On December 2, 2020, Commerce published in the Federal Register a notice of opportunity to request an administrative review of the CVD order on aluminum wire and cable from China covering the POR. 1 On December 31, 2020, Commerce received timely requests for review of several companies from Encore Wire Corporation (Encore) and Southwire Company LLC (collectively, the petitioners), 2 and separately, Repwire LLC (Repwire). 3

On February 4, 2020, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), Commerce published in the Federal Register a notice initiating an administrative review of ICF Cable and Jin Tiong Electrical Materials Manufacturer PTE. Limited (Jin Tiong) (collectively, the Companies Subject to the Review). 4 On February 10, 2021, we notified interested parties that information from U.S. Customs and Border Protection (CBP)'s database, which is comprised of actual U.S. entries of subject merchandise, indicated that there were no POR entries of aluminum wire and cable from China that are subject to CVD duties with respect to the Companies Subject to the Review. 5 We invited interested parties to comment on the CBP Entry Data. 6 On February 18, 2021, Encore submitted comments in response to the CBP Entry Data, alleging that ICF Cable exported Chinese-origin subject merchandise to the United States during the POR, and requested that Commerce select ICF Cable as a mandatory respondent in the instant review. 7

On March 26, 2021, we requested that CBP confirm whether any shipments of aluminum wire and cable from China, produced and/or exported by ICF Cable or Jin Tiong entered the United States during the POR. 8 On April 1, 2021, CBP confirmed that there were no shipments of subject merchandise produced and/or exported by ICF Cable or Jin Tiong during the POR. 9 We invited interested parties to comment on CBP's Confirmation of No Shipments. 10 On April 19, 2021, Encore submitted timely comments in response to CBP's Confirmation of No Shipments. 11 In its comments, Encore reiterated its claim that ICF Cable made sales, shipments, and/or exports of aluminum wire and cable produced in China during the POR without paying applicable cash deposits, and requested that Commerce issue a quantity and value questionnaire to ICF Cable. 12 Our analysis of the record leads us to conclude that there are no reviewable entries of aluminum wire and cable from China during the POR. For a full discussion of the comments raised by Encore and our analysis, see the Rescission Memorandum. 13

It is Commerce's practice to rescind an administrative review of a CVD order, pursuant to 19 CFR 351.213(d)(3), when there are no reviewable entries of subject merchandise during the POR for which liquidation is suspended. 14 Normally, upon completion of an administrative review, the suspended entries are liquidated at the CVD assessment rate calculated for the review period. 15 Therefore, for an administrative review to be conducted, there must be a reviewable, suspended entry that Commerce can instruct CBP to liquidate at the CVD assessment rate calculated for the review period. 16 Accordingly, in the absence of suspended entries of subject merchandise during the POR for either of the companies named in the Initiation Notice , we are hereby rescinding this administrative review in accordance with 19 CFR 351.213(d)(3).

Commerce will instruct CBP to assess countervailing duties on all appropriate entries. Because Commerce is rescinding this review in its entirety, the entries to which this administrative review pertained shall be assessed at rates equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP no earlier than 35 days after the publication of this notice in the Federal Register .

This notice serves as the only reminder to parties subject to the 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). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

This determination is issued and published pursuant to sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).

On August 28, 1986, Commerce published the antidumping duty order on candles from China. 1 On March 31, 2021, Commerce published the notice of initiation of the five-year sunset review of the Order, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). 2 On April 2, 2021, Commerce received a notice of intent to participate in this sunset review from the National Candle Association (the petitioner) within the deadline specified in 19 CFR 351.218(d)(1)(i). 3 The petitioner claimed interested party status under section 771(9)(C) of the Act as the petitioner in the less-than-fair-value investigation whose members are manufacturers, producers, or wholesalers of the domestic like product. On April 29, 2021, the petitioner provided a complete substantive response for this review within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). 4 We received no substantive responses from any other interested parties, nor was a hearing requested. On May 21, 2021, Commerce notified the U.S. International Trade Commission that it did not receive an adequate substantive response from respondent interested parties. 5 As a result, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), Commerce conducted an expedited (120-day) sunset review of this Order.

The products covered by the Order include certain scented or unscented petroleum wax candles made from petroleum wax and having fiber or paper-cored wicks. For a full description of the scope, see the Issues and Decision Memorandum. 6

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

Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, Commerce determines that revocation of the antidumping duty order on candles from China would likely lead to continuation or recurrence of dumping and that the magnitude of the margin of dumping likely to prevail would be weighted-average margins up to 104.33 percent. 7

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

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

On July 22, 2010, the Department of Commerce (Commerce) published the AD and CVD orders on salts from China. 1 On November 1, 2020, the ITC instituted, 2 and on November 3, 2020, Commerce initiated, 3 the second sunset review of the Orders, pursuant to section 751(c) of the Tariff Act of 1930 as amended (the Act). As a result of its reviews, Commerce determined that a revocation of the Orders would likely lead to continuation or recurrence of dumping and countervailable subsidies and, therefore, notified the ITC of the magnitude of the margins and net subsidy rates likely to prevail should the Orders be revoked. 4

On July 7, 2021, the ITC published its determinations, pursuant to sections 751(c) and 752(a) of the Act, that revocation of the Orders would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. 5

The products covered by the Orders include anhydrous Dipotassium Phosphate (DKP) and Tetrapotassium Pyrophosphate (TKPP), whether anhydrous or in solution (collectively “phosphate salts”).

TKPP, also known as normal potassium pyrophosphate, Diphosphoric acid or Tetrapotassium salt, is a potassium salt with the formula K 4 P 2 O 7 . The CAS registry number for TKPP is 7320-34-5. TKPP is typically 18.7 percent phosphorus and 47.3 percent potassium. It is generally greater than or equal to 43.0 percent P 2 O 5 content. TKPP is classified under heading 2835.39.1000 of the Harmonized Tariff Schedule of the United States (HTSUS).

DKP, also known as Dipotassium salt, Dipotassium hydrogen orthophosphate or Potassium phosphate, dibasic, has a chemical formula of K 2 HPO 4 . The CAS registry number for DKP is 7758-11-4. DKP is typically 17.8 percent phosphorus, 44.8 percent potassium and 40 percent P 2 O 5 content. DKP is classified under heading 2835.24.0000, HTSUS.

The products covered by these Orders include the foregoing phosphate salts in all grades, whether food grade or technical grade. The products covered by these Orders includes anhydrous DKP without regard to the physical form, whether crushed, granule, powder or fines. Also covered are all forms of TKPP, whether crushed, granule, powder, fines or solution.

For purposes of the Orders, the narrative description is dispositive, and not the tariff heading, American Chemical Society, CAS registry number or CAS name, or the specific percentage chemical composition identified above.

As a result of the determinations by Commerce and the ITC that revocation of the Orders would likely lead to a continuation or a recurrence of dumping and countervailable subsidies, as well as material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), Commerce hereby orders the continuation of the Orders.

U.S. Customs and Border Protection will continue to collect AD and CVD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of the continuation of the Orders will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act and 19 CFR 351.218(c)(2), Commerce intends to initiate the next five-year review 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 sections 751(c) and 751(d)(2) of the Act and published in accordance with section 777(i)(1) of the Act and 19 CFR 351.218(f)(4).

On January 3, 2018, Commerce published in the Federal Register an AD order on softwood lumber from Canada. 1 On May 5, 2021, Commerce received a request on behalf of CHAP for an expedited CCR to establish CHAP as the successor-in-interest to L'Atelier with respect to the Order. 2 On June 8, 2021, Commerce informed CHAP that it required additional information in order to determine whether to initiate the requested CCR. 3 On June 24, 2021, CHAP provided the requested information. 4

The merchandise covered by the Order is softwood lumber, siding, flooring and certain other coniferous wood (softwood lumber products). Softwood lumber product imports are generally entered under Chapter 44 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 scope of the Order is dispositive. 5

Pursuant to section 751(b)(1) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.216(d), Commerce will conduct a CCR upon receipt of information or a review request showing changed circumstances sufficient to warrant a review of an order. Among other things, Commerce has conducted CCRs to consider the applicability of cash deposit rates after there have been changes in the name or structure of a company, such as a merger or spinoff (successor-in-interest, or successorship, determinations).

We find the information provided is sufficient to warrant a CCR of the Order. Specifically, the information CHAP provided regarding L'Atelier's name change to CHAP demonstrates changed circumstances sufficient to warrant a CCR with respect to the Order.

Therefore, in accordance with section 751(b)(1) of the Act and 19 CFR 351.216(d), we are initiating a CCR to determine whether CHAP is the successor-in-interest to L'Atelier for purposes of the Order.

In addition, Commerce's regulations (19 CFR 351.221(c)(3)(ii)), permit it to initiate a CCR and issue the preliminary results of that CCR simultaneously if it concludes that expedited action is warranted. We have on the record the information necessary to make a preliminary finding and, therefore, we find that expedited action is warranted. 6 Consequently, we are combining the initiation of the CCR described above and our preliminary results, in accordance with 19 CFR 351.221(c)(3)(ii).

In determining whether one company is the successor to another for AD purposes, Commerce examines a number of factors including, but not limited to, changes in: (1) Management; (2) production facilities; (3) suppliers; and (4) customer base. 7 While no one, or several, of these factors will necessarily provide a dispositive indication of succession, Commerce will generally consider one company to be the successor to another company if its resulting operations are essentially the same as those of its predecessor. 8 Thus, if the evidence demonstrates that, with respect to the production and sale of the subject merchandise, the company, in its current form, operates as essentially the same business entity as the prior company, Commerce will assign the new company the cash deposit rate of its predecessor. 9

CHAP provided evidence that: (1) L'Atelier's name changed to CHAP in February 2021; and (2) there were no significant changes to management, 10 production facilities, 11 suppliers, or customer base. 12 Based on the foregoing, which is explained in greater detail in the Preliminary Decision Memorandum, we preliminarily determine that CHAP is the successor-in-interest to L'Atelier for purposes of the Order.

Should our final results of review remain the same as these preliminary results of review, effective the date of publication of the final results of review, we will instruct U.S. Customs and Border Protection to apply L'Atelier's cash deposit rate to CHAP.

Interested parties may submit case briefs not later than 14 days after the date of publication of this notice. 13 Rebuttal briefs, which must be limited to issues raised in case briefs, may be filed not later than seven days after the due date for case briefs. 14 Parties who submit case briefs or rebuttal briefs in this CCR are requested to submit with each argument: (1) A statement of the issues; and (2) a brief summary of the arguments with electronic versions included.

Any interested party may request a hearing within 14 days of publication of this notice. 15 Hearing requests should contain the following information: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm the date and the time of the hearing two days before the scheduled date.

All submissions, with limited exceptions, must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). 16 An electronically filed document must be received successfully in its entirety by 5 p.m. Eastern Time (ET) on the due date.

Consistent with 19 CFR 351.216(e), we intend to issue the final results of this CCR no later than 270 days after the date on which these reviews were initiated or within 45 days if all parties agree to the outcome of the review.

We are issuing and publishing this initiation and preliminary results notice in accordance with sections 751(b)(1) and 777(i)(1) of the Act and 19 CFR 351.216 and 351.221(c)(3).

On January 11, 2021, Commerce received a countervailing duty (CVD) petition concerning imports of R-125 from China filed in proper form on behalf of the petitioner, Honeywell International, Inc. 1 On February 1, 2021, we initiated this investigation, 2 and on June 25, 2021, we published an affirmative Preliminary Determination. 3

Commerce selected Zhejiang Quzhou Juxin Fluorine Chemical Co., Ltd. (Juxin) and Zhejiang Sanmei Chemical Ind. Co., Ltd. (Sanmei) as the individually-examined respondents in this investigation.

On June 4, 2021, the petitioner alleged that critical circumstances exist with respect to imports of R-125 from China, pursuant to section 703(e)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.206. 4 On June 10, 2021, Commerce requested monthly shipment data from Juxin and Sanmei for subject merchandise for the period August 2020 to May 2021, which Commerce received on June 17, 2021. 5

In accordance with section 703(e)(1) of the Act and 19 CFR 351.206(c)(1), because the petitioner submitted its critical circumstance allegation more than 30 days before the scheduled date of the final determination, 6 Commerce will make a preliminary finding as to whether there is a reasonable basis to believe or suspect that critical circumstances exist. Commerce will issue its preliminary finding of critical circumstances within 30 days after the petitioner submits the allegation. 7

The POI is January 1, 2020, through December 31, 2020.

The petitioner alleges that there was a massive increase of imports of R-125 from China and provided monthly import data for the period October 2020 through March 2021. 8 The petitioner states that a comparison of total imports, by quantity, for the base period October 2020 through December 2020 to the comparison period January 2021 through March 2021, shows that imports of R-125 from China increased by 45.5 percent, 9 which is “massive” under 19 CFR 351.206(h)(2). The petitioner also alleges that there is a reasonable basis to believe that there are subsidies in this investigation which are inconsistent with the Subsidies and Countervailing Measures Agreement of the World Trade Organization (SCM Agreement). 10

Section 703(e)(1) of the Act provides that Commerce will preliminarily determine that critical circumstances exist in a CVD investigation if there is a reasonable basis to believe or suspect that: (A) The alleged countervailable subsidy is inconsistent with the SCM Agreement;  11 and (B) there have been massive imports of the subject merchandise over a relatively short period.

In determining whether there are “massive imports” over a “relatively short period,” pursuant to section 703(e)(1)(B) of the Act and 19 CFR 351.206(h) and (i), Commerce normally compares the import volumes of the subject merchandise for at least three months immediately preceding the filing of the petition ( i.e., the base period) to a comparable period of at least three months following the filing of the petition ( i.e., the comparison period). However, the regulations also provide that if Commerce finds that importers, or exporters or producers, had reason to believe, at some time prior to the beginning of the proceeding, that a proceeding was likely, Commerce may consider a period of not less than three months from the earlier time. 12 Imports must increase by at least 15 percent during the comparison period to be considered massive. 13

On May 3, 2021, the petitioner filed a New Subsidies Allegation, alleging that Chinese producers of subject merchandise benefited from additional subsidies provided by the Government of China, including the Export Buyer's Credit Program and the Export Seller's Credit Program. 14 To determine whether there exists a reasonable basis to believe or suspect that an alleged countervailable subsidy is inconsistent with the SCM Agreement, in accordance with section 703(e)(1)(A) of the Act, Commerce considered the evidence on the record pertaining to the petitioner's allegation that the Export Buyer's Credit Program and the Export Seller's Credit Program are inconsistent with the SCM Agreement. Specifically, with regard to these programs, the petitioner has alleged the elements of a subsidy, 15 supported with information reasonably available to the petitioner, 16 that appear to be export contingent, which would render them inconsistent with the SCM Agreement. Therefore, Commerce preliminarily determines that there is a reasonable basis to believe or suspect that alleged subsidies in the New Subsidies Allegation are inconsistent with the SCM Agreement. As a result, we preliminarily find that the criterion under section 703(e)(1)(A) of the Act has been met for Juxin, Sanmei, and all other exporters or producers not individually examined.

As explained in our Preliminary Determination, we preliminarily applied total adverse facts available (AFA) to Arkema Daikin Advanced Fluorochemicals (Changsu) Co., Ltd. (Arkema); Daikin Fluorochemicals (China) Co., Ltd. (Daikin); Hongkong Richmax Ltd. (Hongkong); and Weitron International Refrigeration Equipment (Kunshan) Co., Ltd. (Weitron), pursuant to section 776(b) of the Act. In applying total AFA to these four companies, we preliminarily determined that each benefited from countervailable subsidies under the “Export Loans from Chinese State-Owned Commercial Banks (SOCBs)” program. 17 Although we did not make a preliminary finding as to whether the “Export Loans from SOCBs” program was inconsistent with the SCM Agreement in the Preliminary Determination, we now preliminarily find, pursuant to section 776(b) of the Act, that there is a reasonable basis to believe or suspect that the program, as alleged in the Petition and supported by information reasonably available to the petitioner, is export-contingent within the meaning of section 771(5A)(B) of the Act and, thus, inconsistent with the SCM Agreement. 18 We are making the inconsistency determination with regard to this program, which is the only program which we countervailed in the Preliminary Determination alleged to be inconsistent with the SCM Agreement. In so doing, we intend to limit the corresponding offset to the dumping margin (if one is found) in the companion antidumping duty investigation, which best fulfills our statutory mandate “to ensure that the party does not obtain a more favorable result by failing to cooperate than if it had cooperated fully,”  19 and induce future cooperation by companies in investigations where the petitioners allege the existence of programs potentially inconsistent with the SCM Agreement.

Thus, because we preliminarily find that the “Export Loans from Chinese SOCBs” program is export-contingent, we preliminarily find that the criterion under section 703(e)(1)(A) of the Act has been met for Arkema, Daikin, Hongkong, and Weitron.

Commerce compared the import volumes of Juxin's and Sanmei's reported shipments of subject merchandise for the five months immediately preceding and following the filing of the petition. Because the petition was filed on January 11, 2021, and in order to determine whether there was a massive surge in imports for the mandatory respondents, Commerce compared the total volume of shipments during the period of August 2020 through December 2020 (the base period) with the volume of shipments during the period of January 2021 through May 2021 (the comparison period). 20 We preliminarily determine that imports from both Juxin and Sanmei increased by more than 15 percent between the base and comparison periods. 21

However, for purposes of our “massive imports” determination, we received information on the record about seasonality with respect to Sanmei's imports which we considered as part of our analysis. Sanmei stated that, while it did experience a massive surge of imports of R-125 between the base and comparison periods, this surge was seasonal in nature. Sanmei also provided its shipment data for comparable periods in 2018-2019 and 2019-2020. 22 Based on our analysis of Sanmei's shipment data reported for 2018 through 2021, we find that there is a consistent pattern of seasonality evidenced by a significant increase in shipments during the months of January through May (in 2019, 2020, and 2021), when compared to August through December (in 2018, 2019, and 2020) . As a result, we preliminarily find that the record reflects that any surge in Sanmei's imports between the base and comparison periods in this investigation can be explained by seasonal trends. Therefore, we preliminarily determine that, although the surge in imports of R-125 from Sanmei during the comparison period was massive, the import surge was massive as a result of seasonal trends and, therefore, critical circumstances do not exist for Sanmei, in accordance with section 733(e)(1)(B) of the Act. 23

To determine whether imports were massive for all other exporters or producers, Commerce's normal practice is to subtract shipments reported by the cooperating mandatory respondents from shipment data for subject merchandise from Global Trade Atlas. 24 However, as discussed in the Initiation Notice, 25 the Harmonized Tariff Schedule of the United States number under which the subject merchandise enters is a basket category under which non-subject merchandise may enter. Therefore, consistent with our practice, we preliminarily relied on the data of the mandatory respondents as “facts available,” in accordance with section 776(a)(1) of the Act, to determine whether imports from all other exporters or producers were massive. 26 Because we preliminary determine that imports from both Juxin and Sanmei increased by more than 15 percent between the base and comparison periods, we also preliminarily determine that imports from all other exporters or producers were massive.

Finally, for Arkema, Daikin, Hongkong, and Weitron, we preliminarily determine, pursuant to section 776(b) of the Act, that there was a massive surge in imports between the base and comparison periods.

Accordingly, consistent with section 703(e)(1) of the Act, we preliminarily determine that critical circumstances exist with respect to Arkema, Daikin, Hongkong, Juxin, Weitron, and all other exporters and producers not individually examined.

We will make a final determination concerning critical circumstances in the final determination of this investigation, which is currently scheduled for October 25, 2021.

Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance. Interested parties will be notified of the timeline for the submission of case briefs and written comments at a later date. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than seven days after the deadline date for case briefs. 27 Pursuant to 19 CFR 351.309(c)(2) and (d)(2), parties who submit case briefs or rebuttal briefs in this investigation are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.

In accordance with section 703(e)(2)(A) of the Act, for Arkema, Daikin, Hongkong, Juxin, Weitron, and all other exporters and producers, we intend to direct U.S. Customs and Border Protection (CBP) to suspend liquidation of any unliquidated entries of subject merchandise from China entered, or withdrawn from warehouse for consumption, on or after March 27, 2021, which is 90 days prior to the date of publication of the Preliminary Determination in the Federal Register . For such entries, CBP shall require a cash deposit equal to the estimated preliminary subsidy rates established in the Preliminary Determination. This suspension of liquidation will remain in effect until further notice.

In accordance with section 703(f) of the Act, we intend to notify the ITC of this preliminary determination of critical circumstances.

This determination is issued and published pursuant to sections 703(f) and 777(i)(1) of the Act.

The Mid-Atlantic Fishery Management Council's Bluefish Advisory Panel will meet jointly with the Atlantic States Marine Fisheries Commission's Bluefish Advisory Panel via webinar. The purpose of this meeting is to welcome new Advisory Panel members, review recent management track stock assessment information for bluefish, and to review the recommendations of the Scientific and Statistical Committee (SSC) and Monitoring Committee for 2022-23 catch and landings limits.

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Collins at the Council Office, (302) 526-5253, at least 5 days prior to the meeting date.

Appeals to the Board are normally taken up for decision in the order in which they are docketed. See USPTO Standard Operating Procedure 1, Assignment of judges to panels (Sept. 20, 2018), available at www.uspto.gov/patents/ptab/resources. Currently, the average appeal pendency is about 13 months, down from 15 months in 2020, and from 30 months in 2015. See the PTAB statistics available at www.uspto.gov/patents/ptab/statistics. However, a small number of appeals are advanced out of turn due to a special status reflecting, for example, that the appealed case is a reissue application or a reexamination proceeding, or in light of an inventor's advanced age or poor health.

On July 2, 2020, the PTAB adopted, on a temporary basis, the Fast-Track Appeals Pilot Program, under which an appellant may have an ex parte appeal to the Board advanced out of turn by filing a petition under 37 CFR 41.3, accompanied by the petition fee set forth in 37 CFR 41.20(a). See Fast-Track Appeals Pilot Program, 85 FR 39888 (July 2, 2020) (Fast-Track Notice). The Fast-Track Appeals Pilot Program permits an appellant to accelerate the Board's decision on an ex parte appeal, hastening the pace at which patentability determinations are made and products or services embodying those patented inventions are brought to the marketplace, and thus spurring follow-on innovation, economic growth, and job creation. The USPTO provides a form for the Fast-Track petition, Form PTO/SB/451, which is available on the USPTO's website at www.uspto.gov/patents/apply/forms/forms-patent-applications-filed-or-after-september-16-2012.

The Fast-Track Notice required, inter alia, that a petition be filed before July 2, 2021, to participate in the program. The Fast-Track Notice also set a maximum number of 500 appeals that may be advanced through Fast-Track petitions.

The Fast-Track Appeals Pilot Program is hereby extended to accept petitions for advancing out of turn (according “Fast-Track status” to) ex parte appeals through July 2, 2022. The requirements for the program remain the same as those set forth in the original notice ( see Fast-Track Notice, 85 FR 39888), with the following modification regarding the petition limit.

The upper limit of 500 total granted Fast-Track petitions, as set forth in the Fast-Track Notice, is no longer applicable. To maintain the Board's ability to provide a faster appeal option while timely resolving other appeals, however, the number of granted petitions in the Fast-Track Appeals Pilot Program remains limited to 125 granted petitions per quarter. If a quarterly limit is reached, the PTAB retains the flexibility to accept additional petitions, either for consideration in that quarter or to be held in abeyance for consideration in the next quarter.

The USPTO tracks the number of granted petitions, the average time to answer petitions, and the average time to render a Board decision on the merits of the ex parte appeal after a petition grant. Current information and statistics may be viewed on the PTAB website at www.uspto.gov/PTABFastTrack.

On January 20, 2021, President Biden signed Executive Order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” to address racial, economic, and other disparities faced by underserved communities in the United States. The Order requires Federal agencies to conduct an equity assessment. In furthering this Agency's commitment to bringing together and serving all communities, AmeriCorps seeks general public input on the following:

1. Potential barriers that underserved communities and individuals may face to enrollment in and access to benefits and services in AmeriCorps programs;

2. Potential barriers that underserved communities and individuals may face in taking advantage of Agency procurement and contracting opportunities;

3. Whether new policies, regulations, or guidance documents may be necessary to advance equity in Agency actions and programs; and

4. Knowledge of any offices or divisions within the Agency that are responsible for advancing civil rights or whose mandates specifically include serving underrepresented or disadvantaged communities.

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

Title of Collection: Endowment Excise Tax: Allocation Reduction Waiver.

OMB Control Number: 1840-NEW.

Type of Review: A new information collection.

Respondents/Affected Public: Private Sector.

Total Estimated Number of Annual Responses: 200.

Total Estimated Number of Annual Burden Hours: 200.

Abstract: In accordance with the Coronavirus Response and Relief Supplemental Appropriations Act, 2021 (CRRSAA), Public Law 116-260, section 314(d)(6)(B), the Secretary may waive the requirements to reduce a grantee's CRRSAA allocation by 50 percent, if upon application, an institution of higher education demonstrates need (including need for additional funding for financial aid grants to students, payroll expenses, or other expenditures) for the total amount of funds such institution is allocated under section 314(a)(1) of CRRSAA. The proposed form provides institutions with the opportunity to request this waiver and collects data needed to evaluate their waiver request.

Additional Information: If this emergency collection is not approved, the Department will be unable to receive and review waiver requests in a timely manner, delaying the release of funds to institutions of higher education and students that are still recovering from the effects of the pandemic.

This request for written third-party comments concerning the performance of accrediting agencies under review by the Secretary of Education is required by § 496(n)(1)(A) of the Higher Education Act (HEA) of 1965, as amended, and pertains to the summer 2022 meeting of the National Advisory Committee on Institutional Quality and Integrity (NACIQI). The meeting date and location have not been determined, but will be announced in a later Federal Register notice. In addition, a later Federal Register notice will describe how to register to provide oral comments at the meeting.

Agencies Under Review and Evaluation: The Department requests written comments from the public on the following accrediting agencies, which are currently undergoing review and evaluation by the Accreditation Group, and which will be reviewed at the summer 2022 NACIQI meeting.

The agencies are listed by the type of application each agency has submitted. Please note, each agency's current scope of recognition is indicated below. If any agency requests a change to its scope of recognition, identified are both the current scope of recognition and the requested scope of recognition.

1. Association for Biblical Higher Education, Commission on Accreditation. Scope of recognition: The accreditation and pre-accreditation (“Candidate Status”) of institutions of biblical higher education in the United States offering undergraduate certificates, associate degrees, baccalaureate degrees, graduate certificates, and master's degrees, including the accreditation of educational programs offered via distance education.

2. American Occupational Therapy Association, Accreditation Council for Occupational Therapy Education. Scope of recognition: The accreditation of occupational therapy educational programs offering the professional master's degree, combined baccalaureate/master's degree, and occupational therapy doctorate (OTD) degree; the accreditation of occupational therapy assistant programs offering the associate degree or a certificate; and the accreditation of these programs offered via distance education. Requested scope of recognition: The pre-accreditation and accreditation throughout the United States of occupational therapy education programs offering the professional master's degree, combined baccalaureate/master's degree, and occupational therapy doctorate (OTD) degree; and occupational therapy assistant programs offering the baccalaureate degree, associate degree, or a certificate; including those programs offered via distance education.

3. Accreditation Council for Pharmacy Education. Scope of recognition: The accreditation and pre-accreditation within the United States of professional degree programs in pharmacy leading to the degree of Doctor of Pharmacy, including those programs offered via distance education.

4. Association for Clinical Pastoral Education, Inc., Accreditation Commission. Scope of recognition: The pre-accreditation (provisional) and accreditation of both clinical pastoral education (CPE) centers and Certified Educator CPE programs within the United States, including those that offer those programs via distance education.

5. American Dental Association, Commission on Dental Accreditation. Scope of recognition: The accreditation of predoctoral dental education programs (leading to the D.D.S. or D.M.D. degree), advanced dental education programs, and allied dental education programs that are fully operational or have attained “Initial Accreditation” status, including programs offered via distance education.

6. Distance Education Accrediting Commission. Scope of recognition: The accreditation of postsecondary institutions in the United States that offer degree and/or non-degree programs primarily by the distance or correspondence education method up to and including the professional doctoral degree, including those institutions that are specifically certified by the agency as accredited for Title IV purposes.

7. Middle States Commission on Secondary Schools. Scope of recognition: The accreditation of postsecondary, non-degree granting institutions that offer all or part of their educational programs via distance education modalities in the United States.

8. Southern Association of Colleges and Schools, Commission on Colleges (“SACSCOC”). Scope of recognition: The accreditation and pre-accreditation (“Candidate for Accreditation”) of degree-granting institutions of higher education in Alabama, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Texas, and Virginia, including the accreditation of programs offered via distance and correspondence education within these institutions. This recognition extends to the SACSCOC Board of Trustees and the Appeals Committee of the College Delegate Assembly on cases of initial candidacy or initial accreditation and for continued accreditation or candidacy.

1. New York State Board of Regents, State Education Department, Office of the Professions (Public Postsecondary Vocational Education, Practical Nursing). Scope of Recognition: State agency for the approval of public postsecondary vocational education in the field of practical nursing offered by a Board of Cooperative Educational Services, an Educational Opportunity Center, City School Districts, and County Boards of Supervisors to prepare persons for licensed practical nursing careers in the State of New York. The compliance report includes findings of noncompliance with Criteria in 34 CFR 603 as referenced in the SDO decision letter dated May 27, 2020 available under NACIQI meeting date 02/27/2020 at https://surveys.ope.ed.gov/erecognition/PublicDocuments.

Written comments about the recognition of any of the accrediting agencies listed above must be received by August 15, 2021, in the ThirdPartyComments@ed.gov mailbox. Please include in the subject line “Written Comments: (agency name).” The electronic mail (email) must include the name(s), title, organization/affiliation, mailing address, email address, and telephone number of the person(s) making the comment. Comments should be submitted as a Microsoft Word document or in a medium compatible with Microsoft Word (not a PDF file) that is attached to an email or provided in the body of an email message. Comments about an agency that has submitted a compliance report scheduled for review by the Department must relate to the criteria for recognition cited in the senior Department official's letter that requested the report, or in the Secretary's appeal decision, if any. Comments about an agency that has submitted a petition for initial recognition, renewal of recognition, or an expansion of scope must relate to the agency's compliance with the Criteria for the Recognition of Accrediting Agencies, which are available at http://www.ed.gov/admins/finaid/accred/index.html.

Only written materials submitted by the deadline to the email address listed in this notice, and in accordance with these instructions, become part of the official record concerning agencies scheduled for review and are considered by the Department and NACIQI in their deliberations.

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

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

Title of Collection: Assurance of Compliance—Civil Rights Certificate.

OMB Control Number: 1870-0503.

Type of Review: An extension of a currently approved collection.

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

Total Estimated Number of Annual Responses: 25.

Total Estimated Number of Annual Burden Hours: 8.

Abstract: The Office for Civil Rights (OCR) has enforcement responsibilities under several civil rights laws, including Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, Section 504 of the Rehabilitation Act of 1973, the Age Discrimination Act of 1975, and the Boy Scouts of America Equal Access Act. To meet these responsibilities, OCR collects assurances of compliance from applicants for Federal financial assistance from, and applicants for funds made available through, the Department of Education, as required by regulations. These entities include, for example, State educational agencies, local education agencies, and postsecondary educational institutions. If a recipient violates one or more of these civil rights laws, OCR and the Department of Justice can use the signed assurances of compliance in an enforcement proceeding.

Purpose of Program: The IAL program supports high-quality programs designed to develop and improve literacy skills for children and students from birth through 12th grade in high-need local educational agencies (LEAs) and schools. The Department intends to promote innovative literacy programs that support the development of literacy skills in low-income communities, including programs that (1) develop and enhance effective school library programs, which may include providing professional development for school librarians, books, and up-to-date materials to high-need schools; (2) provide early literacy services, including pediatric literacy programs through which, during well-child visits, medical providers trained in research-based methods of early language and literacy promotion provide developmentally appropriate books and recommendations to parents to encourage them to read aloud to their children starting in infancy; and (3) provide high-quality books on a regular basis to children and adolescents from low-income communities to increase reading motivation, performance, and frequency.

The Explanatory Statement for Division H of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260) (2021 Appropriations Explanatory Statement) includes language directing the Department to reserve no less than 50 percent of funds under the IAL program for grants to develop and enhance effective school library programs, which may include providing professional development to school librarians and books and up-to-date materials to high-need schools (166 Cong. Rec. H8634, 2020). While report language does not create a legal requirement to reserve the specified amount of funding for school library programs, the number of high-quality applications related to school library programs received under IAL competitions generally has allowed the Department to meet this report language directive.

Priorities: This notice contains two absolute priorities and three competitive preference priorities. Absolute Priorities 1 and 2 were established in the notice of final priorities and requirement for IAL (NFP), published elsewhere in this issue of the Federal Register . Competitive Preference Priority 1 is from the Administrative Priorities for Discretionary Grant Programs, published in the Federal Register on March 9, 2020 (85 FR 13640) (Administrative Priorities). Competitive Preference Priorities 2 and 3 are from the NFP.

Absolute Priorities: For FY 2021 and any subsequent year in which we make awards from the list of unfunded applications from this competition, these priorities are absolute priorities. Under 34 CFR 75.105(c)(3), we consider only applications that meet at least one of these absolute priorities.

These priorities are:

Absolute Priority 1—Projects, Carried Out in Coordination With School Libraries, for Book Distribution, Childhood Literacy Activities, or Both.

Projects that propose to coordinate with school libraries to carry out grant activities, such as book distributions, childhood literacy activities, or both, for the proposed project.

Absolute Priority 2—Projects, Carried Out in Coordination With School Libraries, That Provide a Learning Environment That Is Racially, Ethnically, Culturally, Disability Status and Linguistically Responsive and Inclusive, Supportive, and Identity-Safe.

Projects coordinated with school libraries and designed to be responsive to racial, ethnic, cultural, disability, and linguistic differences in a manner that creates inclusive, supportive, and identity-safe learning environments.

In its application, the applicant must—

(a) Describe the types of racially, ethnically, culturally, disability status, and linguistically responsive program design elements that the applicant proposes to include in its project;

(b) Explain how its program design will create inclusive, supportive, and identity-safe environments; and

(c) Describe how its project will be carried out in coordination with school libraries.

Competitive Preference Priorities: For FY 2021 and any subsequent year in which we make awards from the list of unfunded applications from this competition, these priorities are competitive preference priorities. Under 34 CFR 75.105(c)(2)(i), we award up to an additional 13 points to an application, depending on how well the application meets one or more of these priorities. For Competitive Preference Priority 1, we award an additional five points to an application that meets the priority. For Competitive Preference Priority 2, we award an additional five points to an application that meets the priority. For Competitive Preference Priority 3, we award up to an additional three points, depending on which priority subpart (a, b, or c) the applicant meets.

These priorities are:

Competitive Preference Priority 1—Rural Applicants. (0 or 5 points)

Under this priority, an applicant must demonstrate the applicant proposes to serve a community that is served by one or more LEAs with a locale code of 32, 33, 41, 42, or 43.

Competitive Preference Priority 2—Supporting Students in Urban Areas. (0 or 5 points)

Projects that are designed to serve one or more urban LEAs. In its application, an applicant must demonstrate one of the following:

(a) The applicant is an eligible LEA or consortium of eligible LEAs with a locale code of 11, 12, or 13.

(b) The applicant is a national nonprofit that proposes to serve schools within eligible LEAs all of which have a locale code of 11, 12, or 13.

Competitive Preference Priority 3—Supporting Students From Low-Income Families. (up to 3 points)

Projects that serve LEAs serving students from low-income families. In its application, an applicant must demonstrate, based on Small Area Income and Poverty Estimates (SAIPE) data from the U.S. Census Bureau or, for an LEA for which SAIPE data are not available, the same State-derived equivalent of SAIPE data that the State uses to make allocations under part A of title I of the Elementary and Secondary Education Act of 1965, as amended (ESEA), one of the following:

(a) At least 30 percent of the students enrolled in each of the LEAs to be served by the proposed project are from families with an income below the poverty line. (1 point)

(b) At least 40 percent of the students enrolled in each of the LEAs to be served by the proposed project are from families with an income below the poverty line. (2 points)

(c) At least 50 percent of the students enrolled in each of the LEAs to be served by the proposed project are from families with an income below the poverty line. (3 points)

Definitions: The definitions of “demonstrates a rationale,” “logic model,” “project component,” and “relevant outcome” are from 34 CFR 77.1. The definition of “eligible national nonprofit organization” is from section 2226(b)(2) of the ESEA (20 U.S.C. 6646(b)(2)). The definition of “local educational agency” is from section 8101(30) (20 U.S.C. 7801(30)) of the ESEA.

Demonstrates a rationale means a key project component included in the project's logic model is informed by research or evaluation findings that suggest the project component is likely to improve relevant outcomes.

Eligible national nonprofit organization (NNP) means an organization of national scope that—

(a) Is supported by staff, which may include volunteers, or affiliates at the State and local levels; and

(b) Demonstrates effectiveness or high-quality plans for addressing childhood literacy activities for the population targeted by the grant.

Local educational agency means:

(a) In general—The term local educational agency means a public board of education or other public authority legally constituted within a State for either administrative control or direction of, or to perform a service function for, public elementary schools or secondary schools in a city, county, township, school district, or other political subdivision of a State, or of or for a combination of school districts or counties that is recognized in a State as an administrative agency for its public elementary schools or secondary schools.

(b) Administrative Control and Direction—The term includes any other public institution or agency having administrative control and direction of a public elementary school or secondary school.

(c) Bureau of Indian Education Schools—The term includes an elementary school or secondary school funded by the Bureau of Indian Education but only to the extent that including the school makes the school eligible for programs for which specific eligibility is not provided to the school in another provision of law and the school does not have a student population that is smaller than the student population of the local educational agency receiving assistance under this Act with the smallest student population, except that the school shall not be subject to the jurisdiction of any State educational agency other than the Bureau of Indian Education.

(d) Educational Service Agencies—The term includes educational service agencies and consortia of those agencies.

(e) State Educational Agency—The term includes the State educational agency in a State in which the State educational agency is the sole educational agency for all public schools.

Logic model (also referred to as a theory of action) means a framework that identifies key project components of the proposed project ( i.e., the active “ingredients” that are hypothesized to be critical to achieving the relevant outcomes) and describes the theoretical and operational relationships among the key project components and relevant outcomes.

Project component means an activity, strategy, intervention, process, product, practice, or policy included in a project. Evidence may pertain to an individual project component or to a combination of project components ( e.g., training teachers on instructional practices for English learners and follow-on coaching for these teachers).

Relevant outcome means the student outcome(s) or other outcome(s) the key project component is designed to improve, consistent with the specific goals of the program.

Program Authority: Section 2226 of the ESEA (20 U.S.C. 6646).

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. (d) The regulations in 34 CFR part 299. (e) The NFP. (f) The Administrative Priorities.

Type of Award: Discretionary grants.

Estimated Available Funds: $25,000,000.

Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2022 from the list of unfunded applications from this competition.

Estimated Range of Awards: $175,000 to $750,000.

Estimated Average Size of Awards: $500,000.

Estimated Number of Awards: 40-60.

Project Period: 60 months.

1. Eligible Applicants: To be considered for an award under this competition, an applicant must be one or more of the following:

(1) An LEA in which 20 percent or more of the students served by the LEA are from families with an income below the poverty line (as defined in section 8101(41) of the ESEA).

(2) A consortium of such LEAs described in paragraph (1) above.

(3) The Bureau of Indian Education.

(4) An eligible national nonprofit organization (as defined in section 2226(b)(2) of the ESEA) that serves children and students within the attendance boundaries of one or more eligible LEAs.

An entity that meets the definition of an LEA in section 8101(30) of the ESEA and that serves multiple LEAs, such as a county office of education, an education service agency, or regional service education agency, must provide the most recent SAIPE data for each of the individual LEAs it serves. To determine whether the entity meets the poverty threshold, the Department will derive the entity's poverty rate by aggregating the number of students from families below the poverty line (as provided in SAIPE data) in each of the LEAs the entity serves and dividing it by the total number of students (as provided in SAIPE data) in all of the LEAs the entity serves.

An LEA for which SAIPE data are not available, such as a non-geographic charter school, must provide a determination by the State educational agency (SEA) that 20 percent or more of the students aged 5-17 in the LEA are from families with incomes below the poverty line based on the same State-derived poverty data the SEA used to determine the LEA's allocation under part A of title I of the ESEA.

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

b. Supplement-Not-Supplant: This competition involves supplement-not-supplant funding requirements. Section 2301 of the ESEA provides that funds made available under this program must be used to supplement, and not supplant, non-Federal funds that would otherwise be used for IAL program activities by grantees. 20 U.S.C. 1221e-3, 3474, and 6511(a); 34 CFR 76.564 through 76.569.

c. Indirect Cost Rate Information: This program uses a restricted 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.

d. 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.

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 February 13, 2019 (84 FR 3768) and available at www.govinfo.gov/content/pkg/FR-2019-02-13/pdf/2019-02206.pdf, which contain requirements and information on how to submit an application.

2. Submission of Proprietary Information: Given the types of projects that may be proposed in applications for the IAL program, your application may include business information that you consider proprietary. In 34 CFR 5.11 we define “business information” and describe the process we use in determining whether any of that information is proprietary and, thus, protected from disclosure under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552, as amended).

Because we plan to make successful applications available to the public, you may wish to request confidentiality of business information.

Consistent with Executive Order 12600, please designate in your application any information that you believe is exempt from disclosure under Exemption 4. In the appropriate Appendix section of your application, under “Other Attachments Form,” please list the page number or numbers on which we can find this information. For additional information please see 34 CFR 5.11(c).

3. Intergovernmental Review: This program 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. Please note that, under 34 CFR 79.8(a), we have shortened the standard 60-day intergovernmental review period in order to make awards by the end of FY 2021.

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

5. 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 25 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, references, and captions, as well as all text in charts, tables, figures, and graphs.

• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).

• 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; the one-page abstract, resumes, bibliography, logic model, or letters of support. However, the recommended page limit does apply to all of the application narrative.

6. Notice of Intent to Apply: The Department will be able to review grant applications more efficiently if we know the approximate number of applicants that intend to apply. Therefore, we strongly encourage each potential applicant to notify us of their intent to submit an application. To do so, please email the program contact person listed under FOR FURTHER INFORMATION CONTACT with the subject line “Intent to Apply,” and include the applicant's name and a contact person's name and email address. Applicants that do not submit a notice of intent to apply may still apply for funding; applicants that do submit a notice of intent to apply are not bound to apply or bound by the information provided.

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

(a) Significance (up to 20 points).

The Secretary considers the significance of the proposed project. In determining the significance of the proposed project, the Secretary considers the following factors:

(1) The significance of the problem or issue to be addressed by the proposed project.

(2) The extent to which the proposed project is likely to build local capacity to provide, improve, or expand services that address the needs of the target population.

(3) The importance or magnitude of the results or outcomes likely to be attained by the proposed project, especially improvements in teaching and student achievement.

(b) Quality of the project design (up to 20 points).

The Secretary considers the quality of the design of the proposed project. In determining the quality of the design of the proposed project, the Secretary considers the following factors:

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

(2) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs.

(3) The extent to which the proposed project represents an exceptional approach for meeting statutory purposes and requirements.

(4) The extent to which the proposed project demonstrates a rationale (as defined in this notice).

(c) Quality of project services (up to 25 points).

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

In addition, the Secretary considers the following factors:

(1) The extent to which the services to be provided by the proposed project are appropriate to the needs of the intended recipients or beneficiaries of those services.

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

(3) The extent to which the services to be provided by the proposed project are focused on those with greatest needs.

(d) Quality of the management plan (up to 25 points).

The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers:

(1) 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.

(2) The adequacy of procedures for ensuring feedback and continuous improvement in the operation of the proposed project.

(3) 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.

(e) Quality of project evaluation (up to 10 points).

The Secretary considers the quality of the evaluation to be conducted of the proposed project. In determining the quality of the evaluation, the Secretary considers the following factors:

(1) The extent to which the methods of evaluation are appropriate to the context within which the project operates.

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

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. Risk Assessment and Specific Conditions: Consistent with 2 CFR 200.206, before awarding grants under this program 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.

4. 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.

5. 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 or subgrantee 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 purposes of the Government Performance and Results Act of 1993 and for Department reporting under 34 CFR 75.110, the Department has established the following performance measures for the IAL program: (1) The percentage of fourth graders participating in the project who demonstrated individual student growth ( i.e., an improvement in their achievement) over the past year on State reading or language arts assessments under section 1111(b)(2) of the ESEA; (2) the percentage of eighth graders participating in the project who demonstrated individual student growth ( i.e., an improvement in their achievement) over the past year on State reading or language arts assessments under section 1111(b)(2) of the ESEA; (3) the percentage of schools participating in the project whose book-to-student ratios increase from the previous year; and (4) the percentage of participating children who receive at least one free, grade- and language-appropriate book of their own.

All grantees will be expected to submit an annual performance report that includes data addressing these performance measures to the extent that they apply to the grantee's project.

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, whether the grantee has made substantial progress in achieving 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.

Title: FERC-917, Electric Transmission Facilities and FERC-918, Standards for Business Practices and Communication Protocols for Public Utilities.

OMB Control No.: 1902-0233.

Type of Request: Three-year extension of the FERC-917 and FERC-918 information collection requirements with no changes to the reporting requirements.

Type of Respondents: Public utilities transmission providers.

Abstract: On February 17, 2007, the Commission issued Order No. 890 to address and remedy opportunities for undue discrimination under the pro forma Open Access Transmission Tariff (OATT) adopted in 1996 by Order No. 888. 1 Through Order No. 890, the Commission:

1. Adopted pro forma OATT provisions necessary to keep imbalance charges closely related to incremental costs.

2. Increased nondiscriminatory access to the grid by requiring public utilities, working through the North American Electric Reliability Corporation (NERC), to develop consistent methodologies for available transfer capability (ATC) calculation and to publish those methodologies to increase transparency.

3. Required an open, transparent, and coordinated transmission planning process thereby increasing the ability of customers to access new generating resources and promote efficient utilization of transmission.

4. Gave the right to customers to request from transmission providers, studies addressing congestion and/or integration of new resource loads in areas of the transmission system where they have encountered transmission problems due to congestion or where they believe upgrades and other investments may be necessary to reduce congestion and to integrate new resources.

5. Required both the transmission provider's merchant function and network customers to include a statement with each application for network service or to designate a new network resource that attests, for each network resource identified, that the transmission customer owns or has committed to purchase the designated network resource and the designated network resource comports with the requirements for designated network resources. The network customer includes this attestation in the customer's comment section of the request when it confirms the request on the Open Access Same-Time Information System (OASIS).

6. Required with regard to capacity reassignment that: (a) All sales or assignments of capacity be conducted through or otherwise posted on the transmission provider's OASIS on or before the date the reassigned service commences; (b) assignees of transmission capacity execute a service agreement prior to the date on which the reassigned service commences; and (c) transmission providers aggregate and summarize in an electric quarterly report the data contained in these service agreements.

7. Adopted an operational penalties annual filing that provides information regarding the penalty revenue the transmission provider has received and distributed.

8. Required creditworthiness information to be included in a transmission provider's OATT. Attachment L must specify the qualitative and quantitative criteria that the transmission provider uses to determine the level of secured and unsecured credit required.

The Commission required a NERC/NAESB  2 team to draft and review Order No. 890 reliability standards and business practices. The team was to solicit comment from each utility on developed standards and practices and utilities were to implement each, after Commission approval. Public utilities, working through NERC, were to revise reliability standards to require the exchange of data and coordination among transmission providers and, working through NAESB, were to develop complementary business practices. Required OASIS postings included:

1. Explanations for changes in ATC values;

2. Capacity benefit margin (CBM) reevaluations and quarterly postings;

3. OASIS metrics and accepted/denied requests;

4. Planning redispatch offers and reliability redispatch data;

5. Curtailment data;

6. Planning and system impact studies;

7. Metrics for system impact studies; and

8. All rules.

Incorporating the Order No. 890 standards into the Commission's regulations benefits wholesale electric customers by streamlining utility business practices, transactional processes, and OASIS procedures, and by adopting a formal ongoing process for reviewing and upgrading the Commission's OASIS standards and other electric industry business practices. These practices and procedures benefit from the implementation of generic industry standards.

The Commission's Order No. 890 regulations can be found in 18 CFR 35.28 ( pro forma tariff requirements), and 37.6 and 37.7 (OASIS requirements). 18 CFR 35.28(b) states: “Audit data must remain available for download on the OASIS for 90 days, except ATC/TTC postings that must remain available for download on the OASIS for 20 days. The audit data are to be retained and made available upon request for download for five years from the date when they are first posted in the same electronic form as used when they originally were posted on the OASIS.”

Estimate of Annual Burden:   3 The Commission estimates the annual public reporting burden for the information collections as follows. Please note, the zeroes for respondents and responses are based on having no filings of this type over the past four years. In addition, we estimate no filings during the next three years. The requirements remain in the regulations and are included as part of OMB Control Number 1902-0233.

This action is directed to the public in general and may be of interest to those involved with pesticide manufacture, sale, or use; to a member or affiliate of a veterinarian interest group, an animal welfare interest group, an environmental interest group, or a public health interest group; to federal, state, or local regulatory partners; or to a member of the general public interested in the manufacture, sale, or use of pesticides (including pet medications). Given the broad interest, the Agency has not attempted to identify or describe all the specific entities that may be affected by this action.

The following list of North American Industry Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Pesticide and Other Agricultural Chemical Manufacturing (NAICS code 325320).

• Pet and Pet Supplies Stores (NAICS code 453910).

• Pet Care (except Veterinary) Services (NAICS code 812910).

• Veterinarians' medicines merchant wholesalers (NAICS code 424210).

• Veterinary Services (NAICS code 541940).

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

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

A copy of the CBD's Petition, “Re: Petition to Cancel Registration of PNR1427 (Brand Name Seresto) under the Federal Insecticide, Fungicide, and Rodenticide Act; Reg. No. 11556-155”, is available in the docket under docket identification (ID) number EPA-HQ-OPP-2021-0409.

EPA seeks public comment during the next 60 days on a petition received from the CBD requesting that the Agency cancel the Seresto registration, and to suspend Seresto's registration pending such requested cancellation. The petition was submitted under the Administrative Procedure Act (APA), 5 U.S.C. 553(e). The petition argues that Seresto must be cancelled because it poses an unreasonable risk to human health, pets, and the environment. The petition states that, “according to a recent aggregate incident summary report, since this product was introduced in 2012, EPA has received over 75,000 adverse incident reports, including at least 1,698 reports linking the use of this product to pet deaths and at least 700 involving human harm.” CBD asserts that the incidents pose unreasonable adverse effects under FIFRA, and that “cancellation of this product is not only warranted but essential for protecting public health, consumers, imperiled wildlife, and companion animals.”

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2021-0409 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. Please note that due to the public health emergency the EPA Docket Center (EPA/DC) and Reading Room was closed to public visitors on March 31, 2020. Our EPA/DC staff will continue to provide customer service via email, phone, and webform. For further information on EPA/DC services, docket contact information and the current status of the EPA/DC and Reading Room, please visit https://www.epa.gov/dockets.

Proposed Agenda: The agenda for the August 2, 2021, meeting will consist of briefings by the 911 Strike Force working groups. This agenda may be modified at the discretion of the 911 Strike Force Chair and the Designated Federal Officer. The August 2, 2021, meeting will be held in a wholly electronic format to accommodate continuing public health precautions related to the coronavirus (COVID-19) pandemic.

The August 2, 2021, meeting will be open to members of the general public via live broadcast over the internet from the FCC Live web page at http://www.fcc.gov/live/. The public may also follow the meeting on Twitter @fcc or via the Commission's Facebook page at www.facebook.com/fcc . Members of the public may submit any questions that arise during the meeting to livequestions@fcc.gov.

Open captioning will be provided for the live stream. Other reasonable accommodations for people with disabilities are available upon request. To request an accommodation, or for materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). Such requests should include a detailed description of the accommodation needed. In addition, please include a way for the Commission to contact the requester if more information is needed to fulfill the request. Please allow at least five days' advance notice; last-minute requests will be accepted but may not be possible to accommodate.

OMB Control No.: 3060-1095.

Title: Surrenders of Authorizations for International Carrier, Space Station and Earth Station Licensees.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 8 respondents; 8 responses.

Estimated Time per Response: 1 hour.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Voluntary. The statutory authority for this information collection is contained in Sections 4(i), 7(a), 11, 303(c), 303(f), 303(g), and 303(r) of the Communications Act of 1934, as amended; 47 U.S.C. 154(i), 157(a), 161, 303(c), 303(f), 303(g), and 303(r).

Total Annual Burden: 8 hours.

Annual Cost Burden: None.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: In general, there is no need for confidentiality with is collection of information.

Needs and Uses: This collection will be submitted to the Office of Management and Budget (OMB) as an extension after this 60-day comment period has ended in order to obtain the full three-year clearance from OMB. There are no changes in the number of respondents, responses, annual burden hours and total annual costs.

Licensees file surrenders of authorizations with the Commission on a voluntary basis. This information is used by Commission staff to issue Public Notices to announce the surrenders of authorization to the general public. The Commission's release of Public Notices is critical to keeping the general public abreast of the licensees' discontinuance of telecommunications services.

Without this collection of information, licensees would be required to submit surrenders of authorizations to the Commission by letter which is more time consuming than submitting such requests to the Commission electronically. In addition, Commission staff would spend an extensive amount of time processing surrenders of authorizations received by letter. The collection of information saves time for both licensees and Commission staff since they are received in IBFS electronically and include only the information that is essential to process the requests in a timely manner. Furthermore, the E-filing module expedites the Commission staff's announcement of surrenders of authorizations via Public Notice.

The Secretary of HHS, and by delegation, the CDC Director and the HRSA Administrator, are authorized by the PHS Act to: (1) Conduct, encourage, cooperate with, and assist other appropriate public health authorities, scientific institutions, and scientists in the conduct of research, investigations, experiments, demonstrations, and studies related to the cases, diagnosis, treatment, control, and prevention of physical and mental diseases, and other impairments; (2) assist states and their political subdivisions in preventing, suppressing, and treating communicable diseases and other preventable conditions and in promoting health and well-being; (3) assist public and non-profit private entities in preventing, controlling and treating sexually transmitted diseases (STDs), including the Human Immunodeficiency Virus (HIV); (4) improve health and achieve health equity through access to quality services and a skilled health workforce and innovative programs; (5) support healthcare services to persons living with or at risk for HIV, viral hepatitis, and other STDs; and (6) advance the education of health professionals and the public from HIV, viral hepatitis, and other STDs.

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

The CDC/HRSA Advisory Committee on HIV and STD Prevention and Treatment shall advise the Director, CDC, and the Administrator, HRSA, regarding objectives, strategies, policies, and priorities for HIV, viral hepatitis, and other STD prevention and treatment efforts, including surveillance of HIV infection, Acquired Immunodeficiency Syndrome (AIDS), viral hepatitis, other STDs, and related behaviors; epidemiologic, behavioral, health services, and laboratory research on HIV, viral hepatitis, and other STDs; identification of policy issues related to HIV/viral hepatitis/STD professional education, patient healthcare delivery, and prevention services; agency policies about prevention of HIV, viral hepatitis and other STDs, treatment, healthcare delivery, and research and training; strategic issues influencing the ability of CDC and HRSA to fulfill their missions of providing prevention and treatment services; programmatic efforts to prevent and treat HIV, viral hepatitis, and other STDs; and support to the agencies in their development of responses to emerging health needs related to HIV, viral hepatitis and other STDs.

Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of public health; epidemiology; laboratory practice; immunology; infectious diseases; drug abuse; behavioral science; health education; healthcare delivery; state health programs; clinical care; preventive health; medical education; health services and clinical research; and healthcare financing. The Committee shall also include representation of persons with HIV and other affected populations; state and local health and education agencies; HIV/viral hepatitis/STD community-based organizations; and the ethics or faith-based community. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms.

Selection of members is based on candidates' qualifications to contribute to the accomplishment of CHACHSPT objectives. The U.S. Department of Health and Human Services policy stipulates that committee membership be balanced in terms of points of view represented, and the committee's function. Appointments shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, gender identity, HIV status, disability, and cultural, religious, or socioeconomic status. Nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Current participation on federal workgroups or prior experience serving on a federal advisory committee does not disqualify a candidate; however, HHS policy is to avoid excessive individual service on advisory committees and multiple committee memberships. Committee members are Special Government Employees (SGEs), requiring the filing of financial disclosure reports at the beginning and annually during their terms. Individuals who are selected for appointment will be required to provide detailed information regarding their financial interests and, for example, any work they do for the federal government through research grants or contracts. Disclosure of this information is required in order for CDC ethics officials to determine whether there is a conflict between the SGE's public duties as members of CHACHSPT and their private interests, including an appearance of a loss of impartiality as defined by federal laws and regulations, and to identify any required remedial action needed to address the potential conflict. CDC reviews potential candidates for CHACHSPT membership when a vacancy arises and provides a slate of nominees for consideration to the Secretary of HHS for final selection. HHS notifies selected candidates of their appointment near the start of the term in December 1, 2021, or as soon as the HHS selection process has been completed. Note that the need for different expertise varies from year to year and a candidate who is not selected for an open position may be reconsidered for a subsequent open position. SGE nominees must be U.S. citizens, and cannot be full-time employees of the U.S. Government. Candidates should submit the following items:

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

At least one letter of recommendation from person(s) not employed by the U.S. Department of Health and Human Services.

(Candidates may submit letters(s) from current HHS employees if they wish, but at least one letter must be submitted by a person not employed by an HHS agency ( e.g., CDC, NIH, FDA, etc.).

A biographical sketch of the nominee (500 words or fewer).

A letter of interest or personal statement from the nominee stating how their expertise would inform the work of CHACHSPT.

Nominations may be submitted directly by the individual seeking nomination or by the person/organization recommending the candidate.

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

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Using Real-time Prescription and Insurance Claims Data to Support the HIV Care Continuum—New—National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Use of HIV surveillance data to identify out-of-care persons is one strategy for identifying and re-engaging out-of-care persons, and is called Data-to-Care or “D2C.” Data-to-Care uses laboratory reports ( i.e., CD4 and HIV viral load test results) received by a health department's HIV surveillance program as markers of HIV care. In the current D2C model, there is a delay in the identification of out-of-care persons due to the time interval between recommended monitoring tests ( i.e., every three to six months) and the subsequent reporting of these tests to surveillance.

Insurance and prescription administrative claims (billing) data can be used to identify persons who fail to fill antiretroviral (ARV) prescriptions and who are at risk for falling out of care. Because most ARVs are prescribed as a 30-day supply of medication, prescription claims can be used to identify persons who are not filling ARV prescriptions on a monthly basis. Tracking ARV refill data can, therefore, be a more real-time indicator of poor adherence and can act as a harbinger of potential poor retention in care. Using real time insurance and prescription claims data to identify persons who fail to fill ARV prescriptions, and to intervene, could have a significant impact on ARV therapy adherence, viral suppression and potentially on retention in care.

The purpose of the Antiretroviral Improvement among Medicaid Enrollees (AIMS) study is to develop, implement and evaluate a D2C strategy that uses Medicaid insurance and prescription claims data to identify; (1) persons with HIV who have never been prescribed ARV therapy, and (2) persons with HIV who fail to pick up prescribed ARV medications in a timely manner, and to target these individuals for adherence interventions.

A validated HIV case identification algorithm will be applied to the Virginia Medicaid database to identify persons with HIV who have either never filled an ARV prescription or have not filled an ARV prescription within >30 to <90 days of the expected fill date. Deterministic and probabilistic methods will be used to link this list to the Virginia Department of Health's (VDH) Care Markers database (an extract of the VDH HIV surveillance database). Individuals that are matched across the two databases (indicating that the persons are both enrolled in Medicaid and confirmed HIV positive) are eligible for study participation. Additional eligibility criteria include age 19-63 years and continuous enrollment in Virginia Medicaid for the preceding 12 months.

Cluster randomization will occur at the healthcare provider level and will be conducted concurrently with the initial potential participant screening. Providers will be randomized to either the intervention arm or to the usual care arm ( i.e., no intervention or control arm). Study participants are the patients of the randomized healthcare providers. Participants in the intervention arm will be delegated to either a patient-level or provider-level intervention, depending on need; participants who are >30 to <90 days late filling their ARV prescription(s) will receive the patient-level intervention, and participants who have never filled an ARV prescription will be delegated to the provider-level intervention. Participants of the provider-level intervention will not receive direct intervention. Instead, the healthcare providers of these patients (“provider participants”) will receive the provider-level intervention. Potential participants will be contacted by a study Linkage Coordinator to explain the study and obtain consent for participation.

The patient-level intervention has two phases. Phase I is intended for patients who are >30 to <60 days late filling their ARV prescription(s). In Phase I, a Linkage Coordinator will contact participants to discuss the participants' adherence barriers. Once the participant's adherence barriers are identified, the participant will be referred to appropriate resources to assist them in overcoming their adherence barrier(s). Phase II is intended for patients who were enrolled in Phase I but who failed to fill their ARV prescriptions in the subsequent 30 days of the Phase I consultation, and for participants who are >60 to <90 days late at the time the participant was determined to be study eligible. In Phase II, the Linkage Coordinator will lead a similar consultation as in Phase I, but will probe for more complex adherence barriers ( e.g., mental health concerns) and referrals will be made accordingly. The participant will also be offered an evidence-informed mobile application (“app”) which is designed to support ART adherence and retention in care.

The provider-level intervention will consist of a peer-to-peer clinician consultation delivered by clinicians from the Virginia Department of Health's Advisory Committee to the Virginia Medication Assistance Program or by another HIV clinical expert. The peer-to-peer clinician consultations will involve introduction or reinforcement of HIV clinical guidelines for ART initiation, strategies to optimize ART adherence, and resources for supporting adherence for people with HIV. The consultation will be tailored to the needs of the provider participant.

All analyses will be conducted at the patient level. Persons within the intervention arm will be followed prospectively for 12 months. At the end of the intervention arm follow-up period, persons within the usual care arm will be followed retrospectively for 12 months. The primary study outcome of HIV viral suppression (HIV RNA <200 copies/mL) will be compared between study arms.

CDC requests OMB approval to collect standardized information from 500 AIMS study participants (460 participants of the patient-level intervention and 40 participants of the provider-level intervention) and 500 controls over the three-year project period. Secondary data will be abstracted from the Virginia Medicaid and Virginia Care Markers databases to determine study eligibility, to conduct the patient- and provider-level interventions, and to determine study outcomes. During the patient-level intervention, data will be collected on participants' adherence barriers; this information will be used to refer participants to appropriate resources to assist their adherence to ART. During the provider-level intervention data will be collected to inform the peer-to-peer clinician consultation.

CDC requests OMB approval for an estimated 687 burden hours annually. There are no costs to respondents other than their time to participate.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Energy Employees Occupational Illness Compensation Program Act (EEOICPA) Dose Reconstruction Interviews and Forms (OMB Control No. 0920-0530, Exp. 1/31/2022)—Revision—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

On October 30, 2000, the Energy Employees Occupational Illness Compensation Program Act of 2000 (42 U.S.C. 7384-7385) was enacted. This Act established a federal compensation program for employees of the Department of Energy (DOE) and certain of its contractors, subcontractors and vendors, who have suffered cancers and other designated illnesses as a result of exposures sustained in the production and testing of nuclear weapons.

Executive Order 13179, issued on December 7, 2000, delegated authorities assigned to “the President” under the Act to the Departments of Labor, Health and Human Services, Energy and Justice. The Department of Health and Human Services (DHHS) was delegated the responsibility of establishing methods for estimating radiation doses received by eligible claimants with cancer applying for compensation. NIOSH is applying the following methods to estimate the radiation doses of individuals applying for compensation.

In performance of its dose reconstruction responsibilities, under the Act, NIOSH is providing voluntary interview opportunities to claimants (or their survivors) individually, and providing them with the opportunity to assist NIOSH in documenting the work history of the employee by characterizing the actual work tasks performed. In addition, NIOSH and the claimant may identify incidents that may have resulted in undocumented radiation exposures, characterize radiological protection and monitoring practices, and identify co-workers and other witnesses, as may be necessary, to confirm undocumented information. In this process, NIOSH uses a computer assisted telephone interview (CATI) system, which allows interviews to be conducted more efficiently and quickly as opposed to a paper-based interview instrument. Both interviews are voluntary, and failure to participate in either or both interviews will not have a negative effect on the claim, although voluntary participation may assist the claimant by adding important information that may not be otherwise available.

NIOSH uses the data collected in this process to complete an individual dose reconstruction that accounts, as fully as possible, for the radiation dose incurred by the employee in the line of duty for DOE nuclear weapons production programs. After dose reconstruction, NIOSH also performs a brief, voluntary final interview with the claimant to explain the results and to allow the claimant to confirm or question the records NIOSH has compiled. This will also be the final opportunity for the claimant to supplement the dose reconstruction record.

At the conclusion of the dose reconstruction process, the claimant submits a form to confirm that the claimant has no further information to provide to NIOSH about the claim at this time. The form notifies the claimant that signing the form allows NIOSH to forward a dose reconstruction report to DOL and to the claimant, and closes the record on data used for the dose reconstruction. Signing this form does not indicate that the claimant agrees with the outcome of the dose reconstruction. The dose reconstruction results will be supplied to the claimant and to the DOL, the agency that will utilize them as one part of its determination of whether the claimant is eligible for compensation under the Act.

CDC requests approval for an estimated 3,900 burden hours annually. There is no cost to respondents other than their time.

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

The Advisory Board's charter was issued on August 3, 2001, renewed at appropriate intervals, rechartered on March 22, 2020, and will terminate on March 22, 2022.

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

Matters To Be Considered: The agenda will include discussions on the following: NIOSH Program Update; Department of Labor Program Update; Department of Energy Program Update; SEC Petitions Update; Procedures Review Finalization/Document Approvals; Oak Ridge National Laboratory (X-10), Y-12 SEC Petition #250 Addendum Update (Oak Ridge, Tennessee; 1987-1994), and a Board Work Session. Agenda items are subject to change as priorities dictate.

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

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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

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

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

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

5. Assess information collection costs.

Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT)—(OMB Control No. 0920-1100, Exp. 1/31/2022)—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

The Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of HIV/AIDS Prevention (DHAP) requests a three-year Extension for a data collection titled Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT).

CDC provides guidelines for HIV testing and diagnosis for the United States, as well as technical guidance for its grantees. The purpose of this project is to assess characteristics of HIV testing technologies to update these guidance documents to reflect the latest available testing technologies, their performance characteristics, and considerations regarding their use. Specifically, CDC will describe behavioral and clinical characteristics of persons with early infection to help HIV test providers (including CDC grantees) choose which HIV tests to use, and target tests appropriately to persons at different levels of risk. This information will be disseminated primarily through guidance documents and articles in peer-reviewed journals.

The primary study population will be persons at high risk for, or diagnosed with HIV infection, many of whom will be men who have sex with men (MSM), transgender women, minorities, and persons who inject drugs (PWIDs) because the majority of new HIV infections occur each year among these populations. The goals of the project are to: (1) Characterize the performance of new HIV tests for detecting established and early HIV infection at the point of care, relative to each other and to currently used gold standard, non-point-of-care (POC) tests, and (2) identify behavioral and clinical predictors of early HIV infection.

Project DETECT will enroll 1,867 persons annually from two study sites (Seattle and Baltimore). The study will be conducted in two phases.

Phase 1: After a client consents to participate, he/she will be assigned a unique Participant ID, and will then undergo testing with up to seven new HIV tests under study. While awaiting test results, participants will undergo additional specimen collections and complete the Phase 1 Enrollment Survey.

Phase 2: All Phase 1 participants whose results on the seven tests under investigation are not in agreement with one another test (discordant), will be considered to have a potential early HIV infection. Nucleic amplification testing that detects viral nucleic acids will be conducted to confirm an HIV diagnosis and rule out false positives. Study investigators expect that each year, 50 participants with discordant test results will be invited to participate in serial follow-up specimen collections to assess the time point at which all HIV test results resolve and become concordant positive (indicating enrollment during early infection) or concordant negative (indicating one or more false-positive test results in Phase 1).

The follow-up schedule will consist of up to nine visits scheduled at regular intervals over a 70-day period. At each follow-up visit, participants will be tested with the new HIV tests and additional oral fluid and blood specimens will also be collected for storage and use in future HIV test evaluations at CDC. Participants will be followed only to the point at which all their test results become concordant. At each time point, participants will be asked to complete the Phase 2 HIV Symptom and Care survey to collect information on symptoms associated with early HIV infection as well as access to HIV care and treatment since the last Phase 2 visit. When all tests become concordant ( i.e., at the last Phase 2 visit) participants will complete the Phase 2 Behavioral Survey to identify any behavioral changes during follow-up. Of the 50 Phase 2 participants; it is estimated that no more than 26, annually, will have early HIV infection.

All data for the proposed information collection will be collected via an electronic Computer Assisted Self-Interview (CASI) survey. Participants will complete the surveys on an encrypted computer, with the exception of the Phase 2 Symptom and Care survey, which will be administered by a research assistant and then electronically entered into the CASI system. Data to be collected via CASI include questions on sociodemographic characteristics, medical care, HIV testing, pre-exposure prophylaxis, antiretroviral treatment, sexually transmitted diseases (STD) history, symptoms of early HIV infection, substance use and sexual behavior.

Data from the surveys will be merged with HIV test results and relevant clinical data using the unique identification (ID) number. Data will be stored on a secure server managed by the awardee's Information Technology (IT) Services. The participation of respondents is voluntary. There is no cost to the respondents other than their time. The total estimated annual burden hours for the proposed project are 1,594 hours.

ORR is continuously monitoring its capacity to shelter the UAC referred to HHS, as well as the information received from interagency partners, to inform any future decisions or actions.

ORR has specific requirements for the provision of services. Award recipients must have the infrastructure, licensing, experience, and appropriate level of trained staff to meet those requirements. The expansion of the existing program and its services through this supplemental award is a key strategy for ORR to be prepared to meet its responsibility to provide shelter for UAC referred to its care by the Department of Homeland Security (DHS), and so the Customs and Border Protection can continue its vital national security mission to prevent illegal migration, trafficking, and protect the borders of the United States.

Statutory Authority: This program is authorized by—

(A) Section 462 of the Homeland Security Act of 2002, which in March 2003, transferred responsibility for the care and custody of UAC from the Commissioner of the former Immigration and Naturalization Service to the Director of ORR within HHS.

(B) The Flores Settlement Agreement, Case No. CV85-4544-RJK (C.D. Cal. 1996), as well as the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (Pub. L. 110-457), which authorizes post release services under certain conditions to eligible children. All programs must comply with the Flores Settlement Agreement, Case No. CV85-4544-RJK (C.D. Cal. 1996); pertinent regulations; and ORR policies and procedures.

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. “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. The PRA requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, ACL is publishing a notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:

(1) Whether the proposed collection of information is necessary for the proper performance of ACL's functions, including whether the information will have practical utility;

(2) the accuracy of ACL's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and

(4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology.

The Evidence Based Program Fidelity Surveys will be used by ACL to evaluate the fidelity with which ACL's grantee organizations, under the Older Americans Act, implement the required evidence-based programs. States that receive Older Americans Act funds under Title III-D are required to spend those funds on evidence-based programs to improve the health and well-being of their clients and to reduce disease and injury. Since 2003, the aging services network has been steadily moving towards wider implementation of disease prevention and health promotion programs that are based on scientific evidence and demonstrated to improve the health of older adults. The FY 2012 Congressional appropriations law included, for the first time, an evidence-based requirement related to Title III-D funds.

The results of this information collection will be used by ACL/AoA to:

• Effectively report its results to the President, to Congress, to the Department of Health and Human Services and to the public.

• Assess the effectiveness of ACL and its grantees in monitoring program fidelity.

• Aid in program refinement and continuous improvement.

To comment on this information collection please visit the ACL website: https://www.acl.gov/about-acl/public-input.

ACL estimates the burden associated with this collection of information as follows:

FDA is announcing the availability of a draft guidance for FDA staff entitled “FDA Oversight of Food Products Covered by Systems Recognition Arrangements; Draft Guidance for FDA Staff.” The draft guidance is part of FDA's larger effort to take a risk-based approach to food safety to include ensuring the safety of imported food, consistent with the FDA Food Safety Modernization Act. The guidance covers FDA's regulatory oversight activities for food products covered by SRAs between FDA and its foreign regulatory counterparts. Currently, the FDA has signed SRAs with food safety agencies in Australia, Canada, and New Zealand.

The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the topic of Systems Recognition Arrangement implementation. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.

FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov.

FDA is announcing the availability of a revised final guidance for industry entitled “Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised).” The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) was enacted on June 22, 2009, and granted FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products. The Tobacco Control Act also amended section 4 of the Federal Cigarette Labeling and Advertising Act of 1965 (Pub. L. 89-92) (FCLAA) to direct FDA to issue regulations requiring each cigarette package and advertisement to bear a new textual warning label statement accompanied by color graphics depicting the negative health consequences of smoking (section 201 of the Tobacco Control Act). In enacting this legislation, Congress also provided that FDA may adjust the required warnings if FDA found that such a change would promote greater public understanding of the risks associated with the use of tobacco products (section 202 of the Tobacco Control Act). The Tobacco Control Act also modified the requirements of the FCLAA regarding the submission of cigarette plans for the random and equal display and distribution of required warnings on cigarette packages and quarterly rotation of required warnings in cigarette advertisements. It also requires that such cigarette plans be submitted to FDA for review and approval, rather than to the Federal Trade Commission.

In the Federal Register of March 18, 2020, FDA issued a final rule entitled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements” (85 FR 15638). The rule specifies the color graphics that must accompany the new textual warning label statements and establishes marketing requirements for cigarette packages and advertisements. The marketing requirements include, among other things, submission of a cigarette plan that provides for the random and equal display and distribution of the required warnings on cigarette packages and quarterly rotation of the required warnings in cigarette advertisements, as described under section 4 of FCLAA.

On April 3, 2020, the final rule was challenged in the U.S. District Court for the Eastern District of Texas. 1 On May 8, 2020, the Court granted a joint motion to govern proceedings in that case and postpone the effective date of the final rule by 120 days. 2 On December 2, 2020, the same Court granted a new motion by Plaintiffs in the same case to postpone the effective date of the final rule by an additional 90 days. 3 On March 2, 2021, the same Court granted a new motion by Plaintiffs in the same case to postpone the effective date of the final rule by an additional 90 days. 4 On May 21, 2021, the same Court granted a new motion by Plaintiffs in the same case to postpone the effective date of the final rule by an additional 90 days. 5 The new effective date of the final rule is July 13, 2022. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date of the final rule is similarly postponed, and those obligations and deadlines are now tied to the postponed effective date. As such, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon as possible after publication of the final rule, and in any event, by September 13, 2021.

FDA is issuing this guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA regarding the submission of plans for cigarette packages and cigarette advertisements. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR 1141.10 have been approved under 0910-0877.

Persons with access to the internet may obtain an electronic version of the guidance at https://www.regulations.gov, https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance, and https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

In the Federal Register of Monday, December 2, 2019, 84 FR 65986, appearing on page 65986 in FR Doc. 2019-25946, the following correction is made:

On page 65986, in the table, the entries for ANDAs 076709 and 077062 are removed.

Background: The COVID-19 Health Equity Task Force (Task Force) was established by Executive Order 13995, dated January 21, 2021. The Task Force is tasked with providing specific recommendations to the President, through the Coordinator of the COVID-19 Response and Counselor to the President (COVID-19 Response Coordinator), for mitigating the health inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future. The Task Force shall submit a final report to the COVID-19 Response Coordinator addressing any ongoing health inequities faced by COVID-19 survivors that may merit a public health response, describing the factors that contributed to disparities in COVID-19 outcomes, and recommending actions to combat such disparities in future pandemic responses.

The meeting is open to the public and will be live-streamed at www.hhs.gov/live. No registration is required. A public comment session will be held during the meeting. Pre-registration is required to provide public comment during the meeting. To pre-register, please send an email to COVID19HETF@hhs.gov and include your name, title, and organization by close of business on Friday, July 23, 2021. Comments will be limited to no more than three minutes per speaker and should be pertinent to the meeting discussion. Individuals are encouraged to provide a written statement of any public comment(s) for accurate minute-taking purposes. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing COVID19HETF@hhs.gov no later than close of business on Thursday, August 5, 2021. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should contact: COVID19HETF@hhs.gov and reference this meeting. Requests for special accommodations should be made at least 10 business days prior to the meeting.

The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective agreement:

The patent rights in these inventions have been assigned to the Government of the United States of America, the University of Maryland, Sarepta Therapeutics, Inc, and the Progeria Research Foundation (PRF), co-owners of said rights, for commercial development and marketing. The rights to be granted by NHGRI are controlled by NHGRI by virtue of co-ownership and a license received to the listed intellectual property. The prospective patent license will be for the purpose of consolidating the patent rights to PRF. Consolidation of these co-owned rights is intended to expedite development of the invention, consistent with the goals of the Bayh-Dole Act codified as 35 U.S.C. 200-212. The prospective patent license will be worldwide, exclusive, may be limited to those fields of use commensurate in scope with the patent rights, and will be sublicensable.

The subject technology pertains to modified oligonucleotides (called phosphorodiamidate morpholino oligonucleotides or PMOs) targeted to pre-mRNA of human LMNA Lamin A gene. These PMOs can be used to correct aberrant splicing of LMNA gene known to be involved in Hutchinson-Gilford Progeria Syndrome (HGPS), and could be used in treating this ultra-rare disease and related laminopathies.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and may be granted unless, within fifteen (15) days from the date of this published notice, the NHGRI Technology Transfer Office receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Complete applications for a license that are timely filed in response to this notice will be treated as objections to this to the grant of the contemplated exclusive patent license.

In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

I. United States Provisional Patent Application No. 62/131,661 filed Mar. 11, 2015, [HHS Ref. No. E-050-2015-0-US-01];

II. International Patent Application No. PCT/US2016/022072 filed Mar. 11, 2015, [HHS Reference No. E-050-2015-0-PCT-03]; expired

III. Australian National Stage Patent Application No. 2016228751, filed Mar. 11, 2016, [HHS Ref. No. E-050-2015-0-AU-04]; pending

IV. Canadian National Stage Patent Application No. 2979229 filed Mar. 11, 2016, [HHS Ref. No. E-050-2015-0-CA-05]; pending

V. European national Stage Patent Application No. 1662623.3 filed Oct. 11, 2016, [HHS Ref. No. E-050-2015-0-EP-06]; issued (validated in DE, FR and GB)

VI. U.S. national Stage Patent Application No. 15/556,746 filed Sep. 8, 2017 [HHS Ref. No. E-050-2015-0-US-08]; issued

VII. Japanese National Stage Patent Application No. 2017-547425 filed Sep. 8, 2017 [HHS Ref. No. E-050-2015-0-JP-07]; pending

VIII. Divisional European Patent Application No. 20176667.2 filed May 26, 2020 [HHS Ref. No. E-050-2015-0-EP-13]; pending

IX. Divisional Japanese Patent Application No. 2020-167984 filed Oct. 2, 2020 [HHS Ref. No. E-050-2015-0-JP-14]; pending

The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.

The prospective exclusive license territory may be worldwide, and the field of use may be limited to:

“Development and commercialization of RP2 AAV-based gene human therapy for any ocular disease, disorder or condition, including human X-linked retinitis pigmentosa (XLRP)”.

This technology discloses Adeno-Associated Viral (AAV) vectors comprising nucleotide sequences encoding RP2 or RPGR- ORF 15 transgenes and their use in treating or preventing X-linked forms of retinitis pigmentosa (XLRP).

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective agreement to YEDA: PCT Patent Application PCT/IL2020/050708, filed June 24, 2020 and entitled “High ASS1 Expressing Tumors Embody A Purine Rich Genomic Signature And Sensitivity To Purine Depletion” [HHS Reference No. E-210-2020-0-PCT-01].

The patent rights in these inventions have been assigned to the Government of the United States of America and YEDA. The prospective license will be for the purpose of consolidating the patent rights to YEDA, one of the co-owners of said rights, for commercial development and marketing. Consolidation of these co-owned rights is intended to expedite development of the invention, consistent with the goals of the Bayh-Dole Act codified as 35 U.S.C. 200-212.

The prospective patent license will be worldwide, exclusive, and may be limited to those fields of use commensurate in scope with the patent rights. It will be sublicensable, and any sublicenses granted by YEDA will be subject to the provisions of 37 CFR parts 401 and 404.

This technology discloses methods of treating a high argininosuccinate synthase (ASS1) expressing solid tumor with a combination of a purine synthase inhibitor or an agent that increases the pyrimidine to purine ratio in a cell, and an immune-modulating drug, such as a checkpoint inhibitor.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will include terms for the sharing of royalty income with NCI from commercial sublicenses of the patent rights. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Complete applications for a license that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent license. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

In accordance with the 21st Century Cures Act, NIH institutes are required to regularly update their strategic plans. The Interagency Coordinating Committee on Fetal Alcohol Spectrum Disorders (ICCFASD) fosters improved communication, cooperation, and collaboration among disciplines and federal agencies that address health, education, developmental disabilities, alcohol research, and social services and justice issues related to prenatal alcohol exposure. The ICCFASD envisions that collaborative partnerships, using the resources of the federal government in partnership with other organizations, will lead to improved prevention of prenatal alcohol exposure, earlier identification and improved surveillance of fetal alcohol spectrum disorders (FASD), and more effective interventions and services for individuals living with FASD as well as their families. ICCFASD is sponsored and chaired by the National Institute on Alcohol Abuse and Alcoholism.

The information collection notice was previously published in the Federal Register on March 16, 2021, at 86 FR 14468, allowing for a 60-day public comment period. USCIS did not receive any comments in connection with the 60-day notice.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2006-0062 in the search box. The comments submitted to USCIS via this method are visible to the Office of Management and Budget and comply with the requirements of 5 CFR 1320.12(c). All submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

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

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

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

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

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

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

(2) Title of the Form/Collection: Interagency Alien Witness and Informant Record.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-854A and I-854B; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Federal Government. The Form I-854 will enable the U.S. Immigration and Customs Enforcement (ICE) to fulfill those responsibilities. A law enforcement agency may request S nonimmigrant classification for an essential witness or informant by completing this form, which requires certifications by both the law enforcement agency ( e.g., that it will collect the alien's statutorily-required quarterly reports and oversee the alien's departure, if that becomes necessary) and the alien. The law enforcement agency files a properly completed Form I-854 with the Criminal Division, Department of Justice, which may certify the law enforcement agency request to the U.S. Citizenship and Immigration Services (USCIS).

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection I-854A is 10 and the estimated hour burden per response is 3 hours. The estimated total number of respondents for the information collection I-854B is 30 and the estimated hour burden per response is 1 hour.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 60 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $0.

You may access the information collection instrument with instructions or additional information by visiting the Federal eRulemaking Portal site at: https://www.regulations.gov and entering USCIS-2008-0037 in the search box. All submissions will be posted, without change, to the Federal eRulemaking Portal at https://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of https://www.regulations.gov.

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

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

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

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

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

(1) Type of Information Collection: Revision of a Currently Approved Collection.

(2) Title of the Form/Collection: Notice of Entry of Appearance as Attorney or Accredited Representative.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: G-28; G-28I; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for-profit. The data collected via the G-28 and G-28I is used by DHS to determine eligibility of the individual to appear as a representative. Form G-28 is used by attorneys admitted to practice in the United States and accredited representatives of certain non-profit organizations recognized by the Department of Justice. Form G-28I is used by attorneys admitted to the practice of law in countries other than the United States and only in matters in DHS offices outside the geographical confines of the United States. If the representative is eligible, the form is filed with the case and the information is entered into DHS systems.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection G-28 is 3,429,825 and the estimated hour burden per response is 0.833 hours. The estimated total number of respondents for the information collection G-28 online filing is 281,950 and the estimated hour burden per response is 0.667 hours. The estimated total number of respondents for the information collection G-28I is 25,057 and the estimated hour burden per response is 0.700 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 3,062,645 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $0. Any costs associated with this collection of information are included in the cost of the primary forms with which Form G-28 (paper or online) or Form G-28I is filed.

We, the U.S. Fish and Wildlife Service (Service), announce the availability of our draft revised recovery plan for the Gila trout ( Oncorhynchus gilae ), listed as threatened under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ). Gila trout are endemic to mountain streams in the Gila, San Francisco, Agua Fria, and Verde River drainages in New Mexico and Arizona. The draft revised recovery plan includes site-specific management actions and objective, measurable criteria that, when met, will enable us to remove the Gila trout from the list of endangered and threatened wildlife. We request review and comment on this plan from local, State, and Federal agencies; Tribes; and the public. We will also accept any new information on the status of the Gila trout throughout its range to assist in finalizing the recovery plan.

Recovery of endangered or threatened animals and plants to the point where they are again secure, self-sustaining members of their ecosystems is a primary goal of our endangered species program and the ESA. Recovery means improvement of the status of listed species to the point at which listing is no longer appropriate under the criteria set out in section 4(a)(1) of the ESA. The ESA requires the development of recovery plans for listed species, unless such a plan would not promote the conservation of a particular species. The Service approved the original recovery plan for the Gila trout on January 12, 1979 (Service 1979), with subsequent revisions approved on January 3, 1984 (Service 1984), December 8, 1993 (Service 1993), and August 19, 2003 (Service 2003).

This draft revised recovery plan for the Gila trout represents the fourth revision and considers updated information on genetics, population status, and threats (principally wildfire effects and hybridization) in the development of revised recovery objectives, criteria, and actions. We used a streamlined approach to recovery planning and implementation for the Gila trout by preparing separate recovery plan and recovery implementation strategy documents. The information in the draft recovery plan provides the biological background, a threats assessment, a strategy for recovery of the Gila trout, quantitative delisting criteria, a list of prioritized recovery actions, and the estimated time and cost to recovery (Service 2020a). The separate recovery implementation strategy document further describes in detail the specific activities needed to implement the recovery actions (Service 2020b).

Gila trout are endemic to mountain streams within the Gila, San Francisco, Agua Fria, and Verde River drainages in New Mexico and Arizona. Although Gila trout were documented to occur in the upper Gila River basin since at least 1885, the species was not described until 1950, by which time its distribution had been dramatically reduced. On March 11, 1967, we listed the Gila trout as endangered under the Federal Endangered Species Preservation Act of 1966 (32 FR 4001). The Gila trout's endangered status was continued under the Endangered Species Act of 1973, and we reclassified it as a threatened species on July 18, 2006, with a special rule under section 4(d) of the ESA (71 FR 40657).

Gila trout are readily identified by their iridescent gold sides, which blend to a darker shade of copper on the opercles (bony plates surrounding the gills). Spots on the body are small and profuse, generally occurring above the lateral line and extending onto the head, dorsal fin, and caudal fin. These spots are irregularly shaped on the sides and increase in size dorsally. A few scattered spots are sometimes present on the anal fin, and the adipose fin is typically large and well spotted. Dorsal, pelvic, and anal fins have a white to yellowish tip that may extend along the leading edge of the pelvic fins. A yellow cutthroat mark is present on most mature specimens. Parr marks (vertical bars present when trout are less than a year old) are commonly retained by adults, and a faint, salmon-pink band is also present on adults, particularly during spawning season, when the normally white belly may be streaked with yellow or reddish orange. Spawning of Gila trout occurs mainly in April and begins when water temperatures reach about 8 °C (46 °F), but day length may also be an important cue. Gila trout fry [20 to 25 millimeters (mm), or 0.8 to 1.0 inches (in) total length] emerge in 56 to 70 days. Females reach maturity between two to four years after hatching, and males typically reach maturity at two or three years. Most individuals are mature at a length of 150 mm (6 in) or greater, and live five years. Thus, the majority of adult female Gila trout spawn only twice before dying, and most adult males only spawn three or four times before dying.

Gila trout require perennial streamflow and coldwater aquatic habitats with unimpaired water quality to maintain persistent, viable populations. Flow regimes vary depending on the site-specific characteristics of stream reaches ( e.g., stream gradient, seepage, substrate composition, channel dimensions, and watershed hydrology). Suitable water temperature regimes are characterized by maximum water temperatures that do not exceed approximately 20 °C (68 °F) for six or more consecutive hours in a 24-hour period on more than three consecutive days, and maximum temperature that do not exceed 24 °C (77 °F). Suitable water quality for Gila trout is characterized by high dissolved oxygen concentration, low turbidity and conductivity, low levels of total dissolved solids, near-neutral pH, and low conductivity. In addition to perennial stream flow and suitable water temperature and water quality, Gila trout require a diversity of habitats sufficient to sustain all life stages of the species ( i.e., eggs, fry, juveniles, and adults). This includes suitable spawning habitat, habitat where fry can find shelter and food, and areas suitable for occupancy by juvenile and adult Gila trout. Sufficient pool habitat and spawning habitat are likely the two most important habitat features with respect to Gila trout population persistence.

Fragmentation of the historical distribution of Gila trout has resulted in several populations confined to small, isolated habitats throughout the range of the species. Collections from streams in the upper Gila River Basin and San Francisco River Basin, along with genetic analyses, indicate that five lineages of Gila trout exist: Main Diamond Creek, South Diamond Creek, Whiskey Creek, Spruce Creek, and Iron Creek. The distribution of these lineages has fluctuated since 1975, when only five remnant populations ( i.e., a self-sustaining group of Gila trout inhabiting a single stream) were known. Currently, there are 17 extant populations of Gila trout inhabiting approximately 137.5 km (85.2 mi) of stream habitat. These include five populations of the Main Diamond Creek lineage, four populations of the South Diamond Creek lineage, three populations of the Whiskey Creek lineage, two populations of the Spruce Creek lineage, two populations of the Iron Creek lineage, and one population (Dude Creek), which is considered a mixed-lineage population ( i.e., a stream or metapopulation that contains multiple lineages of Gila trout, instead of a single lineage). Recently, the Spruce Creek and Whiskey Creek lineages each lost a population following large-scale, high-severity wildfires in 2011 and 2012, respectively.

For Gila trout to be able to sustain populations in the wild over time (viability), the species requires combinations of sufficiently large, healthy populations that, where possible, have connectivity to dendritic stream networks to maintain adequate population sizes and genetic variation. Dendritic stream networks provide Gila trout with access to suitable habitat enabling the species to respond to changes in their biological and physical environment (representation), environmental stochasticity (resiliency), and catastrophic events (redundancy). Few, if any, extant populations of Gila trout are large enough to survive extremes in environmental conditions, and the existing genetic diversity of the species is limited to five remnant lineages. Recovery actions implemented to date have increased the number of populations of Gila trout; however, the spatial distribution of populations is constrained by the patchy distribution and geographic isolation of cold-water streams, many of which are single-stream systems that are relatively small. Significant factors affecting the viability of Gila trout include habitat loss and fragmentation (Factor A) that result from large-scale, high-severity wildfire and the effects of climate change; unregulated angling (Factor B); predation and competition from nonnative fish that are naturalized throughout the Gila trout's historical range (Factor C); and hybridization with rainbow trout ( Oncorhynchus mykiss ) and small, isolated population sizes (Factor E).

The objective of a recovery plan is to provide a framework for the recovery of a species so that protection under the ESA is no longer necessary. A recovery plan includes scientific information about the species and provides criteria and actions necessary for us to be able to reclassify the species to threatened status or remove it from the lists of endangered and threatened wildlife and plants. Recovery plans help guide our recovery efforts by describing actions we consider necessary for the species' conservation, and by estimating time and costs for implementing needed recovery measures.

In this revised recovery plan, we transition from a strategy of crisis-management focused on preventing extinction to an approach of establishing sustainable populations throughout the historical range of the Gila trout, populations that contain the breadth of genetic diversity of the species. The recovery strategy for the Gila trout will entail incremental replacement of nonnative salmonids with Gila trout in suitable habitat throughout a significant portion of the historical range of the species. This strategy will be implemented by conducting actions to substantially improve redundancy, representation, and resiliency to the point that the species is no longer at risk for extinction and may be delisted. Recovery objectives include securing the existing genetic diversity of Gila trout, increasing the geographic distribution of the species, and increasing the size, dendritic population structure, and interconnectedness of populations. The revised recovery plan provides recovery criteria aimed at managing or eliminating threats to meet the goal of delisting the species. These recovery criteria are based on the area of occupied habitat within the Gila trout's presumed historical range, the conservation of genetically distinct Gila trout lineages, the establishment of dendritic metapopulations, and the absence and management of nonnative salmonids within Gila trout habitat. The site-specific management actions needed to address the threats to Gila trout viability and achieve the recovery criteria involve: (1) Repatriation of Gila trout to streams within its presumed historical range; (2) establishment and maintenance of captive propagation and hatchery facilities; (3) management of nonnative salmonids; (4) monitoring of Gila trout populations; (5) conducting public education and outreach; and (6) developing and implementing regulations to maintain sustainable Gila trout populations in streams open to sport fishing.

Section 4(f) of the ESA requires us to provide public notice and an opportunity for public review and comment during recovery plan development. It is also our policy to request peer review of recovery plans (July 1, 1994; 59 FR 34270). In an appendix to the approved recovery plan, we will summarize and respond to the issues raised by the public and peer reviewers. Substantive comments may or may not result in changes to the recovery plan; comments regarding recovery plan implementation will be forwarded as appropriate to Federal or other entities so that they can be taken into account during the course of implementing recovery actions. Responses to individual commenters will not be provided, but we will provide a summary of how we addressed substantive comments in an appendix to the approved recovery plan.

We invite written comments on the draft recovery plan. In particular, we are interested in additional information regarding the current threats to the species and the implementation of the recommended recovery actions.

All comments received, including names and addresses, will become part of the administrative record and will be available to the public. 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. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

We developed our draft recovery plan and publish this notice under the authority of section 4(f) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ).

In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501 et seq. ) and 5 CFR 1320.8(d)(1), we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

On October 9, 2020, we published in the Federal Register (85 FR 64158) a notice of our intent to request that OMB approve this information collection. In that notice, we solicited comments for 60 days, ending on December 8, 2020. We received one comment in response to the notice that did not address the information collection requirements. The commenter expressed general concerns about lack of transparency in Federal financial assistance funding, specifically funding awarded to a State fish and game agency and foreign assistance. The Service complies with all Federal financial assistance public transparency requirements. Data on all Service financial assistance programs are available at https://beta.sam.gov/. Data on all Service award actions are available at https://www.usaspending.gov/. Data on the Service's foreign assistance authorities and activities are available at https://www.foreignassistance.gov/. The Service also issues press releases for a wide variety of financial assistance programs. The Wildlife and Sport Fish Restoration Program routinely issues press releases for the mandatory formula grants to States awarded under the Pittman-Robertson Wildlife Restoration Act and the Dingell-Johnson Sport Fish Restoration Act. The public can access Service press release archives at https://www.fws.gov/news/.

As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:

(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;

(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;

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

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

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

Abstract: We issue financial assistance through grants and cooperative agreement awards to individuals; commercial organizations; institutions of higher education; nonprofit organizations; foreign entities; and State, local, and Tribal governments. The Service administers a wide variety of financial assistance programs, authorized by Congress to address the Service's mission, as listed in the System for Award Management (SAM) Assistance Listings, previously referred to as the Catalog of Federal Domestic Assistance. SAM provides public descriptions of assistance listings of Federal programs, projects, services, and activities that provide assistance or benefits to the American public. It contains financial and non-financial assistance programs administered by departments and establishments of the Federal government. The Assistance Listings are assigned unique numbers and provide information on program types, the specific type of assistance for each program, and the applicable financial assistance authorities for each program. See the Service's active Assistance Listings on SAM.gov.

The Service currently manages the following types of assistance programs:

Some assistance programs are mandatory and award funds to eligible recipients according to a formula prescribed in law or regulation. Other programs are discretionary and award funds based on competitive selection and merit review processes. Mandatory award recipients must give us specific, detailed project information during the application process so that we may ensure that projects are eligible for the mandatory funding, are substantial in character and design, and comply with all applicable Federal laws. Applicants to discretionary programs must give us information as dictated by the program requirements and as requested in the program's public notice of funding opportunity, including that information that addresses ranking criteria. All recipients must submit financial and performance reports that contain information necessary for us to track costs and accomplishments. The recipients' reports must adhere to schedules and rules in 2 CFR part 200, “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards” and the award terms and conditions. Part 200 prescribes the information that Federal agencies must collect, and financial assistance applicants and recipients must provide to receive benefits under Federal financial assistance programs, and supports this information collection.

The Service provides technical and financial assistance to other Federal agencies, States, local governments, Native American tribes, nongovernmental organizations, citizen groups, and private landowners for the conservation and management of fish and wildlife resources. The process begins with the submission of an application. The respective program reviews and prioritizes proposed projects based on their respective project selection criteria. Pending availability of funding, applicants submit their application documents to the Service through the Federal Grants.gov website or through the Department's grants management system (currently the U.S. Department of Health and Human Services' GrantSolutions), when solicited by the Service through a Funding Opportunity.

As part of this collection of information, the Service collects the following types of information requiring approval under the PRA:

A. Application Package: We use the information provided in applications to: (1) Determine eligibility under the authorizing legislation and applicable program regulations; (2) determine allowability of major cost items under the Cost Principles at 2 CFR part 200; (3) select those projects that will provide the highest return on the Federal investment; and (4) assist in compliance with laws, as applicable, such as the National Environmental Policy Act, the National Historic Preservation Act, and the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970. The full application package (submitted by the applicant) generally includes the following:

• Required Federal financial assistance application forms (SF-424 suite of forms, as applicable to specified project).

• Project Narrative—generally includes items such as:

○ Statement of need,

○ Project goals and objectives,

○ Methods used and timetable,

○ Description of key personnel qualifications,

○ Description of stakeholders or other relevant organizations/individuals involved and level of involvement,

○ Project monitoring and evaluation plan, and/or

○ Other pertinent project specific information.

• Pertinent project budget-related information—generally includes items such as:

○ Budget justification,

○ Detail on costs requiring prior approval,

○ Indirect cost statement,

○ Federally funded equipment list, and/or

○ Certifications and disclosures.

B. Amendments: Recipients must provide written explanation and submit prior approval requests for budget or project plan revisions, reporting due date extensions, or other changes to approved award terms and conditions. The information provided by the recipient is used by the Service to determine the eligibility and allowability of activities and to comply with the requirements of 2 CFR part 200.

C. Reporting Requirements: Reporting requirements associated with financial assistance awards generally include the following types of reports:

• Federal Financial Reports (using the required SF-425),

• Performance Reports, and

• Real Property Status Reports, when applicable (using the required SF-429 forms series).

D. Recordkeeping Requirements: In accordance with 2 CFR 200.334, financial records, supporting documents, statistical records, and all other non-Federal entity records pertinent to a Federal award must be retained for a period of 3 years after the date of submission of the final expenditure report or, for Federal awards that are renewed quarterly or annually, from the date of the submission of the quarterly or annual financial report, respectively, as reported to the Federal awarding agency or pass-through entity (in the case of a subrecipient) (unless an exemption as described in 2 CFR 200.334 applies that requires retention of records longer than 3 years).

The Pittman-Robertson Wildlife Restoration Act (16 U.S.C. 669 et seq. ) and the Dingell-Johnson Sport Fish Restoration Act (16 U.S.C. 777 et seq., except 777e-1) provide authority for Federal assistance to the States for management and restoration of fish and wildlife. These Acts and the regulations in the Code of Federal Regulations (CFR) at 50 CFR part 80, subpart D, require that States, territories, and the District of Columbia annually certify their hunting and fishing license sales. The Service's Wildlife and Sport Fish Restoration (WSFR) program currently collects those certifications under OMB Control No. 1018-0007, “Annual Certification of Hunting and Sport Fishing Licenses Issued, 50 CFR part 80, subpart D.” The WSFR program continues to enhance use of their “Wildlife Tracking and Reporting Actions for the Conservation of Species (TRACS)” system to collect information electronically from financial assistance applicants and recipients. As of Federal fiscal year 2021, WSFR will begin using TRACS to collect State license data and certifications electronically. As this control number includes the Wildlife TRACS system collection, in this revision we are consolidating the OMB Control No. 1018-0007 information collection requirements into this collection. If OMB approves this request, we will discontinue OMB Control Number 1018-0007. Consolidation of OMB approvals for Service financial assistance-related collections into a single collection reduces burden on the public by ensuring consistency in the application and award administration processes across all Service financial assistance programs.

We are implementing the enhanced results-oriented accountability requirements in the Foreign Aid Transparency and Accountability Act (Pub. L. 114-191), OMB guidance memorandum M-18-04, “Monitoring and Evaluation Guidelines for Federal Departments and Agencies that Administer United States Foreign Assistance,” and OMB revisions to 2 CFR part 200 published August 13, 2020 (85 FR 49506). To meet the enhanced requirements, some programs may collect more performance information than previously collected.

Title of Collection: Administrative Procedures for U.S. Fish and Wildlife Service Financial Assistance Programs.

OMB Control Number: 1018-0100.

Form Number: 3-154.

Type of Review: Revision of a currently approved collection.

Respondents/Affected Public: Individuals; commercial organizations; institutions of higher education; nonprofit organizations; foreign entities; and State, local, and Tribal governments.

Total Estimated Number of Annual Respondents: 14,711.

Total Estimated Number of Annual Responses: 16,024.

Estimated Completion Time per Response: Varies from 3 hours to 100 hours, depending on the activity.

Total Estimated Number of Annual Burden Hours: 391,670.

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

Frequency of Collection: On occasion.

Total Estimated Annual Nonhour Burden Cost: None.

An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

We invite review and comment from local, State, and Federal agencies and the public on applications we have received for permits to conduct certain activities with endangered and threatened species under section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ), and our regulations in the Code of Federal Regulations (CFR) at 50 CFR part 17. With some exceptions, the ESA prohibits take of listed species unless a Federal permit is issued that authorizes such take. The ESA's definition of “take” includes hunting, shooting, harming, wounding, or killing, and also such activities as pursuing, harassing, trapping, capturing, or collecting.

A recovery permit issued by us under section 10(a)(1)(A) of the ESA authorizes the permittee to take endangered or threatened species while engaging in activities that are conducted for scientific purposes that promote recovery of species or for enhancement of propagation or survival of species. These activities often include the capture and collection of species, which would result in prohibited take were a permit not issued. Our regulations implementing section 10(a)(1)(A) for these permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.

Proposed activities in the following permit requests are for the recovery and enhancement of propagation or survival of the species in the wild. The ESA requires that we invite public comment before issuing these permits. Accordingly, we invite local, State, Tribal, and Federal agencies and the public to submit written data, views, or arguments with respect to these applications. The comments and recommendations that will be most useful and likely to influence agency decisions are those supported by quantitative information or studies.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.