The Senator Paul Simon Water for the World Act of 2014 (Pub. L. 113-289) requires the Department of State and USAID to jointly deliver a whole-of-government U.S. Global Water Strategy (GWS) by October 1, 2017 and every five years thereafter through 2027. The first revision of the Strategy, Agency-specific Plans, and High-Priority Country Plans (HPC) are due to the Foreign Relations Committee of the Senate, the Appropriations Committee of the Senate, the Foreign Affairs Committee of the House of Representatives, and the Appropriations Committee of the House of Representatives on October 1, 2022.

The Act requires the U.S. Global Water Strategy to include results areas, performance indicators, high priority country plans and roles and responsibilities based on contributing interagency capacities that describe how the U.S. Government will collectively contribute to the success of the Global Water Strategy. The Act also requires that DOS and USAID draft Agency-specific plans to be appended to each Global Water Strategy, along with any other Federal Department and Agency as relevant.

The U.S. Global Water Strategy aims to achieve a water-secure world where people have sustainable supplies of water of sufficient quantity and quality to meet human, economic, and ecosystem needs while improving the adaptive capacity and enhancing the resilience of people and systems to survive shocks and stressors such as floods and droughts. To advance this goal, the U.S. Government will work with partner countries, the private sector, and other stakeholders to advance four interrelated strategic objectives: (1) Promote sustainable access to safe drinking water and sanitation services, and the adoption of key hygiene behaviors; (2) encourage the sound management and protection of freshwater resources; (3) reduce conflict by promoting cooperation on shared waters; and (4) strengthen water sector governance, financing, and institutions

To inform revisions to the Global Water Strategy, DOS and USAID invite written comments from the public on successes and challenges with implementation, monitoring, and reporting on the Global Water Strategy 2017-2022. DOS and USAID are especially interested in comments on the following:

(1) What steps can be taken to strengthen implementation of the Global Water Strategy? (Provide evidence and agency-specific examples if possible.)

(2) What untapped opportunities exist to accelerate progress towards the GWS Strategic Objectives? (Consider cross-cutting issues or emerging priorities. Provide evidence and examples if possible.)

Written comments and information are requested on or before Friday, October 29, 2021, at 5:00 p.m. EDT, and should be submitted by email to waterteam@usaid.gov. Include “Comments: U.S. Global Water Strategy” in the subject line. Please submit comments and information as a Word or PDF attachment to your email. You are encouraged to submit written comments even if you plan to attend the public meeting.

A public meeting to receive input will take place November 17, 2021 at 2:00 p.m. EDT. This meeting is free and open to the public. Persons wishing to attend the meeting must register at the following URL no later than Wednesday, November 3, 2021, at 5:00 p.m. EDT: https://statedept.zoomgov.com/meeting/register/vJItdeCqqzIvE77yMpttzV8W82xO1mkqEXw .

Closed captioning will be provided during the public meeting. Questions about the public meeting or requests for reasonable accommodations should be directed to Danielle Neighbour at NeighbourDG@state.gov. Include “Global Water Strategy Public Meeting: Reasonable Accommodations” in the subject line.

FSIS administers a regulatory program under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq. ), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq. ), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq. ) to, in part, ensure that that the labeling of meat, poultry and egg products is truthful and not misleading. Mandatory labeling requirements for meat and poultry products are prescribed in Title 9 of the Code of Federal Regulations (CFR) section 317.2 and part 381 subpart N.

On July 9, 2019, FSIS announced the availability of and requested comment on the Food Safety and Inspection Service Guideline on Kit Labeling (84 FR 32705). FSIS developed the guideline for establishments and other food handling facilities to provide information on the labeling and inspection of multi-component food kit products that contain an inspected and assembled meat or poultry component.

There are many varieties of food kit products that contain meat or poultry products, including, but not limited to: Wraps, pizza, stew, salads, fajitas, stroganoff, and stir-fry skillet meals. These items are commonly sold as fully cooked, but some may require cooking. Generally, the meat and poultry components are separately wrapped and already inspected and fully labeled before assembly with various food components in the same packaging.

As announced in the July 2019 guideline, FSIS determined that the act of assembling a food kit product whose label refers to meat or poultry in its name does not need to be done under FSIS inspection, provided that the meat or poultry component has already be inspected, packaged, and labeled and as long as the following conditions are met:

1. The meat or poultry component is prepared and separately packaged under FSIS inspection and labeled with all required features, including:

• Product Name;

• Handling statement ( e.g., Keep Refrigerated), if product is perishable;

• USDA legend and establishment number of the official establishment that packaged and labeled the meat or poultry component;

• Name and address of the manufacturer, packer, or distributor;

• Ingredients statement (if composed of more than one ingredient); and

• Safe handling instructions if the meat or poultry components is not ready-to-eat;

2. The outer kit label clearly identifies all the individual components in the kit; and

3. The outer kit label clearly identifies the product as a single unit or “kit” such as “Chicken Barbecue Dinner Kit” and “Beef Lasagna Meal.”

Although FSIS will no longer conduct mandatory inspection of the assembly of the kit product, the meat or poultry component of the kit remains under FSIS' jurisdiction and, as such, is required to meet all applicable FSIS labeling requirements.

The revised guideline is posted at: https://www.fsis.usda.gov/policy/fsis-guidelines. Although comments will no longer be accepted through https://www.regulations.gov/ on this guideline, FSIS will update this document as necessary if new information becomes available.

FSIS received 15 comments on the kit guideline. Most comments were submitted by firms that prepare kits and trade associations that represent the meat and retail industries. In addition, FSIS received comments from an animal welfare organization, a firm that exports kit products from the United States, an FSIS employee, and several individuals. The following is a summary of the comments and FSIS' responses:

Comment: One consumer requested that FSIS provide a clearer definition of a kit and clarify whether Agency policy distinguishes between a kit and a meal kit. One firm that prepares kits similarly requested a clearer definition of a kit and asked for additional guidance on the distinction between a single unit and a kit.

Response: As stated in the guideline, a kit product consists of individually packaged meat or poultry components and other food components sold together as a single unit. FSIS policy does not distinguish between the terms “kit”, “meal kit”, or “single unit.” Although the word “kit” is not required on the label, all labeling should clearly indicate that the product consists of individual components. Because this information is already stated in the guideline, FSIS did not make any changes to it in response to these comments.

Comment: Several commenters, including firms that prepare kit products and trade associations representing the meat and retail food industries, requested that FSIS revise the guideline to provide clarifying or additional information about eligibility for the retail exemption from FSIS inspection. One firm requested explanation of how the retail exemption applies to kits assembled and sold by retail grocery stores, prepared kits sold at retail, and kits sold through online marketplaces and other direct-to-consumer platforms. Several trade associations requested that FSIS clarify which meat or poultry components produced under the retail exemption need not bear all required features for labeling. One firm stated that such clarification would avoid manufacturer confusion about whether meal kits that include a recipe card would be eligible for the retail exemption.

Response: The guideline does not apply to facilities preparing kits under the retail exemption from FSIS inspection (9 CFR 303.1(d) and 381.10(a)(1)) because these facilities were not previously required to assemble kits under FSIS inspection. The retail exemption remains unchanged by the guideline. Kits prepared under the retail exemption may only be sold directly to the end consumer and cannot be sold for resale. FSIS has updated the guideline to clarify that the scope of the document does not include products produced under the retail exemption. The original version and updated version of the guideline explain that FSIS labeling regulations, other than the requirement of the official inspection legend, apply to kits that are assembled under the retail exemption (9 CFR 303.1(f), 381.10(d)(4)).

Comment: One firm that prepares kits requested clarification on whether FSIS inspection and label approval requirements apply to firms that receive and further process bulk product as part of final kit assembly, including portioning and packaging the meat component. Another firm that prepares kits using bulk-packed FSIS-inspected products asked whether the firm may make copies of the label on the bulk container and apply them to the product components that have been separated and rewrapped.

Response: FSIS has updated the guideline to clarify that Agency guidance on the preparation of kit products without FSIS inspection does not apply when the meat or poultry component is processed, including portioned or packaged, by the firm assembling the kit. Such processing activities would require FSIS inspection if the production does not qualify for the retail exemption. Further, the resulting assembled kit product would require label approval by FSIS if the outer kit label met any of the conditions for required label approval under the regulations at 9 CFR 412.1. A firm portioning and repackaging bulk-packed products typically would not be permitted to make a copy of the original label since that label would likely bear the original establishment's USDA legend, company name, and a net weight.

Comment: One consumer requested clarification on whether, if the finished product of the meat or poultry component of a kit is labeled as a product that has a standard of identity, must the fully assembled kit label meet that standardized product name.

Response: FSIS updated the guideline to clarify that if a kit is labeled as a product with a standard of identity as defined under the regulations in 9 CFR part 319 or 381 subpart P, the components, once assembled, must meet the applicable standard of identity. For example, a “Beef Chili Kit” must contain 40 percent beef computed based on the weight of the fresh meat as described in 9 CFR 319.300.

Comment: A USDA employee asked whether a shipping container comprising one or multiple kit products that were assembled at an official establishment without FSIS inspection would need to bear a USDA legend.

Response: The regulatory requirement that the shipping container bear a USDA legend (9 CFR 316.13 and 381.27) only applies to products that have been inspected and passed. FSIS updated the guideline to clarify that when a kit is assembled in an official establishment without FSIS inspection, the shipping container into which the kit is placed may not bear a USDA legend. In such case, the mark of inspection will be displayed on the label and packaging of the meat or poultry component included in the kit.

Comment: Comments from several trade associations, firms that prepare kit products, individuals, and one USDA employee asked FSIS to clarify what language should be used on the kit label to describe the product as a single unit of individual components. These commenters also asked where the description of the individual components should be displayed on the outer label.

Response: FSIS has updated the guideline to clarify that the requirements for the language on the outer kit label that identify the product as a kit are flexible. The outer label for the kit should identify all the individual components in the kit, as well as identify the product as a single unit. The use of the word “kit” on the outer label is not required, nor is a specific location on the outer label for the identification of the individual components. For example, the outer label could display the product name “Chicken Barbecue Dinner Kit” or “Beef Lasagna Meal.”

Comment: One consumer asked whether FSIS would require safe handling instructions on the immediate package of a not ready to eat (NRTE) meat or poultry component in a kit.

Response: As stated in the guideline, if the meat or poultry component of a kit product is NRTE, the immediate package must include safe handling instructions in order to meet the regulatory requirements for kit assembly without FSIS inspection.

Comment: One firm that exports kit products to Canada asked which package components need to include bilingual labels.

Response: FSIS does not require bilingual labels; however, Canada does have such labeling requirements ( i.e., French and English). More information about Canada's requirements can be found on the Import and Export Library available at: https://www.fsis.usda.gov/inspection/import-export/import-export-library. FSIS inspectors verify and certify that products intended to be exported to a foreign country meet the foreign country's requirements.

Comment: An animal welfare organization requested that FSIS require pre-market label approval for animal-raising claims on the exterior packaging of kit products.

Response: As a kit meeting the criteria as described in the guideline may be assembled without FSIS inspection and, as such, the outer label does not bear a USDA legend, the outer label is not subject to label approval requirements under the regulations at 9 CFR 412.1. Outer kit labels for products assembled without FSIS inspection under the conditions described in the guideline are required to comply with FSIS labeling requirements.

Comment: One firm that prepares kits requested that FSIS require allergen declarations to be displayed on the outer packaging and to prohibit ingredient statements on the meat or poultry component. The commenter stated that such requirements would reduce consumer confusion by identifying all allergens and other ingredients in a central location on the retail package.

Response: If the only component within the kit that includes an ingredients statement is the meat or poultry component, that should not cause any confusion. FSIS does not think that consumers will assume other unlabeled components, such as soy sauce or pasta, do not contain allergens. Both the outer kit label and the meat or poultry component must be fully labeled in compliance with FSIS labeling regulations. Therefore, the outer kit label will bear a complete ingredients statement that declares all ingredients in each component within the kit. These labeling requirements were already explained in the previous version of the guideline; therefore, FSIS did not make any changes in response to this comment.

Comment: One individual asked FSIS to explain how the nutrition facts declaration should be displayed on a kit.

Response: A kit label bearing nutrition facts may present this information 1. centrally, based on the prepared, assembled product; 2. with separate panels for each component as packaged; or 3. as one panel with multiple columns for each component as packaged. The nutrition labeling requirements of 9 CFR 317.309 and 381.409 remain unchanged by this guideline. FSIS did not make any changes to the guideline based on this comment. Based on FSIS communications with these facilities, they understand nutrition labeling requirements.

Comment: One firm that prepares kits stated that the Agency should provide clear communication to FSIS inspectors to ensure the consistent application of kit labeling policies.

Response: FSIS will issue a directive to provide instructions to inspection program personal for conducting verification activities for kit products to ensure compliance with FSIS regulations.

Comment: An FSIS employee requested that FSIS clarify whether a kit may be assembled under voluntary FSIS inspection and, therefore, bear a USDA inspection legend.

Response: FSIS clarified in the guideline that the assembly of a kit product as described in this guideline is eligible for voluntary inspection as a food inspection service under 9 CFR 350.3(c). FSIS also announced that, going forward, it will no longer conduct mandatory inspection services for such kits, as the Agency determined that providing inspection for these products as a voluntary food inspection service is the best use of Agency resources. After publication of this notice, FSIS will provide instructions for firms currently receiving mandatory inspection for such products regarding the procedures and timelines for withdrawing mandatory inspection and the option to seek voluntary inspection.

In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information ( e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by: (1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) email: program.intake@usda.gov.

USDA is an equal opportunity provider, employer, and lender.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication online through the FSIS web page located at: https://www.fsis.usda.gov/federal-register. FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

On March 30, 2005, Commerce published the antidumping duty order on tissue paper from China. 1 On June 1, 2021, Commerce published the initiation of the third sunset review of the Order on tissue paper from China, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). 2 On June 11, 2021, Commerce received a timely and complete notice of intent to participate in this sunset review from Seaman Paper Company of Massachusetts, Inc. (Seaman Paper), within the deadline specified in 19 CFR 351.218(d)(1)(i). 3 Seaman Paper claimed interested party status within the meaning of section 771(9)(C) of the Act as a U.S. producer of the domestic like product. 4

On July 1, 2021, Seaman Paper filed a timely and adequate substantive response, within the deadline specified in 19 CFR 351.218(d)(3)(i). 5 Commerce did not receive a substantive response from any respondent interested party. As a result, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), Commerce conducted an expedited (120-day) sunset review of the Order.

The merchandise covered by the Order is certain tissue paper products from China. The subject merchandise may be under one or more of several different subheadings of the Harmonized Tariff Schedule of the United States (HTSUS), including: 4802.30, 4802.54, 4802.61, 4802.62, 4802.69, 4804.31.1000, 4804.31.2000, 4804.31.4020, 4804.31.4040, 4804.31.6000, 4804.39, 4805.91.1090, 4805.91.5000, 4805.91.7000, 4806.40, 4808.30, 4808.90, 4811.90, 4823.90, 4802.50.00, 4802.90.00, 4805.91.90, 9505.90.40. Although HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope is dispositive. 6 A full description of the scope of the Order is contained in the accompanying Issues and Decision Memorandum. 7

A complete discussion of all issues raised in this sunset review, including the likelihood of continuation or recurrence of dumping in the event of revocation of the Order and the magnitude of the margin likely to prevail if the Order was to be revoked, is provided in the Issues and Decision Memorandum. A list of the topics discussed in the Issues and Decision Memorandum is attached as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://enforcement.trade.gov/frn/.

Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, Commerce determines that revocation of the Order on tissue paper from China would be likely to lead to continuation or recurrence of dumping, and that the magnitude of the dumping margin likely to prevail would be a weighted-average margin of 112.64 percent.

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

We are issuing and publishing these final results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act, and 19 CFR 351.218 and 19 CFR 351.221(c)(5)(ii).

Title of Collection: Report of Terms of Credit Card Plans (Form FR 2572) and Consumer and College Credit Card Agreements.

OMB Control Number: 3170-0001.

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

Affected Public: Businesses and other for-profit institutions.

Estimated Number of Respondents: 615.

Estimated Total Annual Burden Hours: 501.

Abstract: The proposed revision to OMB Control Number 3170-0001 will incorporate requirements currently contained in OMB Control Number 3170-0052. The Bureau has and will continue to use both information collections to gather different types of credit card data. Each information collection requires different forms of credit card data from credit card issuers as required by the Truth in Lending Act (TILA) (15 U.S.C. 1601, et seq. ) and implementing regulations:

• Form FR 2572 collects data on credit card pricing and availability from a sample of at least 150 financial institutions that offer credit cards. The data enables the Bureau to present information to the public on terms of credit card plans;

• Sections 204 and 305 of the Credit Card Accountability Responsibility and Disclosure Act of 2009 (CARD Act), amending TILA, and 12 CFR 1026.57(d) and 226.58 require card issuers to submit to the Bureau:

○ Agreements between the issuer and a consumer under a credit card account for an open-end consumer credit plan; and

○ any college credit card agreements to which the issuer is a party and certain additional information regarding those agreements.

The data collections enable the Bureau to provide Congress and the public with a centralized and searchable repository for consumer and college credit card agreements and information regarding the arrangements between financial institutions and institutions of higher education.

Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record.

The OMB is particularly interested in comments which:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions;

• Propose ways to enhance the quality, utility, and clarity of the information to be collected; and

• Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

A 60-day Notice requesting public comment was published in the Federal Register on June 17, 2021 at Vol. 86, 32249. This comment period ended August 17, 2021. A total of thirty-three comments were received. All comments were reviewed and considered. We are especially sensitive to comments regarding the consequences caused due to the Covid-19 pandemic. We will continue to provide clarity on the use of the Independent Living Survey and how it can be best used as a resource to demonstrate grant outcomes.

Title of Collection: Application Package for AmeriCorps Seniors Applications Instructions, Progress Reporting, Independent Living and Respite Surveys.

OMB Control Number: 3045-0035. Type of Review: Renewal.

Respondents/Affected Public: Businesses and Organizations OR State, Local or Tribal Governments.

Total Estimated Number of Annual Responses: 1,250.

Total Estimated Number of Annual Burden Hours: 17,820.

Abstract: The AmeriCorps Seniors Grant Application is for use by prospective and existing sponsors of AmeriCorps Senior projects under the AmeriCorps Seniors RSVP (RSVP), AmeriCorps Seniors FGP (FGP), AmeriCorps Seniors (SCP), and AmeriCorps Seniors Senior Demonstration Program (SDP). The Project Progress Report, Project Progress Report Lite and Project Report Supplement will be used to report progress toward accomplishing work plan goals and objectives, reporting volunteer and service outputs, reporting actual outcomes related to self-nominated performance measures, meeting challenges encountered, describing significant activities, and requesting technical assistance. The Application Instructions and PPR, PPR-Lite, and PRS forms in this package conform to AmeriCorps' web-based electronic grants management system, eGrants. The SCP Independent Living Survey and SCP Respite Survey are instruments that collect information from a sample of Senior Companion clients and caregivers. The purpose of the surveys is to assess the feasibility of conducting a longitudinal, quasi-experimental evaluation of the impact of independent living and respite services on clients' social ties and perceived social support. The results of the surveys may also be used to inform the feasibility of using a similar instrument to measure client and caregiver outcomes for an evaluation of RSVP. AmeriCorps seeks to renew the current information collection. The revisions are intended to (1) provide additional clarity on existing guidance (Grant Application Instructions, Program Progress Report, and Respite and Independent Living survey) and seek additional information on populations served by AmeriCorps Seniors volunteers (Progress Report Supplement). The information collection will otherwise be used in the same manner as the existing application. AmeriCorps also seeks to continue using the current application until the revised application is approved by OMB. The current application is due to expire on 12/31/2021.

An interim final rule published in the Federal Register (FR) on September 29, 2017 (82 FR 45438-45461) established the requirement for the Director, Defense Health Agency, to provide a public notice to TRICARE program beneficiaries with a summary of changes to the TRICARE program each calendar year in connection with the open season enrollment period.

The following changes or improvements to the TRICARE program benefits apply for calendar year 2022:

Open Season is an annual period when you can enroll in or make changes to your coverage for the next year. TRICARE and Federal Employee Dental and Vision Insurance Program (FEDVIP) Open Season for Calendar Year (CY) 2021 occurs November 8-December 13, 2021.

TRICARE Open Season: During TRICARE Open Season you can enroll in or change your TRICARE Prime or TRICARE Select plan.

FEDVIP Open Season: FEDVIP Open Season is to enroll in or make changes to your dental and vision plans. Dental plans are offered by ten different carriers to eligible retirees and their family members and vision plans are offered by four different carriers to beneficiaries who have TRICARE coverage, including TRICARE for Life.

Any changes you make will take effect on January 1, 2022. If you remain eligible and do not make any changes during Open Season, then you will stay in the same plan for 2022. Improving what's covered:

In regards to COVID-19 vaccination, although there is no separate copayment or cost-share for clinical preventive services, there may be a copayment, cost-share, or point of service (POS) charge if the vaccine is administered as part of a primary or specialty care visit for a reason other than preventive care or for other services received during the office visit.

Due to the widespread need for COVID-19 vaccines and the possibility that one day these vaccines may not be free-of-charge, on February 23, 2021, a notice was published in the Federal Register (86 FR 10942) advising TRICARE Prime enrollees, not including Active Duty Service Members (ADSMs), of a temporary waiver to the referral requirement so they may receive COVID-19 vaccines, a clinical preventive service, from any TRICARE Basic (medical) program authorized non-network provider without incurring POS charges where applicable. The effective date of the waiver was December 13, 2020. This waiver will expire when the President of the United States (US) declares the national emergency is terminated.

The following three temporary changes for care and treatment continue to be effective as of May 12, 2020, for care and treatment within the US and effective March 10, 2020, for the TRICARE Overseas Program: Temporary audio-only telephonic office visits; temporary waiver of cost-shares, co-pays and deductibles for all covered in-network telehealth services (for Prime and Select beneficiaries); and temporary interstate and international licensing. These changes will expire when the President of the US declares the national emergency is terminated, unless terminated, extended, or otherwise modified in a final rule published to the Federal Register . Overseas termination date may vary from the US date and will be determined by the Assistant Secretary of Defense for Health Affairs.

The following temporary changes were made and continue to be effective as of September 3, 2020, for care and treatment in the US and effective March 10, 2020, for the TRICARE Overseas Program: Temporary coverage of the treatment use of investigational drugs under expanded access for the treatment of COVID-19 and temporary coverage of temporary hospitals. This change will expire when the President of the US declares the national emergency is terminated, unless terminated, extended, or otherwise modified in a final rule published to the Federal Register .

Effective October 30, 2020, TRICARE temporarily covers National Institute for Allergy and Infectious Disease (NIAID) sponsored clinical trials when for the treatment or prevention of COVID-19. This change will expire when the President of the US declares the national emergency has terminated, unless terminated, extended, or otherwise modified in a final rule published to the Federal Register . A TRICARE beneficiary who is already enrolled in a NIAID-sponsored clinical trial prior to the end of the President's national emergency for COVID-19 will continue to have their care cost-shared through the end of the clinical trial.

Effective January 1, 2021, Transitional Assistant Management Program benefits are extended to National Guard members who have served more than thirty continuous days in support of the COVID-19 mission.

Effective March 9, 2021, the United States Preventive Services Task Force (USPSTF) updated its annual screening recommendation for lung cancer performed through low-dose computer tomography so it is now covered for adults beginning at age fifty to eighty who have a 20 pack-per year smoking history and currently smoke or have quit within the past fifteen years instead of beginning at age fifty-five and only for those with a 30 pack per year smoking history.

Effective May 18, 2021, the USPSTF updated its annual screening recommendation for colorectal cancer for adults at average risk so they may now begin screening at age forty-five instead of beginning at age fifty.

Buckley Prime Service Area (PSA) Pilot. Health Net Federal Services launched a new value-based care pilot beginning January 1, 2021. Beneficiaries who live in the Buckley PSA and are enrolled in TRICARE Prime with a civilian primary care manager are automatically part of the pilot. The Buckley PSA Pilot is expected to run through December 31, 2022.

Childbirth and Breastfeeding Support Demonstration. Congress required the Department of Defense (DoD) to conduct a demonstration project beginning no later than January 1, 2022, to cover the services of doulas and lactation consultants/counselors not otherwise authorized under TRICARE. This demonstration project will run for five years, through December 31, 2026.

Urgent Care Referrals: There is no limit to the number of urgent care visits that a Prime beneficiary (except for most Active Duty members) may receive without a referral. You can receive urgent care from any TRICARE authorized urgent care center (UCC) or network provider. If the enrollee seeks care from a non-network provider (except a TRICARE-authorized UCC), the usual POS deductible and cost-shares shall apply. The Department has no current plans to change this policy but in order to evaluate its ongoing appropriateness, it remains a year-by-year determination.

Prime Service Area Changes: There is no change to locations where TRICARE Prime will be offered. TRICARE Prime locations are a year-to-year determination and will be announced prior to the annual Open Season enrollment period.

Enrollment Fee Payment by Allotment: TRICARE retirees and their family members must pay enrollment fees by allotment, where feasible. Payment by allotment is not required if a beneficiary does not receive retired pay ( e.g., unremarried former spouses, survivors) or the retired pay does not cover the monthly enrollment fee amount.

Effective December 17, 2020, Doctors of Podiatric Medicine or Podiatrists may prescribe physical therapy (PT) and occupational therapy (OT).

Effective February 24, 2021, ablative fractional laser treatment for symptomatic scars resulting from burns and other trauma is covered for up to five-years.

Added coverage of remote physiologic monitoring for chronic and acute conditions, including but not limited to weight, blood pressure, pulse oximetry, and respiratory flow monitoring.

For more information, visit tricare.mil/changes or call your regional TRICARE contractor.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education 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: National Assessment of Educational Progress (NAEP) 2022 Materials Update #2.

OMB Control Number: 1850-0928.

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

Respondents/Affected Public: Individuals and Households.

Total Estimated Number of Annual Responses: 690,917.

Total Estimated Number of Annual Burden Hours: 422,683.

Abstract: The National Assessment of Educational Progress (NAEP), conducted by the National Center for Education Statistics (NCES), is a federally authorized survey of student achievement at grades 4, 8, and 12 in various subject areas, such as mathematics, reading, writing, science, U.S. history, civics, geography, economics, technology and engineering literacy (TEL), and the arts. The National Assessment of Educational Progress Authorization Act (Pub. L. 107-279 Title III, section 303) requires the assessment to collect data on specified student groups and characteristics, including information organized by race/ethnicity, gender, socio-economic status, disability, and limited English proficiency. It requires fair and accurate presentation of achievement data and permits the collection of background, noncognitive, or descriptive information that is related to academic achievement and aids in fair reporting of results. The intent of the law is to provide representative sample data on student achievement for the nation, the states, and subpopulations of students and to monitor progress over time. NAEP consists of two assessment programs: The NAEP long-term trend (LTT) assessment and the main NAEP assessment. The LTT assessments are given at the national level only and are administered to students at ages 9, 13, and 17 in a manner that is very different from that used for the main NAEP assessments. LTT reports mathematics and reading results that present trend data since the 1970s.

The request to conduct NAEP 2021, including operational assessments and pilot tests: Operational national/state/TUDA Digitally Based Assessments (DBA) in mathematics and reading at grades 4 and 8, and Puerto Rico in mathematics at grades 4 and 8; and operational national DBA in U.S. history and civics at grade 8 was approved in April 2020, with further updates to the materials approved in July and November 2020. Throughout 2020 NCES worked with its contractors and with OMB to find the best way to plan for a data collection in schools in 2021, and as the coronavirus pandemic progressed over the course of the year, plans for NAEP 2020 data collection changed multiple times. In November 2020, the NCES Commissioner announced the delay of NAEP 2021 by one year to early 2022.

Since then, NAEP has continued to work to salvage any pieces of their data collection plans for 2021 and begin planning for NAEP 2022. NCES has used the drawn and notified sample from 2021 for two data collections that don't include the student assessment that is central to the NAEP program, instead using that sample to collect information about basic school operations during the coronavirus pandemic (NAEP 2021 School Survey; OMB# 1850-0957) and the experiences of teachers and school staff over the 2019-2020 and 2020-2021 school years (NAEP 2021 School and Teacher Questionnaire Special Study; OMB# 1850-0956).

The request to conduct NAEP operational assessments in 2022, which will follow the traditional NAEP design which assesses each student in 60-minutes for one cognitive subject, was approved in May 2021, and the first update to the NAEP 2022 materials was approved in August 2021. The 2022 data collection will consist of operational national/state/TUDA DBA in mathematics and reading at grades 4 and 8, and Puerto Rico in mathematics at grades 4 and 8; and operational national DBA in U.S. history and civics at grade 8. In addition to the regular NAEP operational assessments delayed from 2021, this submission also contains materials for the LTT, which will be administered to 9-year-olds in 2022. This package finalizes all materials in time for the data collection in early 2022.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education 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: William D. Ford Direct Loan Program General Forbearance Request.

OMB Control Number: 1845-0031.

Type of Review: An extension without change of a currently approved collection.

Respondents/Affected Public: Individuals and Households.

Total Estimated Number of Annual Responses: 2,188,770.

Total Estimated Number of Annual Burden Hours: 175,102.

Abstract: Due to the effects of the COVID-19 pandemic and the suspension of the collection of loans, the Department of Education is requesting an extension without change of the currently approved Direct Loan General Forbearance Request form information collection. The current form includes the Direct Loan, FFEL, and Perkins Loan programs making it easier for borrowers to request this action. There has been no change to the form, the underlying regulations, or anticipated usage.

This information collection request contains:

(1) OMB No.: 1901-0260;

(2) Information Collection Request Title: Form NWPA-830G, Standard Contract for Disposal of Spent Nuclear Fuel and/or High-Level Radioactive Waste, Appendix G;

(3) Type of Request: Three-year extension with changes;

(4) Purpose: The Form NWPA-830G survey included in the Standard Contract for Disposal of Spent Nuclear Fuel and/or High-Level Radioactive Waste, Appendix G, collect information on and is the source document for entries into DOE accounting records to transmit data from purchasers to DOE concerning payment of the Spent Nuclear Fuel Disposal Fee into the Nuclear Waste Fund. Appendix G collects payment data based on a utility's net electricity generated and sold. 15 U.S.C. 772(b) provides that EIA may require all persons owning or operating facilities or business premises who are engaged in any phase of energy supply or major energy consumption to make available to the Administrator such information and periodic reports, records, documents, and other data, relating to the purposes of this Act, including full identification of all data and projections as to source, time and methodology of development.

The Nuclear Waste Policy Act of 1982 (42 U.S.C. 10101 et seq. ) required that DOE enter into Standard Contracts with all generators or owners of spent nuclear fuel and high-level radioactive waste of domestic origin. Form NWPA-830G Appendix G-Standard Remittance Advice for Payment of Fees, including Annex A to Appendix G, is an Appendix to this Standard Contract. Appendix G and Annex A to Appendix G are commonly referred to as Remittance Advice (RA) forms. RA forms must be submitted quarterly by generators and owners of spent nuclear fuel and high-level radioactive waste of domestic origin who signed the Standard Contract. Appendix G is designed to serve as the source document for entries into DOE accounting records to transmit data to DOE concerning payment of fees into the Nuclear Waste Fund for spent nuclear fuel and high-level waste disposal. Annex A to Appendix G is used to provide data on the amount of net electricity generated and sold, upon which these fees are based.

(5) Annual Estimated Number of Respondents: 95;

(6) Annual Estimated Number of Total Responses: 380;

(7) Annual Estimated Number of Burden Hours: 1,900;

(8) Annual Estimated Reporting and Recordkeeping Cost Burden: The cost of burden hours to the respondents is estimated to be $155,135 (1,900 burden hours times $81.65 per hour.) EIA estimates that there are no additional costs to respondents associated with the survey other than the costs associated with the burden hours.

Statutory Authority: 42 U.S.C. 10222 and 15 U.S.C. 772(b).

Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), EPA specifically solicits comments and information to enable it to:

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

2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

3. Enhance the quality, utility, and clarity of the information to be collected.

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

Title: Chemical Data Reporting under the Toxic Substances Control Act (TSCA).

ICR number: EPA ICR No. 1884.13.

OMB control number: OMB Control No. 2070-0162.

ICR status: This ICR is currently scheduled to expire on April 30, 2022. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the Code of Federal Regulations (CFR), after appearing in the Federal Register when approved, are listed in 40 CFR part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: This information collection request addresses the paperwork requirements contained in the most recent Chemical Data Reporting (CDR) rule under the TSCA. Under TSCA section 8(a), EPA is authorized to collect certain information on chemical substances manufactured (including imported) or processed in the United States. The CDR was formerly known as the Inventory Update Rule (IUR).

The CDR collection provides chemical manufacture, processing, and use information that helps EPA identify what chemicals the public may be exposed to as consumers or in commercial and industrial settings. The data also help EPA assess routes of potential exposure to those chemicals. Beginning in 1986, EPA has used the CDR rule eight times to collect basic manufacturing information for selected chemical substances on the TSCA Inventory. More recent collections, beginning in 2006, included additional information relating to the manufacture, processing, and use of those chemical substances. The reporting requirements have been modified through rulemaking, with the most recent major changes occurring in 2020 when EPA promulgated the TSCA Chemical Data Reporting Revisions Under TSCA Section 8(a) rule (85 FR 20122, April 9, 2020) (FRL-10005-56) and the Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements under the TSCA Section 8(a) (85 FR 31986, May 28, 2020) (FRL-10008-14). The 2020 revisions included a phase-in approach for some of its provisions. All provisions will be fully implemented for the 2024 CDR reporting cycle. The changes are described on EPA's CDR web page, at: https://www.epa.gov/chemical-data-reporting/summary-reporting-requirement-changes-due-cdr-revisions-and-small, The CDR collection is on a four-year reporting cycle and contains detailed manufacturing, processing, and use information drawn from the principal reporting year; the rule also contains basic information on production volume, by year, for the three years prior to the principal reporting year ( e.g., for the 2024 reporting cycle, the principal reporting year will be 2023; the three years prior will be 2020, 2021, and 2022).

EPA uses the CDR data in its chemical substance risk-management efforts and for other uses. Individual sites manufacturing (including importing) chemical substances will submit the required information. The information will be stored electronically for reference by EPA staff and others. Within the constraints of confidentiality claims, the information will be made public through the Agency's website: https://www.epa.gov/chemical-data-reporting. Further discussion on how the information is used, stored, and collected is included in this document.

Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to annual average 135 hours per response. Burden is defined in 5 CFR 1320.3(b).

The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized here:

Respondents/Affected Entities: You may be potentially affected by this action if you manufacture, process, import, or distribute in commerce chemical substances and mixtures. The following North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. Potentially affected entities may include, but are not limited to the following: 325 Chemical Manufacturing and 324 Petroleum and Coal Product Manufacturing

Respondent's obligation to respond: Mandatory; TSCA section 8 and 40 CFR 711.

Estimated total number of potential respondents: 5,460.

Frequency of response: Every four years.

Estimated total average number of responses for each respondent: 7.38.

Estimated total annual burden hours: 735,456 hours.

Estimated total annual costs: $79,267,359. This includes an estimated burden cost of $79,267,359 and an estimated cost of $0 for capital investment or maintenance and operational costs.

There is an increase in total annual costs compared with that identified in the ICR currently approved by OMB. The primary reason for changes in respondent burden and cost are a result of changes from finalized regulatory actions in 2020. In addition, the increase in the respondent burden and agency costs were caused by an increase in the hourly wages and a change in the methodology to calculate loaded wages (wages plus fringe benefits and overhead). Please refer to Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions. This change is an adjustment.

In addition, OMB has requested that EPA move towards using the 18-question format for ICR Supporting Statements used by other federal agencies and departments and is based on the submission instructions established by OMB in 1995, replacing the alternate format developed by EPA and OMB prior to 1995. The Agency does not expect this change in format to result in substantive changes to the information collection activities or related estimated burden and costs.

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments. If you have any questions about this ICR or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT .

Authority: 15 U.S.C. 2601 et seq.

This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitters of the PMNs addressed in this action.

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2021-0146, is available at http://www.regulations.gov. Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

This document lists the statements of findings made by EPA after review of notices submitted under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. This document presents statements of findings made by EPA during the period from July 1, 2021 to July 31, 2021.

TSCA section 5(a)(3) requires EPA to review a TSCA section 5(a) notice and make one of the following specific findings:

• The chemical substance or significant new use presents an unreasonable risk of injury to health or the environment;

• The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the chemical substance or significant new use;

• The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects and the chemical substance or significant new use may present an unreasonable risk of injury to health or the environment;

• The chemical substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance; or

• The chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

Unreasonable risk findings must be made without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant under the conditions of use. The term “conditions of use” is defined in TSCA section 3 to mean “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”

EPA is required under TSCA section 5(g) to publish in the Federal Register a statement of its findings after its review of a TSCA section 5(a) notice when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to PMNs, MCANs, and SNUNs submitted to EPA under TSCA section 5.

Anyone who plans to manufacture (which includes import) a new chemical substance for a non-exempt commercial purpose and any manufacturer or processor wishing to engage in a use of a chemical substance designated by EPA as a significant new use must submit a notice to EPA at least 90 days before commencing manufacture of the new chemical substance or before engaging in the significant new use.

The submitter of a notice to EPA for which EPA has made a finding of “not likely to present an unreasonable risk of injury to health or the environment” may commence manufacture of the chemical substance or manufacture or processing for the significant new use notwithstanding any remaining portion of the applicable review period.

In this unit, EPA provides the following information (to the extent that such information is not claimed as Confidential Business Information (CBI)) on the PMNs, MCANs and SNUNs for which, during this period, EPA has made findings under TSCA section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:

• EPA case number assigned to the TSCA section 5(a) notice.

• Chemical identity (generic name if the specific name is claimed as CBI).

• Website link to EPA's decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA section 5(a)(3)(C).

Authority: 15 U.S.C. 2601 et seq.

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 ( http://www2.epa.gov/pesticide-registration/public-participation-process-registration-actions ).

1. File Symbol: 52991-GO. Docket ID number: EPA-HQ-OPP-2021-0468. Applicant: Bedoukian Research, Inc., 6 Commerce Dr., Danbury, CT 06810. Product name: Bedoukian Methyl Dihydro Jasmolate Technical. Active ingredient: Insect pheromone, repellent—Methyl Dihydro Jasmolate (cyclopentaneacetic acid, 3-hydroxy-2-pentyl-, methyl ester) at 95.5%. Proposed use: For manufacturing of insect repellents for indoor, non-food use. Contact: BPPD.

2. File Symbol: 52991-UG. Docket ID number: EPA-HQ-OPP-2021-0425. Applicant: Bedoukian Research, Inc., 6 Commerce Dr., Danbury, CT 06810. Product name: Bedoukian Delta-Dodecalactone Technical. Active ingredient: Insect pheromone, repellent—Delta-Dodecalactone (2H-pyran-2-one, 6-heptyltetrahydro-) at 98.7%. Proposed use: For manufacturing of insect repellents for indoor, non-food use. Contact: BPPD.

3. File Symbol: 67986-RN. Docket ID number: EPA-HQ-OPP-2021-0518. Applicant: OmniLytics, Inc., 9075 South Sandy Parkway, Sandy, UT 84070. Product name: AgriPhage-Nut & Stone Fruit. Active ingredients: Bactericide—Bacteriophage active against Xanthomonas arboricola pv. pruni at 0.000025%, bacteriophage active against Xanthomonas arboricola pv. juglandis at 0.000025%, bacteriophage active against Xanthomonas arboricola pv. corylina at 0.000025%, and bacteriophage active against Pseudomonas syringae pv. syringae at 0.000025%. Proposed use: To control bacterial spot, canker, and blast on nut and stone fruit in commercial and residential settings. Contact: BPPD.

4. File Symbol: 93257-R. Docket ID number: EPA-HQ-OPP-2021-0533. Applicant: Symborg, Inc., P.O. Box 12810, San Luis Obispo, CA 93406. Product name: TrichoSym Biological Fungicide. Active ingredient: Fungicide— Trichoderma harzianum strain T78 at 0.35%. Proposed use: For use on lettuce, melon, sunflower, pepper, tomato, and strawberry in the field or greenhouse to control plant diseases. Contact: BPPD.

5. File Symbol: 95213-A. Docket ID number: EPA-HQ-OPP-2021-0402. Applicant: Indigo Ag, Inc., 500 Rutherford Ave., Boston, MA 02129. Product name: Indigo 405 FP. Active ingredient: Nematode suppression agent— Streptomyces sp. strain SYM00257 at 3.00%. Proposed use: For seed treatment of cereal grains, corn, cotton, legumes, oilseeds, and soybean to suppress plant-parasitic nematodes. Contact: BPPD.

6. File Symbol: 95213-L. Docket ID number: EPA-HQ-OPP-2021-0402. Applicant: Indigo Ag, Inc., 500 Rutherford Ave., Boston, MA 02129. Product name: Streptomyces sp. strain SYM00257 Technical. Active ingredient: Nematode suppression agent— Streptomyces sp. strain SYM00257 at 100.00%. Proposed use: For manufacturing pesticide products. Contact: BPPD.

7. File Symbol: 95699-E. Docket ID number: EPA-HQ-OPP-2021-0570. Applicant: NewLeaf Symbiotics, 1005 North Warson Rd., Suite 102, St. Louis, MO 63132. Product name: TS201. Active ingredient: Insecticide— Methylorubrum extorquens strain NLS0042 at 2.0%. Proposed use: For use on corn to control corn rootworm. Contact: BPPD.

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

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 new uses for pesticide products containing currently registered active ingredients. 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.

1. EPA Registration Numbers: 100-1478, 100-1471, and 100-1476. Docket ID number: EPA-HQ-OPP-2021-0417. Applicant: Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. Active ingredient: Benzovindiflupyr. Product type: Fungicide. Proposed use: Vegetable, root, except sugar beet, subgroup 1B, except ginseng. Contact: RD.

2. EPA Registration Numbers: 100-1609, 100-1601, 100-1648, and 100-1603. Docket ID number: EPA-HQ-OPP-2021-0446. Applicant: Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300. Active ingredient: Pydiflumetofen. Product type: Fungicide. Proposed Use(s): Foliar uses on caneberry subgroup 13-07A, greenhouse lettuce, and greenhouse pepper. Seed treatment uses on cucurbit vegetables crop group 9, edible-podded legume vegetables crop subgroup 6A, and succulent shelled pea and bean crop subgroup 6B. Contact: RD.

3. EPA Registration Numbers: 59639-211 and 50639-185. Docket ID number: EPA-HQ-OPP-2021-0045. Applicant: Valent U.S.A. LLC, P.O. Box 5075, San Ramon, CA 94583-0975. Active ingredient: Ethaboxam. Product type: Fungicide. Proposed Uses: Brassica head and stem vegetables (group 5-16) and Brassica leafy greens (crop subgroup 4-16B). Contact: RD.

4. EPA Registration Number: 59825-6. Docket ID number: EPA-HQ-OPP-2021-0550. Applicant: The Lubrizol Corporation, 29400 Lakeland Blvd., Wickliffe, OH 44092. Active ingredient: Tetraacetyl Ethylenediamine (TAED). Product type: Bactericide, fungicide, insecticide, and miticide. Proposed use: For use in the manufacturing of pesticide products for disease control, pest control, and plant health on all food commodities. Contact: BPPD.

5. EPA File Symbol: 90866-GN and EPA Registration Number: 34704-1057. Docket ID number: EPA-HQ-OPP-2021-0469. Applicants: CH Biotech R&D Co. Ltd., No. 89 Wenxian Rd., Nantou City, Nantou County 54041, Taiwan R.O.C. (c/o CH Biotech LLC, 601 Kettering Dr., Ontario, CA 91761) and Loveland Products, Inc., P.O. Box 1286, Greeley, CO 80632-1286. Active ingredient: Salicylic Acid. Product type: Plant regulator. Proposed use: For abiotic stress reduction; food use. Contact: BPPD.

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

Agenda: The agenda will include updates from the committee members about key challenges facing their communities or organizations. In addition, there will be panel discussions covering housing market trends, tax time opportunities to expand account access as well as highlights from the FDIC Tech Sprint, Breaking Down Barriers: Reaching the `Last Mile' of the Unbanked. Any changes to the agenda will be announced at the beginning of the meeting.

Type of Meeting: This meeting of the Advisory Committee on Economic Inclusion will be Webcast live via the internet http://fdic.windrosemedia.com. For optimal viewing, a high-speed internet connection is recommended.

Proposal to renew the following currently approved collections of information:

1. Title: Notice of Branch Closure.

OMB Number: 3064-0109.

Form Number: None.

Affected Public: FDIC-insured depository institutions.

Burden Estimate:

Total Estimated Annual Burden: 1,738 hours.

General Description of Collection: Section 42 of the Federal Deposit Insurance Act mandates that an insured depository institution closing a branch notify its primary federal regulator not later than 90 days prior to the closing. The statute also provides that a notice be posted on the premises of the branch for the 30-day period immediately prior to the closing and that the customers be notified in a mailing at least 90 days prior to the closing. Each insured depository institution that has one or more branches is required to adopt a written policy for branch closings. There is no change in the methodology or substance of this information collection. The slight increase in total estimated annual burden from 1,550 hours in 2018 to 1,738 hours currently is due to economic factors reflected in the increase in estimated number or respondents and in the frequency of response (number of branch closings per respondent).

2. Title: Notification of Changes of Insured Status.

OMB Number: 3064-0124.

Form Number: None.

Affected Public: Insured depository institutions.

Burden Estimate:

General Description of Collection: This information collection consists of two parts: (1) A certification that insured depository institutions provide the FDIC when all deposit liabilities from one insured depository institution are assumed from another insured depository institution, with the latter institution responsible for providing the certification, and (2) a notification that an insured depository institution provides to its depositors when it seeks to voluntarily terminate its insured status. The certification is necessary to implement the provisions of section 8(q) of the Federal Deposit Insurance Act, 12 U.S.C. 1818(q), regarding termination of the insured status of the transferring institution and termination of the separate deposit insurance coverage provided on deposit accounts assumed by the assuming institution. The depositor notification is required by section 8(a) (6) of the Federal Deposit Insurance Act, 12 U.S.C. 1818(a) (6). This provision ensures that the institution's depositors receive appropriate information regarding the institution's intent to terminate its insured status and that, prior to the termination of the institution's insured status, depositors receive appropriate information concerning federal deposit insurance coverage of their accounts once the institution's insured status is terminated. There is no change in the methodology or substance of this information collection. Based on supervisory experience, the FDIC has revised its estimate of the Time per Response for the Certification component from 0.25 hours to 1 hour and has revised the estimated time to respond to the Notification component from 1 hour to 2 hours. The estimated number of respondents has changed due to economic factors. The estimated number of annual respondents to the Notification component has increased from 2 to 8. The estimated number of annual respondents to the Certification component has increased from 150 to 240. As a result of the foregoing total estimated annual burden has increased from 39.5 hours in 2018 to 256 hours currently.

3. Title: Large-Bank Deposit Insurance Programs.

OMB Number: 3064-0162.

Form Number: None.

Affected Public: Insured depository institutions having at least $2 billion in deposits and at least either: (a) 250,000 Deposit accounts; or (b) $20 billion in total assets, regardless of the number of deposit accounts (a “covered institution”).

Burden Estimate:

General Description of Collection: Upon the failure of an FDIC-insured depository institution, the FDIC is required to pay insured deposits as soon as possible. To do so, the FDIC must be able to quickly determine the total insured amount for each depositor. To make this determination, the FDIC must ascertain the balances of all deposit accounts owned by the same depositor in the same ownership capacity at a failed institution as of the day of failure. The FDIC issued a regulation (12 CFR 360.9) (Section 360.9) to modernize the process of determining the insurance status of each depositor in the event of failure of a covered institution. The FDIC requires institutions that are covered under Section 360.9 to have mechanisms in place that will automatically place a provisional hold on domestic and foreign deposit accounts, and sweep and automated credit account arrangements, in the event that a covered institution is close to failing. A “provisional hold” is defined in 12 CFR Section 360.9(b)(6) as “an effective restriction on access to some or all of a deposit or other liability account after the failure of an insured depository institution.” Section 360.9 also requires institutions to have in place practices and procedures for providing the FDIC, in a standard format upon the close of any day's business, certain data on the accounts and customers of the institution, and to provide the FDIC with this information upon request. The purpose of these requirements is to allow the deposit and other operations of a covered institution to continue functioning on the day following failure, and to permit the FDIC to fulfill its legal requirement to promptly provide liquidity to depositors of a failed institution. This information also helps to ensure equitable treatment of depositors at different institutions, and helps to preserve the franchise value of a failed institution, thereby reducing costs to the FDIC in the event that a covered institution fails.

FDIC-insured depository institutions (IDIs) that are covered by Section 360.9 are defined in Section 360.9(b)(1) as having at least $2 billion in deposits and either (1) 250,000 or more deposit accounts, or (2) $20 billion or more in assets, regardless of the number of deposit accounts. IDIs that meet this criteria for two consecutive quarters qualify as covered institutions.

This information collection consists of seven distinct reporting and recordkeeping requirements (ICs) that impose annual implementation burden on covered institutions. Four of these seven reporting requirements entail an ongoing burden component: (1) Section 360.9(c)(3) (IC requirements C and H, below) requires covered institutions to provide certain information to the FDIC both while the institution is implementing the systems required under 360.9 (IC requirement C) and on an ongoing basis (IC requirement H); (2) Section 360.9(c)(9) (IC requirements D and I, below) permits institutions to request an exemption from certain requirements of Section 360.9. Institutions could submit such requests either while they are implementing the systems required under Section 360.9 (IC requirement D) or after they are already in compliance with Section 360.9 (IC requirement I); (3) Section 360.9(f) (IC requirements G and J, below) permits institutions to request an exemption from all of the requirements of Section 360.9 under certain conditions. Institutions could submit such requests either while they are implementing the systems required under Section 360.9 (IC requirement G) or after they are already in compliance with Section 360.9 (IC requirement J). Since reporting by institutions pursuant to Sections 360.9(c)(3), 360.9(c)(9), and 360.9(f) are counted as both implementation and ongoing requirements, this IC contains eleven  1 requirements in total. These requirements, with corresponding CFR sections, are listed and described as follows:

4. Title: Assessment Rate Adjustment Guidelines for Large and Highly Complex Institutions.

OMB Number: 3064-0179.

Form Number: None.

Affected Public: Large and highly complex depository institutions.

Burden Estimate:

Total Estimated Annual Burden: 160 hours.

General Description of Collection: The FDIC's deposit insurance assessment authority is set forth in Section 7 of the Federal Deposit Insurance Act, 12 U.S.C. 1817(b) and (c) and promulgated in regulations under 12 CFR part 327. These regulations also set out the process for making adjustments to the total score of these institutions used by the FDIC in making deposit insurance assessments. Depository institutions are permitted to make a written request to the FDIC for an assessment adjustment. An institution is able to request review of, or appeal, an upward adjustment, the magnitude of an upward adjustment, removal of a previously implemented downward adjustment or an increase in a previously implemented upward adjustment through the FDIC's internal review process set forth at 12 CFR 327.4(c). An institution can similarly request review of or appeal a decision not to apply an adjustment following a request by the institution for an adjustment.

An institution can submit its written request for an adjustment to the FDIC's Director of the Division of Insurance and Research in Washington, DC In making such a request, the institution will provide support by including evidence of a material risk or risk-mitigating factor that it believes was not adequately considered.

There is no change in the methodology or substance of this information collection. The increase in total estimated annual burden from 80 hours in 2018 to 160 hours currently is due to economic factors as reflected in the increase in estimated number of respondents.

5. Title: Regulatory Capital Rules: Regulatory Capital, Revisions to the Supplementary Leverage Ratio.

OMB Number: 3064-0196.

Form Number: None.

Affected Public: Insured state nonmember banks and state savings associations that are subject to the FDIC's advanced approaches risk-based capital rules.

Burden Estimate:

Agenda: The agenda will include a discussion of a variety of current and emerging issues that have potential implications regarding the regulation and supervision of state-chartered financial institutions. The agenda is subject to change. Any changes to the agenda will be announced at the beginning of the meeting.

Type of Meeting: This meeting of the Advisory Committee of State Regulators will be Webcast live via the internet http://fdic.windrosemedia.com. For optimal viewing, a high-speed internet connection is recommended.

This new system is needed for processing, storing, and maintaining FMCS case records, notices, and agreements.

Authority: 5 U.S.C. 552b (e)(1).

In 1999, the Institute of Medicine called for health care organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System ). To respond to the need for tools to assess patient safety culture in health care, AHRQ developed and pilot tested the Nursing Home Survey on Patient Safety Culture with OMB approval (OMB NO. 0935-0132; Approved July 5, 2007).

The survey is designed to enable nursing homes to assess provider and staff perspectives about patient safety issues, medical error, and error reporting and includes 42 items that measure 12 composites of patient safety culture. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials in November 2008 on the AHRQ website.

The AHRQ Nursing Home SOPS Database consists of data from the AHRQ Nursing Home Survey on Patient Safety Culture. Nursing homes in the U.S. can voluntarily submit data from the survey to AHRQ through its contractor, Westat. The Nursing Home SOPS Database (OMB NO. 0935-0195, last approved on November 5, 2018) was developed by AHRQ in 2011 in response to requests from nursing homes interested in viewing their organizations' patient safety culture survey results. Those organizations submitting data receive a feedback report, as well as a report on the aggregated de-identified findings of the other nursing homes submitting data. These reports are used to assist nursing home staff in their efforts to improve patient safety culture in their organizations.

Rationale for the information collection. The Nursing Home SOPS and Nursing Home SOPS Database support AHRQ's goals of promoting improvements in the quality and safety of health care in nursing home settings. The survey, toolkit materials, and database results are all made publicly available on AHRQ's website. Technical assistance is provided by AHRQ through its contractor at no charge to nursing homes, to facilitate the use of these materials for nursing home patient safety and quality improvement.

This database:

(1) Presents results from nursing homes that voluntarily submit their data,

(2) Provides data to nursing homes to facilitate internal assessment and learning in the patient safety improvement process, and

(3) Provides supplemental information to help nursing homes identify their strengths and areas with potential for improvement in patient safety culture.

This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to surveys and database development. 42 U.S.C 299a(a)(1) and (8).

To achieve the goal of this project the following activities and data collections will be implemented:

(1) Eligibility and Registration Form —The nursing home (or parent organization) point-of-contact (POC) completes a number of data submission steps and forms, beginning with the completion of an online Eligibility and Registration Form. The purpose of this form is to collect basic demographic information about the nursing home and initiate the registration process.

(2) Data Use Agreement —The purpose of the data use agreement, completed by the nursing home POC, is to state how data submitted by nursing homes will be used and provides privacy assurances.

(3) Nursing Home Site Information Form —The purpose of the site information form, completed by the nursing home POC, is to collect background characteristics of the nursing home. This information will be used to analyze data collected with the Nursing Home SOPS survey.

(4) Data File(s) Submission —POCs upload their data file(s) using the data file specifications, to ensure that users submit standardized and consistent data in the way variables are named, coded and formatted. The number of submissions to the database is likely to vary each year because nursing homes do not administer the survey and submit data every year. Data submission is typically handled by one POC who is either a corporate level health care manager for a Quality Improvement Organization (QIO), a survey vendor who contracts with a nursing home to collect their data, or a nursing home Director of Nursing or nurse manager. POCs submit data on behalf of 3 nursing homes, on average, because many nursing homes are part of a QIO or larger nursing home or health system that includes many nursing home sites, or the POC is a vendor that is submitting data for multiple nursing homes.

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 40 POCs, each representing an average of 3 individual nursing homes each, will complete the database submission steps and forms. Each POC will submit the following:

• Eligibility and registration form (completion is estimated to take about 3 minutes).

• Data Use Agreement (completion is estimated to take about 3 minutes).

• Nursing Home Site Information Form (completion is estimated to take about 5 minutes).

• Survey data submission will take an average of one hour.

The total annual burden hours are estimated to be 54 hours.

Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $2,509 annually.

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

In accordance with 41 CFR 102-3.150(b), less than 15 calendar days' notice is being given for this meeting due to the exceptional circumstances of the COVID-19 pandemic and rapidly evolving COVID-19 vaccine development and regulatory processes. The Secretary of Health and Human Services has determined that COVID-19 is a Public Health Emergency. A notice of this ACIP meeting has also been posted on CDC's ACIP website at: http://www.cdc.gov/vaccines/acip/index.html . In addition, CDC has sent notice of this ACIP meeting by email to those who subscribe to receive email updates about ACIP.

Purpose: The committee is charged with advising the Director, CDC, on the use of immunizing agents. In addition, under 42 U.S.C. 1396s, the committee is mandated to establish and periodically review and, as appropriate, revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children (VFC) program, along with schedules regarding dosing interval, dosage, and contraindications to administration of vaccines. Further, under provisions of the Affordable Care Act, section 2713 of the Public Health Service Act, immunization recommendations of the ACIP that have been approved by the Director of the Centers for Disease Control and Prevention and appear on CDC immunization schedules must be covered by applicable health plans.

Matters To Be Considered: The agenda will include discussions on COVID-19 vaccine booster doses. Agenda items are subject to change as priorities dictate. A recommendation vote is scheduled. For more information on the meeting agenda visit https://www.cdc.gov/vaccines/acip/meetings/meetings-info.html .

Meeting Information: The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: http://www.cdc.gov/vaccines/acip/index.html .

Interested persons or organizations are invited to participate by submitting written views, recommendations, and data. Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on https://www.regulations.gov . Therefore, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display. CDC will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted into the docket.

Written Public Comment: Written comments must be received on or before September 22, 2021.

Oral Public Comment: This meeting will include time for members of the public to make an oral comment. Oral public comment will occur before any scheduled votes including all votes relevant to the ACIP's Affordable Care Act and Vaccines for Children Program roles. Priority will be given to individuals who submit a request to make an oral public comment before the meeting according to the procedures below.

Procedure for Oral Public Comment: All persons interested in making an oral public comment at the September 22-23, 2021, ACIP meeting must submit a request at http://www.cdc.gov/vaccines/acip/meetings/ no later than 11:59 p.m., EDT, September 20, 2021, according to the instructions provided.

If the number of persons requesting to speak is greater than can be reasonably accommodated during the scheduled time, CDC will conduct a lottery to determine the speakers for the scheduled public comment session. CDC staff will notify individuals regarding their request to speak by email by 12:00 p.m., EDT, September 21, 2021. To accommodate the significant interest in participation in the oral public comment session of ACIP meetings, each speaker will be limited to 3 minutes, and each speaker may only speak once per meeting.

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

On March 27, 2020, the CARES Act was signed into law. The CARES Act includes provisions that govern the way certain OTC drugs are regulated in the United States. In particular, the CARES Act added section 505G to the FD&C Act (21 U.S.C. 355g), which reforms and modernizes the OTC drug review process that was established in 1972. Under the OTC drug review, OTC drug monographs (also referred to as OTC monographs) for different therapeutic categories are established. OTC drugs are generally recognized as safe and effective (GRASE) if they meet the conditions of an OTC monograph, including the specified active ingredients, uses (indications), doses, routes of administration, labeling, and testing, along with other applicable requirements.

Prior to passage of the CARES Act, OTC monographs were established, revised, and amended using the rulemaking process set out by the Administrative Procedure Act in 21 U.S.C. 553. Final OTC monographs (final monographs) were codified in regulations under title 21 of the CFR. The OTC monograph process was set forth in 21 CFR part 330 (part 330). Prior to establishment of a final monograph, GRASE conditions for a therapeutic category were set forth in proposed rules as tentative final monographs. At the time of the passage of the CARES Act, certain OTC monographs were still at the proposed rulemaking stage, either in whole or in part.

In the course of the OTC drug review, FDA also determined when there was not sufficient evidence to demonstrate certain conditions ( e.g., active ingredients for specific uses) were GRASE. In such cases, FDA often expressly codified these determinations that certain conditions were not GRASE (see, e.g., § 310.545 (21 CFR 310.545)). In addition, part 201, subpart G (21 CFR part 201, subpart G), includes specific labeling requirements for certain drugs, including OTC monograph drugs (see, e.g., § 201.326, requiring warnings and other labeling for OTC drug products containing internal analgesic and antipyretic active ingredients).

The CARES Act added section 505G to the FD&C Act, which revised the framework for the regulation of OTC monograph drugs. 1 Under section 505G of the FD&C Act, the rulemaking process for establishing, revising, and amending OTC monographs was replaced with an administrative order process. In addition, among other things, section 505G of the FD&C Act provides a baseline status that, as of the date of enactment of the CARES Act, a drug that satisfies certain requirements described in section 505G(a)(1) or (2) is: (1) Deemed to be generally recognized as safe and effective under section 201(p)(1) of the FD&C Act (21 U.S.C. 321(p)(1); (2) not a new drug under section 201(p) of the FD&C Act; and (3) not subject to section 503(b)(1) of the FD&C Act (21 U.S.C. 353(b)(1)). To obtain this status, among other things, a drug either must be one that is in conformity with the requirements for nonprescription use of a final monograph issued under part 330 (except as provided in section 505G(a)(2) of the FD&C Act), 2 as well as other requirements;  3 or must be one that is: (1) Classified in category I for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under part 330 and (2) in conformity with the proposed requirements for nonprescription use of such tentative final monograph and any applicable subsequent determination by FDA, as well as other requirements. 4 Other applicable requirements in section 505G(a)(1) of the FD&C Act include conditions or requirements under section 505G(b), (c), and (k) of the FD&C Act.

Complementary to the requirements for conformity to tentative final or final monographs described in section 505G(a)(1) and (2) of the FD&C Act, Congress provided that, under section 505G(b)(8) of the FD&C Act, a final monograph or tentative final monograph that establishes conditions of use for a drug described in section 505G(a)(1) or (2) of the FD&C Act and that represents the most recently issued version of the conditions of use, including as modified, in whole or in part, by any proposed or final rule, is deemed to be a final order. These deemed final orders provide the current OTC drug monograph conditions that are in effect for each therapeutic category addressed by them. Final orders may be amended, revoked, or otherwise modified in accordance with the procedures of section 505G of the FD&C Act. Under section 505G(b)(8)(C) of the FD&C Act, the deemed establishment of a final order is construed to include technical amendments necessary to ensure that the final order is appropriately harmonized, in terms of terminology or cross-references, with the applicable provisions of the FD&C Act (and regulations) and any other final orders issued under section 505G.

Congress also deemed certain regulations, as in effect on the day before the date of the enactment of the CARES Act ( i.e., March 26, 2020), to be final orders under section 505G(b) of the FD&C Act. In particular, section 505G(k)(2)(A) of the FD&C Act deemed the provisions of § 310.545 to be a final order under section 505G(b). Also, section 505G(k)(2)(B) of the FD&C Act deemed regulations establishing requirements for specific nonprescription drugs marketed pursuant to section 505G (including such requirements in 21 CFR parts 201 and 250) to be final orders under section 505G(b), as they apply to drugs subject to section 505G(a)(1) through (4) or otherwise subject to an order under section 505G.

In addition, section 505G(k)(3) of the FD&C Act provides that regulations establishing final monographs and the procedures governing the OTC drug review under part 330 and other relevant parts of title 21 of the CFR, shall be withdrawn or revised to make technical changes to ensure conformity with appropriate terminology and cross-references. Section 505G(k)(3) of the FD&C Act also provides that any such withdrawal or technical changes shall be made without public notice and comment and shall be effective upon publication through notice in the Federal Register (or upon such date as specified in such notice).

The final orders as deemed by section 505G of the FD&C Act were made effective upon enactment of the CARES Act on March 27, 2020. By this notice, FDA is announcing the availability on its website of certain deemed final orders and providing the public information on the process for making available deemed final orders, including details on how the public can access and view the final orders. FDA is posting these final orders to provide the public a convenient resource to view OTC monographs and non-monograph conditions. The process for FDA issuing proposed, final, and interim final orders under section 505G(b) of the FD&C Act to add, modify, or remove OTC monograph conditions is generally described in section 505G(b) and is not addressed in this Notice. Additional information, including questions and answers on this process, can be found on FDA's OTC monograph web page at https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act, and further information will be provided when FDA issues its first proposed order.

FDA is announcing its process for making available final orders as deemed by section 505G(b)(8) of the FD&C Act. FDA reviewed all final monographs published in the CFR, beginning with 21 CFR part 331, and the rulemaking histories for each OTC monograph therapeutic category, to identify all relevant final monographs and tentative final monographs that established conditions of use for a drug described in section 505G(a)(1) of the FD&C Act and that represented the most recently issued version of the conditions of use, including as modified, in whole or in part, by any proposed or final rule. As noted above, the relevant requirements for sunscreen drugs subject to section 505G of the FD&C Act, in terms of conformity with a final monograph for purposes of section 505G(a)(1)(A)(i), were set forth in section 505G(a)(2) and consist of the requirements specified in 21 CFR part 352, as published on May 21, 1999, except that the applicable requirements governing effectiveness and labeling are those specified in § 201.327. Altogether, as indicated in table 1 below, FDA identified 32 final orders created by section 505G(b)(8) of the FD&C Act.

As further discussed below, FDA also identified certain regulations that established requirements for specific nonprescription drugs marketed pursuant to section 505G of the FD&C Act and, therefore, were deemed final orders by section 505G(k)(2)(B), only as they apply to drugs subject to section 505G(a)(1) through (4) or otherwise subject to an order under section 505G ( e.g., § 201.326, which set forth certain labeling requirements regarding warnings for OTC drug products containing internal analgesic and antipyretic active ingredients). To the extent regulations that were deemed to be final orders by section 505G(k)(2)(B) of the FD&C Act apply to OTC drugs addressed by a final order embodying an OTC monograph, as deemed by section 505G(b)(8) of the FD&C Act, the relevant provisions may be incorporated into the final order(s) embodying the OTC monograph(s).

FDA assigned OTC monograph numbers to the resulting deemed final orders (see table 1). Table 1 provides the corresponding OTC monograph number and title for each of these OTC monographs and identifies the CFR citation, if applicable. Additionally, an order ID will be assigned in sequential order upon posting of all orders, including the deemed final orders.

Each OTC monograph embodied by a deemed final order is accompanied by a summary and a background section. In the background section, FDA describes the relevant proposed and final rules that constitute the deemed final order. Additionally, pursuant to section 505G(b)(8)(C) of the FD&C Act, OTC monographs embodied by deemed final orders include any technical amendments that are determined to be necessary to ensure that they are appropriately harmonized, in terms of terminology and cross-references, with applicable provisions of the FD&C Act, FDA regulations, and any other orders issued under section 505G. The background section generally describes any differences between the deemed final order and the proposed and final rules that constitute the order.

Some OTC monographs incorporate by reference specified material, published by an entity other than the United States government ( e.g., an ISO standard). This incorporated material is available for inspection at FDA. For further information about inspecting incorporated materials, see https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act. Copies of incorporated material may also be available from its publisher.

Under section 505G(k)(2)(A) of the FD&C Act, the non-monograph conditions in § 310.545 in effect on the day before the date of enactment of the CARES Act ( i.e., March 26, 2020) were deemed to be a final order under section 505G(b). The provisions of § 310.545 list active ingredients for which there is not sufficient data to establish general recognition of the safety and effectiveness for the specified use in OTC drug products. Before posting the deemed final order containing these provisions, FDA intends to remove the compliance dates found in the regulation because the dates are no longer relevant, since any current product would have been introduced or delivered for introduction into interstate commerce well after the compliance date. FDA also intends to rearrange the listed active ingredients within each provision regarding a particular therapeutic category so that they generally appear in alphabetical order. When posting this final order, FDA will assign a final order ID and OTC non-monograph conditions number.

In addition, under section 505G(k)(2)(B) of the FD&C Act, regulations in effect on March 26, 2020, establishing requirements for specific nonprescription drugs marketed pursuant to section 505G of the FD&C Act were deemed final orders under section 505G(b), only as they apply to drugs subject to section 505G(a)(1) through (4) of the FD&C Act or otherwise subject to a final order under section 505G. As discussed above, provisions from a regulation that was deemed to be a final order by section 505G(k)(2)(B) of the FD&C Act may be incorporated into a relevant final order embodying an OTC monograph under section 505G(b)(8). A deemed final order under section 505G(k)(2)(B) of the FD&C Act may also be posted as a separate, standalone final order. In the latter case, FDA intends to issue an accompanying notice in the Federal Register announcing its availability on our website. Regulations deemed to be final orders by section 505G(k)(2)(B) of the FD&C Act will remain in the CFR to the extent they also apply to drugs that are not subject to section 505G(a)(1) through (4) or otherwise subject to an order under section 505G.

FDA has established a new IT system with a web portal, OTC Monographs@FDA , which can be accessed through FDA's website. The portal will provide access to a repository of final orders under section 505G of the FD&C Act and is available at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm. To access the final orders, go to the OTC Monographs@FDA portal at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm. Under the “Administrative Orders” banner, click on the desired link under the “Order ID” heading and follow the prompts.

For ease of reference, FDA also is posting in the OTC Monographs@FDA portal the individual OTC monographs embodied by final orders under section 505G(b) of the FD&C Act, without any sections that accompany the monograph, such as the background section. To access just the OTC monographs, under the “OTC Monographs” banner, click on the desired link under the “OTC Monograph ID” heading and follow the prompts.

FDA will make available deemed final orders embodying OTC monographs in batches on a rolling basis until all 32 such orders, discussed above in section II.A (see also table 1), are available in the repository. FDA will also make available in the repository the final order that reflects the provisions of § 310.545, as deemed by section 505G(k)(2)(A) of the FD&C Act, and final orders regarding requirements for specific nonprescription drugs, as deemed by section 505G(k)(2)(B).

FDA is announcing that the OTC Monographs@FDA portal currently includes an initial batch of four deemed final orders embodying OTC monographs (see table 2). The posting of the remainder of these 32 deemed final orders, as well as the deemed final order under section 505G(k)(2)(A) of the FD&C Act, will not be announced in the Federal Register but will be announced on FDA's OTC monograph web page, https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act. FDA plans to issue a notice of availability in the Federal Register when posting in the repository final orders deemed by section 505G(k)(2)(B) of the FD&C Act.

FDA encourages the public to frequently view our website at https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act and the OTC Monographs@FDA portal for the most up-to-date information about the status of posted final orders as deemed by section 505G of the FD&C Act. Questions regarding these final orders can be submitted to FDA at druginfo@fda.hhs.gov.

In the future, the repository will also include proposed orders, final orders, and interim final orders to add, amend, or remove OTC monograph conditions that are issued by FDA either on its own initiative or pursuant to an OTC monograph order request under section 505G(b)(5) of the FD&C Act. Information on the process for FDA issuing proposed, final, and interim final orders is provided in section 505G(b) of the FD&C Act. Additional information, including questions and answers on this process, can be found on FDA's OTC monograph web page ( https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-drug-review-otc-monograph-reform-cares-act ), which will continue to be updated as FDA issues new orders.

Under section 505G(k)(3) of the FD&C Act, regulations establishing final monographs and the procedures governing the OTC drug review under part 330 and other relevant parts of title 21 of the CFR (as in effect on March 26, 2020) shall be withdrawn or revised to make technical changes to ensure conformity with appropriate terminology and cross-references. Section 505G(k)(3) of the FD&C Act also provides that any such withdrawal or technical changes shall be made without public notice and comment and shall be effective upon publication through notice in the Federal Register (or upon such date as specified in such notice).

FDA intends to issue a notice to withdraw the regulations establishing final monographs in title 21 of the CFR at a later date once all the relevant deemed final orders have been posted on FDA's OTC monographs@FDA web portal ( i.e., 21 CFR parts 331, 332, 333, 335, 336, 338, 340, 341, 343, 344, 346, 347, 348, 349, 350, 352, 355, 357, and 358). Prior to the withdrawal of such regulations, the public should reference the OTC monographs posted in the OTC Monographs@FDA portal at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm, to the extent the corresponding deemed final order has been added to the portal. Additionally, in either the same notice or a separate notice in the Federal Register , pursuant to section 505G(k)(3) of the FD&C Act, FDA intends to withdraw certain portions of the regulations governing the OTC drug review, and to make certain technical changes.

Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act of 1995 (Chapter 35 of title 44, United States Code) does not apply to collections of information made under section 505G of the FD&C Act. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required for collections of information, if any, in orders deemed to be final orders by section 505G of the FD&C Act.

Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Title of the Collection: Prevention Communication Formative Research.

Type of Collection: Extension.

OMB No.: 0990-0281—Office of Disease Prevention and Health Promotion.

Abstract: The Office of Disease Prevention and Health Promotion (ODPHP) is focused on developing and disseminating health information to the public. ODPHP faces an increasingly urgent interest in finding effective ways to communicate health information to America's diverse population. ODPHP strives to be responsive to the needs of America's diverse audiences while simultaneously serving all Americans across a range of channels, from print to new communication technologies. To carry out prevention information efforts, ODPHP is committed to conducting formative and usability research to provide guidance on the development and implementation of their communication and education efforts. The information collected will be used to improve communication, products, and services that support key office activities including: Healthy People, Dietary Guidelines for Americans, Physical Activity Guidelines for Americans, MyHealthfinder, the Move Your Way® Campaign, the President's Council on Sports, Fitness & Nutrition, health literacy and healthy aging. ODPHP communicates through its websites ( www.health.gov ) and through other channels including social media, print materials, interactive training modules, and reports. This request builds on previous formative research approaches to place more emphasis on Web-based data collection to allow greater geographical diversity among respondents, to decrease respondent burden, and to save government costs. Data collection will be qualitative and quantitative and may include in-depth interviews, focus groups, web-based surveys, omnibus surveys, card sorting, and various forms of usability testing of materials and interactive tools to assess the public's understanding of disease prevention and health promotion content, responses to prototype materials, and barriers to effective use. The program is requesting a 3-year clearance. The type of respondents are consumers and health professionals which will be surveyed on an annual basis.

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

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

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

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

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

The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

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

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

This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP and are used to calculate the appropriate flood insurance premium rates for new buildings, and for the contents in those buildings. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.

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

FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).

These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.

The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.

Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.

The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location https://hazards.fema.gov/femaportal/prelimdownload and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.

The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.

Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.

The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.

The information collection notice was previously published in the Federal Register on June 14, 2021, at 86 FR 31519, allowing for a 60-day public comment period. USCIS did receive one comment in connection with the 60-day notice.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2008-0015 in the search box. The comments submitted to USCIS via this method are visible to the Office of Management and Budget and comply with the requirements of 5 CFR 1320.12(c). All submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

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

(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

(1) Type of Information Collection Request: Extension, Without Change, of a Currently Approved Collection

(2) Title of the Form/Collection: Waiver of Rights, Privileges, Exemptions and Immunities.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: Form I-508; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. This form is used by USCIS to determine eligibility of an applicant to retain the status of an alien lawfully admitted to the United States for permanent residence.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection I-508 is 1,928 and the estimated hour burden per response is .75 hours per response.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 1,446 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $15,424.

In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the AS-IA; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the AS-IA enhance the quality, utility, and clarity of the information to be collected; and (5) how might the AS-IA minimize the burden of this collection on the respondents, including through the use 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 can 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.

Abstract: Submission of this information allows the Office of Indian Economic Development (OIED) to implement the Loan Guarantee, Insurance, and Interest Subsidy Program, 25 U.S.C. 1451 et seq., the purpose of which is to encourage private lending to individual Indians and Indian organizations by providing lenders with loan guarantees or loan insurance to reduce their potential risk. The information collection allows OIED to determine the eligibility and credit-worthiness of respondents and loans and otherwise ensure compliance with Program requirements. This information collection includes the use of several forms.

Title of Collection: Loan Guarantee, Insurance, and Interest Subsidy Program.

OMB Control Number: 1076-0020.

Form Number: LGA10, LIA10, RGI10, ISR10, NOD10, CFL10, ALD10, NIL10, and LGC10.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Lenders, including commercial banks, and borrowers, including individual Indians and Indian organizations.

Total Estimated Number of Annual Respondents: 622.

Total Estimated Number of Annual Responses: 1,377.

Estimated Completion Time per Response: Ranging from 0.5 to 2 hours.

Total Estimated Number of Annual Burden Hours: 2,654 hours.

Respondent's Obligation: Required to Obtain or Retain a Benefit.