The Administrative Conference of the United States makes recommendations to Federal agencies, the President, Congress, and the Judicial Conference of the United States regarding the improvement of administrative procedures (5 U.S.C. 594). The membership of the Conference, when meeting in plenary session, constitutes the Assembly of the Conference (5 U.S.C. 595).

Agenda: Four proposed recommendations will be considered by the Assembly. In addition, there will be updates on past, current, and pending Conference initiatives, as well as other business. Summaries of the recommendations appear below:

Choice of Forum for Judicial Review of Agency Rules. This proposed recommendation identifies a principle that should guide Congress in choosing the appropriate forum for judicial review of agency rules. It also recommends that Congress provide that district courts apply district-wide assignment to certain civil actions seeking to bar or mandate enforcement of federal agency rules or policies and identifies common statutory ambiguities that Congress should avoid in drafting new or amending existing recommendations.

Individualized Guidance. This proposed recommendation examines best practices to promote fairness, accuracy, and efficiency in agency processes for providing written guidance in response to requests for advice from members of the public. It addresses processes for members of the public to request individualized guidance from agencies; agency practices for drafting responses to such requests, including the personnel involved and mechanisms to ensure accuracy and consistency; the public availability of individualized guidance documents; and policies regarding whether and when agencies should allow members of the public to rely on individualized guidance.

Participation of Senate-Confirmed Officials in Administrative Adjudication. This proposed recommendation examines, as a legal and practical matter, whether, when, how, and how often agency heads and other Senate-confirmed officials participate in the adjudication of cases across a range of federal administrative programs. For agencies that have decided to provide or are considering providing for participation by Senate-confirmed officials in the adjudication of individual cases, the proposed recommendation identifies principles and practicalities that agencies should consider in structuring such participation and provides best practices for developing and communicating relevant policies regarding such participation. This proposed recommendation does not address whether agencies should, for constitutional or other reasons, provide for participation by Senate-confirmed officials in specific programs.

Congressional Constituent Service Inquiries. This proposed recommendation examines how federal agencies receive, process, and respond to congressional inquiries made on behalf of constituents who need assistance accessing federal programs or navigating adjudicative and other similar administrative processes. It identifies best practices for agencies to promote quality, efficiency, and timeliness in their procedures for responding to such inquiries. Among other topics, the proposed recommendation addresses the scope, content, internal dissemination, and public availability of these procedures where adopted.

Additional information about the proposals and the agenda, as well as any changes or updates to the same, can be found at the 81st Plenary Session page on the Conference's website prior to the start of the meeting at: https://www.acus.gov/event/81st-plenary-session.

Public Participation: The Conference welcomes the virtual attendance of the public at the meeting. Members of the public wishing to view the meeting are asked to RSVP online at the 81st Plenary Session web page shown above no later than two days before the meeting to ensure adequate bandwidth and accessibility. A link to a livestream of the meeting will be posted the morning of the meeting on the 81st Plenary Session web page. A video recording of the meeting will be available on the Conference's website shortly after the conclusion of the event at https://youtube.com/channel/UC1Gu44Jq1U7XsGdC9Tfl_zA.

Written Comments: Persons who wish to comment on any of the proposed recommendations may do so by submitting a written statement either by email to info@acus.gov with “June 2024 Plenary Session Comments” in the subject line of the email, or by U.S. Mail addressed to: June 2024 Plenary Session Comments, Administrative Conference of the United States, Suite 706 South, 1120 20th Street NW, Washington, DC 20036. Written submissions must be received no later than 10:00 a.m. (EDT), Friday, June 7, 2024, to ensure consideration by the Assembly.

The NACMCF was established in 1988, in response to a recommendation of the National Academy of Sciences for an interagency approach to microbiological criteria for foods, and in response to a recommendation of the U.S. House of Representatives Committee on Appropriations, as expressed in the Rural Development, Agriculture, and Related Agencies Appropriation Bill for fiscal year 1988. The charter for the NACMCF is available for viewing at https://www.fsis.usda.gov/policy/advisory-committees/national-advisory-committee-microbiological-criteria-foods-nacmcf. The NACMCF provides impartial scientific advice and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services on public health issues relative to the safety and wholesomeness of the U.S. food supply, including development of microbiological criteria and review and evaluation of epidemiological and risk assessment data and methodologies for assessing microbiological hazards in foods. The Committee also provides scientific advice and recommendations to the Departments of Commerce and Defense. The Committee reports to the Secretary of Agriculture through the Under Secretary for Food Safety, the Committee's Chair, and to the Secretary of Health and Human Services through the Assistant Secretary for Health, the Committee's Vice-Chair. Currently, Dr. Emilio Esteban, Under Secretary for Food Safety, USDA, is the Committee Chair; Dr. Donald Prater, Acting Director of the Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN), is the Vice-Chair; and Dr. Kristal Southern, USDA FSIS, is the Director of the NACMCF Executive Secretariat and Designated Federal Officer.

NACMCF documents and comments posted on the FSIS website are electronic conversions from a variety of source formats. In some cases, document conversion may result in character translation or formatting errors. The original document is the official, legal copy. To meet the electronic and information technology accessibility standards in Section 508 of the Rehabilitation Act, NACMCF may add alternate text descriptors for non-text elements (graphs, charts, tables, multimedia, etc.). These modifications only affect the internet copies of the documents. Copyrighted documents will not be posted on FSIS' website but will be available for inspection in the FSIS Docket Room.

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

In accordance with Federal civil rights law and USDA civil rights regulations and policies, USDA, its Mission Areas, agencies, staff offices, employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/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.

Program information may be made available in languages other than English. Persons with disabilities who require alternative means of communication to obtain program information ( e.g., Braille, large print, audiotape, American Sign Language) should contact the responsible Mission Area, agency, or staff office; the USDA TARGET Center at (202) 720-2600 (voice and TTY); or the Federal Relay Service at (800) 877-8339.

To file a program discrimination complaint, a complainant should complete a Form AD-3027, USDA Program Discrimination Complaint Form, which can be obtained online at https://www.usda.gov/forms/electronic-forms, from any USDA office, by calling (866) 632-9992, or by writing a letter addressed to USDA. The letter must contain the complainant's name, address, telephone number, and a written description of the alleged discriminatory action in sufficient detail to inform the Assistant Secretary for Civil Rights (ASCR) about the nature and date of an alleged civil rights violation. The completed AD-3027 form or letter must be submitted to USDA by:

(1) Mail: U.S. Department of Agriculture Office of the Assistant Secretary for Civil Rights 1400 Independence Avenue SW, Washington, DC 20250-9410;

(2) Fax: (833) 256-1665 or (202) 690-7442; or

(3) Email: program.intake@usda.gov .

Equal opportunity practices in accordance with USDA's policies will be followed in all appointments to the FACA Committee. To ensure that the recommendations of the Committee have taken into account the needs of the diverse groups served by the Department, membership shall include, to the extent practicable, individuals with demonstrated ability to represent the many communities, identities, races, ethnicities, backgrounds, abilities, cultures, and beliefs of the American people, including underserved communities. USDA is an equal opportunity provider, employer, and lender.

On May 2, 2019, Commerce published the Order on LDWP from Korea. 1 On February 1, 2024, Commerce published the notice of initiation of the first sunset review of the Order, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.218(c). 2 On February 16, 2024, Commerce received a timely notice of intent to participate from the domestic interested party in the underlying investigation, American Line Pipe Producers Association Trade Committee, within the 15-day deadline specified in 19 CFR 351.218(d)(1)(i). 3 The domestic interested party claimed interested party status within the meaning of section 771(9)(F) of the Act and 19 CFR 351.102(b)(29)(viii) as an association in which the majority of its members are producers of the domestic like product. 4

On March 4, 2024, Commerce received an adequate substantive response to the Initiation Notice from the domestic interested party within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). 5 Commerce received no responses from the Government of Korea (GOK) or from any other interested party. In accordance with section 751(c)(3)(B) of the Act, because Commerce did not receive a substantive response from the GOK or a respondent party, pursuant to 19 CFR 351.218(e)(1)(ii)(B) and (e)(1)(ii)(C), respectively, we determined that the respondent interested parties did not provide an adequate response to the Initiation Notice . Therefore, consistent with 19 CFR 351.218(e)(1)(ii)(B)(2) and (e)(1)(ii)(C)(2), on March 22, 2024, Commerce notified the International Trade Commission that it did not receive an adequate substantive response from respondent interested parties, and that it would conduct an expedited (120-day) sunset review of the Order . 6

The product covered by the Order is large diameter welded pipe from Korea. For a complete description of the scope of the Order, see the Issues and Decision Memorandum. 7

A complete discussion of all issues raised in this sunset review, including the likelihood of the continuation or recurrence of subsidization in the event of revocation of the Order and the countervailable subsidy rates likely to prevail if the Order were to be revoked, is provided in the Issues and Decision Memorandum. A list of the topics discussed in the Issues and Decision Memorandum is attached as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS), which is available to registered users at https://access.trade.gov . In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNotices/ListLayout.aspx .

Pursuant to sections 751(c)(1) and 752(b) of the Act, we determine that revocation of the Order would be likely to lead to continuation or recurrence of countervailable subsidies at the following net countervailable subsidy rates:

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

Commerce is issuing and publishing these final results and this notice in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act, and 19 CFR 351.218.

On March 6, 2019, Commerce published the Order on LDWP from India. 1 On February 1, 2024, Commerce published the notice of initiation of the first sunset review of the Order, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.218(c). 2 On February 16, 2024, Commerce received a timely notice of intent to participate from the domestic interested party in the underlying investigation, American Line Pipe Producers Association Trade Committee, 3 within the 15-day deadline specified in 19 CFR 351.218(d)(1)(i). 4 The domestic interested party claimed interested party status within the meaning of section 771(9)(F) of the Act and 19 CFR 351.102(b)(29)(viii) as an association in which the majority of its members are producers of the domestic like product. 5

On March 4, 2024, Commerce received an adequate substantive response to the Initiation Notice from the domestic interested party within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). 6 Commerce received no responses from the Government of India (GOI) or from any other interested party. In accordance with section 751(c)(3)(B) of the Act, because Commerce did not receive a substantive response from the GOI or a respondent party, pursuant to 19 CFR 351.218(e)(1)(ii)(B) and (e)(1)(ii)(C), respectively, we determined that the respondent interested parties did not provide an adequate response to the Initiation Notice. Therefore, consistent with 19 CFR 351.218(e)(1)(ii)(B)(2) and (e)(1)(ii)(C)(2), on March 22, 2024, Commerce notified the International Trade Commission that it did not receive an adequate substantive response from respondent interested parties, and that it would conduct an expedited (120-day) sunset review of the Order. 7

The product covered by the Order is large diameter welded pipe from India. For a complete description of the scope of the Order, see the Issues and Decision Memorandum. 8

A complete discussion of all issues raised in this sunset review, including the likelihood of the continuation or recurrence of subsidization in the event of revocation of the Order and the countervailable subsidy rates likely to prevail if the Order were to be revoked, is provided in the accompanying Issues and Decision Memorandum. A list of the topics discussed in the Issues and Decision Memorandum is attached as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS), which is available to registered users at https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNotices/ListLayout.aspx.

Pursuant to sections 751(c)(1) and 752(b) of the Act, we determine that revocation of the Order would be likely to lead to continuation or recurrence of countervailable subsidies at the following net countervailable subsidy rates:

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

Commerce is issuing and publishing these final results and this notice in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act, and 19 CFR 351.218.

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 the 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 April 15, 2022, we issued a final rule upon request from the Society for authorization to take marine mammals incidental to lighthouse maintenance and preservation activities at NWSR, offshore of Crescent City, CA (87 FR 22484). These activities include aircraft operations, lighthouse renovation, light maintenance activities, and tour operations. These regulations include mitigation, monitoring, and reporting requirements for the incidental take of marine mammals during the specified activities.

NMFS previously issued an LOA under the regulations that was effective from May 15, 2022, through May 14, 2023 (87 FR 30918, May 20, 2022). The Society has requested issuance of a subsequent LOA for remaining work described in the regulations, to be effective until expiration of the regulations on May 15, 2027.

The 2022 LOA included a requirement for quarterly monitoring report submissions, and the notice of issuance for the 2022 LOA stated that NMFS would reevaluate that requirement prior to issuance of subsequent LOAs to the Society. Upon review of the Society's reporting, NMFS has determined that annual reporting is sufficient, as allowed under the regulations (50 CFR 217.55(b)(1)(i)).

NMFS has issued an LOA to the Society for the harassment of small numbers of four marine mammal species incidental to conducting aircraft operations, lighthouse renovation, light maintenance activities, and tour operations at NWSR.

This meeting is being held under the provisions of chapter 10 of title 5, United States Code (U.S.C.) (commonly known as the “Federal Advisory Committee Act” or “FACA”), 5 U.S.C. 552b (commonly known as the “Government in the Sunshine Act”), and 41 CFR 102-3.140 and 102-3.150.

Due to circumstances beyond the control of the DFO, the Defense Business Board was unable to provide public notification required by 41 CFR 102-3.150(a) concerning changes to its May 7-8, 2024 meeting that was previously announced in the Federal Register on April 23, 2024. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

Purpose of the Meeting: The mission of the Board is to examine and advise the Secretary and Deputy Secretary of Defense on overall DoD management and governance. The Board provides independent, strategic-level, private sector and academic advice and counsel on enterprise-wide business management approaches and best practices for business operations and achieving National Defense goals.

Agenda: The Board will begin in closed session on May 7 from 8:10 a.m. to 7:00 p.m. The DFO will start the closed session followed by a welcome by Board Chair, Hon. Deborah James. The Board will have a working breakfast and receive a classified discussion on thawing the “Frozen Middle” from Hon. Kathleen Hicks, Deputy Secretary of Defense. The term `frozen middle' is used when an organization becomes `stuck in its ways' at the middle management levels. Those personnel layers tend to delay or avoid change to remove risk from the process, thereby preventing substantial progress as a result. The discussion will consider the processes and practices that enable private industry to adapt workflows in a way that keep human expertise fully engaged while making the most of the new technologies. Next, the Board will receive a classified discussion on Implementing Emerging Technologies to Create Operational Strategic Effects from Mr. Jay Dryer, Director, Strategic Capabilities Office. This discussion is expected to focus on using existing DoD tools and processes to adapt developing technology to key operational challenges in the National Defense Strategy. Next, the Board will receive a classified discussion on Current Affairs from Hon. Lloyd Austin, Secretary of Defense. This session will focus on the state of the current global security environment and its implications for current and future business operations. The Board will receive a classified briefing on Naval Research Lab (NRL) Operations at the U.S. Naval Research Laboratory, followed by a classified tour. This tour and discussion will explore management constructs unique to NRL's mission and personnel, to include developing and managing talent and communicating across a diverse workforce. This portion of the meeting will cover how NRL partners with industry to fulfill their mandate and demonstrates capabilities made possible by NRL's organizational constructs and authorities. The Board will meet at the Navy Executive Mess for the final session on May 7. The Board Chair, Hon Deborah James will provide remarks, followed by a classified update on Industry Partnerships with the Director of Information Systems Agency (DISA), Lt Gen Robert J. Skinner, Director of DISA and the Commander of the Joint Force Headquarters-Department of Defense Information Network. The Director will offer an overview of DISA's partnerships with various stakeholders to bolster warfighter capabilities, including how DISA is developing global situational awareness and assessing the threat against DISA operations and assets. He will discuss unique challenges of managing a DoD Agency and Field Activity, as well as provide insights on recommendations from the February 2023 DBB IT User Experience Study. The DFO will adjourn the closed session. The Board will reconvene in closed session May 8 from 8:30 a.m. to 11:50 a.m. in room B7 of the Pentagon Library Conference Center. The DFO will begin the closed session followed by a welcome by the Board Chair. The Board will receive a classified discussion on Growing Production Capacity for Crises from Dr. Erin Simpson, Director, Joint Production Accelerator Cell, Office of the Under Secretary of Defense for Acquisition & Sustainment. The conversation is expected to delve into actions the DoD is taking to prioritize resources and to create a modern, resilient defense industrial ecosystem designed to deter U.S. adversaries and meet the production demands posed by evolving threats. Dr. Simpson will elaborate on the obstacles confronting the DoD in building resilient supply chains. Next, the Board will receive a classified discussion on Emerging Global Threats, including the Supply Chain, and their Potential Implications for the National Defense Strategy from MG Joseph “JP” McGee, U.S. Army, Director for Strategy, Plans & Policy, J5. This discussion will focus on strategic proactiveness to ensure adaptability, resilience, and continued effectiveness in an ever-evolving security landscape and on how the DoD can partner with industry before and during crises. After a short break, the Board will receive their final classified discussion on Making DoD Work Attractive to Non-Traditional Companies from Hon. Kathleen Hicks, Deputy Secretary of Defense, along with Mr. Doug Beck, Director, Defense Innovation Unit. The Deputy Secretary and Mr. Beck will share successes DoD has realized in becoming a better partner for non-traditional defense companies, along with how combinations of traditional and non-traditional companies are working together to accelerate capability development and delivery. The DFO will adjourn the closed session. The latest version of the agenda will be available on the Board's website at: https://dbb.dod.afpims.mil/Meetings/Meeting-May-7-8-2024/.

Meeting Accessibility: In accordance with 5 U.S.C. 1009(d) and 41 CFR 102-3.155, it is hereby determined that the May 7-8 meeting of the Board will include classified information and other matters covered by 5 U.S.C. 552b(c)(1) and that, accordingly, the meeting will be closed to the public. This determination is based on the consideration that it is expected that discussions throughout the meeting will involve classified matters of national security. Such classified material is so intertwined with the unclassified material that it cannot reasonably be segregated into separate discussions without defeating the effectiveness and meaning of the meeting. To permit the meeting to be open to the public would preclude discussion of such matters and would greatly diminish the ultimate utility of the Board's findings and recommendations to the Secretary of Defense and the Deputy Secretary of Defense.

Written Comments and Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and 5 U.S.C. 1009(a)(3), the public or interested organizations may submit written comments or statements to the Board in response to the stated agenda of the meeting or regarding the Board's mission in general. Written comments or statements should be submitted to Ms. Cara Allison Marshall, the DFO, via electronic mail (the preferred mode of submission) at the address listed in the FOR FURTHER INFORMATION CONTACT section. Each page of the comment or statement must include the author's name, title or affiliation, address, and daytime phone number. The DFO must receive written comments or statements submitted in response to the agenda set forth in this notice by close of business Friday, May 3, 2024, to be considered by the Board. The DFO will review all timely submitted written comments or statements with the Board Chair and ensure the comments are provided to all members of the Board before the meeting. Written comments or statements received after this date may not be provided to the Board until its next scheduled meeting. Please note that all submitted comments and statements will be treated as public documents and will be made available for public inspection, including, but not limited to, being posted on the Board's website.

The DoD Office of Industrial Base Resilience recognizes that the integration of AI into defense systems is pivotal to national security. The DIB is responsible for developing, manufacturing, and maintaining the systems that the U.S. military uses to defend the nation. DoD collaborates with the DIB to rapidly adopt AI for defense applications and maintain the nation's tactical advantage.

The operation of the MRRIC is in the public interest and provides support to the Corps in performing its duties and responsibilities under Authority: 16 U.S.C. 1531 et seq.; Authority: Sec. 601(a), Public Law 99-662, 100 Stat. 4082; Sec. 334(a), Public Law 106-53, 113 Stat. 269; and sec. 5018, Public Law 110-114, 121 Stat. 1041. Authority: 5 U.S.C. App. 2, does not apply to the MRRIC.

A Charter for the MRRIC has been developed and should be reviewed prior to applying for a stakeholder representative membership position on the Committee. The Charter, operating procedures, and stakeholder application forms are available electronically at www.MRRIC.org.

1. The primary purpose of the MRRIC is to provide guidance to the Corps and U.S. Fish and Wildlife Service with respect to the Missouri River recovery and mitigation plan currently in existence, including recommendations relating to changes to the implementation strategy from the use of adaptive management; coordination of the development of consistent policies, strategies, plans, programs, projects, activities, and priorities for the Missouri River recovery and mitigation plan. Information about the Missouri River Recovery Program is available at www.MoRiverRecovery.org.

2. Other duties of MRRIC include exchange of information regarding programs, projects, and activities of the agencies and entities represented on the Committee to promote the goals of the Missouri River recovery and mitigation plan; establishment of such working groups as the Committee determines to be necessary to assist in carrying out the duties of the Committee, including duties relating to public policy and scientific issues; facilitating the resolution of interagency and intergovernmental conflicts between entities represented on the Committee associated with the Missouri River recovery and mitigation plan; coordination of scientific and other research associated with the Missouri River recovery and mitigation plan; and annual preparation of a work plan and associated budget requests.

Administrative Support. To the extent authorized by law and subject to the availability of appropriations, the Corps provides funding and administrative support for the Committee.

Committee Membership. Federal agencies with programs affecting the Missouri River may be members of the MRRIC through a separate process with the Corps. States and Federally recognized Native American Indian tribes, as described in the Charter, are eligible for Committee membership through an appointment process. Interested State and Tribal government representatives should contact the Corps for information about the appointment process.

This Notice is for individuals interested in serving as a stakeholder member on the Committee. Members and their alternates must be able to demonstrate that they meet the definition of “stakeholder” found in the Charter of the MRRIC. Applications are currently being accepted for representation in the stakeholder interest categories listed below:

a. Environmental/Conservation Organizations;

b. Fish & Wildlife;

c. Hydropower;

d. Irrigation;

e. Local Government;

f. Major Tributaries;

g. Navigation;

h. Recreation;

i. Thermal Power;

j. Water Quality;

k. Water Supply;

l. Waterway Industries.

Terms of stakeholder representative members of the MRRIC are three years. There is no limit to the number of terms a member may serve. Incumbent Committee members seeking reappointment do not need to re-submit an application. However, renewal requests are not guaranteed re-selection and they must submit a renewal request letter and related materials as outlined in the “Streamlined Process for Existing Members” portion of the document Process for Filling MRRIC Stakeholder Vacancies ( www.nwo.usace.army.mil/mrrp/mrric/ ).

Members and alternates of the Committee will not receive any compensation from the federal government for carrying out the duties of the MRRIC. Travel expenses incurred by members of the Committee are currently reimbursed by the federal government.

Application for Stakeholder Membership. Persons who believe that they are or will be affected by the Missouri River recovery and mitigation activities may apply for stakeholder membership on the MRRIC. Committee members are obligated to avoid and disclose any individual ethical, legal, financial, or other conflicts of interest they may have involving MRRIC. Applicants must disclose on their application if they are directly employed by a government agency or program (the term “government” encompasses state, tribal, and federal agencies and/or programs).

Applications for stakeholder membership may be obtained electronically at www.nwo.usace.army.mil/mrrp/mrric/. Applications may be emailed or mailed to the location listed (see ADDRESSES ). In order to be considered, each application must include:

1. The name of the applicant and the primary stakeholder interest category that person is qualified to represent;

2. A written statement describing the applicant's area of expertise and why the applicant believes he or she should be appointed to represent that area of expertise on the MRRIC;

3. A written statement describing how the applicant's participation as a Stakeholder Representative will fulfill the roles and responsibilities of MRRIC;

4. A written description of the applicant's past experience(s) working collaboratively with a group of individuals representing varied interests towards achieving a mutual goal, and the outcome of the effort(s);

5. A written description of the communication network that the applicant plans to use to inform his or her constituents and to gather their feedback, and

6. A written endorsement letter from an organization, local government body, or formal constituency, which demonstrates that the applicant represents an interest group(s) in the Missouri River basin.

To be considered, the application must be complete and received by the close of business on July 31, 2024, at the location indicated (see ADDRESSES ). Applications must include an endorsement letter to be considered complete. Full consideration will be given to all complete applications received by the specified due date.

Application Review Process. Committee stakeholder applications will be forwarded to the current members of the MRRIC. The MRRIC will provide membership recommendations to the Corps as described in Attachment A of the Process for Filling MRRIC Stakeholder Vacancies document ( www.nwo.usace.army.mil/mrrp/mrric/ ). The Corps is responsible for appointing stakeholder members. The Corps will consider applications using the following criteria:

• Ability to commit the time required.

• Commitment to make a good faith (as defined in the Charter) effort to seek balanced solutions that address multiple interests and concerns.

• Agreement to support and adhere to the approved MRRIC Charter and Operating Procedures.

• Demonstration of a formal designation or endorsement by an organization, local government, or constituency as its preferred representative.

• Demonstration of an established communication network to keep constituents informed and efficiently seek their input when needed.

• Agreement to participate in collaboration training as a condition of membership.

All applicants will be notified in writing as to the final decision about their application.

Certification. I hereby certify that the establishment of the MRRIC is necessary and in the public interest in connection with the performance of duties imposed on the Corps by the Endangered Species Act and other statutes.

Purpose of the Board: The Electric Vehicle Working Group (EVWG) was formed by the Joint Office of Energy and Transportation to make recommendations to the Secretaries of Energy and Transportation regarding the development, adoption, and integration of light-, medium-, and heavy-duty electric vehicles (EVs) into the U.S. transportation and energy systems.

Tentative Agenda: The meeting will start at 1 p.m. Eastern Time on Monday, June 17, 2024. The tentative meeting agenda includes: a report out and discussion lead by each of the three subcommittees; medium/heavy-duty adoption, grid integration, charging network. Meeting materials and a link to registration can be found here: https://driveelectric.gov/ev-working-group.

Public Participation: This virtual meeting is open to the public. Individuals who would like to attend must register at: https://driveelectric.gov/ev-working-group.

Individuals and representatives of organizations who would like to offer comments and suggestions may do so during the public comment portion of the meeting. Approximately 20 minutes will be reserved for public comments at the end of the meeting. Time allotted per speaker will depend on the number who wish to speak but will not exceed three minutes. The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Those wishing to speak during the public comment period should indicate so within their registration.

Those not able to attend the meeting or who have insufficient time to address the committee are invited to send a written statement to Dr. Rachael Nealer, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585, or email: evwg@ee.doe.gov.

Minutes: The minutes of the meeting will be available on https://driveelectric.gov/ev-working-group or by contacting Dr. Nealer. She may be reached at the above postal address or email address.

Signing Authority: This document of the Department of Energy was signed on May 16, 2024, by David Borak, Deputy Committee Management Officer, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

In accordance with the Privacy Act of 1974, and to comply with the Office of Management and Budget (OMB) Memorandum M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, January 3, 2017, this notice has fourteen (14) routine uses, including two new routine uses that will permit FERC to disclose information as necessary in response to an actual or suspected breach that pertains to a breach of its own records or to assist another agency in its efforts to respond to a breach that was previously published separately at 87 FR 35543 (June 10, 2022).

The following sections have been updated to reflect changes made since the publication of the last notice in the Federal Register : dates; addresses; system name; system location; authority for maintenance of the system; purpose of the system; categories of individuals covered by the system; categories of records in the system; record source categories; routine uses of records maintained in the system, including categories of users and the purpose of such; policies and practices for storage of records; policies and practices for retrieval of records; policies and practices for retention and disposal of records; administrative, technical, and physical safeguards; records access procedures; contesting records procedures; notification procedures; and history.

In accordance with the Privacy Act of 1974, and to comply with the Office of Management and Budget (OMB) Memorandum M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, January 3, 2017, this notice has twelve (12) new routine uses, including two routine uses that will permit FERC to disclose information as necessary in response to an actual or suspected breach that pertains to a breach of its own records or to assist another agency in its efforts to respond to a breach that was previously published separately at 87 FR 35543 (June 10, 2022).

The following sections have been updated to reflect changes made since the publication of the last notice in the Federal Register : dates; addresses; for further contact information; system location; system manager; purpose of the system; categories of individuals covered by the system; categories of records in the system; record source categories; routine uses of records maintained in the system, including categories of users and the purpose of such; policies and practices for storage of records; policies and practices for retrieval of records; policies and practices for retention and disposal of records; administrative, technical, physical safeguards; records access procedures; contesting records procedures; notification procedures; and history.

The Charter of the WHEJAC states that the advisory committee “will provide independent advice and recommendations to the Chair of the Council on Environmental Quality (CEQ) and to the White House Environmental Justice Interagency Council (IAC) on how to increase the Federal Government's efforts to address current and historic environmental injustice. The WHEJAC will provide advice and recommendations about broad cross-cutting issues related, but not limited, to issues of environmental justice and pollution reduction, energy, climate change mitigation and resiliency, environmental health, and racial inequity. The WHEJAC's efforts will include a broad range of strategic, scientific, technological, regulatory, community engagement, and economic issues related to environmental justice.”

Executive Order 14008 on Tackling the Climate Crisis at Home and Abroad, as amended by Executive Order 14096 on Revitalizing Our Nation's Commitment to Environmental Justice for All, established the IAC to, among other things, pursue a whole-of-government approach to advance environmental justice for all, as defined in Executive Order 14096, including to facilitate interagency coordination and collaboration on programs and activities related to environmental justice; and to develop and sustain a strategy to address current and historic environmental injustice and to cultivate effective strategic planning to advance environmental justice. To facilitate the work of the IAC, each IAC member has designated an official within the agency to serve as an Environmental Justice Officer, with the authority to represent the agency on the IAC. Executive Order 14096 directs the IAC to hold a public meeting in coordination with the WHEJAC. For more information about the IAC, see: https://www.whitehouse.gov/environmentaljustice/white-house-environmental-justice-interagency-council/.

The WHEJAC meeting will focus on several topics including, but not limited to, workgroup updates, updates from the Council on Environmental Quality (CEQ), panels, and final recommendations for CEQ and the IAC.

The IAC/WHEJAC joint public meeting will focus on several topics, such as Federal agencies' progress to advance environmental justice, including through the Justice40 Initiative, the Environmental Justice Scorecard, and environmental justice strategic planning; and formal recommendations from the WHEJAC to CEQ and the IAC. During the session, the WHEJAC and IAC will hear comments from the public relevant to current WHEJAC charges and other topics of interest.

Registration: Individual registration is required for the public meeting. No two individuals can share the same registration link. To register, visit https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council#meetings. Members of the public may register to attend the public meeting throughout the duration of the meeting. Members of the public who wish to speak during the public comment period must register by 11:59 p.m., Eastern Time, May 30, 2024. When registering, please provide your name, organization, city and state, and email address for follow up, and indicate whether you would like to provide public comments during the meeting.

(1) Carbon management.

(2) Environmental justice issues affecting Indigenous Peoples and Tribal Nations.

The WHEJAC Indigenous Peoples and Tribal Nations Workgroup is particularly interested in receiving comments on: (a) Examples of environmental hazards of particular concern for Indigenous Peoples and Tribal Nations (for example, environmental hazards related to Federal activities that may affect sacred sites and areas of cultural significance, cultural or other traditions or practices, subsistence, and ways of life); (b) Ways in which the Federal Government can address community impacts on, and concerns of, Indigenous Peoples and Tribal Nations; and (c) Ways in which the incorporation of Indigenous knowledge into Federal decision making could help address environmental hazards and environmental justice concerns. More information about the WHEJAC's current charges can be found online at https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council, under WHEJAC Membership and Workgroups.

The IAC is interested in receiving public comments relevant to environmental justice goals and priorities, either for the coming year or over a longer term, that could advance the IAC's mission and work as defined in Executive Orders 14008 and 14096, including on ways to address and respond to formal recommendations from the WHEJAC;  1 the future Environmental Justice Science, Data, and Research Plan of the National Science and Technology Council's Environmental Justice Subcommittee; and environmental justice strategic planning and implementation of Executive Order 14096, including specific goals, objectives, priority actions, and metrics that could help agencies advance and assess progress over time. 2

Individuals or groups making remarks during the oral public comment period will be limited to three minutes. EPA will give priority to speak during the meeting to public commenters with comments relevant to the topics and questions listed above. The WHEJAC and the IAC will make every effort to hear from each public commenter who has registered to provide oral comments during the time specified on the agenda but, in the interest of time, commenters are strongly encouraged to consider submitting written comments for the record. You can submit your written comments by using the webform at https://www.epa.gov/environmentaljustice/forms/white-house-environmental-justice-advisory-council-whejac-public-comment; by emailing comments to whejac@epa.gov; or by visiting https://www.regulations.gov and opening Docket ID No. EPA-HQ-OEJECR-2024-0147. The WHEJAC and the IAC will accept written comments through Wednesday, June 19, 2024.

B. Information About Services for Individuals With Disabilities or Requiring English Language Translation Assistance: For information about access or services for individuals requiring assistance, contact Audrie Washington at (202) 441-7295 or whejac@epa.gov. All requests should be sent via this email or phone number. To request special accommodations for a disability or other assistance, please submit your request at least seven (7) working days prior to the meeting, to give EPA sufficient time to process your request.

This is a proposed extension of the ICR, which is currently approved through December 31, 2024. 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. This notice allows 60 days for public comments. Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets. Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate forms of information technology. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: Section 609 of the Clean Air Act Amendments of 1990 (Act) provides general guidelines for the servicing of motor vehicle air conditioners (MVACs). It states that “no person repairing or servicing motor vehicles for consideration may perform any service on a motor vehicle air conditioner involving the refrigerant for such air conditioner without properly using approved refrigerant recycling equipment and no such person may perform such service unless such person has been properly trained and certified.” In 1992, EPA developed regulations under section 609 that were published in 57 FR 31240 and codified at 40 CFR Subpart B (Section 82.30 et seq. ). The information required to be collected under the section 609 regulations is: approved refrigerant handling equipment; approved independent standards testing organizations; technician training and certification; and certification, reporting and recordkeeping.

Form numbers: None.

Respondents/affected entities: The following is a list of NAICS codes for organizations potentially affected by the information requirements covered under this ICR. It is meant to include any establishment that may service or maintain motor vehicle air conditioners.

Other affected groups include independent standards testing organizations and organizations with technician certification programs.

Respondent's obligation to respond: Mandatory (40 CFR 82.36, 82.38, 82.40, 82.42).

Estimated number of respondents: 53,147.

Frequency of response: On occasion, biennially, only once.

Total estimated burden: 4,760 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $255,289 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in estimates: There is an increase of about 502 hours in the total estimated respondent burden compared with the ICR currently approved by OMB (EPA-HQ-OAR-2021-0040). This increase is due to a revision in the estimate of the total annual number of technicians certified under 40 CFR 82 (40,000/year in 2021 to 47,000/year in 2024), and an increase in the number of motor vehicle repair establishments in the United States (165,800 in 2021 to about 170,000 in 2024).

Based on available information, it appears that conditions created by the Government of Canada (Canada) in connection with regulation of ballast water management systems may adversely affect the operation of United States carriers in the United States/Canada Great Lakes trade, in particular the carriers operating vessels that may become subject to regulation in September 2024, within the meaning of 46 U.S. Code, chapter 423 (Foreign Shipping Practices) (46 U.S.C. 42301-307). Title 46 U.S.C. 42302 authorizes the Federal Maritime Commission (Commission) to investigate these conditions, and chapter 423 authorizes the agency to take action in response.

In 2020, the Lake Carriers Association (LCA) filed a petition with the Commission as to pending Canadian regulation of ballast water discharge on the Great Lakes. See FMC Docket No. 20-10, P1-20—Petition of the Lake Carriers' Association Pursuant to Section 19 of the Merchant Marine Act, 1920. LCA's petition alleged that Canadian regulation scheduled to take effect in September 2024 would create conditions unfavorable to shipping by requiring U.S. vessels to install new ballast water management systems. LCA argued that this would impose a severe burden while offering negligible environmental benefits, since the relevant U.S. carriers (Lakers) take in but do not discharge ballast water in Canadian waters. The petition asked the Commission to investigate and adopt its own regulations in response. The Commission opened an investigation under 46 U.S. Code, chapter 421 (Regulations Affecting Shipping in Foreign Trade). See FMC Docket No. 20-10. In that Chapter 421 proceeding, the FMC sought and received comments, including from the Government of Canada. See FMC Notices, 85 FR 37453 (June 22, 2020), 87 FR 6173 (February 3, 2022); Comments of the Embassy of Canada, Government of Canada, Docket No. 20-10 (Doc. No. 3) (July 22, 2020).

Since at least 2020, the U.S. Environmental Protection Agency (EPA) has been engaged in rulemaking to consider similar regulation. See Vessel Incidental Discharge National Standards of Performance, 85 FR 67818 (Oct. 26, 2020) (to be codified in 40 CFR part 139); Supplemental Notice, 88 FR 71788 (Oct. 18, 2023). The EPA's October 2023 Supplemental Notice in that rulemaking indicates that the agency is considering issuing a final rule that is less restrictive than the regulation due to take effect in Canada, as it would require the type of ballast water systems at issue only for covered vessels built in the future. See 88 FR 71803-04 (explaining differences between proposed regulatory option and relevant Canadian regulation); id. at 71,808 (“EPA proposes to define a New Laker as a bulk carrier that operates exclusively on the Great Lakes and that is constructed after the effective date of [U.S. Coast Guard] regulations promulgated pursuant to [Clean Water Act] section 312(p)(5)(A)(i)”).

In February 2024, the LCA filed a public letter in the Commission's Chapter 421 proceeding. See Docket No. 20-10 (Doc. 8) (Feb. 13, 2024). The letter urged the Commission to move forward promptly. The LCA emphasized that its members' Lakers would have to prepare to comply with the stricter Canadian rules before the compliance date of September 8, 2024, even though the EPA was unlikely to require them to meet the stricter standards. Id. At 2-3. In addition, the letter stated that these U.S.-flagged Lakers had been effectively prevented from applying for an exemption or extension from the Canadian regulation, because relevant procedures were not expected to be in place prior to July 2024, despite the impending compliance date. Id. At 2, 4. The letter confirmed that only five of the existing U.S. Lakers would be affected by the regulation in September 2024 (one post-2008 vessel already has the required equipment); the approximately 50 other U.S. Lakers were built prior to 2009. Id. Attachment C. However, the LCA argued that the five post-2008 Lakers would be compelled either to install the required equipment, a “multimillion dollar investment” that they might well need to remove later in light of changing U.S. requirements, or to “walk away from the business.” Id. At 4.

In light of the above, the Commission will, on its own motion, open an investigation under 46 U.S. Code, Chapter 423 (Foreign Shipping Practices). See 46 CFR part 555. In particular, the Commission will investigate whether the laws, rules, policies, or practices of Canada result in conditions that “adversely affect the operations of United States carriers in United States oceanborne trade” and that “do not exist for foreign carriers of [Canada] in the United States under the laws of the United States.” 46 U.S.C. 42302(a). Such conditions may exist here, in view of the LCA's allegations that U.S. carriers will suffer significant adverse effects from the impending Canadian regulation, but Canadian carriers operating in the United States are not subject to comparable requirements under U.S. law. Under 46 U.S.C. 42302(c), the Commission is to complete its investigation and render a decision within 120 days after it is initiated.

If the agency concludes that the standard of section 42302(a) is met, it is authorized to take certain actions to encourage remediation of those conditions. Specifically, the Commission may take actions “against any foreign carrier that is a contributing cause, or whose government is a contributing cause, to those conditions.” 46 U.S.C. 42304(a). Potential actions include imposing limits and/or fees on Canadian-flagged vessels that visit U.S. ports and requesting that the U.S. Department of Homeland Security and the U.S. Coast Guard refuse clearance and deny entry of such vessels into the U.S., or detain such vessels. See 46 U.S.C. 42304, 42305. Any such fees could be substantial, as they are authorized by law at a level up to $2,559,636 per voyage. See 46 CFR 506.4. Under section 42304(b), the Commission “may consult with, seek the cooperation of, or make recommendations as to other appropriate agencies of the United States government” prior to taking such action. When the Commission initiates a Chapter 423 investigation, it will notify the U.S. Secretary of State and may request that the Secretary “seek resolution of the matter through diplomatic channels.” 46 CFR 555.7. Before any action is taken under 46 U.S.C. 42304 or 42305, the relevant determination is submitted for Presidential review, within 10 days of receipt, under 46 U.S.C. 42306.

At this initial stage of the investigation, the Commission will focus on providing a route for interested parties, including the Government of Canada, as well as Canadian carriers operating in the Great Lakes trade, to provide information, perspectives, and proposed solutions.

The Commission has determined that the above situation meets the threshold requirements for consideration under the relevant statutory and regulatory authority. See 46 U.S.C. 42302; 46 CFR 555.3, 555.5. The Commission has therefore determined to initiate an investigation into whether the situation has created conditions that adversely affect the operations of United States carriers as described above. See 46 U.S.C. 42302; 46 CFR 555.5, 555.6. To that end, the Commission has designated the General Counsel to lead an investigation into the conditions and to prepare a report on the investigation's findings and recommendations for Commission consideration.

Interested persons are requested to submit written comments containing arguments, experiences, and/or data relevant to the above-described conditions, with a particular focus on the situation of vessels that will become subject to the Canadian regulation described above in September 2024. It would be especially helpful for the agency to receive comments addressing what options exist for carriers to seek an exemption from the Canadian regulations going into effect in September 2024, and whether any such processes differ based on whether the carrier is a U.S. carrier or a Canadian carrier.

The Commission's jurisdiction under 46 U.S.C. 42302 is broad, and the agency welcomes comments not only from the Government of Canada, but also from container shipping interests, bulk cargo interests, vessel owners, individuals and groups with relevant information on commercial and environmental considerations, and anyone else with relevant information or perspectives on this matter.

As the Commission proceeds with this investigation, it may determine to request additional comment or gather information through other means as authorized under 46 U.S.C. 42303 and 46 CFR 555.5, 555.6.

ETSNext is the next generation governmentwide travel & expense solution being acquired by GSA. It is a mandatory program and GSA has responsibility through the Office of Governmentwide Policy, FAS Program Management and Governmentwide Category Management to provide this ETSNext solution.

The Bulletin provides immediate, actionable and practical steps agencies should take now to prepare for the transition to ETSNext. Agency actions include:

• Engaging with GSA to determine budgets and timelines for your agency's transition to ETSNext.

• Preparing for and prioritizing financial management (FM) systems integration with ETSNext.

• Executing a memorandum of understanding (MOU) with GSA that will memorialize both GSA's and agencies' understanding that certain tasks must be completed in accordance with a defined schedule to ensure a successful transition to ETSNext and the utilization of ETSNext for the life of the contract.

The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Management of Suicidal Thoughts and Behaviors in Youth. AHRQ is conducting this review pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.

The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( e.g., details of studies conducted). We are looking for studies that report on Management of Suicidal Thoughts and Behaviors in Youth. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/suicidal-thoughts-youth/protocol.

This is to notify the public that the EPC Program would find the following information on Management of Suicidal Thoughts and Behaviors in Youth helpful:

A list of completed studies that your organization has sponsored for this topic. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.

For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.

A list of ongoing studies that your organization has sponsored for this topic. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.

Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this topic and an index outlining the relevant information in each submitted file.

Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.

The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.

The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.

KQ 1. For youth, what are the effectiveness, comparative effectiveness, and harms of treatments for suicidal thoughts and behaviors?

(a) What are the components of effective psychosocial treatments ( e.g., frequency or intensity of therapy and/or aspects of the therapeutic modality)?

(b) How do social determinants of health, racism and disparities, care delivery methods, patient demographics and psychiatric or developmental co-occurring conditions affect outcomes?

Patient safety is a pillar of the Agency for Healthcare Research and Quality's (AHRQ's) mission to support the highest quality healthcare. While progress has been made in many areas of patient safety, the field of diagnostic safety has emerged as a particular area of concern. It is estimated that every person in the United States will experience a diagnostic error in their lifetime (Institute of Medicine, 2015) which can lead to inappropriate, delayed, or withheld treatment and ultimately poor health outcomes, distress, and increased costs. Diagnostic errors can occur for many reasons: lack of meaningful engagement between clinicians, patients, and families; a fragmented healthcare system not designed to account for an increasingly complex diagnostic process; minimal (if any) feedback to clinicians about their diagnostic performance; and a culture that does not always support transparent disclosure of diagnostic errors (Institute of Medicine, 2015). Leaders in diagnostic excellence suggest that multi-pronged efforts are needed to address this complex problem and go beyond individual behaviors to system-level changes and empowering patients to engage in their care (Institute of Medicine, 2015; Henriksen, et al., 2017).

Improving diagnostic safety and quality is an AHRQ priority. In recognition of the multifaceted approach needed to effectively advance diagnostic safety, AHRQ recently supported the development of three tools to prevent diagnostic errors and have prioritized these tools for implementation and testing. These resources vary in the types of stakeholders they target, a critical advancement in our approach to diagnostic excellence.

• Calibrate Dx. This tool, targeted to individual clinicians, invites users to select a topic or condition, review diagnostic performance on a sample of cases for insights and learning opportunities, and debrief with a peer. This resource will be tested in all settings where clinicians are involved in the diagnostic process, including both inpatient and ambulatory settings.

• Measure Dx. This tool supports healthcare organizations in building sustainable teams for improving diagnostic excellence, identifying current capacity gaps, engaging in measurement strategies as part of a systematic approach to reviewing available data, and translating findings into learning opportunities. This resource will be tested in both inpatient and ambulatory settings; it is expected to be implemented more commonly in inpatient settings.

• Toolkit for Engaging Patients to Improve Diagnostic Safety (Patient Toolkit). This tool prepares patients, families, and health professionals to work together as partners to improve diagnostic safety; encourages patients to prepare for visits; and encourages providers to listen for 60 seconds before interrupting the patient. This resource will be tested in ambulatory settings only.

The goal of this research is to implement and test these three diagnostic safety resources to identify specific ways in which each resource can be used to maximize its value. For each resource the following will be examined:

(1) Feasibility of implementation—barriers, facilitators, success factors, and time needed for implementation

(2) Level of adoption—number and type of clinicians aware of and/or using the resource, number of organizational leaders endorsing the resource

(3) Effectiveness of the resource—number of diagnostic safety events (Measure Dx and Patient Toolkit), clinician self-efficacy for diagnostic decision-making (Calibrate Dx)

(4) Maintenance and sustainability—the number and type of patient safety processes in place, barriers and facilitators to maintenance and sustainability

This project will implement and test these three diagnostic safety resources across a minimum of 150 sites to up to 219 sites ( i.e., 50 to 73 sites per resource). An Implementation and Testing period for each resource will last 12 months, with Calibrate Dx starting implementation first and Measure Dx and the Toolkit for Engaging Patients starting implementation six months later. This timing allows for staggered recruitment to ensure adequate sample size and to pilot implementation processes with a single diagnostic safety resource first, transferring lessons learned about implementation and testing to the implementation of the two other resources. A Sustainability period will begin as soon as the 12-month Implementation and Testing Period is complete and will continue for 14 additional months for each resource.

To achieve the goals of this project the following data collections will be implemented:

1. Site Interest Form—A short form completed once by up to 1060 sites interested in participating in the project. Used to indicate interest in the project and by AHRQ to evaluate whether the site meets the minimum participation criteria.

2. Site Information Form—Completed once by site leaders at 265 sites that begin the project enrollment process, this form collects additional contact information, data on patient mix, and information on the organization's diagnostic safety teams, resource commitments, and capacity for implementing the resources.

3. Safer Dx Checklist—Completed once by 219 sites who fully complete enrollment activities and begin implementation of one of the three resources (82.6% of the 265 sites who begin enrollment activities). The Safer Dx Checklist is a tool that allows healthcare organizations to understand the current state of their diagnostic practices, identify areas to improve, and track progress toward diagnostic excellence over time. This will be completed prior to actual implementation of the resource.

4. Exit Interviews Protocol—Completed once by an estimated 69 sites (30% of those implementing one of the three resources) that withdraw from the project, this telephone interview will collect information on why the site could not sustain their efforts or participation.

5. A baseline assessment of patient safety culture will be conducted once for each of the 219 sites that begin participation. Completed once by site leads depending on the setting:

a. SOPS® Medical Office Survey with Diagnostic Safety Supplemental Item Set—Completed once by the site lead for 109 ambulatory clinics.

b. SOPS® Hospital Survey with Diagnostic Safety Supplemental Item Set—Completed once by the site lead for 110 inpatient sites.

6. Post-training Evaluation Form—Completed once by 1,350 clinicians and managers (90% of the 1,500 participants) attending the project's training sessions. The data will be used to track the perceived value of the training provided to enrolled sites.

7. Post-technical Assistance Evaluation Form—Administered up to 3 times to 1,500 clinicians and managers participating in the project's Learning Collaborative sessions; an estimated 90% response rate to this collection with a total of 4,050 forms completed. The data will be used to track the perceived value of the technical assistance provided to enrolled sites.

8. Clinical Sustainability Assessment Tool (CSAT)—Completed by 219 site leaders once between months 9 to 12 in advance of the 14-month sustainability period. The CSAT is a self-assessment to evaluate sustainability capacity of a clinical practice.

9. Implementation Interviews Protocol—A qualitative, semi-structured interview will be conducted with 438 site leads and/or frontline staff (up to 2 individuals from each site) at two points in time during implementation ( e.g., 6- and 18-months). The protocol is designed to elicit participant perspectives on implementation of the resource, capture lessons learned and best practices, and when possible, to provide support for adjustment to the implementation.

In addition to those noted above, the project will implement the following data collections specific to the individual resources.

For Measure Dx, the following data collections will be implemented:

10. Measure Dx Organizational Self-Assessment —This is one of the main components of the Measure Dx resource and is designed to gauge the organization's readiness to engage with Measure Dx. This checklist will be completed once by up to 73 Measure Dx sites during the project onboarding process.

11. Measure Dx Declaration of Measurement Strategy —The 73 Measure Dx sites will complete this form once to indicate their selection of measurement strategy to be implemented and provide confirmation of minimum necessary capabilities.

12. Diagnostic Safety Event Report —These reports will provide aggregate information on diagnostic safety events identified during a 12-month reporting period. The report will be completed by each participating site 3 times over the course of the testing and sustainability period at 3-, 12-, and 24-months; a total of 219 reports will be completed over the course of the project. Note that the contractor is not attempting to collect these reports at Month 0. Since part of the Measure Dx resource's goal is to support implementation of a measurement strategy, Month 3 will serve as the baseline.

13. Additional information on site safety culture, including use of diagnostic safety event data, activities to improve the quality of care, and the work environment will be collected through a survey at 3-, 12-, and 24-months during the implementation/sustainment. Five members of the Measure Dx team at each site will be surveyed; the expected response rate is 85% at each of the three administration periods. Depending on the setting, the following survey will be fielded:

a. Omnibus Safety and Culture Survey_Medical Offices —Completed by clinicians at 36 ambulatory clinics.

b. Omnibus Safety and Culture Survey_Hospitals —Completed by clinicians at 37 inpatient sites.

For Calibrate Dx, the following data collections will be implemented:

14. Calibrate Dx Survey —This survey collects clinicians' reflections on their diagnostic performance for 3-5 cases, with additional metrics around time to complete the review and the number of cases reviewed. This will be completed quarterly (following the Calibrate Dx guidance for implementation) during the implementation and testing period by up to 5 clinicians per site; with an estimated a 90% response rate to this collection.

15. Clinician Self-Efficacy Survey —The survey assesses clinician self-efficacy with diagnostic safety case review and improvement. Up to 5 clinicians per site will be asked to complete this survey two times, after training and again at the end of the testing phase, with an estimated 90% response rate to this collection.

For Patient Toolkit, the following data collections will be implemented:

16. Provider Characteristics Form —This form will be completed once by up to 15 providers at each of the 73 enrolled sites. This form collects information on practitioner type, years in practice, specialty, subspecialty, and percent of time spent in clinical practice.

17. Patient Toolkit Survey—Provider —This survey assesses provider-perceived skills and quality of communication. It will be administered to up to 15 providers at each site at five timepoints (Baseline, 3-, 6-, 9-, and 12-months), with a 90% anticipated response rate.

18. Provider Interview Protocol —A total of 50 qualitative, semi-structured interviews with site clinicians will be conducted during implementation. The interview protocol collects information related to diagnostic safety events; patient safety culture; feasibility, acceptability, utility, adoption, and spread of the Patient Toolkit; and insights into clinician experience.

19. Patient Toolkit Survey—Patient —The survey assesses patient-perceived experience and quality of communication, and collects basic patient demographics ( e.g., age, gender, education, race, ethnicity). This will be administered to site patients over a 1-week period at five timepoints (Baseline, 3-, 6-, 9-, and 12-months). The survey will be provided to patients upon check-out from a healthcare visit. A total of 12,500 surveys will be completed during each 1-week period.

20. Patient Interview Protocol —A total of 50 qualitative, semi-structured interviews will be completed with site patients during implementation. The interview protocol collects information on reason for visit, provider communication, and other insights into patient experience.

This study is being conducted by AHRQ through its contractor, RAND, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).

The data collection methods for this evaluation were selected to reduce participant burden and, where possible, to allow participants a choice of response mode. In addition, technology is used for data capture and qualitative coding and analysis.

Several forms and data collection instruments will be administered using a web mode. Site leads and participants will receive a link allowing them to complete the form online. The Site Interest Form will also be accepted as a hardcopy should organizations prefer to mail or fax these forms. All other forms will be administered either by a fillable form that can be returned via email, mail, or fax depending on the site or participant preference.

Interviews will be conducted by phone or video call ( e.g., Microsoft Teams, Zoom) with interviewers using a hardcopy version of the protocol. Interviews will be audio-recorded and transcribed, following verbal consent from participants. Qualitative software will be used for data coding and analysis of interviews.

The patient surveys will be provided to patients upon check-out from a healthcare visit and they will be encouraged to complete the survey before leaving the office. The survey will include a QR code to allow patients to access a web version of the form. Alternatively, the patient can complete the paper survey and it will be collected at the site, minimizing the need for patients to return the paper survey by mail. The paper surveys will be formatted for data scanning, and data from all paper surveys returned to the contractor will be scanned into an electronic datafile.

This section summarizes the total burden hours for this information collection effort in addition to the cost associated with those hours.

Exhibit 1 contains estimated response burdens for each subject population participating in the evaluation's data collection activities.

1. Site Interest Form —A physician or manager at an interested site will complete the form only once to indicate interest in participating. The form will be completed by 1,060 respondents and requires 6 minutes to complete.

2. Site Information Form —A physician or manager at an interested site will complete the form only once to provide additional contact information, data on patient mix, and information on the organization's diagnostic safety teams, resource commitments, and capacity for implementing the resources. The form will be completed by 265 respondents and requires 20 minutes to complete.

3. Safer Dx Checklist —A physician or manager at participating sites will complete the form only once to allow the participating site to understand the current state of their diagnostic practices, identify areas to improve, and track progress toward diagnostic excellence over time. The form will be completed by 219 respondents and requires 15 minutes to complete.

4. Exit Interviews Protocol —A physician or manager at sites that withdraw from the project will complete the form once to provide information on why the site could not sustain their efforts or participation. The form will be completed by 69 respondents and requires 10 minutes to complete.

5a. SOPS® Medical Office Survey with Diagnostic Safety Supplemental Item Set —A physician or manager at participating ambulatory sites will complete the form to provide a baseline assessment of patient safety culture. The form will be completed by 109 respondents and requires 15 minutes to complete.

5b. SOPS® Hospital Survey with Diagnostic Safety Supplemental Item Set —A physician or manager at participating hospital sites will complete the form to provide a baseline assessment of patient safety culture. The form will be completed by 110 respondents and requires 15 minutes to complete.

6. Post-Training Evaluation Form —A physician, nurse practitioner, physician assistant, or manager will complete the form once to indicate the perceived value of the training provided to participating sites. The form will be completed by 1350 respondents and requires 3 minutes to complete.

7. Post-Technical Assistance Evaluation Form —A physician, nurse practitioner, physician assistant, or manager will complete the form up to three times to indicate the perceived value of the technical assistance provided to participating sites. The form will be completed by 1350 respondents, three times, and requires 2 minutes to complete.

8. Clinical Sustainability Assessment Tool (CSAT) —A physician or manager at participating sites will complete the form to evaluate the sustainability capacity of a clinical practice. The form will be completed by 219 respondents and requires 15 minutes to complete.

9. Implementation Interviews Protocol —A physician, nurse practitioner, physician assistant, or manager will participate in an interview two times to provide their perspectives at different stages of the implementation. The interview will be completed by up to 438 respondents, two times, and requires 1 hour to complete.

10. Measure Dx Organizational Self-Assessment —A physician, nurse practitioner, physician assistant, or manager will complete the form only once to gauge the organization's readiness to engage with Measure Dx. The form will be completed by 73 respondents and requires 30 minutes to complete.

11. Measure Dx Declaration of Measurement Strategy —A physician, nurse practitioner, physician assistant, or manager will complete the form only once to indicate their selection of measurement strategy to be implemented and provide confirmation of minimum necessary capabilities. The form will be completed by 73 respondents and requires 5 minutes to complete.

12. Diagnostic Safety Event Report —A physician, nurse practitioner, physician assistant, or manager will complete the form three times to provide aggregate information on diagnostic safety events. The form will be completed by 73 respondents, three times, and requires 1 hour to complete.

13a. Omnibus Safety and Culture Survey_Medical Offices —A physician, nurse practitioner, physician assistant, or manager will complete the form three times to provide information on safety culture at ambulatory sites. The form will be completed by 162 respondents, three times, and requires 20 minutes to complete.

13b. Omnibus Safety and Culture Survey_Hospitals —A physician, nurse practitioner, physician assistant, or manager will complete the form three times to provide information on safety culture at inpatient sites. The form will be completed by 167 respondents, three times, and requires 20 minutes to complete.

14. Calibrate Dx Survey —A physician, nurse practitioner, or physician assistant will complete the form four times to provide reflections on their diagnostic performance for 3-5 cases, with additional metrics around time to complete the review and the number of cases reviewed. The form will be completed by 329 respondents, four times, and requires 30 minutes to complete.

15. Clinician Self-Efficacy Survey —A physician, nurse practitioner, or physician assistant will complete the form two times to provide information on their self-efficacy with diagnostic safety case review and improvement. The form will be completed by 329 respondents, two times, and requires 3 minutes to complete.

16. Provider Characteristics Form —A physician, nurse practitioner, or physician assistant will complete the form once to provide information on practitioner type, years in practice, specialty, subspecialty, and percent of time spent in clinical practice. The form will be completed by 986 respondents and requires 1 minute to complete.

17. Patient Toolkit Survey—Provider —A physician, nurse practitioner, or physician assistant will complete the form five times to provide information on provider-perceived skills and quality of communication. The form will be completed by 986 respondents, five times, and requires 2 minutes to complete.

18. Provider Interview Protocol —A physician, nurse practitioner, or physician assistant will participate in an interview once to provide information related to diagnostic safety events; patient safety culture; feasibility, acceptability, utility, adoption, and spread of the Patient Toolkit; and insights into clinician experience. The interview will be completed by up to 50 respondents and requires 45 minutes to complete.

19. Patient Toolkit Survey—Patient —Patients will complete the form only once to provide information on their experience and quality of communication, and demographics information. The form will be completed by 62,500 respondents and requires 5 minutes to complete.

20. Patient Interview Protocol —Patients will participate in an interview once to provide information on reason for visit, provider communication, and other insights into patient experience. The interview will be completed by up to 50 respondents and requires 45 minutes to complete.

For the three-year clearance period, the estimated annualized burden hours for the data collection activities are 8,195.

Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to complete the data collection forms. The total cost burden is estimated to be $457,432.

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, comments on AHRQ's information collection are requested with regard to any of the following: (a) whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (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 upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

In accordance with the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality (the Council). 5 U.S.C. 1009. The Council is authorized by section 941 of the Public Health Service Act, 42 U.S.C. 299c. In accordance with its statutory mandate, the Council is to advise the Secretary of the Department of Health and Human Services and the Director of AHRQ on matters related to AHRQ's conduct of its mission including providing guidance on (A) priorities for health care research, (B) the field of health care research including training needs and information dissemination on health care quality and (C) the role of the Agency in light of private sector activity and opportunities for public private partnerships. The Council is composed of members of the public, appointed by the Secretary, and Federal ex-officio members specified in the authorizing legislation.

On Friday, June 28, NAC members will meet to conduct preparatory work prior to convening the Council meeting at 1:45 p.m., with the call to order by the Council Chair, an introduction of NAC members, and approval of previous Council summary notes. The NAC members will then receive an update from the AHRQ Director. The agenda will also include a conversation on the vision for Health Services Research, as well as an update on the Age-Friendly Healthcare Systems Strategic Plan, to be followed by a discussion about opportunities for modernizing the measurement of consumer experience. On Saturday, June 29, NAC members will convene the Council meeting at 9:00 a.m. with welcome and call to order. The NAC members will then discuss priority populations and maternity health, as well as listen to an update on AHRQ's Patient-Centered Outcomes Research Trust Fund (PCORTF) Extension Program. For information regarding how to access the meeting as well as other meeting details, including information on how to make a public comment, please go to https://www.ahrq.gov/news/events/nac/. The final agenda will be available on the AHRQ website no later than Thursday, June 14, 2024.

The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Digestible Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review. AHRQ is conducting this review pursuant to section 902 of the Public Health Service Act, 42 U.S.C. 299a.

The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( e.g., details of studies conducted). We are looking for studies that report on Digestible Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/carbohydrate-intake/protocol. This is to notify the public that the EPC Program would find the following information on Digestible Carbohydrate Intake and Maternal-Infant Outcomes: A Systematic Review helpful:

A list of completed studies that your organization has sponsored for this topic. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.

For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.

A list of ongoing studies that your organization has sponsored for this topic. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.

Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this topic and an index outlining the relevant information in each submitted file.

Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.

The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.

The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.

1. What is the association between dietary digestible carbohydrate intake by a person during pregnancy and the weight, length, head circumference, and other measures of size and body composition of the infant obtained at birth? How are these associations affected by characteristics of the pregnant person?

2. What is the association between dietary digestible carbohydrate intake during pregnancy and gestational weight gain? How are these associations affected by characteristics of the pregnant person?

3. What is the association between infant dietary digestible carbohydrate intake, including digestible carbohydrate intake from human milk, and measures of growth, size, and body composition in individuals from birth to 24 months of age?

In the Federal Register of May 16, 2024, in FR Doc 2024-10776, on page 42881 (third column), correct the system number to read:

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

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

This information collection helps to support Agency regulations and guidance. Under Section 513(a)(1)(B) of the Federal Food, Drug and Cosmetics Act (FD&C Act) (21 U.S.C. 360c(a)(1)(B)), FDA may establish special controls, including performance standards, postmarket surveillance, patient registries, guidelines, and other appropriate actions it believes necessary to provide reasonable assurance of the safety and effectiveness of the device. The special control guidance serves as the special control for the automated blood cell separator device operating by centrifugal or filtration separation principle intended for the routine collection of blood and blood components (§ 864.9245 (21 CFR 864.9245)). The guidance entitled “Guidance for Industry and FDA Staff—Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle” (March 2011) is available at https://www.fda.gov/media/124263/download.

For currently marketed products not approved under the premarket approval process, the manufacturer should file with FDA for 3 consecutive years an annual report on the anniversary date of the device reclassification from class III to class II or on the anniversary date of the 510(k) of the FD&C Act (21 U.S.C. 360(k)) clearance. These annual reports are submitted as supplements to the original 510(k) via the electronic submission gateway at https://www.fda.gov/electronic-submissions-gateway. The reports can also be submitted in paper format and sent to the CBER Document Control Center at https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-electronic-and-paper.

Any subsequent change to the device requiring the submission of a premarket notification in accordance with section 510(k) of the FD&C Act should be included in the annual report. Also, a manufacturer of a device determined to be substantially equivalent to the centrifugal or filtration-based automated cell separator device intended for the routine collection of blood and blood components should comply with the same general and special controls.

Reclassification of this device from class III to class II relieves manufacturers of the burden of complying with the premarket approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e) and may permit small potential competitors to enter the marketplace by reducing the burden. Although the special control guidance recommends that manufacturers of these devices file with FDA an annual report for 3 consecutive years, this would be less burdensome than the current postapproval requirements under 21 CFR part 814, subpart E, including the submission of periodic reports under 21 CFR 814.84.

In the special control guidance document, FDA recommends that manufacturers include in their annual reports a summary of adverse reactions maintained by the blood collection establishment or transfusion service or similar reports of adverse events collected.

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

Based on submissions to FDA over the last few years, there are three manufactures of automated blood cell separator devices. We estimate that the manufacturers will spend approximately 5 hours preparing and submitting the annual report.

The annual report should include, at a minimum, a summary of anticipated and unanticipated adverse events that have occurred and that are not required to be reported by manufacturers under Medical Device Reporting (MDR) (part 803 (21 CFR part 803)). The reporting of adverse device events summarized in an annual report will alert FDA to trends or clusters of events that might be a safety issue otherwise unreported under the MDR regulation. The report should also include any subsequent change to the preamendments class III device requiring a 30-day notice in accordance with 21 CFR 814.39(f).

Blood collection establishments and transfusion services, the intended users of the device, and the device manufacturers have certain responsibilities under the Federal regulations. For example, collection establishments and or transfusion services are required to maintain records of any reports of complaints of adverse reactions (21 CFR 606.170), while the device manufacturer is responsible for conducting an investigation of each event that is reasonably known to the manufacturer and evaluating the cause of the event (§ 803.50(b) (21 CFR 803.50(b))). In addition, manufacturers of medical devices are required to submit to FDA individual adverse event reports of death, serious injury, and malfunctions (§ 803.50).

Other burden hours required for § 864.9245 are reported and approved under OMB control number 0910-0120 (premarket notification submission 510(k), 21 CFR part 807, subpart E), and OMB control number 0910-0437 (MDR, part 803).

Based on a review of the information collection from our last request for OMB approval, we estimate that the number of manufacturers of automated blood cell separator devices remains unchanged. As a result, we have made no adjustments to our burden estimates.

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

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

Despite numerous legislative, regulatory, and scientific efforts, there has been little change in the number of devices approved for use in pediatric patients. This has often led to devices being adapted for use in children without an appropriate level of evidence, exposing them to inconsistent benefit risk profiles. This health inequity highlights the need for devices that are designed, evaluated, and labeled for pediatric patients. To address these challenges, this collection is being done to survey industry and other key stakeholders in the medical device ecosystem to identify the barriers that prevent product developers from entering the pediatric device market as well as the proper incentives that would motivate them to innovate and sustain within this market.

This survey is a followup to the public meeting that FDA held in August 2018, entitled, “Pediatric Medical Device Development.” As mandated by section 502(d) of the FDA Reauthorization Act of 2017 (Pub. L. 115-52) the meeting was convened to address several topics, including consideration of ways to: (1) increase FDA assistance to medical device manufacturers in developing devices for pediatric populations that are approved or cleared, and labeled, for their use and (2) identify current barriers to pediatric device development and incentives to address such barriers.

Feedback from this meeting clarified the need to better understand factors influencing suboptimal engagement and participation by diverse innovators in the pediatric medical device space. Information garnered from this survey may help inform strategic plans to optimize existing programs for the needs of pediatric medical device innovators and develop new programs that will support sustained development in this space.

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

The targeted groups for this collection of information include representatives from the medical device industry, academia, recipients of funding under section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 (Pub. L. 110-85; 42 U.S.C. 282 note), and trade organizations, medical provider organizations, organizations and individuals involved with financing and reimbursement associated with medical devices, pediatric healthcare leaders, clinicians who regularly use medical devices in caring for children, and organizations and individuals representing patients and consumers.

Phone survey: Respondents participating in the phone survey will be executives from companies either producing products in pediatrics or from companies that produce products that could be used in pediatrics. Executives will be invited to engage in the 30-minute phone survey.

Online survey: The 1-hour online survey will be administered to leaders within pediatric companies and key decision makers in the pediatric medical device industry ( e.g., venture capitalists, banking investors, leaders in children's hospitals and research networks, and pediatric patient advocates).

Substantial turnover in the graduate students administering the survey made it necessary to bring in a new cohort of students and train them in the issues relevant to the survey. As a result, we were unable to field the B12 Pediatrics survey before the OMB approval expiration date and are seeking a reinstatement to complete data collection. To better ensure timely completion of the data collection, the Yale CERSI team has shifted responsibility for conducting the survey and other aspects of the study to a Yale Staff Associate Research Scientist.

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

The Agency is requesting nominations for nonvoting industry representatives to the panels listed in table 1.

The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. The Committee's panels engage in a number of activities to fulfill the functions the Federal Food, Drug, and Cosmetic Act (FD&C Act) envisions for device advisory panels. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises the Commissioner of Food and Drugs (the Commissioner) regarding recommended classification or reclassification of devices into one of three regulatory categories; advises on any possible risks to health associated with the use of devices; advises on formulation of product development protocols; reviews premarket approval applications for medical devices; reviews guidelines and guidance documents; recommends exemption of certain devices from the application of portions of the FD&C Act; advises on the necessity to ban a device; and responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Committee also provides recommendations to the Commissioner or designee on complexity categorization of in vitro diagnostics under the Clinical Laboratory Improvement Amendments of 1988.

Persons nominated for the device panels should be full-time employees of firms that manufacture products that would come before the panel, or consulting firms that represent manufacturers, or have similar appropriate ties to industry.

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

Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Nomination must include a current, complete résumé or curriculum vitae for each nominee including current business address and telephone number, email address if available, and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Committee Membership Nomination Portal (see ADDRESSES ) within 30 days of publication of this document (see DATES ). Nominations must also specify the advisory panel for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the particular device panels listed in table 1. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process.)

FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore encourages nominations of appropriately qualified candidates from these groups.

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

The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. 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.

In the Federal Register of March 4, 2024 (89 FR 15590), FDA announced that a meeting of the Vaccines and Related Biological Products Advisory Committee would be held on May 16, 2024. On page 15590, in the second column, the SUMMARY and DATES portions of the document are changed to read as follows:

Drug and biological products are widely used in various therapeutic areas during pregnancy to treat various conditions. Some products can be actively or passively transported across the placenta from a pregnant individual to their fetus. When this occurs for products with immunosuppressive properties, it is biologically plausible that these products can exert immunosuppressive effects on the developing fetus and newborn infant. Historically, pregnant individuals have generally been excluded from clinical trials, resulting in a paucity of data available on transplacental transfer and its potential consequences to the developing fetus and newborn infant. This lack of data poses challenges in providing adequate information in product labeling to help prescribers and patients make informed decisions about use of these products during pregnancy.

Pregnant individuals may have chronic and/or acute conditions that need to be treated, and published data show that most pregnant individuals take at least one medication (excluding vitamins) during pregnancy. Therefore, understanding the safety of medications when used during pregnancy is important. The main objective of the “Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products” workshop is to discuss the available data on the placental transfer of drug and biological products with immunosuppressive effects and the potential clinical impact on infants exposed in utero, identify gaps in knowledge, and explore innovative and practical approaches for collection of relevant data. In addition, the workshop will allow for an open dialogue among regulators, academia, industry, and patient organizations regarding the potential safety concerns of medicines that may need to be used during pregnancy and approaches to data collection.

Registration: To register for the public workshop, please visit the following website: https://lu.ma/5vdmbibm. Please register by July 10, 2024, at 11:59 p.m. Eastern time. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by July 10, 2024, at 11:59 p.m. Eastern time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted.

If you need special accommodations due to a disability, please contact Brittany Witcher, OND Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov no later than July 1, 2024.

Streaming Webcast of the Public Workshop: This public workshop will also be streamed virtually via Zoom. Virtual attendees may register at the following website to receive the Zoom link: https://lu.ma/5vdmbibm. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.

Transcripts and Recordings: Please be advised that as soon as transcripts and recordings of the public workshop are available, they will be accessible on the FDA event web page https://www.fda.gov/drugs/news-events- human-drugs/evaluating-immunosuppressive-effects-utero-exposure-drug-and-biologic-products-07112024. The transcripts and recordings will also be accessible at https://www.regulations.gov and may be viewed at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Information Collection Request Title: National Survey of Organ Donation Attitudes and Practices, OMB No. 0915-0290—Revision.

Abstract: The overall purpose of this study is to conduct an independent multi-mode (web and telephone) survey of public opinion regarding various issues related to organ donation. The survey will measure public opinion on issues such as willingness to become an organ donor, financial incentives for donation, living donation, impediments to donation, and level of public knowledge about donation. Previous National Survey of Organ Donation Attitudes and Practices were conducted during 1993, 2005, 2012, and 2019. Similar to the 2019 survey, the goal is to complete 10,000 interviews with adults (18 years of age or older) nationwide. Specifically, this will include 1,000 equal-probability of selection method computer-assisted telephone interviewing (CATI) interviews, 1,000 ethnic oversamples CATI interviews, and a supplemental web panel of 8,000 respondents. The final sample will include 1,000 interviews each with Black or African Americans, Asian Americans, Hispanic/Latino Americans, and American Indian/Alaskan Natives, and a statistically sufficient sample for meaningful comparisons across demographic levels of age group, education, and income groups. A total sample of 10,000 is necessary to achieve sufficiently large subgroups for statistical analysis across demographic groups.

A 60-day notice published in the Federal Register on January 18, 2024, vol. 89, No. 12; pp. 3409-3410. There were no public comments.

Need and Proposed Use of the Information: The Division of Transplantation, within the Health Systems Bureau of HRSA at the Department of Health and Human Services, is the primary federal entity responsible for oversight of the solid organ and blood stem cell transplant systems in the United States and for initiatives to increase organ donor registration and donation. Sponsorship of a national survey on the American public's donation attitudes and practices is one of the services that Division of Transplantation provides for the larger donation community, consistent with its legal authority to establish a public education and awareness program (Section 377A of the Public Health Service Act, 42 U.S.C. 274f-1).

Patients in need of organ transplantation in the United States face a longstanding critical shortage of organs. Approximately 103,000 Americans were on the waiting list for transplantation by the end of 2022, but only 42,000 transplants were performed, which only meets two-fifths of the national need. While this represents an increase from the number of transplants performed in 2021, the organ shortage remains in the United States. Understanding public attitudes about organ donation and how the attitudes change over time is critical to addressing organ shortage through public awareness and education efforts.

The information from this survey will facilitate appropriate tailoring and targeting of donation outreach messages and strategies and provide an overall assessment of the impact of previous outreach messages and strategies. The data will also inform the development of policy related to organ donation and transplantation.

Likely Respondents: A nationally representative sample of adults over the age of 18 with a higher number of responses from populations of interest such as racial-ethnic minorities, including Black or African American, Asian American, American Indian/Alaskan Native, and Hispanic/Latino American respondents, as well as respondents of all age groups and education levels.

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

This proposed information collection was previously published in the Federal Register on Monday, July 31, 2023, Volume 88, pages 49472-49473 (64 FR 16184) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The Office of Clinical Research Education and Collaboration Outreach, Office of the Director, National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Proposed Collection: Application and Impact of Clinical Research Training on Healthcare Professionals in Academia and Clinical Research, 0925-0764-expiration date, 02/28/2026, Office of Clinical Research Education and Collaboration Outreach (OCRECO), National Institutes of Health (NIH), Office of the Director (OD).

Need and Use of Information Collection: The purpose of this survey is to assess the long-term impact and outcomes of clinical research training programs provided by the Office of Clinical Research Education and Collaboration Outreach located in the NIH Office of the Director (OD) over a ten-year follow-up period. The information received from respondents will provide insight on the following: impact of the courses on (a) promotion of professional competence, (b) research productivity and independence, and (c) future career development within clinical, translational and academic research settings. These surveys will provide preliminary data and guidance in (1) developing recommendations for collecting outcomes to assess the effectiveness of the training courses, and (2) tracking the impact of the curriculum on participants' ability to perform successfully in academic, non-academic, research, and non-research settings.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,773.

Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) 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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Proposed Collection Title: Public Health Service (PHS) Post-award Reporting Requirements Revision, OMB 0925-0002, Expiration Date 01/31/2026, Office of the Director (OD), National Institutes of Health (NIH).

Need and Use of Information Collection: Starting in 2025, NIH will require applicable recipients to address progress in association with their approved Data Management and Sharing Plans within the Research Performance Progress Report (RPPR) in accordance with the final NIH Policy for Data Management and Sharing to promote the management and sharing of scientific data generated from NIH-funded or conducted research. The progress report forms will be updated to align with this requirement. The Training Data Tables will also be updated to reduce the burden and promote consistent information collection, including limiting the scope of information collection to data only relevant to the training stage(s) of the proposed program in Table 1 and removing instructions in Table 8 that are reported within the RPPR. Effective May 2025, NIH will be adopting the Common Forms for Biographical Sketch and Current and Pending (Other) Support as part of the directive from Guidance for Implementing National Security Presidential Memorandum (NSPM)-33. The Common Forms are part of a separate OMB collection, currently approved under 3145-0279. As such, elements collected within the Common Forms will be removed from NIH's current NIH Biosketch and Other Support formats. NIH will continue to collect additional information not captured on the Common Forms to adhere to the agency's implementation of the NIH Peer Review Regulations at 42 CFR part 52 as part of the NIH Biosketch form, which will be renamed the NIH Biosketch Supplement to reflect the supplemental information requested. The application and progress report forms and associated instructions will be updated to align with these new requirements. The RPPR is required to be used by all NIH, Food and Drug Administration (FDA), Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality (AHRQ) grantees. Interim progress reports are required to continue support of a PHS grant for each budget year within a competitive segment. This collection also includes other PHS post-award reporting requirements: PHS 416-7 National Research Service Award (NRSA) Termination Notice, PHS 2271 Statement of Appointment, 6031-1 NRSA Annual Payback Activities Certification, HHS 568 Final Invention Statement and Certification, and PHS 3734 Statement Relinquishing Interests and Rights in a PHS Research Grant. The PHS 416-7, 2271, and 6031-1 are used by NRSA recipients to activate, terminate, and provide for payback of an NRSA. Closeout of an award requires a Final Invention Statement (HHS 568) and a Final Progress Report. The PHS 3734 serves as the official record of grantee relinquishment of a PHS award when an award is transferred from one grantee institution to another. Pre-award reporting requirements are simultaneously consolidated under 0925-0001 and the changes to the collection here are related.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 579,365.

Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) 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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Proposed Collection Title: Public Health Service (PHS) Applications and Pre-Award Reporting Requirements, Revision, OMB 0925-0001, Expiration Date 01/31/2026, Office of the Director, National Institutes of Health (NIH).

Need and Use of Information Collection: Effective for due dates on or after January 25, 2025, NIH will be implementing several trans-NIH initiatives to simplify the grants process for applicants and recipients as well as for peer review. NIH will be updating fellowship applications to improve fellowship peer review to facilitate the mission of these programs to identify the most promising candidates and individualized training opportunities that will assist them along their paths to support the advancement of the biomedical research enterprise. NIH will be reducing the number of required attachments and updating instructions for the PHS Fellowship Supplemental Form to align with the revised scored review criteria. NIH will also be updating institutional training grant applications, including adding a new attachment field to the PHS 398 Research Training Program Plan form for the transparent collection of the Recruitment Plan to Enhance Diversity while also providing additional space for applicants within the Program Plan page limit where this information was previously collected. The Training Data Tables will also be updated to reduce the burden and promote consistent information collection, including limiting the scope of information collection to data only relevant to the training stage(s) of the proposed program in Table 1 and removing instructions in Table 8 that are reported within the Research Performance Progress Report (RPPR). Effective for due dates on or after May 25, 2025, NIH will be adopting the Common Forms for Biographical Sketch and Current and Pending (Other) Support as part of the directive from Guidance for Implementing National Security Presidential Memorandum (NSPM)-33. The Common Forms are part of a separate OMB collection, currently approved under 3145-0279. As such, elements collected within the Common Forms will be removed from NIH's current NIH Biosketch and Other Support formats. NIH will continue to collect additional information not captured on the Common Forms to adhere to the agency's implementation of the NIH Peer Review Regulations at 42 CFR part 52 as part of the NIH Biosketch form, which will be renamed the NIH Biosketch Supplement to reflect the supplemental information requested. The application and progress report forms and associated instructions will be updated to align with these new requirements. This collection also continues to include PHS applications and pre-award reporting requirements: PHS 398 [paper] Public Health Service Grant Application forms and instructions; PHS 398 [electronic] PHS Grant Application component forms and agency-specific instructions used in combination with the SF424 (R&R); PHS Fellowship Supplemental Form and agency-specific instructions used in combination with the SF424 (R&R) forms/instructions for Fellowships [electronic]; PHS 416-1 Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Application Instructions and Forms used only for a change of sponsoring institution application [paper]; Instructions for a Change of Sponsoring Institution for NRSA Fellowships (F30, F31, F32 and F33) and non-NRSA Fellowships; PHS 416-5 Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice; and PHS 6031 Payback Agreement. The PHS 398 (paper and electronic are currently approved under 0925-0001. All forms expire 01/31/2026. Post-award reporting requirements are simultaneously consolidated under 0925-0002 and include the RPPR. The PHS 398 and SF424 applications are used by applicants to request Federal assistance funds for traditional investigator-initiated research projects and to request access to databases and other PHS resources. The PHS 416-1 is used only for a change of sponsoring institution application. PHS Fellowship Supplemental Form and agency-specific instructions are used in combination with the SF424 (R&R) forms/instructions for Fellowships and are used by individuals to apply for direct research training support. Awards are made to individual applicants for specified training proposals in biomedical and behavioral research, selected as a result of a national competition. The PHS 416-5 is used by individuals to indicate the start of their NRSA awards. The PHS 6031 Payback Agreement is used by individuals at the time of activation to certify the agreement to fulfill the payback provisions.

OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,175,670.

As the world's largest public funder of biomedical research, NIH seeks to drive effective partnerships that foster a shared commitment to transforming knowledge into improved health for all. These investments are critical to the health of our scientific enterprise, both in terms of supporting research discoveries and by fueling U.S. leadership in the bioeconomy. Indeed, NIH-owned inventions have provided the foundation for new vaccines, drugs, and medical devices. 1 A recent report estimated that technology licensed from the IRP supported an average of 74,500 jobs and contributed an average of over $13 billion to U.S. GDP each year over the last two decades. 2

NIH recognizes that all too often, however, patients across the country and across the globe may be unable to access products they need—a treatment for their disease may not yet exist, or it might exist but be out of reach because it is too expensive or difficult to take. For example, millions of adults skip medications due to high costs, and the rising cost of prescription drugs puts many of these products out of reach. Thus, NIH is exploring how it might leverage partnerships to further enhance health through the biomedical research it funds.

In 2023, NIH hosted a workshop in support of this agenda, Transforming Discoveries into Products: Maximizing NIH's Levers to Catalyze Technology Transfer ( https://osp.od.nih.gov/events/workshop-on-transforming-discoveries-into-products-maximizing-nihs-levers-to-catalyze-technology-transfer/ ), to discuss policies and practices that shape biomedical innovation and promote access to NIH-funded discoveries. At this workshop, NIH heard from participants with experience using “access planning” as a means to prospectively address downstream access challenges. Access planning involves incorporating patient access considerations, at a high level, in agreements related to biomedical research and development. The parties commit to revisit access considerations as product development progresses, but the initial agreement terms are intentionally flexible and not prescriptive.

NIH is proposing a new policy within the NIH IRP (see Appendix), to require that licensees that succeed in bringing certain products toward market submit a plan outlining steps they intend to take to promote patient access to those products. This new IRP policy makes it clear that access, defined broadly to include product affordability, availability, acceptability, and sustainability, is of paramount importance in providing a return on taxpayers' investment in biomedical research. This new policy would apply to patent licenses for the commercialization of drugs, biologics, vaccines, or devices. NIH would also employ a tiered approach, where licenses granted for late-stage inventions that are closer to market launch would include more specific, tailored access-oriented provisions, while licenses granted for early-stage inventions would be more flexible to reflect the higher uncertainty associated with technologies that lead to drugs, biologics, vaccines, or devices. Importantly, a final policy approach should be reasonable and not seek to force licensees into access obligations that obstruct commercial development or damage the viability and sustainability of a product in the market, while also balancing the need to promote access through reforms to various policies. The agency is proposing a flexible approach that allows appropriately tailored, commercially reasonable strategies to promote patient access across a range of technologies. This RFI is in relation to the licensing of government-owned inventions in accordance with 35 U.S.C. 207 and 37 CFR part 404.

NIH seeks information from all interested individuals and communities, including, but not limited to, patients and patient advocates, small business firms, technology transfer and licensing professionals, investigators, public health organizations, investors, industry partners, healthcare providers, universities, research institutions, and other members of the public. While comments are welcome on all elements of this proposal, input would be most welcome on the specific issues identified below:

1. Promoting meaningful access approaches. NIH intends to provide additional guidance to licensees on examples of acceptable, commercially reasonable approaches for promoting access. NIH is seeking input on the range of activities that could be considered and strategies to mitigate access challenges and expand the reach, and benefit, of drugs, biologics, vaccines, and devices stemming from NIH inventions.

2. Promoting transparency in the biomedical research enterprise and return on investment. The process of bringing a new product through research and development, to market, and into the hands of patients is long, fraught with challenges, and expensive. NIH is interested in hearing from potential partners on how access plans could incorporate transparent cost accounting measures to assist NIH in driving down costs associated with innovation and making clearer what costs are incurred along the way and how those affect product costs.

3. Providing flexibility while achieving clear policy objectives. NIH recognizes that its licensees, their partners, and the public will need confidence around what this policy requires and the standards that would be used to evaluate plans. The agency is seeking input on how to maintain flexibility for licensees to pursue their specific product development and commercialization needs while simultaneously promoting certainty and transparency on access efforts and policy enforcement.

4. Helping licensees achieve access goals. NIH is interested in hearing ideas about how it may be able to help licensees deliver patient access to products that stem from these agreements. Licensees could include such information in access plans or at earlier stages of product development. NIH invites input on additional steps it could take or ways to leverage existing U.S. Government programs and resources to assist in this endeavor.

5. Establishing licensee obligations depending on the stage of technology development. Generally, as a product moves closer to market, the odds of successful commercialization improve, and NIH's proposed policy would take this into account. If the agency has advanced products to the point of a first pivotal clinical trials ( e.g., Phase III or the equivalent)—licenses covering those products would include specific, tailored access-oriented provisions that should be clear and understandable. NIH is seeking further input on specific provisions that would meet these objectives.

6. Assessing policy impact. NIH is seeking input on how to assess compliance with the proposed policy and potential metrics for assessing its impact.

In accordance with the Paperwork Reduction Act (PRA, 44 U.S.C. 3501 et seq. ) and its implementing regulations at 5 CFR 1320.8(d)(1), all information collections require approval under the PRA. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

We are especially interested in public comment addressing the following:

(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;

(2) The accuracy of our estimate of the burden for this 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) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of response.

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

Abstract: The Fish and Wildlife Act of 1956 (16 U.S.C. 742d) designates the Department of the Interior as a key agency responsible for the conservation and protection of wildlife and fisheries resources in the United States. This responsibility dictates that we gather accurate data on conservation efforts through means such as research to improve the development, management, and advancement of efforts. At the June 2022 Monarch Butterfly Summit, the Secretary of the Interior announced that the U.S. Fish and Wildlife Service would establish a national Center for Pollinator Conservation, funded through annual appropriations. Formally launched later that year, the Center serves as a science and collaboration hub across internal Service programs and regions as well as with external agencies and partners. The Center helps to direct conservation actions that can reverse declining pollinator population trends.

The Service's Center for Pollinator Conservation is seeking to conduct a social network analysis to collect information regarding the structure and functions of pollinator networks throughout the country, key influencers and network clusters, network gaps, and the diffusion of information across the broad pollinator conservation community. The proposed survey collects information necessary to support the Center's role as a science and collaboration hub helping inform evidence-based decisions to create, sustain, and strengthen relationships and communication channels across individuals and organizations to increase awareness of, collaboration on, and efficacy of pollinator conservation efforts.

In addition to an overview of the survey (Section 1), the proposed survey collects the following information:

• Respondent's organization and its involvement in pollinator conservation efforts (Section 2);

• Collaboration on pollinator conservation, including identification of collaborative organizations and collaboration types (Section 3);

• Network characteristics, including how organizations work together and potential barriers (Section 4);

• Respondent's role within their organization, along with name and email address (Section 5); and

• Additional comments on the survey or pollinator conservation in general (Section 6).

We will use the information collected in this effort to develop multiple products aimed at translating the data into information that can strengthen partnerships, identify gaps, and inform conservation decisions.

The public may request a copy of the draft survey instrument by sending a request to the Service Information Collection Clearance Officer (see ADDRESSES , above).

Title of Collection: Pollinator Conservation Social Network Analysis.

OMB Control Number: 1018-New.

Form Number: None.

Type of Review: New.

Respondents/Affected Public: Private sector and government respondents ( e.g., Federal, State, Tribal, nongovernmental organizations (NGOs), academic, etc.) that work on pollinator conservation efforts throughout North America, with primary focus in the United States.

Total Estimated Number of Annual Respondents: 365 (160 private sector respondents, including academic entities and NGOs, and 205 State/Local/Tribal/Federal agencies/organizations).

Total Estimated Number of Annual Responses: 365.

Estimated Completion Time per Response: 20 minutes.

Total Estimated Number of Annual Burden Hours: 122.

Respondent's Obligation: Voluntary.

Frequency of Collection: One time.

Total Estimated Annual Nonhour Burden Cost: None.

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. ).

In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501 et seq. ) and 5 CFR 1320.8(d)(1), all information collections require approval under the PRA. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

We are especially interested in public comment addressing the following:

(1) 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) The accuracy of our estimate of the burden for the 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) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of response.

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

Abstract: An Indian tribe must ask the Secretary to approve a Tribal revenue allocation plan. In order for Indian Tribes to distribute net gaming revenues in the form of per capita payments, information is needed by the AS-IA to ensure that Tribal revenue allocation plans include: (1) Assurances that certain statutory requirements are met, (2) a breakdown of the specific uses to which net gaming revenues will be allocated, (3) eligibility requirements for participation, (4) tax liability notification, and (5) the assurance of the protection and preservation of the per capita share of minors and legal incompetents. Sections 290.12, 290.17, 290.24 and 290.26 of 25 CFR part 290, Tribal Revenue Allocation Plans, specify the information collection requirement. The information to be collected includes: The name of the Tribe, Tribal documents, the allocation plan, and other documents deemed necessary.

Title of Collection: Tribal Revenue Allocation Plans, 25 CFR 290.

OMB Control Number: 1076-0152.

Form Number: None.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Federally recognized Indian Tribes.

Total Estimated Number of Annual Respondents: 20.

Total Estimated Number of Annual Responses: 20.

Estimated Completion Time per Response: 100 hours.

Total Estimated Number of Annual Burden Hours: 2,000 hours.

Respondent's Obligation: Required to obtain a benefit.

Frequency of Collection: On occasion.

Total Estimated Annual Nonhour Burden Cost: $0.

Abstract: The collection of information will ensure that the provisions of the Indian Gaming Regulatory Act (IGRA) and other applicable requirements are met when federally recognized Tribes submit Class III procedures for review and approval by the Secretary of the Interior. Sections 291.4, 291.10, 291.12 and 291.15 of 25 CFR 291, Class III Gaming Procedures, specify the information collection requirement. An Indian Tribe must ask the Secretary to issue Class III gaming procedures. The information to be collected includes: The name of the Tribe, the name of the State, Tribal documents, State documents, regulatory schemes, the proposed procedures, and other documents deemed necessary.

Title of Collection: Class III Gaming Procedures.

OMB Control Number: 1076-0149.

Form Number: None.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Federally recognized Indian Tribes.

Total Estimated Number of Annual Respondents: 12.

Total Estimated Number of Annual Responses: 12.

Estimated Completion Time per Response: 320 hours.

Total Estimated Number of Annual Burden Hours: 3,840 hours.

Respondent's Obligation: Required to Obtain a Benefit.

Frequency of Collection: On occasion.

Total Estimated Annual Nonhour Burden Cost: $0.

Abstract: The collection of information will ensure that the provisions of IGRA, Federal law, and the trust obligations of the United States are met when Federally recognized Tribes submit an application under 25 CFR part 292. The applications covered by this OMB Control No. are those seeking a secretarial determination that a gaming establishment on land acquired in trust after October 17, 1988, would be in the best interest of the Indian Tribe and its members, and would not be detrimental to the surrounding community.

Title of Collection: Gaming on Trust Lands Acquired After October 17, 1988.

OMB Control Number: 1076-0158.

Form Number: None.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Federally recognized Indian Tribes.

Total Estimated Number of Annual Respondents: 2.

Total Estimated Number of Annual Responses: 2.

Estimated Completion Time per Response: 1,000 hours.

Total Estimated Number of Annual Burden Hours: 2,000 hours.

Respondent's Obligation: Required to obtain a benefit.

Frequency of Collection: On occasion.

Total Estimated Annual Nonhour Burden Cost: $0.

Abstract: We, the Office of the Assistant Secretary—Indian Affairs (AS-IA), are proposing to renew an information collection. The information collected includes Tribal-state compacts or compact amendments entered into by Indian Tribes and State governments. The Secretary of the Interior reviews this information under 25 CFR 293, Class III Tribal-State Gaming Compact Process and the Indian Gaming Regulatory Act (IGRA), 25 U.S.C. 2710(d)(8)(A), (B) and (C), which authorizes the Secretary to approve, disapprove, or “consider approved” ( i.e., deemed approved) a Tribal-state gaming compact or compact amendment and publish notice of that approval or considered approval in the Federal Register .

Title of Collection: Class III Tribal-State Gaming Compact Process.

OMB Control Number: 1076-0172.

Form Number: None.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Indian Tribes and State governments.

Total Estimated Number of Annual Respondents: 40 per year.

Total Estimated Number of Annual Responses: 40 per year.

Estimated Completion Time per Response: 200 hours.

Total Estimated Number of Annual Burden Hours: 8,000 hours.

Respondent's Obligation: Required to obtain a benefit.

Frequency of Collection: One time.

Total Estimated Annual Nonhour Burden Cost: $0.

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 these information collection actions is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Grand Canyon Protection Act (Act) of October 30, 1992, Public Law 102-575, directs the Secretary to consult with the Governors of the Colorado River Basin States and with the general public, including members of the public with certain interests or affiliations, when preparing the requisite criteria and operating plans for Glen Canyon Dam. This group, designated the Glen Canyon Dam Adaptive Management Work Group or AMWG, provides advice and recommendations to the Secretary relative to the operation of the Glen Canyon Dam. The AMWG operates in accordance with the Federal Advisory Committee Act, as amended, 5 U.S.C. ch. 10.

The duties or roles and functions of the AMWG are in an advisory capacity only. They are to: (1) establish AMWG operating procedures, (2) advise the Secretary in meeting environmental and cultural commitments including those contained in the Record of Decision for the Glen Canyon Dam Long-Term Experimental and Management Plan Final Environmental Impact Statement and subsequent related decisions, (3) recommend resource management objectives for development and implementation of a long-term monitoring plan, and any necessary research and studies required to determine the effect of the operation of Glen Canyon Dam on the values for which Grand Canyon National Park and Glen Canyon Dam National Recreation Area were established, including but not limited to, natural and cultural resources, and visitor use, (4) review and provide input on the report identified in the Act to the Secretary, the Congress, and the Governors of the Colorado River Basin States, (5) annually review long-term monitoring data to provide advice on the status of resources and whether the Adaptive Management Program (AMP) goals and objectives are being met, and (6) review and provide input on all AMP activities undertaken to comply with applicable laws, including permitting requirements.

Prospective members of AMWG need to have a strong capacity for advising individuals in leadership positions, teamwork, project management, tracking relevant Federal government programs and policy making procedures, and networking with and representing their stakeholder group. Membership from a wide range of disciplines and professional sectors is encouraged.

Members of the AMWG are appointed by the Secretary and are comprised of:

a. The Secretary's Designee, who serves as Chairperson for the AMWG.

b. One representative each from the following entities: The Secretary of Energy (Western Area Power Administration), Arizona Game and Fish Department, Hopi Tribe, Hualapai Tribe, Navajo Nation, San Juan Southern Paiute Tribe, Southern Paiute Consortium, and the Pueblo of Zuni.

c. One representative each from the Governors from the seven basin States: Arizona, California, Colorado, Nevada, New Mexico, Utah, and Wyoming.

d. Representatives from the general public as follows: two from environmental organizations, two from the recreation industry, and two from contractors who purchase Federal power from Glen Canyon Powerplant.

e. One representative from each of the following Interior agencies as ex-officio non-voting members: Bureau of Reclamation, Bureau of Indian Affairs, U.S. Fish and Wildlife Service, and National Park Service.

At this time, we are particularly interested in applications from representatives of the following to fill vacancies on the committee

a. one from the basin state of Arizona;

b. one from the Native American Tribe of Southern Paiute Consortium;

c. one from National Park Service;

d. one from Arizona Game and Fish;

e. two from Federal Power Purchase Contractors; and

f. one from the Recreational Industry.

After consultation, the Secretary will appoint members to the AMWG. Members will be selected based on their individual qualifications, as well as the overall need to achieve a balanced representation of viewpoints, subject matter expertise, regional knowledge, and representation of communities of interest. AMWG member terms are limited to 3 years from their date of appointment. Following completion of their first term, an AMWG member may request consideration for reappointment to an additional term. Reappointment is not guaranteed.

Typically, AMWG will hold two in-person meetings and one webinar meeting per fiscal year. Between meetings, AMWG members are expected to participate in committee work via conference calls and email exchanges. Members of the AMWG and its subcommittees serve without pay. However, while away from their homes or regular places of business in the performance of services of the AMWG, members may be reimbursed for travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in the government service, as authorized by 5 U.S.C. 5703.

Nominations should include a resume that provides an adequate description of the nominee's qualifications, particularly information that will enable Interior to evaluate the nominee's potential to meet the membership requirements of the AMWG and permit Interior to contact a potential member. Please refer to the membership criteria stated in this notice.

Any interested person or entity may nominate one or more qualified individuals for membership on the AMWG. Nominations from the seven basin states, as identified in this notice, need to be submitted by the respective Governors of those states, or by a state representative formally designated by the Governor. Persons or entities submitting nomination packages on the behalf of others must confirm that the individual(s) is/are aware of their nomination. Nominations must be postmarked no later than June 21, 2024 and sent to Mr. Daniel Picard, Deputy Regional Director, U.S. Bureau of Reclamation, 125 S. State Street, Room 8100, Salt Lake City, UT 84138.

Authority: 5 U.S.C. ch. 10.

The Commission instituted this investigation on March 15, 2023, based on a complaint filed by The Ridge Wallet, LLC of Santa Monica, California (“Ridge” or “Complainant”). 88 FR 16030-031 (Mar. 15, 2023). The complaint, as supplemented, alleged violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain compact wallets and components thereof by reason of trade dress infringement and infringement of claims 1-4, 9, and 12-17 of U.S. Patent No. 10,791,808 (“the '808 patent”). Id. The Commission's notice of investigation named Rosemar Enterprises LLC d/b/a RossM Wallet of Palm Springs, California (“RossM”); INSGG of Hangzhou City, Zhejiang Province, China; Mosaic Brands, Inc. of Alamo, California (“Mosaic”); Shenzhen Swztech Co., Ltd. d/b/a SWZA (“SWZA”) of Shenzhen, Guangdong, China; and Shenzhen Pincan Technology Co., Ltd. d/b/a ARW-Wallet (“ARW”) of Shenzhen, Guangdong, China as respondents. The Office of Unfair Import Investigations (“OUII”) also participated in this investigation.

After institution, Respondents RossM and INSGG were found in default (collectively, the “Defaulting Respondents”). See Order No. 12 (Jul. 11, 2023), unreviewed by Comm'n Notice (Jul. 28, 2023). In addition, Respondent Mosaic was terminated from the investigation based on settlement. See Order No. 16 (Sept. 6, 2023), unreviewed by Comm'n Notice (Sept. 22, 2023).

Before the evidentiary hearing, the investigation was terminated as to Ridge's trade dress allegations and as to Ridge's infringement allegations with respect to claims 3, 4, 9, 12, 13, 15, 16, and 17 of the '808 patent. See Order No. 25 (Oct. 6, 2023), unreviewed by Comm'n Notice (Nov. 6, 2023).

Only Respondents SWZA and ARW (collectively, the “Participating Respondents”) participated at the evidentiary hearing held on November 6-7, 2023. After the hearing, counsel for the Participating Respondents withdrew after being “discharged” by the Participating Respondents. ID at 2 (citing Order No. 30 (Dec. 13, 2023)). The Participating Respondents did not file post-hearing briefs. Id. at 3.

On March 15, 2024, the ALJ issued a combined final ID and recommended determination (“RD”), finding a violation of section 337 by the Defaulting Respondents and the Participating Respondents. Specifically, the final ID found, inter alia, that the importation requirement is satisfied as to the accused products; that the accused products infringe claims 1, 2, and 14 of the '808 patent; that Ridge has satisfied the domestic industry requirement with respect to the '808 patent; and that claims 1, 2, and 14 have not been shown to be invalid. In addition, the RD recommended that the Commission issue a general exclusion order and a cease and desist order directed to each of the respondents. The RD also recommended that the Commission impose a one-hundred percent (100%) bond during the period of Presidential review.

On April 15, 2024, Ridge filed a statement on public interest pursuant to Commission Rule 210.50(a)(4), 19 CFR 210.50(a)(4).

No petitions for review were filed, which means each party has abandoned all issues decided adversely to that party. See 19 CFR 210.43(b)(4).

Having reviewed the record of the investigation, including the final ID, the parties' submissions to the ALJ, and the record evidence, the Commission has determined to review the ID in part on its own initiative. 19 CFR 210.44. Specifically, the Commission has determined to review the ID's findings with respect to jurisdiction and the economic prong.

In connection with its review, the Commission requests responses to the following questions. The parties are requested to brief their positions with reference to the applicable law and the existing evidentiary record.

1. Explain the basis for considering investments prior to the issuance of a patent (pre-issuance investments) for purposes of a domestic industry under 19 U.S.C. 1337(a)(3)(A) and (B). How do the Federal Circuit's cases holding that there is an “articles” requirement for all subparagraphs (A)-(C) of section 337(a)(3) affect the Commission's reasoning in Video Game Systems crediting engineering and research and development investments that predate the issuance of a patent under certain circumstances? See Certain Video Game Systems and Controllers, Inv. No. 337-TA-743, Comm'n Op., 2011 WL 1523774, at *4 (Apr. 14, 2011); Motiva, LLC v. ITC, 716 F.3d 596, 600-601 (Fed. Cir. 2013) (citing Interdigital Commc'ns, LLC v. ITC, 707 F.3d 1295, 1297-98 (Fed. Cir. 2013) (“[J]ust as the “plant or equipment” referred to in subparagraph (A) must exist with respect to articles protected by the patent, such as by producing protected goods, the research and development or licensing activities referred to in subparagraph (C) must also exist with respect to articles protected by the patent, such as by licensing protected products.”)).

2. Regardless of pre- or post-issuance status of investments, how far back in time should the Commission look to in determining whether a domestic industry exists in a section 337 investigation? What factors should the Commission consider in determining the timeframe over which investments may be counted towards a domestic industry analysis?

3. As of the filing of the complaint, how many full-time equivalent (FTE) employees were employed by Complainant in the “design and development team” working on product research, design, development, and/or engineering work related to the domestic industry products?

4. Provide any information in the record about foreign labor expenditures associated with the manufacturing of the domestic industry products for the time period Aug. 2016-Feb. 2023, and also for the narrower post-issuance time period Oct. 2020-Feb. 2023.

5. Provide any information in the record about foreign capital expenditures associated with the manufacturing of the domestic industry products for the time period Aug. 2016-Feb. 2023, and also for the narrower post-issuance time period Oct. 2020-Feb. 2023.

6. Provide any information in the record about foreign plant and equipment expenditures associated with the manufacturing of the domestic industry products for the time period Aug. 2016-Feb. 2023, and also for the narrower post-issuance time period Oct. 2020-Feb. 2023.

In connection with the final disposition of this investigation, the statute authorizes issuance of, inter alia, (1) an exclusion order that could result in the exclusion of the subject articles from entry into the United States; and/or (2) cease and desist orders that could result in the respondents being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843, Comm'n Op. at 7-10 (Dec. 1994).

The statute requires the Commission to consider the effects of that remedy upon the public interest. The public interest factors the Commission will consider include the effect that an exclusion order and cease and desist orders would have on: (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.

If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve, disapprove, or take no action on the Commission's determination. See Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered.

Written Submissions: The parties to the investigation are requested to file written submissions on the issues identified in this notice. Parties to the investigation, interested government agencies, and any other interested parties are encouraged to file written submissions on the issues of remedy, the public interest, and bonding. Such submissions should address the recommended determination by the ALJ on remedy and bonding.

In its initial submission, Complainant is also requested to identify the remedy sought and Complainant and OUII are requested to submit proposed remedial orders for the Commission's consideration. Complainant is further requested to state the date that the Asserted Patent expires, to provide the HTSUS subheadings under which the accused products are imported, and to supply the identification information for all known importers of the products at issue in this investigation. The initial written submissions and proposed remedial orders must be filed no later than close of business on May 30, 2024. Reply submissions must be filed no later than the close of business on June 6, 2024. No further submissions on these issues will be permitted unless otherwise ordered by the Commission.

Persons filing written submissions must file the original document electronically on or before the deadlines stated above. The Commission's paper filing requirements in 19 CFR 210.4(f) are currently waived. 85 FR 15798 (March 19, 2020). Submissions should refer to the investigation number (Inv. No. 337-TA-1355) in a prominent place on the cover page and/or the first page. ( See Handbook for Electronic Filing Procedures, https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf ). Persons with questions regarding filing should contact the Secretary, (202) 205-2000.

Any person desiring to submit a document to the Commission in confidence must request confidential treatment by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) & 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. Any non-party wishing to submit comments containing confidential information must serve those comments on the parties to the investigation pursuant to the applicable Administrative Protective Order. A redacted non-confidential version of the document must also be filed with the Commission and served on any parties to the investigation within two business days of any confidential filing. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. Government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential written submissions will be available for public inspection on EDIS.

The Commission vote for this determination took place on May 16, 2024.

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

While temporary remote operating procedures are in place in response to COVID-19, the Office of the Secretary is not able to serve parties that have not retained counsel or otherwise provided a point of contact for electronic service. Accordingly, pursuant to Commission Rules 201.16(a) and 210.7(a)(1) (19 CFR 201.16(a), 210.7(a)(1)), the Commission orders that the Complainant(s) complete service for any party/parties without a method of electronic service noted on the attached Certificate of Service and shall file proof of service on the Electronic Document Information System (EDIS).

The Commission instituted this investigation on May 11, 2023, based on a complaint, as supplemented (the “Complaint”) filed by West Pharmaceutical Services, Inc. and West Pharma. Services IL, Ltd. (collectively, “West” or “Complainants”). 88 FR 30342 (May 11, 2023). The Complaint alleged violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, based on the importation into the United States, the sale for importation, and the sale within the United States after importation of certain liquid transfer devices with an integral vial adapter by reason of the infringement of claim 1 of U.S. Patent No. 10,688,295 (the “ '295 patent”); the claim of U.S. Design Patent No. D767,124 (“the D'124 patent”); the claim of U.S. Design Patent No. D765,837 (“the D'837 patent”); the claim of U.S. Design Patent No. D630,732 (“the D'732 patent”); and U.S. Trademark Registration No. 5,810,583 (“the '583 mark”). Id. at 30342.

The Commission's notice of investigation named four respondents: Advcare Medical, Inc. (“Advcare”), Dragon Heart Medical Devices Co., Ltd. (“Dragon Heart Devices”), Dragon Heart Medical, Inc. (“Dragon Heart”), and Summit International Medical Technologies, Inc. (“Summit”). Id. The Office of Unfair Import Investigations (“OUII”) is also a party to this investigation. Id.

The investigation was terminated as to Dragon Heart Devices based on withdrawal of the Complaint. Order No. 9 (Aug. 24, 2023), unreviewed by Comm'n Notice (Sept. 20, 2023). The '583 mark was terminated from the investigation by withdrawal of the Complaint. Order No. 12 (Sept. 19, 2023), unreviewed by Comm'n Notice (Oct. 19, 2023). The three asserted design patents, the D'124 patent, the D'837 patent, and the D'732 patent, were also terminated from the investigation by withdrawal of the Complaint. Order No. 14 (Oct. 4, 2023), unreviewed by Comm'n Notice (Nov. 2, 2023). Accordingly, claim 1 of the '295 patent is the sole remaining claim.

On October 16, 2023, West filed an unopposed motion for summary determination that it satisfied the economic prong of the domestic industry requirement, which was granted. Order No. 17 (Nov. 28, 2023), unreviewed by Comm'n Notice (Dec. 28, 2023).

A claim construction hearing was held on October 26, 2023, and the CALJ issued a claim construction order on November 13, 2023. Order No. 15 (Nov. 13, 2023).

An evidentiary hearing was held on December 4-5, 2023, and the CALJ issued the Final ID on March 15, 2024, finding a violation of section 337 based on infringement of claim 1 of the '295 patent. The Final ID included a Recommended Determination on remedy and bonding, recommending the issuance of a limited exclusion order and a cease and desist order. See Final ID at 73-87.