Comments are invited on: (a) Whether the proposed 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 that were 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 those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Title: Federal-State Supplemental Nutrition Programs Agreement.

Form Number: FNS-339.

OMB Number: 0584-0332.

Expiration Date: June 30, 2025.

Type of Request: Revision of a currently approved collection.

Abstract: The Federal-State Supplemental Nutrition Programs Agreement (Form FNS-339) is an annual contract between the U.S. Department of Agriculture (USDA) and each State, Territory, and Indian Tribal Government agency seeking to operate one or more of the following programs: the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), the WIC Farmers' Market Nutrition Program (FMNP), and the Seniors Farmers' Market Nutrition Program (SFMNP). The USDA's Food and Nutrition Service (FNS) is authorized to administer WIC and FMNP under 42 U.S.C. 1786, as amended, and SFMNP under 7 U.S.C. 3007, as amended.

FNS-339 requires the signature of the Chief State agency official and includes a certification/assurance regarding drug free workplace, a certification regarding lobbying, and a disclosure of lobbying activities. The signed agreement thereby authorizes USDA to make funds available to State agencies for the administration of WIC, FMNP, and/or SFMNP, and in accordance with 7 Code of Federal Regulations (CFR) parts 246, 248, and 249. The State agency agrees to accept Federal funds for expenditure in accordance with applicable statutes and regulations and to comply with all the provisions of such statutes and regulations, and amendments thereto.

This information collection is requesting a revision in the burden hours due to Program adjustments that primarily reflect expected changes in the number of WIC, FMNP, and/or SFMNP State agencies from year to year. The number of respondents (agencies administering WIC, FMNP and/or SFMNP) has increased from 127 to 132. This adjustment increased the total annual burden from 31.75 hours to 33 hours.

Affected Public: State, Territory, and Indian Tribal Government Agencies.

Estimated Number of Respondents: The total estimated number of respondents is 132. This includes an unduplicated count of respondents that are responsible for the operation of 88 WIC Programs, 50 FMNP Programs, and 56 SFMNP Programs: 58 State agencies solely operate WIC, 3 State agencies solely operate FMNP; 24 State agencies solely operate SFMNP; 15 State agencies operate both WIC and FMNP; 17 State agencies operate both FMNP and SFMNP; and 15 State agencies operate WIC, FMNP, and SFMNP.

Estimated Number of Responses per Respondent: 2; There is one response per agency for the completion of FNS-339 and one response per State agency to maintain a record of FNS-339. FNS-339 allows State agencies to select one or more of the Program(s) which they administer (WIC/FMNP/SFMNP).

Estimated Total Annual Responses: 264 responses; 132 for reporting and 132 for recordkeeping.

Estimated Time per Response: 7.5 minutes for reporting and 7.5 minutes for recordkeeping. The estimated time for each respondent to report and maintain records is 15 minutes (0.25 hours) combined. It takes respondents approximately 7.5 minutes (0.125 hours) to read and sign the required form. Additionally, respondents spend another 7.5 minutes (0.125 hours) maintaining records each year. Therefore, the number of hours spent per each of the 132 reports per year is 15 minutes (0.25 hours) totaling the requested 33 burden hours.

Estimated Total Annual Burden on Respondents: The total estimated annual burden for reporting is 16.5 and the total estimated annual burden for recordkeeping is 16.5 for a grand total estimate of 33 hours. See the table below for the estimated total annual burden for each type of respondent and each activity.

The purpose of the meeting is to:

1. Introduce National Urban and Community Forestry Council members and guests.

2. Discuss the National Ten-Year Action Plan Five-Year Benchmark Accomplishment Report;

3. Preparation for the Next Ten-Year Action Plan (2027-2037);

4. Approve meeting minutes;

5. Schedule the next meeting; and

6. Other.

The agenda will include time for individuals to make oral statements of three minutes or less. Individuals wishing to make an oral statement should make a request in writing at least three days prior to the meeting date to be scheduled on the agenda. Written comments may be submitted to the Forest Service up to 5 days after the meeting date listed under DATES .

Please contact the person listed under FOR FURTHER INFORMATION CONTACT , by or before the deadline, for all questions related to the meeting. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received upon request.

Meeting Accommodations: The meeting location is compliant with the Americans with Disabilities Act, and the USDA provides reasonable accommodation to individuals with disabilities where appropriate. If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpretation, assistive listening devices, or other reasonable accommodation to the person listed under the FOR FURTHER INFORMATION CONTACT section or contact USDA's TARGET Center at (202) 720-2600 (voice and TTY) or USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

Equal opportunity practices, in accordance with USDA policies, will be followed in all membership appointments to the Committee.

In accordance with Federal civil rights law and U.S. Department of Agriculture (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.

This Committee meeting is available to the public through the registration link above. Any interested members of the public may attend this meeting. An open comment period will be provided to allow members of the public to make oral statements as time allows. Pursuant to the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the meeting platform. To request additional accommodations, please email svillanueva@usccr.gov at least 10 business days prior to the meeting.

Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the scheduled meeting. Written comments may be emailed to Sarah Villanueva at svillanueva@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at (202) 618-4158.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via the file sharing website, https://bit.ly/42t1cCA. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Coordination Unit at svillanueva@usccr.gov.

Commerce's procedures for the conduct of Sunset Reviews are set forth in its Procedures for Conducting Five-Year (Sunset) Reviews of Antidumping and Countervailing Duty Orders, 63 FR 13516 (March 20, 1998) and 70 FR 62061 (October 28, 2005). Guidance on methodological or analytical issues relevant to Commerce's conduct of Sunset Reviews is set forth in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Duty Proceedings; Final Modification, 77 FR 8101 (February 14, 2012).

In accordance with section 751(c) of the Act and 19 CFR 351.218(c), we are initiating the Sunset Reviews of the following antidumping and countervailing duty order(s) and suspended investigation(s):

As a courtesy, we are making information related to sunset proceedings, including copies of the pertinent statute and Commerce's regulations, Commerce's schedule for Sunset Reviews, a listing of past revocations and continuations, and current service lists, available to the public on Commerce's website at the following address: https://enforcement.trade.gov/sunset/. All submissions in these Sunset Reviews must be filed in accordance with Commerce's regulations regarding format, translation, and service of documents. These rules, including electronic filing requirements via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS), can be found at 19 CFR 351.303.

In accordance with section 782(b) of the Act, any party submitting factual information in an AD/CVD proceeding must certify to the accuracy and completeness of that information. Parties must use the certification formats provided in 19 CFR 351.303(g). Commerce intends to reject factual submissions if the submitting party does not comply with applicable revised certification requirements.

Pursuant to 19 CFR 351.103(d), Commerce will maintain and make available a public service list for these proceedings. Parties wishing to participate in any of these five-year reviews must file letters of appearance as discussed at 19 CFR 351.103(d). To facilitate the timely preparation of the public service list, it is requested that those seeking recognition as interested parties to a proceeding submit an entry of appearance within 10 days of the publication of the Notice of Initiation. Because deadlines in Sunset Reviews can be very short, we urge interested parties who want access to proprietary information under administrative protective order (APO) to file an APO application immediately following publication in the Federal Register of this notice of initiation. Commerce's regulations on submission of proprietary information and eligibility to receive access to business proprietary information under APO can be found at 19 CFR 351.304-306. Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information, until further notice. 1

Information Required From Interested Parties

Domestic interested parties, as defined in section 771(9)(C), (D), (E), (F), and (G) of the Act and 19 CFR 351.102(b), wishing to participate in a Sunset Review must respond not later than 15 days after the date of publication in the Federal Register of this notice of initiation by filing a notice of intent to participate. The required contents of the notice of intent to participate are set forth at 19 CFR 351.218(d)(1)(ii). In accordance with Commerce's regulations, if we do not receive a notice of intent to participate from at least one domestic interested party by the 15-day deadline, Commerce will automatically revoke the order without further review. 2

If we receive an order-specific notice of intent to participate from a domestic interested party, Commerce's regulations provide that all parties wishing to participate in a Sunset Review must file complete substantive responses not later than 30 days after the date of publication in the Federal Register of this notice of initiation. The required contents of a substantive response, on an order-specific basis, are set forth at 19 CFR 351.218(d)(3). Note that certain information requirements differ for respondent and domestic parties. Also, note that Commerce's information requirements are distinct from the ITC 's information requirements. Consult Commerce's regulations for information regarding Commerce's conduct of Sunset Reviews. Consult Commerce's regulations at 19 CFR part 351 for definitions of terms and for other general information concerning antidumping and countervailing duty proceedings at Commerce.

Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 3 An electronically filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time on the day on which it is due.

In prior proceedings we have encouraged interested parties to provide an executive summary of their comments, including footnotes. In these sunset reviews, we request that interested parties provide at the beginning of their comments, an executive summary for each issue raised in their comments. Further, we request that interested parties limit their public executive summary of each issue to no more than 450 words, not including citations. We intend to use the public executive summaries as the basis of the comment summaries included in the decision memorandum that will accompany the notice to be published in the Federal Register . Finally, we request that interested parties include footnotes for relevant citations in the public executive summary of each issue.

This notice of initiation is being published in accordance with section 751(c) of the Act and 19 CFR 351.218(c).

On August 1, 2008, Commerce published the AD order on nails from China in the Federal Register . 1 On November 4, 2024, the ITC instituted, 2 and Commerce initiated, 3 the third sunset review of the Order, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). As a result of its review, Commerce determined that revocation of the Order would likely lead to the continuation or recurrence of dumping and, therefore, notified the ITC of the magnitude of the margins of dumping rates likely to prevail should the Order be revoked. 4

On April 24, 2025, the ITC published its determination, pursuant to sections 751(c) and 752(a) of the Act, that revocation of the Order would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. 5

The merchandise covered by the Order includes certain steel nails having a shaft length up to 12 inches. Certain steel nails include, but are not limited to, nails made of round wire and nails that are cut. Certain steel nails may be of one piece construction or constructed of two or more pieces. Certain steel nails may be produced from any type of steel, and have a variety of finishes, heads, shanks, point types, shaft lengths and shaft diameters. Finishes include, but are not limited to, coating in vinyl, zinc (galvanized, whether by electroplating or hot dipping one or more times), phosphate cement, and paint. Head styles include, but are not limited to, flat, projection, cupped, oval, brad, headless, double, countersunk, and sinker. Shank styles include, but are not limited to, smooth, barbed, screw threaded, ring shank and fluted shank styles. Screw-threaded nails subject to the Order are driven using direct force and not by turning the fastener using a tool that engages with the head. Point styles include, but are not limited to, diamond, blunt, needle, chisel and no point. Finished nails may be sold in bulk, or they may be collated into strips or coils using materials such as plastic, paper, or wire. Certain steel nails subject to the Order are currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7317.00.55, 7317.00.65, 7317.00.75, and 7907.00.6000. 7

Excluded from the scope are steel roofing nails of all lengths and diameter, whether collated or in bulk, and whether or not galvanized. Steel roofing nails are specifically enumerated and identified in ASTM Standard F 1667 (2005 revision) as Type I, Style 20 nails, inclusive of the following modifications: (1) Non-collated ( i.e., hand-driven or bulk), steel nails as described in ASTM Standard F 1667 (2005 revision) as Type I, Style 20 nails, as modified by the following description: having a bright or galvanized finish, a smooth, barbed or ringed shank, an actual length of 0.500″ to 4″, inclusive; an actual shank diameter of 0.1015″ to 0.166″, inclusive; and an actual head diameter of 0.3375″ to 0.500″, inclusive; (2) Wire collated steel nails, in coils, as described in ASTM Standard F 1667 (2005 revision) as Type I, Style 20 nails, as modified by the following description: having a galvanized finish, a smooth, barbed or ringed shank, an actual length of 0.500″ to 1.75″, inclusive, an actual shank diameter of 0.116″ to 0.166″, inclusive; and an actual head diameter of 0.3375″ to 0.500″, inclusive; and (3) Non-collated ( i.e., hand-driven or bulk), as described in ASTM Standard F 1667 (2005 revision) as Type I, Style 20 nails, as modified by the following description: steel nails having a convex head (commonly known as an umbrella head), a smooth or spiral shank, a galvanized finish, an actual length of 1.75″ to 3″, inclusive; an actual shank diameter of 0.131″ to 0.152″, inclusive; and an actual head diameter of 0.450″ to 0.813″, inclusive.

Also excluded from the scope are the following steel nails: Non-collated ( i.e., hand-driven or bulk), two-piece steel nails having plastic or steel washers (caps) already assembled to the nail, having a bright or galvanized finish, a ring, fluted or spiral shank, an actual length of 0.500″ to 8″, inclusive; and an actual shank diameter of 0.1015″ to 0.166″, inclusive; and an actual washer or cap diameter of 0.900″ to 1.10″, inclusive.

Also excluded from the scope of the Order are corrugated nails. A corrugated nail is made of a small strip of corrugated steel with sharp points on one side. Also excluded from the scope of the Order are fasteners suitable for use in powder-actuated hand tools, not threaded and threaded, which are currently classified under HTSUS 7317.00.20 and 7317.00.30. Also excluded from the scope of the Order are thumb tacks, which are currently classified under HTSUS 7317.00.10.00.

Also excluded from the scope of the Order are certain brads and finish nails that are equal to or less than 0.0720 inches in shank diameter, round or rectangular in cross section, between 0.375 inches and 2.5 inches in length, and that are collated with adhesive or polyester film tape backed with a heat seal adhesive. Also excluded from the scope of the Order are fasteners having a case hardness greater than or equal to 50 HRC, a carbon content greater than or equal to 0.5 percent, a round head, a secondary reduced-diameter raised head section, a centered shank, and a smooth symmetrical point, suitable for use in gas-actuated hand tools. While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the Order is dispositive.

As a result of the determinations by Commerce and the ITC that revocation of the Order would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, Commerce hereby orders the continuation of the Order. U.S. Customs and Border Protection will continue to collect AD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise.

The effective date of the continuation of the Order will be April 24, 2025. 8 Pursuant to section 751(c)(2) of the Act and 19 CFR 351.218(c)(2), Commerce intends to initiate the next five-year reviews of the Order not later than 30 days prior to the fifth anniversary of the date of the last determination by the ITC.

This notice also serves as a final reminder to parties subject to an APO of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

This five-year (sunset) review and this notice are in accordance with sections 751(c) and 751(d)(2) of the Act and published in accordance with section 777(i) of the Act, and 19 CFR 351.218(f)(4).

On April 25, 1996, Commerce initiated the AD investigation of fresh tomatoes from Mexico. 1 On November 1, 1996, Commerce published the preliminary determination of the AD investigation of fresh tomatoes from Mexico. 2 In the Preliminary Determination, Commerce individually calculated dumping margins for San Vicente Camalu, Ernesto Fernando Echavarria Salazar Grupo Solidario, Administradora Horticola Del Tamazula, Arturo Lomeli Villalobas S.A. de C.V., Ranchos Los Pinos S. de R.L. de C.V., Agricola Yory, S. de P.R. de R.I., and Eco-Cultivos S.A. de C.V. 3 For the Preliminary Determination, the POI was March 1, 1995, through February 29, 1996. 4 Also, effective November 1, 1996, Commerce and certain producers and exporters of fresh tomatoes from Mexico signed an agreement to suspend the investigation. 5 A series of subsequent suspension agreements were negotiated and signed in 2002, 2008, and 2013. 6 Effective May 13, 2019, Commerce terminated the suspension agreement in effect and continued with this investigation in accordance with section VI.B of that suspension agreement. 7 For the continued investigation in 2019, Commerce selected new respondents for individual examination and relied on the data from these new respondents covering the period April 1, 2018 through March 31, 2019, in order to calculate the AD margins for the Final Determination. 8 The newly selected mandatory respondents that we individually examined in 2019 were Bioparques de Occidente, S.A. de C.V./Agricola La Primavera, S.A. de C.V., Ceuta Produce, S.A. de C.V./Rancho La Memoria, S. de R.L. de C.V., and Negocio Agricola San Enrique, S.A. de C.V. 9 Effective September 19, 2019, Commerce suspended the AD investigation of fresh tomatoes from Mexico. 10 On October 25, 2019, Commerce published its Final Determination in the AD investigation of fresh tomatoes from Mexico. 11 No AD order was issued because the 2019 suspension agreement still “remain{ed} in effect.”  12

The USCRTF meeting provides a forum for coordinated planning and action among Federal agencies, State and territorial governments, and non-governmental partners. Registration is requested to participate in the meeting. This meeting has time allotted for public oral comment from 1 p.m. to 1:30 p.m. ET. A written summary of the meeting will be posted on the USCRTF website within two months of occurrence. For more information about the meeting, and registering for the meeting, visit https://www.coralreef.gov/.

The Middle-Class Tax Relief and Job Creation Act of 2012 (Act) created the First Responder Network Authority (FirstNet Authority) as an independent authority within NTIA. The Act charged the FirstNet Authority with ensuring the building, deployment, and operation of a nationwide, interoperable public safety broadband network based on a single, national network architecture. 1 The FirstNet Authority holds the single nationwide public safety license granted for wireless public safety broadband deployment. The FirstNet Authority Board is responsible for providing overall policy direction and oversight of the FirstNet Authority to ensure that the nationwide network continuously meets public safety needs.

The FirstNet Authority Board is composed of 15 voting members. The Act names the Secretary of Homeland Security, the Attorney General of the United States, and the Director of the Office of Management and Budget as permanent members. The Secretary of Commerce (Secretary) appoints 12 non-permanent members. 2

The Act requires each Board member to have experience or expertise in at least one of the following substantive areas: public safety, network, technical, and/or financial. 3 Additionally, the composition of the FirstNet Authority Board must satisfy the other requirements specified in the Act, including that: (i) at least three members have served as public safety professionals; (ii) at least three members represent the collective interests of states, localities, tribes, and territories; and (iii) its members reflect geographic and regional, as well as rural and urban, representation. 4 An individual Board member may satisfy more than one of these requirements. The current non-permanent FirstNet Authority Board members are (noting expiration of term):

Any Board member whose term has expired may serve until such member's successor has taken office, or until the end of the calendar year when such member's term has expired, whichever is earlier. 5 Board members will be appointed for a term of three years. They may not serve more than two consecutive full three-year terms. 6 More information about the FirstNet Authority Board is available at www.firstnet.gov/about/Board. Since one appointment in 2025 will be filling a mid-term vacancy, that newly appointed member will complete the existing term as a board member until September 2027.

FirstNet Authority Board members are appointed as government employees. FirstNet Authority Board members are compensated at the daily rate of basic pay for level IV of the Executive Schedule (approximately $195,200 per year) for each day worked ($748.24 per day) on the FirstNet Authority Board. 7 Board members work intermittent schedules and may not work more than 130 days per year during their term. Each Board member must be a United States citizen, cannot be a registered lobbyist, and cannot be a registered agent of, employed by, or receive payments from, a foreign government. 8

FirstNet Authority Board members must comply with certain federal conflict of interest statutes and ethics regulations, including some financial disclosure requirements. A FirstNet Authority Board member will generally be prohibited from participating in any FirstNet Authority matter that will have a direct and predictable effect on his or her personal financial interests or on the interests of the appointee's spouse, minor children, or non-federal employer.

At the direction of the Secretary, NTIA will conduct outreach to the public safety community, state and local organizations, and industry to solicit nominations for candidates to the Board who satisfy the statutory requirements for membership. In addition, through NTIA, the Secretary will accept expressions of interest from any individual or organization proposing a candidate who satisfies the statutory requirements for membership on the FirstNet Authority Board. To be considered for a calendar year 2025 appointment, expressions of interest must be electronically transmitted on or before June 2, 2025.

All parties submitting an expression of interest should submit the candidate's: (i) full name, title, organization, address, telephone number, and email address; (ii) current resume; (iii) brief biography; (iv) statement of qualifications that references how the candidate satisfies the Act's expertise, representational, and geographic requirements for FirstNet Authority Board membership, as described in this Notice; and (v) a statement describing why the candidate wants to serve on the FirstNet Authority Board, affirming their ability and availability to take a regular and active role in the Board's work.

The Secretary will select FirstNet Authority Board candidates based on the Act's eligibility requirements and NTIA's recommendations. NTIA will recommend candidates based on an assessment of qualifications and demonstrated ability to work collaboratively to achieve the goals and objectives of the FirstNet Authority as set forth in the Act. NTIA may consult with FirstNet Authority Board members or executives to make its recommendation. Board candidates will be vetted through the Department of Commerce and are subject to an appropriate background check for security clearance.

I. Abstract

The USPTO Quality Survey is designed to measure opinions about the services the USPTO provides to its patent application customers. This information collection contains a survey that the USPTO uses to gauge customer satisfaction with patent examination quality.

The results from this voluntary survey will assist the USPTO in guiding improvements and enhancements in the future. The USPTO conducts the Patents External Quality Survey as part of its quality improvement efforts. This survey narrows the focus of customer satisfaction to examination quality and uses a longitudinal, rotating panel design to assess changes in customer perceptions and to identify key areas for examiner training and opportunities for improvement. The USPTO uses this survey to identify problems with examination quality and works to resolve these issues in a timely manner. The USPTO surveys patent agents, attorneys, and other individuals from large domestic corporations (including those with 500+ employees), small and medium-sized businesses, independent inventors, and universities and other non-profit research organizations. This survey does not include foreign entities.

The random sample used in this survey is drawn from One Patent Service Gateway. The sample population is drawn from the top filing firms, which are entities that have filed more than five patent applications in a 12-month period. This ongoing survey is generally conducted twice a year. The USPTO uses a rotating panel design where participants take the survey twice in back-to-back survey periods (waves). Half the participants in each survey period are new and complete the survey for the first time and half return to complete the same survey for a second time. This design allows a precise measurement of changes in customer experience over time. The rotating panels and their impact on respondents are described in more detail in the table below.

The Patents External Quality Survey is primarily a web-based survey, although respondents can also complete the survey via paper and mail if they prefer. Both versions are identical. The USPTO sends potential respondents either an email or mailed pre-survey letter, depending on the respondent's preferred method of contact. At the beginning of each survey period, the USPTO provides respondents with instructions for accessing and completing the survey electronically. After a specified response period, the USPTO sends a survey packet to all sample members who have not yet submitted a response. The packet contains the questionnaire, a separate cover letter, and a postage-paid pre-addressed return envelope. Sampled members receiving a paper survey can still complete the survey electronically if they prefer. The USPTO also uses reminder/thank-you postcards and telephone calls to encourage a response from sample members.

The survey may be submitted electronically or in paper form via mail.

OMB Control Number: 0651-0057.

Forms:

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

Affected Public: Private sector.

Respondent's Obligation: Voluntary.

Frequency: On occasion.

Estimated Number of Annual Respondents: 750 respondents.

Estimated Number of Annual Responses: 1,000 responses.

Estimated Time per Response: The USPTO estimates that the responses in this information collection will take the public approximately 10 minutes (0.17 hours) to complete. This includes the time to gather the necessary information, create the document, and submit the completed item to the USPTO.

Estimated Total Annual Respondent Burden Hours: 171 hours.

Estimated Total Annual Respondent Hourly Cost Burden: $76,437.

Estimated Total Annual Respondent Non-hourly Cost Burden: $0. There are no capital start-up costs, maintenance costs, recordkeeping costs, filing fees, or postage costs associated with this information collection. The USPTO covers the costs of all survey materials and provides postage-paid, pre-addressed return envelopes for the surveys that are returned by mail.

The USPTO is soliciting public comments to:

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

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

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

(d) 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.

All comments submitted in response to this notice are a matter of public record. The USPTO will include or summarize each comment in the request to OMB to approve this information collection. Before including an address, phone number, email address, or other personally identifiable information (PII) in a comment, be aware that the entire comment—including PII—may be made publicly available at any time. While you may ask in your comment to withhold PII from public view, the USPTO cannot guarantee that it will be able to do so.

In a notice published in the Federal Register of April 24, 2025, at 90 FR 17248, “Notice of determination of policy-making positions”, the DNFSB announced its determination that the Deputy General Counsel position is of a policy-determining and policy-advocating character and is not normally subject to change as a result of a Presidential transition. Accordingly, the notice further announced that the position is designated as a Schedule Policy/Career position.

The Federal Register notice announcing this determination and designation is withdrawn. No positions have been designated as Schedule Policy/Career.

I. Executive Summary A. Does this action apply to me?

This action provides information that is directed to the public in general.

EPA is taking this action pursuant to section 3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136a(c)(4), and 40 CFR 152.102.

EPA is hereby providing notice of receipt and opportunity to comment on applications to register pesticide products containing currently registered active ingredients that would entail a changed use pattern. Notice of receipt of these applications does not imply a decision by the Agency on these applications. The applications identified in this document have been received and are currently being evaluated by EPA. For actions being evaluated under EPA's public participation process for registration actions, there will be an additional opportunity for public comment on the proposed decisions. Please see EPA's public participation website for additional information on this process ( https://www.epa.gov/pesticide-registration/public-participation-process-registration-actions ).

1. Submitting CBI. Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. In addition to one complete version of the comment that includes CBI, a copy of the comment without CBI must be submitted for inclusion in the public docket. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

This unit provides the following information about the applications that have been received and are currently being evaluated by EPA: The EPA File Symbol or Registration number(s); EPA docket ID number for the application; Name and address of the applicant; Name of the active ingredient, product type and proposed uses; and the division to contact for that application. Additional information about the application may also be available in the related docket identified for the application.

• EPA Registration Number: 89633-5. Docket ID number: EPA-HQ-OPP-2024-0412.

Applicant: Moghu Research Center, Ltd. c/o to Xcel, LLC, 7140 Heritage Village Plaza, Gainesville, VA 20155. Active ingredient: Methiozolin. Product type: Herbicide. Proposed uses: Residential lawns, Sports and recreational turf fields, and Sod farms. Contact: RD.

• EPA Registration Number: 101563-5. Docket ID number: EPA-HQ-OPP-2025-0081.

Applicant: ENVU Environmental Science U.S., LLC. Active ingredient: Flupyradifurone. Product type: Insecticide. Proposed use: Poultry houses. Contact: RD.

• EPA File Symbol: 264-REGU. Docket ID number: EPA-HQ-OPP-2024-0348.

Applicant: Bayer CropScience LP., 800 N. Lindbergh Blvd., St. Louis, MO 63167. Active ingredient: 2,4-D Trolamine Salt. Product type: Herbicide. Proposed use: Preplant, preemergence and postemergence use on Genetically engineered (GE) soybeans; preplant and preemergence use on non-GE corn; preplant use on non-GE cotton; preplant use on non-GE soybeans; use on fallow to be planted to corn, cotton, and soybean. Contact: RD.

Authority: 7 U.S.C. 136 et seq.

Background: The SAB is a chartered Federal Advisory Committee, established in 1978 under the authority of the Environmental Research, Development and Demonstration Authorization Act (ERDDAA), codified at 42 U.S.C. 4365, to provide independent scientific and technical peer review, consultation, advice, and recommendations to the EPA Administrator on the scientific bases for EPA's actions and programs. Members of the SAB constitute distinguished bodies of non-EPA scientists, engineers, economists, and behavioral scientists who are nationally and internationally recognized experts in their respective fields. Members are appointed by the EPA Administrator for a two or three-year term and serve as Special Government Employees who provide independent expert advice to the agency. All the work of SAB committees and ad-hoc panels is conducted under the auspices of the chartered SAB. Additional information about the SAB is available at https://sab.epa.gov.

Expertise Sought for the SAB: The chartered SAB provides scientific advice to the EPA Administrator on a variety of EPA science and research topics. All the work of SAB standing committees and ad-hoc panels is conducted under the auspices of the chartered SAB. The chartered SAB reviews all SAB standing committee and ad-hoc panel draft reports and determines whether each exhibits the high quality and meets the SAB's criteria to deliver to the EPA Administrator. The SAB Staff Office invites nominations of individuals to serve on the chartered SAB with expertise or extensive experience in the following scientific disciplines and topics as they relate to human health and the environment: air quality; agricultural sciences and economics; analytical chemistry; atmospheric sciences; benefit-cost analysis; biostatistics; citizen science; community environmental health; dose-response assessment; drinking water; drinking water engineering; ecological sciences; ecological risk assessment; ecosystem services; economics; energy and the environment; engineering; epidemiology; exposure assessment; forestry; geochemistry; health sciences; human health risk assessment; hydrology; hydrogeology; medicine; microbiology; modeling; pediatrics; chemical risk assessment, public health; physiologically based pharmacokinetic (PBPK) modeling; risk assessment; social, behavioral and decision sciences; statistics; sustainability; radiological risk assessment; toxicology; uncertainty analysis; water quality; water quantity and reuse; and waste management.

Members selected to the chartered SAB may also participate on standing committees of the SAB. Board members with demonstrated scientific credentials, disciplinary expertise in relevant fields, and experience may be asked to participate on the following SAB Standing Committees:

(1) The Agricultural Science Committee, which provides advice to the chartered SAB on matters that have been determined to have a significant direct impact on farming and agriculture-related industries.

(2) The Chemical Assessment Advisory Committee, which provides advice to the chartered SAB regarding selected toxicological reviews of environmental chemicals.

(3) The Drinking Water Committee, which provides advice to the chartered SAB on the scientific and technical aspects of EPA's national drinking water program.

(4) The Economic Analysis Committee, which provides advice to the chartered SAB on the economic analysis of EPA programs.

(5) The Radiation Advisory Committee, which provides advice to the chartered SAB on radiation protection, radiation science, and radiation risk assessment. Selection Criteria for the SAB and the SAB Committees include:

As the SAB and its standing committees undertake specific advisory activities, the SAB Staff Office will consider two additional criteria for each new activity: absence of financial conflicts of interest and absence of an appearance of a loss of impartiality.

How To Submit Nominations: Any interested person or organization may nominate qualified persons to be considered for appointment to these advisory committees. Individuals may self-nominate. Nominations should be submitted in electronic format (preferred) using the online nomination form on the SAB home page at https://sab.epa.gov. To be considered, all nominations should include the information requested below.

Nominators are asked to identify the specific committee for which nominees are to be considered. The following information should be provided on the nomination form: contact information for the person making the nomination; contact information for the nominee; the disciplinary and specific areas of expertise of the nominee; the nominee's curriculum vitae; and a biographical sketch (if available) of the nominee indicating current position, educational background; research activities; sources of research funding for the last two years; and recent service on other national advisory committees or national professional organizations.

To help the agency evaluate the effectiveness of its outreach efforts, please indicate how you learned of this nomination opportunity. Persons having questions about the nomination process, or the public comment process described below, or those who are unable to submit nominations through the SAB website, should contact a DFO as identified above. The SAB Staff Office will acknowledge receipt of nominations and will invite the nominee to provide any additional information that the nominee feels would be useful in considering the nomination, such as interest to participate as a member of a committee; and address any questions the nominee has regarding membership. The names and biosketches of qualified nominees identified by respondents to this Federal Register notice, and any additional experts identified by the SAB Staff Office, will be posted in a List of Candidates on the SAB website at https://sab.epa.gov. Public comments on each List of Candidates will be accepted for 21 days from the date the list is posted. The public will be requested to provide relevant information or other documentation on nominees that the SAB Staff Office should consider in evaluating candidates.

Candidates invited to serve will be asked to submit the “Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection Agency” (EPA Form 3110-48). This confidential form allows EPA to determine whether there is a statutory conflict between that person's public responsibilities as a Special Government Employee and private interests and activities, or the appearance of a loss of impartiality, as defined by Federal regulation. The form may be viewed and downloaded through the “Ethics Requirements for Advisors” link on the SAB home page at https://sab.epa.gov. This form should not be submitted as part of a nomination.

Background: The CASAC is a chartered Federal Advisory Committee, established pursuant to the Clean Air Act (CAA) Amendments of 1977, codified at 42 U.S.C. 7409(d)(2), to review air quality criteria and National Ambient Air Quality Standards (NAAQS) and recommend to the EPA Administrator any new NAAQS and revisions of existing criteria and standards as may be appropriate. The CASAC shall also: advise the EPA Administrator of areas in which additional knowledge is required to appraise the adequacy and basis of existing, new, or revised NAAQS; describe the research efforts necessary to provide the required information; advise the EPA Administrator on the relative contribution to air pollution concentrations of natural as well as anthropogenic activity; and advise the EPA Administrator of any adverse public health, welfare, social, economic, or energy effects which may result from various strategies for attainment and maintenance of such NAAQS. Members of the CASAC constitute a distinguished body of non-EPA scientists and engineers who are nationally and internationally recognized experts in their respective fields. Members are appointed by the EPA Administrator and serve for a two to three-year term as Special Government Employees who provide independent expert advice to the agency. Additional information is available at https://casac.epa.gov.

Expertise Sought for the CASAC: As required under the CAA section 109(d), the CASAC is composed of seven members, with at least one member of the National Academy of Sciences, one physician, and one person representing state air pollution control agencies. The SAB Staff Office is seeking nominations of experts to serve on the CASAC with expertise in one or more of the following disciplines: air quality, biostatistics, ecology, environmental engineering, epidemiology, exposure assessment, medicine, risk assessment, and toxicology. The SAB Staff Office is especially interested in scientists with expertise described above who have knowledge and experience relating to criteria pollutants (carbon monoxide, lead, nitrogen oxides, ozone, particulate matter, and sulfur oxides).

Selection Criteria for the CASAC: Nominees are selected based on their individual qualifications. Curriculum vitae should reflect the following:

As the committee undertakes specific advisory activities, the SAB Staff Office will consider two additional criteria for each new activity: absence of financial conflicts of interest and absence of an appearance of a loss of impartiality.

How To Submit Nominations: Any interested person or organization may nominate qualified persons to be considered for appointment to this advisory committee. Individuals may self-nominate. Nominations should be submitted in electronic format (preferred) using the online nomination form under “Nomination of Experts” on the CASAC home page at https://casac.epa.gov. To be considered, all nominations should include the information requested below.

The following information should be provided on the nomination form: contact information for the person making the nomination; contact information for the nominee; and the disciplinary and specific areas of expertise of the nominee. Nominees will be contacted and asked to provide additional information, including a curriculum vitae and biographical sketch (indicating current position, educational background, research activities, sources of research funding for the last two years, and recent service on other national advisory committees or national professional organizations). To help the agency evaluate the effectiveness of its outreach efforts, please indicate how you learned of this nomination opportunity. Persons having questions about the nomination process, or the public comment process described below, or who are unable to submit nominations through the CASAC website, should contact the DFO, as identified above. The DFO will acknowledge receipt of nominations and will invite the nominee to provide any additional information that the nominee feels would be useful in considering the nomination, such as availability to participate as a member of the committee; how the nominee's background, skills and experience would help broaden the perspectives on the committee; and any questions the nominee has regarding membership. The names and biosketches of qualified nominees identified by respondents to this Federal Register notice, and additional experts identified by the SAB Staff Office, will be posted in a List of Candidates on the CASAC website at https://casac.epa.gov. Public comments on each List of Candidates will be accepted for 21 days from the date the list is posted. The public will be requested to provide relevant information or other documentation on nominees that the SAB Staff Office should consider in evaluating candidates.

Candidates may be asked to submit the “Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection Agency” (EPA Form 3110-48). This confidential form is required for Special Government Employees (SGEs) and allows EPA to determine whether there is a statutory conflict between that person's public responsibilities as an SGE and private interests and activities, or the appearance of a loss of impartiality, as defined by Federal regulation. The form may be viewed and downloaded through the “Ethics Requirements for Advisors” link on the CASAC home page at https://casac.epa.gov. This form should not be submitted as part of a nomination.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection helps support implementation of FDA's authority over food additives intended for use in animal food. Misbranded foods are prohibited under section 403 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343); food additives are covered in section 409 of the FD&C Act (21 U.S.C. 348), which provides, at section 409(a) of the FD&C Act, that a food additive shall be deemed to be unsafe unless its use is permitted by a regulation that prescribes the condition(s) under which it may safely be used, or unless it is exempted by regulation for investigational use. Section 409(b) of the FD&C Act provides for petitions to establish safety of food additives and specifies information that must be submitted to FDA before a regulation permitting its use may be issued. Agency regulation in 21 CFR part 570 sets forth general provisions applicable to food additives intended for use in animal food, provides relevant definitions, establishes principles for determining safety, and explains prescribed elements to be included in a Generally Recognized as Safe (GRAS) notice. The regulation also provides for certain exemptions for investigational use and discusses related procedures. Agency regulation in 21 CFR part 571 establishes procedural requirements applicable to the submission of petitions filed under section 409(b) of the FD&C Act, including content and format elements to facilitate FDA processing of a food additive petition. Finally, Agency regulation in 21 CFR part 501 establishes disclosure requirements for animal food labeling, including the disclosure of the presence of certified and noncertified color additives (21 CFR 501.22(k)). Additional disclosure requirements are found in 21 CFR parts 573 (food additives permitted in feed and drinking water of animals) and 579 (irradiation in the production, processing, and handling of animal food), and are included in the scope of coverage for the information collection.

We are revising the information collection to include related authority established through enactment of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (2018 Amendments) (Pub. L. 115-234). Intending to help ensure the safety of pet food, section 306(c) of the 2018 Amendments provides for the issuance of guidance on pre-petition consultations for animal food additives. We have issued the following guidance documents to assist respondents in this regard:

Guidance for Industry (GFI) #262, “Pre-Submission Consultation Process for Animal Food Additive Petitions or Generally Recognized as Safe (GRAS) Notices” (December 2020), is available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-262-pre-submission-consultation-process-animal-food-additive-petitions-or-generally. The guidance document describes the types of information our Center for Veterinary Medicine recommends be included in:

1. pre-petition consultations prior to submission of food additive petitions (FAP) for food additives intended for use in animal food;

2. pre-submission consultations regarding an animal food substance for which an entity plans to provide notice of its conclusion that the intended use of the substance is GRAS under FDA's animal food GRAS Notification program; or

3. a Food Use Authorization request to permit the use, in human or animal foods, of animal products derived from animals that have been administered an investigational substance intended for use in animal food.

Additionally, GFI #294, “Animal Food Ingredient Consultation (AFIC)” (January 2025), available for download at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-294-animal-food-ingredient-consultation-afic, describes the AFIC process, which provides for a way, within the regulatory framework, for firms that are developing animal food ingredients to consult with FDA, and for FDA to review information from developers and the public regarding the ingredients and any relevant safety concerns. The AFIC process includes opportunities for public awareness of, and input on, the ingredients for which FDA is providing consultation. The guidance document also explains that FDA generally would not intend to take enforcement action against an ingredient for being an unapproved animal food additive if FDA has sent an AFIC “consultation complete” letter, provided the ingredient is used in accordance with the terms described in the letter and there continues to be no questions or concerns about the safety of the ingredient.

Description of Respondents: Respondents to this collection of information are animal food manufacturers or animal food additive manufactures. With regard to submission activities, we assume 2,508 respondents based on the number of registrants who identify as animal food additive manufacturers. With regard to labeling activities under 21 CFR 501.22(k), we assume 3,120 respondents based on information found in previous Agency rulemaking (RIN-0910AG02) regarding declarations for animal food product labels.

In the Federal Register of December 19, 2024 (89 FR 103838), we published a 60-day notice soliciting public comment on the proposed collection of information. One comment was received offering general support for the utility of the information collection.

We have determined that food additive petitions and investigational food additive files that are submitted, fall into one of two categories of complexity. Fluctuations in the number and types of food and color additive petitions received in any given year are governed by market forces.

§ 571.1(c) Moderate Category: For a food additive petition without complex chemistry, manufacturing, efficacy and/or safety issues, the estimated time requirement per petition is approximately 3,000 hours. We estimate that, annually, 3 respondents will submit 1 such petition, for a total of 9,000 hours.

§ 571.1(c) Complex Category: For a food additive petition with complex chemistry, manufacturing, efficacy and/or safety issues, the estimated time requirement per petition is approximately 10,000 hours. We estimate that, annually, 3 respondents will each submit 1 such petition, for a total of 30,000 hours.

§ 571.6 Amendment of Petition: For a food additive petition amendment, the estimated time requirement per petition is approximately 1,300 hours. We estimate that, annually, 5 respondents will each submit 1 such amendment, for a total of 6,500 hours.

§ 570.17 Moderate Category: For an investigational food additive file without complex chemistry, manufacturing, efficacy and/or safety issues, the estimated time requirement per file is approximately 1,500 hours. We estimate that, annually, 8 respondents will each submit 1 such file, for a total of 12,000 hours.

§ 570.17 Complex Category: For an investigational food additive file with complex chemistry, manufacturing, efficacy and/or safety issues, the estimated time requirement per file is approximately 5,000 hours. We estimate that, annually, 10 respondents will each submit 1 such file, for a total of 50,000 hours.

Consultation Category: We estimate developers of animal food ingredients will spend 3,000 hours consulting with FDA on an ingredient. We estimate that, annually, 12 respondents will consult with FDA, for a total of 36,000 hours.

The labeling requirements for food and color additives were designed to specify the minimum information needed for labeling in order that food and color manufacturers may comply with all applicable provisions of the FD&C Act and other specific labeling acts administered by FDA. Label information does not require any additional information gathering beyond what is already required to assure conformance with all specifications and limitations in any given food or color additive regulation. Label information does not have any specific recordkeeping requirements unique to preparing the label. Therefore, because labeling requirements for a particular color additive or food additive involve information required as part of the safety review process, the burden hours for labeling are included in the estimate for 21 CFR 501.22(k) and 571.1.

We base our estimate of the total annual responses on submissions received over the last 3 years. We base our estimate of the hours per response on our experience with the labeling, food additive petition, and filing processes.

Based on review of the information collection, there was a decrease of food additive petition (FAP) responses and a corresponding decrease in burden hours for FAPs. We attribute this adjustment to an increase in the number of GRAS notices (21 CFR part 570, subpart E) received, which tend to substitute for FAP submissions due to a similar quantity and quality of data and information requirement. These numbers can fluctuate year to year. We also note that investigational food additive file responses have increased due to more respondents providing information during the premarket process prior to providing a more formal regulatory response ( e.g., FAP or GRAS notice). We did not adjust the number of responses received for the declaration of color additives on animal food labels from the previous collection.

Our estimated burden for the information collection reflects an overall increase of 40,600 total hours and 24 responses. We attribute this to accounting for the consultation process for firms developing animal food ingredients.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection helps support implementation of Agency statutory and regulatory requirements regarding new animal drugs containing an antimicrobial active ingredient. Sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient are required by section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b) to submit to FDA an annual report on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals. Sponsors are also required to maintain distribution records for their animal drug products, including separate information for each month of the calendar year, under section 512(l)(3) of the FD&C Act. These provisions were enacted to assist FDA in our continuing analysis of the interactions (including drug resistance), efficacy, and safety of antimicrobials approved for use in both humans and food-producing animals for the purpose of mitigating the public health risk associated with antimicrobial resistance.

Section 514.87 of our regulations (21 CFR 514.87) codifies the reporting requirements established in the FD&C Act. Sponsors submit antimicrobial animal drug sales and distribution reports to us on Form FDA 3744. Each report must specify: (1) the amount of each antimicrobial active ingredient by container size, strength, and dosage form; (2) quantities distributed domestically and quantities exported; and (3) a listing of the target animals, indications, and production classes that are specified on the approved label of the product. The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year. Each report must also provide a species-specific estimate of the percentage of each product that was sold or distributed domestically in the reporting year for use in cattle, swine, chickens, or turkeys for such species that appear on the approved label.

Description of Respondents: Animal drug manufacturers (sponsors). Respondents include individuals and the private sector (for-profit businesses).

In the Federal Register of October 24, 2024 (89 FR 84887), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four collection of information topics solicited.

FDA estimates the burden of this collection of information as follows:

We base our estimate of the average burden per response on our recent experience with the existing antimicrobial animal drug distribution reports program. We base our estimate of the number of affected respondents reported in tables 1 and 2 and the average number of responses per respondent in table 1 on a review of our records of sponsors with active and inactive applications. We estimate sponsors with active applications, who submit an annual antimicrobial annual drug sales and distribution report on paper, will spend 62 hours to assemble the necessary information, prepare, and submit to FDA. We estimate sponsors with active applications, who submit an annual antimicrobial animal drug sales and distribution report electronically, will spend 52 hours to assemble the necessary information, prepare, and submit to FDA. We estimate that sponsors with inactive applications will spend 2 hours preparing their annual antimicrobial animal drug sales and distribution reports, whether electronically or on paper.

Animal drug manufacturers are already required to maintain distribution records for their animal drug products to comply with FDA's current good manufacturing regulations for periodic drug reports under § 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)), approved under OMB control number 0910-0284. Section 512(l)(3) of the FD&C Act differs from § 514.80(b)(4)(i) in that it requires that records include separate information for each month of the calendar year. In addition, under 21 CFR 211.196 (approved under OMB control number 0910-0139), manufacturers currently are required to maintain distribution records that include dosage form, and date drug is distributed. Based on these requirements, FDA believes that manufacturers already keep detailed records of the dates when antimicrobial drugs are distributed for marketing and recall purposes from which monthly reports can be prepared as part of usual and customary business practices. However, FDA estimates an additional recordkeeping burden of 46 hours for further compliance with section 512(l)(3), as detailed in table 2.

After a review of the information collection since our last request for OMB approval, we have adjusted our estimates based on our experience with the antimicrobial animal drug distribution reports program. Our estimated burden for the information collection reflects a decrease of 54 burden hours and a corresponding decrease of 27 total annual responses. We attribute this to respondents who submitted by paper in previous years and are now reporting electronically.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection supports FDA research to obtain information about challenges and opportunities pertaining to human prescription drug compounding by outsourcing facilities. Generally, drug compounding is the practice of combining, mixing, or altering ingredients of a drug to create a medication tailored to an individual patient's needs. Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, compounded drugs also present a risk to patients. Compounded drugs are not FDA-approved; therefore, they do not undergo FDA premarket review for safety, effectiveness, and quality.

Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that must be satisfied for compounded human prescription drug products to be exempt from certain sections of the FD&C Act: (1) section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) (current good manufacturing practice (CGMP) requirements); (2) section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) (labeling of drugs with adequate directions for use); and (3) section 505 of the FD&C Act (21 U.S.C. 355) (approval of drugs under new drug applications or abbreviated new drug applications).

The Drug Quality and Security Act of 2013 (Pub. L. 113-54) created outsourcing facilities—a new industry sector of drug compounders held to higher quality standards to protect patient health. Section 503B of the FD&C Act (21 U.S.C. 353b) describes the conditions that outsourcing facilities must satisfy for drug products compounded in an outsourcing facility by or under the direct supervision of a licensed pharmacist to be exempt from the certain sections of the FD&C Act. Outsourcing facilities are intended to offer a more reliable supply of compounded drugs that hospitals, clinics, and other providers need.

FDA continues to find concerning quality and safety problems during inspections of outsourcing facilities. FDA has implemented and will continue to implement programs to support compounding quality and compliance. One initiative is FDA's Compounding Quality Center of Excellence (Center of Excellence), https://www.fda.gov/drugs/human-drug-compounding/compounding-quality-center-excellence, which was developed to focus on improving the quality of compounded human prescription drugs to promote patient safety. One of our top priorities is to help ensure that compounded drugs are safe by focusing on quality. FDA, state regulators, pharmacy associations, and compounders, including outsourcing facilities, share the responsibility of patient safety.

The Center of Excellence engages and collaborates with compounders, including outsourcing facilities, and other stakeholders to improve the overall quality of compounded drugs. Furthermore, the Center of Excellence promotes collaboration to help compounders implement robust quality management systems that are better for business and the safety of patients.

In addition, the Center of Excellence is conducting in depth research to better understand outsourcing facilities' challenges and opportunities in different areas to help guide decisions regarding future training and other engagement. Outsourcing facilities encounter the following challenges and opportunities: (1) operational barriers and opportunities related to the outsourcing facility market and business viability; (2) knowledge and operational barriers and opportunities related to compliance with Federal policies and good quality drug production; and (3) barriers and opportunities related to outsourcing facility interactions with FDA.

FDA used previous research results under this information collection to develop an understanding of the outsourcing facility sector, the sector's challenges, and opportunities for advancement. The information collected was an essential tool to help FDA identify knowledge and information gaps, operational barriers, and views on interactions with FDA. FDA has presented this information in public settings such as stakeholder meetings. Continuing this collection will enable FDA to deepen our understanding of the outsourcing facility sector and increase our efficacy in developing a Center of Excellence that is responsive to outsourcing facilities' needs. The research results will inform FDA's future activities for the Center of Excellence in the areas of communication, education, training, and other engagement with outsourcing facilities to address challenges and support advancement.

We revised the survey to improve clarity and simplify the experience for participants. We made grammatical, stylistic, format, and other editorial changes to the content. In doing so, we reduced the number of questions from 31 to 20. We anticipate a reduction in burden hours to 30 minutes (.50 hour) per survey response from our previous estimate of 1 hour per response.

Researchers engage with pharmacists, staff, and management from outsourcing facilities and similar compounding businesses, and related stakeholders and use surveys to obtain information about outsourcing facilities' challenges and opportunities. Within this context, we may pose the following questions or similar, related questions:

1. What financial and operational considerations inform outsourcing facility operational and business model decisions?

2. What factors impact developing a sustainable outsourcing facility business?

3. What financial and operational considerations inform outsourcing facility product decisions?

4. Do outsourcing facilities understand the Federal laws and policies that apply to them? What, if any, knowledge gaps do we need to address?

5. What are outsourcing facilities' challenges when implementing Federal CGMP requirements?

6. How do outsourcing facilities implement quality practices at their facilities?

7. How do outsourcing facilities develop CGMP and quality expertise? How do they obtain this knowledge, and what training do they need?

8. What are the economic consequences of CGMP noncompliance and product failures for outsourcing facilities?

9. What are outsourcing facility management and staff views on current interactions with FDA? How do they want the interactions to change?

10. What are outsourcing facilities' understanding of how to engage with FDA during and following an inspection?

Respondents to this information collection are employees at outsourcing facilities and related human prescription drug compounding businesses.

In the Federal Register of September 5, 2024 (89 FR 72410), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received four comment letters from trade organizations and industry, each containing one or more comments on the proposed collection of information.

(Comment 1) Several comments expressed appreciation for FDA's efforts in developing a comprehensive understanding of the outsourcing facility sector, its challenges, and opportunities for advancement. Other comments expressed appreciation for FDA's efforts to ensure that the survey questions capture the most important information from compounding outsourcing facilities and that the survey not place an undue burden on respondents.

(Response 1) We agree that the information being collected has utility for understanding of the outsourcing facility sector, its challenges, and opportunities for advancement and that we are making an effort to not place an undue burden on respondents.

(Comment 2) One comment suggested that certain questions focus on financial considerations and economic consequences and argued that they are not necessary for FDA's oversight of outsourcing facilities and are unrelated to FDA's public health mission and the quality and safety of compounded drugs.

(Response 2) We have considered the comments and disagree. As stated previously, the Center of Excellence is conducting this research to better understand outsourcing facilities' challenges and opportunities in different areas to help guide decisions regarding future training and other engagement. We think that an important component to understanding the challenges and opportunities that outsourcing facilities face includes gaining insight into the financial considerations that impact outsourcing facilities' operations and business models.

(Comment 3) Several comments proposed changes to existing questions or the inclusion of new questions.

(Response 3) We have considered the comments requesting that the Agency update the questionnaire and disagree that certain questions should be modified or added. We believe that the information sought from the proposed questions will be captured within the existing questions or elsewhere in our research.

FDA estimates the burden of this collection of information as follows:

The universe of registered outsourcing facilities and related human prescription drug compounding businesses known to the Center of Excellence will be sent a survey invitation. We reduced our estimate of the number of respondents from 300 to 250. We estimate that approximately 250 respondents will receive an invitation to participate in the survey and will spend 5 minutes reading the invitation and considering whether to take the survey, for a total of 20.825 burden hours per year, rounded to 21 hours. Based on our historical experience, we anticipate that all those invited to participate in the survey will complete the survey. We estimate that respondents will spend 15 to 30 minutes to complete the revised survey. Using the upper-bound estimate, we report a reduction in burden hours to 30 minutes (0.50 hour) per survey response from our previous estimate of 1 hour per response. We estimate that approximately 250 respondents will spend 30 minutes completing the survey, for a total of 146 burden hours per year.

Based on a review of the information collection since our last request for OMB approval, we have made adjustments to our burden estimate. Our estimated burden for the information collection reflects an overall decrease of 454 hours and a corresponding decrease of 100 responses. We have also reduced our estimated burden per survey response from 1 hour to 30 minutes.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection helps support recommendations discussed in FDA guidance. Animal drugs compounded from bulk drug substances by pharmacists and veterinarians do not meet certain important requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). To be legally marketed in accordance with animal drug approval requirements of the FD&C Act, an approval, conditional approval, or listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species  1 is required, and compounded drugs do not go through any of these pre-market review processes. (Information collection associated with new animal drug applications is approved under OMB control no. 0910-0032; information collection pertaining to index of legally marketed unapproved new animal drugs for minor species is approved under OMB control no. 0910-0605.) Further, all animal drugs are required to, among other things, be made in accordance with current good manufacturing practice (CGMP) requirements and have adequate directions for use, requirements not met by compounded drugs. 2 Thus, drugs compounded from bulk drug substances violate the FD&C Act because they are not approved or indexed, are not made according to CGMP, and cannot satisfy the FD&C Act's adequate directions for use provision (which requires, among other things, that a prescription drug have FDA-approved labeling). However, FDA has generally refrained from taking enforcement action against animal drugs compounded from bulk drug substances under certain circumstances when no other medically appropriate treatment options exist.

To assist respondents in understanding FDA's current thinking about animal drug compounding from bulk substances, our Center for Veterinary Medicine developed GFI #256 entitled “ Compounding Animal Drugs from Bulk Drug Substances ” ( https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances ). The guidance describes circumstances under which FDA generally does not intend to take enforcement action against pharmacists and veterinarians who compound animal drugs from bulk drug substances.

FDA estimates the burden of this collection of information as follows:

We base our estimates on our experience with the regulation of compounded animal drugs. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection was established as a special control for the class II device type, Novel Influenza A Reagents. In accordance with section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360c), FDA evaluated an application for an in vitro diagnostic device for detection of influenza subtype H5 (Asian lineage), commonly known as avian flu. FDA concluded that this device is properly classified into class II in accordance with section 513(a)(1)(B) of the FD&C Act, because it is a device for which the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, but there is sufficient information to establish special controls to provide such assurance. The statute permits FDA to establish as special controls many different things, including postmarket surveillance, development and dissemination of guidance recommendations, and “other appropriate actions as the Secretary [of HHS] deems necessary” (section 513(a)(1)(B) of the FD&C Act). This information collection is a measure that FDA determined to be necessary to provide reasonable assurance of safety and effectiveness of reagents for detection of specific novel influenza A viruses.

FDA issued an order classifying the H5 (Asian lineage) diagnostic device into class II on March 22, 2006 (71 FR 14377), establishing the special controls necessary to provide reasonable assurance of the safety and effectiveness of that device and similar future devices. The new classification was codified in 21 CFR 866.3332, a regulation that describes the new classification for reagents for detection of specific novel influenza A viruses and sets forth the special controls that help to provide a reasonable assurance of the safety and effectiveness of devices classified under that regulation. The regulation refers to the document entitled “Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses,” (March 2006) which provides recommendations for measures to help provide a reasonable assurance of safety and effectiveness for these reagents. The guidance recommends that sponsors obtain and analyze postmarket data to ensure the continued reliability of their device in detecting the specific novel influenza A virus that it is intended to detect, particularly given the propensity for influenza viruses to mutate and the potential for changes in disease prevalence over time. The guidance document is available on our website at: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/reagents-detection-specific-novel-influenza-viruses-class-ii-special-controls-guidance-industry-and.

As updated sequences for novel influenza A viruses become available from the World Health Organization, National Institutes of Health, and other public health entities, sponsors of reagents for detection of specific novel influenza A viruses will collect this information, compare them with the primer/probe sequences in their devices, and incorporate the result of these analyses into their quality management system, as required by 21 CFR 820.100(a)(1). These analyses will be evaluated against the device design validation and risk analysis required by 21 CFR 820.30(g) to determine if any design changes may be necessary.

FDA estimates the burden of this collection of information as follows:

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection helps to support Agency regulations and guidance. The statutory authority to collect this information is provided under sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 321 et seq. ). In the Federal Register of January 29, 2001 (66 FR 8120), FDA announced the availability of the “PHS Guideline on Infectious Disease Issues in Xenotransplantation.” The guideline, available from our website at https://www.fda.gov/media/73803/download was developed by the PHS to identify general principles for the prevention and control of infectious diseases associated with xenotransplantation that may pose a risk to public health. The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and to the general public. The PHS guideline is intended to address public health issues raised by xenotransplantation, through identification of general principles of prevention and control of infectious diseases associated with xenotransplantation that may pose a hazard to the public health. The collection of information described in this guideline is intended to provide general guidance on the following topics: (1) the development of xenotransplantation clinical protocols; (2) the preparation of submissions to FDA; and (3) the conduct of xenotransplantation clinical trials. Also, the collection of information will help ensure that the sponsor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation product recipient, xenotransplantation product, source animal(s), animal procurement center, and significant nosocomial exposures. The PHS guideline describes an occupational health service program for the protection of health care workers involved in xenotransplantation procedures, caring for xenotransplantation product recipients, and performing associated laboratory testing. The PHS guideline is intended to protect the public health and to help ensure the safety of using xenotransplantation products in humans by preventing the introduction, transmission, and spread of infectious diseases associated with xenotransplantation.

The PHS guideline also recommends that certain specimens and records be maintained for 50 years beyond the date of the xenotransplantation. These include: (1) records linking each xenotransplantation product recipient with relevant health records of the source animal, herd or colony, and the specific organ, tissue, or cell type included in or used in the manufacture of the product (3.2.7.1); (2) aliquots of serum samples from randomly selected animal and specific disease investigations (3.4.3.1); (3) source animal biological specimens designated for PHS use (3.7.1); animal health records (3.7.2), including necropsy results (3.6.4); and (4) recipients’ biological specimens (4.1.2). The retention period is intended to assist health care practitioners and officials in surveillance and in tracking the source of an infection, disease, or illness that might emerge in the recipient, the source animal, or the animal herd or colony after a xenotransplantation.

The recommendation for maintaining records for 50 years is based on clinical experience with several human viruses that have presented problems in human to human transplantation and are therefore thought to share certain characteristics with viruses that may pose potential risks in xenotransplantation. These characteristics include long latency periods and the ability to establish persistent infections. Several also share the possibility of transmission among individuals through intimate contact with human body fluids. Human immunodeficiency virus (HIV) and Human T-lymphotropic virus are human retroviruses. Retroviruses contain ribonucleic acid that is reverse-transcribed into deoxyribonucleic acid (DNA) using an enzyme provided by the virus and the human cell machinery. That viral DNA can then be integrated into the human cellular DNA. Both viruses establish persistent infections and have long latency periods before the onset of disease, 10 years and 40 to 60 years, respectively. The human hepatitis viruses are not retroviruses, but several share with HIV the characteristic that they can be transmitted through body fluids, can establish persistent infections, and have long latency periods, e.g., approximately 30 years for Hepatitis C.

In addition, the PHS guideline recommends that a record system be developed that allows easy, accurate, and rapid linkage of information among the specimen archive, the recipient's medical records, and the records of the source animal for 50 years. The development of such a record system is a one-time burden. Such a system is intended to cross-reference and locate relevant records of recipients, products, source animals, animal procurement centers, and significant nosocomial exposures.

Respondents to this collection of information are the sponsors of clinical studies of investigational xenotransplantation products under investigational new drug applications (INDs) and xenotransplantation product procurement centers, referred to as source animal facilities. There are an estimated five respondents who are sponsors of seven INDs that include protocols for xenotransplantation in humans and five clinical centers doing xenotransplantation procedures. Other respondents for this collection of information are an estimated two source animal facilities which provide source xenotransplantation product material to sponsors for use in human xenotransplantation procedures. These two source animal facilities keep medical records of the herds/colonies as well as the medical records of the individual source animal(s). There are an estimated three herds of approximately six animals per herd. The burden estimates are based on FDA's records of xenotransplantation-related INDs and estimates of time required to complete the various reporting, recordkeeping, and third-party disclosure tasks described in the PHS guideline.

FDA is requesting an extension of OMB approval for the following reporting, recordkeeping, and third-party disclosure recommendations in the PHS guideline:

FDA estimates the burden for this collection of information as follows:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection supports implementation of the FDA Prescription Drug User Fee program (called “PDUFA” in reference to the Prescription Drug User Fee Act). Under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), we have the authority to assess and collect annual program fees for prescription drug products approved under certain new drug applications (NDAs) and biologics license applications (BLAs). Also under this authority, pharmaceutical companies pay an application fee for certain NDAs and BLAs submitted to FDA for review. Because the submission of user fees concurrently with applications is required, review of an application by FDA cannot begin until the fee is submitted.

PDUFA must be reauthorized every 5 years. The FDA User Fee Reauthorization Act of 2022 (PDUFA VII) included the reauthorization of PDUFA through September 30, 2027 ( https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027 ). PDUFA VII provides for the continued timely review of NDAs and BLAs. Since the initial passage of PDUFA, user fees have played an important role in expediting the drug review and approval process. PDUFA VII reauthorization also includes commitments to meet certain performance goals and procedures. The commitment goals represent the product of FDA's discussions with the regulated industry and public stakeholders, as mandated by Congress.

We are revising the collection to include our current commitment goals, as set forth in the document “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027,” found on our website at https://www.fda.gov/media/151712/download?attachment. The commitment goals represent the product of FDA's discussions with the regulated industry and public stakeholders, as mandated by Congress. FDA is committed to meeting these goals and to continuous operational improvements associated with PDUFA implementation. The commitment goals provide for the development and issuance of topic-specific guidance. We maintain a searchable guidance database on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. In publishing the respective notices of availability for each guidance document, we include an analysis under the PRA and invite public comment on the associated information collection recommendations. In addition, all Agency guidance documents are issued in accordance with our Good Guidance Practices regulations in 21 CFR 10.115, which provide for public comment at any time.

To assist respondents with the information collection, we developed Form FDA 3397 entitled “Prescription Drug User Fee Cover Sheet.” Additional information and associated instructions may be found on our website at https://www.fda.gov/industry/fda-user-fee-programs. The cover sheet (Form FDA 3397) is submitted for original NDAs, BLAs, and resubmissions of these original applications after withdrawal before filing or refusal to file actions. The form is not submitted for certain FDA-regulated products. The list of exempted products is included under the instructions to Form FDA 3397.

Relatedly, sections 735 and 736 of the FD&C Act also provide for waiver, reduction, exemption, and refund requests. We developed the guidance document entitled “Guidance for Industry—Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products,” and Form FDA 3971 (Small Business Waiver and Refund Request), which can be found on our website at https://www.fda.gov/media/131797/download.

To assist respondents in understanding user fees associated with the information collection, we have developed the guidance document entitled “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022” (July 2023). The guidance explains the various fee assessments, procedures for payments and refunds, as well as other topics, and is available on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-prescription-drug-user-fee-amendments-2022.

The PDUFA information collection and all user fee cover sheets, including the “Prescription Drug User Fee Cover Sheet” (Form FDA 3397), are accessed and submitted electronically, as required by statute, through FDA's electronic systems such as the Document Archiving Reporting and Regulatory Tracking System (DARRTS), Electronic Submission Gateway (ESG), and Panorama.

In the Federal Register of November 18, 2024 (89 FR 90705), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received one comment on the information collection indicating general support for the program. The commenter requested better reporting of additional information that is not currently collected for the PDUFA program and additional reports of new drug and biologic application review metrics, improved electronic submissions, and automated data exchange. We will consider the comment in future PDUFA negotiations.

FDA estimates the burden of this collection of information as follows:

Based on a review of Agency records, we estimate that the number of initial waiver requests submitted annually (excluding small business waiver requests under section 736(d)(1)(C) of the FD&C Act) is 181, submitted by 99 different applicants.

We estimate that 35 respondents will each submit a small business waiver request annually. We have included in the burden estimate the time for preparation and submission of application fee waivers for small businesses, including completion of Form FDA 3971. Small businesses requesting a waiver must submit documentation to FDA, including the number of their employees, as well as information that their application is their first human drug application, within the meaning of the FD&C Act, to be submitted to the Agency for approval.

We estimate receiving 22 requests for reconsideration annually (including small business waiver reconsiderations) and assume the average burden for preparing and submitting each request is 24 hours. In addition, we estimate receiving six requests annually for appeal of user fee waiver determinations, and assume the time needed to prepare an appeal is 12 hours. We have included in this estimate both the time needed to prepare the request for appeal to the Chief Scientist and User Fee Appeals Officer within the Office of the Commissioner, and the time needed to create and send a copy of the request for an appeal to the Director Division of User Fee Management within the Office of Management at FDA's Center for Drug Evaluation and Research.

We assume a total of 82 hours of burden for completing and submitting the 164 forms FDA 3397 (Prescription Drug User Fee Coversheet) along with submission of NDAs or BLAs. The burdens associated with submission of NDAs and BLAs are included in OMB control numbers 0910-0001 and 0910-0338, respectively.

The information collection reflects changes and adjustments. We have clarified that the scope of the collection includes provisions found in our current commitment goals letter, negotiated with industry, pertaining to the assessment of fees, waivers, refunds, and exemptions under PDUFA VII. We have also included relevant Agency guidance documents that provide instruction in this regard and for which we attribute attendant burden. Cumulatively, these adjustments have resulted in a total decrease of 3 responses and an overall increase of 203 burden hours annually since the prior renewal of the information collection. We attribute the minor changes in the numbers to normal fluctuations in numbers of waivers, exemptions, reconsideration requests, and appeals received for assessed PDUFA fees. We do not attribute a change in the burden related to the revision request to include the Agency's commitment goals.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection helps support implementation of sections 581 and 582 (21 U.S.C. 360eee and U.S.C. 360eee-1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which govern the pharmaceutical distribution supply chain. Definitions set forth in section 581 of the FD&C Act prescribe specific activities that apply to the individuals identified in section 582, including recordkeeping requirements intended to effectuate the tracing of certain pharmaceutical drugs as they are distributed within the United States. The recordkeeping provisions expressly provided for in sections 582(b) through (e) of the FD&C Act cover tasks associated with product identification, product tracing, transaction data, record verification, and disclosures (exchange) of information. Submissions to FDA, as provided for in section 582 of the FD&C Act, include making specific product notifications, requesting exemption and/or waiver from any of the statutory requirements, and requesting termination of a notification in consultation with FDA.

The requirements of section 582 of the FD&C Act included in the information collection are self-executing. We regard most of the information collection activities required by the statute to be usual and customary recordkeeping activities by respondents and have therefore excluded from our estimated burden the time, effort, and financial resources attributable to those activities consistent with 5 CFR 1320.3(b)(2). Additionally, we note that some respondents are also subject to related reporting, recordkeeping, and disclosure requirements applicable under the Controlled Substances Act (Pub. L. 91-513), for which currently active information collection approvals are maintained by the Department of Justice's Drug Enforcement Administration. At the same time, we account for notifications submitted to FDA, and estimate recordkeeping burden attributable to activities corresponding with illegitimate product notifications, including coordination of investigations of suspect products, among trading partners, as required by the statute.

To assist respondents with submitting specific product notifications to FDA regarding illegitimate product and product with a high-risk of illegitimacy, we have developed and utilize Form FDA 3911 entitled “Drug Notification” and the corresponding instructional document “INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911—DRUG NOTIFICATION.” Instruction regarding the submission of Form FDA 3911 using the Center for Drug Evaluation and Research “NextGen” portal is available from our website at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/notify-fda-illegitimate-products. Form FDA 3911 is intended to provide a uniform format for initial notifications, followup notifications, and requests for the termination of a notification. We believe followup activities regarding suspect and/or illegitimate drug products includes information obtained during the conduct of an official Agency investigation and thus not covered by the PRA. Please see 5 CFR 1320.4(a)(2) and FDA “General Enforcement Regulations” in 21 CFR part 1. We have revised Form FDA 3911, and the instructions for completing the form, to add a new field requesting information about the geographic location of the incident that is the subject of the notification.

We have also published guidance documents, as provided for in section 582 of the FD&C Act, developed specifically to facilitate the efficient adoption of secure interoperable product tracing at the package level by respondents. The guidance documents discuss the recordkeeping activities expressly provided for in section 582 of the FD&C Act. To date we have developed and issued the following guidance documents:

• “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs” guidance (2023 Standards for Interoperable Exchange Guidance) (September 6, 2023).

• “Standardization of Data and Documentation Practices for Product Tracing” draft guidance (Standardization of Data Guidance) (February 28, 2018).

• “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act” guidance (Enhanced Drug Distribution Security Guidance) (August 31, 2023).

• “Verification Systems Under the Drug Supply Chain Security Act [DSCSA] for Certain Prescription Drugs” guidance (Verification Guidance) (December 7, 2023).

• “Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act” guidance (Definitions Guidance) (March 16, 2023).

• “Product Identifiers Under the Drug Supply Chain Security Act—Questions and Answers” guidance (Product Identifier Guidance) (June 3, 2021).

• “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” guidance (Suspect Product Guidance) (June 6, 2021).

• “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act” guidance (Waivers Guidance) (August 4, 2023).

All Agency guidance documents are issued in accordance with our Good Guidance Practice regulations in 21 CFR 10.115, which provide for public comment at any time. We maintain a searchable guidance database on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents that utilizes topic specific search terms.

We also maintain a web page at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/fdas-implementation-drug-supply-chain-security-act-dscsa-requirements that communicates FDA's ongoing implementation of the DSCSA requirements. Since DSCSA enactment on November 27, 2013, FDA has established a public docket to receive information and comments on DSCSA standards for the electronic tracking system, including comments regarding paper- and electronic- formats of information. In 2018, we initiated a pilot project, consistent with section 582(j) of the FD&C Act and approved in OMB control number 0910-0859, focusing on system attributes and demonstrating interoperability. Since completion of the pilot project, we continue to focus on the interoperability of the electronic systems described in section 582 of the FD&C Act and have revised this information collection to capture standardized transaction information.

Respondents to the information collection are manufacturers, wholesale distributors, dispensers, and repackagers of pharmaceutical drug products, as defined in section 581 of the FD&C Act and identified in section 582(a)(1) of the FD&C Act. Based on Agency data, we assume 70,000 respondents: 1,230 manufacturers and 170 repackagers, (1,400 cumulatively); 1,600 distributors; and 67,000 dispensers (including online and chain pharmacies).

In the Federal Register of September 6, 2024 (89 FR 72848), we published a 60-day notice requesting public comment on the proposed collection of information. We received one comment from a trade association suggesting our estimate for burden attendant to requests for waiver, exception, or exemption (WEE) might not include submissions by those respondents who lack readiness to implement final DSCSA requirements and who have more recently submitted such requests to FDA. In anticipation of the end of the enhanced drug security requirements 12-month stabilization period on November 27, 2024, we received an increased number of waiver and exemption requests and have issued two exemptions from the enhanced drug distribution security requirements of section 582 of the FD&C Act for eligible trading partners. The comment thanked FDA for the recent exemptions, acknowledging they allow a phased approach to implementing trading partner data exchange as required under the DSCSA. While the comment proffered no alternative figures, we have adjusted our estimate for this activity by increasing the number of respondents submitting WEE requests from 20 to 100, as reflected in row 3 of table 1. We have made no other adjustment to our estimates but continue to monitor information collection elements applicable to the DSCSA.

We estimate the burden of this collection of information as follows:

As reflected in table 1, reporting activities include the submission of notifications to FDA regarding illegitimate product and product with a high-risk of illegitimacy using Form FDA 3911. Form FDA 3911 is also used to submit requests for termination of a notification in consultation with FDA. FDA may request any additional information it determines necessary to complete the consultation. We believe burden that may be incurred from providing FDA with follow-up information that may be necessary with regard to suspect and/or illegitimate products is excepted from our accounting in accordance with 5 CFR 1320.3(c), and we have therefore not included this activity in our estimate of burden. Finally, an authorized trading partner or other stakeholder seeking a WEE from requirements of section 582 of the FD&C Act may submit a request to FDA, or a request for material changes to or renewal of an approved initial request. These requests are also included in the scope of reporting activities.

As reflected in table 2, the provisions in sections 582(b) through (e) of the FD&C Act require ongoing recordkeeping that documents product identification, tracing information, and verification activities. Records are to be produced to FDA within 24 hours of a request, consistent with section 582 of the FD&C Act. Each category of respondent (manufacturer, distributer, wholesaler, repackager) may expend varying degrees of time, effort, or financial resources to generate, maintain, retain, notify, or disclose such records commensurate with the corresponding tasks prescribed for that category. Data elements required to be documented and disclosed are defined in section 581 and set forth in section 582 of the FD&C Act. A significant portion of recordkeeping activity pertains to product identification and product tracing. Verification activities comprise another significant portion of activity, where respondents expend time, effort, or financial resources respective to their role. Although we have quantified what we believe to be the average amount of time, effort, or financial resources expended cumulatively by respondents, we regard these recordkeeping activities as usual and customary and exclude them from our burden approval request submitted to OMB, consistent with 5 CFR 1320.3(b)(2).

Information exchange activities with authorized trading partners as contemplated by section 582 of the FD&C Act include: (1) providing the transaction information, the transaction history (when applicable), and transaction statement (T3) to the subsequent purchaser, providing relevant transaction information, transaction history, and transaction statement upon a request for information from FDA or other appropriate Federal or State officials if a recall or investigation of suspect or illegitimate product occurs, and, after the Statutory Date, facilitating the gathering of information necessary to produce the transaction information for each transaction  1 going back to the manufacturer at an authorized trading partner's request, or at the request of FDA or other appropriate Federal or State officials; and (2) capturing and maintaining transaction information, transaction history, and transaction statements for each transaction for not less than 6 years after the transaction. Product identification activities include the requirement that manufacturers and repackagers affix or imprint a product identifier to each package and homogeneous case of products that they intend to be introduced in a transaction into commerce and that they maintain product identifier information for each package and homogeneous case of product for not less than 6 years.

Verification activities include: (1) coordinating with other trading partners during an investigation of a suspect product to determine whether the product is illegitimate; (2) for manufacturers and repackagers, responding to trading partners' requests for verification of product identifiers; (3) maintaining records of suspect product investigations and disposition of illegitimate product for not less than 6 years; (4) identifying suspect product; (5) quarantining suspect and illegitimate product; (6) investigating suspect product; (7) notifying FDA of suspect product that is determined not to be illegitimate product (when applicable); (8) processing saleable returns; and (9) establishing systems and processes to comply with all of these requirements.

We assume manufacturers, repackagers, and wholesale distributors will already have systems and processes to comply with many of these requirements. Such systems will therefore only need to be updated to ensure full compliance with the DSCSA. We also anticipate that a chain pharmacy will develop the required systems and processes centrally at its headquarters or at its distribution centers and then distribute to each pharmacy.

Our estimated burden for the information collection reflects some significant increases; most notably burden we attribute to the task of documenting individual transaction information. We have also increased the number of respondents submitting WEE requests.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This notice requests extension of OMB approval of the FDA information collection for a generic clearance that allows FDA to use quantitative social/behavioral science data collection techniques ( i.e., surveys and experimental studies) to test consumers' reactions to FDA communications or educational messaging about FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed. To ensure that communications activities and educational campaigns have the highest potential to be received, understood, and accepted by those for whom they are intended, it is important to assess communications while they are under development. Understanding consumers' attitudes, motivations, and behaviors in response to potential communications and education messaging plays an important role in improving FDA's communications.

If the following conditions are not met, FDA will submit an information collection request to OMB for approval through the normal PRA process:

• The collections are voluntary;

• The collections are low burden for participants (based on considerations of total burden hours, total number of participants, or burden hours per participant) and are low cost for both the participants and the Federal Government;

• The collections are noncontroversial;

• Personally identifiable information (PII) is collected only to the extent necessary  1 and is not retained;

• Information gathered will not be used for the purpose of substantially informing influential policy decisions;  2 and

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

This information collection helps support implementation of statutory and regulatory provisions related to medicated animal feed mill licensing. Feed manufacturers that seek to manufacture a Type B or Type C medicated feed using Category II, Type A medicated articles or manufacture certain liquid and free-choice feed using Category I, Type A medicated articles that must follow proprietary formulas or specifications, are required to obtain a facility license under section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b). Our regulations in 21 CFR part 515 establish the procedures associated with applying for a facility license. We require that a manufacturer seeking a facility license submit a completed medicated feed mill license application using Form FDA 3448 (§ 515.10(b) (21 CFR 515.10(b))). This form may be submitted via U.S. mail or electronically to a dedicated email address, MedicatedFeedsTeamMail@fda.hhs.gov. We use the information submitted to establish that the applicant has made the certifications required by section 512 of the FD&C Act, to register the mill, and to schedule a preapproval inspection. Form FDA 3448 may be accessed on our website at: https:// www.fda.gov/about-fda/reports-manuals-forms/forms.

We require the submission of a supplemental medicated feed mill license application for a change in facility ownership or a change in facility address (§ 515.11(b) (21 CFR 515.11(b))). If a licensed facility is no longer manufacturing medicated animal feed under § 515.23 (21 CFR 515.23), a manufacturer may request voluntary revocation of a medicated feed mill license. An applicant also has the right to file a request for hearing under § 515.30(c) (21 CFR 515.30(c)) to give reasons why a medicated feed mill license should not be refused or revoked.

Under § 510.305 (21 CFR 510.305), we require each applicant to maintain in a single accessible location: (a) A copy of the approved medicated feed mill license (Form FDA 3448) on the premises of the manufacturing establishment; and (b) approved or index listed labeling for each Type B and/or Type C feed being manufactured on the premises of the manufacturing establishment or the facility where the feed labels are generated.

In the Federal Register of November 29, 2024 (89 FR 94740), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

We estimate that respondents will spend 15 minutes to assemble the necessary information, prepare, and submit an application for a feed mill license or revocation of a feed mill license. We estimate that respondents will spend 4 hours to prepare their request for a hearing.

We base our estimates on our recent experience with the existing medicated feed mill license application process. Our estimated burden for the information collection reflects an overall increase of 2.5 hours. We attribute this adjustment to a slight increase in the overall number of submissions we received over the last few years.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection supports Agency guidance. Section 524 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360n) is designed to encourage development of new drug or biological products for prevention and treatment of certain tropical diseases affecting millions of people throughout the world and makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease products. Section 524 of the FD&C Act serves to stimulate new drug development for drugs to treat a “tropical disease” (as defined in section 524(a)(3)) by offering additional incentives for obtaining FDA approval for pharmaceutical treatments for these diseases. As defined in section 524(a)(4) of the FD&C Act, a sponsor of a “tropical disease product application” may be eligible for a voucher that can be used to obtain a priority review for any other application submitted under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262).

Accordingly, we developed the guidance for industry entitled “Tropical Disease Priority Review Vouchers” (October 2016) (available at https://www.fda.gov/media/72569/download ). The guidance explains how FDA implements provisions of section 524 of the FD&C Act and how sponsors may qualify for a priority review voucher based on eligibility criteria set forth in the statute, how to use priority review vouchers, and how priority review vouchers may be transferred to other sponsors.

The guidance also communicates that, under the FDA Reauthorization Act of 2017, section 524 of the FD&C Act requires attestation by the sponsor of eligibility for a priority review voucher upon submission of the marketing application.

Description of Respondents: Sponsors submitting applications under section 505(b)(1) of the FD&C Act or section 351 of the PHS Act.

We estimate the burden of this collection of information as follows:

Based on our evaluation of the information collection since the last OMB review and approval, the burden estimate decreased based on receipt of fewer vouchers and other information collection activities. Our estimated burden for the information collection reflects an overall decrease of 46 hours and a decrease of 8 responses.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection helps support implementation of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a), which requires persons who import food into the United States to perform risk-based foreign supplier verification activities as set forth in part 1, subpart L (21 CFR part 1, subpart L) (Foreign Supplier Verification Programs for Food Importers). The regulatory requirements are intended to verify that food imported into the United States is as safe as food produced and sold within the United States. Specifically, regulations in § 1.501 set forth the applicability of requirements for FSVP, while regulations in §§ 1.502 through 1.508, prescribe specific activities for developing, maintaining, and following an FSVP; as well as for evaluating compliance and for identifying and correcting hazards. Finally, regulations in § 1.509 identify required data elements applicable to food products offered for importation into the United States, while regulations in § 1.510 govern required records, providing that records be made available to FDA upon request and that records be maintained electronically.

The information collection covers activities attendant to statutory and regulatory requirements applicable to establishing and maintaining FSVP records, including recordkeeping pertaining to the hazard controls set forth in the regulations. We have also established and maintain a web page regarding the FSVP program at https://www.fda.gov/food/conversations-experts-food-topics/what-do-importers-need-know-about-fsvp, including relevant resources.

The regulations also include requirements pertaining to reporting to Customs and Border Protection (CBP) for subsequent transfer to FDA. The reporting requirements to CBP specify that the information must be provided electronically. The FSVP Importer Portal for FSVP Records Submission allows for importers to upload and submit records electronically, after receiving a written request from FDA. The portal may be found https://www.access.fda.gov/, and a user guide is available at https://www.fda.gov/media/148312/download. FDA has issued guidance for industry relating to the Unique Facility Identifier (UFI) requirement for FSVP importers found in § 1.509(a). “Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Program Regulation Guidance for Industry” (see https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-recognition-acceptable-unique-facility-identifier-ufi-foreign-supplier ) indicates that the Dun & Bradstreet (D&B) Data Universal Number System (DUNS) would be an acceptable UFI for FSVP importers to submit in compliance with § 1.509(a).

Respondents to the information collection are persons who import food into the United States.

FDA estimates the burden of this collection of information as follows:

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to the currently approved burden estimate.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Respondents to this collection are sponsors of marketing applications that contain clinical data from studies covered by the regulations. These sponsors represent pharmaceutical, biologic, and medical device firms. Respondents are also clinical investigators who provide financial information to the sponsors of marketing applications.

Table 1 shows information that is the basis of the estimated number of respondents in tables 2 through 4.

FDA estimates the burden of this collection of information as follows:

Under § 54.4(a) (21 CFR 54.4(a)), applicants submitting an application that relies on clinical studies must submit a complete list of clinical investigators who participated in a covered clinical study, and must either certify to the absence of certain financial arrangements with clinical investigators (Form FDA 3454) or, under § 54.4(a)(3), disclose to FDA the nature of those arrangements and the steps taken by the applicant or sponsor to minimize the potential for bias (Form FDA 3455).

FDA estimates that almost all applicants submit a certification statement under § 54.4(a)(1) and (2). Preparation of the statement using Form FDA 3454 should require no more than 1 hour per study. The number of respondents is based on the estimated number of affected applications.

When certification is not possible and disclosure is made using Form FDA 3455, the applicant must describe, under § 54.4(a)(3), the financial arrangements or interests and the steps that were taken to minimize the potential for bias in the affected study. As the applicant would be fully aware of those arrangements and the steps taken to address them, describing them will be straightforward. The Agency estimates that it will take about 5 hours to prepare this narrative. Based on our experience with this collection, FDA estimates that approximately 10 percent of the respondents with affected applications will submit disclosure statements.

In the Federal Register of November 29, 2024 (89 FR 94735), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received but was not PRA related.

FDA estimates the burden of this collection of information as follows:

Under § 54.6 (21 CFR 54.6), the sponsors of covered studies must maintain complete records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for 2 years after the date of approval of the applications. Sponsors of covered studies maintain many records regarding clinical investigators, including protocol agreements and investigator resumes or curriculum vitae. FDA estimates an average of 15 minutes will be required for each recordkeeper to add this record to the clinical investigators' file.

Under § 54.4(b), clinical investigators supply to the sponsor of a covered study financial information sufficient to allow the sponsor to submit complete and accurate certification or disclosure statements. Clinical investigators are accustomed to supplying such information when applying for research grants. Also, most people know the financial holdings of their immediate family and records of such interests are generally accessible because they are needed for preparing tax records. For these reasons, FDA estimates that the time required for this task may range from 5 to 15 minutes; we used the median, 10 minutes, for the average burden per disclosure (see table 4). To estimate the number of respondents for each FDA Center, we took the median number of investigators for each application type, multiplied each median number of investigators by the number of affected applications for that application type, then summed those products to get the total number of respondents for the Center.

The burden for this information collection request has changed since the last OMB approval. We have adjusted our estimated burden for the information collection to reflect the number of submissions we received in the last few years. These adjustments result in an increase of 557 total annual responses and a corresponding increase of 87 total hours.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection supports Food and Drug Administration regulations. Tobacco products are generally governed by chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (sections 900 through 920) (21 U.S.C. 387-387t). Specifically, section 919 of the FD & C Act (21 U.S.C. 387s) governs tobacco user fees.

Section 919(a) requires FDA to “assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products” subject to the tobacco product provisions of the FD&C Act. Accordingly, section 919(b)(2)(B)(i) of the FD&C Act (21 U.S.C. 387s (b)(2)(B)(i)) identifies those tobacco products as: cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, and roll-your-own tobacco.

To implement the tobacco user fee program as prescribed in the FD&C Act (as summarized above), FDA must collect the information needed to accurately calculate tobacco user fee assessments. On May 10, 2016, FDA published a final rule that requires domestic manufacturers and importers of the applicable tobacco products (listed above) to submit this information to the FDA (81 FR 28707).

FDA estimates the burden of this collection of information as follows:

We have revised our burden estimates to this information collection request.

21 CFR 1150.5 is reflecting an increase in 120 respondents from 700 to 820. FDA considered the number of active Alcohol and Tobacco Tax and Trade Bureau (TTB) permits (based on TTB data) in FY23 for domestic manufacturers and importers of tobacco products subject to tobacco user fees.

Voluntary premium cigar data submission (monthly) is reflecting a reduction in 50 respondents from 100 to 50 and a reduction in average burden per response from 2.5 to 1.5 hours. FDA updated this data based on reasonable estimates of the burden of voluntary submissions in FY24. There may be some fluctuations in this number.

Section 1150.13 (21 CFR 1150.13) is reflecting a reduction in 57 respondents from 376 to 319. FDA considered the number of user fee assessments issued to domestic manufacturers and importers of tobacco products subject to tobacco user fees on average each quarter for FY23. Note, entities may have more than one TTB permit, however, tobacco user fee assessments are aggregated based on Employer Identification Number and not TTB permit number. Therefore, we expect the number of respondents to be lower for § 1150.13.

21 CFR 1150.15(a) is reflecting a reduction in 3 respondents from 5 to 2, and 21 CFR 1150.15(d) is reflecting a reduction in 2 respondents from 3 to 1 and a reduction in average burden per response from 10 to 5 hours. FDA considered the historical submission of tobacco user fee disputes and requests for additional Agency review.

The cumulative changes to the estimated burden for this information collection reflects an overall increase of 3,377 burden hours and a corresponding increase of 2,047 responses.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection supports Agency export programs and associated guidance. The United States exports a large volume and variety of foods in international trade. Foreign governments often require official certification from the responsible authority of the country of origin about imported foods and establishments involved in their production, storage, or distribution. Some foreign governments establish additional requirements with which exporters are required to comply and ask for additional assurances from the responsible authority. Importing countries may require, and FDA may provide, official certification or assurances for food products in different forms, including certificates that accompany specific products or lists of establishments and products that comply with certain requirements.

To facilitate exports of food subject to importing country listing requirements, FDA has historically provided official certification in the form of country- and product-specific export lists that include establishments and their products when: (1) the establishment has expressed interest in exporting their products to these countries; (2) the establishment and the products are subject to FDA's jurisdiction; and (3) the establishment can demonstrate that it is in good regulatory standing for the products it intends to export, and the products are expected to comply with applicable FDA requirements. As we advised in the guidance document “Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China,” FDA considers “good regulatory standing” as meaning that an establishment is in substantial compliance with applicable FDA requirements and is not the subject of a pending enforcement action ( e.g., an injunction or seizure) or pending administrative action ( e.g., a warning letter).

FDA has generally published guidance documents for these country and product-specific lists under the authority of section 701(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)), which authorizes the Secretary of Health and Human Services (the Secretary) to develop guidance documents with public participation presenting the views of the Secretary on matters under the jurisdiction of FDA. The guidance documents generally explain what information establishments should submit to FDA to be considered for inclusion on the lists and what criteria FDA intends to use to determine eligibility for placement on the lists. The guidance documents also explain how FDA intends to update the lists and communicate any new information to the governments that requested the lists. Finally, the guidance documents note that the information is provided voluntarily by establishments with the understanding that it may be posted on FDA's external website and that it will be communicated to, and possibly further disseminated by, the government that requested the list; thus, FDA considers the information on the lists to be information that is not protected from disclosure under 5 U.S.C. 552(b)(4). The guidance documents include “Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile” (November 2018) and “Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood, Infant Formula, and Formula for Young Children Manufacturers/Processors with Interest in Exporting to China” (November, 2018) available at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documents-regulatory-information-topic-food-and-dietary-supplements. Additional information about FDA's Food Export Lists program is available at https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists. FDA has also published guidance on export certification that contains useful information that applies to export lists: “FDA Export Certification” (August 2021) available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certification.

Foreign governments are increasingly relying on certification as a strategy for ensuring the safety of imported food products, and many countries have announced new requirements for lists of establishments and products certified to comply with certain food safety requirements. FDA is committed to facilitating compliance with new listing requirements for U.S. establishments that export FDA-regulated food products by establishing and maintaining country- and product-specific export lists.

Application for inclusion on all export lists will continue to be voluntary. However, some foreign governments may require inclusion on export lists as a precondition for market access or to satisfy other importing country registration or approval requirements. FDA uses the Export Listing Module (ELM), an electronic system (Form FDA 3972), to receive and process applications for inclusion on export lists for HFP-regulated products. The ELM allows applicants to provide information about the products intended for export, the establishment that produces those products, evidence of the establishment's compliance with applicable requirements for the products intended for export, and any additional data or information (such as third-party certifications) that foreign governments may require. We request that this information be updated every 2 years. Additional information and screenshots of the ELM are available at https://www.fda.gov/food/exporting-food-products-united-states/food-export-lists. If an establishment is unable to submit an application via the ELM, it may contact HFP and request assistance.

We use the information submitted by establishments to determine eligibility for certification and inclusion on the export lists, which may be published on our website or the websites of foreign governments. The purpose of the lists is to help HFP-regulated industries meet the import requirements of foreign governments. This collection of information is intended to cover all of HFP's existing export lists, as well as any additional export lists established by the program.

FDA notes section 801 of the FD&C Act (21 U.S.C. 381) also provides that FDA may charge a fee of up to $175 if the Agency issues export certification within 20 days of receipt of a complete request for such certification.

Description of Respondents: Respondents to this collection of information include U.S. establishments subject to FDA/HFP jurisdiction that wish to be included on export lists.

FDA estimates the burden of this collection of information as follows:

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381 and 21 U.S.C. 382) charge the Secretary of Health and Human Services, through FDA, with the responsibility of helping to ensure that exports of unapproved new drugs, biologics, devices, animal drugs, food, cosmetics, and tobacco products that are not to be sold in the United States meet the requirements of the country to which the product is to be exported. The respondents to this information collection are exporters who have notified FDA of their intent to export unapproved products that may not be sold or offered for sale in domestic commerce in the United States as allowed under section 801(e) of the FD&C Act. In general, the notification identifies the product being exported ( e.g., name, description, and in some cases, country of destination) and specifies where the notifications were sent. These notifications are sent only for an initial export. Subsequent exports of the same product to the same destination or to certain countries identified in section 802(b) of the FD&C Act would not result in a notification to FDA.

Respondents to the information collection are exporters of products that may not be sold in the United States and are regulated by FDA's Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH); Center for Veterinary Medicine (CVM); Human Foods Program (HFP); and Center for Tobacco Products (CTP). Respondents to this collection of information maintain records demonstrating their compliance with the requirements in 21 CFR 1.101.

We estimate the burden of this collection of information as follows:

In table 1 we estimate the number of respondents increased for biologics from 4 to 5. The number of respondents increased for drugs from 3 to 5. However, this increase is offset by respondents for devices as the estimated number of exporters decreased from 22 to 16. The number of responses per respondent increased for biologics from 35 to 92 resulting in an increase in burden for biologics reporting from 2,100 to 6,900. Despite decreases in the number of responses per respondent for drugs and devices the increase in biologics reporting resulted in an overall total reporting burden increase from 5,985 to 7,890.

In table 2 we separated each center's recordkeeping to ensure consistency with table 1 and to accurately capture each center's burden estimates. The average No. of Records Per Recordkeeper increased from 4.12 to 14.15 which represents a total recordkeeping burden increase from 39,094 to 47,828.

Based on a review of Agency data the total burden hours have increased by 13,367. In the previous extension request FDA included burden for the Center for Food Safety and Applied Nutrition (now known as HFP). However, upon reevaluation of these burden estimates, HFP offers a “Certificate of Exportability” for conventional foods, food additives, food contact substances, and infant formula products that cannot be legally marketed in the United States but meets the requirements of section 801(e) of the FD&C Act and may be legally exported ( https://www.fda.gov/food/exporting-food-products-united-states/food-export-certificates ). An interested person may apply for this certificate electronically using the Export Certification Application and Tracking System ( https://www.fda.gov/food/food-export-certificates/online-applications-export-certificates-food ). As part of the application, the interested person attests to compliance with section 801(e) of the FD&C Act as provided in 21 CFR 1.101(b). This information collection activity is approved under OMB control number 0910-0793.

The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before April 12, 2025. Pursuant to Section 60.13 of 36 CFR part 60, comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.

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 can 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.

Nominations submitted by State or Tribal Historic Preservation Officers:

Key: State, County, Property Name, Multiple Name(if applicable), Address/Boundary, City, Vicinity, Reference Number.

Authority: Section 60.13 of 36 CFR part 60.

This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the SDSU, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.

A total of 58 cultural items have been requested for repatriation. The 58 objects of cultural patrimony are ceramic sherds. Collection CMP-SDSU-0687 was donated to SDSU by Lyn Olsson, daughter of archaeologist Jean Krase and includes items collected by Krase from throughout California, Baja California, and elsewhere. The 58 items are cataloged as a single entry (SDSU-0687-045) and are noted to have been removed from Old Sacramento, California. It is unknown whether the items have been treated with any hazardous substances. The cultural items are culturally affiliated with the Shingle Springs Band of Miwok Indians and the Wilton Rancheria.

SDSU has determined that:

• The 58 objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.

• There is a reasonable connection between the cultural items described in this notice and the Shingle Springs Band of Miwok Indians, Shingle Springs Rancheria (Verona Tract), California and the Wilton Rancheria, California.

Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under ADDRESSES . Requests for repatriation may be submitted by any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.

Repatriation of the cultural items in this notice to a requestor may occur on or after June 2, 2025. If competing requests for repatriation are received, SDSU must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. SDSU is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.

Authority: Native American Graves Protection and Repatriation Act, 25 U.S.C. 3004 and the implementing regulations, 43 CFR 10.9.

Background. —On June 1, 2020, the Department of Commerce (“Commerce”) issued antidumping and countervailing duty orders on imports of ceramic tile from China (85 FR 33089 and 33119). The Commission is conducting reviews pursuant to section 751(c) of the Act, as amended (19 U.S.C. 1675(c)), to determine whether revocation of the orders would be likely to lead to continuation or recurrence of material injury to the domestic industry within a reasonably foreseeable time. Provisions concerning the conduct of this proceeding may be found in the Commission's Rules of Practice and Procedure at 19 CFR part 201, subparts A and B, and 19 CFR part 207, subparts A and F. The Commission will assess the adequacy of interested party responses to this notice of institution to determine whether to conduct full or expedited reviews. The Commission's determinations in any expedited reviews will be based on the facts available, which may include information provided in response to this notice.

Definitions. —The following definitions apply to these reviews:

(1) Subject Merchandise is the class or kind of merchandise that is within the scope of the five-year reviews, as defined by Commerce.

(2) The Subject Country in these reviews is China.

(3) The Domestic Like Product is the domestically produced product or products which are like, or in the absence of like, most similar in characteristics and uses with, the Subject Merchandise. In its original determinations, the Commission defined a single Domestic Like Product consisting of all ceramic tile.

(4) The Domestic Industry is the U.S. producers as a whole of the Domestic Like Product, or those producers whose collective output of the Domestic Like Product constitutes a major proportion of the total domestic production of the product. In its original determinations, the Commission defined the Domestic Industry as all U.S. producers of ceramic tile.

(5) The Order Date is the date that the antidumping and countervailing duty orders under review became effective. In these reviews, the Order Date is June 1, 2020.

(6) An Importer is any person or firm engaged, either directly or through a parent company or subsidiary, in importing the Subject Merchandise into the United States from a foreign manufacturer or through its selling agent.

Participation in the proceeding and public service list. —Persons, including industrial users of the Subject Merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in the proceeding as parties must file an entry of appearance with the Secretary to the Commission, as provided in § 201.11(b)(4) of the Commission's rules, no later than 21 days after publication of this notice in the Federal Register . The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the proceeding.

Former Commission employees who are seeking to appear in Commission five-year reviews are advised that they may appear in a review even if they participated personally and substantially in the corresponding underlying original investigation or an earlier review of the same underlying investigation. The Commission's designated agency ethics official has advised that a five-year review is not the same particular matter as the underlying original investigation, and a five-year review is not the same particular matter as an earlier review of the same underlying investigation for purposes of 18 U.S.C. 207, the post-employment statute for Federal employees, and Commission rule 201.15(b) (19 CFR 201.15(b)), 79 FR 3246 (Jan. 17, 2014), 73 FR 24609 (May 5, 2008). Consequently, former employees are not required to seek Commission approval to appear in a review under Commission rule 19 CFR 201.15, even if the corresponding underlying original investigation or an earlier review of the same underlying investigation was pending when they were Commission employees. For further ethics advice on this matter, contact Charles Smith, Office of the General Counsel, at 202-205-3408.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and APO service list. —Pursuant to § 207.7(a) of the Commission's rules, the Secretary will make BPI submitted in this proceeding available to authorized applicants under the APO issued in the proceeding, provided that the application is made no later than 21 days after publication of this notice in the Federal Register . Authorized applicants must represent interested parties, as defined in 19 U.S.C. 1677(9), who are parties to the proceeding. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Certification. —Pursuant to § 207.3 of the Commission's rules, any person submitting information to the Commission in connection with this proceeding must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will acknowledge that information submitted in response to this request for information and throughout this proceeding or other proceeding may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements.

Written submissions. —Pursuant to § 207.61 of the Commission's rules, each interested party response to this notice must provide the information specified below. The deadline for filing such responses is on or before 5:15 p.m. on June 2, 2025. Pursuant to § 207.62(b) of the Commission's rules, eligible parties (as specified in Commission rule 207.62(b)(1)) may also file comments concerning the adequacy of responses to the notice of institution and whether the Commission should conduct expedited or full reviews. The deadline for filing such comments is on or before 5:15 p.m. on July 9, 2025. All written submissions must conform with the provisions of § 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of §§ 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on Filing Procedures, available on the Commission's website at https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf, elaborates upon the Commission's procedures with respect to filings. Also, in accordance with §§ 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the proceeding must be served on all other parties to the proceeding (as identified by either the public or APO service list as appropriate), and a certificate of service must accompany the document (if you are not a party to the proceeding you do not need to serve your response).

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.

No response to this request for information is required if a currently valid Office of Management and Budget (“OMB”) number is not displayed; the OMB number is 3117 0016/USITC No. 25-5-635, expiration date June 30, 2026. Public reporting burden for the request is estimated to average 15 hours per response. Please send comments regarding the accuracy of this burden estimate to the Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436.

Inability to provide requested information. —Pursuant to § 207.61(c) of the Commission's rules, any interested party that cannot furnish the information requested by this notice in the requested form and manner shall notify the Commission at the earliest possible time, provide a full explanation of why it cannot provide the requested information, and indicate alternative forms in which it can provide equivalent information. If an interested party does not provide this notification (or the Commission finds the explanation provided in the notification inadequate) and fails to provide a complete response to this notice, the Commission may take an adverse inference against the party pursuant to § 776(b) of the Act (19 U.S.C. 1677e(b)) in making its determinations in the reviews.

Information To Be Provided in Response to This Notice of Institution: As used below, the term “firm” includes any related firms.

Those responding to this notice of institution are encouraged, but not required, to visit the USITC's website at https://usitc.gov/reports/response_noi_worksheet, where one can download and complete the “NOI worksheet” Excel form for the subject proceeding, to be included as attachment/exhibit 1 of your overall response.

(1) The name and address of your firm or entity (including World Wide Web address) and name, telephone number, fax number, and Email address of the certifying official.

(2) A statement indicating whether your firm/entity is an interested party under 19 U.S.C. 1677(9) and if so, how, including whether your firm/entity is a U.S. producer of the Domestic Like Product, a U.S. union or worker group, a U.S. importer of the Subject Merchandise , a foreign producer or exporter of the Subject Merchandise, a U.S. or foreign trade or business association (a majority of whose members are interested parties under the statute), or another interested party (including an explanation). If you are a union/worker group or trade/business association, identify the firms in which your workers are employed or which are members of your association.

(3) A statement indicating whether your firm/entity is willing to participate in this proceeding by providing information requested by the Commission.

(4) A statement of the likely effects of the antidumping and countervailing duty orders on the Domestic Industry in general and/or your firm/entity specifically. In your response, please discuss the various factors specified in § 752(a) of the Act (19 U.S.C. 1675a(a)) including the likely volume of subject imports, likely price effects of subject imports, and likely impact of imports of Subject Merchandise on the Domestic Industry.

(5) A list of all known and currently operating U.S. producers of the Domestic Like Product. Identify any known related parties and the nature of the relationship as defined in § 771(4)(B) of the Act (19 U.S.C. 1677(4)(B)).

(6) A list of all known and currently operating U.S. importers of the Subject Merchandise and producers of the Subject Merchandise in the Subject Country that currently export or have exported Subject Merchandise to the United States or other countries since the Order Date.

(7) A list of 3-5 leading purchasers in the U.S. market for the Domestic Like Product and the Subject Merchandise (including street address, World Wide Web address, and the name, telephone number, fax number, and Email address of a responsible official at each firm).

(8) A list of known sources of information on national or regional prices for the Domestic Like Product or the Subject Merchandise in the U.S. or other markets.

(9) If you are a U.S. producer of the Domestic Like Product, provide the following information on your firm's operations on that product during calendar year 2024, except as noted (report quantity data in square feet and value data in U.S. dollars, f.o.b. plant). If you are a union/worker group or trade/business association, provide the information, on an aggregate basis, for the firms in which your workers are employed/which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the Domestic Like Product accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm to produce the Domestic Like Product (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix);

(c) the quantity and value of U.S. commercial shipments of the Domestic Like Product produced in your U.S. plant(s);

(d) the quantity and value of U.S. internal consumption/company transfers of the Domestic Like Product produced in your U.S. plant(s); and

(e) the value of (i) net sales, (ii) cost of goods sold (COGS), (iii) gross profit, (iv) selling, general and administrative (SG&A) expenses, and (v) operating income of the Domestic Like Product produced in your U.S. plant(s) (include both U.S. and export commercial sales, internal consumption, and company transfers) for your most recently completed fiscal year (identify the date on which your fiscal year ends).

(10) If you are a U.S. importer or a trade/business association of U.S. importers of the Subject Merchandise from the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in square feet and value data in U.S. dollars). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) The quantity and value (landed, duty-paid but not including antidumping or countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of Subject Merchandise from the Subject Country accounted for by your firm's(s') imports;

(b) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. commercial shipments of Subject Merchandise imported from the Subject Country; and

(c) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. internal consumption/company transfers of Subject Merchandise imported from the Subject Country.

(11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in square feet and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping or countervailing duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in the Subject Country accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm(s) to produce the Subject Merchandise in the Subject Country (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix); and

(c) the quantity and value of your firm's(s') exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from the Subject Country accounted for by your firm's(s') exports.

(12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in the Subject Country since the Order Date, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in the Subject Country, and such merchandise from other countries.

(13) (OPTIONAL) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry; if you disagree with either or both of these definitions, please explain why and provide alternative definitions.

Authority: This proceeding is being conducted under authority of Title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.61 of the Commission's rules.

Background. —On June 22, 2020, the Department of Commerce (“Commerce”) issued countervailing and antidumping duty orders on imports of quartz surface products from India and Turkey (85 FR 37431 and 37422). The Commission is conducting reviews pursuant to section 751(c) of the Act, as amended (19 U.S.C. 1675(c)), to determine whether revocation of the orders would be likely to lead to continuation or recurrence of material injury to the domestic industry within a reasonably foreseeable time. Provisions concerning the conduct of this proceeding may be found in the Commission's Rules of Practice and Procedure at 19 CFR part 201, subparts A and B, and 19 CFR part 207, subparts A and F. The Commission will assess the adequacy of interested party responses to this notice of institution to determine whether to conduct full or expedited reviews. The Commission's determinations in any expedited reviews will be based on the facts available, which may include information provided in response to this notice.

Definitions. —The following definitions apply to these reviews:

(1) Subject Merchandise is the class or kind of merchandise that is within the scope of the five-year reviews, as defined by Commerce.

(2) The Subject Countries in these reviews are India and Turkey.

(3) The Domestic Like Product is the domestically produced product or products which are like, or in the absence of like, most similar in characteristics and uses with, the Subject Merchandise. In its original determinations, the Commission defined the Domestic Like Product as a single like product consisting of quartz slabs and fabricated quartz surface products coextensive with the scope.

(4) The Domestic Industry is the U.S. producers as a whole of the Domestic Like Product, or those producers whose collective output of the Domestic Like Product constitutes a major proportion of the total domestic production of the product. In its original determinations, the Commission defined the Domestic Industry as producers of quartz surface products, including stand-alone fabricators.

(5) The Order Date is the date that the countervailing and antidumping duty orders under review became effective. In these reviews, the Order Date is June 22, 2020.

(6) An Importer is any person or firm engaged, either directly or through a parent company or subsidiary, in importing the Subject Merchandise into the United States from a foreign manufacturer or through its selling agent.

Participation in the proceeding and public service list. —Persons, including industrial users of the Subject Merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in the proceeding as parties must file an entry of appearance with the Secretary to the Commission, as provided in § 201.11(b)(4) of the Commission's rules, no later than 21 days after publication of this notice in the Federal Register . The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the proceeding.

Former Commission employees who are seeking to appear in Commission five-year reviews are advised that they may appear in a review even if they participated personally and substantially in the corresponding underlying original investigation or an earlier review of the same underlying investigation. The Commission's designated agency ethics official has advised that a five-year review is not the same particular matter as the underlying original investigation, and a five-year review is not the same particular matter as an earlier review of the same underlying investigation for purposes of 18 U.S.C. 207, the post-employment statute for Federal employees, and Commission rule 201.15(b) (19 CFR 201.15(b)), 79 FR 3246 (Jan. 17, 2014), 73 FR 24609 (May 5, 2008). Consequently, former employees are not required to seek Commission approval to appear in a review under Commission rule 19 CFR 201.15, even if the corresponding underlying original investigation or an earlier review of the same underlying investigation was pending when they were Commission employees. For further ethics advice on this matter, contact Charles Smith, Office of the General Counsel, at 202-205-3408.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and APO service list. —Pursuant to § 207.7(a) of the Commission's rules, the Secretary will make BPI submitted in this proceeding available to authorized applicants under the APO issued in the proceeding, provided that the application is made no later than 21 days after publication of this notice in the Federal Register . Authorized applicants must represent interested parties, as defined in 19 U.S.C. 1677(9), who are parties to the proceeding. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Certification. —Pursuant to § 207.3 of the Commission's rules, any person submitting information to the Commission in connection with this proceeding must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will acknowledge that information submitted in response to this request for information and throughout this proceeding or other proceeding may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements.

Written submissions. —Pursuant to § 207.61 of the Commission's rules, each interested party response to this notice must provide the information specified below. The deadline for filing such responses is on or before 5:15 p.m. on June 2, 2025. Pursuant to § 207.62(b) of the Commission's rules, eligible parties (as specified in Commission rule 207.62(b)(1)) may also file comments concerning the adequacy of responses to the notice of institution and whether the Commission should conduct expedited or full reviews. The deadline for filing such comments is on or before 5:15 p.m. on July 9, 2025. All written submissions must conform with the provisions of § 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of §§ 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on Filing Procedures, available on the Commission's website at https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf, elaborates upon the Commission's procedures with respect to filings. Also, in accordance with §§ 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the proceeding must be served on all other parties to the proceeding (as identified by either the public or APO service list as appropriate), and a certificate of service must accompany the document (if you are not a party to the proceeding you do not need to serve your response).

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.

No response to this request for information is required if a currently valid Office of Management and Budget (“OMB”) number is not displayed; the OMB number is 3117 0016/USITC No. 25-5-636, expiration date June 30, 2026. Public reporting burden for the request is estimated to average 15 hours per response. Please send comments regarding the accuracy of this burden estimate to the Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436.

Inability to provide requested information. —Pursuant to § 207.61(c) of the Commission's rules, any interested party that cannot furnish the information requested by this notice in the requested form and manner shall notify the Commission at the earliest possible time, provide a full explanation of why it cannot provide the requested information, and indicate alternative forms in which it can provide equivalent information. If an interested party does not provide this notification (or the Commission finds the explanation provided in the notification inadequate) and fails to provide a complete response to this notice, the Commission may take an adverse inference against the party pursuant to § 776(b) of the Act (19 U.S.C. 1677e(b)) in making its determinations in these reviews.

Information To Be Provided in Response to This Notice of Institution: If you are a domestic producer, union/worker group, or trade/business association; import/export Subject Merchandise from more than one Subject Country; or produce Subject Merchandise in more than one Subject Country, you may file a single response. If you do so, please ensure that your response to each question includes the information requested for each pertinent Subject Country. As used below, the term “firm” includes any related firms.

Those responding to this notice of institution are encouraged, but not required, to visit the USITC's website at https://usitc.gov/reports/response_noi_worksheet, where one can download and complete the “NOI worksheet” Excel form for the subject proceeding, to be included as attachment/exhibit 1 of your overall response.

(1) The name and address of your firm or entity (including World Wide Web address) and name, telephone number, fax number, and Email address of the certifying official.

(2) A statement indicating whether your firm/entity is an interested party under 19 U.S.C. 1677(9) and if so, how, including whether your firm/entity is a U.S. producer of the Domestic Like Product, a U.S. union or worker group, a U.S. importer of the Subject Merchandise, a foreign producer or exporter of the Subject Merchandise, a U.S. or foreign trade or business association (a majority of whose members are interested parties under the statute), or another interested party (including an explanation). If you are a union/worker group or trade/business association, identify the firms in which your workers are employed or which are members of your association.

(3) A statement indicating whether your firm/entity is willing to participate in this proceeding by providing information requested by the Commission.

(4) A statement of the likely effects of the revocation of the countervailing and the antidumping duty orders on the Domestic Industry in general and/or your firm/entity specifically. In your response, please discuss the various factors specified in § 752(a) of the Act (19 U.S.C. 1675a(a)) including the likely volume of subject imports, likely price effects of subject imports, and likely impact of imports of Subject Merchandise on the Domestic Industry.

(5) A list of all known and currently operating U.S. producers of the Domestic Like Product. Identify any known related parties and the nature of the relationship as defined in § 771(4)(B) of the Act (19 U.S.C. 1677(4)(B)).

(6) A list of all known and currently operating U.S. importers of the Subject Merchandise and producers of the Subject Merchandise in each Subject Country that currently export or have exported Subject Merchandise to the United States or other countries since the Order Date.

(7) A list of 3-5 leading purchasers in the U.S. market for the Domestic Like Product and the Subject Merchandise (including street address, World Wide Web address, and the name, telephone number, fax number, and Email address of a responsible official at each firm).

(8) A list of known sources of information on national or regional prices for the Domestic Like Product or the Subject Merchandise in the U.S. or other markets.

(9) If you are a U.S. producer of the Domestic Like Product, provide the following information on your firm's operations on that product during calendar year 2024, except as noted (report quantity data in 1,000 of square feet and value data in U.S. dollars, f.o.b. plant). If you are a union/worker group or trade/business association, provide the information, on an aggregate basis, for the firms in which your workers are employed/which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the Domestic Like Product accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm to produce the Domestic Like Product (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix);

(c) the quantity and value of U.S. commercial shipments of the Domestic Like Product produced in your U.S. plant(s);

(d) the quantity and value of U.S. internal consumption/company transfers of the Domestic Like Product produced in your U.S. plant(s); and

(e) the value of (i) net sales, (ii) cost of goods sold (COGS), (iii) gross profit, (iv) selling, general and administrative (SG&A) expenses, and (v) operating income of the Domestic Like Product produced in your U.S. plant(s) (include both U.S. and export commercial sales, internal consumption, and company transfers) for your most recently completed fiscal year (identify the date on which your fiscal year ends).

(10) If you are a U.S. importer or a trade/business association of U.S. importers of the Subject Merchandise from any Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in 1,000 of square feet and value data in U.S. dollars). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) The quantity and value (landed, duty-paid but not including antidumping and countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of Subject Merchandise from each Subject Country accounted for by your firm's(s') imports;

(b) the quantity and value (f.o.b. U.S. port, including antidumping and countervailing duties) of U.S. commercial shipments of Subject Merchandise imported from each Subject Country; and

(c) the quantity and value (f.o.b. U.S. port, including antidumping and countervailing duties) of U.S. internal consumption/company transfers of Subject Merchandise imported from each Subject Country.

(11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in any Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in 1,000 square feet and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping and countervailing duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in each Subject Country accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm(s) to produce the Subject Merchandise in each Subject Country (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix); and

(c) the quantity and value of your firm's(s') exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from each Subject Country accounted for by your firm's(s') exports.

(12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in each Subject Country since the Order Date, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in each Subject Country, and such merchandise from other countries.

(13) (OPTIONAL) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry; if you disagree with either or both of these definitions, please explain why and provide alternative definitions.

Authority: This proceeding is being conducted under authority of Title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.61 of the Commission's rules.

The Commission instituted this investigation on December 29, 2023, based on a complaint filed by Optimum Communications Services, Inc. of Jersey City, New Jersey (“Optimum”). 88 FR 90200-01 (Dec. 29, 2023). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), based upon the importation into the United States, the sale for importation, and the sale in the United States after importation of certain passive optical network equipment by reason of the infringement of certain claims of U.S. Patent Nos. 7,333,511 (“the ’511 patent”) and 7,558,260 (“the ’260 patent”) (collectively, “the asserted patents”). Id. The complaint further alleges that a domestic industry exists. Id. The Commission's notice of investigation (“NOI”) names the following respondents: (i) Hangzhou Softel Optic Co., Ltd. of Hangzhou, China; (ii) Hangzhou DAYTAI Network Technologies Co., Ltd. of Hangzhou, China; and (iii) Hangzhou Sumlo Industrial Co., Ltd. of Hangzhou, China (collectively, “Respondents”). Id. at 90201. The Office of Unfair Import Investigations (“Staff”) is also a party to this investigation. Id.

On May 9, 2024, the Commission found all Respondents in default. Order No. 12 (April 10, 2024), unreviewed by Comm'n Notice (May 9, 2024).

Optimum and Staff opted to have the presiding administrative law judge (“ALJ”) decide the investigation on the briefs rather than hold an evidentiary hearing. Order No. 13 (May 9, 2024). On May 21, 2024, Optimum filed its brief on the issues of violation, remedy, and bonding, which was titled, “Complainant's Pre-hearing Brief.” On June 7, 2024, Staff filed its brief. On June 10, 2024, Optimum also filed a reply brief.

Almost two months after the parties’ briefing was completed, Xenogenic Development, LLC (“Xenogenic”) moved to intervene in the investigation, to stay all proceedings, and to terminate the investigation. On August 16, 2024, Optimum filed a response to Xenogenic's motion to intervene. On August 19, 2024, Staff filed a response to Xenogenic's motion to intervene. On August 22, 2024, Xenogenic filed a reply.

On December 19, 2024, the ALJ issued a final initial determination (“FID”) finding no violation of section 337 with respect to claims 1 and 12-14 of the ’511 patent and claims 1 and 3 of the ’260 patent. Specifically, the FID finds: (1) termination is proper because, due to post-institution assignments of the asserted patents, Optimum is no longer a proper complainant; (2) the importation requirement has not been satisfied; (3) Optimum has not shown that either claims 1 and 12-14 of the ’511 patent or claims 1 and 3 of the ’260 patent are infringed; (4) Optimum has not satisfied the technical prong of the domestic industry requirement for the ’511 patent or the ’260 patent; and (5) Optimum has not satisfied the economic prong of the domestic industry requirement for the ’511 patent or the ’260 patent. The FID also grants in part Xenogenic's motion to intervene for the limited purpose of addressing ownership-related issues in the event of Commission review of the FID's findings of no violation.

The FID includes the ALJ's recommended determination (“RD”) on remedy, the public interest, and bonding should the Commission find a violation of section 337. Specifically, the RD recommends, if the Commission finds a violation, issuing a general exclusion order (“GEO”) under section 337(d)(2)(A). Id. at 49-52. However, the RD recommends that the evidence does not support that there is a widespread pattern of circumvention and, thus, does not support issuance of a GEO under section 337(d)(2)(B). Moreover, because Optimum failed to show a violation of section 337 by substantial, reliable, and probative evidence, the RD does not recommend issuing a GEO under section 337(g)(2). The RD does not recommend issuing any cease and desist orders. The RD also recommends that, because Optimum failed to demonstrate the necessity of a bond, the Commission should issue a zero percent (0%) bond for any infringing products imported during the period of Presidential review.

On December 24, 2024, Optimum filed a petition for review. On January 7, 2025, Staff filed a response to Optimum's petition. Xenogenic did not file a response to Optimum's petition.

On January 21, 2025, the Commission published its post-RD Federal Register notice seeking submissions on public interest issues raised by the relief recommended by the ALJ should the Commission find a violation. 90 FR 7158-59 (Jan. 21, 2025). On February 10, 2025, Antony Hernandez filed a submission supporting Optimum's request for a GEO. On February 11, 2025, Xenogenic filed a submission arguing against issuance of a GEO.

On March 11, 2025, the Commission determined to review the FID in its entirety. 90 FR 12366-67 (Mar. 17, 2025).

Having reviewed the record of the investigation, the Commission has found no violation of section 337. Specifically, the Commission affirms the FID's findings that Optimum has not satisfied the importation requirement, has failed to show infringement, and has not satisfied the domestic industry requirement. The Commission has also determined to strike the FID's statement in its “Conclusions of Law” section that the Commission “lacks statutory authority with respect to this investigation because Optimum is not the owner or exclusive licensee of the asserted patents.” See FID at 46. The Commission has also determined to take no position on the FID's findings regarding ownership. See 19 CFR 210.45(c); see also Beloit Corp. v. Valmet Oy, 742 F.2d 1421, 1423 (Fed. Cir. 1984). Accordingly, the Commission finds no violation of section 337.

The investigation is terminated.

The Commission vote for this determination took place on April 25, 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).

Background. —On March 26, 2003, the Department of Commerce (“Commerce”) issued an antidumping duty order on imports of silicon metal from Russia (68 FR 14578). Commerce issued a continuation of the antidumping duty order on imports of silicon metal from Russia following Commerce's and the Commission's first five-year reviews, effective July 16, 2008 (73 FR 40848), second five-year reviews, effective July 2, 2014 (79 FR 37718), and third five-year reviews, effective June 24, 2020 (85 FR 37831). The Commission is now conducting a fourth review to section 751(c) of the Act, as amended (19 U.S.C. 1675(c)), to determine whether revocation of the order would be likely to lead to continuation or recurrence of material injury to the domestic industry within a reasonably foreseeable time. Provisions concerning the conduct of this proceeding may be found in the Commission's Rules of Practice and Procedure at 19 CFR part 201, subparts A and B, and 19 CFR part 207, subparts A and F. The Commission will assess the adequacy of interested party responses to this notice of institution to determine whether to conduct a full or expedited review. The Commission's determination in any expedited review will be based on the facts available, which may include information provided in response to this notice.

Definitions. —The following definitions apply to this review:

(1) Subject Merchandise is the class or kind of merchandise that is within the scope of the five-year review, as defined by Commerce.

(2) The Subject Country in this review is Russia.

(3) The Domestic Like Product is the domestically produced product or products which are like, or in the absence of like, most similar in characteristics and uses with, the Subject Merchandise . In its original determination, its expedited first five year review, its full second five-year review, and its full third five year review, the Commission defined the Domestic Like Product as all silicon metal, regardless of grade, consistent with Commerce's scope.

(4) The Domestic Industry is the U.S. producers as a whole of the Domestic Like Product, or those producers whose collective output of the Domestic Like Product constitutes a major proportion of the total domestic production of the product. In its original determination, its expedited first five year review, its full second five-year review, and its full third five year review, the Commission defined the Domestic Industry as all domestic producers of silicon metal, regardless of grade, consistent with Commerce's scope.

(5) An Importer is any person or firm engaged, either directly or through a parent company or subsidiary, in importing the Subject Merchandise into the United States from a foreign manufacturer or through its selling agent.

Participation in the proceeding and public service list. —Persons, including industrial users of the Subject Merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in the proceeding as parties must file an entry of appearance with the Secretary to the Commission, as provided in § 201.11(b)(4) of the Commission's rules, no later than 21 days after publication of this notice in the Federal Register . The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the proceeding.

Former Commission employees who are seeking to appear in Commission five-year reviews are advised that they may appear in a review even if they participated personally and substantially in the corresponding underlying original investigation or an earlier review of the same underlying investigation. The Commission's designated agency ethics official has advised that a five-year review is not the same particular matter as the underlying original investigation, and a five-year review is not the same particular matter as an earlier review of the same underlying investigation for purposes of 18 U.S.C. 207, the post-employment statute for Federal employees, and Commission rule 201.15(b) (19 CFR 201.15(b)), 79 FR 3246 (Jan. 17, 2014), 73 FR 24609 (May 5, 2008). Consequently, former employees are not required to seek Commission approval to appear in a review under Commission rule 19 CFR 201.15, even if the corresponding underlying original investigation or an earlier review of the same underlying investigation was pending when they were Commission employees. For further ethics advice on this matter, contact Charles Smith, Office of the General Counsel, at 202-205-3408.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and APO service list. —Pursuant to § 207.7(a) of the Commission's rules, the Secretary will make BPI submitted in this proceeding available to authorized applicants under the APO issued in the proceeding, provided that the application is made no later than 21 days after publication of this notice in the Federal Register . Authorized applicants must represent interested parties, as defined in 19 U.S.C. 1677(9), who are parties to the proceeding. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Certification. —Pursuant to § 207.3 of the Commission's rules, any person submitting information to the Commission in connection with this proceeding must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will acknowledge that information submitted in response to this request for information and throughout this proceeding or other proceeding may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements.

Written submissions. —Pursuant to § 207.61 of the Commission's rules, each interested party response to this notice must provide the information specified below. The deadline for filing such responses is 5:15 p.m. on June 2, 2025. Pursuant to § 207.62(b) of the Commission's rules, eligible parties (as specified in Commission rule 207.62(b)(1)) may also file comments concerning the adequacy of responses to the notice of institution and whether the Commission should conduct an expedited or full review. The deadline for filing such comments is 5:15 p.m. on July 9, 2025. All written submissions must conform with the provisions of § 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of §§ 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on Filing Procedures, available on the Commission's website at https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf, elaborates upon the Commission's procedures with respect to filings. Also, in accordance with §§ 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the proceeding must be served on all other parties to the proceeding (as identified by either the public or APO service list as appropriate), and a certificate of service must accompany the document (if you are not a party to the proceeding you do not need to serve your response).

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.

No response to this request for information is required if a currently valid Office of Management and Budget (“OMB”) number is not displayed; the OMB number is 3117 0016/USITC No. 25-5-637, expiration date June 30, 2026. Public reporting burden for the request is estimated to average 15 hours per response. Please send comments regarding the accuracy of this burden estimate to the Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436.

Inability to provide requested information. —Pursuant to § 207.61(c) of the Commission's rules, any interested party that cannot furnish the information requested by this notice in the requested form and manner shall notify the Commission at the earliest possible time, provide a full explanation of why it cannot provide the requested information, and indicate alternative forms in which it can provide equivalent information. If an interested party does not provide this notification (or the Commission finds the explanation provided in the notification inadequate) and fails to provide a complete response to this notice, the Commission may take an adverse inference against the party pursuant to § 776(b) of the Act (19 U.S.C. 1677e(b)) in making its determination in the review.

Information To Be Provided in Response to this Notice of Institution: As used below, the term “firm” includes any related firms.

Those responding to this notice of institution are encouraged, but not required, to visit the USITC's website at https://usitc.gov/reports/response_noi_worksheet, where one can download and complete the “NOI worksheet” Excel form for the subject proceeding, to be included as attachment/exhibit 1 of your overall response.

(1) The name and address of your firm or entity (including World Wide Web address) and name, telephone number, fax number, and Email address of the certifying official.

(2) A statement indicating whether your firm/entity is an interested party under 19 U.S.C. 1677(9) and if so, how, including whether your firm/entity is a U.S. producer of the Domestic Like Product, a U.S. union or worker group, a U.S. importer of the Subject Merchandi se, a foreign producer or exporter of the Subject Merchandise, a U.S. or foreign trade or business association (a majority of whose members are interested parties under the statute), or another interested party (including an explanation). If you are a union/worker group or trade/business association, identify the firms in which your workers are employed or which are members of your association.

(3) A statement indicating whether your firm/entity is willing to participate in this proceeding by providing information requested by the Commission.

(4) A statement of the likely effects of the revocation of the antidumping duty order on the Domestic Industry in general and/or your firm/entity specifically. In your response, please discuss the various factors specified in section 752(a) of the Act (19 U.S.C. 1675a(a)) including the likely volume of subject imports, likely price effects of subject imports, and likely impact of imports of Subject Merchandise on the Domestic Industry.

(5) A list of all known and currently operating U.S. producers of the Domestic Like Product. Identify any known related parties and the nature of the relationship as defined in § 771(4)(B) of the Act (19 U.S.C. 1677(4)(B)).

(6) A list of all known and currently operating U.S. importers of the Subject Merchandise and producers of the Subject Merchandise in the Subject Country that currently export or have exported Subject Merchandise to the United States or other countries after 2018.

(7) A list of 3-5 leading purchasers in the U.S. market for the Domestic Like Product and the Subject Merchandise (including street address, World Wide Web address, and the name, telephone number, fax number, and Email address of a responsible official at each firm).

(8) A list of known sources of information on national or regional prices for the Domestic Like Product or the Subject Merchandise in the U.S. or other markets.

(9) If you are a U.S. producer of the Domestic Like Product, provide the following information on your firm's operations on that product during calendar year 2024, except as noted (report quantity data in short tons and value data in U.S. dollars, f.o.b. plant). If you are a union/worker group or trade/business association, provide the information, on an aggregate basis, for the firms in which your workers are employed/which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the Domestic Like Product accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm to produce the Domestic Like Product (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix);

(c) the quantity and value of U.S. commercial shipments of the Domestic Like Product produced in your U.S. plant(s);

(d) the quantity and value of U.S. internal consumption/company transfers of the Domestic Like Product produced in your U.S. plant(s); and

(e) the value of (i) net sales, (ii) cost of goods sold (COGS), (iii) gross profit, (iv) selling, general and administrative (SG&A) expenses, and (v) operating income of the Domestic Like Product produced in your U.S. plant(s) (include both U.S. and export commercial sales, internal consumption, and company transfers) for your most recently completed fiscal year (identify the date on which your fiscal year ends).

(10) If you are a U.S. importer or a trade/business association of U.S. importers of the Subject Merchandise from the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in short tons and value data in U.S. dollars). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) The quantity and value (landed, duty-paid but not including antidumping duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of Subject Merchandise from the Subject Country accounted for by your firm's(s') imports;

(b) the quantity and value (f.o.b. U.S. port, including antidumping duties) of U.S. commercial shipments of Subject Merchandise imported from the Subject Country; and

(c) the quantity and value (f.o.b. U.S. port, including antidumping duties) of U.S. internal consumption/company transfers of Subject Merchandise imported from the Subject Country.

(11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in short tons and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in the Subject Country accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm(s) to produce the Subject Merchandise in the Subject Country (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix); and

(c) the quantity and value of your firm's(s') exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from the Subject Country accounted for by your firm's(s') exports.

(12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in the Subject Country after 2019, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in the Subject Country, and such merchandise from other countries.

(13) (OPTIONAL) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry; if you disagree with either or both of these definitions, please explain why and provide alternative definitions.

Authority: This proceeding is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.61 of the Commission's rules.

Background. —On January 8, 2015, the Department of Commerce (“Commerce”) issued antidumping and countervailing duty orders on imports of carbon and certain alloy steel wire rod from China (80 FR 1015 and 1018). Following the five-year reviews by Commerce and the Commission, effective June 26, 2020, Commerce issued a continuation of the antidumping and countervailing duty orders on imports of carbon and certain alloy steel wire rod from China (85 FR 38359). The Commission is now conducting second reviews pursuant to section 751(c) of the Act, as amended (19 U.S.C. 1675(c)), to determine whether revocation of the orders would be likely to lead to continuation or recurrence of material injury to the domestic industry within a reasonably foreseeable time. Provisions concerning the conduct of this proceeding may be found in the Commission's Rules of Practice and Procedure at 19 CFR part 201, subparts A and B, and 19 CFR part 207, subparts A and F. The Commission will assess the adequacy of interested party responses to this notice of institution to determine whether to conduct full or expedited reviews. The Commission's determinations in any expedited reviews will be based on the facts available, which may include information provided in response to this notice.

Definitions. —The following definitions apply to these reviews:

(1) Subject Merchandise is the class or kind of merchandise that is within the scope of the five-year reviews, as defined by Commerce.

(2) The Subject Country in these reviews is China.

(3) The Domestic Like Product is the domestically produced product or products which are like, or in the absence of like, most similar in characteristics and uses with, the Subject Merchandise. In its original and expedited five-year review determinations, the Commission defined one Domestic Like Product comprised of all wire rod products coextensive with Commerce's scope.

(4) The Domestic Industry is the U.S. producers as a whole of the Domestic Like Product, or those producers whose collective output of the Domestic Like Product constitutes a major proportion of the total domestic production of the product. In its original and expedited five-year review determinations, the Commission defined the Domestic Industry as all U.S. producers of wire rod.

(5) An Importer is any person or firm engaged, either directly or through a parent company or subsidiary, in importing the Subject Merchandise into the United States from a foreign manufacturer or through its selling agent.

Participation in the proceeding and public service list. —Persons, including industrial users of the Subject Merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in the proceeding as parties must file an entry of appearance with the Secretary to the Commission, as provided in § 201.11(b)(4) of the Commission's rules, no later than 21 days after publication of this notice in the Federal Register . The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the proceeding.

Former Commission employees who are seeking to appear in Commission five-year reviews are advised that they may appear in a review even if they participated personally and substantially in the corresponding underlying original investigation or an earlier review of the same underlying investigation. The Commission's designated agency ethics official has advised that a five-year review is not the same particular matter as the underlying original investigation, and a five-year review is not the same particular matter as an earlier review of the same underlying investigation for purposes of 18 U.S.C. 207, the post-employment statute for Federal employees, and Commission rule 201.15(b) (19 CFR 201.15(b)), 79 FR 3246 (Jan. 17, 2014), 73 FR 24609 (May 5, 2008). Consequently, former employees are not required to seek Commission approval to appear in a review under Commission rule 19 CFR 201.15, even if the corresponding underlying original investigation or an earlier review of the same underlying investigation was pending when they were Commission employees. For further ethics advice on this matter, contact Charles Smith, Office of the General Counsel, at 202-205-3408.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and APO service list. —Pursuant to § 207.7(a) of the Commission's rules, the Secretary will make BPI submitted in this proceeding available to authorized applicants under the APO issued in the proceeding, provided that the application is made no later than 21 days after publication of this notice in the Federal Register . Authorized applicants must represent interested parties, as defined in 19 U.S.C. 1677(9), who are parties to the proceeding. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Certification. —Pursuant to § 207.3 of the Commission's rules, any person submitting information to the Commission in connection with this proceeding must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will acknowledge that information submitted in response to this request for information and throughout this proceeding or other proceeding may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements.

Written submissions. —Pursuant to § 207.61 of the Commission's rules, each interested party response to this notice must provide the information specified below. The deadline for filing such responses is 5:15 p.m. on June, 2, 2025. Pursuant to § 207.62(b) of the Commission's rules, eligible parties (as specified in Commission rule 207.62(b)(1)) may also file comments concerning the adequacy of responses to the notice of institution and whether the Commission should conduct expedited or full reviews. The deadline for filing such comments is 5:15 p.m. on July 9, 2025. All written submissions must conform with the provisions of § 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of §§ 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on Filing Procedures, available on the Commission's website at https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf, elaborates upon the Commission's procedures with respect to filings. Also, in accordance with §§ 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the proceeding must be served on all other parties to the proceeding (as identified by either the public or APO service list as appropriate), and a certificate of service must accompany the document (if you are not a party to the proceeding you do not need to serve your response).

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.

No response to this request for information is required if a currently valid Office of Management and Budget (“OMB”) number is not displayed; the OMB number is 3117 0016/USITC No. 25-5-634, expiration date June 30, 2026. Public reporting burden for the request is estimated to average 15 hours per response. Please send comments regarding the accuracy of this burden estimate to the Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436.

Inability to provide requested information. —Pursuant to § 207.61(c) of the Commission's rules, any interested party that cannot furnish the information requested by this notice in the requested form and manner shall notify the Commission at the earliest possible time, provide a full explanation of why it cannot provide the requested information, and indicate alternative forms in which it can provide equivalent information. If an interested party does not provide this notification (or the Commission finds the explanation provided in the notification inadequate) and fails to provide a complete response to this notice, the Commission may take an adverse inference against the party pursuant to § 776(b) of the Act (19 U.S.C. 1677e(b)) in making its determinations in the reviews.

Information To Be Provided in Response to This Notice of Institution: As used below, the term “firm” includes any related firms.

Those responding to this notice of institution are encouraged, but not required, to visit the USITC's website at https://usitc.gov/reports/response_noi_worksheet, where one can download and complete the “NOI worksheet” Excel form for the subject proceeding, to be included as attachment/exhibit 1 of your overall response.

(1) The name and address of your firm or entity (including World Wide Web address) and name, telephone number, fax number, and Email address of the certifying official.

(2) A statement indicating whether your firm/entity is an interested party under 19 U.S.C. 1677(9) and if so, how, including whether your firm/entity is a U.S. producer of the Domestic Like Product, a U.S. union or worker group, a U.S. importer of the Subject Merchandise, a foreign producer or exporter of the Subject Merchandise, a U.S. or foreign trade or business association (a majority of whose members are interested parties under the statute), or another interested party (including an explanation). If you are a union/worker group or trade/business association, identify the firms in which your workers are employed or which are members of your association.

(3) A statement indicating whether your firm/entity is willing to participate in this proceeding by providing information requested by the Commission.

(4) A statement of the likely effects of the revocation of the antidumping and countervailing duty orders on the Domestic Industry in general and/or your firm/entity specifically. In your response, please discuss the various factors specified in section 752(a) of the Act (19 U.S.C. 1675a(a)) including the likely volume of subject imports, likely price effects of subject imports, and likely impact of imports of Subject Merchandise on the Domestic Industry.

(5) A list of all known and currently operating U.S. producers of the Domestic Like Product. Identify any known related parties and the nature of the relationship as defined in section 771(4)(B) of the Act (19 U.S.C. 1677(4)(B)).

(6) A list of all known and currently operating U.S. importers of the Subject Merchandise and producers of the Subject Merchandise in the Subject Country that currently export or have exported Subject Merchandise to the United States or other countries after 2018.

(7) A list of 3-5 leading purchasers in the U.S. market for the Domestic Like Product and the Subject Merchandise (including street address, World Wide Web address, and the name, telephone number, fax number, and Email address of a responsible official at each firm).

(8) A list of known sources of information on national or regional prices for the Domestic Like Product or the Subject Merchandise in the U.S. or other markets.

(9) If you are a U.S. producer of the Domestic Like Product, provide the following information on your firm's operations on that product during calendar year 2024, except as noted (report quantity data in short tons and value data in U.S. dollars, f.o.b. plant). If you are a union/worker group or trade/business association, provide the information, on an aggregate basis, for the firms in which your workers are employed/which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the Domestic Like Product accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm to produce the Domestic Like Product (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix);

(c) the quantity and value of U.S. commercial shipments of the Domestic Like Product produced in your U.S. plant(s);

(d) the quantity and value of U.S. internal consumption/company transfers of the Domestic Like Product produced in your U.S. plant(s); and

(e) the value of (i) net sales, (ii) cost of goods sold (COGS), (iii) gross profit, (iv) selling, general and administrative (SG&A) expenses, and (v) operating income of the Domestic Like Product produced in your U.S. plant(s) (include both U.S. and export commercial sales, internal consumption, and company transfers) for your most recently completed fiscal year (identify the date on which your fiscal year ends).

(10) If you are a U.S. importer or a trade/business association of U.S. importers of the Subject Merchandise from the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in short tons and value data in U.S. dollars). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) The quantity and value (landed, duty-paid but not including antidumping or countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of Subject Merchandise from the Subject Country accounted for by your firm's(s') imports;

(b) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. commercial shipments of Subject Merchandise imported from the Subject Country; and

(c) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. internal consumption/company transfers of Subject Merchandise imported from the Subject Country.

(11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in short tons and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping or countervailing duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in the Subject Country accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm(s) to produce the Subject Merchandise in the Subject Country (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix); and

(c) the quantity and value of your firm's(s') exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from the Subject Country accounted for by your firm's(s') exports.

(12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in the Subject Country after 2018, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in the Subject Country, and such merchandise from other countries.

(13) (OPTIONAL) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry; if you disagree with either or both of these definitions, please explain why and provide alternative definitions.

Authority: This proceeding is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.61 of the Commission's rules.

In accordance with 21 CFR 1301.34(a), this is notice that on April 14, 2025, Unither Manufacturing LLC, 331 Clay Road, Rochester, New York 14623-3226, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

The company plans to import the listed controlled substance solely for updated analytical testing purposes to meet European Union requirements for their finished dosage form product. No other activity for this drug code is authorized for this registration.

Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

In accordance with 21 CFR 1301.34(a), this is notice that on February 24, 2025, United States Pharmacopeial Convention, 7135 English Muffin Way, Frederick, Maryland 21704, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

The company plans to import the listed controlled substances for distribution as analytical reference standards to its customers for analytical testing of raw materials. No other activities for these drug codes are authorized for this registration.

Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

The FBI CJIS APB is responsible for reviewing policy issues and appropriate technical and operational issues related to the programs administered by the FBI's CJIS Division, and thereafter, making appropriate recommendations to the FBI Director. The programs administered by the CJIS Division are the Law Enforcement Enterprise Portal, National Crime Information Center, Next Generation Identification, National Instant Criminal Background Check System, National Data Exchange System, and Uniform Crime Reporting.

The meeting will be conducted with a blended participation option. The public may participate as follows: Via phone bridge number to participate in a listen-only mode or in person, which are required to check-in at the meeting registration desk.

Registrations will be taken via email to agmu@leo.gov . Information regarding the phone access will be provided prior to the meeting to all registered individuals. Interested persons whose registrations have been accepted may be permitted to participate in the discussions at the discretion of the meeting chairman and with approval of the Designated Federal Officer (DFO).

Any member of the public may file a written statement with the APB. Written comments shall be focused on the APB's issues under discussion and may not be repetitive of previously submitted written statements. Written comments should be provided to Mr. Nicky J. Megna, DFO, at least seven (7) days in advance of the meeting so the comments may be made available to the APB members for their consideration prior to the meeting.

Individuals requiring special accommodations should contact Mr. Megna by no later than May 28, 2025. Personal registration information will be made publicly available through the minutes for the meeting published on the FACA website.

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:

Abstract: Self-reporting requirements set forth in the Department of Justice (DOJ) Policy Statement 1700.04, Department Personnel Security Reporting Requirements, issued April 18, 2018, apply to non-federal employee personnel affiliated with the DOJ. The policy contains reporting requirements that are applicable to the entire DOJ workforce as well as reporting requirements that apply only to personnel occupying a national security position or who have access to classified information. The requirements relating to national security are mandated by the Director of National Intelligence as the Security Executive Agent. The majority of the reports relate to the submitter's personal conduct and activities. There is one form for personnel to submit information on other personnel, consistent with government-wide reporting requirements. This collection request seeks approval for contractors and other non-federal employees who are processed for access to classified information to utilize the Department's automated reporting system called iReport, or, for the small population with no access to the IT system, to utilize PDF fillable forms to report the required information. The Security and Emergency Planning Staff, and other Department Security Offices, will use the reported information to determine the submitter's continued fitness for employment at the Department of Justice or continued eligibility for access to national security information. The Department security offices for each agency component will review, evaluate, and adjudicate the information received.

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

2. The Title of the Form/Collection: US Department of Justice Self Reportable Activities.

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: OMB #1103-0119.

4. Affected public who will be asked or required to respond, as well as the obligation to respond: Affected Public Federal Government. Individuals who are contractors for the Department of Justice or who are processed for access to classified information by the Department of Justice.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: Department-wide population covered by the requirement to self-report information in the forms listed in Sections 2a and 2b is estimated at 57,744. It is estimated that only three percent (1,732) will actually need to self-report. Department-wide population covered by the requirement to report information in the forms listed in Sections 2c through 2l is estimated to be 604. Amount of time estimated for an average reported is less than ten minutes.

6. An estimate of the total annual burden (in hours) associated with the collection: 389 annual burden hours.

7. An estimate of the total annual cost burden associated with the collection, if applicable:

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

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

2. The Title of the Form/Collection: Federal Coal Lease Form.

3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: The form numbers are ATR-139 and ATR-140. The applicable component within the Department of Justice is the Antitrust Division.

4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for profit. Other: None. The Department of Justice evaluates the competitive impact of issuances, transfers and exchanges of federal coal leases. These forms seek information regarding a prospective coal lessee's existing coal reserves. The Department uses this information to determine whether the issuance, transfer or exchange of the federal coal lease is consistent with the antitrust laws.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: It is estimated that 10 respondents will complete each form, with each response taking approximately two hours.

6. An estimate of the total public burden (in hours) associated with the collection: There are an estimated 20 annual burden hours associated with this collection, in total.

If additional information is required contact: Darwin Arceo, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC 20530.

Table of Contents I. Introduction II. Public Proceeding(s) III. Summary Proceeding(s) I. Introduction

Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an existing product currently appearing on the Competitive product list.

The public portions of the Postal Service's request(s) can be accessed via the Commission's website ( http://www.prc.gov ). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3011.301. 1

Section II identifies the docket number(s) associated with each Postal Service request, if any, that will be reviewed in a public proceeding as defined by 39 CFR 3010.101(p), the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each such request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 and 39 CFR 3000.114 (Public Representative). The Public Representative does not represent any individual person, entity or particular point of view, and, when Commission attorneys are appointed, no attorney-client relationship is established. Section II also establishes comment deadline(s) pertaining to each such request.

The Commission invites comments on whether the Postal Service's request(s) identified in Section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3041. Comment deadline(s) for each such request, if any, appear in Section II.

Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review. See 39 CFR 3041.110(n); 39 CFR 3041.205(a). Such requests are reviewed in summary proceedings pursuant to 39 CFR 3041.325(c)(2) and 39 CFR 3041.505(f)(1). Pursuant to 39 CFR 3041.405(c)-(d), the Commission does not appoint a Public Representative or request public comment in proceedings to review such requests.

1. Docket No(s).: MC2025-1327 and K2025-1327; Filing Title: USPS Request to Add Priority Mail Express International, Priority Mail International & First-Class Package International Service Contract 67 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: April 24, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Maxine Bradley; Comments Due: May 2, 2025.

None. See Section II for public proceedings.

This Notice will be published in the Federal Register .

Table of Contents I. Introduction II. Public Proceeding(s) III. Summary Proceeding(s) I. Introduction

Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an existing product currently appearing on the Competitive product list.

The public portions of the Postal Service's request(s) can be accessed via the Commission's website ( http://www.prc.gov ). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3011.301. 1

Section II identifies the docket number(s) associated with each Postal Service request, if any, that will be reviewed in a public proceeding as defined by 39 CFR 3010.101(p), the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each such request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 and 39 CFR 3000.114 (Public Representative). The Public Representative does not represent any individual person, entity or particular point of view, and, when Commission attorneys are appointed, no attorney-client relationship is established. Section II also establishes comment deadline(s) pertaining to each such request.

The Commission invites comments on whether the Postal Service's request(s) identified in Section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3041. Comment deadline(s) for each such request, if any, appear in Section II.

Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review. See 39 CFR 3041.110(n); 39 CFR 3041.205(a). Such requests are reviewed in summary proceedings pursuant to 39 CFR 3041.325(c)(2) and 39 CFR 3041.505(f)(1). Pursuant to 39 CFR 3041.405(c)-(d), the Commission does not appoint a Public Representative or request public comment in proceedings to review such requests.

1. Docket No(s).: MC2025-1328 and K2025-1328; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 717 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: April 25, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Elsie Lee-Robbins; Comments Due: May 5, 2025.

2. Docket No(s).: MC2025-1329 and K2025-1329; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 718 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: April 25, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Almaroof Agoro; Comments Due: May 5, 2025.

3. Docket No(s).: MC2025-1330 and K2025-1330; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 719 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: April 25, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Kenneth Moeller; Comments Due: May 5, 2025.

4. Docket No(s).: MC2025-1331 and K2025-1331; Filing Title: USPS Request to Add Priority Mail Express, Priority Mail & USPS Ground Advantage Contract 1363 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: April 25, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Kenneth Moeller; Comments Due: May 5, 2025.

None. See Section II for public proceedings.

This Notice will be published in the Federal Register .

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 25, 2025, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail & USPS Ground Advantage® Contract 717 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2025-1328, K2025-1328.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 25, 2025, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail Express, Priority Mail & USPS Ground Advantage® Contract 1363 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2025-1331, K2025-1331.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 21, 2025, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail & USPS Ground Advantage® Contract 713 to Competitive Product List . Documents are available at www.prc.gov, Docket Nos. MC2025-1322, K2025-1322.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 21, 2025, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail & USPS Ground Advantage® Contract 714 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2025-1323, K2025-1323.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 23, 2025, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail & USPS Ground Advantage® Contract 716 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2025-1326, K2025-1326.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 25, 2025, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail & USPS Ground Advantage® Contract 719 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2025-1330, K2025-1330.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 23, 2025, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail Express International, Priority Mail International & First-Class Package International Service Contract 66 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2025-1324 and K2025-1324.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on April 25, 2025, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail & USPS Ground Advantage® Contract 718 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2025-1329, K2025-1329.