Under the regulations in “Subpart L—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-12, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into or disseminated within the United States.

Section 319.56-4 contains a performance-based process for approving the importation of fruits and vegetables that, based on the findings of a pest risk analysis, can be safely imported subject to one or more of the five designated phytosanitary measures listed in paragraph (b) of that section.

APHIS received a request from the national plant protection organization (NPPO) of Colombia to allow fresh mango ( Mangifera indica L.) fruit into the United States. As part of our evaluation of Colombia's request, we have prepared a pest risk assessment (PRA) to identify pests of quarantine significance that could follow the pathway of importation of fresh mango fruit into the United States from Colombia. Based on the PRA, a risk management document (RMD) was prepared to identify phytosanitary measures that could be applied to the fresh mango fruit to mitigate the pest risk.

We have concluded that fresh mango fruit can be safely imported from Colombia into the United States, using one or more of the five designated phytosanitary measures listed in §  319.56-4(b). The NPPO of Colombia would have to enter into an operational workplan with APHIS that spells out the daily procedures the NPPO will take to implement the measures identified in the RMD. These measures will be listed in APHIS' Fruits and Vegetables Import Requirements (FAVIR) database, available at https://epermits.aphis.usda.gov/manual/ .

The mitigation measures identified in the RMD include the following:

• Only commercial consignments of mango fruit may be imported.

• All growers must be registered with the NPPO and follow operational workplan requirements for suppression of fruit flies.

• The NPPO must monitor the system for inspection, packing, wrapping, transportation, and loading of the commodity and ensure that participating growers are following the program guidelines.

• Packinghouses must be registered and approved by the NPPO and meet the requirements listed in the operational workplan.

• The NPPO is expected to maintain program records for at least 1 year and provide them to APHIS upon request.

• The NPPO or its designate must conduct a fruit fly trapping program for the detection of Anastrepha spp. and Medfly ( Ceratitis capitata ) at each production site. Details of trap placement, checking of traps, trap density, and remedial fruit fly control measures will be included in the operational workplan. The NPPO must maintain an APHIS-approved quality control program to monitor or audit the trapping program and maintain records of trap placement, checking of traps, and any fruit fly captures. The trapping records must be maintained for at least 1 year and provided to APHIS upon request.

• The mangos must be treated with an APHIS-approved treatment for Anastrepha spp. fruit flies and Medfly ( Ceratitis capitata ). Either:

• Hot water treatment, T102-a, which is only available for use in a preclearance program in accordance with 7 CFR part 305. Each consignment of fruit treated with the APHIS-approved hot water treatment must be precleared by APHIS inspectors in Colombia. The treatment must be carried out under the supervision and direction of APHIS and each consignment must be inspected jointly by APHIS and the NPPO. Treatment must occur in a pest-exclusionary treatment facility; or

• Irradiation treatment, T105-a-1, which requires the fruit to be irradiated with a minimum absorbed dose of 150 Gray for fruit flies and follow the requirements of part 305. If the approved irradiation treatment is applied outside the United States, each consignment of fruit must be precleared by APHIS inspectors in Colombia. Treatment must occur in a pest-exclusionary treatment facility or, if irradiation is to be applied upon arrival in the United States, each consignment of fruit must be inspected by the NPPO prior to departure and accompanied by a phytosanitary certificate issued by the NPPO. Mangos intended to be irradiated in the United States must be shipped in APHIS-approved packaging that prevents escape of any Anastrepha spp. or Medfly larvae or adults.

• All hot water or irradiation treatment facilities in Colombia to be used for mangos are subject to APHIS approval. APHIS reserves the right to require oversight visits in the event of pest interceptions or other problems.

• Mango fruit must be safeguarded from exposure to Anastrepha spp. or Medfly from the time of treatment to export. The package containing mango fruit may not contain any other fruit, including mango fruit not qualified for importation into the United States.

• Each consignment must be inspected jointly by inspectors from APHIS and the NPPO and accompanied by a phytosanitary certificate issued by the NPPO.

• If more than one Ceratitis capitata or Anastrepha spp. or one Neosilba glaberrima is detected in a consignment, the consignment may not be exported to the United States.

• Each consignment is subject to inspection at the U.S. ports of entry.

In addition to these specific measures, fresh mango fruit from Colombia would be subject to the general requirements listed in § 319.56-3 that are applicable to the importation of all fruits and vegetables.

Therefore, in accordance with § 319.56-4(c), we are announcing the availability of our PRA and RMD for public review and comment. Those documents, as well as a description of the economic considerations associated with the importation of fresh mango fruit from Colombia, may be viewed on the Regulations.gov website or in our reading room (see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room). You may request paper copies of these documents by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT . Please refer to the subject of the analysis you wish to review when requesting copies.

After reviewing any comments we receive, we will announce our decision regarding the import status of fresh mango fruit from Colombia in a subsequent notice. If the overall conclusions of our analysis and the Administrator's determination of risk remain unchanged following our consideration of the comments, then we will authorize the importation of fresh mango fruit from Colombia into the United States subject to the requirements specified in the RMD.

The Federal Economic Statistics Advisory Committee (the “Committee”) was established in accordance with the Federal Advisory Committee Act (Title 5, United States Code, Appendix 2). The following provides information about the Committee, membership, and the nomination process.

The Committee advises the Directors of the Department's statistical agencies, the Bureau of Economic Analysis (BEA) and the U.S. Census Bureau, as well as the Commissioner of the U.S. Department of Labor's Bureau of Labor Statistics (BLS) on statistical methodology and other technical matters related to the design, collection, tabulation, and analysis of federal economic statistics.

The Committee functions solely as an advisory committee to the senior officials of BEA, the Census Bureau, and BLS (the agencies). Important aspects of the committee's responsibilities include, but are not limited to:

a. Recommending research to address important technical problems arising in federal economic statistics;

b. Identifying areas in which better coordination of the agencies' activities would be beneficial;

c. Exploring ways to enhance the agencies' economic indicators to make them timelier, more accurate, and more specific to meeting changing demands and future data needs;

d. Improving the means, methods, and techniques to obtain economic information needed to produce current and future economic indicators; and

e. Coordinating, in its identification of agenda items, with other existing academic advisory committees chartered to provide agency-specific advice, for the purpose of avoiding duplication of effort.

The Committee meets once or twice a year, budget permitting. Additional meetings may be held as deemed necessary by the Under Secretary for Economic Affairs or the Designated Federal Official. All Committee meetings are open to the public in accordance with the Federal Advisory Committee Act.

FESAC will comprise approximately 16 members who serve at the pleasure of the Secretary. Members shall be appointed by the Under Secretary for Economic Affairs in consultation with the agencies. Committee members shall be professionals in appropriate disciplines, including economists, statisticians, survey methodologists, and behavioral scientists who are prominent experts in their fields, recognized for their scientific, professional, and operational achievements and objectivity. Membership will represent data users with expertise from the public sector, academia, and the private sector. Members will be chosen to achieve a balanced membership that will meet the needs of the agencies.

Members shall serve as Special Government Employees (SGEs) and shall be subject to ethics rules applicable to SGEs.

A FESAC member term is three years.

Members may serve more than one term as described in the FESAC Charter, available at: https://apps.bea.gov/fesac/.

Members of the Committee serve without compensation but may receive reimbursement for Committee-related travel and lodging expenses.

The Committee is currently filling one or more positions on the FESAC.

The Under Secretary of Economic Affairs, in consultation with the agencies will consider nominations of all qualified individuals to ensure that the Committee includes the areas of experience noted above. Individuals may nominate themselves or other individuals, and professional associations and organizations may nominate one or more qualified persons for membership on the Committee. Nominations shall state that the nominee is willing to serve as a member and carry out the duties of the Committee. A nomination package should include the following information for each nominee:

1. A letter of nomination stating the name, affiliation, and contact information for the nominee, the basis for the nomination ( i.e., what specific attributes recommend him/her for service in this capacity), and the nominee's field(s) of experience;

2. a biographical sketch of the nominee and a copy of his/her curriculum vitae; and

3. the name, return address, email address, and daytime telephone number at which the nominator can be contacted.

The Department of Commerce Under Secretary of Economic Affairs and the agencies encourage nominations for appropriately qualified female, minority, or disabled candidates. The Department of Commerce Under Secretary of Economic Affairs and the agencies also encourage geographic diversity in the composition of the Committee.

All nomination information should be provided in a single, complete package 30 days after publication of this notice. The Bureau of Economic Analysis will retain nominations received after this date for consideration should additional vacancies occur.

Interested applicants should send their nomination package to Gianna Marrone, Committee Management Official, at Gianna.Marrone@bea.gov (subject line “2021 FESAC Nominations”). The Bureau of Economic Analysis will retain nominations received after this date for consideration should additional vacancies occur.

On October 21, 2015, Commerce published the AD and CVD orders on boltless steel shelving from China. 1 On September 1, 2020, the ITC instituted, 2 and Commerce initiated, the first sunset review of the Orders, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). 3 As a result of its review, Commerce determined that 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 countervailable subsidy rates likely to prevail should the Orders be revoked. 4

On May 5, 2021, the ITC published its determination, 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 scope of the Orders covers boltless steel shelving units prepackaged for sale, with or without decks (boltless steel shelving). The term “prepackaged for sale” means that, at a minimum, the steel vertical supports ( i.e., uprights and posts) and steel horizontal supports ( i.e., beams, braces) necessary to assemble a completed shelving unit (with or without decks) are packaged together for ultimate purchase by the end-user. The scope also includes add-on kits. Add-on kits include, but are not limited to, kits that allow the end-user to add an extension shelving unit onto an existing boltless steel shelving unit such that the extension and the original unit will share common frame elements ( e.g., two posts). The term “boltless” refers to steel shelving in which the vertical and horizontal supports forming the frame are assembled primarily without the use of nuts and bolts or screws. The vertical and horizontal support members for boltless steel shelving are assembled by methods such as, but not limited to, fitting a rivet, punched or cut tab or other similar connector on one support into a hole, slot or similar receptacle on another support. The supports lock together to form the frame for the shelving unit and provide the structural integrity of the shelving unit separate from the inclusion of any decking. The incidental use of nuts and bolts or screws to add accessories, wall anchors, tie-bars or shelf supports does not remove the product from scope. Boltless steel shelving units may also come packaged as partially assembled, such as when two upright supports are welded together with front-to-back supports, or are otherwise connected, to form an end unit for the frame. The boltless steel shelving covered by the Orders may be commonly described as rivet shelving, welded frame shelving, slot and tab shelving, and punched rivet (quasi-rivet) shelving as well as by other trade names. The term “deck” refers to the shelf that sits on or fits into the horizontal supports (beams or braces) to provide the horizontal storage surface of the shelving unit.

The scope includes all boltless steel shelving meeting the description above, regardless of: (1) Vertical support or post type (including but not limited to open post, closed post and tubing); (2) horizontal support or beam/brace profile (including but not limited to Z-beam, C-beam, L-beam, step beam and cargo rack); (3) number of supports; (4) surface coating (including but not limited to paint, epoxy, powder coating, zinc and other metallic coating); (5) number of levels; (6) weight capacity; (7) shape (including but not limited to rectangular, square, and corner units); (8) decking material (including but not limited to wire decking, particle board, laminated board or no deck at all); or (9) the boltless method by which vertical and horizontal supports connect (including but not limited to keyhole and rivet, slot and tab, welded frame, punched rivet and clip).

Specifically excluded from the scope are:

• Wall-mounted shelving, defined as shelving that is hung on the wall and does not stand on, or transfer load to, the floor;

• wire shelving units, which consist of shelves made from wire that incorporates both a wire deck and wire horizontal supports (taking the place of the horizontal beams and braces) into a single piece with tubular collars that slide over the posts and onto plastic sleeves snapped on the posts to create the finished shelving unit;

• bulk-packed parts or components of boltless steel shelving units; and

• made-to-order shelving systems.

Subject boltless steel shelving enters under the United States through Harmonized Tariff Schedule of the United States (HTSUS) statistical subheadings 9403.20.0018, 9403.20.0020, 9403.20.0025, and 9403.20.0026, but may also enter through HTSUS 9403.10.0040. While HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the Orders is dispositive.

As a result of the determinations by Commerce and the ITC that revocation of the Orders would likely lead to a continuation or 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, 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 351.281(c)(2), Commerce intends to initiate the next five-year reviews of the Orders not later than 30 days prior to the fifth anniversary of the effective date of continuation.

These five-year sunset reviews and this notice are in accordance with section 751(c) of the Act and published in accordance with section 777(i)(1) of the Act and 19 CFR 351.218(f)(4).

This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on November 3, 2020. 1 On February 25, 2021, Commerce postponed the preliminary determination of this investigation and the revised deadline is now May 5, 2021. 2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum. 3 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/.

The product covered by this investigation is thermal paper from Germany. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the preamble to Commerce's regulations, 4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage ( i.e., scope). 5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttal responses submitted on the record for this investigation, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum. 6 Commerce is not preliminarily modifying the scope language as it appeared in the Initiation Notice. See the scope in Appendix I to this notice.

Commerce is conducting this investigation in accordance with section 731 of the Act. Constructed export prices have been calculated in accordance with section 772(b) of the Act. Normal value is calculated in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

In accordance with section 733(e) of the Act and 19 CFR 351.206, Commerce preliminarily finds that critical circumstances exist for Papierfabrik August Koehler SE (Koehler), but not the companies covered by the all-others rate. For a full description of the methodology and results of Commerce's critical circumstances analysis, see the Preliminary Decision Memorandum.

Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that in the preliminary determination Commerce shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis margins, and any margins determined entirely under section 776 of the Act.

Commerce calculated an individual estimated weighted-average dumping margin for Koehler, the only individually examined exporter/producer in this investigation. Because the only individually calculated dumping margin is not zero, de minimis, or based entirely on facts otherwise available, the estimated weighted-average dumping margin calculated for Koehler is the margin assigned to all other producers and exporters, pursuant to section 735(c)(5)(A) of the Act.

Commerce preliminarily determines that the following estimated weighted-average dumping margins exist:

In accordance with section 733(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register . Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin, as follows: (1) The cash deposit rate for the respondent listed above will be equal to the company-specific estimated weighted-average dumping margin determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

Commerce intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement, or if there is no public announcement, within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).

As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination. Normally, Commerce verifies information using standard procedures, including an on-site examination of original accounting, financial, and sales documentation. However, due to current travel restrictions in response to the global COVID-19 pandemic, Commerce is unable to conduct on-site verification in this investigation. Accordingly, we intend to verify the information relied upon in making the final determination through alternative means in lieu of an on-site verification.

Case briefs or other written comments on non-scope issues 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 on non-scope issues, may be submitted no later than seven days after the deadline date for case briefs. 7 The deadlines for submitting case and rebuttal briefs on scope issues are identified in the Preliminary Scope Decision Memorandum. Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information, until further notice. 8 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.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, and 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, parties will be notified of the time and date for the hearing. 9

Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioners. 10 Pursuant to 19 CFR 351.210(e)(2), Commerce requires that requests by respondents for postponement of a final AD determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.

On April 14, 2021, Koehler requested that Commerce postpone the final determination and that provisional measures be extended to a period not to exceed six months. 11 In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because: (1) The preliminary determination is affirmative; (2) the requesting exporter accounts for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, Commerce is postponing the final determination and extending the provisional measures from a four-month period to a period not greater than six months. Accordingly, Commerce will make its final determination no later than 135 days after the date of publication of this preliminary determination.

In accordance with section 733(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

Background

This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on November 3, 2020. 1 On February 25, 2021, Commerce postponed the deadline for the preliminary determination in this investigation; the revised deadline is now May 5, 2021. 2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum. 3 A list of topics discussed in the Preliminary Decision Memorandum is in Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/.

The products covered by this investigation are thermal paper from Spain. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the Preamble to Commerce's regulations, 4 in the Initiation Notice we set aside a period of time for parties to raise issues regarding product coverage ( i.e., scope). 5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttals submitted on the record of this investigation, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum. 6 Commerce is not preliminarily modifying the scope language as it appeared in the Initiation Notice. See the scope in Appendix I to this notice.

Commerce is conducting this investigation in accordance with section 731 of the Act. Pursuant to sections 776(a) and (b) of the Act, Commerce has preliminarily relied upon facts otherwise available to assign an estimated weighted-average dumping margin to the sole mandatory respondent in this investigation, Torraspapel S.A. (Torraspapel) because Torraspapel failed to submit a full response to Commerce's antidumping duty questionnaire. Furthermore, Commerce is preliminarily determining that Torraspapel failed to cooperate by not acting to the best of its ability to comply with a request for information and is using an adverse inference when selecting from among the facts otherwise available ( i.e., is basing Torraspapel's dumping margin on total adverse facts available (AFA), in accordance with section 776(b) of Act). For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that, in the preliminary determination, Commerce shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis dumping margins, and any dumping margins determined entirely under section 776 of the Act.

Pursuant to section 735(c)(5)(B) of the Act, if the estimated weighted-average dumping margins established for all exporters and producers individually examined are zero, de minimis or determined based entirely on facts otherwise available, Commerce may use any reasonable method to establish the estimated weighted-average dumping margin for all-other producers or exporters. Commerce has preliminarily determined the estimated weighted-average dumping margin for the sole mandatory respondent, Torraspapel, under section 776 of the Act. Consequently, pursuant to section 735(c)(5)(B) of the Act, Commerce's normal practice under these circumstances has been to calculate the “all-others” ' rate as a simple average of the alleged dumping margins from the petition. 7 For a full description of the methodology underlying Commerce's analysis, see the Preliminary Decision Memorandum.

Commerce preliminarily determines that the following estimated weighted-average dumping margins exist:

In accordance with section 733(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in the Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register . Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondent listed above will be equal to the company-specific estimated weighted-average dumping margin determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin. These suspension of liquidation instructions will remain in effect until further notice.

Normally, Commerce discloses to interested parties the calculations performed in connection with a preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of preliminary determination in the Federal Register , in accordance with 19 CFR 351.224(b). However, because Commerce preliminarily applied AFA to the mandatory respondent in this investigation, Torraspapel, in accordance with section 776 of the Act, and the AFA dumping margin is based solely on the petition, there are no calculations to disclose.

Because the mandatory respondent in this investigation did not act to the best of its ability to provide information requested by Commerce, and Commerce preliminarily determined that the mandatory respondent is uncooperative, we will not conduct verification.

Case briefs or other written comments on non-scope issues may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 21 days after the date of publication of the preliminary determination in the Federal Register . 8 Rebuttal briefs on non-scope issues, limited to issues raised in case briefs on non-scope issues, may be submitted no later than seven days after the deadline for case briefs. 9 The deadlines for submitting case and rebuttal briefs on scope issues are in the Preliminary Scope Decision Memorandum. Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information, until further notice. 10 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.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice in the Federal Register . Requests for a hearing should contain: (1) The requesting party's name, address, and telephone number; (2) the number of individuals from the requesting party's firm that will attend the hearing, including whether any individual is a foreign national; and (3) a list of the issues the party intends to discuss at the hearing. 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 by telephone the date, and time of the hearing two days before the scheduled hearing date.

Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination in the Federal Register if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioner. Section 351.210(e)(2) of Commerce's regulations requires that a request by exporters for postponement of the final determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.

On April 27, 2021, pursuant to 19 CFR 351.210(e), Torraspapel requested that Commerce postpone the final determination and that provisional measures be extended not more than six months. 11 In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because: (1) The preliminary determination is affirmative; (2) the requesting exporter accounts for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, Commerce is postponing the final determination and extending the provisional measures from a four-month period to a period not greater than six months. Accordingly, Commerce will make its final determination no later than 135 days after the date of publication of this preliminary determination in the Federal Register .

In accordance with section 733(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its affirmative preliminary determination. If the final determination is affirmative, the ITC will determine, before the later of 120 days after the date of this preliminary determination or 45 days after Commerce's final determination, whether subject imports are materially injuring, or threaten material injury to, the U.S. industry.

This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

The President's Advisory Council on Doing Business in Africa (Advisory Council) was established pursuant to Executive Order No. 13675 dated August 5, 2014, and continued by Executive Order 13889 until September 30, 2021. The Advisory Council was established in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. App., to advise the President through the Secretary of Commerce (Secretary) on strengthening commercial engagement between the United States and Africa.

The Department of Commerce, International Trade Administration, Office of Africa, is accepting applications for Advisory Council members. The Advisory Council shall provide information, analysis, and recommendations to the President that address the following, in addition to other topics deemed relevant by the President, the Secretary, or the Advisory Council:

(i) Creating jobs in the United States and Africa through trade and investment;

(ii) developing strategies by which the U.S. private sector can identify and take advantage of trade and investment opportunities in Africa;

(iii) building lasting commercial partnerships between the U.S. and African private sectors;

(iv) facilitating U.S. business participation in Africa's infrastructure development;

(v) contributing to the growth and improvement of Africa's agricultural sector by encouraging partnerships between U.S. and African companies to bring innovative agricultural technologies to Africa;

(vi) making available to the U.S. private sector an accurate understanding of the opportunities presented for increasing trade with and investment in Africa;

(vii) developing and strengthening partnerships and other mechanisms to increase U.S. public and private sector financing of trade with and investment in Africa;

(viii) analyzing the effect of policies in the United States and Africa on U.S. trade and investment interests in Africa;

(ix) identifying other means to expand commercial ties between the United States and Africa; and

(x) building the capacity of Africa's young entrepreneurs to develop trade and investment ties with U.S. partners.

Executive Order 13675, as amended, provides that the Advisory Council shall consist of not more than 26 private sector corporate members, including small businesses and representatives from infrastructure, agriculture, consumer goods, banking, services, and other industries. The Secretary of Commerce intends to make appointments under this notice up to the current number of Advisory Council members, consistent with the Executive Order and the Advisory Council charter.

The Advisory Council shall be broadly representative of the key industries with business interests in the functions of the Advisory Council as set forth above. Each Advisory Council member shall serve as the representative of a U.S. company engaged in activities involving trade, investment, development or finance with African markets. The Department particularly seeks applicants who are active executives (Chief Executive Officer, Executive Chairman, President or comparable level of responsibility); however, for very large companies, a person having substantial responsibility for the company's commercial activities in Africa may be considered.

For eligibility purposes, a “U.S. company” is a for-profit firm incorporated in the United States or with its principal place of business in the United States that is (a) majority controlled (more than 50 percent ownership interest and/or voting stock) by U.S. citizens or by another U.S. entity or (b) majority controlled (more than 50 percent ownership interest and/or voting stock) directly or indirectly by a foreign parent company. Members are not required to be a U.S. citizen; however, members may not be registered as a foreign agent under the Foreign Agents Registration Act. Additionally, no member shall represent a company that is majority owned or controlled by a foreign government entity or entities.

Members of the Advisory Council will be selected, in accordance with applicable Department of Commerce guidelines, based on their ability to carry out the objectives of the Advisory Council as set forth above. Members shall be selected in a manner that ensures that the Advisory Council is balanced in terms of points of view, industry subsector, activities in and with African markets, range of products and services, demographics, geography, and company size. Additional factors which will be considered in the selection of Advisory Council members include candidates' proven leadership and experience in the trade, investment, financing, development, or other commercial activities between the United States and Africa. Priority may be given to active executives (Chief Executive Officer, Executive Chairman, President or comparable level of responsibility). Appointments to the Advisory Council shall be made without regard to political affiliation.

The Secretary appoints the members of the Advisory Council in consultation with the Trade Promotion Coordinating Committee (TPCC), a Federal interagency group led by the Secretary and tasked with coordinating export promotion and export financing activities of the U.S. Government and development of a government-wide strategic plan to carry out such activities. Members shall serve a term of two years, at the pleasure of the Secretary.

Members shall serve in a representative capacity, representing the views and interests of their particular industry sector. Advisory Council members are not special government employees, and will receive no compensation for their participation in Advisory Council activities. Members participating in Advisory Council meetings and events will be responsible for their travel, living and other personal expenses. Meetings will be held regularly and, to the extent practical, not less than twice annually, in Washington, DC, or other locations as feasible. Teleconference meetings may also be held as needed.

To be considered for membership, submit the following information by 5:00 p.m. EDT on June 25, 2021 to the email address listed in the ADDRESSES section:

1. Name and title of the individual requesting consideration.

2. A sponsor letter from the applicant on his or her company letterhead containing a brief statement of why the applicant should be considered for membership on the Advisory Council. This sponsor letter should also address the applicant's experience and leadership related to trade, investment, financing, development, or other commercial activities between the United States and Africa.

3. The applicant's personal resume and short bio (less than 300 words).

4. An affirmative statement that the applicant meets all eligibility criteria, including an affirmative statement that the applicant is not required to register as a foreign agent under the Foreign Agents Registration Act of 1938, as amended.

5. Information regarding the ownership and control of the company, including the stock holdings as appropriate, signifying compliance with the criteria set forth above.

6. The company's size, product or service line, and major markets in which the company operates.

7. A profile of the company's trade, investment, development, finance, partnership, or other commercial activities in or with African markets.

8. Brief statement describing how the applicant will contribute to the work of the Advisory Council based on his or her unique experience and perspective (not to exceed 100 words).

This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on November 3, 2020. 1 On February 25, 2021, Commerce postponed the deadline for the preliminary determination in this investigation; the revised deadline is now May 5, 2021. 2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum. 3 A list of topics discussed in the Preliminary Decision Memorandum is in Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/.

The products covered by this investigation are thermal paper from Korea. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the Preamble to Commerce's regulations, 4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage ( i.e., scope). 5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttals submitted on the record of this investigation, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum. 6 Commerce is not preliminarily modifying the scope language as it appeared in the Initiation Notice. See the scope in Appendix I to this notice.

Commerce is conducting this investigation in accordance with section 731 of the Act. Commerce calculated export prices in accordance with section 772(a) of the Act and constructed export prices in accordance with section 772(b) of the Act. Commerce calculated normal value in accordance with section 773 of the Act. For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

In accordance with section 733(e) of the Act and 19 CFR 351.206, Commerce preliminarily finds that critical circumstances exist for Hansol Paper Company (Hansol Paper) and all other producers and exporters in Korea. For a full description of the methodology and results of Commerce's critical circumstances analysis, see the Preliminary Decision Memorandum.

Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that, in the preliminary determination, Commerce shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis dumping margins, and any dumping margins determined entirely under section 776 of the Act.

Commerce calculated an individual estimated weighted-average dumping margin for Hansol Paper, the only individually examined exporter/producer in this investigation. Because the only individually calculated dumping margin is not zero, de minimis, or based entirely on facts otherwise available, we assigned the estimated weighted-average dumping margin that we calculated for Hansol Paper to all other producers and exporters in Korea, pursuant to section 735(c)(5)(A) of the Act.

Commerce preliminarily determines that the following estimated weighted-average dumping margins exist:

In accordance with section 733(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise described in Appendix I on and after the date identified below. Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondent listed above will be equal to the company-specific estimated weighted-average dumping margin determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the later of: (a) The date which is 90 days before the date on which the suspension of liquidation was first ordered; or (b) the date on which the notice of initiation of the investigation was published. As noted above, Commerce preliminarily finds that critical circumstances exist for imports of subject merchandise produced and exported by Hansol Paper and all other exporters and producers in Korea. In accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to unliquidated entries of shipments of subject merchandise from Hansol Paper and all other exporters and producers in Korea that were entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the date of publication of this notice in the Federal Register .

These suspension of liquidation instructions will remain in effect until further notice.

Commerce intends to disclose its preliminary calculations and related analysis to interested parties within five days of any public announcement of the preliminary determination or, if there is no public announcement, within five days of the date of publication of this notice in the Federal Register in accordance with 19 CFR 351.224(b).

As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination. Normally, Commerce verifies information using standard procedures, including an on-site examination of original accounting, financial, and sales documentation. However, due to current travel restrictions in response to the global COVID-19 pandemic, Commerce is unable to conduct on-site verification in this investigation. Accordingly, we intend to verify the information relied upon in making the final determination through alternative means in lieu of an on-site verification.

Case briefs or other written comments on non-scope issues may be submitted to the Assistant Secretary for Enforcement and Compliance. A timeline for the submission of case briefs and written comments on non-scope issues will be provided to interested parties later. Rebuttal briefs, limited to issues raised in case briefs on non-scope issues, may be submitted no later than seven days after the deadline date for case briefs. 7 The deadlines for submitting case and rebuttal briefs on scope issues are identified in the Preliminary Scope Decision Memorandum. Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information, until further notice. 8 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.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice in the Federal Register . Requests for a hearing should contain: (1) The requesting party's name, address, and telephone number; (2) the number of individuals from the requesting party's firm that will attend the hearing, including whether any participant is a foreign national; and (3) a list of the issues the party intends to discuss at the hearing. 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 by telephone the date and time of the hearing two days before the scheduled hearing date.

Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination in the Federal Register if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioner. Section 351.210(e)(2) of Commerce's regulations requires that a request by exporters for postponement of the final determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.

On April 19, 2021, pursuant to 19 CFR 351.210(e), Hansol Paper requested that Commerce postpone the final determination and that provisional measures be extended not more than six months. 9 In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because: (1) The preliminary determination is affirmative; (2) the requesting exporter accounts for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, Commerce is postponing the final determination and extending the provisional measures from a four-month period to a period not greater than six months. Accordingly, Commerce will make its final determination no later than 135 days after the date of publication of this preliminary determination in the Federal Register .

In accordance with section 733(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its affirmative preliminary determination. If the final determination is affirmative, the ITC will determine, before the later of 120 days after the date of this preliminary determination or 45 days after Commerce's final determination whether subject imports are materially injuring, or threaten material injury to, the U.S. industry.

This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

On November 3, 2020, Commerce published in the Federal Register a notice of opportunity to request an administrative review of the AD order on LWTP from China. 1 Commerce received a timely-filed request from Appvion, Inc. (Appvion), a domestic interested party and the petitioner in the underlying investigation, for an administrative review of exports of subject merchandise to the United States during the POR with respect to 20 companies, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b). 2 On January 6, 2021, pursuant to this request, and in accordance with 19 CFR 351.221(c)(1)(i), Commerce published a notice initiating an administrative review of the AD order on LWTP from China. 3 On March 26, 2021, Appvion withdrew its request for an administrative review with respect to all companies for which it requested a review. 4

Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the party or parties that requested a review withdraws the request within 90 days of the publication date of the notice of initiation of the requested review. Appvion timely submitted a request to withdraw its request for an administrative review for all companies for which an administrative review was initiated. No other party requested an administrative review of the order. Therefore, in accordance with 19 CFR 351.213(d)(1), we are rescinding this review, in its entirety.

Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries of LWTP from China. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping 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 35 days after the date of publication of this notice in the Federal Register .

This notice serves as the only reminder to importers whose entries will be liquidated as a result of this rescission notice, of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the presumption that reimbursement of the antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties.

This notice also serves as a reminder to all parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/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 notice is issued and published in accordance with sections 751(a) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).

On January 26, 2021, the Department of Commerce (Commerce), pursuant to section 702(h) of the Trade Agreements Act of 1979 (as amended) (the Act), published the quarterly update to the annual listing of foreign government subsidies on articles of cheese subject to an in-quota rate of duty covering the period July 1, 2020, through September 30, 2020. 1 In the Third Quarter 2020 Update, we requested that any party that has information on foreign government subsidy programs that benefit articles of cheese subject to an in-quote rate of duty submit such information to Commerce. 2 We received no comments, information, or requests for consultation from any party.

Pursuant to section 702(h) of the Act, we hereby provide Commerce's update of subsidies on articles of cheese that were imported during the period September 1, 2020, through December 31, 2020. The appendix to this notice lists the country, the subsidy program or programs, and the gross and net amounts of each subsidy for which information is currently available.

Commerce will incorporate additional programs which are found to constitute subsidies, and additional information on the subsidy programs listed, as the information is developed. Commerce encourages any person having information on foreign government subsidy programs which benefit articles of cheese subject to an in-quota rate of duty to submit such information in writing through the Federal eRulemaking Portal at https://www.regulations.gov, Docket No. ITA-2020-0005, “Quarterly Update to Cheese Subject to an In-Quota Rate of Duty.” The materials in the docket will not be edited to remove identifying or contact information, and Commerce cautions against including any information in an electronic submission that the submitter does not want publicly disclosed. Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF formats only. All comments should be addressed to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, 1401 Constitution Ave. NW, Washington, DC 20230.

This determination and notice are in accordance with section 702(a) of the Act.

This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on November 3, 2020. 1 On February 25, 2021, Commerce postponed the preliminary determination of this investigation; the revised deadline is now May 5, 2021. 2 For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum. 3 A list of topics discussed in the Preliminary Decision Memorandum is included in Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/.

The products covered by this investigation are thermal paper from Japan. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the preamble to Commerce's regulations, 4 the Initiation Notice set aside a period of time for parties to raise issues regarding product coverage ( i.e., scope). 5 Certain interested parties commented on the scope of the investigation as it appeared in the Initiation Notice. For a summary of the product coverage comments and rebuttal responses submitted on the record for this investigation, and accompanying discussion and analysis of all comments timely received, see the Preliminary Scope Decision Memorandum. 6 Commerce is not preliminarily modifying the scope language as it appeared in the Initiation Notice. See the scope in Appendix I to this notice.

Commerce is conducting this investigation in accordance with section 731 of the Act. Commerce has calculated export prices in accordance with section 772(a) of the Act. Constructed export prices have been calculated in accordance with section 772(b) of the Act. Normal value is calculated in accordance with section 773 of the Act. In addition, Commerce has relied on partial facts available under section 776(a)(1) of the Act. For a full description of the methodology underlying the preliminary determination, see the Preliminary Decision Memorandum.

Sections 733(d)(1)(ii) and 735(c)(5)(A) of the Act provide that, in the preliminary determination, Commerce shall determine an estimated all-others rate for all exporters and producers not individually examined. This rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis margins, and any margins determined entirely under section 776 of the Act.

Commerce calculated an individual estimated weighted-average dumping margin for Nippon Paper Industries Co., Ltd. (NPI), the only individually examined exporter/producer in this investigation. Because the only individually calculated dumping margin is not zero, de minimis, or based entirely on facts otherwise available, the estimated weighted-average dumping margin calculated for NPI is the margin assigned to all other producers and exporters, pursuant to section 735(c)(5)(A) of the Act.

Commerce preliminarily determines that the following estimated weighted-average dumping margins exist:

In accordance with section 733(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise, as described in Appendix I, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the Federal Register . Further, pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), Commerce will instruct CBP to require a cash deposit equal to the estimated weighted-average dumping margin or the estimated all-others rate, as follows: (1) The cash deposit rate for the respondent listed above will be equal to the company-specific estimated weighted-average dumping margin determined in this preliminary determination; (2) if the exporter is not a respondent identified above, but the producer is, then the cash deposit rate will be equal to the company-specific estimated weighted-average dumping margin established for that producer of the subject merchandise; and (3) the cash deposit rate for all other producers and exporters will be equal to the all-others estimated weighted-average dumping margin.

Commerce intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination. Normally, Commerce verifies information using standard procedures, including an on-site examination of original accounting, financial, and sales documentation. However, due to current travel restrictions in response to the global COVID-19 pandemic, Commerce is unable to conduct on-site verification in this investigation. Accordingly, we intend to verify the information relied upon in making the final determination through alternative means in lieu of an on-site verification.

Case briefs or other written comments on non-scope issues 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 on non-scope issues, may be submitted no later than seven days after the deadline date for case briefs. 8 The deadlines for submitting case and rebuttal briefs on scope issues are identified in the Preliminary Scope Decision Memorandum. Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information, until further notice. 9 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.

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, and 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, parties will be notified of the time and date for the hearing. 10

Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioners. 11 Pursuant to 19 CFR 351.210(e)(2), Commerce requires that requests by respondents for postponement of a final AD determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.

On April 19, 2021, NPI requested that Commerce postpone the final determination and that provisional measures be extended to a period not to exceed six months. 12 In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because: (1) The preliminary determination is affirmative; (2) the requesting exporter accounts for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, Commerce is postponing the final determination and extending the provisional measures from a four-month period to a period not greater than six months. Accordingly, Commerce will make its final determination no later than 135 days after the date of publication of this preliminary determination.

In accordance with section 733(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its preliminary determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.

This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).

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

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

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

The United States Patent and Trademark Office (USPTO) administers the Trademark Act, 15 U.S.C. 1051 et seq., which provides for the Federal registration of trademarks, service marks, collective trademarks and service marks, collective membership marks, and certification marks. Individuals and businesses that use or intend to use such marks in commerce may file an application to register their marks with the USPTO.

This information collection covers various communications submitted by individuals and businesses to the USPTO occurring after registration of a trademark. One type of communication is a request to amend registrations to delete goods or services that are no longer being used by the registrant or registration owner. Registered marks remain on the register for 10 years and can be renewed, but will be cancelled unless the registration owner files with the USPTO a declaration attesting to the continued use (or excusable non-use) of the mark in commerce, and a renewal application, within specific deadlines. Registration owners may also request to amend or divide a registration, respond to a post-registration Office action, and surrender a registration.

The information in this information collection is used to maintain the quality of the trademark register. The register information may be accessed by an individual or by businesses to determine the availability of a mark. By keeping the register current and accurate, parties may reduce the possibility of initiating use of a mark previously adopted by another.

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

OMB Control Number: 0651-0055.

Form Numbers:

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

Affected Public: Private sector; individuals or households.

Estimated Number of Respondents: 219,694 respondents per year.

Estimated Number of Responses: 219,694 responses per year.

Estimated Time per Response: The USPTO estimates that it takes the public approximately between 10 minutes (0.17 hours) and 45 minutes (0.75 hours), depending on the complexity of the situation. This includes the time to gather the necessary information, prepare the appropriate documents, and submit the information to the USPTO.

Estimated Total Annual Respondent Burden Hour: 113,620 hours.

Estimated Total Annual Respondent (Hourly) Cost Burden: $45,448,000.

Estimated Total Annual (Non-hour) Respondent Cost Burden: $89,646,738. This information collection has no capital startup, maintenance fees, or operating fees. However, this information collection does have filing fees and postage costs. The total annual non-hour respondent cost burden for this information collection in the form of filing fees ($89,646,625) and postage costs ($113) is approximately $89,646,738.

Filing fees are charged per class of goods or services and can vary depending on the number of classes. The filing fees shown here are based on the minimum fee of one class per document associated with this information collection.

Although the USPTO requires that the items in this information collection be submitted electronically, the items may, in limited situations, be submitted by mail through the United States Postal Service (USPS). The USPTO estimates that the average postage cost for a mailed submission, using a Priority Mail 2-day flat rate legal envelope, will be $8.05. The USPTO estimates approximately 14 submissions per year may be mailed to the USPTO, for a total postage cost of $113 per year.

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

The USPTO is soliciting public comments to:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information shall have practical utility;

(b) 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;

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

(d) Minimize the burden of the collection 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.

All comments submitted in response to this notice are a matter of public record. The USPTO will include or summarize each comment in the request to OMB to approve this information collection. Before including an address, phone number, email address, or other personal identifying information (PII) in a comment, be aware that the entire comment—including PII—may be made publicly available at any time. While you may ask in your comment to withhold PII from public view, the USPTO cannot guarantee that it will be able to do so.

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: Early Childhood Longitudinal Study, Kindergarten Class of 2023-24 (ECLS-K:2024) Preschool Round Removal Change Request.

OMB Control Number: 1850-0750.

Type of Review: No material or nonsubstantive change of a currently approved information collection.

Respondents/Affected Public: Individuals or households.

Total Estimated Number of Annual Responses: 46,033.

Total Estimated Number of Annual Burden Hours: 8,655.

Abstract: The Early Childhood Longitudinal Study (ECLS) program, conducted by the National Center for Education Statistics (NCES) within the Institute of Education Sciences (IES) of the U.S. Department of Education (ED), draws together information from multiple sources to provide rich, descriptive data on child development, early learning, and school progress. The ECLS program studies deliver national data on children's status at birth and at various points thereafter; children's transitions to nonparental care, early care and education programs, and school; and children's experiences and growth through the elementary grades. The Early Childhood Longitudinal Study, Kindergarten Class of 2022-23 (ECLS-K:2023) is the fourth cohort in the series of early childhood longitudinal studies. The study will advance research in child development and early learning by providing a detailed and comprehensive source of current information on children's early learning and development, transitions into kindergarten and beyond, and progress through school. Collecting parent data beginning in preschool will enable the study to measure influences on children's development before entry into formal schooling, including children's home environments and access to early care and education. The request to conduct a field test of the ECLS-K:2023 preschool data collection activities from January through October 2020, to field test the preschool data collection materials and procedures, was approved in November 2019 (OMB# 1850-0750 v.19), with change requests approved in January and July 2020 (OMB #1850-0750 v.20-21). In April 2021, OMB approved a one year study delay (OMB #1850-0750 v.22), and the study is now the Early Childhood Longitudinal Study, Kindergarten Class of 2023-24 (ECLS-K:2024). This request is to notify OMB and the public that, following analysis of the results of the preschool field test that was carried out in 2020, NCES has decided not to go forward with the national ECLS-K: 2024 preschool round in spring 2023. No other planned procedures or features of the study will change. Approval for the fall 2022 kindergarten-first grade field test and national study recruitment will be requested in a separate submission later in 2021.

The Board of Advisors, the Standards Board, and the Technical Guidelines Development Committee are federal advisory committees created by statute whose mission is to advise the EAC through review of the voluntary voting systems guidelines, review of voluntary guidance, and review of best practices recommendations. In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, this notice advises interested persons of the renewal of these Charters.

Title: FERC-725V, Mandatory Reliability Standards: COM Reliability Standards.

OMB Control No.: 1902-0277.

Type of Request: Three-year extension of the FERC-725V information collection requirements with no changes to the reporting requirements.

Abstract: On August 15, 2016, the North American Electric Reliability Corporation (NERC) filed a petition for Commission approval, pursuant to section 215(d)(1) of the Federal Power Act (“FPA”)  1 and Section 39.5  2 of the Federal Energy Regulatory Commission's regulations, for Reliability Standard COM-001-3 (Communications), the associated Implementation Plan, retirement of currently-effective Reliability Standard COM-001-2.1, and Violation Risk Factors (“VRFs”) and Violation Severity Levels (“VSLs”) associated with new Requirements R12 and R13 in Reliability Standard COM-001-3. Reliability Standard COM-001-3 reflects revisions developed under Project 2015-07 Internal Communications Capabilities, in compliance with the Commission's directive in Order No. 888 that NERC “develop modifications to COM-001-2, or develop a new standard, to address the Commission's concerns regarding ensuring the adequacy of internal communications capability whenever internal communications could directly affect the reliability opera.

Reliability Standards COM-001-3 and COM-002-4 do not require responsible entities to file information with the Commission. COM-001-3 requires that transmission operators, balancing authorities, reliability coordinators, distribution providers, and generator operators must maintain documentation of Interpersonal Communication capability and designation of Alternate Interpersonal Communication, as well as evidence of testing of the Alternate Interpersonal Communication facilities. COM-002-4 requires balancing authorities, distribution providers, reliability coordinators, transmission operators, and generator operators to develop and maintain documented communication protocols, and to be able to provide evidence of training on the protocols and of their annual assessment of the protocols. Additionally, all applicable entities (balancing authorities, reliability coordinators, transmission operators, generator operators, and distribution providers) must be able to provide evidence of three-part communication when issuing or receiving an Operating Instruction during an Emergency.

Type of Respondents: Public utilities.

Estimate of Annual Burden:   3 The Commission estimates the annual public reporting burden for the information collection as:

Title: FERC Form No. 552, Annual Report of Natural Gas Transactions.

OMB Control No.: 1902-0242.

Type of Request: Three-year extension of the FERC Form No. 552 information collection requirements with no changes to the current reporting requirements.

Abstract: The Commission uses the information collected in the FERC Form No. 552  1 to provide greater transparency into the size of the physical natural gas market and the use of physical fixed-price and index-based natural gas transactions. This information assists the Commission and the public in assessing whether index prices are the result of a robust market of fixed-price transactions.

FERC Form No. 552 had its genesis in the Energy Policy Act of 2005, 2 which added section 23 of the Natural Gas Act (NGA). Section 23 of the NGA, among other things, directs the Commission “to facilitate price transparency in markets for the sale or transportation of physical natural gas in interstate commerce, having due regard for the public interest, the integrity of those markets, and the protection of consumers.”  3

Type of Respondents: Wholesale natural gas market participants.

Estimate of Annual Burden:   4 The Commission estimates the average annual burden and cost  5 for this information collection as follows.

Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

This section is organized as follows:

This proposed permit covers the following entities, as categorized in the North American Industry Classification System (NAICS):

EPA does not intend the preceding table to be exhaustive but provides it as a guide for readers regarding the types of activities EPA is now aware of that could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your site is covered by this action, you should carefully examine the definition of “construction activity” and “small construction activity” in existing EPA regulations at 40 CFR 122.26(b)(14)(x) and 122.26(b)(15), respectively. If you have questions regarding the applicability of this action to a particular entity, consult one of the persons listed for technical information in the preceding FOR FURTHER INFORMATION CONTACT section.

Coverage under this permit will be available to operators of eligible projects located in those areas where EPA is the permitting authority. A list of eligible areas is included in Appendix B of the proposed permit. Eligibility for permit coverage is limited to operators of “new sites,” operators of “existing sites,” “new operators of new or existing sites,” and operators of “emergency-related projects.” A “new site” is a site where construction activities commenced on or after the effective date of the final 2022 CGP. An “existing site” is a site where construction activities commenced prior to the effective date of the final 2022 CGP. A “new operator of a new or existing site” is an operator that through transfer of ownership and/or operation replaces the operator of an already permitted construction site. An “emergency-related project” is a project initiated in response to a public emergency ( e.g., mud slides, earthquake, extreme flooding conditions, disruption in essential public services), for which the related work requires immediate authorization to avoid imminent endangerment to human health or the environment, or to reestablish public services.

This 2022 CGP can provide coverage to eligible operators for stormwater discharges from construction activities that occur in areas not covered by an approved state NPDES program. The areas of geographic coverage for the 2022 CGP are listed in Appendix B, and include the states of New Hampshire, Massachusetts, and New Mexico, as well as most Indian country lands, and areas in selected states operated by a federal operator. Permit coverage can also be obtained by operators in Puerto Rico, the District of Columbia, and the Pacific Island territories ( i.e., Island of American Samoa, Island of Guam, and Johnston Atoll, Commonwealth of the Northern Mariana Islands, Midway Island, and Wake Island). EPA notes that the CGP will no longer offer coverage to construction sites in the state of Idaho, except for sites located on Indian country lands, or to sites located in the state of Texas that involve the exploration, development, or production of oil or gas or geothermal resources, including transportation of crude oil or natural gas by pipeline, as both states are now authorized to issue permits for construction stormwater. Eligible operators in these two states will need to seek permit coverage for their stormwater discharges from their respective state NPDES authority.

1. Docket. EPA has established an official public docket for this action under Docket ID No. EPA-HQ-OW-2021-0169. The official public docket is the collection of materials that is available for public viewing at the Water Docket in the EPA Docket Center, (EPA/DC) WJC West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20460. Although all documents in the docket are listed in an index, some information is not publicly available, i.e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room are closed to the public, with limited exceptions, to reduce the risk of transmitting COVID-19. Our Docket Center staff will continue to provide remote customer service via email, phone, and webform. We encourage the public to submit comments via https://www.regulations.gov/ or email, as there may be a delay in processing mail and faxes. Hand deliveries and couriers may be received by scheduled appointment only. For further information on EPA Docket Center services and the current status, please visit us online at https://www.epa.gov/dockets.

2. Electronic Access. You may access this Federal Register document electronically through the United States government on-line source for Federal regulations at http://www.regulations.gov.

Electronic versions of this proposed permit and fact sheet are available on EPA's NPDES website at https://www.epa.gov/npdes/stormwater-discharges-construction-activities.

An electronic version of the public docket is available through the EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. For additional information about EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the Docket Facility identified in Section I.B.1 of this preamble.

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

EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. As noted previously, CBI information should not be submitted through regulations.gov or by email. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

2. Tips for Preparing Your Comments. When submitting comments, remember to:

• Identify this proposed permit by docket number and other identifying information (subject heading, Federal Register date and page number).

• Where possible, respond to specific questions or organize comments by referencing a section or part of this proposed permit.

• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

• Describe any assumptions and provide any technical information and/or data that you used.

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

• Provide specific examples to illustrate your concerns and suggest alternatives.

• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

• To ensure that EPA can read, understand, and therefore properly respond to comments, the Agency would prefer that commenters cite, where possible, the paragraph(s) or section in the proposed permit or fact sheet to which each comment refers.

• Make sure to submit your comments by the comment period deadline identified.

EPA has not scheduled a public hearing to receive public comment concerning the proposed permit. All persons will continue to have the right to provide written comments during the public comment period. However, interested persons may request a public hearing pursuant to 40 CFR 124.12 concerning the proposed permit. Requests for a public hearing must be sent or delivered in writing to the same address as provided above for public comments prior to the close of the comment period. Requests for a public hearing must state the nature of the issues proposed to be raised in the hearing. Pursuant to 40 CFR 124.12, EPA shall hold a public hearing if it finds, on the basis of requests, a significant degree of public interest in a public hearing on the proposed permit. If EPA decides to hold a public hearing, a public notice of the date, time and place of the hearing will be made at least 30 days prior to the hearing. Any person may provide written or oral statements and data pertaining to the proposed permit at the public hearing.

EPA is hosting at least one public webcast during the week of June 14, 2021 that will provide an overview of the proposed 2022 CGP and an opportunity for participants to ask questions. EPA will announce details of all webcasts and post webcast recordings at https://www.epa.gov/npdes/stormwater-discharges-construction-activities.

After the comment period closes, EPA intends to issue a final permit prior to the expiration date of the current 2017 CGP. EPA will consider all significant comments and make appropriate changes before issuing this permit. EPA's responses to public comments received will be included in the docket as part of the final permit issuance. Once the final permit becomes effective, eligible operators of existing and new sites may seek authorization under the 2022 CGP. Any construction site operator obtaining permit coverage prior to the expiration date of the 2017 CGP will automatically remain covered under that permit until the earliest of:

• Authorization for coverage under the 2022 CGP following a timely submittal of a complete and accurate Notice of Intent (NOI);

• Submittal of a Notice of Termination (NOT); or

• EPA issues an individual permit or denies coverage under an individual permit for the site's stormwater discharges.

For EPA Region 1, contact David Gray: email at gray.davidj@epa.gov.

For EPA Region 2, contact Stephen Venezia: email at venezia.stephen@epa.gov, or for Puerto Rico, contact Sergio Bosques: email at bosques.sergio@epa.gov.

For EPA Region 3, contact Carissa Moncavage: email at moncavage.carissa@epa.gov.

For EPA Region 4, contact Michael Mitchell: email at mitchell.michael@epa.gov.

For EPA Region 5, contact Krista McKim: email at mckim.krista@epa.gov.

For EPA Region 6, contact Suzanna Perea: email at: perea.suzanna@epa.gov.

For EPA Region 7, contact Mark Matthews: email at: matthews.mark@epa.gov.

For EPA Region 8, contact Amy Clark: email at: clark.amy@epa.gov.

For EPA Region 9, contact Eugene Bromley: email at bromley.eugene@epa.gov.

For EPA Region 10, contact Margaret McCauley: email at mccauley.margaret@epa.gov.

The Clean Water Act (CWA) establishes a comprehensive program “to restore and maintain the chemical, physical, and biological integrity of the Nation's waters.” 33 U.S.C. 1251(a). The CWA also includes the objective of attaining “water quality which provides for the protection and propagation of fish, shellfish and wildlife and * * * recreation in and on the water.” 33 U.S.C. 1251(a)(2)). To achieve these goals, the CWA requires EPA to control discharges of pollutants from point sources through the issuance of National Pollutant Discharge Elimination System (NPDES) permits.

The Water Quality Act of 1987 (WQA) added section 402(p) to the CWA, which directed EPA to develop a phased approach to regulate stormwater discharges under the NPDES program. 33 U.S.C. 1342(p). EPA published a final regulation in the Federal Register , often called the “Phase I Rule,” on November 16, 1990, establishing permit application requirements for, among other things, “storm water discharges associated with industrial activity.” See 55 FR 47990. EPA defines the term “storm water discharge associated with industrial activity” in a comprehensive manner to cover a wide variety of facilities. See id. Construction activities, including activities that are part of a larger common plan of development or sale, that ultimately disturb at least five acres of land and have point source discharges to waters of the U.S. were included in the definition of “industrial activity” pursuant to 40 CFR 122.26(b)(14)(x). The second rule implementing section 402(p), often called the “Phase II Rule,” was published in the Federal Register on December 8, 1999. It requires NPDES permits for discharges from construction sites disturbing at least one acre but less than five acres, including sites that are part of a larger common plan of development or sale that will ultimately disturb at least one acre but less than five acres, pursuant to 40 CFR 122.26(b)(15)(i). See 64 FR 68722. EPA is proposing to issue this proposed permit under the statutory and regulatory authorities cited in this section.

NPDES permits for construction stormwater discharges are required under Section 402(a)(1) of the CWA to include conditions to meet technology-based effluent limits established under Section 301 and, where applicable, Section 306. Effluent Limitations Guidelines (ELGs) and New Source Performance Standards (NSPS) are technology-based effluent limitations that are based on the degree of control that can be achieved using various levels of pollutant control technology as defined in Subchapter III of the CWA.

Once a new national standard is established in accordance with these sections, NPDES permits must incorporate limits based on such technology-based standards. See CWA sections 301 and 306, 33 U.S.C. 1311 and 1316, and 40 CFR 122.44(a)(1). On December 1, 2009, EPA published final regulations establishing technology-based ELGs and NSPS for the Construction & Development (C&D) point source category, which became effective on February 1, 2010. See 40 CFR part 450 and 74 FR 62996. EPA amended the Construction & Development Rule, or “C&D rule,” on March 6, 2014 to satisfy EPA's agreements pursuant to a settlement of litigation that challenged the 2009 rule. See 79 FR 12661. All NPDES construction permits issued by EPA or states after this date must incorporate the requirements in the C&D rule.

All NPDES construction stormwater permits issued by EPA or states after March 6, 2014, must incorporate the requirements in the C&D rule, as amended. The non-numeric effluent limitations in the C&D rule are designed to prevent or minimize the mobilization and discharge of sediment and sediment-bound pollutants, such as metals and nutrients, and to prevent or minimize exposure of stormwater to construction materials, debris, and other sources of pollutants on construction sites. In addition, these non-numeric effluent limitations limit the generation of dissolved pollutants. Soil on construction sites can contain a variety of pollutants such as nutrients, pesticides, herbicides, and metals. These pollutants may be present naturally in the soil, such as arsenic or selenium, or they may have been contributed by previous activities on the site, such as agriculture or industrial activities. These pollutants, once mobilized by stormwater, can detach from the soil particles and become dissolved pollutants. Once dissolved, these pollutants would not be removed by down-slope sediment controls. Source control through minimization of soil erosion is, therefore, the most effective way of controlling the discharge of these pollutants.

The non-numeric effluent limits in the C&D rule, upon which certain technology-based requirements in the proposed permit are based, include the following:

• Erosion and Sediment Controls —Permittees are required to design, install, and maintain effective erosion controls and sediment controls to minimize the discharge of pollutants. At a minimum, such controls must be designed, installed, and maintained to:

1. Control stormwater volume and velocity to minimize soil erosion in order to minimize pollutant discharges;

2. Control stormwater discharges, including both peak flow rates and total stormwater volume, to minimize channel and streambank erosion, and scour in the immediate vicinity of discharge points;

3. Minimize the amount of soil exposed during construction activity;

4. Minimize the disturbance of steep slopes;

5. Minimize sediment discharges from the site. The design, installation and maintenance of erosion and sediment controls must address factors such as the amount, frequency, intensity and duration of precipitation, the nature of resulting stormwater discharge, and soil characteristics, including the range of soil particle sizes expected to be present on the site;

6. Provide and maintain natural buffers around waters of the United States. Direct stormwater to vegetated areas and maximize stormwater infiltration to reduce pollutant discharges, unless infeasible;

7. Minimize soil compaction. Minimizing soil compaction is not required where the intended function of a specific area of the site dictates that it be compacted; and

8. Unless infeasible, preserve topsoil. Preserving topsoil is not required where the intended function of a specific area of the site dictates that the topsoil be disturbed or removed.

• Soil Stabilization Requirements —Permittees are required to, at a minimum, initiate soil stabilization measures immediately whenever any clearing, grading, excavating, or other earth disturbing activities have permanently ceased on any portion of the site or temporarily ceased on any portion of the site and will not resume for a period exceeding 14 calendar days. In arid, semiarid, and drought-stricken areas where initiating vegetative stabilization measures immediately is infeasible, alternative stabilization measures must be employed as specified by the permitting authority. Stabilization must be completed within a period of time determined by the permitting authority. In limited circumstances, stabilization may not be required if the intended function of a specific area of the site necessitates that it remains disturbed.

• Dewatering Requirements —Permittees are required to minimize the discharge of pollutants from dewatering trenches and excavations. Discharges are prohibited unless managed by appropriate controls.

• Pollution Prevention Measures —Permittees are required to design, install, implement, and maintain effective pollution prevention measures to minimize the discharge of pollutants. At a minimum, such measures must be designed, installed, implemented, and maintained to:

1. Minimize the discharge of pollutants from equipment and vehicle washing, wheel wash water, and other wash waters. Wash waters must be treated in a sediment basin or alternative control that provides equivalent or better treatment prior to discharge;

2. Minimize the exposure of building materials, building products, construction wastes, trash, landscape materials, fertilizers, pesticides, herbicides, detergents, sanitary waste, and other materials present on the site to precipitation and to stormwater. Minimization of exposure is not required in cases where the exposure to precipitation and to stormwater will not result in a discharge of pollutants or where exposure of a specific material or product poses little risk of stormwater contamination (such as final products and materials intended for outdoor use); and

3. Minimize the discharge of pollutants from spills and leaks and implement chemical spill and leak prevention and response procedures.

• Prohibited Discharges —The following discharges from C&D sites are prohibited:

1. Wastewater from washout of concrete, unless managed by an appropriate control;

2. Wastewater from washout and cleanout of stucco, paint, form release oils, curing compounds, and other construction materials;

3. Fuels, oils, or other pollutants used in vehicle and equipment operation and maintenance; and

4. Soaps or solvents used in vehicle and equipment washing.

• Surface Outlets —When discharging from basins and impoundments, permittees are required to utilize outlet structures that withdraw water from the surface, unless infeasible.

The accompanying fact sheet details how EPA has incorporated these requirements into the proposed permit. The discussion in the fact sheet includes a summary of each provision and the Agency's rationale for articulating the provision in this way.

EPA's regulations at 40 CFR 122.44(d)(1) require permitting authorities to include additional or more stringent permit requirements when necessary to achieve water quality standards. The 2017 CGP contains several provisions to protect water quality and the proposed permit includes those same provisions. It includes a narrative WQBEL requiring that discharges be controlled as necessary to meet applicable water quality standards. Failure to control discharges in a manner that meets applicable water quality standards is a violation of the permit.

In addition to the narrative WQBEL, the 2017 CGP includes related provisions that act together to protect water quality. These provisions are retained in the proposed 2022 CGP. For example, the 2017 CGP and proposed 2022 CGP permit require permittees to implement stormwater control measures and to take corrective action in response to any exceedance of applicable water quality standards. In addition, the permit requires more stringent site inspection frequencies and stabilization deadlines for construction sites that discharge to sensitive waters, such as those waters that are sediment or nutrient-impaired, which are parameters typically associated with stormwater discharges from construction sites, or waters identified by a state, tribe, or EPA as requiring enhanced protection under antidegradation requirements. EPA is also weighing whether to include an additional water quality-based requirement for dewatering discharges to certain sensitive waters in the form of a requirement to monitor the discharge for turbidity, possibly in comparison to a benchmark value. The proposed permit includes a request for public comment that is focused specifically on the potential turbidity monitoring requirement. See specific requests for comment in Section V of this document.

Additionally, EPA expects that, as with the 2017 CGP, the Agency will receive CWA Section 401 certifications for the final 2022 CGP. Some of those certifications may include additional conditions that are required by states, Indian tribes, and territories, pursuant to relevant provisions of the Clean Water Act or their respective legal authorities, and that, when properly submitted, will be incorporated into the permit as legally binding permit limits and conditions in the specific geographic areas that are located within the jurisdiction of the certifying authority.

EPA made a concerted effort in the early stages of developing this proposed permit to reach out to stakeholders that would be affected by any modifications to the permit requirements. This outreach included meetings with stakeholders representing the construction industry, environmental interests, and state permitting authorities. The purpose of these meetings was to help identify areas of the 2017 CGP that require further clarification or modification to more effectively achieve the pollutant reduction objectives of the permit. EPA also queried its Regional enforcement personnel to determine where the permit could be clarified or where further specifics would help improve compliance. The individual feedback obtained from these meetings informed the types of clarifications and other changes EPA is proposing here, as well as the areas where the Agency is soliciting further feedback during the public comment period.

EPA proposes to make several modifications in the 2022 CGP, which are summarized below and discussed in more detail in the fact sheet. EPA also specifically requests comment on several potential permit modifications, which are summarized in Section V of this document. The fact sheet for the proposed permit explains in more detail each proposed permit condition and the rationale for including those conditions and any changes to those conditions. The fact sheet and proposed permit can be found at https://www.epa.gov/npdes/stormwater-discharges-construction-activities. A comprehensive list of all the proposed changes, as well as the corresponding parts of the permit that are modified, is included in a table in Section III.B of the fact sheet.

The types of changes generally fall into one of two categories: (1) Changes to improve the clarity of the permit, and (2) added specificity to the permit requirements. The table of proposed modifications in Section III.B of the fact sheet specifies which changes fall under the type (1) category and which fall into the type (2) category. The following sections briefly describe the proposed changes that are proposed within these two broad categories.

EPA proposes a number of relatively minor changes that focus on improving the clarity of provisions where permittees, EPA compliance staff, or other stakeholders have raised questions. These changes generally do not change the underlying requirement from the 2017 CGP, but rather attempt to make EPA's original intent clearer. It is EPA's hope that these proposed clarifications improve the overall understanding of the permit's requirements from all perspectives, including the permitting authority, permittees, and the general public.

The proposed changes to improve clarity include the following:

• Approved stormwater control and stormwater pollution prevention plan products —EPA includes new language in the permit to clearly state that the Agency does not endorse specific stormwater control or stormwater pollution prevention plan (SWPPP) products or vendors. Industry stakeholders suggested to include such language to help discourage some vendors from misleadingly suggesting that EPA or the permit approves of specific products. See footnotes 12 and 59 in Parts 2.1 and 7.1, respectively, of the proposed permit.

• Differentiate between routine maintenance and corrective action— EPA proposes to define routine maintenance as repairs to or replacement of stormwater controls that can be completed within 24 hours of first discovering the need for the repair or replacement. If a repair (or replacement) takes longer than 24 hours, the permit would require that it be treated as a corrective action. This change addresses feedback provided by industry stakeholders who have observed that there is considerable confusion about which maintenance repairs are considered routine versus those that should be treated as corrective actions. See Parts 2.1.4.b and c, and 5.1.1 of the proposed permit.

• Clarify application of perimeter control and natural buffer requirements— EPA understands from conversations with stakeholders that there is confusion about whether perimeter controls are necessary on the site when the operator is already providing a natural buffer pursuant to the requirements of the permit. To address this confusion, EPA clarifies that perimeter controls must be installed upgradient of any natural buffers except in situations where the perimeter control is being used by the permittee to fulfill one of the buffer alternative requirements, in which case the permittee would not be required to install a second perimeter control. See Part 2.2.3.a of the proposed permit.

• Clarify the permit flexibilities for arid and semi-arid areas —The 2017 CGP establishes alternative stabilization and inspection schedules for arid and semi-arid areas that are reflective of the different climatic and precipitation conditions that exist in those areas. These stabilization and inspection schedule flexibilities apply during the “seasonally dry period” of the year when there is less risk of a discharge-producing storm event. The permit did not previously define the term “seasonally dry period,” and EPA has received a number of questions from construction operators over the past several years about what this term means. For this reason, the proposed permit establishes a new definition to provide clarity, and includes resources in the form of maps and zip code tables to assist construction operators located in an arid or semi-arid area in determining when they may be operating during a seasonally dry period of the year. See Parts 2.2.14.b, 2.2.14.c, and 4.4.2 of the proposed permit, as well as the definition of “seasonally dry period” in Appendix A.

• Clarified requirements for inspections during snowmelt conditions— The permit proposes to add a numeric inspection threshold for snowfall precipitation that is equivalent to the 0.25-inch rain event, which triggers the need for an inspection if the operator chooses to inspect its site on a bi-weekly basis pursuant to Part 4.2.2. This change would clarify that where there is a discharge from snowmelt caused by an accumulation of 3.25 inches or greater of snow, an inspection would be required. Permit holders requested this change and explained to EPA that without a numeric threshold, it is difficult for operators to know which snow events may trigger the need to inspect the site during the winter season. EPA relied on information from the National Oceanic and Atmospheric Administration (NOAA) to derive the 3.25-inch snowfall equivalent to the 0.25-inch rain event. See Part 4.2.2 of the proposed permit.

• Availability of stormwater pollution prevention plan (SWPPP), inspection reports, and corrective action log in electronic form— The 2017 CGP currently enables operators to keep their SWPPP, inspection reports, and corrective action records in electronic form, as long as it can be accessed and read by the permittee and by any EPA, state, or local inspection authorities in the same manner as a paper copy. EPA heard from permittees, however, who were uncertain about whether the flexibility to keep these documents in electronic form was available to them. EPA acknowledges that part of the problem is that its explanation about retaining documents in electronic form is currently included in a frequently asked question section of its stormwater website (see https://www.epa.gov/npdes/construction-general-permit-cgp-frequent-questions ), and is not clearly stated in the permit. For this reason, the proposed permit includes text to make it clear that electronic versions of the SWPPP, inspection reports, and corrective action logs may be used as long as they meet certain minimum requirements. See footnotes 54, 55, and 66 to Parts 4.7.3, 5.4.3, and 7.3, respectively, of the proposed permit.

• Updated process for Endangered Species Act eligibility determinations— EPA proposes several updates to Appendix D of the CGP, which establishes procedures for operators to follow in determining their eligibility for coverage with respect to the protection of endangered and threatened species. The changes to Appendix D are primarily in the form of clarifications to existing procedures or updates to resources that operators can use to determine whether species are located in the “action area” of the construction site. EPA finalized similar changes as part of the Endangered Species Act consultation it completed as part of its issuance of the 2021 Multi-Sector General Permit (MSGP) for discharges from industrial activities (See Appendix E of the 2021 MSGP at https://www.epa.gov/npdes/stormwater-discharges-industrial-activities-epas-2021-msgp). See Appendix D of the proposed permit.

EPA is proposing select modifications to the permit to address specific problems that have come to the Agency's attention during the permit term or to incorporate enhancements that reflect current best practices. These proposed changes are narrowly focused on specific topics. The following is a summary of these proposed changes:

• Perimeter control installation and maintenance requirements— Due to the vital role that sediment controls installed along the downslope side of the construction site perimeter play in minimizing sediment discharges, it is important for the CGP requirements related to these controls to reflect best practices that are available, effective, and practicable. Reviewing a number of state permits and best management practice manuals during the development of the proposed permit, EPA concluded that some targeted proposed changes to the perimeter control requirements in the CGP are appropriate at this time. For this reason, EPA is proposing additional perimeter control installation and maintenance requirements that are focused on ensuring that these controls continue to work effectively. For example, under the proposed provision, if there is evidence of stormwater circumventing or undercutting the perimeter control after a storm event, the operator would be required to extend the length of the perimeter control or repair any undercut areas, whichever applies. This change is intended to ensure that maintenance of these controls is focused on fixing problems as soon as they are found and making sure they work effectively when the next storm event occurs. See Part 2.2.3 of the proposed permit.

• Pollution prevention requirements for chemicals used and stored on site— EPA is proposing changes to the pollution prevention requirements for diesel fuel, oil, hydraulic fuels, or other petroleum products, and other chemicals. These proposed changes respond to feedback EPA received from some permittees who recommended reframing the current permit requirements so they are proportionate to the volume of chemicals being used and stored on the site, and relative to the risk of a spill or leak. EPA agrees that the requirements in this section could be improved by strengthening the linkage between the type of pollution prevention control needed and the volume of the pollutant kept on site. Consistent with this principle, the proposed permit establishes control requirements that are appropriate for smaller-sized containers by requiring that the operator use water-tight containers, place them on a spill containment pallet (or similar device) if kept outside, and have a spill kit available at all times and in good working condition, and personnel available to respond quickly to a spill or leak. These controls will be effective at preventing a discharge from a spill or leak, while also having the added advantage of being moved more easily around the site. The proposed permit also includes controls that are more suitable to larger volumes of chemicals on site, such as requiring a temporary roof or secondary containment to prevent a discharge from a leak or spill. See Part 2.3.3.c of the proposed permit.

• Dewatering discharge requirements— EPA is proposing several changes to the permit's dewatering requirements to improve compliance and further reduce pollutant loads to waterways. EPA has noted violations with the permit's dewatering requirements at sites with controls that are improperly installed and maintained, resulting in significant discharges of sediment and other pollutants to receiving waters. Given the high rate at which dewatered water may be discharged, EPA inspection personnel have observed that it is possible that a site may discharge more sediment in several hours of poorly managed dewatering activities than might otherwise be discharged from a site via stormwater discharges over the entire course of the construction project. Additionally, EPA has found there to be good example provisions from state construction stormwater permits and standalone NPDES dewatering permits that can be used to strengthen the CGP's dewatering conditions.

The proposed revisions to the permit add clarity to the existing pollutant control provisions, increase the number of inspections required while the dewatering discharge is occurring, establish a tailored checklist of problems to review during the inspection, and identify specific triggers for when corrective action is required. For example, one new inspection provision would require the operator to check whether a sediment plume, sheen, or hydrocarbon deposit on the bottom or shoreline of the receiving water was observed during a dewatering discharge. If such a plume, sheen, or deposit is observed, the permit would require the operator to, among other things, take immediate steps to suspend the discharge and ensure that the dewatering controls being used are operating effectively. During an inspection of the dewatering operation, the operator would also be required to take photographs of (1) the dewatering water prior to treatment by a stormwater control(s) and the final discharge after treatment; (2) the stormwater control; and (3) the point of discharge to any waters of the U.S. flowing through or immediately adjacent to the site. This documentation will help demonstrate how well the dewatering controls are working and will show where adaptations made after any problems have been found have resulted in improved pollutant control. See Parts 2.4, 4.3.2, 4.5.5, 4.6.3, and 5.1.5 of the proposed permit.

• Training requirements for personnel conducting site inspections— EPA is proposing to include modifications to the training requirements for personnel conducting site inspections. EPA considers these changes reasonable to address problems found during many of the Agency's own construction site inspections, in which EPA has observed that while some permittees are properly conducting inspections and documenting their findings in accordance with the permit, a large number are not. EPA proposes to address this problem is by strengthening the training requirements for inspection personnel to ensure their competency to conduct such inspections. For this reason, the proposed permit specifies that anyone carrying out inspections must either (1) have completed the new EPA construction inspection course developed for this permit and passed the exam, or (2) hold a current valid certification or license from a program that covers essentially the same principles as EPA's inspection course. The proposal also includes an exception to the new training requirement if the personnel are working under the supervision of a person who has the met the qualifications described above. These new proposed requirements are essentially an extension of what the 2017 CGP (and 2012 CGP) already required for the “qualified person” to conduct inspections. EPA is in the process of developing a construction inspection training program that will be made available as an option to fulfill this new requirement to CGP permittees along with an accompanying exam that, if passed, will provide the person with documentation showing that they have successfully completed the EPA course. EPA plans to have the training program ready for use by the issuance of the final 2022 CGP, or to delay the implementation of the requirement until the EPA training is available. Documentation that the relevant personnel has completed the EPA course and passed the exam will serve as proof that the operator has met the new inspection training requirements. Alternatively, if the relevant personnel elect to obtain the required training through a different program that covers the same basic principles, the operator will need to provide documentation that these personnel have completed the program and are in possession of a current, valid certification or license. See Parts 4.1 and 6.3 of the proposed permit.

• Documenting signs of sedimentation attributable to construction site discharges— EPA specifies in the proposed permit that during the inspection, operators must check for signs of sedimentation ( e.g., sand bars with no vegetation growing on top) at points downstream from the point of discharge that could be attributable to their discharges. This change is intended to address a frequent problem observed during EPA's compliance inspections that the permittee does not document obvious signs that its discharges have caused sedimentation in the receiving water. The intent of this proposed addition is to emphasize that the site inspection is an ideal time to examine whether there are any obvious signs of sedimentation attributable to the site's discharges, and to require documentation of such sedimentation. EPA does not specify in the permit a specific distance downstream of the site that operators much check for sedimentation that could be attributable to the discharge, given variable site-specific conditions. Instead, EPA expects that operators will account for the amount of sediment leaving the site in determining this distance. EPA notes that the CGP already requires operators to check for signs of visible erosion and sedimentation ( i.e., sediment deposits) that have occurred and are attributable to the permittee's discharge at outfalls and, if applicable, on the banks of any waters of the U.S. flowing within or immediately adjacent to the site. See Part 4.6.1.d of the proposed permit.

• Photo documentation of adequate site stabilization— EPA's compliance inspectors have observed cases when operators prematurely terminate coverage under the CGP before the site is properly stabilized. The proposed permit adds a new provision requiring operators as part of their Notice of Termination (NOT) to take and submit photographs showing the stabilized areas of the site following completion of construction. EPA proposes this requirement primarily as an additional level of proof that permittees are complying with the stabilization requirements prior to terminating coverage. Given the importance of stabilization to preventing continuing erosion and sedimentation, EPA views the additional proposed photo documentation requirement to be a relatively inexpensive, effective, and straightforward way for the permittee to show the Agency that it has complied with the permit's final stabilization requirements. See Part 8.2.1.a of the proposed permit. Related to this proposed new requirement, EPA is also adding a check box to the NOT form to confirm that the operator has attached photographs as required by Part 8.2.1.a to document compliance with the permit's final stabilization requirements.

• Notice of Intent (NOI) questions— EPA proposes to add new questions to the NOI form that construction operators will use to obtain coverage under the 2022 CGP. One question asks operators if dewatering water will be discharged during the course of their permit coverage. While EPA suspects that most CGP-covered projects discharge dewatering water during construction, it would be useful to the Agency to know what the prevalence of this practice is at its permitted sites. This question will provide a straightforward way of compiling information broadly about permittees and enable EPA to know which permittees may be affected by the permit's new proposed dewatering requirements. Another question asks the operator completing the NOI whether there are other operators who are also covered by the CGP at the same site and, if so, what their NPDES ID numbers are. Because the 2017 CGP NOI does not ask the operator to indicate whether there are multiple operators permitted for the same site, EPA is often unable to easily determine who all the permitted entities are at larger projects. The NOI form will also include a proposed new question that requires the operator to confirm that any personnel conducting inspections at the site will meet the modified training requirements in Part 6 of the permit. EPA also proposes clarifying edits to better explain the types of documentation that are needed for several of the eligibility criteria and edits to provide links to updated available mapping tools to assist operators in determining whether any listed or threatened species are known to occur in the action area of their project.

While EPA encourages the public to review and comment on all provisions in the proposed permit, EPA has included in the body of the proposed permit several proposed provisions on which EPA specifically requests feedback. The following list summarizes these specific requests for comment, and where they are included in the permit. EPA notes that these are only summaries of the requests for comment. The Agency recommends that the public see the specific wording of each comment request within the body of the permit. Additionally, the request for comment numbers 1, 3, 4, and 5 are not accompanied by a proposed change to the permit, but rather are inviting input on possible revisions to the CGP.

1. Permit coverage clarification —Request for comment on potentially modifying the definition of operator to specifically include parties that determine acceptance of work and pay for work performed. See Request for Comment 1 in Part 1.1.1 of the proposed permit.

2. Prohibition of dewatering discharges from contaminated sites —Request for comment on whether additional sites should be prohibited from coverage under this permit due to the possibility of discharging dewatering water that is contaminated, and whether certain sites should be given case-by-case flexibility if stormwater contact with underground contamination has been prevented through implementation of cleanup controls, such as capping. See Request for Comment 2 in Part 1.3.6 of the proposed permit.

3. Waiting period for discharge authorization —Request for comment on whether to extend the waiting period between the operator's submittal of the NOI and the authorization to discharge from 14 days to 30 days to facilitate review of the site's eligibility related to the protection of endangered or threatened species. See Request for Comment 3 in Part 1.4.3 of the proposed permit.

4. Stabilization deadlines— Request for comment on whether the 5-acre disturbance threshold for stricter stabilization deadlines has the intended effect of encouraging the phasing of construction disturbances. See Request for Comment 4 in Part 2.2.14.a of the proposed permit.

5. Pollution prevention requirements for construction waste— Request for comment on whether existing pollution control flexibilities such as those that apply to building materials and products in Part 2.3.3.a should be applied to certain types of construction wastes. See Request for Comment 5 in Part 2.3.3.e of the proposed permit.

6. Water quality-based requirements for dewatering discharges —Request for comment on requiring targeted sampling of the dewatering discharges from sites discharging to sediment-impaired waters or waters designated as Tier 2, Tier 2.5 or Tier 3 waters. See Request for Comment 6 in Part 3.3 of the proposed permit.

7. Training Requirements —Request for comment on the proposed modifications to the site inspection training requirements, specifically on how EPA can design its own inspection training program and the criteria used to describe the minimum requirements for third-party training programs. See Request for Comment 7 in Part 6.3 of the proposed permit.

8. Photographic documentation of site stabilization— Request for comment on the proposed requirement to take photographs of the stabilized areas of the site and submit them with the NOT. See Request for Comment 8 in Part 8.2.1.a of the proposed permit.

The information collection activities in this permit have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR No. 2686.01, OMB Control No. 2040-NEW. You can find a copy of the ICR in the docket for this permit (Docket ID No. EPA-HQ-OW-2021-0169), and it is briefly summarized here.

CWA section 402 and the NPDES regulations require collection of information primarily used by permitting authorities, permittees (operators), and EPA to make NPDES permitting decisions. The burden and costs associated with the entire NPDES program are accounted in an approved ICR (EPA ICR number 0229.23, OMB control no. 2040-0004). Certain changes in this permit require revisions to the ICR to reflect changes to the forms and other information collection requirements. EPA is reflecting the paperwork burden and costs associated with this permit in a separate ICR instead of revising the existing ICR for the entire program for administrative reasons.

EPA is proposing to collect new information as part of the 2022 CGP. The NOI form was updated from the 2017 CGP to collect new information related to the following: Added one new question related to whether operators will be discharging construction dewatering water during the course of their permit coverage; added questions about whether there are other operators who are also covered by the CGP at the same site and, if so, what their NPDES ID numbers are; added a check box for the operator to confirm that any personnel conducting inspections at the site will meet the modified training requirements in Part 6 of the permit; and added clarifying edits to better explain the types of documentation that are needed for several of the eligibility criteria related to endangered and threatened species and edits to provide links to updated available mapping tools to assist operators in determining whether any such species are known to occur in the vicinity of their project.

EPA added one check box for operators who are submitting an “NOT” because all construction activities have ended and the site has met all of the requirements for terminating permit coverage in Part 8.2.1. The check box confirms that the operator has attached photographs taken to document compliance with the final stabilization requirements pursuant to Part 8.2.1.a.

Respondents/affected entities: Construction operators in the areas where EPA is the NPDES permitting authority.

Respondent's obligation to respond: Compliance with the CGP's information collection and reporting requirements is mandatory for CGP operators.

Estimated number of respondents: EPA estimates that for the duration of the three-year ICR period approximately 7,800 operators will obtain coverage under the 2022 CGP, or 2,600 operators per year.

Frequency of response: Response frequencies in the 2022 CGP vary from once per permit term to quarterly.

Total estimated burden: EPA estimates that the information collection burden of the 2022 CGP is 134,059 hours per year. Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: EPA estimates that the final information collection cost of the 2022 CGP is $8,195,357 per year.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. EPA will respond to ICR-related comments in the final permit.

The cost analysis accompanying this proposed permit monetizes and quantifies certain incremental cost impacts of the proposed permit changes as compared to the 2017 CGP. EPA analyzed each change in the proposed 2022 CGP considering the previous permit's ( i.e., the 2017 CGP) requirements. The objective of this incremental cost analysis is to show where or to what extent the proposed 2022 CGP requirements impose an incremental increase in administrative and compliance costs (such as the cost to conduct site inspections or to prepare compliance reports) on operators in relation to costs that are already accounted for in the 2017 CGP.

More broadly, EPA notes that additional unquantified costs and benefits result from this action. In developing the next CGP (or another NPDES general permit, as appropriate), EPA plans to estimate the broader impacts arising from these actions, including costs and benefits. Estimates under consideration may include: (1) Assessing how costs and benefits are attributed between the CGP and applicable water quality standards (including TMDLs) that may be in effect; (2) developing a new modeling framework to assess how regulated entities understand and implement pollutant controls related to existing and new permit obligations; (3) examining whether any underlying cost and benefit assumptions need to be updated; (4) examining more broadly how EPA can analyze benefits when developing permits; (5) developing more robust approaches to assessing uncertainties associated with the analytic approaches, including how to quantitatively assess uncertainties of key assumptions; and (6) developing a framework to analyze the effect of cooperative federalism.

EPA expects the incremental cost impact on entities that will be covered under the 2022 CGP, including small businesses, to be minimal. EPA anticipates the approximate average annual incremental cost increase (compared to the 2017 CGP) will be $704 to $714 per permitted project per year. A copy of EPA's incremental cost analysis for the proposed permit, titled “Incremental Cost Impact Analysis for the Proposed 2022 Construction General Permit (CGP),” is available in the docket (Docket ID No. EPA-HQ-OW-2021-0169).

The proposed permit is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

Executive Order (E.O.) 12898 (59 FR 7629 (February 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.

EPA has preliminarily determined that this proposed permit will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because the requirements in the proposed permit apply equally to all construction projects that disturb one or more acres (or are part of a larger common plan of development that disturbs one or more acres) in areas where EPA is the permitting authority, and the erosion and sediment control proposed provisions increase the level of environmental protection for all affected populations over the 2017 CGP. EPA requests comment on this preliminary determination and/or any modifications that EPA could make to the proposed permit to address environmental justice concerns.

In compliance with Executive Order 13175, EPA consulted with tribal officials to gain an understanding of and, where necessary, to address the tribal implications of the proposed permit. During this consultation, EPA conducted the following activities:

• August 13, 2020—EPA mailed notification letters to all tribal leaders, initiating consultation and coordination on the proposed permit. The consultation period was from August 13, 2020 to October 27, 2020.

• September 9, 2020—EPA participated in the National Tribal Water Council monthly conference call and received written comments in response.

• September 16, 2020—EPA led an informational webinar to provide an overview of the current CGP and information regarding the ongoing consultation to the National Tribal Caucus. A total of 34 tribal representatives attended.

EPA will provide email notification to tribes of the proposed permit and invite those interested to provide the Agency with comments. EPA also notes that as part of the finalization of this proposed permit, it will complete the Section 401 certification procedures with all applicable tribes where this permit will apply (see Appendix B).

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy and has not otherwise been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action.

Pursuant to the National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4307h), the Council on Environmental Quality's NEPA regulations (40 CFR part 15), and EPA's regulations for implementing NEPA (40 CFR part 6), EPA has determined that the 2022 reissuance of the CGP is eligible for a categorical exclusion requiring documentation under 40 CFR 6.204(a)(1)(iv). This category includes “actions involving reissuance of a NPDES permit for a new source providing the conclusions of the original NEPA document are still valid, there will be no degradation of the receiving waters, and the permit conditions do not change or are more environmentally protective.” EPA completed an Environmental Assessment/Finding of No Significant Impact (EA/FONSI) for the 2012 CGP. The analysis and conclusions regarding the potential environmental impacts, reasonable alternatives, and potential mitigation included in the EA/FONSI are still valid for the 2022 reissuance of the CGP because the proposed permit conditions are either the same or more environmentally protective. Actions may be categorically excluded if the action fits within a category of action that is eligible for exclusion and the proposed action does not involve any extraordinary circumstances. EPA has reviewed the proposed action and determined that the 2022 reissuance of the CGP does not involve any extraordinary circumstances listed in 6.204(b)(1) through (10). EPA made a similar determination for the 2017 CGP. Prior to the issuance of the final 2022 CGP, the EPA Responsible Official will document the application of the categorical exclusion and will make it available to the public on EPA's website at https://cdxnodengn.epa.gov/cdx-enepa-public/action/nepa/search. If new information or changes to the proposed permit involve or relate to at least one of the extraordinary circumstances or otherwise indicate that the permit may not meet the criteria for categorical exclusion, EPA will prepare an EA or Environmental Impact Statement (EIS).

MoveLINQS Relocation Software is an EPA major information system (MIS) that was originally published under the EPA-29 SORN, which also covers EPA travel, other accounts payable, and accounts receivable files. Relocation request data was tracked and coordinated by an EPA-hosted version of the MoveLINQS software. The EPA now proposes this new SORN to reflect a relocation of the MoveLINQS software from an EPA-hosted environment into a separate FedRAMP Government Cloud environment (Microsoft Azure) under the Software as a Service (SaaS) platform. The EPA utilizes the MoveLINQS application to help manage the Federal Employee Relocation Center (FERC), where they process employee relocation moves for the EPA.

OMB Control Number: 3060-0874.

Title: Consumer Complaint Center: Informal Consumer Complaints.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Individuals or households; Business or other for-profit entities; Not for profit institutions; State, Local or Tribal Government.

Number of Respondents and Responses: 292,937 respondents; 292,937 responses.

Estimated Time per Response: 15 minutes (.25 hour) to 1 hour.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Voluntary. The statutory authority for this collection is contained in 47 U.S.C. 208 of the Communications Act of 1934, as amended (the Act).

Total Annual Burden: 73,244 hours.

Total Annual Cost: None.

Nature and Extent of Confidentiality: Confidentiality is an issue to the extent that individuals and households provide personally identifiable information, which is covered under the FCC's updated system of records notice (SORN), FCC/CGB-1, “Informal Complaints, Inquiries and Requests for Dispute Assistance.” As required by the Privacy Act, 5 U.S.C. 552a, the Commission also published a SORN, FCC/CGB-1 “Informal Complaints, Inquiries, and Requests for Dispute Assistance,” in the Federal Register on August 15, 2014 (79 FR 48152) which became effective on September 24, 2014. It may be reviewed at https://www.fcc.gov/general/privacy-act-information#systems.

Privacy Impact Assessment: The FCC completed a Privacy Impact Assessment (PIA) on June 28, 2007. It may be reviewed at http://www.fcc.gov/omd/privacyact/Privacy-Impact-Assessment.html.

Needs and Uses: The Commission consolidated all of the FCC informal consumer complaint intake into an online consumer complaint portal, which allows the Commission to better manage the collection of informal consumer complaints. Informal consumer complaints consist of informal consumer complaints, inquiries and comments. This revised information collection requests OMB approval for the addition of a layer of consumer reported complaint information related to the National Deaf-Blind Equipment Distribution Program rules. The information collection burdens associated with these complaints is being transferred from OMB Control Number 3060-1225 (National Deaf-Blind Equipment Distribution Program) to OMB Control Number 3060-0874 to enable consumers to file complaints related to the National Deaf-Blind Equipment Distribution Program rules through the Commission's Consumer Complaint Center.

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), signed into law on July 29, 2005, was enacted in response to growing concern about patient safety in the United States and the Institute of Medicine's 1999 report, To Err is Human: Building a Safer Health System. The goal of the statute is to create a national learning system. By providing incentives of nation-wide confidentiality and legal privilege, the Patient Safety Act learning system improves patient safety and quality by providing an incentive for health care providers to work voluntarily with experts in patient safety to reduce risks and hazards to the safety and quality of patient care. The Patient Safety Act signifies the Federal Government's commitment to fostering a culture of patient safety among health care providers; it offers a mechanism for creating an environment in which the causes of risks and hazards to patient safety can be thoroughly and honestly examined and discussed without fear of penalties and liabilities. It provides for the voluntary formation of Patient Safety Organizations (PSOs) that can collect, aggregate, and analyze confidential information reported voluntarily by health care providers. By analyzing substantial amounts of patient safety event information across multiple institutions, PSOs are able to identify patterns of failures and propose measures to eliminate or reduce risks and hazards.

In order to implement the Patient Safety Act, the Department of Health and Human Services (HHS) issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule, 42 CFR part 3) which became effective on January 19, 2009. The Patient Safety Rule outlines the requirements that entities must meet to become and remain listed as PSOs, the process by which the Secretary of HHS (Secretary) will accept certifications and list PSOs, and provisions pertaining to the confidentiality and privilege protections for patient safety work product (PSWP).

When specific statutory requirements are met, the information collected and the analyses and deliberations regarding the information receive confidentiality and privilege protections under this legislation. The Secretary delegated authority to the Director of the Office for Civil Rights (OCR) to interpret and enforce the confidentiality protections of the Patient Safety Act ( Federal Register , Vol. 71, No. 95, May 17, 2006, p. 28701-2). AHRQ implements and administers the rest of the statute's provisions.

Pursuant to the Patient Safety Rule (42 CFR 3.102), an entity that seeks to be listed as a PSO by the Secretary must certify that it meets certain requirements and, upon listing, would meet other criteria. To remain listed for renewable three-year periods, a PSO must re-certify that it meets these obligations and would continue to meet them while listed. The Patient Safety Act and Patient Safety Rule also impose other obligations discussed below that a PSO must meet to remain listed. In accordance with the requirements of the Patient Safety Rule (see, e.g., 42 CFR 3.102(a)(1), 3.102(b)(2)(i)(E), 3.102(d)(1), and 3.112), the entities seeking to be listed and to remain listed must complete the proposed forms, in order to attest to compliance with statutory criteria and the corresponding regulatory requirements.

With this submission, AHRQ is requesting approval of the following proposed administrative forms:

1. PSO Certification for Initial Listing Form. This form, containing certifications of eligibility and a capacity and intention to comply with statutory criteria and regulatory requirements, is to be completed, in accordance with 42 U.S.C. 299b-24(a)(1) and the above-cited regulatory certification provisions, by an entity seeking to be listed by the Secretary as a PSO for an initial three-year period.

2. PSO Certification for Continued Listing Form. In accordance with 42 U.S.C. 299b-24(a)(2) and the above-cited regulatory certification provisions, this form is to be completed by a listed PSO seeking continued listing by the Secretary as a PSO for each successive three-year period.

3. PSO Two Bona Fide Contracts Requirement Certification Form. To remain listed, a PSO must meet the requirement in 42 U.S.C. 299b-24(b)(1)(C) that it has contracts with more than one provider, within successive 24-month periods, beginning with the date of the PSO's initial listing. This form is to be used by a PSO to certify whether it has met this statutory requirement and the corresponding regulatory provision.

4. PSO Disclosure Statement Form. This form provides detailed instructions to a PSO regarding the disclosure statement it must submit and provides for the required certification by the PSO of the statement's accuracy in accordance with 42 U.S.C. 299b-24(b)(1)(E), when it (i) has a contract with a provider to carry out patient safety activities, and (ii) it has other financial, reporting, or contractual relationship(s) with that contracting provider, or it is not managed, controlled, and operated independently from that contracting provider. In accordance with the Patient Safety Act and the Patient Safety Rule, the Secretary is required to review each such report and make public findings as to whether a PSO can fairly and accurately carry out its responsibilities.

5. PSO Profile Form. This form is designed to collect voluntarily a minimum level of data necessary to develop aggregate statistics relating to PSOs, the types of providers they work with, and their general location in the US. The PSO Profile is intended to be completed annually by all PSOs that are “AHRQ-listed” during any part of the previous calendar year. This information is collected by AHRQ's PSO Privacy Protection Center (PSOPPC) and is used to populate the AHRQ PSO selection tool on the AHRQ PSO website, to generate slides presented at the PSO Annual Meeting, and to develop content for the AHRQ National Healthcare Quality and Disparities Report, an annual quality report required by 42 U.S.C. 299b-2(b)(2).

6. PSO Change of Listing Information Form. The Secretary is required under 42 U.S.C. 299b-24(d) to maintain a publicly available list of PSOs. Under the Patient Safety Rule, that list includes, among other information, each PSO's current contact information. The Patient Safety Rule, at 42 CFR 3.102(a)(1)(vi), also requires that, during its period of listing, a PSO must promptly notify the Secretary of any changes in the accuracy of the information submitted for listing.

7. PSO Voluntary Relinquishment Form. A PSO may voluntarily relinquish its status as a PSO for any reason. Pursuant to 42 CFR 3.108(c)(2), in order for the Secretary to accept a PSO's notification of voluntary relinquishment, the notice must contain certain attestations and future contact information. This form provides an efficient manner for a PSO seeking voluntary relinquishment to provide all of the required information.

OCR is requesting approval of the following administrative form:

In addition, AHRQ is requesting approval for a set of common definitions and reporting formats (Common Formats). As authorized by 42 U.S.C. 299b-23(b), AHRQ coordinates the development of the Common Formats that facilitate aggregation of comparable data at local, PSO, regional and national levels. The Common Formats allow PSOs and health care providers to voluntarily collect and submit standardized information regarding patient safety events to fulfill the national learning system envisioned by the Patient Safety Act.

OMB previously approved the Common Formats and forms described above in 2008, 2011, 2014, and 2018. AHRQ will use these forms, other than the Patient Safety Confidentiality Complaint Form, to obtain information necessary to carry out its authority to implement the Patient Safety Act and Patient Safety Rule. This includes obtaining initial and subsequent certifications from entities seeking to be or remain listed as PSOs and for making the statutorily required determinations prior to and during an entity's period of listing as a PSO. The PSO Division, housed in AHRQ's Center for Quality Improvement and Patient Safety, uses this information.

OCR will use the Patient Safety Confidentiality Complaint Form to collect information for the initial assessment of an incoming complaint. The form is modeled on OCR's form for complaints alleging violations of the privacy of protected health information. Use of the form is voluntary. It may help a complainant provide the essential information. Alternatively, a complainant may choose to submit a complaint in the form of a letter or electronically. An individual who needs help to submit a complaint in writing may call OCR for assistance.

The PSO information collection forms described below will be implemented at different times and frequencies due to the voluntary nature of seeking listing and remaining listed as a PSO, filing an OCR Patient Safety Confidentiality Complaint Form, and using the Common Formats. The burden estimates are based on the average of the form submissions received over the past three years.

Exhibit 1 shows the estimated annualized burden hours for the respondent to provide the requested information, and Exhibit 2 shows the estimated annualized cost burden associated with the respondents' time to provide the requested information. The total burden hours are estimated to be 100,795.83 hours annually and the total cost burden is estimated to be $4,053,000.33 annually.

PSO Certification for Initial Listing Form: The average annual burden for the collection of information requested by the certification form for initial listing is based upon a total average estimate of 10 respondents per year and an estimated time of 18 hours per response. The estimated response number includes submissions by not only entities listed as PSOs, but also entities that submit initial listing forms that do not become PSOs. After submitting a PSO Certification for Initial Listing Form, an entity may withdraw its form or submit a revised form, particularly after receiving technical assistance from AHRQ. In addition, AHRQ, on behalf of the Secretary, may deny listing if an entity does not meet the requirements of the Patient Safety Act and Patient Safety Rule.

PSO Certification for Continued Listing Form: The average annual burden for the collection of information requested by the certification form for continued listing has an estimated time of eight hours per response and 42 responses annually. The PSO Certification for Continued Listing Form must be completed by any interested PSO at least 75 days before the end of its current three-year listing period.

PSO Two Bona Fide Contracts Requirement Certification Form: The average annual burden for the collection of information requested by the PSO Two Bona Fide Contract Certification Form is based upon an estimate of 51 respondents per year and an estimated one hour per response. This collection of information takes place once per 24-month period when the PSO notifies the Secretary that it has two contracts with providers that meet the requirements.

PSO Disclosure Statement Form: The average burden for the collection of information requested by the Disclosure Statement Form is based upon an estimate of two respondents per year and estimated three hours per response. This information collection takes place within 45 days of when a PSO begins having any of the specified types of additional relationships with a provider with which it has a contract to carry out patient safety activities.

PSO Profile Form. The overall annual burden for the collection of information requested by the PSO Profile Form is based upon an estimate of 72 respondents per year and an estimated three hours per response. The collection of information takes place annually; newly listed PSOs may first submit the form in the calendar year after their initial listing by the Secretary.

PSO Change of Listing Information Form: The average annual burden for the collection of information requested by the PSO Change of Listing Information Form is based upon an estimate of 54 respondents per year and an estimated time of five minutes per response. This collection of information takes place on an ongoing basis as needed when there are changes to the PSO's listing information.

PSO Voluntary Relinquishment Form: The average annual burden for the collection of information requested by the PSO Voluntary Relinquishment Form is based upon a total average estimate of four respondents per year and an estimated time of thirty minutes per response.

OCR Patient Safety Confidentiality Complaint Form: The overall annual burden estimate for the collection of information requested by the OCR Patient Safety Confidentiality Complaint Form is based on an estimate of one respondent per year and an estimated twenty minutes per response. The voluntary use of the form may occur when an allegation of a violation of the confidentiality protections of the Patient Safety Act is made.

Common Formats: AHRQ estimates that 5% full time equivalent (FTE) of a patient safety manager at a facility will be spent to administer the Common Formats, which is approximately 100 hours a year. The use of the formats by PSOs and other entities is voluntary and is on an ongoing basis. This estimate of the 1,000 respondents is based on the feedback that AHRQ has received during meetings and technical assistance calls from PSOs and other entities that have been utilizing the formats.

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; and, for OCR's enforcement of confidentiality; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

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

The Advisory Panel for Outreach and Education (APOE) (the Panel) is governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub. L. 92-463), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of federal advisory committees. The Panel is authorized by section 1114(f) of the Social Security Act (the Act) (42 U.S.C. 1314(f)) and section 222 of the Public Health Service Act (42 U.S.C. 217a).

The Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) signed the charter establishing the Citizen's Advisory Panel on Medicare Education  1 (the predecessor to the APOE) on January 21, 1999 (64 FR 7899) to advise and make recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on the effective implementation of national Medicare education programs, including with respect to the Medicare+Choice (M+C) program added by the Balanced Budget Act of 1997 (Pub. L. 105-33).

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) expanded the existing health plan options and benefits available under the M+C program and renamed it the Medicare Advantage (MA) program. CMS has had substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options available and better tools to evaluate these options. Successful MA program implementation required CMS to consider the views and policy input from a variety of private sector constituents and to develop a broad range of public-private partnerships.

In addition, Title I of the MMA authorized the Secretary and the Administrator of CMS (by delegation) to establish the Medicare prescription drug benefit. The drug benefit allows beneficiaries to obtain qualified prescription drug coverage. In order to effectively administer the MA program and the Medicare prescription drug benefit, we have substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options and benefits available, and to develop better tools to evaluate these plans and benefits.

The Patient Protection and Affordable Care Act (Pub. L. 111-148) and Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively referred to as the Affordable Care Act) expanded the availability of other options for health care coverage and enacted a number of changes to Medicare as well as to Medicaid and CHIP. Qualified individuals and qualified employers are now able to purchase private health insurance coverage through a competitive marketplace, called an Affordable Insurance Exchange (also called Health Insurance Marketplace®, or Marketplace®  2 ). In order to effectively implement and administer these changes, we must provide information to consumers, providers, and other stakeholders through education and outreach programs regarding how existing programs will change and the expanded range of health coverage options available, including private health insurance coverage through the Marketplace®. The APOE allows us to consider a broad range of views and information from interested audiences in connection with this effort and to identify opportunities to enhance the effectiveness of education strategies concerning the Affordable Care Act. The scope of this Panel also includes advising on issues pertaining to the education of providers and stakeholders with respect to the Affordable Care Act and certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5).

On January 21, 2011, the Panel's charter was renewed and the Panel was renamed the Advisory Panel for Outreach and Education. The Panel's charter was most recently renewed on January 19, 2021, and will terminate on January 19, 2023 unless renewed by appropriate action.

In accordance with the January 19, 2021, charter, the APOE will advise the HHS and CMS on developing and implementing education programs that support individuals who are enrolled in or eligible for Medicare, Medicaid, CHIP, or coverage available through the Health Insurance Marketplace® and other CMS programs. The scope of this FACA group also includes advising on education of providers and stakeholders with respect to health care reform and certain provisions of the HITECH Act enacted as part of the ARRA.

The charter will terminate on January 19, 2023, unless renewed by appropriate action. The APOE was chartered under 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended. The APOE is governed by provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

In accordance with the renewed charter, the APOE will advise the Secretary and the CMS Administrator concerning optimal strategies for the following:

• Developing and implementing education and outreach programs for individuals enrolled in, or eligible for, Medicare, Medicaid, the CHIP, and coverage available through the Health Insurance Marketplace® and other CMS programs.

• Enhancing the federal government's effectiveness in informing Medicare, Medicaid, CHIP, or the Health Insurance Marketplace® consumers, issuers, providers, and stakeholders, pursuant to education and outreach programs of issues regarding these programs, including the appropriate use of public-private partnerships to leverage the resources of the private sector in educating beneficiaries, providers, partners and stakeholders.

• Expanding outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of Medicare, Medicaid, the CHIP and the Health Insurance Marketplace® education programs, and other CMS programs as designated.

• Assembling and sharing an information base of “best practices” for helping consumers evaluate health coverage options.

• Building and leveraging existing community infrastructures for information, counseling, and assistance.

• Drawing the program link between outreach and education, promoting consumer understanding of health care coverage choices, and facilitating consumer selection/enrollment, which in turn support the overarching goal of improved access to quality care, including prevention services, envisioned under the Affordable Care Act.

The current members of the Panel as of April 9, 2021, are: E. Lorraine Bell, Chief Officer, Population Health, Catholic Charities USA; Nazleen Bharmal, Medical Director of Community Partnerships, Cleveland Clinic; Julie Carter, Senior Federal Policy Associate, Medicare Rights Center; Scott Ferguson, Director of Care Transitions and Population Health, Mount Sinai St. Luke's Hospital; Leslie Fried, Senior Director, Center for Benefits Access, National Council on Aging; Jean-Venable Robertson Goode, Professor, Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Virginia Commonwealth University; Ted Henson, Director of Health Center Performance and Innovation, National Association of Community Health Centers; Joan Ilardo, Director of Research Initiatives, Michigan State University, College of Human Medicine; Cheri Lattimer, Executive Director, National Transitions of Care Coalition; Cori McMahon, Vice President, Tridiuum; Alan Meade, Director of Rehab Services, Holston Medical group; Michael Minor, National Director, H.O.P.E. HHS Partnership, National Baptist Convention USA, Incorporated; Jina Ragland, Associate State Director of Advocacy and Outreach, AARP Nebraska; Morgan Reed, Executive Director, Association for Competitive Technology; Margot Savoy, Chair, Department of Family and Community Medicine, Temple University Physicians; Congresswoman Allyson Schwartz, President and CEO, Better Medicare Alliance; and; Tia Whitaker, Statewide Director, Outreach and Enrollment, Pennsylvania Association of Community Health Centers.

The Secretary's Charter for the APOE is available on the CMS website at: https://www.facadatabase.gov/FACA/apex/FACAPublicCommittee?id=a10t0000001gzsCAAQ, or you may obtain a copy of the charter by submitting a request to the contact listed in the FOR FURTHER INFORMATION section of this notice.

The APOE shall consist of no more than 20 members. The Chair shall either be appointed from among the 20 members, or a Federal official will be designated to serve as the Chair. The charter requires that meetings shall be held up to four times per year. Members will be expected to attend all meetings. The members and the Chair shall be selected from authorities knowledgeable in one or more of the following fields:

This notice also requests nominations for three individuals to serve on the APOE to fill current vacancies and possible vacancies that may become available later in 2021. This notice is an invitation to interested organizations or individuals to submit their nominations for membership (no self-nominations will be accepted). The CMS Administrator will appoint new members to the APOE from among those candidates determined to have the expertise required to meet specific agency needs, and in a manner to ensure an appropriate balance of membership. We have an interest in ensuring that the interests of both women and men, members of all racial and ethnic groups, and disabled individuals are adequately represented on the APOE. Therefore, we encourage nominations of qualified candidates who can represent these interests. Any interested organization or person may nominate one or more qualified persons.

Each nomination must include a letter stating that the nominee has expressed a willingness to serve as a Panel member and must be accompanied by a curricula vitae and a brief biographical summary of the nominee's experience.

While we are looking for experts in a number of fields, our most specific needs are for experts in outreach to minority and underserved communities, health communications, disease-related advocacy, disability policy and access, health economics research, behavioral health, health insurers and plans, Health IT, social media, direct patient care, and matters of labor and retirement.

We are requesting that all submitted curricula vitae include the following:

In order to permit an evaluation of possible sources of conflict of interest, potential candidates will be asked to provide detailed information concerning such matters as financial holdings, consultancies, and research grants or contracts.

Members are invited to serve for 2-year terms, contingent upon the renewal of the APOE by appropriate action prior to its termination. A member may serve after the expiration of that member's term until a successor takes office. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of that term.

In accordance with section 10(a) of the FACA, this notice announces a meeting of the APOE. The agenda for the May 26, 2021 meeting will include the following:

Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make an oral presentation may submit written comments to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice.

The meeting is open to the public, but attendance is limited to registered participants. Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/e/apoe-may-26-2021-virtual-meeting-tickets-150209828641 or contact the DFO at the address or number listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. This meeting will be held virtually. Individuals who are not registered in advance will be unable to attend the meeting.

This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35).

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

Following is a summary of the use and burden associated with the subject information collection(s). More detailed information can be found in the collection's supporting statement and associated materials (see ADDRESSES ).

1. Title of Information Collection: Medicaid Managed Care Rate Development Guide; Type of Information Collection Request: Revision of a currently approved collection; Use: States are required to submit rate certifications for all Medicaid managed care capitation rates per 42 CFR 438.7. Our collection of information request specifies our requirements for the rate certification and details what types of documentation we expect to be included. Elements include descriptions of data used, projected benefit and non-benefit costs, rate range development, risk and contract provisions, and other considerations in all rate setting packages. We also detail our expectations for states when they submit rate certifications.

Section 1903(m) of the Social Security Act requires capitation rates paid to Medicaid managed care organizations (MCOs) to be actuarially sound. Regulations at § 438.4 require all capitation rates paid to an MCO, Prepaid Inpatient Health Plan (PIHP), or Prepaid Ambulatory Health Plans (PAHP) to be actuarially sound and require that each state submit a rate certification for each set of capitation rates developed. Regulations at § 438.7(e) also require that CMS annually publish this guidance; Form Number: CMS-10398 (#37) (OMB control number: 0938-1148); Frequency: Occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 46; Total Annual Responses: 135; Total Annual Hours: 608. (For policy questions regarding this collection contact Amy Gentile at 410-786-3499.)

FDA is announcing the availability of a guidance for industry entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” The guidance was prepared under the auspices of ICH. ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resource-efficient manner.

By harmonizing the regulatory requirements in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, standardized marketing application submissions, and made many other improvements in the quality of global drug development and manufacturing and the products available to patients.

The six Founding Members of the ICH are FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org/ ).

ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensus-driven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry.

As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

In the Federal Register of May 31, 2018 (83 FR 25018), FDA published a notice announcing the availability of a draft guidance entitled “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” The notice gave interested persons an opportunity to submit comments by December 15, 2018.

After consideration of the comments received and revisions to the guideline, a final draft of the guideline was submitted to the ICH Assembly and endorsed by the regulatory agencies in November 2019. Changes from the draft to the final guideline include: revision of the text regarding the compatibility of the guideline with regional legal frameworks, removal of the terms “implicit” and “explicit” as they referred to established conditions, removal of the term “key process parameter,” and revisions to the text to better explain the concept of critical process parameter and identification of established conditions for manufacturing processes. Other changes included revision of the description for identification of established conditions for analytical methods and development of an illustrative example, revisions to the recommended content of the product lifecycle management document and its location within the common technical document, and revisions to clarify the use of tools described in the guideline for master files. In addition, editorial changes were made to improve clarity.

The guidance provides guidance on postapproval chemistry, manufacturing, and controls changes for new and marketed pharmaceutical drug substances and drug products. The guidance describes regulatory tools and enablers, along with associated guiding principles, that are intended to enhance the management of postapproval changes and transparency between industry and regulatory authorities, encouraging innovation and continual improvement. The guidance is intended to demonstrate how increased product and process knowledge can contribute to a more precise and accurate understanding of which postapproval changes require a regulatory submission as well as the definition of the level of reporting categories for such changes ( i.e., a better understanding of risk to product quality). Increased knowledge and effective implementation of the tools and enablers described in this guidance should enhance industry's ability to manage many chemistry, manufacturing, and controls changes effectively under the company's Pharmaceutical Quality System (PQS) with less need for extensive regulatory oversight prior to implementation. This approach can incentivize continual improvement by providing an opportunity for greater flexibility in making postapproval changes. It could also result in fewer associated postapproval submissions to the Marketing Authorization Application and less associated regulatory burden. The extent of operational and regulatory flexibility and its adequate implementation is subject to the regulatory framework in place as well as product and process understanding (ICH Q8(R2) and Q11), application of risk management principles (ICH Q9), and an effective PQS (ICH Q10).

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” 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.

This guidance contains no collection 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.

However, this guidance refers to previously approved FDA collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001 and in part 601 under OMB control number 0910-0338.

Persons with access to the internet may obtain the guidance at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

FDA is announcing the availability of a final guidance for industry entitled “Qualified Infectious Disease Product Designation—Questions and Answers.” Title VIII of FDASIA created the Generating Antibiotic Incentives Now (GAIN) provisions under section 505E of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355f). GAIN offers incentives for the development of antibacterial and antifungal drugs for human use to treat serious or life-threatening infections. The primary incentive contained in GAIN is a 5-year extension of exclusivity for which a QIDP-designated application qualifies upon approval under the FD&C Act. QIDPs also receive fast-track designation at the sponsor's request (21 U.S.C. 356(b)(1)), and the first marketing application submitted for approval of a QIDP is granted priority review (21 U.S.C. 360n-1).

This guidance provides information about how FDA generally intends to implement GAIN and responses to common questions that might arise about QIDP designation and review of new drug applications for QIDPs.

This guidance finalizes the draft guidance of the same name issued on January 30, 2018 (83 FR 4216). Based on the comments submitted to the docket on the draft guidance, FDA made clarifying changes to this guidance, including further information on what drug products the Agency generally intends to consider to be an antibacterial or antifungal drug for the purposes of QIDP designation. The Agency also provided clarification about when a sponsor should submit a new request for QIDP designation and what information should be included in a QIDP designation request.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on QIDP designation. 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 part 312 have been approved under OMB control number 0910-0014.

Persons with access to the internet may obtain the guidance at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

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

This information collection supports Agency regulations. Specifically, section 310(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 337(b)) authorizes a State to enforce certain sections of the FD&C Act in its own name and within its own jurisdiction. However, before doing so, a State must provide notice to FDA according to § 100.2 (21 CFR 100.2). The information required in a letter of notification under § 100.2(d) enables us to identify the food against which a State intends to take action and to advise that State whether Federal enforcement action against the food has been taken or is in process. With certain narrow exceptions, Federal enforcement action precludes State action under the FD&C Act.

In the Federal Register of December 17, 2020 (85 FR 81932), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

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

The estimated reporting burden for § 100.2(d) is minimal because enforcement notifications are seldom used by States. During the last 3 years, we have not received any new enforcement notifications; therefore, we estimate that one or fewer notifications will be submitted annually. Although we have not received any new enforcement notifications in the last 3 years, we believe these information collection provisions should be extended to provide for the potential future need of a State government to submit enforcement notifications informing us when it intends to take enforcement action under the FD&C Act against a particular food located in the State.

FDA is announcing the availability of a guidance for industry entitled “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” The guidance was prepared under the auspices of ICH. ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resource-efficient manner.

By harmonizing the regulatory requirements in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, standardized marketing application submissions, and made many other improvements in the quality of global drug development and manufacturing and the products available to patients.

The six Founding Members of the ICH are FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org/ ).

ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensus-driven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry.

As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

In the Federal Register of October 31, 2017 (82 FR 50433), FDA published a notice announcing the availability of a draft guidance entitled “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” The notice gave interested persons an opportunity to submit comments by April 30, 2018.

After consideration of the comments received and revisions to the guideline, a final draft of the guideline was submitted to the ICH Assembly and endorsed by the regulatory agencies in November 2019.

This guidance finalizes the draft guidance issued on October 31, 2017. The guidance provides clarification on statistical principles for clinical trials and an update on the choice of estimand to describe a framework for planning, conducting, and interpreting sensitivity analyses of clinical trial data. The focus of the guidance is on statistical principles related to estimands and sensitivity analysis for confirmatory clinical trials. The guidance provides recommendations for aligning the choice of statistical methods with the goals of a clinical trial; on communicating the rationale for such choices to FDA; and on using sensitivity analysis to characterize the robustness of the conclusions to plausible deviations from the assumptions of the main analysis. Revisions made following the public comment period are intended to clarify content within the guidance; however, no new concepts are presented in the revised version.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials.” 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.

Persons with access to the internet may obtain the guidance at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances .

FDA is announcing the availability of a guidance for industry entitled “S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals.” The guidance was prepared under the auspices of ICH. ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resource-efficient manner.

By harmonizing the regulatory requirements in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, standardized marketing application submissions, and made many other improvements in the quality of global drug development and manufacturing and the products available to patients.

The six Founding Members of the ICH are FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org/ ).

ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensus-driven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry.

As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

In the Federal Register of November 13, 2017 (82 FR 52306), FDA published a notice announcing the availability of a draft guidance entitled “S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals.” The notice gave interested persons an opportunity to submit comments by February 12, 2018.

After consideration of the comments received and revisions to the guideline, a final draft of the guideline was submitted to the ICH Assembly and endorsed by the regulatory agency members in January 2020.

The guidance finalizes the guidance issued on November 13, 2017. The guidance has undergone revisions to align with other ICH guidances, elaborate on concepts to consider when designing studies, and identify potential circumstances in which a risk assessment can be made based on preliminary studies. It also clarifies the qualification and potential use of alternative assays.

The purpose of this guidance is to provide key considerations for developing a testing strategy to identify hazard and characterize reproductive risk for human pharmaceuticals. The guidance informs on the use of existing data and identifies potential study designs to supplement available data to identify, assess, and convey risk. General concepts and recommendations are provided that should be considered when interpreting study data and assessing reproductive risk in support of clinical development and marketing approval.

This guidance applies to pharmaceuticals, including biotechnology-derived pharmaceuticals; vaccines (and their novel constitutive ingredients) for infectious diseases; and novel excipients that are part of the final pharmaceutical product. It does not apply to cellular therapies, gene therapies, and tissue-engineered products. The methodological principles ( e.g., study design, dose selection, and species selection) outlined in this guidance can also apply to all compounds for which the conduct of reproductive and/or developmental toxicity studies is appropriate, including vaccines for other indications ( e.g., cancer). (see ICH guidance for industry “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals” (March 2010), available at https://www.fda.gov/media/73161/download ).

The guidance reflects revisions made in response to comments received on the draft guidance. These include reorganization of the guidance to improve readability and clarity, to introduce discussion of conventional assessment strategies earlier in the document, and to clarify which elements of the guidance are more appropriate for biotechnology-derived therapies. To accommodate the rapidly evolving nature of alternative assay development, the discussion of alternative assays was placed in an Annex, subject to a maintenance procedure, to allow for more frequent updating of this material.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals.” 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.

This guidance contains no collection 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.

However, this guidance refers to previously approved FDA collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; and the content and format requirements for pregnancy and lactation labeling of human prescription drug and biological products have been approved under OMB control number 0910-0624.

Persons with access to the internet may obtain the guidance at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances .

FDA is announcing the availability of a guidance for industry entitled “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.” There is currently an outbreak of respiratory disease caused by a novel coronavirus. The virus has been named SARS-CoV-2, and the disease it causes has been named Coronavirus Disease 2019 (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. The public health emergency declaration has been subsequently renewed. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19. The revision to this guidance was posted to the FDA website on February 22, 2021.

This guidance describes FDA's current recommendations regarding phase 2 or phase 3 trials for drugs under development to treat or prevent COVID-19. This guidance focuses on the patient population, trial design, efficacy endpoints, safety considerations, and statistical considerations for such trials. Drugs should have undergone sufficient development before their evaluation in phase 2 or phase 3.

This guidance focuses on the development of drugs with direct antiviral activity or immunomodulatory activity. However, the recommendations in this guidance may be applicable to development plans for drugs for COVID-19 with other mechanisms of action. The mechanism of action of the drug may impact key study design elements ( e.g., population, endpoints, safety assessments, duration of followup, etc.).

Preventative vaccines are not within the scope of this guidance. Nor does this guidance provide general recommendations on early drug development in COVID-19, such as use of animal models.

In light of the public health emergency related to COVID-19 declared by the Secretary of HHS, FDA has determined that prior public participation for this guidance is not feasible or appropriate and is issuing this guidance without prior public comment (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices.

This guidance is intended to remain in effect for the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). However, the recommendations and processes described in the guidance are expected to assist the Agency more broadly in its continued efforts to assist sponsors in the clinical development of drugs for the treatment of COVID-19 beyond the termination of the COVID-19 public health emergency and reflect the Agency's current thinking on this issue. Therefore, within 60 days following the termination of the public health emergency, FDA intends to revise and replace this guidance with any appropriate changes based on comments received on this guidance and the Agency's experience with implementation.

This final guidance revises and replaces the final guidance with the same title issued on May 19, 2020 (85 FR 29949). The revision addresses the potential impact of the emergence of SARS-CoV-2 variants and the availability of COVID-19 vaccines. Additional updates reflecting the evolving landscape of COVID-19 drug development were made to the recommendations on patient population, trial design, efficacy endpoints, safety considerations, and statistical considerations. In addition, FDA considered comments received on the previous guidance, and editorial changes were made to improve clarity.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.” 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 part 314 have been approved under OMB control number 0910-0001; the collections of information in 21 CFR parts 312 and 320 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 58 regarding good laboratory practice for nonclinical laboratory studies have been approved under OMB control number 0910-0119; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910-0130; the collections of information in 21 CFR part 320 have been approved under OMB control number 0910-0291; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information in FDA's draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act Products” have been approved under OMB control number 0910-0429; the collections of information in FDA's final guidance for clinical trial sponsors entitled “Establishment and Operation of Clinical Trial Data Monitoring Committees” have been approved under OMB control number 0910-0581; and the collections of information in FDA's final guidance for industry entitled “Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” have been approved under OMB control number 0910-0733.

Persons with access to the internet may obtain the guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders, or https://www.regulations.gov .

FDA is announcing the availability of a draft guidance for industry entitled “Q3D(R2)—Guideline for Elemental Impurities.” The draft guidance was prepared under the auspices of ICH. ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resource-efficient manner.

By harmonizing the regulatory requirements in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, standardized marketing application submissions, and made many other improvements in the quality of global drug development and manufacturing and the products available to patients.

The six Founding Members of the ICH are FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org/ ).

ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensus-driven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry.

As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

In September 2020, the ICH Assembly endorsed the draft guidance entitled “Q3D(R2)—Guideline for Elemental Impurities” and agreed that the guidance should be made available for public comment. The draft guidance is the product of the Quality Expert Working Group of the ICH. Comments about this draft guidance will be considered by FDA and the Quality Expert Working Group.

The draft guidance provides guidance on PDEs for the cutaneous and transcutaneous routes of administration and relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration. In addition, error corrections to previously identified PDEs for gold (oral, parenteral, and inhalation routes), silver (parenteral route), and nickel (inhalation route) are provided.

This draft guidance has been left in the original ICH format. The final guidance will be reformatted and edited to conform with FDA's good guidance practices regulation (21 CFR 10.115) and style before publication. The draft guidance, when finalized, will represent the current thinking of FDA on “Q3D(R2)—Guideline for Elemental Impurities.” 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.

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 https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

FDA is announcing the availability of a guidance for industry entitled “M9 Biopharmaceutics Classification System-Based Biowaivers.” The guidance was prepared under the auspices of ICH. ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resource-efficient manner.

By harmonizing the regulatory requirements in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, standardized marketing application submissions, and made many other improvements in the quality of global drug development and manufacturing and the products available to patients.

The six Founding Members of the ICH are FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org/ ).

ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensus-driven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry.

As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

In the Federal Register of October 26, 2018 (83 FR 54107), FDA published a notice announcing the availability of a draft guidance entitled “M9 Biopharmaceutics Classification System-Based Biowaivers.” The notice gave interested persons an opportunity to submit comments by January 24, 2019.

After consideration of the comments received and revisions to the guideline, a final draft of the guideline was submitted to the ICH Assembly and endorsed by the regulatory agency members in November 2019.

The guidance provides recommendations to support the biopharmaceutics classification of drug substances and the BCS-based waiver of the in vivo BE study requirement for drug products. The BCS-based biowaiver approach is intended to reduce the need for in vivo bioequivalence studies. In vivo bioequivalence studies may be waived if an assumption of equivalence in in vivo performance can be justified by satisfactory in vitro data. The BCS is a scientific approach based on the aqueous solubility and intestinal permeability characteristics of the drug substance or substances. The BCS categorizes drug substances into one of four BCS classes as follows:

• Class I: High solubility, high permeability

• Class II: Low solubility, high permeability

• Class III: High solubility, low permeability

• Class IV: Low solubility, low permeability

In vivo BE studies are needed to demonstrate lack of impact of significant formulation changes on a drug's bioavailability during its development, for post approval line extensions, and when developing a generic product. Utilizing the critical properties of the drug substance and the drug product, and applying the BCS framework, extensive in vitro studies can support the waiver of the in vivo BE requirement for certain drug products.

Following the public consultation period, clarifications were made to the guidance based on the comments received.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “M9 Biopharmaceutics Classification System-Based Biowaivers.” 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. However, this final guidance refers to previously approved FDA collections of information. The previously approved collections of information are subject to review by OMB under the PRA. The following collections of information have been approved under OMB control number 0910-0001:

• Submitting under 21 CFR 314.50 content and format of new drug applications, including the pharmacokinetics and bioavailability sections.

• Submitting under 21 CFR 314.70 postapproval changes.

• Submitting under 21 CFR 314.94 content and format of abbreviated new drug applications.

The collections of information for submitting under 21 CFR 312.23 information about pharmacokinetics and biological disposition of the drug has been approved under OMB control number 0910-0014.

Persons with access to the internet may obtain the guidance at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

FDA is announcing the availability of a guidance for industry entitled “S11 Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals.” The guidance was prepared under the auspices of ICH. ICH has the mission of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resource-efficient manner. By harmonizing the regulatory requirements in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, standardized marketing application submissions, and made many other improvements in the quality of global drug development and manufacturing and the products available to patients.

The six Founding Members of the ICH are FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org/ ).

ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensus-driven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and for industry.

As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA's guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. In the Federal Register of February 1, 2019 (84 FR 1161), FDA published a notice announcing the availability of a draft guidance entitled “S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines.” The notice gave interested persons an opportunity to submit comments by April 2, 2019. After consideration of the comments received and revisions to the guideline, a final draft of the guideline was submitted to the ICH Assembly and endorsed by the regulatory agencies in April 2020.

This guidance finalizes the draft guidance issued on February 1, 2019. The guidance describes a weight of evidence approach to determine when nonclinical toxicity studies may be recommended in juvenile animals to support development of medicines to be used in pediatric patients. If such studies are recommended, the guidance also provides appropriate study designs. The guidance describes study designs as consisting of a core set of endpoints that can be supplemented by additional endpoints depending on the concerns identified in the weight of evidence approach. The guidance also provides guidance on potential approaches for the nonclinical support of drugs that will be developed only for use in pediatric patients or that will be first tested in pediatric patients. The guidance is intended to promote harmonization of recommendations for such studies and should facilitate the timely conduct of pediatric clinical trials and reduce the use of animals in accordance with the 3R (replace/reduce/refine) principles.

The draft guidance was revised based on comments received. The revisions include refinement of the weight of evidence approach and in descriptions of the core and additional endpoints that can be incorporated into juvenile animal studies. The final guidance also includes a new section on data interpretation. The appendices on age-dependent development of organ systems by species and preweaning litter allocation in the rodent were also updated. Additionally, the title of the guidance was updated from “Nonclinical Safety Testing in Support of Development of Pediatric Medicines” to “Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals.”

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “S11 Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals.” 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 part 312, pertaining to the submission of nonclinical and preclinical data, including a pediatric clinical development plan, have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 58 pertaining to good laboratory practice for nonclinical laboratory studies have been approved under OMB control number 0910-0119; and the collections of information in FDA's guidance for industry on “Expedited Programs for Serious Conditions—Drugs and Biologics” has been approved under OMB control number 0910-0765.

Persons with access to the internet may obtain the guidance at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.