Page,” and, if necessary, NRC Forms 542/542A, “Uniform Low-Level Radioactive Waste Manifest Index and Regional Compact Tabulation,” are collectively referred to as the Uniform LLRW Manifest Forms. The forms were originally developed by the NRC at the request of low-level waste industry groups, and Federal and State agencies. These forms assist in providing a standardized nationwide framework for collecting and transmitting LLRW related information from generation to disposal.

The NRC Forms 540 and 540A or Agreement State equivalent forms are used on a nationwide basis to reflect the minimum safety-related information for an LLRW shipment as required by Federal and State reporting requirements for the safe transportation and disposal of LLRW. The Uniform LLRW Manifest Form 540/540A is completed by shippers of LLRW intended for disposal at a licensed LLRW land disposal facility. These NRC forms include information about the shipper, carrier and designated disposal facility, and specific information about the contents of the shipment, e.g., radionuclides, physical and chemical form and total weight or volume. The completed NRC Manifest Form 540 also contains information necessary to satisfy the Department of Transportation (DOT) regulations in 49 CFR part 172, “Hazardous Materials Table, Special Provisions, Hazardous Materials Communications, Emergency Response Information, Training Requirements, and Security Plans.” These forms must physically accompany the LLRW shipment. The NUREG/BR-0204, Revision 3, contains instructions for completing NRC Uniform LLRW Manifest Forms.

As stated in 10 CFR part 20, appendix G, “Licensees need not use originals of these NRC forms as long as any substitute forms are equivalent to the original documentation in respect to content, clarity, size, and location of information . . .” The NRC previously noticed the availability of revisions to the Uniform LLRW Manifest Forms in the Federal Register on November 23, 2022 (87 FR 71692). The information collection contained in the current extension request does not include any changes to the forms.

The NRC is seeking comments that address the following questions:

1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? Please explain your answer.

2. Is the estimate of the burden of the information collection accurate? Please explain your answer.

3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?

4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?

Please refer to Docket ID NRC-2025-0077 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2025-0077. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC-2025-0077 on this website.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin ADAMS Public Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to PDR.Resource@nrc.gov. A copy of the collection of information and related instructions may be obtained without charge by accessing ADAMS Accession No. ML25150A318. The supporting statement and burden spreadsheet are available in ADAMS under Accession Nos. ML25120A349 and ML25120A388, respectively.

• NRC's PDR: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.

• NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Acting Clearance Officer, Heather Dempsey, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0856 email: Infocollects.Resource@nrc.gov.

The NRC encourages electronic comment submission through the Federal rulemaking website ( https://www.regulations.gov ). Please include Docket ID NRC-2025-0077, in your comment submission.

The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at https://www.regulations.gov and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized as follows.

1. The title of the information collection: Scheduling Information for the Licensing of Accident Tolerant, Higher Burnup, and Increased Enrichment Fuels.

2. OMB approval number: 3150-0258.

3. Type of submission: Extension.

4. The form number, if applicable: Not applicable.

5. How often the collection is required or requested: Annually.

6. Who will be required or asked to respond: All holders of operating licenses for nuclear power reactors under the provisions of part 50 of title 10 of the Code of Federal Regulations (10 CFR), “Domestic Licensing of Production and Utilization Facilities,” or holders of a combined license under 10 CFR part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants,” except those that have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel. All holders of licenses and potential applicants for a fuel cycle facility under the provisions of 10 CFR part 70, “Domestic Licensing of Special Nuclear Material,” and holders of licenses and Certificates of Compliance and potential applicants for transportation and storage systems under the provisions of 10 CFR part 71, “Packaging and Transportation of Radioactive Material,” and 10 CFR part 72, “Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater than Class C Waste.”

7. The estimated number of annual responses: 14.

8. The estimated number of annual respondents: 14.

9. The estimated number of hours needed annually to comply with the information collection requirement or request: 140.

10. Abstract: The accident tolerant fuel (ATF) program is a joint effort between the U.S. nuclear industry and the U.S. Department of Energy to design and pursue approval of various fuel types with enhanced accident tolerance. The ATF program includes development of technologies that would extend fuel burnup and enrichment limits beyond currently authorized levels. In order to deploy these new technologies, the industry will need to seek authorization for various activities throughout the fuel cycle, from fuel fabrication, transportation, and storage to installation and utilization in a reactor. In order to support the timely processing of licensing activities needed to support the deployment of these new technologies, the NRC is seeking scheduling information for licensing submittals from all respondents. This information will allow the NRC to better allocate its resources to support the activities associated with licensing these technologies while being better able to meet the industry's desired timeline.

The NRC is seeking comments that address the following questions:

1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? Please explain your answer.

2. Is the estimate of the burden of the information collection accurate? Please explain your answer.

3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?

4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?

Please refer to Docket ID NRC-2025-0044 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2025-0044. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC-2025-0044 on this website.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin ADAMS Public Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to PDR.Resource@nrc.gov. A copy of the NRC Forms 542 and 542A and related instructions may be obtained without charge by accessing ADAMS Accession Nos. ML25167A156, and ML25167A157, respectively and ML20178A433 (NUREG-BR-0204, Revision 3). The supporting statement is available in ADAMS under Accession Nos. ML25167A153.

• NRC's PDR: The PDR, where you may examine and order copies of publicly available documents, is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m. eastern time (ET), Monday through Friday, except Federal holidays.

• NRC's Clearance Officer: A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Acting Clearance Officer, Heather Dempsey, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0856 email: Infocollects.Resource@nrc.gov.

The NRC encourages electronic comment submission through the Federal rulemaking website ( https://www.regulations.gov ). Please include Docket ID NRC-2025-0044, in your comment submission.

The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at https://www.regulations.gov and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC is requesting public comment on its intention to request the OMB's approval for the information collection summarized as follows.

1. The title of the information collection: NRC Forms 542 and 542A, “Uniform Low-Level Radioactive Waste Manifest Index and Regional Compact Tabulation and Continuation Page.”

2. OMB approval number: 3150-0165.

3. Type of submission: Extension.

4. The form number, if applicable: NRC Forms 542 and 542A.

5. How often the collection is required or requested: NRC Form 542 and 542A, or the Agreement State equivalent forms are required when low-level radioactive waste (LLRW) is shipped by waste collectors and waste processors, for ultimate disposal at a licensed LLRW disposal facility.

6. Who will be required or asked to respond: NRC Form 542 and continuation Form 542A are completed by waste collectors and waste processors who ship LLRW for ultimate disposal at a licensed LLRW disposal facility.

7. The estimated number of annual responses: 623.

8. The estimated number of annual respondents: 71.

9. The estimated number of hours needed annually to comply with the information collection requirement or request: 467.

10. Abstract: The NRC regulations in section 20.2006 of title 10 of the Code of Federal Regulations (10 CFR), “Transfer for Disposal and Manifest” and 10 CFR part 20, appendix G, “Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests,” established requirements for a nationwide system to ensure the safe and efficient transportation and disposal of LLRW. The Uniform LLRW Manifest system is implemented by the utilization of specific NRC forms to document the information required by 10 CFR 20.2006 and 10 CFR part 20, appendix G. The NRC Forms 542/542A, “Uniform LLRW Manifest Index and Regional Compact Tabulation and Continuation Page,” combined with NRC Forms 540/540A, “Uniform LLRW Manifest (Shipping Paper) and Continuation Page” and NRC Forms 541/541A, “Uniform LLRW Manifest Container and Waste Description and Continuation Page,” are collectively referred to as the Uniform LLRW Manifest Forms. The forms were originally developed by the NRC at the request of low-level waste industry groups, and Federal and State agencies. These forms assist in providing a standardized nationwide framework for collecting and transmitting LLRW related information from generation to disposal.

The NRC Forms 542 and 542A or Agreement State equivalent forms are used on a nationwide basis to reflect the minimum safety related information for an LLRW shipment as required by Federal and State reporting requirements for the safe transportation and disposal of LLRW. The forms are completed by waste processors and waste collectors of LLRW that are shipping LLRW received from various waste generators to a licensed LLRW facility for disposal. The NRC Forms 542 and 542A are used to attribute LLRW to the original waste generator for regional waste compact tabulation in accordance with the LLRW Policy Amendments Act of 1985. This information includes generator identification number, generator's name, phone number, address, manifest number, and description of the waste. The Uniform LLRW Manifest Forms 542/542A are not required to physically accompany the shipment. Upon agreement between the shipper and consignee, NRC Form 542/542A are (1) mailed or electronically transferred to the intended consignee prior to the shipment arriving at the consignee; or (2) delivered with the waste to the consignee. The NUREG/BR-0204, Revision 3, contains instructions for completing NRC Uniform LLRW Manifest Forms.

As stated in 10 CFR part 20, appendix G, “Licensees need not use originals of these NRC forms as long as any substitute forms are equivalent to the original documentation in respect to content, clarity, size, and location of information . . .” The NRC previously noticed the availability of revisions to the Uniform LLRW Manifest Forms in the Federal Register on November 23, 2022 (87 FR 71699). The information collection contained in the current extension request does not include any changes to the forms.

The NRC is seeking comments that address the following questions:

1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? Please explain your answer.

2. Is the estimate of the burden of the information collection accurate? Please explain your answer.

3. Is there a way to enhance the quality, utility, and clarity of the information to be collected?

4. How can the burden of the information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?