Background

Chrysanthemum white rust (CWR) is a fungal disease caused by the basidiomycete Puccinia horiana, Henn. The Animal and Plant Health Inspection Service (APHIS) currently considers CWR a quarantine pest. 1 Under international standards, a quarantine pest is defined as a pest of potential economic importance to the area endangered by it and not yet present there, or present but not widely distributed there and being officially controlled.”  2

Because CWR is currently considered a quarantine pest, APHIS' policy  3 provides that any CWR detection domestically triggers an eradication protocol requiring complete destruction of symptomatic plants and those nearby. The policy also requires fungicidal treatments be applied to asymptomatic plants. Affected growers or entities bear the CWR eradication expense.

APHIS has also placed regulatory restrictions and prohibitions on the importation of host material for CWR in order to prevent its introduction into the United States through such importation. The regulations in 7 CFR 319.37-1 through 319.37-23 govern the importation of plants for planting into the United States. Section 319.37-4 of the regulations provides that certain taxa of plants for planting are not authorized for importation into the United States pending pest risk analysis (NAPPRA) to prevent the introduction of quarantine pests into the United States.

Currently, Chrysanthemum spp. and synonymous genera ( Archanthemis marschalliana, Argyranthemum spp., Brachanthemum fruticulosum, Coleostephus multicaulis, C. myconis, Dendranthema spp., Glebionis spp., Heteranthemis spp., Hulteniella integrifolia, Leucanthemella spp., Leucanthemopsis spp., Leucanthemum spp., Mauranthemum paludosum, Nipponanthemum nipponicum, Nivellea nivellei, Opisthopappus taihangensis, Pentzia incana, Plagius spp., Rhodanthemum spp., Tanacetum spp., Tripleurospermum spp., and Xylanthemum spp.) cuttings and in vitro plantlets from Belgium, Bolivia, Brazil, Colombia, Costa Rica, El Salvador, Ethiopia, Germany, Guatemala, Kenya, Mexico, the Netherlands, Nicaragua, Panama, Spain, Tanzania, Tunisia, Uganda, the United Kingdom, and Vietnam are NAPPRA. They were added to the NAPPRA list due to the risk that such importation may pose of introducing CWR. Additionally, cuttings, in vitro plantlets, and plants with roots of the same genera from Canada are also currently NAPPRA due to CWR.

Paragraph (e) of § 319.37-4 describes the process for removing taxa from the NAPPRA list. After receiving a request to remove taxa from the NAPPRA list, APHIS will conduct a pest risk analysis (PRA) in response to such a request and make the PRA available for public review and comment. Following the close of the comment period, we will review all comments received and announce our decision regarding the request in a subsequent notice.

In accordance with this process, the 20 countries referenced above submitted a request to remove Chrysanthemum spp. and synonymous genera cuttings and in vitro plantlets from NAPPRA, and we prepared a pest list regarding the quarantine pests that could follow the pathway on the importation of these commodities into the continental United States. Likewise, the national plant protection organization of Canada made a similar request with regard to the importation of cuttings, in vitro plantlets, and plants with roots of these genera, and again, we prepared a pest list regarding such importation. However, because CWR was among the quarantine pests on these pest lists, based on longstanding APHIS policy, we were not able to take further action at the time.

This notice announces that we have reevaluated that policy. Since CWR was first discovered in the United States in 1977, detections that reappeared several times were believed eradicated. This belief, along with our assumption that the economic consequences of CWR establishment outweighed the costs of control, undergirded our determination that CWR was of quarantine significance.

Evolving biological research has indicated, however, that CWR can be systemic and survive in below-ground parts. Accordingly, APHIS has undertaken an economic evaluation (EE) that analyzes CWR's regulatory status in light of this evolving biological research. The EE concludes that the U.S. eradication policy for CWR appears to be no longer technically and economically justified and recommends that it no longer be considered of quarantine significance.

Based on the recommendations of the EE, we are proposing to change APHIS policy so that CWR would no longer be considered of quarantine significance if detected domestically or on imported plants for planting.

Based on the conclusions of the EE and the pest lists, we have developed a commodity import evaluation document (CIED) that recommends a systems approach to mitigate the quarantine pest risk associated with the importation of Chrysanthemum spp. and synonymous genera ( Archanthemis marschalliana, Argyranthemum spp., Brachanthemum fruticulosum, Coleostephus multicaulis, C. myconis, Dendranthema spp., Glebionis spp., Heteranthemis spp., Hulteniella integrifolia, Leucanthemella spp., Leucanthemopsis spp., Leucanthemum spp., Mauranthemum paludosum, Nipponanthemum nipponicum, Nivellea nivellei, Opisthopappus taihangensis, Pentzia incana, Plagius spp., Rhodanthemum spp., Tanacetum spp., Tripleurospermum spp., and Xylanthemum spp.) cuttings and in vitro plantlets from Belgium, Bolivia, Brazil, Colombia, Costa Rica, El Salvador, Ethiopia, Germany, Guatemala, Kenya, Mexico, the Netherlands, Nicaragua, Panama, Spain, Tanzania, Tunisia, Uganda, the United Kingdom, and Vietnam. The CIED also proposes a systems approach to mitigate the quarantine pest risk associated with the importation of cuttings, in vitro plantlets, and plants with roots of these genera from Canada.

In accordance with paragraph (e) of § 319.37-4, we are announcing the availability of our pest lists, CIED, and EE for public review and comment. These documents may be viewed on the Regulations.gov website or in our reading room (see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room). You may request paper copies of these documents by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT . Please refer to the subject of the analysis you wish to review when requesting copies.

After reviewing any comments that we receive, we will announce our decision regarding whether to no longer consider CWR a quarantine pest domestically and for purposes of our plants for planting regulations. If we determine that it should no longer be considered of quarantine significance, we will also announce our decision regarding the importation of Chrysanthemum spp. and synonymous genera ( Archanthemis marschalliana, Argyranthemum spp., Brachanthemum fruticulosum, Coleostephus multicaulis, C. myconis, Dendranthema spp., Glebionis spp., Heteranthemis spp., Hulteniella integrifolia, Leucanthemella spp., Leucanthemopsis spp., Leucanthemum spp., Mauranthemum paludosum, Nipponanthemum nipponicum, Nivellea nivellei, Opisthopappus taihangensis, Pentzia incana, Plagius spp., Rhodanthemum spp., Tanacetum spp., Tripleurospermum spp., and Xylanthemum spp.) cuttings and in vitro plantlets from Belgium, Bolivia, Brazil, Colombia, Costa Rica, El Salvador, Ethiopia, Germany, Guatemala, Kenya, Mexico, the Netherlands, Nicaragua, Panama, Spain, Tanzania, Tunisia, Uganda, the United Kingdom, and Vietnam into the continental United States, and the importation of cuttings, in vitro plantlets and plants with roots for planting of Chrysanthemum spp. and the specified synonymous genera from Canada under a systems approach in a subsequent notice.

If finalized, the requirements of the systems approach will be added to the Plants for Planting Manual in accordance with paragraph (a) of § 319.37-20.

Authority: 7 U.S.C. 1633, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

Background

The General Conference Committee of the National Poultry Improvement Plan was established in 1971. The committee is governed in accordance with the Federal Advisory Committee Act (FACA) and the regulations of title 9, Code of Federal Regulations (9 CFR), section 147.43. The duties of the committee involve assisting the Department in planning, organizing, and conducting the National Poultry Improvement Plan (NPIP) Biennial Conference. Between Plan Conferences, the committee represents the cooperating States in:

• Advising the Department on administrative procedures and interpretations of the Plan provisions contained in 9 CFR.

• Helping the Department evaluate comments on proposed Plan amendments.

• Recommending to the Secretary any changes in Plan provisions when postponement until the next Plan Conference would seriously impair program operations.

• Serving as a forum for the study of poultry health problems.

The purpose of the General Conference Committee of the National Poultry Improvement Plan (Committee) is to maintain and ensure industry involvement in Federal administration of matters pertaining to poultry health. The committee meets at least annually. In the even years, the committee meets in conjunction with the NPIP Biennial Conference. The NPIP Biennial Conference is the only national meeting where the industry, State and Federal government consider poultry health issues on a routine basis. The committee members are elected at the NPIP Biennial conference by State delegates from their respective regions. There are seven members with a 4-year staggered term. The poultry industry elects the members of the Committee. The members represent six geographic areas with one member-at-large. The Committee Chairperson and the Vice Chairperson shall be elected by the Committee from among its members.

The purpose of the meeting is to:

1. Hear from Forest representatives on recreation fee change proposals;

2. Discussion and Q&A;

3. RAC-made recommendations on fee changes; and

4. Approve meeting minutes.

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

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

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

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

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

The purpose of the meeting is to:

1. Review recommendations for Canelo Hills Recreation fee proposal;

2. Discuss the utilization of Secure Rural Schools funds from 2021 and 2022;

3. Elect a Chairperson; and

4. Approve meeting minutes.

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

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

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

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

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

Members of the public may attend these Committee meetings through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make brief statements as time allows. Per the Federal Advisory Committee Act, public minutes of the meetings will include a list of persons who attend the meetings. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email Evelyn Bohor, ebohor@usccr.gov , at least 10 business days prior to the meeting.

Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following each meeting. Written comments may be emailed to the attention of Ivy Davis at ero@usccr.gov. Persons who desire additional information may contact Evelyn Bohor at ebohor@usccr.gov.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via www.facadatabase.gov under the Commission on Civil Rights, Delaware Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact Evelyn Bohor at ebohor@usccr.gov.

Committee meetings are available to the public through the videoconference link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Closed captions will be provided for individuals who are deaf or hard of hearing. To request additional accommodations, please email bpeery@usccr.gov at least 10 business days prior to the meeting.

Members of the public are also entitled to submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be emailed to Brooke Peery at bpeery@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit Office/Advisory Committee Management Unit at (202) 701-1376.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available at: https://www.facadatabase.gov/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzkZAAQ.

Please click on the “Meeting Details” and “Documents” links. Persons interested in the work of this Committee are also directed to the Commission's website, http://www.usccr.gov, or you may contact the Regional Programs Unit office at the above email address.

This business meeting is open to the public. Computer assisted real-time transcription (CART) will be provided. The web link to access CART (in English) on Friday, April 21, 2023, is https://www.streamtext.net/player?event=USCCR. Please note that CART is text-only translation that occurs in real time during the meeting and is not an exact transcript.

Committee meetings are available to the public through the videoconference link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Closed captions will be provided for individuals who are deaf or hard of hearing. To request additional accommodations, please email bpeery@usccr.gov at least 10 business days prior to the meeting.

Members of the public are also entitled to submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be emailed to Brooke Peery at bpeery@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit Office/Advisory Committee Management Unit at (202) 701-1376.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available at: https://www.facadatabase.gov/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzkZAAQ.

Please click on the “Meeting Details” and “Documents” links. Persons interested in the work of this Committee are also directed to the Commission's website, http://www.usccr.gov, or you may contact the Regional Programs Unit office at the above email address.

Background

On February 16, 2023, Commerce published the preliminary results of the 2021-2022 administrative review of the antidumping duty order on PRCBs from China. 1 We invited parties to comment on the Preliminary Results. 2 No party submitted comments or requested that Commerce hold a hearing. Commerce conducted this review in accordance with sections 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act).

The products covered by the Order are PRCBs which may be referred to as t-shirt sacks, merchandise bags, grocery bags, or checkout bags. The subject merchandise is defined as non-sealable sacks and bags with handles (including drawstrings), without zippers or integral extruded closures, with or without gussets, with or without printing, of polyethylene film having a thickness no greater than 0.035 inch (0.889 mm) and no less than 0.00035 inch (0.00889 mm), and with no length or width shorter than 6 inches (15.24 cm) or longer than 40 inches (101.6 cm). The depth of the bag may be shorter than 6 inches but not longer than 40 inches (101.6 cm).

PRCBs are typically provided without any consumer packaging and free of charge by retail establishments, e.g., grocery, drug, convenience, department, specialty retail, discount stores, and restaurants, to their customers to package and carry their purchased products. The scope of the Order excludes (1) polyethylene bags that are not printed with logos or store names and that are closeable with drawstrings made of polyethylene film and (2) polyethylene bags that are packed in consumer packaging with printing that refers to specific end-uses other than packaging and carrying merchandise from retail establishments, e.g., garbage bags, lawn bags, trash-can liners.

Imports of the subject merchandise are currently classifiable under statistical category 3923.21.0090 of the Harmonized Tariff Schedule of the United States (HTSUS). This subheading also covers products that are outside the scope of this Order. Furthermore, although the HTSUS subheading is provided for convenience and customs purposes, our written description of the scope of this Order is dispositive.

In the Preliminary Results, Commerce preliminarily determined that Nozawa had no shipments of subject merchandise during the POR. 4 We received no comments from interested parties with respect to this claim. Therefore, because we have not received any information to contradict our preliminary no-shipments determination, or any comment in opposition to our preliminary finding, Commerce continues to find that Nozawa had no shipments during the POR.

Commerce's policy regarding conditional review of the China-wide entity applies to this administrative review. 5 Under this policy, the China-wide entity will not be under review unless a party specifically requests, or Commerce self-initiates, a review of the entity. Because no party requested a review of the China-wide entity, and we did not self-initiate a review, the China-wide entity rate ( i.e., 77.57 percent)  6 is not subject to change as a result of this review.

Normally, Commerce discloses to interested parties the calculations performed in connection with the preliminary results within five days of the public announcement, or if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). However, Commerce did not calculate a weighted-average dumping margin for Nozawa, the sole mandatory respondent remaining in this review, 7 or for the China-wide entity. Therefore, there are no calculations to disclose for these final results.

Because we have determined that Nozawa had no shipments of subject merchandise in this review, Commerce will instruct U.S. Customs and Border Protection (CBP) to liquidate any suspended entries that entered under Nozawa's case number at the China-wide entity rate ( i.e., 77.57 percent). 8

Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review 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 for all shipments of PRCBs from China entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review in the Federal Register , as provided by section 751(a)(2)(C) of the Act: (1) for previously investigated or reviewed Chinese and non-Chinese exporters that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (2) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be that for the China-wide entity ( i.e., 77.57 percent); and (3) for all non-Chinese exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the Chinese exporter(s) that supplied that non-Chinese exporter (or, if unidentified, that of the China-wide entity). These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice 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 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 duties occurred and the subsequent assessment of doubled antidumping duties.

This notice also serves as a final reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the 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.

Commerce is issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.213(h)(1) and 19 CFR 351.221(b)(5).

Background: The NCCoE, part of NIST, is a public-private collaboration for accelerating the widespread adoption of integrated cybersecurity and privacy tools and technologies. The NCCoE brings together experts from industry, government, and academia under one roof to develop practical, interoperable cybersecurity and privacy approaches that address the real-world needs of complex Information Technology (IT) systems. By accelerating dissemination and use of these integrated tools and technologies for protecting IT assets, the NCCoE will enhance trust in U.S. IT communications, data, and storage systems; reduce risk for companies and individuals using IT systems; and encourage development of innovative, job-creating cybersecurity and privacy products and services.

Process: NIST is soliciting responses from all sources of relevant security and privacy capabilities (see below) to enter into an NCCoE Cooperative Research and Development Agreement (CRADA) to provide products and technical expertise to support and demonstrate security platforms for the Mitigating Cybersecurity Risk in Telehealth Smart Home Integration project. The full project can be viewed at: https://www.nccoe.nist.gov/healthcare/mitigating-cybersecurity-risk-telehealth-smart-home-integration .

Interested parties can access the template for a letter of interest by visiting the project website at https://www.nccoe.nist.gov/healthcare/mitigating-cybersecurity-risk-telehealth-smart-home-integration and completing the letter of interest webform. On completion of the webform, interested parties will receive a letter of interest template, which the party must complete, certify as accurate, and submit to NIST by email or hardcopy. NIST will contact interested parties if there are questions regarding the responsiveness of the letters of interest to the project objective or requirements identified below. NIST will select participants who have submitted complete letters of interest on a first come, first served basis within each category of product components or desired requirements listed below, up to the number of participants in each category necessary to carry out this project. Once the project participant selection process is complete, NIST will post a notice on the Mitigating Cybersecurity Risk in Telehealth Smart Home Integration project website at https://www.nccoe.nist.gov/healthcare/mitigating-cybersecurity-risk-telehealth-smart-home-integration announcing the completion of the project participant selection and informing the public that it is no longer accepting letters of interest for this project. There may be continuing opportunity to participate even after initial activity commences. Selected participants will be required to enter into an NCCoE consortium CRADA with NIST (for reference, see ADDRESSES section above).

The NCCoE will build an environment that will model patients' use of smart speakers in a telehealth ecosystem. The project's goal is to identify and mitigate cybersecurity and privacy risks associated with these ecosystems. The NCCoE environment will implement a “four-domain” ecosystem where solution components will be deployed in a patient's home, a cloud-hosted service provider, a health technology integration solution, and a healthcare delivery organization where each of these groupings represents a respective “domain.” This project will apply concepts established in the NIST Risk Management Framework, NIST Cybersecurity Framework, and the NIST Privacy Framework to identify both cybersecurity and privacy challenges affecting the ecosystem. This project will describe risk assessment methodologies and will apply cybersecurity and privacy controls to mitigate risks that may be found in the ecosystem. The project environment will use commercially available technology and capabilities that enable patient-centric use cases described in the Mitigating Cybersecurity Risk in Telehealth Smart Home Integration project description available at: https://www.nccoe.nist.gov/healthcare/mitigating-cybersecurity-risk-telehealth-smart-home-integration . The project will result in a publicly available NIST Cybersecurity Practice Guide as a Special Publication 1800-series document that will describe an overview of the ecosystem, practical measures for health delivery organizations that include risk assessment approaches, mitigating control selection, reference architecture, and a detailed description on the lab environment construction.

Requirements for Letters of Interest: Each responding organization's letter of interest should identify which security and privacy platform component(s) or desired requirement(s) it is offering. Letters of interest should not include company proprietary information, and all components and desired requirements must be commercially available.

Components are listed in section 3 of the Mitigating Cybersecurity Risk in Telehealth Smart Home Integration project description at https://www.nccoe.nist.gov/healthcare/mitigating-cybersecurity-risk-telehealth-smart-home-integration . Components will align with each of the four domains that constitute the modelled ecosystem: the patient home environment, a cloud-hosted service provider, a health technology integration solution, and a healthcare delivery organization. Components for the respective domains include, but are not limited to:

○ Smart home devices: Devices ( e.g., smart speakers) that have audio input and output capabilities. These devices are enabled to accept vocalized commands involving natural language processing, speech-to-text, and text-to-speech that allow the user to access internet-hosted resources.

○ Personal firewall: An application that controls network traffic to and from a computer, permitting or denying communications based on a security policy.

○ Wireless access point router: A device that performs the functions of a router and includes the ability for components to connect to the patient's network infrastructure, including having internet communications.

○ Internet router: A device that provides a demarcation point for broadband communications access ( e.g., cable, digital subscriber line [DSL], wireless, long-term-evolution [LTE], 5G) and presents an Ethernet interface to allow internet access via the broadband infrastructure. It may include wireless access point functionality or may allow for wireless access point routers to route network traffic through the internet router.

○ Voice assist platform: An environment that allows the cloud-hosted service provider and other organizations to develop applications that operate with smart home devices such as smart speakers. The voice assist platform enables applications by providing a natural language processing feature.

○ Cloud platform: A hosting environment where voice-enabled applications may be hosted and made available for patients to interact with health information systems.

○ Telehealth integration applications: Code and applications that enable patient-driven functionality to interface with clinical systems. These should provide application logic that meets prevailing regulatory compliance requirements.

○ Electronic health record (EHR) system: A system that includes patient health history information.

○ Patient portal: A patient-facing application that allows the patient to retrieve their medical history information, schedule visitations, and request prescription refills.

○ Network access control: A capability or service that discovers and accurately identifies devices connected to wired networks, wireless networks, and Virtual Private Networks (VPNs) and provides network access controls to ensure that only authorized individuals with authorized devices can access the systems and data that the access policy permits.

○ Network firewall: A network security device that monitors and controls incoming and outgoing network traffic, based on defined security rules.

○ VPN: A secure endpoint access solution that delivers secure remote access through virtual private networking.

Each responding organization's letter of interest should identify how their products address one or more of the following desired requirements in section 3 of the Mitigating Cybersecurity Risk in Telehealth Smart Home Integration project description at https://www.nccoe.nist.gov/healthcare/mitigating-cybersecurity-risk-telehealth-smart-home-integration. The NCCoE intends to apply both the NIST Cybersecurity Framework and the NIST Privacy Framework. Both Frameworks apply a Function-Category-Subcategory paradigm. In this project, the NCCoE will use the Function and Category level concepts from both Frameworks to identify cybersecurity and privacy risk mitigation approaches. The NCCoE applies the Function and Category labelling found in both Frameworks. The Cybersecurity Framework labels Functions with a two-character identifier ( e.g., the Function “Identify” is indicated by “ID”). Categories are labelled with the two-character identifier for the Function followed by a dot and a corresponding two-character identifier for the Category ( e.g., the Category “Asset Management” within the Function “Identify” is indicated by “ID.AM”). Functions and Categories derived from the NIST Privacy Framework follow the same labelling conventions as those in the Cybersecurity Framework, except that “-P” is added to the character identifiers ( e.g., the Function “Identify” is indicated by “ID-P”, and the Category “Inventory and Mapping” within the Function “Identify” is indicated by “ID.IM-P”).

Below are the desired requirements for this project; numbered items represent the Functions by which the NCCoE will examine this project, and the sub-bulleted points represent the corresponding Categories. The NCCoE will leverage these Functions and Categories in identifying cybersecurity and privacy risks and the corresponding risk mitigation approaches. All descriptions are specific to this project.

1. IDENTIFY (ID and ID-P): Organizations should ensure that they are aware of actors, components, integrating systems, and processes that are within or affect the environment. When examining a system, organizations should consider an enterprise view of the system's business value, drivers, outputs, and impact.

• Risk Assessment (ID.RA; ID.RA-P): In context of this project, risk assessment activities examine a holistic reference architecture. Activities include assessing cybersecurity threats, vulnerabilities, problematic data actions, and both cybersecurity and privacy risks.

2. CONTROL (CT-P): These activities enable organizations or individuals to manage data with sufficient granularity to manage privacy risks.

• Data Processing Management (CT.DM-P): Data processing uses standardized formats to increase manageability and effectively manage privacy risk.

• Disassociated Processing (CT.DP-P): Data processing solutions permit selective collection or disclosure of data elements.

3. COMMUNICATE (CM-P): These activities enable organizations to convey design and build solution components to support predictability in data processing.

• Data Processing Awareness (CM.AW-P): promotes a reliable understanding of data processes and privacy risks for both organizations and individuals that:

○ allows the patient visibility into how their data are processed and by which parties; and

○ enables traceability so that organizations and individuals understand where data originates and travels in the data processing ecosystem and information lifecycle.

4. PROTECT (PR and PR-P): These activities support the ability to develop and implement appropriate safeguards based on risk.

• Identity Management, Authentication, and Access Control (PR.AC; PR.AC-P): includes user account management and remote access that:

○ implements controls that limit access to information systems, devices, and data only to authorized individuals, processes, and devices;

○ controls and audits accounts, e.g., administering and monitoring users, processes, and devices;

○ controls (and audits) access by external accounts and devices;

○ enforces least privilege for all (internal and external) accounts; and

○ enforces least functionality.

• Data Security (PR.DS; PR.DS-P): includes data confidentiality, integrity, and availability assurance, as well as protecting individuals' privacy by:

○ securing data-at-rest and data-in-transit, i.e., communications between the smart home device and clinical systems should include data and hardware integrity and protections against unauthorized access and data leaks;

○ validating that cryptographic modules meet appropriate standards such as NIST Federal Information Processing Standards (FIPS) 140-2;

○ configuring systems to provide only essential functions; and

○ protecting communication and control networks.

5. DETECT (DE): These activities enable timely discovery of a cybersecurity event.

• Anomalies and Events (DE.AE): this category ensures that the control environment establishes a baseline of expected behavior, monitors for unusual activity, and alerts appropriate individuals for event management.

In their letters of interest, responding organizations need to acknowledge the importance of and commit to provide:

1. Access for all participants' project teams to component interfaces and the organization's experts necessary to make functional connections among security and privacy platform components.

2. Support for development and demonstration of the Mitigating Cybersecurity Risk in Telehealth Smart Home Integration project for the healthcare sector in NCCoE facilities, which will be conducted in a manner consistent with the following standards and guidance: NISTIR 8228, NIST FIPS 140-3, NIST SP 800-41 Revision 1, NIST SP 800-52 Revision 2, NIST SP 800-57 Part 1 Revision 5, NIST SP 800-77 Revision 1, NIST SP 800-95, NIST SP 800-121, NIST SP 800-144, NIST SP 800-146, and NIST SP 1800-1.

Additional details about the Mitigating Cybersecurity Risk in Telehealth Smart Home Integration project are available at: https://www.nccoe.nist.gov/healthcare/ mitigating-cybersecurity-risk-telehealth-smart-home-integration .

NIST cannot guarantee that all of the products proposed by respondents will be used in the demonstration. Each prospective participant will be expected to work collaboratively with NIST staff and other project participants under the terms of the NCCoE consortium CRADA in the development of the Mitigating Cybersecurity Risk in Telehealth Smart Home Integration project. Prospective participants' contribution to the collaborative effort will include assistance in establishing the necessary interface functionality, connection and set-up capabilities and procedures, demonstration harnesses, environmental and safety conditions for use, integrated platform user instructions, and demonstration plans and scripts necessary to demonstrate the desired capabilities. Each participant will train NIST personnel, as necessary, to operate its product in capability demonstrations. Following successful demonstrations, NIST will publish a description of the security and privacy platform and its performance characteristics sufficient to permit other organizations to develop and deploy security and privacy platforms that meet the security and privacy objectives of the Mitigating Cybersecurity Risk in Telehealth Smart Home Integration project. These descriptions will be public information.

Under the terms of the NCCoE consortium CRADA, NIST will support development of interfaces among participants' products by providing IT infrastructure, laboratory facilities, office facilities, collaboration facilities, and staff support to component composition, security and privacy platform documentation, and demonstration activities.

The dates of the project demonstration of the Mitigating Cybersecurity Risk in Telehealth Smart Home Integration project capability will be announced on the NCCoE website at least two weeks in advance at https://nccoe.nist.gov/ . The expected outcome of the demonstration is to provide guidance on smart home device integration with healthcare information systems. Participating organizations will gain from the knowledge that their products are interoperable with other participants' offerings.

For additional information on the NCCoE governance, business processes, and NCCoE operational structure, visit the NCCoE website https://nccoe.nist.gov/ .

Notices were published in the Federal Register on the dates listed below that requests for a permit or permit amendment had been submitted by the below-named applicants. To locate the Federal Register notice that announced our receipt of the application and a complete description of the activities, go to https://www.federalregister.gov and search on the permit number provided in table 1 below.

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

As required by the ESA, as applicable, issuance of these permit was based on a finding that such permits: (1) were applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) are consistent with the purposes and policies set forth in Section 2 of the ESA.

Authority: The requested permits have been issued under the MMPA of 1972, as amended (16 U.S.C. 1361 et seq. ), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the ESA 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), as applicable.

The following items included in the tentative agenda will be discussed:

The order of business may be adjusted as necessary to accommodate the completion of agenda items. The SSC public hybrid meetings will begin on May 3, 2023, at 9 a.m. AST, and will end on May 5, 2023, at 12 noon, AST. Other than the start time, interested parties should be aware that discussions may start earlier or later than indicated, at the discretion of the Chair. In addition, the meeting may be completed prior to the date established in this notice.

For any additional information on this public virtual meeting, please contact Liajay Rivera-Garcia, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918-1903, telephone: (787) 403-8337.

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

The following items included in the tentative agenda will be discussed:

The order of business may be adjusted as necessary to accommodate the completion of agenda items. The meetings will begin on May 3, 2023, at 9 a.m. AST, and will end on May 5, 2023, at 12 p.m. AST. Other than the start time, interested parties should be aware that discussions may start earlier or later than indicated, at the discretion of the Chair.

For any additional information you may contact Liajay Rivera-Garcia, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918-1903, telephone: (787) 766-5926.

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

The Citizen Science Operations Committee serves as advisors to the Council's Citizen Science Program. Committee members include representatives from the Council's Citizen Science Advisory Panel Pool, NOAA Fisheries' Southeast Regional Office, NOAA Fisheries' Southeast Fisheries Science Center, and the Council's Science and Statistical Committee. Their responsibilities include developing programmatic recommendations, reviewing policies, providing program direction/multi-partner support, identifying citizen science research needs, and providing general advice.

Agenda items include: a Citizen Science Program and Project update; discussion of Committee membership; the Citizen Science Program's project portal tool; the Council's Citizen Science Program initial evaluation plan, including discussing and providing input on phase 3 of the evaluation to gather information from a broader group of fishermen, scientists, and managers; and other business.

These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES ) 5 days prior to the meeting.

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

Background

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

An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

On January 19, 2021, we issued a final rule with regulations to govern the unintentional taking of marine mammals incidental to geophysical survey activities conducted by oil and gas industry operators, and those persons authorized to conduct activities on their behalf (collectively “industry operators”), in Federal waters of the U.S. Gulf of Mexico (GOM) over the course of 5 years (86 FR 5322, January 19, 2021). The rule was based on our findings that the total taking from the specified activities over the 5-year period will have a negligible impact on the affected species or stock(s) of marine mammals and will not have an unmitigable adverse impact on the availability of those species or stocks for subsistence uses. The rule became effective on April 19, 2021.

Our regulations at 50 CFR 217.180 et seq. allow for the issuance of LOAs to industry operators for the incidental take of marine mammals during geophysical survey activities and prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat (often referred to as mitigation), as well as requirements pertaining to the monitoring and reporting of such taking. Under 50 CFR 217.186(e), issuance of an LOA shall be based on a determination that the level of taking will be consistent with the findings made for the total taking allowable under these regulations and a determination that the amount of take authorized under the LOA is of no more than small numbers.

WesternGeco plans to conduct a 3D ocean bottom node (OBN) survey in the Green Canyon, Garden Banks, and Walker Ridge protraction areas, including approximately 616 lease blocks. Approximate water depths of the survey area range from 55 to 2,000 meters (m). See section F of the LOA application for a map of the area.

WesternGeco anticipates using two triple source vessels, towing airgun array sources consisting of 28 elements, with a total volume of 5,240 cubic inches (in 3 ). Please see WesternGeco's application for additional detail.

Consistent with the preamble to the final rule, the survey effort proposed by WesternGeco in its LOA request was used to develop LOA-specific take estimates based on the acoustic exposure modeling results described in the preamble (86 FR 5398, January 19, 2021). In order to generate the appropriate take numbers for authorization, the following information was considered: (1) survey type; (2) location (by modeling zone  1 ); (3) number of days; and (4) season. 2 The acoustic exposure modeling performed in support of the rule provides 24-hour exposure estimates for each species, specific to each modeled survey type in each zone and season.

No 3D OBN surveys were included in the modeled survey types, and use of existing proxies ( i.e., 2D, 3D NAZ, 3D WAZ, Coil) is generally conservative for use in evaluation of 3D OBN survey effort, largely due to the greater area covered by the modeled proxies. Summary descriptions of these modeled survey geometries are available in the preamble to the proposed rule (83 FR 29220, June 22, 2018). Coil was selected as the best available proxy survey type in this case because the spatial coverage of the planned survey is most similar to the coil survey pattern. The planned 3D OBN survey will involve two source vessels sailing along survey lines approximately 70-80 km in length. The coil survey pattern was assumed to cover approximately 144 kilometers squared (km 2 ) per day (compared with approximately 795 km 2 , 199 km 2 , and 845 km 2 per day for the 2D, 3D NAZ, and 3D WAZ survey patterns, respectively). Among the different parameters of the modeled survey patterns ( e.g., area covered, line spacing, number of sources, shot interval, total simulated pulses), NMFS considers area covered per day to be most influential on daily modeled exposures exceeding Level B harassment criteria. Although WesternGeco is not proposing to perform a survey using the coil geometry, its planned 3D OBN survey is expected to cover approximately 130 km 2 per day, meaning that the coil proxy is most representative of the effort planned by WesternGeco in terms of predicted Level B harassment exposures.

In addition, all available acoustic exposure modeling results assume use of a 72-element, 8,000 in 3 array. Thus, estimated take numbers for this LOA are considered conservative due to differences between the airgun array planned for use (28 elements, 5,240 in 3 ) and the proxy array modeled for the rule.

The survey will take place over approximately 85 days, including 65 days of sound source operation. The survey plan includes approximately 57 days within Zone 5 and approximately 8 days within Zone 2. The seasonal distribution of survey days is not known in advance. Therefore, the take estimates for each species are based on the season that produces the greater value.

Additionally, for some species, take estimates based solely on the modeling yielded results that are not realistically likely to occur when considered in light of other relevant information available during the rulemaking process regarding marine mammal occurrence in the GOM. The approach used in the acoustic exposure modeling, in which seven modeling zones were defined over the U.S. GOM, necessarily averages fine-scale information about marine mammal distribution over the large area of each modeling zone. This can result in unrealistic projections regarding the likelihood of encountering particularly rare species and/or species not expected to occur outside particular habitats. Thus, although the modeling conducted for the rule is a natural starting point for estimating take, our rule acknowledged that other information could be considered (see, e.g., 86 FR 5442 (January 19, 2021), discussing the need to provide flexibility and make efficient use of previous public and agency review of other information and identifying that additional public review is not necessary unless the model or inputs used differ substantively from those that were previously reviewed by NMFS and the public). For this survey, NMFS has other relevant information reviewed during the rulemaking that indicates use of the acoustic exposure modeling to generate a take estimate for certain marine mammal species produces results that are inconsistent with what is known regarding their occurrence in the GOM. Accordingly, we have adjusted the calculated take estimates for those species as described below.

Rice's whales (formerly known as GOM Bryde's whales)  3 are mostly found in a “core habitat area” located in the northeastern GOM in waters between 100-400 m depth along the continental shelf break (Rosel et al., 2016). (Note that this core habitat area is outside the scope of the rule.) However, whaling records suggest that Rice's whales historically had a broader distribution within similar habitat parameters throughout the GOM (Reeves et al., 2011; Rosel and Wilcox, 2014). In addition, habitat-based density modeling identified similar habitat ( i.e., approximately 100-400 m water depths along the continental shelf break) as being potential Rice's whale habitat (Roberts et al., 2016), although the core habitat area contained approximately 92 percent of the predicted abundance of Rice's whales. See discussion provided at, e.g., 83 FR 29228, 83 FR 29280 (June 22, 2018); 86 FR 5418 (January 19, 2021).

There are few data on Rice's whale occurrence outside of the northeastern GOM core habitat area. There were two sightings of unidentified large baleen whales (recorded as Balaenoptera sp. or Bryde's/sei whale) in 1992 in the western GOM during systematic survey effort and, more recently, a NOAA survey reported observation of a Rice's whale in the western GOM in 2017 (NMFS, 2018). There were five potential sightings of Rice's whales by protected species observers (PSOs) aboard industry geophysical survey vessels west of New Orleans from 2010-2014, all within the 200-400 m isobaths (Rosel et al., 2021). In addition, sporadic, year-round recordings of Rice's whale calls were made south of Louisiana within approximately the same depth range between 2016 and 2017 (Soldevilla et al., 2022).

Although Rice's whales may occur outside of the core habitat area, we expect that any such occurrence would be limited to the narrow band of suitable habitat described above ( i.e., 100-400 m) and that, based on the few available records, these occurrences would be rare. WesternGeco's planned activities will overlap this depth range, with approximately 19 percent of the area expected to be ensonified by the survey above root-mean-squared pressure received levels (RMS SPL) of 160 dB (referenced to 1 micropascal (re 1 μPa)) overlapping the 100-400 m isobaths. Therefore, while we expect take of Rice's whale to be unlikely, there is some reasonable potential for take of Rice's whale to occur in association with this survey. However, NMFS' determination in reflection of the data discussed above, which informed the final rule, is that use of the generic acoustic exposure modeling results for Rice's whales would result in estimated take numbers that are inconsistent with the assumptions made in the rule regarding expected Rice's whale take (86 FR 5322, 5403, January 19, 2021).

Killer whales are the most rarely encountered species in the GOM, typically in deep waters (>700 m) of the central GOM (Roberts et al., 2015; Maze-Foley and Mullin, 2006). As discussed in the final rule, the density models produced by Roberts et al. (2016) provide the best available scientific information regarding predicted density patterns of cetaceans in the U.S. GOM. The predictions represent the output of models derived from multi-year observations and associated environmental parameters that incorporate corrections for detection bias. However, in the case of killer whales, the model is informed by few data, as indicated by the coefficient of variation associated with the abundance predicted by the model (0.41, the second-highest of any GOM species model; Roberts et al., 2016). The model's authors noted the expected non-uniform distribution of this rarely-encountered species and expressed that, due to the limited data available to inform the model, it “should be viewed cautiously” (Roberts et al., 2015).

NOAA surveys in the GOM from 1992-2009 reported only 16 sightings of killer whales, with an additional 3 encounters during more recent survey effort from 2017-18 (Waring et al., 2013; www.boem.gov/gommapps ). Two other species were also observed on less than 20 occasions during the 1992-2009 NOAA surveys (Fraser's dolphin and false killer whale  4 ). However, observational data collected by protected species observers (PSOs) on industry geophysical survey vessels from 2002-2015 distinguish the killer whale in terms of rarity. During this period, killer whales were encountered on only 10 occasions, whereas the next most rarely encountered species (Fraser's dolphin) was recorded on 69 occasions (Barkaszi and Kelly, 2019). The false killer whale and pygmy killer whale were the next most rarely encountered species, with 110 records each. The killer whale was the species with the lowest detection frequency during each period over which PSO data were synthesized (2002-2008 and 2009-2015). This information qualitatively informed our rulemaking process, as discussed at 86 FR 5334 (January 19, 2021), and similarly informs our analysis here.

The rarity of encounter during seismic surveys is not likely to be the product of high bias on the probability of detection. Unlike certain cryptic species with high detection bias, such as Kogia spp. or beaked whales, or deep-diving species with high availability bias, such as beaked whales or sperm whales, killer whales are typically available for detection when present and are easily observed. Roberts et al. (2015) stated that availability is not a major factor affecting detectability of killer whales from shipboard surveys, as they are not a particularly long-diving species. Baird et al. (2005) reported that mean dive durations for 41 fish-eating killer whales for dives greater than or equal to 1 minute in duration was 2.3-2.4 minutes, and Hooker et al. (2012) reported that killer whales spent 78 percent of their time at depths between 0-10 m. Similarly, Kvadsheim et al. (2012) reported data from a study of four killer whales, noting that the whales performed 20 times as many dives to 1-30 m depth than to deeper waters, with an average depth during those most common dives of approximately 3 m.

In summary, killer whales are the most rarely encountered species in the GOM and typically only in particularly deep water (>700 m). This survey would take place in deep waters that would overlap with depths in which killer whales typically occur. While this information is reflected through the density model informing the acoustic exposure modeling results, there is relatively high uncertainty associated with the model for this species, and the acoustic exposure modeling applies mean distribution data over areas where the species is in fact less likely to occur. In addition, as noted above in relation to the general take estimation methodology, the assumed proxy source (72-element, 8,000-in 3 array) results in a significant overestimate of the actual potential for take to occur. NMFS' determination in reflection of the information discussed above, which informed the final rule, is that use of the generic acoustic exposure modeling results for killer whales for this survey would result in estimated take numbers that are inconsistent with the assumptions made in the rule regarding expected killer whale take (86 FR 5403, January 19, 2021).

In past authorizations, NMFS has often addressed situations involving the low likelihood of encountering a rare species such as Rice's or killer whales in the GOM through authorization of take of a single group of average size ( i.e., representing a single potential encounter). See 83 FR 63268, December 7, 2018; 86 FR 29090, May 28, 2021; 85 FR 55645, September 9, 2020. For the reasons expressed above, NMFS determined that a single encounter of Rice's whales or killer whales is more likely than the model-generated estimates and has authorized take associated with a single group encounter ( i.e., up to 2 animals for Rice's whale and up to 7 animals for killer whales).

Based on the results of our analysis, NMFS has determined that the level of taking authorized through the LOA is consistent with the findings made for the total taking allowable under the regulations for the affected species or stocks of marine mammals. See Table 1 in this notice and Table 9 of the rule (86 FR 5322, January 19, 2021).

Under the GOM rule, NMFS may not authorize incidental take of marine mammals in an LOA if it will exceed “small numbers.” In short, when an acceptable estimate of the individual marine mammals taken is available, if the estimated number of individual animals taken is up to, but not greater than, one-third of the best available abundance estimate, NMFS will determine that the numbers of marine mammals taken of a species or stock are small. For more information please see NMFS' discussion of the MMPA's small numbers requirement provided in the final rule (86 FR 5438, January 19, 2021).

The take numbers for authorization are determined as described above in the Summary of Request and Analysis section. Subsequently, the total incidents of harassment for each species are multiplied by scalar ratios to produce a derived product that better reflects the number of individuals likely to be taken within a survey (as compared to the total number of instances of take), accounting for the likelihood that some individual marine mammals may be taken on more than one day (see 86 FR 5404, January 19, 2021). The output of this scaling, where appropriate, is incorporated into adjusted total take estimates that are the basis for NMFS' small numbers determinations, as depicted in table 1.

This product is used by NMFS in making the necessary small numbers determinations through comparison with the best available abundance estimates (see discussion at 86 FR 5391, January 19, 2021). For this comparison, NMFS' approach is to use the maximum theoretical population, determined through review of current stock assessment reports (SAR; www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and model-predicted abundance information ( https://seamap.env.duke.edu/models/Duke/GOM/ ). For the latter, for taxa where a density surface model could be produced, we use the maximum mean seasonal ( i.e., 3-month) abundance prediction for purposes of comparison as a precautionary smoothing of month-to-month fluctuations and in consideration of a corresponding lack of data in the literature regarding seasonal distribution of marine mammals in the GOM. Information supporting the small numbers determinations is provided in Table 1.

Based on the analysis contained herein of WesternGeco's proposed survey activity described in its LOA application and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the affected species or stock sizes and therefore is of no more than small numbers.

NMFS has determined that the level of taking for this LOA request is consistent with the findings made for the total taking allowable under the incidental take regulations and that the amount of take authorized under the LOA is of no more than small numbers. Accordingly, we have issued an LOA to WesternGeco authorizing the take of marine mammals incidental to its geophysical survey activity, as described above.

Agenda

The Ecosystem-Based Fishery Management (EBFM) Committee and Advisory Panel Chairs will meet to review initial simulations and sample output from the Prototype Management Strategy Evaluation (pMSE). The simulations apply the management alternatives to a set of operating models to achieve objectives, all features that were identified at previous stakeholder workshops. The group will receive a short status report on applications for interested parties to develop and lead two online deep-dive workshops and one plenary meeting during August to mid-September. Other business will be discussed as necessary.

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

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

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

I. Abstract

The Public Wireless Supply Chain Innovation Fund (Innovation Fund), authorized by Section 9202(a)(1) of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021, Public Law 116-283, 134 Stat. 3388 (Jan. 1, 2021) (FY21 NDAA) and appropriated by Div. A., Section 106 of the CHIPS and Science Act of 2022, Public Law 117-167, 136 Stat. 1392 (Aug. 9, 2022) provides funding for efforts that accelerate the development, deployment, and adoption of open and interoperable radio access networks (RAN) through a competitive grant program. NTIA will be publishing the program's Notice of Funding Opportunity (NOFO) at www.grants.gov to describe the requirements under which it will award grants for the Public Wireless Supply Chain Innovation Fund. The NOFO requires award recipients to submit a Baseline Report 45 days after grant award. Award recipients must follow the reporting requirements described in Section A.01 Report Requirement of the Department of Commerce Financial Assistance Standard Terms and Conditions (dated November 12, 2020). Additionally, in accordance with 2 CFR part 170, all recipients of a federal award made on or after October 1, 2010, must comply with reporting requirements under the Federal Funding Accountability and Transparency Act of 2006 (Public Law 109-282).

NTIA will use the information collected from each award recipient to effectively administer and monitor the grant program to ensure the achievement of the Innovation Fund purposes and account for the expenditure of federal funds to deter waste, fraud, and abuse.

The Baseline Report is a one-time collection of information from award recipients covering project plans and details about key outputs and outcomes that will be due within 45 days of the issuance of the award. NTIA will collect data through an electronic submission.

OMB Control Number: 0660-XXXX.

Form Number(s): None.

Type of Review: Regular submission for new information collection.

Affected Public: Grant award recipients consisting of for-profit companies, non-profit companies, institutions of higher education, industry groups, and consortia including two or more such entities.

Estimated Number of Respondents: 30.

Estimated Time per Response: 20.

Estimated Total Annual Burden Hours: 600.

Estimated Total Annual Cost to Public: $28,638.

Respondent's Obligation: Mandatory.

Legal Authority: Section 9202(a)(1) of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021, Public Law 116-283, 134 Stat. 3388 (Jan. 1, 2021) (FY21 NDAA) and Div. A., Section 106 of the CHIPS and Science Act of 2022, Public Law 117-167, 136 Stat. 1392 (Aug. 9, 2022).

We are soliciting public comments to permit the Department 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.

(d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

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

I. Background

In June 2022, the USPTO announced the formation of the AI/ET Partnership, which provides an opportunity to bring stakeholders together through a series of engagements to share ideas, feedback, experiences, and insights on the intersection of intellectual property and AI/ET. To build on the AI/ET Partnership efforts, in February 2023, the USPTO issued a Federal Register Notice titled “Request for Comments Regarding Artificial Intelligence and Inventorship,” 88 FR 9492 (February 14, 2023) (available at https://www.federalregister.gov/documents/2023/02/14/2023-03066/request-for- comments-regarding-artificial-intelligence-and-inventorship ). The AI Inventorship Request for Comments (RFC) posed 11 questions for public comment on the current state of AI technologies and inventorship issues that may arise in view of the advancement of such technologies, especially as AI plays a greater role in the innovation process. As indicated by the AI Inventorship RFC, the USPTO will hold stakeholder engagement sessions that will be announced in the Federal Register and posted on the AI/ET Partnership web page at https://www.uspto.gov/aipartnership. The USPTO is announcing the second of these stakeholder engagement sessions through this notice.

The USPTO will hold a public listening session on May 8, 2023 at Stanford University, Paul Brest Hall, 555 Salvatierra Walk, Stanford, CA 94305. The listening session will be held virtually and in person from 10 a.m. to 3 p.m. PT (1 p.m. to 6 p.m. ET). For registration, please visit https://www.uspto.gov/initiatives/artificial-intelligence/ai-and-emerging-technology-partnership-engagement-and-events. Registrants must indicate whether they are registering as a listen-only attendee or as a speaker participant.

Requests to participate as a speaker must include:

1. The name of the person desiring to participate;

2. The organization(s) that person represents, if any;

3. Contact information (zip code, telephone number, and email address);

4. Information on the specific topic(s) or question(s) from the RFC of interest to the speaker (or their organization); and

5. Full text of comments to be articulated during the listening session (discussed further below).

Speaking slots are limited, preference will be given to speakers based on the specific topic or question(s) provided in the request to participate. Selected speakers may be grouped by topic. Topics and speakers will be announced a few days prior to the event and listening session. Speakers may attend virtually or in person and are required to submit their remarks for the listening session in advance through the Federal eRulemaking Portal at https://www.regulations.gov. We will inform each speaker in advance of their assigned time slot. Time slots will be at least three minutes but may be longer, depending on the number of speakers registered. USPTO personnel may reserve time to ask questions of particular speakers after the delivery of a speaker's remarks.

The listening session will be physically accessible to people with disabilities. Individuals requiring accommodation, such as sign language interpretation or other ancillary aids, should communicate their needs to Sheila Sanchez at disability.access@stanford.edu as soon as possible or at least seven (7) business days prior to the listening session.

The purpose of the listening session is to obtain public input from a broad group of stakeholders on the current state of AI technologies and inventorship issues that may arise in view of the advancement of such technologies, as set forth in the questions presented in the Federal Register Notice titled “Request for Comments Regarding Artificial Intelligence and Inventorship,” 88 FR 9492 (February 14, 2023) (available at https://www.federalregister.gov/documents/2023/02/14/2023-03066/request-for-comments-regarding-artificial-intelligence-and-inventorship ).

We encourage interested speakers to address the questions posed in the AI Inventorship RFC and to submit research and data that explain their comments on these questions. Official written comments to the questions raised in the AI Inventorship RFC should be submitted as outlined in the AI Inventorship RFC. For convenience, a list of the AI Inventorship RFC questions is provided below in their entirety.

1. How is AI, including machine learning, currently being used in the invention creation process? Please provide specific examples. Are any of these contributions significant enough to rise to the level of a joint inventor if they were contributed by a human?

2. How does the use of an AI system in the invention creation process differ from the use of other technical tools?

3. If an AI system contributes to an invention at the same level as a human who would be considered a joint inventor, is the invention patentable under current patent laws? For example:

a. Could 35 U.S.C. 101 and 115 be interpreted such that the Patent Act only requires the listing of the natural person(s) who invent(s), such that inventions with additional inventive contributions from an AI system can be patented as long as the AI system is not listed as an inventor?

b. Does the current jurisprudence on inventorship and joint inventorship, including the requirement of conception, support the position that only the listing of the natural person(s) who invent(s) is required, such that inventions with additional inventive contributions from an AI system can be patented as long as the AI system is not listed as an inventor?

c. Does the number of human inventors impact the answer to the questions above?

4. Do inventions in which an AI system contributed at the same level as a joint inventor raise any significant ownership issues? For example:

a. Do ownership rights vest solely in the natural person(s) who invented or do those who create, train, maintain, or own the AI system have ownership rights as well? What about those whose information was used to train the AI system?

b. Are there situations in which AI-generated contributions are not owned by any entity and therefore part of the public domain?

5. Is there a need for the USPTO to expand its current guidance on inventorship to address situations in which AI significantly contributes to an invention? How should the significance of a contribution be assessed?

6. Should the USPTO require applicants to provide an explanation of contributions AI systems made to inventions claimed in patent applications? If so, how should that be implemented, and what level of contributions should be disclosed? Should contributions to inventions made by AI systems be treated differently from contributions made by other ( i.e., non-AI) computer systems?

7. What additional steps, if any, should the USPTO take to further incentivize AI-enabled innovation ( i.e., innovation in which machine learning or other computational techniques play a significant role in the invention creation process)?

8. What additional steps, if any, should the USPTO take to mitigate harms and risks from AI-enabled innovation? In what ways could the USPTO promote the best practices outlined in the Blueprint for an AI Bill of Rights  1 and the AI Risk Management Framework  2 within the innovation ecosystem?

9. What statutory changes, if any, should be considered as to U.S. inventorship law, and what consequences do you foresee for those statutory changes? For example:

a. Should AI systems be made eligible to be listed as an inventor? Does allowing AI systems to be listed as an inventor promote and incentivize innovation?

b. Should listing an inventor remain a requirement for a U.S. patent?

10. Are there any laws or practices in other countries that effectively address inventorship for inventions with significant contributions from AI systems?

11. The USPTO plans to continue engaging with stakeholders on the intersection of AI and intellectual property. What areas of focus ( e.g., obviousness, disclosure, data protection) should the USPTO prioritize in future engagements?

I. Background

Section 4(j) of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2053(j)) requires the Commission to establish an agenda for action under the laws the Commission administers, and to the extent feasible, select priorities for action at least 30 days before the beginning of each fiscal year. Section 4(j) of the CPSA provides further that when establishing its agenda and priorities, the Commission shall conduct a public hearing and provide an opportunity for the submission of comments.

The hybrid public hearing will be held on May 10, 2023, at 10:00 a.m. EDT in person at CPSC's headquarters and remotely via CPSC Webinar. 1 All attendees who plan on joining remotely should pre-register for the Webinar by visiting https://cpsc.webex.com/weblink/register/rba37185ac315e7e0cf5666a1960c4028 and filling in the information. After registering you will receive a confirmation email containing information about joining the webinar. Detailed instructions for hearing participants and other interested parties will be made available on the CPSC website on the public calendar: https://www.cpsc.gov/Newsroom/Public-Calendar.

The Commission is preparing the agency's fiscal year 2024 Operating Plan and fiscal year 2025 Congressional Budget Request. Fiscal year 2024 begins on October 1, 2023, and fiscal year 2025 begins on October 1, 2024. Through this notice, the Commission invites the public to comment on the Commission's agenda and priorities that will be established in the fiscal year 2024 Operating Plan and the fiscal year 2025 Congressional Budget. Proposed priorities should be aligned with the agency's Strategic Plan for fiscal years 2023-2026, which is available at: www.cpsc.gov/about-cpsc/agency-reports/performance-and-budget.

Persons who desire to make oral presentations at the hearing on May 10, 2023—in person or remotely—should send an email to the Office of the Secretary, U.S. Consumer Product Safety Commission at cpsc-os@cpsc.gov not later than 5 p.m. EDT on April 28, 2023. Texts of intended oral presentations should be captioned “Agenda and Priorities FY 2024, and/or 2025” and must be received not later than 5 p.m. EDT on April 28, 2023. Oral presentations—in person or remotely—should be limited to approximately 10 minutes. The Commission reserves the right to impose further time limitations or other restrictions on presentations.

If you do not want to make an oral presentation, but would like to provide written comments, you may do so. Written comments should be captioned, “Agenda and Priorities FY 2024 and/or 2025,” and sent to Office of the Secretary, U.S. Consumer Product Safety Commission at cpsc-os@cpsc.gov not later than 5 p.m. EDT on April 28, 2023. There is no length restriction for written comments.

Title; Associated Form; and OMB Number: Air Force Safety Automated System; AF Form 978; OMB Control Number 0701-0164.

Needs and Uses: The Air Force collects mishap and safety-related information via AF Form 978, Supervisor Mishap/Incident Report or direct input into the Air Force Safety Automated System (AFSAS), via the Mishap Worksheet, by an assigned investigator. If an investigator uses the AF Form 978, that information will be manually input into the AFSAS once completed. Information will be collected in the AFSAS from individuals (respondents) who were injured or directly involved in the Mishap, or were an eyewitness to the Mishap. On the top of each collection instrument, the OMB control number and expiration date, as well as our Privacy Act Statement are documented for review by respondents. Respondents do not have direct access to the AFSAS or collected information.

Information collected in the AFSAS is utilized directly by assigned Safety Managers and Investigators, to evaluate mishap events for prevention analysis. Each organization staff will compare the information against DoD standards to determine if safety is enforced and to evaluate the safety profile of their organization. Included will be specific recommendations for risk mitigation/reduction in order to preserve assets and save lives. The Air Force Safety Program addresses the maintenance of safe and healthful conditions in the workplace or the occupational environment. It is applicable to all Air Force civilian and military personnel and operations, aviation or occupational functions.

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

Annual Burden Hours: 200.

Number of Respondents: 200.

Responses per Respondent: 1.

Annual Responses: 200.

Average Burden per Response: 1 hour.

Frequency: On occasion.

Title; Associated Form; and OMB Number: Automated Installation Entry (AIE) System; OMB Control Number 0702-0125.

Type of Request: Revision.

Number of Respondents: 1,210,476.

Responses per Respondent: 1.

Annual Responses: 1,210,476.

Average Burden per Response: 2 minutes.

Annual Burden Hours: 40,349.

Needs and Uses: The information collection requirement is necessary to verify the identity of an individual and determine the fitness of said individual requesting and/or requiring access to installations, and issuance of local access credentials. The information collection methodology involves the employment of technological collection of data via an electronic physical access control system (PACS) which provides the capability to rapidly and electronically authenticate credentials and validate an individual's authorization to enter an installation.

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

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

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

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

DoD Clearance Officer: Ms. Angela Duncan.

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

Title; Associated Form; and OMB Number: Freedom of Information/Privacy Act Records Request for Background Investigations; OMB Control Number 0705-0001.

Needs and Uses: This collection is a renewal and revision to the collection under OMB Control Number 0705-0001, Freedom of Information/Privacy Act Records Request for Background Investigations approved in October 2019, when transferred from the Office of Personnel Management, National Background Investigations Bureau (OPM, NBIB) to the DCSA. The purpose of the collection is to enable the DCSA, Freedom of Information and Privacy (FOI/P) Office for Investigations, to locate applicable records and provide the requester responsive records pursuant to the Freedom of Information Act (5 U.S.C. 552), and/or the Privacy Act of 1974 (5 U.S.C. 552a). Authority to collect this information is contained in 5 U.S.C. 552, 5 U.S.C. 552a, 32 CFR 310, and 32 CFR 286.

Affected Public: Individuals and households.

Annual Burden Hours: 841.

Number of Respondents: 10,097.

Responses per Respondent: 1.

Annual Responses: 10,097.

Average Burden per Response: 5 minutes.

Frequency: On occasion.

The Freedom of Information/Privacy Act Records Request for Background Investigations form, is an information collection completed by individuals submitting Freedom of Information Act (FOIA), Privacy Act, and Amendment record requests to DCSA's Freedom of Information and Privacy (FOI/P) Office for Investigations. DCSA's FOIP Office for Investigations utilizes the Freedom of Information/Privacy Act Records Request for Background Investigations to standardize collection of data elements specific to the types of record requests. Current record requests can be submitted to DCSA FOIP Office for Investigations in a format chosen by the requester. Often, requests are missing data elements which require contact with the requester, thereby adding time to the process. Standardization of the process will increase the volume of perfected requests received and strike an appropriate balance between the burden to the public in submitting a request and the DCSA FOIP Office for Investigations being able to fulfill FOIA, Privacy Act, and Amendment requests in an efficient manner.

Title; Associated Form; and OMB Number: Status of the Forces Survey of Active Duty Members; OMB Control Number 0704-0624.

Needs and Uses: The Status of Forces Active Duty Survey (SOFS-A) is an annual DoD-wide large-scale survey of active duty members that is used in evaluating existing policies and programs, establishing baseline measures before implementing new policies and programs, and monitoring the progress of existing policies/programs. The survey assesses topics such as financial well-being, retention intention, stress, tempo, readiness, food security and suicide awareness. Data are aggregated by appropriate demographics, including Service, paygrade, gender, race/ethnicity, and other indicators. To be able to meet reporting requirements for DoD leadership, the Military Services, and Congress, the survey needs to be completed in 2023. The legal requirements for the SOFS-A can be found in the FY2016 NDAA, Title VI, Subtitle F, Subpart 661. This legal requirement mandates that the SOFS-A solicit information on financial literacy and preparedness. Results will be used by the Service Secretaries to evaluate and update financial literacy training and will be submitted in a report to the Committees on Armed Services of the Senate and the House of Representatives.

Affected Public: Individuals or households.

Annual Burden Hours: 4,125.

Number of Respondents: 16,500.

Responses per Respondent: 1.

Annual Responses: 16,500.

Average Burden per Response: 15 minutes.

Frequency: Annually.

The Status of Forces Active Duty Survey (SOFS-A) is a DoD-wide annual survey of active duty members that is used to evaluate existing policies and programs, establishing baseline measures before implementing new policies and programs, and monitoring the progress of established policies/programs. The survey assesses topics such as financial well-being, satisfaction, readiness, stress, retention intention, food security, and suicide awareness.

Title; Associated Form; and OMB Number: EFMP Family Support Feedback Tool; OMB Control Number 0704-FSFT.

Needs and Uses: The EFMP Family Support Feedback Tool gathers feedback from families about their recent experience with EFMP Family Support services. The use of the tool is voluntary and confidential for families. No personally identifiable information is stored. The response data will be used to help inform EFMP policy, programmatic improvements, and to identify potential training needs for EFMP Family Support Providers.

Affected Public: Individuals or households.

Annual Burden Hours: 83.33.

Number of Respondents: 250.

Responses per Respondent: 2.

Annual Responses: 500.

Average Burden per Response: 10 minutes.

Frequency: On occasion.

Title; Associated Form; and OMB Number: Marine Corps Marathon Race Applications; OMB Control Number 0712-0005.

Needs and Uses: The Marine Corps Marathon Organization (MCMO) is tasked with the management of the Marine Corps Marathon (MCM) races on behalf of the Marine Corps. The MCM Race Application collection is necessary to register individuals for MCM races, identify participants for timing and results purposes, determine award categories, and to ensure appropriate contact information is on file if emergency treatment is required. The collection serves a secondary purpose to foster marketing relationships for the Marine Corps and provide participation data for future event planning and promotion.

Affected Public: Individuals or households.

Annual Burden Hours: 4,883.

Number of Respondents: 58,600.

Responses per Respondent: 1.

Annual Responses: 58,600.

Average Burden per Response: 5 minutes.

Frequency: Annually.

Title; Associated Form; and OMB Number: Marine Corps Safety Needs Assessment; OMB Control Number 0712-LMSA.

Needs and Uses: The Defense Suicide Prevention Office (DSPO) has contracted the Center for Naval Analyses (CNA) to conduct a study titled “Assessing the Implementation and Effectiveness of DOD's Lethal Means Safety (LMS) Outreach Materials.” LMS, as defined by DoD Instruction 6400.09, is a non-clinical suicide prevention activity and process of ensuring highly lethal means of suicide or other prohibited abusive and harmful acts are out of reach during times of increased stress, when risk of such acts is heightened. Since Marine Corps suicide attempt rates are among the highest in the DoD, with most attempts occurring via firearm, there is a perception that existing LMS messaging and training are not resonating with Marines.

In order to examine this trend within the Marine Corps and gather relevant baseline data for the larger DSPO initiative, CNA, in conjunction with the Marine Corps Marine and Family Programs Division (MFP), propose the information collection, “Marine Corps Safety Needs Assessment” survey. This voluntary survey examines current LMS program awareness, preferences for safety devices and locations, and the place of safety in Marine Corps culture. This survey will assist MFP in identifying, from the perspective of Marines, the reach of current LMS efforts and the acceptability of potential LMS activities. The results of the survey will be used by MFP and DSPO to better understand which LMS activities and messages resonate with Marines, as well as serve as a baseline data for future LMS activity effectiveness evaluations in accordance with the standards of practice framework prescribed by DoD Instruction 6490.16.

Affected Public: Individuals or households.

Annual Burden Hours: 2,262.

Number of Respondents: 9,048.

Responses per Respondent: 1.

Annual Responses: 9,048.

Average Burden per Response: 15 minutes.

Frequency: Once.

A charge was issued from the Director of Office of Science on October 13, 2022, to the BER Advisory Committee (BERAC) to (1) review the existing and anticipated capabilities in data management and supporting infrastructures that are relevant to the breadth of BER science and (2) recommend a strategy for next-generation data management and analysis within a unified framework. The Director's charge letter may be found here: https://science.osti.gov/ber/berac/Reports/Current-BERAC-Charges. Information collected through this request for information, in addition to other informational sources, may be used by BERAC to recommend strategies to further integrate and strengthen BER's data infrastructure in support of BER research. It may also be used by the BERAC in fulfilling its October 13, 2022, charge from the Director of the Office of Science to recommend a strategy for next-generation data management and analysis within a unified framework.

The objective of this request for information is to gather current and future science questions within BER's mission space that would require a more integrated data infrastructure for data access, processing, and use spanning more than one research area. Current BER research areas are provided online: https://science.osti.gov/ber/Research. Supported research includes Atmospheric Science; Earth and Environmental System Modeling; Environmental Science; Bioenergy and Bioproducts; and Plant and Microbial Genomics. Current data archives and activities that support BER research areas include, but are not limited to, ARM https://www.arm.gov/, ESS-DIVE https://ess-dive.lbl.gov/, ESGF https://esgf.llnl.gov/, KBase https://www.kbase.us/, NMDC https://microbiomedata.org/, MSD-LIVE https://msdlive.org/, and JGI https://jgi.doe.gov/.

Information is specifically requested on how a more unified data infrastructure may better facilitate current or future science questions, and what components or technologies are needed to develop a more unified data infrastructure. Answers or information related, but not limited, to the following questions are specifically requested:

1. Do you conduct research in one of the BER research areas ( i.e., Atmospheric Science; Earth and Environmental System Modeling; Environmental Science; Bioenergy and Bioproducts; or Plant and Microbial Genomics) and, if so, which area(s)? Please limit additional detail on your area(s) of research interest to a brief paragraph.

2. What new or existing research areas might benefit from improvements in data availability or access across research areas, potentially enabling scientific breakthroughs—and why?

3. What data improvements, including those of accessibility and integration, could facilitate new or existing research or scientific breakthroughs?

a. Are there current data sets that should be linked or integrated into existing data infrastructure to facilitate existing or new research? If so, which data sets should be so linked or integrated and why?

b. Are there current barriers to accessing or integrating data from (a) different DOE sources ( e.g., ARM, JGI, ESS-DIVE, MSD-LIVE) or from (b) different sources separately maintained by DOE and another Federal agency? If so, what are those barriers and how might they be addressed to allow for improved data access and integration?

c. What data infrastructure improvements would best support model-experiment feedbacks; facilitate data synthesis and analysis for multi-disciplinary research; and enable application of advanced statistical techniques, including artificial intelligence and machine learning? Please include a brief explanation as to how each identified improvement would support each of these listed tasks.

d. What current barriers need to be addressed in developing a unified infrastructure to promote greater use by a more diverse community of users, with a focus on improving diversity, equity, and inclusion within data usage and application?

While the questions provided above can help guide thinking on this topic, any input is welcome that may assist BERAC in developing a next-generation data infrastructure in support of BER mission science. The information provided through this request will assist in developing specific strategies that the DOE Office of Science may implement.

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

This document of the Department of Energy was signed on April 3, 2023, by Asmeret Asefaw Berhe, Director, Office of Science pursuant to delegated authority from the Secretary of Energy. The document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of DOE, including whether the information shall have practical utility; (b) the accuracy of DOE's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

This information collection request contains:

(1) OMB No.: 1910-5175;

(2) Information Collection Request Title: Office of Energy Efficiency and Renewable Energy (EERE) Environmental Questionnaire;

(3) Type of Request: Revision;

(4) Purpose: The DOE's EERE provides federal funding through federal assistance programs to businesses, industries, universities, and other groups for renewable energy and energy efficiency research and development and demonstration projects. The National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et seq. ) requires that an environmental analysis be completed for all major Federal actions significantly affecting the environment including projects entirely or partly financed by federal agencies. To effectively perform environmental analyses for these projects, the DOE's EERE needs to collect project-specific information from federal financial assistance awardees. DOE's EERE has developed its Environmental Questionnaire to obtain the required information and ensure that its decision-making processes are consistent with NEPA as it relates to renewable energy and energy efficiency research and development and demonstration projects. Minor changes have been made to the Environmental Questionnaire to standardize the process for collecting places of performance associated with a financial assistance project in an extractable and reportable format to better understand what communities are directly impacted by the projects being funded. Most of the changes only separated and created discrete data entry fields for information that was already being collected within the existing Environmental Questionnaire. One new data field was added for foreign location identification. The average hours per response and annual estimated number of burden hours remain the same.

(5) Annual Estimated Number of Total Responses: 300;

(6) Average Hours per Response: 1.5;

(7) Annual Estimated Number of Burden Hours: 433; and

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: There is no cost associated with reporting and recordkeeping.

Statutory Authority: National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq. ).

This document of the Department of Energy was signed on April 11, 2023, by Mathew Blevins, Director, Environment, Safety, and Health Office, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

I. Obtaining a Copy of the Proposed Settlement Agreement

The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2023-0212) contains a copy of the proposed settlement agreement. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.

The electronic version of the public docket for this action contains a copy of the proposed settlement agreement, and is available through https://www.regulations.gov. You may use https://www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select “search.”

The RFS program began in 2006 pursuant to the requirements of the Energy Policy Act of 2005 (EPAct) that were codified in CAA section 211(o). The statutory requirements were subsequently amended by the Energy Independence and Security Act of 2007 (EISA). The RFS statute sets forth annual, nationally applicable volume targets for biomass-based diesel through 2012, and for the other three categories of renewable fuel—total renewable fuel, advanced biofuel, and cellulosic biofuel—through 2022. See 42 U.S.C 7545(o)(2)(B)(i). For calendar years after which the statute provides volume targets, the statute directs EPA to determine the applicable volume targets in coordination with the Secretary of Energy and the Secretary of Agriculture, based on a review of the implementation of the RFS program for prior years and an analysis of specific factors enumerated by 42 U.S.C. 7545(o)(2)(B)(ii) ( e.g., impacts on the environment and energy security, costs to consumers, etc.).

On July 1, 2022, EPA published the RFS annual rules for 2020, 2021, and 2022. Renewable Fuel Standard (RFS) Program: RFS Annual Rules, 87 FR 39600 (July 1, 2022) (“2020-2022 RFS Annual Rule”). On July 20, 2022, CBD filed a petition for review of the 2020-2022 RFS Annual Rule challenging whether EPA complied with the consultation requirements of ESA section 7(a)(2), 16 U.S.C. 1536(a)(2); the CAA, 42 U.S.C. 7545(o)(2)(B)(ii)(I); and the APA, 5 U.S.C. 706. On September 27, 2022, CBD filed a motion for summary vacatur of the 2020-2022 RFS Annual Rule. Center for Biological Diversity v. Environmental Protection Agency, Case No. 22-1164 (D.C. Cir.), Doc. 1966328.

Under the proposed settlement agreement, EPA would commit to complete its ESA section 7(a) consultation for the RFS rule subsequent to the 2020-2022 RFS Annual Rule that EPA proposed on December 30, 2023. Renewable Fuel Standard (RFS) Program: Standards for 2023-2025 and Other Changes, 87 FR 80582 (December 30, 2022) (“2023-2025 RFS Set Rule”). If either the Fish and Wildlife Service or the National Marine Fisheries Service issues a biological opinion in connection with this ESA consultation, EPA would also agree to issue a determination addressing any conservation recommendations, terms and conditions of any incidental take statement, and/or reasonable and prudent alternatives within the time frames set forth in that biological opinion. CBD would agree to dismiss with prejudice its challenge to the 2020-2022 RFS Annual Rule within five days of receiving notice from EPA that it has terminated the ESA section 7(a) consultation for the 2023-2025 RFS Set Rule.

The proposed Settlement Agreement also includes standard language regarding resolution of costs and attorneys' fees, stipulation of extensions, lapses in appropriations, disputes in implementation, preservation of Agency discretion, and the CAA section 113(g) process.

In accordance with section 113(g) of the CAA, for a period of thirty (30) days following the date of publication of this document, the Agency will accept written comments relating to the proposed settlement agreement. EPA or the Department of Justice may withdraw or withhold consent to the proposed settlement agreement if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the CAA.

Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2023-0212, via https://www.regulations.gov. Once submitted, comments cannot be edited or removed from this docket. EPA may publish any comment received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e. , on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. For additional information about submitting information identified as CBI, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section of this document. Note that written comments containing CBI and submitted by mail may be delayed and deliveries or couriers will be received by scheduled appointment only.

If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

Use of the https://www.regulations.gov website to submit comments to EPA electronically is EPA's preferred method for receiving comments. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment.

Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

Background: The EFAB is an EPA advisory committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, to provide advice and recommendations to EPA on innovative approaches to funding environmental programs, projects, and activities. Administrative support for the EFAB is provided by the Water Infrastructure and Resiliency Finance Center within EPA's Office of Water. Pursuant to FACA and EPA policy, notice is hereby given that the EFAB will hold a public meeting via webcast for the following purpose: Receive updates on the Greenhouse Gas Reduction Fund.

Registration for the Meeting: To register for the meeting, please visit https://www.epa.gov/waterfinancecenter/efab#meeting. Interested persons who wish to attend the meeting via webcast must register by May 10, 2023. Pre-registration is strongly encouraged.

Availability of Meeting Materials: Meeting materials, including the meeting agenda and briefing materials, will be available on EPA's website at https://www.epa.gov/waterfinancecenter/efab.

Procedures for Providing Public Input: Public comment for consideration by EPA's federal advisory committees has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office. Federal advisory committees provide independent advice to EPA. Members of the public may submit comments on matters being considered by the EFAB for consideration as the Board develops its advice and recommendations to EPA.

Written Statements: Written statements should be received by May 8, 2023, so that the information can be made available to the EFAB for its consideration prior to the meeting. Written statements should be sent via email to efab@epa.gov. Members of the public should be aware that their personal contact information, if included in any written comments, may be posted to the EFAB website. Copyrighted material will not be posted without explicit permission of the copyright holder.

Accessibility: For information on access or services for individuals with disabilities or to request accommodations for a disability, please register for the meeting and list any special requirements or accommodations needed on the registration form at least 10 business days prior to the meeting to allow as much time as possible to process your request.

OMB Control Number: 3060-1270.

Title: Protecting National Security Through FCC Programs.

Form Number: FCC Form 5640.

Type of Review: Revision of a currently-approved collection.

Respondents: Business or other for profit entities.

Number of Respondents and Responses: 3,500 respondents; 6,584 responses.

Estimated Time per Response: 0.5-12 hours.

Frequency of Response: Annual, semiannual, and recordkeeping requirements.

Obligation to Respond: Mandatory and required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 1603-1604.

Total Annual Burden: 20,236 hours.

Total Annual Cost: $472,500.

Needs and Uses: The Communications Act of 1934, as amended, requires the “preservation and advancement of universal service.” 47 U.S.C. 254(b). The information collection requirements reported under this collection are the result of the Commission's actions to promote the Act's universal service goals.

On November 22, 2019, the Commission adopted the Protecting Against National Security Threats to the Communications Supply Chain Through FCC Programs, WC Docket No. 18-89, Report and Order, Order, and Further Notice of Proposed Rulemaking, 34 FCC Rcd 11423 (2019) ( Report and Order ). The Report and Order prohibits future use of Universal Service Fund (USF) monies to purchase, maintain, improve, modify, obtain, or otherwise support any equipment or services produced or provided by a company that poses a national security threat to the integrity of communications networks or the communications supply chain.

On March 12, 2020, the President signed into law the Secure and Trusted Communications Networks Act of 2019 (Secure Networks Act), Public Law 116-124, 133 Stat. 158 (2020) (codified as amended at 47 U.S.C. 1601-1609), which, among other measures, directs the FCC to establish the Secure and Trusted Communications Networks Reimbursement Program (Reimbursement Program). This program is intended to provide funding to providers of advanced communications service for the removal, replacement and disposal of certain communications equipment and services that poses an unacceptable national security risk ( i.e., covered equipment and services) from their networks. The Commission has designated two entities—Huawei Technologies Company (Huawei) and ZTE Corporation (ZTE), along with their affiliates, subsidiaries, and parents—as covered companies posing such a national security threat. See Protecting Against National Security Threats to the Communications Supply Chain Through FCC Programs—Huawei Designation, PS Docket No. 19-351, Memorandum Opinion and Order, 35 FCC Rcd 14435 (2020); Protecting Against National Security Threats to the Communications Supply Chain Through FCC Programs—ZTE Designation, PS Docket No. 19-352, Memorandum Opinion and Order, DA 20-1399 (PSHSB rel. Nov. 24, 2020).

On December 10, 2020, the Commission adopted the Second Report and Order implementing the Secure Networks Act, which contained new information collection requirements. See Protecting Against National Security Threats to the Communications Supply Chain Through FCC Programs, WC Docket No. 18-89, Second Report and Order, 35 FCC Rcd 14284 (2020) ( Second Report and Order ). These requirements allow the Commission to receive, review and make eligibility determinations and funding decisions on applications to participate in the Reimbursement Program that are filed by certain providers of advanced communications service. These information collection requirements also assist the Commission in processing funding disbursement requests and in monitoring and furthering compliance with applicable program requirements to protect against waste, fraud, and abuse. Participation in the Reimbursement Program is voluntary, but compliance with the information collection requirements is required to obtain Reimbursement Program support.

On August 3, 2021, the Wireline Competition Bureau (Bureau) released a Public Notice adopting procedures for filing and processing applications submitted for the Reimbursement Program. These procedures largely tracked the procedural rules previously adopted by the Commission in the Second Report and Order, but also adopted a new requirement that Reimbursement Program participants notify the Commission of changes in ownership, to ensure accurate information is on file for participants and to help protect the Reimbursement Program against waste, fraud, and abuse.

This submission proposes to revise this currently-approved collection by deleting an existing question on FCC Form 5640 and replacing it with a more detailed query. The new question will ask program participants to describe in detail how they have spent Reimbursement Program funds. The addition of this question will allow the Bureau to satisfy its statutory obligations to collect information about how Reimbursement Program funds have been spent, including detailed accounting of the covered communications equipment and services permanently removed and disposed of, and the replacement equipment or services purchased, rented, leased, or otherwise obtained using Reimbursement Program funds, as well as to combat waste, fraud, and abuse, as required under the Secure Networks Act. The Bureau determined that FCC Form 5640 required this revision in order to elicit the information necessary for the Bureau to better satisfy its statutory obligations.

This proposed addition will increase the information collected, and will impose an additional burden on respondents, which will vary with the number of invoices respondents submit during the relevant reporting period. However, this submission also reflects a decrease in the estimated total annual responses, total annual burden hours, and total annual costs for this collection. These adjustments are due to a reduction of the number of respondents for several categories of information to be collected on Form 5640, based on the Bureau's experience with the Reimbursement Program since this collection was first approved.

The Secretary, Department of Health and Human Services (HHS), and by delegation the Director, Centers for Disease Control and Prevention (CDC), and the Administrator, Health Resources and Services Administration (HRSA), are authorized by the Public Health Service Act to: (1) conduct, encourage, cooperate with, and assist other appropriate public health authorities, scientific institutions, and scientists in the conduct of research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and other impairments; (2) assist states and their political subdivisions in preventing, suppressing, and treating communicable diseases and other preventable conditions and in promoting health and well-being; (3) assist public and non-profit private entities in preventing, controlling, and treating sexually transmitted diseases (STDs), including the human immunodeficiency virus (HIV); (4) improve health and achieve health equity through access to quality services and a skilled health workforce and innovative programs; (5) support healthcare services to persons with or who experience risk for HIV, viral hepatitis, and other STDs; (6) advance the education of health professionals and the public about HIV, viral hepatitis, and other STDs; and (7) adolescent and school health as it pertains to HIV, viral hepatitis, and STDs.

The CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC) meets at least two times each calendar year, or at the discretion of the Designated Federal Officers in consultation with the CHAC co-chairs.

HHS policy stipulates that committee membership be balanced in terms of points of view represented and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. The CHAC charter stipulates that the Committee must include at least four members who are persons with HIV. The Committee may also include representation from persons with lived experience, such as those who have experienced viral hepatitis, STDs, and drug use; state and local health and education agencies; HIV/viral hepatitis/STD community-based organizations; and the ethics or faith-based community.

Committee members are Special Government Employees (SGEs), requiring the filing of financial disclosure reports at the beginning of and annually during their terms. Individuals who are selected for appointment will be required to provide detailed information regarding their financial interests and, for example, any work they do for the federal government through research grants or contracts. Disclosure of this information is required in order for CDC ethics officials to determine whether there is a conflict between the SGE's public duties as a member of CHAC and the SGE's private interests, including an appearance of a loss of impartiality as defined by federal laws and regulations, and to identify any required remedial action needed to address the potential conflict.

CDC and HRSA review potential candidates for CHAC membership when a vacancy arises and provide a slate of nominees for consideration to the Secretary of HHS for final selection. CDC and HRSA each publish a Federal Register notice and will be using a joint process to nominate nominees on a rolling basis; thus, applications received by CDC will be shared with HRSA for consideration. Therefore, potential candidates need only apply in response to one of the Federal Register notices. HHS notifies selected candidates of their appointment near the start of the term in December 2024, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year. Candidates should submit the following items:

Nominations may be submitted directly by the individual seeking nomination or by the person/organization recommending the candidate. CDC and HRSA will collect and retain nominations received for up to two years to create a pool of potential CHAC nominees.

The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

The Advisory Council for the Elimination of Tuberculosis (ACET) provides advice and recommendations regarding the elimination of tuberculosis (TB) to the Secretary, Department of Health and Human Services (HHS); the Assistant Secretary for Health, HHS; and the Director, Centers for Disease Control and Prevention (CDC). ACET (a) makes recommendations on policies, strategies, objectives, and priorities; (b) addresses development and application of new technologies; (c) provides guidance and review of CDC's TB prevention research portfolio and program priorities; and (d) reviews the extent to which progress has been made toward eliminating TB.

Nominations are sought for persons who have expertise and qualifications necessary to contribute to the accomplishment of the objectives of ACET. Nominees will be selected on the basis of their expertise in public health, epidemiology, immunology, infectious diseases, pulmonary disease, pediatrics, tuberculosis, microbiology, or preventive health care delivery. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of ACET objectives.

HHS policy stipulates that committee membership be balanced in terms of points of view represented and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees, requiring the filing of financial disclosure reports at the beginning of and annually during their terms. CDC reviews potential candidates for ACET membership each year and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in July 2024, or as soon as the HHS selection process is completed. Note that the need for different expertise varies from year to year and a candidate who is not selected in one year may be reconsidered in a subsequent year. Candidates should submit the following items:

Current curriculum vitae, including complete contact information (telephone numbers, mailing address, and email address).

At least one letter of recommendation from person(s) not employed by HHS. Candidates may submit letter(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency ( i.e., CDC, National Institutes of Health, Food and Drug Administration, etc.).

Nominations may be submitted by the candidate or by the person/organization recommending the candidate.

The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

Background: The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Advisory Board include providing advice on the development of probability of causation guidelines which have been promulgated by the Department of Health and Human Services (HHS) as a final rule, advice on methods of dose reconstruction which have also been promulgated by HHS as a final rule, advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program, and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC.

The charter was issued on August 3, 2001, renewed at appropriate intervals, and rechartered under Executive Order 13889 on March 22, 2022, and will terminate on March 22, 2024.

Purpose: This Advisory Board is charged with (a) providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advising the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class.

Matters To Be Considered: The agenda will include discussions on the following: Work Group and Subcommittee Reports; Update on the Status of SEC Petitions; and plans for the August 2023 Advisory Board Meeting. Agenda items are subject to change as priorities dictate. For additional information, please contact toll free 1 (800) 232-4636.

The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

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

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals; Use: Section 401 of Division CC of Title IV of the Consolidated Appropriations Act (CAA), 2021 amended section 1847A of the Social Security Act (the Act) to add new section 1847A(f)(2) of the Act, which requires manufacturers without a Medicaid drug rebate agreement to report average sales price (ASP) information to CMS for calendar quarters beginning on January 1, 2022, for drugs or biologicals payable under Medicare Part B and described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of the Act, including items, services, supplies, and products that are payable under Part B as a drug or biological. The reported ASP data are used to establish the Medicare payment amounts. Form Number: CMS-10110 (OMB control number: 0938-0921); Frequency: Quarterly; Affected Public: Private sector, Business or other for-profit; Number of Respondents: 500; Total Annual Responses: 2,000; Total Annual Hours: 26,000. (For policy questions regarding this collection contact Felicia Brown at 410-786-9287)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: CAHPS Hospice Survey; Use: CMS is required to collect and publicly report information on the quality of services provided by hospices under provisions in the Social Security Act. Specifically, sections 1814(i)(5)(A) through (C) of the Act, as added by section 3132(a) of the Patient Protection and Affordable Care Act (PPACA) (Pub. L. 111-148), required hospices to begin submitting quality data, based on measures specified by the Secretary of the Department of Health and Human Services (the Secretary) for FY 2014 and subsequent FYs.

The goal of the survey is to measure the experiences of patients and their caregivers with hospice care. The survey was developed to:

• Provide a source of information from which selected measures could be publicly reported to beneficiaries and their family members as a decision aid for selection of a hospice program;

• Aid hospices with their internal quality improvement efforts and external benchmarking with other facilities;

• Provide CMS with information for monitoring the care provided.

Form Number: CMS-10537 (OMB control number: 0938-1257); Frequency: Once; Affected Public: Individuals and Households; Number of Respondents: 1,140,695; Total Annual Responses: 1,140,695; Total Annual Hours: 198,481. (For policy questions regarding this collection contact Lauren Fuentes at 410-786 2290 or 443-618-2123.)

3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Elimination of Cost-Sharing for full benefit dual-eligible Individuals Receiving Home and Community-Based Services; Use: Section 1860 D-14 of the Social Security Act sets forth requirements for premium and cost-sharing subsidies for low-income beneficiaries enrolled in Medicare Part D. Based on this statute, 42 CFR 423.771, provides guidance concerning limitations for payments made by and on behalf of low-income Medicare beneficiaries who enroll in Part D plans. 42 CFR 423.771 (b) establishes requirements for determining a beneficiary's eligibility for full subsidy under the Part D program. Regulations set forth in 423.780 and 423.782 outline premium and cost sharing subsidies to which full subsidy eligible are entitled under the Part D program

Each month CMS deems individuals automatically eligible for the full subsidy, based on data from State Medicaid Agencies and the Social Security Administration (SSA). The SSA sends a monthly file of Supplementary Security Income-eligible beneficiaries to CMS. Similarly, the State Medicaid agencies submit Medicare Modernization Act files to CMS that identify full subsidy beneficiaries. CMS deems the beneficiaries as having full subsidy and auto-assigns these beneficiaries to bench mark Part D plans. Part D plans receive premium amounts based on the monthly assessments. Form Number: CMS-10344 (OMB control number 0938-1127); Frequency: Monthly; Affected Public: Private Sector (business or other for-profits, not-for-profit institutions); Number of Respondents: 51; Number of Responses: 612; Total Annual Hours: 621. (For policy questions regarding this collection contact Roland Herrera at 410-786-0668).

4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Annual Eligibility Redetermination, Product Discontinuation and Renewal Notices; Use: Section 1411(f)(1)(B) of the Affordable Care Act directs the Secretary of Health and Human Services (the Secretary) to establish procedures to redetermine the eligibility of individuals for premium tax credits on a periodic basis in appropriate circumstances. Section 1321(a) of the Affordable Care Act provides authority for the Secretary to establish standards and regulations to implement the statutory requirements related to Exchanges, qualified health plans (QHPs) and other components of title I of the Affordable Care Act. Under section 2703 of the Public Health Service Act (PHS Act), as added by the Affordable Care Act, and former section 2712 and section 2741 of the PHS Act, enacted by the Health Insurance Portability and Accountability Act of 1996, health insurance issuers in the group and individual markets must guarantee the renewability of coverage unless an exception applies.

The 2014 final rule “Patient Protection and Affordable Care Act; Annual Eligibility Redeterminations for Exchange Participation and Insurance Affordability Programs; Health Insurance Issuer Standards Under the Affordable Care Act, Including Standards Related to Exchanges” (79 FR 52994, September 5, 2014), provides that an Exchange may choose to conduct the annual redetermination process for a plan year (1) in accordance with the existing procedures described in 45 CFR 155.335; (2) in accordance with procedures described in guidance issued by the Secretary for the applicable benefit year; or (3) using an alternative procedure proposed by the Exchange and approved by the Secretary. The 2014 final rule established a renewal and reenrollment hierarchy at 45 CFR 155.335(j) to minimize potential enrollment disruptions. The 2016 final rule “Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017” (81 FR 12204, March 8, 2016) amended the enrollment hierarchy to further minimize potential disruptions of enrollee eligibility for cost-sharing reductions. The final rule “Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2024” adopted changes to 45 CFR 155.335(j) to allow the Exchange, beginning in the 2024 plan year, to direct re-enrollment for enrollees who are eligible for cost-sharing reductions in accordance with §  155.305(g) from a bronze QHP to a silver QHP with a lower or equivalent premium after advance payments of the premium tax credit within the same product and QHP issuer, regardless of whether their current plan is available or not, if certain conditions are met (referred to here as the “bronze to silver crosswalk policy”).

The guidance document “Guidance on Annual Eligibility Redetermination and Re-enrollment for Exchange Coverage for 2019 and Later Years” contains the procedures that the Secretary specified for the coverage year, as noted in (2) above, and specified that these procedures will be used by all Exchanges using the Federal eligibility and enrollment platform, unless otherwise specified in future guidance or rulemaking.

The 2014 final rule also amended the requirements for product renewal and re-enrollment (or non-renewal) notices to be sent by QHP issuers in the Exchanges and specifies content for these notices. The guidance document “Updated Federal Standard Renewal and Product Discontinuation Notices, and Enforcement Safe Harbor for Product Discontinuation Notices in Connection with the Open Enrollment Period for Coverage in the Individual Market in the 2020 Benefit Year” provides standard notices for product discontinuation and renewal to be sent by issuers of individual market QHPs and issuers in the individual market.

The Federal standard notices to be sent by issuers of individual market QHPs and issuers in the individual market have been revised to improve consumer understanding and update out-of-date information, and to include language to reference the potential for a bronze to silver crosswalk under 45 CFR 155.335(j)(4). The revised notices in this information collection will be required for notices provided in connection with coverage beginning in the 2024 plan year.

Issuers in the small group market may use the draft Federal standard small group notices released in the June 26, 2014 bulletin “Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market”, or any forms of the notice otherwise permitted by applicable laws and regulations. States that are enforcing the guaranteed renewability provisions of the Affordable Care Act may develop their own standard notices for product discontinuances, renewals, or both, provided the state-developed notices are at least as protective as the Federal standard notices. Form Number: CMS-10527 (OMB Control Number 0938-1254); Frequency: Annually; Affected Public: Private Sector, State Governments; Number of Respondents: 1,340; Total Annual Responses: 5,881; Total Annual Hours: 72,147. (For policy questions regarding this collection contact Russell Tipps at 301-492-4371.)

Correction

In the Federal Register of April 10, 2023, in FR Doc. 2023-07473, on page 21191, in the third column, correct the fourth paragraph under the ADDRESSES caption to read as follows:

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/regulations-and-guidance/legislation/paperworkreductionactof1995/pra-listing.

I. Background

This public workshop is intended to support the RDEA Pilot Program consistent with the requirements under section 3208 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). Section 3208 of FDORA requires FDA to establish a pilot program to provide increased interaction with sponsors of rare disease drug development programs for purposes of advancing the development of efficacy endpoints, including surrogate and intermediate endpoints, for drugs intended to treat rare diseases. Section 3208 of FDORA also requires FDA to conduct up to three public workshops to discuss various topics relevant to the development of endpoints for rare diseases on or before September 30, 2026. This is the first of up to three public workshops to satisfy the FDORA requirement.

The public workshop is also intended to meet a performance goal under the FDA User Fee Reauthorization Act of 2022, in accordance with the PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027 letter (PDUFA VII Commitment Letter), which is available at https://www.fda.gov/media/151712/download . Specifically, section I.K.4 of the PDUFA VII Commitment Letter, “Advancing Development of Drugs for Rare Diseases” ( https://www.fda.gov/media/151712/download ), outlines commitments, including up to three public workshops to discuss various topics relevant to endpoint development for rare diseases.

The purpose of this public workshop is to: (1) provide an overview of the RDEA Pilot Program (a joint program of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research), (2) discuss the scientific and technical issues associated with developing study endpoints for rare diseases and highlight resources to assist with addressing these issues, (3) discuss lessons learned from previous PDUFA meeting programs that can be applied to the RDEA Pilot Program, and (4) provide opportunity for public comment on the RDEA Pilot Program and issues associated with rare disease endpoint development.

Meeting sessions will focus on: (1) the RDEA Pilot Program and process, (2) elements of RDEA proposal and meeting packages, (3) addressing issues in developing rare disease endpoints, and (4) experience with other FDA pilot programs. At the end of the public workshop, there will be an opportunity for public comment.

Meeting updates, the agenda, and background materials (if any) will be made available at https://duke.is/5ca3k prior to the workshop.

Registration: To register for the public workshop, please visit the following website: https://duke.is/5ca3k . Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration will end at 11:59 p.m. Eastern Time on June 6, 2023.

Registration is free, and persons interested in attending this public workshop must register to receive a link to the meeting. Registrants will receive a confirmation email after they register.

If you need special accommodations due to a disability, please contact Margolisevents@duke.edu no later than May 5, 2023. Please note, closed captioning will be available automatically.

Requests for Oral Comments: During online registration you may indicate if you wish to speak during a public comment session. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their comment and request time for joint commentary. All requests to make oral comments must be received by 11:59 p.m. Eastern Time on May 26, 2023. FDA will determine the amount of time allotted to each commenter and the approximate time each comment is to begin and will select and notify participants by June 2, 2023.

Transcript: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://duke.is/5ca3k . The transcript will also be available at https://www.regulations.gov and may be viewed at the Dockets Management Staff (see ADDRESSES ).

I. Background

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

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

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

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

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

The Authorization follows the August 9, 2022, determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves monkeypox virus. Notice of the Secretary's determination was provided in the Federal Register on August 15, 2022 (87 FR 50090). On the basis of such determination, the Secretary of HHS declared, on September 7, 2022, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. Notice of the Secretary's declaration was provided in the Federal Register on September 13, 2022 (87 FR 56074). On March 17, 2023, having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act are met, FDA issued an EUA to Cue Health, Inc., for the Cue Mpox (Monkeypox) Molecular Test, subject to the terms of the Authorization. The Authorization, which is included below in its entirety after section IV of this document (not including the authorized versions of the fact sheets and other written materials), provides an explanation of the reasons for issuance, as required by section 564(h)(1) of the FD&C Act. Any subsequent revision to the Authorization can be found from FDA's web page at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

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

Authority and Purpose: Under Section 301 of Public Law 101-445 (7 U.S.C. 5341, the National Nutrition Monitoring and Related Research Act of 1990, Title III), the Secretaries of HHS and USDA are directed to publish the Dietary Guidelines for Americans jointly at least every five years. See 88 FR 3423, January 19, 2023, for notice of the first meeting of the 2025 Dietary Guidelines Advisory Committee, the complete Authority and Purpose, and the Committee's Task. The 2025 Dietary Guidelines Advisory Committee is formed and governed under the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C., App).

Purpose of the Meeting: The Committee will meet to discuss their prioritization of the scientific questions proposed by the Departments (see www.DietaryGuidelines.gov ) and share draft plans for their review of the scientific evidence. In accordance with FACA, deliberations of the Committee will occur in a public forum.

Meeting Agendas: A detailed agenda will be announced in advance of the meeting at www.DietaryGuidelines.gov. The agenda will include presentations by each subcommittee and deliberation by the full Committee regarding the prioritization of scientific questions and initial draft protocol development and discussion of plans for future Committee work.

Public Comment: Public comments to the Committee opened on January 19, 2023 and will remain open throughout the Committee's deliberations. Comments may be submitted at https://www.regulations.gov/document/HHS-OASH-2022-0021-0001.

Meeting Registration: This Committee meeting is open to the public. The meeting will be accessible online via livestream and recorded for later viewing. Registration is required for the livestream. To register, go to www.DietaryGuidelines.gov and click on the link for “Meeting Registration.”

Closed captioning will be available to all participants. Individuals who need accommodations should contact Kara Beckman ( Kara.Beckman@hhs.gov ). Requests should be made at least five business days in advance of the meeting.

Meeting materials for each meeting will be accessible at www.DietaryGuidelines.gov. Materials may be requested by email at dietaryguidelines@hhs.gov.