Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the U.S. Department of Agriculture (USDA, the Department) Animal and Plant Health Inspection Service (APHIS) is rescinding the system of records notice, National Animal Health Laboratory Network (NAHLN), USDA/APHIS-5, and removing it from its inventory. This system was used to support activities conducted by the agency and maintain records pursuant to its missions and responsibilities authorized by the Animal Health Protection Act (7 U.S.C. 8301-8317); Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188); Homeland Security Presidential Directive-7; and Homeland Security Presidential Directive-9.

The purpose of NAHLN was to coordinate and network USDA's National Veterinary Services Laboratories with the capacity, facilities, professional expertise, and support of State and university laboratories. The network provides an extensive infrastructure of facilities, equipment, and personnel that is geographically accessible in the event of an animal health emergency.

The Department is rescinding this system of records because the records previously maintained in the system are now maintained within the system of records titled “Animal Health, Disease, and Pest Surveillance and Management System, USDA/APHIS-15,” which supports APHIS' mission of protecting and improving the health, quality, and marketability of animals within the United States and response to animal health emergencies.

Rescinding the National Animal Health Laboratory Network notice will have no adverse impacts on individuals as the records are covered by and maintained under the Animal Health, Disease, and Pest Surveillance and Management System, USDA/APHIS-15. This notice hereby rescinds the National Animal Health Laboratory Network (NAHLN) system of records notice as identified below.

  Incident

Authority: Public Law 115-426, 132 Stat. 5489 (44 U.S.C. 2107)

In the Federal Register of August 14, 2024, in FR Doc. 2024-18105, on page 66033, in the second column, the sentence “Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to October 28, 2024.” is corrected to read as “Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to October 30, 2024.”.

On September 17, 2024, Commerce received timely submitted ministerial error allegations from the Coalition of American Millwork Producers (the petitioner)  1 with respect to the margin calculations for Jinquan/Baiyuan, 2 one of the two mandatory respondents. 3 No other parties submitted comments. On September 18, 2024, Commerce published the Final Results in the Federal Register . 4 We are amending the Final Results to correct one of the petitioner's alleged ministerial errors while finding the other allegation to be methodological in nature rather than a clerical error. 5

Section 751(h) of the Tariff Act of 1930, as amended (the Act), defines a “ministerial error” as including “errors in addition, subtraction, or other arithmetic function, clerical errors resulting from inaccurate copying, duplication, or the like, and any other unintentional error which the administering authority considers ministerial.”  6 With respect to final results of administrative reviews, 19 CFR 351.224(e) provides that Commerce “will analyze any comments received and, if appropriate, correct any . . . ministerial error by amending the final results of review. . . .”

In the Final Results, we stated that we recalculated the freight revenue cap for Jinquan/Baiyuan. 7 In its Ministerial Error Comments, the petitioner alleged that while Commerce correctly calculated the freight revenue cap, Commerce incorrectly applied it to the original gross unit price by: (a) failing to remove the freight expenses from the price; and (b) incorrectly subtracting, rather than adding, the freight revenue cap to the price. 8

We agree with the petitioner that we made a ministerial error pursuant to section 751(h) of the Act and 19 CFR 351.224(f). Pursuant to 19 CFR 351.224(e), we are amending the Final Results to correct this ministerial error in the calculation of the weighted-average dumping margin for Jinquan/Baiyuan. As a result, the margin changes from 4.25 percent to 4.68 percent. Furthermore, based on the revised weighted-average dumping margin calculated for Jinquan/Baiyuan, we are also amending the rate for the companies not selected for individual examination in this review, which changes from 4.25 percent to 4.68 percent.

For a complete discussion of the ministerial error allegation, as well as Commerce's analysis, see the Ministerial Error Memorandum. 9 The Ministerial Error Memorandum is a public document and is on file electronically via ACCESS. ACCESS is available to registered users at https://access.trade.gov.

As a result of correcting the ministerial error described above, we determine the following estimated amended weighted-average dumping margins for the period February 1, 2022, through January 31, 2023:

We intend to disclose the calculations performed in connection with these amended final results of review to interested parties within five days of the date of publication of this notice in the Federal Register , in accordance with 19 CFR 351.224(b).

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the amended final results of review. Commerce intends to issue assessment instructions to CBP for Jinquan/Baiyuan and the non-selected companies under review receiving a separate rate no earlier than 35 days after the date of publication of the amended final results in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

Because Jinquan/Baiyuan's ad valorem weighted-average final dumping margin is not zero or de minimis ( i.e., less than 0.50 percent), we have calculated importer-specific assessment rates for this respondent, in accordance with 19 CFR 351.212(b)(1). 11 For sales for which Jinquan/Baiyuan reported entered value, we have calculated importer-specific ad valorem assessment rates based on the ratio of the total amount of dumping calculated for each importer's examined sales to the total entered value of those sales, in accordance with 19 CFR 351.212(b)(1). For sales for which Jinquan/Baiyuan did not report entered value, we have calculated importer-specific per-unit duty assessment rates based on the ratio of the total amount of antidumping duties calculated for the examined sales to the total quantity of those sales. To determine whether an importer-specific, per-unit assessment rate is de minimis, in accordance with 19 CFR 351.106(c)(2), we also calculated an importer-specific ad valorem ratio based on estimated entered values.

For entries that were not reported in the U.S. sales databases submitted by Jinquan/Baiyuan during this review, Commerce will instruct CBP to liquidate such entries at the China-wide rate ( i.e., 220.87 percent).

For the respondents not selected for individual examination in this administrative review that qualified for a separate rate, the assessment rate will be equal to Jinquan/Baiyuan's amended cash deposit rate ( i.e., 4.68 percent).

The following cash deposit requirements will be effective upon publication of the amended final results of this administrative review for all shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: for Jinquan/Baiyuan and the other companies which were found eligible for a separate rate, the cash deposit rate will be 4.68 percent.

This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties has occurred and the subsequent assessment of double antidumping duties, and/or increase in the amount of antidumping duties by the amount of the countervailing duties.

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

We are issuing and publishing these amended final results of administrative review and notice in accordance with sections 751(h) and 777(i) of the Act, and 19 CFR 351.224(e).

On March 22, 2019, Commerce published in the Federal Register the AD and CVD orders on plastic ribbon from China. 1 On February 1, 2024, the ITC instituted, 2 and Commerce initiated, 3 the first sunset review of the Orders, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). As a result of its review, Commerce determined that revocation of the Orders would likely lead to the continuation or recurrence of dumping and countervailable subsidies, and therefore, notified the ITC of the magnitude of the margins of dumping and subsidy rates likely to prevail should the Orders be revoked. 4

On September 11, 2024, the ITC published its determination, pursuant to sections 751(c) and 752(a) of the Act, that revocation of the Orders would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. 5

The merchandise covered by the Orders is certain plastic decorative ribbon from China. For a complete description of the scope of the Orders, see the appendix to this notice.

As a result of the determinations by Commerce and the ITC that revocation of the Orders would likely lead to continuation or recurrence of dumping, countervailable subsidies, and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, Commerce hereby orders the continuation of the Orders. U.S. Customs and Border Protection will continue to collect AD and CVD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise.

The effective date of the continuation of the Orders will be September 11, 2024. 6 Pursuant to section 751(c)(2) of the Act and 19 CFR 351.218(c)(2), Commerce intends to initiate the next five-year reviews of the Orders not later than 30 days prior to fifth anniversary of the date of the last determination by the ITC.

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

These five-year (sunset) reviews and this notice are in accordance with sections 751(c) and 751(d)(2) of the Act and published in accordance with section 777(i) of the Act, and 19 CFR 351.218(f)(4).

On February 21, 1995, Commerce published in the Federal Register the AD order on SS Bar from India. 1 On August 13, 2024, Commerce published the Preliminary Results of this NSR, wherein we determined that Welspun's sales were bona fide transactions and were not made below NV. 2 We invited interested parties to comment on the Preliminary Results. 3 No interested parties submitted comments. Accordingly, Commerce made no changes to the Preliminary Results and no decision memorandum accompanies this notice. On July 22, 2024, Commerce tolled certain deadlines in this administrative proceeding by seven days. 4 The deadline for the final results is now October 30, 2024. Commerce conducted this review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).

The products covered by the Order are SS Bar. A full description of the scope of the Order is provided in the Preliminary Results. 6

We received no comments on the Preliminary Results and, therefore, have made no changes for the final results of this NSR. Accordingly, Commerce determines that the following weighted-average dumping margin exists for the POR February 1, 2023, through July 31, 2023:

Because Commerce received no comments on the Preliminary Results, we have not modified our analysis, and no decision memorandum accompanies this Federal Register notice. We are adopting the Preliminary Results as the final results of this review. 7 Consequently, there are no new calculations to disclose in accordance with 19 CFR 351.224(b) for these final results.

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this NSR. We intend to instruct CBP to apply the importer-specific ad valorem assessment rates we calculated for the Preliminary Results on the basis of the ratio of the total amount of dumping calculated for each importer's examined sales and the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). 8 If the importer-specific assessment rate is zero or de minimis, then Commerce will instruct CBP to liquidate such entries without regard to antidumping duties.

For entries of subject merchandise during the POR produced by Welspun, for which it did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate ( i.e., 12.45 percent)  9 if there is no rate for the intermediate company(ies) involved in the transaction.

Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of these final results in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements will be effective upon publication in the Federal Register of this notice for all shipments of SS Bar from India entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2)(C) of the Act: (1) for subject merchandise produced and exported by Welspun, no cash deposit will be required;  10 (2) for subject merchandise exported, but not produced by Welspun, the cash deposit rate will be the producer's rate or the all-others rate ( i.e., 12.45 percent)  11 if the producer does not have its own rate; (3) for subject merchandise produced, but not exported by Welspun, the cash deposit rate will be the rate applicable to the exporter, or the all-others rate if the exporter does not have its own rate. These cash deposit requirements, when imposed, shall remain in effect until further notice.

The subject permit is requested under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

The applicant proposes to conduct restoration activities for pillar coral in Puerto Rico in the event the species is listed as endangered. The objective of this project is to preserve the genetic diversity of the species and increase its population numbers in coral reefs in the wild. Restoration practitioners would collect up to 500 colonies or parts of colonies annually from coral reefs in the waters of Puerto Rico and transport them to in situ and ex situ nurseries for maintenance and propagation. Up to 1,500 colonies would be outplanted to the wild from nurseries annually. An additional 25 colonies or parts of colonies annually would be collected from the wild as part of emergency response due to catastrophic events, such as a vessel grounding or storm. These colonies would be reattached or stabilized in the wild (in the same location or at a new location) or transported to a nursery. The permit is requested for 10 years.

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 promulgated or, if the taking is limited to harassment, an incidental harassment authorization is issued.

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 here as “mitigation measures”). NMFS must also prescribe requirements pertaining to monitoring and reporting of such takings. The definition of key terms such as “take,” “harassment,” and “negligible impact” can be found in the MMPA and the NMFS's implementing regulations (see 16 U.S.C. 1362; 50 CFR 216.103).

NMFS' regulations implementing the MMPA at 50 CFR 216.107(e) indicate that IHAs may be renewed for additional periods of time not to exceed 1 year for each reauthorization. In the notice of proposed IHA for the initial IHA, NMFS described the circumstances under which we would consider issuing a renewal for this activity, and requested public comment on a potential renewal under those circumstances. Specifically, on a case-by-case basis, NMFS may issue a one-time 1-year renewal of an IHA following notice to the public providing an additional 15 days for public comments when (1) up to another year of identical, or nearly identical, activities as described in the Detailed Description of Specified Activities section of the initial IHA issuance notice is planned or (2) the activities as described in the Description of the Specified Activities and Anticipated Impacts section of the initial IHA issuance notice would not be completed by the time the initial IHA expires and a renewal would allow for completion of the activities beyond that described in the DATES section of the notice of issuance of the initial IHA, provided all of the following conditions are met:

1. A request for renewal is received no later than 60 days prior to the needed renewal IHA effective date (recognizing that the renewal IHA expiration date cannot extend beyond 1 year from expiration of the initial IHA).

2. The request for renewal must include the following:

• An explanation that the activities to be conducted under the requested renewal IHA are identical to the activities analyzed under the initial IHA, are a subset of the activities, or include changes so minor ( e.g., reduction in pile size) that the changes do not affect the previous analyses, mitigation and monitoring requirements, or take estimates (with the exception of reducing the type or amount of take); and

• A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized; and

3. Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures will remain the same and appropriate, and the findings in the initial IHA remain valid.

An additional public comment period of 15 days (for a total of 45 days), with direct notice by email, phone, or postal service to commenters on the initial IHA, is provided to allow for any additional comments on the proposed renewal. A description of the renewal process may be found on our website at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-harassment-authorization-renewals . Any comments received on the potential renewal, along with relevant comments on the initial IHA, have been considered in the development of this proposed IHA renewal, and a summary of agency responses to applicable comments is included in this notice. NMFS will consider any additional public comments prior to making any final decision on the issuance of the requested renewal, and agency responses will be summarized in the final notice of our decision.

On October 1, 2023, NMFS issued an IHA to the U.S. Navy to take marine mammals incidental to construction associated with the replacement of Pier 302 at Naval Base Point Loma in San Diego, California (88 FR 6703, February 1, 2023), effective from October 1, 2023, through September 30, 2024. On July 31, 2024, NMFS received an application for the renewal of that initial IHA. As described in the application for renewal IHA, the activities for which incidental take is requested consist of activities that are covered by the initial authorization but will not be completed prior to its expiration. As required, the applicant also provided preliminary monitoring data which confirm that the applicant has implemented the required mitigation and monitoring, and which also shows that no impacts of a scale or nature not previously analyzed or authorized have occurred as a result of the activities conducted. There are no changes from the proposed authorization in this final authorization.

The planned activities for this project are a subset of previously planned activities consisting of activities that were not completed in the initial IHA. There are still 17, 6-inch steel round piles to install using a vibratory hammer which will be completed over 2 days. All other aspects (including mitigation, monitoring, and reporting), species for which take is authorized, and anticipated impacts on the affected stocks are the same as those analyzed and authorized through the previously issued IHA.

The purpose of the project is to replace Pier 302 which provides the U.S. Navy's marine mammal program with adequate facilities to house its marine mammals and provide a safe working environment for personnel to support the U.S. Navy's overall mission to maintain, train, and equip combat ready Naval forces. The location, timing, and nature of the activities, including the types of equipment planned for use, are identical to those described in the initial IHA.

Species that are expected to be taken incidental to pile driving activity, by Level B harassment only, are California sea lion ( Zalophus californianus ), northern elephant seal ( Mirounga angustirostris ), harbor seal ( Phoca vitulina ), bottlenose dolphin ( Tursiops truncatus ), Pacific white-sided dolphin ( Lagenorhynchus obliquidens ), and common dolphin ( Delphinus delphis ). Take was calculated using the same method as for the initial IHA, but reflecting the reduced amount of activity, i.e., only installing 17, 6-inch round steel piles.

A detailed description of the demolition and construction activities for which take is requested here may be found in the proposed renewal notice (89 FR 80228, October 2, 2024) and notices of the proposed (87 FR 68442, November 15, 2022) and final (88 FR 6703, February 1, 2023) IHAs for the initial authorization. Since that time, no changes have been made to the planned activities. Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specific activity.

A notice of NMFS' proposal to issue an IHA to the U.S Navy was published in the Federal Register on October 2, 2024 (89 FR 80228). That notice described, in detail, the U.S Navy's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. In that notice, we requested public input on the request for authorization described therein, our analyses, the proposed authorization, and any other aspect of the notice of proposed IHA, and requested that interested persons submit relevant information, suggestions, and comments. During the 15-day public comment period, NMFS did not receive any public comments.

A description of the marine mammals in the area of the activities for which authorization of take is proposed here, including information on abundance, status, distribution, and hearing, may be found in the notices of the proposed and final IHAs for the initial authorization. NMFS has reviewed the monitoring data from the initial IHA, draft 2023 Stock Assessment Reports, information on relevant Unusual Mortality Events, and other scientific literature, and determined there is no new information that affects which species or stocks have the potential to be affected or the pertinent information in the Description of the Marine Mammals in the Area of Specified Activities contained in the supporting documents for the initial IHA.

A description of the potential effects of the specified activity on marine mammals and their habitat for the activities for which an authorization of incidental take is requested here may be found in the notices of the proposed and final IHAs for the initial authorization. NMFS has reviewed the monitoring data from the initial IHA, recent draft Stock Assessment Reports, information on relevant Unusual Mortality Events, and other scientific literature, and determined that there is no new information that affects our initial analysis of impacts on marine mammals and their habitat.

A detailed description of the methods and inputs used to estimate take for the specified activity are found in the notices of the proposed and final IHAs for the initial authorization. Specifically, the source levels, days of operation, and marine mammal occurrence data applicable to this authorization remain unchanged from the previously issued IHA. Similarly, the stocks taken, methods of take, and types of take remain unchanged from the previously issued IHA. As noted above, the amount of estimated take requested for authorization here is lower than that authorized through the initial IHA, corresponding with the subset of activity remaining for completion.

To calculate take, the U.S. Navy estimated average occurrence of each species based on previous nearby completed Navy projects and multiplied it by the number of total piles driving days to get their estimated potential take for authorization. Under the initial IHA 32 days of pile driving were planned, but only 30 days' worth of pile work were completed. There are now 2 days of pile work remaining, with the same estimated abundance numbers used and multiplied by 2 days of pile driving work to produce take estimates for the renewal IHA (table 1).

The mitigation, monitoring, and reporting measures included as requirements in this authorization are identical to those included in the Federal Register notice announcing the issuance of the initial IHA, and the discussion of the least practicable adverse impact included in that document and the notice of the proposed IHA remains accurate.

NMFS has concluded that there is no new information suggesting that our analysis or findings should change from those reached for the initial IHA. Based on the information and analysis contained here and in the referenced documents, NMFS has determined the following: (1) the required mitigation measures will affect the least practicable impact on marine mammal species or stocks and their habitat; (2) the authorized takes will 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) the U.S. Navy's activities will 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 (ESA; 16 U.S.C. 1531 et seq. ) requires that each Federal agency ensure 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.

No incidental take of ESA-listed species is expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.

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 evaluate our proposed action (the issuance of an IHA) and alternatives 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 NAO 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 determined that the issuance of the initial IHA qualified to be categorically excluded from further NEPA review. NMFS has determined that the application of this categorical exclusion remains appropriate for this renewal IHA.

NMFS has issued a renewal IHA to the U.S Navy for the potential harassment of small numbers of six marine mammal species incidental to the Replacement of Pier 302 at Naval Base Point Loma, San Diego, California, that includes the previously explained mitigation, monitoring and reporting requirements.

NMFS has updated its guidance for assessing the effects of anthropogenic sound on the hearing of marine mammal species under NMFS's jurisdiction. Specifically, the 2024 Updated Technical Guidance identifies the received levels and auditory weighting functions, or “acoustic criteria,” that describe the received levels (decibels (dB)) and frequencies (kilohertz (kHz)) where individual marine mammals are predicted to experience changes in their hearing sensitivity (auditory injury (AUD INJ) or temporary threshold shift (TTS)) from exposure to anthropogenic sound sources both in-air and underwater. This document is intended for use by NMFS analysts and managers and other relevant user groups and interested parties, including other Federal agencies, when seeking to determine whether and how their activities are expected to result in auditory impacts to marine mammals via acoustic exposure in-air and underwater. The 2024 Updated Technical Guidance outlines NMFS's updated acoustic criteria and describes in detail how they were developed and how they will be updated in the future. For information on NMFS' 2018 Revised and the original 2016 Technical Guidance, refer to our 2016 Federal Register notification (81 FR 51694, August 4, 2016).

For the 2024 Updated Technical Guidance, NMFS again worked with the U.S. Navy (Navy), which recently updated its marine mammal AUD INJ and TTS criteria (Finneran 2024), to incorporate the best available science. NMFS conducted an independent peer review in October/November 2022. Details of the peer review, peer reviewer comments, and our response to these comments are available at the following website: https://www.noaa.gov/information-technology/update-to-20162018-technical-guidance-for-assessing-effects-of-anthropogenic-sound-on-marine-mammal. In May/June of 2023, NMFS solicited input from other relevant Federal agencies on the 2024 Updated Technical Guidance. Federal agency comments and NMFS responses to those comments are available at the following website: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance. To complete the review process, NMFS solicited additional feedback from user groups and interested parties via a 45-day public comment period in May/June 2024. Comments received via the public comment period can be found at the following website: https://www.regulations.gov/document/NOAA-NMFS-2024-0026-0001.

It is important to note that the use of the acoustic criteria within the 2024 Updated Technical Guidance should not be considered to represent the entirety of an impact assessment, but rather serve as one tool to help evaluate the effects of a proposed action. Furthermore, the 2024 Updated Technical Guidance does not create or confer any rights for or on any person, or operate to bind the public. For the purposes of assessing auditory impacts to marine mammals in support of regulatory processes under NMFS' authority, an alternative approach that has undergone independent peer review may be proposed (by Federal agencies or prospective action proponents or applicants) and used if case-specific information/data indicate that the alternative approach is likely to produce a more accurate portrayal of auditory impacts (AUD INJ or TTS) for the project being evaluated, if NMFS determines the approach satisfies the requirements of the applicable statutes and regulations.

The 2024 Updated Technical Guidance reflects the current state of scientific knowledge regarding the characteristics of sound that have the potential to impact marine mammal hearing sensitivity. NMFS recognizes that the implementation of marine mammal weighting functions and the weighted SEL 24h criteria may extend beyond the capabilities of some action proponents. Thus, NMFS has developed an optional, alternative tool for those who cannot fully incorporate these factors into their own analyses (See 2024 Updated Technical Guidance's companion optional User Spreadsheet tool; https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance ).

NMFS has determined the updated thresholds and associated weighting functions in the 2024 Updated Technical Guidance represent the best available information for assessing whether exposure to specific activities is likely to result in changes in marine mammal hearing sensitivity (AUD INJ or TTS). Prospective applicants for incidental take authorizations under the Marine Mammal Protection Act (MMPA) and Federal agencies seeking Endangered Species Act (ESA) section 7 consultations that have not yet started their acoustic analyses should begin using the 2024 Updated Technical Guidance immediately. At the same time, we recognize that for some proposed actions, analyses may have already substantially progressed using the existing criteria in the 2018 Revised Technical Guidance or other methods for assessing hearing effects, and it may be impractical to begin those analyses anew, taking into account timing constraints, expense, and other considerations. In such “pipeline” cases, the applicant or action agency should contact NMFS as soon as possible to discuss how to best include consideration of the 2024 Updated Technical Guidance to satisfy the applicable requirements. A non-exhaustive list of factors that could affect the extent to which the 2024 Updated Technical Guidance will be quantitatively incorporated for an action include: The relative degree to which the 2024 Updated Technical Guidance is expected to affect the results of the acoustic impact analyses; how far in the process the application or prospective application has progressed; when the activity is scheduled to begin or other timing constraints; the complexity of the analyses and the cost and practicality of redoing them; and the temporal and spatial scope of anticipated effects. We anticipate that after the initial transition period, all applications for MMPA incidental take authorization and all requests for ESA section 7 consultations involving noise that may affect marine mammal hearing will include full consideration of the 2024 Updated Technical Guidance.

NMFS uses acoustic criteria to help quantify “take” and as part of more comprehensive effects analyses under several statutes. The 2024 Updated Technical Guidance's acoustic criteria do not represent the entirety of the comprehensive effects analysis, but rather serve as one tool among others ( e.g., behavioral impact criteria, auditory masking assessments, evaluations to help understand the ultimate effects of any particular type of impact on an individual's fitness, population assessments, etc.) to help evaluate the effects of a proposed action and make findings required by NMFS' various statutes.

Under current agency practice, NMFS considers the onset of auditory injury as an example of “Level A Harassment” as defined in the MMPA and as “harm” as defined in ESA regulations, such that exposing an animal to weighted received sound levels at or above the indicated permanent threshold shift (PTS) threshold is predicted to result in these two types of “take” ( i.e., Level A Harassment under the MMPA and harm under ESA).

As explained below, NMFS does not consider a TTS to be an auditory injury under the MMPA or ESA, and thus it does not qualify as Level A harassment or harm. Nevertheless, TTS is an adverse effect that historically has been treated as “take” by “Level B Harassment” under the MMPA and “harassment” under the ESA.

The MMPA prohibits the take of marine mammals, with certain exceptions, one of which is the issuance of incidental take authorizations (ITAs). Sections 101(a)(5)(A) & (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made. Through delegation by the Secretary of Commerce, NMFS is required to authorize the incidental taking of marine mammals if the agency finds that the total 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 certain subsistence uses. NMFS must also set forth the permissible methods of taking and requirements pertaining to the mitigation, monitoring, and reporting of such takings. (The “small numbers” and “specified geographical region” provisions do not apply to military readiness activities.)

The term “take” means to harass, hunt, capture, or kill, or attempt to harass, hunt, capture or kill any marine mammal. 16 U.S.C. 1362(13).

Except with respect to certain activities described below, “harassment” means any act of pursuit, torment, or annoyance which:

• Has the potential to injure a marine mammal or marine mammal stock in the wild (Level A Harassment); or

• Has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding or sheltering (Level B Harassment).

See id. at 1362(18)(A)(i) & (ii) (emphasis added).

Congress amended the definition of “harassment” as it applies to a “military readiness activity” or research conducted by or on behalf of the Federal government consistent with MMPA section 104(c)(3) as follows (section 3(18)(B) of the MMPA):

• Any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild (Level A Harassment); or

• Any act that disturbs or is likely to disturb a marine mammal or marine mammal stock in the wild by causing disruption of natural behavioral patterns, including, but not limited to, migration, surfacing, nursing, breeding, feeding, or sheltering, to a point where such behavioral patterns are abandoned or significantly altered (Level B Harassment).

See id. at 1362(18)(B)(i) & (ii) (emphasis added).

The term “negligible impact” is defined as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival. 50 CFR 216.103.

In support of the analysis that is necessary to make the required statutory determinations, MMPA implementing regulations require ITA action proponents to provide NMFS with specific information. Although they may also be used to inform the development of mitigation measures, the updated acoustic criteria are particularly relevant to the following 2 of the 14 required pieces of information:

• The type of incidental taking authorization that is being requested ( i.e., takes by Level B Harassment only; Level A Harassment; or serious injury/ mortality) and the method of incidental taking; and

• By age, sex, and reproductive condition (if possible), the number of marine mammals (by species) that may be taken by each type of taking identified in paragraph (a)(5) of this section, and the number of times such takings by each type of taking are likely to occur. 50 CFR 216.104 (emphasis added).

Section 9 of the ESA prohibits the take of ESA-listed species, with limited exceptions. Section 7 of the ESA requires that each Federal agency, in consultation with NMFS and/or the U.S. Fish and Wildlife Service (USFWS), ensure that any action authorized, funded, or carried out by the agency 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. See 16 U.S.C. 1536(a)(2). Provided that NMFS or the USFWS reaches these conclusions through a “formal consultation” process, incidental take of ESA-listed species may be exempted from the section 9 take prohibition through an “incidental take statement” that must specify the impact, i.e., the amount or extent, of the taking on the species. See id. at section 1536(b)(4). Incidental take statements must also include reasonable and prudent measures necessary or appropriate to minimize the impact, and the terms and conditions required to implement those measures.

Under ESA, “take” means to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct. See id. at section 1532(19). “Harm” is defined in NMFS regulations as “an act which actually kills or injures fish or wildlife” (and can include significant habitat modification or degradation). See 50 CFR 222.102.

Under NMFS and the USFWS implementing regulations for section 7 of the ESA, “jeopardize the continued existence of” means to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of that species. See id. at § 402.02.

In support of the analysis necessary to conduct the consultation, the ESA implementing regulations state that in order to initiate formal consultation, the Federal action agency must submit a written request for formal consultation to the Director (of NMFS or the USFWS) that includes, among other things, a description of the manner in which the action may affect any listed species. See id. at § 402.14(c).

The acoustic criterias for AUD INJ will be used in conjunction with sound source characteristics, environmental factors that influence sound propagation, anticipated marine mammal occurrence and behavior in the vicinity of the activity, as well as other available activity-specific factors, to quantitatively estimate (acknowledging the gaps in scientific knowledge and the inherent uncertainties in a marine environment) the takes of marine mammals (by Level A harassment and harm under the MMPA and ESA, respectively) and facilitate compliance with the MMPA and ESA, as described above.

NMFS will use the same AUD INJ criteria in the identification and quantification of MMPA Level A harassment for both military readiness and non-military readiness activities. Because the acoustic criteria for AUD INJ predict the onset of AUD INJ, they are inclusive of the “potential” and “significant potential” language in the two definitions of Level A harassment. The limited data now available do not support the parsing out of a meaningful quantitative difference between the “potential” and “significant potential” for injury and, therefore, the designated AUD INJ criteria will be treated as onset of Level A harassment for both types of activities.

Estimating the numbers of take by Level A harassment and harm is one component of the fuller analyses that inform NMFS' “negligible impact” and “jeopardy” determinations under the MMPA and ESA, respectively. Last, the AUD INJ criteria may be used to inform the development of mitigation and monitoring measures (such as shut-down zones) pursuant to the MMPA or ESA.

When initiating any of the MMPA or ESA processes described above, agencies and other action proponents should utilize the AUD INJ criteria, in combination with activity-specific information, to predict whether, and if so how many, instances of AUD INJ are expected to occur.

As previously stated, NMFS has not considered TTS an auditory injury for purposes of the MMPA and ESA, based on the work of a number of investigators that have measured TTS before and after exposure to intense sound. For example, Ward (1997) suggested that a TTS is within the normal bounds of physiological variability and tolerance and does not represent physical injury. In addition, Southall et al. (2007, 2019) indicate that although AUD INJ is a tissue injury, TTS is not because the reduced hearing sensitivity following exposure to intense sound results primarily from fatigue, not loss, of cochlear hair cells and supporting structures, and is reversible. TTS is not considered Level A harassment under the MMPA. However, given the associated disruptions of behavioral patterns anticipated to co-occur with TTS in some cases, it has been considered take by Level B harassment under the MMPA and harassment under the ESA, which will be the subject of future guidance.

MMPA Level B harassment and ESA harassment are broad categories that encompass not only TTS but also other behaviorally related impacts that almost always involve a lower onset threshold than that for onset of TTS. In quantifying take by Level B harassment or harassment, NMFS considers all effects that fall into those categories of take, not just TTS. NMFS is in the process of developing updated acoustic criteria for the onset of behavioral effects and will further consider the best approach for considering TTS at that time. When that process is completed, NMFS will provide further guidance regarding how to best consider and/or quantify TTS for non-pulse and impulse sources that do not involve instantaneous explosives (see exception below for underwater explosives). In the meantime, except in the case of instantaneous underwater explosives (discussed next), action proponents do not need to quantify estimates of TTS separately from their overall behavioral harassment take calculations. NMFS will consider the TTS acoustic criteria in the 2024 Updated Technical Guidance as part of the larger comprehensive effects analyses under the MMPA and the ESA.

With respect to instantaneous underwater explosives (as distinguished from repeated explosives such as gunnery exercises), NMFS already requires quantification of TTS estimates because instantaneous explosives do not have a separate behavioral component from a lower exposure threshold and there is no time accumulation involved. The rationale for calculating TTS for instantaneous explosives continues to apply with the 2024 Updated Technical Guidance.

The occurrence and estimated number of TTS takes is one component of the larger analysis that informs NMFS's “negligible impact” and “jeopardy” determinations under the MMPA and ESA, respectively. As with AUD INJ, TTS acoustic criteria also may be used to inform the development of mitigation and monitoring measures pursuant to the MMPA or ESA.

On May 3, 2024, NMFS published the draft 2024 Updated Technical Guidance for a 45-day public comment period (89 FR 36762). During the public comment period, NMFS received 7 comments from individual members of the public, Fugro, EnerGeo Alliance and American Petroleum Institute, National Resources Defense Council, and Ocean Conservation Research. Six commenters ( i.e., one commenter provided two separate comments) provided substantive comments addressing technical aspects or issues relating to the implementation of criteria.

Some comments were similar to those received during the public comment periods for the 2016 Technical Guidance. For example, these similar comments addressed topics such as why NMFS does not consider TTS as injury, use of mean/medians, pseudoreplication, uncertainty, development of criteria for low-frequency (LF) cetaceans, Tougaard et al. 2015, and Wright 2015. NMFS will not repeat our responses from 2016 here but instead refers readers to our previous Federal Register notification (81 FR 51694, August 4, 2016) that previously addressed these comment topics.

Comment 1: One commenter stated that Sirenians should be included in the 2024 Updated Technical Guidance.

Response: The 2024 Updated Technical Guidance does not pertain to marine mammal species under the U.S. Fish and Wildlife Service's jurisdiction ( e.g., walrus, polar bears, manatees, dugongs, sea otters). Thus, Sirenians are not included in the main document. However, they are included in the Navy's Technical Report, attached to the 2024 Updated Technical Guidance as Appendix A.

Comment 2: One set of commenters stated that while the main sections of the 2024 Updated Technical Guidance was peer reviewed by experts, the Navy's Technical Report does not seem to be.

Response: The 2024 Updated Technical Guidance document, including the Navy's Technical Report (Appendix A), completed all stages of the review process ( i.e., the entire document underwent NMFS internal review, peer review, Federal agency preview, and public comment). Furthermore, during the peer review, federal agency preview, and public comment period, NMFS worked directly with the Navy to address some of the comments received.

Comment 3: To define a marine mammal hearing group's generalized hearing range, one commenter asked whether the 65 dB level above the threshold of maximum hearing sensitivity was chosen arbitrarily ( i.e., they asked for a reference that supports choosing a threshold specifically 5 dB wider than that in humans).

Response: NMFS did not choose this level arbitrarily. We specifically chose the 65 dB threshold to be slightly wider than how the hearing range for humans is defined in order to encompass the general uncertainty of marine mammal hearing ranges, since we do not have hearing data for all species.

Comment 4: One commenter's letter stated that sperm whales are categorized as high-frequency (HF) cetaceans but produce lower frequency sounds and are expected to hear lower frequencies compared to smaller delphinids. The commenter pointed out that Southall et al. 2019 indicated that sperm whales, killer whales, and beaked whales may be separated from other HF cetaceans in the future ( i.e., compose a mid-frequency (MF) cetacean hearing group), but Appendix A (Finneran Technical Report) does not address this potential future hearing group. The comment also notes there is potential variation of phocid hearing that may necessitate splitting this hearing group in the future. In a related comment, another commenter questioned why killer whale hearing data were not used to define audiograms for a separate MF cetacean group.

Response: While the potential to separate some marine mammal species into a separate MF cetacean hearing group is not directly mentioned in Appendix A (Finneran Technical Report), NMFS does address this in our main document. Specifically, table 1, footnote 1, says Southall et al. 2019 indicates that as more data become available there may be separate hearing group designations for very low-frequency cetaceans (blue, fin, right, and bowhead whales) and MF cetaceans (sperm, killer, and beaked whales). However, at this point, all baleen whales are part of the low-frequency (LF) cetacean hearing group, and sperm, killer, and beaked whales are part of the HF cetacean hearing group. Additionally, recent data indicate that as more data become available for Monachinae seals, separate hearing group designations may be appropriate for the two phocid subfamilies (Ruscher et al. 2021; Sills et al. 2021). NMFS concurs with the aforementioned studies that there are currently not enough data to further separate out MF cetaceans from HF cetaceans or further divide the phocid hearing group.

Comment 5: One comment letter questioned why the LF cetacean generalized hearing range expanded by 1 kHz, if there are no new data.

Response: While there are no new data available for LF cetaceans specifically, the weighting function parameters slightly changed for all hearing groups as a result of maintaining consistency with other hearing groups. As a result, NMFS re-examined the generalized hearing range for all hearing groups.

Comment 6: Numerous commenters inquired why auditory evoked potential (AEP) data are not being considered in deriving composite audiograms for various hearing groups and encouraged that all data be considered. Some commenters advocated for further research to focus on better integrating AEP data.

Response: NMFS agrees that incorporating AEP data into composite audiograms would be preferred and would expand the number of species where hearing data are available. Nevertheless, there are some well-defined reasons this is not done. Behavioral techniques measure perception of sound by a receiver, while AEP methods measure only neural activity (Jewett and Williston 1971) ( i.e., the two methodologies are not necessarily equivalent). Behavioral techniques, which are considered most representative ( i.e., “gold standard” for measuring auditory sensitivity, consistently produce lower thresholds, which are indicative of greater sensitivity, than those obtained by AEPs ( e.g., Szymanski et al. 1999; Yuen et al. 2005; Houser and Finneran 2006). AEP data are considered if they are the only data available for a hearing group ( e.g., LF cetaceans; See Response to next Comment ). Currently, there are no established means for “correcting” AEP data so they are more comparable to behavioral data (Heffner and Heffner 2003; Finneran 2015; Sisneros et al. 2016; Erbe et al. 2016). NMFS is aware that the Navy's Living Marine Resources (LMR) Program is supporting a project entitled Standardizing Auditory Evoked Potential Hearing Thresholds with Behavioral Hearing Thresholds by Dorian Houser, National Marine Mammal Foundation, which may allow for the addition of AEP data to future versions of our Technical Guidance: https://exwc.navfac.navy.mil/Portals/88/Documents/EXWC/Environmental_Security/Living%20Marine%20Resources/LMRFactSheet_Project47.pdf. NMFS also included this topic as a specific data gap in Appendix B to the 2024 Updated Technical Guidance (“Research Recommendations for Improved Criteria”).

Comment 7: Many commenters were interested in learning about recent AEP hearing measurements collected on minke whales by the National Marine Mammal Foundation. One commenter cautioned that the Balaenoptera (blue, fin, Rice's, Bryde's, minke, and sei whales) are just one genus of whale that use sounds in ways differently than Megaptera (humpback whales), Eschrichtius (gray whales), Balaena (bowhead whales), or Eubalaena (right whales) do. Similarly, another comment stated that NMFS should acknowledge that, given substantial differences among these LF cetacean species in their anatomy, sound production, and acoustic ecology, minke whales may not appropriately represent the hearing sensitivity of blue, fin, humpback, gray, and certain other baleen whales in the LF cetacean group; and that a more conservative approach to weighting in the very low frequencies may still be necessary. The commenter also remarked that NMFS should commit to a re-evaluation of LF cetacean group thresholds as soon as those data are published.

Response: NMFS is aware that the National Marine Mammal Foundation successfully collected preliminary hearing data on two minke whales during their third field season (2023) in Norway. These data have implications for not only the generalized hearing range for LF cetaceans but also on their weighting function. However, at this time, no official results have been published. Furthermore, a fourth field season (2024) was recently completed, where more data were collected. Thus, it is premature for NMFS to propose any changes at this time. However, mysticete hearing data is identified as a special circumstance that could merit re-evaluating the acoustic criteria in the 2024 Updated Technical Guidance, once the data from both field seasons are published.

NMFS anticipates the publication of these AEP data from minke whales will help better inform the composite audiogram and associated weighting function for LF cetaceans. We agree that while having direct measurements of minke whale hearing would represent a significant milestone in better understanding mysticete hearing, these data will need to be considered carefully in the context of how they may or may not be appropriate to fill data gaps for other LF cetacean species.

Comment 8: One commenter asserted that table A.3, which provides composite audiogram parameters, contains a number of errors. One error they purportedly identified is the use of hertz (Hz) instead of kHz ( e.g., the F 1 parameter for HF cetaceans is 9910 kHz and for Sirenians is 1680 kHz). Another example is the upper roll-off for the very-high frequency (VHF) cetaceans that begins below 100 kHz in Figure A.4, yet the value for the F 2 parameter (132 kHz) in table A.3 fails to match this result. As a consequence, they assert, they were unable to assess NMFS' use of Δ T values in extrapolating certain parameters across hearing groups.

Response: Table A.3 is correct and does not contain any errors. This can be verified by calculating Eq. (3) ( i.e., median threshold equation for composite audiogram) with the parameters from table A.3 and comparing the results to the composite audiograms. The F 1 and F 2 parameters in table A.3 are not roll-off frequencies, but instead are fitting parameters for use with Eq. (3) to best match the composite audiogram data. Because of the large number of fitting parameters, the values may not always make physical sense, especially for audiograms without a plateau region. This point is specifically made in the Finneran Technical Report (Appendix A, including the example cited by the reviewer) that the large number and possible high dependency of fitting parameters, in some cases the specific fitting parameter values may not make physical sense ( e.g., HF group F1 = 9910 kHz), and the important point is how well the resulting curve fits the median threshold data.

Comment 9: One commenter advocated that the F 1 audiogram fitting parameter for LF cetaceans be changed from 412 Hz to 137 Hz.

Response: NMFS disagrees that the F 1 audiogram fitting parameter for LF cetaceans should be adjusted, since no new data have become available supporting this change. This parameter is the same as published in Southall et al. 2019, as well as what was in the 2018 Revised Technical Guidance, and is appropriate based on our current understanding of LF cetacean hearing. Furthermore, when the new minke whale hearing data become available, it is likely that NMFS will begin the process of updating the acoustic criteria for LF cetaceans based on these data. Thus, the composite audiogram, thresholds, and weighting functions for this hearing group will all be re-examined and appropriate adjustments can be made.

Comment 10: A group of commenters requested that Appendix A (Finneran Technical Report) provide a detailed description of the methodology used to derive equations and criteria. On a few occasions, it is noted that mean values are calculated from data sets for deriving the weighting function, but the number of samples used to derive means or medians are not readily available. When available, this should be provided along with standard deviations.

Response: Figures A14 through A17 in Appendix A show the individual TTS onset values and the mean values used to fit the exposure functions. The number of samples and a sense of the variability can be determined from these plots.

Comment 11: Several commenters had questions about the 2024 Updated Technical Guidance modifying the weighting function high-frequency exponent ( b ) from 2 to 5, which was done to fit better underwater otariid pinniped data. Many asked why this parameter was modified for all hearing groups and not just otariids.

Response: This question was also asked during our Peer Review. In the 2018 Technical Guidance (and Southall et al. 2019), the b parameter was the same for all hearing groups. Thus, the changes made to the 2024 Updated Technical Guidance are consistent keeping this parameter the same for all hearing groups. Increasing the b parameter from two to five was done to fit better the underwater otariid (OW) pinniped function without substantially affecting the other marine mammal hearing group fits. The decision to keep the same b parameter for all groups was made to try to reduce complexity where possible, and there are no data to currently suggest this parameter varies by marine mammal hearing group.

Comment 12: A group of commenters asked for clarification on the R 2 value for underwater phocid (PW) pinnipeds ( i.e., −4.69) in table A.7 displaying weighting function parameters.

Response: A similar question was also asked during our Peer Review. The negative R 2 indicates the curve-fit does not follow the general trend in the data ( i.e., the data would have fit better with a flat line). This is a result of the assumption that the weighting function should be broader than the audiogram, thus F 1 was decreased after fitting for the PW group to match the audiogram 10-dB bandwidth. This prevents the weighting function from adjusting to best-fit the data points and causes the very low R 2 value.

Comment 13: A group of commenters stated that NMFS should clarify which TTS data in table 7 were collected using electrophysiological (AEP) methods vs. behavioral methods. They indicate that table 7 is misleading as it lists all the TTS studies available for integration, while only a small portion of these studies was used in the analysis.

Response: NMFS agrees that this is important information to include and has updated table 7 to distinguish between which studies collected hearing measurements via behavioral methodology vs. AEPs.

Comment 14: A group of commenters disagreed that impulsive sounds are more injurious than non-impulsive sounds. Specifically, their comment indicated that there are no direct or consistent data for marine mammals demonstrating that impulsive sounds are more injurious. They also indicated that marine mammals are able to self-mitigate, which might protect them from noise exposure.

Response: While there are limited marine mammal TTS data associated with exposure to impulsive sound, there is a rich library of literature available for terrestrial mammals that indicates exposure to impulsive sounds more often leads to mechanical damage of the inner ear, as well as more complex patterns of hearing recovery ( e.g., Henderson and Hamernik 1986; Hamernik and Hsueh 1991). Additionally, inner ear anatomy is conserved among all mammals, including marine marine mammals (Grunstra et al. 2024). Thus, lessons learned from terrestrial mammals likely translate to marine mammals. Furthermore, the marine mammal TTS data currently available do support that TTS and AUD INJ onset thresholds are lower for impulsive sounds compared to non-impulsive sounds.

Appendix B (Research Recommendations for Improved Criteria) in the 2024 Updated Technical Guidance acknowledges that odontocetes may have multiple means of reducing or ameliorating the effects of noise exposure. However, at this point, directly incorporating these mechanisms into our AUD INJ and TTS criteria and anticipating the likelihood of exposure ahead of an activity is difficult. More information on these mechanisms, especially associated with real-world exposure scenarios, would be useful.

Comment 15: One commenter remarked that Southall et al. 2019 found an approximately +/−6 dB difference in measured versus predicted TTS onset data. The commenter advocated there should be a similar measure of accuracy in Appendix A (Finneran Technical Report), but that the document provides no measure of natural variability or uncertainty, or any indication of predictability. Thus, they recommend that the agency implement a 6-dB reduction to its TTS and AUD INJ thresholds in line with the suggestions by Tougaard et al. 2015.

Response: There are numerous figures showing TTS onset data and the relationship between the exposure functions and the TTS data. These graphs indicate the variability in the TTS data and the differences between the measurements of TTS onset and the predicted exposure functions. Furthermore, NMFS disagrees that a 6-dB reduction is necessary or justifiable (and despite Southall et al. 2019 indicating variability in TTS data for VHF cetaceans, they did not alter their proposed TTS thresholds).

Comment 16: A group of commenters noted that there are significant changes for HF cetaceans criteria compared to the 2018 Technical Guidance, based on data from Finneran et al. 2023, and indicated that these changes were not highlighted in the draft 2024 Updated Technical Guidance. The comment expressed concern that since numerous HF species travel in large groups, there is a potential that take will be overestimated, as the 2024 Updated Technical Guidance does not account for behavioral responses of the animals. They also noted that in Figure A.14 for 2 kHz, it seems like the mean used for fitting value is much lower than the actual mean of the TTS onset values obtained by three studies (filled icons).

Response: This change was highlighted in Section 1.3 of the draft 2024 Updated Technical Guidance (Changes Associated with 2024 Updated Technical Guidance), specifically the fifth bullet: Lower TTS and AUD INJ thresholds ([cumulative sound exposure level metric] SEL 24h metric) for HF cetaceans, below 10 kHz, based on new data (Finneran et al. 2023a). Furthermore, the behavioral response of marine mammals to anthropogenic sounds is outside the scope of the 2024 Updated Technical Guidance. Finally, there are two TTS onset data points at 2 kHz (brown triangles in Figure A.14). The mean value (large circle in Figure A.14, visually between the two data points) was used during curve-fitting.

Comment 17: A group of commenters noted Appendix A (Navy's Technical Report) indicates “For VHF, new data suggest substantially higher onset TTS SELs at frequencies above ~10 kHz compared to the Phase 3 predictions, with high variability in the TTS onset data for harbor porpoises at 63 kHz (~40 dB difference in TTS onset for the two porpoises). Furthermore, the harbor porpoise behavioral TTS onset SELs are significantly higher than SELs resulting in large amounts ( e.g., 23-45 dB) of AEP TTS in Yangtze finless porpoise (see Fig. A.8). Although some differences in AEP/behavioral TTS data are expected, these large differences indicate that caution is warranted in adopting the high-frequency behavioral TTS data at the present time. For this reason, the VHF behavioral TTS onset data at frequencies >10 kHz were not used during the exposure function fitting process.” They commented this is problematic as it deviates from the other species group and processes used throughout the document as behavioral methodology is preferred.

Response: Numeric TTS onsets for the VHF cetaceans were derived using only behavioral data. For conditions where both behavioral and AEP data were available, the behavioral TTS data were used, because the relationship between AEP and behavioral TTS onsets is not clear. However, the AEP data cannot be completely ignored, and large differences between AEP and behavioral TTS onsets raise concerns. Because of the large difference in VHF cetacean behavioral TTS onset across individuals from the same study, and large differences between some of the behavioral and AEP data, the highest frequency VHF cetacean data were not used during the fitting process; only the lower frequency behavioral TTS data were used. This is consistent with the approach taken with other species groups, such as PW pinnipeds.

Comment 18: A commenter noted the 2024 Updated Technical Guidance generates notably higher TTS onset weighted exposure levels for harbor porpoise than the species-specific Tougaard et al. 2022 publication, even when accounting for different weightings.

Response: Tougaard et al. 2022 advocates examining harbor porpoise TTS data available since 2015 and calls for revisiting the synthesis culminating in Southall et al. 2019. NMFS' 2024 Updated Technical Guidance synthesizes all the same studies mentioned in Tougaard et al. 2022 (table IV from that publication), including those since Southall et al. 2019.

For impulsive sounds, compared to Southall et al. 2019 (which Tougaard et al. 2022 supports), the TTS SEL 24h thresholds in the 2024 Updated Technical Guidance are 4 dB higher. For non-impulsive sounds, compared to Southall et al. 2019 (which Tougaard et al. 2022 indicates updated data below 10 kHz correspond well, with more differences above 10 kHz), the TTS SEL 24h thresholds in the 2024 Updated Technical Guidance are 8 dB higher. However, it should be noted that the weighting function for VHF cetaceans has also shifted, making them more susceptible to noise-induced hearing loss below 10 kHz, where the majority of anthropogenic sound sources have their energy. Thus, both the thresholds and the weighting factors need to be considered in concert when evaluating the acoustic criteria for any marine mammal hearing group.

Comment 19: A group of commenters noted that Appendix A (Finneran Technical Report) indicates that harbor seal TTS onset data below 2.5 kHz were excluded from the Phase 4 fitting process and asked how this data exclusion would affect potential applicants more concerned about Moanachinae vs Phocinae pinnipeds.

Response: All phocids exposed in water are within the PW pinniped group and use the same criteria, therefore the exclusion affects Monachinae and Phocinae in the same way.

Comment 20: A commenter questioned NMFS' inclusion of a 132 dB data point in calculating the mean difference between TTS onset and the auditory threshold at f 0 . The commenter states that if 132 dB is not an outlier among the other cited values (116 dB, 116 dB, and 118 dB), then they do not know what would count as one. More generally, the commenter states that a visual review of Figures A.14 to A.17 indicates the presence of multiple apparent outliers, which collectively are likely to influence the fit of the exposure function.

Response: In combining values or deriving central tendencies, the default approach was to use the mean. Identifying true outliers in the various datasets was difficult because the sample sizes were typically small, and in many cases, the underlying distributions were unknown. Even if individual species group distributions were Gaussian, it is probable that sampling from the different groups would result in a unique, non-Gaussian distribution, and thus a Gaussian distribution for purposes of statistically testing for outliers could not be assumed. Datasets were therefore considered on a case-by-case basis, taking into account not only the range of numeric values, but the specific circumstances under which the data were obtained. There were only four instances where changing from the mean to the median was warranted:

(1) Estimating hearing thresholds for each group to create the composite audiograms. Here, the number of samples was relatively large, and there could be large fluctuations in thresholds across studies at any given frequency. Using the median value was the simplest way to estimate the composite audiogram, while reducing the influence of any outliers;

(2) Calculating the parameter DT 1 . DT 1 and DT 2 ( i.e., the amounts that the composite audiogram exceeded the minimum hearing threshold at the weighting function frequency parameters f 1 and f 2 , respectively). Values of DT 1 and DT 2 were calculated for HF cetaceans, VHF cetaceans, OW pinnipeds, and PW pinnipeds. For the other species groups, the mean or median of these values was used to estimate f 1 and f 2 from their composite audiogram. DT 1 values for groups HF cetaceans, VHF cetaceans, OW pinnipeds, and PW pinnipeds were 36.8, 11.5, 3.9, 6.5 dB, with mean = 14.7 and median = 9. The difference between 36.8 and its nearest neighbor was 25.3, which was almost 10x larger than the smallest value. For this reason, the median was used rather than the mean. In contrast, for DT 2 , values were 38.6, 22.7, 38.9, 39.4, with mean = 34.9 and median = 38.8. Here the mean was used rather than the median, despite a difference of 15.9 between 22.7 and its nearest neighbor;

(3) Cumulative weighted impulse SEL-based TTS onset values for HF cetaceans. There were impulsive TTS onset data from four individuals in the HF cetacean group: 177, 178, 175, 188 dB SEL (mean = 180, median = 178). The associated differences between steady-state and impulsive TTS onsets ( C s - C i ) were 4, 3, 6, and −7 dB (mean = 1.5, median = 3.5). Here, the median was used over concerns that the dolphin subject with the 188 dB onset may not be representative, based on his higher TTS onset and inverted relationship between steady-state and impulsive TTS onset compared to the other HF cetacean individuals. The inverted relationship between the steady-state and impulsive TTS onset values meant that including this subject would have made the impulsive TTS onsets more similar to steady-state onsets, which does not match our current understanding of TTS (impulsive noise is typically more hazardous); and

(4) Estimating the audiogram function parameter B for mysticetes. To estimate B for LF cetaceans, the median of the B values from the composite audiograms for the other in-water species groups was used. The individual values were: 1.66, 24.5, 2.5, 0.786, and 1.79 (mean = 6.25, median = 1.79). The range of values here is extreme, with the largest value >31x the smallest and almost 10x larger than its nearest neighbor. For this reason, the median was used.

In terms of the specific comments, the differences between hearing threshold and TTS onset at f 0 (the frequency of best sensitivity) were 132, 118, 116, and 118 dB for HF cetaceans, VHF cetaceans, OW pinnipeds, and PW pinnipeds (mean = 121, median = 118). The range of values and differences between neighbors is more similar to those for DT 2 , where the mean was used, compared to DT 1 , where the median was used. For this reason, the mean was used. Figures A.14 through A.17 show all available TTS data, regardless of the amount of TTS. These graphs therefore cannot be used to assess whether a data point is an “outlier” or not.

Comment 21: With the inclusion of in-air pinniped acoustic criteria in the 2024 Updated Technical Guidance, a group of commenters asked how NMFS plans on managing pinnipeds entering and leaving the water ( e.g., Does NMFS anticipate having animals 100 percent in air and/or 100 percent underwater during exposure calculations?).

Response: The inclusion of the in-air pinniped criteria in our 2024 Updated Technical Guidance was to promote consistency with other documents that previously have included in-air criteria, such as Southall et al. 2007 and Southall et al. 2019. Their inclusion does not necessitate anything changing in terms of how previous analyses have been completed for pinnipeds.

Comment 22: A group of commenters requested that recovery should be considered within the 2024 Updated Technical Guidance. They recommended that NMFS consider reviewing terrestrial data and comparing it to the cited two references (Finneran et al. 2010a and Finneran and Schlundt 2013) that presented a model to approximate recovery in bottlenose dolphins. They stated that expansion to other odontocetes seems very reasonable and more supportable compared to some of the other decisions made in the 2024 Updated Technical Guidance.

Response: NMFS acknowledges that after sound exposure ceases or between successive sound exposures, the potential for recovery from hearing loss exists, with AUD INJ resulting in incomplete recovery and TTS resulting in complete recovery. Nevertheless, predicting recovery from sound exposure can be complicated. Currently, recovery in wild marine mammals cannot be accurately quantified. As mentioned in the Comment, Finneran et al. 2010a and Finneran and Schlundt 2013 proposed a model that approximates recovery in bottlenose dolphins exposed to tones. However, the applicability of this model to other species, other sound sources, and other exposure conditions has yet to be determined. As more data become available for a broader array of species and sound sources, the incorporation of recovery can be considered for future iterations of the Technical Guidance.

Comment 23: A group of commenters indicated that it was unclear why effective quiet ( i.e., the maximum sound pressure level that will fail to produce any significant threshold shift in hearing despite duration of exposure and amount of accumulation) was not integrated in the 2024 Updated Technical Guidance.

Response: While NMFS agrees that effective quiet is an important consideration, there are limited data available to define effective quiet for marine mammals. As more data become available (identified as a data gap in Appendix B, Research Recommendations for Improved Criteria), they will be useful for a better understanding of appropriate accumulation periods for the weighted SEL 24h metric and noise-induced hearing loss, as well as whether there is potential for low-level ( e.g., Copping et al. 2014; Schuster et al. 2015; Copping and Hemery 2020; Tougaard et al. 2020; Stöber and Thomsen 2021; Kulkarni and Edwards 2022), continuously operating sources ( e.g., alternative energy tidal, wave, or wind turbines) to result in noise-induced hearing loss or not ( i.e., below effective quiet).

Comment 24: One commenter recommended that NMFS move away from establishing AUD INJ/TTS criteria and instead consider an “Auditory Damage Index,” which could include considerations of long-term hearing degeneration because of acute or chronic noise exposure and better allow for the assessment of a continuum of effects.

Response: NMFS agrees that noise-induced hearing loss follows a continuum (Houser 2021). However, to best quantify this continuum in a regulatory context, NMFS has established an onset criteria for both TTS and AUD INJ.

Comment 25: A commenter noted that the definition of AUD INJ includes but is not limited to PTS. They commented that AUD INJ threshold levels in many cases are higher than previous PTS levels in the 2018 Technical Guidance and asked if it is possible to determine levels that will result in the “ loss of cochlear neuron synapses or auditory neuropathy, ” and if NMFS is expanding the range of auditory damage to be considered, whether threshold levels in all cases should be reduced.

Another commenter had a similar comment, where they were concerned that this criterion is not conservative for purposes of representing directly-induced AUD INJ. They indicated that 40 dB TTS cannot continue to represent AUD INJ once indirect or accumulated injury is added. Conceptually, if directly-induced PTS alone equates to 40 dB TTS, then the two processes together must equate to less than 40 dB TTS. Thus, levels of noise exposure that can result in auditory neuropathy are capable of inducing PTS or AUD INJ.

Response: NMFS disagrees that based on our inclusion of AUD INJ, our thresholds should be adjusted or reduced. As stated in the 2024 Updated Technical Guidance, in situations where destruction of auditory tissue has occurred in terrestrial mammals, threshold shifts were 30 to 50 dB measured 24 hours after the exposure. There is no evidence that an exposure resulting in <40 dB TTS measured a few minutes after exposure can produce AUD INJ. Therefore, an exposure producing 40 dB of TTS measured a few minutes after exposure is used as an upper limit of a threshold shift to prevent AUD INJ ( i.e., it is assumed that only exposures beyond those capable of causing 40 dB of TTS have the potential to result in AUD INJ, which may or may not result in PTS).

Comment 26: A group of commenters requested clarification regarding use of the phrase a “ few minutes ” in Appendix A (Finneran Technical Report) where it talks about 40 dB of TTS, measured a few minutes after exposure, being used as a conservative estimate for the onset of PTS. The commenters indicated that this phrase was vague and should be clarified.

Response: In this context, a “few minutes” means the range of time over which marine mammal TTS initial post-exposure thresholds are obtained, typically 2 to 4 minutes.

Comment 27: One commenter noted that 2024 Updated Technical Guidance indicates that SEL 24h metric is not intended to estimate impact of noise exposure “ over various spatial and temporal scales. ” The comment asked if this means the SEL 24h metric is not intended for accumulating exposures that occur at considerably different locations and times; and the reason for such a limitation if that is the case. The commenter asked if auditory recovery plays a role in the explanation.

Response: As the 2024 Updated Technical Guidance indicates, current data available for deriving criteria using the SEL 24h metric are based on exposure to only a single source and therefore may not be appropriate for situations where exposure to multiple sources is occurring. As more data become available, the use of this metric can be re-evaluated for application of exposure from multiple activities occurring in space and time.

While auditory recovery is an important consideration, predicting recovery from sound exposure can be complicated. Currently, recovery in wild marine mammals cannot be accurately quantified. For the 2024 Updated Technical Guidance criteria, for intermittent, repeated exposures within a 24-hour period, NMFS assumes there is no recovery between subsequent exposures, although auditory recovery has been demonstrated in terrestrial mammals (Clark et al. 1987; Ward 1991) and more recently in a marine mammal studies (Finneran et al. 2010b; Kastelein et al. 2014a; Kastelein et al. 2015b). As more data become available, this topic can be further evaluated and potentially considered in future versions of this guidance.

Comment 28: A commenter recommended the incorporation and use of the kurtosis metric in the 2024 Updated Technical Guidance.

Response: NMFS agrees that kurtosis ( i.e., a statistical quantity that represents the impulsiveness or “peakedness” of the event), can be a useful consideration for distinguishing between impulsive and non-impulsive sounds. However, there are questions of how to apply this metric to marine mammal acoustic criteria (Von Benda-Beckmann et al. 2022). NMFS has identified kurtosis as a topic for further research in the 2024 Updated Technical Guidance (Appendix B: Research Recommendations for Improved Criteria). While kurtosis may be useful in helping determine when impulsive vs. non-impulsive criteria might be applicable for a particular sound source in a specific situation, it does not necessitate any changes to the criteria in the 2024 Updated Technical Guidance ( i.e., kurtosis affects implementation of the acoustic criteria, not the criteria themselves).

Comment 29: A group of commenters noted that for VHF cetaceans, there is one study (Kastelein et al. 2017c) where a higher peak sound pressure level (PK SPL) (199 dB) did not trigger TTS (maximum threshold shift of 3 to 5 dB), but Lucke et al. 2009 obtained significant TTS with a lower level PK SPL (195 dB) using AEP measurements. The commenters state these contradicting results highlight that PK SPL is currently not a robust and good predictor of TTS, and suggest that NMFS provide stronger reasoning on the choice of Lucke et al. 2009, while Kastelein et al. 2017c used behavioral methods (preferred method in Acoustic Guidance and Appendix A, Navy's Technical Report).

Response: NMFS acknowledges there are limited marine mammal data available for impulsive sounds reporting the PK SPL metric. However, we disagree that PK SPL is not a good predictor of TTS and believe it has inherent value in establishing marine mammal AUD INJ and TTS criteria. As stated in the 2024 Updated Technical Guidance, sound exposure containing transient components ( e.g., short duration and high amplitude; impulsive sounds) can create a greater risk of causing direct mechanical fatigue to the inner ear (as opposed to strictly metabolic) compared to sounds that are strictly non-impulsive (Henderson and Hamernik 1986; Levine et al. 1998; Henderson et al. 2008). Often the risk of damage from these transient components does not depend on the duration of exposure. Thus, weighted SEL 24h is not an appropriate metric to capture all the effects of impulsive sounds, which is why instantaneous PK SPL has also been chosen as part of NMFS's dual metric criteria for impulsive sounds. Of note, human noise standards recognize and provide separate criteria for impulsive sound sources using the PK SPL metric (Occupational Safety and Health Administration 29 CFR 1910.95; Starck et al. 2003).

As indicated in the document (Appendix A, Navy's Technical Report), PK SPL thresholds for TTS were based on TTS data from single impulsive sound exposures that produced 6 dB or more TTS for the HF and VHF cetaceans (the only groups for which data are available). The PK SPL thresholds from these data were 224 and 196 dB, for HF and VHF cetaceans, respectively (table A.5, Finneran et al. 2002; Lucke et al. 2009). The choice of relying on Lucke et al. 2009, even though it relies on AEP data, is due to the limited nature of the impulse TTS data for marine mammals and the likelihood that the VHF cetaceans are more susceptible than the HF cetaceans ( i.e., use of the HF cetacean value is not appropriate). Based on the limited data, it is reasonable to assume that the exposures described by Lucke et al. 2009, which produced AEP-measured TTS of up to 20 dB, would have resulted in a behavioral TTS of at least 6 dB. Finally, Kastelein et al. 2017c is not used because it did not meet our definition of TTS as requiring a threshold shift of at least 6 dB.

Comment 30: A group of commenters stated it is unclear how/when NMFS will decide the appropriate timeline to next update the Technical Guidance. They also questioned how NMFS will integrate future data in future iterations and whether an update would require another Navy Technical Report or Southall et al. publication.

Response: The 2024 Updated Technical Guidance provides a procedure and timeline for future updates in Section 3.1., where it indicates that NMFS will continue to monitor and evaluate new data as they become available and periodically convene staff from our various offices, regions, and science centers to revise the Updated Technical Guidance as appropriate (anticipating updates to occur on a three to five year cycle). A new Navy Technical Report and/or Southall et al. publication would be considered if either becomes available.

Finally, as mentioned in an earlier response, NMFS is aware that the National Marine Mammal Foundation successfully collected preliminary hearing data on 2 minke whales during their third field season (2023) in Norway. However, at this time, no official results have been published. Furthermore, a fourth field season (2024) was recently completed, where more data were collected. Thus, it is premature for NMFS to propose any changes at this time. However, mysticete hearing data is identified as a special circumstance that could merit re-evaluating the acoustic criteria in the 2024 Updated Technical Guidance, once the data from both field seasons are published.

Comment 31: A group of commenters stated that the absence of consideration of ambient noise in measurements targeted at measuring a single source can be problematic, as certain environments have already elevated ambient noise levels even without the introduction of any specific source or activity. NMFS listed “Multiple sources” as a research priority in Appendix B (Research Recommendations for Improved Criteria), and while the commenters agree that information on multiple sources might be important to better characterize how the acoustic environment of animals might change, it is also critical to recognize the importance of ambient noise, particularly if NMFS recommends applicants consider recording broadband measurements.

Response: NMFS agrees that characterizing the existing soundscape is an important consideration and has added it to the Appendix B (Research Recommendations for Improved Criteria) as suggested.

Comment 32: Several commenters inquired about the status of NMFS updating behavioral disturbance criteria for marine mammals.

Response: Behavioral disturbance criteria are outside the scope of the 2024 Updated Technical guidance. However, NMFS is currently in the process of developing draft marine mammal behavioral disturbance criteria. To date, we have completed a NMFS internal review and have started the peer review via the Center for Independent Experts (July 2024). For more information on how this review is progressing, please see: https://www.noaa.gov/information-technology/national-marine-fisheries-services-development-of-recommended-behavioral-disturbance-criteria-for.

This is a request for an extension of a currently approved collection. The NMFS Office of International Affairs, Trade, and Commerce collects information about United States (U.S.) vessels that fish on the high seas (waters beyond the U.S. exclusive economic zone). Such vessels are required to possess a fishing permit issued under the authority of the High Seas Fishing Compliance Act (HSFCA). Applicants for this permit must submit information (including a photo) to identify their vessels, and about owners and operators of the vessels, and intended fishing areas and fishing gear. The information submitted on the application is used to process permits and to maintain a register of U.S. vessels authorized to fish on the high seas.

Implementing regulations for the HSFCA also require vessels be marked for identification and enforcement purposes. Vessels must be marked in three locations (port and starboard sides of the deckhouse or hull, and on a weatherdeck) with their official number or radio call sign. Additional regulatory requirements include reporting on fishing activities and transshipments, notification of fishing trips for embarking observers (if selected), and operating a vessel monitoring system including power up and power down notifications. Finally, vessel operators may make requests for NMFS to authorize new fisheries (fishing gear, fishing area, target species) for U.S. vessels operating on the high seas. These requirements apply to all U.S. vessels fishing on the high seas.

Owners or operators of high seas fishing vessels must submit electronic permit applications (including vessel photo) via the NMFS online permitting system. Vessel operators submit logbook pages/transshipment notices/declarations to NMFS by email. Notifications for observer coverage and power down/power up of vessel monitoring systems are submitted via email. Requests for authorizing new fisheries on the high seas are submitted via letter/email. No information is submitted for the vessel marking requirement. The markings are only displayed on the vessel.

OMB Number: 0648-0304.

Form Number: None.

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

Affected Public: Business or other for profit organizations.

Estimated Number of Respondents: 600.

Estimated Time per Response: 30 minutes per electronic vessel permit application including uploading a vessel photograph; for logbook reports, 6 minutes per day for days fish are caught, 1 minute per day for days when fish are not caught; 45 minutes (15 minutes for each of 3 locations) for vessel markings; 5 minutes for advance notices of transshipment and 10 minutes for transshipment reports; 5 minutes for power up/power down notifications for enhanced mobile transceiver units; 5 minutes to notify NMFS of a fishing trip to allow for observer coverage; and 30 minutes to prepare/submit requests to authorize a new fishery on the high seas.

Estimated Total Annual Burden Hours: 302.

Estimated Total Annual Cost to Public: $162,919.

Respondent's Obligation: Mandatory (voluntary circumstances for new fishery authorization requests).

Legal Authority: HSFCA (Pub. L. 104-43) codified at 16 U.S.C. 5501 et seq.

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

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

CPSC seeks to extend the following currently approved generic collection of information:

Title: Child Strength Study.

OMB Number: 3041-0187.

Type of Review: Extension of generic collection.

Frequency of Response: On occasion.

Affected Public: Child participants and their caregivers.

Estimated Number of Respondents: We estimate 5,210 people will be invited for the study and 1,563 initial respondents will complete screening. Out of the initial respondents, 563 are expected to be screened out or not expected to ultimately participate after the invitation for study. We estimate that there will be 1,000 participants for the lab portion of the study.

Estimated Time per Response: The estimated time to complete a study session is 2 hours per participant. This does not account for the time for inviting and screening participants via phone conversations with the caregiver, which is additional 12 minutes per respondent.

Total Estimated Annual Burden: Based on CPSC's estimates that 5,210 people will be invited for the study (3 minutes per invite), 1,563 initial respondents will complete screening (9 minutes per screening) and there will be 1,000 participants for the lab portion of the study (2 hours to complete each study session), CPSC estimates that the total burden of this collection is 2,267 hours. The average annual burden is approximately 756 hours; however, because of study timing and efficiency, a single year could have up to 1,850 burden hours. There are no costs to respondents and no respondent recordkeeping requirements associated with the study.

General Description of Collection: CPSC uses data on human strength and capabilities to develop product safety standards and to inform other CPSC staff activities. Strength capabilities of children are used to develop product performance requirements in standards to reduce or eliminate the risk such products might pose to a child ( e.g., breaking, collapsing, or liberating a small part). The information to be collected from child participants ranging in age 3 months to 5 years includes contact and background information necessary to participate in a study to obtain child strength measures for upper and lower extremities and bite strength. Written consent is obtained from caregivers and verbal assent is obtained from children who are old enough to provide it. Researchers will obtain several standard anthropometric measurements from each child, including body weight and standing height. Researchers also record the participant's body shape using a whole-body laser scanner (VITUS XXL) and a Microsoft Kinect sensor.

Request for Comments:

The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:

• whether the collection of information described above is necessary for the proper performance of the Commission's functions, including whether the information would have practical utility;

• whether the estimated burden of the proposed collection of information is accurate;

• whether the quality, utility, and clarity of the information to be collected could be enhanced; and

• whether the burden imposed by the collection of information could be minimized by use of automated, electronic or other technological collection techniques, or other forms of information technology.

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

Title of Collection: International Resource Information System (IRIS).

OMB Control Number: 1840-0759.

Type of Review: A revision of a currently approved ICR.

Respondents/Affected Public: Private Sector; Individuals and Households.

Total Estimated Number of Annual Responses: 6,126.

Total Estimated Number of Annual Burden Hours: 12,928.

Abstract: Information Resource Information System (IRIS) is an online performance reporting system for grantees of International and Foreign Language Education (IFLE) programs. The site also allows for IFLE program officers to process overseas language requests, travel authorization requests, and grant activation requests. IRIS keeps a record of these requests and also of Foreign Language and Area Studies (FLAS) Fellowship recipients and grantee performance reports.

The International and Foreign Language Education (IFLE) office within the Office of Postsecondary Education, of the U.S. Department of Education (the Department) administers 11 institutional and fellowship grant programs authorized under title VI of the Higher Education Act and section 102(b)(6) of the Mutual Educational and Cultural Exchange Act, also known as Fulbright-Hays (F-H). The purpose of these programs is to strengthen the capability and performance of American education in foreign languages and in area and international studies.

The International Resource Information System (IRIS) is an online database that is used for performance reporting by the grantees funded by these 11 programs. The purpose of IRIS is to provide a centralized and effective way of collecting, reporting, and analyzing annual performance data.

This Information Collection Request is a revision of the previously approved IRIS information collection. The IFLE office underwent a strategic assessment of each program using the specific statute, regulations, and program purposes. Our assessment was guided by the following objectives: reduce the reporting burden for grantees; reduce the burden hours for IFLE staff to review APRs; and, increase the quality and usefulness of the data collected.

The strategic assessment resulted in revisions to the program collections that will significantly reduce reporting burden across programs. We anticipate that the overall annual burden hours will be reduced by 64% from the previous collection clearance.

On September 9, 2024, as provided for under 42 U.S.C. 7384 l (14)(C), the Secretary of HHS designated the following class of employees as an addition to the SEC:

This designation is effective as of October 9, 2024, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Federal Register reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC.

Authority: 42 U.S.C. 7384q(b). 42 U.S.C. 7384 l (14)(C).

Description: This request is to remove five forms from this collection, add two new forms, move two forms from a different information collection into this collection (with revisions to one of those forms), and revise three existing forms in this collection. ORR also proposes retitling this information collection “Legal and Advocacy Services for Unaccompanied Children.”

ORR plans to remove the following forms from this information collection:

1. Request for a Flores Bond Hearing (Form LRG-7), Motion to Request a Bond Hearing—Secure or Staff Secure Custody (Form LRG-8A), and Motion to Request a Bond Hearing—Non-Secure Custody (Form LRG-8B): The bond hearing process was replaced with a Risk Determination Hearing process under the UC Program Foundational Rule, 45 CFR 410. These forms were replaced with a new set of form specific to the RDH process, approved under OMB #0970-0633.

2. Motion for Change of Venue (Form L-7): This instrument was created for the UC Path case management system and was intended to be used for filing a motion for change of venue for children transferring to a different ORR care provider program. However, the UC Path system was never implemented, and this form has never been used. In addition, this function is performed by an entity that is party to the proceedings, typically the child's legal representative or Immigration and Customs Enforcement, because the decision to file a change of venue may affect the child's immigration case. A change of venue is filed for cases where a Notice to Appear has been filed. Since neither ORR nor its care provider programs perform this function, the form is not needed.

3. Post Legal Status Plan (Form L-8): The information collected in this form was incorporated into the Legal Services Plan section of the Category 4 Discharge Plan (Form R-9, currently approved under OMB #0970-0552). Therefore, ORR plans to discontinue this form.

ORR plans to add the following new forms to this information collection:

1. Case Status Summary for Executive Office for Immigration Review (Form L-9): This form is completed by the Federal Field Specialist (FFS)or care provider and sent to the Executive Office for Immigration Review (EOIR) in advance of a child's immigration hearing. The form provides basic information needed to ensure that EOIR has accurate information on the child's case status. A copy of the form is also shared with the child's legal service provider or attorney of record and child advocate (if applicable).

2. Recommended States List (Form L-11): This form is completed by legal service providers for children transferring to a long-term foster care (LTFC) placement. The form provides a recommended list of preferred placement locations recommended by the legal service provider (LSP) based on the child's potential for immigration relief in each state, type of immigration relief, and status of court hearings or relief petitions. The LSP's recommendation is one of several factors ORR considers when making an LTFC placement determination.

1. ORR plans to transfer the “Notice of Administrative Review (Form P-18)” into this information collection without revisions. This form is currently approved under OMB #0970-0554.

2. ORR plans to transfer the “Child Advocate Recommendation and Appointment” form into this information collection (currently approved under OMB #0970-0553). The currently approved version has been revised to move Section B: Recommendation and Appointment and Section C: ORR Approval into a separate form to better facilitate the referral, recommendation, and appointment process. The separate form containing the information collected in Sections B and C will be completed by fewer than 10 respondents and is, therefore, not subject to Paperwork Reduction Act and is not included in this request.

Additionally, ORR proposes the following revisions to assist its child advocate contractor in supporting referred children and making recommendations. ORR worked directly with the contractor to improve the form and incorporated recommendations the contractor submitted via public comment.

1. Rename the form “Child Advocate Referral” (Form L-12A).

2. Replace “UC” with “child” throughout the form.

3. Add fields for the Title, Email, and Phone Number of the referrer.

4. Make the following revisions related to the child's biographic information:

5. Add the following fields related to the child's entry into the United States:

6. Make the following revisions related to the child's placement:

7. Add the following fields related to the child's sponsor:

8. Add the following fields related to the child's legal representation:

9. Revise the list of reasons for referral to better reflect the most common reasons child advocate referrals are made.

10. Add a text box where referrers can provide additional details regarding the reason for referral.

11. Revise the burden estimate to reflect the number of child advocate referrals made from April 2023 through March 2024. The annual number of respondents increased from 216 to 300 and the annual number of responses per respondent increased from 5 to 19.

ORR plans to make the following revisions to existing forms in this information collection:

1. Request for Specific Consent to Juvenile Court Jurisdiction (Form L-1):

2. Specific Consent Request Case Summary (Form L-2):

3. Acknowledgement of Receipt of Legal Resource Guide (Form LRG-4):

1. Notice of Attorney Representation (Form L-3):

2. UC Legal Information (Form L-4):

3. Legal Service Provider Record (Form L-6):

Respondents: ORR grantee and contractor staff, unaccompanied children, parents/legal guardians of unaccompanied children, attorneys of record and legal service providers

Annual Burden Estimates:

Authority: 6 U.S.C. 279; 8 U.S.C. 1232; Flores v. Reno Settlement Agreement, No. CV85-4544-RJK (C.D. Cal. 1996).

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

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

This information collection helps support implementation of Agency statutory and regulatory requirements regarding new animal drugs containing an antimicrobial active ingredient. Sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient are required by section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b) to submit to FDA an annual report on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals. Sponsors are also required to maintain distribution records for their animal drug products, including separate information for each month of the calendar year, under section 512(l)(3) of the FD&C Act. These provisions were enacted to assist FDA in our continuing analysis of the interactions (including drug resistance), efficacy, and safety of antimicrobials approved for use in both humans and food-producing animals for the purpose of mitigating the public health risk associated with antimicrobial resistance.

Section 514.87 of our regulations (21 CFR 514.87) codifies the reporting requirements established in the FD&C Act. Sponsors submit antimicrobial animal drug sales and distribution reports to us on Form FDA 3744. Each report must specify: (1) the amount of each antimicrobial active ingredient by container size, strength, and dosage form; (2) quantities distributed domestically and quantities exported; and (3) a listing of the target animals, indications, and production classes that are specified on the approved label of the product. The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year. Each report must also provide a species-specific estimate of the percentage of each product that was sold or distributed domestically in the reporting year for use in cattle, swine, chickens, or turkeys for such species that appear on the approved label.

Description of Respondents: Animal drug manufacturers (sponsors). Respondents include individuals and the private sector (for-profit businesses).

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

We base our estimate of the average burden per response on our recent experience with the existing antimicrobial animal drug distribution reports program. We base our estimate of the number of affected respondents reported in tables 1 and 2 and the average number of responses per respondent in table 1 on a review of our records of sponsors with active and inactive applications. We estimate sponsors with active applications, who submit an annual antimicrobial annual drug sales and distribution report on paper, will spend 62 hours to assemble the necessary information, prepare, and submit to FDA. We estimate sponsors with active applications, who submit an annual antimicrobial animal drug sales and distribution report electronically, will spend 52 hours to assemble the necessary information, prepare, and submit to FDA. We estimate that sponsors with inactive applications will spend 2 hours preparing their annual antimicrobial animal drug sales and distribution reports, whether electronically or on paper.

Animal drug manufacturers are already required to maintain distribution records for their animal drug products to comply with FDA's current good manufacturing regulations for periodic drug reports under § 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)), approved under OMB control number 0910-0284. Section 512(l)(3) of the FD&C Act differs from § 514.80(b)(4)(i) in that it requires that records include separate information for each month of the calendar year. In addition, under 21 CFR 211.196 (approved under OMB control number 0910-0139), manufacturers currently are required to maintain distribution records that include dosage form, and date drug is distributed. Based on these requirements, FDA believes that manufacturers already keep detailed records of the dates when antimicrobial drugs are distributed for marketing and recall purposes from which monthly reports can be prepared as part of usual and customary business practices. However, FDA estimates an additional recordkeeping burden of 46 hours for further compliance with section 512(l)(3), as detailed in table 2.

After a review of the information collection since our last request for OMB approval, we have adjusted our estimates based on our experience with the antimicrobial animal drug distribution reports program. Our estimated burden for the information collection reflects a decrease of 54 burden hours and a corresponding decrease of 27 total annual responses. We attribute this to respondents who submitted by paper in previous years and are now reporting electronically.

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

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

The mission of the Office of Prescription Drug Promotion (OPDP) is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated so that patients and healthcare providers can make informed decisions about treatment options. OPDP's research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission, focusing in particular on three main topic areas: advertising features, including content and format; target populations; and research quality.

Through the evaluation of advertising features, we assess how elements such as graphics, format, and the characteristics of the disease and product impact the communication and understanding of prescription drug risks and benefits. Focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience. Our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first topic area, advertising features.

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

The study described in this notice builds on OPDP's portfolio of research on market claims and disclosures to explore the influence of statements around patient adherence and preference in prescription drug promotion. Previous FDA-funded research has shown that market claims that advertise drug characteristics unrelated to medicinal properties, such as “#1 Prescribed,” influence consumer and provider perceptions about a drug's efficacy (Ref. 1). In the same study, results of a tradeoff analysis suggested that patients prefer a drug over a competitor when this type of claim is present, and a drug without this claim required at least 1.23 percent greater efficacy to be chosen over a drug with this claim (Ref. 2). Treatment preferences may also be influenced by other drug characteristics, including its impact on quality of life, complexity of dosage regimens, administration mode, and cost to family and self (Refs. 3, 6, and 8).

It is not known how claims that appeal to the possibility for greater adherence or to social norms around what other patients or healthcare providers prefer influence perceptions of a drug. A related question is whether including a disclosure stating the uncertainty around such claims ( e.g., there is no conclusive research on whether DRUG A results in better adherence) can mitigate any misleading perceptions or influence preferences. Some evidence suggests that disclosures in prescription drug promotion are typically noticed and may help consumers and healthcare providers understand information (Refs. 2 and 4), but this topic has not been investigated in the context of adherence claims.

The present research is designed to complement previous research by experimentally examining the role of adherence and patient preference claims in prescription drug promotion.

Research questions:

1. Does the presence or absence of an implied adherence claim affect consumers' and primary care physicians' (PCPs') behavioral intentions or risk, benefit, and adherence perceptions?

2. Does the presence or absence of an adherence-related patient preference claim affect consumers' and PCPs' behavioral intentions or risk, benefit, and adherence perceptions?

3. Does the presence of both types of claims (adherence and preference) have a cumulative impact on consumers' and PCPs' behavioral intentions or risk, benefit, and adherence perceptions?

4. Does a disclosure of information to the effect that there is no conclusive research on whether the drug results in better adherence mitigate consumers' and PCPs' behavioral intentions or risk, benefit, and adherence perceptions?

To complete this research, we propose the following design for a total of 8 study conditions: 2 (patient preference claim) × 2 (adherence claim) × 2 (disclosure).

We will recruit the following numbers of participants for the pretest and main study surveys:

Each participant will see one of eight versions of a static web page for a fictitious prescription type 2 diabetes treatment, as reflected in table 1. They will answer a survey designed to take no more than 15 minutes to complete regarding their perception of the product's benefits, risks, and effect on adherence. Consumers and PCPs will receive slightly different versions of the web page and survey, and their data will be analyzed separately.

In the Federal Register of October 12, 2023 (88 FR 70669), FDA published a 60-day notice entitled “Agency Information Collection Activities; Proposed Collection; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion,” requesting public comment on the proposed collection of information. FDA received two submissions, one of which included multiple comments. Responses to all comments follow. For brevity, some public comments are paraphrased and, therefore, may not state the exact language used by the commenter. All comments were considered even if not fully captured by our paraphrasing in this document. The following acronyms are used here: healthcare professional (HCP); Food and Drug Administration (FDA or Agency); and FDA's Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research (OPDP).

(Comment 1) One comment supported the OPDP research program and the current proposed study, with a question as to whether research on disclosures has been previously conducted.

(Response 1) We appreciate this comment for its support of this research and our research program. In response to the query in this comment, OPDP has conducted studies on the topic of disclosures in prescription drug promotion (found at the website listed previously in this document), but none that have addressed disclosures specific to adherence or preference claims.

(Comment 2) One comment inquired whether the Agency intends to publish the results of this study. If so, the comment inquired whether publication will be in the form of a publicly available report or a peer-reviewed publication.

(Response 2) The exact timing and nature of any such dissemination has not been determined but may include presentations at trade and academic conferences, publications, articles, and an internet posting.

(Comment 3) One comment inquired whether the Agency intends to seek an approval or exemption from an Institutional Review Board (IRB) or ethics committee.

(Response 3) The research will be reviewed for exemption by the IRB of record, which will be the FDA contractor's (Westat's) IRB.

(Comment 4) One comment inquired how the Agency will ensure that the samples are representative of the relevant populations, and it asked whether there will be stratification of the sample by specific demographic or clinical characteristics.

(Response 4) The project will recruit individuals from two populations: adult consumers diagnosed with type 2 diabetes and PCPs. For each study segment, internet vendor AllGlobal will recruit study participants using their proprietary panels. Several methodologies are used by AllGlobal to recruit panelists, including opt-in email, co-registration, e-newsletter campaigns, and internal and external affiliate networks. To recruit consumers, AllGlobal will use their LifePoints panel of more than 5.5 million consumers. To recruit PCPs, AllGlobal will use its Global Professional Panel, which includes access to over 2 million physicians, nurses, and other interested healthcare parties across a wide range of therapy areas. AllGlobal uses various metrics to track panel member activity and engagement, which enhances the efficiency of recruitment and quality of survey data from their panelists.

Participants will be drawn from convenience samples, rather than probability-based samples. We will aim for a diverse mix of participants in terms of race/ethnicity, gender, age, and other characteristics, but we will not specifically stratify the data before collecting it. Moreover, no weighting of the data will be required because the objective of the studies is to estimate the causal effects of experimental manipulations rather than to estimate descriptive statistics for these populations.

(Comment 5) One comment notes that Questions 7 and 8 of the questionnaire ask respondents whether HCPs and patients prefer FENTIVA. Considering these questions, the comment suggests that the web page include such statements with appropriate context. For example, the web page might post language such as “more patients prefer FENTIVA versus [Insert product].” In addition, the comment suggests it would be appropriate for the web page to also include a statement referencing the study from which this information was derived. For example, the comment notes that the preference information presented on the website for RITUXAN HYCELA (rituximab and hyaluronidase human) injection includes the following statement: “In a study of previously untreated DLBCL and follicular lymphoma patients, 77 percent of patients preferred subcutaneous administration of RITUXAN HYCELA over intravenous rituximab as it required less time in clinic.”

The comment states that without seeing the stimulus to which participants will be asked to respond, there is uncertainty about the purpose of these questions. If these questions are meant to assess participants' understanding of the information on the web page, then the comment suggests that the question ask the participant to choose the correct statement from a set of statements in which all but one is incorrect. The comment further suggests that if these questions are meant to assess the impression that a participant gets from the information presented on the web page, then responses to these questions likely cannot be interpreted directly.

Lastly, the comment recommends that the Agency clarify the purpose of Questions 7 and 8 and ensure that the conclusions that will be drawn by the responses to these questions can be supported based on the questions themselves and the response options provided to participants.

(Response 5) We appreciate these comments and offer a few points of clarification. Questions 3-11 are intended to assess participants' recall of information provided in the stimuli (website). For example, the statement “Doctors prefer FENTIVA over other medications to control blood sugar.” Question 7 was not mentioned on the website and is asked as a foil. These questions will allow us to determine whether participants' read the stimuli carefully and thus serve as an attention check.

Participants' gist comprehension of the information will be assessed through a different series of questions using a True/False format.

We also address the suggestion to include a statement referencing the study from which the preference information is derived (as is done with the RITUXAN HYCELA website). A key aim of our study is to test the effect of a disclosure statement on perceptions when no such evidence on adherence exists ( e.g., “There is no clinical evidence suggesting better treatment adherence with once-monthly FENTIVA injection compared to daily tablets”). For this reason, we chose not to provide clinical information on preference or adherence in our study stimuli, although we acknowledge that some promotions indeed include this information when available.

(Comment 6) One comment notes that Question 7 reads, “Doctors prefer FENTIVA over other medications to control blood sugar.” The comment suggests clarifying the wording. Specifically, the comment suggests that doctors do not have preferences for medications. Instead, doctors “would be more likely to choose to prescribe one option over another.” In addition, doctors prescribe medications to patients with a condition. Therefore, the comment suggests revising “medications to control blood sugar” to read, “for patients who need to control their blood sugar.”

(Response 6) We appreciate the second point and have changed Question 7 to read: “Doctors prefer FENTIVA over other medications for patients who need to control their blood sugar.” We also refer to our previous explanation (Response 5) about the intent of this item, which is to test recall of information on the website, where the statement about doctors' preferences for FENTIVA was not mentioned on the website and thus included in this survey as a foil.

(Comment 7) One comment suggests that Question 9 is difficult to evaluate without seeing the materials that will be presented to participants. Specifically, the comment notes that if the web page does not say explicitly that the patient doesn't have to think about taking medication every day, but instead says that FENTIVA is taken once a month rather than every day, whether a patient “no longer has to think about taking medication” could be considered leading, and interpreting the results of this question could be problematic. Therefore, the comment recommends that the Agency clarify the purpose of Question 9 and ensure that there is no ambiguity in how the responses to the question will be interpreted.

(Response 7) As explained above, items 3-11 assess recall of information that may or may not have been presented on the website. The statement “With once-monthly FENTIVA injections, I no longer have to think about taking medication every day” is presented on the website. The intent of the question is to assess whether participants read and paid attention to key statements.

(Comment 8) One comment opines that Questions 10 and 11 are difficult to interpret without seeing the information that will be provided to participants. However, the comment continues, the pair of questions taken together seem to indicate that one statement is correct while the other is not. If the purpose of the questions is to test recall, then it would be more appropriate to include both statements in a single question and ask respondents which is correct. If the purpose of the questions is to test the impression that participants get from the information presented in the web page, then there may be no objectively correct answer to the question that does not mirror exactly what is stated in the web page. Therefore, the comment recommends that the Agency clarify the purpose of Questions 10 and 11 and ensure that there is no ambiguity in how the answers to these questions will be interpreted.

(Response 8) We refer to our previous explanation (Response 5) about the intent of these items. To clarify further, consumers and PCPs will receive slightly different versions of the same disclosure statement on the website. Thus, only the consumer group will be asked Question 10 and only the PCP group will be asked Question 11.

(Comment 9) One comment notes that Question 14 asks whether it is true or false that “FENTIVA is given as a shot with a needle.” The comment states that this statement could be interpreted that FENTIVA is administered using a syringe with an exposed needle. If the web page states that the medication is given using an autoinjector, pen, or another device, it may be technically true that the medication is given as a shot with a needle. But it is also plausible that a reasonable person would say that this is untrue because they interpret “shot with a needle” to describe only a syringe with an exposed needle. The comment recommends that the Agency review this question to ensure that there is no ambiguity in participant's interpretation of the statement or in the Agency's interpretation of the results.

(Response 9) We agree with the concern raised in this comment and have since revised this item to read: “FENTIVA is given as an injection under the skin” (True/False) as a measure of comprehension.

(Comment 10) One comment notes that Question 15 asks participants to indicate “what you know.” The comment states that because FENTIVA is a hypothetical product and participants are responding to a specific set of information, asking participants “what you know” may be an imprecise question. Therefore, the comment recommends that the Agency consider revising the question to read: “Please indicate which of the following statements best describes what you understand about FENTIVA based on the information provided in the web page.”

(Response 10) We have revised the question to read: “Please indicate which of the phrases below best completes this statement about FENTIVA, based on what you read on the website.”

(Comment 11) One comment notes that Question 16 presents two statements which are suggested to come from the stimulus material. The comment notes that both statements could be considered incomplete because they mention a specific injection product (“FENTIVA”) contrasted with an unnamed oral medication. The implication is that the oral tablets are an alternative to FENTIVA for achieving the same clinical outcome. However, the comment notes that this conclusion is not included in the stimulus material and recommends that the use of the oral tablet as an alternative for the same condition be stated explicitly.

(Response 11) The language presented in Question 16 refers to the disclosure statements as they appear on the stimuli: “There is no evidence that patients who choose once-monthly FENTIVA injections are more likely to follow their prescribed treatment plan compared to those who choose daily tablets” (consumer version) or “There is no clinical evidence suggesting better treatment adherence with once-monthly FENTIVA injection compared to daily tablets” (HCP version). We intentionally do not state that FENTIVA injection achieves the same clinical benefit as oral daily tablets, as we ask later about participants' perceptions of comparative efficacy, based on the information provided in the stimuli.

(Comment 12) One comment notes that in Questions 17-19, the questions related to importance and usefulness likely require context—important in what way and/or useful in what way? The comment suggests that without clarification, the interpretation of the responses to these questions would be subject to ambiguity and recommends changing “useful” to “useful in . . .” and “important” to “important for . . . .”

(Response 12) These questions are derived from theory and validated scales on “perceived message effectiveness.” This construct is often measured as a set of close-ended judgments such as “useful/not useful” and estimate the degree to which recipients of that message will favorably (or unfavorably) evaluate a message. Identifying why or how the message is considered useful/relevant could be assessed with further questions but is not a focus of this research. Rather, we are interested in participants' more general perceptions of message effectiveness and will compare responses across study arms (Ref. 5).

(Comment 13) One comment suggests that Questions 20-24 include language that could be considered leading. Therefore, the comment recommends changing the questions to capture whether the participant assessed the statement to be true or false and changing the response options to “true,” “false,” or “I don't know.”

(Response 13) We have chosen to use a Likert scale (1 = would not help at all/5 = would help very much) rather than a true/false scale for these items as the intent is to assess the extent to which participants perceive the drug to be beneficial/efficacious. We also note that these items were adapted from validated scales on perceived benefit and risk (Ref. 7).

(Comment 14) One comment suggests that Question 27 includes language that could be considered leading and recommends changing the question to capture whether the participant assessed the statement to be true or false and changing the response options to “true,” “false,” or “I don't know.”

(Response 14) See Response 13 and the referenced citation above. We have chosen to measure benefit and risk perception using Likert scales and note that these measures come from validated scales.

(Comment 15) One comment suggests clarifying whether in Questions 29 and 30, “other daily prescription drugs that treat type 2 diabetes,” includes insulin or other injectable options or is limited to oral options only.

(Response 15) These questions are intended to assess perceptions of the convenience of FENTIVA compared to any other type 2 diabetes drug taken daily.

(Comment 16) One comment suggests that the language in Question 31 could be considered leading. The question asks about likely adherence to a medication over a long period of time during which a patient may experience side effects or lack of efficacy. Therefore, a likelihood to get injections every month assumes that a patient does not have a reason for discontinuing. In addition, the comment notes that it is not clear whether the injections are prescribed instead of an alternative or in addition to an alternative. The comment recommends that the Agency make the assumptions behind the question explicit to the participant.

(Response 16) The reasons mentioned in this comment are the reasons OPDP found it valuable to conduct this study. Those are possible reasons that it could be misleading to suggest that receiving a monthly injection is easier or results in greater adherence than a daily pill. FDA has designed this study to keep our questions as simple as possible, consistent with good practices, to reduce burden on participants. We specifically keep extraneous factors out of the questions to glean what we intend to study. Here, we are interested to know if behavioral intentions around adherence vary by experimental arm. Would information on the website around patient preference or disclosure about the lack of evidence on adherence influence behavioral intentions?

(Comment 17) One comment suggests that Questions 33-35 likely overstate the type of evidence that would be used for this purpose and recommends rephrasing the question in each case to read, “Knowing that more patients preferred FENTIVA monthly injections than other daily prescription drugs . . . .”

(Response 17) We have removed these items from the survey.

The total annual estimated burden imposed by this collection of information is 1,293 hours (table 2). As with most online and mail surveys, it is always possible that some participants are in the process of completing the survey when the target number is reached and that those surveys will be completed and received before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for both participant samples in the study.

Note that this burden chart differs in certain respects from the chart published in the 60-day Federal Register notice. The previous burden chart assumed a 70 percent estimated eligibility for the consumer group; the current chart has adjusted this estimate to 5 percent. The previous chart incorrectly assumed that the vendor already had eligibility information for this panel, and we could specifically target those with this medical condition. Thus, the larger burden estimate is the more accurate, as we will need to screen a larger number of people. We also adjusted the HCP estimate to reflect what we believe is a more accurate projected eligibility of 50 percent.

The following references are on display with the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; these are not available electronically at https://www.regulations.gov as these references are copyright protected. Some may be available at the website address, if listed. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. On December 12, 2024, under Topic I, the Committee will meet in open session to discuss Considerations for RSV Vaccine Safety in Pediatric Populations. Under Topic II, the Committee will meet in open session to hear overviews of the LI and LR research programs in the Division of Viral Products, Office of Vaccines Research and Review, and Center for Biologics Evaluation and Research. After the open session ends for Topic II, the meeting will be closed to the public for Committee deliberations.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting. Background material and the link to the online teleconference and/or video conference meeting will be available at: https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Procedure: On December 12, 2024, from 8:30 a.m. to 3 p.m. Eastern Time for Topic I and from 3:10 p.m. to 4:40 p.m. Eastern Time for Topic II, the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. All electronic and written submissions submitted to the Docket (see ADDRESSES ) on or before December 4, 2024, will be provided to the Committee. Comments received on or after December 4, 2024, and by December 11, 2024, will be taken into consideration by FDA. Oral presentations from the public will be scheduled between approximately 12:15 p.m. to 1 p.m. Eastern Time for Topic I, and between 4:25 p.m. to 4:40 p.m. Eastern Time for Topic II. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, along with their names, email addresses, and direct contact phone numbers of proposed participants, and an indication of the approximate time requested to make their presentation on or before 12 p.m. Eastern Time on November 25, 2024. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 27, 2024.

Closed Committee Deliberations: On December 12, 2024, the meeting will be closed from 4:40 p.m. to 5:30 p.m. to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The recommendations of the advisory committee regarding the progress of the individual investigators' research programs, along with other information, will be discussed during this session. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Sussan Paydar or Kathleen Hayes (see FOR FURTHER INFORMATION CONTACT ) at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq. ). This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform. This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. No participant will be prejudiced by this waiver, and that the ends of justice will be served by allowing for this modification to FDA's advisory committee meeting procedures.

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 section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g). Section 418(a) requires the owner, operator, or agent in charge of a facility to evaluate hazards that could affect food manufactured, processed, packed, or held by the facility; identify and implement preventive controls; monitor the performance of those controls; and maintain records demonstrating compliance. Section 418(b) through (i) of the FD&C Act contains more specific requirements applicable to facilities, including corrective actions (section 418(e)), verification (section 418(f)), a written plan and documentation (section 418(h)), and reanalysis of hazards (section 418(i)). Finally, section 301(uu) of the FD&C Act (21 U.S.C. 331(uu)) prohibits “[t]he operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418 [of the FD&C Act].” FDA has issued regulations in part 117 (21 CFR part 117) governing human food, while regulations governing food for animals are found in part 507 (21 CFR part 507). The purpose of the regulations is to prevent the introduction of adulterated and/or misbranded products into the marketplace and ensure the safety of both human foods and animal foods in accordance with sections 402 and 403 of the FD&C Act (21 U.S.C. 342 and 343). Generally, domestic and foreign food facilities that are required to register in accordance with section 415 of the FD&C Act (21 U.S.C. 350d) must comply with these requirements, unless an exemption applies. It is important to note that applicability of the current good manufacturing practice requirements for animal food is dependent upon whether a facility is required to register, while the applicability of the current good manufacturing practice requirements for human food is not dependent upon whether a facility is required to register. Respondents to the information collection are those who manufacture, prepare, pack, or hold food intended for humans or animals.

The regulations include recordkeeping necessary to demonstrate compliance with the requirements; however, respondents that meet the definition of a “qualified facility,” under §§ 117.3 and 507.3, are subject to reporting. To be subject to the modified requirements set forth in part 117, subpart D and part 507, subpart D for human food and animal food, respectively, respondents must attest to their status. To assist respondents in this regard, we have developed Forms FDA 3942a (Quality Facility Attestation: Human Food) and 3942b (Quality Facility Attestation: Animal Food), available for downloading from our website at https://www.fda.gov/food/registration-food-facilities-and-other-submissions/qualified-facility-attestation.

Information collected will assist FDA in determining facility compliance with current good manufacturing practice requirements and in ensuring that food safety systems include hazard analysis and risk-based preventive controls. Records will be examined during food facility inspections and in the event of an outbreak or other food safety incident involving the food manufactured at the facility.

Section 418(l)(2)(B)(ii) of the FD&C Act directs us to issue guidance on documentation required to determine status as a qualified facility. Accordingly, we issued a guidance for industry entitled “Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals,” also available for downloading from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facility. The guidance discusses the content, format, frequency, and timing of submissions.

In the Federal Register of June 5, 2024 (89 FR 48172) we published a 60-day notice requesting public comment on the proposed collection of information. Although no comments were received, on our own initiative we have modified estimates since publication of our 60-day notice. Specifically, we have modified estimates for certain recordkeeping elements associated with animal foods in tables 2 and 3.

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

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

Information Collection Request Title: HRSA Environmental Information and Documentation, OMB No. 0915-0324—Extension.

Abstract: HRSA proposes an extension of the Paperwork Reduction Act approval for the Environmental Information and Documentation (EID) checklist, which consists of information the agency is required to obtain to comply with the National Environmental Policy Act (NEPA) of 1969 as amended by the Fiscal Responsibility Act of 2023. NEPA establishes the federal government's national policy for protection of the environment. The EID checklist must be completed and submitted by applicants for HRSA funds that plan to engage in construction or other projects that will potentially impact the environment. HRSA uses the checklist to ensure that decision-making processes are consistent with NEPA and other related environmental and historic preservation laws. The extension will support HRSA's implementation of programs with capital improvements that have the potential to significantly affect the human environment, such as construction/expansion and alteration/renovation activities, as defined in the associated HRSA program guidance, or installation of fixed equipment.

Need and Proposed Use of the Information: Applicants for HRSA funds must provide information and assurance of compliance with NEPA on the EID checklist. This information is reviewed during the Pre-Award stage (and/or prior to the implementation of the project). The information is reviewed in the Post-Award stage for project changes and the information is reviewed before the implementation of the project changes.

Likely Respondents: HRSA applicants applying for federal loan guarantees, federal construction grants, and cooperative agreements.

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

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

Subpart M—Medical Review Officer (MRO), Section 13.2 of the Mandatory Guidelines, “How are nationally recognized entities or subspecialty boards that certify MROs approved?” states as follows: “All nationally recognized entities or subspecialty boards which seek approval by the Secretary to certify physicians as MROs for Federal workplace drug testing programs must submit their qualifications, a sample examination, and other necessary supporting examination materials ( e.g., answers, previous examination statistics or other background examination information, if requested). Approval will be based on an objective review of qualifications that include a copy of the MRO applicant application form, documentation that the continuing education courses are accredited by a professional organization, and the delivery method and content of the examination. Each approved MRO certification entity must resubmit their qualifications for approval every two years. The Secretary shall publish at least every two years a notice in the Federal Register listing those entities and subspecialty boards that have been approved.”

HHS has completed its review of entities that certify MROs, in accordance with requests submitted by such entities to HHS.

The HHS Secretary approves the following MRO certifying entities that offer MRO certification through examination:

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.

This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at https://msc.fema.gov.

The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.

Notice is hereby given that, in a letter dated September 10, 2024, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”), as follows:

The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, William F. Roy, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.

The following areas of the State of Vermont have been designated as adversely affected by this major disaster:

The notice of a major disaster declaration for the State of Tennessee is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 2, 2024.

The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.

The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65. The currently effective community number is shown and must be used for all new policies and renewals.

The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).

This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.

This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.

Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at https://msc.fema.gov.