Under the PRA and its implementing regulations (5 CFR part 1320), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information,” within the meaning of the PRA, includes agency requests that pose identical questions to, or impose reporting or recording keeping obligations on, ten or more persons, regardless of whether response to such request is mandatory or voluntary. See 5 CFR 1320.3(c); see also 44 U.S.C. 3502(3). Before seeking clearance from OMB, agencies are generally required, among other things, to publish a 60-day notice in the Federal Register concerning any proposed information collection—including extension of a previously-approved collection—and provide an opportunity for comment. See 44 U.S.C. 3506(c)(2)(A); 5 CFR 1320.8(d)(1).

OMB Control Number: 3014-0012.

Title: Online Architectural Barriers Act (ABA) Complaint Form.

Form Number: The Online Architectural Barriers Act (ABA) Complaint Form is not assigned a form number.

Type of Review: Renewal of an information collection.

Background: The Access Board enforces the Architectural Barriers Act of 1968 (ABA) by investigating complaints from members of the public concerning particular buildings or facilities, i.e., those that are: constructed or altered by or on behalf of the United States; leased with federal funds; or constructed or altered with funds from a federal grant or loan. Over 90% of complaints the Access Board receives each year are submitted using the standardized, user-friendly, and accessible Online ABA Complaint Form; the remainder are submitted in writing, without the need to use a hard-copy complaint form, by email, mail, or fax. The Online ABA Complaint Form allows complaints to be filed 24 hours per day, seven days per week, and allows for greater efficiency, clarity, and timeliness in the complaint filing process and resolution of complaints.

The Online ABA Complaint Form prompts complainants to provide the information the Access Board needs to investigate their complaint. First, complainants must complete the form fields for at least the name of the building or facility and the city and state in which it is located. Second, complainants must describe each barrier to accessibility they have found at the building or facility. Third, complainants are given the option, but are not required, to provide personal information, including their name, address, telephone number(s), and email address. Where provided, personal information is not disclosed outside the agency without the written permission of the complainant. Complainants are also given the option to upload electronic files containing pictures, drawings, or other documents relevant to their complaint. Once any additional information and the complaint is submitted, the system provides complainants confirmation that their complaint has been submitted successfully, a complaint number for them to use when making inquiries about the status of their complaint, and an option to print their complaint. Complainants also receive an automatically generated email (if they have provided an email address) confirming the submission of their complaint.

Respondents: Individual members of the public; approximately 200 individuals file ABA complaints with the Access Board each year.

Frequency: Complainants need only submit one complaint for each building or facility at which they have found accessibility barriers, regardless of the number of barriers they found. Most complainants file only one ABA complaint. Complainants need to submit a separate form for each additional building or facility at which they have found an accessibility barrier.

Estimated Average Burden per Response: On average, less than 30 minutes; the burden may vary depending on how many allegations the complainant includes in the complaint. There is no financial burden on respondents.

Estimated Total Annual Burden: Approximately 100 hours annually.

Request for Comment: Comments are invited on any aspect of this information collection, including: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the estimated burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information from respondents; and (d) ways to minimize the burden of the collection of information on those who are to respond.

This committee meeting is available to the public 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 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. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the meeting platform. To request additional accommodations, please email 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 the meeting. Written comments may be emailed to Mallory Trachtenberg at mtrachtenberg@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at 1-202-809-9618.

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, South Dakota 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 the Regional Programs Coordination Unit at ebohor@usccr.gov.

This meeting will take place in Spanish with English interpretation. This committee meeting is available to the public 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 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. 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 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 the meeting. Written comments may be emailed to Victoria Moreno at vmoreno@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at 1-312-353-8311.

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, Puerto Rico 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 the Regional Programs Coordination Unit at ebohor@usccr.gov.

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

Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the respective meeting. Written comments may be emailed to Victoria Moreno at vmoreno@usccr.gov. All written comments received will be available to the public.

Persons who desire additional information may contact the Regional Programs Unit at (202) 809-9618. Records and documents discussed during the meeting will be available for public viewing as they become available at the www.facadatabase.gov. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Regional Programs Unit at the above phone number or email address.

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, June 16, 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.

This committee meeting is available to the public through the meeting 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. 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 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 the meeting. Written comments may be emailed to Barbara Delaviez at bdelaviez@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at 1-312-353-8311.

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, Colorado 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 the Regional Programs Coordination Unit at ebohor@usccr.gov.

I. Abstract

Section 1761(h) under the Export Control Reform Act (ECRA) of 2018, authorizes the President and the Secretary of Commerce to issue regulations to implement the ECRA including those provisions authorizing the control of exports of U.S. goods and technology to all foreign destinations, as necessary for the purpose of national security, foreign policy and short supply, and the provision prohibiting U.S. persons from participating in certain foreign boycotts. Export control authority has been assigned directly to the Secretary of Commerce by the ECRA and delegated by the President to the Secretary of Commerce. This authority is administered by the Bureau of Industry and Security through the Export Administration Regulations (EAR).

BIS administers a system of export, re-export, and in-country transfer controls in accordance with the EAR. In doing so, BIS requires that parties wishing to engage in certain transactions apply for licenses, submit Encryption Review Requests, or submit notifications to BIS. BIS also reviews, upon request, specifications of various items and determines their proper classification under the EAR.

Electronic.

OMB Control Number: 0694-0088.

Form Number(s): BIS-748P, BIS-748P-A, BIS-748P-B.

Type of Review: Regular submission, revision of a current information collection.

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 72,744.

Estimated Time per Response: 29.4 minutes.

Estimated Total Annual Burden Hours: 35,739.

Estimated Total Annual Cost to Public: 0.

Respondent's Obligation: Voluntary.

Legal Authority: Section 1761(h) of the Export Control Reform Act (ECRA).

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

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

Background

Commerce has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various AD and CVD orders with April anniversary dates.

All deadlines for the submission of various types of information, certifications, or comments or actions by Commerce discussed below refer to the number of calendar days from the applicable starting time.

With respect to antidumping administrative reviews, if a producer or exporter named in this notice of initiation had no exports, sales, or entries during the period of review (POR), it must notify Commerce within 30 days of publication of this notice in the Federal Register . All submissions must be filed electronically at https://access.trade.gov, in accordance with 19 CFR 351.303. 1 Such submissions are subject to verification, in accordance with section 782(i) of the Tariff Act of 1930, as amended (the Act). Further, in accordance with 19 CFR 351.303(f)(1)(i), a copy must be served on every party on Commerce's service list.

In the event Commerce limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, Commerce intends to select respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports during the POR. We intend to place the CBP data on the record within five days of publication of the initiation notice and to make our decision regarding respondent selection within 35 days of publication of the initiation Federal Register notice. Comments regarding the CBP data and respondent selection should be submitted within seven days after the placement of the CBP data on the record of this review. Parties wishing to submit rebuttal comments should submit those comments within five days after the deadline for the initial comments.

In the event Commerce decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act, the following guidelines regarding collapsing of companies for purposes of respondent selection will apply. In general, Commerce has found that determinations concerning whether particular companies should be “collapsed” ( e.g., treated as a single entity for purposes of calculating antidumping duty rates) require a substantial amount of detailed information and analysis, which often require follow-up questions and analysis. Accordingly, Commerce will not conduct collapsing analyses at the respondent selection phase of this review and will not collapse companies at the respondent selection phase unless there has been a determination to collapse certain companies in a previous segment of this AD proceeding ( e.g., investigation, administrative review, new shipper review, or changed circumstances review). For any company subject to this review, if Commerce determined, or continued to treat, that company as collapsed with others, Commerce will assume that such companies continue to operate in the same manner and will collapse them for respondent selection purposes. Otherwise, Commerce will not collapse companies for purposes of respondent selection.

Parties are requested to (a) identify which companies subject to review previously were collapsed, and (b) provide a citation to the proceeding in which they were collapsed. Further, if companies are requested to complete the Quantity and Value (Q&V) Questionnaire for purposes of respondent selection, in general, each company must report volume and value data separately for itself. Parties should not include data for any other party, even if they believe they should be treated as a single entity with that other party. If a company was collapsed with another company or companies in the most recently completed segment of this proceeding where Commerce considered collapsing that entity, complete Q&V data for that collapsed entity must be submitted.

Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that Commerce may extend this time if it is reasonable to do so. Determinations by Commerce to extend the 90-day deadline will be made on a case-by-case basis.

Section 504 of the Trade Preferences Extension Act of 2015 amended the Act by adding the concept of a particular market situation (PMS) for purposes of constructed value under section 773(e) of the Act. 2 Section 773(e) of the Act states that “if a particular market situation exists such that the cost of materials and fabrication or other processing of any kind does not accurately reflect the cost of production in the ordinary course of trade, the administering authority may use another calculation methodology under this subtitle or any other calculation methodology.” When an interested party submits a PMS allegation pursuant to section 773(e) of the Act, Commerce will respond to such a submission consistent with 19 CFR 351.301(c)(2)(v). If Commerce finds that a PMS exists under section 773(e) of the Act, then it will modify its dumping calculations appropriately.

Neither section 773(e) of the Act nor 19 CFR 351.301(c)(2)(v) set a deadline for the submission of PMS allegations and supporting factual information. However, in order to administer section 773(e) of the Act, Commerce must receive PMS allegations and supporting factual information with enough time to consider the submission. Thus, should an interested party wish to submit a PMS allegation and supporting new factual information pursuant to section 773(e) of the Act, it must do so no later than 20 days after submission of initial responses to section D of the questionnaire.

In proceedings involving non-market economy (NME) countries, Commerce begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is Commerce's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.

To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, Commerce analyzes each entity exporting the subject merchandise. In accordance with the separate rates criteria, Commerce assigns separate rates to companies in NME cases only if respondents can demonstrate the absence of both de jure and de facto government control over export activities.

All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a Separate Rate Application or Certification, as described below. For these administrative reviews, in order to demonstrate separate rate eligibility, Commerce requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on Commerce's website at https://access.trade.gov/Resources/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the certification, please follow the “Instructions for Filing the Certification” in the Separate Rate Certification. Separate Rate Certifications are due to Commerce no later than 30 calendar days after publication of this Federal Register notice. The deadline and requirement for submitting a Separate Rate Certification applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers who purchase and export subject merchandise to the United States.

Entities that currently do not have a separate rate from a completed segment of the proceeding  3 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. In addition, companies that received a separate rate in a completed segment of the proceeding that have subsequently made changes, including, but not limited to, changes to corporate structure, acquisitions of new companies or facilities, or changes to their official company name, 4 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. The Separate Rate Application will be available on Commerce's website at https://access.trade.gov/Resources/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the Separate Rate Application, refer to the instructions contained in the application. Separate Rate Applications are due to Commerce no later than 30 calendar days after publication of this Federal Register notice. The deadline and requirement for submitting a Separate Rate Application applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers that purchase and export subject merchandise to the United States.

Exporters and producers must file a timely Separate Rate Application or Certification if they want to be considered for individual examination. Furthermore, exporters and producers who submit a Separate Rate Application or Certification and subsequently are selected as mandatory respondents will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.

In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following AD and CVD orders and findings. We intend to issue the final results of these reviews not later than April 30, 2024.

Background

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

The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

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 July 14, 2021, NMFS published final notice of our issuance of an IHA authorizing take of marine mammals incidental to the Debris Dock Replacement project (86 FR 37124). The effective dates of that IHA were September 1, 2021, through August 31, 2022. On December 14, 2021, the ACOE informed NMFS that the project was delayed. None of the work identified in the initial IHA application ( e.g., pile driving and removal) had occurred. The ACOE submitted a request that we reissue an identical IHA that would be effective from January 5, 2022 through January 4, 2023, in order to conduct the construction work that was analyzed in support of the previously issued IHA. An identical IHA was reissued on December 27, 2021 (86 FR 73261). However, the project remains delayed and no work has been conducted. On December 6, 2022, the ACOE informed NMFS that, due to a project delay, none of the work identified in the original IHA ( e.g., pile driving and removal) has been conducted. The ACOE submitted a request that we reissue another IHA identical to the IHA issued July 14, 2021. The IHA was reissued on March 17, 2023 (88 FR 16412) with effective dates of January 1, 2024 through December 31, 2024. On May 2, 2023, the ACOE requested that the dates of the reissued IHA be updated to be effective from July 15, 2023 through July 14, 2024. As the project activities, anticipated effects, and required mitigation, monitoring, and reporting remain the same, re-issuance of the IHA is appropriate.

The planned activities (including mitigation, monitoring, and reporting), authorized incidental take, and anticipated impacts on the affected stocks are the same as those analyzed and authorized through the previously issued IHA.

The purpose of the ACOE's construction project is to replace the existing decaying dock and other onshore infrastructure used to move marine debris collected from San Francisco Bay onto land for disposal. The location, timing, and nature of the activities, including the types of equipment planned for use, are identical to those described in the initial IHA. The mitigation and monitoring are also as prescribed in the initial IHA.

Species that are expected to be taken by the planned activity include harbor porpoise ( Phocoena phocoena ), harbor seal ( Phoca vitulina ), gray whale ( Eschrichtius robustus ), bottlenose dolphin ( Tursiops truncatus ), California sea lion ( Zalophus californianus ), northern fur seal ( Callorhinus ursinus ), and northern elephant seal ( Mirounga angustirostris ). A description of the methods and inputs used to estimate take anticipated to occur and, ultimately, the take that was authorized is found in the previous documents referenced above. The data inputs and methods of estimating take are identical to those used in the initial IHA. NMFS has reviewed recent Stock Assessment Reports, information on relevant Unusual Mortality Events, and recent scientific literature, and determined that no new information affects our original analysis of impacts or take estimate under the initial IHA.

We refer to the documents related to the previously issued IHA, which include the Federal Register notice of the issuance of the initial 2021 IHA for the ACOE's construction work (86 FR 37124), the ACOE's application, the Federal Register notice of the proposed IHA (86 FR 28768), and all associated references and documents.

The ACOE will conduct activities as analyzed in support of the initial 2021 IHA. As described above, the number of authorized takes of the same species and stocks of marine mammals are identical to the numbers that were found to meet the negligible impact and small numbers standards and authorized under the initial IHA and no new information has emerged that would change those findings. The re-issued 2023 IHA includes identical required mitigation, monitoring, and reporting measures as the initial IHA, and there is no new information suggesting that our analysis or findings should change.

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

This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental take authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS determined that the issuance of the initial IHA qualified to be categorically excluded from further NEPA review. NMFS has determined that the application of this categorical exclusion remains appropriate for this reissued IHA.

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

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

NMFS has issued an IHA to the ACOE for in-water construction activities associated with the specified activity from July 15, 2023 through July 14, 2024. All previously described mitigation, monitoring, and reporting requirements from the initial 2021 IHA are incorporated.

Title; Associated Form; and OMB Number: Global Air Transportation Execution System; OMB Control Number 0704-0530.

Needs and Uses: GATES is the single DoD port processing and manifesting system providing support for the global air and surface movement of personnel and materiel, to include processing and tracking from port to port. It supports USTRANSCOM air and surface port management, provides functionality for Defense Courier Divisions, SDDC/G3, and AMC/A4T, while providing billing information for Transportation Working Capital Fund (TWCF) accounting.

Affected Public: Individuals or households.

Annual Burden Hours: 17,239.

Number of Respondents: 517,163.

Responses per Respondent: 1.

Annual Responses: 517,163.

Average Burden per Response: 2 minutes.

Frequency: On occasion.

The ASD(HA) approved temporary modifications to TRICARE regulations in response to the COVID-19 pandemic and the President's national emergency for the COVID-19 outbreak (Proclamation 9994, 85 Federal Register (FR) 15337). Interim final rules (IFRs) implementing temporary changes to the TRICARE regulation were published on May 12, 2020 (85 FR 27921); September 3, 2020 (85 FR 54914); October 30, 2020 (85 FR 68753); and January 12, 2023 (88 FR 1992). All provisions of the IFR published on May 12, 2020, and all but one provision of the IFR published on September 3, 2020, were finalized, with changes, in a final rule published June 1, 2022 (87 FR 33001).

The temporary provisions in the four IFRs, as modified by the final rule where applicable, were set to expire automatically, depending on the particular temporary provision, at: (1) the termination of the President's national emergency; (2) the termination of the associated Secretary of HHS's PHE; (3) the termination of the Centers for Medicare and Medicaid Services' (CMS's) Hospitals Without Walls initiative; or (4) at the end of the fiscal year in which the HHS PHE terminates. On January 30, 2023, the Biden Administration announced plans to terminate both the President's national emergency and the HHS PHE on May 11, 2023. 1 CMS has previously stated that the Hospital Without Walls initiative would terminate when the HHS PHE ended. 2 Public Law 118-3 was subsequently enacted on April 10, 2023, immediately terminating the President's national emergency. 3 Several provisions in the IFRs are permanent changes; these provisions will not expire.

The Department stated in its IFRs that the ASD(HA) would publish a document in the FR announcing the termination dates for the temporary provisions; this FR notice satisfies that requirement. This document also provides notice that the ASD(HA) is not extending any of the provisions overseas beyond their termination in the United States.

A. The following temporary regulatory changes ended at the end of the day on April 10, 2023, in the United States and overseas as stated in this notice. DoD will publish final rules removing these temporary regulatory changes from the Code of Federal Regulations (CFR) after their termination date:

1. Paragraph 199.4(b)(3)(xiv) of Title 32 of the CFR: Temporary waiver of the requirement for a three-day prior hospital stay before admission to a skilled nursing facility ended for all new skilled nursing facility admissions after April 10, 2023.

2. Title 32 CFR 199.4(e)(26)(iii)(B): Temporary coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored COVID-19 clinical trials ended on April 10, 2023. Eligible beneficiaries who enrolled in a covered trial on or before April 10, 2023, will continue to have their care covered through the end of the trial.

3. Title 32 CFR 199.4(g)(15)(i)(A): Temporary coverage of the treatment use of investigational drugs under U.S. Food and Drug Administration (FDA)-approved expanded access programs ended for all new episodes of treatment after April 10, 2023.

4. Title 32 CFR 199.6(c)(2)(i): Temporary waiver of certain interstate and international licensing requirements ended for all care received after April 10, 2023.

B. The following temporary regulatory changes ended at the end of the day on May 11, 2023, in the United States and overseas as stated in this notice. DoD will publish final rules removing these temporary regulatory changes from the CFR after their termination date:

1. Title 32 CFR 199.6(b)(4)(i)(I): Temporary waiver of certain acute care facility requirements for facilities registering with Medicare as a hospital under CMS's Hospitals Without Walls initiative ended on May 11, 2023. Care provided after May 11, 2023, will be reimbursed under the methodology appropriate for the facility's current status (ambulatory surgery center, etc.), consistent with Medicare's guidance to facilities qualified as acute care facilities under the Hospital Without Walls initiative. 4

2. Title 32 CFR 199.14(a)(1)(iii)(E)( 2 ): Temporary adjustments to the DRG-based reimbursement amounts for patients diagnosed with COVID-19 ended for all new admissions after May 11, 2023.

3. Title 32 CFR 199.14(a)(9)(i): Temporary reimbursement of all long-term care hospitals (LTCHs) at the LTCH prospective payment system standard Federal rate ended for all new admissions after May 11, 2023.

C. The temporary regulation change creating a DRG add-on for NCTAPs (32 CFR 199.14(a)(1)(iv)(C)) will end for all new admissions after September 30, 2023. The NCTAP is designed to mitigate potential financial disincentives for hospitals to provide new COVID-19 treatments for eligible inpatient cases that use certain new products with current FDA approval or emergency use authorization to treat COVID-19. DoD will publish a final rule removing this temporary regulatory change from the CFR after its termination date.

D. The following provisions permanently adopted in the IFRs, as modified by the final rule, where applicable, remain in effect:

1. Title 32 CFR 199.6(b)(4)(xxi) and paragraph 199.14(c): Addition of freestanding End Stage Renal Disease (ESRD) facilities as authorized institutional providers and adoption of a reimbursement system for freestanding ESRD facilities.

2. Title 32 CFR 199.14(a)(1)(iv)(A): Adoption of Medicare's New Technology Add On Payments; permanent, special payments that are offered because new medical services and new technologies are not yet included in the calculation of standardized DRG rates.

3. Title 32 CFR 199.14(a)(1)(iv)(B): Adoption of Medicare's Hospital Value Based Purchasing Program.

E. The Department is evaluating certain temporary provisions adopted in the IFRs not yet finalized in a final rule (specifically, temporary coverage of the treatment use of investigational drugs approved under FDA expanded access program, NIAID-sponsored clinical trials, and NCTAPs). If the ASD(HA) determines permanent changes to the regulation are required, such changes would be announced in future final rules. The effective date of such coverage would be announced in the final rule. Until such rules publish, these provisions expire as stated in the original IFRs and announced in this notice.

The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Federal Work Study (FWS) Wages for Student Aid Index.

OMB Control Number: 1845-NEW.

Type of Review: New ICR.

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

Total Estimated Number of Annual Responses: 3,043.

Total Estimated Number of Annual Burden Hours: 673,465.

Abstract: This new collection will be used to gather information available to participating institutions of higher education (IHE) which is required to fully calculate eligibility for title IV student financial aid for applicants under the Higher Education Act of 1965, as amended (HEA).

The FAFSA Simplification Act (Pub. L. 116-260) introduced a change to the manner in which the Department of Education (ED) may obtain the amount of income an applicant has earned from work under the Federal Work Study (FWS) Program, for the purposes of calculating the applicant's student aid index (SAI) and determine their eligibility for certain title IV aid. Pursuant to section 483(a)(2)(F) of the FAFSA Simplification Act, ED is required to collect an applicant's income earned under the FWS program from the IHE participating in the FWS program and can no longer add additional questions to the FAFSA to obtain this information from the FAFSA applicant.

Purpose of Program: The FLAS Program allocates academic year and summer fellowships to institutions of higher education (IHEs) and consortia of such institutions to assist meritorious undergraduate and graduate students receiving modern foreign language training in combination with area studies, international studies, or the international aspects of professional studies. FLAS fellowships may also assist graduate students engaged in predissertation level study, preparation for dissertation research, dissertation research abroad, or dissertation writing.

FLAS Fellowship Subsistence Allowances: In FY 2021, the Department published a notice soliciting applications for the FLAS Program (86 FR 71466). That notice established the subsistence allowance for a graduate student academic year fellowship at $20,000; the subsistence allowance for an undergraduate student academic year fellowship at $5,000; and the subsistence allowance for a summer fellowship at $2,500 for graduate and undergraduate students.

In accordance with 34 CFR 657.31(b)(1), the Department is publishing this notice to increase the subsistence allowance amount for a summer session to $3,500 per fellow.

Note: This notice does not solicit applications.

Program Authority: 20 U.S.C. 1122.

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

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

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

I. General Information A. Does this action apply to me?

This action applies to the public in general. As such, the Agency has not attempted to describe all the specific entities that may be affected by this action.

The docket for this action, identified by docket identification (ID) number EPA-EPA-HQ-OPP-2023-0068, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 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 OPP Docket is (202) 566-0294. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets.

Under contract number No. 68HERD23R0003, the contractor will perform the following: The contractor will provide support for OPP Docket to support and officially document an agency's rulemaking or other related activities. Those activities typically follow a three-step sequence in which the government first issues a draft of its proposed action, then receives public feedback on its proposal, and finally publishes a finished product. Dockets contain the Federal Register documents, supporting documentation and materials, and public comments associated with each of those steps. Agencies are required to use dockets in the development of regulatory actions. Most agencies, including EPA, also use them in other instances where there is a need to officially distribute information and/or solicit public input on their activities. The OPP Docket primary responsibilities are to provide support to rule writers and other docket owners in creating and populating dockets in the Federal Docket Management System (FDMS) and then post them to Regulations.gov (a cross-government public portal for docketing). Both FDMS and Regulations.gov are operated by the eRulemaking Program Management Office (PMO) within the General Services Administration (GSA). At different stages in this process, EPA/DC staff engage in activities such as customer service, training, sorting, digitizing, metadata indexing, quality assurance (QA), and records management.

This contract will involve no subcontractors.

OPP has determined that the contracts described in this document involve work that is being conducted in connection with FIFRA, in that pesticide chemicals will be the subject of certain evaluations to be made under this contract. These evaluations may be used in subsequent regulatory decisions under FIFRA.

Some of this information may be entitled to confidential treatment. The information has been submitted to EPA under FIFRA sections 3, 4, 6, and 7 and under FFDCA sections 408 and 409.

In accordance with the requirements of 40 CFR 2.307(h)(3), the contracts with Agile Decision Sciences, prohibits use of the information for any purpose not specified in these contracts; prohibits disclosure of the information to a third party without prior written approval from the Agency; and requires that each official and employee of the contractor sign an agreement to protect the information from unauthorized release and to handle it in accordance with the FIFRA Information Security Manual. In addition, Agile Decision Sciences is required to submit for EPA approval a security plan under which any CBI will be secured and protected against unauthorized release or compromise. No information will be provided to Agile Decision Sciences until the requirements in this document have been fully satisfied. Records of information provided to Agile Decision Sciences will be maintained by EPA Project Officers for these contracts. All information supplied to Agile Decision Sciences by EPA for use in connection with these contracts will be returned to EPA when Agile Decision Sciences has completed its work.

Authority: 7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq.

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

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

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

EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications. For actions being evaluated under EPA's public participation process for registration actions, there will be an additional opportunity for public comment on the proposed decisions. Please see EPA's public participation website for additional information on this process ( https://www2.epa.gov/pesticide-registration/public-participation-process-registration-actions ).

1. File Symbol: 100361-R. Docket ID number: EPA-HQ-OPP-2023-0218. Applicant: Valto BV, Leehove 81, 2678 MB De Lier Zuid-Holland, 2678-MB, Netherlands (c/o SciReg., Inc., 12733 Director's Loop Woodbridge, VA 22192). Product name: V10. Active ingredients: Virucide— Pepino mosaic virus, strain LP, isolate VX11 at 0.0025% and Pepino mosaic virus, strain CH2, isolate VC1 at 0.0025%. Proposed use: For the protection of tomato plants grown in commercial production greenhouses from aggressive strains of Pepino mosaic virus. Contact: BPPD.

2. File Symbol: 101252-E. Docket ID number: EPA-HQ-OPP-2023-0241. Applicant: Lavie-Bio, Gad Feinstein 13, Rehovot 41732 Israel (c/o Delta Analytical Corporation, 12510 Prosperity Drive, Suite 160, Silver Spring, MD 20904). Product name: LAV.311 V. Active ingredient: Fungicide— Pseudomonas coleopterorum strain 49762 at 20%. Proposed classification/Use: Pre-harvest treatment. Contact: BPPD.

3. File Symbol: 101252-G. Docket ID number: EPA-HQ-OPP-2023-0241. Applicant: Lavie-Bio, Gad Feinstein 13, Rehovot 41732 Israel (c/o Delta Analytical Corporation, 12510 Prosperity Drive, Suite 160, Silver Spring, MD 20904). Product name: LAV.311 VC. Active ingredient: Fungicide— Pseudomonas coleopterorum strain 49762 at 20%. Proposed classification/Use: Pre-harvest treatment. Contact: BPPD.

4. File Symbol: 101252-R. Docket ID number: EPA-HQ-OPP-2023-0241. Applicant: Lavie-Bio, Gad Feinstein 13, Rehovot 41732 Israel (c/o Delta Analytical Corporation, 12510 Prosperity Drive, Suite 160, Silver Spring, MD 20904). Product name: LAV.311 C. Active ingredient: Fungicide— Pseudomonas coleopterorum strain 49762 at 20%. Proposed classification/Use: Pre-harvest treatment. Contact: BPPD.

5. File Symbol: 101252-U. Docket ID number: EPA-HQ-OPP-2023-0241. Applicant: Lavie-Bio, Gad Feinstein 13, Rehovot 41732 Israel (c/o Delta Analytical Corporation, 12510 Prosperity Drive, Suite 160, Silver Spring, MD 20904). Product name: LAV.311 WDG. Active ingredient: Fungicide— Pseudomonas coleopterorum strain 49762 at 28%. Proposed classification/Use: Pre-harvest treatment. Contact: BPPD.

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

I. Background

The Clean Water Act (CWA) section 312 establishes the statutory framework through which EPA and the U.S. Coast Guard regulate the discharge of sewage from vessels with installed toilets operating in U.S. navigable waters. EPA is responsible for establishing national standards of performance for marine sanitation devices (MSDs) to prevent inadequately treated sewage from polluting U.S. waters, while the U.S. Coast Guard is responsible for issuing regulations governing the design, construction, certification, installation, and operation of MSDs, consistent with EPA's standards. MSDs are equipment installed onboard vessels that either treat sewage prior to discharge or store sewage onboard for later disposal. If a State determines that some or all of the State's waters require greater protection, the CWA allows the State to apply to EPA for the establishment of a vessel sewage no-discharge zone. A vessel sewage no-discharge zone is an area where the discharge of both treated and untreated sewage from vessels is prohibited. There are three different types of vessel sewage no-discharge zones that may be designated under CWA section 312(f). For each type, the State must submit an application to EPA pursuant to the regulatory requirements detailed in 40 CFR 140.4.

In 1994, EPA published guidance, “Protecting Coastal Waters from Vessel and Marina Discharges: A Guide for State and Local Officials, Volume 1. Establishing No-Discharge Areas under §  312 of the Clean Water Act” (EPA 842-B-94-004, August 1994), to assist States in preparing applications based on the regulatory requirements. The “Guidance for Vessel Sewage No-Discharge Zone Applications (Clean Water Act Section 312(f))” supersedes the 1994 guidance.

The guidance provides background information on the environmental impacts of vessel sewage and the regulations in place to protect U.S. waters from this type of discharge. The guidance also explains and clarifies the information that EPA requires in an application and provides examples of the information that the State may choose to include to assist EPA in making an informed decision. The appendices contain sample applications, information on related programs, a walkthrough of the tool that supports EPA's analysis of costs for one of the three designation types, and strategies States may consider to encourage compliance with a no-discharge zone designation.

Key updates made to the guidance since the 1994 version include the addition of new guidance and sample applications for the two CWA section 312(f)(4) designations, as well as updated introductory sections on the impact of sewage discharges and the regulatory framework in place to mitigate these impacts. The guidance also clarifies how to account for mobile pumpout facilities, such as boats and trucks, and provides additional information on how to demonstrate that sewage removed from vessels is being treated in conformance with Federal law. Finally, in the sections pertaining to CWA section 312(f)(3) applications, the guidance distinguishes between recreational and commercial vessels in acknowledgement of differing vessel profiles and pumpout facility needs.

Other updates were made to explain EPA's process for evaluating State applications. The most substantial update to EPA's review process is the inclusion of a new cost analysis for applications submitted under CWA section 312(f)(3). In addition to describing how EPA may conduct cost analyses for CWA section 312(f)(3) applications, the guidance is also accompanied by a spreadsheet-based tool, the “No-Discharge Zone Cost Analysis Tool,” to help standardize the agency's approach to evaluating costs.

On June 27, 2022, EPA published a Federal Register notice (87 FR 38151) to solicit public comments on the draft guidance. EPA received 10 comments during the 60-day comment period. Commenters provided recommendations regarding the types of information identified as required versus optional for State applications and the inputs to the “No-Discharge Zone Cost Analysis Tool.” Commenters also provided general feedback on the application process, including the timing and nature of communication between EPA, States, and stakeholders. A complete comment response document is available in EPA's docket.

The “Guidance for Vessel Sewage No-Discharge Zone Applications (Clean Water Act Section 312(f))” and accompanying “No-Discharge Zone Cost Analysis Tool” are now available for use by State officials in the development of vessel sewage no-discharge zone applications. They are available in the docket and on EPA's website at https://www.epa.gov/vessels-marinas-and-ports/guidance-vessel-sewage-no-discharge-zone-applications.

The Age Discrimination in Employment Act (ADEA) allows for individuals to waive rights and claims protected under the Act, provided certain circumstances are met; particularly that the waiver is knowing and voluntary. In order for an individual's waiver in connection with a program to be considered knowing and voluntary, the employer must inform the individual in writing in a manner calculated to be understood by the average individual eligible to participate, as to (i) any class, unit, or group of individuals covered by such program, any eligibility factors for such program, and any time limits applicable to such program; and (ii) the job titles and ages of all individuals eligible or selected for the program, and the ages of all individuals in the same job classification or organizational unit who are not eligible or selected for the program. The EEOC's regulations clarify that the relevant section of the ADEA addresses two principal issues: to whom information must be provided, and what information must be disclosed to such individuals. The purpose of the informational requirements is to provide an employee with enough information regarding the program to allow an employee to make an informed choice whether or not to sign a waiver agreement. The employer does not provide this information to the EEOC; the ADEA and the EEOC's regulation solely require that the employer provide this information to any employee it would apply to, and not to the Federal government.

The EEOC, in accordance with the PRA and OMB regulation 5 CFR 1320.8(d)(1), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the EEOC to assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public to understand the EEOC's information collection requirements and provide the requested data in the desired format. The EEOC is soliciting comments on the information collection that is described below. The EEOC is especially interested in public comment that will assist the EEOC in the following: (1) Evaluating whether the collection of information is necessary for the proper performance of the Commission's functions, including whether the collection has practical utility; (2) Evaluating the accuracy of the Commission's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) Enhancing the quality, utility, and clarity of the information to be collected; and (4) Minimizing the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Please note that written comments received in response to this notice will be considered public records.

Collection title: Waivers of Rights and Claims Under the ADEA; Informational Requirements.

OMB number: 3046-0042.

Type of Respondent: Business, state or local governments, not for profit institutions.

Description of affected public: Any employer with 20 or more employees that seeks waiver agreements in connection with exit incentive or other employment termination program.

Number of respondents: 1,489.

Burden Hours per Respondent: 16.19.

Total Annual Burden Hours: 24,1067.

Number of forms: 0.

Abstract: The EEOC enforces the Age Discrimination in Employment Act (ADEA), which prohibits discrimination against employees and applicants for employment who are age 40 or older. The OWBPA, enacted in 1990, amended the ADEA to require employers to disclose certain information to employees (but not to EEOC) in writing when they ask employees to waive their rights under the ADEA in connection with an exit incentive program or other employment termination program. The regulation at 29 CFR 1625.22 reiterates those disclosure requirements. The EEOC seeks an extension without change for the third-party disclosure requirements contained in this regulation.

Burden statement: In 2016, the EEOC conducted a limited survey as the foundation for estimating the burden hours per Respondent. The estimated burden hours per Respondent are a combination of the estimated hours to create an ADEA waiver and the estimated hours to distribute an ADEA waiver to employees as part of an exit incentive program or other employment termination program. The goal of the 2016 survey was to identify the actual costs of creating and distributing ADEA waivers and to better understand what type of employees were involved in this process. The EEOC learned that the human resource managers (both senior and junior) and legal counsel and staff (both internal and external counsel) carry most of the paperwork and human capital burden for drafting and distributing the waivers to employees.

In sum, the burden hours for the creation of the ADEA waiver are estimated to be 8.25 per Respondent ( i.e., employer), while burden hours for the distribution of the ADEA waiver are estimated to be 7.94 per Respondent ( i.e., employer). Thus, the total burden hours per Respondent ( i.e., employer) is 16.19.

The total annual burden hours for this information collection is calculated by multiplying the number of Respondents ( i.e., employers) by the total burden hours per Respondent. Thus, the total burden hours for this information collection is 24,107 hours [1,489 Respondents × 16.19 hours per Respondent].

Per Table 1 and 2 below, EEOC found that the approximate cost of preparing the ADEA waiver notice is $384.36 per Respondent ( i.e., employer), and the approximate cost of distributing the ADEA waiver notice is $390.88 per Respondent ( i.e., employer). Thus, the total cost per Respondent is $775.24. For all 1,489 Respondents ( i.e., employers) who are projected to have reductions in force and request waiver notices, the total preparation cost is $572,312.78, and the total distribution cost is $582,022.70. Thus, the total cost for all 1,489 Respondents ( i.e., employers) is $1,154,334.70 [$572,312.78 + $582,022.70]. Table 1 reflects the calculation of the costs of creating the ADEA waiver and Table 2 reflects the calculation of the costs of distribution of the ADEA waiver.

OMB Control Number: 3060-0208.

Title: Section 73.1870, Chief Operators.

Form Number: Not applicable.

Type of Review: Extension of a currently approved collection.

Respondents: Business and other for-profit; Not-for-profit institutions.

Number of Respondents and Responses: 18,498 respondents; 36,996 responses.

Estimated Time per Response: 0.166-26 hours.

Frequency of Response: Recordkeeping requirement; Third party disclosure requirement; Weekly reporting requirement.

Total Annual Burden: 484,019 hours.

Total Annual Cost: None.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in sections 154(i) of the Communications Act of 1934, as amended.

Needs and Uses: The information collection requirements contained in 47 CFR 73.1870 require that the licensee of an AM, FM, or TV broadcast station designate a chief operator of the station. Section 73.1870(b)(3) requires that this designation must be in writing and posted with the station license. Section 73.1870(c)(3) requires that the chief operator, or personnel delegated and supervised by the chief operator, review the station records at least once each week to determine if required entries are being made correctly, and verify that the station has been operated in accordance with FCC rules and the station authorization. Upon completion of the review, the chief operator must date and sign the log, initiate corrective action which may be necessary and advise the station licensee of any condition which is repetitive. The posting of the designation of the chief operator is used by interested parties to readily identify the chief operator. The review of the station records is used by the chief operator, and FCC staff in investigations, to ensure that the station is operating in accordance with its station authorization and the FCC rules and regulations.

OMB Control No.: 3060-1205.

Title: Section 74.802, Low Power Auxiliary Stations Co-channel Coordination with TV Broadcast Stations.

Form No.: Not applicable.

Type of Review: Extension of a currently approved collection.

Respondents: Individuals and households; business or other for-profit entities; not-for-profit institutions; Federal Government; and State, local or Tribal government.

Number of Respondents and Responses: 200 respondents and 200 responses.

Estimated Time per Response: 1.0 hour.

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

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in 47 U.S.C. 151, 154, 301, 303, 307, 308, 309, 310, 316, 319, 325(b), 332, 336(f), 338, 339, 340, 399b, 403, 534, 535, 1404, 1452, and 1454.

Total Annual Burden: 200 hours.

Total Annual Cost: $25,000.

Needs and Uses: On June 2, 2014, the Commission released a Report and Order, FCC 14-50, GN Docket No. 12-268, “Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions.” This order adopted a revision to a Commission rule, 47 CFR 74.802(b), to permit low power auxiliary stations (LPAS), including wireless microphones, to operate in the bands allocated for TV broadcasting at revised distances from a co-channel television's contour, and provided LPAS operators to operate even closer to television stations proved that any such operations are coordinated with TV broadcast stations that could be affected by the LPAS operations.

The Commission seeks Office of Management and Budget (OMB) approval for an extension of the currently approved information collection for the coordination process adopted in the Commission's Report and Order, FCC 14-50 for such co-channel operations, in 47 CFR 74.802d(b)(2).

The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

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

OMB Control No.: 3060-1275.

Title: 3.7 GHz Band Relocation Payment Clearinghouse; 3.7 GHz Band Relocation Coordinator; 3.7 GHz Band Space Station Operators.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

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

Number of Respondents and Responses: 3,007 respondents and 9,362 responses.

Estimated Time per Response: 0.5 hours-600 hours.

Frequency of Response: Recordkeeping requirement; on occasion, weekly, monthly, quarterly, semi-annual, and annual reporting requirements; third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in sections 1, 2, 4(i), 4(j), 5(c), 201, 302, 303, 304, 307(e), 309, and 316 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 154(j), 155(c), 201, 302, 303, 304, 307(e), 309, and 316.

Total Annual Burden: 77,754 hours.

Annual Cost Burden: $10,705,353.

Needs and Uses: On February 28, 2020, in furtherance of the goal of releasing more mid-band spectrum into the market to support and enabling next-generation wireless networks, the Commission adopted a Report and Order, FCC 20-22, (3.7 GHz Report and Order), in which it reformed the use of the 3.7-4.2 GHz band, also known as the C-band. Currently, the 3.7-4.2 GHz band is allocated in the United States exclusively for non-Federal use on a primary basis for Fixed Satellite Service (FSS) and Fixed Service (FS). Domestically, space station operators use the 3.7-4.2 GHz band to provide downlink signals of various bandwidths to licensed transmit-receive, registered receive-only, and unregistered receive-only earth stations throughout the United States.

The 3.7 GHz Report and Order calls for the relocation of existing FSS operations in the band into the upper 200 megahertz of the band (4.0-4.2 GHz) and relocation of existing FS operations into other bands, making the lower 280 megahertz (3.7-3.98 GHz) available for flexible use throughout the contiguous United States through a Commission-administered public auction of overlay licenses that is scheduled to occur later this year. The Commission adopted a robust transition schedule to achieve a prompt relocation of FSS and FS operations so that a significant amount of spectrum could be made available quickly for next-generation wireless deployments. At the same time, the Commission sought to ensure the effective accommodation of relocated incumbent users. To facilitate an efficient transition, the Commission adopted a process for fully reimbursing existing operators for the costs of this relocation and for offering accelerated relocation payments to encourage a timely transition. Flexible-use licensees will be required to pay any accelerated relocation payments, if elected by eligible space station operators, and reimburse incumbent operators for their actual relocation costs associated with clearing the lower 300 megahertz of the band while ensuring continued operations for their customers. The 3.7 GHZ Report and Order establishes a Relocation Payment Clearinghouse to oversee the cost-related aspects of the transition and establishes a Relocation Coordinator to establish a timeline and take actions necessary to migrate and filter incumbent earth stations to ensure continued, uninterrupted service during and following the transition.

FCC staff will use this data to ensure that 3.7-4.2 GHz band stakeholders adopt practices and standards in their operations to ensure an effective, efficient, and streamlined transition. Status reports and other information required in this collection will be used to ensure that the process of clearing the lower portion of the band is efficient and timely, so that the spectrum can be auctioned for flexible-use service licenses and deployed for next-generation wireless services, including 5G, as quickly as possible. The collection is also necessary for the Commission to satisfy its oversight responsibilities and/or agency specific/Government-wide reporting obligations.

The Commission concluded in the 3.7 GHz Report and Order that a Relocation Payment Clearinghouse and Relocation Coordinator are critical to ensuring that the reconfiguration is administered in a fair, transparent manner and that the transition occurs as expeditiously as possible. To accomplish these goals most effectively, the Commission is seeking approval for a new information collection to collect information from the Relocation Payment Clearinghouse, the Relocation Coordinator, and incumbent space station operators and allow the Relocation Payment Clearinghouse and Relocation Coordinator to collection information to ensure that the band is transitioned effectively.

A. Paperwork Reduction Act

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests or requirements that ten or more persons submit information to a third party. Section 3506(c)(2)(A) of title 44 requires Federal agencies to provide a 60-day notice  1 in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection of information to OMB for approval. FHFA's collection of information set forth in this document is titled “Members of the Banks” (assigned control number 2590-0003 by OMB). To comply with the PRA requirement, FHFA is publishing notice of a proposed three-year extension of this collection of information and reinstatement of the control number, which is due to expire on September 30, 2023.

The Federal Home Loan Bank System consists of eleven regional Federal Home Loan Banks (Banks) and the Office of Finance (a joint office that issues and services the Banks' debt securities). The Banks are wholesale financial institutions, organized under the authority of the Federal Home Loan Bank Act (Bank Act) to serve the public interest by enhancing the availability of residential housing finance and community lending credit through their member institutions and, to a limited extent, through certain eligible nonmembers. Each Bank is structured as a regional cooperative that is owned and controlled by member institutions located within its district, which are also its primary customers. The Banks carry out their public policy functions primarily by providing low-cost loans, known as advances, to their members. With limited exceptions, an institution may obtain advances and access other products and services provided by a Bank only if it is a member of that Bank.

The Bank Act limits membership in any Bank to specific types of financial institutions located within the Bank's district that meet specific eligibility requirements. Section 4 of the Bank Act specifies the types of institutions that may be eligible for membership and establishes eligibility requirements that each type of applicant must meet in order to become a Bank member. 2 That provision also specifies that (with limited exceptions) an eligible institution may become a member only of the Bank of the district in which the institution's “principal place of business” is located. 3 With respect to the termination of Bank membership, section 6(d) of the Bank Act sets forth requirements pursuant to which an institution may voluntarily withdraw from membership or a Bank may terminate an institution's membership for cause. 4

FHFA's “Members of the Banks” regulation, set forth at 12 CFR part 1263, implements those statutory provisions and otherwise establishes substantive and procedural requirements relating to the initiation and termination of Bank membership. Many of the provisions in the membership regulation require that an institution submit information to a Bank or to FHFA, in most cases to demonstrate compliance with statutory or regulatory requirements or to request action by the Bank or FHFA.

There are four types of information collections that may occur under part 1263. First, the regulation provides that (with limited exceptions) no institution may become a member of a Bank unless it has submitted to that Bank an application that documents the applicant's compliance with the statutory and regulatory membership eligibility requirements and that otherwise includes all required information and materials. 5 Second, the regulation provides applicants that have been denied membership by a Bank the option of appealing the decision to FHFA. To file such an appeal, an applicant must submit to FHFA a copy of the Bank's decision resolution denying its membership application and a statement of the basis for the appeal containing sufficient facts, information, and analysis to support the applicant's position. 6 Third, the regulation provides that, in order to initiate a voluntary withdrawal from Bank membership, a member must submit to its Bank a written notice of intent to withdraw. 7 Fourth, under certain circumstances, the regulation permits a member of one Bank to transfer its membership to a second Bank “automatically” without either initiating a voluntary withdrawal from the first Bank or submitting a membership application to the second Bank. Despite the regulatory reference to such a transfer as being “automatic,” a member meeting the criteria for an automatic transfer must initiate the transfer process by filing a request with its current Bank, which will then arrange the details of the transfer with the second Bank. 8

The Banks use most of the information collected under part 1263 to determine whether an applicant satisfies the statutory and regulatory requirements for Bank membership and should be approved as a Bank member. The Banks may use some of the information collected under part 1263 as a means of learning that a member wishes to withdraw or to transfer its membership to a different Bank so that the Bank can begin to process those requests. FHFA may also use the collected information to determine whether an institution that has been denied membership by a Bank should be permitted to become a member of that Bank.

The OMB control number for this information collection is 2590-0003, which is due to expire on September 30, 2023. The likely respondents are financial institutions that are, or are applying to become, Bank members.

FHFA has analyzed the time burden imposed on respondents by the four collections under this control number and estimates that the average annual burden imposed on all respondents by those collections over the next three years will be 2,181 hours. This estimate is derived from the following calculations:

FHFA estimates that the average number of applications for Bank membership submitted annually will be 141 and that the average time to prepare and submit an application and supporting materials will be 15 hours. Accordingly, the estimate for the annual hour burden associated with preparation and submission of applications for Bank membership is (141 applications × 15 hours per application) = 2,115 hours.

FHFA estimates that the average number of applicants that have been denied membership by a Bank that will appeal such a denial to FHFA will be 1 and that the average time to prepare and submit an application for appeal will be 50 hours. Accordingly, the estimate for the annual hour burden associated with the preparation and submission of membership appeals is (1 appellants × 50 hours per application) = 50 hours.

FHFA estimates that the average number of Bank members submitting a notice of intent to withdraw from membership annually will be 4 and that the average time to prepare and submit a notice will be 1.5 hours. Accordingly, the estimate for the annual hour burden associated with preparation and submission of notices of intent to withdraw is (4 withdrawing members × 1.5 hours per application) = 6 hours.

FHFA estimates that the average number of Bank members submitting a request for transfer to another Bank will be 5 and that the average time to prepare and submit a request will be 2 hours. Accordingly, the estimate for the annual hour burden associated with preparation and submission of requests for automatic transfer is (5 transferring members × 2 hours per request) = 10 hours.

FHFA requests written comments on the following: (1) Whether the collection of information is necessary for the proper performance of FHFA functions, including whether the information has practical utility; (2) the accuracy of FHFA's estimates of the burdens of the collection of information; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) 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.

Background

Priority for technical evaluations are rapid tests or mail-in sample collection methods that can be self-administered outside of clinic settings. Secondarily, tests or collection methods that have the potential for both HIV-1 diagnostic and prognostic use for monitoring responses to therapy are preferred.

The objective of the collaboration is timely collection of data to evaluate the performance characteristics of simplified nucleic acid and serologic tests or protocols when used in their intended applications. Only tests that are under or near production ( i.e., not first-generation prototypes) will be eligible for the collaboration. Companies that are interested in collaborating must be planning to market a test protocol for distribution in the United States and to seek FDA approval for diagnostic or prognostic use.

Currently, nucleic acid testing conducted as part of CDC's laboratory algorithm has a delay in returning results because testing is often conducted in referral laboratories. Likewise, pooled nucleic acid testing causes delays due to the time required to create and break down pools in the event of a positive pool. Moreover, there are significant financial stability, geographic isolation, and stigma barriers to accessing testing in clinical settings that prevent sustained continuum of care for many populations, including the most vulnerable. Methods to support rapid identification of HIV-1 infection or viral suppression using a simplified nucleic acid or serologic test, or use of self-collection methods, may have a significant impact on individuals by allowing them to obtain care and services more quickly.

Tests should be simple to use on unprocessed specimens ( e.g., whole blood) or include specimen processing in the design of the test. For nucleic acid tests, preference may also be given to tests that are capable of both qualitative and quantitative applications. Key benchmarks are the ability to demonstrate improved sensitivity of diagnostic tests over current FDA-approved laboratory-based tests and nucleic acid monitoring test protocols that are suitable for lower complexity settings.

CDC's role may include, but will not be limited to, the following:

(1) Providing scientific and technical expertise needed for the research project;

(2) Providing assistance with project management and data analysis;

(3) Providing testing support as determined by CDC as needed; and

(4) Publishing research results.

CDC anticipates that the role of the successful collaborator(s) will include the following:

(1) Providing tests and finalized protocols that can be used in the evaluation; and

(2) Providing the CDC Division of HIV Prevention access to necessary data about the diagnostic tests in support of the evaluation activities.

Proposals submitted for consideration should address, as fully as possible and to the extent relevant to the proposal, each of the following:

(1) Data available on the performance of the test in persons with acute and established HIV-1 infection.

(2) Information on the technology used for the test and its basic operating principals for detecting HIV RNA, DNA, antibody, or antigen.

(3) Information on:

a. the time required to perform the test or sample collection method;

b. whether the test is performed on whole blood, serum, plasma, or dried blood spots; and

c. the steps involved in performing the test on each specimen type or sample collection method;

(4) Information on the storage requirements and stability of the test.

(5) Plans, capability, and clinical trial designs of the company to seek HHS/FDA approval and whether the company intends to seek a diagnostic claim, a prognostic claim (for patient monitoring), or both.

(6) Plans the company has for seeking CLIA waiver status, for appropriate tests, if FDA approved.

The letter of interest is not considered a formal proposal and is not required; however, it is highly recommended as it will assist CDC in planning for the review process. The formal proposal will still need to be submitted according to the instructions in this notice.

Confidential proposals, preferably six pages or less (excluding appendices), are solicited from companies which have a product that is suitable for regulatory approval and commercialization. This collaboration will have an expected duration of 1 to 4 years.

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: Extension of a currently approved collection; Title of Information Collection: Request for Enrollment in Supplementary Medical Insurance (SMI); Use: CMS regulations 42 CFR 407.11 lists the CMS-4040 as the application to be used by individuals who are not eligible for monthly Social Security/Railroad Retirement Board benefits or free Part A. The CMS-4040 solicits the information that is used to determine entitlement for individuals who meet the requirements in section 1836 as well as the entitlement of the applicant or their spouses to an annuity paid by OPM for premium deduction purposes. The application follows the application questions and requirements used by SSA. This is done not only for consistency purposes but to comply with other Title II and Title XVIII requirements because eligibility to Title II benefits and free Part A under Title XVIII must be ruled out in order to qualify for enrollment in Part B only. Form Number: CMS-4040 (OMB control number: 0938-0245); Frequency: Once; Affected Public: Individuals or households; Number of Respondents: 42,011; Total Annual Responses: 42,011; Total Annual Hours: 10,503. (For policy questions regarding this collection contact Carla Patterson at 410-786-8911.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Request for Employment Information; Use: The form CMS-L564, also referred to as CMS-R-297, is used, in conjunction with form CMS-40-B, Application for Supplementary Medical Insurance, during an individual's special enrollment period (SEP). Completed by an employer, the CMS-L564 provides proof of an applicant's employer group health coverage. The Social Security Administration (SSA) uses it to obtain information from employers regarding whether a Medicare beneficiary's coverage under a group health plan is based on current employment status. The form is available online via Medicare.gov and CMS.gov for individuals who are requesting the SEP to obtain and submit to their employer for completion. The employer must complete and sign the form, and submit it to the individual to accompany their enrollment or late enrollment penalty reduction request. The information on the completed form is reviewed manually by SSA. Form Number: CMS-R-297 (OMB control number: 0938-0787); Frequency: Once; Affected Public: Individuals or households, Business or other for-profits, Not-for-profit institutions; Number of Respondents: 676,526; Total Annual Responses: 676,526; Total Annual Hours: 56,355. (For policy questions regarding this collection contact Carla Patterson at 410-786-8911.)

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

This information collection helps support implementation of FDA regulations found in part 10 (21 CFR part 10), parts 12 through 16 (21 CFR parts 12 through 16), and part 19 (21 CFR part 19). These regulations are established in accordance with the Administrative Procedures Act (5 U.S.C. subchapter II) and implement administrative practice and procedures to give instructions to those conducting business with FDA. Regulations in part 10 describe general administrative practices and include content and format instruction on submitting information to the Agency, petitions for Agency action, and other topics such as the public calendar. Regulations in parts 12 through 16 cover formal evidentiary, public, and regulatory hearings. The information collection also includes burden associated with waiver requests under § 10.19 (21 CFR 10.19). Unless a waiver, suspension, or modification submitted under § 10.19 is granted by the Commissioner of Food and Drugs, the regulations in part 10 apply to all petitions, hearings, and other administrative proceedings and activities conducted by FDA. Because information associated with regulations in parts 12 through 16 is obtained during the conduct of an official administrative action as described under 5 CFR 1320.4, we account only for burden we attribute to initiating the respective actions.

The information collection also includes burden associated with general meeting requests and correspondence submitted to FDA under § 10.65 (21 CFR 10.65), as well as general submissions associated with § 10.115 (21 CFR 10.115) which provides for public participation in the development of Agency guidance documents through requests to our Dockets Management Staff. Most burden attributable to recommendations found in FDA guidance documents is accounted for within information collection request approvals respective to the topic-specific guidance document; however here we are accounting for burden associated with general public submissions as described in § 10.115(f)(3).

The information collection also includes burden that may be associated with the procedural guidance document, “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” (September 2019), available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/citizen-petitions-and-petitions-stay-action-subject-section-505q-federal-food-drug-and-cosmetic-act. The guidance document provides information regarding our current thinking on interpreting section 505(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)) and includes procedural instruction on submitting certain citizen petitions and petitions for stay of FDA action. The guidance document also describes how FDA interprets the provisions of section 505(q) requiring that (1) a petition include a certification and (2) supplemental information or comments on a petition include a verification. It also addresses the relationship between the review of petitions and pending abbreviated new drug applications (ANDAs), 505(b)(2) applications, and 351(k) applications for which a decision on approvability has not yet been made.

In the Federal Register of February 7, 2023 (88 FR 7981), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. On our own initiative, however we are revising the information collection to include requests for FDA speakers. As communicated on our website at https://www.fda.gov/training-and-continuing-education/contacts-requesting-fda-speaker, FDA receives thousands of requests each year from trade associations and industry-based groups for speakers to participate in external meetings, conferences, and workshops. To facilitate the processing of these requests and direct them appropriately to determine participation, we have developed web-based templates and questionnaires, and have established dedicated points of contact throughout the Agency. We have therefore revised the estimated burden for the information collection as follows:

Based on submissions to FDA's Division of Dockets Management since our last evaluation of the information collection, we have made adjustments to burden estimates associated with the individual activities that correspond to the applicable provisions.

We have also added 3,900 responses and 663 hours, annually, to reflect burden we believe is associated with requests to FDA for speaker participation at an external Agency event, assuming an average burden of 10 minutes for each request. As a result of these adjustments, the information collection reflects an annual increase in responses of 3,119 and an annual decrease in hours of 3,360.

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

This information collection supports the implementation of FDA statutory and regulatory requirements that govern current good manufacturing practice (cGMP) for Type A medicated articles. A Type A medicated article is an animal feed product containing a concentrated drug diluted with a feed carrier substance. A Type A medicated article is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease or for growth promotion and feed efficiency. Section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351), governs current cGMP for drugs, including Type A medicated articles, and these statutory requirements are codified in part 226 (21 CFR part 226).

Manufacturers are required to establish, maintain, and retain records for Type A medicated articles including records to document procedures required under the manufacturing process to assure that proper quality control is maintained under part 226. Type A medicated articles, which are not manufactured in accordance with these regulations, are considered adulterated under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).

Description of Respondents: The respondents to this information collection are manufacturers of Type A medicated articles.

In the Federal Register of January 31, 2023 (88 FR 6281), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

The burden we attribute to recordkeeping activities associated with the provisions in 21 CFR part 226 are assumed to be distributed among the individual elements and averaged among respondents. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.

I. Background

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

On July 22, 2022, Mr. Moran was convicted, as defined in section 306(l)(1) of FD&C Act, in the U.S. District Court for the Southern District of Florida-West Palm Beach Division, when the court accepted his plea of guilty and entered judgment against him for the offense of smuggling goods into the United States, in violation of 18 U.S.C. 545. FDA's finding that debarment is appropriate is based on the felony conviction referenced herein.

The factual basis for this conviction is as follows: as contained in the indictment, filed on October 6, 2021, and the plea agreement, filed on April 14, 2022, in Mr. Moran's case, Jhanna Novikov agreed to treat the facial wrinkles of an individual who was an undercover investigator with the Florida Department of Health with “fillers” for $600 and “Botox” for $300. BOTOX, or botulinum neurotoxin Type A, is the most well-known neurotoxin approved by FDA to treat facial wrinkles. On August 10, 2018, the investigator returned to Ms. Novikov's residence for her “Botox” treatment, and as Ms. Novikov made preparations and drew a liquid into a syringe, agents from FDA's Office of Criminal Investigations (OCI) entered and took control of her residence. After obtaining a warrant, OCI agents searched Ms. Novikov's home. Agents seized various vials of white powder from Ms. Novikov's residence, including two labeled “NEUROXIN Botulinum Toxin Type A,” 14 labeled “CASPIS,” and 1 with no label. Analysis by the FDA Forensic Chemistry Center determined that the two NEUROXIN vials, a sample of four of the CASPIS vials, and the unlabeled vial all contained botulinum toxin, the active ingredient in BOTOX; however, a search of FDA records revealed that these drugs had not been approved by FDA and were unapproved new drugs as well as misbranded drugs. Agents did not find any BOTOX or other FDA-approved drugs containing botulinum toxin in Ms. Novikov's home.

During the search of Ms. Novikov's residence, agents seized her cell phone and subsequently conducted a computer forensic examination of the phone. The examination revealed that, from August 10, 2016 through June 26, 2018, Mr. Moran exchanged messages with Ms. Novikov about the products he sold her, referring to them as “botox,” “bx,” and “tox.” In some cases, Mr. Moran's messages discussed sending packages to Ms. Novikov from outside the United States. For example, in response to Ms. Novikov's October 3, 2016, inquiry about a package, Mr. Moran replied that “[i]t was in customs.” In another instance on April 18, 2017, Ms. Novikov wrote to Mr. Moran that a package had been “opened at customs” but “all fine[.]” In response, Mr. Moran stated he had “put it as anti dandruff.” In another exchange, on June 22, 2018, Ms. Novikov messaged Mr. Moran, “I need bx” and agreed to pay $1,200, plus $100 shipping. Ms. Novikov sent Mr. Moran a photograph of a deposit slip on June 25, 2018, indicating that $1,300 had been deposited into a bank account. That same day, Mr. Moran sent Ms. Novikov a photograph of a shipping confirmation for a package he shipped to her from Mexico. On June 26, 2018, Ms. Novikov sent Mr. Moran a message asking, “Why Caspis? They like Neuroxin better.” Mr. Moran replied, “is for customs . . . issues” and offered to send Ms. Novikov “Neuroxin labels” and “boxes and stickers[,]” but she declined.

As a result of this conviction, FDA sent Mr. Moran, by certified mail, on February 9, 2023, a notice proposing to debar him for a 5-year period from importing or offering for import any drug into the United States. The proposal was based on a finding under section 306(b)(3)(C) of the FD&C Act that Mr. Moran's felony conviction under Federal law for smuggling goods into the United States, in violation of 18 U.S.C. 545, was for conduct relating to the importation into the United States of any drug or controlled substance because he illegally imported unapproved new drugs containing botulinum toxin for use in treatments conducted by others for money. In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr. Moran's offense and concluded that the offense warranted the imposition of a 5-year period of debarment.

The proposal informed Mr. Moran of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Moran received the proposal and notice of opportunity for a hearing at his residence on February 28, 2023. Mr. Moran failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment. (21 CFR part 12).

Therefore, the Assistant Commissioner, Office of Human and Animal Food Operations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Assistant Commissioner, finds that Mr. Luis Anarbol Moran has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act.

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

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

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

This information collection supports the voluntary submission of allegations of regulatory misconduct to CDRH. An allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices or electronic products regulated by CDRH may be doing so in a manner that violates the law. Reporting these allegations can help make FDA aware of regulatory concerns it may not learn of otherwise. This information can help FDA identify the potential risks to patients and determine whether further investigation is warranted, as well as any steps needed to address or correct a potential violation. Anyone may file a complaint reporting an allegation of regulatory misconduct. FDA encourages people submitting allegations to include supporting information and contact information in case additional information is needed for FDA to understand the allegation and act on the report; however, you can choose to submit a report anonymously. FDA will not share your identity or contact information with anyone outside FDA unless required to do so by law, regulation, or court order.

Allegations of regulatory misconduct may include failure to register and list a medical device, marketing uncleared or unapproved products, failure to follow quality system requirements, or misleading promotion.

You can submit an allegation through the Allegations of Regulatory Misconduct Form ( https://www.fda.gov/medical-devices/reporting-allegations-regulatory-misconduct/allegations-regulatory-misconduct-form ), by email, or by regular mail.

Allegations of regulatory misconduct related to medical devices and electronic products are reviewed by CDRH. CDRH prioritizes the review of allegations based on the level of potential risks, within the context of an overall benefit-risk profile, to patients. There are different processes based on the type of allegation and the completeness of the information submitted. The general steps CDRH takes after receiving an allegation of regulatory misconduct and some examples of the kind of allegations FDA has received are provided on our website ( https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct ).

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

We recently consolidated the intake of allegations across CDRH Offices. This has improved our estimate and we have adjusted the number of responses accordingly. The number of responses is based on the voluntary allegations received by CDRH in 2022. The adjusted estimated burden for the information collection reflects an increase of 900 responses and a corresponding increase of 225 hours.

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

Section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360i) authorizes FDA to require: (1) manufacturers to report medical device-related deaths, serious injuries, and malfunctions and (2) user facilities to report device-related deaths directly to manufacturers and FDA and serious injuries to the manufacturer. Section 213 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 519(b) of the FD&C Act relating to mandatory reporting by user facilities of deaths, serious injuries, and serious illnesses associated with the use of medical devices. This amendment legislated the replacement of universal user facility reporting by a system that is limited to a “. . . subset of user facilities that constitutes a representative profile of user reports” for device-related deaths and serious injuries. This amendment is reflected in section 519(b)(5)(A) of the FD&C Act (21 U.S.C. 360i(b)(5)(A)). This legislation provides FDA with the opportunity to design and implement a national surveillance network, composed of well-trained clinical facilities, to provide high-quality data on medical devices in clinical use. This system is called MedSun. FDA is seeking OMB clearance to continue to use electronic data collection to obtain information related to medical devices and tissue products from the user facilities participating in MedSun, to obtain a demographic profile of the facilities, and for additional questions, which will permit FDA to better understand the cause of reported adverse events. Participation in the program is voluntary and includes approximately 300 facilities. In addition to collecting data on the electronic adverse event report form, MedSun collects additional information from participating sites about reported problems emerging from the MedSun hospitals. This data collection is also voluntary and is collected on the same website as the report information. The burden estimate is based on the number of facilities participating in MedSun (300). FDA estimates an average of 18 reports per site annually. This estimate is based on MedSun working to promote reporting in general from the sites, as well as promoting reporting from specific parts of the hospitals, such as the pediatric intensive care units, the electrophysiology laboratories, and the hospital laboratories.

In the Federal Register of January 19, 2023 (88 FR 3417), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

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

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

This information collection helps support implementation of statutory provisions that govern premarket clearance of devices. Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(k)) and implementing regulations in part 807, subpart E (21 CFR part 807, subpart E), establish premarket notification procedures. Persons who intend to market a medical device, for which a premarket approval application (PMA) is not required, must submit a premarket notification to FDA, unless the device is exempt from 510(k) requirements and does not exceed the limitations of exemptions of the device classification regulations, at least 90 days before proposing to begin the introduction, or delivery for introduction into interstate commerce, for commercial distribution of a device intended for human use. Based on the information provided in the notification, FDA must determine whether the new device is substantially equivalent to a legally marketed device. If a device is determined to be not substantially equivalent to a legally marketed device, it must have an approved PMA, product development protocol, humanitarian device exemption (HDE), request for an evaluation of automatic class III designation (De Novo request), or be reclassified into class I or class II before being marketed. The information collection also helps support section 510(l) of the FD&C Act, which provides for exemption from premarket notification.

The following instruments are included in the information collection:

We are revising the information collection to include Form FDA 3674, “Certification of Compliance, Under 42 U.S.C., 282(j)(5)(B), with Requirements of ClinicalTrials.gov. ” Under applicable authorities, applications under sections 505, 515, or 520(m) of the FD&C Act (21 U.S.C. 355, 360e, or 360j(m)), or under section 351 of the Public Health Service Act (42 U.S.C. 262), or submission of a report under section 510(k) of the FD&C Act, must be accompanied by a certification. Where available, such certification must include the appropriate National Clinical Trial numbers.

The information collection also includes an “Acceptance Checklist.” As discussed in the guidance document “Refuse to Accept Policy for 510(k)s” (April 2022), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks, we believe the checklist can be a helpful resource for 510(k) submitters and may simplify preparation of the 510(k). Similarly, the guidance document “Recognition and Withdrawal of Voluntary Consensus Standards” (September 2020), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards, communicates procedures followed by the Center for Devices and Radiological Health (CDRH) when requests for recognition of a voluntary consensus standard for medical products are received. The guidance document outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard. Section 514 of the FD&C Act (21 U.S.C. 360d) allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions, including premarket notifications or other requirements. We publish and update the list of recognized standards regularly at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. As instructed in the guidance document, any interested party may submit a request for recognition of a standard by mail directed to the CDRH Standards Program ( i.e., paper copy) or electronically via email.

For efficiency of Agency operations, we are also revising the information to include activities associated with section 520(b) of the FD&C Act, governing custom devices. Regulations in 21 CFR 812.3 define a custom device and implementing regulations in 21 CFR 807.85 provide for exemption from premarket notification. Section 520(b) of the FD&C Act also provides for the issuance of guidance. The guidance document entitled, “Custom Device Exemption” (September 2014), and available for download at https://www.fda.gov/media/89897/download, explains how FDA interprets provisions in section 520(b)(2)(B) of the FD&C Act, describes what information should be submitted in a Custom Device Annual Report (“annual report”), and provides recommendations on how to submit an annual report for devices distributed under the custom device exemption.

Finally, we discuss the guidance document entitled, “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” announced in the Federal Register of March 27, 2023 (88 FR 18153), which describes a phased approach intended to help avoid disruption in device supply and help facilitate compliance with applicable legal requirements. The recommendations discussed in the guidance document result in the one-time collection of information intended to ensure an orderly and transparent transition from temporary policies established during the COVID-19 public health emergency to normal operations. Because the information collection recommendations apply to specific medical devices already in distribution, we believe the information discussed is appropriately characterized as nonstandardized followup designed to clarify responses to approved collections of information ( i.e., plans for compliance with applicable requirements unique to that distributed device). We therefore believe the activity constitutes the collection of non-identical and/or followup information, as defined under 5 CFR 1320.3. At the same time, we expect some degree of fluctuation in future submissions under part 807, subpart E, as a result of implementation of the medical device transition plan.

In the Federal Register of February 21, 2023 (88 FR 10517), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. However, since publication of our 60-day notice, we have adjusted our previous estimate to include burden associated with Form FDA 3674 (submission certification), as well as custom device reporting currently included in OMB control number 0910-0767 and discussed in the Federal Register of March 13, 2023 (88 FR 15410).

We estimate the burden of the information collection as follows:

Both the regulations in part 807, subpart E and the associated guidance documents prescribe specific format and content elements necessary for FDA action on submissions. Based on recent trends, an estimated 3,800 submissions are expected each year. Our administrative and technical staff, who are familiar with the requirements for submission of premarket notifications, estimate that it takes an average of 79.25 hours to prepare a submission. Because the PRA defines a recordkeeping requirement to include a requirement to report those records to the Federal government, we account for burden associated with preparing, transmitting, and responding to followup requests from FDA for supplemental information in our estimate. We expect to receive approximately 100 510(k) submissions via eSTAR per year and estimate that eSTAR submissions will each require 40 hours to complete. In addition, based on a recent review of submissions, we estimate 1,906 summary cover sheets will be received annually. We assume 30 minutes are needed to complete the summary cover sheet. We further estimate that 9 respondents will submit information pertaining to a request for recognition of a voluntary standard and that the activity requires an average of 1 hour. We also account for a one-time setup burden of 5 minutes for an estimated 80 new eSTAR users annually.

As a result of adding burden previously included under OMB control numbers 0910-0616 (submission certification element) and 0910-0767 (custom device exemptions), we have adjusted our burden upward. We have also made nominal adjustments on individual provisions to reflect expected fluctuations in submissions. Cumulatively, these actions result in an overall increase of 3,671 hours and a corresponding increase of 4,210 responses annually.