The Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401, referred to below as the Act) provides for the regulation of certain biological agents and toxins that have the potential to pose a severe threat to animal and plant health, or to animal and plant products. The Animal and Plant Health Inspection Service (APHIS) has the primary responsibility for implementing the provisions of the Act within the U.S. Department of Agriculture.

In accordance with the Act, APHIS promulgated the select agent and toxin regulations found in 7 CFR part 331 and 9 CFR part 121. Paragraph (e) in § 121.3 states that an attenuated strain of a select agent or a select toxin modified to be less potent or toxic may be excluded from the requirements of this part based upon a determination by the Administrator that the attenuated strain or modified toxin does not pose a severe threat to animal health or animal products.

African swine fever virus (ASFV) is listed as a select agent in § 121.3(b) of the select agent and toxin regulations. APHIS approved the initial select agent regulatory exclusions of two ASFV strains, ASFV-G-ΔMGF and ASFV-G-Δ9GL/ΔMGF, based on applications submitted in accordance with the select agent and toxin regulations and with review and recommendations from the Agriculture Interagency Select Agents and Toxins Technical Advisory Committee (Ag-ISATTAC) at meetings on January 27, 2020, and April 8, 2021. Pursuant to § 121.3(e)(1), APHIS listed the exclusions on the National Select Agent Registry website at https://www.selectagents.gov.

On January 7, 2022, APHIS withdrew the previously approved select agent regulatory exclusions for the ASFV-G-ΔMGF and ASFV-G-Δ9GL/ΔMGF strains and removed them from the list on the National Select Agent Registry website. In addition, APHIS notified all entities that were known to have the previously excluded ASFV strains that possession, use, and transfer of these ASFV strains must now comply with the select agent and toxin regulations in part 121. APHIS based the decision to withdraw the exclusions on newly acquired information regarding safety and genome instability potentially leading to reversion of virulence that was either unavailable or not provided to either APHIS or Ag-ISATTAC during either the January 2020 or April 2021 discussions for regulatory exclusion. More specifically, among other sources, two journal articles published in 2020 and 2021 from China's Harbin Veterinary Research Institute identified instability within the MGF genome segments.

With the publication of this notice, we are informing the public that we withdrew the previously approved select agent regulatory exclusions for the ASFV-G-ΔMGF and ASFV-G-Δ9GL/ΔMGF strains, effective on January 7, 2022, and that the possession, use, and transfer of these ASFV strains must now comply with the select agent and toxin regulations in part 121. This notice serves as an official record and public notification of these actions.

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

Authority: 7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.

Title: International Agricultural Education Fellowship Program application.

OMB Number: 0551-New.

Expiration Date of Approval: Three years from approval date.

Type of Request: Existing collection in use without an OMB control number.

Abstract: The International Agricultural Education Fellowship Program (IAEFP) was established in 2020. IAEFP provides opportunities to eligible U.S. citizens to assist developing countries in establishing school-based agricultural education and youth extension programs under the Agriculture Improvement Act of 2018. The intention of the IAEFP is to develop globally minded United States agriculturalists with experience living abroad, focus on meeting the food and fiber needs of the domestic population of eligible countries, and strengthen and enhance trade linkages between eligible countries and the United States agricultural industry.

To achieve its objectives, IAEFP relies on the solicitation for qualified program applicants through a written application. FAS Posts across Africa provide this application to potential Fellows to assist in determining the adequacy of their candidacy alongside FAS Washington. The application is designed to capture the professional status of the applicant, the applicant's personal contact information, and the applicant's suitability for the program. Thus, the IAEFP application is an integral tool to Fellowship Programs Division and FAS' strategic goals at large.

In addition to information related to program objectives, the IAEFP application collects information that may be considered Personal Identifiable Information (PII), including the following: first name, middle name, last name, gender, salutation, birth date, birth city, citizenship country, country of residence, work phone, permanent home address, work address, personal email, work email, and emergency contact information (family contact: name, relationship, home phone, cell phone, and email).

Estimate of Burden: The public reporting burden for each respondent resulting from information collection under IAEFP varies in direct relation to the number of fellowships that each respondent participates in.

Type of Respondents: Individuals.

Estimated Number of Respondents: 25 per annum.

Estimated Number of Responses per Respondent: 1 per annum.

Estimated Total Annual Burden of Respondents: 13 hours per annum.

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

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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

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

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact FAS-ReasonableAccommodation@usda.gov or Felice Robinson (Senior Reasonable Accommodations Specialist), Felice.Robinson@usda.gov.

Title: Faculty Exchange Program application.

OMB Number: 0551-New.

Expiration Date of Approval: Three years from approval date.

Type of Request: Existing collection in use without an OMB control number.

Abstract: The Faculty Exchange Program (FEP) was established in 1995 and currently focuses on improving veterinary education and research in selected African countries for early- to mid-career instructors at colleges of veterinary medicine. FEP training programs are designed and organized in conjunction with U.S. universities, USDA veterinarians and other federal government agencies. Since the program began, FEP has trained 54 early to mid-career instructors at colleges of veterinary medicine in Nigeria, Ghana, Kenya, Uganda, Tanzania, and Ethiopia.

To achieve its objectives, FEP relies on the solicitation for qualified program applicants through a written application. FAS Posts across the globe provide this application to potential Fellows to assist in determining the adequacy of their candidacy alongside FAS Washington. The application is designed to capture the professional status of the applicant, the applicant's personal contact information, and the applicant's suitability for the program. Thus, the FEP application is an integral tool to Fellowship Programs Division and FAS' strategic goals at large.

In addition to information related to program objectives, the FEP application collects information that may be considered Personal Identifiable Information (PII), including the following: first name, middle name, last name, gender, salutation, birth date, birth city, citizenship country, country of residence, work phone, permanent home address, work address, personal email, work email, and emergency contact information (family contact: name, relationship, home phone, cell phone, and email).

Estimate of Burden: The public reporting burden for each respondent resulting from information collection under FEP varies in direct relation to the number of fellowships that each respondent participates in.

Type of Respondents: Individuals.

Estimated Number of Respondents: 40 per annum.

Estimated Number of Responses per Respondent: 1 per annum.

Estimated Total Annual Burden of Respondents: 20 hours per annum.

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

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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

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

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact FAS-ReasonableAccommodation@usda.gov or Felice Robinson (Senior Reasonable Accommodations Specialist), Felice.Robinson@usda.gov.

Title: Cochran Fellowship Program.

OMB Number: 0551-New.

Expiration Date of Approval: Three years from approval date.

Type of Request: Existing collection in use without an OMB control number.

Abstract: Since 1984, U.S. Congress has made funds available to USDA's Cochran Fellowship Program to provide short-term training to Fellows from middle-income and emerging market countries in order to expose agricultural officials and industry representatives to U.S. agriculture products and policies, helping facilitate lasting, global relationships. The Cochran Fellowship Program is implemented by USDA's Foreign Agricultural Service, Global Programs, Fellowship Programs, and has hosted U.S.-based trainings for over 19,000 international participants from 127 countries worldwide.

To achieve its objectives, the Cochran Fellowship Program relies on the solicitation for qualified program applicants through a written application. FAS Posts across the globe provide this application to potential Fellows to assist in determining the adequacy of their candidacy alongside FAS Washington. The application is designed to capture the professional status of the applicant, the applicant's personal contact information, and the applicant's suitability for the program. Thus, the Cochran Fellowship Program application is an integral tool to Fellowship Programs Division and FAS' strategic goals at large.

In summary, excluding discrete questions related to program objectives, the Cochran Fellowship Program application collects the following personal information (that may be considered Personal Identifiable Information (PII)): first name, middle name, last name, gender, salutation, birth date, birth city, birth country, citizenship country, country of residence, home phone, work phone, mobile phone, permanent home address, work address, personal email, work email, passport information, U.S. contacts information (name, title, address, phone number, email), emergency contact information (US implementer), and emergency contact information (family contact: name, relationship, home phone, cell phone, and email).

Estimate of Burden: The public reporting burden for each respondent resulting from information collection under the Cochran Fellowship Program varies in direct relation to the number of fellowships that each respondent participates in.

Type of Respondents: Individuals.

Estimated Number of Respondents: 620 per annum.

Estimated Number of Responses per Respondent: 1 per annum.

Estimated Total Annual Burden of Respondents: 207 hours per annum.

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

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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

Comments will be summarized and included in the submission for Office of Management and Budget approval.

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact FAS-ReasonableAccommodation@usda.gov or Felice Robinson (Senior Reasonable Accommodations Specialist), Felice.Robinson@usda.gov.

Title: Scientific Cooperation Exchange Program application.

OMB Number: 0551-New.

Expiration Date of Approval: Three years from approval date.

Type of Request: Existing collection in use without an OMB control number.

Abstract: The Scientific Cooperation Exchange Program (SCEP) was established in 1979 to support bilateral exchanges between teams of scientific and technical experts from the United States and the People's Republic of China. SCEP has facilitated exchanges for more than 3,000 participants on topics of trade importance to USDA, including food safety and security, animal and plant health, and agricultural biotechnology and emerging technologies. The program promotes U.S. agricultural priorities, encourages long-term cooperation in agricultural science and technology, creates a positive atmosphere for agricultural trade, and enhances overall relations between the United States and China.

To achieve its objectives, SCEP relies on the solicitation for qualified program applicants through a written application. FAS Posts within China provide this application to potential Fellows to assist in determining the adequacy of their candidacy alongside FAS Washington. The application is designed to capture the professional status of the applicant, the applicant's personal contact information, and the applicant's suitability for the program. Thus, the SCEP application is an integral tool to Fellowship Programs Division and FAS' strategic goals at large.

In summary addition to information related to program objectives, the SCEP application collects information that may be considered Personal Identifiable Information, including the following: first name, middle name, last name, gender, salutation, birth date, birth city, citizenship country, country of residence, work phone, permanent home address, work address, personal email, work email, and emergency contact information (family contact: name, relationship, home phone, cell phone, and email).

Estimate of Burden: The public reporting burden for each respondent resulting from information collection under SCEP varies in direct relation to the number of fellowships that each respondent participates in.

Type of Respondents: Individuals.

Estimated Number of Respondents: 30 per annum.

Estimated Number of Responses per Respondent: 1 per annum.

Estimated Total Annual Burden of Respondents: 30 hours per annum.

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

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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

Comments will be summarized and included in the submission for Office of Management and Budget approval.

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact FAS-ReasonableAccommodation@usda.gov or Felice Robinson (Senior Reasonable Accommodations Specialist), Felice.Robinson@usda.gov.

Title: Borlaug Fellowship Program.

OMB Number: 0551-New.

Expiration Date of Approval: Three years from approval date.

Type of Request: Existing collection in use without an OMB control number.

Abstract: The Borlaug International Agricultural Science and Technology Fellowship Program (Borlaug) was established in 2008. Borlaug promotes agricultural productivity, food security, trade, and economic growth by providing training and collaborative research opportunities to early and mid-career scientists, researchers, or policymakers from eligible countries. An eligible country is a developing country, as determined by the Secretary using a gross national income per capita test selected by the Secretary. Since the program's inception, USDA has sponsored more than 920 Borlaug Fellows from 69 countries.

To achieve its objectives, Borlaug relies on the solicitation for qualified program applicants through a written application. FAS Posts across the globe provide this application to potential Fellows to assist in determining the adequacy of their candidacy alongside FAS Washington. The application is designed to capture the professional status of the applicant, the applicant's personal contact information, and the applicant's suitability for the program. Thus, the Borlaug application is an integral tool to Fellowship Programs Division and FAS' strategic goals at large.

In summary, excluding discrete questions related to program objectives, the Borlaug application collects the following personal information (that may be considered Personal Identifiable Information (PII)): first name, middle name, last name, gender, salutation, birth date, birth city, country of birth, citizenship country, country of residence, home/mobile phone, work phone, permanent home address, work address, personal email, work email, and emergency contact information (family contact: name, phone, and email), supervisors' contact information (name, email, phone number), professional contacts' information (name, email, phone number), and passport information.

Estimate of Burden: The public reporting burden for each respondent resulting from information collection under Borlaug varies in direct relation to the number of fellowships that each respondent participates in.

Type of Respondents: Individuals.

Estimated Number of Respondents: 145 per annum.

Estimated Number of Responses per Respondent: 1 per annum.

Estimated Total Annual Burden of Respondents: 218 hours per annum.

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

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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

Comments will be summarized and included in the submission for Office of Management and Budget approval.

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact FAS-ReasonableAccommodation@usda.gov or Felice Robinson (Senior Reasonable Accommodations Specialist), Felice.Robinson@usda.gov.

Title: Scientific Exchanges Program application.

OMB Number: 0551-New.

Expiration Date of Approval: Three years from approval date.

Type of Request: Existing collection in use without an OMB control number.

Abstract: The Scientific Exchanges Program (SEP) supports USDA's agricultural research goals of promoting collaborative programs among agricultural professionals of eligible countries, agricultural professionals of the United States, the international agricultural research system, and U.S. entities conducting research. SEP helps eligible countries by providing scientific training and collaborative research opportunities to early and mid-career scientists, researchers, and policymakers. The focus of SEP is to establish and harmonize sanitary and phytosanitary (SPS) regulatory regimes across the eight Regional Economic Communities of the African Union and improve animal health governance in Kenya.

To achieve its objectives, SEP relies on the solicitation for qualified program applicants through a written application. FAS Posts throughout the African Union provide this application to potential Fellows to assist in determining the adequacy of their candidacy alongside FAS Washington. The application is designed to capture the professional status of the applicant, the applicant's personal contact information, and the applicant's suitability for the program. Thus, the SEP application is an integral tool to Fellowship Programs Division and FAS' strategic goals at large.

In addition to information related to program objectives, the SEP application collects information that may be considered Personal Identifiable Information (PII), including the following: first name, middle name, last name, gender, salutation, birth date, birth city, citizenship country, country of residence, work phone, permanent home address, work address, personal email, work email, and emergency contact information (family contact: name, relationship, home phone, cell phone, and email).

Estimate of Burden: The public reporting burden for each respondent resulting from information collection under SEP varies in direct relation to the number of fellowships that each respondent participates in.

Type of Respondents: Individuals.

Estimated Number of Respondents: 165 per annum.

Estimated Number of Responses per Respondent: 1 per annum.

Estimated Total Annual Burden of Respondents: 165 hours per annum.

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

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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

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

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact FAS-ReasonableAccommodation@usda.gov or Felice Robinson (Senior Reasonable Accommodations Specialist), Felice.Robinson@usda.gov.

Title: Embassy Science Fellows Program application.

OMB Number: 0551-New.

Expiration Date of Approval: Three years from approval date.

Type of Request: Existing collection in use without an OMB control number.

Abstract: The Embassy Science Fellows Program (ESFP) was established in 2002 as a collaboration between USDA's Foreign Agricultural Service and the U.S. Department of State to provide U.S. embassies access to the subject matter expertise of U.S. government officials in science and technology fields. Fifteen U.S. Government agencies, including FAS, participate in the ESFP. The Program provides technical experts to U.S. embassies all over the world to assist with issues related to agriculture, science, technology, and health. Since the program's inception, FAS has sponsored 42 Fellows in 27 countries.

To achieve its objectives, ESFP relies on the solicitation for qualified program applicants through a written application. FAS Posts across the globe provide this application to potential Fellows to assist in determining the adequacy of their candidacy alongside FAS Washington. The application is designed to capture the professional status of the applicant, the applicant's personal contact information, and the applicant's suitability for the program. Thus, the ESFP application is an integral tool to Fellowship Programs Division and FAS' strategic goals at large.

In addition to information related to program objectives, the ESFP application collects information that may be considered Personal Identifiable Information (PII), including the following: name, gender, birth date, birth city, citizenship country, country of residence, work phone, permanent home address, work address, personal email, work email, and emergency contact information (family contact: name, relationship, home phone, cell phone, and email).

Estimate of Burden: The public reporting burden for each respondent resulting from information collection under ESFP varies in direct relation to the number of fellowships that each respondent participates in.

Type of Respondents: Individuals.

Estimated Number of Annual Respondents: 10.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Total Annual Burden of Respondents: 8 hours.

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

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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

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

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact FAS-ReasonableAccommodation@usda.gov or Felice Robinson (Senior Reasonable Accommodations Specialist), Felice.Robinson@usda.gov.

Title: Scientific Cooperation Research Program application.

OMB Number: 0551-New.

Expiration Date of Approval: Three years from approval date.

Type of Request: Existing collection in use without an OMB control number.

Abstract: The Scientific Cooperation Research Program (SCRP) was established in 1980 and supports the Borlaug Fellowship Program by utilizing the scientific community's accumulated knowledge and technologies to develop practical solutions to agricultural trade, market access, animal health, plant health, biotechnology, food safety, food security, and sustainable natural resource management. Since the program's inception, USDA has sponsored more than 400 projects with about 95 partnering countries.

To achieve its objectives, SCRP relies on the solicitation for qualified program applicants through a written application. FAS Posts across the globe provide this application to potential Fellows to assist in determining the adequacy of their candidacy alongside FAS Washington. The application is designed to capture the professional status of the applicant, the applicant's personal contact information, and the applicant's suitability for the program. Thus, the SCRP application is an integral tool to Fellowship Programs Division and FAS' strategic goals at large.

In additional to information related to program objectives, the SCRP application collects information that may be considered Personal Identifiable Information (PII), including the following: first name, middle name, last name, gender, salutation, birth date, birth city, citizenship country, country of residence, work phone, permanent home address, work address, personal email, work email, and emergency contact information (family contact: name, relationship, home phone, cell phone, and email).

Estimate of Burden: The public reporting burden for each respondent resulting from information collection under SCRP varies in direct relation to the number of fellowships that each respondent participates in.

Type of Respondents: Individuals.

Estimated Number of Respondents: 20 per annum.

Estimated Number of Responses per Respondent: 1 per annum.

Estimated Total Annual Burden of Respondents: 20 hours per annum.

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

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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

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

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact FAS-ReasonableAccommodation@usda.gov or Felice Robinson (Senior Reasonable Accommodations Specialist), Felice.Robinson@usda.gov.

This meeting is available to the public through the Zoom link above. If joining only via phone, callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Individuals who are deaf, deafblind and hard of hearing may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the call-in number found through registering at the web link provided above for the meeting.

Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the respective meeting. Written comments may be emailed to Barbara Delaviez at ero@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (202) 809- 9618. Records and documents discussed during the meeting will be available for public viewing as they become available at the www.facadatabase.gov. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Regional Programs Unit at the above phone number or email address.

Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given fewer than 15 calendar days prior to the meeting because of the exceptional circumstances of panelist availability.

Pursuant to section 805 of title VIII of the Tariff Act of 1930 (the Softwood Lumber Act of 2008), the Secretary of Commerce is mandated to submit to the appropriate Congressional committees a report every 180 days on any subsidy provided by countries exporting softwood lumber or softwood lumber products to the United States, including stumpage subsidies. Commerce submitted its last subsidy report to the Congress on June 30, 2022.

Given the large number of countries that export softwood lumber and softwood lumber products to the United States, we are soliciting public comment only on subsidies provided by countries which had exports accounting for at least one percent of total U.S. imports of softwood lumber by quantity, as classified under Harmonized Tariff Schedule of the United States (HTSUS) codes 4407.1100, 4407.1200, 4407.1300, 4407.1400, and 4407.1900, during the period January 1, 2022, through June 30, 2022. 1 Official U.S. import data, published by the United States International Trade Commission's DataWeb, indicate that six countries (Austria, Brazil, Canada, Germany, Romania, and Sweden) exported softwood lumber to the United States during that time period in amounts sufficient to account for at least one percent of U.S. imports of softwood lumber products. We intend to rely on similar six-month periods to identify the countries subject to future reports on softwood lumber subsidies. For example, we will rely on U.S. imports of softwood lumber and softwood lumber products during the period July 1, 2022, through December 31, 2022, to select the countries subject for the next report.

Under U.S. trade law, a subsidy exists where an authority: (i) provides a financial contribution; (ii) provides any form of income or price support within the meaning of article XVI of the GATT 1994; or (iii) makes a payment to a funding mechanism to provide a financial contribution to a person, or entrusts or directs a private entity to make a financial contribution, if providing the contribution would normally be vested in the government and the practice does not differ in substance from practices normally followed by governments, and a benefit is thereby conferred. 2

Parties should include in their comments: (1) the country which provided the subsidy; (2) the name of the subsidy program; (3) a brief description (no more than 3-4 sentences) of the subsidy program; and (4) the government body or authority that provided the subsidy.

As specified above, to be assured of consideration, comments must be received no later than 30 days after the publication of this notice in the Federal Register . All comments must be submitted through the Federal eRulemaking Portal at http://www.regulations.gov, Docket No. ITA-2022-0011. The materials in the docket will not be edited to remove identifying or contact information, and Commerce cautions against including any information in an electronic submission that the submitter does not want publicly disclosed. Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF formats only.

All comments should be addressed to Ryan Majerus, Deputy Assistant Secretary for Policy and Negotiations, at U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.

On April 12, 2022, MTD requested the initiation of a circumvention inquiry pursuant to section 781(a) of the Tariff Act of 1930, as amended (the Act), to determine whether certain lawn mowers assembled or completed by Daye North America, Inc. by joining, in the United States, a cutting deck shell (attached to at least one significant non-engine component) made in China to an internal combustion engine are circumventing the Orders. 1 However, Commerce rejected MTD's circumvention inquiry request because we found that MTD had not adequately alleged the elements necessary for a circumvention determination under section 781(a) of the Act. 2 On July 5, 2022, pursuant to section 781(a) of the Act and 19 CFR 351.226, MTD filed an amended circumvention inquiry request alleging that the Orders were being circumvented by merchandise completed or assembled in the United States. 3 On August 18, 2022, Commerce rejected MTD's amended request based on certain deficiencies identified in the amended circumvention inquiry request, and issued a deficiency questionnaire to MTD. 4

On September 7, 2022, pursuant to section 781(a) of the Act and 19 CFR 351.226, the domestic interested parties filed a third circumvention inquiry request alleging that the Orders are being circumvented by merchandise completed or assembled in the United States. 5 The domestic interested parties also provided information in response to Commerce's August 18, 2022 Deficiency Questionnaire. 6 On September 21, 2022, Ningbo Daye Garden Machinery Co., Ltd. (Ningbo Daye), Ningbo Lingyue Intelligent Equipment Co., Ltd., and Daye North America, Inc. (Daye North America) (collectively, Daye), filed comments in opposition to the domestic interested parties' request. 7 On October 6, 2022, we extended the deadline to initiate this circumvention inquiry by 14 days, to October 21, 2022, in accordance with 19 CFR 351.226(d)(1). 8

The products covered by these Orders are lawn mowers from China. A full description of the scope of the Orders is provided in the Circumvention Initiation Memorandum. 9

The merchandise subject to this circumvention inquiry are lawn mower sub-assemblies imported from China and comprised of a cutting deck shell attached to at least one other significant non-engine component, such as, but not limited to, a handle, wheels, grass catcher bag, or an electronic starter. 10 These sub-assemblies are assembled or completed in the United States by attaching internal combustion engines to produce rotary walk-behind lawn mowers of the type that would be subject to the Orders. 11 The cutting deck shell is the portion of the lawn mower—typically of aluminum or steel—that houses and protects a user from a rotating blade. Cutting deck shells are typically entered under Harmonized Tariff Schedule of the United States (HTSUS) subheading 8433.11 or 8433.90.

If Commerce determines that a request for a circumvention inquiry satisfies the requirements of 19 CFR 351.226(c), then Commerce “will accept the request and initiate a circumvention inquiry.”  12 Each circumvention inquiry request must allege “that the elements necessary for a circumvention determination under section 781 of the Act exist” and be “accompanied by information reasonably available to the interested party supporting these allegations.”  13 The domestic interested parties allege circumvention pursuant to section 781(a) of the Act, which pertains to merchandise completed or assembled in the United States.

For companion AD and CVD proceedings, “the Secretary will initiate and conduct a single inquiry with respect to the product at issue for both orders only on the record of the antidumping proceeding.”  14 Further, once “the Secretary issues a final circumvention determination on the record of the antidumping duty proceeding, the Secretary will include a copy of that determination on the record of the countervailing duty proceeding.”  15 Accordingly, once Commerce concludes this circumvention inquiry, Commerce intends to place its final circumvention determination on the record of the companion CVD proceeding.

Section 781(a)(1) of the Act provides that Commerce may find circumvention of an order when merchandise of the same class or kind subject to the order is completed or assembled in the United States from parts or components produced in the country subject to the order. In conducting a circumvention inquiry, under section 781(a)(1) of the Act, Commerce relies on the following criteria: (A) merchandise sold in the United States is of the same class or kind as any merchandise that is the subject of an AD or CVD order; (B) such merchandise sold in the United States is completed or assembled in the United States from parts or components produced in the foreign country with respect to which such order applies; (C) the process of assembly or completion in the United States is minor or insignificant; and (D) the value of the parts or components referred to in subparagraph (B) is a significant portion of the total value of the merchandise. As discussed below, the domestic interested parties provided evidence with respect to these criteria.

However, no single factor, by itself, controls Commerce's determination of whether the process of assembly or completion in the United States is minor or insignificant. 16 Accordingly, it is Commerce's practice to evaluate each of these five factors as they exist in the United States, and to reach an affirmative or negative circumvention determination based on the totality of the circumstances of the particular circumvention inquiry. 17

In addition, section 781(a)(3) of the Act sets forth additional factors to consider in determining whether to include merchandise assembled or completed in a foreign country within the scope of an AD or CVD order. Specifically, Commerce shall take into account such factors as: (A) the pattern of trade, including sourcing patterns; (B) whether the manufacturer or exporter of the parts or components is affiliated with the person who assembles or completes the merchandise sold in the United States from the parts or components produced in the foreign country to which the order applies; and (C) whether imports into the United States of the parts or components produced in such foreign country have increased after the initiation of the investigation that resulted in the issuance of such order.

Based on our analysis of the domestic interested parties' circumvention request, Commerce determines that the domestic interested parties have satisfied the criteria under 19 CFR 351.226(c) to warrant the initiation of a circumvention inquiry of the Orders. For a full discussion of the basis for our decision to initiate this circumvention inquiry, see the Circumvention Initiation Memorandum. A list of topics discussed in the Circumvention Initiation Memorandum is included as the appendix to this notice. As explained in the Circumvention Initiation Memorandum, the information provided by the domestic interested parties warrants initiating this circumvention inquiry on a country-wide basis. Commerce has taken this approach in prior circumvention inquiries, where the facts warranted initiation on a country-wide basis. 18

Consistent with the approach in the prior circumvention inquiries that were initiated on a country-wide basis, Commerce intends to issue questionnaires to solicit information from producers and exporters in China concerning shipments of Chinese cutting deck shells (attached to at least one significant non-engine component) to the United States to be attached to internal combustion engines and assembled or completed into lawn mowers in the United States. A company's failure to respond completely to Commerce's requests for information may result in the application of partial or total facts available, pursuant to section 776(a) of the Act, which may include adverse inferences, pursuant to section 776(b) of the Act.

Pursuant to 19 CFR 351.226(l)(1), Commerce will notify U.S. Customs and Border Protection (CBP) of the initiation of this circumvention inquiry and direct CBP to continue the suspension of liquidation of entries of products subject to the circumvention inquiry that were already subject to the suspension of liquidation under the Orders and to apply the cash deposit rate that would be applicable if the products were determined to be covered by the scope of the Orders. Should Commerce issue preliminary or final circumvention determination, Commerce will follow the suspension of liquidation rules under 19 CFR 351.226(l)(2)-(4).

In accordance with 19 CFR 351.226(d) and section 781(a) of the Act, Commerce determines that the MTD's request for this circumvention inquiry satisfies the requirements of 19 CFR 351.226(c). Accordingly, Commerce is notifying all interested parties of the initiation of this circumvention inquiry to determine whether certain lawn mowers assembled in the United States with Chinese cutting deck shells (attached to at least one significant non-engine component) and internal combustion engines, are circumventing the Orders. In addition, we included a description of the product that is the subject of this inquiry, and an explanation of the reasons for Commerce's decision to initiate this inquiry as provided above and in the accompanying Circumvention Initiation Memorandum. In accordance with 19 CFR 351.226(e)(1), Commerce intends to issue its preliminary determination no later than 150 days from the date of publication of the notice of initiation of this circumvention inquiry in the Federal Register .

This notice is published in accordance with section 781(a) of the Act and 19 CFR 351.226(d)(1)(ii).

On June 7, 2022, Commerce published in the Federal Register its preliminary affirmative determination in the LTFV investigation of SAP from Korea, in which it also postponed the final determination until October 20, 2022. 1 We invited interested parties to comment on the Preliminary Determination. A summary of the events that occurred since Commerce published the Preliminary Determination, as well as a full discussion of the issues raised by parties for this final determination, may be found in the Issues and Decision Memorandum. 2

The products covered by this investigation are SAP from Korea. For a complete description of the scope of this investigation, see appendix I.

During the course of this investigation, Commerce received scope comments from interested parties. Commerce issued a Preliminary Scope Decision Memorandum to address these comments. 3

We received comments from interested parties on the Preliminary Scope Decision Memorandum, 4 which we addressed in a Final Scope Decision Memorandum. 5 Commerce is not modifying the scope language as it appeared in the correction to the Preliminary Determination. See Appendix I for the final scope of the investigation.

All issues raised in the case and rebuttal briefs submitted by interested parties in this investigation are addressed in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is attached to this notice as appendix II. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

Commerce conducted verification of the information relied upon in making its final determination in this investigation, in accordance with section 782(i) of the Tariff Act of 1930, as amended (the Act). Specifically, Commerce conducted on-site verifications of the home market sales, U.S. sales, and cost of production responses submitted by LG Chem, Ltd. (LGC) and its U.S. affiliate, LG Chem America Inc.

Based on our analysis of the comments received and additional information obtained since the Preliminary Determination, we made certain changes to the margin calculation for this final determination. For a discussion of these changes, see the Issues and Decision Memorandum.

Section 735(c)(5)(A) of the Act provides that the estimated weighted-average dumping margin for all other producers and exporters not individually investigated shall be equal to the weighted average of the estimated weighted-average dumping margins established for individually-investigated exporters and producers, excluding rates that are zero, de minimis, or determined entirely under section 776 of the Act, i.e., facts otherwise available.

In this investigation, Commerce calculated an individual estimated weighted-average dumping margin for LGC, the only individually-examined exporter/producer in this investigation. Because the only individually calculated dumping margin is not zero, de minimis, or based entirely on facts otherwise available, the estimated weighted-average dumping margin calculated for LGC is the margin assigned to all other producers and exporters, pursuant to section 735(c)(5)(A) of the Act.

Commerce determines that the following estimated weighted-average dumping margins exist for the period October 1, 2020, through September 30, 2021:

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

In accordance with section 735(c)(1)(B) of the Act, Commerce will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all entries of subject merchandise, as described in appendix I of this notice, which were entered, or withdrawn from warehouse, for consumption on or after June 7, 2022, the date of publication of the Preliminary Determination in the Federal Register . This suspension of liquidation instructions will remain in effect until further notice.

Pursuant to sections 735(c)(1)(B)(ii) and 735(c)(5)(A) of the Act and 19 CFR 351.210(d), upon the publication of this notice, we will instruct CBP to require a cash deposit for estimated antidumping duties for such entries as follows: (1) the cash deposit rate for the respondent listed in the table above is the company-specific estimated weighted-average dumping margin determined in this final determination; (2) if the exporter is not identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for the producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be the all-others estimated weighted-average dumping margin listed above.

In accordance with section 735(d) of the Act, Commerce will notify the U.S. International Trade Commission (ITC) of its final determination of sales at LTFV. Because the final determination in this investigation is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports or sales (or the likelihood of sales) for importation of SAP no later than 45 days after this final determination. If the ITC determines that such injury does not exist, this proceeding will be terminated, all cash deposits posted will be refunded, and suspension of liquidation will be lifted. If the ITC determines that such injury does exist, Commerce will issue an antidumping duty order directing CBP to assess, upon further instruction by Commerce, antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed in the “Continuation of Suspension of Liquidation” section above.

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

This determination is issued and published in accordance with sections 735(d) and 777(i) of the Act and 19 CFR 351.210(c).

The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three-step process including: (1) Data Workshop; (2) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.

The items of discussion at the SEDAR 77 HMS Hammerhead Shark Assessment Webinar VI are as follows: discuss any leftover data issues that were not cleared up during the data process, answer any questions that the analysts have, and discuss model development and model setup.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice 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.

This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the South Atlantic Fishery Management Council office (see ADDRESSES ) at least 5 business days prior to the meeting.

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

The National Marine Fisheries Service (NMFS), Alaska Regional Office, is requesting extension of a currently approved information collection that contains applications for permits and transfers necessary for NMFS to manage the Amendment 80 Program (A80 Program).

Under the Magnuson-Stevens Fishery Conservation and Management Act 16 U.S.C. 1801 et seq., the Secretary of Commerce is responsible for the conservation and management of marine fishery resources within the Exclusive Economic Zone (EEZ) of the United States through NOAA/NMFS. NMFS Alaska Region manages the EEZ off Alaska under the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP) and the Fishery Management Plan for Groundfish of the Gulf of Alaska. The North Pacific Fishery Management Council recommended A80 to the BSAI FMP in June 2006 ( 72 FR 52668, September 14, 2007 ). A80 allocates several Bering Sea and Aleutian Islands (BSAI) non-pollock trawl groundfish species among trawl fishery sectors, established a limited access privilege program (LAPP), and facilitated the formation of harvesting cooperatives in the non-American Fisheries Act (non-AFA) trawl catcher/processor sector. More information on the A80 Program is provided on the NMFS Alaska Region website at https://www.fisheries.noaa.gov/alaska/sustainable-fisheries/bering-sea-and-aleutian-islands-amendment-80-groundfish-trawl-fishery.

This collection contains applications used by an individual or business entity to apply for A80 quota share, used by A80 quota shareholders to transfer A80 quota share and to apply for an A80 limited access fishery permit, used by A80 cooperatives to apply for cooperative quota and transfer cooperative quota, used by cooperatives or Community Development Quota groups to exchange community quota for one eligible flatfish species with community quota of a different eligible flatfish species, and used by A80 vessel owners to replace their vessels. This information collection also contains the appeals process for an application that is denied.

The type of information collected includes information on the applicants, transferors, transferees, permits, vessels, quota share, cooperative quota, and flatfish harvest quota.

NMFS uses this information to establish eligibility to receive A80 quota share, cooperative quota, and permits; transfer and assign harvest quota; replace vessels used in the A80 Program; determine A80 species initial total allowable catch assignments; determine which vessels must be tracked for catch accounting; and review ownership and control information to ensure that quota share and cooperative quota use caps are not exceeded.

The information is collected primarily by mail, fax, electronically through eFISH, or delivery. The Flatfish Exchange Application must be submitted through eFISH on the NMFS Alaska Region website at https://alaskafisheries.noaa.gov/webapps/efish/login. The Application for Inter-cooperative Transfer of Amendment 80 CQ is submitted to NMFS online through eFISH with the option to mail, fax, or deliver the application. The applications are available as fillable PDFs on the NMFS Alaska Region website at https://alaskafisheries.noaa.gov/fisheries-applications.

OMB Control Number: 0648-0565.

Form Number(s): None.

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

Affected Public: Individuals or households; Business or other for-profit organizations.

Estimated Number of Respondents: 25.

Estimated Time per Response: Application for A80 Quota Share: 2 hours; Application for A80 Limited Access Fishery Permit: 2 hours; Application for A80 Cooperative Quota Permit: 2 hours; Application to Transfer A80 Quota Share: 2 hours; Application for Inter-cooperative Transfer of A80 Cooperative Quota: 2 hours; Application for A80 Vessel Replacement: 2 hours; A80 appeals letter: 4 hours; Flatfish Exchange Application: 5 minutes.

Estimated Total Annual Burden Hours: 20 hours.

Estimated Total Annual Cost to Public: $525 in recordkeeping and reporting costs.

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

Legal Authority: Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801 et seq.

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.

The Recreational Advisory Panel will discuss draft alternatives and draft impacts analysis for Framework Adjustment 65/Specifications & Management Measures, and make recommendations to the Groundfish Committee for final action to include: status determination criteria, rebuilding plan for Gulf of Maine (GOM) cod, FY2023-FY2024 US/CA total allowable catches, FY2023-FY2024 specifications: Georges Bank (GB) yellowtail flounder and GB cod (including a catch target for the recreational fishery), FY2023-FY2025 specifications for 14 stocks, additional measures to promote stock rebuilding for GB cod and GOM cod, and revised acceptable biological catch (ABC) control rules, in consultation with the Scientific and Statistical Committee. The Panel will also discuss Atlantic Cod Management the development of a draft white paper on potential approaches to allocate “Georges Bank cod” to the recreational fishery delivered in 2022 to inform the 2023 priorities discussion. They will also discuss possible 2023 Council Priorities and make recommendations to the Committee, as appropriate. Other business may be discussed, 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.

The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a multi-step process including: (1) Data Workshop; (2) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report that compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report that describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, HMS Management Division, and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGO's; International experts; and staff of Councils, Commissions, and state and federal agencies.

The items of discussion for the webinar are as follows:

Participants will review data and discuss modeling approaches for use in the assessment of Gulf of Mexico red snapper.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice 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 meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see ADDRESSES ) at least 5 business days prior to each workshop.

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

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ), and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

The applicant proposes to take, by harassment, up to 480 transient killer whales and 100 gray whales ( Eschrichtius robustus ); 60 Dall's ( Phocoenoides dalli ) and 60 harbor ( Phocoena phocoena ) porpoises; 50 northern elephant ( Mirounga angustirostris ) and 800 harbor seals ( Phoca vitulina ); 200 California ( Zalophus californianus ) and 400 Eastern Steller ( Eumetopias jubatus ) sea lions, annually. Filming and observations may occur from vessels, underwater (snorkelers, divers, and towed or pole cameras), unmanned aircraft systems, and land-based platforms within Washington inland waters. The permit is requested for 3 years.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Concurrent with the publication of this notice in the Federal Register , NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three-step process including: (1) Data Workshop; (2) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.

The items of discussion at the SEDAR 76 South Atlantic Black Sea Bass Assessment Webinar 2 are as follows: discuss any known data issues and model development and model setup.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice 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.

This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the South Atlantic Fishery Management Council office (see ADDRESSES ) at least 5 business days prior to the meeting.

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

Title of Collection: Survey Screening Question List.

OMB Control Number: 3170-00XX.

Type of review: New information collection.

Affected Public: Individuals.

Estimated Number of Respondents: 50,000.

Estimated Total Annual Burden Hours: 12,500.

Abstract: The Bureau conducts a variety of research efforts to ascertain financial issues the American public may be experiencing. The Bureau developed a list of potential screener questions formulated to allow the Bureau's research efforts to focus on the appropriate consumers for each study and strengthen our ability to address financial needs and concerns of the public and to improve the Bureau's delivery of services and programs. Usage of questions included and approved within this list will reduce administrative burden on the Bureau and grant greater expediency in conducting research on emergent financial issues.

Request for Comments: The Bureau published a 60-day Federal Register notice on 4/7/2022 (87 FR 20394) under Docket Number: CFPB-2022-0022. The Bureau is soliciting comments on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be submitted to OMB as part of its review of this request. All comments will become a matter of public record.

Title of Collection: AmeriCorps NCCC Member Experience Survey.

OMB Control Number: 3045-0181.

Type of Review: Renewal.

Respondents/Affected Public: Current AmeriCorps NCCC Members.

Total Estimated Number of Annual Responses: 600.

Total Estimated Number of Annual Burden Hours: 150 hours.

Abstract: The AmeriCorps NCCC Member Experience Survey is completed by AmeriCorps members who have been a part of an AmeriCorps NCCC team. Each year, AmeriCorps NCCC engages teams of members in projects in communities across the United States. Service projects, which typically last from six to eight weeks, address critical needs in natural and other disasters, infrastructure improvement, environmental stewardship and conservation, energy conservation, and urban and rural development. Members construct and rehabilitate low-income housing, respond to natural disasters, clean up streams, help communities develop emergency plans, and address other local needs.

AmeriCorps seeks to renew and potentially revise the current survey. The survey tool will be used in the same manner as the existing survey. AmeriCorps additionally seeks to continue using the current survey until the revised survey tool is approved by OMB. The current survey is due to expire on January 21, 2023.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the 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 collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose, or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. All written comments will be available for public inspection on regulations.gov.

Title; Associated Form; and OMB Number: SDDC Transportation Financial Management System Access Request; SDDC Form 417; OMB Control Number 0704-0587.

Type of Request: Revision.

Number of Respondents: 993.

Responses per Respondent: 1.

Annual Responses: 993.

Average Burden per Response: 25 minutes.

Annual Burden Hours: 414.

Needs and Uses: The information collection requirement is necessary to establish Human Resource accounts within the Transportation Financial Management System (TFMS) for the Military Surface Deployment and Distribution Command (SDDC). The information is used to establish and control user accounts in TFMS and Oracle Business Intelligence Enterprise Edition, and to authenticate Transportation Enhanced Access Management Service access. Respondents are new employees that will be paid through the Defense Civilian Pay System, travelers that will be reimbursed using the SDDC line of accounting, or anyone requiring access to the accounting system to enter data or query exiting data. They are responding to the information collection to ensure they receive pay and benefits or to gain access to the accounting system as part of their assigned duties.

Affected Public: Individuals or households.

Frequency: As required.

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 document notifies the public of revisions in per diem rates prescribed by the Per Diem, Travel and Transportation Allowance Committee for travel to non-foreign areas outside the continental United States. The FY 2022 lodging rate review for Alaska resulted in rate changes for multiple locations. Bulletin Number 321 is published in the Federal Register to ensure that Government travelers outside the DoD are notified of revisions to the current reimbursement rates.

If you believe the lodging, meal or incidental allowance rate for a locality listed in the following table is insufficient, you may request a rate review for that location. For more information about how to request a review, please see the Defense Travel Management Office's Per Diem Rate Review Frequently Asked Questions (FAQ) page at https://www.defensetravel.dod.mil/site/faqraterev.cfm.

Title; Associated Form; and OMB Number: Application for Commission in the U.S. Navy/U.S. Naval Reserve; NAVCRUIT Forms 1131/238 and 1130/104; OMB Control Number 0703-0029.

Type of Request: Revision.

Number of Respondents: 25,500.

Responses per Respondent: 1.

Annual Responses: 25,500.

Average Burden per Response: 60 minutes.

Annual Burden Hours: 25,500.

Number of Respondents: 18,000.

Responses per Respondent: 1.

Annual Responses: 18,000.

Average Burden per Response: 30 minutes.

Annual Burden Hours: 9,000.

Number of Respondents: 25,500.

Annual Responses: 43,500.

Annual Burden Hours: 34,500.

Needs and Uses: All persons interested in entering the U.S. Navy or U.S. Navy Reserve in a commissioned status must provide various personal data in order for a selection board to determine their qualifications for naval service and for specific fields of endeavor that the applicant intends to pursue. The NAVCRUIT 1131/238 form, “Application Processing and Summary Record,” is used to collect information from any persons who are applying to the U.S. Navy. The NAVCRUIT 1130/104 form, “United States Navy Tattoo Screening Certificate” is used to collect information from the applicant in order to determine whether tattoos, body art or brands meets Navy accession requirements for content, location, size and cosmetic appearance.

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.

The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: School Pulse Panel 2023-24 Preliminary Field Activities.

OMB Control Number: 1850-NEW.

Type of Review: A new information collection.

Respondents/Affected Public: State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 9,939.

Total Estimated Number of Annual Burden Hours: 2,661.

Abstract: The School Pulse Panel (SPP) is a data collection originally designed to collect voluntary responses from a nationally representative sample of public schools to better understand how schools, students, and educators are responding to the ongoing stressors of the coronavirus pandemic. It is conducted by the National Center for Education Statistics (NCES), part of the Institute of Education Sciences (IES), within the United States Department of Education, in cooperation with the U.S. Census Bureau. Due to the immediate need to collect information from schools during the pandemic to satisfy the requirement of Executive Order 14000, an emergency clearance was issued to develop and field the first several monthly collections of the SPP in 2021, and a full review of the SPP data collection was completed in 2022 (OMB# 1850-0969). SPP's innovative design and timely dissemination of findings have been used and cited frequently among Department of Education senior leadership, the White House Domestic Policy Counsel, the USDA's Food and Nutrition Service, the Centers for Disease Control and Prevention, Congressional deliberations, and the media. The ongoing, growing interest by stakeholders has resulted in the request for dedicated funding to create an established NCES quick-turnaround data collection vehicle, with the goal of standing up a post-pandemic panel to begin with the 2023-24 school year.

One notable difference for the next SPP study will be the addition of a district-level survey. The purpose of the district component is two-fold: (1) to collect data on topics that schools cannot report about such as facilities, supply chain issues and finances; and (2) to reduce burden on schools by allowing district staff to report on district policies and school level data tracked at the district. The district component will enhance the breadth of data that can be collected in SPP. For the 23-24 school year, the survey may ask school and district staff about a range of topics, including but not limited to instructional mode offered; enrollment counts of subgroups of students for various subject interests; strategies to address learning recovery; safe and healthy school mitigation strategies; mental health services; use of technology; information on staffing, nutrition services, absenteeism, usage of federal funds, facilities, and overall principal and district staff experiences. Some new content will be rotated in and out monthly.

As in previous waves, for SPP 2023-24 roughly 5,000 (4,000 in an initial sample and 1,000 in a reserve sample) public elementary, middle, high, and combined-grade schools will be randomly selected to participate in a panel. It is expected these schools will come from roughly 3,000 districts with a reserve sample of 300 districts to replace district refusals. The goal is national representation from 1,000 responding schools and districts to report national estimates. School and district staff will be asked to provide requested data as frequently as monthly during the 23-24 school year. This approach provides the ability to collect detailed information on various topics while also assessing changes over time for items that are repeated. Given the high demand for data collection, the content of the survey will change monthly.

This request is to conduct the SPP 2023-24 preliminary activities, including contacting and obtaining research approvals from public school districts with an established research approval process (“special contact districts”), notifying sampled schools and districts of their selection for the survey, and inviting them to complete short Screener Surveys to establish a point of contact at their school and at the district.

The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed ICR that is described below. The Department is especially interested in public comments addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public record.

Title of Collection: Study of the Impact of English Learner Reclassification Policies.

OMB Control Number: 1850-NEW.

Type of Review: New collection.

Respondents/Affected Public: State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 30.

Total Estimated Number of Annual Burden Hours: 817.

Abstract: The data collection described in this submission will assist policymakers in understanding the impact of reclassification policies that exit students from English learner (EL) status. Specifically, the study will examine (1) whether reclassification was implemented more consistently across districts within states after the start of the Every Student Succeeds Act (ESSA) and (2) whether reclassification at current thresholds helps, harms, or is neutral for former ELs' instructional opportunities, experiences, achievement, and attainment. Data for the study will come from extant state longitudinal data systems and publicly available data on state policies.

Issuance of this FOA is an important step toward building understanding between interested communities, organizations, and DOE about consent-based siting. While DOE is not soliciting volunteer sites to host consolidated interim storage facilities as part of this funding opportunity, the Department hopes to encourage engagement, open dialogue, and building capacity among interested stakeholders and communities about the consent-based siting process. In later phases, DOE will engage with communities that express interest in potentially hosting one or more facilities.

Who should apply?: This FOA invites proposals from communities and organizations located within the continental United States interested in learning more about consent-based siting. Eligible awardees include, but are not limited to: higher-education institutions (colleges, universities, and other institutions of higher learning); Tribal, State, and local governments (municipalities, towns, cities, and counties); Community foundations; and Non-governmental organizations (trade associations, 501(c)(3) organizations, and other public groups). Federally funded research and development centers are not eligible to apply for funding. More detailed information on eligibility is provided in the FOA.

Public Information Webinar: DOE hosted an informational webinar about this FOA on October 3, 2022, to discuss the scope and answer questions about the application process. The webinar was recorded and is available at https://www.energy.gov/ne/consent-based-siting.

Management of the nation's spent nuclear fuel and high-level radioactive waste is the US DOE's responsibility. This includes finding sites to store and dispose of the Nation's spent nuclear fuel. DOE is committed to a consent-based approach to siting and an integrated waste management system that enables broad participation and centers equity and environmental justice. In the Consolidated Appropriations Act, 2021, and Consolidated Appropriations Act, 2022, Congress appropriated funds to the Department for Federal interim storage activities using a consent-based approach. Interim storage is an important component of an integrated waste management system and will enable near-term consolidation and temporary storage of spent nuclear fuel until a disposal capability is identified. A Federal interim storage capability will enable removal of spent nuclear fuel from reactor sites, provide useful research opportunities, and build trust and confidence with stakeholders and the public by demonstrating a consent-based approach to facility siting.

In December 2021, DOE issued a request for information on “ Using a Consent-Based Siting Process to Identify Federal Interim Storage Facilities ” (86 FR 68244). The 225 submissions received by the DOE (available at https://www.energy.gov/ne/consent-based-siting ) included comments from Tribal, State, and local governments; Non-governmental organizations; members of academia, industry; other stakeholders and individual commenters. This consent-based siting FOA is responsive to public feedback on the need to provide resources for interested communities to learn more about consent-based siting and spent nuclear fuel management. Specifically, the FOA seeks to advance mutual learning between stakeholders, communities, and DOE and to foster open discussions about consent-based siting, spent nuclear fuel management, and the role one or more federal consolidated interim storage facilities could have in interested communities. For more information on DOE's consent-based siting activities, please go to https://www.energy.gov/ne/consent-based-siting.

Confidential Business Information: Pursuant to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery two well-marked copies: one copy of the document marked “confidential” including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. Submit these documents via email, if feasible. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

This document of the Department of Energy was signed on October 21, 2022, by Dr. Kathryn Huff, Assistant Secretary for the Office of Nuclear Energy, 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 .

Title: FERC-923, Communication of Operational Information between Natural Gas Pipelines and Electric Transmission Operators.

OMB Control No.: 1902-0265.

Type of Request: Three-year extension of the information collection requirements described below with no changes to the current reporting requirements.

Abstract: In 2013, the Commission revised its regulations to provide explicit authority to interstate natural gas pipelines and public utilities that own, operate, or control facilities used for the transmission of electric energy in interstate commerce to voluntarily share non-public, operational information with each other for the purpose of promoting reliable service and operational planning on either the pipeline's or public utility's system. This helped ensure the reliability of natural gas pipeline and public utility transmission services by permitting transmission operators to share with each other the information that they deem necessary to promote the reliability and integrity of their systems. FERC removed actual or perceived prohibitions to the information sharing and communications between industry entities. The information shared is not submitted to FERC. Rather, the non-public information is shared voluntarily between industry entities. FERC does not prescribe the content, medium, format, or frequency for the information sharing and communications. Those decisions are made by the industry entities, depending on their needs and the situation.

Type of Respondent: Natural gas pipelines and public utilities.

Estimate of Annual Burden:   1 The Commission estimates the annual public reporting burden and cost 2 for FERC-923 as:

Comments: Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov. Materials can also be viewed at the Reading Room located at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operations are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal Holidays). The telephone number for the Docket Center is 202-566-1744.

Abstract: The collection of information is necessary in order to ensure that the hazardous waste airbag modules and airbag inflators exempted under this rule are safely disposed of and that defective airbag modules and airbag inflators are not reinserted into vehicles where they would pose an unreasonable risk of death or serious injury. Information collection activities include maintaining at the airbag handler for no less than three years records of (1) all off-site shipments and (2) confirmations of receipt of airbag waste.

Form Numbers: None.

Respondents/affected entities: Business or other for-profit.

Respondent's obligation to respond: required to obtain or retain a benefit (sections 2002, 3001, 3002, 3003, 3004, 3006, 3010, and 3017 of the Solid Waste Disposal Act).

Estimated number of respondents: 15,175.

Frequency of response: On occasion.

Total estimated burden: 4,250 hours per year. Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $13,322 (per year), which includes $0 annualized capital or operation & maintenance costs.

Changes in the estimates: There is a slight decrease in the burden estimates for this ICR due to a decrease in the number of respondents.

Public Comment Information: Interested persons may submit written comments on the Draft General Permit Modification to EPA Region 1 at the address listed above. In reaching a final decision on this Draft General Permit Modification, the Regional Administrator will respond to all significant comments and make responses available to the public on EPA Region 1's website. All comments must be postmarked or delivered by the close of the public comment period.

General Information: The Draft General Permit Modification includes effluent limitations and requirements for eligible facilities based on technology and/or water quality considerations of the unique discharges from these facilities. The effluent limits established in the Draft General Permit Modification ensure that the surface water quality standards of the receiving water(s) will be attained and/or maintained.

Obtaining Authorization: To obtain coverage under the General Permit, facilities meeting the eligibility requirements outlined in Part I of this General Permit may submit a notice of intent (NOI) in accordance with Part V of this General Permit and 40 CFR 122.28(b)(2)(i) & (ii). The contents of the NOI shall include at a minimum, the legal name and address of the owner or operator, the facility name and address, type of facility or discharges, the receiving stream(s) and be signed by the operator in accordance with the signatory requirements of 40 CFR 122.22. Alternately, based on 40 CFR 122.28(b)(2)(vi), the Director may notify a discharger that it is covered by a general permit, even if the discharger has not submitted an NOI to be covered. EPA has determined that the facilities identified in Attachment E of the Draft General Permit Modification all meet the eligibility requirements for coverage under the Draft General Permit and may be authorized to discharge under the General Permit Modification by this type of notification.

Other Legal Requirements: Endangered Species Act (ESA): In accordance with the ESA, EPA has updated the provisions and necessary actions and documentation related to potential impacts to endangered species from WWTFs being added for coverage under the Draft General Permit Modification. Concurrently with the public notice of the Draft General Permit Modification, EPA has initiated an informal consultation with the National Oceanic and Atmospheric Administration, National Marine Fisheries Service (NOAA Fisheries) under ESA section 7, through the submission of a letter and biological assessment (BA) summarizing the results of EPA's assessment of the potential effects to endangered and threatened species and their critical habitats under NOAA Fisheries jurisdiction as a result of EPA's issuance of the Draft General Permit Modification. In this document, EPA has made a preliminary determination that the proposed issuance of the Draft General Permit Modification is not likely to adversely affect the shortnose sturgeon, Atlantic sturgeon, leatherback sea turtles, loggerhead sea turtles, Kemp's ridley sea turtles, green sea turtles, North Atlantic right whales, and fin whales. EPA has requested that NOAA Fisheries review this submittal and inform EPA whether it concurs with this preliminary finding.

In addition, EPA has initiated an informal consultation with the U.S. Fish and Wildlife Service (USFWS) under ESA section 7, through the submission of a letter summarizing the results of EPA's assessment of the potential effects to endangered and threatened species and their critical habitats under USFWS jurisdiction as a result of EPA's issuance of the Draft General Permit Modification. In this document, EPA has made a preliminary determination that the proposed issuance of the Draft General Permit Modification is not likely to adversely affect the northern long-eared bat. EPA has completed an informal consultation with USFWS regarding the threatened northern long-eared bat, as activities conducted as part of the Small WWTF GP Modification are consistent with activities analyzed in the USFWS January 5, 2016, Programmatic Biological Opinion (PBO).

Essential Fish Habitat (EFH): Under the 1996 Amendments (Pub. L. 104-267) to the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq. (1998)), EPA is required to consult with NOAA Fisheries if EPA's actions or proposed actions that it funds, permits or undertakes “may adversely impact any essential fish habitat.” 16 U.S.C. 1855(b). This consultation will only include an analysis of the proposed additional facilities and will not include the facilities that are already covered based on the 2021 issuance of the General Permit. In the Statement of Basis accompanying the Draft General Permit Modification, EPA notes that the general permit action minimizes adverse effects to aquatic organisms, including those with designated EFH in the receiving waters. EFH species associated with the receiving waters of facilities covered by the Draft General Permit Modification may include Atlantic salmon as well as the life stages of a number of coastal EFH designated species, along with two habitat areas of particular concern. EPA has made the determination that additional mitigation is not warranted under Section 305(b)(2) of the Magnuson-Stevens Act and has provided this determination to NOAA Fisheries for their review.

National Historic Preservation Act (NHPA): Facilities which adversely affect properties listed or eligible for listing in the National Registry of Historic Places under the NHPA are not authorized to discharge under the Draft General Permit Modification. Based on the nature and location of the discharges, EPA has determined that all facilities eligible for authorization under the Draft General Permit do not have the potential to affect a property that is either listed or eligible for listing on the National Register of Historic Places.

Coastal Zone Management Act (CZMA): The CZMA, 16 U.S.C. 1451 et seq., and its implementing regulations (15 CFR part 930) require a determination that any federally licensed activity affecting the coastal zone with an approved Coastal Zone Management Program (CZMP) is consistent with the CZMA.

On June 7, 2021, the Massachusetts CZMP determined that the Small WWTF GP is consistent with its enforceable policies. Concurrent with the public notice EPA will request that the Executive Office of Environmental Affairs, MA CZM, Project Review Coordinator provide a consistency concurrence that the proposed Small WWTF GP Modification is consistent with the MA CZMP.

On June 7, 2021, the New Hampshire Coastal Program (NHCP) determined that the Small WWTF GP is consistent with its enforceable policies. On June 30, 2022, the NHCP determined that any additional facilities that qualify for coverage under the Small WWTF GP are also consistent with its enforceable policies. On June 30, 2022, EPA submitted a formal letter to NHCP describing this determination. Therefore, additional CZMA federal consistency review by the NHCP is not required.

Authority: This action is being taken under the Clean Water Act, 33 U.S.C. 1251 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 www.regulations.gov. Materials can also be viewed at the Reading Room located at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004. The Docket Center's hours of operations are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal Holidays). The telephone number for the Docket Center is 202-566-1744.

Abstract: Subpart K within 40 CFR part 262 provides a flexible and protective set of regulations that address the specific nature of hazardous waste generation and accumulation in laboratories owned by colleges and universities, including teaching hospitals and non-profit research institutes that are either owned by or formally affiliated with a college or university. In addition, eligible academic entities have the discretion to determine the most appropriate and effective method of compliance with these requirements—by allowing them the choice of either managing their hazardous wastes in accordance with the alternative regulations as set forth in Subpart K, or remaining subject to the existing generator regulations.

Form Numbers: None.

Respondents/affected entities: Business and other for-profit, as well as State, Local, and Tribal governments.

Respondent's obligation to respond: Required to obtain or retain a benefit (Sections 2002, 3001, 3002, 3004 of RCRA).

Estimated number of respondents: 246.

Frequency of response: On occasion.

Total estimated burden: 146,157 hours per year. Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $8,088,511 (per year), which includes $255,192 in annualized capital or operation & maintenance costs.

Changes in the Estimates: There is a decrease of 11,815 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is in the number of respondents.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's dockets, visit https://www.epa.gov/dockets.

Abstract: EPA procures contract support to facilitate the performance of certain duties. EPA may require contractors to handle TSCA CBI. Each contractor employee who will use TSCA CBI in the performance of his or her duties must be authorized for access to TSCA CBI through a multi-step process. The TSCA CBI Protection Manual provides Federal and contractor employees with guidelines and operating procedures for handling TSCA CBI while performing their official duties, as well as the procedures to obtain authorization for access to TSCA CBI.

Specifically, for purposes of this information collection, contractor personnel must submit to EPA the EPA form titled “TSCA CBI Access Request, Agreement, and Approval” (EPA Form 7740-6). The Agency uses EPA Form 7740-6 to collect information about contractor personnel so that the Agency can evaluate their suitability for access to TSCA CBI.

Form Numbers: 7740-6.

Respondents/affected entities: Potentially affected entities may include but are not limited to the following: NAICS codes 514 (Information Services) and 561 (Administrative and Support Services).

Respondent's obligation to respond: Mandatory, 15 U.S.C. 2613.

Estimated number of respondents: 241 (total).

Frequency of response: On occasion.

Total estimated burden: 341 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $19,740 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in the estimates: The estimated annual burden to contractors is unchanged at 341 hours compared with that identified in the ICR currently approved by OMB. Also, the costs to the industry respondents increased by $435, reflecting increases in labor and overhead costs over time.

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 Engine Test Cells/Stands (40 CFR part 63, subpart PPPPP) apply to any existing, new, or reconstructed engine test cells/stands located at major source facilities that are used for testing internal combustion engines. Owners and operators of engine test cells/stands are required to comply with reporting and record keeping requirements for the general provisions of 40 CFR part 63, subpart A, as well as the applicable specific standards in 40 CFR part 63 Subpart PPPPP. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. These notifications, reports, and records are essential in determining compliance with 40 CFR part 63, subpart PPPPP and must be maintained for at least 5 years from the date on which it was generated.

Form Numbers: 5900-523.

Respondents/affected entities: Engine test cells/stands.

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

Estimated number of respondents: 8 (total).

Frequency of response: Semiannually.

Total estimated burden: 830 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $101,000 (per year), which includes $2,400 in annualized capital/startup and/or operation & maintenance costs.

Changes in the estimates: There is a decrease in burden from the most-recently approved ICR as currently identified in the OMB Inventory of Approved Burdens. The regulations were previously amended in a Risk and Technology Review (RTR) on June 3, 2020 at 85 FR 34326. The change in the burden and cost estimates in this ICR occurred because the revised standard has been in effect for 1.5 years and the requirements are different during initial compliance (new facilities) as compared to on-going compliance (existing facilities). The previous ICR (2066.09) reflected those burdens and costs associated with the initial activities for those facilities subject to the June 3, 2020 final rule. This ICR (2066.10) reflects the ongoing burden and costs for existing facilities. The final rule amendments eliminated the SSM exemption, removed the SSM plan and SSM recordkeeping requirements, and required electronic submittal of performance test results. This ICR adjusts the burden, following the June 3, 2020 final rule, to reflect the current number of entities anticipated to be subject to the rule, and assumes the one new source identified in the RTR has already complied with the initial notification and testing requirements, resulting in a decrease in the capital/startup costs. This ICR retains the assumption in the final rule ICR that two new sources will submit an initial notification over the next three years, but will not be subject to emission limits, performance testing, recordkeeping, and reporting requirements. No new sources that would be subject to the emission limits, performance testing, recordkeeping and reporting requirements are anticipated during the three-year period of this ICR.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

Abstract: Agency officials developed this form to comply with Executive Order (14035): Diversity, Equity, Inclusion and Accessibility in the Federal Workforce, Section 5(e) that directs the U.S. Environmental Protection Agency to collect and analyze voluntarily self-reported demographic data regarding the membership of federal advisory committees to pursue opportunities to increase diversity, equity, inclusion, and accessibility. When creating the ethnicity, race and demographic items for the form, EPA followed the format of the Employee Viewpoint Survey administered by the U.S. Office of Personnel Management.

This information collection request will assist EPA when selecting members to EPA's scientific and technical federal advisory committees to strengthen opportunities so that members and future nominees reflect the diversity of the American people in terms of gender, race, ethnicity, geography, and other characteristics.

Form Numbers: 5800-068.

Respondents/affected entities: Entities potentially affected by this action are approximately 200 candidates for membership on EPA's federal advisory committees. In an effort to strive for federal advisory committees where future nominees reflect the diversity of America, all nominees are encouraged to complete and submit the form when applying for membership in accordance with Executive Order 14035 of June 25, 2021: Diversity, Equity, Inclusion, and Accessibility in the Federal Workforce.

Respondent's obligation to respond: Voluntary.

Estimated number of respondents: 200 (total).

Frequency of response: Annually.

Total estimated burden: 16.6 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $651 (per year). There are no annualized capital or operation & maintenance costs.

Changes in the estimates: There is no change in burden because this is a new information collection request.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's dockets, visit http://www.epa.gov/dockets.

Abstract: Under TSCA section 8(e), any person who manufactures (defined by statute to include imports), processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment is required to immediately inform EPA of such information unless they have actual knowledge that EPA has been adequately informed of such information.

EPA receives and screens TSCA section 8(e) submissions covering a large number of chemical substances and mixtures on a wide range of chemical toxicity/exposure information. Although EPA's receipt of TSCA section 8(e) information does not necessarily trigger immediate regulatory action under TSCA or other authorities administered by EPA, all TSCA section 8(e) submissions receive screening level evaluations by EPA's Office of Pollution Prevention and Toxics (OPPT) to identify priorities for further Agency action and appropriate referrals to other programs.

In addition, EPA is offering an electronic reporting option for use both by those who are required to submit a notification of substantial risk under TSCA section 8(e) and by those who wish voluntarily to submit “For Your Information” (FYI) notices by registering and submitting information electronically using the Agency's Central Data Exchange (CDX).

Form Numbers: None.

Respondents/affected entities: Entities potentially affected are those that manufacture, process, import, or distribute in commerce chemical substances and mixtures. The following North American Industrial Classification System (NAICS) codes have been provided to assist in determining whether this action might apply to certain entities: Chemical manufacturing (NAICS code 325) and petroleum and coal product manufacturing (NAICS code 324).

Respondent's obligation to respond: Mandatory, 15 U.S.C. 2607(e).

Estimated number of respondents: 51 (total).

Frequency of response: On occasion.

Total estimated burden: 17,565 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $1,635,246 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in the estimates: There is a decrease of 3,777 hours from the ICR currently approved by OMB (from 21,412 to 17,635 hours). This reflects an overall decrease in the number of 8(e) and FYI submissions, which decreased from 408 to 343 for 8(e) submissions and from 13 to 6 for FYI submissions respectively.

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 Chemical Preparations Industry (40 CFR part 63, subpart BBBBBBB) were proposed on August 5, 2009, and promulgated on December 30, 2009. These regulations apply to both existing and new chemical preparation facilities that conduct the mixing, milling, blending or extruding of industrial chemicals and that are area sources of hazardous air pollutants (HAPs). Area sources are classified as sources that emit less than 10 tons per year of a single HAP and less than 25 tons per year of any combination of HAPs. New facilities include those that commenced construction, modification or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR part 63, subpart BBBBBBB.

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: Chemical preparation facilities that conduct the mixing, milling, blending or extruding of industrial chemicals.

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

Estimated number of respondents: 3 (total).

Frequency of response: Initially, annually, and semiannually.

Total estimated burden: 176 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $21,100 (per year), which includes $45 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: The adjustment decrease in burden from the most-recently approved ICR is due to a decrease in the number of sources. This ICR reflects a substantial decrease in the number of respondents in the currently approved ICR, based on data collected from the chemical preparations industry as part of a 2020 section 114 information collection request. There were 26 affected sources estimated in the most-recently approved ICR, and this ICR renewal estimates there are three affected sources. The number of sources has decreased by 88 percent, which reflects an overall decline in the industry. There are no capital/startup costs in this ICR. The O&M costs decreased due to the decreased number of affected sources.

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 Iron and Steel Foundries Area Sources (40 CFR part 63, subpart ZZZZZ) apply to both new and existing iron and/or steel foundries that are an area source of hazardous air pollutants (HAP) emissions. There are different requirements for foundries based on size. Existing foundries with an annual metal melt production greater than 20,000 tons and new foundries with an annual melt capacity of 10,000 tons are classified as large foundries. Existing foundries with an annual metal melt capacity of 10,000 tons or less are classified as small foundries. Research and development facilities are not covered by the rule. New facilities include those that commenced either construction, modification or reconstruction after the date of proposal. 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 with 40 CFR part 63, subpart ZZZZZ.

Form Numbers: 5900-521.

Respondents/affected entities: Iron and steel foundries.

Respondent's obligation to respond: Mandatory (40 CFR 63, Subpart ZZZZZ).

Estimated number of respondents: 390 (total).

Frequency of response: Initially, occasionally, quarterly, semiannually, and annually.

Total estimated burden: 12,970 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $1,540,000 (per year), which includes $0 in annualized capital/startup and/or operation & maintenance costs.

Changes in the estimates: There is an adjustment decrease in the total estimated burden as currently identified in the OMB Inventory of Approved Burdens. This decrease is not due to any program changes. There are no changes in the regulatory requirements and there is no significant industry growth since the most-recently approved ICR was developed. The previous ICR reflected those burdens and costs associated with certain one-time activities including reviewing record keeping systems, adjusting methods, and training employees as a result of the 2020 rule revisions (85 FR 56080). This ICR, by and large, reflects the on-going burden and costs for existing facilities.

OMB Control No.: 3060-0740.

Title: Section 95.2109, AMTS Notifications; 95.2195, LPRS Disclosures.

Form No.: Not applicable.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 26 respondents and 26 responses.

Estimated Time per Response: 1 hour.

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

Obligation To Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in 47 U.S.C. 154 and 303.

Total Annual Burden: 26 hours.

Annual Cost Burden: $1,300.

Needs and Uses: Manufacturers of Low Power Radio Service (LPRS) used for auditory assistance, health care assistance, and law enforcement tracking purposes must include with each transmitting device the following statement: “This transmitter is authorized by rule under the Low Power Radio Service (47 CFR part 95) and must not cause harmful interference to TV reception or United States Navy SPASUR installations. You do not need an FCC license to operate this transmitter. This transmitter may only be used to provide: Auditory assistance to persons with disabilities, persons who require language translation, or persons in educational settings; health care services to the ill; law enforcement tracking services under agreement with a law enforcement agency; or automated maritime telecommunications system (AMTS) network control communications. Two-way voice communications and all other types of uses not mentioned above are expressly prohibited.”

The reporting requirement contained in section 95.2109 states that Prior to operating a LPRS transmitter with an AMTS, the AMTS licensee must notify, in writing, each television station that may be affected by such operations, as defined in section 80.215(h). The notification provided with the station's license application is sufficient to satisfy this requirement if no new television stations would be affected.

The information collection requirement contained in section 95.2195 requires that manufacturers of LPRS transmitters used for auditory assistance, health care assistance, and law enforcement tracking purposes must include with each transmitting device the following statement:

This transmitter is authorized by rule under the Low Power Radio Service (47 CFR part 95) and must not cause harmful interference to TV reception or to the United States Air Force Space Surveillance System operating in the 216.88-217.08 MHz band. With the exception of automated maritime telecommunications system (AMTS) devices, you do not need an FCC license to operate this transmitter. This transmitter may only be used to provide: Auditory assistance to persons with disabilities, persons who require language translation, or persons in educational settings; health care services to the ill; law enforcement tracking services under agreement with a law enforcement agency; or AMTS network control communications. Two-way voice communications and all other types of uses not mentioned above are expressly prohibited.

Please note that sections 95.1015(a) and (b) were renumbered to sections 95.2195 and 95.2109 via FCC 17-57.

Title: Rule Concerning Disclosure of Written Consumer Product Warranty Terms and Conditions.

OMB Control Number: 3084-0111.

Type of Review: Extension of a currently approved collection.

Abstract: The Warranty Rule is one of three rules  1 that the FTC implemented pursuant to requirements of the Magnuson-Moss Warranty Act, 15 U.S.C. 2301 et seq. (Warranty Act or Act). 2 The Warranty Rule specifies the information that must appear in a written warranty on a consumer product  3 costing more than $15. The Rule tracks Section 102(a) of the Warranty Act, 4 specifying information that must appear in the written warranty and, for certain disclosures, mandates the exact language that must be used. 5 Neither the Warranty Rule nor the Act requires that a manufacturer or retailer warrant a consumer product in writing, but if they choose to do so, the warranty must comply with the Rule.

Estimated Annual Hours Burden: 216,752 hours.

Estimated Annual Labor Cost Burden: $29,652,215.

As required by Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), the FTC is providing this opportunity for public comment before requesting that OMB extend the existing clearance for the information collection requirements contained in the Warranty Rule.

Burden Statement:

Total annual hours burden: 216,752 hours.

In its 2019 submission to OMB, the FTC estimated that the information collection burden of including the disclosures required by the Warranty Rule was 242,296 hours per year. Although the Rule's information collection requirements have not changed, the current estimate decreases the number of manufacturers subject to the Rule based on recent Census data. 6 Further, because most warrantors likely would continue to disclose the information required by the Rule, even if there were no statute or rule requiring them to do so, staff's estimates likely overstate the PRA-related burden attributable to the Rule. Moreover, the Warranty Rule has been in effect since 1976, and warrantors have long since modified their warranties to include the information the Rule requires.

Based on conversations with various warrantors' representatives over the years, staff has concluded that eight hours per year is a reasonable estimate of warrantors' PRA-related burden attributable to the Warranty Rule. This estimate includes the number of hours warrantors may need to ensure new warranties and any changes to existing warranties comply with the Rule. Based on recent Census data, staff now estimates that there are 27,094 manufacturers covered by the Rule. 7 This results in an annual burden estimate of approximately 216,752 hours (27,094 manufacturers x 8 hours of burden per year).

Total annual labor costs: $29,652,215.

Labor costs are derived by applying appropriate hourly cost figures to the burden hours described above. The work required to comply with the Warranty Rule—ensuring that new warranties and changes to existing warranties comply with the Rule—requires a mix of legal analysis (50%), legal support (paralegals) (25%) and clerical help (25%). Staff estimates that half of the total burden hours (108,376 hours) requires legal analysis at an average hourly wage of $250 for legal professionals, 8 resulting in a labor cost of $27,094,000. Assuming that 25% of the total burden hours requires legal support at the average hourly wage of $28.46, and that the remaining 25% requires clerical work at an average hourly wage of $18.75; the resulting labor cost is approximately $2,558,215 ($1,542,190 + $1,016,025). Thus, the total annual labor cost is approximately $29,652,215 ($27,094,000 for legal professionals + $1,542,190 for legal support + $1,016,025 for clerical workers).

The Rule imposes no appreciable current capital or start-up costs that businesses do not already spend in the normal course of business. To comply with the Warranty Rule, warrantors need only the ordinary office equipment to draft new warranties and to change the wording of existing warranties to include the required disclosures. Thus, compliance requires no capital equipment or special technology apart from what the manufacturer or seller would already be using as part of the normal course of business, such as computer or other word processing equipment, and photocopying equipment. Similarly, distribution of the warranty does not impose any special capital costs apart from the packaging and printing equipment already in use by the business. It is not possible to state with any precision what fraction of the cost of that equipment could be attributed to distributing the warranty.

The only ongoing costs involved with compliance are those costs associated with maintenance and repair of computer word processing and photocopying equipment used to generate the warranty document that contains the required disclosures. These are costs that the seller or manufacturer already bears in the normal cost of business; it is unlikely that Warranty Rule compliance would impose significant incremental costs. Likewise, the cost of distributing warranty information involves such things as the purchase of supplies (such as paper), the maintenance of equipment, or the purchase of services to print, package, and distribute the warranty. These are costs that would be already built into the packaging and distribution of the product itself and which are already assumed as part of the normal course of business.

Pursuant to Section 3506(c)(2)(A) of the PRA, the FTC invites comments on: (1) 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) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of maintaining records and providing disclosures to consumers. All comments must be received on or before December 27, 2022.

You can file a comment online or on paper. For the FTC to consider your comment, we must receive it on or before December 27, 2022. Write “Paperwork Reduction Act Comment: FTC File No. P072108” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including the https://www.regulations.gov website.

Due to the public health emergency in response to the COVID-19 outbreak and the agency's heightened security screening, postal mail addressed to the Commission will be subject to delay. We encourage you to submit your comments online through the https://www.regulations.gov website.

If you prefer to file your comment on paper, write “Paperwork Reduction Act Comment: FTC File No. P072108” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex J), Washington, DC 20580; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

Because your comment will become publicly available at https://www.regulations.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “trade secret or any commercial or financial information which . . . . is privileged or confidential” —as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted publicly at www.regulations.gov, we cannot redact or remove your comment unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request.

The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before December 27, 2022. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in the PRA and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. The PRA requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, ACL is publishing a notice of the proposed collection of information set forth in this document. With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:

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

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

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

(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; and

(5) this IC collects Caregiver and Care Recipient demographics. Demographic questions include information about age, gender identity, transgender, sexual orientation, geographic location, ethnicity, and race. Racial equity and sexual orientation and gender identity (SOGI) data elements are consistent with recommendations regulated under Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government and the Executive Order on Advancing Equality for Lesbian, Gay, Bisexual, Transgender, Queer, and Intersex Individuals.

ACL's Office of Supportive and Caregiver Services aims to improve Lifespan Respite Care Program grantee performance measurement and tracking through a new quantitative grantee reporting tool. The existing reporting template used by most ACL grantees funded from discretionary sources consists of four open-ended, narrative questions related to program implementation and outputs, making comparisons between different grant periods and grantees challenging. The proposed tool will allow ACL to meet the additional requirements stated in Section 2904 of the Lifespan Respite Care Reauthorization Act of 2020, by adding quantitative data elements to the existing reporting requirements in accordance with program statute. This tool will allow for more effective tracking of how federal funds are being used, including aggregate data on people served and program development toward stated goals.

In this IC, the new quantitative grant reporting tool will be disseminated to all new Lifespan Respite Program grantees upon grant award. Specifically, the tool will collect information related to respite care services delivered, caregiver demographics, care recipient demographics, respite training, and lifespan respite program systems and providers. Ultimately, this reporting will assist ACL's Office of Supportive and Caregiver Services to assess the performance of the Lifespan Respite Program grantees in improving the delivery and quality of respite services for family caregivers of children and adults of all ages with special needs.

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

Estimated Program Burden: ACL estimates the burden of this collection of information as follows:

A maximum of 40 grantees are expected to respond to the grant reporting tool semiannually. The approximate burden for completion may be 6 hours per respondent for a total estimate of 480 hours. The estimated completion burden includes time to review the instructions, read the questions, compile information, and complete responses.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in in the PRA and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. The PRA requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, ACL is publishing a notice of the proposed collection of information set forth in this document. With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:

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

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

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

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

The Administration for Community Living (ACL) is currently engaged in an effort to streamline and standardize grantee profiles across three programs managed by the Office of Healthcare Information and Counseling (OHIC): the State Health Insurance Assistance Program (SHIP), Senior Medicare Patrol (SMP), and Medicare Improvements for Patients and Providers Act (MIPPA). Grantees in each program must adhere to a specific set of reporting requirements and associated reporting schedules outlined in their Program Reporting Guidelines. While reporting requirements are effective in ensuring grantees data, there is no consistency or uniformity in how individual grantees submit their data. For example, SHIP profiles currently exist; these profiles are accessible to the SHIP grantee network via the program's technical assistance center, and they can be updated directly by grantee states. SMP and MIPPA profiles have yet to be developed. The goal of this data collection effort is to obtain consistent data elements for the three programs that will allow ACL to reimagine the existing profiles into a comparable set of data elements across programs.

These data will allow RTI International, a contractor to ACL, to develop an updated set of grantee profiles that are accessible, visually appealing, and consistent across programs. Specifically, the purpose of this data collection effort is to update the SHIP grantee profiles, which were last updated in 2016, and develop similar profiles for SMP and MIPPA. These profiles will be internal to ACL and will only be shared with grantees.

A web-based questionnaire will be emailed to all 125 grant managers (representing 54 states and territories) electronically via Smartsheet. The collected data will be imported into a dataset and will be used to create program profiles accessible to ACL and grantees.

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

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

A maximum of 125 grantees are expected to respond to the web-based data collection instrument. The approximate burden for pre-data collection preparation is 30 minutes per respondent and approximate burden for form completion is 20 minutes per respondent for a total annual estimate of 103.75 hours. The estimated completion burden includes time to review the instructions, read the questions and complete and responses.

Alzheimer's disease (AD) is a major public health concern worldwide and its accurate diagnosis and staging is critical for the optimal management of patients at risk for or afflicted with this devastating disorder. The accuracy of clinical diagnosis of AD by dementia experts is modest when compared to postmortem diagnosis. Amyloid burden is one of the pathological hallmarks of the disease, and in patients presenting with cognitive and memory disturbances, quantitative imaging of brain amyloid offers the potential to enhance the assessment and management of patients with suspected or confirmed AD. This workshop aims to evaluate the role of quantitative PET measures of amyloid deposition in the brain in clinical trials and as well as in clinical use in patients with suspected or confirmed AD.

The workshop will provide an overview of clinical and investigational uses of brain amyloid PET imaging, the regulatory history of marketed imaging drug products and devices for amyloid quantitation, clinical pharmacology of tracers, quantitation methodology, metrics and analytical validity, and use of quantitative amyloid in clinical trials with perspectives from industry, trade and professional organizations, academic investigators, and patient advocacy group.

Registration: To register for the public workshop, persons interested in attending this public workshop virtually or in-person must register online by November 16, 2022, 11:59 p.m. Eastern Time. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. No same-day registration will be available.

Registration is free and in-person participation is limited due to space availability constraints; therefore, FDA may limit the number of onsite participants from each organization. Registrants will receive confirmation when they have been accepted. If there are COVID-19 restrictions in place at the time of the event, this conference will move to an all-virtual event.

If you need special accommodations due to a disability, please contact Kyong “Kaye” Kang no later than November 16, 2022.

Streaming Webcast of the Public Workshop: This public workshop will also be webcast at https://fda.zoomgov.com/webinar/register/WN_ezA-_Y94QMSaT0SHBdlS5g.

If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES ). A link to the transcript will also be available on the internet at https://www.fda.gov/drugs/news-events-human-drugs/fda-cder-cdrh-snmmi-and-mita-workshop-quantitative-brain-amyloid-pet-imaging-patients-alzheimers.

The joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee was originally announced in the Federal Register of September 13, 2022 (87 FR 56071). The meeting has been postponed to allow time for FDA to review new information. Future meeting dates will be announced in the Federal Register .

Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives (among other criteria).

Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces, including personnel operating under the authority of title 10 or title 50, U.S. Code, of attack with (A) a biological, chemical, radiological, or nuclear agent or agents or (B) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. military forces;  1 (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or the health and security of U.S. citizens living abroad.

Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Under section 564(h)(1) of the FD&C Act, revisions to an authorization shall be made available on the internet website of FDA. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use in an actual or potential emergency when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved under section 571 of the FD&C Act (21 U.S.C. 360ccc).

FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA  2 concludes: (1) that an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that (A) the product may be effective in diagnosing, treating, or preventing (i) such disease or condition or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; (4) in the case of a determination described in section 564(b)(1)(B)(ii) of the FD&C Act, that the request for emergency use is made by the Secretary of Defense; and (5) that such other criteria as may be prescribed by regulation are satisfied.

No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act.

The Authorization follows the August 9, 2022, determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves monkeypox virus. Notice of the Secretary's determination was provided in the Federal Register on August 15, 2022 (87 FR 50090). On the basis of such determination, the Secretary of HHS declared, on September 7, 2022, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. Notice of the Secretary's declaration was provided in the Federal Register on September 13, 2022 (87 FR 56074). On October 7, 2022, having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act are met, FDA issued an EUA to Abbott Molecular, Inc. for the Alinity m MPXV, subject to the terms of the Authorization. The Authorization, which is included below in its entirety after section IV of this document (not including the authorized versions of the fact sheets and other written materials), provides an explanation of the reasons for issuance, as required by section 564(h)(1) of the FD&C Act. Any subsequent revision to the Authorization can be found on FDA's web page at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

An electronic version of this document and the full text of the Authorization is available on the internet at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

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

This information collection supports FDA's implementation of Agency guidance. In 2017, FDA developed and published for comment a draft guidance entitled “Best Practices for Convening a Generally Recognized as Safe Panel,” ( https://www.fda.gov/media/109006/download ) which, once finalized, would assist persons who choose to convene a panel of experts in support of a conclusion that the use of a substance in food is generally recognized as safe (GRAS).

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that all food additives (as defined by section 201(s) (21 U.S.C. 321(s)) be approved by FDA for their intended use in food before they are marketed. Section 409 of the FD&C Act (21 U.S.C. 348) establishes a premarket approval requirement for “food additives.” Section 201(s) of the FD&C Act provides an exclusion to the definition of “food additive,” and thus from the premarket approval requirement, for uses of substances that are generally GRAS by qualified experts.

The GRAS provision of section 201(s) of the FD&C Act is implemented in 21 CFR part 170 for human food and 21 CFR part 570 for animal food. The regulations provide the criteria for when the use of a substance in food for humans or animals is GRAS. Part 170, subpart E and part 570, subpart E provide the procedure under which a person (also referred to as the “proponent” of a GRAS conclusion) may notify FDA about a conclusion that a substance is GRAS under the conditions of its intended use in human and/or animal food. This includes a standard format for the submission of a GRAS notice. The information submitted to us in a GRAS notice is necessary to allow us to administer efficiently the FD&C Act's various provisions that apply to the use of substances added to food; specifically, whether a substance is GRAS under the conditions of its intended use or whether it is a food additive subject to premarket review and approval by FDA. To support a GRAS conclusion, a proponent may convene a panel of qualified experts to provide evidence that generally available safety data and information about the intended use of the substance in food are generally accepted among experts, which is one of the criteria for eligibility for GRAS status (81 FR 54959 at 54975; August 17, 2016).

From 2008 to 2010, the Government Accountability Office (GAO) conducted a study related to ingredients used in human food on the basis of the GRAS provision in section 201(s) of the FD&C Act. In 2010, GAO issued a report (the GAO report  1 ) that included recommendations for FDA. Of relevance here, the GAO report recommended that FDA develop a strategy to minimize the potential for conflicts of interest among GRAS panel members, including issuing guidance for companies on conflict of interest, and we requested comment on issuing such a guidance in our reopening notice (75 FR 81536 at 81542; December 28, 2010). In the GRAS final rule, we stated our intent to issue such guidance (see Response 125, 81 FR 54959 at 55026). This guidance recommends an assessment for conflict of interest and the appearance of conflict of interest as part of the best practices for convening a GRAS panel and would address the final outstanding GAO recommendation for FDA from the 2010 report.

The guidance document recommends specific content elements pertaining to recordkeeping and third-party disclosure. The guidance explains a recordkeeping recommendation for proponents to develop a one-time, written GRAS panel policy record describing how it will convene a panel. The proponent creates the written policy to fit its needs. The guidance document discusses a third-party disclosure recommendation for prospective panel members to provide vetting information to proponents, to ascertain expertise and reduce risk of bias. The guidance document also explains a recordkeeping recommendation for proponents to document the application of the GRAS panel policy to each GRAS panel member as part of the vetting process. Respondents do not submit to FDA the recordkeeping or third-party disclosure information.

The guidance will assist respondents convening a GRAS panel. The information collection recommendations (establishment of a written GRAS panel policy, solicitation of information from prospective GRAS panel members about potential conflicts of interest and other sources of bias, and documentation of the application of the GRAS panel policy to each GRAS panel member) would help the respondent to identify GRAS panel members who have appropriate and balanced expertise and reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel's output.

Description of Respondents: Respondents to this collection of information are persons (“proponents”) who are responsible for a conclusion that a substance may be used in food on the basis of the GRAS provision of the FD&C Act when such persons convene a GRAS panel to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. Respondents would also include members and prospective members of GRAS panels. We estimate that there are 1,260 such respondents as discussed more fully below. The term “GRAS panel” is defined as a panel of individuals convened for the purpose of evaluating whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in food.

In the Federal Register of November 16, 2017 (82 FR 53433), we published a draft guidance requesting public comment on the proposed collection of information. We received 13 comments with almost half being responsive to PRA topics. All comments were considered even if they were not fully captured by our paraphrasing in this document. Most comments communicated general support for the information collection. Comments articulated that the guidance would promote uniformity of practices for industry and mitigate potential conflicts and biases. One comment expressed that the recommendations for preparing a GRAS panel policy are not unusual or burdensome to proponents, although another comment believed that establishment and implementation of a written GRAS panel policy would be burdensome. However, the comment recognized that the proponent drafts the written policy, which allows the proponent to tailor the policy to itself and make the policy broad enough to cover the wide range of issues it may encounter. The comment further stated that many in industry already employ policies and procedures recommended in the guidance. Another comment believed that the time estimates to perform the information collections are reasonable. No other comments were received disputing the need for the information, the accuracy of our burden estimate, or ways to minimize burden. Although we are preparing to finalize the guidance document to clarify discussions around evaluating and managing conflicts of interest and appearance issues, to emphasize that a GRAS panel is not necessary, and providing additional background information regarding the value of a GRAS panel in providing evidence to support the “general acceptance” aspect of the criteria for eligibility for GRAS status through scientific procedures, none of the revisions pertain to the information collection recommendations discussed in our 60-day notice.

Since the publication of the 60-day notice, we have further considered the burden estimate and adjusted it based on updated information available to us from FDA's GRAS Notices Inventory and the Independent GRAS Conclusion Inventory Database (Refs. 1, 2, and 3).

The records recommended in the guidance to be maintained by a proponent include a one-time information collection burden pertaining to a written GRAS panel policy to govern the assembly and conduct of a GRAS panel. The records recommended in the guidance also include annual information collection burdens pertaining to documenting the application of the written GRAS panel policy to each member of a GRAS panel convened in a given year and collecting information from prospective members of the GRAS panel to conduct the vetting process as detailed in the written GRAS panel policy. Finally, the guidance recommends that a GRAS panel provides a written report of its findings; however, we consider a written GRAS panel report as customary business practice that is already being created by GRAS panels and, thus, we do not estimate an annual information collection burden for the creation of a GRAS panel report.

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

For the purpose of this analysis, we make the conservative assumption that all proponents who document a GRAS conclusion will create a written GRAS panel policy that would apply to GRAS panels convened in the first year that the final guidance would be in effect, as well as to GRAS panels convened in subsequent years. We also assume that these proponents will create a written GRAS panel policy regardless of whether they report the panel's documented GRAS conclusion to FDA in the form of a GRAS notice. Therefore, for the purpose of this analysis we: (1) calculated the number of proponents who have submitted at least one GRAS notice to FDA and (2) estimated the number of proponents who have documented at least one GRAS conclusion without reporting that documented GRAS conclusion to FDA in the form of a GRAS notice.

Using the data in our inventories of GRAS notices submitted for substances intended for use in human food (Ref. 1) and animal food (Ref. 2) during the time period of April 17, 1997, through October 2, 2020, we calculate that 466 proponents submitted at least one GRAS notice for a substance intended for use in human food, and 20 proponents submitted at least one GRAS notice for a substance intended for use in animal food. For the purpose of this analysis, we make the conservative assumption that there will be no overlap between proponents who submit GRAS notices for substances intended for use in human food and proponents who submit GRAS notices for substances intended for use in animal food. Therefore, the total number of proponents who have submitted at least one GRAS notice to FDA is 486 (466 human food proponents + 20 animal food proponents).

We have very little information about the number of proponents who have documented a GRAS conclusion without reporting that GRAS conclusion to FDA in the form of a GRAS notice. To estimate the number of such proponents, we used a publicly available database entitled “Independent GRAS (Generally Recognized As Safe) Conclusion Inventory Database” (Ref. 3), which is a compilation of the results of a consulting company's search of publicly available information in industry trade journals about documented GRAS conclusions for substances intended for use in human food. The oldest entry is for the year 1995. We received the first GRAS notice for substances intended for use in human food in 1998 and, thus, the database covers the entire timeframe during which FDA has been receiving GRAS notices for substances intended for use in human food. As of October 2, 2020, that database recorded that there had been a total of 213 documented GRAS conclusions, with 41 of those documented GRAS conclusions reported to FDA as a GRAS notice and 172 of those documented GRAS conclusions not reported to FDA as a GRAS notice. In contrast, as of October 2, 2020, FDA's inventory of GRAS notices shows that the number of GRAS conclusions reported to FDA during this timeframe was 937, not 41 (Ref. 1). We assume that the reduced number of documented GRAS conclusions that the database recorded as being reported to FDA is due to the mechanism by which the database searches for documented GRAS conclusions ( i.e., publications in industry trade journals). For example, there could be less incentive for a business that reports its documented GRAS conclusion to FDA to publicize that GRAS conclusion through industry trade journals, because the business can publicize FDA's response to the GRAS notice in other ways.

The database attributes the 172 documented GRAS conclusions not reported to FDA to 146 different proponents. However, 62 of these proponents have also submitted a GRAS notice to FDA and, thus, we calculate that the database attributes documented GRAS conclusions to 84 proponents who have not submitted a GRAS notice to FDA (146 proponents listed in the database—62 proponents whom we already counted because they submitted a GRAS notice to FDA). We also make the conservative assumption that the number of proponents who have documented GRAS conclusions without reporting them to FDA since FDA began receiving GRAS notices is twice as high as recorded in the database— i.e., 168 proponents (84 proponents listed in the database × 2).

The publicly available database does not record documented GRAS conclusions for substances intended for use in animal food. In the burden estimate for the approved information collection “Substances Generally Recognized as Safe: Notification Procedure” (OMB control number 0910-0342), we estimated that 100 GRAS notices would be submitted to FDA for substances intended for use in human food and that 25 GRAS notices will be submitted to FDA for substances intended for use in animal food (86 FR 64943; November 19, 2021). For the purpose of our current analysis, we use that 25 percent ratio to estimate that the number of proponents who have documented GRAS conclusions for substances intended for use in animal food without reporting those GRAS conclusions to FDA is 25 percent of the number of proponents who documented GRAS conclusions for substances intended for use in human food without reporting those GRAS conclusions to FDA— i.e., 42 proponents (168 estimated proponents who have documented GRAS conclusions without reporting those GRAS conclusions to FDA × 0.25). We estimate that the total number of proponents who documented GRAS conclusions without reporting those GRAS conclusions to FDA is 210 proponents (168 estimated proponents who have documented GRAS conclusions for substances intended for use in human food + 42 estimated proponents who have documented GRAS conclusions for substances intended for use in animal food).

To estimate the total number of proponents, we are adding 210 estimated proponents who have not reported their documented GRAS conclusions to FDA to the 486 proponents who have already submitted at least one GRAS notice to FDA for a total of 696 proponents who will document a GRAS conclusion (210 non-reporting proponents + 486 reporting proponents). As already stated, for the purpose of this analysis we make the conservative assumption that all of these proponents who document GRAS conclusions ( i.e., 696 proponents) will create a written GRAS panel policy. We estimate that it will take 40 hours to create a written GRAS panel policy, including 8 hours to review relevant, publicly available policies that address conflict of interest and 32 hours to tailor a GRAS panel policy specific to the proponent, using relevant information from such existing policies as appropriate to the needs of the proponent. As shown in table 1, the total one-time burden to create a written GRAS panel policy is 40 hours per proponent × 696 proponents = 27,840 hours.

Based on the number of annual GRAS notices submitted to FDA in recent years, we previously estimated that 100 GRAS notices will be submitted to FDA for substances intended for use in human food and that 25 GRAS notices will be submitted to FDA for substances intended for use in animal food (OMB control number 0910-0342; 86 FR 64943), for a total number of 125 GRAS notices submitted to FDA each year. We count each GRAS notice as a single GRAS conclusion, and, for the purpose of our analysis, we assume that a different proponent submits each of these GRAS notices. Therefore, we estimate that the total number of documented GRAS conclusions submitted to FDA on an annual basis is 125 GRAS conclusions and that these GRAS conclusions are submitted by 125 proponents.

We have not previously estimated the annual number of documented GRAS conclusions that are not reported to FDA as a GRAS notice. To estimate such GRAS conclusions, we used the same database (Ref. 3) that we used to estimate the total number of proponents who document GRAS conclusions without reporting the GRAS conclusions to FDA in the form of a GRAS notice. As already stated, the oldest recorded entry in the database is for the year 1995. However, with the exception of that single entry for 1995, the remaining entries are for the years 2001 and beyond. Therefore, we use 20 years ( i.e., from 2001 through 2020) as the number of years covering those documented GRAS conclusions that are not reported to FDA. For the purpose of calculating the annual number of documented GRAS conclusions that are for substances intended for use in human food and are not reported to FDA, we estimate that there are 171 such GRAS conclusions (172 documented, unreported GRAS conclusions for substances intended for use in human food minus 1 GRAS conclusion reported before 2001). We calculate that, on average, the annual number of documented, unreported GRAS conclusions for substances intended for use in human food and recorded in the database is 9 (171 documented, unreported GRAS conclusions/20 years = 8.55 documented, unreported GRAS conclusions per year recorded in the database, rounded up to 9). As with our analysis of the total number of proponents, we conservatively assume that the annual number of documented, unreported GRAS conclusions for substances intended for use in human food could be twice as high as the annual number of documented, unreported GRAS conclusions recorded in the database— i.e., 18 documented, unreported GRAS conclusions for substances intended for use in human food each year (9 documented, unreported GRAS conclusions recorded in the database on an annual basis × 2). As with documented GRAS conclusions that are reported to FDA, we assume that a different proponent is responsible for each documented GRAS conclusion not reported to FDA and, thus, on an annual basis there are 18 proponents who do not report their documented GRAS conclusions for substances intended for use in human food to FDA. We previously estimated that 100 GRAS notices will be submitted to FDA for substances intended for use in human food and that 25 GRAS notices will be submitted to FDA for substances intended for use in animal food (OMB control number 0910-0342; 84 FR 29216). Using that ratio, we conservatively assume that the annual number of documented, unreported GRAS conclusions for substances intended for use in animal food is 25 percent of the annual number of documented, unreported GRAS conclusions for substances intended for use in human food— i.e., 5 documented, unreported GRAS conclusions for substances intended for use in animal food on an annual basis (18 documented, unreported GRAS conclusions for substances intended for use in human food × 0.25 = 4.5, rounded up to 5). We also calculate that there are a total of 23 documented, unreported GRAS conclusions each year (18 documented, unreported GRAS conclusions for substances intended for use in human food + 5 documented, unreported GRAS conclusions for substances intended for use in animal food). We therefore calculate that there are 148 proponents who document a GRAS conclusion on an annual basis (125 proponents who submit their documented GRAS conclusions to FDA in a GRAS notice + 23 proponents who do not submit their documented GRAS conclusions to FDA in a GRAS notice).

We have information about the percentage of proponents who convene a GRAS panel for a documented GRAS conclusion and also submit a GRAS notice to FDA. During the time period April 17, 1997, through October 2, 2020, on average, 57 percent of proponents who submitted a GRAS notice for a substance intended for use in human food, and 55 percent of proponents who submitted a GRAS notice for a substance intended for use in animal food, convened a GRAS panel. We therefore estimate that, on an annual basis, 57 proponents will convene a GRAS panel and submit a GRAS notice to FDA for substances intended for use in human food (57 percent × 100 proponents), and 14 proponents will convene a GRAS panel and submit a GRAS notice to FDA for substances intended for use in animal food (55 percent × 25 proponents). We calculate that the total number of proponents who will convene a GRAS panel and submit a GRAS notice to FDA is 71 proponents (57 human food proponents + 14 animal food proponents). We also assume that all proponents will document the application of a written GRAS panel policy to each member of the GRAS panel.

We have very little information about the percentage of proponents who convene a GRAS panel for a documented GRAS conclusion but do not report their documented GRAS conclusions to FDA in a GRAS notice. For the purpose of this analysis, we make the conservative assumption that all 23 proponents who annually document GRAS conclusions without reporting them to FDA will convene a GRAS panel. Taking into account the estimated number of proponents who convene a GRAS panel and submit a GRAS notice to FDA, and the estimated number of proponents who convene a GRAS panel but do not submit a GRAS notice to FDA, we calculate that the total number of proponents who will convene a GRAS panel and document the application of the written GRAS panel policy to each member of a GRAS panel on an annual basis is 94 proponents (71 proponents who submit GRAS notices to FDA + 23 proponents who do not submit GRAS notices).

Based on the recommendations in the guidance, we assume that all GRAS panels will include at least 3 panel members and that some GRAS panels will include as many as 6 panel members. We assume that a GRAS panel will include 5 panel members on average. We also assume that the proponent will reject at least one individual with applicable expertise due to a conflict of interest and, thus, that 94 proponents will document the application of the written GRAS panel policy to 6 individual GRAS panel members, for a total of 564 documentations of the application of the written GRAS panel policy (94 proponents × 6 panel members). As shown in table 2, we estimate that it will take the proponent 16 hours to document the application of the written GRAS policy to each panel member, for a total of 9,024 hours (564 documentations × 16 hours).

As shown in table 3, we assume that all 564 individuals who are being considered as members of a GRAS panel will each need 4 hours to provide information related to the panel selection and vetting process to the proponent, as detailed in the written GRAS panel policy, for a total of 2,256 hours (564 individuals × 4 hours).

FDA plans to consolidate this collection with OMB control number 0910-0342, “Substances Generally Recognized as Safe: Notification Procedure” which contains the regulatory procedures under which a person may notify FDA about a conclusion that a substance is GRAS under the conditions of its intended use in human and/or animal food and includes a standard format for the submission of a GRAS notice. The revision will add 39,120 burden hours and 1,260 respondents.

This guidance also refers to previously approved FDA collections of information. The collections of information in 21 CFR parts 170 and 570 have been approved under OMB control number 0910-0342.

The following references are on display with 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 are also available electronically at https://www.regulations.gov. 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.

In connection with the seventh iteration of PDUFA, FDA committed to conduct a pilot program to advance rare disease drug development programs by providing a mechanism for sponsors to collaborate with FDA throughout the efficacy endpoint development process (see “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027,” section I.K.4.a, https://www.fda.gov/media/151712/download ).

FDA is announcing this pilot program to satisfy the above-mentioned commitment. The goals of the early meeting discussions granted under this program are to provide advice on how a proposed novel endpoint can be used in a specific rare disease drug development program and to promote innovation by allowing FDA to publicly present the proposed novel endpoints (or natural history studies in which the proposed endpoint is intended to be studied) considered through the program, including novel endpoints for drugs or biological products that have not yet been approved or licensed by FDA for a given indication. FDA has committed to accepting a limited number of qualified proposals for admission into the RDEA Pilot Program that increases after the first year of PDUFA VII. For FY 2023, sponsors may submit RDEA proposals beginning in the fourth quarter, and FDA will accept a maximum of one proposal. For FYs 2024 through 2027, FDA will accept up to one RDEA proposal per quarter with a maximum of three proposals per year.

Complete RDEA proposals may be submitted throughout the quarter on a rolling basis; however, only those received by the quarterly closing date, which will be the last day of each quarter of the fiscal year ( i.e., December 31, March 31, June 30, September 30), will be considered for selection in the following quarter. Within 60 days after the quarterly closing date, FDA will review the RDEA proposals, select a proposal to proceed to disclosure discussions, and notify sponsors of their proposal status. When FDA and the sponsor agree on the information that FDA may share publicly, FDA will notify the sponsor of admission into the program.

Sponsors admitted to the RDEA Pilot Program may participate in up to four focused meetings with relevant FDA staff to discuss endpoint development. FDA's advice provided during and between RDEA meetings does not constitute a regulatory decision and is considered nonbinding. Being admitted into the RDEA Pilot Program and completing four RDEA meetings does not guarantee approval for a regulatory submission that includes efficacy endpoints discussed during RDEA meetings. Likewise, being denied admission into the RDEA Pilot Program does not mean that the proposed novel endpoint is unacceptable for regulatory decision making.

After completion of four RDEA meetings, the sponsor can request additional input on their novel endpoint from FDA, as needed, through other formal meeting mechanisms, such as Type B, Type C, Type C Surrogate Endpoint, or Type D meetings. Sponsors that do not participate in the RDEA Pilot Program will have an opportunity to interact with the Agency through traditional channels.

The listed eligibility and selection factors outlined in this notice reflect the current thinking at the time of publication. Information about the process for applying to and participating in the RDEA pilot meeting program will be communicated on the following web page: https://www.fda.gov/drugs/development-resources/rare-disease-endpoint-advancement-pilot-program.

The RDEA Pilot Program will be jointly administered by the following Centers:

• CDER: CDER's Rare Diseases Team, in the Office of New Drugs, Division of Rare Diseases and Medical Genetics, which is the point of contact for RDEA Pilot Program communications for CDER products.

• CBER: CBER's Rare Disease Liaison, in the Office of the Director, Policy Staff, which is the point of contact for RDEA Pilot Program communications for CBER products.

To be eligible for the RDEA Pilot Program:

• The associated development program should be active and address a rare disease, with an active investigational new drug application (IND) or pre-IND for the rare disease.

○ Sponsors that do not yet have an active development program but have, or are initiating, a natural history study where the proposed endpoint is intended to be studied are also eligible to apply.

○ FDA may also consider accepting a proposal for a development program for a common disease that includes innovative or novel endpoint elements, including the specific endpoint and/or the methodology being developed if there is sufficient justification that the proposal could be applicable to a rare disease.

• The proposed endpoint is a novel efficacy endpoint intended to establish substantial evidence of effectiveness for a rare disease treatment. An endpoint is considered novel if it has never been used to support drug approval or if it has been substantially modified from previous use to support drug approval.

Preference will be given to proposals:

• That have the potential to impact drug development more broadly, such as one that uses a novel approach to develop an efficacy endpoint or an endpoint that could potentially be relevant to other diseases.

• That collectively reflect a range of different types of endpoints.

• That have novel approaches for collecting additional clinical data in the premarket stage to advance validation of the endpoint for a surrogate endpoint proposal. If the sponsor is proposing to develop a surrogate endpoint as part of a rare disease application, participation in a prior Type C Surrogate Endpoint meeting is encouraged.

To promote innovation in this area, novel efficacy endpoints developed through the RDEA Pilot Program may be presented by FDA ( e.g., in a guidance, at public workshops and conferences, or on FDA's website) as case studies, including while the drug studied in the trial has not yet been approved by FDA. Accordingly, before FDA grants the initial meeting under the program, FDA and the sponsor must agree on the information that FDA may include in these public case studies. The specific information to be disclosed will depend on the content of each novel efficacy endpoint and associated natural history study if applicable. FDA intends to focus on information that is beneficial to advancing efficacy endpoint development for drugs that treat rare diseases and those elements relevant to understanding the novel efficacy endpoint and its potential use in a clinical trial intended to support regulatory approval.

Sponsors wishing to participate in the program should identify aspects of the proposed novel endpoint and associated natural history, if applicable, that they consider nondisclosable and provide a rationale for withholding the information. Participation in the program, including any agreement on information disclosure, will be voluntary and at the discretion of the sponsor. Sponsors that do not wish to make such disclosures may seek regulatory input through other existing channels.

While this notice contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required for this notice. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 for INDs and clinical trials have been approved under OMB control number 0910-0014. The collections of information in 21 CFR part 601 for biologic new drug applications (NDAs) have been approved under OMB control number 0910-0338. The collections of information in 21 CFR part 314 for the submission of NDAs and for requesting meetings with FDA about drug development programs have been approved under OMB control number 0910-0001. The collections of information relating to rare disease drug and biological product development programs have been approved under OMB control number 0910-0765.

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

Section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360m), directs FDA to accredit persons in the private sector to review certain premarket notifications (510(k)s; see 21 U.S.C. 360(k)). Participation in the 510(k) third-party (3P510k) review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer's 510(k) submission for selected devices. After reviewing a submission, the reviewer will forward a copy of the 510(k) submission, along with the reviewer's documented review and recommendation, to FDA. Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually 3 years.

Respondents to this information collection are businesses or government, and can be for-profit or not-for-profit organizations.

The guidance “510(k) Third-Party Review Program, Guidance for Industry, Food and Drug Administration Staff and Third Party Review Organizations” (March 2020) ( https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program ) is intended to provide a comprehensive look into FDA's current thinking regarding the 3P510k review program. This guidance document also reflects section 523 of the FD&C Act, which directs FDA to issue guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person. The 3P510k review program is intended to allow review of devices by third-party 510k review organizations (3PROs) to provide manufacturers of these devices an alternative review process that allows FDA to best utilize our resources on higher risk devices.

In the Federal Register of June 24, 2022 (87 FR 37863), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although four comments were received, they were not responsive to the four collection of information topics solicited.

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

510(k) reviews: The 3PROs should retain copies of all 510(k) reviews and associated correspondence. Based on FDA's recent experience with this program, we estimate the number of 510(k)s submitted for 3P510k review to be 126 annually; approximately 14 annual reviews for each of the 9 3PROs. We estimate the average burden per recordkeeping to be 10 hours.

Records regarding qualifications to receive FDA recognition as a 3PRO: Under section 704(f) of the FD&C Act (21 U.S.C. 374(f)), a 3PRO must maintain records that support their initial and continuing qualifications to receive FDA recognition, including documentation of the training and qualifications of the 3PRO and its personnel; the procedures used by the 3P510k review organization for handling confidential information; the compensation arrangements made by the 3PRO; and the procedures used by the 3PRO to identify and avoid conflicts of interest. Additionally, the guidance states that 3PROs should retain information on the identity and qualifications of all personnel who contributed to the technical review of each 510(k) submission and other relevant records. Because most of the burden of compiling the records is expressed in the reporting burden for requests for accreditation, we estimate the maintenance of such records to be 1 hour per recordkeeping annually.

Recordkeeping system regarding complaints: Section 523(b)(3)(F)(iv) of the FD&C Act requires 3PROs to agree in writing that they will promptly respond and attempt to resolve complaints regarding their activities. The guidance recommends that 3PROs establish a recordkeeping system for tracking the submission of those complaints and how those complaints were resolved, or attempted to be resolved. Based on our experience with the program and the recommendations in the guidance, we estimate the average burden per recordkeeping to be 2 hours annually.

Based on our experience with the program since our last request for OMB approval, we have adjusted our burden estimate, which has resulted in a decrease to the currently approved burden.

When submitting comments or requesting information, please include the information collection request title for reference.

Information Collection Request Title: Evaluation of the Maternal and Child Health Bureau Pediatric Mental Health Care Access Program and the Screening and Treatment for Maternal Depression and Related Behavioral Disorders Program, OMB No. 0906-xxxx-New.

Abstract: This notice describes information collection requests for two of HRSA's Maternal and Child Health programs: the Pediatric Mental Health Care Access (PMHCA) program and the Screening and Treatment for Maternal Depression and Related Behavioral Disorders (MDRBD) program. Both of these programs aim to increase identification of behavioral health conditions by providing support for screening of specified populations ( e.g., children, adolescents, young adults, and pregnant and postpartum women, especially those living in rural, isolated, and/or underserved areas); providing clinical behavioral health consultation, care coordination support ( i.e., communication/collaboration, accessing resources, referral services), and training to health professionals (HP);  1 and increasing access to clinical interventions, including by telehealth. HP education and training will support the knowledge and skills acquisition needed to accomplish this goal.

The information will be collected with recipients of awards that were issued in 2018 (PMHCA and MDRBD), 2019 (PMHCA), and 2021 (PMHCA). The 2018, 2019, and 2021 PMHCA programs are authorized by 42 U.S.C § 254c-19 (§ 330M of the Public Health Service Act), using Section 2712 of the American Rescue Plan Act of 2021 (P.L. 117-2) for 2021 awardees. The 2018 MDRBD program is authorized by 42 U.S.C. 247b-13a (§ 317L-1 of the Public Health Service Act). To evaluate progress made toward the programs' goals, this data collection will use eight instruments: the HP Survey, Practice-Level Survey, Program Implementation Survey, Program Implementation Semi-Structured Interview (SSI), Champion SSI, Champion Focus Group Discussion (FGD), Community Resources SSI, and Care Coordinator SSI.

A 60-day Notice published in the Federal Register , Vol. 87, No. 127, FR pp. 39841-42 (July 5, 2022). There was one public comment.

Need and Proposed Use of the Information: HRSA needs this information to evaluate the PMHCA and MDRBD programs and guide future policy decisions regarding increasing HPs' capacity to address patients' behavioral health and access to behavioral health services. Specifically, data collected for the evaluation will be used to study the efforts of awardee programs to achieve key awardee outcomes ( e.g., increase in access to behavioral health services; health professionals trained; available community-based resources, including counselors or family service providers) and to measure whether and to what extent awardee programs are associated with changes in these outcomes. The evaluation will also examine changes over time, within a state, political subdivision of a state, Indian tribe, or tribal organization, and/or across the PMHCA and MDRBD programs, with regard to (1) enrolled health professionals/practices related to screening, referral, and care coordination support for behavioral health conditions; (2) provision of behavioral health services for mental illness and substance use in primary care settings; (3) use of consultative services; and (4) provision of access to behavioral health services for mental illness and substance use.

Likely Respondents: Likely respondents include:

• HP Surveys (2021 PMHCA only) : Pediatricians, family physicians, physician assistants, advanced practice nurses/nurse practitioners, licensed practical nurses, registered nurses, counselors, social workers, medical assistants, patient care navigators.

• Practice-Level Surveys (2021 PMHCA only): Practice managers ( e.g., office managers, office leadership, nurse champions).

• Program Implementation Survey and SSI (2021 PMHCA only): 2021 PMHCA cooperative agreement-funded project directors/principal investigators.

• Champion SSI or FGD (all awardees): PMHCA and MDRBD program champions, who may include HPs, community and social service specialists, and others.

• Community Resources SSI (all awardees): PMHCA and MDRBD program-level community resource partner representatives, who may include counselors, social workers, other community and social service specialists, other HPs/support workers ( e.g., patient care navigators, medical assistants), and practice/organization managers.

• Care Coordinator SSI (all awardees): PMHCA and MDRBD program-level care coordinators.

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

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. 3501 et seq., chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) the practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.

We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2022-0341], and must be received by November 28, 2022.

We encourage you to submit comments through the Federal eRulemaking Portal at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments to the Coast Guard will be posted without change to https://www.regulations.gov and will include any personal information you have provided. For more about privacy and submissions to the Coast Guard in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020). For more about privacy and submissions to OIRA in response to this document, see the https://www.reginfo.gov, comment-submission web page. OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625-0104.

This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (87 FR 44415, July 26, 2022) required by 44 U.S.C. 3506(c)(2). That notice elicited no comments. Accordingly, no changes have been made to the Collection.

Title: Barges Carrying Bulk Hazardous Materials.

OMB Control Number: 1625-0104.

Summary: This information is needed to ensure the safe shipment of bulk hazardous liquids in barges. The requirements are necessary to ensure that barges meet safety standards and to ensure that barge's crewmembers have the information necessary to operate barges safely.

Need: 46 U.S.C. 3703 authorizes the Coast Guard to prescribe rules related to the carriage of liquid bulk dangerous cargoes. 46 CFR 151 prescribes rules for barges carrying bulk liquid hazardous materials.

Forms: N/A.

Respondents: Owners and operators of tank barges.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden has increased from 24,752 hours a year to 27,262 hours, due to an increase in the estimated annual number of respondents.

Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. et seq., chapter 35, as amended.

This notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. 3501 et seq., chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) the practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.

We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2022-0343], and must be received by November 28, 2022].

We encourage you to submit comments through the Federal eRulemaking Portal at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments to the Coast Guard will be posted without change to https://www.regulations.gov and will include any personal information you have provided. For more about privacy and submissions to the Coast Guard in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020). For more about privacy and submissions to OIRA in response to this document, see the https://www.reginfo.gov, comment-submission web page. OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625-0126.

This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (87 FR 44413, July 26, 2022) required by 44 U.S.C. 3506(c)(2). That notice elicited no comments. Accordingly, no changes have been made to the Collection.

Title: Requirements for Vessels that Perform Certain Aquaculture Support Operations.

OMB Control Number: 1625-0126.

Summary: This information is required to ensure that a vessel engaged in certain aquaculture operations has applied for and received a waiver in accordance with 46 U.S.C. 12102(d)(1). A vessel owner or operator must notify Coast Guard and provide a copy of the waiver.

Need: The Coast Guard regulations are prescribed 46 CFR part 106. The Coast Guard uses the information in this collection to ensure compliance with the requirements.

Forms: None.

Respondents: Owners and operators of aquaculture operations.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden has increased from 2 hours to 3 hours a year, due to an increase in the estimated annual number of responses.

Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. et seq., chapter 35, as amended.

This notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. 3501 et seq., chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) the practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.

We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2022-0342], and must be received by November 28, 2022.

We encourage you to submit comments through the Federal eRulemaking Portal at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments to the Coast Guard will be posted without change to https://www.regulations.gov and will include any personal information you have provided. For more about privacy and submissions to the Coast Guard in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020). For more about privacy and submissions to OIRA in response to this document, see the https://www.reginfo.gov, comment-submission web page. OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625-0105.

This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (87 FR 44414, July 26, 2022) required by 44 U.S.C. 3506(c)(2). That notice elicited no comments. Accordingly, no changes have been made to the Collection.

Title: Regulated Navigation Area; Reporting Requirements for Barges Loaded with Certain Dangerous Cargoes, Inland Rivers, Eighth Coast Guard District and the Illinois Waterway, Ninth Coast Guard District.

OMB Control Number: 1625-0105.

Summary: The Coast Guard requires position and intended movement reporting, and fleeting operations reporting, from barges carrying certain dangerous cargoes (CDCs) in the inland rivers within the Eighth and Ninth Coast Guard Districts. The reporting requirements are found in 33 CFR 165.830 and 165.921.

Need: This information is used to ensure port safety and security and to ensure the uninterrupted flow of commerce.

Forms: N/A.

Respondents: Owners, agents, masters, towing vessel operators, or persons in charge of barges loaded with CDCs or having CDC residue operating on the inland rivers located within the Eighth and Ninth Coast Guard Districts.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden remains 4 hours a year.

Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. et seq., chapter 35, as amended.

CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). This proposed information collection was previously published in the Federal Register (87 FR 39107) on June 30, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) 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) 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) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.

Title: Exportation of Used Self-Propelled Vehicles.

OMB Number: 1651-0054.

Form Number: N/A.

Current Actions: CBP proposes to extend the expiration date of this information collection with a change to the collection and a decrease in burden.

Type of Review: Extension (with change).

Affected Public: Individuals and Businesses.

Abstract: U.S. Customs and Border Protection (CBP) regulations require a person attempting to export a used self-propelled vehicle to furnish documentation to CBP at the port of export. Exportation of a vehicle is permitted only upon compliance with these requirements. The required documentation includes, but is not limited to, a Certificate of Title or a Salvage Title, the Vehicle Identification Number (VIN), a Manufacturer's Statement of Origin, etc. CBP will accept originals or certified copies of the Certificate of Title. The purpose of this information is to help ensure that stolen vehicles or vehicles associated with other criminal activity are not exported.

Collection of this information is authorized by 19 U.S.C. 1627a, which provides CBP with authority to impose export reporting requirements on all used self-propelled vehicles. It is also authorized by Title IV, Section 401 of the Anti-Car Theft Act of 1992, 19 U.S.C. 1646c, which requires all persons exporting a used self-propelled vehicle to provide to CBP, at least 72 hours prior to export, the VIN and proof of ownership of each automobile. This information collection is provided for by 19 CFR part 192. Further guidance regarding these requirements is provided at: https://www.cbp.gov/trade/basic-import-export/export-docs/motor-vehicle.

New Change: Respondents are now able to submit supporting documentation through the Document Image System (DIS).

Type of Information Collection: Exportation of Self-Propelled Vehicles.

Estimated Number of Respondents: 750,000.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Number of Total Annual Responses: 750,000.

Estimated Time per Response: 5 minutes.

Estimated Total Annual Burden Hours: 62,500.

CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). This proposed information collection was previously published in the Federal Register (87 FR 37882) on June 24, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) 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) 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) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.

Title: Declaration for Free Entry of Unaccompanied Articles.

OMB Number: 1651-0014.

Form Number: CBP Form 3299.

Current Actions: This submission is being made to extend the expiration date with no changes to the burden hours or to the information being collected.

Type of Review: Extension (without change).

Affected Public: Businesses and individuals.

Abstract: 19 U.S.C. 1498 provides that when personal and household effects enter the United States but do not accompany the owner or importer on his/her arrival in the country, a declaration is made on CBP Form 3299, Declaration for Free Entry of Unaccompanied Articles. The information on this form is needed to support a claim for duty-free entry for these effects. This form is provided for by 19 CFR 148.6, 148.52, 148.53 and 148.77. CBP Form 3299 is accessible at: https://www.cbp.gov/document/forms/form-3299-declaration-free-entry-unaccompanied-articles?language_content_entity=en .

Type of Information Collection: Form 3299.

Estimated Number of Respondents: 150,000.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Number of Total Annual Responses: 150,000.

Estimated Time per Response: 45 minutes.

Estimated Total Annual Burden Hours: 112,500.

CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). This proposed information collection was previously published in the Federal Register (87 FR 39105) on June 30, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) 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) 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) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.

Title: User Fees.

OMB Number: 1651-0052.

Form Number: CBP Form 339A, 339C and 339V.

Current Actions: This submission is being made to extend the expiration date with a change to the annual burden hours previously reported. There is no change to the information collected.

Type of Review: Extension (with change).