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

Members of the public are entitled to make comments during the open period at the end of the meetings. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be emailed to Mallory Trachtenberg at mtrachtenberg@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (202) 539-8246. Records and documents discussed during the meetings will be available for public viewing as they become available at www.facadatabase.gov. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Regional Programs Unit at the above phone number or email address.

Committee meetings are available to the public through the conference link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Individuals who are deaf, deafblind, and hard of hearing may also follow the proceedings by first calling the Federal Relay Service at (800) 877-8339 and providing the Service with the conference details found through registering at the web link above. To request additional accommodations, please email mtrachtenberg@usccr.gov at least seven (7) business days prior to the meeting.

Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Liliana Schiller at lschiller@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at (202) 809-9618.

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

On August 6, 2021, Commerce published the Preliminary Results of this administrative review in the Federal Register . 1 We invited parties to comment on the Preliminary Results. On September 7, 2021, case briefs were filed by the following interested parties: Global Aluminum Distributor; Kingtom Aluminio S.R.L. (Kingtom); and JL Trading Co., Puertas Y Ventanas JM Inc., and Industrias Feliciano Al Inc. 2 On September 17, 2021, the Aluminum Fair Trade Committee (the petitioner) submitted a rebuttal brief. 3 On December 2, 2021, Commerce extended the final results of review by 48 days, until January 21, 2021. 4 On January 20, 2022, Commerce extended the final results by an additional 12 days, until February 2, 2022. 5 For a full description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum. 6 On January 27, 2022, Commerce placed a memorandum on the record regarding Commerce's AFA determination with respect to Kingtom for the preliminary results of review (Kingtom AFA Memorandum) and invited interested parties to submit comments. 7 On January 31, 2022, and on February 1, 2022, the petitioner and Kingtom, respectively, submitted comments on the Kingtom AFA Memorandum. 8

The merchandise covered by the Order is aluminum extrusions from China. For the complete description of the scope of the Order, see Issues and Decision Memorandum.

All issues raised in interested parties' briefs and comments are addressed in the Issues and Decision Memorandum. A list of the issues raised by interested parties, and to which Commerce responded in the Issues and Decision Memorandum, is provided in the 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://access.trade.gov/public/FRNoticesListLayout.

Based on our review and analysis of the comments received from parties, Commerce made changes to certain program-specific rates applied to Kingtom on the basis of adverse facts available (AFA). See AFA Calculation Memorandum. 10

Commerce is conducting this review in accordance with section 751(a)(l)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we find that there is a subsidy, i.e., a government-provided financial contribution that gives rise to a benefit to the recipient, and the subsidy is specific. 11 For a full description of the methodology underlying all of Commerce's conclusions, including any determination that relied upon the use of AFA pursuant to section 776(a) and (b) of the Act, see the Issues and Decision Memorandum.

In the Preliminary Results, we stated our intent to rescind the review with respect to companies named in the Initiation Notice for which all review requests were timely withdrawn in accordance with 19 CFR 351.213(d)(1). These companies are listed in Appendix II of this notice. For these companies, Commerce is rescinding the administrative review and will assess duties at rates equal to the rates of the cash deposits for estimated countervailing duties required at the time of entry, or withdrawn from warehouse, for consumption, during the POR, in accordance with 19 CFR 351.212(c)(1). 12

For the companies not selected for individual examination, because we have not calculated rates for any company selected for individual examination, we have no such rates to use as a basis to determine the rate for companies not selected for individual examination in this review. Thus, we applied the above- de minimis, non-AFA countervailable subsidy rate from the most recently completed administrative review of the Order, in which we calculated a subsidy rate for an individual mandatory respondent, i.e., the 2014 administrative review of this Order. 13 For further discussion, see the Issues and Decision Memorandum.

We determine the following final countervailable subsidy rates for the period January 1, 2019, through December 31, 2019:  14

In this case, the only calculation to disclose is the calculation of the AFA rate assigned to certain respondents. Therefore, Commerce will disclose to the parties in this proceeding the calculation performed for these final results within five days of the date of publication of this notice in the Federal Register , in accordance with 19 CFR 351.224(b).

Pursuant to 19 CFR 351.212(b)(2), Commerce will determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries of subject merchandise in accordance with the final results of this review, for the above-listed companies at the applicable ad valorem assessment rates, Commerce intends to issue assessment instructions, including assessment instructions for those companies for which we rescinded the review, to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

In accordance with section 751(a)(1) of the Act, Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties at the rates shown for each of the companies listed above on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review. For all non-reviewed firms, Commerce will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the most recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

Commerce regulations provide that it will publish in the Federal Register a list of scope rulings on a quarterly basis. 1 Our most recent notification of scope rulings was published on December 8, 2021. 2 This current notice covers all scope rulings and anti-circumvention determinations made by Enforcement and Compliance between October 1, 2021-December 31, 2021.

Requestor: Mando America Corporation. Twenty-one base shells are not covered by the scope of the antidumping duty order on certain circular welded non-alloy steel pipe from Korea because they are mechanical tubing or are cold drawn; November 19, 2021.

Requestor: Mando America Corporation. Twenty-one base shells are not covered by the scope of the antidumping duty order on certain circular welded non-alloy steel pipe from Mexico because they are mechanical tubing or are cold drawn; November 19, 2021.

Requestor: Roy G. Evans Co., Inc., dba EVCO. The stock keeping unit (SKU) number NP100S steel mobile home skirting spikes and the steel mobile home skirting spikes found within the SKU KNP100S mobile home skirting kit are covered by the scope of the antidumping duty order on certain steel nails from China because the physical characteristics of the products in question fell under the description listed in the scope language; November 5, 2021.

Requester: Jimco Lamp & Manufacturing Co. Six chests are not covered by the scope of the antidumping duty order on wooden bedroom furniture from China because they are accent furniture rather than wooden bedroom furniture; December 3, 2021.

Requestor: Boise Cascade Company. Solid sawn wood planking imported by Boise Cascade is not covered by the scopes of the antidumping and countervailing duty orders on wood mouldings and millwork products from because the product is an exterior siding product which is not laminated veneer lumber (LVL) or finger-jointed; December 14, 2021.

Requestor: Global Product Sourcing LLC. Exterior siding products/solid sawn wood planks are not covered by the scopes of the antidumping and countervailing duty orders on wood mouldings and millwork products from China because the products are not LVL and are not finger-jointed; December 15, 2021.

Requestor: FNA Group, Inc (FNA). FNA's dual-piston engines are not covered by the scope of the antidumping and countervailing duty orders on small vertical engines from China because the plain language of the scope only covers “single-cylinder” engines; December 27, 2021.

Requestor: Valeo Group and its affiliates. The T-series aluminum sheet imported by Valeo Group and its affiliates is covered by the scope of the antidumping and countervailing duty orders on common alloy aluminum sheet from China because it is a flat aluminum product having a thickness of 6.3 mm or less, but greater than 0.2 mm, is a multi-alloy, clad aluminum sheet produced from a 3XXX-series core. Commerce found that an unregistered alloy ( i.e., a proprietary alloy) is still covered by the scope of the orders if it corresponds to one of the one-digit alloy series identified in the scope language, i.e., series 1XXX, 3XXX, or 5XXX; October 15, 2021.

Requestors: Domtar Corporation; Packaging Corporation of America; North Pacific Paper Company; Finch Paper LLC; and United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union. Certain uncoated paper rolls that are commonly, but not exclusively, known as “sheeter rolls” from Brazil that are further processed in the United States into individual sheets of uncoated paper are subject to the order ( i.e., paper that weighs at least 40 grams per square meter but not more than 150 grams per square meter; and that either is a white paper with a GE brightness level of 83 +/−1% or higher or is a colored paper (as defined in the scope of the order)). The uncoated paper rolls covered by the order are converted into sheets of uncoated paper using specialized cutting machinery prior to printing, and are typically, but not exclusively, between 52 and 103 inches wide and 50 inches in diameter. These uncoated paper rolls are classified under HTSUS category 4802.55; December 14, 2021.

Requestor: Self-initiated. Imports of welded oil country tubular goods completed in Brunei or the Philippines using inputs manufactured in China are circumventing the antidumping and countervailing duty orders on welded oil country tubular goods from China; November 26, 2021.

Requestors: Domtar Corporation; Packaging Corporation of America; North Pacific Paper Company; Finch Paper LLC; and United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union. Certain uncoated paper rolls that are commonly, but not exclusively, known as “sheeter rolls” from China that are further processed in the United States into individual sheets of uncoated paper are subject to the order ( i.e., paper that weighs at least 40 grams per square meter but not more than 150 grams per square meter; and that either is a white paper with a GE brightness level of 83 +/−1% or higher or is a colored paper (as defined in the scope of the order)). The uncoated paper rolls covered by the order are converted into sheets of uncoated paper using specialized cutting machinery prior to printing, and are typically, but not exclusively, between 52 and 103 inches wide and 50 inches in diameter. These uncoated paper rolls are classified under HTSUS category 4802.55; December 14, 2021.

Requestors: Domtar Corporation; Packaging Corporation of America; North Pacific Paper Company; Finch Paper LLC; and United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union. Certain uncoated paper rolls that are commonly, but not exclusively, known as “sheeter rolls” from Indonesia that are further processed in the United States into individual sheets of uncoated paper are subject to the order ( i.e., paper that weighs at least 40 grams per square meter but not more than 150 grams per square meter; and that either is a white paper with a GE brightness level of 83 +/−1% or higher or is a colored paper (as defined in the scope of the order)). The uncoated paper rolls covered by the order are converted into sheets of uncoated paper using specialized cutting machinery prior to printing, and are typically, but not exclusively, between 52 and 103 inches wide and 50 inches in diameter. These uncoated paper rolls are classified under HTSUS category 4802.55; December 14, 2021.

Interested parties are invited to comment on the completeness of this list of completed scope inquiries and anti-circumvention determinations made during the period October 1, 2021 through December 31, 2021. Any comments should be submitted to the Deputy Assistant Secretary for AD/CVD Operations, Enforcement and Compliance, International Trade Administration, via email to CommerceCLU@trade.gov.

This notice is published in accordance with 19 CFR 351.225(o).

On March 3, 2016, Commerce published AD orders on uncoated paper from Australia, Brazil, China, Indonesia, and Portugal, and CVD orders on uncoated paper from China and Indonesia. 1 On February 1, 2021, Commerce initiated the first five-year (sunset) reviews of the Orders pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). 2 As a result of its reviews, Commerce determined that revocation of the AD Orders would likely lead to a continuation or recurrence of dumping and that revocation of the CVD Orders would likely lead to the continuation or recurrence of countervailable subsidies. Therefore, Commerce notified the ITC of the magnitude of the margins and net countervailable subsidy rates likely to prevail should the Orders be revoked. 3 On February 3, 2022, the ITC published its determination, pursuant to section 751(c) of the Act, that revocation of the Orders would likely lead to a continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. 4

The scope of the Orders includes uncoated paper in sheet form; weighing at least 40 grams per square meter but not more than 150 grams per square meter; that either is a white paper with a GE brightness level 3 of 85 or higher or is a colored paper; whether or not surface-decorated, printed (except as described below), embossed, perforated, or punched; irrespective of the smoothness of the surface; and irrespective of dimensions (Certain Uncoated Paper).

Certain Uncoated Paper includes: (a) Uncoated free sheet paper that meets this scope definition; (b) uncoated ground wood paper produced from bleached chemi-thermo-mechanical pulp (BCTMP) that meets this scope definition; and (c) any other uncoated paper that meets this scope definition regardless of the type of pulp used to produce the paper.

Specifically excluded from the scope are: (1) Paper printed with final content of printed text or graphics; and (2) lined paper products, typically school supplies, composed of paper that incorporates straight horizontal and/or vertical lines that would make the paper unsuitable for copying or printing purposes. For purposes of this scope definition, paper shall be considered “printed with final content” where at least one side of the sheet has printed text and/or graphics that cover at least five percent of the surface area of the entire sheet.

On December 14, 2021, Commerce determined that imports of certain uncoated paper rolls that are commonly, but not exclusively, known as “sheeter rolls” from Brazil, China, and Indonesia that are further processed in the United States into individual sheets of uncoated paper that would be subject to the Orders ( i.e., paper that weighs at least 40 grams per square meter but not more than 150 grams per square meter; and that either is a white paper with a GE brightness level of 83 +/−1% or higher or is a colored paper (as defined above)). The uncoated paper rolls covered by the scope of these Orders are converted into sheets of uncoated paper using specialized cutting machinery prior to printing, and are typically, but not exclusively, between 52 and 103 inches wide and 50 inches in diameter. For clarity, we herein refer to “subject-paper rolls” when referencing the certain uncoated paper rolls that may be converted into subject merchandise. Subject-paper rolls are classified under HTSUS category 4802.55.

Certain importers of the subject-paper rolls that are not converted into subject merchandise may certify that the rolls will not be further processed into subject merchandise covered by the scope of these Orders. Failure to comply with the requisite certification requirement may result in the merchandise being found subject to AD and CVD duties. 5

Imports of the subject merchandise are provided for under Harmonized Tariff Schedule of the United States (HTSUS) categories 4802.55.1000, 4802.55.2000, 4802.55.3000, 4802.55.4000, 4802.55.6000, 4802.55.7020, 4802.55.7040, 4802.56.1000, 4802.56.2000, 4802.56.3000, 4802.56.4000, 4802.56.6000, 4802.56.7020, 4802.56.7040, 4802.57.1000, 4802.57.2000, 4802.57.3000, and 4802.57.4000. Some imports of subject merchandise may also be classified under 4802.62.1000, 4802.62.2000, 4802.62.3000, 4802.62.5000, 4802.62.6020, 4802.62.6040, 4802.69.1000, 4802.69.2000, 4802.69.3000, 4811.90.8050 and 4811.90.9080. While HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the Orders is dispositive.

As a result of the determinations by Commerce and the ITC that revocation of the Orders would likely lead to a continuation or recurrence of dumping, countervailable subsidies, and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, Commerce hereby orders the continuation of the AD orders on uncoated paper from Australia, Brazil, China, Indonesia, and Portugal, and the continuation of the CVD orders on uncoated paper from China and Indonesia. U.S. Customs and Border Protection will continue to collect AD and CVD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of the continuation of the Orders will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act, Commerce intends to initiate the next five-year reviews of the Orders not later than 30 days prior to the fifth anniversary of the effective date of continuation.

This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return/destruction or conversion to judicial protective order of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Failure to comply is a violation of the APO which may be subject to sanctions.

These five-year (sunset) reviews and this notice are in accordance with section 751(c) of the Act and published pursuant to section 777(i)(1) of the Act.

On October 13, 2021, Commerce published the Preliminary Results of this administrative review in the Federal Register . 1 No interested party submitted comments concerning the Preliminary Results or requested a hearing in this administrative review. Commerce conducted this administrative review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).

The product covered by the Order is magnesium metal from China, which includes primary and secondary alloy magnesium metal, regardless of chemistry, raw material source, form, shape, or size. Magnesium is a metal or alloy containing by weight primarily the element magnesium. Primary magnesium is produced by decomposing raw materials into magnesium metal. Secondary magnesium is produced by recycling magnesium-based scrap into magnesium metal. The magnesium covered by the Order includes blends of primary and secondary magnesium. The subject merchandise includes the following alloy magnesium metal products made from primary and/or secondary magnesium including, without limitation, magnesium cast into ingots, slabs, rounds, billets, and other shapes; magnesium ground, chipped, crushed, or machined into rasping, granules, turnings, chips, powder, briquettes, and other shapes; and products that contain 50 percent or greater, but less than 99.8 percent, magnesium, by weight, and that have been entered into the United States as conforming to an “ASTM Specification for Magnesium Alloy”  3 and are thus outside the scope of the existing antidumping orders on magnesium from China (generally referred to as “alloy” magnesium).

The scope of the Order excludes: (1) All forms of pure magnesium, including chemical combinations of magnesium and other material(s) in which the pure magnesium content is 50 percent or greater, but less than 99.8 percent, by weight, that do not conform to an “ASTM Specification for Magnesium Alloy;”  4 (2) magnesium that is in liquid or molten form; and (3) mixtures containing 90 percent or less magnesium in granular or powder form by weight and one or more of certain non-magnesium granular materials to make magnesium-based reagent mixtures, including lime, calcium metal, calcium silicon, calcium carbide, calcium carbonate, carbon, slag coagulants, fluorspar, nephaline syenite, feldspar, alumina (Al203), calcium aluminate, soda ash, hydrocarbons, graphite, coke, silicon, rare earth metals/mischmetal, cryolite, silica/fly ash, magnesium oxide, periclase, ferroalloys, dolomite lime, and colemanite. 5 The merchandise subject to this Order is classifiable under items 8104.19.00, and 8104.30.00 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise is dispositive.

In the Preliminary Results, Commerce determined TMI and TMM had no shipments of subject merchandise to the United States during the POR. 6 As noted in the Preliminary Results, we received no-shipment statements from TMI and TMM, 7 and the statements were consistent with the information we received from U.S. Customs and Border Protection (CBP). 8 Because Commerce did not receive any comments on its preliminary finding, Commerce continues to find that TMI and TMM did not have any shipments of subject merchandise during the POR.

Based on record evidence, we have determined that TMI and TMM had no shipments of subject merchandise during the POR, and, therefore, pursuant to Commerce's assessment practice, any suspended entries entered under their case numbers will be liquidated at the China-wide entity rate. 9

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

The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) For previously investigated or reviewed Chinese and non-Chinese exporters that received a separate rate in a prior segment of this proceeding, including TMI, the cash deposit rate will continue to be the existing exporter-specific rate; (2) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, including TMM, the cash deposit rate will be the China-wide rate of 141.49 percent;  10 and (3) for all non-Chinese exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the Chinese exporter(s) that supplied that non-Chinese exporter. These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return of destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

This notice is issued and published in accordance with sections 751(a) and 777(i) of the Act, and 19 CFR 351.213(h).

This is a request for extension of an existing information collection.

The NOAA Commissioned Officer Corps is the uniformed service of the National Oceanic and Atmospheric Administration (NOAA), a bureau of the United States Department of Commerce. Officers serve under Senate-confirmed appointments and Presidential commissions (33 U.S.C. chapter 17, subchapter 1, sections 853 and 854). The NOAA Corps provides a cadre of professionals trained in engineering, earth sciences, oceanography, meteorology, fisheries science, and other related disciplines who serve their country by supporting NOAA's mission of surveying the Earth's oceans, coasts, and atmosphere to ensure the economic and physical well-being of the Nation.

NOAA Corps officers operate vessels and aircraft engaged in scientific missions and serve in leadership positions throughout NOAA. Persons wishing to apply for an appointment in the NOAA Commissioned Officer Corps must complete an application package, including NOAA Form 56-42, at least three letters of recommendation, and official transcripts. A personal interview must also be conducted. Eligibility requirements include a bachelor's degree with at least 48 credit hours of science, engineering, or other disciplines related to NOAA's mission, excellent health, and normal color vision with uncorrected visual acuity no worse than 20/400 in each eye (correctable to 20/20).

Applicants must utilize the E-recruit electronic application process and then submit paper forms via mail. An in-person interview is also required.

OMB Control Number: 0648-0047.

Form Number(s): NOAA 56-42 and NOAA 56-42A.

Type of Review: Regular submission [extension of an existing information collection].

Affected Public: Individuals or households.

Estimated Number of Respondents: 300.

Estimated Time per Response: Written applications, 2 hours; interviews, 5 hours; references, 15 minutes.

Estimated Total Annual Burden Hours: 2,475.

Estimated Total Annual Cost to Public: $21,750.

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

Legal Authority: 33 U.S.C. chapter 17, subchapter 1, sections 853 and 854.

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

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

This collection of information is required by the Trademark Act of 1946, 15 U.S.C. 1051 et seq., which provides for the Federal registration of trademarks, service marks, collective trademarks and service marks, collective membership marks, and certification marks. The Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks (Madrid Protocol) is an international treaty that allows a trademark owner to seek registration in any of the participating countries by filing a single international application. The International Bureau (IB) of the World Intellectual Property Organization (WIPO) in Geneva, Switzerland, administers the international registration system. The Madrid Protocol Implementation Act of 2002 amended the Trademark Act to provide that: (1) The owner of a U.S. application or registration may seek protection of its mark in any of the participating countries by submitting a single international application through the USPTO and (2) the holder of an international registration may request an extension of protection of the international registration to the United States. The Madrid Protocol came into effect in the United States on November 2, 2003, and is implemented under 15 U.S.C. 1141 et seq. and 37 CFR part 2 and Part 7. Individuals and businesses that use or intend to use such marks in commerce may file an application to register the marks with the USPTO. Both the register and the information provided in pending applications for registration can be accessed by the public in order to determine the availability of a mark and lessen the likelihood of initiating the use of a mark previously adopted by another.

Items in this information collection must be submitted via online electronic submissions through the Trademark Electronic Application System (TEAS). In limited circumstances, applicants may also be permitted to submit the information in paper form by mail or hand delivery.

OMB Control Number: 0651-0051.

Forms:

Type of Review: Extension and revision of a currently approved information collection.

Affected Public: Private sector; individuals and households.

Respondent's Obligation: Required to obtain or retain benefits.

Estimated Number of Annual Respondents: 54,082 respondents.

Estimated Number of Annual Responses: 54,082 responses.

Estimated Time per Response: The USPTO estimates that the responses in this information collection will take the public approximately between 40 minutes (0.66 hours) to 75 minutes (1.25 hours) to complete. This includes the time to gather the necessary information, prepare the forms or documents, and submit the completed request to the USPTO.

Estimated Total Annual Respondent Burden Hours: 48,671 hours.

Estimated Total Annual Respondent Hourly Cost Burden: $21,171,885.

The U.S. Air Force Scientific Advisory Board will now be known as the DAF SAB, and its charter is being amended in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C., Appendix) and 41 CFR 102-3.50(d). The charter and contact information for the DAF SAB's Designated Federal Officer (DFO) are found at https://www.facadatabase.gov/FACA/apex/FACAPublicAgency Navigation.

The DAF SAB provides the Secretary of Defense and Deputy Secretary of Defense with independent advice and recommendations on matters supporting the Department of the Air Force's (DAF) scientific and technical enterprise and specifically on matters pertaining to (a) conducting studies on topics deemed critical by the Secretary of the Air Force; (b) recommending applications of technology to improve DAF capabilities; and (c) providing independent reviews of the quality and relevance of the DAF science and technology (S&T) programs. The DAF SAB is composed of no more than 20 members who are eminent authorities in the fields of defense and/or S&T. These members come from varied backgrounds such as science, technology, manufacturing, acquisition, logistics, public or private sector business management, Federally Funded Research and Development Centers, National Laboratories, and academia (universities and colleges).

Individual members are appointed according to DoD policy and procedures, and serve a term of service of one-to-four years with annual renewals. One member will be appointed as Chair of the DAF SAB. No member, unless approved according to DoD policy and procedures, may serve more than two consecutive terms of service on the DAF SAB, or serve on more than two DoD Federal advisory committees at one time.

DAF SAB members who are not full-time or permanent part-time Federal civilian officers or employees, or active duty members of the Uniformed Services, are appointed as experts or consultants, pursuant to 5 U.S.C. 3109, to serve as special government employee members. DAF SAB members who are full-time or permanent part-time Federal civilian officers or employees, or active duty members of the Uniformed Services are appointed pursuant to 41 CFR 102-3.130(a), to serve as regular government employee members.

All DAF SAB members are appointed to provide advice based on their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Except for reimbursement of official DAF SAB-related travel and per diem, members serve without compensation.

The public or interested organizations may submit written statements about the DAF SAB's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the DAF SAB. All written statements shall be submitted to the DFO for the DAF SAB, and this individual will ensure that the written statements are provided to the membership for their consideration.

Purpose of Program: The purposes of the Educational Technology, Media, and Materials for Individuals with Disabilities (ETechM2) Program are to improve results for children with disabilities by (1) promoting the development, demonstration, and use of technology; (2) supporting educational activities designed to be of educational value in the classroom; (3) providing support for captioning and video description that is appropriate for use in the classroom; and (4) providing accessible educational materials (AEM) to children with disabilities in a timely manner. 1

Priority: This competition includes one absolute priority. In accordance with 34 CFR 75.105(b)(2)(v), this priority is from allowable activities specified in the statute (see sections 674(c)(1)(D) and 681(d) of the Individuals with Disabilities Education Act (IDEA); 20 U.S.C. 1474(c)(1)(D) and 1481(d)).

Absolute Priority: For FY 2022 and any subsequent year in which we make awards from the list of unfunded applications from this competition, this priority is an absolute priority. Under 34 CFR 75.105(c)(3), we consider only applications that meet this priority.

This priority is:

Educational Technology, Media, and Materials for Individuals with Disabilities—Educational Materials in Accessible Formats for Eligible Children and Students with Disabilities.

Background:

IDEA requires State educational agencies (SEAs) and local educational agencies (LEAs) to provide free educational materials, including textbooks and instructional materials, in accessible formats  2 to eligible early intervention, preschool, elementary, and secondary children and students in a timely manner (IDEA Part B, section 612(a)(23)(B) and section 613(a)(6)(B)).

Further, under section 504 of the Rehabilitation Act of 1973, as amended, recipients of Federal financial assistance that are institutions of higher education (IHEs), SEAs, and LEAs must provide educational materials in accessible formats as a means to accommodate students with disabilities, including those who are blind, have a visual impairment or perceptual or reading disability, or have a physical disability. The accessible formats are needed to provide these students with an equal educational opportunity. 34 CFR 104.4.

Title II of the Americans with Disabilities Act (ADA) of 1990 is also applicable and requires, among other things, that public entities, including LEAs, SEAs, and public IHEs, ensure that students with disabilities have an equal opportunity to participate in a school's services, programs, or activities and ensure that communication with students with disabilities is as effective as communication with students without disabilities, through the provision, in a timely manner, of auxiliary aids and services. 28 CFR 35.130, 35.160.

To help ensure the free distribution of educational materials in accessible formats, Congress has granted exceptions to copyright holders' exclusive rights to replication and distribution through 17 U.S.C. 121 (the Chafee Amendment), which authorizes entities to reproduce or distribute copies of previously published works in accessible formats exclusively for use by eligible persons. 3

In the 2019-2020 school year, States reported that there were 28,132 enrolled students, ages 3 through 21, receiving services through IDEA whose primary disability eligibility category was deaf-blindness or visual impairment including blindness and 2,381,411 students had a specific learning disability, many of whom would typically qualify as having a reading or perceptual disability that inhibits access to printed educational materials (U.S. Department of Education, 2020). For more than 15 years, previous projects supported by the Department have provided equitable access to materials that enable access to and progress in the general education curriculum for more than 800,000 individuals who have downloaded more than 10,045,000 files. These numbers continue to grow daily ( www.bookshare.org ). In order to provide access to educational content that is otherwise denied to individuals with disabilities when content is inaccessible, the provision of AEM is required. The provision of AEM enables those individuals to access content and experience equal opportunity and benefit from their education.

Priority:

The purpose of this priority is to fund a cooperative agreement to establish and operate a Center that will provide free educational materials, 4 including textbooks, in fully accessible media for eligible children and students  5 enrolled in early intervention, preschool, elementary, and secondary schools, and eligible students enrolled in postsecondary schools. This Center will provide high-quality AEM to eligible children and students with disabilities, including individuals from racially and ethnically diverse backgrounds, at no cost, in a timely manner including dedicated outreach and collaboration with stakeholders (including those in high needs communities) to increase awareness and use of AEM. As a condition of this grant, the educational materials and textbooks distributed by the Center must be in accessible formats that are of high quality and meet or exceed industry standards for accessibility ( e.g., Web Content Accessibility Guidelines (WCAG) 2.1 Level AA Standard; EPUB 3.2 Accessibility Standards) and digital rights management. Processes, strategies, and models used in the production, dissemination, and in digital rights management must be user-friendly, efficient, and cost effective. The AEM distributed by the Center must exemplify accessibility features required to receive third-party certification for accessibility. The Center will improve access to text, images, charts, graphics, equations, and other expressions, notations, or numerical content included in educational materials. To facilitate continuous improvement and promote equity in access to free, high-quality products and services, the Center will collect and analyze relevant data on the needs of its' users  6 and barriers encountered by children and students eligible to use, but not currently using AEM.

The Center must achieve, at a minimum, the following expected outcomes:

(a) Improved access to text, images, charts, graphics, equations, and other expressions, notations, or numerical content disseminated in AEM;

(b) An increase in the number of children and students accessing high-quality AEM, including those in underserved communities ( e.g., urban, rural, and high-poverty areas);

(c) An increase in the number of early intervention providers, LEAs, and postsecondary schools enrolling eligible children or students and accessing AEM on behalf of eligible children and students;

(d) An increase in the number of eligible children and students enrolling and accessing AEM directly from the Center;

(e) An increase in the number of publishers and producers who create and disseminate student-ready accessible files to the Center and provide eligible children and students direct access to student-ready accessible files;

(f) An increase in the number and quality of science, technology, engineering, and mathematics (STEM) textbooks and educational materials, including STEM images, graphics, descriptions, charts, equations, and other expressions, notations, or numerical content distributed to eligible children and students;

(g) Improved implementation of a model or models for producing and disseminating educational materials in accessible formats for children served under Part C of IDEA and section 619 of IDEA;

(h) Expanded or enhanced models for postsecondary schools to produce and disseminate accessible educational materials and textbooks that align with the key recommendations from the Advisory Commission on Accessible Instructional Materials in Postsecondary Education for Students with Disabilities (2011);  7 and

(i) Increased provision of educational materials in accessible formats, including any specialized software needed to use the materials, at no cost to SEAs, LEAs, families, schools for use by students who are eligible to receive accessible materials through the National Instructional Materials Access Center (NIMAC). 8

In addition to these programmatic requirements, to be considered for funding under this priority, applicants must meet the application and administrative requirements in this priority, which are:

(a) Demonstrate, in the narrative section of the application under “Quality of project services,” how the proposed project will—

(1) Acquire materials from publishers or authorized entities and make those materials accessible and available as high-quality, user-friendly AEM, including digital text, braille-ready files, and audio formats at no cost to eligible children and students;

(2) Ensure equal access and treatment for eligible children and students from groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. To meet this requirement, the applicant must describe how it will—

(i) Apply knowledge of diverse populations, inclusive with regard to race, ethnicity, culture, language, and disability status, to determine preferences and respond to unmet needs of eligible children and students in selecting the materials and services made available by the Center;

(ii) Use criteria to develop and implement processes for selecting, producing, and adding high-quality products and services to meet the needs of eligible children and students; and

(iii) Increase engagement in high-need communities to ensure educators in these communities are accessing professional development and learning to support the effective use of AEM in their instructional practice.

(3) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—

(i) Measurable intended project outcomes; and

(ii) A plan to implement the services and provide the products described in paragraph one of this section including the provision of no cost, compatible software for use with a variety of electronic devices and operating systems ( e.g., e-readers, computers, smart phones, and tablets);

(iii) A plan that focuses on improving the quality, timeliness, ease of use, and access to AEM for eligible children and students, including anticipating and responding to future needs and technologies across the five years of the project;

(iv) A plan to ensure that eligible children and students will continue to be able to access at no cost the educational materials, including textbooks, in accessible formats, when the Center is no longer federally funded;

(v) A plan to ensure that resources developed by the Center are, to the maximum extent allowable under the law, openly licensed  9 through an open licensing authority;

(vi) A detailed digital rights management plan that will be implemented during the project and will protect the interests of rights holders while maintaining ease of access to AEM for eligible children and students;

(vii) A plan to consult with publishers, software developers, other manufacturers of AEM for eligible children and students, and the NIMAC, to ensure that the project uses the most efficient, cost-effective technology available to provide timely access to AEM. This plan should also address strategies to provide consistent features across all interfaces and media formats;

(viii) A plan to encourage and support the inclusion of accessibility features that are embedded during the development and production of the AEM by publishers and producers, where possible;

(ix) A plan for how the project will proactively coordinate across authorized entities to include IHEs, SEAs, and LEAs to reduce costs of production and duplication of materials, and to improve the timeliness of distribution;

(x) Information on how the project will collaborate with the National Library Service (NLS), Described and Captioned Media Program (DCMP), NIMAC, the National AEM Center, and other projects supporting accessibility to ensure awareness of work, share developed products to improve the quality of AEM, and minimize duplicative efforts;

(xi) Information on how the project will collaborate with the National AEM Center and other projects supporting accessibility to implement a plan for improving IHE, SEA, and LEA systems for providing educational material in accessible formats to eligible children and students; and

(xii) A description of how the project will ensure that project activities are conducted in compliance with 17 U.S.C. 121. ( www.copyright.gov/title17/92chap1.html#121 ).

(4) Provide direct support to eligible children and students to address any technical assistance (TA) needs;

(5) Implement outreach activities to systematically distribute information, products, and services to varied audiences, including underserved individuals and their families ( e.g., individuals from racially, ethnically, linguistically diverse backgrounds and individuals living in poverty or experiencing homelessness), using a variety of engagement strategies, to promote awareness and use of the Center's products and services; and

(6) Develop a professional learning plan to increase awareness of AEM, develop educator capacity, and create support systems for current and future educators. The plan must include strategies to engage faculty from teacher preparation programs responsible for preparing future educators as well as outreach to and engagement with current educators to support the effective use of AEM in their instructional practice.

(b) In the narrative section of the application under “Quality of the project evaluation,” include an evaluation plan for the project developed in consultation with and implemented by a third-party evaluator. 10 The evaluation plan must—

(1) Include the logic model  11 by which the proposed project will achieve its intended outcomes that depicts, at a minimum, the goals and how they will be measured, activities, outputs, and intended outcomes of the proposed project;

(2) Describe a formative and summative evaluation plan, including important process and outcome evaluation questions. The plan must describe how the formative evaluation will use clear performance objectives to ensure continuous improvement in the operation of the proposed project, including objective measures of progress in implementing the project and ensuring quality of products and services. This plan should be related to the project's proposed logic model required in paragraph (b)(1) of the application and administrative requirements in this priority;

(3) Describe how progress in and fidelity of implementation, as well as project outcomes, will be measured to answer the evaluation questions. Specify the measures and associated instruments to be used so that the project can better meet the needs of current users and identify the needs of eligible, non-users. Identify and justify the sources for data appropriate to the evaluation questions. Include information regarding procedures for establishing reliability and validity of measures and data quality, where appropriate. Data sources must include, at a minimum—

(i) Information on the numbers of free educational materials requested by, produced for, available to, distributed to, and accessed by eligible children and students;

(ii) Information on the characteristics of the free educational materials ( e.g., descriptive metadata, file types, types of literary work, source of materials), requested by, produced for, available to, distributed to, and accessed by eligible children and students;

(iii) Information on the characteristics of the current users ( e.g., qualifying disability type (visual, learning, physical), individualized education program status, 504 plan status, age, grade level, member type, National Center for Education Statistics District ID or Institution) who request and access the free educational materials;

(4) Describe strategies for analyzing data and how data collected as part of this plan will be used to inform and improve product development and service delivery over the course of the project and to refine the proposed logic model and evaluation plan, including subsequent data collection;

(5) Include cost and efficiency measures, or a plan for cost and efficiency measures, for the production of AEM and using information from those measures to incorporate the most efficient, cost-effective technology available to provide timely access to AEM that can be used across alternative media formats;

(6) Provide a timeline for conducting the evaluation and include staff assignments for completing the plan. The timeline must indicate that the data will be available annually for the annual performance report (APR) and at the end of Year 2 for the review process described under the heading, Fourth and Fifth Years of the Project;

(7) Dedicate sufficient funds in each budget year to cover the costs of developing or refining the evaluation plan in consultation with a third-party evaluator, as well as the costs associated with the implementation of the evaluation plan by the third-party evaluator.

(c) Demonstrate, in the narrative section of the application under “Adequacy of resources and quality of project personnel,” how—

(1) The proposed project will encourage applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability, as appropriate;

(2) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to carry out the proposed activities and achieve the project's intended outcomes;

(3) The applicant and any key partners have adequate resources to carry out the proposed activities; and

(4) The proposed costs are reasonable in relation to the anticipated results and benefits.

(d) Demonstrate, in the narrative section of the application under “Quality of the management plan,” how—

(1) The proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this requirement, the applicant must describe—

(i) Clearly defined responsibilities for key project personnel, consultants, and subcontractors, as applicable; and

(ii) Timelines and milestones for accomplishing the project tasks;

(2) Key project personnel and any consultants and subcontractors will be allocated and how these allocations are appropriate and adequate to achieve the project's intended outcomes;

(3) The proposed management plan will ensure that the products and services provided are of high quality, relevant, and useful to recipients; and

(4) The proposed project will benefit from a diversity of perspectives, including those of eligible children or students, families, educators, TA providers, researchers, and policy makers, among others, in its development and operation.

(5) The proposed project will establish and maintain an advisory committee consisting of representatives from an SEA and an LEA; representatives from community colleges and four-year IHEs; representatives from vocational rehabilitation agencies; eligible children and students, and/or parents or family members of eligible children or students; and representatives of schools or other institutions where AEM are used. The purpose of this advisory committee is to provide the project with input and ongoing advice on the project's goals, objectives, products, and services. The project must submit the proposed membership of the advisory committee to the Office of Special Education Programs (OSEP) for approval within eight weeks after receipt of the award;

(6) The project will communicate and collaborate on an ongoing basis with OSEP-funded projects (see www.osepideasthatwork.org/find-center-or-grant/find-a-center ), including NIMAS-related projects. Activities could include jointly developing products, training sessions, and materials; and improving the AEM delivery system to ensure timely and easy access; and

(7) The project will maintain ongoing communication with the OSEP project officer through phone conferences, email communication, and face-to-face meetings, as appropriate.

(e) Address the following application requirements. The applicant must—

(1) Include, in Appendix A, personnel-loading charts and timelines, as applicable, to illustrate the management plan described in the narrative;

(2) Use a conceptual framework (and provide a copy in Appendix A) to develop project plans and activities, describing any underlying concepts, assumptions, expectations, beliefs, or theories, as well as the presumed relationships or linkages among these variables, and any empirical support for this framework;

Note: The following websites provide more information on logic models and conceptual frameworks: www.osepideasthatwork.org/logicModel and www.osepideasthatwork.org/resources-grantees/program-areas/ta-ta/tad-project-logic-model-and-conceptual-framework.

(3) Include, in the budget, attendance at the following:

(i) A one and one-half day kick-off meeting in Washington, DC, or virtually, after receipt of the award, and an annual planning meeting in Washington, DC, or virtually, with the OSEP project officer and other relevant staff during each subsequent year of the project period.

Note: Within 30 days of receipt of the award, a post-award teleconference must be held between the OSEP project officer and the grantee's project director or other authorized representative;

(ii) A two and one-half day project directors' conference in Washington, DC, or virtually, during each year of the project period;

(iii) Two annual two-day trips, or virtually, to attend Department briefings, Department-sponsored conferences, and other meetings, as requested by OSEP; and

(iv) A one-day intensive 3+2 review meeting in Washington, DC, or virtually, during the last half of the second year of the project period;

(4) Include, in the budget, a line item for an annual set-aside of 5 percent of the grant amount to support emerging needs that are consistent with the proposed project's intended outcomes, as those needs are identified in consultation with, and approved by, the OSEP project officer. With approval from the OSEP project officer, the project must reallocate any remaining funds from this annual set-aside no later than the end of the third quarter of each budget period; and

(5) Maintain a high-quality website, with an easy-to-navigate design, that meets or exceeds government or industry-recognized standards for accessibility;

(6) Ensure that annual project progress toward meeting project goals is posted on the project website; and

(7) Include, in Appendix A, an assurance to assist OSEP with the transfer of pertinent resources and products and to maintain the continuity of services to eligible children and students during the transition to this new award period and at the end of this award period, as appropriate.

Fourth and Fifth Years of the Project:

In deciding whether to continue funding the project for the fourth and fifth years, the Secretary will consider the requirements of 34 CFR 75.253(a), including—

(a) The recommendations of a 3+2 review team consisting of experts who have experience and knowledge in providing educational materials in accessible formats for eligible children and students with disabilities. This review will be conducted during a one-day intensive meeting that will be held during the last half of the second year of the project period;

(b) The timeliness with which, and how well, the requirements of the negotiated cooperative agreement have been or are being met by the project; and

(c) The quality, relevance, and usefulness of the project's products and services and the extent to which the project's products and services are aligned with the project's objectives and likely to result in the project achieving its intended outcomes.

Under 34 CFR 75.253, the Secretary may reduce continuation awards or discontinue awards in any year of the project period for excessive carryover balances or a failure to make substantial progress. The Department intends to closely monitor unobligated balances and substantial progress under this program and may reduce or discontinue funding accordingly.

References:

Waiver of Proposed Rulemaking: Under the Administrative Procedure Act (APA) (5 U.S.C. 553) the Department generally offers interested parties the opportunity to comment on proposed priorities. Section 681(d) of IDEA, however, makes the public comment requirements of the APA inapplicable to the priority in this notice.

Program Authority: 20 U.S.C. 1474 and 1481.

Note: Projects will be awarded and must be operated in a manner consistent with the nondiscrimination requirements contained in Federal civil rights laws.

Applicable Regulations: (a) The Education Department General Administrative Regulations in 34 CFR parts 75, 77, 79, 81, 82, 84, 86, 97, 98, and 99. (b) The Office of Management and Budget Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474.

Note: The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian Tribes.

Note: The regulations in 34 CFR part 86 apply to IHEs only.

Type of Award: Cooperative agreement.

Estimated Available Funds: The Administration has requested $29,547,000 for the Educational Technology, Media, and Materials for Individuals with Disabilities program for FY 2022, of which we intend to use an estimated $8,500,000 for this competition. The actual level of funding, if any, depends on final congressional action. However, we are inviting applications to allow enough time to complete the grant process if Congress appropriates funds for this program.

Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2023 from the list of unfunded applications from this competition.

Maximum Award: We will not make an award exceeding $8,500,000 for a single budget period of 12 months.

Estimated Number of Awards: 1.

Note: The Department is not bound by any estimates in this notice.

Project Period: Up to 60 months.

1. Eligible Applicants: SEAs; State lead agencies under Part C of IDEA; LEAs, including public charter schools that are considered LEAs under State law; IHEs; other public agencies; private nonprofit organizations; freely associated States and outlying areas; Indian Tribes or Tribal organizations; and for-profit organizations.

2. a. Cost Sharing or Matching: This competition does not require cost sharing or matching.

b. Indirect Cost Rate Information: This program uses an unrestricted indirect cost rate. For more information regarding indirect costs, or to obtain a negotiated indirect cost rate, please see www2.ed.gov/about/offices/list/ocfo/intro.html.

c. Administrative Cost Limitation: This program does not include any program-specific limitation on administrative expenses. All administrative expenses must be reasonable and necessary and conform to Cost Principles described in 2 CFR part 200 subpart E of the Uniform Guidance.

3. Subgrantees: A grantee under this competition may not award subgrants to entities to directly carry out project activities described in its application. Under 34 CFR 75.708(e), a grantee may contract for supplies, equipment, and other services in accordance with 2 CFR part 200.

4. Other General Requirements:

a. Recipients of funding under this competition must make positive efforts to employ and advance in employment qualified individuals with disabilities (see section 606 of IDEA).

b. Applicants for, and recipients of, funding must, with respect to the aspects of their proposed project relating to the absolute priority, involve individuals with disabilities, or parents of individuals with disabilities ages birth through 26, in planning, implementing, and evaluating the project (see section 682(a)(1)(A) of IDEA).

1. Application Submission Instructions: Applicants are required to follow the Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the Federal Register on December 27, 2021 (86 FR 73264) and available at www.federalregister.gov/d/2021-27979. Please note that these Common Instructions supersede the version published on February 13, 2019, and, in part, describe the transition from the requirement to register in SAM.gov a Data Universal Numbering System (DUNS) number to the implementation of the Unique Entity Identifier (UEI). More information on the phase-out of DUNS numbers is available at https://www2.ed.gov/about/offices/list/ofo/docs/unique-entity-identifier-transition-fact-sheet.pdf.

2. Intergovernmental Review: This competition is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this competition.

3. Funding Restrictions: We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice.

4. Recommended Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. We recommend that you (1) limit the application narrative to no more than 70 pages and (2) use the following standards:

• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.

• Double-space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, reference citations, and captions, as well as all text in charts, tables, figures, graphs, and screen shots.

• Use a font that is 12 point or larger.

• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial.

The recommended page limit does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications; or the abstract (follow the guidance provided in the application package for completing the abstract), the table of contents, the list of priority requirements, the resumes, the reference list, the letters of support, or the appendices. However, the recommended page limit does apply to all of the application narrative, including all text in charts, tables, figures, graphs, and screen shots.

1. Selection Criteria: The selection criteria for this competition are from 34 CFR 75.210 and are listed below:

(a) Quality of project services (30 points).

(1) The Secretary considers the quality of the services to be provided by the proposed project.

(2) In determining the quality of the services to be provided by the proposed project, the Secretary considers the quality and sufficiency of strategies for ensuring equal access and treatment for eligible project participants who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.

(3) In addition, the Secretary considers the following factors:

(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable.

(ii) The likely impact of the services to be provided by the proposed project on the intended recipients of those services.

(iii) The extent to which the services to be provided by the proposed project reflect up-to-date knowledge from research and effective practice.

(iv) The extent to which the training or professional development services to be provided by the proposed project are of sufficient quality, intensity, and duration to lead to improvements in practice among the recipients of those services.

(v) The extent to which the technical assistance services to be provided by the proposed project involve the use of efficient strategies, including the use of technology, as appropriate, and the leveraging of non-project resources.

(b) Quality of the project evaluation (30 points).

(1) The Secretary considers the quality of the evaluation to be conducted of the proposed project.

(2) In determining the quality of the evaluation, the Secretary considers the following factors:

(i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project.

(ii) The extent to which the methods of evaluation provide for examining the effectiveness of project implementation strategies.

(iii) The extent to which the methods of evaluation will provide timely guidance for quality assurance.

(iv) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes.

(v) The extent to which the methods of evaluation will provide valid and reliable performance data on relevant outcomes.

(c) Adequacy of resources and quality of project personnel (20 points).

(1) The Secretary considers the adequacy of resources for the proposed project and the quality of the personnel who will carry out the proposed project.

(2) In determining the quality of project personnel, the Secretary considers the extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.

(3) In addition, the Secretary considers the following factors:

(i) The qualifications, including relevant training and experience, of the project director or principal investigator.

(ii) The qualifications, including relevant training and experience, of key project personnel.

(iii) The qualifications, including relevant training and experience, of project consultants or subcontractors.

(iv) The qualifications, including relevant training, experience, and independence, of the evaluator.

(v) The adequacy of support, including facilities, equipment, supplies, and other resources, from the applicant organization or the lead applicant organization.

(vi) The relevance and demonstrated commitment of each partner in the proposed project to the implementation and success of the project.

(vii) The extent to which the budget is adequate to support the proposed project.

(viii) The extent to which the costs are reasonable in relation to the objectives, design, and potential significance of the proposed project.

(d) Quality of the management plan (20 points).

(1) The Secretary considers the quality of the management plan for the proposed project.

(2) In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:

(i) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.

(ii) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project.

(iii) The adequacy of mechanisms for ensuring high-quality products and services from the proposed project.

(iv) How the applicant will ensure that a diversity of perspectives are brought to bear in the operation of the proposed project, including those of parents, teachers, the business community, a variety of disciplinary and professional fields, recipients or beneficiaries of services, or others, as appropriate.

2. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

In addition, in making a competitive grant award, the Secretary requires various assurances, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

3. Additional Review and Selection Process Factors: In the past, the Department has had difficulty finding peer reviewers for certain competitions because so many individuals who are eligible to serve as peer reviewers have conflicts of interest. The standing panel requirements under section 682(b) of IDEA also have placed additional constraints on the availability of reviewers. Therefore, the Department has determined that for some discretionary grant competitions, applications may be separated into two or more groups and ranked and selected for funding within specific groups. This procedure will make it easier for the Department to find peer reviewers by ensuring that greater numbers of individuals who are eligible to serve as reviewers for any particular group of applicants will not have conflicts of interest. It also will increase the quality, independence, and fairness of the review process, while permitting panel members to review applications under discretionary grant competitions for which they also have submitted applications.

4. Risk Assessment and Specific Conditions: Consistent with 2 CFR 200.206, before awarding grants under this competition the Department conducts a review of the risks posed by applicants. Under 2 CFR 200.208, the Secretary may impose specific conditions, and under 2 CFR 3474.10, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

5. Integrity and Performance System: If you are selected under this competition to receive an award that over the course of the project period may exceed the simplified acquisition threshold (currently $250,000), under 2 CFR 200.206(a)(2) we must make a judgment about your integrity, business ethics, and record of performance under Federal awards—that is, the risk posed by you as an applicant—before we make an award. In doing so, we must consider any information about you that is in the integrity and performance system (currently referred to as the Federal Awardee Performance and Integrity Information System (FAPIIS)), accessible through the System for Award Management. You may review and comment on any information about yourself that a Federal agency previously entered and that is currently in FAPIIS.

Please note that, if the total value of your currently active grants, cooperative agreements, and procurement contracts from the Federal Government exceeds $10,000,000, the reporting requirements in 2 CFR part 200, Appendix XII, require you to report certain integrity information to FAPIIS semiannually. Please review the requirements in 2 CFR part 200, Appendix XII, if this grant plus all the other Federal funds you receive exceed $10,000,000.

6. In General: In accordance with the Office of Management and Budget's guidance located at 2 CFR part 200, all applicable Federal laws, and relevant Executive guidance, the Department will review and consider applications for funding pursuant to this notice inviting applications in accordance with—

(a) Selecting recipients most likely to be successful in delivering results based on the program objectives through an objective process of evaluating Federal award applications (2 CFR 200.205);

(b) Prohibiting the purchase of certain telecommunication and video surveillance services or equipment in alignment with section 889 of the National Defense Authorization Act of 2019 (Pub. L. 115—232) (2 CFR 200.216);

(c) Providing a preference, to the extent permitted by law, to maximize use of goods, products, and materials produced in the United States (2 CFR 200.322); and

(d) Terminating agreements in whole or in part to the greatest extent authorized by law if an award no longer effectuates the program goals or agency priorities (2 CFR 200.340).

1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN); or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

If your application is not evaluated or not selected for funding, we notify you.

2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

3. Open Licensing Requirements: Unless an exception applies, if you are awarded a grant under this competition, you will be required to openly license to the public grant deliverables created in whole, or in part, with Department grant funds. When the deliverable consists of modifications to pre-existing works, the license extends only to those modifications that can be separately identified and only to the extent that open licensing is permitted under the terms of any licenses or other legal restrictions on the use of pre-existing works. Additionally, a grantee that is awarded competitive grant funds must have a plan to disseminate these public grant deliverables. This dissemination plan can be developed and submitted after your application has been reviewed and selected for funding. For additional information on the open licensing requirements please refer to 2 CFR 3474.20.

4. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

5. Performance Measures: For the purposes of Department reporting under 34 CFR 75.110, we have established a set of performance measures, including long-term measures, that are designed to yield information on various aspects of the effectiveness and quality of the ETechM2 Program. These measures are:

• Program Performance Measure #1: The percentage of ETechM2 Program products and services judged to be of high quality by an independent review panel of experts qualified to review the substantial content of the products and services.

• Program Performance Measure #2: The percentage of ETechM2 Program products and services judged to be of high relevance to improving outcomes for infants, toddlers, children, and youth with disabilities.

• Program Performance Measure #3: The percentage of ETechM2 Program products and services judged to be useful in improving results for infants, toddlers, children, and youth with disabilities.

• Program Performance Measure #4.1: The Federal cost per unit of accessible educational materials funded by the ETechM2 Program.

• Program Performance Measure #4.2: The Federal cost per unit of accessible educational materials from the National Instructional Materials Access Center funded by the ETechM2 Program.

• Program Performance Measure #4.3: The Federal cost per unit of video description funded by the ETechM2 Program.

The measures apply to projects funded under this competition, and grantees are required to submit data on these measures as directed by OSEP.

Grantees will be required to report information on their project's performance in annual and final performance reports to the Department (34 CFR 75.590 and 75.591).

The Department will also closely monitor the extent to which the products and services provided by the Center meet needs identified by stakeholders and may require the Center to report on such alignment in their quarterly, annual, and final performance reports.

6. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: Whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, the performance targets in the grantee's approved application.

In making a continuation award, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

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

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

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

Background: The SAB was established pursuant to the Environmental Research, Development, and Demonstration Authorization Act (ERDDAA), codified at 42 U.S.C. 4365, to provide independent scientific and technical advice to the EPA Administrator on the scientific and technical basis for agency positions and regulations. The SAB is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. The SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. Pursuant to FACA and EPA policy, notice is hereby given that the Science Advisory Board Scientific and Technological Achievement Awards (STAA) Panel, will hold a closed meeting to review the 2021 STAA nominations and to make recommendations for awards and recommendations for improvement of the Agency's STAA program.

The STAA awards are established to honor and recognize EPA employees who have made outstanding contributions in the advancement of science and technology through their research and development activities, as exhibited in publication of their results in peer reviewed journals. In conducting its review, the SAB considers each nomination in relation to the following four award levels:

• Level I awards are for those who have accomplished an exceptionally high-quality research or technological effort. The awards recognize the creation or general revision of a scientific or technological principle or procedure, or a highly significant improvement in the value of a device, activity, program, or service to the public. Awarded research is of national significance or has high impact on a broad area of science/technology. The research has far reaching consequences and is recognizable as a major scientific/technological achievement within its discipline or field of study.

• Level II awards are for those who have accomplished a notably excellent research or technological effort that has qualities and values similar to, but to a lesser degree, than those described under Level I. Awarded research has timely consequences and contributes as an important scientific/technological achievement within its discipline or field of study.

• Level III awards are for those who have accomplished an unusually notable research or technological effort. The awards are for a substantial revision or modification of a scientific/technological principle or procedure, or an important improvement to the value of a device, activity, program, or service to the public. Awarded research relates to a mission or organizational component of the EPA, or significantly affects a relevant area of science/technology.

• Honorable Mention awards acknowledge research efforts that are noteworthy but do not warrant a Level I, II or III award. Honorable Mention applies to research that: (1) May not quite reach the level described for a Level III award; (2) show a promising area of research that the STAA Panel wants to encourage; or (3) show an area of research that the STAA Panel feels is too preliminary to warrant an award recommendation at this time.

The SAB reviews the STAA nomination packages according to the following five evaluation factors:

• The extent to which the work reported in the nominated publication(s) resulted in either new or significantly revised knowledge. The accomplishment is expected to represent an important advancement of scientific knowledge or technology relevant to environmental issues and EPA's mission.

• The extent to which environmental protection has been strengthened or improved, whether of local, national, or international importance.

• The degree to which the research is a product of the originality, creativeness, initiative, and problem-solving ability of the researchers, as well as the level of effort required to produce the results.

• The extent of the beneficial impact of the research and the degree to which the research has been favorably recognized from outside EPA.

• The nature and extent of peer review, including stature and quality of the peer-reviewed journal or the publisher of a book for a review chapter published therein.

I have determined that the meetings of the STAA Panel and Chartered SAB will be closed to the public because they are concerned with selecting employees deserving of awards. In making these recommendations, the Agency requires full and frank advice from the SAB. This advice will involve professional judgments on the relative merits of various employees and their respective work. Such personnel matters involve the discussion of information that is of a personal nature and the disclosure of which would be a clearly unwarranted invasion of personal privacy and, therefore, are protected from disclosure by section 10(d) of the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, and sections (c)(2) and (c)(6) of the Government in the Sunshine Act, 5 U.S.C. 552b(c)(2) and (6). Minutes of the meetings of the STAA Panel and the Chartered SAB will be kept and certified by the chair of those meetings.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at https://www.regulations.gov, or in person, at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Printing, Coating and Dyeing of Fabrics and Other Textiles apply to each existing, new, or reconstructed source involved in printing, coating, slashing, dyeing or finishing of fabric and other textiles. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance with 40 CFR part 63, subpart OOOO.

Form Numbers: 5900-530.

Respondents/affected entities: Printing, coating, slashing, dyeing, or finishing of fabric and other textiles facilities.

Respondent's obligation to respond: Mandatory (40 CFR part 63, subpart OOOO).

Estimated number of respondents: 44 (total).

Frequency of response: Initially and semiannually.

Total estimated burden: 7,080 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $960,000 (per year), which includes $123,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the estimates: There is an increase in burden from the most-recently approved ICR as currently identified in the OMB Inventory of Approved Burdens. This is due to three considerations. This ICR incorporates the incremental burden from the 2019 RTR amendment (ICR No. 2071.09) into the total cost of the rule. The regulations were revised in the 2019 RTR amendment adding a requirement to periodically test add-on control devices, resulting in an increase in capital/startup costs for this testing, as well as for increased labor burden for conducting the tests, submitting reports, and keeping records. An additional facility that is subject to this subpart was identified in a search of EPA's ECHO database. This facility became subject to this subpart after the 2019 RTR; therefore, the respondent counts in this ICR renewal are updated to include this facility.

For thirty (30) days following the date of publication of this document, EPA will receive written comments relating to the proposed Agreement. EPA will consider all comments received and may modify or withdraw its consent to the proposed Agreement if comments received disclose facts or considerations that indicate that the proposed Agreement is inappropriate, improper, or inadequate. EPA's response to any comments received will be available for public inspection online and/or at EPA Region 2, 290 Broadway, New York, New York 10007-1866.

Proposal to renew the following currently approved collections of information:

1. Title: Notices Required of Government Securities Dealers or Brokers (Insured State Nonmember Banks).

OMB Number: 3064-0093.

Form Number: G-FIN; G-FINW; G- FIN4 & G-FIN5.

Affected Public: Insured state nonmember banks acting as government securities brokers and dealers.

Burden Estimate:

General Description of Collection: The Government Securities Act of 1986 requires all financial institutions acting as government securities brokers and dealers to notify their Federal regulatory agencies of their broker dealer activities, unless exempted from the notice requirements by Treasury Department regulation. The Form G-FIN and Form G-FINW are used by insured State nonmember banks that are government securities brokers or dealers to notify the FDIC of their status or that they have ceased to function as a government securities broker or dealer. The Form G-FIN-4 is used by associated persons of insured State nonmember banks that are government securities brokers or dealers to provide certain information to the bank and to the FDIC concerning employment, residence, and statutory disqualification. The Form G-FIN-5 is used by insured State nonmember banks that are government securities brokers or dealers to notify the FDIC that an associated person is no longer associated with the government securities broker or dealer function of the bank.

There is no change in the method or substance of the collection. The overall increase in burden hours is the result of economic fluctuation. In particular, the estimated number of submissions of form G-FIN-4 has increased by four, the hours per response increased by one and frequency of responses have remained the same.

2. Title: Activities and Investments of Insured State Banks.

OMB Number: 3064-0111.

Form Numbers: None.

Affected Public: Insured state nonmember banks and insured state savings associations.

Burden Estimate:

General Description of Collection: Section 24 of the Federal Deposit Insurance (FDI Act), 12 U.S.C. 1831a, limits investments and other activities in which state banks may engage, as principal, to those permissible for national banks and those approved by the FDIC under procedures set forth in part 362 of the FDIC's Rules and Regulations, 12 CFR part 362. With certain exceptions, section 24 of the FDI Act limits the activities and investments of state banks to those activities and investments that are permissible for national banks. In addition, the statute prohibits a state bank from directly engaging, as a principal, in any activity or investment that is not permissible for a national bank, or indirectly through a subsidiary in an activity or investment that is not permissible for a subsidiary of a national bank, unless such bank meets its minimum capital requirements and the FDIC determines that the activity or investment does not pose a significant risk to the Deposit Insurance Fund (DIF). The FDIC can make such a determination for exception by regulation or by order. Section 28(a), 12 U.S.C. 1831e, similarly limits the investments and activities of state savings associations and their service corporations to those permitted by federal savings associations and their service corporations, absent FDIC approval. Part 362 details the activities that state banks or their subsidiaries may engage in, under certain criteria and conditions and identifies the information that state banks must furnish to the FDIC in order to obtain the FDIC's approval or non-objection. Part 362 also applies to the activities and investments of state savings associations and their subsidiaries.

There is no change in the method or substance of the collection. The increase in burden hours is the result of economic fluctuation. In particular, the number of respondents has increased while the hours per response and frequency of responses have remained the same.

3. Title: Privacy of Consumer Financial Information.

OMB Number: 3064-0136.

Form Number: None.

Affected Public: Insured state nonmember banks and consumers.

Burden Estimate:

General Description of Collection: The elements of this collection are required under sections 503 and 504 of the Gramm-Leach-Bliley Act, 15 U.S.C. 6803, 6804. The collection mandates notice requirements and restrictions on a financial institution's ability to disclose nonpublic personal information about consumers to nonaffiliated third parties.

There is no change in the method or substance of the collection. The overall decrease in burden hours is the result of economic fluctuation. In particular, the estimated number of respondents to the Consumer Opt-out component increased, the number of respondents to the other components decreased and the hours per response and frequency of responses have remained the same.

Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

Proposal to renew the following currently approved collections of information:

1. Title: ID Theft Red Flags.

OMB Number: 3064-0152.

Form Number: None.

Affected Public: Insured state nonmember banks.

Burden Estimate:

General Description of Collection: The regulation containing this information collection requirement is 12 CFR part 334, which implements sections 114 and 315 of the Fair and Accurate Credit Transactions Act of 2003 (FACT Act), Public Law 108-159 (2003). FACT Act Section 114: Section 114 requires the Board of Governors of the Federal Reserve System, the Office of the Comptroller of the Currency and the FDIC (the Agencies) to jointly propose guidelines for financial institutions and creditors identifying patterns, practices, and specific forms of activity that indicate the possible existence of identity theft. In addition, each financial institution and creditor is required to establish reasonable policies and procedures to address the risk of identity theft that incorporate the guidelines. Credit card and debit card issuers must develop policies and procedures to assess the validity of a request for a change of address under certain circumstances. The information collections pursuant to section 114 require each financial institution and creditor to create an Identity Theft Prevention Program and report to the board of directors, a committee thereof, or senior management at least annually on compliance with the proposed regulations. In addition, staff must be trained to carry out the program. Each credit and debit card issuer is required to establish policies and procedures to assess the validity of a change of address request. The card issuer must notify the cardholder or use another means to assess the validity of the change of address. FACT Act Section 315: Section 315 requires the Agencies to issue regulations providing guidance regarding reasonable policies and procedures that a user of consumer reports must employ when such a user receives a notice of address discrepancy from a consumer reporting agencies. Part 334 provides such guidance. Each user of consumer reports must develop reasonable policies and procedures that it will follow when it receives a notice of address discrepancy from a consumer reporting agency. A user of consumer reports must furnish an address that the user has reasonably confirmed to be accurate to the consumer reporting agency from which it receives a notice of address discrepancy.

There is no change in the method or substance of the information collection. The total estimated annual burden hours have increased due to the inclusion of estimated program establishment costs for de novo institutions and the introduction of the costs of responses to specific address discrepancy incidents for newly established consumer accounts.

2. Title: Interagency Appraisal Complaint Form.

OMB Number: 3064-0190.

Form Numbers: None.

Affected Public: Individuals, financial institutions and other private sector entities.

Burden Estimate:

General Description of Collection: As provided in section 1473(p) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), on January 12, 2011, the Appraisal Subcommittee (“ASC”), of the Federal Financial Institutions Examination Council (FFIEC) determined that no national hotline existed to receive complaints of noncompliance with appraisal standards. A notice of that determination was published in the Federal Register on January 28, 2011 (76 FR 5161). As required by the Dodd-Frank Act, the ASC established a hotline to refer complaints to appropriate state and Federal regulators. For those instances where the ASC determines the FDIC, OCC, FRB, or NCUA is the appropriate regulator, the agencies developed the Interagency Appraisal Complaint Form as a means to efficiently collect necessary information. The Interagency Appraisal Complaint Form is designed to collect information necessary for one or more agencies to take further action on a complaint from an appraiser, other individual, financial institution, or other entities. The FDIC will use the information to take further action on the complaint to the extent it relates to an issue within its jurisdiction.

There is no change in the method or substance of the collection. The overall increase in burden hours (from 20 hours to 58 hours) is the result of a change in the agency's estimate of the number of annual responses based on a review of the actual number of complaints received over the last five years. In particular, the estimated number of respondents has increased from 40 to 116 while the estimated time per response and the frequency of response have remained the same.

Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

The Commission published the required 60-day notice for ICR 3072-0071 in the Federal Register on December 7, 2021, which provided the incorrect number of annual respondents and the incorrect total annual burden for this notice. See 86 FR 69254 (December 7, 2021). The number of annual respondents was reported to be 194, and the total annual burden was reported to be 247 hours. The correct number of annual respondents is 2,129 and the correct total annual burden is 2,402 hours. Additionally, since publication of the 60-day notice on December 7, 2021, the legal authority to conduct this collection was extended through 30 days after this publication.

AHRQ awarded a contract to the MedStar Health Research Institute (MHRI) in 2019 and received OMB fast track clearance (OMB control number 0935-0179, expiration date of 11/30/23), to provide program support and expertise related to improving diagnostic safety and quality across five distinct contract tasks. Task 3 of the contract is to develop, pilot test and promote a TeamSTEPPS® Course to improve communication among providers related to diagnosis. TeamSTEPPS® to Improve Diagnosis provides communication strategies, including methods to improve intra-professional communication and communication during the referral process and to practice mutual support and situation monitoring during the diagnostic process. TeamSTEPPS® to Improve Diagnosis includes an educational module for leaders on strategies to facilitate improved communication with and among providers related to diagnosis. This module also includes a Team Assessment Tool for Improving Diagnosis (the “Team Assessment Tool”).

The Team Assessment Tool is an instrument developed as a method of self-assessment, with the goal of helping teams reflect on their current diagnostic and teamwork practices. In addition, it orients them to the repertoire of tools available within the TeamSTEPPS for Improving Diagnosis course that are available to support improvement efforts. The Team Assessment Tool asks participants to complete self-assessment ratings as a mechanism to identify strengths and opportunities for improvement in unit-based teamwork. The unit level aggregate results of the assessments help unit leaders identify priorities for training via use of course modules and specific interventions with their diagnostic improvement teams.

AHRQ would like to further develop this Team Assessment Tool into a measurement instrument, expanding on its intended use as an educational activity and formative assessment. The opportunity to provide evidence (via publication in peer reviewed journals) that the tool is both valid and reliable will strengthen its acceptance in the care delivery community and provide a scientifically sound method for teams to assess changes in performance overtime. The Team Assessment Tool requires psychometric testing in order to ensure validity and reliability.

Psychometrics is the construction and validation of measurement instruments and assessing if these instruments are reliable (have consistency in measurement) and valid (have accuracy in measurement). Reliability and validity indicate how well a method, technique, test, or instrument is truly measuring what it intends to measure.

The contractor has conducted precursor psychometric testing on the Team Assessment Tool, which included the following: (1) Item wording and scale refinement, (2) Project Team Subject Matter Expert content review, (3) Non-Project Team Subject Matter Expert review, (4) End-user feedback, and (5) Instrument refinement. This work puts the reliability and validity of the indicators of the instrument at an optimal starting point for full psychometric testing.

Full psychometric testing of this instrument means the scaling must be evaluated extensively, which will require a sample of at least 359 individual care team members (physicians, nurses, ancillary staff, etc.,) from diverse clinical settings to participate in a 15-minute, anonymous, online survey distributed via a shared electronic survey link. Individual care team members will be recruited from across 9 health systems or care settings. The survey will ask participants to read through and complete the questions; participants will not be privy to the results of the survey.

The contractor will examine this sample of results via analyses to determine the stability of the instrument and its indicators, ensuring parallel measurements, homogeneity among indicators, concurrent, convergent, and discriminant validity, latent constructs of the tool, the extent to which measures of the same concept correlate and diverge, and the degree of that correlation in evaluating the instrument's ability to discriminate between different groups with various levels and familiarity with safety culture. It is important to note the responses on the surveys are not being evaluated, but rather the consistency with which the questions are answered is being evaluated ( i.e., determining whether the questions are being interpreted the same by all the users), despite diverse healthcare settings and varying levels of experience and familiarity with TeamSTEPPS. The combination of these psychometric methods will allow for internal and external validity and reliability to be assessed, to create a psychometrically sound instrument vetted for potential widespread adoption.

The Team Assessment Tool instrument will undergo remote usability testing of a survey to refine questions. To execute this task, the contractor has assembled an interprofessional team to execute any or all of the following methods for generating reliability and validity evidence that would be applicable to this specific tool: (1) Parallel forms reliability, (2) internal consistency reliability, (3) inter-rater reliability, (4) content validity, and (5) construct validity, using a multitrait-multimethod matrix and/or known groups testing.

This information collection has the following goal:

1. To determine the stability of the Team Assessment Tool instrument and its indicators in improving communication to reduce diagnostic errors, by quantitatively examining the correlation among responses of each indicator.

This study is being conducted by AHRQ through its contractor, MedStar Health Research Institute, 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 vale of healthcare services and with respect to quality measurement and improvement. 42 U.S.C 299a(a)(1) and (2).

To achieve the goal of this project the following information collection instruments will be completed using individual surveys:

(1) Setting Demographics Survey: Prior to testing of the instrument, each health system will take a brief survey to describe the characteristics of the sites engaged in pilot testing ( e.g., size, diagnostic team member role diversity, and familiarity with patient safety and quality improvement activities).

(2) TeamSTEPPS® Team Assessment Tool for Improving Diagnosis: This is collected from individual survey respondents, who are diverse staff members in a diagnostic team. The consistency with which the questions are interpreted and answered among respondents will be evaluated to determine the stability among indicators on the instrument.

AHRQ will use the information collected through this Information Collection Request to assess and enhance the feasibility of adopting a course to improve communication among providers related to diagnosis. AHRQs' ability to publicly share a Team Assessment Tool that has been scientifically validated is expected to be of great interest to the health care community and important in helping organizations prioritize improvement efforts.

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ).

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Outcome and Assessment Information Set OASIS-E; Use: This request is for OMB approval to modify the Outcome and Assessment Information Set (OASIS) that home health agencies (HHAs) are required to collect in order to participate in the Medicare program. The current version of the OASIS, OASIS-D (0938-1279) data item set was approved by the Office of Management and Budget (OMB) on December 6, 2018 and implemented on January 1, 2019. We are seeking OMB approval for the proposed revised OASIS item set, referred to hereafter as OASIS-E, scheduled for implementation on January 1, 2023. The OASIS-E includes changes pursuant to the Improving Medicare Post-Acute Care Transformation Act of 2014 (the IMPACT Act); and, to accommodate data element removals to reduce burden; and improve formatting throughout the document. Form Number: CMS-10545 (OMB control number: 0938-1279); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 11,354; Total Annual Responses: 18,030,766; Total Annual Hours: 13,139,904. (For policy questions regarding this collection contact Joan Proctor at 410-786-0949).

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Marketplace Quality Standards; Use: The Patient Protection and Affordable Care Act establishes requirements to support the delivery of quality health care coverage for health insurance issuers offering Qualified Health Plans (QHPs) in Exchanges. Section 1311(c)(3) of the Patient Protection and Affordable Care Act directs the Secretary to develop a system to rate QHPs on the basis of quality and price and requires Exchanges to display this quality rating information on their respective websites. Section 1311(c)(4) of the Patient Protection and Affordable Care Act requires the Secretary to develop an enrollee satisfaction survey system to assess enrollee experience with each QHP (with more than 500 enrollees in the previous year) offered through an Exchange. Section 1311(h) requires QHPs to contract with certain hospitals that meet specific patient safety and health care quality standards.

This collection of information is necessary to provide adequate and timely health care quality information for consumers, regulators, and Exchanges as well as to collect information to appropriately monitor and provide a process for a survey vendor to appeal HHS' decision to not approve a QHP Enrollee Survey vendor application. Form Number: CMS-10520 (OMB control number: 0938-1249); Frequency: Annually; Affected Public: Public sector (Individuals and Households); Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 314; Total Annual Responses: 314; Total Annual Hours: 384,014. For policy questions regarding this collection contact Nidhi Singh Shah at 301-492-5110.

The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue various manuals, memoranda, and statements necessary to administer and oversee the programs efficiently.

Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register .

This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS website or the appropriate data registries that are used as our resources. This is the most current up-to-date information and will be available earlier than we publish our quarterly notice. We believe the website list provides more timely access for beneficiaries, providers, and suppliers. We also believe the website offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and “real time” accessibility. In addition, many of the websites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the website. These listservs avoid the need to check the website, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a website proves to be difficult, the contact person listed can provide information.

This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at http://www.cms.gov/manuals.

The Director of the Office of Strategic Operations and Regulatory Affairs of the Centers for Medicare & Medicaid Services (CMS), Kathleen Cantwell, having reviewed and approved this document, authorizes Trenesha Fultz-Mimms, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.

Section 1877 of the Social Security Act (the Act), also known as the physician self-referral law: (1) Prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship unless the requirements of an applicable exception are satisfied; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for any improperly referred designated health services. A financial relationship may be an ownership or investment interest in the entity or a compensation arrangement with the entity. The statute establishes a number of specific exceptions and grants the Secretary of the Department of Health and Human Services (the Secretary) the authority to create regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse.

Section 1877(d) of the Act sets forth exceptions related to ownership or investment interests held by a physician (or an immediate family member of a physician) in an entity that furnishes designated health services. Section 1877(d)(2) of the Act provides an exception for ownership or investment interests in rural providers (the “rural provider exception”). In order to qualify for the rural provider exception, the designated health services must be furnished in a rural area (as defined in section 1886(d)(2) of the Act) and substantially all the designated health services furnished by the entity must be furnished to individuals residing in a rural area, and, in the case where the entity is a hospital, the hospital must meet the requirements of section 1877(i)(1) of the Act no later than September 23, 2011. Section 1877(d)(3) of the Act provides an exception for ownership or investment interests in a hospital located outside of Puerto Rico (the “whole hospital exception”). In order to qualify for the whole hospital exception, the referring physician must be authorized to perform services at the hospital, the ownership or investment interest must be in the hospital itself (and not merely in a subdivision of the hospital), and the hospital must meet the requirements of section 1877(i)(1) of the Act no later than September 23, 2011.

Section 6001(a)(3) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148) amended the rural provider and whole hospital exceptions to provide that a hospital may not increase the number of operating rooms, procedure rooms, and beds beyond that for which the hospital was licensed on March 23, 2010 (or, in the case of a hospital that did not have a provider agreement in effect as of this date, but did have a provider agreement in effect on December 31, 2010, the effective date of such provider agreement) (the hospital's “baseline number of operating rooms, procedure rooms, and beds”). Thus, since March 23, 2010, a physician-owned hospital that seeks to avail itself of either exception is prohibited from expanding the number of operating rooms, procedure rooms, and beds (“facility capacity”) unless it qualifies as an “applicable hospital” or “high Medicaid facility” (as defined in sections 1877(i)(3)(E), (F) of the Act and 42 CFR 411.362(c)(2), (3) of our regulations) and has been granted an exception to the prohibition by the Secretary.

Section 6001(a)(3) of the Affordable Care Act added new section 1877(i)(3)(A)(i) of the Act, which required the Secretary to establish and implement an exception process to the prohibition on expansion of facility capacity for hospitals that qualify as an “applicable hospital.” Section 1106 of the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) amended section 1877(i)(3)(A)(i) of the Act to require the Secretary to establish and implement an exception process to the prohibition on expansion of facility capacity for hospitals that qualify as either an “applicable hospital” or a “high Medicaid facility.” These terms are defined at sections 1877(i)(3)(E) and 1877(i)(3)(F) of the Act. The process for requesting an exception to the prohibition on expansion of facility capacity is discussed in section III of this notice.

The requirements for qualifying as an applicable hospital are set forth at § 411.362(c)(2), and the requirements for qualifying as a high Medicaid facility are set forth at § 411.362(c)(3). An applicable hospital means a hospital: (1) That is located in a county in which the percentage increase in the population during the most recent 5-year period (as of the date that the hospital submits its request for an exception to the prohibition on expansion of facility capacity) is at least 150 percent of the percentage increase in the population growth of the State in which the hospital is located during that period, as estimated by the Bureau of the Census; (2) whose annual percent of total inpatient admissions under Medicaid is equal to or greater than the average percent with respect to such admissions for all hospitals in the county in which the hospital is located during the most recent 12-month period for which data are available (as of the date that the hospital submits its request for an exception to the prohibition on expansion of facility capacity); (3) that does not discriminate against beneficiaries of Federal health care programs and does not permit physicians practicing at the hospital to discriminate against such beneficiaries; (4) that is located in a State in which the average bed capacity in the State is less than the national average bed capacity; and (5) that has an average bed occupancy rate that is greater than the average bed occupancy rate in the State in which the hospital is located. The regulations at § 411.362(c)(2)(ii), (iv), and (v) specify acceptable data sources for determining whether a hospital qualifies as an applicable hospital. A “high Medicaid facility” means a hospital that: (1) Is not the sole hospital in a county; (2) with respect to each of the three most recent 12-month periods for which data are available, has an annual percent of total inpatient admissions under Medicaid that is estimated to be greater than such percent with respect to such admissions for any other hospital located in the county in which the hospital is located; and (3) does not discriminate against beneficiaries of Federal health care programs and does not permit physicians practicing at the hospital to discriminate against such beneficiaries. The regulation at § 411.362(c)(3)(ii) specifies the acceptable data sources for determining whether a hospital qualifies as a high Medicaid facility.

In the Calendar Year (CY) 2012 Outpatient Prospective Payment System/Ambulatory Surgical Centers (OPPS/ASC) final rule (76 FR 74121), we published regulations establishing the process for a hospital to request an exception from the prohibition on facility expansion (the “exception process”) at § 411.362(c)(4), community input related to a hospital's request at § 411.362(c)(5), and related definitions at § 411.362(a). In the CY 2021 OPPS/ASC final rule (85 FR 85866), we revised the regulations that set forth the exception process with respect to high Medicaid facilities to remove certain regulatory restrictions that are not included in the Act. As of January 1, 2021, a high Medicaid facility may request an exception to the prohibition on expansion of facility capacity more frequently than once every 2 years; may request to expand its facility capacity beyond 200 percent of the hospital's baseline number of operating rooms, procedure rooms, and beds; and is not restricted to locating approved expansion capacity on the hospital's main campus.

Section 1877(i)(3)(A)(ii) of the Act and our regulations at § 411.362(c)(5) provide that individuals and entities in the community in which the provider requesting the exception is located must have an opportunity to provide input with respect to the provider's application for the exception. For further information, we refer readers to the CMS website at: http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Physician_Owned_Hospitals.html. As stated in our regulations, we will solicit community input on the request for an exception by publishing a notice of the request in the Federal Register . Individuals and entities in the hospital's community will have 30 days to submit comments on the request. Community input must take the form of written comments and may include documentation demonstrating that the physician-owned hospital requesting the exception does or does not qualify as an “applicable hospital” or “high Medicaid facility,” as such terms are defined in § 411.362(c)(2) and (3). In the CY 2012 OPPS/ASC final rule, we gave examples of community input, such as documentation demonstrating that the hospital does not satisfy one or more of the data criteria or that the hospital discriminates against beneficiaries of Federal health programs; however, we noted that these were examples only and that we will not restrict the type of community input that may be submitted (76 FR 74522). If we receive timely comments from the community, we will notify the hospital, and the hospital will have 30 days after such notice to submit a rebuttal statement (§ 411.362(c)(5)).

A request for an exception to the facility expansion prohibition is considered complete as follows:

• If the request, any written comments, and any rebuttal statement include only filed Medicare hospital cost report data (Healthcare Cost Report Information System (“HCRIS”) data): (1) The end of the 30-day comment period if CMS receives no written comments from the community; or (2) the end of the 30-day rebuttal period if CMS receives written comments from the community, regardless of whether the hospital submitting the request submits a rebuttal statement (§ 411.362(c)(5)(i)).

• If the request, any written comments, or any rebuttal statement include data from an external data source, no later than: (1) 180 days after the end of the 30-day comment period if CMS receives no written comments from the community; and (2) 180 days after the end of the 30-day rebuttal period if CMS receives written comments from the community, regardless of whether the hospital submitting the request submits a rebuttal statement (§ 411.362(c)(5)(ii)).

The CMS decision to grant or deny a hospital's request for an exception to the prohibition on expansion of facility capacity must be published in the Federal Register in accordance with our regulations at § 411.362(c)(7).

As permitted by section 1877(i)(3) of the Act and our regulations at § 411.362(c), the following physician-owned hospital has requested an exception to the prohibition on expansion of facility capacity:

We seek comments on this request from individuals and entities in the community in which the hospital is located. We encourage interested parties to review the hospital's request, which is posted on the CMS website at: http://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Physician_Owned_Hospitals.html. We especially welcome comments regarding whether the hospital qualifies as a high Medicaid facility.

Individuals and entities wishing to submit comments on the hospital's request should state whether or not they are in the community in which the hospital is located. We suggest that parties review the DATES and ADDRESSES sections above to ensure timely submission of their comments.

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

We will consider all comments we receive by the date and time specified in the DATES section of this preamble.

The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .

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

This information collection supports implementation of FDA's Generic Drug User Fee program. The Generic Drug User Fee Amendments (GDUFA) (Pub. L. 112-144, Title 111) were enacted to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. GDUFA authorizes FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA's generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications. GDUFA is currently authorized through September 30, 2022, with reauthorization activities currently underway. For more information regarding GDUFA and ongoing implementation, we invite you to visit our website at https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments.

GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry intended to address continuing regulatory challenges. GDUFA reflects input received during an open process that includes regular public meetings, posting of meeting minutes, and consideration of comments from a public docket. We are revising the information collection to include the current GDUFA agreement, or “goals letter,” as reflected in the document “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022,” available for download from our website at https://www.fda.gov/media/101052/download. The performance goals and program enhancements specified in the goals letter apply to aspects of the generic drug review program that are important for facilitating timely access to quality, affordable generic medicines. FDA is committed to meeting the performance goals specified in the goals letter and to continuous improvement of its performance.

Included among the performance goals is the issuance of topic-specific guidance documents. We maintain a searchable guidance database on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. In publishing the respective notices of availability for each guidance document, we include an analysis under the PRA and invite public comment on the associated information collection recommendations. In addition, all Agency guidance documents are issued in accordance with our Good Guidance Practice regulations in 21 CFR 10.115, which provide for public comment at any time.

We have developed Form FDA 3794, the Generic Drug User Fee Cover Sheet, available at https://www.fda.gov/industry/fda-user-fee-programs which requests the minimum necessary information from generic drug applicants to account for and track user fees and to determine the amount of the fee required. Applicants complete and submit the cover sheets to accompany payments. While applicants may submit payment through multiple means, all cover sheets are prepared using FDA's web-based electronic User Fee System. Upon submitting the completed cover sheet, the User Fee System generates a user fee identification number, which is provided to applicants at the bottom of the cover sheet. It also notes the correct fiscal year user fee assessment that is due for the submission or program. FDA requests that applicants submit a copy of this completed cover sheet along with the abbreviated new drug application, as well as other additional GDUFA fees, so FDA can verify that the applicant has paid the correct user fee and their account is current.

Respondents to the information collection are potential or actual generic drug application holders or related active pharmaceutical ingredient and finished dosage form manufacturers. Companies with multiple user fee obligations may submit a cover sheet for each user fee obligation.

In the Federal Register of November 19, 2021 (86 FR 64945), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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