Type of Information Collection: BHA Workplace Culture Survey.

Type of Request: Notice for public comment.

Originating Office: USAID Bureau for Humanitarian Affairs.

Respondents: BHA personnel, including ISCs that are not federal employees for PRA purposes.

Respondent's Obligation to Respond: Voluntary.

Estimated Number of Respondents: 400.

Average Time per Response: 15 minutes for survey respondents.

Frequency of Response: Approximately once per year.

Total Estimated Burden: 100 hours.

Total Estimated Burden Cost: None.

We are soliciting public comments to permit USAID/BHA to include ISCs in its workforce survey to assess and gauge its processes for developing and improving a more cohesive BHA culture.

Please see the Privacy Act Statement in its entirety in the ensuing section.

As a part of the transformation of the Office of Foreign Disaster Assistance (OFDA) and Food For Peace (FFP) into BHA in 2020, we enlisted the support of USAID Staff Care organizational consultants to both assess the cultures* of FFP and OFDA, and then engage staff in the design of a BHA culture that melds the best of both offices. To that end, BHA conducted a cultural assessment survey in March/April 2020, which has informed Staff Care's culture work with BHA offices and senior management. This culminated in a July 2021 workshop where office representatives integrated all the office-level work on culture into a BHA-wide culture document.

In 2021 BHA conducted a second culture survey. This survey was implemented and analyzed by the Training Resources Group, Inc. (TRG) to ensure confidentiality of responses. TRG analyzed the data and shared results from the survey with BHA leadership and staff in early 2022. Subsequently, BHA Offices held meetings to focus on individual office results and action planning discussions.

The 2021 survey provides baseline data for our 2023 survey. This year's survey will allow us to gauge the process to date on developing a BHA culture.

Your participation is critical, so please note this survey is confidential. While we will be requesting demographic information so that we can analyze survey responses in a variety of ways, this information will not be attached to individuals who respond, and TRG consultants will be the only ones with access to the raw data.

( *Culture for the purposes of this survey means BHA's values, norms and behaviors that guide and inform BHA staff and how we work together. )

( *Culture for the purposes of this survey means BHA's values, norms and behaviors that guide and inform BHA staff and how we work together. )

Unit defined as: The immediate BHA team/office/group that you work closest with.

Bureau leadership defined as: BHA Front Office, Office directors based in Washington, DC.

In accordance with E.O. 14035: Executive Order on Diversity, Equity, Inclusion, and Accessibility in the Federal Workforce, we are collecting information relating to the culture of BHA and to the morale of all of our employees to help inform efforts to improve workplace culture.

BHA intends to use the voluntarily-given basic demographic information along with responses gauging morale and workplace culture at an aggregate level to examine where pain points in BHA's approach to work may be. With information about how employees of different genders, sexual identities, hiring mechanisms, disability statuses, and racial or ethnic groups feel about their unit and BHA's culture, office and bureau leadership will be better informed about how to focus and prioritize efforts related to culture change. Identifying how staff feel about their workplace culture and what factors are affecting their morale will allow leaders at all levels in the bureau to create a better culture and improve conditions for groups where needed. The survey will be sent to staff at their USAID email address, the survey will indicate that staff will be asked for their consent to share demographic data, which they may decline to provide at their discretion. Staff will be notified about the purpose of the collection, what will be done with the information provided, and how the information will be retained and protected.

We will use this information to inform office and bureau-level follow up actions. Additionally, leaders at different levels in the bureau will be able to use the disaggregated data to inform their office culture improvement action plans. We plan to conduct annual cultural surveys to continue to track and invest in BHA culture change over time. Information will not be shared with any other entity or source, and will not be used for any other purpose beyond what is specified here.

In order to isolate the data from anyone who would have the ability to identify participants, our consultant partner, the Training Resources Group, Inc. (TRG), will execute, house, and disaggregate the data from this survey, protecting this information with the utmost integrity in accordance with their corporate privacy policies. No PII will be collected or shared. Two individuals in TRG will have access to the raw data only through two-factor authentication. Further, raw data will be deleted after one year after which a new culture survey will be disseminated to BHA staff.

Title: Regional Agricultural Promotion Program.

OMB Number: 0551-0049.

Expiration Date of Approval: August 31, 2025.

Type of Request: Revision of a currently approved information collection.

Abstract: Under the Regional Agricultural Promotion Program (RAPP), information will be gathered from applicants to the program and from existing program participants that have been approved to conduct market promotion activities that promote U.S. agricultural commodities in foreign markets, including activities that address existing or potential non-tariff barriers to trade. The information collected will be used primarily by FAS to manage, plan, evaluate, and account for government resources. This revision is necessary to update the burden estimate to account for new applications being received under RAPP.

Estimate of Burden: The public reporting burden for each respondent resulting from information collected under the RAPP varies in direct relation to the number and type of agreements entered into by such respondents. The estimated average reporting burden for the RAPP is 16 hours per response.

Type of Respondents: Nonprofit U.S. agricultural trade organizations, nonprofit state regional trade groups, U.S. agricultural cooperatives, and state agencies.

Estimated Number of Respondents: 70 per annum.

Estimated Number of Responses per Respondent: 55 per annum.

Estimated Total Annual Burden of Respondents: 55,029 hours.

Copies of this information collection can be obtained from Dacia Rogers, the Agency Information Collection Coordinator, at Dacia.Rogers@usda.gov.

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption 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 through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be available without change, including any personal information provided, for inspection online at https://www.regulations.gov and at the mail address listed above between 8:00 a.m. and 4:30 p.m., Monday through Friday, except holidays.

Comments will be summarized and included in the submission for OMB approval.

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact RARequest@usda.gov.

The primary purpose of the watershed plan is to provide a reliable drinking water supply to meet current and future demands in Clarke County, Iowa. Watershed planning is authorized under the Watershed Protection and Flood Prevention Act of 1954 (Pub. L. 83-566), as amended, and the Flood Control Act of 1944 (Pub. L. 78-534). The sponsoring local organization (SLO) is the Clarke County Reservoir Commission (CCRC) whose members are the cities of Osceola, Murray, and Woodburn, Iowa; Clarke County, Iowa; Osceola Water Works Board of Trustees; and Southern Iowa Rural Water Association (SIRWA).

The study area includes all of Clarke County where the water supply is provided by the existing West Lake Reservoir. Osceola Water Works treats raw water from West Lake, which is the sole water supply source reservoir. SIRWA purchases potable water from Osceola Water Works and distributes it to other users in Clarke County.

This action is needed to address deficiencies in the agricultural water delivery system, which are having negative impacts on current public health and economic growth. Limited water supply can impact public health and safety due to the lack of safe drinking water and the lack of water supply for other public needs, such as firefighting. Quality of life for residents is impacted due to the potential for water use restrictions during droughts. Economic growth has been limited in the area because the supply is too limited to support new businesses. Additionally, future water demands are anticipated to grow, and the current supply will be increasingly insufficient.

The reservoir at West Lake has insufficient storage during moderate to severe droughts. The reservoir has gone through substantial draw down during four drought periods over the last 40 years requiring various degrees of water restrictions. West Lake is in its third year with lake levels below the spillway and Clarke County remains in a moderate to severe drought. The remaining water supply in West Lake was estimated to be less than a year in October 2023. The water conservation ordinance has been increased to Section 3—Water Emergency.

To meet the purpose of agricultural water supply for the Clarke County service area, a safe and reliable water supply with an average daily capacity of 2.0 million gallons per day is being requested. There is a long history of water supply investigations in Clarke County. The city of Osceola commissioned a study by an engineering firm in 1990 to evaluate West Lake. The result of the study showed that West Lake would not meet the projected water supply demand. At the request of local officials, USDA Soil Conservation Service conducted a study of six potential sites and published the results in a report titled, “Reconnaissance Report: Potential Water Supply Reservoirs, City of Osceola and Rural Users, Clarke County, Iowa” (1991). Local sponsors made requests for PL-566 planning assistance in 1992 and 1996, however funding for pre-authorization planning activities was not available on either occasion. Two other studies, one in 1996 and the other in 1999, were conducted evaluating alternative water supply sources and the potential for increasing yield from West Lake. In 2002, the Osceola Water Board of Trustees, rural users, and other sponsoring bodies organized and formed a 28E organization to become the CCRC. The CCRC requested planning assistance from NRCS in 2003 which was authorized late in 2004.

Estimated federal funds required for the construction of the proposed action may exceed $25 million and the proposed action will, therefore, require congressional approval per the Consolidated Appropriations Act, 2018 amended funding threshold. In accordance with the regulation in 7 CFR 650.7(a)(2), an EIS is required for projects requiring congressional approval.

The EIS objective is to formulate and evaluate alternatives for the agricultural water supply in the Clarke County service area. The EIS is expected to evaluate three alternatives: two action alternatives, and one no action alternative. The alternatives that may be considered for detailed analysis include:

• Alternative 1—Proposed Action—Water Supply Reservoir: The proposed action is to evaluate a water supply reservoir developed with a dam at site 4B, which would include an earthfill embankment dam with reinforced concrete pressure pipe spillway and vegetated auxiliary spillway. The proposed project would also include a 6-mile water supply pipeline to transport water from the reservoir to the water treatment plant. The dam construction and inundated area would require the relocation of a segment of a local road (Truro Pavement). The normal pool (at 1001 foot elevation) would inundate 790 acres. The maximum height of the dam would be 58 feet. The reservoir has 11,030 acre-feet of storage and a design withdrawal capacity of 2.0 million gallons per day on an average daily basis during drought conditions, which would meet the need of the project.

• Alternative 2—Proposed Action—Single Purpose Water Supply Pipeline: The proposed action would evaluate purchasing water from Des Moines Water Works. This alternative would require a one-time construction cost to install of 20-inch diameter pipeline 38.5 miles long from the Des Moines Waterworks to the City of Osceola, and a booster station in between. A buy-in fee would be part of the start-up cost for service. Monthly rates and fees for treated water use would apply over the life of the project. The proposed action would be able to provide 2.0 million gallons per day on an average daily basis during drought conditions which would meet the need of the project.

• Alternative 3—No Action Alternative: Taking no action would consist of activities conducted if no federal action or funding were provided. If the No Action Alternative is selected water supply limitations would continue to impact residents of Clarke County quality of life, public health and safety, and future economic growth. No federal action or funding would be associated with the No Action Alternative.

As mentioned above, the estimated Federal contribution to construction cost will exceed $25 million. The EIS will be prepared as required by section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA); the Council on Environmental Quality Regulations (40 CFR parts 1500-1508); and NRCS regulations that implement NEPA in 7 CFR part 650.

CCRC and NRCS evaluated the current relevant project conditions with early scoping and a preliminary conceptual design, which indicates that the proposed alternatives may have local, regional, or national impacts on the environment. The impacts may include: dam structure and inundation from the reservoir; temporary and adverse impacts from construction activities; and permanent beneficial impacts from adequate drinking water supply. NRCS will coordinate with the appropriate federal agencies throughout the planning process to minimize impacts, and consider mitigation.

Potential effects include the following:

• soils;

• prime and unique farmland;

• land use;

• water resources, including wetlands, streams, and water quality;

• floodplains;

• terrestrial and aquatic wildlife, including threatened and endangered species and those included under the Migratory Bird Treaty Act;

• cultural resources and historic properties;

• public health, safety, and transportation; and

• social and economic conditions.

Long-term beneficial effects would occur with an increase in agricultural water supply.

The following permits and authorizations are anticipated to be required:

• Clean Water Act (CWA) and National Pollutant Discharge Elimination System (NPDES). The project would require water quality certification under Section 401 of the CWA, permitting under Section 402 of the NPDES, and Section 404 of the CWA for potential wetland impacts.

• Endangered Species Act Section 7. NRCS and CCRC are currently developing a Biological Assessment (BA) to support ESA Section 7 consultation with the U.S. Fish and Wildlife Service.

• National Historic Preservation Act (NHPA) Section 106. Consultation with Tribal Nations and interested parties would be conducted as required by the NHPA.

• National Flood Insurance Program. A Letter of Map Revision/Conditional Letter of Map Revision would be required from the Federal Emergency Management Agency.

• Dam Safety and Floodplain Permit. Local dam safety and floodplain permits will be required for construction and operation of the dam from the Iowa Department of Natural Resources (IDNR) as required in Iowa Administrative Code (IAC) 567.

• IAC, Environmental Protection Commission 567, Chapter 43, Water Supplies—Design and Operation. Water Supply Storage, Water Use, and Construction Permits must be obtained from IDNR Water Supply Engineering Section for the Reservoir, Intake and Pipeline. Requirements must be met for the Water Allocation and Use program, including a Water Use Permit. Construction standards for public water supplies must be met as set forth under IAC 567, Chapter 43.

• Review and acceptance of Final Engineering Plans and Specifications. The final design and construction drawings and specifications must be reviewed and approved by IDNR and NRCS prior to implementation. Using the NRCS National Operation and Maintenance Manual (O&M), an O&M plan will be prepared.

• Development—Conditional Use Permit, Grading Permit, Utility Permit, and Entrance Permit. These are all local permits that must be obtained from Clarke County.

A Draft EIS (DEIS) will be prepared and circulated for review and comment by agencies, Tribes, consulting parties, and the public for 45 days as required by the regulations in 40 CFR 1503.1, 1502.20, 1506.11, and 1502.17, and 7 CFR 650.13. The DEIS is anticipated to be published in the Federal Register , approximately 6 months after publication of this NOI. A Final EIS is anticipated to be published within 6 months of completion of the public comment period for the DEIS.

NRCS will decide whether to implement one of the action alternatives as evaluated in the EIS. A Record of Decision will be completed after the required 30-day waiting period and will be publicly available. The responsible Federal official and decision maker for the NRCS is the Iowa NRCS State Conservationist.

A public scoping meeting was held on August 19, 2021. Comments received, including the names and addresses of those who commented, were part of the public record. Scoping meeting presentation materials were available for review and comment for 30 days from Thursday, August 19, 2021, through Saturday, September 18, 2021.

Federal, State, Tribal, local agencies and representatives, and the public were invited to take part in the watershed plan scoping period through which coordination sought input on issues of economic, environmental, cultural, and social importance in the watershed. CCRC and NRCS organized the public scoping meeting to provide an opportunity to review and evaluate the project alternatives, express concern or support, and gain further information regarding the project. To determine the most viable alternatives to carry forward to the EIS, the CCRC used input obtained during public scoping discussions to focus on relevant resource concerns and issues and eliminated those that were not relevant from further detailed study.

NRCS invites agencies, Tribes, consulting parties, and individuals who have special expertise, legal jurisdiction, or interest in the Clarke County Water Supply project to provide comments concerning the scope of the analysis and identification of potential alternatives, information, and analyses relevant to the Proposed Action.

NRCS will coordinate the scoping process to correspond with any required NHPA processes, as allowed in the regulations in 36 CFR 800.2(d)(3) and 800.8 (54 U.S.C. 306108). The information about historic and cultural resources within the area potentially affected by the proposed project will assist NRCS in identifying and evaluating impacts to such resources in the context of both NEPA and NHPA.

NRCS will consult with Native American tribes on a government-to-government basis in accordance with the regulations in 36 CFR 800.2 and 800.3, Executive Order 13175, and other policies. Tribal concerns, including impacts on Indian trust assets and potential impacts to cultural resources and historic properties, will be given due consideration.

This document is published as specified by the NEPA regulations regarding publication of an NOI to issue an EIS (40 CFR 1501.9(d)). Watershed planning is authorized under the Watershed Protection and Flood Prevention Act of 1954, as amended, and the Flood Control Act of 1944.

The title and number of the Federal Assistance Program as found in the Assistance Listing  1 to which this document applies is 10.904, Watershed Protection and Flood Prevention.

Executive Order 12372, “Intergovernmental Review of Federal Programs,” requires consultation with State and local officials that would be directly affected by proposed Federal financial assistance. The objectives of the Executive order are to foster an intergovernmental partnership and a strengthened federalism, by relying on State and local processes for State and local government coordination and review of proposed Federal financial assistance and direct Federal development. This project is subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

In accordance with Federal civil rights law and USDA civil rights regulations and policies, 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, gender identity (including gender expression), sexual orientation, disability, age, marital status, family or 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.

Individuals who require alternative means of communication for program information (for example, braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or the USDA TARGET Center at (202) 720-2600 (voice and telephone) or dial 711 for Telecommunications Relay Service (both voice and text telephone users can initiate this call from any phone). Additionally, program information may be made available in languages other than English.

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

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

This meeting will take place in Spanish with English interpretation. This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per 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 will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email ebohor@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 meeting. Written comments may be emailed to Victoria Moreno at vmoreno@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at 1-312-353-8311.

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 www.facadatabase.gov under the Commission on Civil Rights, Puerto Rico Advisory Committee link. 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 ebohor@usccr.gov.

On May 9, 2023, Commerce published the initiation of this administrative review of the countervailing duty order on OTR tires from India. 1 The mandatory company respondents are ATC Tires Private Limited (ATC) and Balkrishna Industries Ltd. On November 9, 2023, Commerce extended the time limit for these preliminary results to March 29, 2024. 2

For a complete description of the events that followed the initiation of the review, see the Preliminary Decision Memorandum. 3 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade/gov/public/FRNoticesListLayout.aspx.

The merchandise covered by the order is OTR tires. OTR tires are tires with an off road tire size designation. The tires included in the scope may be either tube-type or tubeless, radial, or non-radial, regardless of whether for original equipment manufacturers or the replacement market. For a complete description of the scope of this order, see the Preliminary Decision Memorandum.

Commerce is conducting this administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs preliminarily found to be countervailable, Commerce preliminarily determines that there is a subsidy, i.e., a financial contribution from an authority that gives rise to a benefit to the recipient and that the subsidy is specific. 4 For a full description of the methodology underlying Commerce's preliminary conclusions, see the Preliminary Decision Memorandum.

The Act and Commerce's regulations do not directly address the subsidy rate to be applied to companies not selected for individual examination where Commerce limits its examination in an administrative review pursuant to section 777A(e)(2) of the Act. However, Commerce normally determines the rates for non-selected companies in reviews in a manner that is consistent with section 705(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation. Section 777A(e)(2) of the Act provides that “the individual countervailable subsidy rates determined under subparagraph (A) shall be used to determine the all-others rate under section 705(c)(5) {of the Act}.” Section 705(c)(5)(A) of the Act states that for companies not investigated, in general, we will determine an all-others rate by weight averaging the countervailable subsidy rates established for each of the companies individually investigated, excluding zero and de minimis rates or any rates based solely on the facts available.

Accordingly, to determine the rate for companies not selected for individual examination, Commerce's practice is to weight average the net subsidy rates for the selected mandatory respondents, excluding rates that are zero, de minimis, or based entirely on facts available. 5 We preliminarily determine that ATC received countervailable subsidies that are above de minimis and are not based entirely on facts available. Therefore, we preliminarily determine to apply the net subsidy rates calculated for ATC. The companies for which a review was requested, which were not selected as mandatory respondents or found to be cross-owned with a mandatory respondent, are listed in Appendix II.

Commerce preliminarily determines the net countervailable subsidy rates exist for the period January 1, 2022, through December 31, 2022:

Commerce intends to disclose its calculations and analysis performed to interested parties for these preliminary results within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance. Commerce will notify interested parties of the deadline for submission of case briefs. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs. 8 Interested parties who submit case briefs or rebuttal briefs in this proceeding must submit: (1) a table of contents listing each issue; and (2) a table of authorities. 9

As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. 10 Further, we request that interested parties limit their executive summary of each issue to no more than 450 words, not including citations. We intend to use the executive summaries as the basis of the comment summaries included in the issues and decision memorandum that will accompany the final results in this administrative review. We request that interested parties include footnotes for relevant citations in the executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 11

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. Hearing requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. An electronically filed hearing request must be received successfully in its entirety by Commerce's electronic records system, ACCESS, by 5 p.m. Eastern Time, within 30 days of the publication date of this notice. If a request for a hearing is made, parties will be notified of the time and date of the hearing. 12

Unless the deadline is extended, Commerce intends to issue the final results of this administrative review, which will include the results of Commerce's analysis of the issues raised in the case briefs, within 120 days after the date of the preliminary results, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).

In accordance with 19 CFR 351.221(b)(4)(i), Commerce preliminarily assigned a subsidy rate in the amount for the producers/exporters shown above. Upon completion of the administrative review, consistent with section 751(a)(1) of the Act and 19 CFR 351.212(b)(2), Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register .

If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

In accordance with section 751(a)(2)(C) of the Act, Commerce also intends upon publication of the final results, to instruct CBP to collect cash deposits of the estimated countervailing duties in the amounts calculated in the final results of this review for the respective companies listed above with regard to shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review. If the rate calculated in the final results is zero or de minimis, no cash deposit will be required on shipments of the subject merchandise entered or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review.

For all non-reviewed firms, CBP will continue to collect cash deposits of estimated countervailing duties at the all-others rate or the most recent company-specific rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.

These preliminary results of review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213 and 351.221(b)(4).

On May 9, 2023, Commerce initiated an administrative review of the AD order on uncoated paper from Brazil, 1 in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). 2 This review covers two producers/exporters of subject merchandise, Suzano  3 and Sylvamo. 4

On November 9, 2023, Commerce extended the deadline for these preliminary results until March 29, 2024. 5 For a complete description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum. 6

The merchandise subject to the Order is uncoated paper from Brazil. For a full description of the scope, see the Preliminary Decision Memorandum.

Commerce is conducting this review in accordance with section 751(a)(1)(B) of the Act. We calculated constructed export price in accordance with section 772 of the Act. We calculated NV in accordance with section 773 of the Act.

For a full description of the methodology underlying these preliminary results, see the Preliminary Decision Memorandum. A list of the topics discussed in the Preliminary Decision Memorandum is included as an appendix to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

We preliminarily determine that the following weighted-average dumping margins exist for the period March 1, 2022, through February 28, 2023:

We intend to disclose the calculations performed to parties within five days after public announcement of the preliminary results or, if there is no public announcement, within five days of the date of publication of this notice. 7 Interested parties may submit case briefs no later than 30 days after the date of publication of this notice. 8 Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs. 9 Interested parties who submit case or rebuttal briefs in this proceeding must submit: (1) a table of contents listing each issue; and (2) a table of authorities. 10

As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. 11 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 issues and decision memorandum that will accompany the final results in this administrative review. We request that interested parties include footnotes for relevant citations in the public executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 12

Interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. 13 Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants and whether any participant is a foreign national; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in case and rebuttal briefs. 14 If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. A hearing request must be filed electronically using ACCESS and received in its entirety by 5:00 p.m. Eastern Time within 30 days after the publication of this notice.

Upon completion of the final results of this administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. 15 Pursuant to 19 CFR 351.212(b)(1), if the weighted-average dumping margin for Suzano or Sylvamo is not zero or de minimis ( i.e., less than 0.50 percent) in the final results of this review, we will calculate importer-specific assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales. If either respondent's weighted-average dumping margin is zero or de minimis in the final results of review, or if an importer-specific assessment rate is zero or de minimis, Commerce will instruct CBP to liquidate appropriate entries without regard to antidumping duties. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by this review, and for future deposits of estimated duties, where applicable. 16

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Suzano or Sylvamo for which the company did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate established in the original less-than-fair-value (LTFV) investigation ( i.e., 27.11 percent)  17 if there is no rate for the intermediate company(ies) involved in the transaction. 18

Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies listed above will be equal to the weighted-average dumping margins established in the final results of this review, except if the rate is less than 0.50 percent and, therefore, de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rate will be zero; (2) for merchandise exported by a company not covered in this review, but covered in a prior segment of the proceeding, the cash deposit rate will be the company-specific rate published for the most recently-completed segment in which it was reviewed; (3) if the exporter is not a firm covered in this review or in the original LTFV investigation, but the producer is, then the cash deposit rate will be the rate established for the most recently-completed segment of this proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 27.11 percent, the all-others rate established in the LTFV investigation. 19 These cash deposit requirements, when imposed, shall remain in effect until further notice.

Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, no later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).

This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

Commerce is issuing and publishing these results in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.213(h)(2) and 19 CFR 351.221(b)(4).

On March 6, 2017, Commerce published in the Federal Register an antidumping duty order on off-the-road tires from India. 1 On May 9, 2023, based on timely requests for review, we initiated an administrative review of the Order covering 24 companies. 2 On November 4, 2023, we extended the time limit for these preliminary results to March 29, 2024. 3 For a complete description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum. 4

The merchandise subject to the Order is certain new pneumatic off-the-road tires from India. For a full description of the scope of the Order, see the Preliminary Decision Memorandum.

Pursuant to 19 CFR 351.213(d)(3), it is Commerce's practice to rescind an administrative review of an antidumping duty order where it concludes that there were no suspended entries of subject merchandise during the POR. 5 Normally, upon completion of an administrative review, the suspended entries are liquidated at the antidumping duty assessment rate for the review period. 6 Therefore, for an administrative review to be conducted, there must be a reviewable, suspended entry that Commerce can instruct U.S. Customs and Border Protection (CBP) to liquidate at the calculated antidumping duty assessment rate for the review period. 7 On December 22, 2023, we notified parties of our intent to rescind the instant review regarding the companies listed in Appendix III because there were no reviewable, suspended entries of subject merchandise from these companies during the POR and invited interested parties to comment. 8 No parties commented on our intent to rescind the review, in part. In the absence of any suspended entries of subject merchandise from these companies during the POR, we are rescinding this administrative review for the companies listed in Appendix III, in accordance with 19 CFR 351.213(d)(3).

Commerce is conducting this review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). We calculated export price and constructed export price in accordance with section 772 of the Act. We calculated NV in accordance with section 773 of the Act.

For a full description of the methodology underlying these preliminary results, see the Preliminary Decision Memorandum. A list of the topics discussed in the Preliminary Decision Memorandum is attached as Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The statute and Commerce's regulations do not address the rate to be applied to companies not selected for individual examination when Commerce limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a market economy investigation, for guidance when calculating the rate for companies which were not selected for individual examination in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero or de minimis margins, and any margins determined entirely on the basis of facts available.

We preliminarily calculated dumping margins for the two mandatory respondents, ATC Tires Private Limited and ATC Tires AP Private Ltd. (collectively, ATC) and Asian Tire Factory Ltd. and Lyallpur Rubber Mills (collectively, ATF), of 2.68 percent and 3.18 percent, respectively, and we have assigned to the non-selected companies a rate of 2.71 percent, which is the weighted average of ATC's and ATF's dumping margins, weighted by their publicly ranged U.S. sales values. 9

As a result of this review, we preliminarily determine the following estimated weighted-average dumping margins exist for the period March 1, 2022, through February 28, 2023:

We intend to disclose the calculations performed in connection with these preliminary results to interested parties within five days after the date of publication of this notice in the Federal Register . 11 Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs. 12 Interested parties who submit case briefs or rebuttal briefs in this administrative review must submit: (1) a table of contents listing each issue; and (2) a table of authorities. 13

As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings, we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide, at the beginning of their briefs, a public executive summary for each issue raised in their briefs. 14 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 issues and decision memorandum that will accompany the final results in this administrative review. We request that interested parties include footnotes for relevant citations in the public executive summary of each issue.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS within 30 days after the date of publication of this notice. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing. 15

All submissions, including case and rebuttal briefs, as well as hearing requests, should be filed via ACCESS. 16 An electronically filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time on the established deadline. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 17

Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, no later than 120 days after the date of publication of this notice in the Federal Register , pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).

Upon completion of this administrative review, pursuant to section 751(a)(2)(A) of the Act, Commerce shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.

Pursuant to 19 CFR 351.212(b)(1), because ATC reported the entered value of its U.S. sales, we calculated importer-specific ad valorem duty assessment rates based on the ratio of the total amount of dumping calculated for the examined sales to the total entered value of the sales for which entered value was reported. ATF did not report the actual entered value for its U.S. sales; thus, we calculated importer-specific per-unit duty assessment rates by aggregating the total amount of antidumping duties calculated for the examined sales and dividing this amount by the total quantity of those sales. Where either the respondent's weighted-average dumping margin is zero or de minimis within the meaning of 19 CFR 351.106(c)(1), or an importer specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

For entries of subject merchandise during the POR produced by either of the individually examined respondents for which they did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate these entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. 18

For the companies listed in Appendix II which were not selected for individual review, we will assign an assessment rate based on the review-specific rate, calculated as noted in the “Rate for Non-Examined Companies” section, above.

For the companies listed in Appendix III for which we are rescinding this review, we will instruct CBP to assess antidumping duties on all appropriate entries at a rate equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, in accordance with 19 CFR 351.212(c)(l)(i). Commerce intends to issue these rescission instructions to CBP no earlier than 35 days after the date of publication of this notice in the Federal Register .

Commerce intends to issue assessment instructions to CBP regarding ATC, ATF, and the companies listed in Appendix II no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by this review and for future deposits of estimated duties, where applicable. 19

The following deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies listed above will be that established in the final results of this review, except if the rate is less than 0.05 percent and therefore, de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rate will be zero; (2) for previously investigated or reviewed companies not covered by this review, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value (LTFV) investigation, but the producer is, then the cash deposit rate will be the rate established for the most recently-completed segment of this proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 3.67 percent, the all-others rate established in the LTFV investigation. 20 These deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing and the subsequent assessment of doubled antidumping duties, and/or an increase in the amount of antidumping by the amount of countervailing duties.

We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(4).

On May 9, 2023, Commerce initiated an administrative review of the antidumping duty order on uncoated paper from Portugal, 1 in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). 2 This review covers one producer/exporter of subject merchandise, The Navigator Company, S.A. (Navigator).

On November 3, 2023, Commerce extended the time limit for completing the preliminary results of this review until March 29, 2024. 3 For details regarding the events that occurred subsequent to the initiation of the review, see the Preliminary Decision Memorandum. 4

The products covered by the Order are certain uncoated paper products from Portugal. For a complete description of the scope, see the Preliminary Decision Memorandum.

Commerce is conducting this review in accordance with section 751(a) of the Act. We calculated constructed export price in accordance with section 772 of the Act. We calculated normal value in accordance with section 773 of the Act. For a full description of the methodology underlying these preliminary results, see the Preliminary Decision Memorandum. A list of topics included in the Preliminary Decision Memorandum is included as an appendix to this notice. The Preliminary Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum is available at https://access.trade.gov/public/FRNoticesListLayout.aspx.

We preliminarily determine that the following estimated weighted-average dumping margin exists for the period March 1, 2022, through February 28, 2023:

We intend to disclose the calculations performed to parties within five days after public announcement of the preliminary results or, if there is no public announcement, within five days of the date of publication of this notice in the Federal Register in accordance with 19 CFR 351.224(b).

Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs. 5 Interested parties who submit case briefs or rebuttal briefs in this proceeding must submit: (1) a table of contents listing each issue; and (2) a table of authorities. 6 As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their briefs that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs. 7 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 issues and decision memorandum that will accompany the final results in this administrative review. We request that interested parties include footnotes for relevant citations in the public executive summary of each issue. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 8

Interested parties who wish to request a hearing must do so within 30 days of publication of these preliminary results by submitting a written request to the Assistant Secretary, filed electronically via ACCESS. 9 Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. 10 If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm the date and time of the hearing two days before the scheduled date. Parties are reminded that all briefs and hearing requests must be filed electronically using ACCESS and received successfully in their entirety by 5 p.m. Eastern Time on the due date.

Upon completion of the final results of this administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. If Navigator's weighted-average dumping margin is not zero or de minimis ( i.e., less than 0.5 percent) in the final results of this review, we will calculate importer-specific ad valorem antidumping duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific assessment rate calculated in the final results of this review is not zero or de minimis. If Navigator's weighted-average dumping margin is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable. 11

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Navigator for which it did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate established in the original less-than-fair value (LTFV) investigation ( i.e., 7.80 percent)  12 if there is no rate for the intermediate company(ies) involved in the transaction. 13

Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for Navigator in the final results of review will be equal to the weighted-average dumping margin established in the final results of this administrative review except if the rate is less than 0.50 percent and, therefore, de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rate will be zero; (2) for merchandise exported by producers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment of this proceeding in which they were reviewed; (3) if the exporter is not a firm covered in this review or the original LTFV investigation but the producer is, then the cash deposit rate will be the rate established for the most recently-completed segment of this proceeding for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 7.80 percent, 14 the all-others rate established in the LTFV investigation. These cash deposit requirements, when imposed, shall remain in effect until further notice.

Unless extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).

This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

This administrative review and notice are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213 and 351.221(b)(4).

The EFPs are requested under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ), and regulations at 50 CFR 600.745(b) concerning exempted fishing.

The projects described in these EFP requests are two of several projects that NMFS has recommended for funding based on a notice of funding opportunity that NMFS published last fall, seeking projects that would explore new approaches to better understand and reduce red snapper dead discards and increase fishing opportunities in the South Atlantic snapper-grouper fishery.

The most recent South Atlantic red snapper stock assessment (Southeast Data, Assessment, and Review (SEDAR) 73, 2021) indicates that the South Atlantic red snapper stock is undergoing overfishing and is overfished. Discard mortality continues to be the primary source of fishing mortality, with a high number of discards coming from the recreational sector. Therefore, NMFS has identified a need to test management strategies that could be used by the Council to reduce recreational discards of red snapper and other managed snapper-grouper species, ensure opportunities for sustainable harvest, and improve angler satisfaction.

Considering this need, the FWC has proposed two projects that would accomplish the following objectives: (1) Directly collaborate with members of the snapper-grouper recreational sector and collect catch and discard information at a representative scale within the snapper-grouper fishery; (2) Recruit recreational fishermen to test a unique snapper-grouper aggregate recreational bag limit, and compare that with control groups to quantify the potential impact alternative management strategies have on reducing the magnitude of snapper-grouper regulatory discards; (3) Allow a select number of recreational fishermen recruited for these projects to harvest red snapper outside of the South Atlantic Federal red snapper recreational season, accompanied by a mandatory reporting requirement and provisions for validation and proof of participation; (4) Develop a unique web-based application to record information from project participants; (5) Develop an education course required for all project participants that highlights best fishing practices, species identification, and methods to safely descend fish experiencing barotrauma; and (6) Evaluate recreational fisherman satisfaction through pre- and post-participation surveys and semi-structured interviews with project participants.

NMFS notes that this notification of receipt of applications for EFPs encompasses two FWC projects. Each of these projects is identical in project scope, purpose, and exempted Federal regulations. The primary differences between the two requested projects are location of the project and the maximum allowed number of recreational fishing trips per participant for each location.

One proposed project boundary is offshore of the east coast of Florida from the Florida/Georgia state line south to 28°35.1′ north latitude in the Atlantic Ocean (due east of the NASA Vehicle Assembly Building, Cape Canaveral, Florida). The other project boundary is offshore of the east coast of Florida from 28°35.1′ north latitude in the Atlantic Ocean (due east of the NASA Vehicle Assembly Building, Cape Canaveral, Florida) south to the Dry Tortugas, the southern boundary of the South Atlantic Fishery Management Council jurisdictional waters(50 CFR 600.105(c)). The project locations includes state and Federal waters, but FWC expects that the majority of snapper-grouper harvest and fishing effort would occur in Federal waters.

The EFPs would begin on July 1, 2024, and end on June 30, 2025. FWC would solicit applications from individual recreational fishermen who would be entered into a lottery to participate in either study. The application and lottery process, both administered by FWC, would occur once every 3 months and FWC would select 200 participants for each 3-month study. Participants would be screened by the FWC for resource violations and randomly assigned to either a control group or an experimental group. Participants in the northern study would be referred to as the “Experimental Hot Spot Fleet” and participants in the southern study would be referred to as the “Southeast Florida Snapper Grouper Fleet.” Each participant would be required to hold a valid saltwater recreational fishing license issued by the State of Florida (or be state exempt), have declared themselves a Florida State Reef Fish Survey angler, and take an educational course aimed at reducing discard mortality of snapper-grouper species. The EFPs would only apply to recreational fishermen who apply for and are selected to be part of FWC's Experimental Hot Spot Fleet or Southeast Florida Snapper-Grouper Fleet. Therefore, under each EFP, for each 3-month period, FWC would be able to account for and provide NMFS with a list of participants ( e.g., state license, registration of each vessel and vessel name during designated fishing trips, name of participants and contact information, etc. ) to be covered under each EFP before operations begin under the EFPs.

Every 3 months during the 12-month fishing period of each EFP, half of the fishermen would be selected for a control group and the other half for an experimental group. Participants assigned to the control group of either fleet would follow the current recreational Federal regulations for snapper-grouper species. Each participant in the Experimental Hot Spot Fishing Fleet, regardless of group assignment, would be able to take a maximum of three recreational fishing trips per 3-month period. Each participant in the Southeast Florida Snapper-Grouper Fleet, regardless of group assignment, would be able to take a maximum of two recreational fishing trips per 3-month period.

For both fleets, participants assigned to an experimental group would be permitted to harvest no more than 15 fish under a unique snapper-grouper aggregate bag limit per person per day in state and Federal waters combined, in addition to the three red snapper described below. Participants in an experimental group would be required to stop directed snapper-grouper recreational trips once their unique aggregate snapper-grouper bag limit has been reached, and they would not be allowed to target or harvest any snapper-grouper species managed by the Council for the remainder of the trip. Participants may then target other species such as coastal migratory pelagics and dolphinfish. In addition to the unique aggregate bag limit described above, participants in an experimental group would be allowed to harvest three red snapper outside of any Federal red snapper recreational fishing season under the EFPs until the unique aggregate snapper-grouper bag limit is reached. If approved, the EFPs would exempt those recreational fishermen in an experimental group participating in FWC's Experimental Hot Spot Fleet or Southeast Florida Snapper-Grouper Fleet from the Federal regulations at 50 CFR 622.183(b)(5) (recreational sector closures for red snapper), 50 CFR 622.187(b)(9) (bag and possession limits for red snapper), and 50 CFR 622.193(y)(2) (ACLs and AMs for red snapper). The FWC is not requesting exemptions from any Federal regulations other than these. Participants would have to abide by all fishery regulations otherwise not exempted from this study.

Under the EFPs, the unique 15-fish snapper-grouper aggregate recreational bag limit requested by FWC is as follows:

• Only 1 fish can be gag, black grouper, or scamp.

• Up to 2 fish can be red grouper, yellowfin grouper, yellowmouth grouper, coney, graysby, red hind, or rock hind.

• Only 1 fish can be red porgy, blueline tilefish, or golden tilefish.

• Only 1 fish can be greater amberjack.

• Up to 3 fish can be lesser amberjack, almaco jack, or banded rudderfish.

• Up to 5 fish can be black sea bass.

• Up to 5 fish can be gray triggerfish.

• Up to 10 fish can be grunts.

• Up to 10 fish can be Atlantic spadefish or bar jack.

• Up to 10 fish can be porgies (excluding red porgy).

• Up to 10 fish can be schoolmaster snapper, gray snapper, lane snapper, yellowtail snapper, queen snapper, silk snapper, or blackfin snapper.

• Up to 5 fish can be vermilion snapper, cubera snapper, or mutton snapper.

Until the unique snapper-grouper aggregate bag limit is reached, all species within the snapper-grouper fishery, except those with regulatory closures, could be harvested by participants. Should a regulatory closure occur for any species (other than red snapper), participants would be prohibited from harvesting those species. The requested recreational bag limits within FWC's proposed 15-fish snapper-grouper aggregate bag limit do not exceed current Federal recreational bag limits for any of the included snapper-grouper species. This aggregate bag limit is intended to cause recreational fishermen to reach their daily bag limit faster, which would then result in them stopping fishing. This would likely then lead to reduced discards and enhanced fisherman satisfaction across the snapper-grouper recreational sector. Throughout the duration of the proposed projects, the total amount of South Atlantic red snapper allowed to be harvested under these EFPs by the recreational fishermen is 3,600 on Experimental Hot Spot Fleet trips and 2,400 on Southeast Florida Snapper-Grouper Fleet trips.

Recreational fishermen can choose the date and time of each trip within each 3-month period of the project. Prior to taking a fishing trip, the selected participant, using their unique FWC provided identification number, must notify FWC 24 hours in advance of a planned trip and report the date and state registration number of the vessel they intend to fish from in order to receive an FWC authorization document, which must then be available to present to law enforcement if requested, either at sea or dockside. Selected participants can also elect to take their fishing trips on a charter vessel or headboat (for-hire). Aboard that for-hire vessel, only participants who have been selected to participate in an EFP and declared they are taking a trip authorized under an EFP on the identified for-hire vessel can take red snapper (if in an experimental group). As the vessel, private or for-hire, with the participant onboard is returning to port, the participant must hail in and let FWC know the estimated time and location of arrival. Upon return to port from a trip, all participants would be required to submit catch and discard data to the FWC within 48 hours through an FWC web-based application. To evaluate recreational fishermen satisfaction, FWC social scientists would conduct pre- and post-participation surveys and randomly select a subset of participants in each group to participate in semi-structured interviews.

NMFS finds the applications warrants further consideration based on a preliminary review. Possible conditions the agency may impose on the EFPs, if granted, include but are not limited to, a prohibition on fishing within marine protected areas, marine sanctuaries, or special management zones without additional authorization.

A final decision on issuance of the EFPs will depend on NMFS' review of public comments received on the applications, consultations with the appropriate fishery management agencies of the affected states, the Council, and the U.S. Coast Guard, and a determination that the activities to be taken under the EFPs are consistent with all other applicable laws.

Authority: 16 U.S.C. 1801 et seq.

The EFP is requested under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ), and regulations at 50 CFR 600.745(b) concerning exempted fishing.

The project described in this EFP request is one of several projects that NMFS has recommended for funding based on a notice of funding opportunity that NMFS published last fall, seeking projects that would explore new approaches to better understand and reduce red snapper dead discards and increase fishing opportunities in the South Atlantic snapper-grouper fishery.

The most recent South Atlantic red snapper stock assessment (Southeast Data, Assessment, and Review (SEDAR) 73, 2021) indicates that the South Atlantic red snapper stock is undergoing overfishing and is overfished. Discard mortality continues to be the primary source of fishing mortality, with a high number of discards coming from the recreational sector. Therefore, NMFS has identified a need for improved data to support the evaluation of alternative management strategies that could be used by the Council to reduce recreational discards of red snapper and other managed snapper-grouper species, ensure opportunities for sustainable harvest, and improve angler satisfaction.

Considering this need, FWC has proposed this project to accomplish the following objectives: (1) Collaborate with recreational vessel captains and recreational fishermen to collect catch and discard information within the snapper-grouper fishery; (2) Recruit charter vessel and private recreational vessel captains to test a unique snapper-grouper aggregate recreational bag limit and its impact on reducing the magnitude of regulatory discards; (3) Allow project participants to harvest red snapper outside of the Federal red snapper recreational season, accompanied by a mandatory reporting requirement and provisions for validation; (4) Develop a unique web-based application to record information from project participants; (5) Develop an education course required for all project participants; and (6) Evaluate recreational fishermen satisfaction through pre- and post-participation surveys.

The EFP would begin on July 1, 2024, and end on June 30, 2025. The project location would occur offshore of the east coast of Florida and include state and Federal waters from the Florida/Georgia state line south to a line running east from the NASA General Assembly Building in Cape Canaveral, Florida. For this project, FWC proposes to create a “Study Fleet” of five private recreational vessels and five charter vessels that would each take up to three fishing trips per quarter (a 3-month project period). The sampling period for the entire study would be 12 months and thus each quarter would last 3 months. All Study Fleet fishing trips would be limited to a maximum of six recreational fishermen per vessel (excluding the captain and crew of charter vessels) and all recreational fishermen onboard a selected vessel would be participants in the study. All recreational fishermen on project vessels would be required to fish with a single hook rig with a circle hook. The FWC Study Fleet would be allowed to retain up to a maximum vessel limit of 60 South Atlantic red snapper per day, regardless of the number of persons onboard the vessel. In addition, recreational fishermen onboard a vessel would be allowed to harvest no more than 15 fish under a unique snapper-grouper aggregate bag limit per person per day in state and Federal waters. All recreational fishermen onboard the selected vessels would be required to keep all snapper-grouper species that meet legal requirements, such as size limits, and would retain all red snapper caught, up to the 60 red snapper vessel limit, while trying to obtain the unique 15-fish snapper-grouper aggregate bag limit. Each recreational fisherman on a Study Fleet vessel trip would be required to stop directed snapper-grouper fishing once the unique snapper-grouper aggregate bag limit of 15-fish has been met or the vessel limit of 60 red snapper has been met, whichever occurs first. After meeting one of these limits, participants may target other species such as coastal migratory pelagics and dolphinfish, but they would be required to stop directed snapper-grouper fishing for the remainder of the trip.

If approved, the EFP would exempt recreational fishermen participating in FWC's Study Fleet from the Federal regulations at 50 CFR 622.183(b)(5) (recreational sector closures for red snapper), 50 CFR 622.187(b)(9) (bag and possession limits for red snapper), and 50 CFR 622.193(y)(2) (ACLs and AMs for red snapper). The FWC is not requesting exemptions from any Federal regulations other than these. Participants would have to abide by all fishery regulations otherwise not exempted from this study.

Under the EFP, the unique 15-fish snapper-grouper aggregate recreational bag limit requested by FWC is as follows:

• Only 1 fish can be gag, black grouper, or scamp.

• Up to 2 fish can be red grouper, yellowfin grouper, yellowmouth grouper, coney, graysby, red hind, or rock hind.

• Only 1 fish can be red porgy, blueline tilefish, or golden tilefish.

• Only 1 fish can be greater amberjack.

• Up to 3 fish can be lesser amberjack, almaco jack, or banded rudderfish.

• Up to 5 fish can be black sea bass.

• Up to 5 fish can be gray triggerfish.

• Up to 10 fish can be grunts.

• Up to 10 fish can be Atlantic spadefish or bar jack.

• Up to 10 fish can be porgies (excluding red porgy).

• Up to 10 fish can be schoolmaster snapper, gray snapper, lane snapper, yellowtail snapper, queen snapper, silk snapper, or blackfin snapper.

• Up to 5 fish can be vermilion snapper, cubera snapper, or mutton snapper.

Until the unique snapper-grouper aggregate bag limit is reached or the red snapper vessel limit is reached, all species within the snapper-grouper fishery, except those with regulatory closures, could be recreationally harvested by participants. However, species not listed above would not count towards the FWC's proposed 15- fish snapper-grouper aggregate recreational bag limit. Should a regulatory closure occur for any species (other than red snapper), participants would be prohibited to harvest those species. This unique aggregate bag limit is intended to cause recreational fishermen to reach their daily bag limit faster which would then result in them stopping fishing for snapper-grouper species. This would then lead to reduced discards and enhanced fisherman satisfaction across the snapper-grouper recreational sector. Throughout the duration of the proposed project, recreational fishermen would harvest a maximum of 7,200 South Atlantic red snapper on Study Fleet trips.

If the project is approved, FWC would solicit applications from captains of charter vessels and private recreational vessels that fish within the proposed study location. Charter vessel captains are defined as someone who will be responsible for safe operation of the vessel during FWC Study Fleet trips and is licensed by the United States Coast Guard to carry passengers for hire and has one or more passengers onboard who are paying a fee to take or pursue an organism. Project charter vessels would need to have a valid Federal Charter Vessel/Headboat Permit for South Atlantic Snapper-Grouper. For this project, private recreational captains are defined as someone who will be responsible for the safe operation of the vessel during FWC Study Fleet trips and, if born after January 1, 1988, has successfully completed an approved boating safety course and obtained a Boating Safety Education Identification Card issued by FWC. A captain may be exempt from these requirements if they are licensed by the United States Coast Guard as master of a vessel or are a nonresident that has completed a National Association of State Boating Law Administrators approved boater safety course or equivalent examination from another state. Any private recreational captain or charter vessel captain that does not have a resource violation as determined by FWC would be eligible to participate in the FWC Study Fleet.

From the applications received from the public by FWC, FWC would select five private vessels and five charter vessels to be part of the FWC Study Fleet each quarter. Vessels would partly be selected based on the area intended to be fished, vessel type, and the homeport of these vessels. The selection criteria are intended to result in a comprehensive coverage of the study location. Both charter and private vessels would be limited to a maximum of six recreational fishermen (excluding the captain and crew of charter vessels) per designated fishing trip. The terms of the EFP would apply to all captains and recreational fishermen on the selected vessels during FWC Study Fleet trips. All charter vessels would be required to have the Federal Charter Vessel/Headboat Permit for South Atlantic Snapper-Grouper species and a Florida Saltwater Charter License prior to participating in the FWC Study Fleet. All recreational fishermen fishing from private vessels would be required to have a valid Florida recreational fishing license (or be exempt) and be signed up for Florida's State Reef Fish Survey prior to fishing aboard a trip as part of the FWC Study Fleet. All project participants fishing in the FWC Study Fleet would be required to view and complete an online educational course provided by the FWC. The EFP would only apply to the captains and vessels that are selected to be a part of the FWC Study Fleet. Therefore, FWC would be able to account for and provide NMFS with a list of participants ( e.g., state license, registration of each vessel and vessel name during designated fishing trips, name of participants and contact information, etc. ) to be covered under the EFP before operations begin under the EFP.

Prior to taking a FWC Study Fleet fishing trip, each captain would have to coordinate the date/dates of the trip with FWC. Using their unique FWC provided identification number, captains would be required to notify FWC 24 hours prior to a planned project trip and report the date and state registration number of the vessel they intend to fish from in order to receive an FWC authorization document, which must be available to present to law enforcement if requested at-sea or dockside. When the FWC Study Fleet vessel returns to port, the captain must hail in and let FWC know the estimated time and location of arrival. Upon return to port from a trip, the captain and all recreational fishermen aboard a project vessel would be required to allow FWC to collect biological samples from harvested fish and conduct interviews. All captains would be required to report data through an FWC web-based application about their fishing trip within 48 hours of returning to port.

NMFS finds the application warrants further consideration based on a preliminary review. Possible conditions the agency may impose on the EFP, if granted, include but are not limited to, a prohibition on fishing within marine protected areas, marine sanctuaries, or special management zones without additional authorization.

A final decision on issuance of the EFP will depend on NMFS' review of public comments received on the application, consultations with the appropriate fishery management agencies of the affected states, the Council, and the U.S. Coast Guard, and a determination that the activities to be taken under the EFP are consistent with all other applicable laws.

Authority: 16 U.S.C. 1801 et seq.

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

On January 19, 2021, we issued a final rule with regulations to govern the unintentional taking of marine mammals incidental to geophysical survey activities conducted by oil and gas industry operators, and those persons authorized to conduct activities on their behalf (collectively “industry operators”), in U.S. waters of the GOM over the course of 5 years (see 86 FR 5322, January 19, 2021). The rule was based on our findings that the total taking from the specified activities over the 5-year period will have a negligible impact on the affected species or stock(s) of marine mammals and will not have an unmitigable adverse impact on the availability of those species or stocks for subsistence uses. The rule became effective on April 19, 2021.

Our regulations at 50 CFR 217.180 allow for the issuance of LOAs to industry operators for the incidental take of marine mammals during geophysical survey activities and prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat (often referred to as mitigation), as well as requirements pertaining to the monitoring and reporting of such taking. Under 50 CFR 217.186(e), issuance of an LOA shall be based on a determination that the level of taking will be consistent with the findings made for the total taking allowable under these regulations and a determination that the amount of take authorized under the LOA is of no more than small numbers.

WesternGeco plans to conduct a three-dimensional (3D) ocean bottom node (OBN) survey over Walker Ridge and Green Canyon areas, with approximate water depths ranging from approximately 700 to 3,000 meters (m). WesternGeco anticipates using a single dual source vessel, either towing airgun array sources consisting of 28 elements, with a total volume of 5,240 cubic inches (in 3 ; 0.086 cubic meters (m 3 )), or a Gemini enhanced frequency source (EFS) array. Please see WesternGeco's LOA application for additional detail.

The Gemini source operates on the same basic principles as a traditional airgun source in that it uses compressed air to create a bubble in the water column, which then goes through a series of collapses and expansions creating primarily low-frequency sounds. However, the Gemini source consists of one physical element with two large chambers of 4,000 in 3 (0.066 m 3 ) each (total volume of 8,000 in 3 (0.131 m 3 )). This creates a larger bubble resulting in more of the energy being concentrated in low frequencies, with a fundamental frequency of 3.7 hertz. In addition to concentrating energy at lower frequencies, the Gemini source is expected to produce lower overall sound levels than the conventional airgun proxy source. The number of airguns in an array is highly influential on overall sound energy output, because the output increases approximately linearly with the number of airgun elements. In this case, because the same air volume is used to operate two very large guns, rather than tens of smaller guns, the array produces lower sound levels than a conventional array of equivalent total volume. NMFS anticipates that take by Level B harassment associated with use of the Gemini source would be less than would occur for a similar survey instead using the modeled airgun array as a sound source. Please see prior notices ( e.g., 88 FR 72739, October 23, 2023) for additional detail regarding the Gemini source.

Consistent with the preamble to the final rule, the survey effort proposed by WesternGeco in its LOA request was used to develop LOA-specific take estimates based on the acoustic exposure modeling results described in the preamble (see 86 FR 5398, January 19, 2021). In order to generate the appropriate take number for authorization, the following information was considered: (1) survey type; (2) location (by modeling zone  1 ); (3) number of days; and (4) season. 2 The acoustic exposure modeling performed in support of the rule provides 24-hour exposure estimates for each species, specific to each modeled survey type in each zone and season.

No 3D OBN surveys were included in the modeled survey types, and use of existing proxies ( i.e., two-dimensional (2D), 3D narrow-azimuth (NAZ), 3D wide-azimuth (WAZ), Coil) is generally conservative for use in evaluation of 3D OBN survey effort, largely due to the greater area covered by the modeled proxies. Summary descriptions of these modeled survey geometries are available in the preamble to the proposed rule (83 FR 29212, 29220, June 22, 2018). Coil was selected as the best available proxy survey type in this case because the spatial coverage of the planned survey is most similar to the coil survey pattern. The planned 3D OBN survey will involve a single source vessel sailing along closely spaced survey lines that are approximately 345 m apart and approximately 100 kilometers (km) in length. The coil survey pattern was assumed to cover approximately 144 kilometers squared (km 2 ) per day (compared with approximately 795 km 2 , 199 km 2 , and 845 km 2 per day for the 2D, 3D NAZ, and 3D WAZ survey patterns, respectively). Among the different parameters of the modeled survey patterns ( e.g., area covered, line spacing, number of sources, shot interval, total simulated pulses), NMFS considers area covered per day to be most influential on daily modeled exposures exceeding Level B harassment criteria. Although WesternGeco is not proposing to perform a survey using the coil geometry, its planned 3D OBN survey is expected to cover approximately 69 km 2 per day, meaning that the coil proxy is most representative of the effort planned by WesternGeco in terms of predicted Level B harassment exposures.

All available acoustic exposure modeling results assume use of a 72-element, 8,000 in 3 array. Thus, take numbers authorized through the LOA are considered conservative due to differences in the airgun array (28 elements, 5,240 in 3 or Gemini), as compared to the source modeled for the rule.

The survey will take place over approximately 65 days, with 43 days in Zone 5 and 22 days in Zone 7. Although WesternGeco plans to conduct all 65 survey days in the “summer” season, we have calculated estimated take numbers based on an assumption that the survey could occur in either season in order to accommodate any potential delay of survey dates.

For some species, take estimates based solely on the modeling yielded results that are not realistically likely to occur when considered in light of other relevant information available during the rulemaking process regarding marine mammal occurrence in the GOM. The approach used in the acoustic exposure modeling, in which seven modeling zones were defined over the U.S. GOM, necessarily averages fine-scale information about marine mammal distribution over the large area of each modeling zone. Thus, although the modeling conducted for the rule is a natural starting point for estimating take, the rule acknowledged that other information could be considered (see, e.g., 86 FR 5322, 5442, January 19, 2021), discussing the need to provide flexibility and make efficient use of previous public and agency review of other information and identifying that additional public review is not necessary unless the model or inputs used differ substantively from those that were previously reviewed by NMFS and the public. For this survey, NMFS has other relevant information reviewed during the rulemaking that indicates use of the acoustic exposure modeling to generate a take estimate for Rice's whales and killer whales produces results inconsistent with what is known regarding its occurrence in the GOM. Accordingly, we have adjusted the calculated take estimates for these species as described below.

NMFS' final rule described a “core habitat area” for Rice's whales (formerly known as GOM Bryde's whales)  3 located in the northeastern GOM in waters between 100 and 400 m depth along the continental shelf break (Rosel et al., 2016). However, whaling records suggest that Rice's whales historically had a broader distribution within similar habitat parameters throughout the GOM (Reeves et al., 2011; Rosel and Wilcox, 2014). In addition, habitat-based density modeling has identified similar habitat ( i.e., approximately 100-400 m water depths along the continental shelf break) as being potential Rice's whale habitat (Roberts et al., 2016; Garrison et al., 2023), and Rice's whales have been detected within this depth band throughout the GOM (Soldevilla et al., 2022, 2024). See discussion provided at, e.g., 83 FR 29228, June 22, 2018; 83 FR 29280, June 22, 2018; 86 FR 5418, January 19, 2021.

Although Rice's whales may occur outside of the core habitat area, we expect that any such occurrence would be limited to the narrow band of suitable habitat described above ( i.e., 100-400 m) and that, based on the few available records, these occurrences would be rare. WesternGeco's planned activities will overlap this depth range, with approximately 3.6 percent of the area expected to be ensonified by the survey above root-mean-squared pressure received levels (RMS SPL) of 160 decibel (dB) (referenced to 1 micropascal (re 1 μPa)) overlapping the 100-400 m isobaths. Therefore, while we expect take of Rice's whale to be unlikely, there is some reasonable potential for take of Rice's whale to occur in association with this survey. However, NMFS' determination in reflection of the data discussed above, which informed the final rule, is that use of the generic acoustic exposure modeling results for Rice's whales would result in estimated take numbers that are inconsistent with the assumptions made in the rule regarding expected Rice's whale take (86 FR 5322, January 19, 2021).

Killer whales are the most rarely encountered species in the GOM, typically in deep waters of the central GOM (Roberts et al., 2015; Maze-Foley and Mullin, 2006). The approach used in the acoustic exposure modeling, in which seven modeling zones were defined over the U.S. GOM, necessarily averages fine-scale information about marine mammal distribution over the large area of each modeling zone. NMFS has determined that the approach results in unrealistic projections regarding the likelihood of encountering killer whales.

As discussed in the final rule, the density models produced by Roberts et al. (2016) represent the output of models derived from multi-year observations and associated environmental parameters that incorporate corrections for detection bias. However, in the case of killer whales, the model is informed by few data, as indicated by the coefficient of variation associated with the abundance predicted by the model (0.41, the second-highest of any GOM species model; Roberts et al., 2016). The model's authors noted the expected non-uniform distribution of this rarely-encountered species (as discussed above) and expressed that, due to the limited data available to inform the model, it “should be viewed cautiously” (Roberts et al., 2015).

NOAA surveys in the GOM from 1992-2009 reported only 16 sightings of killer whales, with an additional 3 encounters during more recent survey effort from 2017-2018 (Waring et al., 2013; https://www.boem.gov/gommapps ). Two other species were also observed on fewer than 20 occasions during the 1992-2009 NOAA surveys (Fraser's dolphin and false killer whale  4 ). However, observational data collected by protected species observers (PSOs) on industry geophysical survey vessels from 2002-2015 distinguish the killer whale in terms of rarity. During this period, killer whales were encountered on only 10 occasions, whereas the next most rarely encountered species (Fraser's dolphin) was recorded on 69 occasions (Barkaszi and Kelly, 2019). The false killer whale and pygmy killer whale were the next most rarely encountered species, with 110 records each. The killer whale was the species with the lowest detection frequency during each period over which PSO data were synthesized (2002-2008 and 2009-2015). This information qualitatively informed our rulemaking process, as discussed at 86 FR 5334 (January 19, 2021), and similarly informs our analysis here.

The rarity of encounters during seismic surveys is not likely to be the product of high bias on the probability of detection. Unlike certain cryptic species with high detection bias, such as Kogia spp. or beaked whales, or deep-diving species with high availability bias, such as beaked whales or sperm whales, killer whales are typically available for detection when present and are easily observed. Roberts et al. (2015) stated that availability is not a major factor affecting detectability of killer whales from shipboard surveys, as they are not a particularly long-diving species. Baird et al. (2005) reported that mean dive durations for 41 fish-eating killer whales for dives greater than or equal to 1 minute in duration was 2.3-2.4 minutes, and Hooker et al. (2012) reported that killer whales spent 78 percent of their time at depths between 0-10 m. Similarly, Kvadsheim et al. (2012) reported data from a study of 4 killer whales, noting that the whales performed 20 times as many dives 1-30 m in depth than to deeper waters, with an average depth during those most common dives of approximately 3 m.

In summary, killer whales are the most rarely encountered species in the GOM and typically occur only in particularly deep water (>700 m). This survey would take place in deep waters that would overlap with depths in which killer whales typically occur. While this information is reflected through the density model informing the acoustic exposure modeling results, there is relatively high uncertainty associated with the model for this species, and the acoustic exposure modeling applies mean distribution data over areas where the species is in fact less likely to occur. NMFS' determination in reflection of the data discussed above, which informed the final rule, is that use of the generic acoustic exposure modeling results for killer whales will generally result in estimated take numbers that are inconsistent with the assumptions made in the rule regarding expected killer whale take (86 FR 5403, January 19, 2021).

In past authorizations, NMFS has often addressed situations involving the low likelihood of encountering a rare species, such as Rice's whales and killer whales in the GOM, through authorization of take of a single group of average size ( i.e., representing a single potential encounter). See 83 FR 63268, December 7, 2018. See also 86 FR 29090, May 28, 2021 and 85 FR 55645, September 9, 2020. For the reasons expressed above, NMFS determined that a single encounter of Rice's whales and killer whales are more likely than the model-generated estimates and has authorized take associated with a single group encounter ( i.e., up to two animals for Rice's whales and up to seven animals for killer whales).

Based on the results of our analysis, NMFS has determined that the level of taking expected for this survey and authorized through the LOA is consistent with the findings made for the total taking allowable under the regulations. See table 1 in this notice and table 9 of the rule (86 FR 5322, January 19, 2021).

Under the GOM rule, NMFS may not authorize incidental take of marine mammals in an LOA if it will exceed “small numbers.” In short, when an acceptable estimate of the individual marine mammals taken is available, if the estimated number of individual animals taken is up to, but not greater than, one-third of the best available abundance estimate, NMFS will determine that the numbers of marine mammals taken of a species or stock are small. For more information please see NMFS' discussion of the MMPA's small numbers requirement provided in the final rule (see 86 FR 5438, January 19, 2021).

The take numbers for authorization are determined as described above in the Summary of Request and Analysis section. Subsequently, the total incidents of harassment for each species are multiplied by scalar ratios to produce a derived product that better reflects the number of individuals likely to be taken within a survey (as compared to the total number of instances of take), accounting for the likelihood that some individual marine mammals may be taken on more than 1 day (see 86 FR 5404, January 19, 2021). The output of this scaling, where appropriate, is incorporated into adjusted total take estimates that are the basis for NMFS' small numbers determinations, as depicted in table 1.

This product is used by NMFS in making the necessary small numbers determinations through comparison with the best available abundance estimates (see discussion at 86 FR 5391, January 19, 2021). For this comparison, NMFS' approach is to use the maximum theoretical population, determined through review of current stock assessment reports (SAR; https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and model-predicted abundance information ( https://seamap.env.duke.edu/models/Duke/GOM/ ). For the latter, for taxa where a density surface model could be produced, we use the maximum mean seasonal ( i.e., 3-month) abundance prediction for purposes of comparison as a precautionary smoothing of month-to-month fluctuations and in consideration of a corresponding lack of data in the literature regarding seasonal distribution of marine mammals in the GOM. Information supporting the small numbers determinations is provided in table 1.

Based on the analysis contained herein of WesternGeco's proposed survey activity described in its LOA application and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the affected species or stock sizes ( i.e., less than one-third of the best available abundance estimate) and therefore the taking is of no more than small numbers.

NMFS has determined that the level of taking for this LOA request is consistent with the findings made for the total taking allowable under the incidental take regulations and that the amount of take authorized under the LOA is of no more than small numbers. Accordingly, we have issued an LOA to WesternGeco authorizing the take of marine mammals incidental to its geophysical survey activity, as described above.

The EFP is requested under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C 1801 et seq. ), and regulations at 50 CFR 600.745(b) concerning exempted fishing.

Red drum, king mackerel, and Spanish mackerel are Federally-managed species that occur in Gulf waters that are caught as bycatch in the Louisiana commercial menhaden purse seine fishery, which operates in state and Federal waters. The proposed research would quantify bycatch from the Louisiana menhaden purse seine fishery as they occur in purse seine nets, fish excluder grates, dewatering screens, and release chutes, with the goal of quantifying bycatch for each exclusion method within the fishery and evaluate the post-release mortality of red drum, king mackerel, and Spanish mackerel caught as bycatch by the fishery.

Approximately 400 purse seine sets are expected to occur during the 2024 menhaden purse seine season (April 15-November 1, 2024) in water depths less than 60 feet (18 meters). During fishing operations, the applicant would accompany 1 of the 53 state-permitted vessels, which deploys a 1,200 to 1,500 foot (366 to 457 meters) purse seine for a soak time of 20 to 45 minutes and a second vessel pumps the catch (catch-collecting vessel) from the net into the hold. In this project, researchers on board the catch-collecting vessel would record bycatch caught by each exclusion method described in the previous paragraph. Off Louisiana, the commercial harvest of menhaden is restricted to waters seaward of a boundary line described in the states' statutes (Louisiana Title 76) and includes both state and some Federal waters. The majority of fishing activities under this EFP are expected to occur in Louisiana State waters, but fishing operations could occur in Federal waters as the menhaden migrate from inshore estuarine waters to offshore marine waters in October. NMFS estimates that 64 of the 400 sets anticipated for the 2024 menhaden season could occur in Federal waters.

The EFP would allow the applicant to harvest up to 200 individuals each of red drum, king mackerel, and Spanish mackerel during the 2024 menhaden season to determine sex ratios. An additional number of red drum, king mackerel, and Spanish mackerel (up to 400 per species) would be held for 24 hours in tanks with continuous water flow on board the catch-collecting vessel to assess short-term survival and then would be tagged and released. All other bycatch initially retained by the applicant would be returned to the water. Red drum, king mackerel, and Spanish mackerel that die during normal fishing operations, or that die in the survival study, would be preferentially biopsied to minimize mortality attributed to this study. No red drum, king mackerel, and Spanish mackerel landed as part of the project would be sold.

Federal regulations at 50 CFR 622.92(b) prohibit the harvest and possession of red drum in or from the Gulf Federal waters and any red drum caught in the Gulf Federal waters must be released immediately with a minimum of harm. The EFP would allow the applicant to biopsy up to 200 red drum and possess for up to 24 hours an additional 400 red drum during the 2024 menhaden purse seine season (April 15-November 1, 2024).

Federal regulations at 50 CFR 622.375(a)(1)(iv) and 622.375(b)(3) prohibit the harvest of king mackerel and Spanish mackerel by purse seine gear. Additionally, regulations at 50 CFR 622.380(b) prohibit possession of king mackerel less than 24 inches (61 cm), fork length, and 622.380(c) prohibit possession of Spanish mackerel less than 12 inches (30.5 cm), fork length. The EFP would allow the applicant to biopsy up to 200 of each species, including undersized fish, and possess for up to 24 hours an additional 400 each of king mackerel and Spanish mackerel and using purse seine gear during the 2024 menhaden purse seine season.

If granted, the EFP would be effective from April 15, 2024, through December 31, 2024. The applicant and commercial menhaden fishermen and vessels participating in the EFP must comply with all other applicable laws and regulations.

NMFS finds the application warrants further consideration based on a preliminary review. At its January 2024 meeting, the Gulf of Mexico Fishery Management Council reviewed the application and recommended that NMFS issue the EFP. A final decision on issuance of the EFP will depend on NMFS' review of public comments received on the application, consultations with the appropriate fishery management agencies of the affected states, and the U.S. Coast Guard, and a determination that the activities to be taken under the EFP are consistent with all other applicable laws.

Authority: 16 U.S.C 1801 et seq.

The National Marine Fisheries Service (NMFS), Alaska Regional Office, is requesting renewal of this currently approved information collection that contains requirements for the Pacific Halibut and Sablefish Individual Fishing Quota Program (IFQ Program).

Commercial halibut and sablefish fisheries in the Gulf of Alaska and Bering Sea and Aleutian Islands are managed primarily under the IFQ Program. The IFQ Program is managed under the authority of the Northern Pacific Halibut Act of 1982 (16 U.S.C. 773c; Halibut Act), with respect to Pacific halibut, and the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.; Magnuson-Stevens Act), with respect to sablefish. Regulations implementing the IFQ Program are set forth at 50 CFR part 679.

A key objective of the IFQ Program is to support the social and economic character of the fisheries and coastal fishing communities where many of these fisheries are based. Participation in the IFQ Program is limited to persons that hold quota share (QS), although there are several very limited provisions for “leasing” of annual IFQ. QS is a transferable permit that was initially issued to persons who owned or leased vessels that made legal commercial fixed-gear landings of Pacific halibut or sablefish in the waters off Alaska from 1988 through 1990.

NMFS annually issues eligible QS holders an IFQ fishing permit that authorizes participation in the IFQ fisheries. Those to whom IFQ permits are issued may harvest their annual allocation at any time during the eight plus-month IFQ halibut and sablefish seasons.

More information on the IFQ Program is provided on the NMFS Alaska Region website at https://www.fisheries.noaa.gov/alaska/sustainable-fisheries/pacific-halibut-and-sablefish-individual-fishing-quota-ifq-program.

Some of the collection instruments in this information collection are used by participants in the Western Alaska Community Development Quota (CDQ) Program. The purpose of the CDQ Program is to provide eligible western Alaska villages with the opportunity to participate and invest in fisheries in the Bering Sea and Aleutian Islands Management Area (BSAI); to support economic development in western Alaska; to alleviate poverty and provide economic and social benefits for residents of western Alaska; and to achieve sustainable and diversified local economies in western Alaska. In fitting with these goals, NMFS allocates a portion of the annual catch limits for a variety of commercially valuable marine species in the BSAI to the CDQ Program. Pacific halibut is one of these species. More information on the CDQ Program is provided on the NMFS Alaska Region website at https://www.fisheries.noaa.gov/alaska/sustainable-fisheries/community-development-quota-cdq-program. Information collection requirements for the CDQ Program are also approved under OMB Control Number 0648-0269.

This information collection for the IFQ Program is required to manage commercial halibut and sablefish fishing under the Magnuson-Stevens Act, the Halibut Act, and under 50 CFR parts 300 and 679.

This information collection contains the forms used by participants in the IFQ Program to apply for, renew, or replace permits; transfer or lease IFQ and QS; determine compliance with IFQ program requirements; and designate a beneficiary for a QS holder. Two of the permit applications are also used by participants in the CDQ Program. This information collection also contains annual reports and other collections submitted by telephone or other methods and that do not have forms.

The type of information collected includes information on the applicants, transferors, transferees, permits, IFQ or QS types and owners, beneficiaries, vessels, business operations, medical declarations, landings, gear types, products, and harvests and harvest areas.

This information is used to identify and authorize participants in the halibut and sablefish fisheries, to track and transfer quota share, to limit transfers to authorized participants, and to monitor quota share balances and harvest in these fisheries.

The information is collected primarily by mail, delivery, fax, email, telephone, or eFISH. eFISH is the NMFS Alaska Region online Fisheries Information System. The forms and applications are available as fillable pdfs on the NMFS Alaska Region website at https://www.fisheries.noaa.gov/permit/alaska-ifq-halibut-sablefish-and-cdq-halibut-program-fishery-applications-and-reporting.

OMB Control Number: 0648-0272.

Form Number(s): None.

Type of Review: Regular submission (extension of a current information collection).

Affected Public: Individuals or households; Business or other for-profit organizations; Not-for-profit institutions.

Estimated Number of Respondents: 3,441.

Estimated Time per Response: Application for IFQ/CDQ Hired Master Permit, 1 hour; Application for IFQ/CDQ Registered Buyer Permit, 30 minutes; Application for Replacement of Certificates or Permits, 30 minutes; Application for Eligibility to Receive QS/IFQ by Transfer, 2 hours; QS Holder: Identification of Ownership Interest, 2 hours; Application for Transfer of QS, 2 hours; Application for Transfer of QS/IFQ by Self Sweep Up, 2 hours; Application for Medical Transfer of IFQ, 1.5 hours; Application for Temporary Transfer of Halibut/Sablefish IFQ, 2 hours; (emergency) Application for Temporary Transfer of Halibut/Sablefish IFQ, 2 hours; Annual Report for CDQ IFQ Transfers, 40 hours; QS/IFQ Beneficiary Designation Form, 30 minutes; Appeals, 4 hours; IFQ Administrative Waiver, 6 minutes; Prior Notice of Landing, 15 minutes; IFQ Departure Report, 15 minutes; Transshipment Authorization, 12 minutes; Dockside sales, 6 minutes; Application for a Non-profit Corporation to be Designated as a Recreational Quota Entity, 200 hours; Application for Transfer of Quota Share To or From a Recreational Quota Entity, 2 hours; Recreational Quota Entity Annual Report, 40 hours.

Estimated Total Annual Burden Hours: 11,236 hours.

Estimated Total Annual Cost to Public: $28,225 in recordkeeping and reporting costs.

Respondent's Obligation: Voluntary, Required to Obtain or Retain Benefits, Mandatory.

Legal Authority: Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801 et seq.; Northern Pacific Halibut Act of 1982, 16 U.S.C. 773c.

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

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

On 3/1/2024, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List. This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3.

After consideration of the relevant matter presented, the Committee has determined that the product(s) and service(s) listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.

2. The action may result in authorizing small entities to furnish the product(s) and service(s) to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product(s) and service(s) deleted from the Procurement List.

Accordingly, the following product(s) and service(s) are deleted from the Procurement List:

Effective July 1, 2024, borrowers may select the ICR plan only for repayment of non-defaulted Direct Consolidation Loans that repaid one or more Direct or Federal PLUS Loans made to a parent borrower. However, borrowers who were repaying other types of Direct Loans under the ICR plan as of July 1, 2024, may continue to repay their loans under that plan. Under the ICR plan, the borrower's monthly payment amount is based on the borrower's Adjusted Gross Income (AGI), family size, loan amount, and the interest rate applicable to each of the borrower's loans.

A Direct Loan borrower who repays under the ICR plan pays the lesser of: (1) the monthly amount that would be required over a 12-year repayment period with fixed payments, multiplied by an income percentage factor; or (2) 20 percent of their discretionary income.

We adjust the income percentage factors annually to reflect changes in inflation and announce the adjusted factors in the Federal Register , as required by 34 CFR 685.209(b)(1)(ii)(A). We use the adjusted income percentage factors to calculate a borrower's monthly ICR payment amount when the borrower initially applies for the ICR plan or when the borrower submits annual income documentation, as required under the ICR plan. This notice contains the adjusted income percentage factors for 2024, examples of how the monthly ICR payment amount is calculated, and charts showing sample repayment amounts based on the adjusted ICR plan formula. This information is included in the following three attachments:

In Attachment 1, to reflect changes in inflation, we updated the income percentage factors that were published in the Federal Register on April 26, 2023 (88 FR 25388). Specifically, we have revised the table of income percentage factors by changing the dollar amounts of the incomes shown by a percentage equal to the estimated percentage change between the not-seasonally-adjusted Consumer Price Index for all urban consumers for December 2023 and December 2024.

The income percentage factors reflected in Attachment 1 may cause a borrower's payments to be lower than they were in prior years, even if the borrower's income is the same as in the prior year. The revised repayment amount more accurately reflects the impact of inflation on the borrower's current ability to repay.

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

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

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

Program Authority: 20 U.S.C. 1087 et seq.

General notes about the examples in this attachment:

• We have a calculator that borrowers can use to estimate what their payment amounts would be under the ICR plan. The calculator is called the “Loan Simulator” and is available at studentaid.gov/loan-simulator. Based on information entered into the calculator by the borrower (for example, income, family size, and tax filing status), this calculator provides a detailed, individualized assessment of a borrower's loans and repayment plan options, including the ICR plan.

• The interest rates used in the examples are for illustration only. The actual interest rates on an individual borrower's Direct Loans depend on the loan type and when the loan was first disbursed.

• The Poverty Guideline amounts used in the examples are from the 2024 U.S. Department of Health and Human Services (HHS) Poverty Guidelines for the 48 contiguous States and the District of Columbia. Different Poverty Guidelines apply to residents of Alaska and Hawaii. The Poverty Guidelines for 2024 were published in the Federal Register on January 17, 2024 (89 FR 2961).

• All of the examples use an income percentage factor corresponding to an adjusted gross income (AGI) in the table in Attachment 1. If an AGI is not listed in the income percentage factors table in Attachment 1, the applicable income percentage can be calculated by following the instructions under the “Interpolation” heading later in this attachment.

• Married borrowers may repay their Direct Loans jointly under the ICR plan if both spouses have loans eligible for the ICR plan. If a married couple elects this option, we determine a joint ICR payment amount based on the combined outstanding balances of each borrower's Direct Loans and the combined AGIs of both borrowers. We then prorate the joint payment amount for each borrower based on the proportion of that borrower's debt to the total outstanding balance. We bill each borrower separately.

• For example, if a married couple, John and Briana, has a total outstanding Direct Loan debt of $60,000 that is eligible for repayment under the ICR plan, of which $40,000 belongs to John and $20,000 to Briana, we would apportion 67 percent of the monthly ICR payment to John and the remaining 33 percent to Briana. To take advantage of a joint ICR payment, married couples need not file taxes jointly; they may file separately and subsequently provide the other spouse's tax information to the borrower's Federal loan servicer.

Calculating the monthly payment amount using a standard amortization and a 12-year repayment period.

The formula to amortize a loan with a standard schedule (in which each payment is the same over the course of the repayment period) is as follows:

In the formula—

• M is the monthly payment amount;

• P is the outstanding principal and interest balance of the loan at the time the loan entered repayment;

• I is the annual interest rate on the loan, expressed as a decimal (for example, for a loan with an interest rate of 6 percent, 0.06); and

• N is the total number of months in the repayment period (for example, for a loan with a 12-year repayment period, 144 months).

For example, assume that Billy has a $10,000 Direct Loan that is eligible for repayment under the ICR plan with an interest rate of 6 percent.

Step 1: To solve for M, first simplify the numerator of the fraction by which we multiply P, the outstanding principal balance. To do this divide I (the interest rate expressed as a decimal) by 12. In this example, Billy's interest rate is 6 percent. As a decimal, 6 percent is 0.06.

Step 2: Next, simplify the denominator of the fraction by which we multiply P. To do this divide I (the interest rate expressed as a decimal) by 12. Then, add one. Next, raise the sum of the two figures to the negative power that corresponds to the length of the repayment period in months. In this example, because we are amortizing a loan to calculate the monthly payment amount under the ICR plan, the applicable figure is 12 years, which is 144 months. Finally, subtract the result from one.

Step 3: Next, resolve the fraction by dividing the result from Step 1 by the result from Step 2.

Step 4: Finally, solve for M, the monthly payment amount, by multiplying the outstanding principal balance of the loan by the result of Step 3.

The remainder of the examples in this attachment will only show the results of the formula. In each of the examples, the Direct Loan amounts represent the outstanding principal balance at the time the loans entered repayment.

Example 1. Kesha is single with no dependents and has $15,000 in Direct Loans that are eligible for repayment under the ICR plan. The interest rate on Kesha's loans is 6 percent, and she has an AGI of $35,153.

Step 1: Determine the total monthly payment amount based on what Kesha would pay over 12 years using standard amortization. To do this, use the formula that precedes Example 1. In this example, the monthly payment amount would be $146.38.

Step 2: Multiply the result of Step 1 by the income percentage factor shown in the income percentage factors table (see Attachment 1 to this notice) that corresponds to Kesha's AGI. In this example, an AGI of $35,153 corresponds to an income percentage factor of 71.89 percent.

Purpose of the Board: The purpose of the Board is to make recommendations to the Department of Energy Environmental Management Program in the areas of environmental restoration, waste management, and related activities.

• Public Comment

• Board Business/Open Discussion

Public Participation: This meeting will be open to the public and public comments will be accepted. Public comments can be submitted from those unable to attend. Comments received in writing no later than 5:00 p.m. EDT on Monday, April 29, 2024, will be read aloud during the meeting. Please send comments to Kelly Snyder at kelly.snyder@em.doe.gov. The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business.

Minutes: Minutes will also be available at the following website: https://energy.gov/em/listings/chairs-meetings.

Signing Authority: This document of the Department of Energy was signed on March 29, 2024, by David Borak, Deputy Committee Management Officer, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

WAPA is responsible for marketing power from the Provo River Project, which is done independently from the other projects marketed by WAPA's CRSP MC, including the Salt Lake City Area Integrated Projects (SLCA/IP), Olmsted Project, and the Falcon-Amistad Projects. In addition to marketing power from these federal hydroelectric projects, WAPA's CRSP MC is responsible for approximately 2,316 miles of transmission lines and associated infrastructure across Arizona, New Mexico, Colorado, Utah, and Wyoming.

The Provo River Project is a small water development project, with a powerplant located in northern Utah. It was authorized by President Franklin D. Roosevelt, in part, as a response to the Great Depression and a severe drought that devastated Utah's agriculture and threatened municipal water supplies in the 1930s. The Provo River Project's primary function is to provide irrigation, municipal, and industrial water to users in Salt Lake and Utah Counties, Utah. The Department of the Interior, Bureau of Reclamation (Reclamation), finished construction of the Deer Creek Dam in 1938 and the Deer Creek Powerplant in 1958, which included two 2.475-megawatt generators. On June 27, 1936, Reclamation signed contract number Ilr-874 making the Provo River Water Users' Association (PRWUA) the operator of the dam and responsible for repayment of the Provo River Project. The initial investment in the power facilities was repaid in 1984 but there are ongoing costs associated with operation, maintenance, and replacement of equipment. Surplus power revenues may be used to aid the repayment of the Provo River Project irrigation investment.

Between October 15 and April 15, water may be diverted from the adjacent Weber River Basin into the Provo River Basin and stored in Deer Creek Reservoir for irrigation, municipal, and industrial purposes pursuant to the terms of the 1938 contract number Ilr-1082 between the PRWUA, PacifiCorp (formerly Utah Power and Light Company), and Reclamation, among others. The diversion creates a loss of power generation at the Weber Powerplant on the Weber River, downstream from the diversion. As a result, PacifiCorp, the owner of the Weber Powerplant, is reimbursed for its winter energy losses with Provo River Project power (Weber/Provo Water Exchange). During this winter period, Provo River Project generation above the power reimbursement amount owed to PacifiCorp is sold to Provo River Project customers as non-firm surplus energy; during the summer period, Provo River Project generation is sold to customers as non-firm energy, both without capacity. It is expected that the annual energy production from the Provo River Project will average around 17,243,527 kilowatt-hours per year.

WAPA's Final 2025 Provo River Project Marketing Plan and Call for 2025 Resource Pool Applications (Marketing Plan) was published in the Federal Register on March 17, 2023 (88 FR 16433). WAPA reviewed and considered the single application received and published the 2025 Provo River Project Resource Pool Proposed Power Allocation and initiated a public comment period in the Federal Register on October 31, 2023 (88 FR 74488). During the public comment period, WAPA received one written comment and one verbal comment on the proposal. In preparing the Final Allocation of Provo River Project Power, WAPA reviewed and considered both comments received. This section summarizes and responds to those comments.

Comment(s): Utah Associated Municipal Power Systems (UAMPS) submitted one oral and one written comment, both in support of WAPA's proposal not to alter existing power allocations under the 2025 Resource Pool. UAMPS submitted an application for a portion of the 2025 Resource Pool on behalf of three of its members currently receiving Provo River Project power (Payson, Utah; Springville City, Utah; and South Utah Valley Electric Service District) to pursue a share of the 2025 Resource Pool in the event of reallocation to new applicants. However, UAMPS stated its preference was to not reallocate power under the Resource Pool.

Response: WAPA appreciates UAMPS comments in support of the proposal.

WAPA did not receive applications for Provo River Project power from new, eligible preference entities. As noted, UAMPS submitted an application on behalf of three of its members, all existing Provo River Project contractors. After analyzing the application and taking into consideration all existing federal hydropower allocations to all Provo River Project contractors, WAPA determined no significant benefit of additional widespread use would occur by continuing forward with the 2025 Resource Pool. Therefore, WAPA will not reduce Provo River Project contractor allocations by 3 percent and will not reallocate power under the 2025 Resource Pool. All current Provo River Project allocations will remain unchanged, as defined in the Final Allocation of Provo River Project Power table below:

After the effective date of this notice, WAPA will begin the contracting process pursuant to the Marketing Plan. That process requires each individual allottee identified in the table above to execute and return without modification WAPA's electric service contract to purchase Provo River Project energy within 6 months of the contract offer, unless otherwise agreed to in writing by WAPA. WAPA reserves the right to withdraw and reallocate any allocation if an allottee does not execute the new electric service contract by close of business September 30, 2024. The date of initial service under these contracts will be October 1, 2024, and these contracts will remain in effect through September 30, 2054.

If there is any unallocated power after this process, WAPA reserves the right to reallocate such power according to the eligibility and allocation criteria set forth in the Marketing Plan. Entities who have submitted an application pursuant to this process need not re-submit an application if they wish to be considered. WAPA will contact such eligible entities.

The Marketing Plan, published in the Federal Register (88 FR 16433) on March 17, 2023, was established under the following authorities: the Provo River Project was initially authorized under a feasibility finding of the Secretary of the Interior, which was approved by the President, on November 16, 1935, pursuant to § 4 of the Act of June 25, 1910 (36 Stat. 836), and subsection B of § 4 of the Act of December 5, 1924 (43 Stat. 702) (see also Act of March 29, 1948, ch. 159, 62 Stat. 92); Reclamation Act of June 17, 1902 (Pub. L. 57-161) (32 Stat. 388); Reclamation Project Act of August 4, 1939 (Pub. L. 76-260) (53 Stat. 1187); Department of Energy Organization Act of August 4, 1977 (Pub. L. 95-91) (91 Stat. 565); and Reclamation Projects Authorization and Adjustment Act of 1992 (Pub. L. 102-575) (106 Stat. 4600, 4605), as such acts may be supplemented or amended. Allocating power from the resource pool falls within the Marketing Plan and is covered by this authority.

WAPA has determined that this proposed action fits within the categorical exclusion listed in Appendix B to subpart D of 10 CFR part 1021 (B4.1 contracts, policies, and marketing and allocation plans for electric power). Categorically excluded projects and activities do not require preparation of either an environmental impact statement or an environmental assessment. A copy of the categorical exclusion determination is available on the CRSP website at: wapa.gov/wp-content/uploads/2023/04/cx-02-14-22-prp-marketing-plan.pdf.

WAPA has an exemption from centralized regulatory review under Executive Order 12866. Accordingly, no clearance of this notice by the Office of Management and Budget is required.

This document of the Department of Energy was signed on April 1, 2024, by Tracey A. LeBeau, Administrator, Western Area Power Administration pursuant to the above identified legal authority. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit this document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Western Area Power Administration (WAPA) published a Federal Register notice (Proposed FRN) on January 19, 2024 (89 FR 3651), proposing to extend the existing formula rates under Rate Schedule WC-8. The Proposed FRN initiated a 14-day public consultation and comment period.

By Delegation Order No. S1-DEL-RATES-2016, effective November 19, 2016, the Secretary of Energy delegated: (1) the authority to develop power and transmission rates to the WAPA Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, or to remand or disapprove such rates, to the Federal Energy Regulatory Commission (FERC). By Delegation Order No. S1-DEL-S3-2023, effective April 10, 2023, the Secretary of Energy also delegated the authority to confirm, approve, and place such rates into effect on an interim basis to the Under Secretary for Infrastructure. By Redelegation Order No. S3-DEL-WAPA1-2023, effective April 10, 2023, the Under Secretary for Infrastructure further redelegated the authority to confirm, approve, and place such rates into effect on an interim basis to WAPA's Administrator. This extension is issued under Redelegation Order No. S3-DEL-WAPA1-2023 and Department of Energy rate extension procedures set forth in 10 CFR part 903. 1

Following review of the Regions' proposal, Rate Order No. WAPA-215 is hereby confirmed, approved, and placed into effect on an interim basis. This extends, without adjustment, the existing Rate Schedule WC-8 through September 30, 2026. WAPA will submit Rate Order No. WAPA-215 and the extended rate schedule to FERC for confirmation and approval on a final basis.

The formula rates in Rate Order No. WAPA-215 are established following Section 302 of the Department of Energy (DOE) Organization Act (42 U.S.C. 7152). 1 By Delegation Order No. S1-DEL-RATES-2016, effective November 19, 2016, the Secretary of Energy delegated: (1) the authority to develop power and transmission rates to the Western Area Power Administration (WAPA) Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, or to remand or disapprove such rates, to the Federal Energy Regulatory Commission (FERC). By Delegation Order No. S1-DEL-S3-2023, effective April 10, 2023, the Secretary of Energy also delegated the authority to confirm, approve, and place such rates into effect on an interim basis to the Under Secretary for Infrastructure. By Redelegation Order No. S3-DEL-WAPA1-2023, effective April 10, 2023, the Under Secretary for Infrastructure further redelegated the authority to confirm, approve, and place such rates into effect on an interim basis to WAPA's Administrator. This extension is issued under Redelegation Order No. S3-DEL-WAPA1-2023 and DOE rate extension procedures set forth in 10 CFR part 903. 2

On December 15, 2014, FERC approved and confirmed Rate Schedule WC-8, under Rate Order No. WAPA-163, on a final basis for a 5-year period through May 31, 2019. 3 On June 20, 2019, FERC approved and confirmed the extension of Rate Schedule WC-8, under Rate Order No. WAPA-187, on a final basis through May 31, 2024. 4 This rate schedule applies to WestConnect regional on-peak and off-peak non-firm transmission service that uses one or more of the following WAPA transmission projects: Central Arizona Project, Colorado River Storage Project, Loveland Area Projects, Pacific Northwest-Pacific Southwest Intertie Project, and Parker-Davis Project. Details about the rate schedule and the formula rates are viewable on WAPA's website at: www.wapa.gov/about-wapa/regions/dsw/power-marketing/westconnect. The rate continues the formula-based methodology that includes an annual update to the data in the rate formulas which provides adequate revenue to recover annual expenses, including interest expense, and repay capital investment within the allowable periods. This ensures repayment within the cost recovery criteria set forth in DOE Order RA 6120.2.

In accordance with 10 CFR 903.23(a), the Colorado River Storage Project Management Center (CRSP MC), Desert Southwest Region (DSW), and Rocky Mountain Region (RM) (collectively referred to herein as the “Regions”) published a notice in the Federal Register (Proposed FRN) on January 19, 2024, proposing to extend, without adjustment, Rate Schedule WC-8 under Rate Order No. WAPA-215. 5 The Regions determined it was not necessary to hold public information or public comment forums on the proposed formula rate extension, but provided a 14-day consultation and comment period to give the public an opportunity to comment on the proposed extension. During the 14-day consultation and comment period, which ended on February 2, 2024, the Regions received written comments from one entity.

Written comments were received from the following organization: Colorado River Energy Distributors Association, Arizona.

The comments expressed have been paraphrased and/or combined, where appropriate, without compromising the meaning of the comments.

Comment: The commenter supports the proposed formula rate extension as described in the Proposed FRN. The commenter also requested removal of language referenced in the Proposed FRN which was “unnecessary and refers to potential future actions that are the subject of separate processes.”

Response: The Regions appreciate the support for this rate action. The Regions agree the Proposed FRN language refers to specific future events subject to separate processes and a more general reference to future market activity could have been used. The intent of including the language in the Proposed FRN was to provide context for pursuing an extension as opposed to a major rate action, along with the reasoning for the length of the extension period.

Categorical exclusion determinations were previously issued for the underlying rates of the transmission projects included in the WestConnect PA under the following categorical exclusion listed in appendix B to subpart D of 10 CFR part 1021: B4.3 (Electric power marketing rate changes). 6 Those categorical exclusion determinations are also applicable to this rate action. Copies of the categorical exclusion determinations are available on WAPA websites. For CRSP MC, the website is: www.wapa.gov/about-wapa/regions/crsp/about-crsp/environment and the file is titled “SLCA/IP Rate Determination—WAPA-206—(CX Determination 2024-2028).” For DSW, the website is: www.wapa.gov/about-wapa/regions/dsw/environment. The file titled, “Rate Order WAPA-209” is located within the “2023” folder. For RM, the website is: www.wapa.gov/about-wapa/regions/rm/rm-environment/cx2016 and the file is titled “2016-077-Proposed-Formula-Rate-Adjustment-for-Transmission-Ancillary-Services-and-Sale-of-Surplus.”

WAPA has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.

The provisional formula rates herein confirmed, approved, and placed into effect on an interim basis, together with supporting documents, will be submitted to FERC for confirmation and final approval.

In view of the above and under the authority delegated to me, I hereby confirm, approve, and place into effect, on an interim basis, Rate Order No. WAPA-215, which extends the existing formula rates under Rate Schedule WC-8 through September 30, 2026. The rates will remain in effect on an interim basis until: (1) FERC confirms and approves of this extension on a final basis; (2) subsequent rates are confirmed and approved; or (3) such rates are superseded.

This document of the Department of Energy was signed on April 1, 2024, by Tracey A. LeBeau, Administrator, Western Area Power Administration, pursuant to delegated authority from the Secretary of Energy. That document, with the original signature and date, is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy.

This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Effective: The first day of the first full billing period beginning on or after June 1, 2014, through May 31, 2019, unless WAPA withdraws from the WestConnect Point-to-Point Regional Transmission Service Participation Agreement, and posts notice of such withdrawal on the Open Access Same-Time Information System (OASIS), prior to May 31, 2019. [Note: This rate schedule was extended by Rate Order No. WAPA-187 through May 31, 2024, and by Rate Order No. WAPA-215 through September 30, 2026.]

Applicable: This schedule of rates applies to any WestConnect Regional, Non-Firm, Point-to-Point Transmission Service that uses a Western Area Power Administration Transmission Project (TP), i.e., Central Arizona Project, Colorado River Storage Project, Loveland Area Projects, Pacific Northwest-Pacific Southwest Intertie Project, and Parker-Davis Project.

Rate: The transmission rates to be used in this formula rate calculation will be the applicable TP's in effect hourly, non-firm, point-to-point transmission rate as posted on the applicable TP's website and on the OASIS.

Formula Rate Calculation: On-peak, hourly, non-firm, point-to-point transmission rate:

Off-peak, hourly, non-firm, point-to-point transmission rate:

The converted rates resulting from using this formula will be posted on the applicable TP's website and on the OASIS and will be used for applicable WestConnect Regional Non-Firm Point-to-Point Transmission Service transactions only.

Background: The SAB was established pursuant to the Environmental Research, Development, and Demonstration Authorization Act (ERDDAA), codified at 42 U.S.C. 4365, to provide independent scientific and technical advice to the EPA Administrator on the scientific and technical basis for agency positions and regulations. The SAB is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C. 10. The SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. Pursuant to FACA and EPA policy, notice is hereby given that the Science Advisory Board Radionuclide Cancer Risk Coefficients Review Panel will hold two public meetings to review and discuss charge questions, listen to agency presentations, listen to public comments and peer review the EPA's draft Cancer Risk Coefficients for Environmental Exposure to Radionuclides (Federal Guidance Report No. 16).

Availability of meeting materials: All meeting materials, including the agenda, will be available on the SAB web page at https://sab.epa.gov.

Procedures for providing public input: Public comment for consideration by EPA's Federal advisory committees and panels has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a Federal advisory committee is different from the process used to submit comments to an EPA program office. Federal advisory committees and panels, including scientific advisory committees, provide independent advice to the EPA. Members of the public can submit relevant comments pertaining to the committee's charge or meeting materials. Input from the public to the SAB will have the most impact if it provides specific scientific or technical information or analysis for the SAB to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comments should follow the instruction below to submit comments.

Oral statements: In general, individuals or groups requesting an oral presentation at a meeting conducted virtually will be limited to three minutes, and individuals or groups requesting an oral presentation at an in-person meeting will be limited to five minutes. Each person making an oral statement should consider providing written comments as well as their oral statement so that the points presented orally can be expanded upon in writing. Persons interested in providing oral statements should contact the DFO, in writing (preferably via email) at the contact information noted under FOR FURTHER INFORMATION CONTACT , by April 18, 2024, for the April 25, 2024 meeting and by May 22, 2024, for the May 29-31, 2024 meeting, to be placed on the list of registered speakers.

Written statements: Written statements will be accepted throughout the advisory process; however, for timely consideration by SAB members, statements should be submitted to the DFO by April 18, 2024, for consideration at the April 25, 2024 meeting and May 22, 2024, for consideration at the May 29-31, 2024 meeting. Written statements should be supplied to the DFO at the contact information above via email. Submitters are requested to provide an unsigned version of each document because the SAB Staff Office does not publish documents with signatures on its websites. Members of the public should be aware that their personal contact information if included in any written comments, may be posted to the SAB website. Copyrighted material will not be posted without the explicit permission of the copyright holder.

Accessibility: For information on access or services for individuals with disabilities, please contact the DFO, at the contact information noted above, preferably at least ten days before the meetings, to give the EPA as much time as possible to process your request.

The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2024-0166) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.

The electronic version of the public docket for this action contains a copy of the proposed consent decree, and is available through https://www.regulations.gov. You may use https://www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select “search.”

Plaintiffs filed a complaint in the United States District Court for the District of Columbia alleging that the EPA's failure to issue final Federal plans implementing emissions guidelines for CISWI and OSWI facilities in states which had not submitted approvable state plans constituted “agency action unreasonably delayed” within the meaning of section 304(a)(2) of the Clean Air Act, 42 U.S.C. 7604(a).

EPA promulgated revised CISWI emission guidelines for existing facilities at 40 CFR subpart DDDD in 2011 and further revised them in February 2013, June 2016, and April 2019. EPA proposed a Federal plan for existing CISWI facilities in 2017, and to date, EPA has not promulgated a final Federal plan implementing CISWI standards under 42 U.S.C. 7429(b)(3).

EPA promulgated emission guidelines for existing OSWI facilities in December 2005 at 40 CFR subpart FFFF. To date, EPA has not finalized a Federal plan implementing standards for existing OSWI facilities under 42 U.S.C. 7429(b)(3).

Under the terms of the consent decree, with respect to the CISWI emission guidelines at 40 CFR subpart DDDD, no later than September 16, 2024, the appropriate EPA official would be required to sign a final rule establishing a Federal plan under 42 U.S.C. 7429(b)(3) for existing CISWI facilities located in any state which has not submitted an approvable state plan.

Under the terms of the consent decree, with respect to the OSWI emission guidelines at 40 CFR subpart FFFF, (1) no later than June 30, 2026, the appropriate EPA official would be required to sign a proposed rulemaking proposing a Federal plan under 42 U.S.C. 7429(b)(3) for existing OSWI facilities located in any state which has not submitted an approvable state plan; and (2) no later than June 30, 2027, the appropriate EPA official would be required to sign a final rule establishing a Federal plan under 42 U.S.C. 7429(b)(3) for existing OSWI facilities located in any state which has not submitted an approvable state plan.

In accordance with section 113(g) of the CAA, for a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed consent decree. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act.

Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2024-0166, via https://www.regulations.gov. Once submitted, comments cannot be edited or removed from this docket. The EPA may publish any comment received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. For additional information about submitting information identified as CBI, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section of this document. Note that written comments containing CBI and submitted by mail may be delayed and deliveries or couriers will be received by scheduled appointment only.

If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

Use of the https://www.regulations.gov website to submit comments to EPA electronically is EPA's preferred method for receiving comments. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment.

Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

9000-0076, Novation and Change-of-Name Agreements.

This clearance covers the information that contractors must submit to comply with the following requirements in Federal Acquisition Regulation (FAR) subpart 42.12:

• FAR 42.1203(a), Written Request. If a contractor wishes the Government to recognize a successor in interest to its contracts or a name change, the contractor must submit a written request to the responsible contracting officer. The request is used by the contracting officer to determine what additional supporting documentation should be submitted by the contractor and to determine what other contract administration offices should be notified of the contractor's request.

• FAR 42.1204(e) and (f), Novation Agreement. Pursuant to FAR 42.1203(b)(1), upon request from the contracting officer, the contractor shall submit three signed copies of the proposed novation agreement, plus copies of the supporting documentation listed at 42.1204(e) and (f), as applicable. The documentation is used by the contracting officer to evaluate and, if appropriate, execute a proposed agreement for recognizing a third party as a successor in interest.

• FAR 42.1205(a), Change-of-Name Agreement. Pursuant to FAR 42.1203(b)(1), upon request from the contracting officer, the contractor shall submit three signed copies of the proposed change-of-name agreement, plus copies of the supporting documentation listed at 42.1205(a), as applicable. The documentation is used by the contracting officer to evaluate and, if appropriate, execute a proposed agreement for recognizing a contractor's name change.

Respondents: 1,625.

Total Annual Responses: 1,625.

Total Burden Hours: 3,163.

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000-0076, Novation and Change-of-Name Agreements.

The FEIS describes the purpose and need for the project; alternatives considered; the existing environment that could be affected; the potential impacts resulting from each of the alternatives; and proposed best management practices and/or mitigation measures. The FEIS also includes a Floodplain Assessment and Statement of Findings, which provides a FONPA for construction in floodplains at the proposed Commercial LPOE and RHC LPOE. The floodplain assessment was revised to include floodplain impacts at the Commercial LPOE due to updated hydrologic data. Based on impacts analyses and public comments, GSA has identified Alternative 2 (Concurrent Construction—Westward Expansion) as its preferred alternative. GSA has also identified sub-alternative d (combination of adaptive reuse, relocation, or demolition) as the preferred alternative for managing historic structures at the RHC LPOE. GSA is continuing consultation with the State Historic Preservation Office as required under section 106 of the National Historic Preservation Act, and updates will be provided in the Record of Decision (ROD). Under the Endangered Species Act, GSA coordinated with the U.S. Fish and Wildlife Service (USFWS) per section 7 requirements to determine effects to federally protected species. The USFWS concurred with GSA findings that the Proposed Action would not likely adversely affect federally threatened or endangered species. Correspondence with USFWS and the findings are incorporated in the FEIS.

The views and comments of the public are necessary in helping GSA in its decision-making process with impacts to environmental, cultural, and economic impacts. The meeting will be an informal open house, where visitors may speak with GSA representatives and provide written comments on the FEIS and FONPA. No formal presentation will be provided. All comments will be considered equally and will be part of the public record.

Additional information on the project, including an electronic copy of the FEIS, may also be found online at: https://www.gsa.gov/about-us/regions/welcome-to-the-pacific-rim-region-9/ land-ports-of-entry/douglas-commercial-land-port-of-entry and https://www.gsa.gov/about-us/regions/welcome-to-the-pacific-rim-region-9/land-ports-of-entry/raul-hector-castro-land-port-of-entry.

In accordance with the Federal Advisory Committee Act, 5 U.S.C. 1009(a)(2), AHRQ announces meetings of the above-listed scientific peer review groups, which are subcommittees of AHRQ's Health Services Research Initial Review Group Committee. The subcommittee meetings will be closed to the public in accordance with the provisions set forth in 5 U.S.C. 1009(d), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(6). The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Agenda items for these meetings are subject to change as priorities dictate.

The meeting referenced above will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5, U.S.C., and the Determination of the Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, pursuant to 5 U.S.C. 1009(d) (Pub. L. 92-463, as amended).

Purpose: The Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC) will: (1) conduct, encourage, cooperate with, and assist other appropriate public health authorities, scientific institutions, and scientists in the conduct of research, investigations, experiments, demonstrations, and studies relating to the causes and strategies related to the prevention of injury, overdose, and violence; (2) assist States and other entities in preventing intentional and unintentional injuries, and to promote health and well-being; and (3) make recommendations of grants and cooperative agreements for research and prevention activities related to injury, overdose, and violence. The BSC, NCIPC makes recommendations regarding policies, strategies, objectives, and priorities and reviews progress toward injury, overdose, and violence prevention. The Board also provides advice on the appropriate balance of intramural and extramural research and provides guidance on the needs, structure, progress, and performance of intramural programs. Further, the Board provides guidance on extramural scientific program matters. Additionally, the Board provides second-level scientific and programmatic review of applications for research grants, cooperative agreements, and training grants related to injury, overdose, and violence prevention, and recommends approval of projects that merit further consideration for funding support. The Board also provides feedback and input on strategic plans, resources, and priority publications related to injury, overdose, and violence prevention.

Matters to be Considered: The closed meeting will focus on the secondary peer review of extramural research grant applications received in response to three (3) Notices of Funding Opportunity: RFA-CE-24-013—“Research Grants to Identify Effective Community-Based Strategies for Overdose Prevention”; RFA-CE-24-029—“Grants to Support New Investigators in Conducting Research Related to Preventing Interpersonal Violence Impacting Children and Youth”; and RFA-CE-24-034—“Rigorous Evaluation of Policies for their Impacts on the Primary Prevention of Multiple Forms of Violence.” Agenda items are subject to change as priorities dictate.

The Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

DFWED National Hypothesis Generation and Investigation Module—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

The Division of Foodborne, Waterborne, and Environmental Diseases (DFWED) at the Centers for Disease Control and Prevention (CDC) aims to protect public health through the prevention and control of disease, disability, and death caused by foodborne, enteric, waterborne, and environmentally transmitted infections. To overcome challenges presented by the changing landscape of enteric diseases, the need for comprehensive hypothesis generating questionnaires focused on a range of settings, activities, and potential modes of transmission are essential to guide prevention and control activities. The submitted forms standardize hypothesis generating instruments used during enteric disease outbreak investigations and surveillance. This includes foodborne, waterborne, and zoonotic disease surveillance and outbreak investigations. In addition, enhanced surveillance for antibiotic resistant isolates is also included in this package.

CDC requests OMB approval for an estimated 5,852 annual burden hours. There is no cost to respondents other than their time to participate.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Assisted Reproductive Technology (ART) Program Reporting System (OMB Control No. 0920-0556, Exp. 12/31/2024)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

Section 2(a) of Public Law 102-493 (known as the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), 42 U.S.C. 263a-1(a)) requires that each assisted reproductive technology (ART) program shall annually report to the Secretary through the Centers for Disease Control and Prevention: (1) pregnancy success rates achieved by such ART program; and (2) the identity of each embryo laboratory used by such ART program and whether the laboratory is certified or has applied for such certification under the Act. The required information is currently reported by ART programs to CDC as specified in the Assisted Reproductive Technology (ART) Program Reporting System (OMB Control No. 0920-0556, Exp. 12/31/2024). The current revision seeks to revise burden hour estimates, modify data elements collected, implement a new process for sharing data externally, and to extend OMB approval for a period of three years. The revised total burden estimate is higher than the previous approval, due to an increase in the utilization of ART in the United States and the number of reported cycles. Data elements collected will be modified to remove five data elements no longer needed and add one new data element to reflect current clinical practice. The average estimated burden for reporting information related to each cycle is not anticipated to change from the time burden previously approved (43 minutes). Data will be made available in the National Center for Health Statistics Research Data Center to increase accessibility of Assisted Reproductive Technology (ART) Program Reporting System data for secondary epidemiological analyses.

The currently approved program reporting system, also known as the National ART Surveillance System (NASS), collects information about all ART cycles initiated by ART programs in the United States. The start of an ART cycle is considered when a woman begins taking medication to stimulate egg production or begins monitoring with the intent of having embryos transferred. For each cycle, CDC collects information about the pregnancy outcome, as well as several data elements deemed by experts in the field to be important to explain variability in success rates across ART programs and individuals.

Each ART program reports its annual ART cycle data to CDC in mid-December. The annual data reporting consists of information about all ART cycles that were initiated in the previous calendar year. For example, ART programs that submit their data in mid-December 2021 will include all ART cycles that were initiated between January 1, 2020, and December 31, 2020.

Data elements and definitions currently in use reflect CDC's prior consultations with representatives of the Society for Assisted Reproductive Technology (SART), the American Society for Reproductive Medicine (ASRM), and RESOLVE: the National Infertility Association (a national, nonprofit consumer organization), as well as a variety of individuals with expertise and interest in this field.

The estimated number of respondents (ART programs or clinics) is 453, based on the number of clinics that provided information in 2021. This number is lower than the previous number of reporting clinics (456). The estimated average number of responses (ART cycles) per respondent is 913. The total burden estimate is higher than the previous approval due to an increase in the utilization of ART in the United States. Additionally, approximately 5-10% of responding clinics will be randomly selected each year to participate in data validation and quality control activities; an estimated 35 clinics will be selected to report validation data on 70 cycles each on average. Finally, respondents may provide feedback to CDC about the usability and utility of the reporting system. The option to participate in the feedback survey is presented to respondents when they complete their required data submission. Participation in the feedback survey is voluntary and is not required by the FCSRCA. CDC estimates that 50% of ART programs will participate in the feedback survey. Due to this lower response rate and reduced number of reporting clinics, CDC estimates 203 clinics will respond to voluntary feedback survey.

The collection of ART cycle information allows CDC to publish clinic-specific success rates annually as specified by the FCSRCA and to provide information needed by consumers. OMB approval is requested for three years. CDC requests approval for 297,352 annual burden hours. There are no costs to respondents other than their time.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Documenting outcomes associated with Persistent Tic Disorders (including Tourette Syndrome) in Children, Adolescents, and Young Adults through Surveillance—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

There are an estimated 1.4 million people in the U.S. affected by persistent tic disorders (PTD), including Tourette syndrome (TS). To support people with these conditions, the impact of PTD/TS must be understood. Although some data on the impact of PTD/TS on social relationships and education are available, other potential outcomes associated with PTD/TS have not been well-documented; including associated costs, suicidality, health care transition, and the prevalence of co-occurring disorders and how co-occurring disorders modify these outcomes. Limited data are available on how these outcomes may differ among sub-populations ( e.g., by sex, race/ethnicity, age group, and geography [ e.g., urban/rural]).

This data collection aims to document priority outcomes including costs ( e.g., education level, employment, healthcare beyond those available in claims data), prevalence of suicidality risk, transition to adult healthcare, and the prevalence of co-occurring conditions and how they modify these outcomes among children and adolescents (4-17 years) and young adults (18-26 years) with PTD/TS. Data will be collected once from a participant ( i.e., individuals with PTD/TS and/or their caregiver), via a survey, and a clinical assessment of tic symptoms. All questions for the Tic Impact Surveillance Survey, the survey created for this surveillance project, were selected from national surveys or previously validated measures. This will allow us to compare estimates from the Tic Impact Surveillance Survey to external prevalence estimates for the same health indicators in US children, adolescents, and young adults in the general population and to previously published findings. Data will be used to inform where resources for families and healthcare providers ( e.g., professional trainings) are most needed to support people with PTD/TS and their families and to address health inequities among the population.

CDC requests OMB approval for an estimated 401 annual burden hours. There is no cost to respondents other than their time to participate.

CDC is providing notice under 5 U.S.C. 1001-1014 of the renewal of the charter of the Advisory Board on Radiation and Worker Health, Centers for Disease Control and Prevention, Department of Health and Human Services. This charter has been renewed for a two-year period through March 22, 2026.

The Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

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

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

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Outcome and Assessment Information Set OASIS-E1; Use: This request is to modify the Outcome and Assessment Information Set (OASIS) that home health agencies (HHAs) are required to collect to participate in the Medicare program. The current OASIS version, OASIS-E, OMB control number 0938-1279, was approved by the OMB on November 30, 2022, and implemented on January 1, 2023. We are seeking OMB approval for the proposed revised OASIS data set, referred to hereafter as OASIS-E1, scheduled for implementation in the HH QRP on January 1, 2025. The OASIS-E1 includes changes related to addition of one item supporting an assessment-based quality measure (QM), removal of one item due to retirement of a QM, and removal of two data elements no longer used in the HH QRP or for other purposes in CMS programs. Form Number: CMS-10545 (OMB control number: 0938-1279); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 11,866; Total Annual Responses: 18,017,056; Total Annual Hours: 16,683,290. (For policy questions regarding this collection contact Jermama Keys at 410-786-7778).

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Advantage, Medicare Part D, and Medicare Fee-For-Service Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey; Use: CMS is required to collect and report information on the quality of health care services and prescription drug coverage available to persons enrolled in a Medicare health or prescription drug plan under provisions in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). Specifically, the MMA under Sec. 1860D-4 (Information to Facilitate Enrollment) requires CMS to conduct consumer satisfaction surveys regarding Medicare prescription drug plans and Medicare Advantage plans and report this information to Medicare beneficiaries prior to the Medicare annual enrollment period. The Medicare CAHPS survey meets the requirement of collecting and publicly reporting consumer satisfaction information. The Balanced Budget Act of 1997 also requires the collection of information about fee-for-service plans. The CAHPS survey measures are incorporated into the Part C and D Star Ratings that are published on www.medicare.gov each fall to help consumers choose a Medicare plan. A subset of the CAHPS measures is also included in the Medicare & You Handbook. CAHPS information from MA contracts also feeds into the calculation of MA Quality Bonus Payment Ratings that are required by statute and regulation.

The primary purpose of the Medicare CAHPS surveys is to provide information to Medicare beneficiaries to help them make more informed choices among health and prescription drug plans available to them. Survey results are reported by CMS in the Medicare & You Handbook published each fall and on the Medicare Plan Finder website. Beneficiaries can compare CAHPS scores for each health and drug plan as well as compare MA and FFS scores when making enrollment decisions. The Medicare CAHPS also provides data to help CMS and others monitor the quality and performance of Medicare health and prescription drug plans and identify areas to improve the quality of care and services provided to enrollees of these plans. CAHPS data are included in the Medicare Part C & D Star Ratings and used to calculate MA Quality Bonus Payments. Form Number: CMS-R-246 (OMB control number: 0938-0732); Frequency: Yearly; Affected Public: Individuals and Households Number of Respondents: 794,500; Total Annual Responses: 794,500; Total Annual Hours: 192,265. (For policy questions regarding this collection contact Lauren Fuentes at 410-786-2290 or lauren.fuentes@cms.hhs.gov ).

3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Application for Part A (Hospital Insurance) and Part B (Medical Insurance) for People with End-Stage Renal Disease; Use: Form CMS-43 (Application for Part A (Hospital Insurance) and Part B (Medical Insurance) for People with End-Stage Renal Disease) supports section 226A(a) of the Social Security Act (the Act) and corresponding regulations at 42 CFR 406.7(c)(3) and 406.13.

Individuals with End-Stage Renal Disease (ESRD) have the opportunity to apply for Medicare benefits and obtain premium-free Part A if they meet certain criteria outlined in statute. Sections 226A of the Act authorizes entitlement for Medicare Hospital Insurance (Part A) if the individual with ESRD files an application for benefits and meets the requisite contributions through one's own employment or the employment of a related individual to meet the statutory definition of a “currently insured” individual outlined in section 214 of the Act. Further, for individuals who meet the requirements for premium-free Part A entitlement, Medicare coverage starts based on the dates in which the individual started dialysis treatment or had a kidney transplant. These statutory provisions are codified at 42 CFR 406.7(c)(3) and 407.13. Form Number: CMS-43 (OMB control number: 0938-0080); Frequency: Once; Affected Public: Individuals and Households Number of Respondents: 45,200; Total Annual Responses: 45,200; Total Annual Hours: 18,984. (For policy questions regarding this collection contact Candace Carter at 410-786-8466 or Candace.Carter@cms.hhs.gov ).

4. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: End Stage Renal Disease (ESRD) Annual Home Dialysis within Nursing Home Survey Form; Use: The End Stage Renal Disease (ESRD) Network program is responsible to collect, validate, and analyze data as well as to evaluate the process by which facilities determine the appropriateness of patients for a treatment modality. Additional responsibilities of the ESRD Network program include encouraging participation in the placement of patients in a self-care setting, such as home hemodialysis or peritoneal dialysis, as described in Sec. 1881. [42 U.S.C. 1395rr] (c)(1)(A)(i)(2) of the Social Security Act. On September 21, 2018, CMS clarified guidance that residents in a nursing home facility can receive dialysis either administered and/or supervised by personnel who meet the criteria for training, and competency verification at 42 CFR 494.100(a) and (b) for providing dialysis. The provision of dialysis within a nursing home requires that the dialysis facility have an agreement with the nursing home. This guidance was reinforced and updated on March 22, 2023, in a memo to the State Survey Agency Directors titled, “Guidance and Survey Process for Reviewing Home Dialysis Services in a Nursing Home REVISED”. Since the provision of dialysis within nursing homes is relatively new, CMS designed the CMS-10842 form to capture home modality information from dialysis facilities that provide dialysis within the nursing home in alignment with the Centers for Disease Control and Prevention (CDC).

The care provided to residents of a nursing home is of particular interest because of the fragile health state of the patient and the susceptibility to infection. Each facility certification/survey record represents one provider. CMS-10842 collects information on dialysis facilities providing home dialysis services within the nursing home related to the number of patients, setting of dialysis services provided, who is providing dialysis services, who is providing dressing changes to dialysis access, staff education and use of CDC Core Interventions used. The aggregate patient information is collected from each Medicare-approved home dialysis provider to identify the specialized needs of the ESRD community where home dialysis is provided in Long Term Care facilities. Form Number: CMS-10842 (OMB control number: 0938-NEW); Frequency: Yearly; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 7,726; Total Annual Responses: 7,726; Total Annual Hours: 5,795. (For policy questions regarding this collection contact Christina Goatee at 410-786-6689).

Description: Funding for facilities under the CCDF is authorized by Section 658O(c)(6) of the Child Care and Development Block Grant (CCDBG) Act, 42 U.S.C. 9858(c)(6), and is managed by the Office of Child Care (OCC). Funding for Head Start facilities projects is authorized by 45 CFR part 1303 (Subpart E) Head Start Program Performance Standards and is managed by the Office of Head Start (OHS). The guide streamlines the process for Tribal CCDF Lead Agencies and American Indian and Alaska Native (AI/AN) Head Start programs submitting collaborative, joint applications to use federal CCDF and Head Start funds for facilities projects where funds can be used for reasonable costs and fees related to planning for a facilities project and to support the application development in tribal communities. Both funds aim to construct or improve early childhood facilities, often serving the same children, but application submission and review processes are currently unique to each respective funding stream. The proposed information collection will provide instructions to Tribal CCDF Lead Agencies and AI/AN Head Start programs on submitting joint plans for how proposed facilities projects will enable the programs to better serve current AI/AN families or increase enrollment currently limited by inadequate facilities. The guide will provide critical information and resources, so recipients understand the requirements of each program and develop plans that reflect the needs of their communities. Reducing and streamlining administrative burdens for tribal constituents follows policy priorities laid out in the 2022 HHS Equity Action Plan and is in alignment with Executive Order 14095—Executive Order on Increasing Access to High-Quality Care and Supporting Caregivers.

Respondents: AI/AN Head Start Facilities and Tribal CCDF Lead Agencies (information collection does not include direct interaction with individuals or families that receive the services).

Annual Burden Estimates: We estimate at most 10 applications per year and have estimated burden based on this maximum number.

Authority: 42 U.S.C. 9858(c)(6); 45 CFR part 1303 Subpart E.

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

GLUCOTROL (glipizide) tablets, 5 mg and 10 mg, are the subject of NDA 017783, held by Pfizer Inc., and initially approved on May 8, 1984. GLUCOTROL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

In a letter dated June 30, 2022, Pfizer Inc., notified FDA that GLUCOTROL (glipizide) tablets, 5 mg and 10 mg, were being discontinued, and FDA moved these drug products to the “Discontinued Drug Product List” section of the Orange Book.

Graviti Pharmaceuticals Private Limited submitted a citizen petition dated January 3, 2024, Docket No. FDA-2024-P-0105, under 21 CFR 10.30, requesting that the Agency determine whether GLUCOTROL (glipizide) tablets, 5 mg and 10 mg, were withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that GLUCOTROL (glipizide) tablets, 5 mg and 10 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that GLUCOTROL (glipizide) tablets, 5 mg and 10 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of GLUCOTROL (glipizide) tablets, 5 mg and 10 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that these drug products were not withdrawn from sale for reasons of safety or effectiveness. 1

Accordingly, the Agency will continue to list GLUCOTROL (glipizide) tablets, 5 mg and 10 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to these drug products. Additional ANDAs for these drug products may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

Section 520 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360j), as amended, provides that DGMPAC shall be composed of two representatives of interests of the device manufacturing industry. The Agency is requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on DGMPAC. FDA is publishing a separate document announcing the request for notification for voting members on DGMPAC.

DGMPAC reviews proposed regulations, prior to their issuance, regarding good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packaging, storage, installation, and servicing of devices, and makes recommendations regarding the feasibility and reasonableness of those proposed regulations. The committee also reviews and makes recommendations on proposed guidelines developed to assist the medical device industry in meeting the good manufacturing practice requirements and provides advice with regard to any petition submitted by a manufacturer for an exemption or variance from good manufacturing practice regulations.

Persons nominated for DGMPAC should possess appropriate qualifications to understand and contribute to the committee's work as described in the committee's function.

Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry views should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT ) within 30 days of publication of this document (see DATES ). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations, and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry views for the committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within the 60 days, the Commissioner will select the nonvoting member to represent industry views.

Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Nominations must include a current, complete résumé or curriculum vitae for each nominee, including current business address, telephone number, email address if available, and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Committee Membership Nomination Portal (see ADDRESSES ) within 30 days of publication of this document (see DATES ). Nominations must also specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process.

FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. Specifically, nominations for nonvoting representatives of industry interests are encouraged from the device manufacturing industry.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq. ) and 21 CFR part 14, relating to advisory committees.

FDA is requesting nominations for voting members to fill upcoming vacancies on the Patient Engagement Advisory Committee. This notice does not include consumer and industry representative nominations. The Agency will publish two separate notices announcing the vacancy of a representative of consumer interests and vacancy of representatives of interests of the device manufacturing industry.

The Committee provides relevant skills and perspectives to improve communication of benefits, risks, and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. The Committee performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy. The Committee provides advice on complex scientific issues related to medical devices, the regulation of devices, and their use by patients. Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient-reported outcomes, device-related quality of life measures, or health status issues are among the topics that may be considered by the Committee.

The Committee consists of a core of nine voting members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities who are knowledgeable in areas such as clinical research, patient or caregiver experience, healthcare needs of patient groups in the United States, or are experienced in the work of patient and health professional organizations, scientific methodologies for patient-reported outcomes and other clinical outcome assessments, scientific methodologies for eliciting patient preferences, and strategies for communicating benefits, risks, and clinical outcomes to patients and research subjects, as well as other relevant areas. Members will be invited to serve for overlapping terms of up to 4 years. Prospective members should also have an understanding of the broad spectrum of patients in a particular disease area. Almost all non-Federal members of this Committee serve as Special Government Employees, with the exception of the representatives from industry.

Any interested person may nominate one or more qualified individuals for membership on the Committee. Self-nominations are also accepted. Nominations must include a cover letter; a current, complete résumé or curriculum vitae for each nominee, including current business and/or home address, telephone number, and email address if available; and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES ). Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq. ) and 21 CFR part 14, relating to advisory committees.

Section 306(b)(1)(D) of the FD&C Act permits FDA to debar a person from importing or offering for import any drug into the United States if FDA finds, as required by section 306(b)(3)(C) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance.

On October 26, 2023, Robert Lance Shuffert was convicted as defined in section 306(l)(1) of the FD&C Act, in the U.S. District Court for the Southern District of Texas when the court accepted his plea of guilty and entered judgment against him for the offense of importing, causing misbranding, and distribution for sale a misbranded drug in violation of 21 U.S.C. 331(k) and 333(a)(2) (sections 301(k) and 303(a)(2) of the FD&C Act). The underlying facts supporting the conviction are as follows:

As contained in the Information from his case, Mr. Shuffert worked for Science Production Products LLC (SPP); although, in SPP's corporate filings with the Texas Secretary of State, he was listed as SPP's owner and operator, and someone else owned SPP and directed Mr. Shuffert's activities. SPP imported, created, marketed, and distributed for sale purported bodybuilding and dietary supplements, including, but not limited to, Selective Androgen Receptor Modulators (SARMs). SARMs are synthetic chemicals designed to mimic the effects of testosterone and other anabolic steroids. At the direction of SPP's owner, Mr. Shuffert operated SPP and SPP manufactured, marketed, and sold a SARM product called Ostarine MK-2866. This product was misbranded because it was labeled as a “Research Product” but was in fact intended to be used by humans as a drug to increase lean muscle mass and lose unwanted fat. Mr. Shuffert worked with others to import SARMs from China. Mr. Shuffert then would use the imported SARMs as components of a drug (Ostarine MK-2866) that he and others caused to become misbranded and then distributed for sale such misbranded drugs in the United States. Mr. Shuffert knowingly took steps to mislead and defraud the Government and consumers in the sale of SARMs, including Ostarine MK-2866.

FDA sent Mr. Shuffert, by certified mail, on January 30, 2024, a notice proposing to debar him for a 5-year period from importing or offering for import any drug into the United States. The proposal was based on FDA's finding under section 306(b)(3)(C) of the FD&C Act that Mr. Shuffert's felony conviction under Federal law for importing, causing misbranding, and distribution for sale a misbranded drug in violation of 21 U.S.C. 331(k) and 333(a)(2), was for conduct relating to the importation of any drug or controlled substance into the United States because Mr. Shuffert illegally imported SARMs from China, which he would use as components of a drug (Ostarine MK-2866) that he caused to become misbranded and then distributed for sale in the United States. Mr. Shuffert knowingly took steps to mislead and defraud the Government and consumers in the sale of SARMs, including Ostarine MK-2866. In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr. Shuffert's offense and concluded that the offense warranted the imposition of a 5-year period of debarment.

The proposal informed Mr. Shuffert of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Shuffert received the proposal and notice of opportunity for a hearing on February 3, 2024. Mr. Shuffert failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).

Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. Shuffert has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act.

As a result of the foregoing finding, Mr. Shuffert is debarred for a period of 5 years from importing or offering for import any drug into the United States, effective (see DATES ). Pursuant to section 301(cc) of the FD&C Act, the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Mr. Shuffert is a prohibited act.

Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. Amendments made by section 504 of the 2017 FDA Reauthorization Act to section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) required, for original applications submitted on or after August 18, 2020, pediatric investigations of certain targeted cancer drugs with new active ingredients, based on molecular mechanism of action rather than clinical indication. The Committee will discuss perspectives relating to implementation of this legislation and its impact on pediatric cancer drug development to date.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting. Background material and the link to the online teleconference and/or video conference meeting will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. All electronic and written submissions to the Docket (see ADDRESSES ) on or before May 8, 2024, will be provided to the Committee. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 30, 2024. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 1, 2024.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Jessica Seo (see FOR FURTHER INFORMATION CONTACT ) at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq. ). This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform. This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. The conditions for issuance of a waiver under 21 CFR 10.19 are met.

In a Federal Register notice issued on August 10, 2023 (88 FR 54332), NIH proposed a series of actions to the NIH Guidelines for public comment. NIH is amending the NIH Guidelines to ensure the continued responsible research involving GDMOs in contained research settings. Specifically, the NIH Guidelines will be amended to:

1. clarify minimum containment requirements for research involving GDMOs;

2. provide considerations for risk assessment;

3. define additional institutional responsibilities for IBCs and BSOs.

In addition to the amendments related to contained research involving GDMOs, the NIH Guidelines will also be amended to:

1. replace the term “helper viruses” with the broader term “helper systems”; and

2. reclassify WNV and SLEV as risk group 2 agents for consistency with containment guidance provided in the BMBL.

The revisions apply to GDMO research in contained settings, which is subject to the NIH Guidelines. These revisions are consistent with the recommendations of the Novel and Exceptional Technology Research Advisory Committee report, Gene Drives in Biomedical Research (NExTRAC Report). NIH does not currently support research involving field release of GDMOs and the NIH Guidelines pertain to contained research; accordingly, no changes regarding potential field release are included in this Notice. NIH is also revising the NIH Guidelines to harmonize with the 6th edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL) regarding the Risk Group (RG) categorization of West Nile Virus (WNV) and Saint Louis Encephalitis Virus (SLEV).

The NIH received 28 comments (available at https://osp.od.nih.gov/wp-content/uploads/2023/11/RFI_Nucleic_Final_508.pdf ) submitted by individuals from the general public, academic institutions, and professional or membership organizations in response to the proposal to amend the NIH Guidelines posted to the Federal Register on August 10, 2023. All comments were reviewed and considered by the NIH. Most comments did not express general concerns with the proposed amendments, but many included comments or questions on specific sections. These comments, along with NIH responses, are summarized below.

Several of the comments requested additional guidance or resources to accompany any changes. As a source of information in addition to that in the NIH Guidelines, the NIH will provide a supplementary reference document, Biosafety Considerations for Contained Research Involving Gene Drive Modified Organisms, that institutions, investigators, and the biosafety community can reference as they consider conducting contained gene drive research. The reference document is intended to organize the relevant sections of the NIH Guidelines in an accessible format and to provide some additional information and resources. It will be available on the NIH Office of Science Policy (OSP) NIH Guidelines website, along with Frequently Asked Questions.

Definition of “gene drive” in Section I-E-7. Several comments requested additional clarification of the definition and that the definition specify “engineered” gene drives to exclude natural gene drives. Under the scope of NIH Guidelines, only contained research with gene drives involving recombinant or synthetic nucleic acids would be subject to the NIH Guidelines. The definition language is based on the definition in the NExTRAC report, Gene Drives in Biomedical Research. Other comments asked whether certain research with prokaryotes or viruses could be considered to involve GDMOs. While gene drive technologies are usually applied to sexually reproducing organisms, the risk assessment section of the NIH Guidelines will include guidance on the consideration of modifications with properties similar to a gene drive. The supplementary reference document will include sources for additional information on gene drive technologies and capabilities.

Section II-A-3 Risk Assessment. In response to comments seeking additional risk assessment guidance, in particular regarding relevant biosafety data, the reference document will include links to sources with additional information including the NExTRAC report, the National Academy of Sciences report, Gene Drives on the Horizon, and other relevant literature sources.

Regarding the requirement of a minimum of biosafety level 2 (BL2) containment for work with GDMOs, several comments asked about appropriate BL2 containment for specific species. Gene drive research may be conducted in a broad range of species, and institutions may wish to consult containment guidance tailored to the specific species or type of organism utilized in a particular protocol. For work with arthropods, the NIH Guidelines will be amended to reference the Arthropod Containment Guidelines and Addendum 1 Containment Practices for Arthropods Modified with Engineered Transgenes Capable of Gene Drive. The reference document will include sources for additional species. In particular, there were comments about Saccharomyces and Kluyveromyces Host-Vector Systems. The amendments will only affect research involving host vector systems modified by a gene drive and does not pertain to other yeast research.

Other comments requested a process for handling requests to lower containment levels for research involving GDMOs. As with requests to lower containment for research involving infectious agents outlined in Section IV-C-b-(2)-(a), OSP will consider containment lowering requests for research involving GDMO on a case-by-case basis.

Section III-D and III-E. Comments were supportive of the terminology shift from “helper virus” to “helper system,” but several asked that the examples of helper systems that were included in the Federal Register notice also be included in the NIH Guidelines. To provide that information, the preamble to III-D-3 will state: “The potential for reversion or generation of replication competent virus should be considered when generating or using defective viruses or vectors in the presence of helper systems ( e.g., helper viruses, packaging cell lines, transient transfection systems, replicon systems).”

Several comments asked whether NIH was proposing to expand Section III-E-3 to include the use of transgenic rodents. There are two instances where transgenic rodents are specifically exempted from the NIH Guidelines. Appendix C-VII exempts the purchase or transfer of transgenic rodents and Appendix C-VIII exempts the generation of BL1 rodents by breeding. The use of exempt rodents remains exempt unless the subsequent research involves the use of recombinant or synthetic nucleic acid molecules. The language added to III-E-3 is not an expansion to include the use of de novo generated rodents covered under that section. Rodents covered under III-E-3 are not exempt and, as such, their subsequent use is not exempt. The inclusion of the language referring to the use of such rodents is intended to clarify that their subsequent use is not exempt.

Section IV Roles and Responsibilities and V-N. Several comments asked for clarification regarding the requirement for adequate expertise on IBCs reviewing GDMO research including consideration of ecological impacts. Consistent with expectations in the NIH Guidelines for the review of research with plants, animals, or human research participants, appropriate expertise regarding ecological impacts may be provided by members of the IBC or ad hoc consultants. An ad hoc consultant with expertise in ecological impacts would only be needed for review of specific GDMO research and, if an institution has multiple IBCs, would only be required to serve on the specific IBC reviewing such research. An ad hoc consultant may be from a partner or unrelated institution and does not need to be local to the institution.

Several comments addressed the additional requirement for a biological safety officer (BSO) to be appointed if research involving GDMOs is to be conducted. Some commenters interpreted this language to mean that a BSO must be appointed if the institution engages in any BL2 research. To clarify, a BSO must be appointed if the institution engages in recombinant or synthetic nucleic acid molecule research that involves GDMOs. Section IV-B-1-c will be revised to clarify this requirement. Others commented on the qualifications of a BSO and the reference to the Laboratory Safety Monograph. The duties of a BSO are specifically outlined in Section IV-B-3 of the NIH Guidelines.

Appendix B Classification of Human Etiologic Agents on the Basis of Hazard. All comments regarding this proposed change supported the reclassification of West Nile Virus and Saint Louis Encephalitis virus (SLEV) as risk group 2 agents to harmonize with guidance provided by the BMBL. One comment noted that SLEV was improperly classified as an alphavirus. Appendix B will be amended to classify SLEV as a flavivirus. As minor actions under the NIH Guidelines, Appendix B-IV-D Risk Group 4 Viral Agents will be amended from “Hemorrhagic fever agents and viruses as yet undefined” to “Hemorrhagic fever viruses as yet undefined” to prevent possible misinterpretation that all undefined viruses require RG4 containment, and the listing of Ebola and Marburg virus will be pluralized to harmonize with recent changes in taxonomy nomenclature to cover multiple viruses. The amendment to “Ebola viruses” and “Marburg viruses” will clarify that the virus name applies to the multiple species.

Section I-E will be amended as follows:

Section I-E-7. “Gene drive” is defined as a technology whereby a particular heritable element biases inheritance in its favor, resulting in the heritable element becoming more prevalent than predicted by Mendelian laws of inheritance in a population over successive generations.

Section II-A-3 will be amended as follows:

In deciding on the appropriate containment for an experiment, the first step is to assess the risk of the agent itself. Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard, classifies agents into Risk Groups based on an assessment of their ability to cause disease in humans and the available treatments for such disease. Once the Risk Group of the agent is identified, this should be followed by a thorough consideration of how the agent is to be manipulated. Factors to be considered in determining the level of containment include agent factors such as: virulence, pathogenicity, infectious dose, environmental stability, route of spread, communicability, operations, quantity, availability of vaccine or treatment, and gene product effects such as toxicity, physiological activity, and allergenicity. Any strain that is known to be more hazardous than the parent (wild-type) strain should be considered for handling at a higher containment level. Certain attenuated strains or strains that have been demonstrated to have irreversibly lost known virulence factors may qualify for a reduction of the containment level compared to the Risk Group assigned to the parent strain (see Section V-B, Footnotes and References of Sections I-IV).

While the starting point for the risk assessment is based on the identification of the Risk Group of the parent agent, as technology moves forward, it may be possible to develop an organism containing genetic sequences from multiple sources such that the parent agent may not be obvious. In such cases, the risk assessment should include at least two levels of analysis. The first involves a consideration of the Risk Groups of the source(s) of the sequences and the second involves an assessment of the functions that may be encoded by these sequences ( e.g., virulence or transmissibility). It may be prudent to first consider the highest Risk Group classification of all agents that are the source of sequences included in the construct. Other factors to be considered include the percentage of the genome contributed by each parent agent and the predicted function or intended purpose of each contributing sequence. The initial assumption should be that all sequences will function as they did in the original host context.

The Principal Investigator and Institutional Biosafety Committee must also be cognizant that the combination of certain sequences in a new biological context may result in an organism whose risk profile could be higher than that of the contributing organisms or sequences. The synergistic function of these sequences may be one of the key attributes to consider in deciding whether a higher containment level is warranted, at least until further assessments can be carried out. A new biosafety risk may occur with an organism formed through combination of sequences from a number of organisms or due to the synergistic effect of combining transgenes that results in a new phenotype.

A final assessment of risk based on these considerations is then used to set the appropriate containment conditions for the experiment (see Section II-B, Containment). The appropriate containment level may be equivalent to the Risk Group classification of the agent or it may be raised or lowered as a result of the above considerations. The Institutional Biosafety Committee must approve the risk assessment and the biosafety containment level for recombinant or synthetic nucleic acid experiments described in Sections III-A, Experiments that Require NIH Director Approval and Institutional Biosafety Committee Approval, Before Initiation; III-B, Experiments that Require NIH OSP and Institutional Biosafety Committee Approval Before Initiation; III-C, Experiments Involving Human Gene Transfer that Require Institutional Biosafety Committee Approval Prior to Initiation; III-D, Experiments that Require Institutional Biosafety Committee Approval Before Initiation.

Research involving gene drive modified organisms may require risk assessments that incorporate a broader scope of considerations because of greater uncertainty of the technology and potential uncertainty of the impact of the newly modified organism. Specific attention must be paid to risks of an unintended release from the laboratory and the potential impact on humans, other populations of organisms, and the environment.

Considerations for conducting risk assessments for research involving gene drive modified organisms might include:

1. The specific types of manipulations based on:

a. Function or intended function of the genetic/gene drive construct ( i.e., a designed or engineered assembly of sequences);

b. Source of the genetic material ( e.g., sequences of transgenes) in the construct;

c. The modifications to the construct;

d. Whether it is possible to predict the consequences of a construct, including the recognition of an unintended gene drive ( i.e., construct not specifically designed as a gene drive but nonetheless having properties of a gene drive) and the possible consequences of escape into the environment;

e. The potential ability of the gene drive to spread or persist in local populations;

2. Options for approaches to risk mitigation for specific types of risks in experiments or when dealing with a high degree of uncertainty about risks;

3. Considerations for implementing more stringent containment measures until biosafety data are accrued to support lowering containment.

Careful consideration should be given to the types of manipulation planned for some higher Risk Group agents. For example, the RG2 dengue viruses may be cultured under the Biosafety Level (BL) 2 containment (see Section II-B); however, when such agents are used for animal inoculation or transmission studies, a higher containment level is recommended. Similarly, RG3 agents such as Venezuelan equine encephalomyelitis and yellow fever viruses should be handled at a higher containment level for animal inoculation and transmission experiments.

Individuals working with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or other bloodborne pathogens should consult the applicable Occupational Safety and Health Administration (OSHA) regulation, 29 CFR 1910.1030, and OSHA publication 3127 (1996 revised). BL2 containment is recommended for activities involving all blood-contaminated clinical specimens, body fluids, and tissues from all humans, or from HIV- or HBV-infected or inoculated laboratory animals. Activities such as the production of research-laboratory scale quantities of HIV or other bloodborne pathogens, manipulating concentrated virus preparations, or conducting procedures that may produce droplets or aerosols, are performed in a BL2 facility using the additional practices and containment equipment recommended for BL3. Activities involving industrial scale volumes or preparations of concentrated HIV are conducted in a BL3 facility, or BL3 Large Scale if appropriate, using BL3 practices and containment equipment.

Exotic plant pathogens and animal pathogens of domestic livestock and poultry are restricted and may require special laboratory design, operation and containment features not addressed in Biosafety in Microbiological and Biomedical Laboratories (see Section V-C, Footnotes and References of Sections I through IV). For information regarding the importation, possession, or use of these agents see Sections V-G and V-H, Footnotes and References of Sections I through IV.

A portion of Section III-C-1 will be amended as follows:

Human gene transfer is the deliberate transfer into human research participants of either:

1. Recombinant nucleic acid molecules, or DNA or RNA derived from recombinant nucleic acid molecules, or

2. Synthetic nucleic acid molecules, or DNA or RNA derived from synthetic nucleic acid molecules, that meet any one of the following criteria:

a. Contain more than 100 nucleotides; or

b. Possess biological properties that enable introduction of stable genetic modifications into the genome ( e.g., cis elements involved in integration, gene editing); or

c. Have the potential to replicate in a cell; or

d. Can be translated or transcribed.

Section III-F-1 will be amended as follows:

Section III-F-1. Those synthetic nucleic acids that: (1) can neither replicate nor generate nucleic acids that can replicate in any living cell ( e.g., oligonucleotides or other synthetic nucleic acids that do not contain an origin of replication or contain elements known to interact with either DNA or RNA polymerase), and (2) are not designed to introduce a stable genetic modification, and (3) do not produce a toxin that is lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight. If a synthetic nucleic acid is deliberately transferred into one or more human research participants and meets the criteria of Section III-C, it is not exempt under this section.

Section III-D-4 will be amended as follows:

This section covers experiments involving deliberate transfer of recombinant or synthetic nucleic acid molecules, DNA or RNA derived from recombinant or synthetic nucleic acid molecules, or recombinant or synthetic nucleic acid molecule-modified microorganisms into whole animals and experiments involving whole animals in which the animal's genome has been altered by recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefrom, into the germ-line (transgenic animals). Experiments involving gene drive modified animals or experiments involving viable recombinant or synthetic nucleic acid molecule-modified microorganisms, except for viruses that are only vertically transmitted, may not be conducted at BL1-N containment. A minimum containment of BL2 or BL2-N is required (see Section III-D-8).

Caution —Special care should be used in the evaluation of containment conditions for some experiments with transgenic animals. For example, such experiments might lead to the creation of novel mechanisms ( e.g., a gene drive; refer to Section III-D-8) or increased transmission of a recombinant pathogen or production of undesirable traits in the host animal. In such cases, serious consideration should be given to increasing the containment conditions.

Section III-D-4-a. Recombinant or synthetic nucleic acid molecules, or DNA or RNA molecules derived therefrom, from any source except for greater than two-thirds of eukaryotic viral genome may be transferred to any non-human vertebrate or any invertebrate organism and propagated under conditions of physical containment comparable to BL1 or BL1-N and appropriate to the organism under study (see Section V-B, Footnotes and References of Sections I-IV). Animals that contain sequences from viral vectors, which do not lead to transmissible infection either directly or indirectly as a result of complementation or recombination in animals, may be propagated under conditions of physical containment comparable to BL1 or BL1-N and appropriate to the organism under study. Experiments involving the introduction of other sequences from eukaryotic viral genomes into animals are covered under Section III-D-4-b, Experiments Involving Whole Animals. For experiments involving recombinant or synthetic nucleic acid molecule-modified Risk Groups 2, 3, 4, or restricted organisms, see Sections V-A, V-G, and V-L, Footnotes and References of Sections I-IV. It is important that the investigator demonstrate that the fraction of the viral genome being utilized does not lead to productive infection. A U.S. Department of Agriculture permit is required for work with plant or animal pathogens (see Section V-G, Footnotes and References of Sections I-IV).

Section III-D-4-b. For experiments involving recombinant or synthetic nucleic acid molecules, or DNA or RNA derived therefrom, involving whole animals, including transgenic animals, and not covered by Section III-D-1, Experiments Using Human or Animal Pathogens (Risk Group 2, Risk Group 3, Risk Group 4, or Restricted Agents as Host-Vector Systems), or Section III-D-4-a, the appropriate containment shall be determined by the Institutional Biosafety Committee. Experiments involving gene drive modified animals generated by recombinant or synthetic nucleic acid molecules shall be conducted at a minimum of BL2 or BL2-N (see Section III-D-8).

Section III-D-4-c. Exceptions under Section III-D-4, Experiments Involving Whole Animals

Section III-D-4-c-(1). Experiments involving the generation of transgenic rodents that require BL1 containment are described under Section III-E-3, Experiments Involving Transgenic Rodents.

Section III-D-4-c-(2). The purchase or transfer of BL1 transgenic rodents is exempt from the NIH Guidelines under Section III-F, Exempt Experiments (see Appendix C-VII, The Purchase or Transfer of Transgenic Rodents).

Section III-D-4-c-(3). Experiments involving the generation or use of gene drive modified animals require a minimum of BL2 containment and are covered under III-D-8, Experiments Involving Gene Drive Modified Organisms.

A portion of Section III-D-5 will be amended as follows:

Experiments to genetically engineer plants by recombinant or synthetic nucleic acid molecule methods, to use such plants for other experimental purposes ( e.g., response to stress), to propagate such plants, or to use plants together with microorganisms or insects containing recombinant or synthetic nucleic acid molecules, may be conducted under the containment conditions described in Sections III-D-5-a through III-D-5-e. If experiments involving whole plants are not described in Section III-D-5 and do not fall under Sections III-A, III-B, III-D or III-F, they are included in Section III-E. Experiments involving the generation or use of gene drive modified organisms require a minimum of BL2 containment and are described under Section III-D-8, Experiments Involving Gene Drive Modified Organisms.

Section III-D-8 will be added as follows:

Experiments involving gene drive modified organisms generated by recombinant or synthetic nucleic acid molecules shall be conducted at a minimum of Biosafety Level (BL) 2, BL2-N (Animals) or BL2-P (plant) containment.

A portion of Section III-E-3 will be amended as follows:

This section covers experiments involving the generation or use of rodents in which the animal's genome has been altered by stable introduction of recombinant or synthetic nucleic acid molecules, or nucleic acids derived therefrom, into the germ-line (transgenic rodents). Only experiments that require BL1 containment are covered under this section; experiments that require BL2, BL3, or BL4 containment are covered under Section III-D-4, Experiments Involving Whole Animals or Section III-D-8, Experiments Involving Gene Drive Modified Organisms.

Section IV-B-1-c will be amended as follows:

Section IV-B-1-c. Appoint a Biological Safety Officer (who is also a member of the Institutional Biosafety Committee) if the institution: (i) conducts recombinant or synthetic nucleic acid molecule research at Biosafety Level (BL) 3 or BL4, (ii) engages in large-scale (greater than 10 liters) research or (iii) conducts any research involving gene drive modified organisms, which all must be conducted at BL2 or higher containment. The Biological Safety Officer carries out the duties specified in Section IV-B-3.

Section IV-B-2-a-(1) will be amended as follows:

Section IV-B-2-a-(1). The Institutional Biosafety Committee must comprise no fewer than five members so selected that they collectively have experience and expertise in recombinant or synthetic nucleic acid molecule technology and the capability to assess the safety of recombinant or synthetic nucleic acid molecule research and to identify any potential risk to public health or the environment. At least two members shall not be affiliated with the institution (apart from their membership on the Institutional Biosafety Committee) and who represent the interest of the surrounding community with respect to health and protection of the environment ( e.g., officials of state or local public health or environmental protection agencies, members of other local governmental bodies, or persons active in medical, occupational health, or environmental concerns in the community). The Institutional Biosafety Committee shall include at least one individual with expertise in plant, plant pathogen, or plant pest containment principles when experiments utilizing Appendix L, Physical and Biological Containment for Recombinant or Synthetic Nucleic Acid Molecule Research Involving Plants, require prior approval by the Institutional Biosafety Committee. The Institutional Biosafety Committee shall include at least one scientist with expertise in animal containment principles when experiments utilizing Appendix M, Physical and Biological Containment for Recombinant or Synthetic Nucleic Acid Molecule Research Involving Animals, require Institutional Biosafety Committee prior approval. When the institution conducts research involving gene drive modified organisms, the institution must ensure that the Institutional Biosafety Committee has adequate expertise ( e.g., specific species containment, ecological or environmental risk assessment) using ad hoc consultants if necessary. When the institution conducts recombinant or synthetic nucleic acid molecule research at BL3, BL4, or Large Scale (greater than 10 liters) or research involving gene drive modified organisms, a Biological Safety Officer is mandatory and shall be a member of the Institutional Biosafety Committee (see Section IV-B-3, Biological Safety Officer). When the institution conducts research with gene drive modified organisms, the impact on ecosystems should be assessed by the Institutional Biosafety Committee (see Section V-N, Footnotes and References of Sections I-IV). When the institution participates in or sponsors recombinant or synthetic nucleic acid molecule research involving human research participants, the institution must ensure that the Institutional Biosafety Committee has adequate expertise and training (using ad hoc consultants if necessary). Institutional Biosafety Committee approval must be obtained from the clinical trial site. Section IV-B-3, Biological Safety Officer (BSO), will be amended as below in Section IV-B-3-a along with the addition of a new Section IV-B-3-c and re-lettering of the current Section IV-B-3-c to IV-B-3-d as follows:

Section IV-B-3-a. The institution shall appoint a Biological Safety Officer if it engages in large-scale research or production activities involving viable organisms containing recombinant or synthetic nucleic acid molecules. The Biological Safety Officer shall be a member of the Institutional Biosafety Committee.