Title: Bovine Spongiform Encephalopathy; Importation of Animals and Animal Products.

OMB Control Number: 0579-0393.

Type of Request: Extension of approval of an information collection.

Abstract: The Animal Health Protection Act (7 U.S.C. 8301 et seq. ) authorizes the Secretary of Agriculture to, among other things, prohibit or restrict the importation and interstate movement of animals and animal products into or through the United States to prevent the introduction and dissemination of animal diseases and pests.

To guard against the introduction of animal diseases, the Animal and Plant Health Inspection Service (APHIS) regulates the importation of animals and animal products into the United States. The regulations in 9 CFR parts 92, 93, 94, 95, and 96 govern the importation of certain animals, birds, poultry, meat, and other animal products and byproducts into the United States to prevent the introduction of various animal diseases, including bovine spongiform encephalopathy (BSE), a chronic degenerative disease that affects the central nervous system of cattle.

Section 92.5 of the regulations provides that all countries of the world are considered by APHIS to be in one of three BSE risk categories: Negligible risk, controlled risk, or undetermined risk. These risk categories are defined in §  92.1. Any region that is not classified by APHIS as presenting either negligible risk or controlled risk for BSE is considered to present an undetermined risk. Under the regulations, APHIS may classify a region for BSE in one of two ways. One way is for countries that have not received a risk classification from the World Organization for Animal Health (WOAH)  1 to request classification by APHIS. The other way is for APHIS to concur with the classification given to a country by WOAH.

To ensure BSE is not introduced into the United States, the regulations place specific conditions on the importation of animals and animal products. These requirements necessitate the use of several information collection activities, including, but not limited to, certifications, official identification, request for and retention of classification as negligible or controlled risk, declarations of importation, import and export certificates, applications, import and movement permits, agreements, certification statements, seals, notifications, and recordkeeping.

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

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

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

(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

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

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

Estimate of burden: The public burden for this collection of information is estimated to average 0.639 hours per response.

Respondents: Shippers, U.S. importers of regulated animal products, herd owners, salaried veterinarians of foreign regions, foreign exporters of processed animal protein and other regulated materials and products, accredited veterinarians, slaughter facility managers, and educators and researchers.

Estimated annual number of respondents: 150.

Estimated annual number of responses per respondent: 6,922.

Estimated annual number of responses: 1,038,336.

Estimated total annual burden on respondents: 663,778 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

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

The purpose of the meeting is to:

1. Hear from Title II project proponents and discuss Title II project proposals; and

2. Make funding recommendations on Title II projects.

The agenda will include time for individuals to make oral statements of three minutes or less. Individuals wishing to make an oral statement should make a request in writing at least three days prior to the meeting date to be scheduled on the agenda. Written comments may be submitted to the Forest Service up to 14 days after the meeting date listed under DATES .

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

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

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

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

The purpose of the meeting is to:

1. Approve meeting minutes;

2. Hear from Title II project proponents and discuss Title II project proposals;

3. Make funding recommendations on Title II projects; and

4. Schedule the next meeting.

The agenda will include time for individuals to make oral statements of three minutes or less. Individuals wishing to make an oral statement should make a request in writing at least three days prior to the meeting date to be scheduled on the agenda. Written comments may be submitted to the Forest Service up to 14 days after the meeting date listed under DATES .

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

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

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

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

The meeting agenda will include:

1. Board Member Presentations; and

2. Forest Plan Revision update.

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

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

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

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

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

Background: The Middle-Class Tax Relief and Job Creation Act of 2012 (codified at 47 U.S.C. 1401 et seq. ) (Act) established the FirstNet Authority as an independent authority within NTIA. The Act directs the FirstNet Authority to ensure the building, deployment, and operation of a nationwide interoperable public safety broadband network. The FirstNet Authority Board is responsible for making strategic decisions regarding the operations of the FirstNet Authority.

Matters to be Considered: The FirstNet Authority will post a detailed agenda for the Combined Board and Board Committees Meeting on FirstNet.gov prior to the meeting. The agenda topics are subject to change. Please note that the subjects discussed by the Board and Board Committees may involve commercial or financial information that is privileged or confidential, or other legal matters affecting the FirstNet Authority. As such, the Board may, by majority vote, close the meeting only for the time necessary to preserve the confidentiality of such information, pursuant to 47 U.S.C. 1424(e)(2).

Other Information: The public Combined Board and Board Committees Meeting is accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Janell Smith at (202) 257-5929 or email: Janell.Smith@FirstNet.gov at least five (5) business days (August 16) before the meeting.

Records: The FirstNet Authority maintains records of all Board proceedings. Minutes of the Combined Board and Board Committees Meeting will be available on FirstNet.gov.

Status: The meeting will be open to public participation with a public comment period on Sunday, September 10 at 8:40 a.m. The Board expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of three (3) minutes. Written comments should be received by Ms. Donna Brown by Thursday, August 31, 2023 to provide sufficient time for Board review. Written comments received after the deadline will be distributed to the Board, but may not be reviewed prior to the meeting date.

Special Accommodations: The Board meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Ms. Donna Brown by Thursday, August 31, 2023.

The Board, which consists of a balanced representation from academia, industry, state government and citizens groups, was established in 1976 by section 209 of the Sea Grant Improvement Act (Pub. L. 94-461, 33 U.S.C. 1128). The Board advises the Secretary of Commerce and the Director of the National Sea Grant College Program with respect to operations under the Act, and such other matters as the Secretary refers to them for review and advice.

Matters To Be Considered: Board members will discuss and vote on new membership for the Board's Executive Committee, Biennial Report to Congress Committee and Evaluation Committee, as well as discuss and vote on the Allocation Committee report: https://seagrant.noaa.gov/About/Advisory-Board.

Privacy Act Statement: Authority. The collection of information concerning nominations to the MCAM FAC is authorized under the FACA, as amended, 5 U.S.C. app. and its implementing regulations, 41 CFR part 102-3, and in accordance with the Privacy Act of 1974, as amended, (Privacy Act) 5 U.S.C. 552a. Purpose. The collection of names, contact information, resumes, professional information, and qualifications is required in order for the Under Secretary to appoint members to the MCAM FAC. Routine Uses. NOAA will use the nomination information for the purpose set forth above. The Privacy Act of 1974 authorizes disclosure of the information collected to NOAA staff for work-related purposes and for other purposes only as set forth in the Privacy Act and for routine uses published in the Privacy Act System of Records Notice COMMERCE/DEPT-11, Candidates for Membership, Members, and Former Members of Department of Commerce Advisory Committees, available at https://www.osec.doc.gov/opog/PrivacyAct/SORNs/dept-11.html, and the System of Records Notice COMMERCE/DEPT-18, Employees Personnel Files Not Covered by Notices of Other Agencies, available at https://www.osec.doc.gov/opog/PrivacyAct/SORNs/DEPT-18.html.

Disclosure: Furnishing the nomination information is voluntary; however, if the information is not provided, the individual would not be considered for appointment as a member of the MCAM FAC.

The Skate Advisory Panel will meet to receive a brief progress update on the 2023 management track stock assessment for skates. They will also receive a progress update on the development of Framework Adjustment 12 to the Northeast Skate Complex Fishery Management Plan (2024-2025 specifications and possession limits) and provide additional recommendations to the Skate Committee on the development of possession limit alternatives. The panel will make recommendations to the Committee for skate-related work in 2024. Other business will 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 Skate Committee will meet to receive Advisory Panel comments on a brief progress update on the 2023 management track stock assessment for skates. They will receive a progress update on the development of Framework Adjustment 12 to the Northeast Skate Complex Fishery Management Plan (2024-2025 specifications and possession limits) and provide additional recommendations to the Council on the development of possession limit alternatives. The Committee will make recommendations to the Council for skate-related work in 2024.

Other business will 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 Cate O'Keefe, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

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

The Pacific Pelagics Fishery Ecosystem Plan Team will meet on Monday, August 28, from 12:30 p.m. to 5 p.m. FIAC will meet on Wednesday, August 30, from 2 p.m. to 5 p.m.; American Samoa Archipelago FEP AP will meet on Wednesday, August 30, from 6 p.m. to 8 p.m.; the Education Committee will meet on Thursday, August 31, from 1 p.m. to 3 p.m.; Mariana Archipelago FEP Guam AP will meet on Thursday, August 31, from 6 p.m. to 8 p.m.; Mariana Archipelago CNMI AP will meet on Saturday, September 2, from 10 a.m. to 1 p.m.; and the Hawaii Archipelago FEP AP will meet on Friday, September 8, from 9 a.m. to 4 p.m.. All times listed are local island times.

Public Comment periods will be provided in the agendas. The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business.

These meetings are accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.

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 for the Alaska Subsistence Halibut Program.

The International Pacific Halibut Commission (IPHC) promulgates regulations governing the North Pacific halibut fishery under the Convention between the United States and Canada for the Preservation of the Halibut Fishery of the Northern Pacific Ocean and Bering Sea (Convention). The IPHC's regulations are subject to approval by the Secretary of State with the concurrence of the Secretary of Commerce. The Northern Pacific Halibut Act of 1982 (Halibut Act; 16 U.S.C. 773c(a)-(b)), provides the Secretary of Commerce with general responsibility for carrying out the Convention and the Halibut Act, including the authority to adopt regulations necessary to carry out the purposes and objectives of the Convention. The Halibut Act, 16 U.S.C. 773c(c), also provides the North Pacific Fishery Management Council (Council) with authority to develop regulations, including limited access regulations, that are in addition to, and not in conflict with, IPHC regulations.

Regulations the Council recommends may be implemented by NMFS only after approval by the Secretary of Commerce. The Council has exercised this authority in the development of subsistence halibut fishery management measures. NMFS has responsibility for managing the subsistence halibut fishery according to regulations approved by the Secretary. Regulations governing the subsistence halibut fishery are at 50 CFR 300.2, 300.4, and subpart E, and in the annual management measures published in the Federal Register pursuant to 50 CFR 300.62.

This information collection is necessary for NMFS to manage the Alaska Subsistence Halibut Program. Subsistence halibut means halibut caught by a rural resident or a member of an Alaska Native tribe for direct personal or family consumption as food, sharing for personal or family consumption as food, or customary trade. The Alaska Subsistence Halibut Program is intended to allow eligible persons to practice the long-term customary and traditional harvest of Pacific halibut for food in a non-commercial manner. This program provides NMFS the opportunity to enhance estimates of subsistence removals for stock assessment purposes.

Before fishing under subsistence halibut regulations, a Subsistence Halibut Registration Certificate (SHARC) must be obtained. This information collection contains the forms used by participants in the subsistence halibut fishery to apply for SHARCs, apply for special use permits, and submit harvest information for special use permits. This information collection contains two collections for which no forms are used: the appeals process for denied permits and marking subsistence setline fishing gear.

Information collected by the permit applications includes applicant information and depending on the permit type may include information on the educational program or a description of the cultural or ceremonial occasion the permit will be used for. NMFS uses this information to determine the eligibility of applicants to receive or renew permits.

The permit coordinators submit the harvest logs for Community Harvest Permits, Ceremonial Permits, and Educational Permits. Harvest logs collect identification information and harvest information for the subsistence fishermen fishing under that permit.

An appeals process is provided for an applicant who receives an adverse initial administrative determination related to their permit application.

Subsistence setline gear buoys must be marked with identification information that consists of the participant's name and address and an “S” to indicate subsistence halibut gear. This information is used by NMFS to link fishing gear to the vessel owner or operator and facilitate enforcement of regulations.

The information is collected primarily by mail, fax, and delivery. SHARC renewals may be submitted online through eFISH on the NMFS Alaska Region website. The applications and harvest logs are available as fillable pdfs on the NMFS Alaska Region website at https://www.fisheries.noaa.gov/permit/alaska-subsistence-halibut-fishery-applications-and-reporting-forms. The fishing gear identification information is painted on marker buoys and is not submitted to NMFS.

OMB Control Number: 0648-0512.

Form Number(s): None.

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

Affected Public: Individuals or households; State, local, or Tribal government.

Estimated Number of Respondents: 6,293.

Estimated Time per Response: Application for SHARC Rural Resident: 10 minutes; Application for SHARC Alaska Native Tribal Member: 10 minutes; Application for SHARC Alaska Native Tribe: 30 minutes; Subsistence Halibut Special Permits Application: 30 minutes; Harvest logs: 30 minutes; Ceremonial or Educational Permit Log: 2 hours; Appeal for permit denial: 4 hours; Gear marking: 15 minutes.

Estimated Total Annual Burden Hours: 1,340 hours.

Estimated Total Annual Cost to Public: $59,660 in recordkeeping and reporting costs.

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

Legal Authority: Northern Pacific Halibut Act of 1982 (16 U.S.C. 773c).

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

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

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

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.

The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.

On April 8, 2022, NMFS received a request from Atlantic Shores for an IHA to take marine mammals incidental to marine site characterization surveys offshore of New Jersey and New York, in the area of Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf Lease Area (OCS-A 0541) and the associated ECR area. Atlantic Shores requested authorization to take small numbers of 15 species of marine mammals by Level B harassment only. NMFS published a notice of the proposed IHA in the Federal Register on June 27, 2022 (87 FR 30867). After a 30-day public comment period and consideration of all public comments received, we subsequently issued the 2022 IHA, which is effective from August 10, 2022, to August 9, 2023 (87 FR 50293, August 16, 2022).

Atlantic Shores completed a subset of the survey work under the 2022 IHA. Atlantic Shores conducted the required marine mammal mitigation and monitoring and did not exceed authorized levels of take under previous IHAs issued for surveys offshore of New York and New Jersey (see 85 FR 21198, April 16, 2020 and 86 FR 21289, April 22, 2021). These previous monitoring results are available to the public on our website: https://www.fisheries.noaa.gov/action/incidental-take-authorization-atlantic-shores-offshore-wind-llc-marine-site-characterization.

On March 20, 2023, NMFS received a request from Atlantic Shores for an IHA to take marine mammals incidental to high-resolution geophysical (HRG) marine site characterization surveys offshore of New Jersey and New York in the areas of Bureau of Ocean Energy and Management (BOEM) Commercial Lease of Submerged Lands for Renewable Energy Development on the OCS Lease Area (OCS A-0541) and associated ECR area. Following NMFS' review of the application, Atlantic Shores submitted a revised request on April 7, 2023. The application (the 2023 request) was deemed adequate and complete on April 20, 2023. Atlantic Shores' request is for take of 15 species of marine mammals, by Level B harassment only. Neither Atlantic Shores nor NMFS expect serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.

The activities described in Atlantic Shores' request, the overall survey duration, the project location, and the acoustic sources planned for use are identical to what was previously analyzed in support of the IHA issued by NMFS to Atlantic Shores for 2022 site characterization surveys (2022 IHA) (87 FR 38067, June 27, 2022; 87 FR 50293, August 16, 2022). All mitigation, monitoring, and reporting requirements remain the same. While Atlantic Shores' planned activity would have qualified for renewal of the 2022 IHA, due to the availability of updated marine mammal density data ( https://seamap.env.duke .edu/models/Duke/EC/ ), which NMFS has determined represents the best available scientific data, NMFS determined to proceed with a new IHA process rather than a renewal, providing a 30-day period for the public to comment on this action.

The 2023 request is identical to the 2022 IHA. In evaluating the 2023 request and to the extent deemed appropriate, NMFS also relied on the information presented in notices associated with issuance of the 2022 IHA (87 FR 38067, June 27, 2022; 87 FR 50293, August 16, 2022).

No changes were made from the proposed IHA to the final IHA.

Atlantic Shores will conduct HRG marine site characterization surveys in the BOEM Lease Area OCS-A 0541 and along the export cable route (ECR) off of New Jersey and New York. The purpose of surveys is to obtain an assessment of seabed (geophysical, geotechnical, and geohazard), ecological, and archeological conditions within the footprint of a planned offshore wind facility development area. Surveys are also conducted to support engineering design and to map unexploded ordnance. As many as three survey vessels may operate concurrently as part of the planned surveys. During survey effort, the vessels would operate at a maximum speed of 3.5 knots (kn) (6.5 kilometers (km)). Underwater sound resulting from Atlantic Shores' activities has the potential to result in incidental take of marine mammals in the form of Level B harassment.

The planned activity is estimated to require up to 360 survey days using a maximum of three vessels operating concurrently over the course of the 1-year period of effectiveness of the IHA. It is expected that each vessel would cover approximately 55 km of track line per day based on Atlantic Shores' data acquisition efficiency expectations.

Underwater sound resulting from Atlantic Shores' survey activities during use of specific active acoustic sources has the potential to result in incidental take of marine mammals in the form of behavioral harassment (Level B harassment). Geophysical activities were discussed previously for the 2022 IHA NMFS issued to Atlantic Shores (87 FR 50293, August 16, 2022) and, as no new information has been presented that changed our determinations on these activities, this information will not be reiterated here. The mitigation, monitoring, and reporting measures are described in more detail later in this document (please see Description of Mitigation, Monitoring, and Reporting).

A detailed description of the planned surveys is provided in the Federal Register notice for the proposed IHA (88 FR 41912, June 28, 2023) and 2022 Federal Register notice (87 FR 50293, August 16, 2022). Since that time, no changes have been made to the planned activities. Therefore, a detailed description is not provided here. Please refer to those Federal Register notices for the description of the specific activity.

A notice of NMFS' proposal to issue an IHA to Atlantic Shores was published in the Federal Register on June 28, 2023 (88 FR 41912). That notice described, in detail, Atlantic Shores' proposed activities, the marine mammal species that may be affected by these activities, and the anticipated effects on marine mammals. We requested public input on the request for authorization described therein, our analyses, the proposed authorization, and requested that interested persons submit relevant information, suggestions, and comments.

NMFS received 19 public comment letters. Four of these comment letters were from non-governmental organizations: Clean Ocean Action (COA), Oceana, Sea Life Conservation (SLC), and Green Oceans. The remaining 15 comment letters were from private citizens. The majority of these expressed general opposition to issuance of the IHA or to the underlying associated activities, but without providing specific information relevant to NMFS' request for public comment. Seven of the letters from private citizens provided substantive comments that are addressed below.

We reiterate here that NMFS' action concerns only the authorization of marine mammal take incidental to the planned surveys—NMFS' authority under the MMPA does not extend to the surveys themselves or to wind energy development more generally. Many of the comments requested that NMFS not issue any IHAs related to wind energy development and/or expressed opposition for wind energy development generally without providing information relevant to NMFS' decision to authorize take incidental to Atlantic Shores' survey activities. We do not specifically address comments expressing general opposition to activities related to wind energy development or respond to comments not relevant to the scope of the proposed IHA (88 FR 41912, June 28, 2023), such as comments on other Federal agency processes and activities not authorized under this IHA ( e.g., seismic surveys, offshore wind construction, installation of wind turbines, other marine site characterization surveys).

All substantive comments and NMFS' responses are provided below, and all substantive comments are available on NMFS' website: https://www.fisheries.noaa.gov/permit/incidental-take-authorizations-under-marine-mammal-protection-act. Please see the comment letters for full details regarding the comments and associated rationale.

Comment 1: COA, SLC, and Green Oceans expressed concern regarding ocean noise and the interference it has on communication between whales. In addition, Green Oceans claimed that NMFS failed to “meaningfully consider” the potential for Atlantic Shores' HRG survey activities to mask marine mammal communication. Specifically, Green Oceans stated that the proposed IHA did not address how increasing ocean noise will impact masking of “interspecies cooperation and communication,” and their “survival,” as a result.

Response: NMFS agrees that noise pollution in marine waters is an issue with the potential to affect marine mammals, including their ability to communicate when noise reaches certain levels. NMFS disagrees that the potential impacts of masking were not properly considered. NMFS acknowledges our understanding of the scientific literature that Green Oceans cited but, fundamentally, the masking effects to any one individual whale from one survey are expected to be minimal. Masking is referred to as a chronic effect because one of the key harmful components of masking is its duration—the fact that an animal would have reduced ability to hear or interpret critical cues becomes much more likely to cause a problem the longer it is occurring. Also, inherent in the concept of masking is the fact that the potential for the effect is only present during the times that the animal and the source are in close enough proximity for the effect to occur (and further this time period would need to coincide with a time that the animal was utilizing sounds at the masked frequency) and, as our analysis (both quantitative and qualitative components) indicates, because of the relative movement of whales and vessels, we do not expect these exposures with the potential for masking to be of a long duration within a given day. Further, because of the relatively low density of mysticetes, and relatively large area over which the vessels travel, we do not expect any individual whales to be exposed to potentially masking levels from these surveys for more than a few days in a year.

As noted above, any masking effects of this survey are expected to be limited and brief, if present. Given the likelihood of significantly reduced received levels beyond even short distances from the survey vessel, combined with the short duration of potential masking and the lower likelihood of extensive additional contributors to background noise offshore within these short exposure periods, we believe that the incremental addition of the survey vessel is unlikely to result in more than minor and short-term masking effects, likely occurring to some small number of the same individuals captured in the estimate of behavioral harassment.

NMFS does not expect that the generally short-term, intermittent, and transitory marine site characterization survey activities planned by Atlantic Shores will create conditions of acute or chronic acoustic exposure leading to long-term physiological impacts in marine mammals. NMFS' prescribed mitigation measures are expected to further reduce the duration and intensity of acoustic exposure, while limiting the potential severity of any possible behavioral disruption.

Comment 2: Multiple commenters urged NMFS to deny the proposed project and/or postpone any offshore wind (OSW) activities until NMFS determines effects of all OSW activities on marine mammals in the region and determines that the recent whale deaths are not related to OSW activities. Similarly, some commenters provided general concerns regarding recent whale stranding events on the Atlantic Coast, including speculation that the strandings may be related to wind energy development-related activities and that Atlantic Shores' surveys could lead to marine mammal mortalities. However, the commenters did not provide any specific information supporting these concerns.

Response: NMFS authorizes take of marine mammals incidental to marine site characterization surveys but does not authorize the surveys themselves. Therefore, while NMFS has the authority to modify, suspend, or revoke an IHA if the IHA holder fails to abide by the conditions prescribed therein (including, but not limited to, failure to comply with monitoring or reporting requirements), or if NMFS determines that (1) the authorized taking is having or is likely to have more than a negligible impact on the species or stocks of affected marine mammals, or (2) the prescribed measures are likely not or are not effecting the least practicable adverse impact on the affected species or stocks and their habitat, it is not within NMFS' jurisdiction to impose a moratorium on offshore wind development or to require surveys to cease on the basis of unsupported speculation.

NMFS reiterates that there is no evidence that noise resulting from offshore wind development-related site characterization surveys could potentially cause marine mammal strandings, and there is no evidence linking recent large whale mortalities and currently ongoing surveys. The commenters offer no such evidence. NMFS will continue to gather data to help us determine the cause of death for these stranded whales. We note the Marine Mammal Commission's recent statement: “There continues to be no evidence to link these large whale strandings to offshore wind energy development, including no evidence to link them to sound emitted during wind development-related site characterization surveys, known as HRG surveys. Although HRG surveys have been occurring off New England and the mid-Atlantic coast, HRG devices have never been implicated or causatively-associated with baleen whale strandings.” (Marine Mammal Commission Newsletter, Spring 2023).

There is an ongoing Unusual Mortality Event (UME) for humpback whales along the Atlantic coast from Maine to Florida, which includes animals stranded since 2016. Partial or full necropsy examinations were conducted on approximately half of the whales. Necropsies were not conducted on other carcasses because they were too decomposed, not brought to land, or stranded on protected lands ( e.g., national and state parks) with limited or no access. Of the whales examined (roughly 90), about 40 percent had evidence of human interaction, either ship strike or entanglement. Vessel strikes and entanglement in fishing gear are the greatest human threats to large whales. The remaining 50 necropsied whales either had an undetermined cause of death (due to a limited examination or decomposition of the carcass), or had other causes of death including parasite-caused organ damage and starvation.

Acoustic sources used in these HRG surveys are very different from seismic airguns used in oil and gas surveys and produce much smaller impact zones because, in general, they have lower source levels and produce output at higher frequencies. The area within which HRG sources might behaviorally disturb a marine mammal is orders of magnitude smaller than the impact areas for seismic airguns or military sonar. Any marine mammal exposure would be at significantly lower levels and shorter duration, which is associated with less severe impacts to marine mammals.

The best available science indicates that only Level B harassment, or disruption of behavioral patterns ( e.g., avoidance), may occur as a result of Atlantic Shores' HRG surveys. NMFS emphasizes that there is no credible scientific evidence available suggesting that mortality and/or serious injury is a potential outcome of the planned survey activity. Additionally, NMFS cannot authorize mortality or serious injury via an IHA, and such taking is prohibited under Condition 3(c) of the IHA and may result in modification, suspension, or revocation of the IHA. NMFS notes there has never been a report of any serious injuries or mortalities of a marine mammal associated with site characterization surveys.

We also refer to the Greater Atlantic Regional Fisheries Office (GARFO) 2021 Programmatic Consultation, which finds that these survey activities are in general not likely to adversely affect Endangered Species Act (ESA)-listed marine mammal species ( i.e., GARFO's analysis conducted pursuant to the ESA finds that marine mammals are not likely to be taken at all (as that term is defined under the ESA), much less be taken by serious injury or mortality). That document is found at https://www.fisheries.noaa.gov/new-england-mid-atlantic/consultations/section-7-take-reporting-programmatics-greater-atlantic#offshore-wind-site-assessment-and-site-characterization-activities-programmatic-consultation.

Comment 3: Green Oceans claims that the proposed IHA does not properly value biodiversity in its assessment of harm and that “impacts to the abundance or distribution of marine mammals can disrupt vital systems that regulate the ocean and the climate.” Green Oceans further claims that NMFS dismisses the effects of habitat displacement or abandonment on North Atlantic right whales (NARWs) from the project.

Response: Green Oceans provides no further development of this comment, e.g., in what way it believes that the MMPA requires that “biodiversity” be accounted for in the analyses required under the MMPA, how it believes that these surveys would be likely to impact the abundance or distribution of marine mammals, or how such impacts might be likely to disrupt unspecified “vital systems.” However, we reiterate that the magnitude of behavioral harassment authorized is very low and the severity of any behavioral responses are expected to be primarily limited to temporary displacement and avoidance of the area when some activities that have the potential to result in harassment are occurring (see Negligible Impact Determinations section for our full analysis). NMFS does not anticipate that marine mammals would be permanently displaced or displaced for extended periods of time from the area where Atlantic Shores' marine site characterization surveys would occur, and commenters do not provide evidence that this effect should be a reasonably anticipated outcome of the specified activity. We expect temporary avoidance to occur, at worst, but that is distinctly different from displacement, which suggests longer-term, reduced usage of habitat. Similarly, NMFS is not aware of any scientific information suggesting that the survey activity would cause meaningful shifts in abundance and distribution of marine mammals and disagrees that this would be a reasonably anticipated effect of the specified activities. The authorized take of NARWs by Level B harassment is precautionary but considered unlikely as NMFS' take estimation analysis does not account for the use of mitigation and monitoring measures ( e.g., the requirement for Atlantic Shores to implement a shutdown zone for NARWs (500 m) that is more than three times as large as the estimated harassment zone (141 m)). These requirements are expected to largely eliminate the actual occurrence of Level B harassment events and to the extent that harassment does occur, would minimize the duration and severity of any such events. Level B harassment authorized by this IHA is not expected to negatively impact abundance or distribution of other marine mammal species particularly given that it does not account for the suite of mitigation and monitoring measures NMFS has prescribed, and would be comprised of temporary low severity impacts, with no lasting biological consequences. Therefore, even if marine mammals are in the area of the specified activities, a displacement impact is not anticipated.

Comment 4: Commenters stated that NMFS was not utilizing the best available science when assessing impacts to marine mammals. Green Oceans asserted that NMFS had not fully considered the effect of the project on NARWs, claiming that “90% of the population could be affected” by the proposed survey.

Response: NMFS relied upon the best scientific evidence available, including, but not limited to, the most recent Stock Assessment Report (SAR) data, scientific literature, and Duke University's density models (Roberts et al., 2023), in analyzing the impacts of Atlantic Shores' specified activities on marine mammals. While commenters suggest generally that NMFS consider the best scientific evidence available, none of the commenters provided additional relevant scientific information for NMFS to consider.

NMFS determined that Atlantic Shores' surveys have the potential to take marine mammals by Level B harassment and does not anticipate or authorize mortality (death), serious injury, or Level A harassment of any marine mammal species, including NARW. Atlantic Shores requested and NMFS is authorizing only five takes of NARWs by Level B harassment, which is less than 2 percent of the population. Further, NMFS does not expect that the generally short-term, intermittent, and transitory nature of Atlantic Shores' marine site characterization survey activities will create conditions of acute or chronic acoustic exposure leading to long-term physiological stress responses in marine mammals.

Comment 5: Green Oceans states that the “precautionary principle” does not allow NMFS to authorize the “introduction of stressors” to populations undergoing an UME, that authorization of take for such species “violates the spirit and intent of the MMPA,” and that NMFS is “precluded from authorizing wind energy development” in habitat utilized by relevant species for which there are active UMEs ( i.e., humpback, minke, and North Atlantic right whales).

Response: Green Oceans refers to supposed standards that do not exist in the MMPA, e.g., the MMPA contains no reference to the “precautionary principle,” and fails to adequately explain its supposition that NMFS has violated the “spirit and intent” of the MMPA. As described previously, an IHA does not authorize or allow the activity itself but authorizes the take of marine mammals incidental to the “specified activity” for which incidental take coverage is being sought. In this case, NMFS is responding to Atlantic Shores' request to incidentally take marine mammals while engaged in marine site characterization surveys and determining whether the necessary findings can be made based on Atlantic Shores' application. The authorization of Atlantic Shores' survey activities, or any other activities that introduce stressors, is not within NMFS' jurisdiction.

Regarding UMEs, the MMPA does not preclude authorization of take for species or stocks with ongoing UMEs. Rather, NMFS considers the ongoing UME as part of the environmental baseline for the affected species or stock as part of its negligible impact analyses. Elevated NARW mortalities began in June 2017 and there is an active UME. Overall, preliminary findings support human interactions, specifically vessel strikes and entanglements, as the cause of death for the majority of NARWs. As noted previously, the survey area overlaps a migratory corridor for NARWs. Due to the fact that the survey activities are temporary and the spatial extent of sound produced by the survey would be very small relative to the spatial extent of the available migratory habitat in the biologically important area (BIA), NARW migration is not expected to be impacted by the survey. Given the relatively small size of the ensonified area, it is unlikely that prey availability would be adversely affected by HRG survey operations. Required vessel strike avoidance measures will also decrease risk of ship strike during migration; no ship strike is expected to occur during Atlantic Shores' planned activities. Additionally, only very limited take by Level B harassment of NARWs has been requested and has been authorized by NMFS as HRG survey operations are required to maintain a 500 m shutdown zone for NARWs. The 500 m shutdown zone for NARWs is conservative, considering the Level B harassment isopleth for the most impactful acoustic source ( i.e., sparker) is estimated to be 141 m, and thereby minimizes the potential for behavioral harassment of this species. As noted previously, Level A harassment is not expected due to the small permanent threshold shift (PTS) zones associated with HRG equipment types proposed for use. NMFS does not anticipate NARW takes that would result from Atlantic Shores' activities would impact annual rates of recruitment or survival. Thus, any takes that occur would not result in population level impacts.

Elevated humpback whale mortalities have occurred along the Atlantic coast from Maine through Florida since January 2016. Of the cases examined, approximately half had evidence of human interaction (ship strike or entanglement). The UME does not yet provide cause for concern regarding population-level impacts. Despite the UME, the relevant population of humpback whales (the West Indies breeding population, or distinct population segment (DPS)) remains stable at approximately 12,000 individuals.

Beginning in January 2017, elevated minke whale strandings have occurred along the Atlantic coast from Maine through South Carolina, with highest numbers in Massachusetts, Maine, and New York. This event does not provide cause for concern regarding population level impacts, as the likely population abundance is greater than 20,000 whales. The minke whale UME is currently non-active, with closure pending.

The required mitigation measures are expected to reduce the number and/or severity of takes for all species in Table 2, including those with active UMEs, to the level of least practicable adverse impact. In particular they would provide animals the opportunity to move away from the sound source throughout the survey area before HRG survey equipment reaches full energy, thus preventing them from being exposed to sound levels that have the potential to cause injury (Level A harassment) or more severe Level B harassment. No Level A harassment is anticipated, even in the absence of mitigation measures, or authorized.

NMFS expects that takes would be in the form of short-term Level B behavioral harassment by way of brief startling reactions and/or temporary vacating of the area, or decreased foraging (if such activity was occurring)—reactions that (at the scale and intensity anticipated here) are considered to be of low severity, with no lasting biological consequences. Since both the sources and marine mammals are mobile, animals would only be exposed briefly to a small ensonified area that might result in take. Additionally, required mitigation measures would further reduce exposure to sound that could result in more severe behavioral harassment.

Comment 6: Some commenters objected to NMFS' small numbers and negligible impact determinations for the numbers of marine mammals, particularly NARWs, taken by Level B harassment under Atlantic Shores' planned activities. Green Oceans claims that NMFS' determination is “arbitrary and capricious,” in part because it fails to account for the total amount of take for a given species across all current wind development activities for which NMFS has issued incidental take authorizations (ITAs). Green Oceans also claims that, for Atlantic Shores, NMFS is violating the “intent of the MMPA” by proposing to authorize incidental take for “over 12 percent of the stock for over 8 species.” Green Oceans also states that NMFS' small numbers finding “fails to consider the conservation status of the [NARW].”

Response: NMFS disagrees with the commenters' arguments on the topic of small numbers and negligible impact findings, and the commenters do not provide a reasoned basis for finding the effects of the specified activity would be greater than negligible on any species or stock. The Negligible Impact Analysis and Determination section of the proposed and final 2022 IHA (87 FR 38067, April 27, 2022; 87 FR 50293, August 16, 2022) provides a detailed qualitative discussion supporting NMFS' determination that any anticipated impacts from this action would be negligible. The section contains a number of factors that were considered by NMFS based on the best available scientific data and why we concluded that impacts resulting from the specified activity are not reasonably expected to, or reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

Although there is limited legislative history available to guide NMFS and an apparent lack of biological underpinning to the concept, we have worked to develop a reasoned approach to small numbers. NMFS explains the concept of “small numbers” in recognition that there could also be quantities of individuals taken that would correspond with “medium” and “large” numbers. As such, for an individual incidental take authorization, NMFS considers that one-third of the most appropriate population abundance number—as compared with the assumed number of individuals taken—is an appropriate limit with regard to “small numbers.” This relative approach is consistent with the statement from the legislative history that “[small numbers] is not capable of being expressed in absolute numerical limits” (H.R. Rep. No. 97-228, at 19 (September 16, 1981)), and relevant case law (Center for Biological Diversity v. Salazar, 695 F.3d 893, 907 (9th Cir. 2012) (holding that the U.S. Fish and Wildlife Service reasonably interpreted “small numbers” by analyzing take in relative or proportional terms)). As noted above, there is no biological significance associated with “small numbers” and, as such, NMFS appropriately does not consider “conservation status” or other issues related to the status of a species or stock in making its small numbers finding. Instead, these concepts are appropriately considered as part of the negligible impact analysis—consideration of “conservation status” as part of the small numbers finding, as Green Oceans suggests, would inappropriately conflate these two independent findings.

Atlantic Shores requested, and NMFS proposed to authorize, incidental take that amounts to less than 2 percent of the Western Atlantic stock of NARWs, Gulf of Maine stock of humpback whales, and Western North Atlantic stock of gray seals, and less than 1 percent of all other stocks, values which do not align with those presented by Green Oceans—which do not appear to relate to the proposed action.

NMFS has made the necessary small numbers finding for all affected species and stocks, specifically for the issuance of the Atlantic Shores IHA.

Comment 7: Oceana and Green Oceans noted that chronic stressors are an emerging concern for NARW conservation and recovery, and stated that chronic stress may result in energetic effects for North Atlantic right whales. Oceana and Green Oceans suggested that NMFS has not fully considered both the use of the area and the effects of both acute and chronic stressors on the health and fitness of North Atlantic right whales, as disturbance responses in North Atlantic right whales could lead to chronic stress or habitat displacement, leading to an overall decline in their health and fitness.

Response: NMFS agrees with Oceana and Green Oceans that both acute and chronic stressors are of concern for NARW conservation and recovery. We recognize that acute stress from acoustic exposure is one potential impact of these surveys, and that chronic stress can have fitness, reproductive, etc. impacts at the population-level scale. NMFS has carefully reviewed the best available scientific information in assessing impacts to marine mammals, and recognizes that Atlantic Shores' surveys have the potential to impact marine mammals through behavioral effects, stress responses, and auditory masking. However, NMFS does not expect that the generally short-term, intermittent, and transitory marine site characterization survey activities planned by Atlantic Shores will create conditions of acute or chronic acoustic exposure leading to long-term physiological stress responses in marine mammals. NMFS has prescribed a robust suite of mitigation measures, including extended distance shutdowns for NARW that are expected to further reduce the duration and intensity of acoustic exposure, while limiting the potential severity of any possible behavioral disruption, and may prevent any actual harassment from occurring under this IHA. The potential for chronic stress was evaluated in making the determinations presented in NMFS' negligible impact analyses. Although Green Oceans correctly states that Atlantic Shores' surveys would occur in the NARW migratory corridor, they incorrectly claim that the project area is a known feeding habitat for NARWs and that any displacement would have “devastating effects on the species.” NMFS does not anticipate that NARWs would be displaced from the area where Atlantic Shores' marine site characterization surveys would occur, and neither comment provides evidence that this effect should be a reasonably anticipated outcome of the specified activity.

Similarly, NMFS is not aware of any scientific information suggesting that the survey activity would drive marine mammals out of the survey area, and disagrees that this would be a reasonably anticipated effect of the specified activities. The take by Level B harassment authorized by NMFS is precautionary and also considered unlikely to actually occur, as NMFS' take estimation process does not account for the use of extremely precautionary mitigation measures, e.g., the requirement for Atlantic Shores to implement a Shutdown Zone that is more than 3 times as large as the estimated harassment zone. These requirements are expected to largely eliminate the actual occurrence of Level B harassment events and, to the extent that harassment does occur, would minimize the duration and severity of any such events. Therefore, even if a NARW was in the area of Atlantic Shores' surveys, a displacement impact is not anticipated.

Because NARW generally use this location in a transitory manner, specifically for migration, any potential impacts from these surveys are lessened for other behaviors due to the brief periods where exposure is possible. Thus, the transitory nature of occurrence of NARWs as they migrate means it is unlikely for any exposure to cause chronic effects, as Atlantic Shores' planned survey area and ensonified zones are small relative to the overall migratory corridor. As such, NMFS does not expect acute or cumulative stress to be a detrimental factor to NARWs from Atlantic Shores' described survey activities. The potential for impacts related to an overall increase in the amount of other OSW development activities is separate from the aforementioned analysis of potential for impacts from the specified survey activities and is not discussed further as it is outside the scope of this specific action.

Comment 8: Green Oceans criticized NMFS's use of the 160-decibel (dB) root mean square (rms) Level B harassment threshold, stating that the threshold is based on outdated information and that the best available science shows that behavioral impacts can occur at levels below the threshold. Criticism of our use of this threshold also focused on its nature as a step function, i.e., it assumes animals don't respond to received noise levels below the threshold but always do respond at higher received levels. Green Oceans also suggests that reliance on this threshold results in consistent underestimation of impacts because it is “not sufficiently conservative” and that any determination that relies on this threshold is “arbitrary and capricious.” Green Oceans implied that NMFS should revise its generalized behavioral take thresholds to mirror linear risk functions to account for intraspecific and contextual variability, and potential impacts at lower received levels (particularly for baleen whales).

Response: NMFS acknowledges that the 160-dB rms step-function approach is simplistic, and that an approach reflecting a more complex probabilistic function may more effectively represent the known variation in responses at different levels due to differences in the receivers, the context of the exposure, and other factors. Green Oceans suggested that our use of the 160-dB threshold implies that we do not recognize the science indicating that animals may react in ways constituting behavioral harassment when exposed to lower received levels. However, we do recognize the potential for Level B harassment at exposures to received levels below 160 dB rms, in addition to the potential that animals exposed to received levels above 160 dB rms will not respond in ways constituting behavioral harassment. These comments appear to evidence a misconception regarding the concept of the 160-dB threshold. While it is correct that in practice it works as a step-function, i.e., animals exposed to received levels above the threshold are considered to be “taken” and those exposed to levels below the threshold are not, it is in fact intended as a sort of mid-point of likely behavioral responses (which are extremely complex depending on many factors including species, noise source, individual experience, and behavioral context). What this means is that, conceptually, the function recognizes that some animals exposed to levels below the threshold will in fact react in ways that are appropriately considered take, while others that are exposed to levels above the threshold will not. Use of the 160-dB threshold allows for a simple quantitative estimate of take, while we can qualitatively address the variation in responses across different received levels in our discussion and analysis.

We also note Green Oceans' statement that the 160-dB threshold is “not sufficiently conservative.” Green Oceans does not further describe the standard of conservatism that it believes NMFS must attain, or how that standard relates to the legal requirements of the MMPA. Green Oceans goes on to imply that use of the 160-dB threshold is inappropriate because it addresses only exposures that cause disturbance, versus those exposures that present the potential to disturb through disruption of behavioral patterns. Green Oceans does not further develop this comment or offer any justification for this contention. NMFS affirms that use of the 160-dB criterion is expected to be inclusive of acoustic exposures presenting the potential to disturb through disruption of behavioral patterns, as required through the MMPA's definition.

Green Oceans cites reports of changes in vocalization, typically for baleen whales, as evidence in support of a lower threshold than the 160-dB threshold currently in use. A mere reaction to noise exposure does not, however, mean that a take by Level B harassment, as defined by the MMPA, has occurred. For a take to occur requires that an act have “the potential to disturb by causing disruption of behavioral patterns,” not simply result in a detectable change in motion or vocalization. Even a moderate cessation or modification of vocalization might not appropriately be considered as being of sufficient severity to result in take (Ellison et al., 2012). Green Oceans claims these reactions result in biological consequences indicating that the reaction was indeed a take but does not provide a well-supported link between the reported reactions at lower received levels and the claimed consequences.

Overall, there is a lack of scientific consensus regarding what criteria might be more appropriate. Defining sound levels that disrupt behavioral patterns is difficult because responses depend on the context in which the animal receives the sound, including an animal's behavioral mode when it hears sounds ( e.g., feeding, resting, or migrating), prior experience, and biological factors ( e.g., age and sex). Other contextual factors, such as signal characteristics, distance from the source, and signal to noise ratio, may also help determine response to a given received level of sound. Therefore, levels at which responses occur are not necessarily consistent and can be difficult to predict (Southall et al., 2007, 2019; Ellison et al., 2012; Bain and Williams, 2006; Gomez et al., 2016).

Green Ocean references linear risk functions developed for use specifically in evaluating the potential impacts of Navy tactical sonar. However, Green Oceans provides no suggestion regarding a risk function that it believes would be appropriate for use in this case. There is currently no agreement on these complex issues, and this threshold has remained in use in part because of the practical need to use a relatively simple threshold based on available information that is both predictable and measurable for most activities.

Comment 9: Oceana raised objections to NMFS' proposed renewal process for potential extension of the 1-year IHA with an abbreviated 15-day public comment period. Oceana recommended that an additional 30-day public comment period is necessary for any IHA renewal request.

Response: NMFS' IHA renewal process meets all statutory requirements. In prior responses to comments about IHA renewals ( e.g., 84 FR 52464, October 2, 2019; 85 FR 53342, August 28, 2020), NMFS explained the IHA renewal process is consistent with the statutory requirements contained in section 101(a)(5)(D) of the MMPA, and further, promotes NMFS' goals of improving conservation of marine mammals and increasing efficiency in the MMPA compliance process. Therefore, we intend to continue to implement the existing renewal process.

All IHAs issued, whether an initial IHA or a renewal, are valid for a period of not more than 1 year. The public has 30 days to comment on proposed IHAs, with a cumulative total of 45 days for IHA renewals. The notice of the proposed IHA published in the Federal Register on June 28, 2023 (88 FR 41912) provided a 30-day public comment period and made clear that NMFS was seeking comment on the proposed IHA and the potential issuance of a renewal for this survey. As detailed in the Federal Register notice for the proposed IHA and on the agency's website, eligibility for renewal is determined on a case-by-case basis, renewals are subject to an additional 15-day public comment period, and the renewal is limited to up to another year of identical or nearly identical activities as described in the Description of Proposed Activities section of the proposed IHA notice or the activities described in the Description of Proposed Activities section of the proposed IHA notice would not be completed by the time the IHA expires and a renewal would allow for completion of the activities beyond that described in the Dates and Duration section of this notice of the proposed IHA (88 FR 41912, June 28, 2023). NMFS' analysis of the anticipated impacts on marine mammals caused by the applicant's activities covers both the initial IHA period and the possibility of a 1-year renewal. Therefore, a member of the public considering commenting on a proposed initial IHA also knows exactly what activities (or subset of activities) would be included in a proposed renewal IHA, the potential impacts of those activities, the maximum amount and type of take that could be caused by those activities, the mitigation and monitoring measures that would be required, and the basis for the agency's negligible impact determinations, least practicable adverse impact findings, small numbers findings, and (if applicable) the no unmitigable adverse impact on subsistence use finding—all the information needed to provide complete and meaningful comments on a possible renewal at the time of considering the proposed initial IHA. Reviewers have the information needed to meaningfully comment on both the immediate proposed IHA and a possible 1-year renewal, should the IHA holder choose to request one.

While there would be additional documents submitted with a renewal request, for a qualifying renewal these would be limited to documentation that NMFS would make available and use to verify that the activities are identical to those in the initial IHA, are nearly identical such that the changes would have either no effect on impacts to marine mammals or decrease those impacts, or are a subset of activities already analyzed and authorized but not completed under the initial IHA. NMFS would also need to confirm, among other things, that the activities would occur in the same location; involve the same species and stocks; provide for continuation of the same mitigation, monitoring, and reporting requirements; and that no new information has been received that would alter the prior analysis. The renewal request would also contain a preliminary monitoring report, in order to verify that effects from the activities do not indicate impacts of a scale or nature not previously analyzed. The additional 15-day public comment period, which includes NMFS' direct notice to anyone who commented on the proposed initial IHA, provides the public an opportunity to review these few documents, provide any additional pertinent information, and comment on whether they think the criteria for a renewal have been met. Combined together, the 30-day public comment period on the initial IHA and the additional 15-day public comment period on the renewal of the same or nearly identical activities, provides the public with a total of 45 days to comment on the potential for renewal of the IHA.

In addition to the IHA renewal process being consistent with all requirements under section 101(a)(5)(D) of the MMPA, it is also consistent with Congress' intent for issuance of IHAs to the extent reflected in statements in the legislative history of the MMPA. Through the description of the process and express invitation to comment on specific potential renewals in the Request for Public Comments section of each proposed IHA, the description of the process on NMFS' website, further elaboration on the process through responses to comments such as these, posting of substantive documents on the agency's website, and provision of 30 or 45 days for public review and comment on all proposed initial IHAs and renewals respectively, NMFS has ensured that the public is “invited and encouraged to participate fully in the agency's decision-making process,” as Congress intended.

Comment 10: Several commenters asserted that NMFS must fully consider the discrete effects of each activity and the cumulative effects of the suite of approved, proposed and potential activities on marine mammals and North Atlantic right whales in particular and ensure that the cumulative effects are not excessive before issuing or renewing an IHA.

Response: Neither the MMPA nor NMFS' codified implementing regulations call for consideration of other unrelated activities and their impacts on marine mammal populations. The preamble for NMFS' implementing regulations (54 FR 40338, September 29, 1989) states in response to comments that the impacts from other past and ongoing anthropogenic activities are to be incorporated into the negligible impact analysis via their impacts on the baseline. Consistent with that direction, NMFS has factored into its negligible impact analysis the impacts of other past and ongoing anthropogenic activities via their impacts on the baseline, e.g., as reflected in the density, distribution and status of the species, population size and growth rate, and other relevant stressors. The 1989 final rule for the MMPA implementing regulations also addressed public comments regarding cumulative effects from future, unrelated activities. There, NMFS stated that such effects are not considered in making findings under MMPA section 101(a)(5) concerning negligible impact. In this case, this IHA, as well as other IHAs currently in effect or proposed within the specified geographic region, are appropriately considered an unrelated activity relative to the others. The IHAs are unrelated in the sense that they are discrete actions under section 101(a)(5)(D), issued to discrete applicants.

Section 101(a)(5)(D) of the MMPA requires NMFS to make a determination that the take incidental to a “specified activity” will have a negligible impact on the affected species or stocks of marine mammals. NMFS' implementing regulations at 50 CFR 216.104(a)(1) require applicants to include in their request a detailed description of the specified activity or class of activities that can be expected to result in incidental taking of marine mammals. Thus, the “specified activity” for which incidental take coverage is being sought under section 101(a)(5)(D) is generally defined and described by the applicant. Here, Atlantic Shores was the applicant for the IHA, and we are responding to the specified activity as described in that application and making the necessary findings on that basis.

Through the response to public comments in the 1989 implementing regulations, NMFS also indicated (1) that we would consider cumulative effects that are reasonably foreseeable when preparing a National Environmental Policy Act (NEPA) analysis, and (2) that reasonably foreseeable cumulative effects would also be considered under section 7 of the ESA for ESA-listed species, as appropriate. Accordingly, NMFS has written Environmental Assessments (EA) that addressed cumulative impacts related to substantially similar activities, in similar locations ( e.g., the 2019 Avangrid EA for survey activities offshore North Carolina and Virginia; the 2017 Ocean Wind, LLC EA for site characterization surveys off New Jersey; and the 2018 Deepwater Wind EA for survey activities offshore Delaware, Massachusetts, and Rhode Island). Cumulative impacts regarding issuance of IHAs for site characterization survey activities such as those planned by Atlantic Shores have been adequately addressed under NEPA in prior environmental analyses that support NMFS' determination that this action is appropriately categorically excluded from further NEPA analysis. NMFS independently evaluated the use of a categorical exclusion (CE) for issuance of Atlantic Shores' IHA, which included consideration of extraordinary circumstances.

Separately, the cumulative effects of substantially similar activities in the northwest Atlantic Ocean have been analyzed in the past under section 7 of the ESA when NMFS has engaged in formal intra-agency consultation, such as the 2013 programmatic Biological Opinion for BOEM Lease and Site Assessment Rhode Island, Massachusetts, New York, and New Jersey Wind Energy Areas ( https://repository.library.noaa.gov/view/noaa/29291 ). Analyzed activities include those for which NMFS issued previous IHAs (82 FR 31562, July 7, 2017; 85 FR 21198, April 16, 2020; 86 FR 26465, May 10, 2021), which are similar to those planned by Atlantic Shores under this current IHA request. This Biological Opinion (BiOp) determined that NMFS' issuance of IHAs for site characterization survey activities associated with leasing, individually and cumulatively, are not likely to adversely affect listed marine mammals. NMFS notes that, while issuance of this IHA is covered under a different consultation, this BiOp remains valid.

Comment 11: SLC states its opposition to the use of a categorical exclusion under NEPA, asserting that, at minimum, an Environmental Assessment is the appropriate level of review.

Response: NMFS does not agree with SLC's comment. A CE is a category of actions that an agency has determined does not individually or cumulatively have a significant effect on the quality of the human environment, and is appropriately applied for such categories of actions so long as there are no extraordinary circumstances present that would indicate that the effects of the action may be significant. Extraordinary circumstances are situations for which NOAA has determined further NEPA analysis is required because they are circumstances in which a normally excluded action may have significant effects. A determination of whether an action that is normally excluded requires additional evaluation because of extraordinary circumstances focuses on the action's potential effects and considers the significance of those effects in terms of both context (consideration of the affected region, interests, and resources) and intensity (severity of impacts). Potential extraordinary circumstances relevant to this action include (1) adverse effects on species or habitats protected by the MMPA that are not negligible; (2) highly controversial environmental effects; (3) environmental effects that are uncertain, unique, or unknown; and (4) the potential for significant cumulative impacts when the proposed action is combined with other past, present, and reasonably foreseeable future actions.

The relevant NOAA CE associated with issuance of incidental take authorizations is CE B4, “Issuance of incidental harassment authorizations under Section 101(a)(5)(A) and (D) of the MMPA for the incidental, but not intentional, take by harassment of marine mammals during specified activities and for which no serious injury or mortality is anticipated.” This action falls within CE B4. In determining whether a CE is appropriate for a given incidental take authorization, NMFS considers the applicant's specified activity and the potential extent and magnitude of takes of marine mammals associated with that activity along with the extraordinary circumstances listed in the Companion Manual for NOAA Administrative Order (NAO) 216-6A and summarized above. The evaluation of whether extraordinary circumstances (if present) have the potential for significant environmental effects is limited to the decision NMFS is responsible for, which is issuance of the incidental take authorization. While there may be environmental effects associated with the underlying action, potential effects of NMFS' action are limited to those that would occur due to the authorization of incidental take of marine mammals. NMFS prepared numerous EAs analyzing the environmental impacts of the categories of activities encompassed by CE B4 which resulted in Findings of No Significant Impact (FONSIs) and, in particular, EAs prepared in support of issuance of IHAs related to similar survey actions are part of NMFS' administrative record supporting CE B4. These EAs demonstrate the issuance of a given incidental harassment authorization does not affect other aspects of the human environment because the action only affects the marine mammals that are the subject of the incidental harassment authorization. These EAs also addressed factors in 40 CFR 1508.27 regarding the potential for significant impacts and demonstrate the issuance of incidental harassment authorization for the categories of activities encompassed by CE B4 do not individually or cumulatively have a significant effect on the human environment.

Specifically for this action, NMFS independently evaluated the use of the CE for issuance of Atlantic Shores' IHA, which included consideration of extraordinary circumstances. As part of that analysis, NMFS considered whether this IHA issuance would result in cumulative impacts that could be significant. In particular, the issuance of an IHA to Atlantic Shores is expected to result in minor, short-term behavioral effects on marine mammal species due to exposure to underwater sound from site characterization survey activities. Behavioral disturbance is possible to occur intermittently in the vicinity of Atlantic Shores' survey area during the 1-year timeframe. Level B harassment will be reduced through use of mitigation measures described herein. Additionally, as discussed elsewhere, NMFS has determined that Atlantic Shores' activities fall within the scope of activities analyzed in GARFO's programmatic consultation regarding geophysical surveys along the U.S. Atlantic coast in the three Atlantic Renewable Energy Regions (completed June 29, 2021; revised September 2021), which concluded surveys such as those planned by Atlantic Shores are not likely to adversely affect ESA-listed species or adversely modify or destroy critical habitat. Accordingly, NMFS has determined that the issuance of this IHA will result in no more than negligible (as that term is defined by the Companion Manual for NAO 216-6A) adverse effects on species protected by the ESA and the MMPA.

Further, the issuance of this IHA will not result in highly controversial environmental effects or result in environmental effects that are uncertain, unique, or unknown because numerous entities have been engaged in site characterization surveys that result in Level B harassment of marine mammals in the United States. This type of activity is well documented; prior authorizations and analysis demonstrates issuance of an IHA for this type of action only affects the marine mammals that are the subject of the specific authorization and, thus, no potential for significant cumulative impacts are expected, regardless of past, present, or reasonably foreseeable actions, even though the impacts of the action may not be significant by itself. Based on this evaluation, we concluded that the issuance of the IHA qualifies to be categorically excluded from further NEPA review.

Comment 12: SLC asserts that NMFS is permitting the proposed activities without any empirically-determined benchmark for what is the injury-causing sound pressure level (“SPL”) against which to measure the proposed activities. In addition, SLC indicates that basing the shutdown and clearance distances on PTS thresholds is insufficient as PTS thresholds are modeled from temporary threshold shift (TTS) data and threshold for tissue injury may occur at a lower level than TTS.

Response: NMFS does not agree with the commenter that shutdown and clearance distances based upon PTS thresholds are insufficient due to thresholds being modeled from TTS data. Marine mammal PTS thresholds are appropriately extrapolated from marine mammal TTS data and data from terrestrial mammals, as described in NMFS' 2018 Technical Guidance. We refer the commenter to that guidance. Further, TTS is not considered injury, as defined for Level A harassment under the MMPA, because it is fully recoverable.

Comment 13: Oceana states that NMFS must make an assessment of which activities, technologies and strategies are truly necessary to achieve site characterization to inform development of the offshore wind projects and which are not critical, asserting that NMFS should prescribe the appropriate survey techniques. In general, Oceana stated that NMFS must require the IHA applicant to avoid adverse effects on NARWs in and around the survey site, and then minimize and mitigate the impacts of underwater noise to the fullest extent feasible, including through the use of best available technology and methods to minimize sound levels from geophysical surveys such as through the use of technically and commercially feasible and effective noise reduction and attenuation measures.

Response: The MMPA requires that an IHA include measures that will effect the least practicable adverse impact on the affected species and stocks and, in practice, NMFS agrees that the IHA should include conditions for the survey activities that will first avoid adverse effects on NARWs in and around the survey site, where practicable, and then minimize the effects that cannot be avoided. NMFS has determined that the IHA meets this requirement to effect the least practicable adverse impact. As part of the analysis for all marine site characterization survey IHAs, NMFS evaluated the effects expected as a result of the specified activity, made the necessary findings, and prescribed mitigation requirements sufficient to achieve the least practicable adverse impact on the affected species and stocks of marine mammals. It is not within NMFS' purview to set the activities, technologies, and strategies that applicants may employ to meet their objectives. As explained above, the “specified activity” for which incidental take coverage is being sought under section 101(a)(5)(D) is defined and described by the applicant, not by NMFS.

Comment 14: Oceana suggests that NMFS require the use of Protected Species Observers (PSOs) and that PSOs complement their survey efforts using additional technologies, such as infrared detection devices when in low-light conditions. In addition, COA noted a lack of standardization for PSOs which could result in differences in recorded take responses, and urged NMFS to incorporate updated guidance on national standards for PSOs and data management into the take authorization process.

Response: NMFS agrees with the commenters regarding these suggestions and requirements to utilize PSOs for monitoring, for PSOs to use a thermal (infrared) device during low-light conditions, and to include updated standardization of PSO requirements and data management. These requirements were included in the proposed Federal Register Notice as well as in the issued IHA.

The report that COA references, National Standards for a Protected Species Observer and Data Management Program: A Model Using Geological and Geophysical Surveys (Baker et al., 2013), currently serves as a basis for NMFS' current standardized PSO requirements, specifically review of PSO qualifications as well as collecting and reporting data.

Comment 15: Oceana recommended that NMFS restrict all vessels of all sizes associated with the proposed survey activities to speeds less than 10 knots (kn) (18.5 km/hour) at all times due to the risk of vessel strikes to NARWs and other large whales.

Response: While NMFS acknowledges that vessel strikes can result in injury or mortality, we have analyzed the potential for vessel strike resulting from Atlantic Shores' activity and have determined that based on the nature of the activity and the required mitigation measures specific to vessel strike avoidance included in the IHA, potential for vessel strike is so low as to be discountable. The required mitigation measures, all of which were included in the proposed IHA and are now required in the final IHA, include: A requirement that all vessel operators comply with 10 kn (18.5 km/hour) or less speed restrictions in any Seasonal Management Area (SMA), Dynamic Management Area (DMA), or Slow Zone while underway, and check daily for information regarding the establishment of mandatory or voluntary vessel strike avoidance areas (SMAs, DMAs, Slow Zones) and information regarding NARW sighting locations; a requirement that all vessels greater than or equal to 19.8 meters (m) in overall length operating from November 1 through April 30 operate at speeds of 10 kn (18.5 km/hour) or less; a requirement that all vessel operators reduce vessel speed to 10 kn (18.5 km/hour) or less when any large whale, any mother/calf pairs, pods, or large assemblages of non-delphinid cetaceans are observed near the vessel; a requirement that all survey vessels maintain a separation distance of 500 m or greater from any ESA-listed whales or other unidentified large marine mammals visible at the surface while underway; a requirement that, if underway, vessels must steer a course away from any sighted ESA-listed whale at 10 kn (18.5 km/hour) or less until the 500 m minimum separation distance has been established; a requirement that, if an ESA-listed whale is sighted in a vessel's path, or within 500 m of an underway vessel, the underway vessel must reduce speed and shift the engine to neutral; a requirement that all vessels underway must maintain a minimum separation distance of 100 m from all non-ESA-listed baleen whales; and a requirement that all vessels underway must, to the maximum extent practicable, attempt to maintain a minimum separation distance of 50 m from all other marine mammals, with an understanding that at times this may not be possible ( e.g., for animals that approach the vessel). We have determined that the vessel strike avoidance measures in the IHA are sufficient to ensure the least practicable adverse impact on species or stocks and their habitat. Furthermore, no documented vessel strikes have occurred for any marine site characterization surveys which were issued IHAs from NMFS during the survey activities themselves or while transiting to and from survey sites.

Comment 16: Oceana suggests that NMFS require vessels maintain a separation distance of at least 500 m from NARWs at all times.

Response: NMFS agrees with Oceana regarding this suggestion and a requirement to maintain a separation distance of at least 500 m from NARWs at all times was included in the proposed Federal Register Notice and as a requirement in the issued IHA.

Comment 17: Oceana recommended that the IHA should require all vessels supporting site characterization to be equipped with and using Class A Automatic Identification System (AIS) devices at all times while on the water. Oceana suggested this requirement should apply to all vessels, regardless of size, associated with the survey.

Response: NMFS is generally supportive of the idea that vessels involved with survey activities be equipped with and using Class A Automatic Identification System (devices) at all times while on the water. Indeed, there is a precedent for NMFS requiring such a stipulation for geophysical surveys in the Atlantic Ocean (38 FR 63268, December 7, 2018); however, these activities carried the potential for much more significant impacts than the marine site characterization surveys to be carried out by Atlantic Shores, with the potential for both Level A and Level B harassment take. Given the small isopleths and small numbers of take authorized by this IHA, NMFS does not agree that the benefits of requiring AIS on all vessels associated with the survey activities outweigh and warrant the cost and practicability issues associated with this requirement and therefore the agency has not included this within the issued IHA.

Comment 18: Oceana asserts that the IHA must include requirements to hold all vessels associated with site characterization surveys accountable to the IHA requirements, including vessels owned by the developer, contractors, employees, and others regardless of ownership, operator, and contract. They state that exceptions and exemptions will create enforcement uncertainty and incentives to evade regulations through reclassification and redesignation. They recommend that NMFS simplify this by requiring all vessels to abide by the same requirements, regardless of size, ownership, function, contract or other specifics.

Response: NMFS agrees with Oceana and required these measures in the proposed IHA and final IHA. The IHA requires that a copy of the IHA must be in the possession of Atlantic Shores, the vessel operators, the lead PSO, and any other relevant designees of Atlantic Shores operating under the authority of this IHA. The IHA also states that Atlantic Shores must ensure that the vessel operator and other relevant vessel personnel, including the PSO team, are briefed on all responsibilities, communication procedures, marine mammal monitoring protocols, operational procedures, and IHA requirements prior to the start of survey activity, and when relevant new personnel join the survey operations.

Comment 19: Oceana stated that the IHA must include a requirement for all phases of site characterization to subscribe to the highest level of transparency, including frequent reporting to Federal agencies. Oceana recommended requirements to report all visual and acoustic detections of NARWs and any dead, injured, or entangled marine mammals to NMFS or the Coast Guard as soon as possible and no later than the end of the PSO shift. Oceana states that to foster stakeholder relationships and allow public engagement and oversight of the permitting, the IHA should require all reports and data to be accessible on a publicly available website.

Response: NMFS agrees with the need for reporting and indeed, the MMPA calls for IHAs to incorporate reporting requirements. As included in the proposed IHA, the final IHA includes requirements for reporting that supports Oceana's recommendations. Atlantic Shores is required to submit a monitoring report to NMFS within 90 days after completion of survey activities that fully documents the methods and monitoring protocols, and summarizes the data recorded during monitoring. PSO datasheets or raw sightings data must also be provided with the draft and final monitoring report.

Further, the draft IHA and final IHA stipulate that if a NARW is observed at any time by any survey vessels, during surveys or during vessel transit, Atlantic Shores must immediately report sighting information to the NMFS NARW Sighting Advisory System within 2 hours of occurrence, when practicable, or no later than 24 hours after occurrence. Atlantic Shores may also report the sighting to the U.S. Coast Guard. Additionally, Atlantic Shores must report any discoveries of injured or dead marine mammals to the NMFS Office of Protected Resources and to the New England/Mid-Atlantic Regional Stranding Coordinator as soon as feasible. This includes entangled animals. All reports and associated data submitted to NMFS are included on the website for public inspection.

Daily visual and acoustic detections of NARWs and other large whale species along the Eastern Seaboard, as well as Slow Zone locations, are publicly available on WhaleMap ( https://whalemap.org/WhaleMap/ ). Further, recent acoustic detections of NARWs and other large whale species are available to the public on NOAA's Passive Acoustic Cetacean Map website https://apps-nefsc.fisheries.noaa.gov/pacm/#/narw.

Comment 20: Oceana recommended that for site characterization activities that have the potential to injure or harass NARWs, NMFS require a visual clearance and exclusion zone of at least 1,000 m for NARWs around each vessel conducting activities with noise levels that could result in injury to or harassment of large whales, and also require an acoustic clearance and exclusion zone of at least 1,000 m for NARWs around each vessel conducting activities with noise levels that could harass NARWs.

Response: NMFS notes that the 500 m clearance Zone for NARWs exceeds the modeled distance to the largest 160 dB Level B harassment isopleth (141 m during sparker use) by a substantial margin. Oceana does not provide a compelling rationale for why the clearance zone should be even larger. Given that these surveys are relatively low impact and that, regardless, NMFS has prescribed a NARW clearance zone that is significantly larger (500 m) than the conservatively estimated largest harassment zone (141 m), NMFS has determined that the clearance zone is appropriate.

Comment 21: Oceana recommends a shutdown requirement if a NARW or other ESA-listed species are detected in the clearance zone as well as a publicly available explanation of any exemptions allowing the applicant not to shut down in these situations.

Response: NMFS reiterates that use of the planned sources is not expected to have any potential to cause injury of any species, including NARW, even in the absence of mitigation. Consideration of the anticipated effectiveness of the mitigation measures ( i.e., clearance zones and shutdown measures) discussed below and in the Description of Mitigation, Monitoring, and Reporting Measures section of this notice further strengthens the conclusion that injury is not a reasonably anticipated outcome of the survey activity. Nevertheless, there are several shutdown requirements described in the Federal Register notice of the proposed IHA (88 FR 41912, June 28, 2023), and which are included in the final IHA, including the stipulation that geophysical survey equipment must be immediately shut down if any marine mammal is observed within or entering the relevant Clearance Zone while geophysical survey equipment is operational. There is no exemption for the shutdown requirement for NARW and ESA-listed species.

Atlantic Shores is required to implement a 30-minute pre-start clearance period prior to the initiation of ramp-up of specified HRG equipment. During this period, clearance zones will be monitored by the PSOs using the appropriate visual technology. Ramp-up may not be initiated if any marine mammal(s) is within its respective clearance zone. If a marine mammal is observed within a clearance zone during the pre-start clearance period, ramp-up may not begin until the animal(s) has been observed exiting its respective exclusion zone or until an additional time period has elapsed with no further sighting ( i.e., 15 minutes for small odontocetes and seals, and 30 minutes for all other species). If the acoustic source is shut down for reasons other than mitigation ( e.g., mechanical difficulty) for less than 30 minutes, it may be activated again without ramp-up if PSOs have maintained constant observation and no detections of any marine mammal have occurred within the respective clearance zones.

In regards to reporting, Atlantic Shores must notify NMFS if a NARW is observed at any time by any survey vessels during surveys or during vessel transit. Additionally, Atlantic Shores is required to report the relevant survey activity information, such as the type of survey equipment in operation, acoustic source power output while in operation, and any other notes of significance ( i.e., pre-clearance survey, ramp-up, shutdown, end of operations, etc. ) as well as the estimated distance to an animal and its heading relative to the survey vessel at the initial sighting and survey activity information. We note that if a NARW is detected within the Clearance Zone before a shutdown is implemented, the NARW and its distance from the sound source, including if it is within the Level B harassment zone, would be reported in Atlantic Shores' final monitoring report and made publicly available on NMFS' website. Atlantic Shores is required to immediately notify NMFS of any sightings of NARWs and report upon survey activity information. NMFS believes that these requirements address the commenter's concerns.

Comment 22: Oceana recommended that NMFS should require Passive Acoustic Monitoring (PAM) to establish a clearance zone and maximize the probability of detection for NARWs.

Response: NMFS does not agree that a measure to require PAM is warranted, as it is not expected to be effective for use in detecting the species of concern. It is generally accepted that, even in the absence of additional acoustic sources, using a towed passive acoustic sensor to detect baleen whales (including NARWs) is not typically effective because the noise from the vessel, the flow noise, and the cable noise are in the same frequency band and will mask the vast majority of baleen whale calls. Vessels produce low-frequency noise, primarily through propeller cavitation, with main energy in the 5-300 Hertz (Hz) frequency range. Source levels range from about 140 to 195 decibel (dB) re 1 μPa (micropascal) at 1 m (NRC, 2003; Hildebrand, 2009), depending on factors such as ship type, load, and speed, and ship hull and propeller design. Studies of vessel noise show that it appears to increase background noise levels in the 71-224 Hz range by 10-13 dB (Hatch et al., 2012; McKenna et al., 2012; Rolland et al., 2012). PAM systems employ hydrophones towed in streamer cables approximately 500 m behind a vessel. Noise from water flow around the cables and from strumming of the cables themselves is also low-frequency and typically masks signals in the same range. Experienced PAM operators participating in a recent workshop (Thode et al., 2017) emphasized that a PAM operation could easily report no acoustic encounters, depending on species present, simply because background noise levels rendered any acoustic detection impossible. The same workshop report stated that a typical eight-element array towed 500 m behind a vessel could be expected to detect delphinids, sperm whales, and beaked whales at the required range, but not baleen whales, due to expected background noise levels (including seismic noise, vessel noise, and flow noise).

Comment 23: Oceana recommended that when HRG surveys are allowed to resume after a shutdown event, the surveys should be required to use a ramp-up procedure to encourage any nearby marine life to leave the area.

Response: NMFS agrees with this recommendation and included this requirement in the Federal Register notice of the proposed IHA (88 FR 41912, June 28, 2023) and the final IHA as a stipulation that when technically feasible, survey equipment must be ramped up at the start or restart of survey activities. Ramp-up must begin with the power of the smallest acoustic equipment at its lowest practical power output appropriate for the survey. When technically feasible the power must then be gradually turned up and other acoustic sources added in a way such that the source level would increase gradually. NMFS notes that ramp-up is not required for short periods where acoustic sources were shut down ( i.e., less than 30 minutes) if PSOs have maintained constant visual observation and no detections of marine mammals occurred within the applicable Shutdown Zones.

Comment 24: COA states that there is no legal authority for permitting offshore geotechnical and geophysical survey activities under BOEM, based on text from the proposed BOEM Renewable Energy Modernization proposed rule (88 FR 5968, January 30, 2023; 88 FR 19578, April 3, 2023). They further state that this has allowed for no oversight with regards to surveys off New Jersey and New York and that they do not understand how BOEM can make assertions without regulations/guidance for HRG survey work.

Response: NMFS' statutory authority for this particular action is limited to authorizing incidental take of marine mammals. NMFS respectfully refers the commenter to BOEM, the agency with responsibility for managing development of U.S. Outer Continental Shelf energy and mineral resources in an environmentally and economically responsible way.

Comment 25: COA is concerned regarding the number of species that could be impacted by the activities, as well as a lack of baseline data available for species in the area, specifically for harbor seals.

Response: We appreciate the concern expressed by COA. NMFS utilizes the best available science when analyzing which species may be impacted by an applicant's proposed activities. Based on information found in the scientific literature, as well as based on density models developed by Duke University, all marine mammal species included in the proposed Federal Register notice have some likelihood of occurring in Atlantic Shores' survey areas. Furthermore, the MMPA requires us to evaluate the effects of the specified activities in consideration of the best scientific evidence available and, if the necessary findings are made, to issue the requested take authorization. The MMPA does not allow us to delay decision making in hopes that additional information may become available in the future.

Regarding the lack of baseline information cited by COA, with specific concern pointed out for harbor seals, NMFS points to two sources of information for marine mammal baseline information: the Ocean/Wind Power Ecological Baseline Studies, January 2008-December 2009 completed by the New Jersey Department of Environmental Protection in July 2010 ( https://dspace.njstatelib.org/xmlui/handle/10929/68435 ) and the Atlantic Marine Assessment Program for Protected Species (AMAPPS; https://www.fisheries.noaa.gov/new-england-mid-atlantic/population-assessments/atlantic-marine-assessment-program-protected ) with annual reports available from 2010 to 2020 ( https://www.fisheries.noaa.gov/resource/publication-database/atlantic-marine-assessment-program-protected-species ) that cover the areas across the Atlantic Ocean. NMFS has duly considered this and all available information.

Based on the information presented, NMFS has determined that no new information has become available, nor do the commenters present additional information, that would change our determinations since the publication of the proposed notice.

Comment 26: COA and SLC assert that Level A harassment may occur, and that this was not accounted for by NMFS.

Response: NMFS acknowledges the concerns brought up regarding the potential for Level A harassment of marine mammals. However, no Level A harassment is expected to result, even in the absence of mitigation, given the characteristics of the sources planned for use. This is additionally supported by the required mitigation, which further reduces the unlikely potential for any Level A harassment to occur, and very small estimated Level A harassment zones described in Atlantic Shores' 2022 Federal Register notice (87 FR 50293, August 16, 2022) and carried through to the 2023 IHA (88 FR 41912, June 28, 2023). Furthermore, the commenter does not provide any support for the apparent contention that Level A harassment is a potential outcome of these activities.

As discussed in the notice of proposed IHA, NMFS considers this category of survey operations to be near de minimis, with the potential for Level A harassment for any species to be discountable.

Comment 27: COA and Green Oceans expressed concerns regarding the increased amount of vessel traffic associated with the offshore wind project and its impacts on protected resources, as well as concern for vessel noise.

Response: Atlantic Shores did not request authorization for take incidental to vessel traffic during their marine site characterization survey. Nevertheless, NMFS analyzed the potential for vessel strikes to occur during the survey, and determined that the potential for vessel strike is so low as to be discountable. NMFS does not authorize any take of marine mammals incidental to vessel strike resulting from the survey. If Atlantic Shores were to strike a marine mammal with a vessel, this would be an unauthorized take in violation of the MMPA. This gives Atlantic Shores a strong incentive to operate its vessels with all due caution and to effectively implement the suite of vessel strike avoidance measures required by the IHA. Atlantic Shores proposed a very conservative suite of mitigation measures related to vessel strike avoidance, including measures specifically designed to avoid impacts to NARWs. Section 4(g) in the IHA contains a suite of non-discretionary requirements pertaining to vessel strike avoidance, including vessel operation protocols and monitoring. To date, NMFS is not aware of any site characterization vessel from surveys reporting a vessel strike within the United States. When considered in the context of low overall probability of any vessel strike by Atlantic Shores vessels, given the limited additional survey-related vessel traffic relative to existing traffic in the survey area, the comprehensive visual monitoring, and other additional mitigation measures described herein, NMFS believes these measures are sufficiently protective to avoid vessel strike. These measures are described fully in the Description of Mitigation, Monitoring, and Reporting section below, and include, but are not limited to: training for all vessel observers and captains, daily monitoring of NARW Sighting Advisory System, WhaleAlert app, and USCG Channel 16 for situational awareness regarding NARW presence in the survey area, communication protocols if whales are observed by any Atlantic Shores personnel, vessel operational protocol should any marine mammal be observed, and visual monitoring.

The potential for impacts related to an overall increase in the amount of vessel traffic due to offshore wind development is separate from the aforementioned analysis of potential for vessel strike during Atlantic Shores' specified survey activities. For more information, please see the response to comment 11 discussing cumulative impacts.

Comment 28: SLC asserts that NMFS' assessment of sound propagation from the proposed activities does not adequately account for sound bouncing off the underside of the water's surface and other surface reflection.

Response: NMFS does not agree with the commenter that NMFS' analysis of sound propagation is insufficient. While the transmission loss model ( i.e., spherical spreading) used for HRG sources is fairly simplistic and does not directly account for reflections at the surface, it adequately accounts for how sound would propagate through the environment (note that NMFS' isopleth estimates also account for frequency-dependent absorption), and thus provides a realistic approximation of how sounds from these sources are believed to travel through the environment. Accounting for scattering at the surface is heavily dependent on the roughness of the sea surface, with rougher surfaces resulting in more propagation loss (dB) per bounce as the sound hits the water surface ( i.e., this additional dB loss is not accounted for in more simple models). Only flat surfaces would allow for complete reflection of sound.

Comment 29: SLC claims that the weighting curves for low frequency (LF) cetaceans do not align with mysticetes' infrasonic hearing, and urged NMFS to incorporate better estimations for low frequency cetaceans and corresponding thresholds based upon the best available data.

Response: NMFS disagrees that the current low-frequency (LF) cetacean weighting functions are not based on the best available science. While there are very limited data to inform our understanding of mysticete hearing, the generalized hearing range used by NMFS for mysticetes extends from 7 Hz up to 35 kHz, which reflects recommendations made by Southall et al. 2007 and Southall et al. 2019. Hearing predictions for mysticetes are based on other methods including: anatomical studies and modeling (Houser et al., 2001; Parks et al., 2007; Tubelli et al., 2012; Cranford and Krysl, 2015); vocalizations (see reviews in Richardson et al., 1995; Wartzok and Ketten, 1999; Au and Hastings, 2008); taxonomy; and behavioral responses to sound (Dahlheim and Ljungblad, 1990; see review in Reichmuth, 2007). The existing weighting functions reflect LF cetacean infrasonic hearing capabilities to the greatest extent allowed by available data.

Comment 30: Green Oceans suggests that the surveys may result in acute injury of whales as a result of rectified diffusion, i.e., bubble growth caused by acoustic exposure.

Response: With regard to Green Oceans' suggestion that acute injury of whales could occur as a result of bubble formation, this effect is extremely unlikely to occur in the circumstances considered here, i.e., relatively low-level sound exposure in shallow waters. We acknowledge that non-auditory physiological effects or injuries can theoretically occur in marine mammals exposed to high level underwater sound or as a secondary effect of extreme behavioral reactions ( e.g., change in dive profile as a result of an avoidance reaction) caused by exposure to sound. These include neurological effects, resonance effects, and other types of organ or tissue damage (Cox et al., 2006; Southall et al., 2007; Zimmer and Tyack, 2007). The bubble formation, or rectified diffusion, referenced by Green Oceans is another such effect ( e.g., Houser et al., 2001; Tal et al., 2015). However, the survey activities considered here do not involve the use of devices such as explosives or mid-frequency tactical sonar that produce the high-intensity sounds that are associated with these types of effects. While these bubble formation effects remain a theoretical potential cause of marine mammal stranding, it is important to note that theoretical analysis of this potential considers as necessary precedent the condition of deep diving and slow ascent/descent speed, which contributes to increased gas-tissue saturation, prior to high-intensity sound exposure. The survey conditions here, aside from the absence of the high-intensity sound that would be expected to be necessary to cause this effect, preclude the deep diving conditions in which gas supersaturation and the potential for bubble growth might occur—as noted previously, the maximum survey depth is 38 meter (m). Houser et al. (2001) emphasize the importance of dive depth to the rectified diffusion concept in marine mammals, stating that beaked whales and sperm whales (species not expected to be impacted by the proposed survey) may be at greatest risk, with other odontocete species at lesser potential risk. Green Oceans focused its concern on “whales,” which we presume to mean mysticete species, which would be at even lower risk due to typically shallow dive patterns. In summary, the concern raised by Green Oceans regarding potential injury resulting from rectified diffusion is unwarranted due to the shallow survey depths, which preclude the gas-tissue saturation conditions necessary to potentially lead to bubble formation, and the lack of high-intensity sounds necessary to cause bubble expansion.

A description of the marine mammals in the area of the activities can be found in the previous documents and notices for the 2022 IHA (87 FR 38067, June 27, 2022; 87 FR 50293, August 16, 2022), which remain applicable to this IHA. NMFS reviewed the most recent draft Stock Assessment Reports (SARs, found on NMFS' website at https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ), up-to-date information on relevant Unusual Mortality Events (UMEs; https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-unusual-mortality-events ), and recent scientific literature and determined that no new information affects our original analysis of impacts under the 2022 IHA. More general information about these species ( e.g., physical and behavioral descriptions) may be found on NMFS's website ( https://www.fisheries.noaa.gov/find-species ).

NMFS notes that, since issuance of the 2022 IHA, a new SAR is available for the NARW. We note that the estimated abundance for the species declined from 368 to 338. However, this change does not affect our analysis of impacts, as described under the 2022 IHA.

Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities ( e.g., Richardson et al., 1995; Wartzok and Ketten, 1999; Au and Hastings, 2008). To reflect this, Southall et al. (2007) recommended that marine mammals be divided into functional hearing groups based on directly measured or estimated hearing ranges on the basis of available behavioral response data, audiograms derived using auditory evoked potential techniques, anatomical modeling, and other data. Note that no direct measurements of hearing ability have been successfully completed for mysticetes ( i.e., low-frequency cetaceans). Subsequently, NMFS (2018) described generalized hearing ranges for these marine mammal hearing groups. Generalized hearing ranges were chosen based on the approximately 65 dB threshold from the normalized composite audiograms, with the exception for lower limits for low-frequency cetaceans where the lower bound was deemed to be biologically implausible and the lower bound from Southall et al. (2007) retained. Marine mammal hearing groups and their associated hearing ranges are provided in Table 1.

The pinniped functional hearing group was modified from Southall et al. (2007) on the basis of data indicating that phocid species have consistently demonstrated an extended frequency range of hearing compared to otariids, especially in the higher frequency range (Hemilä et al., 2006; Kastelein et al., 2009; Reichmuth and Holt, 2013). For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information.

A description of the potential effects of the specified activities on marine mammals and their habitat may be found in the documents supporting the 2022 IHA (87 FR 38067, June 27, 2022; 87 FR 50293, August 16, 2022). NMFS has determined that there is no new information on potential effects that would impact our analysis.

A detailed description of the methods used to estimate take anticipated to occur incidental to the project is found in the previous Federal Register notices (87 FR 38067, June 27, 2022; 87 FR 50293, August 16, 2022). The methods of estimating take are identical to those used in the 2022 IHA. Atlantic Shores updated the marine mammal densities based on new information (Roberts et al., 2016; Roberts et al., 2023), available online at: https://seamap.env.duke.edu/models/Duke/EC/. We refer the reader to Table 6 in Atlantic Shores' 2023 IHA request for specific density values used in the analysis. The IHA request is available online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-other-energy-activities-renewable.

The take that NMFS has authorized can be found in Table 2, which presents the results of Atlantic Shores' density-based calculations for the survey area. For comparative purposes, we have provided the 2022 IHA authorized take (87 FR 50293, August 16, 2022). NMFS notes that take by Level A harassment was not requested nor does NMFS anticipate that it could occur. Therefore, NMFS has not authorized any take by Level A harassment. Mortality or serious injury is neither anticipated to occur nor authorized.

The required mitigation, monitoring, and reporting measures are identical to those included in the Federal Register notice announcing the final 2022 IHA and the discussion of the least practicable adverse impact included in that document remains accurate. The measures are found below.

Atlantic Shores must also abide by all the marine mammal relevant conditions in the NOAA Fisheries GARFO programmatic consultation (specifically Project Design Criteria (PDC) 4, 5, and 7) regarding geophysical surveys along the U.S. Atlantic coast in the three Atlantic Renewable Energy Regions (NOAA GARFO, 2021; https://www.fisheries.noaa.gov/new-england-mid-atlantic/consultations/section-7-take-reporting-programmatics-greater-atlantic#offshore-wind-site-assessment-and-site-characterization-activities-programmatic-consultation ), pursuant to Section 7 of the Endangered Species Act.

Additionally, on August 1, 2022, NMFS announced proposed changes to the existing NARW vessel speed regulations to further reduce the likelihood of mortalities and serious injuries to endangered NARWs from vessel collisions, which are a leading cause of the species' decline and a primary factor in an ongoing Unusual Mortality Event (87 FR 46921, August 1, 2023). Should a final vessel speed rule be issued and become effective during the effective period of this IHA (or any other MMPA incidental take authorization), the authorization holder would be required to comply with any and all applicable requirements contained within the final rule. Specifically, where measures in any final vessel speed rule are more protective or restrictive than those in this or any other MMPA authorization, authorization holders would be required to comply with the requirements of the rule. Alternatively, where measures in this or any other MMPA authorization are more restrictive or protective than those in any final vessel speed rule, the measures in the MMPA authorization would remain in place. The responsibility to comply with the applicable requirements of any vessel speed rule would become effective immediately upon the effective date of any final vessel speed rule and, when notice is published of the effective date, NMFS would also notify Atlantic Shores if the measures in the speed rule were to supersede any of the measures in the MMPA authorization such that they were no longer applicable.

Establishment of Shutdown Zones (SZ) —Marine mammal SZs must be established around the HRG survey equipment and monitored by NMFS-approved PSOs as follows:

• 500-m SZ for NARWs during use of specified acoustic sources (impulsive: Sparkers; non-impulsive: Non-parametric sub-bottom profilers); and,

• 100-m SZ for all other marine mammals (excluding NARWs) during use of specified acoustic sources (except as specified below). The only exception for this is for pinnipeds (seals) and small delphinids ( i.e., those from the genera Delphinus, Lagenorhynchus, Stenella or Tursiops ).

If a marine mammal is detected approaching or entering the SZs during the HRG survey, the vessel operator will adhere to the shutdown procedures described below to minimize noise impacts on the animals. During use of acoustic sources with the potential to result in marine mammal harassment (sparkers and non-parametric sub-bottom profilers; i.e., anytime the acoustic source is active, including ramp-up), occurrences of marine mammals within the monitoring zone (but outside the SZs) must be communicated to the vessel operator to prepare for potential shutdown of the acoustic source.

Visual Monitoring —Monitoring must be conducted by qualified PSOs who are trained biologists, with minimum qualifications described in the Federal Register notices for the 2022 project (87 FR 38067, June 27, 2022; 87 FR 50293, August 16, 2022). Atlantic Shores must have one PSO on duty during the day and a minimum of two NMFS-approved PSOs must be on duty and conducting visual observations when HRG equipment is in use at night. Visual monitoring must begin no less than 30 minutes prior to ramp-up of HRG equipment and continue until 30 minutes after use of the acoustic source. PSOs must establish and monitor the applicable clearance zones, SZs, and vessel separation distances as described in the 2022 IHA (87 FR 38067, June 27, 2022; 87 FR 50293, August 16, 2022). PSOs must coordinate to ensure 360-degree visual coverage around the vessel from the most appropriate observation posts, and must conduct observations while free from distractions and in a consistent, systematic, and diligent manner. PSOs are required to estimate distances to observed marine mammals. It is the responsibility of the Lead PSO on duty to communicate the presence of marine mammals as well as to communicate action(s) that are necessary to ensure mitigation and monitoring requirements are implemented as appropriate.

Pre-Start Clearance —Marine mammal CZs will be established around the HRG survey equipment and monitored by NMFS-approved PSOs prior to use of sparkers and non-parametric sub-bottom profilers as follows:

• 500-m CZ for all ESA-listed species; and,

• 100-m CZ for all other marine mammals.

Prior to initiating HRG survey activities, Atlantic Shores will implement a 30-minute pre-start clearance period. The operator must notify a designated PSO of the planned start of ramp-up where the notification time should not be less than 60 minutes prior to the planned ramp-up to allow the PSOs to monitor the CZs for 30 minutes prior to the initiation of ramp-up. Prior to ramp-up beginning, Atlantic Shores will receive confirmation from the PSO that the CZs are clear prior to preceding. Any PSO on duty has the authority to delay the start of survey operations if a marine mammal is detected within the applicable pre-start clearance zones.

During this 30-minute period, the entire CZ must be visible. The exception to this would be in situations where ramp-up must occur during periods of poor visibility (inclusive of nighttime) as long as appropriate visual monitoring has occurred with no detections of marine mammals in 30 minutes prior to the beginning of ramp-up. Acoustic source activation must only occur at night where operational planning cannot reasonably avoid such circumstances.

If a marine mammal is observed within the relevant CZs during the pre-start clearance period, initiation of HRG survey equipment must not begin until the animal(s) has been observed exiting the respective clearance zone, or until an additional period has elapsed with no further sighting ( i.e., minimum 15 minutes for small odontocetes and seals; 30 minutes for all other species). The pre-start clearance requirement includes small delphinids. PSOs must also continue to monitor the zone for 30 minutes after survey equipment is shut down or survey activity has concluded.

Ramp-Up of Survey Equipment— When technically feasible, a ramp-up procedure must be used for geophysical survey equipment capable of adjusting energy levels at the start or re-start of survey activities. The ramp-up procedure must be used at the beginning of HRG survey activities in order to provide additional protection to marine mammals near the project area by allowing them to detect the presence of the survey and vacate the area prior to the commencement of survey equipment operation at full power. Ramp-up of the survey equipment must not begin until the relevant SZs have been cleared by the PSOs, as described above. HRG equipment operators must ramp up acoustic sources to half power for 5 minutes and then proceed to full power. If any marine mammals are detected within the SZs prior to or during ramp-up, the HRG equipment must be shut down (as described below).

Shutdown Procedures— If an HRG source is active and a marine mammal is observed within or entering a relevant SZ (as described above), an immediate shutdown of the HRG survey equipment is required. When shutdown is called for by a PSO, the acoustic source must be immediately deactivated and any dispute resolved only following deactivation. Any PSO on duty has the authority to delay the start of survey operations or to call for shutdown of the acoustic source if a marine mammal is detected within the applicable SZ. The vessel operator must establish and maintain clear lines of communication directly between PSOs on duty and crew controlling the HRG source(s) to ensure that shutdown commands are conveyed swiftly while allowing PSOs to maintain watch. Subsequent restart of the HRG equipment may only occur after the marine mammal has been observed exiting the relevant SZ, or, until an additional period has elapsed with no further sighting of the animal within the relevant SZ.

Upon implementation of shutdown, the HRG source may be reactivated after the marine mammal that triggered the shutdown has been observed exiting the applicable SZ or following a clearance period of 15 minutes for small odontocetes and seals and 30 minutes for all other species with no further observation of the marine mammal(s) within the relevant SZ. If the HRG equipment is shut down for brief periods ( i.e., less than 30 minutes) for reasons other than mitigation ( e.g., mechanical or electronic failure), the equipment may be re-activated as soon as is practicable at full operational level, without 30 minutes of pre-clearance, only if PSOs have maintained constant visual observation during the shutdown and no visual detections of marine mammals occurred within the applicable SZs during that time. For a shutdown of 30 minutes or longer, or if visual observation was not continued diligently during the pause, pre-clearance observation is required, as described above. The acoustic source(s) must be deactivated when not acquiring data or preparing to acquire data, except as necessary for testing. Unnecessary use of the acoustic source shall be avoided.

The shutdown requirement is waived for pinnipeds (seals) and certain genera of small delphinids ( i.e., Delphinus, Lagenorhynchus, Stenella, or Tursiops ) under certain circumstances. If a delphinid(s) from these genera is visually detected within the SZ, shutdown would not be required. If there is uncertainty regarding identification of a marine mammal species ( i.e., whether the observed marine mammal(s) belongs to one of the delphinid genera for which shutdown is waived), PSOs must use best professional judgment in making the decision to call for a shutdown.

If a species for which authorization has not been granted, or a species for which authorization has been granted but the authorized number of takes have been met, approaches or is observed within the area encompassing the Level B harassment isopleth (141 m), shutdown must occur.

Vessel Strike Avoidance— Atlantic Shores must comply with vessel strike avoidance measures as described in the Federal Register notice for the 2022 IHA (87 FR 50293, August 16, 2022). This includes speed restrictions (10 kn (18.5 km/hour) or less) when mother/calf pairs, pods, or large assemblages of cetaceans are spotted near a vessel; species-specific vessel separation distances; appropriate vessel actions when a marine mammal is sighted ( e.g., avoid excessive speed, remain parallel to animal's course, etc. ); and monitoring of the NMFS NARW reporting system and WhaleAlert daily.

Throughout all phases of the survey activities, Atlantic Shores must monitor NOAA Fisheries NARW reporting systems for the establishment of a DMA. If NMFS establishes a DMA in the surrounding area, including the project area or export cable routes being surveyed, Atlantic Shores is required to abide by the 10-kn (18.5 km/hour) speed restriction.

Seasonal Operating Requirements— Atlantic Shores will conduct HRG survey activities in the vicinity of a NARW Mid-Atlantic SMA. Activities must comply with the seasonal mandatory speed restriction period for this SMA (November 1 through April 30) for any survey work or transit within this area.

Training —Project-specific training is required for all vessel crew prior to the start of survey activities.

Reporting —PSOs must record specific information as described in the Federal Register notice of the issuance of the 2022 IHA (87 FR 50293, August 16, 2022). Within 90 days after completion of survey activities, Atlantic Shores must provide NMFS with a monitoring report, which must include summaries of recorded takes and estimates of the number of marine mammals that may have been harassed.

In the event of a ship strike or discovery of an injured or dead marine mammal, Atlantic Shores must report the incident to the Office of Protected Resources (OPR), NMFS and to the New England/Mid-Atlantic Regional Stranding Coordinator as soon as feasible. The report must include the information listed in the Federal Register notice of the issuance of the initial IHA (87 FR 50293, August 16, 2022).

Atlantic Shores' HRG survey activities are unchanged from those analyzed in support of the 2022 IHA. The effects of the activity, taking into consideration the mitigation and related monitoring measures, remain unchanged from those evaluated in support of the 2022 IHA, regardless of the minor increases in estimated take for two marine mammal species (humpback whale and minke whale). NMFS expects that all potential takes would be short-term Level B behavioral harassment in the form of temporary avoidance of the area or decreased foraging (if such activity was occurring), reactions that are considered to be of low severity and with no lasting biological consequences ( e.g., Southall et al., 2007). In addition to being temporary, the maximum expected harassment zone around a survey vessel is 141 m from use of the AA Dura-spark sparker. Although this distance is assumed for all survey activity evaluated here and in estimating authorized take numbers, in reality, much of the survey activity would involve use of non-impulsive acoustic sources with a reduced acoustic harassment zone of up to 56 m, producing expected effects of particularly low severity. The ensonified area surrounding each vessel is extremely small compared to the overall distribution of the animals in the area and the available habitat.

Feeding behavior is not likely to be significantly impacted as prey species are mobile and are broadly distributed throughout the survey area; therefore, marine mammals that may be temporarily displaced during survey activities are expected to be able to resume foraging once they have moved away from areas with disturbing levels of underwater noise. Because of the temporary nature of the disturbance and the availability of similar habitat and resources in the surrounding area, the impacts to marine mammals and the food sources that they utilize are not expected to cause significant or long-term consequences for individual marine mammals or their populations. Even considering the increased estimated take for some species, the impacts of these lower severity exposures are not expected to accrue to a degree that the fitness of any individuals would be impacted and, therefore, no impacts on the annual rates of recruitment or survival would result.

As previously discussed in the 2022 IHA (87 FR 50293, August 16, 2022), impacts from the survey are expected to be localized to the specific area of activity and only during periods when Atlantic Shores' acoustic sources are active. There are no rookeries, mating or calving grounds, or any feeding areas known to be biologically important to marine mammals within the survey area. There is no designated critical habitat for any marine mammals listed under the ESA in the survey area.

As noted for the 2022 IHA (87 FR 50293, August 16, 2022), the survey area overlaps a migratory corridor BIA and migratory route SMA (Port of New Jersey/New York) for NARWs. As the survey activities would be temporary and the spatial acoustic footprint produced by the survey would be very small relative to the spatial extent of the available migratory habitat in the BIA (269,448 km 2 ), NMFS does not expect NARW migration to be impacted by the survey. Required vessel strike avoidance measures would also decrease risk of ship strike during migration; no ship strike is expected to occur during Atlantic Shores' activities. Atlantic Shores would be required to comply with seasonal speed restrictions of these SMAs, and in any DMA, should NMFS establish one (or more) in the survey area. Additionally, Atlantic Shores requested, and NMFS has authorized, only five takes by Level B harassment of NARWs. This amount is less than the 24 Level B harassment takes authorized in the 2022 IHA due to the updated Duke University density data (Roberts et al., 2023).

Although take by Level B harassment of NARWs has been authorized by NMFS, we anticipate such take may not actually occur, and should it occur, we anticipate a very low level of harassment because Atlantic Shores is required to maintain a shutdown zone of 500 m if a NARW is observed. The authorized takes account for any missed animals wherein the survey equipment is not shut down immediately. As shutdown would be called for immediately upon detection (if the whale is within 500 m), it is likely the exposure time would be very limited and received levels would not be much above the harassment threshold. Further, the 500-m SZ for NARWs is conservative, considering the Level B harassment isopleth for the most impactful acoustic source ( i.e., AA Dura-spark sparker) is estimated to be 141 m, and thereby minimizes the potential for behavioral harassment of this species. As noted previously, Level A harassment is not expected due to the small PTS zones associated with HRG equipment types planned for use. NMFS does not anticipate NARW takes that would result from Atlantic Shores' activities would impact annual rates of recruitment or survival. Thus, any takes that occur would not result in population level impacts.

We also note that our findings for other species with active UMEs that were previously described for the 2022 IHA remain applicable to this project. Therefore, in conclusion, there is no new information suggesting that our analysis or findings should change.

Based on the information contained here and in the referenced documents, NMFS has determined the following: (1) the required mitigation measures would effect the least practicable impact on marine mammal species or stocks and their habitat; (2) the authorized takes would have a negligible impact on the affected marine mammal species or stocks; (3) the authorized takes represent small numbers of marine mammals relative to the affected stock abundances; (4) Atlantic Shores' activities would not have an unmitigable adverse impact on taking for subsistence purposes as no relevant subsistence uses of marine mammals are implicated by this action; and (5) appropriate monitoring and reporting requirements are included.

Section 7(a)(2) of the Endangered Species Act of 1973 (ESA; 16 U.S.C. 1531 et seq. ) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS consults internally whenever we propose to authorize take for endangered or threatened species.

NMFS has authorized the incidental take of four species of marine mammals which are listed under the ESA, the North Atlantic right, fin, sei, and sperm whale, and has determined that this activity falls within the scope of activities analyzed in NMFS Greater Atlantic Regional Fisheries Office's programmatic consultation regarding geophysical surveys along the U.S. Atlantic coast in the three Atlantic Renewable Energy Regions (completed June 29, 2021; revised September 2021).

To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq. ) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action ( i.e., the issuance of an IHA) with respect to potential impacts on the human environment. This action is consistent with categories of activities identified in Categorical Exclusion B4 (IHAs with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review.

NMFS has issued an IHA to Atlantic Shores for the potential harassment of small numbers of 15 marine mammal species incidental to marine site characterization surveys offshore of New Jersey and New York, provided the previously mentioned mitigation, monitoring, and reporting requirements are followed.

Section 117 of the MMPA (16 U.S.C. 1361 et seq. ) requires NMFS and the U.S. Fish and Wildlife Service (FWS) to prepare stock assessments for each stock of marine mammals occurring in waters under the jurisdiction of the United States, including the U.S. Exclusive Economic Zone (EEZ). These SARs must contain information regarding the distribution and abundance of the stock, population growth rates and trends, estimates of annual human-caused mortality and serious injury (M/SI) from all sources, descriptions of the fisheries with which the stock interacts, and the status of the stock. Initial SARs were completed in 1995.

The MMPA requires NMFS and FWS to review the SARs at least annually for strategic stocks and stocks for which significant new information is available, and at least once every 3 years for non-strategic stocks. The term “strategic stock” means a marine mammal stock: (A) for which the level of direct human-caused mortality exceeds the potential biological removal level or PBR (defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population); (B) which, based on the best available scientific information, is declining and is likely to be listed as a threatened species under the Endangered Species Act (ESA) within the foreseeable future; or (C) which is listed as a threatened species or endangered species under the ESA or is designated as depleted under the MMPA. NMFS and FWS are required to revise a SAR if the status of the stock has changed or can be more accurately determined.

In order to ensure that marine mammal SARs are based on the best scientific information available, the updated SARs under NMFS' jurisdiction are peer-reviewed within NOAA Fisheries Science Centers and by members of three regional independent Scientific Review Groups (SRGs) established under the MMPA to independently advise NMFS and FWS on marine mammal issues. Because of the time it takes to review, revise, and assess available data, the period covered by the 2022 Final SARs is 2016 through 2020. While this results in a time lag, the extensive peer review process ensures that the SARs are based on the best scientific information available.

NMFS reviewed the status of all marine mammal strategic stocks and considered whether significant new information was available for all non- strategic stocks under NMFS' jurisdiction. As a result of this review, NMFS revised reports for 25 stocks in the Alaska, Atlantic, and Pacific regions to incorporate new information. The 2022 revisions to the SARs include revisions to stock structures, updated or revised human-caused mortality/serious injury (M/SI) estimates, and updated abundance estimates. With the publication of these SARs, the revised stock structure for all North Pacific humpback whale stocks and Southeast Alaska harbor porpoises is finalized. The revisions to stock structure and the addition of new reports resulted in five newly designated strategic stocks and three newly designated non-strategic stocks. No stocks changed in status from “non-strategic” to “strategic.” One Western North Atlantic common bottlenose dolphin stock, the Northern South Carolina Estuarine System Stock, changed from “strategic” status to “non-strategic.” A technical update was made to the Northern Gulf of Mexico Bay, Sound, and Estuary stocks of common bottlenose dolphin SAR that covers 23 Northern Gulf of Mexico stocks to move Florida Bay from the Western North Atlantic to the Gulf of Mexico. Florida Bay is now included within Table 1 and Figure 1 of the SAR, and the number of stocks in the Gulf of Mexico has been updated accordingly. No other changes or updates were made to that SAR.

NMFS received comments on the draft 2022 SARs from the Marine Mammal Commission (Commission); the Department of Fisheries and Oceans Canada (DFO); the Washington Department of Fish and Wildlife (WDFW); the Alaska Department of Fish and Game (ADFG); seven fishing industry associations (California Coast Crab Association (CCCA), West Coast Pelagic (WCP), Maine Lobstermen's Association (MLA), Washington Dungeness Crab Fishermen's Association (WDCFA, United Fishermen of Alaska (UFA), Southeast Alaska Fishermen's Alliance (SEAFA), and United Southeast Alaska Gillnetters (USAG)); a non-governmental organization (Natural Resources Defense Council (NRDC)); and two letters from the public. Responses to substantive comments are below. Responses to comments not related to the SARs are not included. Comments suggesting editorial or minor clarifying changes were incorporated in the reports, but they are not included in the summary of comments and responses. We did not reply to comments outside the scope of the SARs ( e.g., regulating impacts of offshore wind). In some cases, NMFS' responses state that comments would be considered or incorporated in future revisions of the SARs rather than being incorporated into the final 2022 SARs.

Comment 1: The Commission recommends that NMFS secures the resources necessary to conduct the surveys required to produce complete and up-to-date SARs and work with other agencies to collect the information needed. Additionally, the Commission recommends NMFS provide sufficient personnel and resources to maximize the value of surveys by allowing for photo-identification, biopsy sampling, satellite tagging, acoustic monitoring, and other efforts, which provide valuable information for understanding marine mammal distribution, habitat use, health, and behavior.

Response: NMFS acknowledges the Commission's comment and will continue to prioritize our efforts to collect needed data, as resources allow.

Comment 2: The Commission recommends that NMFS set a deadline to make draft SARs available for public review no later than the end of September each year and allow for more thoughtful review by interested parties.

Response: NMFS thanks the Commission for the recommendation; we strive to keep the SARs on schedule and released to the public as quickly as possible.

Comment 3: A member of the public comments that the SARs fail to provide information on whether dolphin populations are increasing, decreasing, or staying the same. They state that the lack of information on population trends in these reports makes them of little use to scientists trying to protect dolphins.

Response: NMFS agrees that long-term time series trend analyses are useful while also acknowledging that it is difficult to achieve the appropriate precision and accuracy needed to detect trends (Authier et al. 2020). When sufficient information is available to evaluate trends, the information is included within the SAR. We will continue to prioritize our efforts to collect data to address abundance estimates and trends as resources allow.

Comment 4: The Commission comments that the change to the status of four bottlenose dolphin stocks from “strategic” to “non-strategic” lacks adequate justification. The Commission notes estimates of human-caused M/SI are based on minimum counts and are likely to be higher in reality and is concerned about the proposed changes. Also, the Commission notes that Wells et al. (2015) estimated the proportion of carcasses recovered to be 0.33 for common bottlenose dolphins near Sarasota, Florida, but less populated areas and those with intricate networks of marsh habitat likely have substantially lower carcass detections. The Commissions recommends the following: reevaluate the strategic status of these four stocks, considering all available scientific information regarding plausible human-caused M/SI beyond the minimum count of detected strandings and at-sea observations; substantially increase efforts to investigate alternative strategies for collecting information on human-caused M/SI for bays, sounds, and estuaries (BSE) common bottlenose dolphin stocks for which entanglements are difficult to detect or quantify, and for which observer programs are lacking.

Response: NMFS had proposed to change the status of four stocks of bottlenose dolphin (the Northern South Carolina Estuarine System, the Central Georgia Estuarine System, the Southern Georgia Estuarine System, and the Biscayne Bay—88 FR 4162 01-24-34). Based on the Commission's comment, NMFS reevaluated the strategic status of the four stocks. We revisited Wells et al. (2015) and implemented a lower stranded carcass recovery rate for some stocks as recommended by the Commission. We estimated M/SI (NMFS 2023) based on two carcass recovery rate estimates: 0.33 for Sarasota Bay (Wells et al. 2015) and 0.16 for Barataria Bay (DWH MMIQT 2015). Using the best available scientific information on the minimum abundance for each of these stocks, we concluded that annual human-caused M/SI for three stocks (Central Georgia Estuarine System, Southern Georgia Estuarine System, and Biscayne Bay) exceed PBR. Hence, these stocks' strategic status will remain unchanged. Regardless of the stranded carcass recovery rate, the Northern South Carolina Estuarine System Stock is non-strategic. An additional explanation for the rationale of each stock's status was provided within the Status of Stock sections.

Comment 5: The DFO strongly disagrees with the gear origin country assignment given to North Atlantic right whale (NARW) #3920. The gear removed from #3920 was reviewed by the DFO and country/fishery of origin was found to be inconclusive. The cases which DFO disagrees with the country of origin assignment are as follows: Mortalities—right whale #3893, #3694, #3920 and Serious Injury—right whale #4094 and #3125.

Response: NMFS responds to the specific cases below and looks forward to continuing work with Canada on transboundary gear analyses to further our understanding of incident origins. Right whale cases #3893, #3694, and #3125 would benefit from bilateral gear analysis; but without new incident documentation, under longstanding NMFS protocols ( https://www.greateratlantic.fisheries.noaa.gov/policyseries/index.php/GARPS/article/view/30/26 ), NMFS would not change the current attribution. Regarding #3920 and the potential uncertainties described in the DFO report “Recovered Gear Analysis of North Atlantic Right Whale Eg #3920 `Cottontail' ”—references multiple isolated gear elements. The collective evidence (see report here https://media.fisheries.noaa.gov/2022-10/E22-20Cottontail-gear-analysis-updated-draft-GARFO.pdf ) supports the conclusion that the recovered gear is consistent with the 2018/2019 Canadian Snow Crab Fishery. Regarding #4094, NMFS would consider changing the status to XC if Canada revises the published incident report (of which DFO are contributing authors) that identified this as Canadian snow crab gear.

Comment 6: MLA comments that the Pace model's initial estimated population decline from 2011-2015 occurred during a time when NARW geographic distribution shifted to areas lacking survey effort and may be an underestimate of the population. MLA requests NMFS discuss the model's limitations and ensure they are taken into account as new data from the realigned survey effort are incorporated into the model. The draft SAR underweights the existence of natural predation as demonstrated by Taylor (2013), Curtis (2014), and Sharp (2019). MLA comments that the SAR must cite relevant literature on natural mortality in both NARW and closely related species, and discuss how the treatment of this significant factor affects population models. Finally, MLA believes Pace (2021) incorrectly assumes an equal sex ratio and probability of mortality. Males are known to make up a larger portion of the population and are statistically more likely to encounter and become entangled in a vertical line.

Response: The Pace et al. (2017) and slightly updated Pace (2021) Mark-Recapture-Resight (MRR) model have been reviewed by both a journal peer review process for publication as well as more than 6 years of Atlantic SRG meetings across 20 expert members. Its contents are publicly available to review as the documents are cited within the SAR.

The MRR model published by Pace et al. (2017) uses the sighting histories of individuals (adults and subadults) to estimate interval (in this case, annual) capture probabilities, which are allowed to vary at each interval. Indeed, the estimated capture probabilities since 2011 of NARW have shown considerable variation compared with the previous decade. The statistical methodology employed simultaneously estimates rates of survival and capture and estimates the number of whales still alive. Additionally, the MRR model allows individual animals to have unique catchability parameters, thus reducing biases in capture rates found in simpler MRR models. The model does not assume an equal sex ratio and allows survival and capture rates to differ between the sexes. Although there is no accommodation for permanent emigration, there is no evidence that even modest numbers of NARW have permanently left all the areas surveyed in the United States and Canada, and all individuals identified in extralimital sightings have been seen in U.S. waters again following their oceanic sojourns. Hence, NMFS concludes that the estimated survival rates presented in the SAR and reflected in the abundance estimates represent actual survival rates of the stock and not merely apparent survival rates. Finally, it is important to note that the Pace et al. (2017) model relies on individual animals being photographically identifiable from their callosity patterns in order for them to be recruited into the population. Since these patterns do not typically stabilize until animals are at least 1 year old, the resulting abundance estimates, as well as the associated estimated total mortality estimated sensu Pace et al. (2021), only represent adult and subadult animals.

Regarding natural mortality, NMFS and the SAR acknowledge that some natural mortality of calves exists, which is not inconsistent with the documented shark predation on calves, as noted by the commenter (Taylor 2013; Curtis 2014). However, we cannot speak to the comments related to a Sharp et al. (2019) reference. Our reading of Sharp et al. (2019) included a review of only 70 NARW incidents, and the paper does not support the cited incident designations. There are no observations that attribute adult or subadult mortality to natural causes and only these age classes are included in the Pace et al. (2021) model estimates of total mortality. NMFS reviewed relevant data, existing models, and the literature with the Atlantic SRG on September 2, 2021, and requested their expert guidance on how to attribute estimated total mortality (adults and sub adults) to cause. The Atlantic SRG recommended NMFS continue to assign 100 percent of the total estimated mortalities of non-calf NARW ( i.e., adult and subadult) to anthropogenic origins (Atlantic SRG letter to NMFS September 16, 2021).

Comment 7: MLA asserts that NMFS' determination that 87 percent of undetected, assumed carcasses represent whales killed by fishing entanglements is unsupported and arbitrary. The draft 2022 SAR includes new text that entanglement is more likely to be detected than vessel strikes, which raises concern with NMFS' method of apportioning unknown sources of human-caused mortality. MLA questions NMFS' conclusion that because 87 percent of the observed, seriously injured right whales are caused by an entanglement, then 87 percent of assumed, undetected carcasses are similarly killed by entanglements. MLA believes it is more likely that the observed data with respect to carcass status as discussed in Pace (2021) are correct—that entanglements and vessel strikes kill whales in roughly equal proportions as reported in Sharp (2019). MLA thinks it is also plausible that when a whale is struck by a vessel, it is more likely to be killed than it is to be seriously injured. In contrast, MLA notes a majority of entanglements are of minor severity, when an incident occurs it is less likely to result in death, and mortality as a result of entanglement would probably be detected due to the amount of time that elapses between when an animal is entangled and when the animal ultimately dies.

Response: NMFS continues to agree that no empirical study supports that whale carcasses are more likely to be detected when caused by vessel strikes, as opposed to entanglement. However, SARs provide published information on our current understanding of the right whale population, including trends in strandings and sightings data and a published hypothesis suggesting a disparity between detected entanglement/vessel strike serious injuries. Moore et al.' s (2020) hypothesis is founded in the physics of buoyancy on marine mammal bodies under varying conditions. There may be factors that increase the likelihood of detection of entanglements due to serious injuries. Lacking sufficient evidence regarding the likelihood of detecting vessel strikes or entanglements to inform an understanding of the cause of unseen, estimated mortalities of adults and sub adults, NMFS proposed many alternative scenarios to the Atlantic SRG on how best to apportion cryptic mortality (NMFS intersessional September 21, 2021). The Atlantic SRG recommended that the ratio between entangled and vessel-struck NARW, 70 percent (Table 2, NARW SAR), calculated from documented observations of Serious Injuries and Mortalities over the last 5 years, be used to apportion cause. NMFS scientists will continue to review published literature and work on improving methods of apportioning causes of estimated but unseen mortalities of adults and subadults. The Atlantic SRG will continue to consider the evidence presented as part of their responsibility in peer reviewing the SARs.

Comment 8: MLA requests the draft SAR present the annual mortality and serious injury estimates by each fishery and describe area differences in such injuries. By lumping Canadian and U.S. fisheries together in the annual summaries presented in Table 2, MLA feels NMFS misleads the public with the implication that all of these injuries are attributable to U.S. fisheries. MLA requests that NMFS describe the observed M/SI by fishery for each year of the relevant 5-year reporting period. Specifically, MLA requests Table 2 to include summarized data concerning the country of origin of NARW entanglements during the relevant time period, taking into account scientific observations of entangling gear, the differentiating attributes of that gear, such as rope diameter and strength which influence comparative lethality, and describe the differences between the conservation programs and relative effectiveness of measures to protect NARW in each country.

Response: NMFS continues to provide all available details on locations where right whale serious injury and mortality incidents are first observed and, when available, where the incidents originated (see Table 3, NARW SAR). Additionally, NMFS attempts to provide the maximum precision and resolution in apportioning all M/SI to fishery, vessel, or other causes following practices that have been peer-reviewed and recommended by the Atlantic SRG. However, sufficient evidence to assign entanglements to a specific country or fishery is usually lacking, given the rare instances of recovered gear with sufficient markings to distinguish initial entanglement location, gear type, or fishery. Because right whales are able to travel thousands of miles in short periods of time, even when trailing gear, it is very difficult to attribute entanglement based on the region of the initial sighting. Upon conferring with the Atlantic SRG, NMFS determined that there was insufficient information to provide guidance on the apportionment of estimated entanglements to a country of origin. We believe the expansion of gear marking and reporting requirements will assist us in this area moving forward.

NMFS has invested considerable effort in developing better methods for apportioning M/SI to appropriate sources in light of increased mortality overall, including increasing observations determined to have occurred in Canadian fisheries. We are also working to improve our ability to quantify unseen (estimated) mortality of adults and subadults and to evaluate if and how to apportion natural versus anthropogenic mortality. As mentioned above, as part of this effort, the agency convened a special session of the Atlantic SRG in September 2021 for scientific and technical input. The Atlantic SRG supported its prior position that 100 percent of the mortalities of non-calf NARW should be considered to be of anthropogenic origin. The Atlantic SRG also considered the various approaches provided by NMFS for apportioning M/SI between the United States and Canada but did not have enough information to provide a robust scientific alternative. Therefore, NMFS continues to use the best available information available to assign documented (and unobserved, estimated) mortalities and serious injuries (those identified as likely to result in mortality) to country and type of fishery. We continue to work with Canada on transboundary retrieved gear analyses and risk modeling. As science advances and more data become available, NMFS will consider assigning M/SI with greater resolution if scientifically appropriate, and if resources allow.

Comment 9: MLA believes the NARW SAR should describe interactions between NARW and commercial fisheries, and this must include the information called for in section 117(a)(4) of the MMPA. MLA comments the SAR should also include data on the severity of entanglements, and MLA believes the SAR does not provide understanding of scarring data for the relevant time period.

Response: The fisheries are summarized in “Appendix 3—Fishery Descriptions” because there are multiple species interactions with multiple fisheries. They are also available online at https://www.fisheries.noaa.gov/national/marine-mammal-protection/list-fisheries-summary-tables with table II category I and II fisheries referenced. NMFS cites our annual report that documents the details of our determination process for all reported injuries during the SAR time frame. Analyses of gear retrieved from large whales are also available online at https://www.fisheries.noaa.gov/new-england-mid-atlantic/marine-mammal-protection/atlantic-large-whale-take-reduction-plan. However, because only a small fraction of entanglements have gear recovered and a smaller fraction of that is traceable to the fishery, we have not been able to estimate the annual M/SI to the resolution of fishery and region of origin. Given new recommendations for the Atlantic SRG at the 2021 meeting and additional analysis from Pace et al. (2021), we are working to improve our understanding of this issue toward the resolution requested above for future SARs. We address this to the extent that data can support in Table 3. We discuss non-serious injuries in the third paragraph of the section titled “Fishery-Related Mortality and Serious Injury.” The report cites Knowlton et al. (2016) and, more recently, Hamilton et al. (2019), which indicate that the percentage of the population experiencing non-serious injuries is increasing (26 and 30 percent, respectively). Despite roughly 100 injuries per annum in recent years, the incidents causing injuries are rarely observed. Wounds can persist for years, while animals may travel thousands of miles. Therefore, NMFS takes a conservative approach to not apportion injury by fishery or areas where data are unavailable. Additional language to address this concern has been added to the first paragraph of the “Fishery-Related Mortality and Serious Injury” section of the SAR.

Comment 10: MLA asserts that the draft NARW SAR should include additional available scientific information about NARW behavior and associated risk of harm from fishing gear. MLA believes there are areas where NARW are rarely, if ever, observed and so NMFS' characterization of NARW year-round presence in the Gulf of Maine is misleading. These findings were most recently summarized and reported in Meyer-Gutbrod (2021); MLA requests this paper be referenced and discussed in the draft SAR. Additionally, Crowe (2021) determined that the Gulf of St. Lawrence is currently an important habitat for 40 percent of the right whale population.

Response: The distribution changes and observations in the comment are correct. However, they are based on the assumption that NARW are only subject to mortality when they occur in dense aggregations and that those areas are the only regions that should be managed for NARWs. In reality, dense aggregations in limited, small regions only occur during a portion of the year, and at no time of year are all right whales detected within known aggregations. NMFS recognizes that management measures must also reflect the documented acoustic presence of NARW during much of the year across their entire range, including areas of overlap with the Maine lobster fishery. There has been more recent acoustic monitoring, but these surveys cannot detect mortality/injury, determine the number of animals, or detect the presence of animals if they are not calling. Thus, gaps in visual survey data contribute to gaps in our understanding of NARW distribution and the locations of M/SI events. Recent congressional appropriations to increase surveillance in the Gulf of Maine may result in refining the identification of risk areas.

Comment 11: MLA comments that the NARW SAR's reference to “New England” waters must specify that these important areas are located in southern New England. Also, MLA notes that the draft SAR under-reports recent calving data, stating that “despite high survey effort, only 5 and 0 calves were detected in 2017 and 2018, respectively,” and adding that 7 were born in 2019 and 10 in 2020. The draft SAR omits the most recent calf detections from 2021, 2022, and 2023 (to date) with 20, 15 and 12 calves detected, respectively. The section summarizing M/SI should be renamed “Vessel Strike-Related Mortality and Serious Injury” as is done for the section on M/SI from fishery-related M/SI. In the 2020 SAR, NMFS removed language stating that the majority of right whale sightings occur within 90 kilometers (km) of the shoreline of the southeastern United States. NMFS correspondingly added a sentence stating that “telemetry data have shown rather lengthy excursions, including into deep water off the continental shelf (Mate et al. 1997; Baumgartner and Mate 2005).” Both statements should be included and NMFS can simply add a sentence explaining the effort discrepancy. Finally, the SAR should report recent findings from the Canadian government that determined: “[T]he movement behaviour of individual NARW [in the Gulf of St. Lawrence] was highly variable. Some individuals did not move far between successive days while others moved considerable distances. Some whales in the southwestern Gulf of St. Lawrence were estimated to move as much as 50 km in a single day.”

Response: The description of NARW feeding grounds reflects NMFS' current understanding. Acoustic monitoring in the central Gulf of Maine indicates right whales are present in areas besides southern New England. The calves born during 2021-2023 fall outside of the reporting period for this report. The “Other Mortality” heading has been a standard heading for stock assessment reports for all species. The “vessel strike” classification is accounted for in Table 3. NMFS believes our description of right whale sightings, distribution, and movement is as comprehensive and accurate as the data and available analyses currently allow.

Comment 12: MLA states that the draft NARW SAR continues to cite Kenney (2018) and asserts that this reference is fundamentally flawed. Specifically, MLA believes the methods used in the study fail to account for basic biological processes—namely, natural death. Further, calves have natural mortality rates that are ignored during scenarios when they are included in this model.

Response: As stated in previous responses to public comments, the Kenney (2018) reference is a relevant, peer-reviewed study that helps provide context to the impacts of fishery-related mortality on the NARW population. The study does account for non-fisheries mortality ( e.g., vessel strikes, calving declines, resource limitation, etc.), removing only confirmed fishery-related deaths and serious injuries (likely to result in death). Several scenarios are provided with varying levels of hypothetically-reduced entanglement mortality rates corresponding to degrees of compliance with MMPA regulations. While the paper presents a simple representation of complex processes, the model parameters are reasonable, and the results are informative for the reader to appreciate the cumulative impact of entanglement on the population. Any element of natural mortality or other processes affecting the population other than documented entanglement mortality is accounted for by using the time series of abundance estimates as a baseline.

The inclusion of the unrealized calves in the paper acknowledges basic population biology and the outsized effect of removing productive females on a population's trajectory cannot be ignored. Kenny (2018) treats this effect conservatively. Proven female calving intervals have varied between 3 and 10 years, but are primarily in the 3- to 7-year range, so the choice of a 5-year calving interval is well-founded. The paper's total of 26 calves lost due to the deaths of 15 females over 27 years equals an unrealized population increase of much less than 0.01 per year (1 divided by the average annual population size). This undoubtedly underrepresents the actual value, given that only known females documented as dead or seriously injured were used in the analysis.

Comment 13: MLA notes that the draft NARW SAR includes recent research by Stewart et al. (2021) without stating that the NARW body size since 1981 does not correlate with calving rates. MLA believes there are limitations to the study's sample size of seven individuals with severe maternal entanglement injuries, particularly when these instances are conflated by the primary factor driving body size—birth year ( i.e., oceanographic conditions). To this point, MLA comments that the draft SAR should not only cite Christiansen (2020) when drawing inferences from the southern population of right whales, but also Miller et al. (2011). Additionally, in the years following 1998-2002 (the time period sampled by Miller et al. (2011)), there were 9 consecutive above-average years in NARW calving rate.

Response: NMFS agrees that prey availability is likely an important contributor to the observed decrease in right whales' size. Decreased size also appears to be related to reduced fecundity, with smaller and less robust females less likely to calve (Stewart et al. 2022). Miller et al. (2011) is a good addition to this section, along with Fortune et al. (2013). The impact of injury on the physiological state of females is also well documented ( i.e., Rolland et al. 2016; Pettis et al. 2017; van der Hoop 2017), so it is likely the population's fecundity is being impacted by injury as well. Variation in birth rates should be expected for capital breeders in a variable environment, and the current downward trend in calving corresponds to documented shifts in right whale prey. However, the impacts of injury must be considered. Mortality rates have increased significantly during the same period, and sublethal injuries have likely increased as well.

Comment 14: Natural Resource Defense Council (NRDC) is concerned by the draft's assessment of scientific information on Rice's whale habitat use in the western Gulf of Mexico, and particularly by its suggestion that the whale's regularity of occurrence there is “unknown.” The persistent occurrence of some Rice's whales in the northwestern Gulf of Mexico has recently been documented using passive acoustics. This evidence of regular use of the continental shelf break by at least a portion of the Rice's whale population complements newly available habitat suitability predictions as well as forthcoming habitat suitability and prey condition analyses from NOAA, all of which indicate an extension of the whale's habitat between the 100 and 400 meter (m) isobaths across the northwestern Gulf. NRDC recommends that the draft be lightly edited to make this distinction clear, and also recommends that the present distribution map be replaced with one that displays the species' extended habitat, with the hydrophone locations from Soldevilla et al. (2022a, 2022b) and the 3 western Gulf sightings also indicated, if desired.

Response: NMFS has slightly edited the “Stock Definition and Geographic Range” section per the suggestion to remove “unknown” and better clarify that there is some information regarding Rice's whale distribution in the northwestern Gulf. The distribution map includes the genetically confirmed sighting in the northwestern Gulf off Texas, and the core habitat is shaded. All information about known distribution, including the genetically confirmed sighting, is included within the text. We believe that including the locations of high-frequency acoustic recording packages (HARP) on the map, which typically includes locations of visual sightings only, could confuse readers. We refer those interested in details of the calls detected from HARPs to see Soldevilla et al. (2022a), which we reference and summarize within the SAR.

Comment 15: NRDC recommends that NMFS update the Rice's whale draft SAR to align with the 2023 revisions to the Guidelines for Preparing Stock Assessment Reports Pursuant to the MMPA and report PBR as 0.07.

Response: NMFS has edited the SAR to report PBR as 0.07, per this public comment.

Comment 16: NRDC recommends including information on the potential for disturbance from vessel noise and activity in the draft SAR for Rice's whale.

Response: Per the comment, NMFS has edited the “Habitat Issues” text to include the anecdotal evidence from Soldevilla et al. (2022b) regarding Rice's whales that temporarily stopped calling when approached by the research vessel.

Comment 17: The Commission recommends using a maximum net productivity rate (R max ) of 8.2 percent for the Mainland Mexico-CA/OR/WA stock and a default Rmax value of 4 percent for the Central America/Southern Mexico-CA/OR/WA stock.

Response: Current estimated annual rates of increase for the Central America/Southern Mexico-CA/OR/WA stock (1.6 percent, incorrectly stated as 1.8 percent in the draft SAR) should not be confused with the R max . Where annual rates of increase have been estimated for different humpback populations, they have consistently been higher than the MMPA default of 4.0 percent (Zerbini et al. 2010 [7.3 percent and 8.6 percent annually, using 2 different approaches], Zerbini et al. 2006 [6.6 percent], Barlow and Clapham 1997 [6.5 percent], Calambokidis and Barlow 2020 [8.2 percent]). Zerbini et al. (2010) proposed an upper 99th percentile of 11.8 percent annually. Still, this value has not been utilized in MMPA stock assessments due to the availability of region and/or stock-specific estimates for U.S. waters. Based on the best available data on estimated rates of increase for multiple humpback populations, use of the MMPA default of 4.0 percent for the Central America/Southern Mexico-CA/OR/WA is unnecessarily conservative, given the spatial and temporal overlap with the larger Mainland Mexico-CA/OR/WA stock of humpbacks, both of which are exposed to the same types of anthropogenic threats along the U.S. West Coast. The mean estimate of annual growth rate of 8.2 percent reported by Calambokidis and Barlow (2020) for all humpbacks in U.S. West Coast waters also includes anthropogenic-related mortality; thus, the true R max is likely to be higher than that observed. Additionally, the PBR calculated for the Central America/Southern Mexico-CA/OR/WA stock is conservative, based on a recovery factor of 0.1 to reflect its endangered status. Therefore, NMFS will continue to use an R max of 8.2 percent.

Comment 18: The Commission notes that the PBR levels for the Mainland Mexico-CA/OR/WA and Central America/Southern Mexico-CA/OR/WA Stocks are divided by two to produce a “U.S. PBR” to assess the status of each stock. The Commission emphasizes there are no data, analyses, or references to support the conclusion that each stock spends approximately half its time outside the U.S. EEZ. The Commission recommends that NMFS use information on the timing of arrival to and departures from the U.S. EEZ by these two humpback whale stocks, as well as information on seasonal occupancy rates within the U.S. EEZ, to provide a more precise estimate of the “proportion of time spent in U.S. waters” for calculating the U.S. PBRs for these two humpback whale stocks. Response: NMFS agrees that a more refined estimate of humpback residency time in California, Oregon, and Washington, is required to prorate PBR for the Mainland Mexico-CA/OR/WA and Central America/Southern Mexico-CA/OR/WA Stocks. Ryan et al. (2019) provides both sighting and acoustic data suggesting that: (1) humpbacks are present in central California waters at least 8/12 months annually, and (2) December and April represent “transition months,” where whales are moving out of or into the central California region (see Figure 5d in Ryan et al. 2019). Counting December and April each as 1/2 of a month of residency time during migration, plus the 7 months of May through November when sightings are abundant, yields 8/12 months of residency time, or 2/3 of the year. This may be considered as a minimum residency time, as some whales are still present within the U.S. EEZ in waters north or south of the central California study area. NMFS has implemented this new PBR proration in the final SARs, which increased the calculated PBR for the Central America/Southern Mexico-CA-OR-WA stock from 2.6 to 3.5, and for the Mainland Mexico-CA-OR-WA stock, from 32.5 to 43.

Comment 19: The Commission comments that the Mainland Mexico-California/Oregon/Washington and Central America/Southern Mexico-California/Oregon/Washington SARs do not estimate or apply an appropriate correction factor to account for the undetected “cryptic mortality” of humpbacks due to fisheries interactions, and recommends that NMFS revise the SARs to provide estimates of total fisheries M/SI for these stocks using appropriate correction factors to account for undetected whale carcasses.

Response: There are no published estimates of carcass detection rates for humpback whales in this region. Some range-wide estimates were made for gray whales (Punt and Wade 2012), including remote coastlines of Mexico, Canada, and Alaska that are not directly applicable to the U.S. West Coast. As such, these estimates are not applied to gray whale strandings involving anthropogenic sources in U.S. waters. Most cases of humpback whale injury and mortality due to fishery entanglements are based on opportunistic detection of injured whales at sea, stranded animals, and floating carcasses. This detection process does not include quantifiable “search effort,” which is needed to estimate the undetected portion. Methods used to estimate carcass detection for more coastal species, such as bottlenose dolphins (Wells et al. 2015; Carretta et al. 2016), are also not applicable to humpback whales, given the differences in detection processes. With regard to vessel strikes, NMFS is already using the estimated vessel strike deaths reported by Rockwood et al. (2017) in the Central America/Southern Mexico-CA-OR-WA and Mainland Mexico-CA-OR-WA SARs; thus, no correction is necessary for that source of anthropogenic mortality. We also compare reported numbers with estimates from Rockwood et al. (2017) to give the reader a sense of the detected fraction of vessel strikes. NMFS continues to work on the issue of undetected injury and mortality and states in SARs that reported entanglement cases represent a minimum accounting of total interactions.

Comment 20: WDFW comments pertain to the Central America/Southern Mexico-CA-OR-WA, Mainland Mexico-CA-OR-WA and Hawaii stocks of humpback whales in the Pacific. WDFW is concerned about the exclusion of whales that summer in WA state waters from the Hawai'i distinct population segment (DPS), which affects estimates of M/SI for Washington fisheries. WDFW recommends that estimates of total mortality and proration to ESA-listed stocks include an estimate of non-listed stocks off Washington, and that more research is conducted on understanding the stock and DPS/Demographically Independent Population (DIP) composition of whales in Southern British Columbia (SBC), northern WA, and the Salish Sea.

Response: NMFS agrees that more research will aid in determining the relative fractions of whales summering in WA State waters that winter in Hawai'i waters. In the final SAR, we revised the proration scheme to prorate WA State human-caused M/SI to all three stocks that occur in these waters (Central America/Southern Mexico-CA/OR/WA, Mainland Mexico-CA/OR/WA, and Hawai'i) based on summer to winter area movement probabilities in Wade (2021). Human-caused M/SI from CA/OR/WA waters for the Hawai`i stock (based on movement probabilities from WA/SBC to Hawai'i) has now been added to the Hawai'i stock SAR published in the Alaska stock assessments (Young et al. 2023).

Comment 21: WDCFA comments that the SARs contradict previous studies by Wade in 2016 and 2021 in relation to the composition of humpback populations that forage off the coast of Washington. WDCFA believes that Wade's analysis revealed that the humpback populations off Washington differ significantly from those in California and Oregon. Instead of two distinct populations (both ESA-listed), WDCFA comments that Washington's foraging humpbacks consist of three distinct population segments (two listed and one not). Also, WDCFA comments that the exclusion of the SBC/WA stock (estimated at 1,593 distinct animals) from the SARs' total estimated humpback whale abundance for the U.S. West Coast (4,973 humpback whales) is problematic. WDCFA believes a more accurate calculation for the minimum population estimate (N min ) and PBR would benefit and be more reflective of population abundance from a proportional inclusion of SBC/WA populations.

Response: The 1,593 whales noted by the commenters are partially included in the estimate of abundance for CA/OR/WA waters because three stocks (Central America/Southern Mexico-CA/OR/WA, Mainland Mexico-CA/OR/WA, and Hawai'i) use CA/OR/WA waters during summer and autumn. Becker et al. (2020) estimated humpback abundance in 2018 for all CA/OR/WA waters to be 4,784 whales. Becker et al.'s estimate is lower than that of Calambokidis and Barlow (2020) for CA/OR mark-recapture data (4,973), which lends support to Calambokidis and Barlow (2020) noting that their estimate likely represents whales in WA waters (representing multiple stocks), as there is interchange between CA/OR and WA. The fraction of SBC/WA whales attributable to the Hawai'i stock that occur north of the U.S. EEZ is unknown; thus, it is incorrect to imply that the 1,593 SBC/WA whales should be added to the estimates of either Becker et al. (2020) or Calambokidis and Barlow (2020). NMFS has changed the language in the SAR to reduce this confusion, now noting that some whales from the Hawai'i stock are present in U.S. west coast waters during the summer. We have also prorated CA/OR/WA human-caused M/SI for Hawai'i stock whales in addition to Central America/Southern Mexico-CA/OR/WA and Mainland Mexico-CA/OR/WA whales, based on movement probabilities in Wade (2021). The Hawai'i stock M/SI totals derived from the U.S. West Coast fisheries and vessel strikes in Washington State are summarized in the Hawai'i SAR, published with the Alaska marine mammal stock assessments (Young et al. 2023).

Comment 22: CCCA notes that while the M/SI data are averaged over the period from 2016 to 2020, 22 humpback whale interactions occurred in 2016 out of the 34 reported in the SAR. CCCA requests NMFS to acknowledge in the final SAR that the interaction rates and M/SI rates for the fishery are skewed higher due to the spike in 2015-2016, and do not accurately reflect the current lower interaction rates based on the best available scientific information.

Response: The entanglement data for 2016-2020 reported in the SAR are based on the number of reported cases, presumably related to fishing effort and the number of people on the water (or beaches) that detect entangled whales. In order to assess the “rate of interactions” (and any change thereof), both the number of entanglement cases and total fishing effort are required. Information on the total number of traps set annually is lacking; therefore, it is unclear if the decline in reported entanglement cases after 2016 is related to reduced fishing effort, a change in humpback distribution, or both. The 5-year total entanglement summary also includes the year 2020, with the lowest number of pot-trap fishery entanglements recorded for the period. This is likely a reflection of reduced economic activity due to COVID-19 shutdowns. Thus, NMFS believes the additional text requested is not warranted.

Comment 23: CCCA believes that the Mainland Mexico-CA/OR/WA humpback whale stock is too narrowly defined, and that the stock should include all animals that interbreed when mature. CCCA emphasizes that the draft SAR improperly skews the impact of fisheries that interact with the stock because it compares the M/SI from those fisheries against a PBR that is based only on a portion of the actual stock.

Response: NMFS disagrees. Martien et al. (2021) note that humpback whale stocks in the North Pacific were previously designated at large geographically defined scales with names referring to feeding grounds (for example, the CA/OR/WA stock). However, these feeding ground aggregations do not represent DIPs. Rather, they comprise animals originating from multiple wintering grounds, which NMFS has recognized as different DPSs under the ESA. Martien et al. (2020) suggest that humpback research and management under the MMPA should focus on “migratory whale herds,” defined as groups of animals that share the same feeding ground and wintering ground. Recruitment into a herd is almost entirely through maternally directed learning of the migratory destinations. Photographic and genetic data show strong fidelity of animals to a given feeding and wintering area and, therefore, to a herd, suggesting very little dispersal (permanent movement of animals) between herds. If dispersal between herds is low enough to render them demographically independent, a migratory whale herd is a particular case of a DIP. Two strong lines of evidence (movements and genetics) support that the Mainland Mexico-CA/OR/WA unit of humpback whales meet the DIP definition, with levels of movement and genetic differentiation similar to those used to define DPSs.

Comment 24: CCCA comments that the Central America Stock is not being prevented from reaching or maintaining its optimum sustainable population. Curtis et al. (2022) estimate that the “Central America CA/OR/WA DIP” (which corresponds to the Central America Stock) has been growing at an annual rate of 4.8 percent from the period of 2004-2006 to the more recent period of 2019-2021. Although there is uncertainty with that estimated growth rate, the most recent population numbers indicate that there are approximately 1,494 whales that are part of the Central America Stock (Curtis et al. 2022), which is a significant increase of 1,083 whales since the Central America DPS (which also corresponds to the Central America Stock) was listed 7 years ago. CCCA argues that NMFS should revisit the assumptions it has made for this stock because the low PBR proposed in the draft SAR does not reflect the fact that this population is growing significantly despite the M/SI rates reported in the draft SAR.

Response: NMFS disagrees. The PBR reference point has several features that allow for a population to be increasing while human-caused M/SI exceed PBR. The calculation of PBR involves using: (1) One-half of the theoretical or estimated maximum net productivity level (instead of the point estimate); (2) The minimum population size estimate (or 20th percentile, rather than the point estimate); (3) A recovery factor below 1 for all stocks that are not at an optimum sustainable population (OSP) level. The goal of keeping M/SI below PBR is to ensure populations reach or maintain OSP. There is no evidence that the Central America/Southern Mexico-CA/OR/WA stock is at OSP. The depletion level of this population is unknown; if the population is well below OSP, it is possible for it to be increasing now, but may level off and not reach OSP if M/SI is too high. NMFS also notes that the estimated population growth rate for this population is lower than that of other humpback whale populations in the North Pacific (Curtis et al. 2022; Calambokidis and Barlow 2020; Mizroch et al. 2004; Zerbini et al. 2010).

Comment 25: WCP comments that it is difficult to accurately compile population numbers for transboundary stocks, and that sampling a mixture of similar populations is challenging for assessments. WCP believes counting these animals when they return to their birth-origin habitat should predominate other methods for censuses.

Response: Conducting wintering area surveys is not always feasible, but NMFS notes that estimates of wintering area abundance are available for multiple DPSs ( e.g., Central America, Hawai'i). In cases where wintering area abundance is not available, it is necessary to assess human-caused M/SI against summering area abundance determined from U.S. waters, where anthropogenic threats from U.S. fisheries and vessel strikes are well-documented.

Comment 26: The Commission recommends that NMFS use the default R max value of 4.0 percent for the Eastern Bering Sea (EBS) beluga whale stock until uncertainties are resolved or an R max value specific to the EBS stock is available. The draft 2022 SAR for the EBS beluga whale stock suggests that the default R max value of 4.0 percent should be used for the stock, as an R max value specific to the EBS beluga whale is not available. Although an R max of 4.8 percent was calculated for the Bristol Bay beluga whale stock, the most recently published SAR for that stock rejected the 4.8 percent value in favor of the 4.0 percent default due to the large coefficient of variation (CV) associated with the estimate.

Response: NMFS has considered the concern raised in the comment and decided to continue to use 4.8 percent for R max for the EBS beluga stock for the following reasons. As stated in the draft SAR, NMFS' “Guidelines for Preparing Stock Assessment Reports Pursuant to the MMPA” (Guidelines) suggest that, in general, substitution of other values for the default R max value should be made with caution and when reliable stock-specific information is available on R max (NMFS 2023). However, the NMFS Guidelines also state that for stocks subject to subsistence harvests, NMFS will consult with appropriate Alaska Native co-management partners regarding scientific and other information relevant to preparing SARs, including information used to calculate PBR. Co-management of the EBS beluga whale stock is conducted by the Alaska Beluga Whale Committee (ABWC) and NMFS. Through the co-management process, NMFS, in consultation with ABWC, determined that the nearby Bristol Bay beluga whale stock has similar environmental conditions and habitat to the EBS beluga whale stock. Since the Bristol Bay beluga stock exhibited an estimated rate of increase of 4.8 percent per year (95 percent confidence interval (CI): = 2.1-7.5 percent), and despite the large CV associated with this estimate, NMFS determined that the actual realized value for the growth rate of the Bristol Bay beluga population is a more accurate value to use for the EBS beluga whale stock's R max than the default value. The Alaska SRG supported the use of 4.8 percent for R max for the EBS beluga whale stock.

Comment 27: ADFG, SEAFA, USAG, and two members of the public expressed concern regarding NMFS' genetic analyses of Southeast Alaska (SEAK) harbor porpoise. They assert that the genetic differences observed between stocks is, at least in part, an artifact of limitations in the spatial distribution of the collected environmental DNA (eDNA) samples (Parsons et al. in prep). In addition, they state that based on the methodology described in Zerbini et al. (2022b), the eDNA samples could not have resulted in independently identifiable individuals. Zerbini et al. (2022b) and the SAR treat the sampled haplotypes as independently sampled individuals for analysis when it is likely that a large portion of samples were pseudo-replicates. They assert that this makes it impossible to verify if the results presented reflect a genuine biological pattern, and said additional genetic analyses based on appropriate independent sampling are necessary to assess harbor porpoise stock structure in SEAK.

Response: NMFS appreciates the concerns raised in the comment. Regarding the spatial distribution of the eDNA sample collection, we note that samples included in the analysis of population genetic structure included both tissue and eDNA samples (using the methods presented in Parsons et al. 2018). The eDNA samples were collected during several vessel surveys, between July 2016 and September 2019. eDNA samples were used to capture mitochondrial DNA (mtDNA) genetic diversity across geographic regions where harbor porpoise aggregations were detected. The data generated from eDNA included an informative section of the mitochondrial control region that is comparable to that sequenced from tissue samples. eDNA samples were collected immediately after a porpoise sighting, directly in the fluke prints of individuals, or small groups of harbor porpoise. Individual genotypes were not generated from eDNA samples; however, both tissue and eDNA samples were collected over multiple days, months, and years in both Northern-SEAK (N-SEAK) and Southern-SEAK (S-SEAK) inland water stocks, minimizing the likelihood that the same individual would be sampled more than once. Surveys were conducted throughout inland waters of SEAK, whereby eDNA sampling reflects the locations of harbor porpoise aggregations at the time of the survey. Regarding the concerns of pseudo-replication, while the possibility of genetic recaptures (or pseudo-replicates) cannot be completely excluded, efforts were made to minimize possible pseudo-replicates by moving away from small groups of porpoises between consecutive sample collections. In addition, the elusive or evasive nature of harbor porpoise behavior limits the likelihood of repeated close approaches by the sampling vessel of the sampled individuals. Samples of eDNA collected in the fluke prints of cetaceans often result in the discovery of multiple unique mtDNA haplotypes from a single sample. This highlights the likelihood of capturing eDNA from multiple individuals in a single sample, even when sample collections target the fluke prints of a single animal. This is not surprising given that shed cellular material can diffuse (and decay) in the marine environment in which it has been shed. Treating each sampled mtDNA haplotype as a single occurrence is a conservative approach adopted when samples represent an unknown number of unique individuals. This approach offers a valuable method for generating genetic haplotypes from eDNA samples, but likely results in an underestimate of the true haplotype frequency, particularly for common haplotypes.

Comment 28: ADFG requests NMFS reevaluate the harbor porpoise population structure in N-SEAK and S-SEAK SARs, and reconsider the calculations for the PBR. Dahlheim et al. (2015) found differing trends in abundance between N-SEAK and S-SEAK harbor porpoise populations, with an unusually high growth rate of 25 percent in S-SEAK between 2006 and 2007, and 2010 and 2012. The study acknowledged that such an increase is not biologically possible for a closed population, implying immigration into the area. However, the authors used this influx to hypothesize fine-scale population structure, which contradicts the evidence of significant immigration. This discrepancy necessitates a reevaluation of the population structure and PBR calculations.

Response: NMFS appreciates this comment and the opportunity to provide more context. The increasing trend in abundance of 25 percent per year implied by the estimates of abundance of S-SEAK between 2006 and 2007 and 2010 and 2012 presented in Dahlheim et al. (2015) applies only for the high density areas of harbor porpoise near Zarembo Island and the town of Wrangell, not the entire range of the S-SEAK DIP. It is conceivable that the unusual trend occurred because animals from areas within the range of the DIP that were not surveyed in 2006-2007 by Dahlheim et al. (2015) may have moved towards the region around Zarembo Island and Wrangell and may have been sampled in the early 2010s. Additionally, taking the CIs of the abundance estimate in Wrangell/Zarembo in 2006-2007 and 2010-2012 into consideration, the trend implied by the data is still within biologically plausible values. For example, the trend between the upper CI for the 2006-2007 estimate (317 individuals) and the lower CI of the 2010-2012 estimate (392 individuals) is approximately 4.7 percent per year, which is biologically feasible given the reproductive potential for harbor porpoise and has been documented in other regions ( e.g., California, Forney et al. 2021). Finally, the differential trend between N-SEAK and S-SEAK was used as supporting, not primary, evidence that harbor porpoise in these two areas should be considered two separate DIPs. Other lines of evidence ( e.g., differences in mitochondrial DNA between the two regions and areas of low density/potential gaps in distribution between N-SEAK and S-SEAK) provide stronger support for the separation of the two regions into two DIPs. Given all this, NMFS has determined that a re-evaluation of the population structure in N-SEAK and S-SEAK is not warranted at this time.

Comment 29: ADFG comments that NMFS should assess the degree of intermixing between harbor porpoise populations using a more rigorous sampling design and appropriate genetic methods and data. The distribution of harbor porpoise is not discontinuous, with high-density areas and regular observations outside these hotspots. Although no harbor porpoise were observed in Wrangell Narrows during aerial or boat-based surveys (Zerbini et al. 2022b), an eDNA sample was collected there (Parson et al., in prep). ADFG notes that a more comprehensive assessment using proper sampling design and genetic methods is needed to better understand their population structure.

Response: NMFS agrees that additional genetic samples throughout the region would be helpful to better understand putative genetic boundaries and seasonal variances in porpoise density and distribution. However, existing information on the genetics of harbor porpoise in the inland waters of SEAK is currently sufficient to separate stocks following NMFS' process for reviewing and designating stocks (NMFS 2019). NMFS acknowledges that harbor porpoise are notoriously difficult to study and approach for genetic sampling, requiring considerable resources and limiting the number of genetic samples available for analysis. Moreover, the movement of harbor porpoise can result in temporary spatial aggregations in response to tidal cycles and prey concentrations. As a result, the distribution of harbor porpoise is often patchy and variable on relatively small scales, which is reflected in the spatial distribution of samples and the large number of surveys conducted to collect the represented samples. Ideally, population genetic analyses would make use of tissue samples collected by remote biopsy sampling approaches; however, dedicated efforts to collect tissue samples from SEAK harbor porpoise demonstrated that this method is not efficient enough to be feasible. The tissue samples included in Zerbini et al. (2022b) were collected over multiple decades, highlighting the challenges of amassing a representative sample size for this species. Vessel-based surveys for eDNA samples were conducted throughout inshore waters of SEAK in 2016 (July and September) and 2019. Samples of eDNA collected during these surveys are representative of regions where harbor porpoise were encountered in those years. Rough boundaries between marine mammal stocks can be identified using known low-density areas or discontinuities. Of the boundaries identified using this approach, two boundaries between the northern and southern stocks were identified. These include the boundary at the north end of Wrangell Narrows and the boundary at Keku Strait. Low harbor porpoise density, not a lack of harbor porpoise, is implied. Known low-density areas or discontinuities in distribution have been used to identify boundaries for other harbor porpoise stocks (Carretta et al. 2002). Therefore, NMFS continues to rely on the original methodology and resulting stock structure at this time.

Comment 30: ADFG, SEAFA, UFA, USAG, and two members of the public request that NMFS reevaluate the bycatch estimation methods for harbor porpoise in the SEAK salmon drift gillnet fishery, taking into account interannual variability and adequacy of survey effort, and reassess whether the PBR level is being exceeded for the proposed S-SEAK stock. The current bycatch estimation is based on the 2012-2013 Alaska Marine Mammal Observer Program (AMMOP), which only observed 6-7 percent of the drift gillnet fishery. The large CVs for serious injury and mortality indicate a lack of precision in the estimate. The draft SAR does not account for interannual variability, with no observed bycatch in 2012 but documented interactions in 2013. The low survey coverage and potential for Type I or Type II errors make it difficult to determine if the PBR level is being exceeded or if the documented interactions were merely a fluke. A member of the public commented that the fishery had changed significantly since it was observed, thus invalidating the estimates, and a new observer program to monitor fishery takes should be undertaken.

Response: NMFS acknowledges the concerns raised in the comment. Analyses predicting the expected precision of the SEAK AMMOP for given levels of effort were conducted prior to the implementation of the observer program. The achieved effort level (~6.5 percent observer coverage for the three observed fishing districts) was considered sufficient to detect harbor porpoise bycatch if it was occurring at a level greater than the PBR level. For example, if the true bycatch level was 1.5 times PBR, there is a very low (2 percent) probability that no harbor porpoise bycatch would be observed. The estimated bycatch does take into account the lack of observations of bycatch in 2012; the estimate from 2013 is averaged with the zero from 2012 to estimate an annual bycatch. The effect of averaging with the zero in 2012 is included in the estimated CVs for the annual average, which are still 0.7 and 1.0 for the two stocks. Although the CVs of the estimated bycatch are high, this is well within the range of CVs tested in the development of the PBR framework ( i.e., a robustness trial was run with CV of bycatch estimate equal to 1.2). Therefore, it is still appropriate to use these estimates in the SAR. The Guidelines specify that the recovery factor should be lowered to a value less than 0.5 in situations such as these, where the CV of bycatch is relatively high. This adjustment will be evaluated for incorporation in the next SAR revision.

The bycatch estimate presented in the SAR should be considered a minimum. AMMOP only operated in fishing districts six, seven, and eight, representing only a fraction ( i.e., 16 percent of fish landed, the metric used to represent effort in the fishery) of the SEAK salmon drift gillnet fishery. The other fishing districts represent 84 percent of the landings, and bycatch estimates from districts six, seven, and eight were not extrapolated to those other areas. In other words, bycatch has not been estimated for the other districts. If one were to extrapolate the observed bycatch estimates in districts six, seven, and eight to the effort in the other districts, the estimated bycatch for the entire fishery would be six times higher, indicating that the current estimate of bycatch could be substantially underestimated. Another reason why the estimated bycatch should be considered a minimum estimate, with the potential for substantial negative bias, is that the observers were on a separate boat from the fishing vessel and their view of the gear during hauls was usually poor. In more than 90 percent of the hauls: (1) the observer's view of the portion of the net being pulled was obstructed for 25-50 percent of the time and (2) the observer could not see the net underwater. This means that the detection rate may not have been 100 percent in observed hauls and that the observations should be considered minimums. Less than a 100 percent detection would lead to a negative bias in the bycatch estimates.

It is worthwhile to consider Type I and II error rates in planning survey effort levels. To evaluate whether the estimated M/SI level would cause a fishery to be considered Category I in the List of Fisheries, the most important metric to measure accurately is whether the number of M/SI harbor porpoise per year is below 50 percent of the PBR level for S-SEAK harbor porpoise. Using binomial probabilities, the false positive rate (incorrectly estimating M/SI to be above PBR) for this situation would be 0.236. Similarly, it is important to measure accurately when M/SI is well above PBR ( e.g., 150 percent of PBR), and the false negative rate for that situation (incorrectly estimating M/SI to be below PBR) would be 0.298. These error rates are similar and not exceptionally high, and could be improved by increasing observer coverage relative to what was conducted previously. NMFS acknowledges the age of available data; regardless, without additional data, it remains the best available data on bycatch in the fishery. Planning efforts are underway for the AMMOP to consider new observer effort in the SEAK salmon drift gillnet fishery to gather more recent bycatch information for the fishery, as resources allow.

Comment 31: ADFG, SEAFA, UFA, USAG, and two members of the public request that NMFS reevaluate the most recent boat-based survey estimate for harbor porpoise in SEAK, considering potential biases such as the species' elusive nature, avoidance of approaching boats, and inadequate sampling in nearshore shallow waters and known concentration areas, and one member of the public recommended that a new aerial-based survey be completed. Harbor porpoise are known to be shy, elusive, and difficult to detect, which may lead to underestimation in boat-based surveys. The assumption of perfect detection at a Beaufort wind scale of 0 is unrealistic for such an elusive species. The survey's effective strip width does not appear to account for the effects of the sun's position on the detection probability. The vessel size used in the survey may have limited sampling in shallow waters where harbor porpoise are known to frequent. Furthermore, the survey did not include Duncan Canal, a known concentration area in S-SEAK (Parsons et al. in prep), because it was assumed to have no harbor porpoise based on results from other S-SEAK inlets.

Response: NMFS acknowledges the concerns raised in the comment and agrees that harbor porpoise is an elusive species that tends to avoid vessels. We considered this in the 2019 survey sampling design. Highly experienced observers participated in the 2019 survey in SEAK with the goal of minimizing the negative effect of animal behavior during data collection. Search effort for porpoise during the survey was performed in a manner that maximized detection before the porpoise responded to the vessel. Search effort was focused several hundred meters ahead of the vessel. Vessel avoidance can typically be detected in line transect surveys when examining histograms of perpendicular distance data ( e.g., Buckland et al. 2001). In such circumstances (presence of negative responsive movement by the porpoise), the number of sightings is expected to be greater farther away from the survey line than on or very near the survey line. Inspection of the perpendicular distance data in the 2019 survey in SEAK did not provide any evidence of responsive movement. On the contrary, it suggested porpoise groups were detected prior to showing any response to the presence of the vessel (see Zerbini et al. 2022a, detection function in the Supplemental Material: https://www.frontiersin.org/articles/10.3389/fmars.2022.966489/full ).

NMFS disagrees that sampling was inadequate. The survey was designed using advanced, well-established, and robust statistical methods to minimize bias in survey coverage. Sampling transects followed a systematic “zig-zag” design that covered most known habitats of harbor porpoise within SEAK inland waters, either near the shore or in the center of channels and inlets. In the past, NMFS was criticized for not sampling small bays and narrow inlets, and time was allocated in the 2019 survey to sample and estimate abundance within these areas. Given the resources available at the time, it was not practical to sample the large number of small bays and inlets (~170) in SEAK. Therefore, an algorithm was implemented to randomly select inlets and bays for sampling, allowing for nearly 40 percent survey coverage in the area of all inlets and bays combined. The proportion of bays and inlets sampled in the N-SEAK and S-SEAK areas was approximately the same.

The estimated average effective search width of harbor porpoise in SEAK (700-900 m) is substantially greater than that of open ocean surveys (130-375 m) (see detailed discussion and relevant literature in Zerbini et al. 2022a), suggesting that it is much easier to see harbor porpoise in enclosed environments such as inland waters of SEAK. Greater detectability of harbor porpoise in SEAK likely occurs because survey conditions in inland waters improve visibility of this species. For example, the presence of land in most of the region allows observers to focus on a smaller search area ahead of the vessel, likely increasing their detectability. Perhaps more importantly, sea conditions provided confidence in detectability during the 2019 surveys (92 percent of the sampling effort occurred in Beaufort state conditions varying between 0 and 3) and a rigorous protocol was implemented to stop sampling in poor visibility conditions to ensure the quality of the data were appropriate to develop density estimates of harbor porpoise. In addition, large swells, which greatly affect detection of cetaceans at sea, were extremely rare within most of SEAK inland waters where harbor porpoise were documented in the 2019 survey. Because detection of harbor porpoise is imperfect, a method was used to estimate the proportion of animals missed on the survey line—a quantity known as g(0)—under the assumption that observers will detect all porpoise in flat, calm conditions (Beaufort 0). NMFS determined this approach is appropriate, especially in a region where the environmental conditions favor the detectability of harbor porpoise.

The effect of many covariates in the probability of detecting harbor porpoise were considered as described in Zerbini et al. (2022a). The effect of the sun's position can affect the detectability of cetaceans, but other covariates considered in that study are typically more important ( e.g., sea state, group size, observer, swell height, cue; Barlow et al. 2001). In addition, most of the survey was conducted under cloudy or partially cloudy conditions, when the effect of glare is substantially reduced or is non-existent given the sun is not visible. The vessel used was small (~27.4 m long) compared to the size of other vessels used in similar surveys in SEAK in the past and allowed for sampling most of the habitats identified prior to completing the 2019 survey. Note that nearly all regions proposed for sampling were surveyed (Fig. 1 in Zerbini et al. 2022a). In addition, the vessel used in the 2019 survey towed a small rigid hull inflatable boat (RHIB) for collecting eDNA samples. This RHIB was launched to visit certain areas where depth was such that the larger survey vessel was unable to survey. One of these areas was Duncan Canal, where aggregations of harbor porpoise had been previously documented. No porpoise were seen in Duncan Canal during the small boat survey. It is important to note that Duncan Canal is adjacent to eastern Sumner Strait, an area of high density of harbor porpoise. It is possible that animals move in and out of the canal and were sampled by the survey vessel in Sumner Strait, even if they regularly occur in Duncan Canal. Therefore, the fact that the primary survey vessel did not visit Duncan Canal (and potentially other areas) does not mean that porpoise that visit the canal were not seen and are not accounted for in the estimates of abundance.

Finally, NMFS agrees that additional surveys are important to improve our knowledge of abundance and stock structure of harbor porpoise in SEAK; study platform and survey design depends on many factors, including the purpose of the project, the desired level of precision, and need for consistency with previous surveys. Studies to better understand the population identity of porpoise along the outer coast are also extremely useful to assess whether animals in inland waters are separate from those in more offshore habitats.

Comment 32: ADFG and UFA request that NMFS assess trends in harbor porpoise abundance in SEAK stocks, comparing historical and recent data, and evaluate the impact of drift gillnet fishery bycatch on the population. Despite differences in survey and analytical methods, the uncorrected abundance estimates from Zerbini et al. (2022a) can be compared with earlier surveys to analyze trends in abundance. The comparison suggests that harbor porpoise abundance increased in N-SEAK and remained constant in S-SEAK between 2013 and 2019. Historical abundance trends can inform assessments of stock status, potential threats, and the impact of bycatch. Considering the drift gillnet fishery occurred across the time series of harbor porpoise surveys, and the most recent abundance estimates for the Wrangell and Zarembo Island area are comparable to early 1990s estimates, bycatch in the drift gillnet fishery does not seem to be a driving factor affecting abundance. The rapid increase in abundance between 2006 and 2007, and 2010 and 2012, indicates that the drift gillnet fishery may not hinder harbor porpoise population growth in the area, suggesting that the stock may be able to reach its optimum sustainable population.

Response: NMFS recognizes the need to assess trends in abundance and to evaluate the impact of the drift gillnet fishery on harbor porpoise. The latter requires calculating new estimates of mortality through a fisheries monitoring program ( e.g., to place the estimates of mortality in perspective with more recent abundance estimates). The uncorrected abundance from Zerbini et al. (2022a) cannot be directly compared to those from previous surveys because the area covered in 2019 differs from the area covered in previous years. For example, by comparing the trackline design and area coverage in Fig. 1 in Zerbini et al. (2022a) and those in Figs. 2, 3, and 4 in Dahlheim et al. (2015), one can see the differences in the spatial coverage between the two surveys, which demonstrate the potential comparability issues between estimates from the two studies. For example, note that Chatham Strait, Lynn Canal, and lower Clarence Strait were not surveyed in 2006, 2007, and 2010, whereas high coverage was achieved in these areas in 2019. The most accurate way to assess the current trend would be to conduct a survey comparable to that done in 2019 and evaluate the trend based on two recent, comparable surveys; resources to do this are currently unavailable. Nonetheless, the depletion level of this population is unknown; if it is well below OSP, it is possible for the population to be increasing now, but may level off and not reach OSP if M/SI is too high.

Comment 33: ADFG emphasizes that the timeliness and transparency of data availability should be improved to ensure that stakeholders have adequate time to review and comment on proposed changes to the SARs. A member of the public commented that the State of Alaska should be provided with all data to peer review. ADFG commented that despite a data availability statement in Zerbini et al. (2022a), the data were provided late in the comment period, leaving insufficient time for thorough review. Similarly, the data from Parsons et al. (in prep) and the associated eDNA genetic sampling and analysis methods were provided with less than 10 working days left in the comment period. ADFG stated that the lack of timely data and methods sharing hinders transparency and the ability to properly assess the potential impacts of proposed changes to the SAR, particularly in relation to the small exceedance of PBR estimated for the proposed S-SEAK stock.

Response: Data availability is important and NMFS strives to make data available in a timely manner. We experienced significant set-backs and limitations in the years between tissue and eDNA sample collection and publication of genetics results due to restrictions imposed during the global pandemic. These delays impacted progress on the publication of the genetics results, which in turn impacted the release of the data. Summary genetic data were provided to the requestor to the best of the agency's ability; raw genetic data will be made available after the results are published in a peer-reviewed journal. We note that key information used in the draft harbor porpoise SAR was included in a peer-reviewed scientific paper (Zerbini et al. 2022a) and a NOAA technical memorandum (Zerbini et al. 2022b), and those documents were also made available to the public and to the Alaska SRG during their review of the draft SARs. In addition, Alaska SRG meetings held in 2018-2022 involved discussions about new studies on abundance and genetics of harbor porpoise, and the results of those studies. Minutes from the Alaska SRG meetings include considerable detail and are available to the public at https://www.fisheries.noaa.gov/national/marine-mammal-protection/scientific-review-groups#alaska-scientific-review-group.

Comment 34: ADFG, UFA, and SEAFA request that NOAA carefully consider the potential economic impacts of proposed changes to the SEAK harbor porpoise SAR on the salmon gillnet fishery and coastal communities before implementing any changes. The proposed changes in the draft SAR would split the SEAK harbor porpoise stock into three separate stocks and categorize the proposed S-SEAK stock as a strategic stock under the MMPA. This categorization would require the establishment of a take reduction plan, leading to changes in regulation and operation of the salmon gillnet fishery. These changes could result in significant economic costs for the fishery and the coastal communities that rely on it, and should only be pursued if deemed necessary.

Response: NMFS' policies for delineating demographically independent populations and designating stocks under the MMPA section 117 is made on the basis of the best available science and is independent of any future agency actions under MMPA section 118 for establishing a take reduction plan that may or may not occur in the future. If a take reduction plan were implemented, NMFS recognizes that there may be economic implications for the fishery and the coastal communities that rely on the relevant stocks. Those implications would be considered as appropriate in other processes that flow from these determinations.

Comment 35: A member of the public commented that NMFS' proposal to split harbor porpoise stocks with lines of demarcation at Dry Straights, Rocky Pass, Cape Decision, and Wrangell Narrows is arbitrary and unproven, lacking in robust genetic data to support it clearly. The commenter asserted that additional sampling from multiple areas is needed to better establish a delineation between stocks.

Response: NMFS has concluded that the available evidence supports placing the boundaries between the N-SEAK and the S-SEAK stocks in Dry Straight, Wrangell Narrows, Keku Strait (Rocky Pass), and Cape Decision. These are areas with extremely low density or no recent records of harbor porpoise in the last 20 years as summarized in Zerbini et al. (2022b) and likely represent natural geographic/ecological boundaries supporting demographic independence of harbor porpoise between Frederick Sound and Sumner Strait. Despite being relatively wide (1.2 km), Dry Strait is shallow (~0.4-0.5 m) and strongly influenced by the shoaling waters of the Stikine River Delta. The Stikine River Delta is continually expanding and depositing sediment on the ocean floor, creating tidal flats throughout the strait. It is unclear whether harbor porpoise use Dry Strait; the area has not been surveyed by vessel because of navigational constraints, but no harbor porpoise were there during aerial surveys in 1997 (Hobbs and Waite 2010). Harbor porpoise were documented in the Wrangell Narrows in the early 1990s, but infrequently since then (only one sighting in the lower portion of the Narrows in 2011) (Hobbs and Waite 2010; Dahlheim et al. 2015; Zerbini et al. 2022). Keku Strait is a narrow channel with complex bathymetry and shallow areas in its narrowest portion. The northern end of Keku Strait (near the town of Kake) was surveyed in 2019 and data generated from eDNA samples collected there suggest that harbor porpoise in that area are genetically more similar to harbor porpoise in Glacier Bay and Icy Strait (Parsons et al. in prep., Zerbini et al. 2022b) than those in Sumner Strait. It is unclear whether harbor porpoise cross the narrow parts of Keku Strait (Rocky Pass) towards Sumner Strait. No porpoise were seen there during aerial surveys in 1997 (Hobbs and Waite 2010). The geography and the bathymetry in the narrow reaches could represent a geographic barrier, separating animals from the northern and southern inland water DIPs. The passage between Cape Decision and Coronation Island separates two relatively large straits in SEAK: lower Chatham and lower Sumner straits. Harbor porpoise have been documented in lower Sumner Strait, to the east of Cape Decision (Dahlheim et al. 2015; Zerbini et al. 2022a) and occasionally in lower Chatham Strait (Hobbs and Waite 2010), but occurrence in these regions is uncommon. Whether harbor porpoise move between the two straits (or whether animals from offshore areas move into the straits) is presently unknown. It is important to note that demographic independence does not require a complete lack of interchange of animals between two or more DIPs. NMFS (2023) defines the term “demographic independence” to mean that “the population dynamics of the affected group is more a consequence of births and deaths within the group (internal dynamics) rather than immigration or emigration (external dynamics). Thus, the exchange of individuals between population stocks is not great enough to prevent the depletion of one of the populations as a result of increased mortality or lower birth rates.”

On 7/14/2023, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List. This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3.

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

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

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

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

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

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

This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the product(s) and service(s) listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

The following product(s) and service(s) are proposed for addition to the Procurement List for production by the nonprofit agencies listed:

Section 165 of the Water Resources Development Act of 2020 requires the Secretary to implement a pilot program for carrying out up to 20 projects under a continuing authority program for economically disadvantaged communities at 100 percent Federal cost. Additional information on the section 165 pilot program can be found in the Assistant Secretary of the Army for Civil Works (ASA(CW)) policy guidance issued on June 12, 2023. A copy of the guidance can be obtained at https://www.usace.army.mil/Missions/Civil-Works/Project-Planning/Legislative-Links/wrda_2020/ .

The term “economically disadvantaged community” means as defined in the ASA(CW) memorandum, Implementation Guidance for Section 160 of the Water Resources Development Act of 2020, Definition of Economically Disadvantaged Community, dated 14 March 2023. A copy of the guidance can be obtained at https://usace.contentdm.oclc.org/utils/getfile/collection/p16021coll5/id/36002 .

The term “continuing authority program” (CAP) means any of the following:

1. Section 14 of the Flood Control Act of 1946 (33 U.S.C. 701r).

2. Section 3 of the Act of August 13, 1946 (33 U.S.C. 426g). This authority is commonly identified as “Section 103” by the U.S. Army Corps of Engineers (USACE).

3. Section 107 of the River and Harbor Act of 1960 (33 U.S.C. 577).

4. Section 111 of the River and Harbor Act of 1968 (33 U.S.C. 426i).

5. Section 204 of the Water Resources Development Act of 1992 (33 U.S.C. 2326).

6. Section 205 of the Flood Control Act of 1948 (33 U.S.C. 701s).

7. Section 206 of the Water Resources Development Act of 1996 (33 U.S.C. 2330).

8. Section 2 of the Act of August 28, 1937 (33 U.S.C. 701g). This authority is commonly identified as “Section 208” by USACE.

9. Section 1135 of the Water Resources Development Act of 1986 (33 U.S.C. 2309a).

Notwithstanding the cost share authorized for the applicable CAP section, pursuant to section 165(a), the Federal share of the cost of a project selected under this authority shall be 100 percent. Therefore, the maximum total Federal cost of a project implemented under section 165(a) will be the sum of the applicable statutory per project Federal participation limit (see table below) plus the amount that the non-Federal interest would pay as its cost share.

Non-Federal interest requirements:

1. Provide all required lands, easements, rights-of-way, relocations, and disposal areas (LERRDs) required for the project.

2. Perform and pay for all costs associated with any required hazardous, toxic, and radioactive wastes (HTRW) cleanup and response in, on, or under any real property interest required for the project.

3. Operate and maintain the project at full non-Federal expense (except for a project for commercial navigation).

4. Hold and save the United States free from all damages arising from the project that are not due to the fault or negligence of the United States or its contractors.

5. For a project for navigation, provide all required local service facilities.

6. Pay all costs of planning, design, and construction that exceed the sum of the statutory per project Federal participation limit for the applicable CAP section plus the amount that the non-Federal interest would normally provide as its cost share.

Project Proposals: All information provided in a proposal is public information. Therefore, information that is confidential business information, information that should not be disclosed because of statutory restrictions, or other information that a non-Federal interest would not want to appear publicly should not be included in the submittal. Proposals to convert an active CAP or specifically authorized study or project to a section 165 pilot program study or project will not be considered. The authority to initiate a project under the pilot program terminates on December 27, 2030.

Entities submitting proposals for a project must include the following information:

1. Name, location, and description of the proposed project.

2. Description of the Economically Disadvantaged Community. The proposal must include a map and a narrative description of the economically disadvantaged community that will be benefited by the proposed project. The narrative description must include sufficient information to validate the community's classification as economically disadvantaged. The narrative must also describe the type and complexity of the urbanization in the community and identify any existing infrastructure in the community that is related to the purpose of the proposed project.

3. Description of the non-Federal interest for the proposed project. The description must include sufficient information to validate the non-Federal interest's eligibility as an applicant for the pilot program.

4. A letter of intent to partner with USACE in conducting a study, completing a design, constructing the project, and the long-term operation and maintenance of the constructed project. The letter of intent must include information demonstrating the non-Federal interest ability to be a partner in the study and project.

5. Description of the need for the proposed project and what the project would provide to the disadvantaged community.

6. For a project for flood risk management or coastal storm risk management (CSRM) purposes, the proposal must include a description of the history of flooding and the population at risk in the economically disadvantaged community. The narrative should include the dates of flood events and describe the property damages and life loss attributable to each event. It should also include a qualitative description or range of how deep the water was and how fast it was flowing. The description should identify any characteristics of the population that have a bearing on risk, such as the total number of people subject to flooding or a coastal storm, low per capita income, or unemployment rate above the national average.

7. A proposal for a project for CSRM purposes must include assurance of local willingness and capability to establish conditions of public use and access to beaches and shores. The proposal must identify whether the proposed project may result in a CSRM project that benefits beaches or shores the majority of which are private. In such cases, the applicant must provide assurance in the proposal that it is capable and willing to establish sufficient conditions of public use and access as a condition of Federal financial participation in a project.

8. For a project for ecosystem restoration, the proposal must describe the degraded habitat targeted for restoration and the causes of the degradation. Regionally and nationally significant habitat or natural resources should be identified.

9. For a project under section 14, the proposal must describe the ownership and function of the facility to be protected and the nature of the damage caused by flooding adjacent to the facility.

10. For a project under section 111, the proposal must describe the shoreline damage and identify the Federal navigation project responsible for the damage.

11. For a project for commercial navigation under Section 107, the proposal must describe existing facilities, vessel traffic, and the navigation problem the proposed project will address.

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: Higher Education Act (HEA) Title II Report Cards on State Teacher Credentialing and Preparation.

OMB Control Number: 1840-0744.

Type of Review: Revision of a currently approved ICR.

Respondents/Affected Public: State, local, and Tribal governments; private sector.

Total Estimated Number of Annual Responses: 2,283.

Total Estimated Number of Annual Burden Hours: 185,000.

Abstract: This request is for a revision of the State Report Card and Institution and Program Report Card required by the Higher Education Act of 1965, as amended in 2008 by the Higher Education Opportunity Act (HEOA). States must report annually on criteria and assessments required for initial teacher credentials using a State Report Card (SRC), and institutions of higher education (IHEs) with teacher preparation programs (TPP), and TPPs outside of IHEs, must report on key program elements on an Institution and Program Report Card (IPRC). IHEs and TPPs outside of IHEs report annually to their states on program elements, including program numbers, type, enrollment figures, demographics, completion rates, goals and assurances to the state. States, in turn, must report on TPP elements to the Secretary of Education in addition to information on assessment pass rates, state standards, initial credential types and requirements, numbers of credentials issued, TPP classification as at-risk or low-performing. The information from states, institutions, and programs is published annually in The Secretary's Report to Congress on Teacher Quality.

The revisions to the IPRC consist of the following:

• A new sub-section about the impact of COVID-19 in Section I: Program Information. The section would have four questions in the first data collection year in which it is implemented, due to retrospective questions going back to academic year 2019-20, but only one question in subsequent data collection years.

• A new question about student completion rate in Section I: Program Information.

• Minor revisions to the gender and race/ethnicity categories in Section I: Program Information.

The revisions to the SRC consist of the following:

• Two new items showing completion rate, total and by program, pre-loaded from the IPRC for state review, in Section I: Program Information.

• Five new multiple choice questions in Section VII: Teacher Shortages and Teacher Preparation, which are replacing three open text items.

• A new “other” response option for a multiple choice item in Section IX: Improvement Efforts.

• A new multiple choice and open text item in Section IX: Improvement Efforts.

• A new section (Section X) about the impact of COVID-19. The section would have three questions in the first data collection year in which it is implemented, due to retrospective questions going back to academic year 2019-20, but only one question in subsequent data collection years.

• Minor revisions to the gender and race/ethnicity categories in Section I: Program Information.

I. Background

In November 2021, Congress passed and President Joseph R. Biden, Jr. signed the Infrastructure Investment and Jobs Act (IIJA, Pub. L. 117-58), also known as the Bipartisan Infrastructure Law (BIL). 1 The BIL provides historic levels of funding to modernize and upgrade American infrastructure to enhance U.S. competitiveness, drive the creation of good-paying jobs, tackle the impacts of climate change, and ensure strong access to economic, environmental, and other benefits for disadvantaged communities. 2 The BIL appropriates more than $62 billion to the U.S. Department of Energy (DOE)  3 to invest in American manufacturing and workers; expand access to energy efficiency and clean energy; deliver reliable, clean, and affordable power to more Americans; and demonstrate and deploy clean energy technologies.

To support the goal of building a clean and equitable energy economy, the BIL-funded projects are required to (1) support meaningful community and labor engagement; (2) invest in America's workforce; (3) advance diversity, equity, inclusion, and accessibility; and (4) contribute to the President's goal that 40% of the overall benefits flow to disadvantaged communities.

Carbon management approaches such as carbon capture, transport, and storage and carbon dioxide removal are essential climate tools for meeting 1.5 °C targets. When deployed responsibly, these approaches are complementary, and not a replacement for, parallel efforts to reduce emissions through the deployment of energy efficiency, renewables, nuclear power, clean hydrogen, etc.

As part of the BIL, DOE will deploy approximately $12 billion in new carbon management funding over five years, largely for direct air capture and carbon capture, transport, use, and storage. And the 2022 Inflation Reduction Act (IRA, Pub. L. 117-169), which features a comprehensive package of clean energy and industrial tax credits, includes the most ambitious incentives in the world to date for the deployment of carbon management technologies. 4 Taken together, BIL and IRA have the potential to incentivize large scale commercial deployment of carbon management projects.

DOE FECM intends to launch a “Responsible Carbon Management Initiative” (Initiative) to recognize and encourage project developers and others in industry to pursue the highest levels of safety, environmental stewardship, accountability, community engagement, and societal benefits in carbon management projects. The Initiative will also aim to encourage transparency and learning through greater data and information sharing among industry, governments, communities, and other stakeholders.

This Initiative will be sequenced in two phases. In Phase 1, FECM intends to publish Principles for Responsible Carbon Management Projects (Principles). Companies can pledge to abide by the Principles, which include the following categories: Community Engagement, Workforce Development and Quality Jobs, Tribal Consultation, Environmental Justice, Environmental Responsibility, Air and Water Quality, Regulatory Requirements, Health and Safety, Emergency Response, Transparency, and Long-Term Stewardship. The Principles apply to the full range of carbon management technologies—including carbon capture, transport, use, and storage, as well as carbon dioxide removal technologies. A draft of the Principles can be found in Section III. FECM's goal for this initial phase of the Initiative is to facilitate industry intention and transparency regarding responsible carbon management deployment.

Project developers interested in demonstrating their commitment to responsible carbon management projects will complete an intake form, which may require describing how they plan to meet the Principles. FECM plans to publish the information from the completed intake forms on DOE's website. In addition, FECM will encourage project developers to publish information on how they are implementing the Principles on their own websites.

FECM will also encourage nongovernmental organizations, labor, State and local officials, and Tribal leaders (non-industry stakeholders) to consider formally endorsing the Principles. By endorsing, these stakeholders will affirm the important role that carbon management plays in meeting climate goals but also the importance of delivering societal and environmental co-benefits to communities hosting carbon management projects. FECM intends to publish non-industry stakeholder endorsements on DOE's website.

Interested industry and non-industry stakeholders can indicate their early support of the Principles and the Initiative by contacting responsiblecarbonmanagementinitiative@hq.doe.gov. In Phase 2, FECM intends to provide technical assistance through a Funding Opportunity Announcement (FOA). Through this FOA, FECM would provide resources to support project developers seeking to meet the Principles or other aspects of this effort (including increasing transparency or third-party verification). FECM intends Phase 2 to focus on evaluation of Principle implementation, accountability, and leadership. FECM does not anticipate requiring participation in Phase 1 as a prerequisite for participation in Phase 2.

Provided that Phases 1 and 2 are successful, FECM may consider developing a robust recognition program to increase and maintain visibility of industry leaders and projects that significantly advance responsible carbon management. The program would include more detailed guidance and metrics on what qualifies for recognition and would be subject to the availability of sufficient resources and funding. There may be the possibility for a FOA to be issued as part of this recognition program.

Community Engagement —Project developers will be considerate of parties who are or may reasonably be affected by project deployment and will share project-related information in a timely and transparent way. Project developers will include robust two-way community engagement plans, including training on carbon management technology risks and benefits, so that communities can understand and weigh the potential opportunities and risks of hosting a project—including the social, economic, environmental, and cultural effects. Project developers will provide clear mechanisms for modifying aspects of their projects in response to community priorities and concerns raised through engagement and will provide benefits to communities and workers.

Workforce Development and Quality Jobs —Project developers will seek to create jobs within host communities and the surrounding region that provide good pay, benefits, predictable schedules, a safe work environment, and with assurances that workers will have a free and fair chance to join or form a union. Project developers will foster broad access to these jobs by making investments in training and career awareness through partnerships that serve workers ( e.g., apprenticeship programs, schools, and universities). Project developers will also prioritize providing long-term employment for workers when possible and support the mobility of workers to advance in their careers.

Tribal Consultation —Project developers will respect Tribal sovereignty and self-determination, lands, assets, resources, treaty, and other federally recognized and reserved rights, considering sacred tribal lands and other areas and resources of religious or cultural significance. Project developers will consult Tribes in a manner that recognizes tribal sovereignty.

Environmental Justice —Through all phases of carbon management deployment—including siting, design, operation, and decommissioning—project developers will pursue fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income. Project developers will embrace environmental justice principles and comply with Federal requirements and guidance on these issues. In particular, project developers will consider the cumulative impacts on communities hosting carbon management projects.

Environmental Responsibility —Project developers will thoroughly evaluate and mitigate environmental impacts using best practices with respect to planning, implementation, monitoring, and closure. Project developers will publish environmental impact analyses and project monitoring data in a way that is timely and easy for the public to access. Environmental analysis will include energy use and life-cycle environmental impacts, including greenhouse gases (GHGs), to ensure that projects meet their intended emissions reduction goals.

Air and Water Quality —Project developers will implement operational practices or equipment to monitor and mitigate potential non-greenhouse gas air and water emissions. Monitoring and reporting will be inclusive of N-amines and changes in co-pollutants. Project developers for carbon dioxide storage projects will thoroughly evaluate risks and avoid impacts to groundwater and other subsurface resources.

Regulatory Requirements —Project developers will rigorously and transparently adhere to all applicable regulatory requirements for protecting human health and the environment, and apply best practices developed by regulatory authorities or other standard-setting bodies. This includes timely public reporting of any regulatory violations.

Health and Safety —Project developers will site, design, construct, and operate their projects in a safe and secure manner that is protective of human health, including worker and public health and safety.

Emergency Response —Project developers will develop emergency response and remediation plans, including timely emergency alert provisions; make the plans publicly available; and provide training and resources to local emergency responders.

Transparency —Project developers will implement robust mechanisms for transparency—before, during, and after the project ceases. In particular, project developers will ensure that the siting process is open to public input and transparent with respect to how decisions are made. Project developers will work with communities to identify the types of data that will be collected and shared with the public, including the level of detail, frequency of monitoring and reporting, response to findings, and means of disseminating information.

Long-Term Stewardship —Project developers of carbon dioxide storage projects will develop closure and post-operational monitoring and reporting plans and ensure financial responsibility for any future stewardship.

FECM is requesting comment on the Principles and the Initiative. The Principles are intended to provide project developers with a high-level framework for executing carbon management projects responsibly. DOE specifically welcomes comment on the following questions:

1. Would the Initiative and the Principles be likely to meaningfully advance responsible carbon management? If not, what changes could be made to better advance this goal?

2. At a high level, do the Principles address what is needed for responsible carbon management? If not, what additional principles may be needed?

3. In what ways, if any, could the Principles be revised to better reflect responsible carbon management?

4. Once finalized, would you agree to pledge to abide by or endorse the Principles? If not, what changes could be made to Phase 1 to encourage you to pledge to abide by or endorse the Principles?

5. How could Phase 2 and a recognition program be structured and executed to maximize adoption of the Principles?

6. Would the technical assistance envisioned in Phase 2 be helpful to advance responsible carbon management projects? Would you take advantage of this service or encourage others to take advantage? If not, why not?

NOI/RFI responses shall include:

1. NOI/RFI title and reference number;

2. Name(s), phone number(s), and email address(es) for the principal point(s) of contact;

3. Institution or organization affiliation and postal address; and

4. Clear indication of the specific question(s) to which you are responding.

Responses including confidential business information will be handled per guidance in Section VI.

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 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. 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 August 4, 2023, by Brad Crabtree, Assistant Secretary, Office of Fossil Energy and Carbon Management, 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 .

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Part C and Part D Data Validation; Use: Sections 1857(e) and 1860D-12 of the Social Security Act (“the Act”) authorize CMS to establish information collection requirements with respect to MAOs and Part D sponsors. Section 1857(e)(1) of the Act requires MAOs to provide the Secretary of the Department of Health and Human Services (DHHS) with such information as the Secretary may find necessary and appropriate. Section 1857(e)(1) of the Act applies to Prescription Drug Plans (PDPs) as indicated in section 1860D-12. Pursuant to statutory authority, CMS codified these information collection requirements in regulation at §§ 422.516(g) Validation of Part C Reporting Requirements, and 423.514(j) Validation of Part D Reporting Requirements, respectively.

Data collected via Medicare Part C and Part D reporting requirements are an integral resource for oversight, monitoring, compliance and auditing activities necessary to ensure quality provision of Medicare benefits to beneficiaries. CMS uses the findings collected through the data validation process to substantiate the data reported via Medicare Part C and Part D reporting requirements. Data validation provides CMS with assurance that plan-reported data are credible and consistently collected and reported by Part C and D SOs. CMS uses validated data to respond to inquiries from Congress, oversight agencies, and the public about Part C and D SOs. The validated data also allows CMS to effectively monitor and compare the performance of SOs over time. Validated plan-reported data may be used for Star Ratings, Display measures and other performance measures. Additionally, SOs can take advantage of the DV process to effectively assess their own performance and make improvements to their internal operations and reporting processes. Form Number: CMS-10305 (OMB control number: 0938-1115); Frequency: Yearly; Affected Public: State, local, or Tribal governments; Number of Respondents: 809; Total Annual Responses: 809; Total Annual Hours: 10,500. For policy questions regarding this collection contact Chanelle Jones at 410-786-8008.

Description: ACF programs promote the economic and social well-being of families, children, individuals, and communities. The Office of Planning, Research, and Evaluation (OPRE) studies ACF programs, and the populations they serve, through rigorous research and evaluation projects. These include evaluations of existing programs, evaluations of innovative approaches to helping low-income children and families, research syntheses, and descriptive and exploratory studies. OPRE's research offers further understanding of current programs and service populations, explores options for program improvement, and assesses alternative policy and program designs. OPRE anticipates undertaking a variety of new research projects related to welfare, employment and self-sufficiency, Head Start, child care, healthy marriage and responsible fatherhood, family and youth services, home visiting, child welfare, trafficking, community services, and other areas of interest to ACF. Some ACF program offices conduct their own research and evaluation projects and may utilize this generic.

Under this generic clearance, ACF engages in a variety of formative data collections with researchers, practitioners, technical assistance providers, service providers, and potential participants throughout the field to fulfill the following goals: (1) inform the development of ACF research, (2) maintain a research agenda that is rigorous and relevant, (3) ensure that research products are as current as possible, and (4) inform the provision of technical assistance and supports around research and evaluation. ACF envisions using a variety of techniques including semi-structured discussions, focus groups, surveys, and telephone or in-person interviews, in order to reach these goals. Information collected under this overarching generic is meant to inform ACF research activities and may be incorporated into documents or presentations that are made public.

The following are some examples of ways in which we may share information resulting from these data collections: research design documents or reports; research or technical assistance plans; background materials for technical workgroups; concept maps, process maps, or conceptual frameworks; contextualization of research findings from a follow-up data collection that has full PRA approval; informational reports to TA providers; or project specific reports, or other documents relevant to the field, such as federal leadership and staff, grantees, local implementing agencies.

Following standard OMB requirements, ACF has and will continue to submit to OMB information about individual information collection activities proposed under the generic clearance. ACF will provide OMB with a copy of the individual instruments or questionnaires, as well as other materials describing the project. ACF requests OMB's review within 10 days of submission of individual requests under this generic.

Respondents: Respondents could include key groups involved in ACF projects and programs, state or local government officials, service providers, participants in ACF programs or similar comparison groups, experts in fields pertaining to ACF research and programs, or others involved in conducting ACF research or evaluation projects.

Annual Burden Estimates

Find currently approved information collections here: https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=0970-0356. The request to OMB will include an extension request for approved information collections that are planned to continue beyond November 2023.

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

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

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).

FDA has approved for marketing the medical device VERCISE GENUS DBS SYSTEM. VERCISE GENUS DBS SYSTEM is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson's disease (PD) that are not adequately controlled with medication. Subsequent to this approval, the USPTO received a patent term restoration application for VERCISE GENUS DBS SYSTEM (U.S. Patent No. 8,606,362) from Boston Scientific Neuromodulation Corporation, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 8, 2022, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of VERCISE GENUS DBS SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for VERCISE GENUS DBS SYSTEM SYSTEM is 274 days. Of this time, 0 days occurred during the testing phase of the regulatory review period, while 274 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption for this device, under section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)), became effective: Not Applicable. The applicant claims no investigational device exemption (IDE) for the regulatory review period.

2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): April 23, 2020. FDA has verified the applicant's claim that the premarket approval application (PMA) for VERCISE GENUS DBS SYSTEM was initially submitted April 23, 2020.

3. The date the application was approved: January 21, 2021. FDA has verified the applicant's claim that PMA P150031 S034 was approved on January 21, 2021.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 273 days of patent term extension.

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

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

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

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

This information collection supports FDA regulations in §§ 189.5 and 700.27 (21 CFR 189.5 and 700.27), which set forth bovine spongiform encephalopathy (BSE)-related restrictions applicable to FDA-regulated human food and cosmetics. The regulations designate certain materials from cattle as “prohibited cattle materials,” including specified risk materials (SRMs), the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, and mechanically separated (MS) beef. Sections 189.5(c) and 700.27(c) set forth the requirements for recordkeeping and records access for FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle. FDA issued these recordkeeping regulations under the adulteration provisions in sections 402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c), and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c), and 371(a)). Under section 701(a) of the FD&C Act, we are authorized to issue regulations for the FD&C Act's efficient enforcement. With regard to records concerning imported human food and cosmetics, FDA relied on our authority under sections 701(b) and 801(a) of the FD&C Act (21 U.S.C. 371(b) and 381(a)). Section 801(a) of the FD&C Act provides requirements with regard to imported human food and cosmetics and provides for refusal of admission of human food and cosmetics that appear to be adulterated into the United States. Section 701(b) of the FD&C Act authorizes the Secretaries of Treasury and Health and Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of the FD&C Act.

These requirements are necessary because once materials are separated from an animal it may not be possible, without records, to know the following: (1) whether cattle material may contain SRMs (brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia from animals 30 months and older and tonsils and distal ileum of the small intestine from all animals of all ages); (2) whether the source animal for cattle material was inspected and passed; (3) whether the source animal for cattle material was nonambulatory disabled, or MS beef; and (4) whether tallow in human food or cosmetics contain less than 0.15 percent insoluble impurities.

FDA's regulations in §§ 189.5(c) and 700.27(c) require that manufacturers and processors of human food and cosmetics manufactured from, processed with, or otherwise containing material from cattle establish and maintain records sufficient to demonstrate that the human food or cosmetics are not manufactured from, processed with, or otherwise contain prohibited cattle materials. These records must be retained for 2 years at the manufacturing or processing establishment or at a reasonably accessible location. Maintenance of electronic records is acceptable, and electronic records are considered to be reasonably accessible if they are accessible from an onsite location. Records required by these sections and existing records relevant to compliance with these sections must be available to FDA for inspection and copying. Existing records may be used if they contain all of the required information and are retained for the required time period.

Because we do not easily have access to records maintained at foreign establishments, FDA regulations in §§ 189.5(c)(6) and 700.27(c)(6), respectively, require that when filing for entry with U.S. Customs and Border Protection, the importer of record of human food or cosmetics manufactured from, processed with, or otherwise containing, cattle material must affirm that the human food or cosmetics were manufactured from, processed with, or otherwise contains, cattle material and must affirm that the human food or cosmetics were manufactured in accordance with the applicable requirements of §§ 189.5 or 700.27. In addition, if human food or cosmetics were manufactured from, processed with, or otherwise contains cattle material, the importer of record must provide within 5 business days records sufficient to demonstrate that the human food or cosmetics were not manufactured from, processed with, or otherwise contains prohibited cattle material, if requested.

Under FDA's regulations, we may designate a country from which cattle materials inspected and passed for human consumption are not considered prohibited cattle materials, and their use does not render human food or cosmetics adulterated. Sections 189.5(e) and 700.27(e) provide that a country seeking to be designated must send a written request to the Director of the Center for Food Safety and Applied Nutrition. The information the country is required to submit includes information about a country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining whether SRMs, the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, or MS beef from the country seeking designation should be considered prohibited cattle materials. We use the information to determine whether to grant a request for designation and to impose conditions if a request is granted.

Sections 189.5 and 700.27 further state that countries designated under §§ 189.5(e) and 700.27(e) will be subject to future review by FDA to determine whether their designations remain appropriate. As part of this process, we may ask designated countries to confirm their BSE situation and the information submitted by them, in support of their original application, has remained unchanged. We may revoke a country's designation if we determine that it is no longer appropriate. Therefore, designated countries may respond to periodic FDA requests by submitting information to confirm their designations remain appropriate. We use the information to ensure their designations remain appropriate.

Description of Respondents: Respondents to this information collection include manufacturers, processors, and importers of FDA-regulated human food, including dietary supplements, and cosmetics manufactured from, processed with, or otherwise containing material derived from cattle, as well as, with regard to §§ 189.5(e) and 700.27(e), foreign governments seeking designation under those regulations.

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

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

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 helps support implementation of the Animal Drug User Fee Act of 2003 (ADUFA) (Pub. L. 108-130) and Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Pub. L. 110-316), established in sections 740 and 741 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C 379j-12 and 21 U.S.C. 379j-21), respectively. Under ADUFA, FDA assesses and collects user fees for certain new animal drug applications and supplements, products, establishments, and sponsors of new animal drug applications and/or investigational new animal drug file submissions. The ADUFA program is currently reauthorized through September 30, 2023, and FDA efforts to engage interested stakeholders in the 2023 reauthorization is ongoing. More information can be found at https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa, including current user fee rates applicable to animal drug submissions. Under AGDUFA, FDA assesses and collects user fees for certain abbreviated (generic) new animal drug applications and supplements, products, and sponsors of generic new animal drug applications and/or generic investigational new animal drug file submissions. The AGDUFA program is currently reauthorized through September 30, 2023, and FDA efforts to engage interested stakeholders in the 2023 reauthorization is ongoing. More information regarding the AGDUFA program can be found at https://www.fda.gov/industry/fda-user-fee-programs/animal-generic-drug-user-fee-act-agdufa, including current user fee rates applicable to generic animal drug submissions.

These user fee program resources support FDA's responsibilities to ensure that new animal drugs are safe and effective for animals, as well as ensuring the safety of food from treated animals. Sponsors of new animal drug applications complete a user fee cover sheet and submit it through the Center for Veterinary Medicine (CVM) eSubmitter. The Animal Drug User Fee cover sheet (Form FDA 3546) is designed to collect the minimum necessary information to determine whether a fee is required for the review of an application or supplement or whether an application fee waiver was granted, to determine the amount of the fee required, and to ensure that each animal drug user fee payment is appropriately linked to the animal drug application for which payment is made. The form, when completed electronically, results in the generation of a unique payment identification number used by FDA to track the payment. The information collected is used by FDA's CVM to initiate the administrative screening of new animal drug applications and supplements.

Similarly, sponsors of abbreviated new animal drug applications also complete a user fee cover sheet and submit it through CVM's eSubmitter. The AGDUFA cover sheet (Form FDA 3728) is also designed to collect the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to ensure that each animal generic drug user fee payment is appropriately linked to the abbreviated new animal drug application for which payment is made. The form, when completed electronically, results in the generation of a unique payment identification number used by FDA to track the payment. The information collected is used by CVM to initiate the administrative screening of abbreviated new animal drug applications.

Both sections 740 and 741 of the FD&C Act provide for waivers, reductions, and exemptions of fees. To assist respondents with submitting requests for waivers or reductions of ADUFA user fees, we developed guidance for industry (GFI) #170 entitled “Animal Drug User Fees and Fee Waivers and Reductions” (April 2023), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-170-animal-drug-user-fees-and-fee-waivers-and-reductions. This document discusses the types of fees FDA is authorized to collect under section 740 of the FD&C Act, and how to request waivers or reductions from these fees. Further, this guidance also describes what information FDA recommends be submitted in support of a request for a fee waiver or reduction, a request for reconsideration of denial of a fee waiver or reduction request, or an appeal of the denial decision in accordance with 21 CFR 10.75; how to submit such a request or appeal; and FDA's process for reviewing such requests or appeals.

Similarly, we developed guidance for industry (GFI) #199 entitled “Animal Generic Drug User Fees and Fee Waivers and Reductions” (May 2009), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-199-animal-generic-drug-user-fees-and-fee-waivers-and-reductions. This document discusses the types of fees FDA is authorized to collect under section 741(a)(1) of the FD&C Act, and how to request waivers or reductions from these fees. Further, this guidance also describes what information FDA recommends be submitted in support of a request for a fee waiver or reduction, a request for reconsideration of denial of a fee waiver or reduction request, or an appeal of the denial decision in accordance with 21 CFR 10.75; how to submit such a request or appeal; and FDA's process for reviewing such requests or appeals.

We use the information submitted by respondents to determine whether requests for waiver or reduction of user fees, reconsideration requests, or appeals may be granted.

In the Federal Register of April 27, 2023 (88 FR 25658), we published a 60-day notice soliciting public comment on the proposed information collection. One general comment was received encouraging FDA in its mission to promote and protect animal health.

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

Our estimated burden for the information collection reflects an overall increase. We attribute this adjustment to an increase in the number of submissions we have received since our last evaluation. The total number of annual responses is based on the average number of submissions received by FDA in fiscal years 2019 to 2021. The estimated time we attribute to the hours per response is based on our experience with the various submissions and reflects the average burden we attribute to all respondents.

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 implementation of provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(g)) requiring device manufacturers and importers to report promptly to FDA certain actions concerning device corrections and removals and to maintain associated records. Applicable regulations are found in 21 CFR part 806 and set forth definitions, prescribe format and required content elements for reporting, and identify actions that are exempt from the reporting requirements. The information collected is used by FDA to identify marketed devices that have serious problems and to ensure that defective devices are removed from the market. The information also helps ensure that FDA has current and complete information regarding these corrections and removals to determine whether recall action is adequate.

Reports of corrections and removals may be submitted to FDA via mail, email, or using FDA's Electronic Submission Gateway (ESG). To assist respondents with submitting reports of corrections or removals, we developed a fillable PDF electronic submission template entitled, “Device Correction/Removal Report for Industry,” that transmits required data to FDA's Recall Enterprise System. Instructions for the fillable template are provided in pop-up text boxes that appear over each data field. We expect that use of the fillable template will expedite processing of the reports of corrections or removals submitted to FDA.

In the Federal Register of April 11, 2023 (88 FR 21677), we published a 60-day notice soliciting comment on the proposed collection of information. No comments were received.

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

For respondents who submit corrections and removals using the ESG, the operating and maintenance costs associated with this information collection are approximately $50 per year to purchase a digital verification certificate (certificate must be valid for 1 to 3 years). This burden may be reduced if the respondent has already purchased a verification certificate for other electronic submissions to FDA. This burden may also be reduced if respondents utilize the new PDF template and submit it to the Agency using email, mitigating the need for a digital verification certificate.

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate, however we have revised the collection to include the new electronic reporting instrument “Device Correction/Removal Report for Industry.” We estimate that 50 percent of submitters will use the ESG to submit the required information. Our estimate of the reporting and recordkeeping burden is based on Agency records and our experience with this program, as well as similar programs that utilize FDA's ESG. For the purposes of estimating the burden, we assume that all respondents who submit corrections and removals using the electronic process will establish a new WebTrader account and purchase a digital verification certificate.

FDA is announcing the availability of a draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biosimilar products regulated by CDER or CBER. This draft guidance does not apply to meetings associated with the development of products intended for submission in, or review of, new drug applications or abbreviated new drug applications under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355), biologics license applications (BLAs) under section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)), or submissions for devices under the FD&C Act. For the purposes of this draft guidance, a formal meeting includes any meeting that is requested by a sponsor or applicant following the procedures provided in this draft guidance and includes meetings conducted in any format ( i.e., in-person, virtual (video conference), teleconference, or written response only). This guidance discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.

This draft guidance for industry revises and replaces the draft guidance of the same name issued on June 5, 2018 (83 FR 26060). This revision includes:

FDA also made certain clarifying and editorial changes. Editorial changes were made primarily for clarification.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance 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 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 regarding sponsor requests to FDA related to the submission of an investigational new drug application have been approved under OMB control number 0910-0014. The collections of information in section 351(a) of the PHS Act and part 601 (21 CFR part 601) relating to the submission of a BLA have been approved under OMB control number 0910-0338. The collections of information in section 351(k) of the PHS Act and part 601 relating to the submission of biosimilar applications and biosimilar user fee applications have been approved under OMB control number 0910-0718.

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

FDA is announcing the availability of a draft guidance for industry entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials.” The purpose of this draft guidance is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products, when appropriate, in the postmarketing setting in historically underrepresented patient populations in clinical trials. FDA regulations require sponsors to present information from premarket clinical trials on the safety and effectiveness of drugs in terms of gender, age, and racial subgroups. These clinical trials should include patient populations that are historically underrepresented in clinical research, including but not limited to, populations based on race, ethnicity, sex, age, geographic location, gender identity, socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity. Obtaining information early in development can be advantageous in that information may help inform subsequent clinical trials and ultimately result in more efficient, informative, and successful drug development. However, if despite the sponsor's best efforts, these populations are not adequately represented in premarket clinical trials or if the data suggests there may be serious safety concerns in these populations, it may be appropriate to collect such data in the postmarketing setting. Reviews of clinical trial data indicate that there is often underrepresentation of patient populations, based on race, ethnicity, sex, or age. The draft guidance discusses mechanisms by which FDA can require or request information on safety and effectiveness be collected in the postmarketing setting; design and statistical considerations for subpopulation analyses; and postmarketing approaches to obtain information on the benefit-risk profile in underrepresented clinical trial populations.

Underrepresentation in clinical trials remains a significant issue despite the Agency's efforts to encourage sponsors and investigators to improve representation of historically under-represented patient populations. We welcome further dialogue in other settings or collaborative efforts to explore methods to enhance representation in clinical trials.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910-0130; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; and the collections of information pertaining to submission of a biologics license application (BLA) under section 351(k) of the Public Health Service Act have been approved under OMB control number 0910-0338.

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

FDA is announcing the availability of a draft guidance for industry entitled “Classification Categories for Certain Supplements Under BsUFA III.” This draft guidance provides recommendations for applicants and FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements (hereafter “supplements”) submitted to approved applications under section 351(k) of the PHS Act (42 U.S.C. 262(k)).

These classification categories pertain to supplements for biosimilar and interchangeable biosimilar products seeking the following:

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

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

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

ANJESO (meloxicam) solution, 30 mg/mL, is the subject of NDA 210583, held by Baudax Bio, Inc., and initially approved on February 20, 2020. ANJESO is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-nonsteroidal anti-inflammatory drug analgesics. ANJESO (meloxicam) solution, 30 mg/mL, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.

Emprise Pharma, LLC submitted a citizen petition dated March 11, 2023 (Docket No. FDA-2023-P-0915), under 21 CFR 10.30, requesting that the Agency determine whether ANJESO (meloxicam) solution, 30 mg/mL, was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that ANJESO (meloxicam) solution, 30 mg/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that ANJESO (meloxicam) solution, 30 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of ANJESO (meloxicam) solution, 30 mg/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list ANJESO (meloxicam) solution, 30 mg/mL, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to ANJESO (meloxicam) solution, 30 mg/mL, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

1. United States Provisional Patent Application No. 63/113,428, filed 13 November 2020 (HHS Reference No. E-010-2021-0-US-01);

2. International Patent Application No. PCT/US2021/059109, filed 12 November 2021 (HHS Reference No. E-010-2021-0-PCT-02);

3. United States Patent Application No. 18/036,112, filed 09 May 2023 (HHS Reference No. E-010-2021-0-US-02);

4. European Patent Application No. 21824143.8, filed 30 March 2023 (HHS Reference No. E-010-2021-0-EP-01); and

5. any and all other U.S. and ex-U.S. patents and patent applications claiming priority to any one of the foregoing, now or in the future.

The patent and patent application rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America.

The prospective exclusive license territory may be worldwide and the fields of use may be limited to the following: manufacture, distribution, sale and use of T-cell-based immunotherapies for solid tumors.

These technologies disclose, e.g., cells expressing a modified CD3 subunit chain comprising at least one ITAM deletion. The inventive cells and populations thereof can be formulated into a composition, such as a pharmaceutical composition. Such cells and compositions thereof can be utilized to treat a wide variety of conditions, including but not limited to the indications within the scope of the contemplated exclusive license.

This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published Notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.

In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

Notice of these meetings is in compliance with the Federal Advisory Committee Act (Pub. L. 117-286, 5 U.S.C. ch. 10). The National Merchant Marine Personnel Advisory Committee is authorized by section 601 of the Frank LoBiondo Act of 2018 (Pub. L. 115-282, 132 Stat. 4192) and is codified in 46 U.S.C. 15103. The Committee operates under the provisions of the Federal Advisory Committee Act and 46 U.S.C. 15109. The National Merchant Marine Personnel Advisory Committee provides advice and recommendations to the Secretary of Homeland Security through the Commandant of the United States Coast Guard on matters relating to personnel in the United States Merchant Marine including the training, qualifications, certification, documentation, and fitness of mariners.

Agenda: The National Merchant Marine Personnel Advisory Committee will meet on Wednesday, September 6, 2023, and Thursday, September 7, 2023 to review, discuss, deliberate and formulate recommendations, as appropriate on the following topics:

The agenda for the September 6, 2023 meeting is as follows:

(1) The full Committee will meet briefly to discuss the subcommittees business and task statements, which are listed under paragraph (10) under Day 2 below.

(2) During the morning session of the meeting, subcommittees will separately address and work on the following task statements, which are available for viewing at https://homeport.uscg.mil/missions/federal-advisory-committees/national-merchant-marine-personnel-advisory-committee-(nmerpac)/task-statements:

(a) Task Statement 21-2, Communications Between External Stakeholders and the Mariner Credentialing Program;

(b) Task Statement 23-X2, Critical Skills for Navigation Using Nautical Charts and Training and Assessments of Skills Using Electronic Navigational Charts; and

(c) Task Statement 23-X3, Critical Skills for Radar Navigation and Collision Avoidance and Training and Assessment of Skills Using Radar and Automatic Radar Plotting Aids (ARPA).

(3) During the afternoon session of the meeting, subcommittees will separately address and work on the following task statements, which are available for viewing at https://homeport.uscg.mil/missions/federal-advisory-committees/national-merchant-marine-personnel-advisory-committee-(nmerpac)/task-statements:

(a) Task Statement 22-1, Propulsion Power Limitations;

(b) Task Statement 23-X2, Critical Skills for Navigation Using Nautical Charts and Training and Assessments of Skills Using Electronic Navigational Charts; and

(c) Task Statement 23-X3, Critical Skills for Radar Navigation and Collision Avoidance and Training and Assessment of Skills Using Radar and Automatic Radar Plotting Aids (ARPA).

(d) Report of subcommittees. At end of the day, the Chair or Co-Chairs of the subcommittees will report to the full Committee on what was accomplished. The full Committee will not take action on this date and the Chair or Co-Chairs of the subcommittees will present a full report to the Committee on Day 2 of the meeting.

(4) Adjournment of meeting.

The agenda for the September 7, 2023 meeting is as follows:

(1) Introduction.

(2) Designated Federal Officer and Coast Guard Leadership remarks.

(3) Swearing In of New Members.

(4) Roll call of Committee members and determination of a quorum.

(5) Adoption of the agenda.

(6) Election of Vice Chair.

(7) Acceptance of Minutes from Committee Meeting Four (March 31, 2023).

(8) Introduction of new tasks.

(9) Public comment period.

(10) Reports from the subcommittee Chair or Co-Chairs.

The Committee will review the information presented on the following Task Statements and deliberate on any recommendations presented by the subcommittees. Recommendations may be approved and completed tasks may be closed. Official action on these topics may be taken:

(a) Task Statement 21-1, Review of IMO Model Courses Being Validated by the IMO HTW Subcommittee;

(b) Task Statement 21-2, Communication Between External Stakeholders and the Mariner Credentialing Program, including amendment Task Statement 21-2A, Reviewing Assessments in NVICS for STCW;

(c) Task Statement 21-3, Military Education, Training, and Assessment for STCW and National Mariner Endorsement;

(d) Task Statement 21-4, STCW Convention and Code Review;

(e) Task Statement 21-5, Review of Merchant Mariner Rating and Officer Endorsement Job Task Analyses, including amendment Task Statement 21-5A, JTA to Mass Mapping;

(f) Task Statement 21-6, Sea Service for Merchant Mariner Credential Endorsements;

(g) Task Statement 21-8, Remote Operators of Maritime Autonomous Surface Ships;

(h) Task Statement 21-9, Sexual Harassment and Sexual Assault-Prevention and Culture Change in the Merchant Marine, including amendment Task Statement 21-9A, Training for Sexual Assault and Sexual Harassment Prevention and Response;

(i) Task Statement 22-1, Propulsion Power Limitations; and

(j) Task Statement 22-2, Alternative Methods for Meeting STCW Training Requirements at the Operational Level;

(k) Task Statement 23-1, Review of Navigation and Vessel Inspection Circular (NVIC) 03-14, Guidelines for Approval of Training Courses and Programs;

(l) Task Statement 23-X2, Critical Skills for Navigation Using Nautical Charts and Training and Assessments of Skills Using Electronic Navigational Charts; and

(m) Task Statement 23-X3, Critical Skills for Radar Navigation and Collision Avoidance and Training and Assessment of Skills Using Radar and Automatic Radar Plotting Aids (ARPA).

(11) Office of Merchant Mariner Credentialing update presentation.

(12) National Maritime Center update presentation.

(13) Closing remarks.

(14) Adjournment of meeting.

A copy of all meeting documentation will be available at https://homeport.uscg.mil/missions/federal-advisory-committees/national-merchant-marine-personnel-advisory-committee-(nmerpac) by August 30, 2023. Alternatively, you may contact the individual noted in the FOR FURTHER INFORMATION CONTACT section above.

Public comments or questions will be taken throughout the meetings as the Committee discusses the issues, and prior to deliberations and voting. There will also be a public comment period during the meeting on September 7, 2023 at approximately 12:30 p.m. EDT. Public comments will be limited to 3 minutes per speaker. Please note that the public comments period will end following the last call for comments.

Please contact the individual listed in the FOR FURTHER INFORMATION CONTACT section to register as a speaker.

FEMA proposes to collect information from parties who apply for compensation under FEMA-established fire claims programs stemming from its role providing financial assistance and direct services to individuals applying for disaster assistance benefits in the event of a federally declared disaster as specified by the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act), Public Law 93-288, as amended (42 U.S.C. 5121-5207). On September 30, 2022, President Biden signed into law the Hermit's Peak/Calf Canyon Fire Assistance Act (“Act”) Public Law 117-180, Division G—Hermit's Peak/Calf Canyon Fire Assistance Act. Congress passed the Act to compensate those claimants who suffered injury and loss of property from the Hermit's Peak/Calf Canyon Fire. A generic clearance will help minimize delays in FEMA's ability to respond to future fire incidents resulting in the establishment of claims offices.

This proposed information collection previously published in the Federal Register on May 5, 2023, at 88 FR 29144 with a 60-day public comment period. No comments were received. The purpose of this notice is to notify the public that FEMA will submit the information collection abstracted below to the Office of Management and Budget for review and clearance.

Title: Generic Clearance for Notice of Loss and Proof of Loss.

Type of Information Collection: New information collection.

OMB Number: 1660-NW163.

FEMA Forms: None.

Abstract: The Federal Emergency Management Agency (FEMA) will use the collected information to commence the process and procedures for claimants to seek compensation for injury or loss of property resulting from the Hermit's Peak/Calf Canyon Fire, and other fires that meet the criteria. Affected State, local and Tribal governments, private sector businesses, not-for-profit organizations, and individuals and households that suffered injuries resulting from fires will be eligible to apply for compensation. Claimants will submit a Notice of Loss to the Agency, meet with a FEMA Claims Reviewer, obtain documentation needed to substantiate claims, sign a Proof of Loss, and complete and return a Release and Certification form.

Affected Public: Individuals or households, State, local or Tribal government, private sector businesses, and not-for-profit organizations.

Estimated Number of Respondents: 287,250.

Estimated Number of Responses: 287,250.

Estimated Total Annual Burden Hours: 732,489.

Estimated Total Annual Respondent Cost: $31,606,900.

Estimated Respondents' Operation and Maintenance Costs: $0.

Estimated Respondents' Capital and Start-Up Costs: $0.

Estimated Total Annual Cost to the Federal Government: $65,103,002.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the Agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) 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 information collected is required for Fire Management Assistance Grant Program (FMAGP) eligibility determinations, grants management, and compliance with other Federal laws and regulations. The FMAGP was established under section 420 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C 5187, as amended by § 303 of the Disaster Mitigation Act of 2000 and authorizes the President to provide assistance to any state or local government for the mitigation, management, and control of any fire on public or private forest land or grassland that threatens such destruction as would constitute a major disaster. 44 CFR part 204 specifies the information collections necessary to facilitate the provision of assistance under the FMAGP. Additionally, the information collection is used by both FEMA Regional and State staff to facilitate the declaration request and grant administration processes of FMAGP, as well as end of year internal reporting of overall declaration requests and estimated grant outlays.

Title: Fire Management Assistance Grant Program.

Type of Information Collection: Extension, with change, of a currently approved information collection.

OMB Number: 1660-0058.

FEMA Forms: FEMA Form FEMA Form FF-104-FY-21-165 (formerly FEMA Form 078-0-1), Principal Advisor's Report; FEMA Form FF-104-FY-21-166 (formerly FEMA Form 078-0-1), Request for Fire Management Assistance Declaration; FEMA Form FF-104-FY-21-167 (formerly FEMA Form 089-0-24), Request for Fire Management Assistance Subgrant; FEMA Form FF-104-FY-23-100, Application for Management Costs; FEMA Form FF-104-FY-23-101, Project Application for Emergency Protective Measures; FEMA Form FF-104-FY-23-102, Project Application for Firefighting Activities; FEMA Form FF-104-FY-23-103 Time Extensions; No form, FEMA-State Agreement and Amendment; No form, State Administrative Plan for Fire Management Assistance; No form, Appeal Letter; No form, Duplication of Benefits Letter; and No form, Training Sessions.

Abstract: The information collected is required for Fire Management Assistance Grant Program (FMAGP) eligibility determinations, grants management, and compliance with other Federal laws and regulations. The FMAGP was established under the Robert T. Stafford Disaster Relief and Emergency Assistance Act and authorizes the President to provide assistance to any state or local government for the mitigation, management, and control of any fire on public or private forest land or grassland that threatens such destruction as would constitute a major disaster. Federal regulations specify the information collections necessary to facilitate the provision of assistance under the FMAGP. Additionally, the information collection is used by both FEMA Regional and State staff to facilitate the declaration request and grant administration processes of FMAGP, as well as end of year internal reporting of overall declaration requests and estimated grant outlays.

Affected Public: State, local or Tribal government.

Estimated Number of Respondents: 278.

Estimated Number of Responses: 953.

Estimated Total Annual Burden Hours: 1,211.

Estimated Total Annual Respondent Cost: $105,406.

Estimated Respondents' Operation and Maintenance Costs: $0.

Estimated Respondents' Capital and Start-Up Costs: $0.

Estimated Total Annual Cost to the Federal Government: $682,930.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the Agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) 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.

E.O. 12862 directs Federal Agencies to provide service to the public that matches or exceeds the best service available. Section 1(b) of E.O. 12862 requires government agencies to “survey customers to determine the kind and quality of services they want.” In addition, the Foundations for Evidence-Based Policymaking Act of 2018 (“Evidence Act”) enables agencies to collect and analyze data to use as evidence in policymaking, as well as assess the effectiveness and efficiency of current programs. To work continuously to ensure that our programs are effective and meet our customers' needs, FEMA seeks to obtain the Office of Management and Budget's (OMB) approval of a generic clearance to collect information through mixed methods (quantitative and qualitative) to improve marketing, outreach, and other promotional activities of services, programs, and opportunities offered by FEMA.

This proposed information collection previously published in the Federal Register on May 5, 2023, at 88 FR 29143 with a 60-day public comment period. No comments were received. The purpose of this notice is to notify the public that FEMA will submit the information collection abstracted below to the Office of Management and Budget for review and clearance.

Title: Generic Clearance for the Multi-Modal Mixed Methods Collection of Information to Inform Agency Marketing and Outreach.

Type of Information Collection: New information collection.

OMB Number: 1660-NW131.

FEMA Forms: Not applicable.

Abstract: In accordance with the Evidence Act, the collected information will equip FEMA with vital feedback from the general public and stakeholders that will allow for evidence-based improvements to FEMA's programs and services. FEMA will collect, analyze, and interpret information to identify strengths and weaknesses of programs based on current stakeholder experience and make improvements in the marketing and other promotional activities based on feedback.

Affected Public: Individuals and households, business or other for-profit, Federal Government, State, local or Tribal government, non-profit institutions.

Estimated Number of Respondents: 45,600.

Estimated Number of Responses: 45,600.

Estimated Total Annual Burden Hours: 7,861.

Estimated Total Annual Respondent Cost: $374,020.

Estimated Respondents' Operation and Maintenance Costs: $0.

Estimated Respondents' Capital and Start-Up Costs: $0.

Estimated Total Annual Cost to the Federal Government: $748,830.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the Agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) 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.

In 2014, U.S. Citizenship and Immigration Services (USCIS) launched HFRP to expedite family reunification through lawful, safe, and orderly channels of migration to the United States, increase existing avenues for lawful migration from Haiti, and help Haiti in its recovery from the long-term impacts of the January 12, 2010 earthquake that devastated the country. 1 Under HFRP, the U.S. Government (USG) invites certain eligible United States citizen (U.S.C.) and LPR petitioners to file a request and initiate consideration for parole for certain family members in Haiti who are the beneficiaries of an approved Form I-130, Petition for Alien Relative. Since it was established in 2014, HFRP has allowed certain beneficiaries of family-based immigrant petitions that were approved on or before December 18, 2014 to request a discretionary grant of parole to enter the United States up to approximately two years before their immigrant visas become available, rather than remain in Haiti awaiting availability of their immigrant visas. 2

If travel is authorized for the beneficiaries, these family members are allowed to travel to the United States before their immigrant visas become available and seek parole on a case-by-case basis upon arrival at a port of entry (POE) in the United States. 3 If granted parole into the United States, HFRP parolees may apply for employment authorization while they wait for their immigrant visas to become available so they may apply to adjust to LPR status. 4

As launched in 2014, USCIS required invited petitioners to file a completed Form I-131, Application for Travel Document, and submit the required fee(s) or fee waiver request for consideration of parole for each beneficiary. USCIS also required that USCIS officers interview beneficiaries in Port-au-Prince, Haiti, to verify their eligibility for HFRP. The National Visa Center (NVC) at the U.S. Department of State (State) first issued invitations to eligible petitioners to apply for HFRP in March 2015. Due to several factors, including anticipated policy changes, 5 a change in Administrations, the permanent closure of USCIS's field office in Port-au-Prince, Haiti, on December 20, 2019, extremely limited visa processing due to COVID-19, 6 and severe insecurity in the country, 7 new invitations to the HFRP process have not issued since June 2016 and interviews have not taken place since December 2019.

In the meantime, technology has evolved since the launch of HFRP in 2014. DHS is now able to electronically collect biographic information and evidentiary documents to facilitate identity verification, national security checks, and public safety vetting. DHS has expanded capacity to intake forms through online processes and allow individuals to upload supporting documentation directly online as part of the application process. The updated process for HFRP utilizes these technological developments to make the advance travel authorization and parole process more efficient and accessible while maintaining national security and public safety vetting measures as well as other measures for case-by-case adjudication.

In addition, DHS has recently implemented parole processes that are similar to HFRP but that follow different procedures, which utilize these recent technological developments. These include the filing of a Form I-134A, Online Request to be a Supporter and Declaration of Financial Support, the use of a fully electronic request for advance travel authorization (as opposed to the petitioner's use of the Form I-131 under the 2014 HFRP procedures), and processing without a requirement for an in-person interview abroad. Most recently, on July 10, 2023, DHS implemented family reunification parole (FRP) processes for certain Colombians, 8 Guatemalans, 9 Hondurans, 10 and Salvadorans  11 along these lines. DHS is now conforming the HFRP process to these recently announced processes.

Invitations to participate in the HFRP process will continue to issue to certain petitioners who have an approved Form I-130 filed on behalf of a Haitian principal beneficiary. Invitations will continue to issue at the USG's discretion, based on operational capacity, the expected period of time until the principal beneficiary's immigrant visa becomes available and in a manner calibrated to best achieve the foreign policy aims of this process.

Petitioners who have an approved  12 Form I-130 filed on behalf of a Haitian principal beneficiary outside the United States should ensure that their mailing address and other contact information are up to date with State's NVC as this is the information that will be used to issue invitations. The invitations will provide information about how the petitioner may file a request to be a supporter with USCIS to initiate this process on behalf of a Haitian principal beneficiary of an approved Form I-130 and how to file separate requests for any immediate family members  13 of the principal beneficiary.

As part of the request process, the petitioner will be required to provide evidence of their income and assets and commit to provide financial support to the beneficiary named in the request for the period of parole. Petitioners will also be required to provide evidence to verify the familial relationship between the principal beneficiary of the Form I-130 and all immediate family members of the principal beneficiary for whom the petitioner will be filing a request to be a supporter under this process. As part of the review process, the petitioner must also pass security and background vetting, including for public safety, national security, human trafficking, and exploitation concerns.

Previously, the HFRP process limited eligibility to Haitian principal beneficiaries of Forms I-130 and their immediate family members that were approved by USCIS on or before December 18, 2014 and for whom an immigrant visa was not currently available. The volume of invitations issued was limited based on operational capacity and other factors, as described above. The revised process is open to all Haitian principal beneficiaries of an approved Form I-130 and their immediate family members who have not yet received an immigrant visa regardless of the date on which USCIS approved the Form I-130. However, as mentioned above, the process will still be available on an invitation-only basis.

In addition, individuals whose immigrant visas were not available but were expected to become available within a specific time range were previously sent invitations to participate in the HFRP process. USCIS will no longer apply a time limit for expected immigrant visa availability. However, USCIS will consider when a beneficiary's immigrant visa is expected to become available when determining which petitioners will receive invitations to initiate this process on behalf of the beneficiary of their approved Form I-130.

To be eligible to be considered under this process, a beneficiary must not have been issued an immigrant visa at the time the invitation issues to the petitioner and, if authorized to travel, must now travel by commercial air with sufficient documentation ( e.g., international passport) to an interior POE.

In addition, as with the 2014 HFRP process, each beneficiary must undergo and pass national security and public safety vetting and must demonstrate that they otherwise merit a favorable exercise of discretion by DHS. Under this updated process, U.S. Customs and Border Protection (CBP) will consider a beneficiary's previous immigration history, encounters with USG entities, and the results of national security and public safety vetting when determining a beneficiary's eligibility to be issued advance authorization to travel to the United States. CBP will determine, on a case-by-case basis, whether to exercise discretion to grant parole to the beneficiary at an interior POE upon their arrival. CBP also will consider other factors in making discretionary determinations consistent with long-standing policy and practice.

Upon arrival at an interior POE, each beneficiary must demonstrate to CBP that a grant of parole is warranted based on a significant public benefit or for urgent humanitarian reasons and that the beneficiary merits a favorable exercise of discretion. Each beneficiary must also comply with all additional requirements, including vaccination requirements and other public health guidelines, prior to traveling to the United States.

Participation in this process is not limited to beneficiaries currently living in Haiti. However, as noted above, beneficiaries must be outside the United States to participate in the process, and the principal beneficiaries must be Haitian nationals.

A beneficiary of this process who enters the United States between POEs rather than being considered for parole under this process will be processed under Title 8 of the U.S. Code and face appropriate consequences. For example, they may be subject to potential criminal prosecution, 14 expedited removal proceedings, 15 or removal proceedings under section 240 of the INA, 8 U.S.C. 1229a. In addition, beneficiaries who enter the United States between POEs rather than being considered for parole under this process may already be, or may become, ineligible for adjustment of status  16 or for an immigrant visa  17 as a result of entering without inspection and not having been admitted or paroled. 18

DHS announces these updates to the HFRP process in light of lessons learned, technological advancements made, and efficiencies created in parole processes developed and implemented since HFRP's inception in 2014. Except for the medical exam by a panel physician and the ultimate parole determination made in person, on a case-by-case basis, by CBP at an interior POE, all steps of the updated HFRP process will generally be completed online. As a result, the process will no longer require an in-country interview for each beneficiary.

An invitation may be sent to a petitioner who has filed an approved Form I-130 on behalf of the principal beneficiary and any derivative beneficiaries listed on the Form I-130. The decision whether to send the invitation is based on multiple discretionary factors. Such factors may include operational capacity considerations, the expected period of time until the beneficiary's immigrant visa becomes available, as well as other measures calibrated to best achieve the policy aims of this process as described in this notice.

Only after receiving an invitation may the petitioner file a Form I-134A request to initiate consideration under this HFRP process. Participation in the process will continue to be voluntary. The invitation will instruct the petitioner on next steps to initiate this process on behalf of the beneficiaries, including instructions on documentation to include in their Form I-134A filing. Each invitation will include an identifying number that the petitioner must include in the Form I-134A for each beneficiary on whose behalf they wish to request to be a supporter.

After receiving an invitation to initiate this process, the U.S. citizen (U.S.C.) or LPR petitioner who filed the approved Form I-130 on behalf of the beneficiaries will submit a Form I-134A for each beneficiary with USCIS through the USCIS online web portal. The petitioner must submit a separate Form I-134A for each beneficiary, including derivatives of the principal beneficiary. The petitioner will not be required to pay a fee to file Form I-134A. The Form I-134A identifies and collects information on both the petitioner and the beneficiary.

The petitioner must submit evidence establishing their income and assets and commit to provide financial support to the beneficiary for the duration of parole. The petitioner must also submit evidence establishing the family relationships between the principal beneficiary and all derivative beneficiaries.

USCIS will perform background checks on the petitioner and verify their financial information to ensure that the petitioner is able to financially support the beneficiary. If the petitioner's Form I-134A is confirmed, the request proceeds to the next step.

If a petitioner's Form I-134A is confirmed by USCIS, the beneficiary named in the Form I-134A will receive an email from USCIS with instructions to create a USCIS online account and next steps for completing the request. The beneficiary will be required to confirm their biographic information in their online account and attest to meeting eligibility requirements.

As part of confirming eligibility in their USCIS online account, a beneficiary who seeks advance authorization to travel to the United States will need to confirm that they meet public health requirements, including certain vaccination requirements.

After confirming biographic information in their USCIS online account and completing required eligibility attestations, the beneficiary will receive instructions through their USCIS online account for accessing the CBP One mobile application. The beneficiary must enter certain biographic and biometric information—including a “live” facial photograph—into CBP One.

A beneficiary who establishes eligibility for this process, passes all the requisite vetting, and demonstrates that they otherwise warrant a favorable exercise of discretion, may receive an electronic advance authorization from CBP to travel to the United States. This will facilitate their ability to travel to the United States to seek a discretionary grant of parole, on a case-by-case basis, at an interior POE.

The beneficiary will receive a notice in their USCIS online account confirming whether CBP has, in its discretion, provided the beneficiary with advance authorization to travel to the United States. If approved, the beneficiary is responsible for securing their own travel via commercial air to an interior POE inside a U.S. airport. 19

Approval of advance authorization to travel does not guarantee a beneficiary will be paroled into the United States upon inspection at the POE. Whether to parole the beneficiary is a discretionary, case-by-case determination made by CBP at the time the beneficiary arrives at the interior POE.

To use the advance authorization to travel to the United States, the beneficiary must have sufficient documentation ( e.g., international passport) to travel on a commercial airline. Beneficiaries under the age of 18 to whom CBP issues advance authorization to travel under this process may be subject to additional screening and/or travel parameters in coordination with U.S. authorities to ensure appropriate travel arrangements and coordination with their parent(s) or legal guardian(s). This FRP process does not affect CBP's legal obligations regarding the identification and processing of unaccompanied children. 20

CBP will inspect each beneficiary arriving at an interior POE under this process and consider each individual, on a case-by-case basis, for a grant of discretionary parole for a period of up to three years. Upon arrival at an interior POE, the beneficiary will be required to submit additional biometrics to DHS, including another photograph and fingerprints. This biometric information will support additional vetting against available databases to inform an independent determination by CBP officers as to whether parole is warranted on a case-by-case basis and whether the beneficiary merits a favorable exercise of discretion.

A beneficiary who is determined to pose a national security or public safety threat will be denied parole. A beneficiary who otherwise does not warrant parole pursuant to section 212(d)(5)(A) of the INA, 8 U.S.C. 1182(d)(5)(A), as a matter of discretion upon inspection, will be processed under an appropriate disposition and may be referred to U.S. Immigration and Customs Enforcement (ICE) for detention.

If granted parole at the POE, on a case-by-case basis, parole will generally be granted for a period of up to three years, subject to satisfying applicable health and vetting requirements, and the parolee will be eligible to apply for employment authorization for the duration of the parole period. 21

Parole may be terminated upon notice at DHS's discretion, and the noncitizen may be placed into removal proceedings and/or detained if, for example, the parolee fails to maintain the conditions for the parole or other derogatory information emerges during the parole period. A noncitizen paroled into the United States under this process may request additional periods of parole. DHS will determine whether an additional period is warranted, on a case-by-case basis, for urgent humanitarian reasons or significant public benefit. All of the steps in this process, including the decision to confirm or non-confirm the Form I-134A, as well as the decision whether to issue advance authorization to travel and make the parole decision at the interior POE, are entirely discretionary and not subject to appeal on any grounds.

The Secretary retains the sole discretion to terminate this HFRP process at any point. This process is being implemented as a matter of the Secretary's discretion. It is not intended to and does not create any rights, substantive or procedural, enforceable by any party in any matter, civil or criminal. The 2014 decision to implement this process remains unchanged and is severable from the procedural updates announced in this notice.

The changes to the HFRP process announced in this notice are exempt from notice-and-comment rulemaking and delayed effective date requirements on multiple grounds and are therefore amenable to immediate issuance and implementation.

First, the HFRP process, and these updates to that process, constitute a general statement of policy, 22 i.e., a “statement issued by an agency to advise the public prospectively of the manner in which the agency proposes to exercise a discretionary power.”  23 As section 212(d)(5)(A) of the INA, 8 U.S.C. 1182(d)(5)(A), provides, parole decisions are made by the Secretary “in his discretion.” This policy creates a process for making discretionary, case-by-case parole decisions. The updates to the process do not change the nature of the policy and fall under the exception for general statements of policy. Additionally, this falls under the separate exception for rules of agency organization, procedure, or practice  24 because it sets forth updates to how agencies will implement the HFRP process.

Second, even if the updates to this process were considered to be a legislative rule that will normally be subject to requirements for notice-and-comment rulemaking and a delayed effective date, the updates are exempt from such requirements because they involve a foreign affairs function of the United States. 25 As discussed in the July 10, 2023 notices announcing four new family reunification processes, 26 the United States continues to engage hemispheric partners to increase their efforts to collaboratively manage irregular migration. 27 Improving the efficiency and accessibility of HFRP is necessary to ensure our foreign partners' continued collaboration on migration issues, including the ability of the United States to meet other immigration-management priorities such as the implementation of the initial phases of Safe Mobility Offices (SMOs) in Guatemala, Costa Rica, and Colombia. 28 Also, as with the four new processes, delays in implementing these procedural changes would complicate broader ongoing and future discussions and negotiations with key foreign partners about migration management. As such, foreign partners have requested that the United States ensure that functional, efficient lawful pathways exist for Haitian nationals.

Under the Paperwork Reduction Act (PRA), 44 U.S.C. chapter 35, all Departments are required to submit to the Office of Management and Budget (OMB), for review and approval, any new reporting requirements they impose. The updates to the HFRP process announced by this notice require changes to the collection of information on Form I-134A, Online Request to be a Supporter and Declaration of Financial Support (OMB control number 1615-0157), and the collection of information on Form I-131, Application for Travel Document (OMB control number 1615-0013), which will be used for this HFRP process and are being revised in connection with this notice by adjusting the burden estimate. The updates to this process also require changes to the collection of information for Advance Travel Authorization (ATA) (OMB Control Number 1651-0143). USCIS and CBP have submitted, and OMB has approved, requests for emergency authorization of the required changes (under 5 CFR 1320.13) to Form I-134A, Form I-131, and ATA for a period of six (6) months. USCIS and CBP will issue respective 60-day Federal Register notices seeking comment on these changes on or before August 25, 2023. 29

In 2007, U.S. Citizenship and Immigration Services (USCIS) launched CFRP in furtherance of the United States' commitment under the U.S.-Cuba Migration Accords  1 to direct Cuban migration into lawful, safe, and orderly channels and to continue regular review of the migration situation and proper implementation of the Accords. 2 Under CFRP, the U.S. Government (USG) invites certain eligible United States citizen (U.S.C.) and LPR petitioners to file a request and initiate consideration for parole for certain family members in Cuba who are the beneficiaries of an approved Form I-130, Petition for Alien Relative. 3

If travel is authorized for the beneficiaries, these family members are allowed to travel to the United States before their immigrant visas become available and seek parole on a case-by-case basis upon arrival at a port of entry (POE) in the United States. 4 If granted parole into the United States, CFRP parolees may apply for employment authorization while they wait to apply to adjust to LPR status. 5 Unlike parolees under similar family reunification parole (FRP) processes, CFRP beneficiaries may apply for adjustment one year after their parole into the United States under the Cuban Adjustment Act. 6 They do not need to wait for their immigrant visas to become available to apply for adjustment. 7

Beneficiaries must have a petitioner who filed a Form I-130 on behalf of a principal beneficiary and has been invited to participate in the CFRP process after the Form I-130 was approved. The principal beneficiary of that petitioner's Form I-130 must be a Cuban national. Consistent with a Federal Register notice updating the CFRP process in 2014, beginning February 17, 2015, USCIS required invited petitioners to file a completed Form I-131, Application for Travel Document, and submit the required fee(s) or fee waiver request for consideration of parole for each beneficiary. 8 Also consistent with that notice, USCIS required that USCIS officers or U.S. Department of State (State) consular officers interview beneficiaries in Havana, Cuba, to verify their eligibility for the program. 9 If USCIS issued a travel document to a given beneficiary, that individual could then travel to the United States to seek parole.

In May 2022, the United States announced the resumption of CFRP operations following suspension of CFRP interviews in September 2017  10 and closure of the USCIS Havana Field Office on December 10, 2018. 11 In August 2022, USCIS began mailing CFRP interview notices to petitioners with instructions for the beneficiary interview. On August 18, 2022, USCIS restarted interviews at the U.S. Embassy in Cuba. However, USCIS has had limited capacity to conduct interviews due to operational constraints in Cuba. Specifically, while both State and USCIS are working to fully resume operations in Havana, these efforts are taking time to fully realize, which is one reason DHS is implementing these operational changes. Furthermore, the economic and political crisis in Cuba, which has been marked by food shortages, rolling blackouts, and countrywide internet outages, 12 impacts the USG capacity to process parole requests in Cuba for Cuban nationals and their immediate family members  13 under CFRP.