The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of specified animals and animal products to prevent the introduction into the United States of various animal diseases, including African swine fever (ASF). ASF is a highly contagious disease of wild and domestic swine that can spread rapidly with extremely high rates of morbidity and mortality. A list of regions where ASF exists or is reasonably believed to exist is maintained on the Animal and Plant Health Inspection Service (APHIS) website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import- information/animal-health-status-of-regions/. This list is referenced in § 94.8(a)(2) of the regulations.

Section 94.8(a)(3) of the regulations states that APHIS will add a region to the list referenced in § 94.8(a)(2) upon determining ASF exists in the region or having reason to believe the disease exists in the region, based on reports APHIS receives of outbreaks of the disease from veterinary officials of the exporting country, from the World Organization for Animal Health (WOAH), 1 or from other sources the Administrator determines to be reliable, or upon determining that there is reason to believe the disease exists in the region. Section 94.8(a)(1) of the regulations specifies the criteria on which the Administrator bases the reason to believe ASF exists in a region. Section 94.8(b) prohibits the importation of pork and pork products from regions listed in accordance with § 94.8 except if processed and treated in accordance with the provisions specified in that section or consigned to an APHIS-approved establishment for further processing. Section 96.2 restricts the importation of swine casings that originated in or were processed in a region where ASF exists, as listed under § 94.8(a).

On May 18, 2022, the veterinary authorities of the Federal Democratic Republic of Nepal reported to WOAH the occurrence of ASF in that country. In response to that report, on May 23, 2022, APHIS added the Federal Democratic Republic of Nepal to the list of regions where ASF exists or the Administrator has reason to believe that ASF exists, in compliance with § 94.8(a)(3). This notice serves as an official record and public notification of that action.

As a result, pork and pork products from Nepal, including casings, are subject to APHIS import restrictions designed to mitigate the risk of ASF introduction into the United States.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this action as not a major rule, as defined by 5 U.S.C. 804(2).

Authority: 7 U.S.C. 1633, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

Title: Comprehensive Aquaculture Health Program; Use of MI-CO Application.

OMB Control Number: 0579-XXXX.

Type of Request: Approval of a new information collection.

Abstract: The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) unit is responsible for, among other things, protecting the health of the nation's aquatic livestock and supporting safe trade of those animals and their products. This authority is provided under the Animal Health Protection Act (7 U.S.C. 8301 et seq. ). Further, Executive Order 13921, Promoting American Seafood Competitiveness and Economic Growth, rescinded the 2008 National Aquatic Animal Health Plan, and authorized a new national aquaculture health plan establishing USDA as the competent authority for the protection, inspection, and certification of aquatic livestock health.

The National Aquaculture Health Plan and Standards (NAHPS) provides guidance for pathogen testing, reporting, and laboratory standards in addition to outlining health inspection options for aquatic livestock. One of these inspection options is the Comprehensive Aquaculture Health Program Standards (CAHPS). CAHPS was developed in partnership with the U.S. aquaculture industry as a voluntary program that establishes a framework to improve and verify the health of aquatic livestock produced in the United States. Principles outlined in the CAHPS provide for early disease detection, surveillance, risk mitigation, reporting, and response for the control of aquatic animal pathogens, especially those reportable to the World Organization for Animal Health (WOAH), and to prevent their dissemination via aquatic animal sale, movement, and trade.

VS and its CAHPS/aquaculture industry affiliates will use a mobile application provided through the MI-Corporation (MI-CO) to carry out CAHPS functions and evaluate and verify aquatic livestock health on premises. The application uses a MI-CO platform for a server/client-based mobile application that supports data collection using forms that can be deployed to a mobile device, like a smartphone or tablet, and used in an internet-connected or disconnected environment. CAHPS participants will use the application to collect general participant and aquatic health team information; assess the risk of incursion and spread of aquatic pathogens of concern; carry out disease detection and surveillance and report laboratory test results; report any disease outbreaks and presence of pathogens of concern; and document outbreak response and recovery via surveillance and response plans. Participants can also log outbreak communication plans and biosecurity plans using the application and use a CAHPS Workbook as a template for CAHPS work.

The MI-CO app will retain information from inspection to inspection. VS will update participants' information annually. VS will not physically collect or remove from the premises any of the documentation unless the participant gives express permission to attach documents to their CAHPS portfolio in the app. VS personnel will annually review and enter information for every CAHPS participant to support compliance with CAHPS.

We are asking Office of Management and Budget (OMB) to approve our use of these information collection activities for 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

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

(2) Evaluate the accuracy of our estimate of the burden of the 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; and

(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public burden for this collection of information is estimated to average 0.96 hours per response.

Respondents: U.S. aquaculture producers and industry representatives.

Estimated annual number of respondents: 30.

Estimated annual number of responses per respondent: 13.

Estimated annual number of responses: 395.

Estimated total annual burden on respondents: 378 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Title: Importation of Animals and Poultry, Animal and Poultry Products, Certain Animal Embryos, Semen, and Zoological Animals.

OMB Control Number: 0579-0040.

Type of Request: Revision to and extension of approval of an information collection.

Abstract: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq. ), the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) is authorized, among other things, to prohibit or restrict the importation of animals, animal products, and other articles into the United States to prevent the introduction of animal diseases and pests. Disease prevention is the most effective method for maintaining a healthy animal population and for enhancing APHIS' ability to compete in the world market of animal and animal product trade.

Among other things, APHIS' Veterinary Services is responsible for preventing the introduction of foreign or certain other communicable animal diseases into the United States and for rapidly identifying, containing, eradicating, or otherwise mitigating such diseases when feasible. In connection with this mission, APHIS collects information from individuals, businesses, and farms that are involved with importation of animals or poultry, animal or poultry products, or animal germplasm (semen, oocytes, embryos, and cloning tissues, as well as eggs for hatching) into the United States, as well as from foreign countries and States to support these imports. Some of the information collection activities include agreements, permits, application and space reservation requests, inspections, registers, declarations of importation, requests for hearings, daily logs, additional requirements, application for permits, import health certificates, letters, written notices, daily record of horse activities, written requests, opportunities to present views, reporting, applications for approval of facilities, certifications, arrival notices, on-hold shipment notifications, reports, test submission forms, quarantine documents, affidavits, animal identification, written plans, checklists, specimen submissions, emergency action notifications, refusal of entry and order to dispose of fish, premises information, recordkeeping, and application of seals.

In addition, APHIS evaluates the animal health statuses of foreign regions and evaluates the risk of disease introduction via commodities to allow for the importation of animals and animal-related commodities into the United States by receiving and evaluating information collection activities. These information collection activities include recognition of the animal health status of a region, applications for recognition of the animal health status of a region, applications for recognition of a region as historically free of a disease, requests for additional information about the region, appeals of classifications of animal health status, and written recommendations and proof of implementation from foreign animal health authorities seeking to engage in the regionalization process.

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

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

(2) Evaluate the accuracy of our estimate of the burden of the 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; and

(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public burden for this collection of information is estimated to average 0.76 hours per response.

Respondents: Foreign animal health authorities; U.S. importers; foreign exporters; veterinarians and animal health technicians in other countries; State animal health authorities; shippers, owners and operators of foreign processing plants and farms; USDA-approved zoos, laboratories, and feedlots; private quarantine facilities; and other entities involved (directly or indirectly) in the importation of animals and poultry, animal and poultry products, zoological animals, and animal germplasm.

Estimated annual number of respondents: 73,769.

Estimated annual number of responses per respondent: 11.

Estimated annual number of responses: 795,301.

Estimated total annual burden on respondents: 600,320 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

The purpose of the meeting is to discuss:

1. Recreation Enhancement Act;

2. Great American Outdoors Act Projects;

3. Heritage; and

4. Environmental Stewardship.

The agenda will include time for individuals to make oral statements of three minutes or less. Individuals wishing to make an oral statement should make a request in writing at least one week prior to the meeting date to be scheduled on the agenda. Written comments may be submitted to the Forest Service up to 7 days after the meeting date listed under DATES .

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

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

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/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.

Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the Board. To ensure that the recommendations of the Board have taken in account the needs of the diverse groups served by USDA, membership shall include to the extent possible, individuals with demonstrated ability to represent minorities, women, and persons with disabilities. USDA is an equal opportunity provider, employer, and lender.

The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RBCS is submitting to OMB as a revision to an existing collection.

Title: Rural Economic Development Loan and Grant Program.

OMB Control Number: 0570-0035.

Expiration Date of Approval: August 31, 2024.

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

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 2.26 hours per response.

Respondents: Not-for-profit institutions.

Estimated Number of Respondents: 120.

Estimated Number of Responses per Respondent: 17.

Estimated Annual Reporting Number of Responses: 2,012.

Estimated Annual Reporting Burden on Respondents: 4,562.

Estimated Annual Recordkeeping Number of Responses: 90.

Estimated Annual Recordkeeping Burden on Respondents: 180.

Estimated Total Annual Number of Responses: 2,102.

Estimated Total Annual Burden on Respondents: 4,742.

Abstract: Under this program, loans and grants are provided to electric and telecommunications utilities that have borrowed funds from the Agency. The purpose of the program is to encourage these electric and telecommunications utilities to promote rural economic development and job creation projects such as business start-up costs, business expansion, community development, and business incubator projects. The utilities must use program loan funds to make a pass-through loan to an ultimate recipient such as a business. The utility is responsible for fully repaying its loan to the Government, even if the ultimate recipient does not repay its loan. The intermediary must use program grant funds, along with its required contribution, to create a revolving loan fund that the utility will operate and administer. Loans to the ultimate recipient are made from the revolving loan fund for a variety of community development projects. The information requested is necessary and vital in order for the Agency to be able to make prudent and financial analysis decisions.

The information collected will be used to evaluate applications for funding consideration, conduct an environmental review, prepare legal documents, receive loan payments, oversee the operation of a revolving loan fund, monitor the use of RBS funds, and enforce other Government requirements such as compliance with civil rights regulations.

Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on 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. Comments may be sent by the Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.

Copies of this information collection can be obtained from Kimble Brown, Innovation Center, at (202) 720-6780, Email: kimble.brown@usda.gov.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

These appointments are announced in accordance with 5 U.S.C. 4314(c)(4).

The names and position titles of the members of the PRB are set forth below:

Ron Jarmin, Deputy Director, Census Bureau, Chair, OUS/EA Performance Review Board approved the publication of this notice in the Federal Register .

On October 21, 2022, Commerce published in the Federal Register the final results of a scope ruling regarding imports of quartz surface products manufactured in China and further processed in Malaysia, finding that such imports are covered by the scope of the Orders. 1 Moreover, because exporters of quartz surface products from Malaysia export both subject and non-subject merchandise, Commerce established a scope certification process for all imports of quartz surface products from Malaysia. Commerce also determined that certain companies processing Chinese quartz slab in Malaysia, including Bada Industries, were ineligible to participate in this scope certification process, but indicated that they could request reconsideration of their exclusion from the certification process in a future segment of the proceeding. 2

On June 26, 2023, based on a request filed by Global Stone, 3 Commerce initiated a CCR to determine whether Bada Industries is eligible to certify that its quartz surface products are not produced from Chinese-origin quartz slab. 4 On July 26, 2023, Global Stone filed a timely request for administrative review for its exporter, Bada Industries. 5 On September 11, 2023, Commerce initiated AD and CVD administrative reviews of Bada Industries, among other Malaysian exporters. 6

Commerce has determined that a CCR is not the appropriate segment to reconsider ineligible parties' exclusion from a certification process, where that ineligibility was due to a party's failure to cooperate in a prior segment of a proceeding. 7 Commerce explained that an administrative review is the proper segment of a proceeding for a party deemed ineligible from participating in a certification process to request reconsideration of its eligibility to certify, absent evidence of a changed circumstance. 8 In light of Solar Cells, Commerce has reevaluated Global Stone's CCR request and determines that a party's newfound willingness to participate is not a changed circumstance sufficient to warrant such a review. Additionally, as noted above, Commerce recently initiated AD and CVD administrative reviews of Bada Industries, among other exporters. 9 As a result, consistent with Solar Cells, Commerce will reevaluate the eligibility of Bada Industries to participate in the certification process as part of these administrative reviews. Consequently, we are rescinding this CCR with respect to Bada Industries.

This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended and 19 CFR 351.213(d)(4).

On October 21, 2022, Commerce published in the Federal Register the final results of a scope ruling regarding imports of quartz surface products manufactured in China and further processed in Malaysia, finding that such imports are covered by the scope of the Orders. 1 Moreover, because exporters of quartz surface products from Malaysia export both subject and non-subject merchandise, Commerce established a scope certification process for all imports of quartz surface products from Malaysia. Commerce also determined that certain companies processing Chinese quartz slab in Malaysia, including Universal Quartz, were ineligible to participate in this scope certification process, but indicated that they could request reconsideration of their exclusion from the certification process in a future segment of the proceeding. 2

On June 26, 2023, based on a request filed by AM Stone, 3 Commerce initiated a CCR to determine whether Universal Quartz is eligible to certify that its quartz surface products are not produced from Chinese-origin quartz slab. 4 On July 26, 2023, AM Stone filed a timely request for administrative review for its exporter, Universal Quartz. 5 On September 11, 2023, Commerce initiated AD and CVD administrative reviews of Universal Quartz, among other Malaysian exporters. 6

Commerce has recently determined that a CCR is not the appropriate segment to reconsider ineligible parties' exclusion from a certification process, where that ineligibility was due to a party's failure to cooperate in a prior segment of a proceeding. 7 Commerce explained that an administrative review is the proper segment of a proceeding for a party deemed ineligible from participating in a certification process to request reconsideration of its eligibility to certify, absent evidence of a changed circumstance. 8 In light of Solar Cells, Commerce has reevaluated AM Stone's CCR request and determines that a party's newfound willingness to participate is not a changed circumstance sufficient to warrant such a review. Additionally, as noted above, Commerce recently initiated AD and CVD administrative reviews of Universal Quartz, among other exporters. 9 As a result, consistent with Solar Cells, Commerce will reevaluate the eligibility of Universal Quartz to participate in the certification process as part of these administrative reviews. Consequently, we are rescinding this CCR with respect to Universal Stone.

This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended and 19 CFR 351.213(d)(4).

Based upon timely requests for review, Commerce initiated administrative reviews of certain companies for the PORs and the AD and CVD orders listed in the table below, pursuant to 19 CFR 351.221(c)(1)(i). 1 All requests for these reviews have been timely withdrawn. 2

Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the parties that requested the review withdraw their review requests within 90 days of the date of publication of the notice of initiation for the requested review. All parties withdrew their requests for the reviews listed in the table below within the 90-day deadline. No other parties requested administrative reviews of these AD/CVD orders for the PORs noted in the table. Therefore, in accordance with 19 CFR 351.213(d)(1), Commerce is rescinding, in their entirety, the administrative reviews listed in the table below.

Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping and/or countervailing duties on all appropriate entries during the PORs noted above for each of the listed administrative reviews at rates equal to the cash deposit of estimated antidumping or countervailing duties, as applicable, required at the time of entry, or withdrawal of merchandise from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of this recission notice in the Federal Register for rescinded administrative reviews of AD/CVD orders on countries other than Canada and Mexico. For rescinded administrative reviews of AD/CVD orders on Canada or Mexico, Commerce intends to issue assessment instructions to CBP no earlier than 41 days after the date of publication of this recission notice in the Federal Register .

This notice serves as the only reminder to importers of merchandise subject to AD/CVD orders of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties and/or countervailing duties prior to liquidation of the relevant entries during the review period. Failure to comply with this requirement could result in the presumption that reimbursement of antidumping duties and/or countervailing duties occurred and the subsequent assessment of doubled antidumping duties and/or countervailing duties.

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

This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

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 (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 et seq. 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.

Murphy plans to conduct a vertical seismic profile (VSP) within Atwater Valley Block 138. The survey will occur at a water depth of 1,050 meters (m). Murphy plans to use a 12-element, 2,400 cubic inch (in 3 ) airgun array. The survey is planned to occur for 2 days during the period from November 1, 2023 to October 30, 2024. Please see Murphy's application for additional detail.

Consistent with the preamble to the final rule, the survey effort proposed by Murphy in its LOA request was used to develop LOA-specific take estimates based on the acoustic exposure modeling results described in the preamble (86 FR 5322, 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 VSP surveys were included in the modeled survey types, and use of existing proxies ( i.e., two-dimensional (2D), three-dimensional narrow azimuth (3D NAZ), 3D wide-azimuth (WAZ), Coil) is generally conservative for use in evaluation of VSP survey effort. Summary descriptions of these modeled survey geometries are available in the preamble to the proposed rule (83 FR 29212, June 22, 2018). Coil was selected as the best available proxy survey type because the spatial coverage of the planned survey is most similar to that associated with the coil survey pattern.

For the planned survey, the seismic source array will be deployed from a stationary drilling rig at or near the borehole, with the seismic receivers ( i.e., geophones) deployed in the borehole on wireline at specified depth intervals. The coil survey pattern in the model 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. Because Murphy's planned survey would not cover any additional area beyond that ensonified by the stationary source, the coil proxy is most representative of the effort planned by Murphy in terms of predicted Level B harassment.

In addition, all available acoustic exposure modeling results assume use of a 72 element, 8,000 in 3 array. Thus, estimated take numbers for this LOA are considered conservative due to the differences in both the airgun array (12 elements and 2,400 in 3 ), and in daily survey area planned by Murphy, as compared to those modeled for the rule.

The survey is planned to occur in Zone 5. The survey could take place in any season. Therefore, the take estimates for each species are based on the season that has the greater value for the species ( i.e., winter or summer).

Additionally, 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. This can result in unrealistic projections regarding the likelihood of encountering particularly rare species and/or species not expected to occur outside particular habitats. Thus, although the modeling conducted for the rule is a natural starting point for estimating take, our rule acknowledged that other information could be considered (see, e.g., 86 FR 5322, (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 their occurrence in the GOM. Accordingly, we have adjusted the calculated take estimates for those 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 100-400 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 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), although the core habitat area contained approximately 92 percent of the predicted abundance of Rice's whales. See discussion provided at, e.g., 83 FR 29228, 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. Murphy's planned activities will occur in water depths of approximately 1,050 m in the central GOM. Thus, NMFS does not expect there to be the reasonable potential for take of Rice's whale in association with this survey and, accordingly, does not authorize take of Rice's whale through the LOA.

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). As discussed in the final rule, the density models produced by Roberts et al. (2016) provide the best available scientific information regarding predicted density patterns of cetaceans in the U.S. GOM. The predictions 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 5322, 86 FR 5334 (January 19, 2021), and similarly informs our analysis here.

The rarity of encounter 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. 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. In addition, as noted above in relation to the general take estimation methodology, the assumed proxy source (72-element, 8,000-in 3 array) results in a significant overestimate of the actual potential for take to occur. NMFS' determination in reflection of the information 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 5322, 86 FR 5403, January 19, 2021). In this case, use of the acoustic exposure modeling produces an estimate of one killer whale exposure. Given the foregoing, it is unlikely that any killer whales would be encountered during this at most 2-day survey, and accordingly no take of killer whales is authorized through this LOA.

In addition, in this case, use of the exposure modeling produces results that are smaller than average GOM group sizes for one species (Maze-Foley and Mullin, 2006). NMFS' typical practice in such a situation is to increase exposure estimates to the assumed average group size for a species in order to ensure that, if the species is encountered, exposures will not exceed the authorized take number. However, other relevant considerations here lead to a determination that increasing the estimated exposures to the average group size would likely lead to an overestimate of actual potential take. In this circumstance, the very short survey duration (maximum of 2 days) and relatively small Level B harassment isopleths produced through use of the 12-element, 2,400-in 3 airgun array (compared with the modeled 72-element, 8,000 in 3 array) mean that it is unlikely that certain species would be encountered at all, much less that the encounter would result in exposure of a greater number of individuals than is estimated through use of the exposure modeling results. As a result, in this case NMFS has not increased the estimated exposure values to assumed average group sizes in authorizing take.

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 for the affected species or stocks of marine mammals. 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 (86 FR 5322, 86 FR 5438, January 19, 2021).

The take numbers for authorization, which are determined as described above, are used by NMFS in making the necessary small numbers determinations through comparison with the best available abundance estimates (see discussion at 86 FR 5322, 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 Murphy'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 Murphy authorizing the take of marine mammals incidental to its geophysical survey activity, as described above.

The USPTO has been actively engaged in discussions in the WIPO IGC, along with other Federal agencies, and has been responsible for leading the development of U.S. positions on WIPO IGC issues. The USPTO's announcement for formal Tribal Consultation on WIPO IGC issues aligns with the Federal Government's policies and relationship with Tribal Governments, including: Executive Order 13175;  1 President Biden's Memorandum on Tribal Consultation and Strengthening Nation-to-Nation Relationships;  2 President Biden's Memorandum on Uniform Standards for Tribal Consultation;  3 and the Tribal Consultation and Coordination Policy for the U.S. Department of Commerce (“Policy”). 4 The Policy requires that the Department and operating units engage in meaningful dialogue with Tribes regarding policies that have Tribal implications. This Tribal Consultation will consist of a webinar for federally recognized Tribal Nations and their proxies and a separate webinar for state recognized Tribes and other Tribal members, Native Hawaiians, and inter-tribal associations.

In addition to these webinars, the USPTO seeks written comments regarding the questions in this Notice. Written comments may include comments responsive to the questions in this Notice, comments responsive to issues discussed during the webinars, and any other related concerns.

WIPO is a specialized United Nations agency based in Geneva, Switzerland, that focuses on intellectual property (IP). Established in September 2000, the WIPO IGC serves as a forum where WIPO Member States  5 and accredited observers can discuss the intellectual property issues that arise in the context of access to GR and benefit-sharing, as well as the protection of TK and folklore/TCEs.

Since 2009, the WIPO IGC has been engaged in text-based negotiations on an international legal instrument for GR, TK, and TCEs. The U.S. understands the term “international legal instrument(s)” in the WIPO IGC mandate  6 to include declarations, recommendations, best practices, toolkits, and other forms of “soft law” and actively seeks practical recommendations in addressing the matters under discussion within the WIPO IGC. WIPO also has the authority to initiate norm-setting discussions and to propose international rules for adoption by a diplomatic conference or adoption by another WIPO body. “International legal instrument(s)” could also include a treaty or international agreement, although there is no requirement that prescribes this particular outcome. This request for comments seeks Tribal input on, among other topics, whether a treaty or forms of soft law are necessary to address issues regarding TK and TCEs.

The WIPO General Assembly, held in Geneva, Switzerland, on July 14-22, 2022, decided to convene a diplomatic conference to conclude an International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources, based on document WIPO/GRTKF/IC/43/5 (the Chair's text) and any other contributions by Member States. The diplomatic conference is to be held no later than 2024. 7 In September 2023, a special session of the IGC was held to close certain existing gaps in the text to the extent possible. The special session of the IGC was able to agree on only minor changes to the original Chair's text. Also in September 2023, a Preparatory Committee of the Diplomatic Conference convened and adopted rules of procedure for the diplomatic conference. 8 Tribes also may wish to review the USPTO Federal Register Notice on WIPO IGC Negotiations on Genetic Resources and associated Traditional Knowledge.

In July 2023, the WIPO General Assembly also decided to continue the WIPO IGC text-based negotiations on IP and the protection of TK and TCEs in the 2024-2025 biennium. Under its current mandate, the WIPO IGC meets three times per year, with each meeting typically lasting for one week, at the WIPO headquarters in Geneva, Switzerland. 9 Participants are WIPO Member States  10 and various accredited Observers. 11 The USPTO, in consultation with other Federal agencies, 12 has been leading the development of United States positions on issues before the WIPO IGC. This request for comments seeks Tribal input to inform the U.S. Government as it participates in the ongoing WIPO IGC meetings on TK/TCEs and in meetings related to the anticipated diplomatic conference in 2024 on GR and associated TK.

On June 28, 2022, the USPTO hosted a webinar providing background information on the WIPO IGC text-based negotiations to assist American Indians, Alaska Natives, and Native Hawaiians and their representatives in preparing for this Tribal Consultation. The webinar outlined the Federal Government's positions on issues involving IP and GR, TK, and TCEs, and opportunities for Tribal input with respect to the WIPO IGC and with the Federal Government. Links to this webinar and to WIPO IGC resources mentioned in the webinar can be found under “Resources” below.

Definitions. While “Genetic Resources” is defined in the Convention on Biological Diversity (CBD) as “genetic material of actual or potential value” and “genetic material” is defined as “any material of plant, animal, microbial or other origin containing functional units of heredity,”  13 the term GR has not been given an agreed upon definition in the WIPO IGC. Definitions of TK and TCEs are not the subject of international agreement and remain under discussion in the WIPO IGC. For purposes of providing supplementary information only, possible attributes of TK might include, but are not limited to, knowledge that is passed from generation to generation, in fixed or unfixed form, and linked with the national or social identity of Indigenous Peoples and local communities. TK might include know-how, skills, innovations, practices, teachings, and learning. Attributes of TCEs might include, but are not limited to, subject matter that is passed from generation to generation, usually in unfixed form but not necessarily, based on community-oriented creativity and generally not attributable to individual authors, and continuously used and developed within the community. TCEs might take the forms of literature, music, dance, games, mythology, rituals, and handicrafts. TCEs may also encompass religious and sacred texts, arts and customs, other expressions of faith, and ancient beliefs. Some forms of TCEs may be considered secret or sacred, while others may be routinely used commercially.

The issue of “public domain” is a fundamental concept in the WIPO IGC TCEs and TK discussions, defining the boundary between the interests of holders of exclusive rights and the ability of others, including the public, to access and use the subject matter to be protected. Each type of intellectual property—patent, trade secret, trademark, and copyright—recognizes a form of public domain. Various approaches to defining the public domain have been considered in the WIPO IGC, including in WIPO IGC 40: “Public domain refers for the purposes of this instrument to tangible and intangible materials that by their nature are not or may not be protected by established intellectual property rights or related forms of protection by the legislation in the country where the use of such material is carried out.” Indigenous Peoples within the WIPO IGC have expressed concern that defining the public domain is not susceptible to a uniform dividing line between protected and unprotected elements and must be more elastic. While WIPO IGC Member States generally have familiarity with the concept of public domain in intellectual property, they may not have experience in creating exclusive rights around TK or TCEs. Thus, taking TK or TCEs out of the public domain remains a principal issue of discussion within the WIPO IGC.

Request for information: While the USPTO welcomes any relevant comments on the topics described in this Request for Comments, the USPTO is particularly interested in comments responsive to the questions below. A non-exclusive list of WIPO IGC resources on the WIPO website— WIPO.int —and the USPTO website— USPTO.gov —follows the questions below and may provide useful background information in considering these questions. When responding to the questions, please identify yourself and either your Tribal Government or that you are a Native Hawaiian. If you are a Tribal or Native Hawaiian representative, please identify yourself, whom you represent, and your involvement to date, if any, in the WIPO IGC in person or virtually. Commenters need not respond to every question and may provide relevant information, even if not responsive to a particular question. For purposes of the Questions for Comment below, please note that “Tribe” is intended to refer to Tribal Nations, state recognized Tribes, other Tribes, and Native Hawaiians.

1. Please describe how Tribes protect genetic resources, traditional knowledge, and/or traditional cultural expressions.

2. Please describe your views on using the framework of intellectual property concepts and laws, such as patents, trademarks, copyrights, or trade secrets, to protect genetic resources, traditional knowledge, and/or traditional cultural expressions.

3. Please describe your views regarding using any other means to protect genetic resources, traditional knowledge, and/or traditional cultural expressions. Please also include your views regarding:

a. whether eligibility criteria should be used to determine which types of traditional knowledge, traditional cultural expressions, and/or genetic resources would be protected and, if so, what criteria should be used, and

b. what parameters, if any, should be placed on the scope or term of protection for traditional knowledge, traditional cultural expressions, and/or genetic resources.

4. Please describe your views regarding whether an international treaty should be pursued to protect genetic resources, traditional knowledge and/or traditional cultural expressions. If so, please describe your views on what essential elements or conditions would be necessary to include in an international treaty to ensure protection of genetic resources, traditional knowledge and/or traditional cultural expressions.

5. The WIPO IGC has not come to any conclusions about how to define “traditional knowledge.” Please describe how you would recommend defining “traditional knowledge” or, alternatively, please provide your views regarding the attributes of traditional knowledge.

6. The WIPO IGC has not come to any conclusions about how to define “traditional cultural expressions.” Please describe how you would recommend defining “traditional cultural expressions” or, alternatively, please provide your views regarding the attributes of traditional cultural expressions.

7. The WIPO IGC has not come to any conclusions about how to define “public domain.”

a. Please describe how you would recommend defining “public domain.”

b. Please share your views regarding how the concept of “public domain” relates to genetic resources, traditional knowledge, and/or traditional cultural expressions.

8. Please share your views regarding whether genetic resources, traditional knowledge, and/or traditional cultural expressions that have been widely diffused to the public are capable of protection, whether they should be protected, and, if so, how they should be protected, including any specific examples you may have. Please also share your views on whether there should be any exceptions to such protection.

9. Please share your views regarding whether genetic resources, traditional knowledge, and/or traditional cultural expressions that have been widely diffused to the public can continue to impact holders and, if so, please share any specific examples you may have.

10. Please describe your recommendations, if any, on how to identify traditional knowledge that has entered the public domain and, therefore, may be freely used by others.

11. Please describe your recommendations, if any, on how to identify traditional cultural expressions that have entered the public domain and, therefore, may be freely used by others.

12. Please describe your recommendations, if any, on how to identify genetic resources that have entered the public domain and, therefore may be freely used by others.

13. Please describe the circumstances, if any, in which a holder of a traditional cultural expression, genetic resource, and/or traditional knowledge might be interested in permitting third party use. Please include your views regarding:

a. what conditions or requirements a holder might place on third parties in exchange for granting permission for such use;

b. how a third party, interested in potential use, could determine whether something is a traditional cultural expression, genetic resource, or traditional knowledge, and who holds it; and

c. who, with respect to the holder of a traditional cultural expression, genetic resource, or traditional knowledge, would be the appropriate authority to control, or grant permission for, such third-party use.

14. Please describe real-world examples, if any, in which a Tribe has authorized others to commercially use its traditional cultural expressions, genetic resources, or traditional knowledge.

15. Please describe your views and any recommendations, including any real-world examples, regarding the use by third parties of genetic resources, traditional knowledge, and/or traditional cultural expressions for research.

16. Please describe your views and any recommendations, including any real-world examples, regarding the use of genetic resources, traditional knowledge, and/or traditional cultural expressions by archives, libraries, museums, or cultural institutions.

17. Please describe your views regarding how the unauthorized use of traditional knowledge, traditional cultural expressions, and/or genetic resources impacts Tribes, including any real-world examples.

18. Please provide your recommendations, including any real-world examples, regarding how best to address unauthorized uses of genetic resources, traditional knowledge, and/or traditional cultural expressions.

Below is a non-exclusive list of WIPO IGC resources on the World Intellectual Property Organization website, WIPO.int , that may be useful in answering the above questions. In addition, the USPTO hosted a webinar on June 28, 2022, providing information about the WIPO IGC text-based negotiations to assist American Indians, Alaska Natives, and Native Hawaiians in preparing for this Tribal Consultation. A recording of the webinar can be found here: https://www.uspto.gov/ip-policy/patent-policy/uspto-formal-tribal-consultation-preview. The USPTO.gov website also contains information about intellectual property, including “IP eLearning modules” on intellectual property protection and enforcement.

Report of Indigenous Expert Workshop on Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions, dated February 26, 2023, can be found here: https://www.wipo.int/meetings/en/doc_details.jsp?doc_id=601231.

Documents for the WIPO IGC meeting on June 5-9, 2023, including the latest traditional knowledge (TK) and traditional cultural expressions (TCEs) texts, can be found here: www.wipo.int/meetings/en/details.jsp?meeting_id=75419.

IGC 47 Summary can be found here: www.wipo.int/tk/en/news/igc/2023/news_0005.html.

The Non-paper Chair's Text of a Draft International Legal Instrument relating to Intellectual Property and Traditional Knowledge/Traditional Cultural Expressions:

The First Draft, dated February 21, 2023, can be found here: www.wipo.int/meetings/en/doc_details.jsp?doc_id=600911.

The Second Draft, dated May 26, 2023, can be found here: www.wipo.int/meetings/en/details.jsp?meeting_id=75419.

WIPO IGC Press Release: WIPO Member States Approve Diplomatic Conferences for Two Proposed Accords, dated July 21, 2022, can be found here: www.wipo.int/pressroom/en/articles/2022/article_0009.html.

Text associated with the announcement of the Diplomatic Conference on Intellectual Property and Genetic Resources: “Substantive articles” (Articles 1 through 9) from WIPO/GRTKF/IC/43/5 Chair's Text of a Draft International Legal Instrument relating to Intellectual Property, Genetic Resources and Traditional Knowledge associated with Genetic Resources: Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore: Forty-Third Session ( wipo.int ), as revised in the Special Session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, September 4-8, 2023, is included as the Annex to document WIPO/GRTKF/IC/SS/GE/23/4 on the Decisions adopted by the Committee on genetic resources and associated traditional knowledge, and can be found here: www.wipo.int/meetings/en/doc_details.jsp?doc_id=620066.

General Information on the Diplomatic Conference on Intellectual Property and Genetic Resources can be found here: www.wipo.int/diplomatic-conferences/en/genetic-resources/index.html.

Note that documents for all WIPO IGC meetings can be found here: www.wipo.int/meetings/en/topic.jsp?group_id=110&items=10.

WIPO Publication: Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions can be found here: www.wipo.int/edocs/pubdocs/en/wipo_pub_933_2020.pdf.

WIPO Publication: Protect and Promote Your Culture A Practical Guide to Intellectual Property for Indigenous Peoples and Local Communities can be found here: www.wipo.int/publications/en/details.jsp?id=4195.

WIPO Webinar Series: How to Protect and Promote Your Culture can be found here: www.wipo.int/tk/en/protect_and_promote.html. These webinars focus on intellectual property (IP) tools that can be used to protect and promote traditional knowledge (TK) and traditional cultural expressions (TCEs).

Documents describing key issues related to protecting traditional cultural expressions (TCE)/folklore and traditional knowledge (TK) can be found here: www.wipo.int/tk/en/igc/issues.html.

Presentations on Indigenous and Local Community Experiences can be found here: www.wipo.int/tk/en/igc/panels.html. See also Indigenous Peoples and Local Communities' Engagement: www.wipo.int/tk/en/engagement.html.

IGC Related Seminars, on intellectual property and genetic resources, on IP and traditional knowledge, and on IP and traditional cultural expressions can be found here: www.wipo.int/tk/en/igc/related_seminars.html.

Views from Speakers at the Seminar on Intellectual Property and Traditional Cultural Expressions, on June 8 and 9, 2017, can be found here: www.wipo.int/tk/en/news/tk/2017/news_0009.html.

P. Jaszi, “Protecting traditional cultural expressions—some questions for lawmakers,” WIPO Magazine, dated August 2017, can be found here: www.wipo.int/export/sites/www/wipo_magazine/en/pdf/2017/wipo_pub_121_2017_04.pdf.

Information on how to participate in the IGC, including virtually, can be found here: www.wipo.int/tk/en/igc/participation.html. Note that organizations requesting to be accredited as an observer at the IGC must complete an accreditation form and submit it to WIPO at least 60 days prior to the first session that it wishes to attend.

WIPO is a specialized United Nations agency based in Geneva, Switzerland, that focuses on intellectual property. Established in September 2000, the WIPO IGC serves as a forum where WIPO Member States  1 and accredited observers can discuss and address the intellectual property issues that arise in the context of access to GRs and benefit-sharing as well as the protection of TK and traditional cultural expressions (TCEs).

Since 2009, the WIPO IGC has been engaged in separate text-based negotiations on (1) an international legal instrument for the protection of genetic resources and associated traditional knowledge and (2) an international legal instrument for TK and TCEs. The United States understands the term “international legal instrument” in the WIPO IGC mandate  2 to include declarations, recommendations, best practices, toolkits, and other forms of “soft law” and actively seeks a practical outcome. WIPO also has the authority to initiate norm-setting discussions and to propose international rules for adoption by a diplomatic conference or by another WIPO body. Thus the phrase “international legal instrument(s)” could also include a treaty or international agreement, although there is no requirement that prescribes this particular outcome.

During the 42nd and 43rd sessions of the WIPO IGC held in Geneva in 2022, the IGC completed its designated sessions on Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources for the 2022/2023 biennium. These sessions made some progress and achieved a level of convergence around document WIPO/GRTKF/IC/43/4, the “Consolidated Document Relating to Intellectual Property and Genetic Resources” (the consolidated text). The consolidated text had been drafted and revised through negotiations between the WIPO Member States over an extended period of time, during multiple meetings of the IGC. This document reflected the many divisions and differences of views on key concepts and definitions among the participants to the sessions.

The previous Chair of the IGC, Mr. Ian Goss of Australia, drafted document IPO/GRTKF/IC/43/5, the “Chair's Text of a Draft International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources” (the Chair's text), on his own authority, based on his interpretation of discussions between Member States.

The current Chair, Ms. Lilyclaire Bellamy of Jamaica, made the Chair's text available to Member States during IGC 43 as a text for discussion but not for negotiation. Both the Chair's text and the consolidated text include provisions for a mandatory disclosure requirement of the country of origin/source of genetic resource(s) in a patent application where the claimed invention is based on genetic resources. While the term GR is defined in the Convention on Biological Diversity (CBD)  3 as “all genetic material of actual or potential value,” and that definition is used in the non-negotiated Chair's text with the footnote that it is ” . . . not intended to include “human genetic resources”.”, the term GR has not been given an agreed definition in the consolidated text.

At its Fifty-Fifth (30th Extraordinary) Session, held in Geneva on July 14-22, 2022, the WIPO General Assembly decided to convene a diplomatic conference to conclude an International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources, based on document WIPO/GRTKF/IC/43/5 (the Chair's text) and any other contributions by Member States. The diplomatic conference is to be held in 2024.

A Preparatory Committee of the Diplomatic Conference was convened in September 2023 to establish the procedures for the diplomatic conference and also consider “administrative provisions and final clauses” of the instrument drafted by the WIPO Secretariat (Articles 10 through 23). A special session of the IGC was also convened in September 2023, preceding the Preparatory Committee, to close any existing gaps in “substantive articles” (Articles 1 through 9) of the Chair's text to the extent possible. The Preparatory Committee and special session concluded with the adoption of rules of procedure for the diplomatic conference but with only minor changes to the “substantive articles” of the Chair's text and “administrative provisions and final clauses” from the WIPO Secretariat, reflecting the significant differences in interests between the parties involved, which will have to be addressed in further negotiations at next year's diplomatic conference.

Within the U.S. Government, the USPTO, based on authority delegated by the State Department, takes the lead in the WIPO IGC among other Federal agencies and coordinates and develops U.S. positions on issues before the WIPO IGC. The text-based negotiations before the WIPO IGC include the protection of genetic resources and associated traditional knowledge. These negotiations may result in changes to requirements for filing patent applications and for challenging patent rights.

The WIPO IGC will also continue its text-based negotiations on IP and the protection of TK and TCEs to the renewed mandate of the IGC for the biennium 2024/2025 as decided by the WIPO General Assembly at the 64th Series of Meetings of the Assemblies of the Member States of WIPO held July 6-14, 2023.

This request for comments seeks public and stakeholder input to inform U.S. Government participation in the ongoing WIPO IGC meetings and in anticipation of a diplomatic conference to conclude an International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources, expected to be held in 2024.

In addition, this request for comments seeks input to inform the U.S. Government as it participates in the ongoing WIPO IGC meetings on TK/TCEs.

The following is particularly useful in forming an understanding of the issues under discussion, and in answering the questions below.

Both the Chair's text and the consolidated text include provisions for mandatory disclosure requirements of the country of origin or source of GR and associated TK (ATK) in a patent application where the claimed invention is based on GR. Article 29.1 of the TRIPS Agreement provides that TRIPS member countries must require a patent applicant to disclose the invention in a manner that is sufficiently clear and complete for the invention to be carried out by a person skilled in the art. The term “disclosure requirements,” which is expected to be addressed by the diplomatic conference, generally refers to additional requirements that would include the source or origin of the GR and associated TK as part of the patent application. Details of the disclosure requirements have not been agreed to as part of the Chair's text nor the consolidated text.

These additional requirements to disclose the source or origin of the GR and associated TK as part of a patent application involve a number of issues that likely will be the subject of negotiations at the upcoming diplomatic conference, some of which are highlighted below.

“Genetic resources” are defined in the Convention on Biological Diversity (CBD) as “genetic material of actual or potential value” wherein “genetic material” is defined as “any material of plant, animal, microbial or other origin containing functional units of heredity.” Agreement has yet to be reached by the IGC on the definition of “genetic resources” in the Chair's text or the consolidated text.

The content of what is required to be disclosed in a patent application with respect to the mandatory disclosure requirements has been the topic of much debate in the IGC negotiations. Under different versions, patent applicants may be required to disclose:

• the country of origin of the GRs;

• the source of the GRs (for example, a gene bank that provided genetic material);

• the legal provenance of the GRs (the chain of custody pursuant to legal authority);

• the legal status of the GRs and/or ATK, such as compliance with any legal obligations relating to access and benefit-sharing or prior informed consent for accessing and using GRs; and

• a due diligence declaration that the applicant has complied with all applicable legal requirements concerning access to and use of GRs and/or ATK.

Agreement has yet to be reached on the definition of “content.”

The application of patent disclosure requirements in the Chair's text and the consolidated text is dependent on a “trigger” or link between the claimed invention and relevant GRs or ATK—that is, the relationship with the subject matter of disclosure.

The trigger may bring about or give rise to the disclosure requirements in response to various situations, such as:

• whether the GR/ATK is incidental or material to the development of the invention;

• whether the GR/ATK is necessary to assess, understand, replicate, or carry out the invention, or the GR/ATK is in effect only a vehicle for a separate innovative concept;

• whether the GR/ATK contributes to one earlier step in a chain of innovations that over time culminated in the invention, or is a direct input to the claimed inventive step;

• whether particular qualities of the GR/ATK are essential to the invention; and

• whether a GR/ATK is used in a particular embodiment or one example in a description of the invention, but is not indispensable to arrive at or replicate the invention as claimed.

There has yet to be agreement on a definition of the “trigger.”

Agreement has yet to be reached regarding the sanctions and/or remedies for non-compliance with the disclosure requirements. A wide range of remedies and sanctions for non-compliance is provided in the national laws of jurisdictions across the globe. These range from administrative sanctions to the denial, revocation or finding of unenforceability of a patent.

Depending on the final form of this provision in the instrument which may result from the diplomatic conference, and its potential implementation in various countries, the sanctions could include rendering a patent unenforceable for non-compliance with the disclosure requirement. This could be analogous to the operation of the USPTO Rule 56 (37 CFR 1.56) relating to inequitable conduct.

The USPTO welcomes any relevant comments on the topics described in this Request for Comments. However, the USPTO is particularly interested in comments responsive to the questions below. When responding to the questions, please identify yourself. Commenters need not respond to every question and may provide relevant information even if it is not responsive to a particular question.

1. Have you or any of your members, partners, co-workers, legal representatives or clients filed for patent protection in a jurisdiction that requires disclosure of the source of genetic resources and associated traditional knowledge in a patent application seeking protection for inventions based on genetic resources (hereafter “patent disclosure requirement”)? If yes, to the extent possible, please identify the jurisdiction(s) that required disclosure and describe the circumstances and your experiences associated with satisfying the patent disclosure requirement in that jurisdiction.

2. How would you characterize the level of difficulty in complying with the aforementioned patent disclosure requirement? Please describe any anticipated or unanticipated problems that resulted or may result from the disclosure itself or the associated requirement for the disclosure.

3. Please describe how your experiences with the patent disclosure requirement in the aforementioned jurisdiction or other jurisdictions across the globe affect your business. Where possible, please identify the jurisdiction as well as any relevant details of the patent disclosure requirement.

4. Please identify any type of patent disclosure requirement, in the context of Genetic Resources and Traditional Knowledge, you believe is necessary and any benefits or detriments stemming from a patent disclosure requirement.

5. Please identify any instances where you are aware of patent rights—yours, someone you represent or another party's—being impacted by the existence of a patent disclosure requirement, including but not limited to, any loss of rights, additional costs or other negative impacts.

6. Please share whether or not the existence of a patent disclosure requirement was (or is) a consideration in pursuing patent protection on an invention in a given jurisdiction. Please provide details in relation to relevant technologies where this may be a consideration as well as alternative actions you took or would take in lieu of pursuing patent protection in the jurisdiction.

7. Do you believe the patent system—through the use of a patent disclosure requirement in jurisdictions where such requirement exists—has been an effective regulator of access and benefit sharing for genetic resources? Please explain.

8. Do you believe that a patent disclosure requirement would enable interested groups to locate information on the use of a country's genetic resources? Please explain.

9. Where a claimed invention is based on genetic resources, please identify the appropriate range of subject matter of genetic resources that should be within the scope of a disclosure requirement.

10. Please comment on the effectiveness of the following options relating to disclosure of genetic resources and/or traditional knowledge associated with genetic resources in a patent application:

a) Disclosure when genetic resource information is material to patentability.

b) Voluntary disclosure of genetic resource information.

c) Disclosure requirement if the genetic resource information is known.

d) Mandatory disclosure requirement in all instances when an invention is based on genetic resources.

e) Disclosure of access and benefit sharing compliance.

f) Compliance/non-compliance with a disclosure requirement.

11. Please describe your views on what trigger mechanism should be used, if any, for a patent disclosure requirement pursuant to the Chair's text or the consolidated text.

12. Please describe your views on what a patent applicant should be compelled to disclose in a patent application, in the context of a patent disclosure requirement.

13. Please describe your views on whether a patent disclosure requirement should include provisions that impact the grant or the validity and enforceability of a patent in cases of non-compliance with a disclosure requirement.

14. Please describe your views on the current working text for an International Legal Instrument Relating to Intellectual Property, Genetic Resources and Traditional Knowledge Associated with Genetic Resources, which has been approved for consideration by the Diplomatic Conference. Please describe recommendations, if any, for additions, deletions or changes that you would recommend to Articles 1 through 9 (“substantive articles”) from the Chair's text and Articles 10 through 23 (“administrative provisions and final clauses”) drafted by the WIPO Secretariat, including whether any language from the “consolidated text,” a previous working text in these discussions, should be incorporated into or replace the current working text. These texts can be found at the links below:

a) Current working text “substantive articles” (Articles 1 through 9 from the WIPO IGC “Chair's text”), as revised in the Special Session of the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, held in Geneva on September 4-8, 2023, is included as the Annex to document WIPO/GRTKF/IC/SS/GE/23/4 on the Decisions adopted by the committee on genetic resources and associated traditional knowledge, which can be found on the WIPO website, https://www.wipo.int/meetings/en/doc_details.jsp?doc_id=620066.

b) Current working text “administrative provisions and final clauses” are contained in GRATK/PM/2, which can be found on the WIPO website, https://www.wipo.int/edocs/mdocs/diplconf/en/gratk_pm/gratk_pm_2.pdf, with a minor revision to delete “to advise it on the matters referred to in Articles [7] and [9], and on any other matter” in Article 11.2(e), as reflected in Summary Report of the Preparatory Committee, which can be found on the WIPO website, https://www.wipo.int/edocs/mdocs/diplconf/en/gratk_pm/gratk_pm_5.pdf.

c) The latest consolidated text, contained in the Annex to document WO/GRTKF/IC/43/4, which can be found on the WIPO website, https://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_43/wipo_grtkf_ic_43_4.pdf.

15. Please describe whether you believe any additional requirements, in particular a mandatory disclosure requirement relating to genetic resources and associated traditional knowledge, would negatively impact your patent filing strategy in overseas markets, your ability to protect innovation, or your business and investment strategy.

16. Please describe your views and experiences regarding the use of sui generis exclusive rights to protect traditional knowledge and traditional cultural expressions.

17. Please describe your views and experiences regarding the use of intellectual property rights to protect traditional knowledge and traditional cultural expressions.

18. Please describe your views and experiences regarding the use of means or methods other than sui generis exclusive rights or intellectual property rights to protect traditional knowledge and traditional cultural expressions. Among other means and methods, this could include soft law, such as declarations, recommendations, best practices, toolkits, and voluntary codes of conduct.

19. Please provide your recommendations regarding how best to address unauthorized uses of traditional knowledge or traditional cultural expressions.

Title: Part 41 Relating to Security Futures Products (OMB Control No. 3038-0059). This is a request for extension of a currently approved information collection.

Abstract: Section 4d(c) of the Commodity Exchange Act (“CEA”), 7 U.S.C. 6d(c), requires the CFTC to consult with the Securities and Exchange Commission (“SEC”) and issue such rules, regulations, or orders as are necessary to avoid duplicative or conflicting regulations applicable to firms that are fully registered with the SEC as brokers or dealers and the CFTC as futures commission merchants, involving provisions of the CEA that pertain to the treatment of customer funds. The CFTC, jointly with the SEC, issued regulations requiring such dually-registered firms to make choices as to how its customers' transactions in security futures products will be treated, either as securities transactions held in a securities account or as futures transactions held in a futures account. How an account is treated is important in the unlikely event of the insolvency of the firm. Only securities accounts receive insurance protection under provisions of the Securities Investor Protection Act. By contrast, only futures accounts are subject to the protections provided by the segregation requirements of the CEA.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. 2 The Federal Register notice with a 60-day comment period soliciting comments on this collection of information was published on August 9, 2023 (88 FR 53871). The Commission did not receive any relevant comments pursuant to the 60-Day Notice.

Burden Statement: The respondent burden for this collection is estimated to average .9 hours per response. This estimate includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; and transmit or otherwise disclose the information.

Affected Entities: Entities potentially affected by this action are businesses and other for-profit institutions.

Respondents/Affected Entities: 9.

Estimated average burden hours per respondent: 52 hours (rounded).

Estimated total annual burden on respondents: 467 hours.

Frequency of collection: On occasion.

There are no capital costs or operating and maintenance costs associated with this collection.

Pursuant to 5521 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017, as amended by § 531(k) of the FY 2018 NDAA, the Secretary of Defense established this panel to conduct independent periodic reviews and assessments of the operation of the Uniform Code of Military Justice (UCMJ). 10 U.S.C. 946. Art. 146 (effective Jan 1, 2019).

Purpose of the Meeting: Pursuant to UCMJ, Article 146, the Panel shall conduct independent periodic reviews and assessments of the operation of the UCMJ, including the review and assessment of the implementation of amendments made to the UCMJ and sentencing data. This will be the seventh meeting held by the MJRP. On Day 1, the Panel will hear from Service defense counsel. On Day 2, Panel members will hold two open sessions. The first session will be composed of Service trial counsel; and for the second open session, the Panel will receive a briefing from representatives from the Joint Service Committee on Military Justice on the recent military justice Executive Order.

Title; Associated Form; and OMB Number: Understanding Service Member Experiences with Family Planning; OMB Control Number: 0704-SMFP.

Needs and Uses: The recent Supreme Court decision in Dobbs v. Jackson Women's Health removed the Constitutional right to abortion. In its wake, several states banned or severely restricted access to abortion, and several more states are poised to do so. In addition to restricting access to abortion, the Dobbs decision raises questions about miscarriage and infertility care. Several of the states that have severely restricted access to or banned abortion are also home to large military instillations. This raises questions about service member access to abortion care, as well as a range of family planning options. There is little existing research on service members' experiences with family planning.

Building on prior experience executing the DoD Women's Reproductive Health Survey (WRHS) and other research on the health and health behaviors of service members ( e.g., the Health Related Behaviors Survey [HRBS]), RAND National Defense Research Institute (NDRI) will conduct a series of focus groups with men and women across DoD service branches (Air Force, Army, Marine Corps, Navy, and Space Force) to augment this survey data and better understand how service members experience family planning both within the Military Health System and via community providers. These focus groups will also gather information on service members' experiences with any new policies that the DoD unveils in response to the Dobbs decision.

This study will highlight areas related to family planning that may threaten the DoD's ability to field a ready and lethal force. It will also point to areas where DoD may need to augment or develop care, programs, services, or policies that provide needed reproductive health care and family planning services to the force in order to maintain and enhance health, readiness, retention, and lethality.

Affected Public: Individuals and households.

Annual Burden Hours: 4,800.

Number of Respondents: 4,800.

Responses per Respondent: 1.

Annual Responses: 4,800.

Average Burden per Response: 1 hour.

Frequency: Once.

The purpose of the data collection effort is to better understand service members experiences with family planning services provided by both DoD and community providers. Respondents include approximately 4,800 active duty service members from all service branches (below the rank of flag officer) at 24 CONUS installations. Data will be collected via 60-minute focus group. These focus groups will be in-person, conducted separately by gender ( i.e., men vs women) and rank ( i.e., E1-E4, E5-E6, E7-E9/W1-W5, O1-O3, O4-O5, O6). Each group will be led by one facilitator and include one notetaker. Consent will be obtained verbally at the beginning of each session and each participant will receive an information sheet containing the consent information. A recruitment flyer will be used to assist installation POCs with recruitment.

Dedicated notetakers will take verbatim notes during each focus group and discussion. These notes will be immediately cleaned to remove any identifying information ( e.g., names, titles). Notes will be entered into a COTS software package for analyzing qualitative data ( e.g., NVivo) and will be stored on RAND-issued laptops and RAND servers, both of which require two-factor authentication. A Data Safety Plan has been approved for the study.

A six-item post-focus group survey will also be given to participants. The purpose is to collect sociodemographic and military characteristics that will be used to understand the representativeness of participants compared to the larger active-duty force. The survey will be paper-and-pencil and is anonymous. It should take no more than two minutes to complete. Data from the survey will be hand-entered into Excel and analyzed using the same software.

Southern LNG is currently authorized to export domestically-produced LNG in a volume equivalent to 130 Bcf/yr of natural gas  1 to any countries with which the United States has not entered into a free trade agreement (FTA) requiring national treatment for trade in natural gas and with which trade is not prohibited by U.S. law or policy (non-FTA countries), through December 31, 2050, pursuant to NGA section 3(a). 2 Southern LNG is authorized to export this LNG from the existing Elba Island Terminal.

In this Application, filed in Docket No. 23-109-LNG, Southern LNG states that it filed an application in April 2023 with the Federal Energy Regulatory Commission (FERC) for authorization to modify its existing liquefaction facilities and install and operate a new condensate plant and liquid nitrogen vaporizers at the Elba Island Terminal. The modifications would increase the Terminal's authorized maximum LNG production capacity to 158.25 Bcf/yr of natural gas. The requested increase in authorized volume would align Southern LNG's total authorized volume with the additional volume that the Terminal could handle with FERC's approval. Thus, in light of the modifications, Southern LNG asks DOE to authorize the export of an additional 28.25 Bcf/yr of natural gas in the form of LNG from the Elba Island Terminal to non-FTA countries.

Southern LNG seeks the authorization on its own behalf and as agent for other entities who themselves hold title to the LNG. Southern LNG requests the authorization for a term to extend through December 31, 2050.

Additional details can be found in Southern LNG's Application, posted on the DOE website at: https://www.energy.gov/sites/default/files/2023-10/2023%2009%2025%20SLNG%20Non%20FTA%20Long%20Term%20EOP%20Export%20Authorization%20Request.pdf.

In reviewing Southern LNG's Application, DOE will consider any issues required by law or policy. DOE will consider domestic need for the natural gas, as well as any other issues determined to be appropriate, including whether the arrangement is consistent with DOE's policy of promoting competition in the marketplace by allowing commercial parties to freely negotiate their own trade arrangements. As part of this analysis, DOE will consider the study entitled, Macroeconomic Outcomes of Market Determined Levels of U.S. LNG Exports (2018 LNG Export Study), 3 and DOE's response to public comments received on that Study. 4

Additionally, DOE will consider the following environmental documents:

• Addendum to Environmental Review Documents Concerning Exports of Natural Gas From the United States, 79 FR 48132 (Aug. 15, 2014);  5

• Life Cycle Greenhouse Gas Perspective on Exporting Liquefied Natural Gas From the United States, 79 FR 32260 (June 4, 2014);  6 and

• Life Cycle Greenhouse Gas Perspective on Exporting Liquefied Natural Gas From the United States: 2019 Update, 84 FR 49278 (Sept. 19, 2019), and DOE's response to public comments received on that study. 7

Parties that may oppose this Application should address these issues and documents in their comments and/or protests, as well as other issues deemed relevant to the Application.

The National Environmental Policy Act (NEPA), 42 U.S.C. 4321 et seq., requires DOE to give appropriate consideration to the environmental effects of its proposed decisions. No final decision will be issued in this proceeding until DOE has met its NEPA responsibilities.

In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable. Interested parties will be provided 60 days from the date of publication of this Notice in which to submit comments, protests, motions to intervene, or notices of intervention.

Any person wishing to become a party to this proceeding evaluating Southern LNG's Application must file a motion to intervene or notice of intervention. The filing of comments or a protest with respect to the Application will not serve to make the commenter or protestant a party to the proceeding, although protests and comments received from persons who are not parties will be considered in determining the appropriate action to be taken on the Application. All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by the regulations in 10 CFR part 590, including the service requirements.

Filings may be submitted using one of the following methods:

(1) Submitting the filing electronically at fergas@hq.doe.gov;

(2) Mailing the filing to the Office of Regulation, Analysis, and Engagement at the address listed in the ADDRESSES section; or

(3) Hand delivering the filing to the Office of Regulation, Analysis, and Engagement at the address listed in the ADDRESSES section.

For administrative efficiency, DOE prefers filings to be filed electronically. All filings must include a reference to “Docket No. 23-109-LNG” or “Southern LNG Application” in the title line.

For electronic submissions: Please include all related documents and attachments ( e.g., exhibits) in the original email correspondence. Please do not include any active hyperlinks or password protection in any of the documents or attachments related to the filing. All electronic filings submitted to DOE must follow these guidelines to ensure that all documents are filed in a timely manner.

The Notice, and any filed protests, motions to intervene, notices of intervention, and comments will also be available electronically on the DOE website at www.energy.gov/fecm/regulation.

A decisional record on the Application will be developed through responses to this Notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Order may be issued based on the official record, including the Application and responses filed by parties pursuant to this Notice, in accordance with 10 CFR 590.316.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

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

EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.

1. EPA Registration Number: 71512-35. Docket ID number: EPA-HQ-OPP-2023-0246. Applicant: ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio 44077. Active ingredient: Tiafenacil. Product type: Herbicide. Proposed uses: Barley (crop subgroup 15-22B); canola, citrus (crop group 10-10); corn (sweet corn subgroup 15-22D); dry shelled beans except soybean (crop subgroup 6-22E); dry shelled peas (crop subgroup 6-22F); flax, grain sorghum (crop subgroup 15-22E); peanut, pome fruit (crop group 11-10); rapeseed (oilseed subgroup 20A); stone fruit (crop group 12-12); tree nuts (crop group 14-12); ornamentals, and industrial vegetative management/non-agricultural uses including: Private, public and military lands to airports, ditch banks, dry canals, fence rows, highway, railroad and utility rights-of-way, industrial sites, manufacturing sites, storage areas, and warehouse areas. Contact: RD.

2. EPA Registration Numbers: 71512-36 and 71512-37. Docket ID number: EPA-HQ-OPP-2023-0246. Applicant: ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio 44077. Active ingredient: Tiafenacil. Product type: Herbicide. Proposed uses: Barley (crop subgroup 15-22B); citrus fruit (crop group 10-10); corn (sweet corn subgroup 15-22D); pulses, dried shelled beans, except soybean (crop subgroup 6-22E); pulses, dried shelled peas (crop subgroup 6-22F); grain sorghum (crop subgroup 15-22E); peanut, pome fruit (crop group 11-10); rapeseed (oilseed subgroup 20A); stone fruit (crop group 12-12); tree nuts (crop group 14-12); industrial vegetative management/non-agricultural uses, ornamentals, and sucker control for grape. Contact: RD.

3. EPA Registration Number: 7969-275. Docket ID number: EPA-HQ-OPP-2023-0080. Applicant: BASF Corporation. P.O. Box 13528, Research Triangle Park, NC 27709-3528. Active ingredient: Saflufenacil. Product type: Herbicide. Proposed uses: Peppermint and spearmint; crop group use expansions to cereal grains (crop subgroups 15-22A through 15-22F and group 16-22); legume vegetables (crop subgroups 6-22A through 6-22F and group 7-22); citrus fruit (crop group 10-10); pome fruit (crop group 11-10); stone fruit (crop group 12-12); and tree nut (crop group 14-12). Contact: RD.

4. EPA Registration Number: 7969-276. Docket ID number: EPA-HQ-OPP-2023-0080. Applicant: BASF Corporation. P.O. Box 13528, Research Triangle Park, NC 27709-3528. Active ingredient: Saflufenacil. Product type: Herbicide. Proposed uses: Crop group use expansions to citrus fruit (crop group 10-10); pome fruit (crop group 11-10); stone fruit (crop group 12-12); and tree nut (crop group 14-12). Contact: RD.

5. EPA Registration Number: 7969-278. Docket ID number: EPA-HQ-OPP-2023-0080. Applicant: BASF Corporation. P.O. Box 13528, Research Triangle Park, NC 27709-3528. Active ingredient: Saflufenacil. Product type: Herbicide. Proposed use: Mint (peppermint and spearmint). Contact: RD.

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

This document provides the receipt and status reports for the period from 9/01/2023 to 9/30/2023. The Agency is providing notice of receipt of PMNs, SNUNs, and MCANs (including amended notices and test information); an exemption application under 40 CFR part 725 (Biotech exemption); TMEs, both pending and/or concluded; NOCs to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review.

EPA is also providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a weekly basis.

Under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., a chemical substance may be either an “existing” chemical substance or a “new” chemical substance. Any chemical substance that is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory) is classified as a “new chemical substance,” while a chemical substance that is listed on the TSCA Inventory is classified as an “existing chemical substance.” (See TSCA section 3(11).) For more information about the TSCA Inventory please go to: https://www.epa.gov/tsca-inventory.

Any person who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose, or to manufacture or process a chemical substance in a non-exempt manner for a use that EPA has determined is a significant new use, is required by TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as appropriate, before initiating the activity. EPA will review the notice, make a risk determination on the chemical substance or significant new use, and take appropriate action as described in TSCA section 5(a)(3).

TSCA section 5(h)(1) authorizes EPA to allow persons, upon application and under appropriate restrictions, to manufacture or process a new chemical substance, or a chemical substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a)(2), for “test marketing” purposes, upon a showing that the manufacture, processing, distribution in commerce, use, and disposal of the chemical will not present an unreasonable risk of injury to health or the environment. This is referred to as a test marketing exemption, or TME. For more information about the requirements applicable to a new chemical go to: https://www.epa.gov/chemicals-under-tsca.

Under TSCA sections 5 and 8 and EPA regulations, EPA is required to publish in the Federal Register certain information, including notice of receipt of a PMN/SNUN/MCAN (including amended notices and test information); an exemption application under 40 CFR part 725 (biotech exemption); an application for a TME, both pending and concluded; NOCs to manufacture a new chemical substance; and a periodic status report on the new chemical substances that are currently under EPA review or have recently concluded review.

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

No.

1. Submitting confidential business information (CBI). Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

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

In the past, EPA has published individual notices reflecting the status of TSCA section 5 filings received, pending or concluded. In 1995, the Agency modified its approach and streamlined the information published in the Federal Register after providing notice of such changes to the public and an opportunity to comment (see the Federal Register of May 12, 1995 (60 FR 25798) (FRL-4942-7)). Since the passage of the Lautenberg amendments to TSCA in 2016, public interest in information on the status of section 5 cases under EPA review and, in particular, the final determination of such cases, has increased. In an effort to be responsive to the regulated community, the users of this information, and the general public, to comply with the requirements of TSCA, to conserve EPA resources and to streamline the process and make it more timely, EPA is providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. This information is updated on a weekly basis.

For the PMN/SNUN/MCANs that have passed an initial screening by EPA during this period, Table I provides the following information (to the extent that such information is not subject to a CBI claim) on the notices screened by EPA during this period: The EPA case number assigned to the notice that indicates whether the submission is an initial submission, or an amendment, a notation of which version was received, the date the notice was received by EPA, the submitting manufacturer ( i.e., domestic producer or importer), the potential uses identified by the manufacturer in the notice, and the chemical substance identity.

As used in each of the tables in this unit, (S) indicates that the information in the table is the specific information provided by the submitter, and (G) indicates that this information in the table is generic information because the specific information provided by the submitter was claimed as CBI. Submissions which are initial submissions will not have a letter following the case number. Submissions which are amendments to previous submissions will have a case number followed by the letter “A” ( e.g. P-18-1234A). The version column designates submissions in sequence as “1”, “2”, “3”, etc. Note that in some cases, an initial submission is not numbered as version 1; this is because earlier version(s) were rejected as incomplete or invalid submissions. Note also that future versions of the following tables may adjust slightly as the Agency works to automate population of the data in the tables.

In Table II of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the NOCs that have passed an initial screening by EPA during this period: The EPA case number assigned to the NOC including whether the submission was an initial or amended submission, the date the NOC was received by EPA, the date of commencement provided by the submitter in the NOC, a notation of the type of amendment ( e.g., amendment to generic name, specific name, technical contact information, etc.) and chemical substance identity.

In Table III of this unit, EPA provides the following information (to the extent such information is not subject to a CBI claim) on the test information that has been received during this time period: The EPA case number assigned to the test information; the date the test information was received by EPA, the type of test information submitted, and chemical substance identity.

If you are interested in information that is not included in these tables, you may contact EPA's technical information contact or general information contact as described under FOR FURTHER INFORMATION CONTACT to access additional non-CBI information that may be available.

Authority: 15 U.S.C. 2601 et seq.

EPA received petitions from Greater-Birmingham Alliance to Stop Pollution, Mobile Environmental Justice Action Coalition, Clean Healthy Educated Safe Sustainable Africatown, and Mobile Alabama NAACP Unit #5044 Environmental and Climate Justice Committee dated January 4 and 9, 2023, requesting that EPA object to the issuance by ADEM of operating permit nos. 503-3013 to Plains Marketing Mobile Terminal at Magazine Point, 503-3035 to Alabama Bulk Terminal Blakeley Island Terminal, 503-2012 to Kimberly-Clark Mobile Operations, 503-6001 to Epic Alabama Maritime Assets LLC Alabama Shipyard LLC, and 503-8010 to UOP LLC Mobile Plant, all located in Mobile County, Alabama. On September 18, 2023, the EPA Administrator issued an order granting in part and denying in part the petitions. The order itself explains the bases for EPA's decision. Sections 307(b) and 505(b)(2) of the CAA provide that a petitioner may request review of those portions of an order that deny issues in a petition. Any petition for review shall be filed in the United States Court of Appeals for the appropriate circuit within 60 days from the date this notice is published in the Federal Register .

General Services Acquisition Regulations (GSAR) requires that contractors accessing information systems that support the operations and assets of GSA, another agency, contractor, or other source, to comply with GSA's IT security policies including GSA IT's security policies outlined in CIO 09-48, IT Security Procedural Guide: Security and Privacy IT Acquisition Requirements and CIO 12-2018, IT Policy Requirements Guide.

Respondents: 117.

Responses per Respondent: 2.

Total Annual Responses: 234.

Hours per Response: 5.

Total Burden Hours: 1,170.

Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the GSAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the Regulatory Secretariat Division (MVCB), at GSARegSec@gsa.gov. Please cite OMB Control No. 3090-0300, Implementation of Information Technology Security Requirements, in all correspondence.

Purpose: The Mine Safety and Health Research Advisory Committee is charged with providing advice to the Secretary, Department of Health and Human Services; the Director, Centers for Disease Control and Prevention; and the Director, National Institute for Occupational Safety and Health (NIOSH), on priorities in mine safety and health research, including grants and contracts for such research, 30 U.S.C. 812(b)(2), Section 102(b)(2).

Matters To Be Considered: The agenda will include discussions on NIOSH mining safety and health research organizational structure, capabilities, projects, and outcomes, as well as a verbal report from the Mace Development Workgroup. The meeting will also include an update from the NIOSH Associate Deputy Director, Mine Safety and Research. Agenda items are subject to change as priorities dictate.

Written Public Comment: The public may submit written comments or questions in advance of the meeting, to the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT above). Written comments received in advance of the meeting will be included in the official record of the meeting, and questions will be answered during the oral comment period open to public participation.

Oral Public Comment: The meeting will include time for members of the public to make an oral comment. The public comment session will be held on November 15, 2023, at 12:50 p.m., EST, or the conclusion of the planned presentations, whichever comes first. Members of the public will be allocated 5 to 10 minutes each for presentations or comments, as a function of the number of commenters.

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.

Purpose: The Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID) provides advice and guidance to the Secretary, Department of Health and Human Services; the Director, Centers for Disease Control and Prevention (CDC); and the Directors of the National Center for Emerging and Zoonotic Infectious Diseases, the National Center for HIV, Viral Hepatitis, STD, and TB Prevention, the National Center for Immunization and Respiratory Diseases, concerning strategies, goals, and priorities for the programs and research within the national centers and monitors the overall strategic direction and focus of CDC's infectious disease programs and centers.

Matters To Be Considered: The agenda will include updates and discussions on recent outbreaks and disease surveillance strategies, as well as a brief report from one of the Board's workgroups: the Food Safety Modernization Act Surveillance Working Group. 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.

The Family First Prevention Services Act (FFPSA) was signed into law as part of the Bipartisan Budget Act (H.R. 1892) on February 9, 2018. FFPSA amended the Social Security Act (the Act) to enable use of Federal funds available under parts B and E of title IV of the Social Security Act to provide enhanced support to children and families and prevent foster care placements through the provision of evidence-based “mental health and substance abuse prevention and treatment services, in-home parent skill-based programs, and kinship navigator services.” As described in the statutory language, these services and programs are intended “for children who are candidates for foster care or who are pregnant or parenting foster youth and the parents or kin caregivers of the children.” The Act requires an independent systematic review of evidence to designate programs and services as “promising,” “supported,” and “well-supported” practices.

In order to meet these requirements, ACF established the Title IV-E Prevention Services Clearinghouse (the Clearinghouse). The Clearinghouse carries out a systematic review process implemented by trained reviewers using consistent, transparent standards and procedures. The Handbook of Standards and Procedures, Version 1.0 ( https://preventionservices.acf.hhs.gov/review-process ) provides a detailed description of the standards used to identify and review programs and services for the Clearinghouse and the procedures followed by the Clearinghouse staff. The Handbook of Standards and Procedures, Version 1.0 was informed by public comments submitted in response to Federal Register Notice 83 FR 29122 ( https://www.federalregister.gov/documents/2018/06/22/2018-13420/decisions-related-to-the-development-of-a-clearinghouse-of-evidence-based-practices-in-accordance ), consultations with research and practice experts, and the review processes developed and used by other prominent evidence clearinghouses.

ACF solicited feedback on the Prevention Services Clearinghouse Handbook of Standards and Procedures, Version 1.0 (subsequently referred to as Handbook Version 1.0 ) through a Federal Register Notice 86 FR 37332 ( https://www.federalregister.gov/documents/2021/07/15/2021-15065/title-iv-e-prevention-services-clearinghouse-handbook-of-standards-and-procedures ) published on July 15, 2021. This comment period was open for 30 days and closed on August 16, 2021. One hundred four unique commenters submitted feedback, including 10 commenters from state and local child welfare agencies. Commenters included state and local government administrators, program and service developers, Federal staff, researchers and evaluators, foundation and non-profit organization staff, and other interested parties. ACF ensured the careful review and consideration of all of the comments in developing the draft Handbook of Standards and Procedures, Version 2.0 (subsequently referred to as Handbook Version 2.0 ). Comments were considered within the context of the statutory requirements of FFSPA, the necessity to conduct a systematic, objective, and transparent evidence review, and resource considerations. The public comments informed discussions with a large number of experts whose comments were also considered in developing the proposed revisions.

Summary of Comments. Comments highlighted how the standards and procedures specified in Handbook Version 1.0 might be revised to better reflect the goals and requirements of the Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. For example, commenters recommended prioritizing the review of programs and services that have been implemented and/or studied with diverse populations (Section 2.2). Commenters also recommended engaging diverse individuals and those with lived experience to inform the systematic review process and allowing greater flexibility for culturally adapted programs and services. Commenters recommended providing additional detail to clarify the existing standards and procedures. For example, comments requested technical clarification regarding the definition of an available written protocol, manual, or other documentation (Section 2.1.2), determination of the length of time after the end of treatment (Section 6.2.3), determination of whether program or service or study adaptations are substantial (Section 4.1.6), and calculations of effect size and statistical significance (Section 5.1.0). Commenters recommended broadening the definitions of the program or service areas (Section 2.1.2) to be more inclusive regarding the types of programs and services that may be eligible for review. Commenters recommended broadening the definition of eligible comparison conditions (Section 4.1.4) and making the design and execution standards (Chapter 5), particularly those related to baseline equivalence (Section 5.7), more flexible. Finally, commenters provided recommendations to ACF that did not pertain to the Clearinghouse. For example, comments recommended ACF provide further support and investment in building evidence, particularly of programs and services designed to serve communities of color and others disproportionally represented in the child welfare system as well as for kinship navigator programs.

Summary of Proposed Revisions. The draft Handbook Version 2.0 aims to be responsive to the diversity of comments received, to enhance the transparency of the systematic review process, and to support efforts to advance equity in accordance with the Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. For example, revised program or service area definitions (Section 2.1) are inclusive of a broader range of programs and services, new program or service prioritization criteria have been added to consider the child welfare relevance and diversity of populations served (Section 2.2) with similar criteria also added for study prioritization (Section 2.3), and the range of eligible comparison conditions for studies has been expanded to include studies that compare one intervention to another intervention (Section 4.1.7). Additional clarification and guidance are now provided on program or service and study adaptations, including new examples of how standards are applied to culturally adapted programs and services (Sections 2.3.2 and 4.1.9). Clarification is also provided that eligible outcomes and outcome measures may be defined differently across studies to reflect the different ages, backgrounds, cultures, locations, and contexts of the study participants, with examples provided (Section 4.1.8). Formulae used in effect size and statistical significance calculations are now provided directly in the Handbook (Chapter 6) and additional guidance and clarification is provided on design confounds, including clarification that studies with a single provider unit shared across the intervention and comparison conditions are not considered a confound (Section 5.9.3). A broader range of options is provided for establishing baseline equivalence and low attrition randomized group design contrasts are no longer assessed for baseline equivalence (Section 5.7). The Handbook now provides additional information on how the risk of harm assessment is conducted, with additional considerations for cases where the comparison group receives another intervention (Section 7.2.1). Further, additional clarification on how time since the end of treatment is calculated is provided (Section 7.2.3). The Handbook now clearly specifies how any member of the public can submit recommendations of programs or services for review or information about studies of those recommended programs and services to the Clearinghouse at any time (Chapters 1 and 3).

Additional Relevant Activities. The Clearinghouse also intends to conduct additional activities to be responsive to public comments and to support efforts to advance equity in accordance with the Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. First, the Clearinghouse is planning to display study participant characteristics on the program or service page of the Clearinghouse website. Display of participant characteristics is intended to promote transparency on the extent to which diverse populations are represented in research reviewed by the Clearinghouse. Second, the Clearinghouse plans to develop two new reports focused on equity. These two reports are intended to provide additional information about diverse populations included in studies of the programs and services that have been reviewed by the Clearinghouse and identify gaps in evidence. Third, enhanced activities are planned for future public calls for program and service recommendations in order to comprehensively identify culturally adapted and culturally grounded programs and services that may be eligible for review. The Clearinghouse plans to conduct targeted outreach to providers of culturally adapted and culturally grounded programs and services and community-based organizations serving diverse populations to improve engagement. The Clearinghouse also plans to clearly communicate in future public calls how the public, including community-based organizations and providers of culturally adapted and culturally grounded programs and services, can recommend programs and services and submit relevant studies of programs and services to the Clearinghouse. Further, the Clearinghouse plans to make future public call materials available in both English and Spanish. Fourth, the Clearinghouse intends to revise its author Reporting Guide to clarify recommended reporting related to culturally adapted and culturally grounded programs and services and the characteristics of their participants. Fifth, the Clearinghouse intends to revise existing resources for Clearinghouse users, such as its Frequently Asked Questions (FAQ) website section and fact sheet resources, with person-centered design principles to ensure information about the Clearinghouse and its standards and procedures are accessible. Sixth, the Clearinghouse plans to publicly post all programs and services that have been recommended for review and will continue to explore additional ways to improve transparency such as through data sharing.

A comprehensive list of specific revisions and clarifications to the Clearinghouse's Standards and Procedures is provided in the following section. Subsequent chapter and section numbers all refer to the chapter and section numbering for the draft Handbook Version 2.0 unless the text explicitly indicates a reference to Handbook Version 1.0 chapter and section numbering.

The revised introduction includes a description of the Clearinghouse website and resources available on the website. This includes reference to the FAQ section that includes information on how members of the public can submit a program or service recommendation and how to provide information about studies to the Clearinghouse.

Revisions clarify that all program and service recommendations are retained for consideration, including those submitted during public calls and ad hoc recommendations submitted to the Prevention Services Clearinghouse inbox. Revisions also clarify that any member of the public may submit a program or service recommendation at any time to the Clearinghouse via email and that suggested information to include as part of a program or service recommendation can be found on the FAQ section of the Clearinghouse website. Additionally, this section now indicates that all programs and services identified as potential candidates for review will be posted on the Clearinghouse website.

Based on FRN feedback and consultation with experts in the fields of mental health, substance use, parenting and parent skill-based programs and services, kinship navigator programs, and child welfare, the draft Handbook Version 2.0 revised and clarified the in-home parent-skill based and substance use prevention and treatment program or service area definitions, as noted below.

• In-home parent skill-based programs and services. The revised definition is more flexible and now indicates that eligible programs and services involve direct intervention with a parent or caregiver and target parenting skills or other skills that can be applied to where the child resides, including in the home. The revised definition also clarifies that delivery of programs and services can occur in the home or other settings and defines necessary content for a program or services to be considered “skill-based.”

Revised examples of eligible and ineligible in-home skill-based programs and services are provided in Exhibit 2.3.

• Substance use prevention and treatment programs and services. The revised definition clarifies that programs or services:

• targeting recovery from substance use (as well as those targeting prevention, treatment, remediation, elimination and/or reduction of substance use or misuse) are eligible; and

• without client-oriented substance use prevention or treatment components, such as mass communications/media campaigns or interventions that solely target broader community-level or policy systems, remain not eligible.

Revised examples of eligible and not eligible programs and services are now provided in Exhibit 2.2. Specifically, one new example clarifies that programs or services targeting parents or caregivers aiming to prevent substance use among children and youth are eligible.

Minor wording changes were made to the kinship navigator program or service area definition for clarification purposes. Experts did not suggest any changes to eligible outcomes for kinship navigator programs and services.

No changes were made to the mental health prevention and treatment programs and services definition. New examples of eligible and ineligible programs and services are provided in Exhibit 2.1.

To be eligible for review by the Prevention Services Clearinghouse, programs and services must be clearly defined and replicable. To meet this criterion, programs and services must have available written or recorded protocols, manuals, or other documentation that describes how to implement or administer the practice (referred to subsequently in this notice as a “manual” for brevity). Revisions to this section clarify that materials to satisfy this requirement may be presented in a web-based format and that “manual” can include recorded videos or online learning systems if these materials describe how to implement or administer the practice. The Clearinghouse notes that, consistent with Handbook Version 1.0, there are no language requirements for manual eligibility.

As of July 2023, the Prevention Services Clearinghouse has reviewed 148 programs and services. Yet there remains a high volume of potentially eligible programs and services identified for review. As a result, the Prevention Services Clearinghouse must continue to prioritize programs and services for review. The draft Handbook Version 2.0 continues to highlight the prioritization of programs and services with available evidence of eligibility and programs and services in active use (Section 2.2). New to this section is further clarification about additional prioritization considerations. These additional prioritization criteria were informed by recommendations from public comments and consultation with experts. Listed below are the additional prioritization criteria included in the draft Handbook Version 2.0.

• Number and source of program or service recommendations received;

• Child welfare relevance;

• Population(s) served;

• Previous evaluations and studies; and

• Implementation supports.

The Clearinghouse continues to prioritize programs and services in a way that ensures representation across the four program and service areas. Additional clarification is provided in draft Handbook Version 2.0 noting that the Clearinghouse assesses prioritization criteria by examining publicly available information, other clearinghouses' websites, and materials submitted with program or service recommendations.

Given the large volume of programs and services identified, resource considerations mean that not all programs and services can be selected for review at once. To help clarify the distinction between the prioritization and reviewing process, the draft Handbook Version 2.0 adds a new section on selection of a program or service for review (Section 2.3.1). Based on the prioritization process, specific programs and services are selected for review at a given time, as indicated by publication on the working list of programs and services planned for review available on the Prevention Services Clearinghouse website. The final eligibility of a program or service for review by the Clearinghouse is determined after a program or service is selected for the working list.

Multiple public comments requested clarification regarding the program or service adaptation standards specified in Handbook Version 1.0 (found in Section 4.1.6 of this version) and recommended increased inclusivity, particularly with respect to cultural adaptations. The Prevention Services Clearinghouse sought input from a range of experts specifically focusing on program or service adaptations, including those with expertise in cultural adaptations designed to serve historically underserved communities. Underserved communities, as articulated in the Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, include Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.

To meet the eligibility criteria of being clearly defined and replicable, a program or service must have publicly available written or recorded protocols, manuals, or the documentation (hereafter referred to as “manuals”) that describe how to implement the practice (Section 2.1.2). A new section (2.3.2) clarifies the procedures used to identify and review relevant manuals for a program or service. This includes procedures for identifying a primary manual for review and addressing cases with multiple potential manuals.

Many programs and services have multiple manuals, including manual editions ( e.g., editions of a manual as a program or service evolves over time or expands) and manual variants ( e.g., adaptations of a program or service or a manual to address new issues, different populations, or alternative approaches to delivering the program or service). This section clarifies the standard process by which the Prevention Services Clearinghouse assesses whether alternative manual editions or variants have any substantial adaptations, compared to the primary manual identified. This process consists of the following steps, followed as needed based on the nature of the program or service:

• Step 1: Determining whether the adaptation is explicitly prohibited in the primary program or service manual under review or is the result of adding another separate program or service to the existing program or service ( i.e., “bundling”);

• Step 2: Determining whether the adaptation is explicitly allowed by the primary program or service manual under review;

• Step 3: Determining whether the adaptation substantially changes a program element in the primary program or service manual under review;

• Step 4: Gathering additional information and consulting with senior content experts on the Clearinghouse.

A revised table (Exhibit 2.4) classifies program elements and gives examples of acceptable and substantial adaptations—including expanded examples of adaptations that may be made in the process of culturally adapting a program or service. (These criteria and procedures are aligned with those used to assess any program or service adaptations identified in studies during the study eligibility process, described in Section 4.1.9). Manuals that are substantially adapted from a primary manual may be considered as a separate program or service when reviewing studies. Studies with these substantial adaptations would be ineligible in a review based on the primary manual identified for a particular program or service. Alternatively, manuals without substantial adaptations may be considered the same program or service when reviewing studies. Studies without substantial adaptations would be included in a review based on the primary manual.

To help ensure identification of studies conducted with American Indian and Alaska Native populations, the draft Handbook Version 2.0 adds Healthy Native Youth to its list of clearinghouses used to identify relevant research. The list of bibliographic databases has been trimmed for efficiency and resource considerations. Some databases in Handbook Version 1.0 were largely providing duplicative results. This section clarifies that any publicly available research from program or service websites is incorporated into the search. Clarification is also provided on procedures for incorporation of research that is submitted to the Prevention Services Clearinghouse inbox ad hoc or during public calls.

In alignment with other Federal evidence clearinghouses, the Prevention Services Clearinghouse intends to focus on degree of sample overlap in applying its definition of a study as “one research investigation of a defined subject sample, and the interventions, measures, and statistical analyses applied to that sample.” Additional study definition criteria (based on the What Works Clearinghouse v4.0 study definition) in Handbook Version 1.0 have been dropped in the draft Handbook Version 2.0.

The draft Handbook Version 2.0 clarifies the definition of “publicly available” and “published” for the source of publication standard (Section 4.1.2), in response to public comments. Dissertations, theses, and conference papers remain ineligible. Given the priority of reviewing a large number of programs and services, the Prevention Services Clearinghouse intends to continue to exclude such sources in the interests of efficiency.

Some public comments indicated confusion about whether studies conducted outside of the United States or those conducted in non-English-speaking countries are eligible. The draft Handbook Version 2.0 clarifies that the standard from Handbook Version 1.0 that studies must be available in English (Section 4.1.3) is inclusive of studies originally published in another language that have published English language translations available. The draft Handbook Version 2.0 explicitly clarifies that studies conducted in any country are eligible (Section 4.1.4), as they were under Handbook Version 1.0.

The draft Handbook Version 2.0 provides clarification on definitions for randomized group designs and quasi-experimental group designs with respect to eligible study designs (Section 4.1.5). It clarifies that single-group pretest-posttest designs and interrupted time series designs without comparison groups are not eligible. It also clarifies that group assignment must be exclusive for an outcome measured at a given point in time—that is, participants cannot be counted in both the intervention and comparison condition. The criterion for eligible intervention conditions—that the intervention group is offered an eligible program or service that is essentially the same for all participants in the group—remains the same as in Handbook Version 1.0, with minor clarifications, but is presented as a distinct subsection in the draft Handbook Version 2.0 (Section 4.1.6) for clarity.

Many public comments requested expansion of eligible study comparison conditions beyond no or minimal treatment and treatment as usual to include more active comparison conditions. Many experts also recommended that the Prevention Services Clearinghouse consider including active comparison conditions. One consideration voiced by multiple experts consulted is that active comparison conditions are increasingly recommended, particularly if there are other available interventions considered to be efficacious. Revision to this standard was considered in the context of the FFSPA legislative criterion that a program or service must be demonstrated as being superior to an appropriate comparison practice.

The draft Handbook Version 2.0 allows for five types of eligible comparison conditions:

• No intervention or wait list —offered no services or services at a later date (clarifying that outcomes measured after a wait list group is offered the intervention are not eligible).

• Minimal intervention —including informational materials or psychoeducation, referrals to available services, or similar nominal services.

• Placebo or attention control —conditions designed to account for nonactive effects of treatment, such as participants' expectations, contact time with an interventionist, or the relationship between interventionist and participants; includes psychological or pharmacological placebos, attention placebos, and nonspecific therapy in which participants receive the same or similar amount of attention or contact as the participants in the intervention condition.

• Treatment as usual —The draft Handbook Version 2.0 clarifies that both “usual or typical services” ( i.e., individuals do not receive anything they would not have been able to receive outside the context of the study) or “services consistent with usual or typical services” ( i.e., services as part of the study that are not offered in the community but are clearly described as consistent with the usual or typical services that would be received by individuals or families similar to those in the study) are considered eligible under treatment as usual. Therapeutic or pharmacological interventions that meet the definition of treatment as usual are eligible.

• Head-to-head comparisons —assigned to another intervention that is not a variant of the program or service under review (may also be referred to as alternative interventions, active interventions, or comparator interventions); excluded are comparisons to pharmacological interventions that do not meet the definition of treatment as usual above.

The draft Handbook Version 2.0 indicates three types of comparison conditions that are explicitly not eligible for review and provides a rationale for each:

• Intervention variants —assigned to an intervention that is a variation of the intervention under review. Examples include dismantling studies ( e.g., full version of intervention compared to one lacking one or more components); bundled intervention studies ( e.g., full version of intervention compared to a version with a second intervention added); studies comparing different delivery modes, providers, dosage, or fidelity levels for the same intervention; sequencing studies ( e.g., both conditions receive the same interventions, but in a different order).

• Population-level data or benchmarks —constructed from population norms or statistics derived from other studies, surveys, censuses, or similar sources.

• Comprised only of intervention refusers or dropouts —composed entirely of individuals who were offered the intervention condition but refused the offer or dropped out of the intervention after being offered the intervention.

Definitions of outcome domain, outcome, and outcome measurement have been provided for clarity. Clarifications have been included regarding eligible outcomes within the child safety and child permanency outcome domains and family functioning outcomes within the adult well-being outcome domain. The clarifications to the child safety and child permanency outcomes were previously described in the FAQ section of the Prevention Services Clearinghouse website. Additionally, eligible educational achievement and attainment outcomes in the child well-being outcome domain have been expanded to include school attendance and absenteeism as eligible outcomes. These outcomes, though not direct measures of educational achievement and attainment, are viewed as closely related and relevant outcomes. Clarification is provided that outcomes that are composites of one or more eligible outcomes within the eligible outcome domains are eligible; those that are composites of eligible and ineligible outcomes are not eligible. Clarification is also provided that eligible outcomes and outcome measures may be defined differently across studies to reflect the different ages, backgrounds, cultures, locations, and contexts of the study participants, with examples provided.

The Prevention Services Clearinghouse currently does not have measurement standards for assessing the validity or reliability of biomarker measures ( i.e., a physiological measure used as an indicator of a physical, psychological or emotional state), such as the use of cortisol as a measure of psychological stress. Expert consultations on biomarkers did not indicate a clear set of standards that could be broadly applied for review of such measures. As a result, the draft Handbook Version 2.0 indicates that biomarker measures are not currently eligible for review as child well-being or adult well-being outcomes.

Consistent with Handbook Version 1.0, the draft Handbook Version 2.0 indicates that, to be eligible for review, studies of a program or service must all represent similar implementations of the program or service selected for review. Revisions in the draft Handbook Version 2.0 clarify that the process of assessing program or service adaptations for study eligibility is based on having identified a particular manual (or set of manuals) of the program or service under review (see Sections 2.3.1, 2.3.2).

The standard process used to identify whether program or service adaptations are present in the studies being screened for eligibility is clarified. The procedures and criteria for assessing whether adaptations identified in studies are acceptable or substantial mirror those specified in Section 2.3.2 for adaptations found in manual editions or variants. The end result of these procedures is the determination of study eligibility for the particular program or service under review (in Section 2.3.2, the end determination is whether two manuals are substantively similar or represent different programs or services). Studies with any substantial adaptations are ineligible for review as a study of the program or service under review (such studies may be eligible for review as a study of different program or service and its associated manual). Studies with only minor adaptations may potentially be eligible if all other study eligibility criteria are met.

The Prevention Services Clearinghouse notes that study prioritization criteria are distinct from study eligibility criteria. When a program or service has more than 15 studies eligible for review, study prioritization criteria are applied to order the review of eligible studies. The study prioritization process ensures efficiencies in the reviewing process to review a large number of programs and services.

The Prevention Services Clearinghouse notes that only 12 of the 148 programs and services reviewed as of July 2023 had more than 15 eligible studies identified, requiring the use of study prioritization criteria in these reviews to prioritize the first 15 eligible studies for review using the design and execution standards. Of these 12 programs and services, nine had 16 to 25 eligible studies, with a few having a much larger number of eligible studies ( e.g., 75 or 90). All other programs and services reviewed had 15 or fewer eligible studies, with all eligible studies reviewed using the design and execution standards. Therefore, as in Handbook Version 1.0, the study prioritization criteria continue to apply only when there are 15 or more eligible studies of a program or service in the draft Handbook Version 2.0.

Three modifications have been made to the process of assigning prioritization points for identifying the order in which studies are reviewed in the draft Handbook Version 2.0. First, given that programs or services must demonstrate sustained favorable effects 6 or 12 months beyond the end of treatment (Section 7.2.3) to receive a rating of supported or well-supported, the Prevention Services Clearinghouse intends to increase the prioritization points given to studies that include outcomes measured 6 or 12 months beyond the end of treatment to ensure that these studies are reviewed earlier when present, increasing the prioritization points for such studies to 3 and 6 points, respectively (compared to 1 and 2 points, respectively, in Handbook Version 1.0 ). Second, some public commenters and experts consulted noted the importance of statistical power for being able to detect intervention effects. The draft Handbook Version 2.0 adds one prioritization score point for studies that report an analysis of statistical power. Third, many public comments recommended that points be awarded to studies based on populations served. The draft Handbook Version 2.0 intends to add one prioritization score point for the child welfare relevance of populations served and two prioritization points for studies with samples from underserved communities. Prioritization points for studies with outcomes in multiple outcome domains have been decreased from a maximum of three to a maximum of one. The draft Handbook Version 2.0 provides procedural details clarifying how ties in prioritization scores are resolved in cases where more than 15 eligible studies are identified.

The draft Handbook Version 2.0 includes efficiency enhancements based on the study prioritization process for programs and services where more than 15 eligible studies are identified. If, after review of the first 15 eligible studies prioritized for review, a program or service has not achieved a rating of well-supported, additional studies are reviewed using the design and execution standards in their prioritized order until either no eligible studies remain that could result in further improvement to the program or service rating or all eligible studies have been reviewed. Determination of potential for program or service ratings to improve upon review of additional eligible studies is based on (1) the program rating from studies already reviewed using the design and execution standards and (2) the duration of effects examined in the remaining studies (as assessed according to study review prioritization criteria). Detailed examples of the application of this policy are described in Section 4.2. The draft Handbook Version 2.0 retains the policy from Handbook Version 1.0 of reviewing all studies against design and execution standards when 15 or fewer eligible studies are identified. All eligible studies are reviewed for risk of harm.

The draft Handbook Version 2.0 indicates that contrasts from all eligible comparison conditions (Section 5.1) will be rated, whereas under Handbook Version 1.0, only contrasts from the least-intensive eligible comparison condition for a particular contrast were rated if multiple comparison conditions were eligible for review ( Handbook Version 1.0, Section 4.1.4). Given the priority of reviewing a large number of programs and services, the draft Handbook Version 2.0 retains the policy from Handbook Version 1.0 of only reviewing full-sample analyses and not reviewing subgroup or sensitivity analyses due to resource considerations. For any studies that receive a moderate or high design and execution rating and report subgroup analyses, the Clearinghouse intends to indicate whether subgroup analyses were conducted for informational purposes only. New and revised examples are provided to clarify integrity of randomization standards for individual and cluster-assignment designs.

Based on expert feedback, and in alignment with other Federal clearinghouses (in particular, the What Works Clearinghouse and Home Visiting Evidence of Effectiveness [HomVEE]), the draft Handbook Version 2.0 no longer requires baseline equivalence to be established for a contrast from a low attrition randomized group design to receive a “High” support of causal evidence rating.

Public comments expressed a desire for greater flexibility regarding options for demonstrating baseline equivalence and reconsideration of participant sociodemographic characteristics that could be used to establish baseline equivalence when a pretest alternative is not available. Informed by expert consultations, the draft Handbook Version 2.0 maintains a general preference for using the same (or nearly the same) measure as the outcome ( i.e., a “direct pretest”) for baseline equivalence but now allows any eligible outcome measure demonstrated to be correlated with the outcome at a threshold of 0.60 or higher to be used to establish baseline equivalence (here referred to as a “correlated pretest measure”). Also informed by expert feedback, when a correlated pretest measure or pretest alternative is not available, the draft Handbook Version 2.0 provides greater flexibility in the form of two options for establishing equivalence on sociodemographic characteristics, allowing an expanded set of individual characteristics and the use of a set of neighborhood characteristics if only one individual characteristic is available. Option 1 requires demonstration of baseline equivalence on at least two of the following individual characteristics: race or ethnicity, socioeconomic status, household composition, or age. If only one of the four individual characteristics from Option 1 is available, baseline equivalence can still be established under Option 2 if equivalence is demonstrated on a measure of each of the following neighborhood characteristics: race or ethnicity, socioeconomic status, and household composition. When sociodemographics are used to establish baseline equivalence, a new requirement indicates that study authors must clearly describe all criteria used to create the intervention and comparison groups and affirmatively indicate that the same or similar criteria were used to create each group.

Binary measures have different statistical properties than continuous measures that can potentially reduce their reliability as indicators of baseline equivalence—particularly when events are rare or in smaller samples. To address this, the draft Handbook Version 2.0 indicates a preference for continuous correlated pretests over direct pretests when establishing baseline equivalence for a binary outcome. It also permits use of continuous pretest alternative measures when outcomes are binary, even if it was feasible to measure a direct pretest. Specifically, continuous measures that meet the correlated pretest measure or pretest alternative criteria are preferred over a direct pretest of the binary measure, when available.

The statistical model standards (Section 5.9.1) have been revised in the draft Handbook Version 2.0 to clarify procedures used when statistical models do not meet standards and alternative statistical models are not available or do not meet standards. In such cases, the Prevention Services Clearinghouse will seek to review the contrast based on unadjusted means and standard deviations and the statistical significance test procedures specified in Chapter 6.

The measurement reliability standard for inter-rater reliability in Handbook Version 1.0 was revised in the draft Handbook Version 2.0 (Section 5.9.2), with specific thresholds for inter-rater reliability (correlation), inter-rater agreement on the basis of percentage agreement (0.80 or higher), and inter-rater agreement based on kappa (0.60 or higher). These revised standards are aligned with current What Works Clearinghouse standards.

Some public comments expressed concern that confound standards prevent inclusion of studies conducted in rural or underserved areas where only a single service provider is available may not be able to meet standards. The draft Handbook Version 2.0 clarifies that studies with a single person or administrative unit are not automatically confounded, with detailed clarifying examples added to this section. Specifically, if a single provider (or a single administrative unit) provides treatment or services to at least some participants in both the intervention and comparison condition, a design confound is not considered to be present. Expert feedback indicated that the confound standards in Handbook Version 1.0 were appropriate causal evidence standards, informing the retention of these confound standards in the draft Handbook Version 2.0.

Public comments requested additional information about the formulae used for computing effect sizes and procedures used for determining statistical significance. The draft Handbook Version 2.0 provides all standard formulae used in computing effect sizes reported and for computing statistical significance. For models that meet statistical model standards in the design and execution requirements (Section 5.9), the draft Handbook Version 2.0 indicates that author-reported statistical significance is preferred in covariate-adjusted models and certain models for which the Prevention Services Clearinghouse does not currently have standards for computing statistical significance ( e.g., time-to-event models). When such models are not available or do not meet statistical model standards, the formulae provided are used to conduct a post-hoc statistical significance test based on the natural metric of the outcome reported ( e.g., continuous, binary, count, or time-to-event).

Clarification is provided on information needed and procedures used to compute effect sizes and statistical significance for repeated measures models ( e.g., growth curve models). In alignment with other Federal clearinghouses (in particular, What Works Clearinghouse, HomVEE), point-in-time estimates for each measurement time period are required. If such information is not reported, unadjusted means and standard deviations for each point in time are used (or requested if not reported), with appropriate post-hoc significance tests performed based on the natural metric of the outcome.

No changes were made to the criteria for promising, supported, or well-supported program or service ratings in the draft Handbook Version 2.0 (Section 7.1). This section clarifies that intention of the Prevention Services Clearinghouse is for program or service ratings from reviews conducted under Handbook Version 1.0 to be retained until such time that a program or service is re-reviewed under Handbook Version 2.0 (see Section 8.5.1 below regarding re-review procedures).

A new standard specified in the risk of harm section (Section 7.2.1) of the draft Handbook Version 2.0 is that contrasts in head-to-head comparison conditions or placebo or attention control comparison conditions where the comparison condition has any evidence for risk of harm cannot contribute to a promising, supported, or well-supported rating. If risk of harm is present in these kinds of comparison conditions, impact estimates are not clearly interpretable as evidence of intervention effectiveness—as it is possible that both the intervention and comparison condition could be made worse off than if they had not participated in the study at all. When risk of harm is not present in the comparison condition, favorable impacts can be interpreted as the intervention group being at least better off than they would have been if no treatment had been offered at all and can potentially contribute as evidence of effectiveness. Standard procedures for identifying potential risk of harm in comparison conditions are detailed in this section.

The definition of usual care or practice settings (Section 7.2.2) in the draft Handbook Version 2.0 has been clarified to indicate that community settings, such as schools, with embedded service providers that may provide eligible programs or services as part of their typical operations ( e.g., school counselors), are also considered usual care or practice settings. It clarifies that clinics that provide services solely for participants in research studies or clinical trials ( i.e., that do not provide any services to persons not participating in research studies as part of their typical operations) do not constitute usual care or practice settings.

Some public comments requested clarification on how the Prevention Services Clearinghouse assesses the duration of sustained effects, particularly in cases where the end of treatment is flexible across participants. Section 7.2.3 of the draft Handbook Version 2.0 includes revisions to clarify the order of preference for information that may be provided in studies about the end of treatment and procedures for computing the duration of sustained effects when the duration of treatment is fixed, when the duration of treatment is defined and varies across participants, and when the duration of treatment is undefined. Treatment of boosters in computing the duration of sustained effects is now explicitly addressed. Detailed procedures and examples can be found in Section 7.2.3 of the draft Handbook Version 2.0.

The draft Handbook Version 2.0 represents the first update to the Handbook of Standards and Procedures since the beginning of the Title IV-E Prevention Services Clearinghouse in 2018. The basic procedures for identifying eligible studies (Section 8.3) and reviewing studies against the design and execution standards (Section 8.4) remain essentially the same, with minor clarifications to operational procedures. Author query policies (Section 8.4.2) have been clarified; new content has been added clarifying the reasons that the Prevention Services Clearinghouse may query program and service developers for information about programs or services (Section 8.4.3). New content and more substantive revisions are described below.

The intention of the Prevention Services Clearinghouse is to conduct reviews of any program or service not previously reviewed under Handbook Version 1.0 solely under the standards and procedures specified in Handbook Version 2.0 once it is finalized. Programs or services that are included on the working list prior to when Handbook Version 2.0 is finalized may be reviewed under Handbook Version 1.0 or Handbook Version 2.0. The version of the handbook used to conduct a review (or re-review) of a program or service will be clearly stated on the working list and on the program or service's review page on the Prevention Services Clearinghouse website.

The Prevention Services Clearinghouse intends to conduct program and service re-reviews solely under Handbook Version 2.0 after it is finalized (Section 8.5.1). The intention of the Prevention Services Clearinghouse is that all existing program and service ratings determined under Handbook Version 1.0 will remain in effect until such time that a program or service re-review is conducted of a program or service.

Programs and services reviewed by the Prevention Services Clearinghouse under Handbook Version 1.0 may be considered for re-review under Handbook Version 2.0 if a re-review has the potential to change the program or service rating (Section 8.5.1). Program or service ratings could potentially change due to application of Handbook Version 2.0 standards to studies already identified in a prior review ( e.g., studies previously ineligible now being eligible; studies being able to demonstrate baseline equivalence under revised standards) or the emergence of new evidence since the original review. The intention of the Prevention Services Clearinghouse is that the rating of a re-reviewed program or service would be based solely on the standards and procedures in Handbook Version 2.0 ( i.e., the previously assigned rating would no longer be in effect).

The intention of the Prevention Service Clearinghouse is to conduct study re-reviews ( i.e., due to missing information or errors in the currently published review of an individual study) under the version of the handbook used to review the program or service (Section 8.5.2). That is, for a program or service reviewed under Handbook Version 1.0 where the program or service has not been re-reviewed under Handbook Version 2.0, a study re-review would be conducted under Handbook Version 1.0. For a program or service where a program or service rating has been assigned using Handbook Version 2.0, study re-reviews would be conducted using Handbook Version 2.0. This policy is consistent with other Federal evidence clearinghouses with multiple handbook versions ( e.g., HomVEE). The Prevention Services Clearinghouse's intention is that the emergence of substantial new evidence that has the potential to change program or service ratings ( e.g., a newly published study) should be addressed through a program or service re-review. Similarly, cases where application of Handbook Version 2.0 standards to a study reviewed under Handbook Version 1.0 could affect the program or service rating are intended to be addressed through a program or service re-review. Study re-reviews are intended to be limited solely to addressing missing information or errors in studies already reviewed.

The Prevention Services Clearinghouse recognizes that program or service manuals may be updated in the course of time after a review of a program or service has been published. Should a new manual edition (as defined in Section 2.3.2) be published, the public may request consideration of an update to the manual citation used for the program or service as outlined in Section 8.5.3 of the draft Handbook Version 2.0. If updated manual editions do not have substantive modifications or adaptations from the manual reviewed (per the criteria specified in Section 2.3), a manual citation may be updated to reflect that a newer manual edition is in active use that is substantively similar to the original primary manual selected for the review of the program or service. In considering whether an update to a manual citation is warranted, the Prevention Services Clearinghouse must have sufficient information available to be able to apply the procedures specified in Section 2.3 for determining whether any substantive adaptations are present in the newer manual edition compared to the original edition reviewed. If the manual citation is updated, the original manual citation used to conduct the review of evidence for the program or service will also be noted for clarity.

The Prevention Services Clearinghouse proposes to apply the standards and procedures upon publication of a final Handbook Version 2.0. The public will be clearly notified on the Prevention Services Clearinghouse website and via other avenues ( e.g., email to subscribers to the Prevention Services Clearinghouse email list) when the final published Handbook Version 2.0 will go into effect for reviewing programs and services.

Per the procedures in Chapters 7 and 8 of the draft Handbook Version 2.0, all existing program and service ratings established under Handbook Version 1.0 will remain in effect until such time that a program or service re-review is conducted of a program or service under Handbook Version 2.0.

To facilitate the review of submissions, please identify the chapter, section, and/or page number of the draft Handbook of Standards and Procedures, Version 2.0 ( https:// preventionservices.acf.hhs.gov/resources/comment-draft-handbook ) that your comments address. This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of ACF or HHS. For more information about the Prevention Services Clearinghouse, visit: https://preventionservices.acf.hhs.gov.

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. “Collection of information” is defined as and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. The PRA requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, ACL is publishing a notice of the proposed collection of information set forth in this document. With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:

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

(2) ways to enhance the quality, utility, and clarity of the information to be collected;

(3) accuracy of ACL's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates;

And (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology.

The Older American's Act requires ACL to evaluate “demonstration projects that support the objectives of this Act, including activities to bring effective demonstration projects to scale with a prioritization of projects that address the needs of underserved populations, and promote partnerships among aging services, community-based organizations, and Medicare and Medicaid providers, plans, and health (including public health) systems. (Section 201 (42 U.S.C. 3011) Sec. 127. Research and Evaluation).

To fulfill the evaluation requirements and allow for optimal federal and state-level management of ACL's Alzheimer's Disease Program, specific information must be collected from grantees.

The current reporting tool is set to expire 12/31/2023. The Alzheimer's and Dementia Program (ADP) Project Officer has reviewed the current data collection procedures to ensure the acceptability of these items as appropriate and thorough evaluation of the program, while minimizing burden for grantees.

The result of this process is the proposed modifications to the existing data collection tool. ACL is aware that different grantees have different data collection capabilities. It is understood that, following the approval of the modified data collection tool, ACL will work with its grantees to offer regular training to ensure minimal burden.

To support alignment with Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, Executive Order 14075 on Advancing Equality for Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex Individuals, and Executive Order 13988 on Preventing and Combating Discrimination on the Basis of Gender Identity and Sexual Orientation, ACL is adding three sexual orientation and gender identity (SOGI) items to the ADP-DRT. Understanding these disparities can and should lead to improved service delivery for ACL's programs and populations served.

The proposed data collection tools may be found on the ACL website for review at https://www.acl.gov/about-acl/public-input.

Estimated Program Burden:

ACL estimates the burden associated with this collection of information as follows:

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. “Collection of information” is defined as and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. The PRA requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, ACL is publishing a notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:

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

(2) ways to enhance the quality, utility, and clarity of the information to be collected;

(3) accuracy of ACL's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates;

(4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology.

This information collection gathers sub-award data required from State Health Insurance Assistance Program (SHIP) grantees to provide the amount of federal funds provided annually to each sub-contractor and sub-grantee that are delivering SHIP services. Congress requires this data collection for program monitoring of the SHIP under the Bipartisan Budget Act of 2018, SEC. 50207 (b). Collection of this data allows ACL to communicate with Congress and the public on the SHIP network of agencies. The data collected is electronically posted on the ACL website to educate the network on who the SHIP state sub-recipients are and how much money they are receiving.

The proposed data collection tools may be found on the ACL website for review at https://www.acl.gov/about-acl/public-input.

Estimated Program Burden: ACL estimates the respondent burden hours to prepare and complete all reports associated with this collection will be hours.

FDA is announcing the availability of a revised draft guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” Specifically, this revised draft guidance relates to firms sharing the following types of communications with HCPs:

• published scientific or medical journal articles (reprints),

• published clinical reference resources, as follows:

○ clinical practice guidelines (CPGs),

○ scientific or medical reference texts (reference texts),

○ materials from independent clinical practice resources, and

• firm-generated presentations of scientific information from an accompanying published reprint.

For the purposes of this revised draft guidance, these specific types of communications from firms to HCPs of scientific information on unapproved uses (SIUU) of approved/cleared medical products in combination with the disclosures recommended in the guidance are referred to as “ SIUU communications. ” We acknowledge that firms share SIUU communications through different media ( e.g., paper, digital), and the recommendations in this guidance apply regardless of the medium of the communication. Other communications by firms are not specifically addressed by this revised draft guidance, and we do not intend to convey any views on such communications in issuing this revised draft guidance.

This revised draft guidance represents a continuation of FDA's ongoing efforts to consider, develop, and refine its policies and recommendations relating to communications by firms about unapproved uses of their approved/cleared medical products. In 2009, FDA issued a final guidance for industry entitled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices” (74 FR 1694) to provide guidance to firms on distributing “journal articles” and “scientific or medical reference publications.” Then, FDA issued the 2014 revised draft guidance (79 FR 11793) to clarify the Agency's position on firms disseminating scientific or medical reference texts and CPGs that include information on unapproved uses of the firm's medical products and to provide additional explanation on these topics.

In developing this revised draft guidance, FDA considered stakeholder feedback, including comments received on the 2014 revised draft guidance. This revised draft guidance will supersede the 2014 revised draft guidance. Changes include a revised title, a question-and-answer format, and certain changes in scope.

The Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and their implementing regulations prohibit, among other things, the introduction (or causing the introduction) into interstate commerce of a medical product that fails to comply with applicable premarket requirements or is otherwise misbranded or adulterated. This prohibition includes introducing (or causing the introduction) into interstate commerce a medical product that is intended for a use that has not been approved or cleared by FDA, even if that same product is approved or cleared for a different use. These premarket requirements further multiple important government interests and distributing approved/cleared medical products for unapproved uses can undermine these interests. In certain circumstances, however, HCPs may be interested in scientific information about unapproved uses of approved/cleared medical products to inform clinical practice decisions for the care of an individual patient. In developing this draft guidance, FDA has sought to strike a careful balance between supporting HCP interest in scientific information about unapproved uses of approved/cleared medical products to inform clinical practice decisions for the care of an individual patient, and mitigating the potential that the government interests advanced by these statutory requirements will be undermined.

In light of those goals, FDA believes it is critical that SIUU communications be truthful, non-misleading, factual and unbiased and provide all information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the information in the SIUU communication. In addition, any study or analysis described in a source publication that serves as the basis for an SIUU communication should be scientifically sound. The studies or analyses should also provide information that is relevant to HCPs engaged in making clinical practice decisions for the care of an individual patient (as used in this revised draft guidance, “clinically relevant”). The manner of presentation of SIUU communications is also critical to consider. This revised draft guidance provides recommendations addressing all of these considerations.

If a firm shares an SIUU communication with HCPs in a manner that is consistent with the recommendations in this revised draft guidance, FDA does not intend to use such communication standing alone as evidence of a new intended use.

This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The revised draft guidance, when finalized, will represent the current thinking of FDA on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

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

The revised draft guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers,” discusses information disclosures that we recommend firms include in SIUU communications if the firms choose to publicly share such communications.

We estimate the burden of the information collection as follows:

Based on a current listing of firms promoting approved/cleared human and animal drug products (747), combined with an estimated number of device firms marketing products (261), we assume 1,008 firms (“number of respondents” in table (1) may each choose to publicly share 30 SIUU communications annually. Our estimate of the burden per disclosure (2.5 hours) reflects what we believe is the average burden based on the number and content and complexity of disclosures as recommended in the guidance.

FDA is interested in additional matters related to communications by firms about scientific information on unapproved use(s) of approved/cleared medical products. This revised draft guidance pertains to these communications by firms to HCPs engaged in making clinical practice decisions for the care of an individual patient. FDA is specifically seeking input on the following:

1. What considerations, if any, exist that are unique to communications of scientific information about unapproved use(s) of approved/cleared medical products by firms to researchers (including HCPs working in their capacity as researchers)?

2. What other factors should firms consider when sharing firm-generated presentations (as described in the draft guidance) to ensure that presentations are truthful, non-misleading, factual and unbiased and provide all information necessary for HCPs to interpret the strengths and weaknesses and validity and utility of the presented information?

Persons with access to the internet may obtain an electronic version of the draft guidance at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm , https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances , https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm , https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry , https://www.fda.gov/regulatory-information/search-fda-guidance-documents , or https://www.regulations.gov .

The Bright Futures Periodicity Schedule is maintained through a cooperative agreement, the Infant, Child, and Adolescent Preventive Services Program, for which the American Academy of Pediatrics (AAP) is the current recipient. When its preventive care and screening recommendations have been accepted by HRSA, the Bright Futures Periodicity Schedule is part of the HRSA-supported preventive services guidelines for infants, children, and adolescents. Under section 2713 of the Public Health Service Act (42 U.S.C. 300gg-13) and pertinent regulations, non-grandfathered group health plans and health insurance issuers must provide coverage, without cost sharing, for certain preventive services for plan years (in the individual market, policy years) that begin on or after the date that is 1 year after the date the recommendation or guideline is issued. These include HRSA-supported preventive health services provided for in the Bright Futures Periodicity Schedule as part of the HRSA-supported preventive services guidelines for infants, children, and adolescents under 42 U.S.C. 300gg-13(a)(3).

Through the Infant, Child, and Adolescent Preventive Services cooperative agreement, the AAP is required to administer a process for developing and regularly recommending, as needed, updates to the Bright Futures Periodicity Schedule through a comprehensive, objective, and transparent review of available evidence that incorporates opportunity for public comment. Accordingly, AAP reviews the evidence to determine whether updates are needed, develops recommended updates, seeks and considers public comments, and makes recommendations to HRSA. The proposed update to the Bright Futures Periodicity Schedule includes additions to existing footnotes, which provide up-to-date information and recommendations to providers but will not change the clinical recommendations and associated requirement for coverage without cost-sharing under section 2713 of the Public Health Service Act. The footnotes that AAP proposes to be revised are as follows:

1. Footnote 4, relating to the first week well-child visit, also called the 3-5 Day Visit, will be revised with an updated reference that aligns with the Bright Futures recommendation regarding providers helping families that choose to breastfeed.

2. Footnote 5, relating to Body Mass Index, is the Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents with Obesity ( https://doi.org/10.1542/peds.2022-060640 ) published in the January 2023 issue of Pediatrics. This updated reference aligns with the Bright Futures recommendation regarding measuring body mass index starting at the 24-month visit through the 21-year visit and provides non-stigmatizing recommendations for evaluating and treating children who are experiencing weight gains.

3. Footnote 14, relating to Behavioral/Social/Emotional Screening, is the U.S. Preventive Services Task Force Recommendation Statement, Screening for Anxiety in Children and Adolescents ( https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-anxiety-children-adolescents ) published in the October 2022 issue of the Journal of the American Medical Association. This additional reference aligns with the Bright Futures recommendation to use screening instruments to better identify children experiencing anxiety, followed by a confirmatory diagnostic assessment and follow-up.

4. Footnote 15, relating to Tobacco, Alcohol, or Drug Use Assessment, is the Centers for Disease Control and Prevention's Evidence-Based Strategies for Preventing Opioid Overdose: What's Working in the United States ( https://www.cdc.gov/drugoverdose/pdf/pubs/2018-evidence-based-strategies.pdf ) and the National Institute on Drug Abuse's policy brief, Naloxone for Opioid Overdose: Life-Saving Science ( https://nida.nih.gov/publications/naloxone-opioid-overdose-life-saving-science ). The proposed footnote aligns with the Bright Futures recommendation to assess patients for substance use with a validated screening tool. These additional references also describe the utility of prescribing Naloxone if there is concern for substance or opioid use.

5. Footnote 21, relating to Newborn Bilirubin Screening, is Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation ( https://doi.org/10.1542/peds.2022-058859 ), published in the August 2022 issue of Pediatrics. This reference aligns with the Bright Futures recommendation for universal bilirubin screening for all newborn infants between 24 and 28 hours after birth.

6. Footnote 35, relating to Oral Health, is Maintaining and Improving the Oral Health of Young Children ( https://doi.org/10.1542/peds.2022-060417 ), published in the December 2022 issue of Pediatrics. This reference aligns with the Bright Futures recommendation that every child has a dental home by 1 year of age. Additionally, the updated reference encourages providers to screen for social determinants of health, as well as access to medical and dental care, as they influence oral health status and oral health inequities.

With respect to Footnote 15, HRSA welcomes comment on the evidence regarding the effect of prescribing Naloxone in the setting of a primary care preventive visit on preventing or reducing opioid overdoses and opioid overdose deaths.

Authority: Section 2713(a)(3) of the Public Health Service Act, 42 U.S.C. 300gg-13(a)(3).

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case:

Lara S. Hwa, Ph.D., Baylor University and University of North Carolina at Chapel Hill: Based on the report of an investigation conducted by BU and UNC-CH and additional analysis conducted by ORI in its oversight review, ORI found that Lara S. Hwa, Ph.D., who is an Assistant Professor, Department of Psychology and Neuroscience, BU, and formerly was a Postdoctoral Fellow, School of Medicine, UNC-CH, engaged in research misconduct in research supported by PHS funds, specifically NIAAA, NIH, grants K99/R00 AA027576, T32 AA007573, F31 AA027129, F32 AA026485, R01 AA019454, U01 AA020911, R01 AA025582, and P60 AA011605 and included in two grant applications submitted for PHS funds, specifically K99 AA027576 submitted to NIAAA, NIH, and R01 DK136486 submitted to NIDDK, NIH.

ORI found that Respondent engaged in research misconduct by knowingly or recklessly falsifying and/or fabricating data, methods, results, and conclusions in animal models of alcohol use disorders. Specifically, Respondent falsified and/or fabricated experimental timelines, group conditions, sex of animal subjects, mouse strains, and behavioral response data in the following two (2) published papers and two (2) PHS grant applications:

• Alcohol Drinking Alters Stress Response to Predator Odor via BNST Kappa Opioid Receptor Signaling in Male Mice. Elife. 2020 Jul 21;9:e59709. doi: 10.7554/eLife.59709 (hereafter referred to as “ Elife 2020”). Retraction in: Elife. 2021 Nov 2;10:e74986. doi: 10.7554/eLife.74986.

• Predator Odor Increases Avoidance and Glutamatergic Synaptic Transmission in the Prelimbic Cortex via Corticotropin-releasing Factor Receptor 1 Signaling. Neuropyschopharmacology. 2019 Mar;44(4):766-775. doi: 10.1038/s41386-018-0279-2 (hereafter referred to as “ Neuropyschopharmacology 2019”).

• K99/R00 AA027576, “Long-term Alcohol Drinking Alters Stress Engagement of BNST Circuit Elements,” submitted to NIAAA, NIH, Funding Period: September 20, 2019-August 31, 2024.

• R01 DK136486, “Neuropeptide Characterization of Limited Access Sugar Drinking in Mice,” submitted to NIDDK, NIH, administratively withdrawn on December 9, 2022.

Specifically, ORI finds that Respondent knowingly or recklessly:

Respondent entered into a Voluntary Settlement Agreement (Agreement) and voluntarily agreed to the following:

(1) Respondent will have her research supervised for a period of four (4) years beginning on August 24, 2023 (the “Supervision Period”). Prior to the submission of an application for PHS support for a research project on which Respondent's participation is proposed and prior to Respondent's participation in any capacity in PHS-supported research, Respondent will submit a plan for supervision of Respondent's duties to ORI for approval. The supervision plan must be designed to ensure the integrity of Respondent's research. Respondent will not participate in any PHS-supported research until such a supervision plan is approved by ORI. Respondent will comply with the agreed-upon supervision plan.

(2) The requirements for Respondent's supervision plan are as follows:

i. A committee of 2-3 senior faculty members at the institution who are familiar with Respondent's field of research, but not including Respondent's supervisor or collaborators, will provide oversight and guidance for a period of four (4) years from the effective date of the Agreement. The committee will review primary data from Respondent's laboratory on a quarterly basis and submit a report to ORI at six (6) month intervals setting forth the committee meeting dates and Respondent's compliance with appropriate research standards and confirming the integrity of Respondent's research.

ii. The committee will conduct an advance review of each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved. The review will include a discussion with Respondent of the primary data represented in those documents and will include a certification to ORI that the data presented in the proposed application, report, manuscript, or abstract are supported by the research record.

(3) During the Supervision Period, Respondent will ensure that any institution employing her submits, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported and not plagiarized in the application, report, manuscript, or abstract.

(4) If no supervision plan is provided to ORI, Respondent will provide certification to ORI at the conclusion of the Supervision Period that her participation was not proposed on a research project for which an application for PHS support was submitted and that she has not participated in any capacity in PHS-supported research.

(5) During the Supervision Period, Respondent will exclude herself voluntarily from serving in any advisory or consultant capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee.

(6) Respondent will request that the following paper be corrected or retracted:

• Neuropyschopharmacology. 2019 Mar;44(4):766-775. doi: 10.1038/s41386-018-0279-2. Respondent will copy ORI and the Research Integrity Officer at UNC-CH on the correspondence with the journal.

This information collection will be used to initiate the fitness screening process for determining if a person invited to perform work under a contract for the Department of Homeland Security (DHS), is fit to perform such work and eligible for access to DHS resources, based on the risk levels of the designated position. The respondent provides and/or verifies biographical information to complete Section II of DHS Form 11000-25.

This collection of information is necessary to initiate the contractor fitness screening process for determining whether a person ( i.e., the respondent) who has been invited to perform work under a contract for, or on behalf of the Department of Homeland Security (DHS), should be deemed fit to perform such work and eligible for logical and/or physical access to DHS resources based on the risk levels of the designated position. The respondent is responsible for providing and/or verifying information to complete Section II of DHS Form 11000-25; the remaining sections of DHS Form 11000-25 (Sections I, III, and IV) are completed by DHS federal employees. Authorities that that support this information collection include:

This is a new information collection. DHS collects this information from the respondent, so Personnel Security entities can initiate the appropriate screening process for determining whether the respondent should be deemed fit to perform work under a contract for, or on behalf of DHS, and eligible for logical and/or physical access to DHS resources based on the risk levels of the designated position.

This information collection utilizes an automated technological solution ( i.e., Personnel Security Forms application) which negates the need for a paper-based DHS Form 11000-25, thereby reducing the burden on the respondent during the initiation phase of the contractor fitness screening process. After receiving an invitation to perform work under a contact, the respondent ( i.e., DHS contractor applicant) submits and verifies certain biographical information ( e.g., full name, position title, SSN, gender, date and place of birth, U.S. citizenship status, telephone number, and email address) through a public facing web portal. Once the information intake is complete, the Personnel Security Forms application produces an automated electronic version of the DHS Form 11000-25 for use by the appropriate Personnel Security entities to make a fitness determination. This information collection does not have an impact on small businesses or other small entities.

The information collection for DHS Form 11000-25 is voluntary; however, failure to provide this information may delay or prevent an individual's fitness determination and eligibility for physical and logical access to federally controlled facilities or information systems.

There is no assurance of confidentiality provided to the respondents. Consistent with DHS' information sharing mission, all or a portion of the information collection may be disclosed outside DHS consistent with the routine uses set forth in Privacy Impact Assessment, DHS/ALL/PIA-038, Integrated Security Management System (ISMS), and System of Record Notice, DHS/ALL-023 Department of Homeland Personnel Security Management.

This is a new collection.

The Office of Management and Budget is particularly interested in comments which:

5. 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;

6. 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;

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

8. 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.

Agency: Department of Homeland Security (DHS).

Title: Contractor Fitness/Security Screening Request Form.

OMB Number: 1601-NEW.

Frequency: Annually.

Affected Public: Individuals or Households.

Number of Respondents: 45,000.

Estimated Time per Respondent: 15 mins.

Total Burden Hours: 11,250 hrs.

Department of Homeland Security (DHS) Form 11000-16 is used to request a DHS Personal Identity Verification Official (PIV-O) credential, and if applicable, a shield ( i.e., metallic law enforcement or non-law enforcement badge) to accompany the credential, for DHS employees, contractors, and affiliates authorized to perform specific official functions pursuant to law, statute, regulation, or DHS Directive. This collection of information, using Department of Homeland Security (DHS) Form 11000-16, is necessary to support Homeland Security Presidential Directive 12: Policy for a Common Identification Standard for Federal Employees and Contractors, issued on August 27, 2004, which mandates a federal standard for secure and reliable forms of identification. The collection is used in accordance with System of Record Notice DHS/ALL-026 Department of Homeland Security Personal Identity Verification Management System and Department policy to request a DHS Personal Identity Verification Official (PIV-O) credential, and if applicable, a shield ( i.e., metallic law enforcement or non-law enforcement badge) to accompany the credential. A DHS PIV-O credential describes authorities delegated to specific DHS employees, contractors, and affiliates who interact with the public or federal, state, local, or tribal entities to perform authorized official functions pursuant to law, statute, regulation, or DHS Directive.

The collection of information is obtained from (or on behalf of) the respondent, who may be a current or prospective DHS contractor ( i.e., member of the public). The information is collected electronically using a fillable PDF form submitted to the respective DHS credentialing office. The respondent is responsible for only completing Sections 1, 2, and 3 of DHS Form 11000-16; the remaining sections of the form (Sections 4, 5, and 6) are completed by DHS federal employees. Qualified personnel within the DHS credentialing office holding a requisite role in the Identity and Credential System(s) of Record use the collected information to adjudicate the action requested in Section 1 of the DHS Form 11000-16, and as necessary, enroll, identify, and retrieve the applicant's record in the DHS Identity and Credential System(s) of Record.

The collection of information is obtained from the respondent electronically using a fillable PDF form: upon completion, the form is submitted to the respective DHS Component credentialing office in accordance with internal procedures.

This information collection does not have an impact on small businesses or other small entities.

Collection of the information on DHS Form 11000-16 is voluntary; however, failure to provide the information requested may prevent the respondent ( i.e., applicant) from receiving the requested DHS PIV-O credential and/or shield.

There is no assurance of confidentiality provided to the respondents. Consistent with DHS's information sharing mission, this information collection may be shared with Federal, state, local, tribal, foreign or international government agencies, including other DHS Components and offices. This sharing will only take place after DHS determines that the receiving entity has a need to know the information to carry out national security, law enforcement, immigration, intelligence, or other functions consistent with the routine uses set forth in Privacy Impact Assessment, DHS/ALL/PIA-014 Personal Identity Verification/Identity Management System (PIV/IDMS) and System of Records Notice, DHS/ALL-026 Department of Homeland Security Personal Identity Verification Management System.

This is a new collection.

The Office of Management and Budget is particularly interested in comments which:

5. 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;

6. 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;

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

8. 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.

Agency: Department of Homeland Security (DHS).

Title: Personal Identity Verification Official (PIV-O) Credential and Shield Request.

OMB Number: 1601-NEW.

Frequency: Annually.

Affected Public: Individuals or Households.

Number of Respondents: 1,500.

Estimated Time per Respondent: 15 mins.

Total Burden Hours: 375 hrs.

Section 2122(a)(9) of the Housing and Economic Recovery Act of 2008 (HERA) amended Section 255 of the National Housing Act to authorize the Department of Housing and Urban Development (HUD) to insure HECMs used for the purchase of a 1- to 4-family dwelling unit, one unit of which will serve as the borrower's principal residence. In 2008, based on the authority in section 255, FHA implemented the HECM for Purchase program through Mortgagee Letter (ML) 2008-33, permitting mortgagees to originate HECM for Purchase transactions. ML 2008-33 was superseded by Mortgage Letter 2009-11, which required borrowers to satisfy a monetary investment using cash on hand or cash from the sale or liquidation of the mortgagor's assets, or certain additional funding sources defined in HUD Handbook 4155.1 REV-5, section 2-10.

FHA through ML 2009-11, however, prohibited certain funding sources for the borrower's required monetary investment. Specifically, borrowers were prohibited from satisfying the monetary investment requirement using sweat equity, trade equity, rent credit, or cash or its equivalent, in whole or in part, received from the seller or any other person or entity that financially benefits from the HECM for Purchase transaction, or any third party or entity that is reimbursed, directly or indirectly, by the seller or any other person or entity that financially benefits from the HECM for Purchase transaction. Additionally, ML 2009-11 prohibited seller contributions, also known as seller concessions, in any HECM for Purchase transaction. Seller concessions were defined as the use of loan discount points, interest rate buy-downs, closing cost down payment assistance, builder incentives, gifts or personal property given by the seller, or any other party involved in the transaction. These limitations on funding sources and interested party contributions redirected expenses customarily paid by the seller or other interested parties to the HECM for Purchase borrower.

On January 19, 2017, FHA codified the requirements for the HECM for Purchase program, and other program changes, in the “Federal Housing Administration (FHA): Strengthening the Home Equity Conversion Mortgage Program” Final Rule (82 FR 7094) (“the final rule”) amending 24 CFR part 206. The final rule changed the funding source restrictions from ML 2009-11, to permit interested party contributions to pay fees required to be paid by the seller under state or local law, for fees that are customarily paid by a seller in the locality of the subject property, and for purchase of the Home Warranty policy by the seller (24 CFR 206.44(c)(1)).

FHA also codified three permitted funding sources for the borrower's required monetary investment: cash on hand, cash from the sale or liquidation of the borrower's assets, and HECM proceeds. The final rule codified regulatory provisions that grant the Commissioner the authority to permit additional funding sources and interested party contributions through future notice in the Federal Register , 24 CFR 206.44(b)(4) and (c)(2), respectively. Based on the foregoing regulatory authority, FHA is issuing this notice to permit additional funding sources and interested party contributions in HECM for Purchase transactions.

HECM for Purchase requires Borrowers to contribute substantial liquid assets to meet the negotiated contract sales price for the property plus standard origination fees and charges. By expanding the list of permitted interested party contributions, FHA is more closely aligning its HECM interested party contribution policies with FHA's forward mortgage programs, while meaningfully increasing the sources of funds available for HECM borrowers to satisfy their capital requirements to originate a HECM for Purchase.

For example, a borrower purchasing a property in the state of Arizona with a HECM for Purchase, where:

• Contract sales price is $491,974.00;

• Borrower's Closing Costs are $20,300.00;

• Appraised Value is $492,000.00; and

• Principal Limit is $189, 902.00 (maximum proceeds available to borrower from the HECM).

Under current policy, the total amount of cash due from the borrower at closing to complete this transaction is $322,372 ($491,974 plus $20,300 minus $189,902). Under the proposed notice, interested parties could contribute up to 6 percent of the sales price, or $29,518.44, toward the borrower's monetary requirements, reducing the total amount due from the borrower at closing from $322,372 to $292,853.56.

Therefore, pursuant to the Commissioner's authority under 24 CFR 206.44(b)(4) and 206.44(c)(2), HUD is, through this notice, informing the public and program participants of changes to the FHA's HECM program, which HUD intends to make effective in a future update to HUD's Single Family Housing Policy Handbook.

For the HECM for Purchase program, FHA will permit the use of an “interested party contribution,” up to six percent of the sales price. “Interested party contribution” will be defined as a payment by an interested party  1 or combination of parties, toward the borrower's origination fees, other closing costs including any items paid outside of closing, prepaid items, and discount points. The six percent limit may be applied towards but may not exceed the cost of: origination fees; other closing costs paid outside of closing, such as a credit report and appraisal; prepaid items; discount points; interested party payment for permanent and temporary interest rate buydowns; and payment of the initial mortgage insurance premium.

Through this notice, FHA will permit additional funding sources that may be used to satisfy the borrower's monetary investment including premium pricing;  2 gifts; disaster relief grants; and employer assistance. These permitted sources are in addition to cash on hand, cash from the sale or liquidation of the borrower's assets, and HECM proceeds that are already permitted by regulation.

Premium pricing credits from the mortgagee or third-party originator will be excluded from the six percent interested party contribution limit, provided the mortgagee or third-party originator is not the seller, real estate agent, builder, or developer. Fees required to be paid by a seller under state or local law or customarily paid by a seller in the subject property locality, including real estate agent commissions or fees, and the purchase of the Home Warranty policy by the seller are already permitted under § 206.44(c)(1)  3 and will be excluded from the six percent interested party contribution limit. Further, as with FHA's policy for forward-mortgages, FHA will exclude the satisfaction of a Property Assessed Clean Energy (“PACE”) lien or obligation against the property by the property seller from the definition of an interested party contribution in the HECM for Purchase program.

This document seeks comment from interested members of the public on this document generally, and on the issues discussed previously in this notice. HUD will carefully consider the public comments received through this solicitation as part of a future policy update.

In accordance with the Paperwork Reduction Act of 1995, BOEM provides the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps BOEM assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand BOEM's information collection requirements and provide the requested data in the desired format.

Title of Collection: “30 CFR part 583, Negotiated Noncompetitive Agreements for the Use of Outer Continental Shelf Sand, Gravel, and/or Shell Resources.”

Abstract: Part 583 in title 30 of the Code of Federal Regulations addresses the use of Outer Continental Shelf (OCS) sand, gravel, and shell resources for shore protection, beach restoration, or coastal wetlands restoration projects undertaken by Federal, State, or local government agencies, or for use in construction projects authorized by or funded in whole or in part by the Federal Government.

The OCS Lands Act, 43 U.S.C. 1331 et seq., authorizes the Secretary of the Interior to prescribe rules and regulations to administer leasing of mineral resources on the OCS. Section 1337(k)(2) of title 43 authorizes the Secretary to “. . . negotiate with any person an agreement for the use of Outer Continental Shelf sand, gravel and shell resources—(i) for use in a program of, or project for, shore protection, beach restoration, or coastal wetlands restoration undertaken by a Federal, State, or local government agency; or (ii) for use in a construction project . . . that is funded in whole or in part by or authorized by the Federal Government.” The Secretary delegated this authority to BOEM.

This ICR allows BOEM to collect information from an applicant requesting a non-competitive, negotiated agreement. This information is used to determine if the applicant is qualified to enter into such an agreement and to determine if the requested action is warranted.

OMB Control Number: 1010-0191.

Form Number: None.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Potential respondents include Federal, State, or local governments.

Total Estimated Number of Annual Responses: 45 responses.

Total Estimated Number of Annual Burden Hours: 299 hours (Hours are same as currently approved).

Respondent's Obligation: Required to retain or obtain a benefit.

Frequency of Collection: On occasion.

Total Estimated Annual Non-hour Burden Cost: BOEM has identified no non-hour paperwork cost burdens for this collection.

A Federal Register notice with a 60-day public comment period on the proposed ICR was published on May 26, 2023 (88 FR 34182). BOEM did not receive any comments.

BOEM is again soliciting comments on the proposed ICR. BOEM is especially interested in public comments addressing the following issues: (1) is the collection necessary to the proper functions of BOEM; (2) what can BOEM do to ensure that this information is processed and used in a timely manner; (3) is the burden estimate accurate; (4) how might BOEM enhance the quality, utility, and clarity of the information to be collected; and (5) how might BOEM minimize the burden of this collection on the respondents, including minimizing the burden through the use of information technology?

Comments submitted in response to this notice are a matter of public record and will be available for public review on www.reginfo.gov. You should be aware that your entire comment—including your address, phone number, email address, or other personally identifiable information included in your comment—may be made publicly available at any time. In order for BOEM to consider withholding from disclosure your personal identifying information, you must identify, in a cover letter, any information contained in your comment that, if released, would constitute a clearly unwarranted invasion of your personal privacy. You must also briefly describe any possible harmful consequences of the disclosure of information, such as embarrassment, injury, or other harm. Note that BOEM will make available for public inspection all comments in their entirety (except for proprietary information submitted by organizations and businesses, or by individuals identifying themselves as representatives of organizations or businesses).

Even if BOEM withholds your information in the context of this ICR, your comment is subject to the Freedom of Information Act (FOIA) (5 U.S.C. 552). If your submission is requested under FOIA, your information will only be withheld if a determination is made that one of the FOIA exemptions to disclosure applies. Such a determination will be made in accordance with the Department's FOIA implementing regulations (43 CFR part 2) and applicable law.

BOEM protects proprietary information in accordance with FOIA and DOI's implementing regulations.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

On October 6, 2023, the Commission determined that it should proceed to full reviews in the subject five-year reviews pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)). 1 The Commission found that both the domestic and respondent interested party group responses to its notice of institution (88 FR 42751, July 3, 2023) were adequate, and determined to conduct full reviews of the orders on imports from Spain. A record of the Commissioners' votes will be available from the Office of the Secretary and at the Commission's website.

Authority: These reviews are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.62 of the Commission's rules.

The Controlled Substances Act (CSA), as amended by the Comprehensive Methamphetamine Control Act of 1996 (MCA), provides for the publication of a Special Surveillance List by the Attorney General. 1 The Special Surveillance List identifies laboratory supplies which are used in the manufacture of controlled substances and listed chemicals. The CSA defines “laboratory supply” as “a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals.”  2 The CSA provides for a civil penalty of not more than $250,000 for the distribution of a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, if that distribution was made with “reckless disregard” for the illegal uses to which such a laboratory supply will be put. 3 The CSA further states that, for purposes of 21 U.S.C. 842(a)(11), “there is a rebuttable presumption of reckless disregard at trial if the Attorney General notifies a firm in writing that a laboratory supply sold by the firm, or any other person or firm, has been used by a customer of the notified firm, or distributed further by that customer, for the unlawful production of controlled substances or listed chemicals a firm distributes and 2 weeks or more after the notification the notified firm distributes a laboratory supply to the customer.”  4

The publication of the Special Surveillance List serves two purposes. First, it informs individuals and firms of the potential use of the items on the list in the manufacture of controlled substances and listed chemicals. Second, it reminds individuals and firms that civil penalties may be imposed on them if they distribute a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, in violation of the CSA, with reckless disregard for the illegal uses to which such a laboratory supply will be put. 5 The publication of the updated Special Surveillance List provides an increased level of public awareness and law enforcement control to prevent the diversion of laboratory supplies used for the manufacture of listed chemicals and controlled substances.

The first Special Surveillance List was published in 1999 and has not been updated since. 6 Although the CSA does not require notice and comment for changes to the Special Surveillance List, DEA provided notice of proposed changes and an opportunity for the public to comment because the list has not been updated in over 23 years. 7

DEA received 29 comments in response to the notice of proposed updates to the Special Surveillance List, all of which were in opposition to the proposed changes. According to the commenters, the update to the Special Surveillance List will further regulate the chemical industry, which would impose additional regulatory burdens on small businesses. Several commenters also objected to the addition of three chemicals to the Special Surveillance List: sodium borohydride, propiophenone, and propionyl chloride.

DEA Response: As explained in the notice of proposed updates to the Special Surveillance List, the updates do not impose any new regulatory burden on the public, and they do not impose any recordkeeping or reporting requirements for any of the laboratory supplies. The chemicals that are being added to the Special Surveillance List are not themselves being regulated as listed chemicals or controlled substances under the CSA. The Special Surveillance List is being updated to reflect changes in the chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals, to include additional laboratory supplies that are used in the illicit manufacture of controlled substances and listed chemicals.

Several commenters objected to the addition of three chemicals to the Special Surveillance List: sodium borohydride, propiophenone, and propionyl chloride. These objections were devoid of acknowledgement that these chemicals are used in the illicit manufacture of controlled substances and listed chemicals. Specifically, sodium borohydride is a reducing agent and can be used in the illicit manufacture of fentanyl and fentanyl analogues. Propionyl chloride is a chemical that can be used in the illicit manufacture of fentanyl and fentanyl analogues. Propiophenone is a chemical that can be used in the illicit manufacture of several substituted cathinones that are controlled in schedule I of the CSA.

In developing the updated Special Surveillance List, DEA consulted with federal, state, local, and foreign law enforcement officials, forensic laboratory authorities, intelligence groups, drug profiling programs, and international organizations. DEA examined clandestine laboratory seizure reports and drug profiling reports for information regarding: (1) illicit drug production methods; (2) chemicals actually used in the clandestine production of controlled substances and listed chemicals; and (3) the role and importance of chemicals used in the synthesis of controlled substances and listed chemicals. The updated Special Surveillance List includes chemicals used in the production of synthetic drugs such as fentanyl, amphetamine, methamphetamine, PCP, LSD, and other controlled substances and listed chemicals.

DEA is updating the Special Surveillance List by adding the following laboratory supplies to the existing Special Surveillance List:

Chemicals, including their salts whenever the existence of such salts is possible

In addition to the chemicals listed above, DEA is updating the listing of tableting machines under equipment to explicitly include punches and dies. DEA updates the listing of tableting machines to read as follows:

The Special Surveillance List continues to include all listed chemicals as specified in 21 CFR 1310.02(a) or (b). DEA is removing two individually listed chemicals from the Special Surveillance List (hypophosphorus acid and red phosphorus), given that those chemicals have since been added to List I and are, therefore, automatically included as laboratory supplies. The phrase “all listed chemicals” includes all chemical mixtures and all over-the-counter (OTC) pharmaceutical products and dietary supplements which contain a listed chemical, regardless of their dosage form or packaging and regardless of whether the chemical mixture, drug product or dietary supplement is exempt from regulatory controls. The following is the updated Special Surveillance List for laboratory supplies used in the manufacture of controlled substances and listed chemicals, including the additions listed above:

The Attorney General has delegated authority under the CSA and all subsequent amendments to the CSA to the Administrator of the DEA pursuant to 28 CFR 0.100. The Special Surveillance List may be updated as needed to reflect changes in the chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals by publication of a notice in the Federal Register . DEA will disseminate the updated Special Surveillance List as widely as possible. In addition, the Special Surveillance List will be available on the DEA Diversion Control homepage at https://www.deadiversion.usdoj.gov /.

The updated Special Surveillance List applies to all individuals and firms which distribute the listed chemicals and laboratory supplies (chemicals, products, materials, or equipment) on the list. As noted above, the Special Surveillance List serves two purposes. First, it informs individuals and firms of the potential use of the items on the list in the manufacture of controlled substances and listed chemicals. Second, it reminds individuals and firms that civil penalties may be imposed on them if they distribute a laboratory supply to a person with reckless disregard for the illegal use to which such a laboratory supply will be put.

This update provides an increased level of law enforcement control to prevent the diversion of laboratory supplies used for the manufacture of listed chemicals and controlled substances. It does not impose any new regulatory burden on the public as there are no corresponding recordkeeping or reporting requirements of the laboratory supplies. However, it does impose potential civil penalties for the distribution of a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, if that distribution was made with reckless disregard for the illegal uses to which such laboratory supply will be put. This update fulfills the requirement imposed by section 205 of the MCA that the Attorney General shall publish a Special Surveillance List which contains chemicals, products, materials, or equipment used in the manufacture of listed chemicals and controlled substances.

Purpose: The President's Committee on the International Labor Organization was established in 1980 by Executive Order (E.O.) 12216 to monitor and assess the work of the ILO and make recommendations to the President regarding United States policy towards the ILO. The committee is chaired by the Secretary of Labor and the Department of Labor's Bureau of International Labor Affairs is responsible for providing the necessary support for the committee. The committee is composed of seven ex officio members: The Secretary of Labor, the Secretary of State, the Secretary of Commerce, the Assistant to the President for National Security Affairs, the Assistant to the President for Economic Policy, and one representative each from organized labor and the business community, designated by the Secretary of Labor. The labor and business members are the presidents of the American Federation of Labor and Congress of Industrial Organizations and the United States Council for International Business, respectively, as the most representative organizations of U.S. workers and employers engaged in ILO matters.

Authority: The authority for this notice is granted by FACA (5 U.S.C. 10) and E.O. 14109 of September 29, 2023.

The Department of Labor, as part of the continuing effort to reduce paperwork and respondent ( i.e., employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, the collection instruments are clearly understood, and OSHA's estimate of the information collection burden is accurate. The Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et seq. ) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of effort in obtaining information (29 U.S.C. 657).

The following sections describe who use the information collected under each requirement, as well as how they use it. The purposes of these requirements are to address the burden hours associated with gathering information to complete the OSHA 70 Form. The OSHA 70 Form is used by applicants seeking accreditation from OSHA to be able to test or examine certain equipment and material handling devices as required under the maritime regulations, part 1915 (Shipyard Employment), part 1917 (Marine Terminals), and part 1918 (Longshoring). The OSHA 70 Form application for accreditation provides an easy means for companies to apply for accreditation.

OSHA has a particular interest in comments on the following issues:

• Whether the proposed information collection requirements are necessary for the proper performance of the agency's functions to protect workers, including whether the information is useful;

• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;

• The quality, utility, and clarity of the information collected; and

• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection, and transmission techniques.

OSHA is requesting that OMB extend the approval of the information collection requirements contained in the Gears Certification Standard. The agency is requesting that there is no change in burden hours in the information collection requirements of this standard. The costs are adjusted due to updated calculations.

OSHA will summarize the comments submitted in response to this notice and will include this summary in the request to OMB to extend the approval of the information collection requirements.

Type of Review: Extension of a currently approved collection.

Title: Gear Certification Standard (29 CFR part 1919).

OMB Control Number: 1218-0003.

Affected Public: Business or other for-profits.

Number of Respondents: 664.

Frequency of Responses: Varies.

Total Responses: 5,035.

Average Time per Response: Varies.

Estimated Total Burden Hours: 109.

Estimated Cost (Operation and Maintenance): $2,612,500.

You may submit comments in response to this document as follows: (1) electronically at http://www.regulations.gov, which is the Federal eRulemaking Portal; (2) by facsimile (fax); if your comments, including attachments, are not longer than 10 pages you may fax them to the OSHA Docket Office at 202-693-1648. or (3) by hard copy. All comments, attachments, and other material must identify the agency name and the OSHA docket number for the ICR (OSHA-2010-0042). You may supplement electronic submissions by uploading document files electronically.

Comments and submissions are posted without change at http://www.regualtions.gov . Therefore, OSHA cautions commenters about submitting personal information such as Social Security numbers and dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information ( e.g., copyrighted material) is not publicly available to read or download from this website. All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. Information on using the http://www.regualtions.gov website to submit comments and access the docket is available at the website's “User Tips” link.

Contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627) for information about materials not available from the website, and for assistance in using the internet to locate docket submissions.

James S. Frederick, Deputy Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506 et seq. ) and Secretary of Labor's Order No. 8-2020 (85 FR 58393).

NSF supports students and early career professionals at all stages of their academic journey through a wide range of opportunities that foster professional growth, facilitating exposure to and induction into the practice of science. The new system of records, NSF-80, Education and Training Application Data System (ETAP), will be used to collect, maintain, and manage individual applications to education and training opportunities funded by NSF, allow tracking of participants' program experiences and career outcomes over time, and provide high-quality data that NSF can use to respond to Administration priorities, the Foundations for Evidence-Based Policymaking Act of 2018 (Evidence Act), the America COMPETES Reauthorization Act of 2010, and the CHIPS+ Act.

Please refer to Docket ID NRC-2023-0181 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:

• Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2023-0181.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email to PDR.Resource@nrc.gov. The draft BTP 7-19, Revision 9, “Guidance for Evaluation of Defense In Depth and Diversity to Address Common-Cause Failure Due to Latent Design Defects in Digital Safety Systems” is available in ADAMS under Accession No. ML23222A237.

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

The NRC encourages electronic comment submission through the Federal rulemaking website ( https://www.regulations.gov ). Please include Docket ID NRC-2023-0181 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at https://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

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

The NRC seeks public comment on the draft BTP 7-19 Revision 9, “Guidance for Evaluation of Defense In Depth and Diversity to Address Common-Cause Failure Due to Latent Design Defects in Digital Safety Systems.” This draft revision BTP 7-19, provides the NRC staff with guidance for evaluating an applicant's assessment of the adequacy of D3 for a proposed DI&C system. The applicant performs this D3 assessment to identify and address potential common-cause failures (CCFs) in a proposed DI&C system and to evaluate the effects of any unprevented CCFs on plant safety.

The purpose of this proposed update is to implement the expanded policy in SRM-SECY-22-0076, “Expansion of Current Policy on Potential Common-Cause Failures in Digital Instrumentation and Control Systems,” (ADAMS Accession Nos. ML23145A181 and ML23145A182) for addressing DI&C CCFs. The proposed update provides guidance for the review of risk-informed D3 assessments, in addition to the existing guidance for assessments based on best-estimate methods. The proposed update also provides review guidance for design techniques or mitigating measures, other than diversity, to address the effects of a DI&C CCF.

Following NRC staff evaluation of public comments, the NRC intends to finalize BTP 7-19, Revision 9 in ADAMS and post it on the NRC's public website at https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr0800. The SRP is guidance for the NRC staff. The SRP is not a substitute for the NRC regulations, and compliance with the SRP is not required.

The guidance in this draft SRP is updated to implement the Commission's policies in SRM-SECY-22-0076 for review of applicant assessments of defense in depth and diversity to prevent or mitigate common-cause failure of digital instrumentation and control systems used in light-water nuclear power reactors. Issuance of this draft SRP, if finalized, would not constitute backfitting as defined in section 50.109 of title 10 of the Code of Federal Regulations (10 CFR), “Backfitting” (the Backfit Rule), and as described in NRC Management Directive (MD) 8.4, “Management of Backfitting, Forward Fitting, Issue Finality, and Information Requests”; would not affect the issue finality of an approval under 10 CFR part 52; and would not constitute forward fitting as that term is defined and described in MD 8.4. The NRC staff's position is based upon the following considerations.

1. The draft SRP positions, if finalized, would not constitute backfitting or forward fitting or affect issue finality, inasmuch as the SRP would be internal guidance to the NRC staff.

The SRP provides guidance to the NRC staff on how to review an application for NRC regulatory approval in the form of licensing. Changes in internal staff guidance, without further NRC action, are not matters that meet the definition of backfitting or forward fitting or affect the issue finality of a 10 CFR part 52 approval.

2. Current or future applicants are not—with limited exceptions not applicable here—within the scope of the backfitting and issue finality regulations and forward fitting policy.

Applicants are not, with certain exceptions, within the scope of the Backfit Rule or any issue finality provisions under 10 CFR part 52. The backfitting and issue finality regulations include language delineating when those provisions begin; in general, they begin after the issuance of a license, permit, or other approval. Furthermore, neither the Backfit Rule nor the issue finality provisions under 10 CFR part 52—with certain exclusions discussed further in this notice—were intended to apply to NRC actions that substantially change the expectations of current and future applicants.

The exceptions to the general principle are applicable when an applicant references a 10 CFR part 52 license ( e.g., an early site permit) and/or NRC regulatory approval ( e.g., a design certification rule) with specified issue finality provisions or a construction permit under 10 CFR part 50. The NRC staff does not, at this time, intend to impose the positions represented in the draft SRP (if finalized) in a manner that would constitute backfitting or affect the issue finality of a 10 CFR part 52 approval. If, in the future, the staff seeks to impose a position in the draft SRP (if finalized) in a manner that constitutes backfitting or affects the issue finality of a 10 CFR part 52 approval, then the staff would need to address the Backfit Rule, or the criteria described in the applicable issue finality provision.

The Commission's forward fitting policy generally does not apply when an applicant files an initial licensing action for a new facility. Nevertheless, the NRC staff does not, at this time, intend to impose the positions represented in the draft SRP (if finalized) in a manner that would constitute forward fitting. If, in the future, the staff seeks to impose a position in the draft SRP (if finalized) in a manner that constitutes forward fitting, then the staff would need to address the forward fitting criteria in MD 8.4.

Section 4314(c) (1) through (5) of title 5, U.S.C., requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more SES performance review boards. The board reviews and evaluates the initial appraisal of a senior executive's performance by the supervisor and considers recommendations to the appointing authority regarding the performance of the senior executive.

The following have been designated as members of the Fiscal Year 2023 Performance Review Board of the U.S. Office of Personnel Management:

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

Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.

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

The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern Market Dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern Competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.

1. Docket No(s).: MC2024-16 and CP2024-16; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 76 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: October 18, 2023; Filing Authority: 39 U.S.C. 3642, 39 CFR 3040.130 through 3040.135, and 39 CFR 3035.105; Public Representative: Kenneth R. Moeller; Comments Due: October 26, 2023.

2. Docket No(s).: MC2024-17 and CP2024-17; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 77 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: October 18, 2023; Filing Authority: 39 U.S.C. 3642, 39 CFR 3040.130 through 3040.135, and 39 CFR 3035.105; Public Representative: Kenneth R. Moeller; Comments Due: October 26, 2023.

3. Docket No(s).: MC2024-18 and CP2024-18; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 78 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: October 18, 2023; Filing Authority: 39 U.S.C. 3642, 39 CFR 3040.130 through 3040.135, and 39 CFR 3035.105; Public Representative: Christopher C. Mohr; Comments Due: October 26, 2023.

4. Docket No(s).: MC2024-19 and CP2024-19; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 79 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: October 18, 2023; Filing Authority: 39 U.S.C. 3642, 39 CFR 3040.130 through 3040.135, and 39 CFR 3035.105; Public Representative: Christopher C. Mohr; Comments Due: October 26, 2023.

5. Docket No(s).: MC2024-20 and CP2024-20; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 80 to Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: October 18, 2023; Filing Authority: 39 U.S.C. 3642, 39 CFR 3040.130 through 3040.135, and 39 CFR 3035.105; Public Representative: Christopher C. Mohr; Comments Due: October 26, 2023.

This Notice will be published in the Federal Register .

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 12, 2023, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail Express International, Priority Mail International & First-Class Package International Service Contract 28 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2024-7 and CP2024-7.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 16, 2023, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail Express International, Priority Mail International & Commercial ePacket Contract 2 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2024-13 and CP2024-13.

The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on October 16, 2023, it filed with the Postal Regulatory Commission a USPS Request to Add Priority Mail Express International, Priority Mail International & First-Class Package International Service Contract 29 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2024-12 and CP2024-12.

For Applicants' representations, legal analysis, and condition, please refer to Applicants' third amended and restated application, dated October 11, 2023, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field, on the SEC's EDGAR system. The SEC's EDGAR system may be searched at http://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You may also call the SEC's Public Reference Room at (202) 551-8090.