FSA is hosting three listening sessions for public input about a recently announced planned farm labor stabilization and protection pilot grant program focused on improving the resiliency of our food and agricultural supply chain by addressing current labor shortages in agriculture, reducing irregular migration through increased use of legal pathways, and improving labor protections for farmworkers. The farm labor stabilization and protection pilot grant program will use up to $65 million in American Rescue Plan Act funding to provide support for agricultural employers to hire seasonal workers from the northern Central American countries Guatemala, Honduras, and El Salvador and implement robust labor standards to promote a safe, healthy work environment for both U.S. workers and workers hired under the seasonal H-2A visa program. The H-2 category allows U.S. employers to bring noncitizens into the U.S. on temporary agricultural (H-2A) visas.

FSA is interested in input from agricultural employer organizations, labor unions, farmworker advocates, farmworkers, and other relevant stakeholders. From agricultural employer organizations, FSA is interested in understanding the challenges that employers face in securing a stable workforce; the incentives employers seek from the U.S. Department of Agriculture (USDA) in order to hire workers from northern Central American countries under the seasonal H-2A visa program; and the enhanced labor standards that employers are willing to accept in order to receive USDA support to stabilize the workforce. From labor unions and the broader farmworker advocacy community, FSA is interested in understanding the scope and set of robust worker protections, along with the best methods for verification of those protections, that will help improve labor standards and promote a safer, healthier work environment for both U.S. workers and workers hired from northern Central American countries under the seasonal H-2A visa program as well as the challenges workers currently face in accessing those protections and proposed solutions within statutory authority. Questions for each of the groups are provided below. We invite stakeholders to participate in the listening session that best aligns with the perspective they are able and willing to offer to FSA.

All listening sessions will be posted publicly and open to the public for registration.

The listening sessions will provide an opportunity for stakeholders and interested members of the public to share their thoughts about how FSA can best support agricultural employers in meeting their labor needs, while improving worker protections for both U.S. and H-2A workers.

Each listening session will begin with brief opening remarks from USDA officials. Individual speakers providing oral comments will be limited to 5 minutes each; however, if all speakers can be accommodated within the allotted time for the listening session, individual speaking times may be adjusted at the written request of the stakeholder (see the FOR FURTHER INFORMATION CONTACT section above). As noted above, we request that speakers providing oral comments also provide a written copy of their comments by October 24, 2022. All stakeholders and interested members of the public are welcome to register to provide oral and written comments; however, based on the listening session time or topic area constraints, FSA may not be able to allocate time for all registered attendees to provide oral comments during the listening sessions.

The purpose of the listening sessions is for FSA to hear from agricultural employer organizations, labor unions, farmworker advocacy organizations, farmworkers, and other interested members of the public. In your comments, provide your input about the farm labor stabilization and protection pilot grant program, changes, and anything else that may be helpful for FSA to be aware of or consider. We welcome public input that we can factor into decisions that need to be made to implement the provisions of the farm labor stabilization and protection pilot grant program.

FSA is interested in all comments but requests input from key stakeholders on specific topics.

The following are questions for agricultural employers:

1. What barriers and challenges do agricultural employers currently face in accessing the H-2A visa program? What specific barriers and challenges do agricultural employers face in hiring workers from northern Central America?

2. Do agricultural employers have specific feedback on the housing components of the H-2A visa program? What challenges do you face related to housing?

3. What incentives are employers seeking from USDA to improve their ability to hire workers from northern Central American countries under the seasonal H-2A visa program?

4. What enhanced worker protections and labor standards are employers willing to accept in order to receive USDA support to stabilize the workforce? What mechanisms would be helpful in achieving these enhanced protections and standards?

5. What suggestions do you have to help ensure compliance for any additional standards required by recipients of grants as part of this farm labor stabilization and protection pilot grant program?

The following are questions for labor unions:

1. What barriers or challenges do farmworkers, specifically those in northern Central American countries, face in participating in the H-2A visa program?

2. What do you recommend to enhance farmworker protections, including during recruitment and employment? What methods do you recommend for enforcement and verification of those protections that will promote a safer, healthier work environment for both U.S. workers and workers hired from northern Central American countries under the seasonal H-2A visa program?

3. What suggestions do you have to help ensure compliance for any additional standards required by recipients of grants as part of this farm labor stabilization and protection pilot grant program?

4. What recommendations do you have to increase farmworker awareness of their resources and worker rights both for workers within the United States and for H-2A visa holders in their country of origin?

The following are questions for farmworker advocacy organizations:

1. What barriers or challenges do farmworkers, specifically those in northern Central American countries, face in participating in the H-2A visa program?

2. What do you recommend to enhance farmworker protections, including during recruitment and employment? What methods do you recommend for enforcement and verification of those protections that will promote a safer, healthier work environment for both U.S. workers and workers hired from northern Central American countries under the seasonal H-2A visa program?

3. What suggestions do you have to help ensure compliance for any additional standards required by recipients of grants as part of this farm labor stabilization and protection pilot grant program?

4. What recommendations do you have to increase farmworker awareness of their resources and worker rights both for workers within the United States and for H-2A visa holders in their country of origin?

All persons wishing to attend the listening session must register at fsa.usda.gov/farmworkers by September 28, 2022. To register, information will be required including:

• Attendee contact information (email and phone number);

• Organization representative information (organization name and representative's title within the organization); and

• If you would like to speak, provide written comments.

All written comments received will be publicly available on www.regulations.gov.

If you require special accommodations, such as a sign language interpreter, use the contact information above. The listening session location is accessible to persons with disabilities.

Instructions for registering for this meeting can be obtained by contacting Linda Cronin by or before the deadline.

If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpretation, assistive listening devices, or other reasonable accommodation, including language translation, to Linda Cronin as identified in the FOR FURTHER INFORMATION CONTACT section above. Determinations for reasonable accommodation will be made on a case-by-case basis.

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

Persons with disabilities who require alternative means of communication for program information (for example, braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA TARGET Center at (202) 720-2600 (voice and TTY) or (844) 433-2774 (toll-free nationwide). Additionally, program information may be made available in languages other than English.

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

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

Title: Interstate Shipment of Meat and Poultry.

OMB Number: 0583-0143.

Type of Request: Request to renew an approved information collection.

Abstract: FSIS has been delegated the authority to exercise the functions of the Secretary (7 CFR 2.18, 2.53), as specified in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601, et seq. ), and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, et seq. ). These statutes mandate that FSIS protect the public by verifying that meat and poultry products are safe, wholesome, unadulterated, and properly labeled and packaged.

FSIS administers a voluntary cooperative inspection program under which State-inspected establishments in participating states with 25 or fewer employees are eligible to ship meat and poultry products in interstate commerce (21 U.S.C. 683 and U.S.C. 472) (9 CFR 321.3, 9 CFR part 332, 9 CFR 381.187, and 9 CFR part 381 subpart Z). In participating States, State-inspected establishments selected to take part in this program are required to comply with all Federal standards under the FMIA and the PPIA, as well as with all State standards. These establishments receive inspection services from State inspection personnel who have been trained in the enforcement of the FMIA and PPIA.

Meat and poultry products produced under the program that have been inspected and passed by designated State personnel bear an official Federal mark of inspection and are permitted to be distributed in interstate commerce. FSIS provides oversight and enforcement of the program.

States that are interested in participating in the cooperative interstate shipment program need to submit a request for an agreement to establish such a program through the appropriate FSIS District Office (9 CFR 332.4 and 9 CFR 381.514). In its request, a State must agree to comply with certain conditions to qualify for the interstate shipment program. The State must also: (1) Identify establishments in the State that the State recommends for initial selection into the program, if any, and (2) include documentation to demonstrate that the State is able to provide necessary inspection services to selected establishments in the State and conduct any related activities that would be required under a cooperative interstate shipment program. FSIS reviews the State's request to determine whether to approve the State to participate in the cooperative interstate shipment program.

If a State determines that an establishment qualifies to participate in the cooperative interstate shipment program, and the State is able, and willing, to provide the necessary inspection services at the establishment, the State is to submit its evaluation of the establishment to the FSIS District Office that covers the State (76 FR 24713).

FSIS, in coordination with the State, will then decide whether to select the establishments for the program. Establishments that qualify for this program must meet all requirements under the FMIA or PPIA, and implementing regulations, including FSIS requirements for recordkeeping (9 CFR 332.5 and 9 CFR 381.515). Most State-inspected establishments will already have met these recordkeeping requirements, but some establishments will need to make minor adjustments to their recordkeeping to meet FSIS requirements.

The FSIS selected establishment coordinator (SEC) is responsible for overseeing a State's cooperative inspection program. The SEC will visit each selected establishment in the State on a regular basis to verify that the establishment is operating in a manner that is consistent with the FMIA or PPIA and the implementing regulations (9 CFR 332.7 and 9 CFR 381.517).

The approval for this information collection will expire on February 28, 2023. FSIS is making no changes to the information collection. FSIS has made the following estimates based on an information collection assessment:

Estimate of Burden: FSIS estimates that it will take each new State an average of 40 hours to prepare and submit a request to establish a cooperative interstate shipment program.

FSIS estimates that it will take each State 24 hours to prepare and submit an evaluation for each new establishment entering the program. FSIS estimates that States will submit approximately 3 evaluations per year.

FSIS estimates that 15 establishments per year, out of the current 60 participating establishments, will spend 16 hours to modify their recordkeeping procedures to comply with Federal standards and 5 minutes per establishment to file these records. The State will need to provide these records during the initial verification visit when the FSIS SEC verifies the State nomination to select the establishment into the program. FSIS estimates 15 minutes per establishment to provide the records for the verification assessment.

Respondents: States and establishments.

Estimated No. of Respondents: 7 states and 60 establishments.

Estimated No. of Annual Responses per Respondent: FSIS estimates there will be one request per each new State to establish a cooperative interstate shipment program per year. There will be a one-time modification of records for each newly selected establishment whose recordkeeping does not comply with all Federal standards. The total number of estimated annual responses is 777.

Estimated Total Annual Burden on Respondents: 733 hours. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW, Mailstop 3758, South Building, Washington, DC 20250-3700; (202) 720-5627.

Comments are invited on: (a)whether the proposed collection of information is necessary for the proper performance of FSIS' functions, including whether the information will have practical utility; (b) the accuracy of FSIS' estimate of the burden of the proposed collection of information, including the validity of the method and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Washington, DC 20253.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: https://www.fsis.usda.gov/federal-register.

FSIS will also announce and provide a link to this Federal Register publication 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 U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, 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.

Persons with disabilities who require alternative means of communication for program information ( e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992.

Submit your completed form or letter to USDA by: (1) mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) email: program.intake@usda.gov.

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

The federal government operates several different stockpiles, and these are managed by different federal agencies depending on the stockpile's purpose. For example, the Department of Health and Human Services (HHS) manages the Strategic National Stockpile, which contains medicines and medical equipment. HHS' stockpile can supplement medical countermeasures needed by states, tribal nations, territories and the largest metropolitan areas during public health emergencies. Another example, the Department of Energy operates the Strategic Petroleum Reserve for use when the international oil market is severely disrupted.

The Department of Defense (DOD) maintains a stockpile of critical and strategic materials known as the National Defense Stockpile (NDS). In a war or national emergency, this stockpile is meant to provide strategic and critical materials to support national defense and essential civilian requirements in a time of national emergency. The stockpile currently contains 57 materials, primarily minerals, that are deemed strategic and critical to national security. 1

Under the authority of the Strategic and Critical Materials Stock Piling Revision Act of 1979, as amended (the Stock Piling Act) (50 U.S.C. 98 et seq. ), the Department of Defense's Defense Logistics Agency (DLA) is the National Defense Stockpile Manager. The NDS is a strategic stockpile, not an economic stockpile. It is not intended to influence prices in the market or insulate private industry from supply shocks. Rather, its purpose is to ensure the defense and essential civilian industrial base has consistent access to the materiel it needs—and the private industries making products have the raw materials they need—in war or national emergency.

Congress authorizes the sale of excess materials in the stockpile, and proceeds of the sales are transferred to the National Defense Stockpile Transaction Fund. The NDS does not receive annual appropriations in the defense budget—neither for new purchases of materials nor for operations expenses. Instead, the stockpile has a revolving fund in the US Treasury called the National Defense Stockpile Transaction Fund. 2 Whenever materials in the stockpile are sold, the proceeds of that sale are added to the fund. The DLA then uses that money to pay for the operational expenses of maintaining the stockpile and to purchase new materials. Information about stockpile transactions—what was bought, what was sold, at what value it was sold—is publicly available in annual and monthly reports published by DLA. 3

Section 3314 of the National Defense Authorization Act for Fiscal Year 1993 (FY 1993 NDAA) (50 U.S.C. 98h-1) formally established a Market Impact Committee (the Committee) to “advise the National Defense Stockpile Manager on the projected domestic and foreign economic effects of all acquisitions and disposals of materials from the stockpile. . . .” The Committee must also balance market impact concerns with the statutory requirement to protect the U.S. Government against avoidable loss. See 50 U.S.C. 98e (b)(2).

The Committee is comprised of representatives from the Departments of Commerce, State, Agriculture, Defense, Energy, Interior, the Treasury, and Homeland Security. The FY 1993 NDAA directs the Committee to consult with industry representatives that produce, process, or consume the types of materials stored in the Stockpile as the National Defense Stockpile Manager, the DLA must produce an Annual Materials Plan (AMP) proposing the maximum quantity of each listed material that may be acquired, disposed of, upgraded, converted, recovered, or sold by the DLA in a particular fiscal year. With this notice, Commerce, on behalf of DLA, lists the quantities and types of activity—potential disposals, potential acquisitions, potential conversions (upgrade, rotation, reprocessing, etc.) or potential recovery (from government sources)—associated with each material in its proposed FY 2024 AMP.

The quantities listed in Attachment 1 are not acquisition, disposal, upgrade, conversion, recovery, reprocessing, or sales target quantities, but rather a statement of the proposed maximum quantity of each listed material that may be acquired, disposed of, upgraded, converted, recovered, or sold in a particular fiscal year by the DLA. The quantity of each material that will actually be acquired or offered for sale will depend on the market for the material at the time of the acquisition or offering, as well as on the quantity of each material approved by Congress for acquisition, disposal, conversion, or recovery.

The Committee is interested in any supporting data and documentation on the potential market impact of the quantities associated with the proposed FY 2024 AMP.

While regulations.gov allows users to provide comments by filling in a “Type Comment” field or by attaching a document using an “Upload File” field, BIS prefers comments be provided in an attached document—preferably in Microsoft Word (.doc) or Adobe Acrobat (.pdf). If the submission is in an application format other than Microsoft Word or Adobe Acrobat, please indicate the name of the application in the “Type Comment” field. Please do not attach separate cover letters to electronic submissions; rather, include any information that might appear in a cover letter within the comments. Please include any exhibits, annexes, or other attachments in the same file, so the submission consists of one instead of multiple files. All filers should name their files using the name of the person or entity submitting the comments.

Submitted materials properly marked as business confidential information with a valid statutory basis for confidentiality and which is accepted as such by BIS will not be disclosed publicly. Commenters submitting business confidential information should clearly identify the business confidential portion at the time of submission, include a statement justifying nondisclosure and referring to the specific legal authority claimed with the submission, and provide a non-confidential version of the submission which will be placed in the public file on https://www.regulations.gov . For comments containing business confidential information, the file name of the business confidential version should begin with the characters “BC”. Any page containing business confidential information must be clearly marked “BUSINESS CONFIDENTIAL” on the top of that page. The file name of the non-confidential version should begin with the character “P”. The non-confidential version must be clearly marked “PUBLIC” on the top of the first page. The “BC” and “P” should be followed by the name of the person or entity submitting the comments.

The Office of Administration, Bureau of Industry and Security, U.S. Department of Commerce, displays public comments on the BIS Freedom of Information Act (FOIA) website at https://efoia.bis.doc.gov/ . This office does not maintain a separate public inspection facility. If you have technical difficulties accessing this website, please call BIS's Office of Administration at (202) 482-1900 for assistance.

In the Federal Register of September 6, 2022, in FR Doc 2022-19190, on page 54455, after the paragraph, “Methodology,” add the following paragraph regarding alignment:

As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final CVD determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of WGJC from Argentina, based on a request made by the petitioner. 1 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than January 10, 2023, unless postponed.”

On September 6, 2022, Commerce published in the Federal Register the Preliminary Determination in the CVD investigation on WGJC from Argentina. 2 In that notice, Commerce did not state, as it had in the accompanying Preliminary Decision Memorandum, that it is aligning the final CVD determination in this investigation with the final determination in the companion AD investigation of WGJC from Argentina. Commerce is hereby correcting the Preliminary Determination .

This notice is issued and published in accordance with sections 703(f) and 777(i) of the Tariff Act of 1930, as amended, and 19 CFR 351.205(c).

On June 30, 2021, Commerce received petitions for the imposition of AD and countervailing duties (CVD) on UAN imported into the United States from Russia and the Republic of Trinidad and Tobago. In the petitions, 1 the petitioner stated that information that was reasonably available to it indicated that Russia does not operate on market principles. As such, the petitioner argued that Commerce should initiate an investigation into whether, and should determine that, Russia is a non-market economy (NME) country. After finding that the petitioner's allegation met the requirements of section 732 of the Tariff Act of 1930, as amended (the Act), on July 30, 2021, Commerce initiated an AD investigation of UAN from Russia, as well as an examination of Russia's status as an ME country. 2

On October 29, 2021, based on the information on the record, Commerce determined that Russia remained an ME country for purposes of AD law. 3 However, in its determination, Commerce noted that,

In its March 26, 2022, case brief in the AD investigation of UAN from Russia, the petitioner argued that the final phase of the AD investigation of UAN from Russia was an appropriate time in the “near future” for Commerce to revisit its determination regarding Russia's ME status and examine whether its October 2021 findings regarding that status remain valid, including its “findings concerning ruble convertibility, the environment for foreign investment, the {Government of Russia's} control over Russia's economy, rule of law, and freedom of information.”  5 Given Commerce's observations in its October 29, 2021 determination, the request in the petitioner's case brief, and the additional information gathered concerning changes to the economic conditions in Russia, Commerce determined to revisit Russia's status as an ME country in the context of a CCR initiated on May 6, 2022. 6 Commerce detailed recent developments in Russia in an accompanying decision memorandum, finding that good cause exists within the meaning of 19 CFR 351.216(c) to initiate a CCR to review whether Russia remains an ME country for purposes of administration of the AD law. 7 Therefore, Commerce initiated a CCR to determine whether Russia remains an ME country for purposes of the AD law, pursuant to sections 751(b) and 771(18)(C)(ii) of the Act, and 19 CFR 351.216(c).

On July 25, 2022, EuroChem Switzerland (EuroChem), a global fertilizer supplier and a mandatory respondent in the UAN from Russia AD investigation, requested that the CCR be terminated. 8 EuroChem cited the negative injury determination as to UAN by the U.S. International Trade Commission (ITC) as grounds for terminating the CCR. 9 EuroChem also argued that the comments it had provided in response to the CCR Initiation, along with comments from the Government of Russia, had effectively rebutted Commerce's claim that good cause existed to examine Russia's ME status. 10

Commerce has concluded that it is necessary to terminate the CCR, because as a result of the ITC's finding of no material injury or threat of material injury, there is no AD order of UAN from Russia to review through a CCR. 11

As Commerce is now terminating the CCR of UAN from Russia, Commerce is now examining Russia's ME status within the context of the AD investigation of ESBR from Russia, pursuant to section 771(18)(C)(ii) of the Act. The final determination of the investigation of ESBR from Russia is scheduled to be issued not later than November 9, 2022. While Commerce intends to complete the review of Russia's ME status by the final determination, Commerce does not intend to reconsider the calculation methodology used for determining the AD margins in the ESBR from Russia final determination, as there will not be sufficient time to do so.

Certain parties submitted public comments and factual information for consideration in the CCR pursuant to the Federal eRulemaking Portal: www.Regulations.gov. These include comments and, where applicable, rebuttal comments from:

Commerce is now requesting these parties resubmit their comments to the ESBR from Russia AD investigation (A-821-835) segment on ACCESS. The parties listed above must resubmit their comments to the ACCESS ESBR from Russia AD investigation segment no later than 5:00 p.m. Eastern Time, September 28, 2022. The parties listed above resubmitting their comments must follow the additional instructions provided by Commerce in a memorandum issued concurrently with this notice and placed on the records of both the ESBR investigation and the UAN CCR. 12

Commerce is also providing interested parties that have not already submitted comments in the CCR with an opportunity to submit public comments and factual information regarding developments in the Russian economy since October 2021 with respect to the six factors enumerated in section 771(18)(B) of the Act. If parties have already submitted comments on Russia's status as an ME country in the context of the CCR discussed above, new comments from those parties will not be accepted.

The six factors enumerated in section 771(18)(B) of the Act are:

Interested parties may submit comments and factual information regarding Russia's current status as an ME country no later than 21 days after the date of publication of this notice in the Federal Register . Rebuttal comments, limited to comments on issues raised in parties' affirmative comments, may be filed no later than 10 days after the date for filing affirmative comments. Comments, factual information, and rebuttal comments must contain all public information.

Parties may request a hearing in their comments. After reviewing all comments, and factual information, Commerce will determine whether to hold a public hearing in the AD investigation of ESBR from Russia, limited to Russia's current status as an ME country. 13 If Commerce determines that a public hearing on this issue is warranted, it will announce a time and forum for the hearing.

This notice is issued and published in accordance with section 771(18)(C)(ii) of the Act.

In the Preliminary Determination, Commerce established a certification program and a deadline for certain exporters and importers to certify that entries of hardwood plywood exported from Vietnam that entered, or were withdrawn from warehouse, for consumption on or after June 17, 2020, and until August 28, 2022, are not subject to the AD/CVD orders on hardwood plywood from China. 1 The deadline for exporters and importers to complete these certifications was September 12, 2022. 2

On September 12, 2022, Commerce issued a memorandum via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System ( i.e., ACCESS) notifying interested parties that the deadline for the certifications to be complete was extended by 80 days. 3 Also on September 12, 2022, Commerce transmitted instructions to U.S. Customs and Border Protection (CBP) notifying CBP of the extended deadline. 4 The deadline for exporters and importers to complete the certification requirements established in the Preliminary Determination is now December 1, 2022. We note that the 36 companies that Commerce precluded from participating in this certification program in the Preliminary Determination are still precluded from participating in the certification program we established for applicable exports of hardwood plywood from Vietnam. 5

This notice is issued and published in accordance with sections 781(b) of the Tariff Act of 1930, as amended and 19 CFR 351.225(f) and (h). 6

The purpose of the meeting is to conduct a salmon methodology review to discuss and review proposed changes to analytical methods used in salmon management. At its September 2022 meeting, the Pacific Council adopted the following priority items for the 2022 Salmon Methodology Review.

1. Technical review of the updates associated with `Round 7.1.1' of the Fishery Regulation Assessment Model (FRAM) base period as they relate to modeled abundances of Chinook salmon stocks used in determining the southern resident killer whale (SRKW) Chinook salmon abundance threshold.

2. Technical review of the updates to Chinook salmon ocean distribution models that derive from two publications (Shelton et al. 2019, 2021) and are used to apportion the modeled abundance of Chinook salmon stocks among ocean regions.

3. Discussion of whether the Sacramento Index forecast should be expressed as a mean or median.

4. Review of the basis behind the Sacramento River Fall Chinook conservation objective.

5. FRAM technical detail documentation.

If time allows additional topics may be discussed, including but not limited to future Pacific Council agenda items and salmon related topics of interest to the STT and SSC Salmon Subcommittee.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt ( kris.kleinschmidt@noaa.gov; (503) 820-2412) at least 10 days prior to the meeting date.

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

This request is for revision and extension of a currently approved information collection. The Magnuson Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) authorizes the establishment of eight Regional Fishery Management Councils to manage fisheries within regional jurisdictions. Section 302(j) of the Magnuson-Stevens Act requires that affected individuals, including Council members appointed by the Secretary of Commerce, Scientific and Statistical Committee (SSC) members appointed by a Council, and individuals nominated by the State Governor, Territorial Governor or Tribal Government for possible appointment as a Council member (50 CFR 600.235), must disclose their financial interest in any Council fishery. Financial interests include harvesting, processing, lobbying, advocacy, or marketing activity that is being, or will be, undertaken within any fishery over which the Council concerned has jurisdiction. Information on financial interests must be disclosed on NOAA Form 88-195, Statement of Financial Interests, under OMB collection 0648-0192. The information collected is used to assess potential conflicts of interest and to make determinations about when recusals from Council voting decisions are necessary to avoid such conflicts. NOAA Fisheries and Council offices are required to maintain current Statement of Financial Interests forms on file that are publically available for transparency. The Statement of Financial Interests form is being revised at this time for consistency with the final rule 0648-BH73 to clarify guidance on council members' financial disclosures and voting recusals (50 CFR 600.235; as amended at 85 FR 56177, Sept. 11, 2020).

Information will be collected electronically. Paper forms will be accepted if needed.

OMB Control Number: 0648-0192.

Form Number(s): NOAA Form 88-195.

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

Affected Public: Individuals or households.

Estimated Number of Respondents: 330.

Estimated Time per Response: 45 minutes.

Estimated Total Annual Burden Hours: 248 hours.

Estimated Total Annual Cost to Public: $0.

Respondent's Obligation: Mandatory.

Legal Authority: MSA Section 302(j) and 50 CFR 600.235.

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

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

The National Marine Fisheries Service (NMFS) Office of International Affairs, Trade, and Commerce requests a regular submission for the extension of a current information collection. The Security and Accountability for Every Port Act of 2006 (SAFE Port Act, Pub. L. 109-347) requires all Federal agencies with a role in import admissibility decisions to collect information electronically through the International Trade Data System (ITDS). The Department of the Treasury has the U.S. Government lead on ITDS development and Federal agency integration. U.S. Customs and Border Protection (CBP) developed the Automated Commercial Environment (ACE) as an internet-based system for the collection and dissemination of information for ITDS. The Office of Management and Budget (OMB), through its e-government initiative, oversees Federal agency participation in ITDS, with a focus on reducing duplicate reporting across agencies and migrating paper-based reporting systems to electronic information collection. Numerous Federal agencies are involved in the regulation of international trade and many of these agencies participate in the decision-making process related to import, export, and transportation. Agencies also use trade data to monitor and report trade activity. NMFS is a partner government agency in the ITDS project as it monitors the trade of certain fishery products. Electronic collection of seafood trade data through a single portal has resulted in an overall reduction of the public reporting burden and the agency's data collection costs, has improved the timeliness and accuracy of admissibility decisions, and has increased the effectiveness of applicable trade restrictive measures.

NMFS is responsible for implementation of trade measures and monitoring programs for fishery products subject to the documentation requirements of Regional Fishery Management Organizations (RFMO) and/or domestic laws. RFMOs are international fisheries organizations, established by treaties, to promote international cooperation to achieve effective and responsible marine stewardship and ensure sustainable fisheries management. The United States is a signatory to many RFMO treaties, and Congress has passed legislation to carry out U.S. obligations under those treaties, including trade measures to support conservation. Trade measures and monitoring programs enable the United States to exclude products that do not meet the RFMO criteria for admissibility to U.S. markets.

Pursuant to domestic statutory authorities and/or multilateral agreements, NMFS has implemented a number of monitoring programs to collect information from the seafood industry regarding the origin of certain fishery products. The purpose of these programs is to determine the admissibility of the products in accordance with the specific criteria of the trade measure or documentation requirements in effect. The three NMFS trade monitoring programs originally included in the OMB information collection approved under Control Number 0648-0732 are the Highly Migratory Species International Trade Program (HMS ITP) which regulates trade in specified commodities of tuna, swordfish, billfish, and shark fins; the Antarctic Marine Living Resources (AMLR) trade program which regulates trade in Antarctic and Patagonian toothfish and other fishery products caught in the area where the Convention on the Conservation of Antarctic Marine Living Resources (CCAMLR) applies; and the Tuna Tracking and Verification Program (TTVP), which regulates trade in frozen and/or processed tuna products (refer to 50 CFR 216.24(f)(2)(iii) for a complete list).

Separately, NMFS initially received approval from OMB for the Seafood Import Monitoring Program (SIMP) under Control Number 0648-0739. NMFS implemented SIMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (MSA). Section 307(1)(Q) of the MSA prohibits the importation of fish or fish products that have been harvested in violation of a foreign law or regulation, or in contravention of a binding conservation measure of an RFMO to which the United States is a contracting party. Under SIMP, information on the harvest event must be submitted in ACE as part of the entry filing for designated fish products to allow NMFS to determine that the fish or fish products were lawfully acquired and are therefore admissible into U.S. commerce. In 2019, NMFS included shrimp and abalone entries in SIMP, and received initial OMB approval for the additional reporting burden for shrimp and abalone entries under a separate Control Number (0648- 0776).

In the 2020 collection renewal of 0648-0732, OMB granted the NMFS request to merge all the trade monitoring programs under one collection, which incorporated the reporting burdens associated with collections 0648-0739 and 0648-0776 within the scope of 0648-0732. Generally, these trade monitoring programs are similar and require anyone who intends to import, export, and/or re-export regulated species to: Obtain an International Fisheries Trade Permit (IFTP) from NMFS; obtain documentation on the flag-nation authorization for the harvest from the foreign exporter; and submit this information to NMFS. Depending on the commodity, specific information may also be required, such as the flag-state of the harvesting vessel, the ocean area of catch, the fishing gear used, the harvesting vessel name, and details and authorizations related to harvest, landing, transshipment, and export.

The initial requirement for U.S. entities trading in reportable commodities is to apply for an IFTP. To obtain an IFTP, U.S. importers, exporters, and re-exporters of seafood products covered under the TTVP, AMLR, HMS ITP, and SIMP programs would be required to electronically submit their application and fee for the IFTP via the National Permits System available online at: NOAA Fisheries Permits.

OMB Control Number: 0648-0732.

Form Number(s): None.

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

Affected Public: Business or other for-profit organizations; Federal government.

Estimated Number of Respondents: 1,800 per year.

Estimated Time per Response: International Trade Fisheries Permits, 20 minutes; Dataset submission in ITDS/ACE, 18 minutes; Audit Response, 30 minutes; Supply Chain Recordkeeping, 15 minutes.

Estimated Total Annual Burden Hours: 103,717 hours.

Estimated Total Annual Cost to Public: $1,854,000.

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

Legal Authority: 16 U.S.C. 1385, 16 U.S.C. 1826(a), 16 U.S.C. 971(a), 19 U.S.C. 1411

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

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

The agenda will include staff reports on: (1) the status of Bristol Bay red king crab, Bering Sea snow crab, and Bering Sea tanner crab stocks, (2) updates on snow crab rebuilding, (3) federal Pacific cod stock assessment and management, (4) Council action on small boat access, (5) State Pacific cod management, and (6) State-managed Pacific cod proposals, along with public testimony and committee discussion on these items. The agenda is subject to change, and the latest version will be posted at https://www.adfg.alaska.gov/index.cfm?adfg=fisheriesboard.meetinginfo&date=10-13-2022&meeting=anchorage prior to the meeting, along with meeting materials.

You can watch the meeting online using a computer, tablet, or smart phone. Connection information will be posted online at: https://www.adfg.alaska.gov/index.cfm?adfg=fisheriesboard.meetinginfo&date=10-13-2022&meeting=anchorage.

Public comment letters will be accepted and should be submitted electronically to: https://arcg.is/1ze8ii by 11:59 p.m. Alaska time on Wednesday, October 5, 2022. An opportunity for oral public testimony will also be provided during the meeting.

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

On April 20, 2010, the mobile offshore drilling unit Deepwater Horizon, which was being used to drill a well for BP Exploration and Production, Inc. (BP) in the Macondo prospect (Mississippi Canyon 252-MC252), experienced a significant explosion, fire, and subsequent sinking in the Gulf of Mexico, resulting in an unprecedented volume of oil and other discharges from the rig and from the wellhead on the seabed. The DWH oil spill is the largest offshore oil spill in U.S. history, discharging millions of barrels of oil over a period of 87 days. In addition, well over one million gallons of dispersants were applied to the waters of the spill area in an attempt to disperse the spilled oil. An undetermined amount of natural gas was also released into the environment as a result of the spill.

The DWH Federal and State natural resource trustees (DWH Trustees) conducted the natural resource damage assessment (NRDA) for the DWH oil spill under OPA (33 U.S.C. 2701 et seq. ). Pursuant to OPA, Federal and State agencies act as trustees on behalf of the public to assess natural resource injuries and losses and to determine the actions required to compensate the public for those injuries and losses. OPA further instructs the designated trustees to develop and implement a plan for the restoration, rehabilitation, replacement, or acquisition of the equivalent of the injured natural resources under their trusteeship, including the loss of use and services from those resources from the time of injury until the time of restoration to baseline (the resource quality and conditions that would exist if the spill had not occurred) is complete.

The DWH Trustees are:

• U.S. Department of the Interior (DOI), as represented by the National Park Service, U.S. Fish and Wildlife Service, and Bureau of Land Management;

• National Oceanic and Atmospheric Administration (NOAA), on behalf of the U.S. Department of Commerce;

• U.S. Department of Agriculture (USDA);

• U.S. Environmental Protection Agency (EPA);

• State of Louisiana Coastal Protection and Restoration Authority (CPRA), Oil Spill Coordinator's Office (LOSCO), Department of Environmental Quality (LDEQ), Department of Wildlife and Fisheries (LDWF), and Department of Natural Resources (LDNR);

• State of Mississippi Department of Environmental Quality;

• State of Alabama Department of Conservation and Natural Resources and Geological Survey of Alabama;

• State of Florida Department of Environmental Protection and Fish and Wildlife Conservation Commission; and

• State of Texas: Texas Parks and Wildlife Department, Texas General Land Office, and Texas Commission on Environmental Quality.

The DWH Trustees reached and finalized a settlement of their natural resource damage claims with BP in an April 4, 2016 Consent Decree approved by the United States District Court for the Eastern District of Louisiana. Pursuant to that Consent Decree, restoration projects in the Louisiana Restoration Area are selected and implemented by the Louisiana TIG. The Louisiana TIG is composed of the following Trustees: CPRA; LOSCO; LDEQ; LDWF; LDNR; NOAA; DOI; EPA; and USDA.

The DWH oil spill resulted in the oiling of more than 1,100 kilometers of wetlands, nearly all of which were located in coastal Louisiana. The heaviest oiling occurred in the Barataria Basin, resulting in substantial injuries to natural resources in the basin. The impact of those injuries was intensified by the fragile nature of the basin. Already suffering from significant coastal erosion, marshes in the Barataria Basin that experienced heavy oiling subsequently experienced double or triple the rate of marsh loss. Recognizing that the resulting loss of marsh productivity affected resources throughout the northern Gulf of Mexico ecosystem, the State of Louisiana and the federal Trustees that negotiated the DWH Natural Resource Damages settlement allocated $4 billion, almost half of the total settlement amount, to restoring Louisiana's wetland, coastal, and nearshore habitats.

The DWH NRDA Trustees began analyzing strategies for restoring those coastal losses that resulted from the DWH oil spill beginning as part of the settlement process and leading to the preparation of the Deepwater Horizon Oil Spill: Final Programmatic Damage Assessment and Restoration Plan and Final Programmatic Environmental Impact Statement (Final PDARP/PEIS, DWH NRDA Trustees, 2016). To address the large-scale impacts, they agreed that “[d]iversions of Mississippi River water into adjacent wetlands have a high probability of providing these types of large-scale benefits for the long-term sustainability of deltaic wetlands” (DWH NRDA Trustees, 2016, page 5-25).

Building on the Final PDARP/PEIS, the Louisiana TIG began evaluating restoration strategies that could restore for injuries to natural resources in the Barataria Basin, which resulted in the Strategic Restoration Plan and Environmental Assessment #3: Restoration of Wetlands, Coastal, and Nearshore Habitats in the Barataria Basin, Louisiana (SRP/EA #3).

In the SRP/EA #3, the LA TIG ultimately determined that a combination of “marsh creation and ridge restoration plus a large-scale sediment diversion would provide the greatest level of benefits to injured Wetlands, Coastal, and Nearshore Habitats and to the large suite of injured resources that depend in their life cycle on productive and sustainable wetland habitats” (LA TIG, 2018, page 3-32) in the basin and in the broader northern Gulf of Mexico.

Since finalizing the SRP/EA #3, the Louisiana TIG has evaluated a variety of potential alternatives for a large-scale sediment diversion in the Barataria Basin. This Final Phase II RP #3.2, along with the MBSD FEIS released simultaneously by the USACE CEMVN, set forth the results of that evaluation.

The Final Phase II RP #3.2 is being released in accordance with NRDA regulations for restoration planning under OPA in 15 CFR part 990, NEPA (42 U.S.C. 4321 et seq. ), the Consent Decree, and the Final PDARP/PEIS. The structural features of the Proposed MBSD Project and its alternatives are located in south Louisiana on the west bank of the Mississippi River at River Mile (RM) 60.7, just north of the Town of Ironton. The anticipated outfall area for sediment, freshwater, and nutrients conveyed from the river is located within the Mid-Barataria Basin. The area of the Proposed MBSD Project and its alternatives includes the hydrologic boundaries of the Barataria Basin and the lower Mississippi River Delta Basin, also known as the birdfoot delta. The Mississippi River itself, beginning near RM 60.7 and extending to the mouth of the river, is also included in the Proposed MBSD Project area.

In the Final Phase II RP #3.2, the Louisiana TIG selects its preferred alternative under the DWH Louisiana Restoration Area Wetlands, Coastal and Nearshore Habitats restoration type. The preferred alternative (Alternative 1) consists of a controlled sediment and freshwater intake diversion structure in Plaquemines Parish on the right descending bank of the Mississippi River at RM 60.7. The preferred alternative would have a maximum diversion flow of 75,000 cfs, which would occur when the Mississippi River gauge at Belle Chase reaches 1,000,000 cfs or higher. The diversion would operate at up to 5,000 cfs (base flow) when the river is below 450,000 cfs at Belle Chase; at river flows above 450,000 cfs, the diversion would be opened fully. At the downstream end of the diversion channel, an engineered “outfall transition feature” would be constructed to guide and disperse the channel flow into the Barataria Basin. The preferred alternative is projected to increase land area, including emergent wetlands and mudflats, in the Barataria Basin across the 50-year analysis period relative to natural recovery, with a maximum increase of 17,300 acres in 2050, at the approximate mid-point of the 50-year analysis period.

The cost of the Proposed MBSD Project at the time of the Draft Phase II RP #3.2 was anticipated to be approximately $2 billion. Since the publication of the Draft Phase II RP #3.2, substantial increases in the general inflation rate as well as corresponding increases to most cost components of the Proposed MBSD Project, including but not limited to construction materials, construction activities, and wages, have occurred. CPRA has experienced an average 25% increase in costs on its recent restoration projects. If selected for implementation, CPRA will not know the amount of the cost increase for the Proposed MBSD Project until it completes negotiations for a Guaranteed Maximum Price for project construction with the Construction Management At Risk contractor. Those negotiations will not begin until after the publication of this Final Phase II RP #3.2. In light of this uncertainty as to total project costs, the Louisiana TIG intends to limit its contribution to the overall project costs to $2.26 billion if it is selected for implementation. This would help ensure that DWH settlement funding would be available to construct all projects currently under consideration as well as for future large-scale wetlands, coastal, and nearshore habitat restoration projects not yet proposed. The cap would also ensure that planned DWH payments to the Louisiana TIG would be sufficient to cover project costs as it continues to be designed and implemented. To ensure the Monitoring and Adaptive Management (MAM) and Mitigation and Stewardship Plans are fully funded, the Louisiana TIG's contribution would cover the majority of MAM associated costs (a NRDA investment of up to $148,800,000, including contingency funding) and the Mitigation and Stewardship costs (currently estimated at $378,000,000, including contingency funding). A portion of the engineering and design costs has been paid by the National Fish and Wildlife Federation's Gulf Environmental Benefit Fund. The remaining Louisiana TIG contribution would be applied toward other project cost categories. CPRA has committed to providing funding for all costs that exceed the Louisiana TIG's funding cap of $2,260,000,000.

The Louisiana TIG fully evaluated a smaller-capacity diversion with a maximum capacity of 50,000 cfs (Alternative 2). The Trustees found that such a diversion would provide substantially less benefit in marsh preservation and restoration, with only a small reduction in adverse impacts and a slight cost reduction.

The Louisiana TIG also fully evaluated a larger-capacity diversion with a maximum capacity of 150,000 cfs (Alternative 3). While the marsh creation benefits of such a large diversion would be significantly greater, the collateral injuries would also increase to levels unacceptable to the Trustees.

Three other alternatives (Alternatives 4-6) would divert the same flow (cfs) capacities as described above for Alternatives 1-3, and would include marsh terrace outfall features. While providing some benefits, the outfall feature alternatives do not substantially change the extent to which the corresponding alternatives with similar capacities and without terraces meet the Louisiana TIG's goals and objectives for the project.

While the Louisiana TIG has rejected the No-Action-Alternative for this Final Phase II RP #3.2, the OPA analysis provided in Chapter 3 integrates information about the MBSD FEIS No-Action Alternative (40 CFR 1502.14(c)) because it provides a baseline against which the benefits and collateral injuries of the Proposed MBSD Project and its alternatives can be compared.

The Louisiana TIG is committed to continuing efforts to restore the resources that would be adversely affected by the Proposed MBSD Project if selected for implementation, many of which were also injured by the DWH oil spill. The Proposed MBSD Project includes a MAM Plan and a Mitigation and Stewardship Plan. The Project also now includes a Marine Mammal Intervention Plan, which was developed in response to public comments. These plans serve as an integral part of the proposed restoration action. The MAM Plan includes (1) methods for specific types of monitoring, (2) key performance measures/indicators for assessing the success of the Proposed MBSD Project in meeting its objectives, and (3) decision criteria and processes for modifying (“adapting”) current or future management actions. The Mitigation and Stewardship Plan includes actions to help to address collateral impacts of construction and operation of the Proposed MBSD Project. The Marine Mammal Intervention Plan outlines a spectrum of potential response actions for dolphins affected by the operation of the Proposed MBSD Project, ranging from recovery/relocation to no intervention to euthanasia. As part of the Project, CPRA would have responsibility for ensuring implementation of the measures outlined in each of these Plans.

The Louisiana TIG has examined the injuries assessed by the DWH Trustees and evaluated restoration alternatives to address the injuries. In Final Phase II RP #3.2, the Louisiana TIG presents to the public its plan for providing partial compensation to the public for injured natural resources and ecological services in the Louisiana Restoration Area. The preferred alternative is intended to continue the process of using DWH restoration funding to restore natural resources injured or lost as a result of the DWH oil spill. Additional restoration planning for the Louisiana Restoration Area will continue irrespective of whether the preferred alternative is selected for implementation.

Trustees typically choose to combine a restoration plan and the required NEPA analysis into a single document (33 CFR 990.23(a), (c)(1)). In this case, the Final Phase II Restoration Plan #3.2 does not include integrated NEPA analysis. This is because prior to evaluation of the Proposed MBSD Project by the Louisiana TIG as a restoration project under OPA, the USACE CEMVN initiated scoping for the MBSD Project EIS based on a permit application for the Project by CPRA. In this case, to increase efficiency, reduce redundancy, and be consistent with Federal policy and 40 CFR 1506.3, the four Federal Trustees in the Louisiana TIG decided to participate as cooperating agencies in the development of a single MBSD EIS. As the lead agency, the USACE CEMVN has primary responsibility for preparing the MBSD EIS (40 CFR 1501.5(a)). The Louisiana TIG is relying on the MBSD Final EIS to evaluate potential environmental effects of the MBSD Project and its alternatives evaluated in this Final Phase II RP #3.2.

The Louisiana TIG solicited public comment on the Draft Phase II RP #3.2 for a total of 90 days between March 5, 2021 and June 3, 2021 (86 FR 12915, March 5, 2021). Three public meetings were held during the comment period. This period ran concurrently with the USACE CEMVN public comment period on the MBSD DEIS. Following the comment period, the 40,699 comment submissions received were reviewed by the Louisiana TIG and taken into consideration in the preparation of this Final Phase II RP #3.2. The Final Phase II RP #3.2 includes a summary of the comments received and responses to those comments.

Following publication of the Louisiana TIG's Final Phase II RP #3.2 and the USACE CEMVN's MBSD FEIS, conclusion of the NEPA 30-day wait period, and issuance of the Louisiana TIG's Record of Decision, the Louisiana TIG intends to finalize its decision (15 CFR 990.23(c)(2)(ii)(G)) and document such by Louisiana TIG Resolution. Until that time, the Louisiana TIG would not have made a final decision on the proposed Project on the proposed Project.

You may request a CD of the Final Phase II RP #3.2 (see FOR FURTHER INFORMATION CONTACT above). Copies of the Final Phase II RP #3.2 and MBSD FEIS are also available at the following locations:

The Executive Summary of the Final Phase II RP #3.2 is available in Vietnamese and Spanish from the Louisiana TIG website at: http://www.gulfspillrestoration.noaa.gov/restoration-areas/louisiana. Vietnamese and Spanish translations of materials prepared for the public review of the MBSD DEIS and Draft Phase II RP #3.2 remain available on USACE CEMVN's project web page. Pre-recorded presentations from the MBSD DEIS and Draft Phase II RP #3.2 public meetings also remain available on USACE CEMVN's project web page. The recordings are available in English, Vietnamese, Khmer, and Spanish.

The documents comprising the Administrative Record for the Final Phase II RP #3.2 can be viewed electronically at http://www.doi.gov/deepwaterhorizon/adminrecord.

The authority of this action is the Oil Pollution Act of 1990 (33 U.S.C. 2701 et seq. ) and its implementing Oil Pollution Act Natural Resource Damage Assessment regulations found at 15 CFR part 990 and the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ).

The principal purpose of this meeting is to discuss and prepare analyses supporting Council action on hard caps for the California large mesh driftnet (DGN) fishery. This action would establish hard caps ( i.e., limits) on the number of observed mortalities/injuries of nine high priority protected species identified by the Council. Hard caps may apply to individual vessels or the fishery as a whole. If a limit is met or exceeded, both the observed vessel and any vessels determined to be unobservable would stop fishing, or the DGN fishery as a whole, would close for a prescribed time period. At its June 2022 meeting, the Council chose a range of alternatives for a hard caps fishery management regime to support further consideration of the action. The HMSMT will also discuss ongoing work to reevaluate the definition of essential fish habitat described in the HMS Fishery Management Plan, other relevant items on the agenda of the November 2022 Council meeting, and future HMSMT work on tasks assigned to it by the Council. A meeting agenda will be posted to the Council website at least one week before the start of the meeting.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

The public listening station is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt ( kris.kleinschmidt@noaa.gov; (503) 820-2412) at least 10 days prior to the meeting date.

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

The Scientific and Statistical Committee will meet to review the information provided by the Council's Scallop Plan Development Team and recommend the overfishing limits (OFLs) and acceptable biological catches (ABCs) for Atlantic sea scallops for fishing years 2023 and 2024 (default). Also on the agenda is the review the information provided by the Council's Groundfish Plan Development Team and the results of the Level 1 management track stock assessments for witch flounder, ocean pout, and Atlantic wolffish. Using the Council's acceptable biological catch (ABC) control rules, recommend the overfishing levels (OFL) and the ABCs for each stock for fishing years 2023, 2024 and 2025. They will consider other business as necessary.

Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

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

This is a request for extension of an existing information collection.

NOAA's National Ocean Service's U.S. Integrated Ocean Observing System (IOOS) Office is requesting approval to continue a web-based survey of employers who provide either services or infrastructure to IOOS or organizations that add value to the IOOS data and other outputs by tailoring them for specific end uses. The purpose of the survey and overall project is to gather data to articulate the collective and derived value of the IOOS enterprise and to create a profile of businesses and organizations who are involved with providing services or utilizing the data for other specific end uses. This survey was conducted in FY2015 and FY2020, and is intended to be repeated on a regular basis in order to track the growth of the U.S. Ocean Enterprise. The survey is a critical data collection piece of the project and is necessary in order to collect demographic, financial, and functional information for each organization with regard to their involvement with IOOS. The final deliverable of this project is an analytic report detailing the findings of the web survey and the analysis of the employer database. The results will demonstrate the size and economic impact of IOOS data to the United States marine ocean sector.

Electronically and via email.

OMB Control Number: 0648-0712.

Form Number(s): None.

Type of Review: Regular submission; Extension of a current information collection.

Affected Public: Business or other for-profit organizations and Not-for-profit institutions.

Estimated Number of Respondents: 300.

Estimated Time Per Response: 0.5 hours.

Estimated Total Annual Burden Hours: 150.

Estimated Total Annual Cost to Public: $0.

Respondent's Obligation: Voluntary.

Legal Authority: Section 12304 of the Integrated Coastal and Ocean Observation System Act, part of the Omnibus Public Land Management Act of 2009 (Pub. L. 111- 11), and reauthorized under the Coordinated Ocean Observations and Research Act of 2020 (Pub. L. 116-271).

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

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

On 4/29/2022, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List. This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3.

After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the service(s) and impact of the additions on the current or most recent contractors, the Committee has determined that the service(s) listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.

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

1. The action will not result in any additional reporting, recordkeeping, or other compliance requirements for small entities other than the small organizations that will furnish the product(s) and service(s) to the Government.

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

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

Accordingly, the following service is added to the Procurement List:

This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to register to attend a public meeting.

Summary: This notice provides information to access and participate in the October 25, 2022, regular quarterly public meeting of the Committee for Purchase From People Who Are Blind or Severely Disabled, operating as the U.S. AbilityOne Commission (Commission), via Zoom webinar. The Commission oversees the AbilityOne Program, which provides employment opportunities through Federal contracts for people who are blind or have significant disabilities in the manufacture and delivery of products and services to the Federal Government. The Javits-Wagner-O'Day Act (41 U.S.C. Chapter 85) authorizes the contracts and established 15 Presidential appointees, including private citizens conversant with the employment interests and concerns of people who are blind or significantly disabled. Presidential appointees also include representatives of Federal agencies. The public meetings include updates from the Commission and staff.

Date and Time: October 25, 2022, from 1:00 p.m. to 4:00 p.m., ET.

Place: This meeting will occur via Zoom webinar.

Commission Statement: The Commission invites public comments or suggestions regarding the scope, requirements, and metrics for the next generation of Cooperative Agreements between the Commission and its designated Central Nonprofit Agencies (CNAs). The Cooperative Agreements cover the roles and responsibilities of the CNAs and the Commission in the administration of the AbilityOne Program. The current Cooperative Agreements may be viewed on www.abilityone.gov (see Cooperative Agreements link under the Quick Links heading).

Registration: Attendees not requesting speaking time must register not later than 11:59 p.m. EDT on Monday, October 24, 2022. Attendees requesting speaking time should register not later than 11:59 p.m. EDT on Thursday, October 13, 2022, and use the comment fields in the registration form to specify the intended speaking topic/s. The registration link will be posted on the Commission's home page, www.abilityone.gov, not later than Tuesday, September 27, 2022. During registration, you may choose to submit comments, or you may request speaking time at the meeting. The Commission may invite some attendees who submit advance comments to speak to their comments during the meeting. Comments submitted via the registration link will be reviewed with the Commission members prior to the meeting. Comments posted in the chat box during the meeting will be shared with the Commission members after the meeting.

Personal Information: Do not include any information that you do not want publicly disclosed.

For Further Information, Contact: Angela Phifer, (703) 798-5873.

The Commission is not subject to the requirements of 5 U.S.C. 552(b); however, the Commission published this notice to encourage the broadest possible participation in its October 25, 2022, public meeting.

Title; Associated Form; and OMB Number: Formative Research for Sexual Assault Leadership Training at USAF Academy; OMB Control Number 0701-0169.

Needs and Uses: This study supports the Sexual Assault Prevention and Response Office's (SAPRO) mission (and that of the larger USAF) to work toward an Air Force culture that is free of sexual violence. This effort will also support completion of USAF Academy SAPRO's DoD Junior Leader Working Group's plan of action and milestones. Ultimately, the implementation of the adapted curriculum may result in a reduced number of sexual assaults and enhanced psychological health and well-being among Airmen, enabling them to remain fit for duty. This study will collect formative research data through focus groups and interviews to inform recommendations to enhance the current USAF Academy sexual assault leadership training curriculum. Research partners at the University of Florida and RTI International will collect feedback from trainees in Squadron Officer School at Maxwell Air Force Base concerning perceived readiness for duty, perceptions of the leadership training received at USAF Academy, and opportunities for enhancement across the four-year USAF Academy curriculum.

Affected Public: Individuals or households.

Annual Burden Hours: 59.4 hours.

Number of Respondents: 330.

Responses per Respondent: 1.

Annual Responses: 330.

Average Burden per Response: 10.8 minutes.

Frequency: Once.

Title; Associated Form; and OMB Number: Application for Establishment or Amendment of a Junior Reserve Officer's Training Corps or National Defense Cadet Corps Unit; DA Form 3126, DA Form 3126-1, DA Form 918B; OMB Control Number 0702-0021.

Type of Request: Reinstatement with change of a previously approved collection.

Number of Respondents: 70.

Responses per Respondent: 1.

Annual Responses: 70.

Average Burden per Response: 60 minutes.

Annual Burden Hours: 70.

Number of Respondents: 70.

Responses per Respondent: 1.

Annual Responses: 70.

Average Burden per Response: 60 minutes.

Annual Burden Hours: 70.

Number of Respondents: 18.

Responses per Respondent: 1.

Annual Responses: 18.

Average Burden per Response: 30 minutes.

Annual Burden Hours: 9.

Annual Responses: 158.

Annual Burden Hours: 149.

Needs and Uses: The Junior Reserve Officers' Training Corps (JROTC) and the National Defense Cadet Corps (NDCC) are citizenship programs designed to motivate young people to be better citizens. Title 10, United States Code (U.S.C.), Section 2031 and 32 CFR part 542 provide for the establishment of units by the Department of the Army at public and private secondary schools. Educational institutions that desire to host a JROTC or NDCC unit may apply using DA Form 3126, “Application and Contract for Establishment of a Junior Reserve Officers' Training Corps Unit,” and 3126-1 “Application and Contract for Establishment of a National Defense Cadet Corps Unit,” respectively. The programs provide unique education opportunities for young citizens through their participation in a Federally sponsored curriculum while pursuing their civilian education. Students develop citizenship, leadership, communication skills, an understanding of the role of the U.S. army in support of national objectives, and an appreciation for the importance of physical fitness. The DA Form 918B, “Amendment to Application and Agreement for Establishment of Army Reserve Officers' Training Corps Unit,” is used by hosting institutions to amend or cancel existing contracts for JROTC or NDCC programs, as well as Senior ROTC programs authorized under 10 U.S.C. 103. The forms are prescribed by Army Regulation (AR) 145-1, “Senior Reserve Officers' Training Corps Program: Organization, Administration, and Training,” and AR 145-2, “Organization, Administration, Operation, and Support.”

Affected Public: Not-for-profit Institutions; State, Local, or, Tribal Government.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: Recreation Area and Visitor Center Visitor Comment Cards; OMB Control Number 0710-0019.

Type of Request: Revision.

Number of Respondents: 45,000.

Responses per Respondent: 1.

Annual Responses: 45,000.

Average Burden per Response: 5 minutes.

Annual Burden Hours: 3,750.

Needs and Uses: The information collection requirement is necessary to understand and determine the satisfaction of recreation visitors to U.S. Army Corps of Engineers managed recreation areas and visitor centers.

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: ArmyFit Family Global Assessment Tool; OMB Control Number 0702-0147.

Type of Request: Revision.

Number of Respondents: 500,000.

Responses per Respondent: 1.

Annual Responses: 500,000.

Average Burden per Response: 15 minutes.

Annual Burden Hours: 125,000.

Needs and Uses: This collection supports the mission of the Army Resiliency Directorate (ARD), HQDA G-1, to improve the readiness of the force and quality of life for the soldiers. ARD owns the Army Fitness Platform (ArmyFit). ArmyFit hosts the Global Assessment Tool (GAT), which is an assessment promoting self-development through its user feedback and enables the creation of a customized ArmyFit profile that directs individuals to tailored self-development and training resources for soldiers, their families, and Army civilians.

The Family GAT is a self-appraisal survey for assessing an individual's fitness in dimensions of strength: physical, emotional, social, spiritual, and family. It is a tool for building resilience. The survey is taken by all Soldiers and offered to family members, Department of the Army Civilians, and contractors.

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150. Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public.

Purpose of the Meeting: The purpose of the meeting will include discussion on accreditation compliance, organizational management, resource management, and other matters of interest to the National Defense University.

Agenda: Thursday, October 27, 2022 from 9:00 a.m. to 3:45 p.m. (Eastern Time): Call to Order and Administrative Notes; State of the University Address; Update on Reaffirmation of Middle States Commission on Higher Education (MSCHE) Accreditation; Performance Management; Joint Forces Staff College Overview; Discussion of Public Written Comments; Board of Visitors Member Deliberation and Feedback; Wrap-up and Closing Remarks.

Meeting Accessibility: Limited space made available for observers will be allocated on a first come, first served basis. Meeting location is handicap accessible. The Main Gate/Visitor's Gate on 2nd Street SW is open 24/7. All non-DoD, non-federally-affiliated visitors MUST use this gate to access Fort McNair.

Base Access Requirements: All visitors without a U.S. DoD Common Access Card (CAC) or U.S. military ID must be vetted in advance to gain entry onto the base. Per the U.S. Army, all non-DoD civilians are required to have a background check before being allowed on a military installation; better known as vetting. It is highly recommended that visitors undergo the pre-vetting process and apply online as detailed in this notice.

For pre-vetting: To allow sufficient time for processing, access requests should be submitted 10 days before the event. The visitor will receive notification via email, and, if approved, a one-day visitor's pass for entry onto the base. The visitor must print the pass and present it to the guard at the gate to enter Fort McNair.

(a) If the visitor has a valid U.S. driver's license: The visitor can apply for access online at https://pass.aie.army.mil/jbmhh/. Under Reason for Visit, select “Other.” Alternatively, the visitor can apply in person at the Fort McNair Visitor Control Center (VCC)/Police Substation (Building 65) from 8:00 a.m. to 4:00 p.m. Monday through Friday.

(b) If the visitor does not have a U.S. driver's license: The visitor must fill out a paper application in person at the Fort McNair Visitor Control Center (VCC)/Police Substation (Building 65) from 8:00 a.m. to 4:00 p.m. Monday through Friday.

For vetting the day of the event: The visitor must apply in person at the Fort McNair Visitor Control Center (VCC)/Police Substation (Building 65) from 8:00 a.m. to 4:00 p.m. Monday through Friday. The visitor should plan to arrive early, as the procedure for running background checks and issuing passes can take much longer than expected.

For additional information, please go to https://home.army.mil/jbmhh/index.php/my-fort/allservices/access-gate-info .

Vehicle Search: Non-DoD, non-federally-affiliated visitors' vehicles are subject to search.

Written Statements: Pursuant to 41 CFR 102-3.105 and 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, written statements to the committee may be submitted to the committee at any time or in response to a stated planned meeting agenda by email or fax to Ms. Joycelyn Stevens at bov@ndu.edu or Fax (202) 685-3920. Any written statements received by 5:00 p.m. on Wednesday, October 26 will be distributed to the Board of Visitors, National Defense University in the order received. Comments pertaining to the agenda items will be discussed during the public meeting. Any written statements received after the deadline will be provided to the members of the Board of Visitors, National Defense University prior to the next scheduled meeting and posted on the website.

Title; Associated Form; and OMB Number: Request for Armed Forces Participation in Public Events (Non-Aviation); DD Form 2536, DD Form 2535; OMB Control Number 0704-0290.

Needs and Uses: This information collection requirement is necessary to evaluate the eligibility of events to receive Armed Forces community outreach support and to determine whether requested military assets are available.

Affected Public: State, local, or tribal governments; Federal agencies or employees; for-profit and non-profit institutions; and individuals or households.

Annual Burden Hours: 17,850.

Number of Respondents: 51,000.

Responses per Respondent: 1.

Annual Responses: 51,000.

Average Burden per Response: 21 minutes.

Frequency: On occasion.

Title; Associated Form; and OMB Number: PFPA Recruitment, Medical, and Fitness Division Forms; PFPA Form 1400, PFPA Form 1407, PFPA Form 1408, PFPA Form 1409, PFPA Form 1410, PFPA Form 6040; OMB Control Number 0704-0588.

Needs and Uses: This information collection is essential to the Pentagon Force Protection Agency and is used to make a determination of fitness for federal employment in the field of law enforcement. To that end, criminal, background and medical information is collected on the applicants.

Affected Public: Individuals.

Annual Burden Hours: 520 hours.

Number of Respondents: 3,600.

Responses per Respondent: 1.

Annual Responses: 3,600.

Average Burden per Response: PFPA Form 1400: 5 minutes; PFPA Form 1407: 5 minutes; PFPA Form 1408: 5 minutes; PFPA Form 1409: 10 minutes; PFPA Form 1410: 10 minutes; PFPA Form 6040: 20 minutes.

Frequency: On occasion.

On January 14, 2008, and as amended on August 19, 2016, we published in the Federal Register final regulations for 34 CFR part 462, Measuring Educational Gain in the National Reporting System for Adult Education (NRS regulations) (73 FR 2305, January 14, 2008, as amended at 81 FR 55552, August 19, 2016). The NRS regulations established the process the Secretary uses to determine the suitability of tests for use in the NRS by States and local eligible providers. We annually publish in the Federal Register , and post on the internet at www.nrsweb.org, a list of the names of tests and the educational functioning levels the tests are suitable to measure in the NRS as required by § 462.12(c)(2).

On August 7, 2020, the Secretary published in the Federal Register (85 FR 47952) an annual notice consolidating information from previous notices that announced tests determined to be suitable for use in the NRS, in accordance with §  462.13 (August 2020 notice). Also, in the August 2020 notice, the Secretary announced that English as a Second Language (ESL) tests and test forms approved for an extended period through February 2, 2021, are approved for an additional extended period through February 2, 2023, and that an Adult Basic Education (ABE) test and test forms previously approved for a three-year period through March 7, 2021, are approved for an extended period through March 7, 2023.

On December 6, 2021, the Secretary published in the Federal Register (86 FR 69021), an annual notice with the same list of approved tests and test forms as was published in the August 2020 notice (December 2021 notice). 1

In this notice, the Secretary announces that ESL tests and test forms previously approved for an extended period through February 2, 2023, are approved for an additional extended period through February 2, 2024, and that an ABE test and test forms previously approved for an extended period through March 7, 2023, are approved for an additional extended period through March 7, 2024.

The Secretary is taking this action with respect to the previously approved tests and test forms, due to the Department's desire to minimize the continuing potential disruption in access to new tests for its grantees caused by the Novel Coronavirus Disease (COVID-19).

Adult education programs must use only the forms and computer-based delivery formats for the tests approved in this notice. If a particular test form or computer delivery format is not explicitly specified for a test in this notice, it is not approved for use in the NRS.

TESTS DETERMINED TO BE SUITABLE FOR USE IN THE NRS FOR A SEVEN-YEAR PERIOD FROM THE PUBLICATION DATE OF THE ORIGINAL NOTICE IN WHICH THEY WERE ANNOUNCED:

The Secretary has determined that the following test is suitable for use in Literacy/English Language Arts and Mathematics at all ABE levels of the NRS until September 7, 2024:

(1) Tests of Adult Basic Education (TABE 11/12). Forms 11 and 12 are approved for use on paper and through a computer-based delivery format. Publisher: Data Recognition Corporation—CTB, 13490 Bass Lake Road, Maple Grove, MN 55311. Telephone: 800-538-9547. Internet: www.ctb.com/ .

The Secretary has determined that the following test is suitable for use in Literacy/English Language Arts at all ABE levels of the NRS until February 5, 2025:

(1) Comprehensive Adult Student Assessment System (CASAS) Reading GOALS Series. Forms 901, 902, 903, 904, 905, 906, 907, and 908 are approved for use on paper and through a computer-based delivery format. Publisher: CASAS, 5151 Murphy Canyon Road, Suite 220, San Diego, CA 92123-4339. Telephone: (800) 255-1036. Internet: www.casas.org/ .

The Secretary has determined that the following tests are suitable for use at ABE levels 2 through 6 of the NRS until May 2, 2026:

(1) Massachusetts Adult Proficiency Test—College and Career Readiness (MAPT-CCR) for Reading. This test is approved for use through a computer-adaptive delivery format. Publisher: Massachusetts Department of Elementary and Secondary Education and University of Massachusetts Amherst, College of Education, N110, Furcolo Hall, 813 North Pleasant Street Amherst, MA 01003. Telephone: (413) 545-0564. Internet: www.doe.mass.edu/acls/assessment/ .

(2) Massachusetts Adult Proficiency Test—College and Career Readiness (MAPT-CCR) for Mathematics. This test is approved for use through a computer-adaptive delivery format. Publisher: Massachusetts Department of Elementary and Secondary Education and University of Massachusetts Amherst, College of Education, N110, Furcolo Hall, 813 North Pleasant Street, Amherst, MA 01003. Telephone: (413) 545-0564. Internet: www.doe.mass.edu/acls/assessment/ .

TEST DETERMINED TO BE SUITABLE FOR USE IN THE NRS FOR A THREE-YEAR PERIOD FROM THE PUBLICATION DATE OF THE ORIGINAL NOTICE IN WHICH IT WAS ANNOUNCED, PREVIOUSLY APPROVED FOR AN EXTENDED PERIOD THROUGH MARCH 7, 2023, AND APPROVED FOR AN ADDITIONAL EXTENDED PERIOD THROUGH MARCH 7, 2024:

The Secretary has determined that the following test is suitable for use in Mathematics at all ABE levels of the NRS until March 7, 2024:

(1) Comprehensive Adult Student Assessment System (CASAS) Math GOALS Series. Forms 900, 913, 914, 917, and 918 are approved for use on paper and through a computer-based delivery format. Publisher: CASAS, 5151 Murphy Canyon Road, Suite 220, San Diego, CA 92123-4339. Telephone: (800) 255-1036. Internet: www.casas.org/ .

ESL TESTS PREVIOUSLY APPROVED FOR AN EXTENDED PERIOD THROUGH FEBRUARY 2, 2023, AND APPROVED FOR AN ADDITIONAL EXTENDED PERIOD THROUGH FEBRUARY 2, 2024:

The Secretary has determined that the following tests are suitable for use at all ESL levels of the NRS until February 2, 2024:

(1) Basic English Skills Test (BEST) Literacy. Forms B, C, and D are approved for use on paper. Publisher: Center for Applied Linguistics, 4646 40th Street NW, Washington, DC 20016-1859. Telephone: (202) 362-0700. Internet: www.cal.org .

(2) Basic English Skills Test (BEST) Plus 2.0. Forms D, E, and F are approved for use on paper and through the computer-adaptive delivery format. Publisher: Center for Applied Linguistics, 4646 40th Street NW, Washington, DC 20016-1859. Telephone: (202) 362-0700. Internet: www.cal.org .

(3) Comprehensive Adult Student Assessment Systems (CASAS) Life and Work Listening Assessments (LW Listening). Forms 981L, 982L, 983L, 984L, 985L, and 986L are approved for use on paper and through the computer-based delivery format. Publisher: CASAS, 5151 Murphy Canyon Road, Suite 220, San Diego, CA 92123-4339. Telephone: (800) 255-1036. Internet: www.casas.org .

(4) Comprehensive Adult Student Assessment Systems (CASAS) Reading Assessments (Life and Work, Life Skills, Reading for Citizenship, Reading for Language Arts—Secondary Level). Forms 27, 28, 81, 82, 81X, 82X, 83, 84, 85, 86, 185, 186, 187, 188, 310, 311, 513, 514, 951, 952, 951X, and 952X of this test are approved for use on paper and through the computer-based delivery format. Publisher: CASAS, 5151 Murphy Canyon Road, Suite 220, San Diego, CA 92123-4339. Telephone: (800) 255-1036. Internet: www.casas.org .

(5) Tests of Adult Basic Education Complete Language Assessment System-English (TABE/CLAS-E). Forms A and B are approved for use on paper and through a computer-based delivery format. Publisher: Data Recognition Corporation—CTB, 13490 Bass Lake Road, Maple Grove, MN 55311. Telephone: (800) 538-9547. Internet: www.tabetest.com .

REVOCATION OF TESTS:

Under certain circumstances, the Secretary may revoke the determination that a test is suitable (see § 462.12(e)). If the Secretary revokes the determination of suitability, the Secretary announces the revocation, as well as the date by which States and local eligible providers must stop using the revoked test, through a notice published in the Federal Register and posted on the internet at www.nrsweb.org .

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

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

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

Program Authority: 29 U.S.C. 3292.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

Tentative Agenda:

Public Participation: The meeting is open to the public. The EM SSAB, Hanford, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gary Younger at least seven days in advance of the meeting at the telephone number listed above. Written statements may be filed with the Board either before or within five business days after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Gary Younger. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

Minutes: Minutes will be available at the following website: http://www.hanford.gov/page.cfm/hab/FullBoardMeetingInformation.

This document of the Department of Energy was signed on September 19, 2022, by Shena Kennerly, Acting 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 .

This action is directed to the public in general and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager for PCNB identified in Table 1 in Unit IV.

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

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

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed a proposed final decision PCNB, as listed in Table 1 in Unit IV. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.

EPA is conducting its registration review of PCNB pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of FIFRA provides, among other things, that the registrations of pesticides are to be reviewed every 15 years. Under FIFRA, a pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with widespread and commonly recognized practice, the pesticide product must perform its intended function without unreasonable adverse effects on the environment; that is, without any unreasonable risk to man or the environment, or a human dietary risk from residues that result from the use of a pesticide in or on food.

Pursuant to 40 CFR 155.58, this notice announces the availability of EPA's proposed final registration review decision for PCNB shown in Table 1 and opens a 60-day public comment period on the proposed final registration review decision.

The registration review docket for a pesticide includes earlier documents related to the registration review case. For example, the review opened with a Preliminary Work Plan, for public comment. A Final Work Plan was placed in the docket following public comment on the Preliminary Work Plan.

The documents in the docket for PCNB describe EPA's rationales for conducting additional risk assessments for the registration review of PCNB, as well as the Agency's subsequent risk findings and consideration of possible risk mitigation measures. This proposed final registration review decision is supported by the rationales included in those documents. Following public comment, the Agency plans to issue a final registration review decision for PCNB.

The registration review final rule at 40 CFR 155.58(a) provides for a minimum 60-day public comment period on all proposed final registration review decisions. This comment period is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the proposed final decision. All comments should be submitted using the methods in ADDRESSES and must be received by EPA on or before the closing date. These comments will become part of the docket for PCNB. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

The Agency will carefully consider all comments received by the closing date and may provide a “Response to Comments Memorandum” in the docket. The final registration review decision will explain the effect that any comments had on the final decision and provide the Agency's response to significant comments.

Background on the registration review program is provided at: https://www.epa.gov/pesticide-reevaluation.

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

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 https://www.regulations.gov, or in person at the EPA Docket Center, WJC West Building, 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.

Abstract: Owners and operators of affected facilities are required to comply with reporting and record keeping requirements for the General Provisions (40 CFR part 63, subpart A and 40 CFR part 60, subpart A), as well as for the specific requirements at 40 CFR part 63, subpart NNN and 40 CFR part 60 Subpart PPP. This includes submitting initial notification reports, performance tests and periodic reports and results, and maintaining records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These reports are used by EPA to determine compliance with these standards. This information is being collected to assure compliance with 40 CFR part 60, subpart PPP.

Form Numbers: None.

Respondents/affected entities: Wool fiberglass insulation manufacturing plants.

Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart PPP and 40 CFR part 63, subpart NNN).

Estimated number of respondents: 38 (total).

Frequency of response: Semiannual.

Total estimated burden: 5,580 hours (per year) (total). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $1,250,000 (per year), which includes $585,445 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is a net adjustment decrease in burden from the most-recently approved ICR due to more accurate estimates of existing sources. The industry trade organization North American Insulation Manufacturers Association (NAIMA) commented in response to consultation that an estimate of five facilities subject to 40 CFR part 63, subpart NNN is more accurate than the previous estimate, while the previous estimate of facilities subject to subpart PPP is increasing by one due to construction of a new facility. The labor cost per facility has increased due to updated labor rates from the most-recent Bureau of Labor Statistics report (September 2021).

There is a net adjustment decrease in the operation and maintenance (O&M) costs as calculated in section 6(b)(iii) compared with the costs in the previous ICR, due to the decreased number of respondents subject to Subpart NNN based on the information provided by NAIMA. This offsets the increase in capital and O&M costs due to the addition of one facility subject to Subpart PPP.

This ICR also includes an adjustment decrease in the annual estimated hours to familiarize with regulatory requirements (Table 1b) to align with the typical time required for existing respondents to refamiliarize themselves with the NESHAP regulations each year.

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 https://www.regulations.gov, or in person at the EPA Docket Center, WJC West Building, 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.

Abstract: The New Source Performance Standards (NSPS) apply to each affected facility at any grain terminal elevator or any grain storage elevator. The facilities are each truck unloading station, truck loading station, barge and ship loading station, railcar loading station, railcar unloading station, grain dryer and all grain handling operations that commenced construction, modification or reconstruction after August 3, 1978. Owners or operators of the affected facilities must make a one-time-only report of the date of construction or reconstruction, notification of the actual date of startup, notification of any physical or operational change to existing facility that may increase the rate of emission of the regulated pollutant, notification of initial performance test; and results of initial performance test. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction, or any period during which the monitoring system is inoperative.

Form Numbers: None.

Respondents/affected entities: Grain elevator operators.

Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart DD).

Estimated number of respondents: 200 (total).

Frequency of response: Initially.

Total estimated burden: 460 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $55,000 (per year), which includes no annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is no change in burden from the most-recently approved ICR as currently identified in the OMB Inventory of Approved Burdens. This is due to two considerations: (1) the regulations have not changed over the past three years and are not anticipated to change over the next three years; and (2) the growth rate for this industry is very low or non-existent, so there is no significant change in the overall burden. Since there are no changes in the regulatory requirements and there is no significant industry growth, there are also no changes in the capital/startup and/or operation and maintenance (O&M) costs.

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 https://www.regulations.gov, or in person at the EPA Docket Center, WJC West Building, 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.

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Secondary Aluminum Production (40 CFR part 63, subpart RRR) were proposed on February 11, 1999; and promulgated on March 23, 2000; and amended on the following dates: December 30, 2002 (67 FR 79808); September 3, 2004 (69 FR 53980); October 3, 2005 (70 FR 57513); December 19, 2005 (70 FR 75320); September 18, 2015 (80 FR 56700); and June 13, 2016 (81 FR 38085). These regulations apply to existing facilities and new facilities that are secondary aluminum production facilities and major sources of hazardous air pollutants (HAP) either commencing construction, or reconstruction, after the date of proposal. This includes facilities that operate aluminum scrap shredders, thermal chip dryers, scrap dryers/delacquering kilns/decoating kilns, group 1 furnaces, group 2 furnaces, sweat furnaces, dross only furnaces, rotary dross coolers, and secondary aluminum processing units (SAPUs). The SAPUs include group 1 furnaces and in-line fluxers. The regulations also apply to secondary aluminum production facilities that are area sources of HAP only with respect to emissions of dioxins/furans (D/F) from thermal chip dryers, scrap dryers/delacquering kilns/decoating kilns, group 1 furnaces, sweat furnaces, and SAPUs. New facilities include those that either commenced construction, or reconstruction, after the date of proposal. This information is being collected to assure compliance with 40 CFR part 63, subpart RRR.

In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP.

Form Numbers: None.

Respondents/affected entities: Secondary aluminum production facilities.

Respondent's obligation to respond: Mandatory (40 CFR part 63 subpart RRR).

Estimated number of respondents: 161 (total).

Frequency of response: Initially and semiannually.

Total estimated burden: 12,400 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $5,590,000 (per year), which includes $4,110,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is no change in burden from the most-recently approved ICR as currently identified in the OMB Inventory of Approved Burdens. This is due to two considerations; (1) the regulations have not changed over the past three years and are not anticipated to change over the next three years; and (2) the growth rate for this industry is very low or non-existent, so there is no significant change in the overall burden. Since there are no changes in the regulatory requirements and there is no significant industry growth, there are also no changes in the capital/startup or operation and maintenance (O&M) costs. There is a slight decrease in the number of responses, based on the correction of a mathematical error in the calculation of the number of responses from the currently approved ICR.

As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

OMB Control Number: 3060-0853.

Title: Certification by Administrative Authority to Billed Entity Compliance with the Children's Internet Protection Act Form, FCC Form 479; Receipt of Service Confirmation and Certification of Compliance with the Children's Internet Protection Act Form, FCC Form 486; and Funding Commitment and Adjustment Request Form, FCC Form 500.

Form Numbers: FCC Forms 479, 486 and 500.

Type of Review: Extension of a currently approved collection.

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

Number of Respondents and Responses: 58,500 respondents; 73,400 responses.

Estimated Time per Response: 1 hour for FCC Form 479, 1 hour for FCC Form 486, 1 hour for FCC Form 500, and 0.75 hours for maintaining and updating the internet Safety Policy.

Frequency of Response: On occasion and annual reporting requirements and recordkeeping requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151, 154(i), 155, 201, 205, 214, 219, 220, 254, 303(r), 403, and 1302.

Total Annual Burden: 68,275 hours.

Total Annual Cost: No cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no assurance of confidentiality provided to respondents concerning this information collection. However, respondents may request materials or information submitted to the Commission or the Administrator be withheld from public inspection under 47 CFR 0.459 of the FCC's rules.

Needs and Uses: The Commission is requesting the Office of Management and Budget (OMB) approval to revise the currently approved requirements contained in this information collection. There is an increase in burden hours of 14,900 hours. The purpose of this information is to ensure that schools and libraries that are eligible to receive discounted Internet Access Services (Category One), and Broadband Internal Connections, Managed Internal Broadband Services, and Basic Maintenance of Broadband Internal Connections (Basic Maintenance) (known together as Category Two Services) have in place internet safety policies. Schools and libraries receiving these services must certify, by completing a FCC Form 486 (Receipt of Service Confirmation and Certification of Compliance with the Children's Internet Protection Act), that respondents are enforcing a policy of internet safety and enforcing the operation of a technology prevention measure. Also, respondents who received a Funding Commitment Decision Letter indicating services eligible for universal service funding must file FCC Form 486 to indicate their service start date and to start the payment process. In addition, all members of a consortium must submit signed certifications to the Billed Entity of their consortium using a FCC Form 479; Certification by Administrative Authority to Billed Entity of Compliance with Children's Internet Protection Act, in language consistent with the certifications adopted for the FCC Form 486. Consortia must, in turn, certify collection of the FCC Forms 479 on the FCC Form 486. FCC Form 500 is used by E-rate participants to adjust previously filed forms, such as changing the contract expiration date filed with the FCC Form 471, changing the funding year service start date filed with the FCC Form 486, cancelling or reducing the amount of funding commitments, requesting extensions of the deadline for nonrecurring services, and notifying USAC of equipment transfers. All requirements contained herein are necessary to implement the congressional mandate for universal service.

OMB Control Number: 3060-0989.

Title: Sections 63.01, 63.03, 63.04, Procedures for Applicants Requiring Section 214 Authorization for Domestic Interstate Transmission Lines Acquired Through Corporate Control.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents and Responses: 92 respondents; 92 responses.

Estimated Time per Response: 1.5-14 hours.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Mandatory. Statutory authority for this collection is contained in 47 U.S.C. 152, 154(i)-(j), 201, 214, and 303(r).

Total Annual Burden: 1,201 hours.

Total Annual Cost: $107,925.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality. The FCC is not requiring applicants to submit confidential information to the Commission. If applicants want to request confidential treatment of the documents they submit to Commission, they may do so under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: A Report and Order, FCC 02-78, adopted and released in March 2002 (Order), set forth the procedures for common carriers requiring authorization under section 214 of the Communications Act of 1934, as amended, to acquire domestic interstate transmission lines through a transfer of control. Under section 214 of the Act, carriers must obtain FCC approval before constructing, acquiring, or operating an interstate transmission line. Acquisitions involving interstate common carriers require affirmative action by the Commission before the acquisition can occur. This information collection contains filing procedures for domestic transfer of control applications under sections 63.03 and 63.04. The FCC filing fee amount for section 214 applications is currently $1,230 per application, which reflects an increase from the previous fee of $1,195 per application.

(a) Sections 63.03 and 63.04 require domestic section 214 applications involving domestic transfers of control, at a minimum, should specify: (1) the name, address and telephone number of each applicant; (2) the government, state, or territory under the laws of which each corporate or partnership applicant is organized; (3) the name, title, post office address, and telephone number of the officer or contact point, such as legal counsel, to whom correspondence concerning the application is to be addressed; (4) the name, address, citizenship, and principal business of any person or entity that directly or indirectly owns at least ten percent of the equity of the applicant, and the percentage of equity owned by each of those entities (to the nearest one percent); (5) certification pursuant to 47 CFR 1.2001 that no party to the application is subject to a denial of Federal benefits pursuant to section 5301 of the Anti-Drug Abuse Act of 1988; (6) a description of the transaction; (7) a description of the geographic areas in which the transferor and transferee (and their affiliates) offer domestic telecommunications services, and what services are provided in each area; (8) a statement as to how the application fits into one or more of the presumptive streamlined categories in section 63.03 or why it is otherwise appropriate for streamlined treatment; (9) identification of all other Commission applications related to the same transaction; (10) a statement of whether the applicants are requesting special consideration because either party to the transaction is facing imminent business failure; (11) identification of any separately filed waiver request being sought in conjunction with the transaction; and (12) a statement showing how grant of the application will serve the public interest, convenience, and necessity, including any additional information that may be necessary to show the effect of the proposed transaction on competition in domestic markets.

In FCC 20-133, adopted September 30, 2020, and released October 1, 2020, the Commission, in order to reduce the need for supplemental requests and to ensure expeditious processing of applications, added the requirements in § 63.04(a)(4) for carrier applicants seeking domestic section 214 authorization to transfer control to specify the voting interests of any person or entity owning 10 percent of the applicants, as well as provide an ownership diagram that illustrates an applicant's vertical ownership structure: (i) The name, address, citizenship, and principal business of any person or entity that directly or indirectly owns ten percent or more of the equity interests and/or voting interests, or a controlling interest, of the applicant, and the percentage of equity and/or voting interest owned by each of those entities (to the nearest one percent). Where no individual or entity directly or indirectly owns ten percent or more of the equity interests and/or voting interests, or a controlling interest, of the applicant, a statement to that effect; and (ii) An ownership diagram that illustrates the applicant's vertical ownership structure, including the direct and indirect ownership (equity and voting) interests held by the individuals and entities named in response to paragraph (a)(4)(i) of this section. Every individual or entity with ownership shall be depicted and all controlling interests must be identified. The ownership diagram shall include both the pre-transaction and post-transaction ownership of the authorization holder.

Where an applicant wishes to file a joint international section 214 transfer of control application and domestic section 214 transfer of control application, the applicant must submit information that satisfies the requirements of 47 CFR 63.18. In the attachment to the international application, the applicant must submit information described in 47 CFR 63.04(a)(6).

When the Commission, acting through the Wireline Competition Bureau, determines that applicants have submitted a complete application qualifying for streamlined treatment, it shall issue a public notice commencing a 30-day review period to consider whether the transaction serves the public interest, convenience and necessity. Parties will have 14 days to file any comments on the proposed transaction, and applicants will be given 7 days to respond. (b) Applicants are not required to file post-consummation notices of pro forma transactions, except that a post transaction notice must be filed with the Commission within 30 days of a pro forma transfer to a bankruptcy trustee or a debtor-in-possession. The notification can be in the form of a letter (in duplicate to the Secretary, Federal Communications Commission). The letter or other form of notification must also contain the information listed in sections (a)(1). A single letter may be filed for more than one such transfer of control. The information will be used by the Commission to ensure that applicants comply with the requirements of 47 U.S.C. 214.

Title: Section 15.615, General Administrative Requirements (Broadband Over Power Line (BPL).

OMB Control Number: 3060-1087.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit; not-for-profit institutions; and State, local or Tribal Government.

Number of Respondents and Responses: 100 respondents; 100 responses.

Estimated Time per Response: 26 hours.

Frequency of Response: On occasion reporting requirement and third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154(i), 301, 302, 303(e), 303(f) and 303(r).

Total Annual Burden: 2,600 hours.

Total Annual Cost: $60,000.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: The FCC does not require any confidentiality in the information provided to the database. There are no proprietary or trade/technological standards to which these BPL entities wish to restrict access.

Needs and Uses: The Commission will submit this expiring information collection after this 60 day comment period to the Office of Management and Budget (OMB) to obtain the full three year clearance. Section 15.615 requires entities operating Access BPL systems shall supply to an industry-recognized entity, information on all existing Access BPL systems and all proposed Access BPL systems for inclusion into a publicly available database, within 30 days prior to installation of service. Such information should include the name of the Access BPL provider; the frequencies of the Access BPL operation; the postal ZIP codes served by the specific Access BPL operation; the manufacturer and type of Access BPL equipment and its associated FCC ID number, contact information; and proposed/or actual date of operation.

OMB Control Number: 3060-1104.

Title: Section 73.682(d), DTV Transmission and Program System and Information Protocol (“PSIP”) Standards.

From Number: N/A.

Type of Review: Extension of currently approved collection.

Respondents: Business or other for-profit entities; not-for-profit institutions.

Number of Respondents and Responses: 1,812 respondents and 1,812 responses.

Estimated Hours per Response: 0.50 hours.

Frequency of Response: Third Party Disclosure requirement; Weekly reporting requirement.

Total Annual Burden: 47,112 hours.

Total Annual Cost: No costs.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in Sections 309 and 337 of the Communications Act of 1934, as amended.

Needs and Uses: Section 73.682(d) of the Commission's rules incorporates by reference the Advanced Television Systems Committee, Inc. (“ATSC”) Program System and Information Protocol (“PSIP”) standard “A/65C.” PSIP data is transmitted along with a TV broadcast station's digital signal and provides viewers (via their DTV receivers) with information about the station and what is being broadcast, such as program information. The Commission has recognized the utility that the ATSC PSIP standard offers for both broadcasters and consumers (or viewers) of digital television (“DTV”).

ATSC PSIP standard A/65C requires broadcasters to provide detailed programming information when transmitting their broadcast signal. This standard enhances consumers' viewing experience by providing detailed information about digital channels and programs, such as how to find a program's closed captions, multiple streams and V-chip information. This standard requires broadcasters to populate the Event Information Tables (“EITs”) (or program guide) with accurate information about each event (or program) and to update the EIT if more accurate information becomes available. The previous ATSC PSIP standard A/65-B did not require broadcasters to provide such detailed programming information but only general information.

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

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Customer Surveys Generic Clearance for the National Center for Health Statistics (OMB Control No.0920-0729, Exp. 08/31/2023)—Extension—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).

Section 306 of the U.S. Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, shall collect statistics on “the extent and nature of illness and disability of the population of the United States.” This is an Extension request for a Generic approval from OMB to conduct customer surveys over the next three years at an overall burden rate of 2,250 hours annually.

As part of a comprehensive program, the National Center for Health Statistics (NCHS) plans to continue to assess its customers' satisfaction with the content, quality and relevance of the information it produces. NCHS will conduct voluntary customer surveys to assess strengths in agency products and services and to evaluate how well it addresses the emerging needs of its data users. Results of these surveys will be used in future planning initiatives.

The data will be collected using a combination of methodologies appropriate to each survey. These may include: evaluation forms, mail surveys, focus groups, automated and electronic technology ( e.g., email, Web-based surveys), and telephone surveys. Systematic surveys of several groups will be folded into the program. Among these are federal customers and policy makers, state and local officials who rely on NCHS data, the broader educational, research, and public health community, and other data users. Respondents may include data users who register for and/or attend NCHS sponsored conferences; persons who access the NCHS website and the detailed data available through it; consultants; and others. Respondent data items may include (in broad categories) information regarding respondent's gender, age, occupation, affiliation, location, etc., to be used to characterize responses only. Other questions will attempt to obtain information that will characterize the respondents' familiarity with and use of NCHS data, their assessment of data content and usefulness, general satisfaction with available services and products, and suggestions for improvement of surveys, services and products.

In order to capture anticipated feedback opportunities, this extension request allows for both respondents and time per response for a total estimated annual burden total of 2,250 hours. There is no cost to respondents other than their time to participate in the survey. The resulting information will be for NCHS internal use.

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

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Study of PrEPline Reported PrEP-Adherent Patients with HIV Acquisition—New—National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

As the use of antiretroviral preexposure prophylaxis (PrEP) continues to grow in the United States, despite the high effectiveness of PrEP (>95%) when taken as prescribed, sporadic case reports are appearing that document HIV acquisition among patients apparently adherent to the prescribed PrEP dosing schedule. Because PrEP medications can alter the immune responses on which HIV testing relies, ambiguous test results also occur and present diagnostic challenges to clinicians. Careful selection of tests, and the timing and sequence in which they are done to confirm whether HIV infection has occurred, and resistance characteristics of the virus, if present, are increasingly necessary. In addition, objective measures of the amount of PrEP drug in patients around the time of potential HIV acquisition is important to assess medication adherence and further characterize PrEP effectiveness in “real world” settings. A system of active case detection and confirmation of HIV acquisition in PrEP-adherent patients was successfully piloted and can now be continuously implemented by leveraging clinician contacts to the National Clinician Consultation Center's (NCCC) PrEPline, PEPline, and HIV Warmline; and by obtaining consent for specimens to be shipped to the University of California San Francisco (UCSF) or the Centers for Disease Control and Prevention (CDC) for research assays. Monitoring and improving our understanding of the occurrence of ambiguous test results, HIV acquisition among PrEP patients, and their relationship to medication adherence is necessary to inform clinician management of these patients and to ensure clear messaging about PrEP “failures” (most of which are a result of non-adherence) and HIV testing in PrEP patients.

The PrEPline (and other “warmlines” operated by NCCC) and health department HIV case reporting are complementary sources of case identification. Clinicians call the PrEPline with testing and management questions soon after receiving test results for patients continuing or re-initiating PrEP, or transitioning from PEP to PrEP, and have direct access to clinical records and patients. In addition, clinicians call the HIV Warmline with questions about HIV screening/testing results and best practices in evaluation and management of patients who acquire HIV while on PrEP. Health departments typically identify such patients later (especially if by periodic review of National HIV Surveillance System data) and then must reach out to clinicians for clinical records, and sometimes for patient consents for research specimens, to confirm HIV status.

The goals are to conduct a study that obtains consent and case report information from clinicians calling the NCCC's PrEPline and HIV Warmline to help identify, assess, and discuss clinical management of: (1) PrEP patients with ambiguous HIV test results; and (2) patients who acquire HIV infection while being prescribed PrEP. This information will allow CDC to: (a) assess the proportion of clinicians with eligible patients who provide case information from medical records; (b) measure the completeness and utility of data collection forms to be sent to CDC; (c) assess the proportion of clinicians with eligible patients who refer patients to participate in a UCSF National Institutes of Health-funded study called SeroPrEP that involves specimen testing to be performed at designated specialty reference/research labs; and (d) assess the proportion of eligible patients who consent to enroll in the SeroPrEP study and provide specimens to reference/research labs to confirm HIV status and measure PrEP drug levels.

The study's target population includes clinicians calling to NCCC within 90 days of a reactive/detectable HIV test (in cases of oral PrEP use) or 180 days of a reactive/detectable HIV test (in cases of long-acting injectable cabotegravir use) about case-patients who reported:

○ Regularly taking prescribed oral PrEP medication (emtricitabine or lamivudine co-formulated with either tenofovir disoproxil fumarate or tenofovir alafenamide, or oral cabotegravir) either:

Throughout the interval from the last negative HIV test to the date of first reactive or detectable HIV test results; or

During the interval from the last negative HIV test to stopping injections, within 18 months before the date of first reactive or detectable HIV test results.

and for whom either:

○ Laboratory tests confirm acquisition of HIV infection while reportedly medication-adherent; or

○ Laboratory tests are ambiguous (do not clearly confirm HIV status).

The study data will be collected via phone interviews with clinicians calling the NCCC PrEPline (or other warmlines) for clinical advice about diagnostic testing and clinical management of patients with ambiguous HIV test results or diagnosed HIV infection while taking PrEP medications. Data collection will last approximately five years.

Participation is voluntary. An estimated one-time reporting burden for this collection will be approximately 62 hours. This includes the time burden associated with the Provider Verbal Consent and completing the Patient Data Collection Form. CDC will enroll approximately 125 providers, at 10 minutes per Provider Verbal Consent and 20 minutes per Patient Data Collection Form, to provide patient information over five years. There are no costs to respondents other than time.

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

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Youth Outreach Generic Clearance for the National Center for Health Statistics (NCHS) (OMB Control No. 0920-1185, Exp. 7/31/2023)—Extension—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).

NCHS is authorized to collect data under Section 306 of the Public Health Service Act (42 U.S.C. 242k). NCHS has a history of reaching out to young people to encourage their interest in Science, Technology, Engineering and Math (STEM). Examples of past involvement include adopting local schools, speaking at local colleges, conducting a Statistics Day for high school students, and, most recently, conducting the NCHS Data Detectives Camp for middle school students.

The success of these programs has inspired NCHS leadership and staff to want to look for new and continuing opportunities to positively impact the lives of young people and expand their interest, understanding of, and involvement in the sciences. NCHS requests approval for a New Generic Clearance mechanism to collect information for these youth outreach activities and to inform future NCHS planning activities. The activities include hosting the Data Detectives Camp annually; hosting Statistics Day annually; creating youth poster sessions for professional conferences (such as the NCHS National Conference on Health Statistics or the American Statistical Association Conference etc.); hosting a statistical or health sciences fair or other STEM related competitions; organizing a STEM Career Day or similar activity; developing web-based sites or materials with youth focus as well as other programs developed to meet future youth outreach needs, particularly activities that encourage STEM.

Information will be collected using a combination of methodologies appropriate to each program. These may include: Registration forms, letters of recommendation, evaluation forms; mail surveys; focus groups; automated and electronic technology ( e.g., email, Web-based surveys); and telephone surveys.

OMB approval is requested for three years to conduct the Youth Outreach Generic Clearance for the National Center for Health Statistics (NCHS). The total estimated annualized burden hours are 1,750. Participation is voluntary, and there is no cost to respondents other than their time to participate.

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

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

The Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STAR net ) Muscular Dystrophy Questionnaire—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

Since its establishment in 2002, the MD STAR net has been a population-based surveillance system that aims to identify and collect clinical data on individuals with muscular dystrophy (MD) in select surveillance areas. MD STAR net identifies and collects data on cases at sources, including healthcare facilities where patients with MD receive care and administrative datasets such as vital records and hospital discharge data. While MDs are rare genetic diseases with an estimated prevalence of 16.1/100,000, they have a high impact on affected individuals, their families, and society. MDs can be classified into nine major groups: Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), myotonic dystrophy (DM), facioscapulohumeral muscular dystrophy (FSHD), limb-girdle muscular dystrophy (LGMD), congenital muscular dystrophy (CMD), Emery-Dreifuss muscular dystrophy (EDMD), and distal MD. A recent MD STAR net study has estimated the combined prevalence for DMD and BMD to be 1.92-2.48/10,000 males age 5-9 years old. MD STAR net aims to improve understanding of MDs and ultimately the quality of life of people and their families living with MD. Individuals with MDs frequently report pain and fatigue, but studies have largely been conducted in clinic-based populations and included the three most common MDs. Population-based studies are needed to describe the frequency and management of pain and fatigue and their impact on the lives of individuals with various types of MD.

The purpose of the proposed study is to describe the epidemiology of COVID-19 and flu and the experience with pain, fatigue, pregnancy, and infertility for adults living with MD who are identified through MD STAR net. Results generated from the study will provide a better understanding of: (1) the occurrence, testing, treatment and severity of COVID-19 in relation to MD; (2) vaccination status and reasons for not receiving COVID-19 and flu vaccinations; (3) the frequency, intensity, and management of pain and fatigue; and (4) the effect of having MD on pregnancy and fertility on adults living with MD. Ultimately, this information can be used to develop interventions that improve the lives of people with MD and their families.

CDC requests OMB approval for an estimated 974 annual burden hours. There are no costs to respondents other than their time to participate.

Contents

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

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

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Notice of Denial of Medicare Prescription Drug Coverage; Use: Part D plan sponsors are required to issue the Notice of Denial of Medicare Prescription Drug Coverage notice when a request for a prescription drug or payment is denied, in whole or in part. The written notice must include a statement, in understandable language, the reasons for the denial and a description of the appeals process.

The purpose of this notice is to provide information to enrollees when prescription drug coverage has been denied, in whole or in part, by their Part D plans. The notice must be readable, understandable, and state the specific reasons for the denial. The notice must also remind enrollees about their rights and protections related to requests for prescription drug coverage and include an explanation of both the standard and expedited redetermination processes and the rest of the appeal process. Form Number: CMS-10146 (OMB control number 0938-0973); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profits); Number of Respondents: 683; Number of Responses: 2,627,898; Total Annual Hours: 656,975. (For policy questions regarding this collection contact Coretta Edmondson at 410-786-0512).

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

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

1. Type of Information Collection Request: Revision of a currently aproved collection; Title of Information Collection: Hospice Survey and Deficiencies Report Form and Supporting Regulations; Use: We use the information collected as the basis for certification decisions for hospices that wish to obtain or retain participation in the Medicare and Medicaid programs. The information is used by CMS regional offices, which have the delegated authority to certify Medicare facilities for participation, and by State Medicaid agencies, which have comparable authority under Medicaid. The information on the Hospice Survey and Deficiencies Report Form is coded for entry into the OSCAR system. The data is analyzed by the CMS regional offices and by the CMS central office components for program evaluation and monitoring purposes. The information is also available to the public upon request. Form Number: CMS-643 (OMB control number: 0938-0379); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 6,153; Total Annual Responses: 2,051; Total Annual Hours: 49,224. (For policy questions regarding this collection contact Thomas Pryor at 410-786-1132.)

Description: The final rule within 45 CFR part 309, published in the Federal Register on March 30, 2004, contains a regulatory reporting requirement that, in order to receive funding for a Tribal IV-D program, a tribe or tribal organization must submit a plan describing how the tribe or tribal organization meets or plans to meet the objectives of section 455(f) of the Social Security Act, including establishing paternity; establishing, modifying, and enforcing support orders; and locating noncustodial parents. The plan is required for all tribes requesting funding; however, once a tribe has met the requirements to operate a comprehensive program, a new plan is not required annually unless a tribe makes changes to its title IV-D program. If a tribe or tribal organization intends to make any substantial or material changes, a Tribal IV-D plan amendment must be submitted for approval. Tribes and tribal organizations must have an approved plan and submit any required plan amendments to receive funding to operate a Tribal IV-D program.With this request to extend approval of this information collection, OCSE is proposing a change to the paperwork by providing optional plan pages. The optional plan pages organize the Tribal IV-D plan, identify required attachments, and streamline plan amendment submissions. Tribes and tribal organizations who choose to participate will attest to complying with the regulatory requirements in 45 CFR, Parts 309 and 310 and submit plan amendments for changes to the required attachments identified in the Table of Contents. The optional plan pages organize the Tribal IV-D plan, identify required attachments, and streamline plan amendment submissions.

Respondents: Tribes and tribal Organizations.

Annual Burden Estimates

Estimated Total Annual Burden Hours: 7,260.

Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

Authority: Title IV-D of the Social Security Act; 45 CFR 309.

Award funds will support the continued expansion and use of the National Training Initiative on Mental Health Competency across the nation. This curriculum was developed through an initial 5-year grant to C.A.S.E. and pilot tested prior to being supplemented and extended for 3 additional years for the further dissemination and integration of this important web-based training in the state child welfare training systems so there would be consistent use of the knowledge imparted by it across all child welfare systems.

This funding will allow for the continued scale up of the web-based trainings for the child welfare workforce and mental health practitioners to remaining states in the nation; the refinement and update of the curricula as needed; and additional and updated evaluation of the curricula.

Statutory Authority: Title II, section 203 of the Child Abuse Prevention and Treatment and Adoption Reform Act of 1978 (42 U.S.C. 5113(b)), as amended by CAPTA Reauthorization Act of 2010.

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 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.

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out the provisions of the FD&C Act.

The mission of the OPDP is to protect the public health by helping to ensure that prescription drug promotional material is truthful, balanced, and accurately communicated. OPDP's research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission, focusing in particular on three main topic areas: advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and the characteristics of the disease and product impact the communication and understanding of prescription drug risks and benefits. Focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience, and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first topic area, advertising features.

Because we recognize that the strength of data and the confidence in the robust nature of the findings are improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our home page at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes links to the latest Federal Register notices and peer-reviewed publications produced by our office.

The objective of the present research is to conduct experimental studies to examine issues related to endorsers in DTC prescription drug promotion. This study complements one that is currently in progress (FDA-2019-N-5900, OMB control number 0910-0894, Expiration Date: February 29, 2024). As that study examined a number of different endorser types in print or internet settings and focused on examining how various disclosures of the payment status of the endorser influenced audience reactions, this proposed research extends the prior research by examining actual-use disclosures and a different medium, television ads. Prior research has shown that endorsements by expert physicians and pharmacists were the most likely to lead to purchase intentions, followed by endorsements by consumers, and lastly, by celebrities (Refs. 1 and 2).

For healthcare providers (HCPs) endorsing a prescription drug product, guiding industry principles advise that advertisements should contain a disclosure that the HCP has been compensated for the endorsement (Ref. 3). Industry guiding principles further recommend that an advertisement disclose when an actor is being used as an HCP to promote direct-to-consumer (DTC) prescription drugs.

Pharmaceutical firms also often use everyday people, either actual patients or actors portraying patients, in DTC promotion, relying on qualities of identification with the individual endorsing the product and perceived credibility (Ref. 4). While industry guidelines recommend that companies choosing to feature actors in the roles of HCPs in a DTC television or print ad acknowledge in the ad that actors are being used, the guidelines do not mention disclosures that the “patient” in an ad is being portrayed by an actor (Ref. 3). Some advertisers endeavor to gain credibility among viewers by using actual patients to endorse the product, with a disclosure that states they are actual users of the product (“actual-use disclosure”) (Ref. 5).

The present research will specifically examine the influence of two independent variables—endorser type (patient, physician) and an actual-use disclosure (utilizer, actor, none)—in television advertisements. Dependent variables will include perceptions of the risks and benefits of the promoted prescription drug, attitudes toward and perceptions of the endorser, attention paid to the ad, and behavioral intentions. Because age and education level may affect perceptions of the ad, we plan to explore whether age and education level influence these effects.

This research will involve two studies. Studies 1 and 2 will use a 2×3 factorial design run concurrently and independently with a sample of consumers who have been diagnosed with diabetes (Study 1) or rheumatoid arthritis (Study 2), each watching a DTC television ad for a fictitious drug indicated to treat the corresponding medical conditions. The ad will be manipulated to assess the impact of two categories of commonly used industry spokespeople: a patient and a physician. We will test three actual-use disclosure conditions: (1) an actual-use disclosure that indicates that the endorser either uses or prescribes the prescription drug in real life ( i.e., utilizer), (2) an actual-use disclosure that specifies the endorser is an actor, and (3) a control with no actual-use disclosure. The design for Studies 1 and 2 is presented in table 1.

In both studies, participants will be randomly assigned to one of six experimental conditions (see table 1), view their assigned stimulus, complete a survey, and provide feedback on one of the other ad versions. We will conduct pretests with 126 consumers who self-identify as having been diagnosed with diabetes and 126 consumers who self-identify as having been diagnosed with rheumatoid arthritis, recruited from a web-based research vendor. For the main study, we will then recruit 648 consumers who self-identify as having been diagnosed with diabetes and 648 consumers who self-identify as having been diagnosed with rheumatoid arthritis. Each participant will see one of six versions of a television ad for a fictitious prescription diabetes or rheumatoid arthritis treatment, as reflected in table 1. They will answer a questionnaire designed to take no more than 20 minutes.

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

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

FDA is announcing the availability of a final guidance for industry entitled “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency.” We are issuing this guidance consistent with our good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate (§ 10.115(g)(2)). The Agency made this determination because the guidance requires immediate implementation for public health reasons. Although this guidance document is immediately in effect, it remains subject to comment in accordance with FDA's GGP regulation.

Combating the opioid overdose epidemic is an urgent public health priority for FDA. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. FDA understands that naloxone is being made available to underserved communities through entities such as harm reduction programs. FDA is aware of concerns that harm reduction programs are having difficulty acquiring naloxone. The Agency is aware that some stakeholders have viewed as a contributing factor the current availability of approved naloxone products only as prescription drugs and FDA has recently become aware that some stakeholders have viewed as a contributing factor certain requirements under the Drug Supply Chain Security Act (DSCSA) for distribution of FDA-approved prescription drug products., e.g., being an authorized trading partner. FDA is issuing this guidance to clarify the scope of the public health emergency exclusion and exemption under the DSCSA as they apply to the distribution of FDA-approved naloxone products indicated for the emergency treatment of opioid overdose to harm reduction programs during the opioid public health emergency.

The guidance represents the current thinking of FDA on “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

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

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 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.

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes the FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out the provisions of the FD&C Act.

The mission of the Office of Prescription Drug Promotion (OPDP) is to protect the public health by helping to ensure that prescription drug promotional material is truthful, balanced, and accurately communicated so that patients and health care providers can make informed decisions about treatment options. OPDP's research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission, focusing in particular on three main topic areas: advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and the characteristics of the disease and product impact the communication and understanding of prescription drug risks and benefits. Focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience. Our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first topic area, advertising features.

Because we recognize that the strength of data and the confidence in the robust nature of the findings are improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our home page at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, which includes links to the latest Federal Register notices and peer-reviewed publications produced by our office.

Patient non-adherence to medication regimens is a well-known challenge in health care. The World Health Organization defines adherence as the extent to which a person's behavior—taking medication, following a diet, and/or executing lifestyle changes—corresponds with agreed recommendations from a health care provider (Ref. 1). It is estimated that only half of all patients with chronic health conditions take their medications as prescribed (Ref. 2), leading to as many as 100,000 preventable deaths and $100 billion in additional medical costs every year (Ref. 3). Numerous solutions have been tried to improve adherence, including resource-intensive approaches such as directly observed therapy, which entails a trained observer watching as the patient takes their medications (Ref. 4), and technology-supported tools for patients ( e.g., smartphone apps) (Ref. 5). As attention to the public health issue of medication adherence has grown, OPDP has noted a corresponding increase in the number of claims and presentations in prescription drug promotion that focus, either directly or through implication, on a product's potential to improve adherence to treatment regimens. Many of these presentations include information about options and capabilities available to help patients track their medication usage.

One avenue that prescription drug sponsors have begun exploring to track medication use includes the development of software that is disseminated by or on behalf of the drug sponsor and accompanies one or more of the sponsor's prescription drugs. This software is called prescription drug use-related software. 1 Studies exploring drug products with prescription drug use-related software have been conducted with medications to treat an array of chronic disorders, including psychiatric disorders (Ref. 6), uncontrolled type 2 diabetes (Ref. 7), end-stage renal disease requiring transplants (Ref. 8), and opioid use among patients with acute fractures (Ref. 9).

In recent years, new technologies that capture data on medication-taking behavior and drug administration have been employed. The SureClick 2.0 autoinjector for the prescription medication ENBREL, for example, has Bluetooth built into the white cap that covers the needle. The autoinjector records initial removal of the cap and can send this data via Bluetooth to a paired smartphone using a mobile app (Ref. 10). Technology can also now support the use of ingestible sensors embedded in pills that will emit a weak signal to a receiver (patch or lanyard) worn by the patient after the pill has been swallowed (Ref. 11). This data can then be transmitted to a paired mobile device and viewed by the patient through a smartphone app (Ref. 12). Whether these new technologies will have an impact on adherence is currently unknown.

Very little is known about patient and health care provider perceptions of products that track medication use or that work in tandem with software to track medication use, with most commentaries having been largely theoretical (Refs. 13, 14). The focus of the present study is to explore patient and health care provider perceptions of a fictitious prescription drug product that is accompanied by software that is intended to track medication use.

We have the following specific questions:

Research questions:

1. When prescription drug promotional communications include claims about a product's ability to track medication use, do these claims influence perceptions about the product's risks and/or benefits (including its effect on medication adherence)?

2. If the promotional claims about the product's ability to track medication use are accompanied by a disclosure that describes what is known about the effect of medication tracking on medication adherence, does this have an influence on perceptions of the product's risks and/or benefits (including its effect on medication adherence)?

To complete this research, we propose the design in table 1, which varies based on:

• Whether the fictitious prescription drug product includes technology that tracks medication use;

• Whether the prescription drug promotional communication includes a disclosure describing what is known about the tracking technology's effect on medication adherence; and

• What the disclosure communicates about the tracking technology's effect on medication adherence (positive effect shown, no effect shown, or unknown effect).

We will conduct pretests with 50 consumers who self-identify as having been diagnosed with diabetes and 50 primary care physicians who treat diabetes (both obtained from a web-based research vendor) to ensure that the questionnaire programming works as expected. For the main study, we will then recruit 350 consumers who self-identify as having been diagnosed with diabetes and 350 primary care physicians who treat diabetes. Each participant will see one of five versions of a consumer web page for a fictitious prescription diabetes treatment, as reflected in table 1. They will answer a questionnaire designed to take no more than 20 minutes regarding their perception of the product's benefits, risks, and effect on adherence.

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

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

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 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 labelled 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).

I. Background

Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C)) permits FDA to debar an individual from importing an article of food or offering such an article for import into the United States if FDA finds, as required by section 306(b)(3)(A) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any food.

On November 9, 2021, Mr. Tuccillo was convicted as defined in section 306( l )(1)(A) of the FD&C Act, in the U.S. District Court for the Eastern District of New York, when the court accepted his plea of guilty and entered judgment against him for the offense of conspiracy to commit wire fraud in violation of 18 U.S.C. 371 and 1343.

FDA's finding that the debarment is appropriate is based on the felony conviction referenced herein. The factual basis for this conviction is as follows: As stated in the indictment, filed September 26, 2018, transcript of guilty pleas, filed December 26, 2019, and Magistrate Judge Steven Locke's report and recommendation, filed May 10, 2020, all from Mr. Tuccillo's case, Mr. Tuccillo was the manager of Anchor Foods, Inc. and Advanced Frozen Foods, Inc. (collectively, “Anchor Foods”), responsible for the purchase, sale, shipment, and storage of food products, including octopus and squid, by both businesses. Both Anchor Foods companies were located in Westbury, New York.

From on or about February 2011 and continuing through January 2014, Mr. Tuccillo knowingly and willfully conspired with Anchor Foods, Roy Tuccillo, Sr., and others to import giant squid from Peru to Mr. Tuccillo's companies' location in Westbury, New York, and repackage and sell that squid falsely labeled and identified as “octopus.” Mr. Tuccillo sold the falsely labeled squid in interstate commerce to grocery stores in New Jersey, Texas, and Massachusetts. Mr. Tuccillo used email and fax to sell and receive payments for the squid falsely labeled as octopus. In total, Anchor Foods made $1,128,388.50 worth of fraudulent sales of squid.

As a result of this conviction, FDA sent Mr. Tuccillo, by certified mail on June 6, 2022, a notice proposing to debar him for a period of 5 years from importing articles of food or offering such articles for import into the United States. The proposal was based on a finding under section 306(b)(1)(C) of the FD&C Act that Mr. Tuccillo's felony conviction of Conspiracy to Commit Wire Fraud in violation of 18 U.S.C. 371 and 1343, constitutes conduct relating to the importation into the United States of an article of food because Mr. Tuccillo knowingly and willfully conspired with Anchor Foods, Roy Tuccillo, Sr., and others to import giant squid from Peru to his companies' location in Westbury, New York, and repackage and sell that squid falsely labeled and identified as “octopus” in interstate commerce, using email and fax to sell and receive payments for the falsely labeled squid. The proposal was also based on a determination, after consideration of the relevant factors set forth in section 306(c)(3) of the FD&C Act, that Mr. Tuccillo should be subject to a 5-year period of debarment. The proposal also offered Mr. Tuccillo an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Tuccillo failed to respond within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).

Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(b)(1)(C) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. Tuccillo has been convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food and that he is subject to a 5-year period of debarment.

As a result of the foregoing finding, Mr. Tuccillo is debarred for a period of 5 years from importing articles of food or offering such articles for import into the United States, effective (see DATES ). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of an article of food by, with the assistance of, or at the direction of Roy Tuccillo, Jr., is a prohibited act.

Any application by Mr. Tuccillo for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA-2022-N-0317 and sent to the Dockets Management Staff ( ADDRESSES ). The public availability of information in these submissions is governed by 21 CFR 10.20.

Publicly available submissions will be placed in the docket and will be viewable at https://www.regulations.gov or at the Dockets Management Staff (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C)) permits FDA to debar an individual from importing an article of food or offering such an article for import into the United States if FDA finds, as required by section 306(b)(3)(A) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any food.

On November 9, 2021, Mr. Tuccillo was convicted as defined in section 306( l )(1)(A) of the FD&C Act, in the U.S. District Court for the Eastern District of New York, when the court accepted his plea of guilty and entered judgment against him for the offense of conspiracy to commit wire fraud in violation of 18 U.S.C. 371 and 1343.

FDA's finding that the debarment is appropriate is based on the felony conviction referenced herein. The factual basis for this conviction is as follows: as stated in the indictment, filed September 26, 2018, transcript of guilty pleas, filed December 26, 2019, and Magistrate Judge Steven Locke's report and recommendation, filed May 10, 2020, all from Mr. Tuccillo's case, Mr. Tuccillo was the owner, president, and chief operating officer of Anchor Foods, Inc. and Advanced Frozen Foods, Inc. (collectively, “Anchor Foods”), and had overall responsibility for the operation of both businesses and their employees. Both Anchor Foods companies were located in Westbury, New York.

From on or about February 2011 and continuing through January 2014, Mr. Tuccillo knowingly and willfully conspired with Anchor Foods, Roy Tuccillo, Jr., and others to import giant squid from Peru to Mr. Tuccillo's companies' location in Westbury, New York and repackage and sell that squid falsely labeled and identified as “octopus.” Mr. Tuccillo sold the falsely labeled squid in interstate commerce to grocery stores in New Jersey, Texas, and Massachusetts. Mr. Tuccillo used email and fax to sell and receive payments for the squid falsely labeled as octopus. In total, Mr. Tuccillo's companies made $1,128,388.50 worth of fraudulent sales of squid.

As a result of this conviction, FDA sent Mr. Tuccillo, by certified mail on June 6, 2022, a notice proposing to debar him for a period of 5 years from importing articles of food or offering such articles for import into the United States. The proposal was based on a finding under section 306(b)(1)(C) of the FD&C Act that Mr. Tuccillo's felony conviction of conspiracy to commit wire fraud in violation of 18 U.S.C. 371 and 1343, constitutes conduct relating to the importation into the United States of an article of food because Mr. Tuccillo knowingly and willfully conspired with Anchor Foods, Roy Tuccillo, Jr., and others to import giant squid from Peru to his companies' location in Westbury, New York and repackage and sell that squid falsely labeled and identified as “octopus” in interstate commerce, using email and fax to sell and receive payments for the falsely labeled squid. The proposal was also based on a determination, after consideration of the relevant factors set forth in section 306(c)(3) of the FD&C Act (21 U.S.C. 335a(c)(3)), that Mr. Tuccillo should be subject to a 5-year period of debarment. The proposal also offered Mr. Tuccillo an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Tuccillo failed to respond within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).

Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(b)(1)(C) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. Tuccillo has been convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food and that he is subject to a 5-year period of debarment.

As a result of the foregoing finding, Mr. Tuccillo is debarred for a period of 5 years from importing articles of food or offering such articles for import into the United States, applicable (see DATES ). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of an article of food by, with the assistance of, or at the direction of Roy Tuccillo, Sr., is a prohibited act.

Any application by Mr. Tuccillo for termination of debarment under section 306(d)(1) of the FD&C Act should be identified with Docket No. FDA-2022-N-0316 and sent to the Dockets Management Staff ( ADDRESSES ). The public availability of information in these submissions is governed by 21 CFR 10.20.

Publicly available submissions will be placed in the docket and will be viewable at https://www.regulations.gov or at the Dockets Management Staff (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

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

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out the provisions of the FD&C Act.

The Office of Prescription Drug Promotion's (OPDP) mission is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. OPDP's research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission. Our research focuses in particular on three main topic areas: advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits. Focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience, and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first two topic areas, advertising features and target populations.

Because we recognize the strength of data and the confidence in the robust nature of the findings are improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our home page, which can be found at: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. The website includes links to the latest Federal Register notices and peer-reviewed publications produced by our office.

In 2014, OPDP conducted focus groups designed to provide insights on how consumers and healthcare providers (HCPs), including physicians, nurse practitioners, and physician assistants, interpret the term “targeted” in prescription drug promotional materials. Although diverse views were voiced, there appeared to be some tendency toward the impression that products with promotional materials using this term would be safer and more effective than other similar treatments. OPDP is also now conducting a nationally representative survey regarding the ways in which consumers and primary care physicians (PCPs) interpret terms and phrases commonly used in prescription drug promotional materials, including assessment of impressions of the terms “targeted” and “targeted mechanism of action” (targeted MoA) (86 FR 24867, May 10, 2021). Building upon this line of research, the proposed study will investigate the influence of targeted MoA claims, graphics, and disclosures that provide context about a drug's targeted MoA, utilizing an experimental design with both consumer and HCP samples. The experimental approach described here is intended to complement and augment the prior research by facilitating assessment of causality. Specifically, the proposed study will explore how varied targeted MoA presentations affect consumer and HCP understanding of the MoA of a drug, perception of drug benefits and risks, attention to risk information, and interest in the drug.

Table 1 depicts the study design. Participants will be randomly assigned to one of 12 experimental conditions in which the presence versus absence of: (1) a targeted MoA claim, (2) a graphic depicting a targeted MoA, and (3) a disclosure that provides context about the targeted MoA of the drug are varied in a branded website for a fictitious prescription drug indicated to treat bladder cancer and cancers of the urinary tract (renal pelvis, ureter, or urethra) that have spread or cannot be removed by surgery. We selected cancer as the medical condition for study given the prevalence of targeted MoA presentations in promotional materials for prescription drugs indicated to treat various forms of cancer. Notably, there will be three variations related to the targeted MoA graphic: (1) no graphic, (2) an inaccurate graphic (graphic 1) showing only the effect of the drug on cancerous cells but not on healthy cells, and (3) an accurate graphic (graphic 2) that will show the effect of the drug on both cancerous and healthy cells. The design will be replicated in both the consumer and HCP samples with stimuli specifically created for each audience. Draft stimuli were informed by, but not identical to, actual targeted MoA presentations from a marketplace evaluation conducted under FDA guidance. Draft stimuli were also informed by an FDA subject matter expert's review. Following exposure to the stimuli, the participants will complete a questionnaire designed to assess relevant outcome measures. A copy of the questionnaire is available upon request. All aspects of this study will be completed online. Participation is estimated to take approximately 20 minutes, excluding the screener's time.

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

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

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

FDA has approved for marketing the human drug product, NURTEC ODT (rimegepant sulfate). NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults. Subsequent to this approval, the USPTO received a patent term restoration application for NURTEC ODT (U.S. Patent Nos. 8,314,117 and 8,759,372) from Biohaven Pharmaceutical Holding Company Ltd. and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated March 1, 2021, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of NURTEC ODT represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for NURTEC ODT is 3,390 days. Of this time, 3,144 days occurred during the testing phase of the regulatory review period, while 246 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: November 18, 2010. The applicant claims November 20, 2010, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was November 18, 2010, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: June 27, 2019. FDA has verified the applicant's claim that the new drug application (NDA) for NURTEC ODT (NDA 212728) was initially submitted on June 27, 2019.

3. The date the application was approved: February 27, 2020. FDA has verified the applicant's claim that NDA 212728 was approved on February 27, 2020.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 368 days or 1,102 days of patent term extension.

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

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