On December 8, 2020, Commerce initiated an administrative review of the antidumping duty order on flanges from India, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act). 1 This administrative review covers 19 companies, 2 including the mandatory respondents Chandan Steel Limited (Chandan) and Kisaan Die Tech Private Limited (KDT). 3 On June 24, 2021, we extended the deadline for the preliminary results until October 29, 2021. 4 For details regarding the events that occurred subsequent to the initiation of this review, see the Preliminary Decision Memorandum. 5 A list of topics included in the Preliminary Decision Memorandum is included as an appendix to this notice. The Preliminary Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum is available at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The merchandise covered by the Order is stainless steel flanges from India. 6 For a full description of the scope, see the Preliminary Decision Memorandum.

BFN Forgings reported that, during the POR, it changed its name from “Bebitz Flanges Works Private Limited” to “BFN Forgings Private Limited.” Based on our analysis of the information on the record regarding any changes with respect to corporate structure, manufacturing facilities, customers, and suppliers, we preliminarily determine that BFN Forgings is the successor-in-interest to Bebitz Flanges, and, as a result, should be accorded the same treatment previously accorded to Bebitz Flanges. For further discussion, see the Preliminary Decision Memorandum at “Preliminary Successor-In-Interest Determination.”

Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if a party who requested the review withdraws the request within 90 days of the date of the date of publication of notice of initiation of the requested review. On March 8, 2021, the Coalition of American Flange Producers (the petitioner) timely withdrew its request for an administrative review for 38 companies. No other party requested a review of these companies. For a complete list of the companies for which we are rescinding this review, see Appendix II. Accordingly, we are rescinding this review with respect to these companies, pursuant to 19 CFR 351.213(d)(1).

The Act and Commerce's regulations do not address the rate to be applied to companies not selected for individual examination when Commerce limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a less-than-fair value (LTFV) investigation, for guidance when calculating the rate for companies which were not selected for individual examination in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted average of the estimated weighted average dumping margins established for exporters and producers individually investigated, excluding any zero or de minimis margins, and any margins determined entirely {on the basis of facts available}.” We preliminarily calculated a 5.78 percent dumping margin for Chandan and a 1.18 percent dumping margin for KDT, the mandatory respondents in this review, and we have assigned to the non-selected companies a rate of 5.28 percent, which is the weighted-average of Chandan's and KDT's margins based on publicly ranged data. 7 For additional information, see the Preliminary Decision Memorandum at “Rates for Non-Selected Companies.”

Commerce is conducting this review in accordance with section 751(a)(1) and (2) of the Act. We calculated export price and constructed export price in accordance with section 772 of the Act. We calculated NV in accordance with section 773 of the Act. For a full description of the methodology underlying these preliminary results, see the Preliminary Decision Memorandum.

We preliminarily determine the following weighted-average dumping margins exist for the period October 1, 2019, through September 30, 2020:

Upon completion of the final results of this administrative review, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries.

Pursuant to 19 CFR 351.212(b)(1), because the individually-examined respondents reported the entered value for their U.S. sales, we will calculate importer-specific ad valorem antidumping duty assessment rates based on the ratio of the total amount of antidumping duties calculated for the examined sales to the total entered value of those same sales. Where either the respondent's weighted-average dumping margin is zero or de minimis within the meaning of 19 CFR 351.106(c), or an importer-specific rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by each respondent for which the company did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate established in the original LTFV investigation ( i.e., 7.00 percent)  9 if there is no rate for the intermediate company(ies) involved in the transaction. 10

For the companies which were not selected for individual review, we intend to assign an assessment rate based on the review-specific average rate, calculated as noted in the “Preliminary Results of Review” section, above. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by this review and for future deposits of estimated duties, where applicable. 11

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

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the finals results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the companies under review will be equal to the weighted-average dumping margin established in the final results of this review, except if the rate is de minimis within the meaning of 19 CFR 351.106(c)(1) ( i.e., less than 0.50 percent), in which case the cash deposit rate will be zero; (2) for previously reviewed or investigated companies not in this review, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment of this proceeding in which they were examined; (3) if the exporter is not a firm covered in this review, a prior review, or the original LTFV investigation, but the producer is, the cash deposit rate will be the rate established for the most recently-completed segment of this proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 7.00 percent, 12 the all-others rate established in the amended final determination of the LTFV investigation. These cash deposit requirements, when imposed, shall remain in effect until further notice.

We intend to disclose the calculations performed to parties within five days after public announcement of the preliminary results. 13 Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than seven days after the date for filing case briefs. 14 Parties who submit case briefs or rebuttal briefs in this proceeding 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. 15 Case and rebuttal briefs should be filed using ACCESS  16 and must be served on interested parties. 17 Executive summaries should be limited to five pages total, including footnotes. Note that Commerce has modified certain of its requirements for serving documents containing business proprietary information until further notice. 18

Interested parties who wish to request a hearing must do so within 30 days of publication of these preliminary results by submitting a written request to the Assistant Secretary for Enforcement and Compliance using Enforcement and Compliance's ACCESS system. 19 Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. 20 Parties are reminded that all briefs and hearing requests must be filed electronically using ACCESS and received successfully in their entirety by 5:00 p.m. Eastern Time on the due date.

Unless otherwise extended, Commerce intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1).

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

This administrative review and notice are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213 and 351.221(b)(4).

On December 8, 2020, Commerce published a notice of initiation of an administrative review of the countervailing duty order on stainless steel flanges from India. 1 On June 2, 2021, Commerce extended the time period for issuing these preliminary results by 118 days, in accordance with section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act). 2 The revised deadline for these preliminary results is now October 29, 2021.

For a complete description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum. 3 A list of topics discussed in the Preliminary Decision Memorandum is included at the appendix 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 http://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The merchandise covered by the Order are stainless steel flanges from India. For a complete description of the scope of the Order, see the Preliminary Decision Memorandum.

Commerce is conducting this review in accordance with section 751(a)(1)(A) of the Act. For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy, i.e., a financial contribution that gives rise to a benefit to the recipient, and the subsidy is specific. 4 For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.

The Act and Commerce's regulations do not directly address the subsidy rate to be applied to companies not selected for individual examination where Commerce limits its examination in an administrative review pursuant to section 777A(e)(2) of the Act. However, Commerce normally determines the rates for non-selected companies in reviews in a manner that is consistent with section 705(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation. Section 777A(e)(2) of the Act provides that “the individual countervailable subsidy rates determined under subparagraph (A) shall be used to determine the all-others rate under section 705(c)(5) {of the Act}.” Section 705(c)(5)(A) of the Act states that for companies not investigated, in general, we will determine an all-others rate by weight-averaging the countervailable subsidy rates established for each of the companies individually investigated, excluding zero and de minimis rates or any rates based solely on the facts available.

Accordingly, to determine the rate for companies not selected for individual examination, Commerce's practice is to weight average the net subsidy rates for the selected mandatory companies, excluding rates that are zero, de minimis, or based entirely on facts available. 5 We preliminarily determine that Chandan Steel Limited (Chandan) and Kisaan Die Tech Pvt Ltd. (Kisaan) received countervailing subsidies that are above de minimis and are not based entirely on facts available. Therefore, we preliminarily determine to apply the weighted-average of the net subsidy rates calculated for Chandan and Kisaan using publicly-ranged sales data submitted by those respondents to the non-selected companies. 6 For a list of the 54 companies for which a review was requested, and which were not selected as mandatory respondents or found to be cross-owned with a mandatory respondent, see Appendix II to this notice.

For the period January 1, 2019, through December 31, 2019, we preliminarily find that the following net subsidy rates exist:

Consistent with section 751(a)(2)(C) of the Act, upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries in accordance with the final results of this review. If the assessment rate calculated in the final results in zero or de minimis, we will instruct CBP to liquidate all appropriate entries without regard to countervailing duties. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

Pursuant to section 751(a)(2)(C) of the Act, Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts indicated above, except, where the rate calculated in the final results is de minimis, no cash deposit will be required on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review. For all non-reviewed firms, we will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the most recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposit instructions, when imposed, shall remain in effect until further notice.

We will disclose to parties to this proceeding the calculations performed in reaching the preliminary results within five days of the date of publication of these preliminary results. 8 Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than seven days after the date for filing case briefs. 9 Parties who submit case briefs or rebuttal briefs in this proceeding 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. 10 Case and rebuttal briefs should be filed using ACCESS  11 and must be served on interested parties. 12 Executive summaries should be limited to five pages total, including footnotes. Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information, until further notice. 13

Interested parties who wish to request a hearing must do so within 30 days of publication of these preliminary results by submitting a written request to the Assistant Secretary for Enforcement and Compliance using Enforcement and Compliance's ACCESS system. 14 Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. 15 If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm the date and time of the hearing two days before the scheduled date. Parties are reminded that all briefs and hearing requests must be filed electronically using ACCESS and received successfully in their entirety by 5:00 p.m. Eastern Time on the due date.

Unless the deadline is extended pursuant to section 751(a)(3)(A) of the Act, Commerce intends to issue the final results of this administrative review, including the results of our analysis of the issues raised by the parties in their comments, within 120 days after publication of these preliminary results.

This administrative review and notice are in issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213.

The TFAC was originally chartered on August 11, 2016, pursuant to discretionary authority and in accordance with the Federal Advisory Committee Act, as amended, 5 U.S.C. App., and was most recently re-chartered on August 7, 2020. The TFAC serves as the principal advisory body to the Secretary of Commerce on policy matters relating to access to trade finance for U.S. exporters, including small- and medium-sized enterprises, and their foreign buyers. The TFAC is the sole mechanism by which the Department of Commerce (the Department) convenes private sector stakeholders to identify and develop consensus-based solutions to trade finance challenges. The Council is comprised of a diverse group of stakeholders from the trade finance industry and the U.S. exporting community, as well as experts from academia and public policy organizations.

On Thursday, December 2, 2021, the TFAC will hold the second meeting of its 2020-2022 charter term. During the meeting, members will discuss initial recommendations put forth by the TFAC's four subcommittees: Inclusive Growth, International Policy, Fintech, and Supply Chain Finance. The TFAC will deliberate over the proposed recommendations, provide feedback to the subcommittees, and establish next steps in order to finalize the recommendations by the end of the TFAC's third term.

Meeting minutes will be available within 90 days of the meeting upon request or on the TFAC's website at https://www.trade.gov/about-us/trade-finance-advisory-council-tfac.

The meeting will be open to the public and there will be limited time permitted for public comments. Members of the public seeking to attend the meeting, make comments during the meeting, request auxiliary aids, or submit written comments for consideration prior to the meeting, are required to submit their requests electronically to Patrick.Zimet@trade.gov by 5:00 p.m. EST on Monday, November 29, 2021. Requests received after this deadline will be accepted but may not be possible to accommodate.

Members of the public may submit written comments concerning TFAC affairs at any time before or after a meeting. Comments may be submitted to Patrick Zimet, at the contact information indicated above. All comments and statements received, including attachments and other supporting materials, are part of the public record and subject to public disclosure.

On December 8, 2020, Commerce published a notice of initiation of an administrative review of the countervailing duty (CVD) order on hot-rolled steel from Korea. 1 On January 12, 2021, Commerce selected Hyundai Steel as the mandatory respondent in this administrative review. 2 On June 16, 2021, Commerce extended the deadline for the preliminary results of this review. 3 The revised deadline for these preliminary results is now October 29, 2021.

For a complete description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum. 4 A list of topics discussed in the Preliminary Decision Memorandum is included at Appendix I 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 http://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The product covered by the Order is hot-rolled steel from Korea. For a complete description of the scope of the Order, see the Preliminary Decision Memorandum.

Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation. Commerce received a timely-filed withdrawal request from the petitioners, 5 pursuant to 19 CFR 351.213(d)(1). Because the withdrawal request was timely filed, and no other party requested a review of these companies, in accordance with 19 CFR 351.213(d)(1), Commerce is rescinding this review with respect to the following companies: DCE Inc; Dong Chuel America Inc.; Dong Chuel Industrial Co., Ltd.; Dongbu Incheon Steel Co., Ltd.; Dongbu Steel Co., Ltd.; Dongkuk Industries Co., Ltd.; Dongkuk Steel Mill Co., Ltd.; Hyewon Sni Corporation (H.S.I.); JFE Shoji Trade Korea Ltd.; POSCO Coated & Color Steel Co., Ltd.; POSCO Daewoo Corporation; Soon Hong Trading Co., Ltd.; and Sung-A Steel Co., Ltd.

Commerce is conducting this review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy, i.e., a government-provided financial contribution that gives rise to a benefit to the recipient, and that the subsidy is specific. 6 For a full description of the methodology underlying all of Commerce's conclusions, see the Preliminary Decision Memorandum.

There is one company in this review that was not selected as a mandatory respondent, i.e., POSCO. The Act and Commerce's regulations do not directly address the rates to be applied to companies not selected for individual examination where Commerce limits its examination in an administrative review pursuant to section 777A(e)(2) of the Act. However, Commerce normally determines the rates for non-selected companies in reviews in a manner that is consistent with section 705(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation.

Section 705(c)(5)(A)(i) of the Act instructs Commerce, as a general rule, to calculate an all-others rate equal to the weighted average of the countervailable subsidy rates established for exporters and/or producers individually examined, excluding any rates that are zero, de minimis, or based entirely on facts available. Commerce is, accordingly, basing the subsidy rate for POSCO on the rate calculated for Hyundai Steel.

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

We will disclose to the parties in this proceeding the calculations performed in reaching the preliminary results within five days of the date of publication of these preliminary results. 7 Case briefs, or other written comments, may be submitted to the Assistant Secretary for Enforcement and Compliance at a date to be determined. Rebuttal comments (rebuttal briefs), limited to issues raised in case briefs, may be filed within seven days  8 after the time limit for filing case briefs. Parties who submit arguments are requested to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities. 9 All briefs must be filed electronically using ACCESS. Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information under further notice. 10

Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS by 5 p.m. Eastern Time within 30 days after the date of publication of this notice. 11 Hearing requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Issues addressed at the hearing will be limited to those raised in the briefs. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm the date and time of the hearing two days before the scheduled date. Parties are reminded that all briefs and hearing requests must be filed electronically using ACCESS and received successfully in their entirety by 5:00 p.m. Eastern Time on the due date.

Pursuant to section 751(a)(2)(C) of the Act, upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries of subject merchandise in accordance with the final results of this review. If the assessment rate calculated in the final results in zero or de minimis, we will instruct CBP to liquidate all appropriate entries without regard to countervailing duties. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

In accordance with section 751(a)(2)(C) of the Act, Commerce intends to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts shown for the companies listed above, except, where the rate calculated in the final results is de minimis, no cash deposit will be required on shipments of the subject merchandise entered or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review. For all non-reviewed firms, we will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the most recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposits, when imposed, shall remain in effect until further notice.

Commerce intends to issue the final results of this administrative review, including the results of our analysis of the issues raised by the parties in their comments, no later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h)(1), unless this deadline is extended.

These preliminary results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213 and 19 CFR 351.221(b)(4).

On October 29, 2002, Commerce published the antidumping duty order on wire rod from Mexico in the Federal Register . 1 On October 1, 2020, we published in the Federal Register a notice of opportunity to request an administrative review of the Order. 2 On December 8, 2020, pursuant to section 751(a)(1) of the Act, Commerce initiated an administrative review of the Order. 3 On June 14, 2021, Commerce extended the deadline for the preliminary results to October 29, 2021. 4 For a complete description of the events that followed the initiation of this review, see the Preliminary Decision Memorandum. 5

The merchandise subject to the Order is wire rod, in coils, of approximately round cross section, 5.00 mm or more, but less than 19.00 mm, in solid cross-sectional diameter. The subject merchandise is classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) primarily under the subheadings: 7213.91.3000, 7213.91.3010, 7213.91.3011, 7213.91.3015, 7213.91.3020, 7213.91.3090, 7213.91.3091, 7213.91.3092, 7213.91.3093, 7213.91.4500, 7213.91.4510, 7213.91.4590, 7213.91.6000, 7213.91.6010, 7213.91.6090, 7213.99.0030, 7213.99.0031, 7213.99.0038, 7213.99.0090, 7227.20.0000, 7227.20.0010, 7227.20.0020, 7227.20.0030, 7227.20.0080, 7227.20.0090, 7227.20.0095, 7227.90.6010, 7227.90.6020, 7227.90.6030, 7227.90.6035, 7227.90.6050, 7227.90.6051, 7227.90.6053, 7227.90.6058, 7227.90.6059, 7227.90.6080, and 7227.90.6085. The HTSUS subheadings are provided for convenience and customs purposes only; the written product description remains dispositive.

A full description of the scope of the Order is contained in the Preliminary Decision Memorandum.

Nucor Corporation withdrew its request for an administrative review of Grupo Villacero S.A. de C.V. (Villacero) and Talleres y Aceros S.A. de C.V. (Talleres y Aceros). 6 As no other party requested a review of Talleres y Aceros, and Villacero, we are therefore partially rescinding this administrative review with respect to Talleres y Aceros and Villacero pursuant to 19 CFR 351.213(d)(1). The review will continue with respect to Deacero S.A.P.I. de C.V. and Ternium Mexico S.A. de C.V.

Commerce is conducting this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act). Constructed export price was calculated in accordance with section 772 of the Act. Normal value was calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. 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 https://access.trade.gov/public/FRNoticesListLayout.aspx. A list of topics discussed in the Preliminary Decision Memorandum is attached as an appendix to this notice.

As a result of this review, we preliminarily determine the following weighted-average dumping margins exist for the POR:

Upon issuance of the final results, Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. If the weighted-average dumping margin for Deacero S.A.P.I. de C.V. (Deacero) ( i.e., the sole individually examined respondent in this review) is not zero or de minimis ( i.e., less than 0.5 percent), we will calculate importer-specific ad valorem antidumping duty assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). 7 We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific assessment rate calculated in the final results of this review is above de minimis ( i.e., 0.5 percent). Where either the respondent's weighted-average dumping margin is zero or de minimis, or an importer-specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review where applicable.

For the company which was not selected for individual review ( i.e., Ternium Mexico S.A. de C.V.), we will assign an assessment rate based on the weighted-average dumping margin calculated for the sole individually examined respondent in this review, Deacero. The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, where applicable. 8

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Deacero which did not know that its merchandise was destined for the United States, we will instruct CBP to liquidate entries not reviewed at the all-others rate of 20.11 percent  9 if there is no rate for the intermediate company(ies) involved in the transaction. Commerce intends to issue assessment instructions to CBP no earlier than 41 days after the date of publication of the final results of this review in the Federal Register , in accordance with 19 CFR 356.8(a).

For the companies for which this review is rescinded, Villacero and Talleres y Aceros, antidumping duties shall be assessed at rates equal to the cash deposit rate of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption. Commerce intends to issue assessment instructions to CBP no earlier than 41 days after the date of publication of this rescission notice in the Federal Register .

The following cash deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of wire rod from Mexico entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results, as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for the firms listed above will be equal to the dumping margins established in the final results of this review, except if the ultimate rates are de minimis within the meaning of 19 CFR 351.106(c)(1), in which case the cash deposit rates will be zero; (2) for merchandise exported by producers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the producer or exporter participated; (3) if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value investigation but the producer is, then the cash deposit rate will be the rate established for the most recently completed segment of the proceeding for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 20.11 percent, the all-others rate established in the antidumping duty investigation. 10 These cash deposit requirements, when imposed, shall remain in effect until further notice.

We intend to disclose the calculations performed in these preliminary results to parties in this proceeding within five days of the date of publication of this notice. 11

Pursuant to 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than seven days after the date for filing case briefs. 12 Parties who submit case briefs or rebuttal briefs in this proceeding 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. 13 All briefs must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety by the established deadline. Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information, until further notice. 14

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, within 30 days after the date of publication of this notice. Requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. 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, time, and location of the hearing two days before the scheduled date.

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

We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h)(1).

NIST's Standards Coordination Office (SCO), initiates and manages programs, tools and activities to enhance U.S. industry competitiveness and federal agencies' coordination on issues related to technical standards and conformity assessment.

SCO monitors and participates in standards development and conformity assessment activities globally, consults with other federal agencies on standards policy issues, offers workshops and educational seminars for domestic and international audiences, and provides standards-related research and information services. More information can be found at https://www.nist.gov/standardsgov/about-standardsgov.

All industries use standardized processes and specifications to ensure that products are built to work together seamlessly. If each country or company did not adhere to the same standards, technologies would not be able to easily work with products designed by other companies or to work in other markets. In effect, standards allow products to be designed and produced at scale and used worldwide, which facilitates global trade. For example, the Wi-Fi standard provides the requirements for wireless local area networks and has facilitated the broad-based adoption of Wi-Fi wireless technology, which is now ubiquitous and has become indispensable for home networking, public internet connectivity, supporting the Internet of Things, and more.

Standards can also be proprietary and for-profit. For example, an operating system in a phone is open-source in order to promote standardization among smartphone makers and app developers, but companies still must pay licensing fees to use it.

There is not a single process by which all standards are created. Generally speaking, standards are set by a combination of private companies who are industry leaders as well as by international industry associations. Standards are enforced either as a convention—a “best practice”—or as formal agreements, depending on the industry and product.

Standards are not just useful for solving practical issues of compatibility, but also because they accelerate innovation. When companies use open standards rather than proprietary ones, they do not need to devote resources to developing their own internal systems and can instead follow established practices. International standards allow regulators and governments to improve trade policies and develop better regulations. International standards developed in a process consistent with the World Trade Organization's Technical Barriers to Trade Agreement provide an ideal tool to support trade agreements, and to provide confidence that requirements for products and testing have global relevance and are accepted worldwide.

Section 9414 of the National Defense Authorization Act for Fiscal Year 2021 (“William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021”) (Pub. L. 116-283) requires NIST to enter into an agreement with an appropriate entity to study the effect of the policies of the People's Republic of China and coordination among industrial entities within the People's Republic of China on international bodies engaged in developing and setting international standards for emerging technologies.

“Made in China 2025” is a strategic plan that was initiated in 2015 to reduce China's dependence on foreign technology and promote Chinese technological manufacturers in the global marketplace. The goal was to reach this objective by the year 2025, a decade from the year when the plan first took root. More information on the “Made in China 2025” policy can be found at http://english.www.gov.cn/policies/latest_releases/2015/05/19/content_281475110703534.htm.

The “China Standards 2035” project will most likely build upon Made in China 2025. The “China Standards 2035” plan will lay out a blueprint for China's government and leading technology companies to set global standards for emerging technologies in areas such as artificial intelligence and advanced communications technology.

International standards need to be relevant and to effectively respond to regulatory and market needs, as well as scientific and technological developments in various countries. They should not distort the global market, have adverse effects on fair competition, or stifle innovation and technological development. In addition, they should not give preference to the characteristics or requirements of specific countries or regions when different needs or interests exist in other countries or regions. Whenever possible, international standards should be performance based rather than based on design or descriptive characteristics.

To ensure that the broad perspective of the standards community informs the development of and aligns with government's future plans and approaches, this RFI invites stakeholders throughout the scientific research, advocacy, industry, and non-scientific communities, including the general public, to comment. The enumerated list of topics below covers the major areas about which NIST seeks comment and is not intended to limit the topics that may be addressed. Commenters may provide responses to other relevant issues, such as the extent to which the PRC partners with foreign governments or multinational corporations to promote technical standards that may advantage PRC companies, entities, or state objectives; the aims of the PRC in international standards setting organizations, including an analysis of Chinese-language sources; the standardization strategy of the PRC, as identified in the stated intentions of the “China Standards 2035” plan, including how and to what extent that strategy has been implemented and has influenced PRC industry and academic sectors, including in the development of indigenous standards with international implications. Commenters may also offer comments on whether international standards for select emerging technologies ( e.g., electronics, artificial intelligence, the Internet of Things (IoT), blockchain and financial technologies, clean energy technologies, and quantum information technologies) are being designed to promote or favor interests of the PRC, as expressed in the “Made in China 2025” plan, to the exclusion or disadvantage of other participants or in a way that may not result in the best technological solution. Responses may include any topic believed to have implications for the study.

1. The participation of the People's Republic of China in international standards setting organizations over the previous 10 years, including leadership roles in standards drafting technical committees, and the quality or value of that participation;

2. The effect of the standardization strategy of the People's Republic of China, as identified in the “China Standards 2035” plan on international bodies engaged in developing and setting standards for select emerging technologies, such as advanced communication technologies, or cloud computing and cloud services;

3. Whether international standards for select emerging technologies are being designed to promote interests of the People's Republic of China as expressed in the “Made in China 2025” plan to the exclusion of other participants;

4. How previous practices used by the People's Republic of China while participating in international standards setting organizations may foretell how the People's Republic of China is likely to engage in international standardization activities of critical technologies like artificial intelligence and quantum information science, and what may be the consequences;

5. Recommendations on how the United States can take steps to mitigate the influence of the People's Republic of China and bolster United States public and private sector participation in international standards-setting bodies.

Pursuant to 15 CFR 921.33(c), a state must revise the management plan for a research reserve at least every five years. Changes to a reserve's management plan may be made only after receiving written approval from NOAA. NOAA approves changes to management plans via notice in the Federal Register . On November 02, 2020, NOAA issued a notice in the Federal Register announcing a thirty-day public comment period for the proposed revision of the management plan for the Lake Superior National Estuarine Research Reserve (81 FR 69320). On July 1, 2021, NOAA issued a notice in the Federal Register announcing a thirty-day public comment period for the proposed revision of the management plan for the Mission-Aransas National Estuarine Research Reserve (86 FR 35072). Responses to written and oral comments received, and an explanation of how comments were incorporated into the final versions of the revised management plans, are available in appendix B of the Lake Superior plan and appendix 8 of the Mission-Aransas plan.

The revised management plans outline each reserve's: Strategic goals and objectives; administrative structure; programs for conducting research and monitoring, education, and training; resource protection, restoration, and manipulation plans; public access and visitor use plans; consideration for future land acquisition; and facility development to support reserve operations.

The Lake Superior revised management plan focuses on changes to facilities through acquiring permanent housing for visiting students and researchers; growing the sectors by structurally supporting additional staff; advancing geographic information systems (GIS) and data management priorities; and developing a formal advisory board and strategic relationships with the private sector in the region. Since September 2010, the reserve has acquired permanent facilities for the reserve's operations; hired core sector leads and support staff; opened a public interpretive center and classroom; and expanded formal partnerships in research and education across the region. The revised management plan will serve as the guiding document for the 16,697-acre research reserve for the next five years.

The Mission-Aransas revised management plan builds upon past successes and accomplishments and is designed to address specific priority coastal management issues. The priority issues for research and monitoring include marine debris, industrial growth impacts, eDNA, freshwater inflow, biological monitoring, and sea level rise and coastal subsidence. For education and training, priorities to be addressed include connecting children and nature; outdoor education programming, climate change and its effects on coastal environments; coastal ecology and habitat diversity; marine debris and its impacts on the coastal environment; and stewardship of estuarine and coastal resources.

Since its inception, this reserve has engaged in strategic partnerships with its land managing partners and others based on mutual interests. These partnerships are expected to be maintained or expanded through the revised management plan including reserve administration of the Amos Rehabilitation Keep (ARK), providing animal rehabilitation services for species endemic to the estuary. The reserve is also planning to maintain and improve reserve facilities including Fennessey Ranch, the Bay Education Center, the ARK, and the Patton Marine Science Education Center.

Neither the Lake Superior or Mission-Aransas revised management plans change the total acreage of either reserve.

NOAA reviewed the environmental impacts of the Lake Superior and Mission-Aransas revised management plans and determined that these actions are categorically-excluded from further analysis under the National Environmental Policy Act, consistent with NOAA Administrative Order 216-6.]

Authority: 16 U.S.C. 1451 et seq.; 15 CFR 921.33.

Title; Associated Form; and OMB Number: On-Site Installation Evaluations; OMB Control Number 0704-0610.

Needs and Uses: These information collections continue to support a high-visibility requirement directed in Secretary of Defense Memorandum, “Immediate Actions to Counter Sexual Assault and Harassment and the Establishment of a 90-Day Independent Review Commission on Sexual Assault in the Military,” February 26, 2021. Immediate Action 2 directs the Under Secretary of Defense for Personnel and Readiness (USD(P&R)) to develop a plan of action and milestones to conduct high risk installation evaluations. Memorandum “Plan of Action and Milestones for High Risk Installation Evaluations,” March 30, 2021 USD(P&R) approved the plan of action and milestones. The end result of the data collection will be a series of ratings for each installation to characterize the maturity of prevention at each installation ( i.e., how consistently prevention is prioritized, how consistently people are prepared to conduct needed prevention, and how consistently prevention is done well).

Affected Public: Individuals or households.

Annual Burden Hours: 2,938 hours.

Number of Respondents: 4,100.

Responses per Respondent: 1.

Annual Responses: 4,100.

Average Burden per Response: 43 minutes.

Frequency: On occasion.

Title; Associated Form; and OMB Number: Status of Forces Survey of Reserve Component Members; OMB Control Number 0704-0616.

Needs And Uses: The purpose of the Status of the Forces Survey of Reserve Component Members (SOFS-R) is to assess the attitudes and opinions of Reserve component members and to provide key metrics to the OUSD(P&R). Results of this survey are used to provide direct feedback on key strategic indicators such as satisfaction and retention. These indicators provide primary data on personnel career plans, retention decisions, morale, commitment, and quality of life and historically provide the ability to evaluate the impact of policies and programs with regard to readiness and retention.

Affected Public: Individuals or households.

Annual Burden Hours: 5,505 hours.

Number of Respondents: 16,515.

Responses per Respondent: 1.

Annual Responses: 16,515.

Average Burden per Response: 20 minutes.

Frequency: Annually.

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: Guaranty Agencies Security Self-assessment and Attestation.

OMB Control Number: 1845-0134.

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

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

Total Estimated Number of Annual Responses: 20.

Total Estimated Number of Annual Burden Hours: 6,320.

Abstract: This is a request for an extension of the approved information collection used by Federal Student Aid (FSA) to ensure that all data collected and managed by Guaranty Agencies (GAs) in support federal student financial aid programs is secure. FSA continues to use a formal assessment program that ensures the GAs have security protocols in place to protect the confidentiality and integrity of data entrusted to FSA by students and families. This assessment will identify security deficiencies based on the federal standards described in the National Institute of Standards and Technology publications.

In the Federal Register of October 15, 2021, in the FR Doc. 2021-22494 on page 57422, column 3 correct paragraph 2 to read:

Per NEEA, the EPA Administrator appoints and reappoints eligible individuals to serve on NEEF's Board of Directors. The Administrator announces the following four-year appointments to NEEF's Board of Directors, effective 90 days after publication of the original notice:

Mr. Kevin Butt, Toyota Motor North America, Inc., will be re-appointed for an additional four-year term.

Submit your comments, identified by Docket ID No. EPA-HQ-OECA-2021-0763, at https://www.regulations.gov (our preferred method), or the other methods identified in the ADDRESSES section. Once submitted, comments cannot be edited or removed from the docket. The EPA may publish any comment received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Proprietary Business Information (PBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

Due to public health concerns related to COVID-19, the EPA Docket Center and Reading Room are open to the public by appointment only. Our Docket Center staff also continues to provide remote customer service via email, phone, and webform. For further information and updates on EPA Docket Center services, please visit us online at https://www.epa.gov/dockets.

The EPA continues to carefully and continuously monitor information from the Centers for Disease Control and Prevention (CDC), local area health departments, and our Federal partners so that we can respond rapidly as conditions change regarding COVID-19.

This announcement matters to you if you are a PMC, if you are employed by a PMC, if you live in target housing managed by a PMC, or if you work with PMCs on renovation, repair or painting activities covered by the EPA's RRP rule. Target housing includes residential dwellings constructed before 1978. This notice also matters to you if you have a child under the age of 6 years who regularly visits a “child-occupied facility,” such as a daycare or a kindergarten, in a pre-1978 building managed by a PMC.

This Notice by the Environmental Protection Agency (EPA) announces it intends to withdraw two Frequently Asked Questions (“FQs”) concerning property managers and property management companies (collectively, “property management companies” or “PMCs”) and their compliance responsibilities under the Lead-based Paint Renovation, Repair, and Painting Rule (“RRP rule”), section 402(c) of the Toxic Substances Control Act (TSCA), 40 CFR part 745, subpart E, including the pre-renovation information distribution requirements promulgated under TSCA section 406(b) and codified at 40 CFR 745.84. The FQs are viewable on the EPA website: www.epa.gov/lead/fqs-rrp-rule.

The first of the PMC FQs to be withdrawn indicated the EPA's prior statement that a PMC did not need to obtain firm certification for itself or renovator certification for an employee if none of its employees “do the work” of the renovation:

The second of the two PMC FQs explained how the EPA would exercise its enforcement discretion under circumstances in which a certified firm hired by the PMC fails to comply with a requirement of the RRP rule:

With the withdrawal of FQ 23002-13650 and FQ 23002-18348, the EPA would assess compliance by PMCs with the RRP rule, as it would for any other entity, according to the broadly applicable language of the RRP rule: That no firm may perform, offer, or claim to perform renovations without certification from EPA in target housing or child-occupied facilities (unless the renovation qualifies for a specified exception). See, e.g., 40 CFR 745.81(a)(2)(ii). Furthermore, the EPA will evaluate compliance and appropriate enforcement actions on the basis of each case's individual facts and circumstances, and the EPA may exercise its enforcement discretion regarding PMC obligations.

As stated in the introduction to the current FQs document (available at https://www.epa.gov/lead/answers-frequent-questions-about-epas-lead-renovation-repair-and-painting-rrp-rule ), the FQs present the agency's preliminary responses, may be periodically revised, and do not necessarily bind the EPA to a specific application of the RRP rule. This notice, like the PMC FQs, is intended solely for guidance and does not alter any statutory or regulatory requirements and does not create binding obligations.

For information on how to get certified, please see https://www.epa.gov/lead/renovation-repair-and-painting-program-contractors.

The RRP rule is intended to protect residents of pre-1978 homes from lead-based paint disturbed in the course of renovation, repair or painting activities. Compliance with the RRP rule's requirements protects people from the hazardous health effects of lead, especially children six years old and younger and pregnant women, both of whom are most susceptible to the effects of lead. Even low levels of lead in the blood of children can result in: Behavior and learning problems; lower IQ and hyperactivity; slowed growth; hearing problems; and anemia. In rare cases, ingestion of lead can cause seizures, coma and even death. Lead accumulates in the body over time, where it is stored in the bones along with calcium. During pregnancy, lead is released from the pregnant mother's bones, along with calcium, and can pass from the mother, exposing the fetus or the breastfeeding infant to lead. This can result in serious effects to the developing fetus and infant. It can cause the baby to be born too early or too small; hurt the baby's brain, kidneys, and nervous system; increase the likelihood of learning or behavioral problems; and put the mother at risk for miscarriage.

Congress recognized almost thirty years ago, upon enactment of the legislation that included TSCA Title IV, that lead in paint was responsible for “low-level lead poisoning [that was] widespread among American children, afflicting as many as 3,000,000 children under age 6, with minority and low-income communities disproportionately affected.” 42 U.S.C. 4851. Disproportionate risks of lead exposure in minority and low-income communities persist today. 1 Withdrawal of the PMC FQs is important for the safety of all who live in PMC-managed housing, and it is vitally important to the health of children under the age of 6 years, particularly in communities burdened by exposure to high levels of lead-based paint in pre-1978 housing. Communities with environmental justice concerns often include a higher proportion of rental housing. PMCs manage a significant portion of the nation's rental housing market, and each PMC often manages a large number of rental housing units. For example, the largest 50 PMCs alone control 3.4 million units. 2 PMCs also manage approximately 205,000 family housing projects, which comprise 99% of privatized military housing. More than 3.18 million children under the age of 6 years live in pre-1980 rental housing. 3 A portion of these children may be at risk of exposure to lead-based paint hazards.

The RRP rule broadly applies to renovation, repair or painting activities performed for compensation that disturb painted surfaces in target housing and child occupied facilities.

When the EPA developed the RRP rule, as required by section 402(c) of TSCA, it defined the scope of the RRP rule based on the circumstances of the renovation, repair and painting activity, rather than the person or entity performing the renovation. The RRP rule “applies to all renovations performed for compensation in target housing and child-occupied facilities. . . .” 40 CFR 745.82(a). The purpose of this broad application, as stated in the regulation is “to ensure” that “individuals performing renovations . . . are properly trained; renovators and firms performing these renovations are certified; and the work practices in [the regulation] are followed. . . .” § 745.80(b). Work practice requirements, such as work-area containment, and a prohibition on certain work practices, such as open-flame burning, minimize exposure to lead-based paint hazards.

The regulations provide that “no firm may perform, offer, or claim to perform renovations without certification from EPA . . . in target housing or child-occupied facilities [unless an exception applies].” § 745.81(a)(2)(ii). The regulations broadly define “firms” to include: “a company, partnership, corporation, sole proprietorship or individual doing business, association, or other business entity; a Federal, State, Tribal or local government agency; or a nonprofit organization.” § 745.83.

In an effort to help the public understand and comply with the RRP rule, the EPA posted answers to frequent questions on its website at https://www.epa.gov/lead/fqs-rrp-rule (“FQ document”). When the EPA added the PMC FQs to the FQ document in 2010, it did not have experience with implementation of the RRP rule and the PMC industry's response to it. PMC FQ 23002-13650 states, “if the property management company hires a renovation firm to perform the renovation, the property management company does not need firm or renovator certification.” The FQ, which as noted above is not binding, analogized PMCs to landlords and provided that a PMC that did not use its own employees “to do the work” would not have enforceable obligations under the RRP rule and, for example, would not need to ensure that lead-safe work practices were followed. The FQ did not elaborate on the phrase “do the work.” At the time the FQ was written, EPA generally did not think that a PMC that hired a renovation firm to perform a renovation would itself be doing work such that it also would be performing or offering to perform the renovation for compensation. Therefore, EPA did not think the PMC would need to comply with the RRP rule and need to be a certified firm. Consistent with this prior interpretation, FQ 23002-18348 states that any enforcement action taken would be against the renovation firm, not the PMC. EPA now has experience implementing the RRP rule and understands there are circumstances where a PMC hires a renovation firm to perform the renovation, and also engages in activities such that the PMC also performs or offers to perform the renovation, and these circumstances are described in more detail in this notice.

The EPA has gained experience implementing the RRP rule since 2010 and, based on this experience, has a better understanding of the activities commonly undertaken by PMCs. As explained below, the EPA has concluded that it is not appropriate to make categorical assumptions about PMC compliance obligations and that these obligations should be determined based on the facts and circumstances of each individual case. While PMCs may in some instances and in some circumstances act as agents of a landlord, unlike landlords they are not property owners, but instead are a distinct type of entity that performs services for compensation. In the EPA's experience, PMCs often do not hire certified renovation firms. Furthermore, the EPA has found many circumstances where a PMC that hires a renovation firm for a renovation also performs or offers to perform the renovation for compensation in target housing. For example, in some cases, the PMC might offer to perform renovation, repair, or painting activities through its contractual agreements with the building owner, and in other cases the PMC might perform an element of the renovation for compensation.

Given the EPA's understanding of these circumstances, the EPA intends to assess compliance by PMCs with the RRP rule, just as it would for any other entity, in accordance with the broadly applicable language of the RRP rule: That no firm may perform, offer, or claim to perform regulated renovations without certification from the EPA in target housing or child-occupied facilities. See, e.g., 40 CFR 745.81(a)(2)(ii). Consistent with the requirements in the RRP rule, the EPA will evaluate compliance and appropriate enforcement actions on the basis of each case's individual facts and circumstances, and the EPA may exercise its enforcement discretion regarding PMC obligations.

The following discussion is intended to help elaborate on how the RRP rule may apply to PMCs when they hire a renovation firm. In some cases, the PMC might offer to perform renovation, repair, or painting activities through its contractual agreements with the building owner, and in other cases the PMC might perform an element of the renovation for compensation.

When a PMC enters into a business relationship with the property owner, the PMC typically agrees to perform various property management services. In some circumstances, a PMC's services may be strictly limited to leasing and rent collection. That circumstance would be unlikely to give rise to facts indicating that a PMC “performed” a renovation.

More often, a PMC agrees to provide—and is compensated for—property management services that include maintenance, repair, painting, renovations, or other activities that disturb painted surfaces and may be subject to the RRP rule and require a certified renovator. In such agreements, oral contracts, or written contracts, the agreement obligates the PMC to perform the renovation. Whether the PMC uses its own employees to perform the work or hires an outside firm to perform the work, the PMC remains obligated by such an agreement with the property owner (and typically is compensated for fulfilling such obligations) to ensure that the renovation is performed.

Specification of such “renovation” responsibilities in a written contract between a property owner and a PMC is not essential to establishing RRP rule applicability to the PMC, especially if other facts establish that the PMC offered to perform or actually did perform some other action necessary to ensure the performance of a renovation activity.

When a PMC hires a firm for renovation, repair or painting activities, the PMC, as part of the business relationship with the property owner, is typically compensated for managing certain activities that are necessary or even integral to the performance of the renovation, repair or painting activity, including (but not limited to):

• Soliciting and evaluating contractor bids;

• Applying for permits, as appropriate;

• Granting contractors access to the property;

• Overseeing contractor work on the property;

• Informing tenants of renovation activity;

• Verifying completion of renovation activity; or

• Remitting payment to the contractors.

The PMC may even oversee or supervise the outside renovation firms, individuals and contractors who are not the PMC's employees but are doing activities that are recognized as part of the renovation in the RRP rule. The PMC may also coordinate work schedules of the various outside contractors.

Compensation of a PMC by the property owner for any of these or similar activities may establish that a PMC is performing a renovation for compensation and must comply with the RRP rule, even if the PMC uses an independent contractor instead of its own employees to do the specific activities that disturb paint surfaces. Consistent with the requirements in the RRP rule, the EPA will evaluate compliance and appropriate enforcement actions on the basis of each case's individual facts and circumstances, and the EPA may exercise its enforcement discretion regarding PMC obligations.

The EPA has over ten years of experience with the PMC FQs and has concluded, as discussed above, that these FQs have contributed to non-compliance with the RRP rule in rental property managed by PMCs.

EPA's experience also has shown that PMCs routinely hire smaller, uncertified firms to conduct RRP activities. Collectively these hiring decisions by PMCs have an outsized impact on worksite compliance at properties managed by PMCs as the numerous contractors for renovation, repair and painting activities are often small and transitory. Withdrawing the PMC FQs signals that EPA plans to hold both the PMCs and the contractors they hire responsible for compliance if the circumstances indicate that both entities performed or offered to perform renovations for compensation in target housing or child-occupied facilities.

Withdrawal of the PMC FQs and the discussion in this notice helps to increase the impact and effectiveness of the RRP Rule and improve compliance in rental properties managed by PMCs. The EPA seeks to explain the circumstances that may give rise to compliance obligations for PMCs under the RRP Rule. We also aim to identify the potential enforcement consequences for a PMC that performs or offers to perform renovations for compensation without considering its role in RRP rule compliance.

The EPA is cognizant that PMCs relying on the EPA's PMC FQs may have declined to obtain RRP certification themselves or ensure the RRP compliance of contractors they hired. Therefore, through this notice, the EPA is informing the public and PMCs that EPA intends to withdraw FQs 23002-13650 and 23002-18348 and intends, upon withdrawal, to assess compliance by PMCs that are performing or offering to perform renovations for compensation—either by using their own employees or hiring an outside firm—according to the same requirements placed upon any other entity that performs or offers to perform a renovation for compensation in target housing or child-occupied facilities.

Consistent with the RRP rule, any individual or entity (including PMCs) is subject to the RRP rule requirements when they perform or offer to perform renovation, repair or painting activities for compensation in housing and child-occupied facilities built before 1978, and therefore must be a certified firm.

Requirements for certified firms include, among other things: Obtaining firm certification; providing owners and occupants with the EPA's Renovate Right pamphlet; assigning a certified renovator to the RRP activity (or ensuring assignment of a contractor's certified renovator); ensuring all workers onsite are certified or receive on-the-job training from a certified renovator; ensuring use of lead-safe work practices and clean-up; ensuring documentation of compliance of lead-safe work practices that minimize the release of lead-based paint hazards such as paint chips and dust containing lead; and providing that documentation to the EPA and to EPA-authorized state programs upon request.

By providing advance notice of the planned withdrawal of the FQs in 135 days, the EPA is providing more than sufficient time for PMCs to obtain any needed certification under the Lead RRP rule. For information on how to get certified, please see https://www.epa.gov/lead/renovation-repair-and-painting-program-contractors.

On June 15, 1984, OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collections of information conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. The OMB inventory, as well as copies of the PRA Submission, supporting statements, and approved collection of information instrument(s) are available at https://www.reginfo.gov/public/do/PRAMain. These documents are also available on the Federal Reserve Board's public website at https://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears above.

Report title: Reporting, Recordkeeping, and Disclosure Requirements Associated with the CFPB's Home Mortgage Disclosure Act Loan/Application Register required by Regulation C.

Agency form number: FR HMDA LAR.

OMB control number: 7100-0247.

Frequency: Annually and quarterly.

Respondents: State member banks and their subsidiaries, subsidiaries of bank holding companies, U.S. branches and agencies of foreign banks (other than federal branches, federal agencies, and insured state branches of foreign banks), commercial lending companies owned or controlled by foreign banks, and organizations operating under section 25 or 25A of the Federal Reserve Act.

Estimated number of respondents: Reporting—Tier 1 Annual Reporter, 3; Tier 1 Quarterly Reporter, 1; Tier 2, 131; Tier 2 Partial Reporter, 308; and Tier 3 Partial Reporter, 33; Recordkeeping—Tier 1 Annual Reporter, 3; Tier 1 Quarterly Reporter, 1; Tier 2, 439; and Tier 3, 33; and Disclosure—Tier 1 Annual Reporter, 3; and Tier 1 Quarterly Reporter, 1.

Estimated average hours per response: Reporting—Tier 1 Annual Reporter, 5,969; Tier 1 Quarterly Reporter, 6,903; Tier 2, 1,232; Tier 2 Partial Reporter, 986; and Tier 3 Partial Reporter, 64; Recordkeeping—Tier 1 Annual Reporter, 4,130; Tier 1 Quarterly Reporter, 4,130; Tier 2, 83; and Tier 3, 27; and Disclosure—Tier 1 Annual Reporter, 5; and Tier 1 Quarterly Reporter, 5.

Estimated annual burden hours: Reporting—Tier 1 Annual Reporter, 17,907; Tier 1 Quarterly Reporter, 27,612; Tier 2, 161,392; Tier 2 Partial Reporter, 303,688; and Tier 3 Partial Reporter, 2,112; Recordkeeping—Tier 1 Annual Reporter, 12,390; Tier 1 Quarterly Reporter, 16,520; Tier 2, 36,437; and Tier 3, 891; and Disclosure—Tier 1 Annual Reporter, 15; and Tier 1 Quarterly Reporter, 20.

General description of report: The Home Mortgage Disclosure Act (HMDA) was enacted in 1975 and is implemented by Regulation C. Generally, the HMDA requires certain depository and non-depository institutions that make certain mortgage loans to collect, report, and disclose data about originations and purchases of mortgage loans, as well as loan applications that do not result in originations (for example, applications that are denied or withdrawn). The HMDA was enacted to provide regulators and the public with loan data that can be used to (1) help determine whether financial institutions are serving the housing needs of their communities, (2) assist public officials in distributing public-sector investments so as to attract private investment to areas where it is needed, and (3) assist in identifying possible discriminatory lending patterns and enforcing anti-discrimination statutes. 1 Supervisory agencies, state and local public officials, and members of the public use the data to aid in the enforcement of the Community Reinvestment Act, the Equal Credit Opportunity Act, and the Fair Housing Act and to aid in identifying areas for residential redevelopment and rehabilitation.

Legal authorization and confidentiality: The FR HMDA LAR is authorized pursuant to section 304(j) of the HMDA, which requires that the Consumer Financial Protection Bureau (CFPB) prescribe by regulation the form of loan application register information that must be reported by covered financial institutions. Section 1003.5 of Regulation C implements this statutory provision, and requires covered financial institutions to submit reports to their appropriate federal agency. Section 304(h)(2)(A) of the HMDA designates the Board as the appropriate agency with respect to the entities described above. The FR HMDA LAR is mandatory.

The HMDA requires the information collected on the FR HMDA LAR to be made available to the general public in the form required under regulations prescribed by the CFPB. The CFPB is authorized to redact or modify the scope of the information before it is publicly disclosed to protect the privacy of loan applicants and to protect depository institutions from liability under any federal or state privacy law. The redacted information may be kept confidential under exemption 6 of the Freedom of Information Act, which protects from release information that, if disclosed, would “constitute a clearly unwarranted invasion of personal privacy.”  2

Current actions: On July 19, 2021, the Board published a notice in the Federal Register (86 FR 38090) requesting public comment for 60 days on the extension, without revision, of the Reporting, Recordkeeping, and Disclosure Requirements Associated with the CFPB's Home Mortgage Disclosure Act Loan/Application Register required by Regulation C. The comment period for this notice expired September 17, 2021. The Board did not receive any comments.

On June 15, 1984, OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collections of information conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

During the comment period for this proposal, a copy of the proposed PRA OMB submission, including the draft reporting form and instructions, supporting statement, and other documentation, will be made available on the Board's public website at https://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears above. Final versions of these documents will be made available at https://www.reginfo.gov/public/do/PRAMain, if approved.

The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:

a. Whether the proposed collection of information is necessary for the proper performance of the Board's functions, including whether the information has practical utility;

b. The accuracy of the Board's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

c. Ways to enhance the quality, utility, and clarity of the information to be collected;

d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Board should modify the proposal.

Report title: Recordkeeping and Disclosure Requirements Associated with Loans Secured by Real Estate Located in Flood Hazard Areas Pursuant to Section 208.25 of Regulation H.

Agency form number: FR H-2.

OMB control number: 7100-0280.

Frequency: On occasion.

Respondents: State member banks (SMBs).

Estimated number of respondents: Recordkeeping: Private flood insurance (Sections 208.25(c)(3)(iii) and (iv)), 11,171; Retention of standard Federal Emergency Management Agency (FEMA) form (Section 208.25(f)(2)), 728; Notice of special flood insurance (Section 208.25(i)), 728; Disclosure: Notice of special flood hazards and availability of federal disaster relief assistance with escrow notice, as applicable (Sections 208.25(i) and (e), as applicable), 728; Notice to FEMA of servicer (Section 208.25(j)(1)), 728; Notice to FEMA of change of servicer (Section 208.25(j)(2)), 728; Notice to borrowers of lapsed mandated flood insurance (Section 208.25(g)), 728; Purchase of flood insurance on the borrower's behalf (Section 208.25(g)), 728; Notice to borrowers of lapsed mandated flood insurance due to remapping (Section 208.25(g)), 728; Purchase of flood insurance on the borrower's behalf due to remapping (Section 208.25(g)), 728; One-time notice for any designated loan outstanding on July 1 of the year SMB no longer qualifies for small lender exception, 12.

Estimated average time per response: Recordkeeping: Private flood insurance (Sections 208.25(c)(3)(iii) and (iv)), 15 minutes; Retention of standard FEMA form (Section 208.25(f)(2)), 2.5 minutes; Notice of special flood insurance (Section 208.25(i)), 2.5 minutes; Disclosure: Notice of special flood hazards and availability of federal disaster relief assistance with escrow notice, as applicable (Sections 208.25(i) and (e), as applicable), 5 minutes; Notice to FEMA of servicer (Section 208.25(j)(1)), 5 minutes; Notice to FEMA of change of servicer (Section 208.25(j)(2)), 5 minutes; Notice to borrowers of lapsed mandated flood insurance (Section 208.25(g)), 5 minutes; Purchase of flood insurance on the borrower's behalf (Section 208.25(g)), 15 minutes; Notice to borrowers of lapsed mandated flood insurance due to remapping (Section 208.25(g)), 5 minutes; Purchase of flood insurance on the borrower's behalf due to remapping (Section 208.25(g)), 15 minutes; One-time notice for any designated loan outstanding on July 1 of the year SMB no longer qualifies for small lender exception, 40 hours.

Estimated annual burden hours: Recordkeeping: Private flood insurance (Sections 208.25(c)(3)(iii) and (iv)), 2,793; Retention of standard FEMA form (Section 208.25(f)(2)), 12,255; Notice of special flood insurance (Section 208.25(i)), 2,457; Disclosure: Notice of special flood hazards and availability of federal disaster relief assistance with escrow notice, as applicable (Sections 208.25(i) and (e), as applicable), 4,914; Notice to FEMA of servicer (Section 208.25(j)(1)), 4,914; Notice to FEMA of change of servicer (Section 208.25(j)(2)), 2,487; Notice to borrowers of lapsed mandated flood insurance (Section 208.25(g)), 971; Purchase of flood insurance on the borrower's behalf (Section 208.25(g)), 728; Notice to borrowers of lapsed mandated flood insurance due to remapping (Section 208.25(g)), 485; Purchase of flood insurance on the borrower's behalf due to remapping (Section 208.25(g)), 728; One-time notice for any designated loan outstanding on July 1 of the year SMB no longer qualifies for small lender exception, 480.

General description of report: In general, the federal flood insurance statutes and Regulation H—Membership of State Banking Institutions in the Federal Reserve System (12 CFR 208) provide that a lender shall not make, increase, extend, or renew a loan secured by a building or mobile home located in a special flood hazard area unless the secured property is covered by flood insurance for the term of the loan. With respect to the recordkeeping and disclosure provisions, the regulation generally requires state member banks to retain certain flood hazard documentation and to notify borrowers and servicers regarding properties in flood hazard areas and requirements related to flood insurance. State member banks also must notify FEMA of the identity of, and any change in, the servicer of a loan secured by improved property in a special flood hazard area.

Proposed revisions: The Board proposes to revise the FR H-2 information collection to account for the recordkeeping provision in section 208.25(i) of Regulation H that had not been previously cleared by the Board under the PRA. When a state member bank makes, increases, extends, or renews a loan secured by a building or a mobile home located or to be located in a special flood hazard area, Regulation H requires that the bank mail or deliver a written notice to the borrower and to the servicer in all cases indicating whether flood insurance is available under the National Flood Insurance Program (NFIP) for the collateral securing the loan. The state member bank must retain a record of the receipt of the notices by the borrower and the servicer for the period of time the bank owns the loan.

Legal authorization and confidentiality: Section 102 of the Flood Disaster Protection Act of 1973, as amended, 1 and section 1364 of the National Flood Insurance Act, as amended, 2 authorize the Board to impose the disclosure and recordkeeping requirements in section 208.25 of Regulation H. The obligation to comply is mandatory.

Because the Federal Reserve does not collect information from the FR H-2, confidentiality issues generally would not arise. In the event the records are obtained by the Board as part of the examination or supervision of a financial institution, this information may be considered confidential pursuant to exemption 8 of the Freedom of Information Act, which protects information contained in “examination, operating, or condition reports” obtained in the bank supervisory process. 3

On June 15, 1984, OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collections of information conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

During the comment period for this proposal, a copy of the proposed PRA OMB submission, including the draft reporting form and instructions, supporting statement, and other documentation, will be made available on the Board's public website at https://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears above. Final versions of these documents will be made available at https://www.reginfo.gov/public/do/PRAMain, if approved.

The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:

a. Whether the proposed collection of information is necessary for the proper performance of the Board's functions, including whether the information has practical utility;

b. The accuracy of the Board's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

c. Ways to enhance the quality, utility, and clarity of the information to be collected;

d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Board should modify the proposal.

Report title: Domestic Finance Company Report of Consolidated Assets and Liabilities.

Agency form number: FR 2248.

OMB control number: 7100-0005.

Frequency: Monthly, quarterly, as needed.

Respondents: Finance companies. 1

Estimated number of respondents: Monthly, 150; Quarterly, 150; Addendum; 150.

Estimated average minutes per response: Monthly, 20; Quarterly, 30; Addendum, 10.

Estimated annual burden hours: Monthly, 400; Quarterly, 300; Addendum; 50.

General description of report: The FR 2248 is collected monthly as of the last calendar day of the month from a stratified sample  2 of finance companies. Each monthly report collects balance sheet data on major categories of consumer and business credit receivables and on major short-term liabilities. For quarter-end months (March, June, September, and December), additional asset and liability items are collected to provide a full balance sheet. A supplemental section collects data on securitized assets. Board staff may ask either quantitative or qualitative questions through the use of a special addendum section no more than twice per year. The data are used to construct universe estimates of finance company holdings, which are published in the monthly statistical releases Finance Companies (G.20) and Consumer Credit (G.19) and in the quarterly statistical release Financial Accounts of the United States (Z.1). 3

Legal authorization and confidentiality: The FR 2248 is authorized by sections 2A and 12A of the Federal Reserve Act (FRA). Section 2A of the FRA requires that the Board and the Federal Open Market Committee (FOMC) maintain long-run growth of the monetary and credit aggregates commensurate with the economy's long run potential to increase production, so as to promote effectively the goals of maximum employment, stable prices, and moderate long-term interest rates. 4 Section 12A of the FRA further requires the FOMC to implement regulations relating to the open market operations conducted by Federal Reserve Banks with a view to accommodating commerce and business and with regard to their bearing upon the general credit situation of the country. 5 The Board and FOMC use the information obtained through the FR 2248 to discharge these responsibilities. The FR 2248 is voluntary.

Although the Board releases aggregate data derived from the FR 2248 in the monthly G.20 and G.19 statistical releases, and in the quarterly Z.1 statistical release, individual finance company information provided by each respondent is generally treated as confidential. Information collected on the FR 2248 is likely to constitute nonpublic commercial or financial information, which is both customarily and actually treated as private by the respondent. Accordingly, such information may be kept confidential by the Board pursuant to exemption 4 of the Freedom of Information Act. 6 If it should be determined that any information collected on the FR 2248 must be released, respondents would be notified.

On June 15, 1984, OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collections of information conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. The OMB inventory, as well as copies of the PRA Submission, supporting statements, and approved collection of information instrument(s) are available at https://www.reginfo.gov/public/do/PRAMain. These documents are also available on the Federal Reserve Board's public website at https://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears above.

Report title: New Hire Information Collection.

Agency form number: FR 27.

OMB control number: 7100-0375.

Effective Date of Revisions: December 6, 2021.

Frequency: As needed.

Respondents: The FR 27 panel comprises individuals who are new hires to the Board but have not yet become employees.

Estimated number of respondents: Regular hire: 312; intern hire: 122; federal transfer: 10.

Estimated average hours per response: Regular hire: 1; intern hire: 0.75; federal transfer: 1.08.

Estimated annual burden hours: Regular hire: 312; intern hire: 92; federal transfer: 11.

General description of report: This information collection provides for the electronic collection of certain personnel information from new hires using a secure web-based portal, the “New Hire Portal,” before the first day of employment of a new hire. As part of the onboarding process for new hires, a Human Resources professional at the Board identifies the necessary information that must be collected from the new hire, which is dependent upon whether the person will be starting as a full- or part-time employee, including a Governor or Board officer (Regular Hire) or starting as an intern (Intern Hire), or whether the Regular Employee is transferring from another federal agency (Federal Transfer). The new hire is then sent an email asking him or her to provide the information described below through the New Hire Portal prior to their official start date.

The New Hire Portal is broken out into different sections and each section corresponds to the hardcopy forms that new employees previously filled out and provide to the Board during or after the first day of new employee orientation (NEO). Thus, the information collection involves a new hire electronically providing this personnel information and filling out the applicable sections of the New Hire Portal before their first day of orientation. The sections of the portal that each new hire is asked to complete electronically depends upon the type of position that the new hire has been offered at the Board.

Legal authorization and confidentiality: The New Hire Information Collection is authorized pursuant to sections 10(3), 10(4), 11(l), and 11(q) of the Federal Reserve Act, which provide the Board broad authority over employment of staff and security of its building. 1 In addition, Executive Order 9397 (Nov. 22, 1943) authorizes Federal agencies to use an individual's social security number to identify individuals in agency records.

Providing information collected as part of the New Hire Information Collection is voluntary. However, if certain information requested as part of the New Hire Information Collection is not provided by the new hire, the hiring process cannot be completed. 2

The Federal Trade Commission (“FTC” or “Commission”) issues this Policy Statement to provide guidance regarding its enforcement of various statutes and FTC regulations addressing negative option marketing and operating. 1 This Statement is intended to assist the business community and practitioners by providing specific guidance on the Commission's interpretation of existing law as it applies to negative option practices. This Statement may also assist the courts in developing an appropriate framework for interpreting and applying the various statutes and regulations addressing negative option marketing discussed herein.

Negative option offers come in a variety of forms, but all share a central feature: Each contains a term or condition under which the seller may interpret a consumer's silence or failure to take affirmative action to reject a good or service or to cancel the agreement as acceptance or continuing acceptance of the offer. 2 Typically, negative option arrangements include, but are not limited to, automatic renewals, continuity plans, free-to-pay or fee-to-pay conversions, and prenotification plans. Automatic renewals allow sellers ( e.g., a magazine publisher) to unilaterally renew consumers' subscriptions when they expire, unless consumers affirmatively cancel their subscriptions by a certain date. Continuity plans allow consumers to agree in advance to receive periodic shipments of goods or provision of services ( e.g., bottled water delivery), which they continue to receive until they cancel the agreement. Free trial marketing ( e.g., free-to-pay conversions) provides consumers the opportunity to receive goods or services for free (or at a nominal fee) for a trial period. After the trial period, sellers can automatically begin charging a fee (or higher fee) unless consumers affirmatively cancel or return the goods or services. Finally, under prenotification plans  3 ( e.g., book-of-the-month clubs), sellers provide periodic notices offering goods to participating consumers and then send—and charge for—those goods only if the consumers take no action to decline the offer. The periodic announcements and shipments can continue indefinitely. 4

Negative option programs are widespread in the marketplace and can provide substantial benefits for sellers and consumers. At the same time, consumers suffer costs when marketers fail to make adequate disclosures, bill consumers without their consent, or make cancellation difficult or impossible. Over the years, unfair or deceptive negative option practices have remained a persistent source of consumer harm, often saddling shoppers with recurring payments for products and services they did not intend to purchase or did not want to continue to purchase. 5 To address this problem, the Commission and states regularly bring cases challenging a variety of harmful negative option practices. These matters involve a range of deceptive or unfair practices, including inadequate disclosures of hidden charges in ostensibly “free” offers and other products or services, enrollment without consumer consent, and inadequate or overly burdensome cancellation and refund procedures. 6 In addition, the Commission receives thousands of complaints each year related to negative option marketing. The number of ongoing cases and high volume of complaints demonstrate there is prevalent, unabated consumer harm in the marketplace.

The FTC's enforcement actions primarily rely on Section 5 of the FTC Act (15 U.S.C. 45(a)), the Restore Online Shoppers' Confidence Act (“ROSCA”) (15 U.S.C. 8401 through 8405), and the Telemarketing Sales Rule (16 CFR part 310). However, the Rule on the Use of Prenotification Negative Option Plans (16 CFR part 425), the Electronic Fund Transfer Act (“EFTA”) (15 U.S.C. 1693 through 1693r), and the Postal Reorganization Act ( i.e., the Unordered Merchandise Statute) (39 U.S.C. 3009) also address various aspects of negative option marketing.

Section 5 of the FTC Act: Section 5 of the FTC Act, which prohibits unfair or deceptive acts or practices, is the core consumer protection statute enforced by the Commission, and therefore, has traditionally served as the primary mechanism for addressing deceptive negative option claims. 7 In its guidance and cases, the FTC has highlighted four basic Section 5 requirements negative option marketing must follow to comply with Section 5. 8 First, marketers must clearly and conspicuously disclose the material terms of a negative option offer including, at a minimum, key terms such as the existence of the negative option offer, the offer's total cost, and how to cancel the offer. 9 Second, sellers must disclose these material terms before consumers agree to the purchase. 10 Third, marketers must obtain consumers' express informed consent to such offers. 11 Finally, marketers must not erect unreasonable barriers to cancellation or impede the effective operation of promised cancellation procedures, and must honor cancellation requests that comply with such procedures. 12 Although these basic guidelines are useful, the legality of a particular negative option depends on an individualized assessment of the advertisement's net impression and the marketer's business practices. 13

ROSCA: Enacted by Congress in 2010 to address ongoing problems with online negative option marketing, ROSCA prohibits charging or attempting to charge consumers for goods or services sold on the internet through any negative option feature  14 unless the marketer: (1) Clearly and conspicuously discloses all material terms of the transaction  15 before obtaining the consumer's billing information; (2) obtains a consumer's express informed consent before charging the consumer's account;  16 and (3) provides simple mechanisms for the consumer to stop recurring charges. 17

ROSCA also addresses offers made by, or on behalf of, third-party sellers during, or immediately following, a transaction with an initial merchant. Specifically, ROSCA prohibits post-transaction, third-party sellers  18 from charging or attempting to charge consumers unless the seller: (1) Before obtaining billing information, clearly and conspicuously discloses the offer's material terms; and (2) receives the consumer's express informed consent by obtaining the consumer's name, address, contact information, as well as the full account number to be charged, and requiring the consumer to perform an additional affirmative action indicating consent. 19 ROSCA also prohibits initial merchants from disclosing billing information to any post-transaction third-party seller for use in any internet-based sale of goods or services. 20

Furthermore, ROSCA provides a violation of that Act is a violation of a Commission trade regulation rule under Section 18 of the FTC Act. 21 Thus, the Commission may seek a variety of remedies for violations of ROSCA, including civil penalties under Section 5(m)(1)(A) of the FTC Act;  22 injunctive relief under Section 13(b) of the FTC Act;  23 and consumer redress, such as damages, and other relief under Section 19 of the FTC Act. 24 Although Congress charged the Commission with enforcing ROSCA, it did not direct the FTC to promulgate implementing regulations. 25

Telemarketing Sales Rule: The TSR prohibits deceptive telemarketing acts or practices, including those involving negative option offers, and certain types of payment methods common in deceptive negative option marketing. Specifically, the TSR requires telemarketers to disclose all material terms and conditions of the negative option feature, including the need for affirmative consumer action to avoid the charges, the date (or dates) the charges will be submitted for payment, and the specific steps the customer must take to avoid the charges. It also prohibits telemarketers from misrepresenting such information and contains specific requirements related to payment authorization. 26 Finally, the TSR prohibits the use of payment methods often used in deceptive marketing, including negative options, such as remotely created checks. 27 The rule, however, only applies to negative option offers made over the telephone.

Prenotification Plan Rule: The Commission promulgated the “Use of Prenotification Negative Option Plans” Rule (“Prenotification Plan Rule”) (16 CFR part 425). 28 The Prenotification Plan Rule requires sellers of such plans to clearly and conspicuously disclose their plan's material terms before consumers subscribe. It enumerates seven material terms sellers must disclose: (1) How subscribers must notify the seller if they do not wish to purchase the selection; (2) any minimum purchase obligations; (3) the subscribers' right to cancel; (4) whether billing charges include postage and handling; (5) that subscribers have at least ten days to reject a selection; (6) that, if any subscriber is not given ten days to reject a selection, the seller will credit the return of the selection and postage to return the selection, along with shipping and handling; and (7) the frequency with which announcements and forms will be sent. 29 In addition, sellers must provide particular periods during which they will send introductory merchandise, give consumers a specified period to respond to announcements, provide instructions for rejecting merchandise in announcements, and promptly honor written cancellation requests. 30

The Prenotification Plan Rule applies only to plans like book-of-the-month clubs in which sellers provide periodic notices offering goods to participating consumers and then send—and charge for—those goods only if the consumers take no action to decline the offer. These types of plans, however, account for only a small fraction of current negative option marketing. Therefore, the rule does not reach most modern negative option marketing. 31

Other Relevant Requirements: EFTA  32 and the Unordered Merchandise Statute  33 also contain provisions relevant to negative option marketing. EFTA prohibits sellers from imposing recurring charges on a consumer's debit cards or bank accounts without written authorization. The Unordered Merchandise Statute provides that mailing unordered merchandise, or a bill for such merchandise, constitutes an unfair method of competition and an unfair trade practice in violation of Section 5 of the FTC Act.

Given the number of applicable statutory and regulatory requirements and the ongoing problems in the marketplace, the Commission now issues the following enforcement guidance based on its enforcement history. 34 This guidance covers three areas commonly addressed by the Commission in its negative option cases: Disclosures, consent, and cancellation. These principles convey the Commission's current views on the application of relevant statutes and regulations to negative option marketing and, as such, should help marketers in their compliance efforts and better understand how the Commission enforces the law.

Disclosures: ROSCA  35 requires marketers to clearly and conspicuously disclose the material terms of the transaction. 36 Pursuant to longstanding precedent, any express claim or deliberately implied claim is presumed to be material. 37 Moreover, the FTC's cases for failure to disclose under Section 5 of the FTC Act are generally consistent with ROSCA. 38 Those terms at minimum should include:

• Any material terms related to the underlying product or service that are necessary to prevent deception, regardless of whether that term directly relates to the terms of the negative option offer;  39

• That consumers will be charged  40 for the good or service, or that those charges will increase after any applicable trial period ends, and, if applicable, that the charges will be on a recurring basis, unless the consumer timely takes steps to prevent or stop such charges;

• Each deadline (by date or frequency) by which the consumer must act in order to stop the charges;

• The amount (or range of costs) the consumer will be charged or billed and, if applicable, the frequency of such charges a consumer will incur unless the consumer takes timely steps to prevent or stop those charges;

• The date (or dates) each charge will be submitted for payment; and

• All information necessary to cancel the contract.

• In any communication that is solely visual or solely audible, the disclosure should be made through the same means through which the communication is presented. In any communication made through both visual and audible means, such as a television advertisement, the disclosure should be presented simultaneously in both the visual and audible portions of the communication even if the representation requiring the disclosure is made in only one means.

• A visual disclosure, by its size, contrast, location, the length of time it appears, and other characteristics, should stand out from any accompanying text or other visual elements so it is easily noticed, read, and understood.

• An audible disclosure, including by telephone or streaming video, should be delivered in a volume, speed, and cadence sufficient for ordinary consumers to easily hear and understand it.

• In any communication using an interactive electronic medium, such as the internet or software, the disclosure should be unavoidable. A disclosure is not clear and conspicuous if a consumer needs to take any action, such as clicking on a hyperlink or hovering over an icon, to see it.

• The disclosure should use diction and syntax understandable to ordinary consumers and should appear in each language in which the representation that requires the disclosure appears.

• The disclosure should comply with these requirements in each medium through which it is received, including all electronic devices and face-to face communications.

• The disclosure should not be contradicted or mitigated by, or inconsistent with, anything else in the communication. 42

• When the representation or sales practice targets a specific audience, such as children, the elderly, or the terminally ill, “ordinary consumers” includes reasonable members of that group.

• if related to the negative option feature, appear immediately adjacent to the means of recording the consumer's consent for the negative option feature;

• if not related to the negative option feature, appear before consumers make a decision to buy ( e.g., before they “add to shopping cart”); and

• not contain any other information that interferes with, detracts from, contradicts, or otherwise undermines the ability of consumers to read and understand the disclosures, including any information not directly related to the material terms and conditions of any negative option feature.

For all telephone and other oral offers, the disclosures should not contain any other information that interferes with, detracts from, contradicts, or otherwise undermines the ability of consumers to understand the disclosures, including any information not directly related to the material terms and conditions of any negative option feature.

Consent:   43 ROSCA, judicial decisions applying Section 5, and cases brought by the Commission under those laws make clear marketers should obtain the consumer's express informed consent before charging the consumer. 44 To attain express informed consent, the negative option seller should:

• obtain the consumer's acceptance of the negative option feature offer separately from any other portion of the entire transaction;

• not include any information that interferes with, detracts from, contradicts, or otherwise undermines the ability of consumers to provide their express informed consent to the negative option feature;  45

• obtain the consumer's unambiguously affirmative consent to the negative option feature;  46

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human biologic product SEVENFACT (coagulation factor VIIa (recombinant)-jncw (eptacog beta)). SEVENFACT is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors. Subsequent to this approval, the USPTO received a patent term restoration application for SEVENFACT (U.S. Patent No. 9,029,316) from Laboratoire Francais du Fractionnement et des Biotechnologies S.A. (LFB S.A.), and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated January 4, 2021, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of SEVENFACT represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for SEVENFACT is 2,785 days. Of this time, 1,518 days occurred during the testing phase of the regulatory review period, while 1,267 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 18, 2012. The applicant claims August 17, 2012, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was August 18, 2012, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): October 13, 2016. FDA has verified the applicant's claim that the biologics license application (BLA) for SEVENFACT (BLA 125641) was initially submitted on October 13, 2016.

3. The date the application was approved: April 1, 2020. FDA has verified the applicant's claim that BLA 125641 was approved on April 1, 2020.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 482 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human biologic product ADAKVEO (crizanlizumab-tmca). ADAKVEO is indicated to reduce the frequency of vaso-occlusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease. Subsequent to this approval, the USPTO received a patent term restoration application for ADAKVEO (U.S. Patent Nos. 8,377,440 and 9,556,266) from Novartis AG, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 14, 2020, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of ADAKVEO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for ADAKVEO is 3,152 days. Of this time, 2,968 days occurred during the testing phase of the regulatory review period, while 184 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: April 1, 2011. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on April 1, 2011.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): May 16, 2019. FDA has verified the applicant's claim that the biologics license application (BLA) for ADAKVEO (BLA 761128) was initially submitted on May 16, 2019.

3. The date the application was approved: November 15, 2019. FDA has verified the applicant's claim that BLA 761128 was approved on November 15, 2019.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,323 or 601 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product, AKLIEF (trifarotene), which is indicated for topical treatment of acne vulgaris in patients 9 years of age and older. Subsequent to this approval, the USPTO received patent term restoration applications for AKLIEF (U.S. Patent Nos. 7,807,708; 8,227,507; and 8,470,871) from Galderma Research & Development, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated December 14, 2020, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of AKLIEF represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for AKLIEF is 3,137 days. Of this time, 2,771 days occurred during the testing phase of the regulatory review period, while 366 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: March 5, 2011. The applicant claims June 8, 2011, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was March 5, 2011, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: October 4, 2018. FDA has verified the applicant's claim that the new drug application (NDA) for AKLIEF (NDA 211527) was initially submitted on October 4, 2018.

3. The date the application was approved: October 4, 2019. FDA has verified the applicant's claim that NDA 211527 was approved on October 4, 2019.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 5 years, or 1,498 days, or 1,329 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product, SCENESSE (afamelanotide acetate) indicated to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporpyria. Subsequent to this approval, the USPTO received a patent term restoration application for SCENESSE (U.S. Patent No. 8,334,265) from Clinuvel Pharmaceuticals Limited, and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated May 26, 2020, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of SCENESSE represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for SCENESSE is 3,914 days. Of this time, 3,579 days occurred during the testing phase of the regulatory review period, while 335 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: January 21, 2009. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on January 21, 2009.

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: November 8, 2018. The applicant claims June 21, 2018, as the date the new drug application (NDA) for SCENESSE (NDA 210797) was initially submitted. However, FDA records indicate that NDA 210797, submitted on June 21, 2018, was incomplete. The completed NDA was then submitted on November 8, 2018, which is considered to be the initially submitted date.

3. The date the application was approved: October 8, 2019. FDA has verified the applicant's claim that NDA 210797 was approved on October 8, 2019.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,481 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FDA is announcing the availability of a document entitled “Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers; Guidance for Industry.” The guidance document provides blood establishments that collect or process blood and blood components with recommendations for implementing a pathogen reduction device for the manufacture of pathogen-reduced blood components. The guidance, in a question-and-answer format, addresses the most frequently asked questions on this topic. The guidance also provides recommendations to licensed manufacturers on reporting the manufacturing changes associated with implementation of a pathogen reduction device under 21 CFR 601.12.

The recommendations in the guidance apply to blood establishments that intend to manufacture pathogen-reduced platelet and plasma products using an FDA approved pathogen reduction device. Currently, the INTERCEPT® Blood System has been approved for the manufacture of certain pathogen-reduced platelet and plasma products. If the product platforms for this FDA approved device change, or FDA approves another pathogen reduction device with a similar intended use in the future, the Agency will consider providing additional recommendations to blood establishments.

In the Federal Register of December 27, 2017 (82 FR 61304), FDA announced the availability of the draft document entitled “Implementation of Pathogen Reduction Technology in the Manufacture of Blood Components in Blood Establishments: Questions and Answers; Draft Guidance for Industry.” FDA received a few comments on the draft guidance. The comments addressed various issues, including the indications for use of the INTERCEPT® Blood System for Platelets and Plasma; sampling plans for quality control and validation of the manufacturing process in blood establishments; labeling of pathogen reduced blood components; submissions to FDA for changes to an approved application; and requirements for licensure of pathogen reduced blood components. One comment raised a concern that the guidance addresses a single product. FDA made changes to the guidance to reflect revised labeling for the INTERCEPT® Blood System, and to improve clarity of the recommendations, including those related to quality control and submissions to FDA. Additionally, FDA changed the title of the guidance to clarify that the purpose of the guidance is to provide recommendations for implementing a pathogen reduction device in blood establishments, as opposed to providing recommendations regarding the clinical use of products. However, FDA did not make substantive changes to the guidance in response to the public comments. The guidance announced in this notice finalizes the draft guidance dated December 2017.

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 the manufacture of blood components using a pathogen reduction device in blood establishments. 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 refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338; the collections of information in 21 CFR parts 606 and 630 have been approved under OMB control number 0910-0116.

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

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human biologic product DENGVAXIA (dengue tetravalent vaccine, Live). DENGVAXIA is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas. Subsequent to this approval, the USPTO received a patent term restoration application for DENGVAXIA (U.S. Patent No. 8,142,795) from Sanofi Pasteur, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated December 26, 2019, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of DENGVAXIA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for DENGVAXIA is 5,710 days. Of this time, 5,466 days occurred during the testing phase of the regulatory review period, while 244 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: September 14, 2003. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on September 14, 2003.

2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): August 31, 2018. The applicant claims August 30, 2018, as the date the biologics license application (BLA) for DENGVAXIA (BLA 125682) was initially submitted. However, FDA records indicate that BLA 125682 was submitted on August 31, 2018.

3. The date the application was approved: May 1, 2019. FDA has verified the applicant's claim that BLA 125682 was approved on May 1, 2019.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,248 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product, RECARBRIO. RECARBRIO is a combination of cilastatin, imipenem, and relebactam indicated in patients 18 years of age and older who have limited or no alternative treatment options for the treatment of the following infections caused by susceptible gram-negative bacteria: Complicated urinary tract infections, including pyelonephritis, and complicated intra-abdominal infections. Approval of these indications is based on limited clinical safety and efficacy data for RECARBRIO. Subsequent to this approval, the USPTO received a patent term restoration application for RECARBRIO (U.S. Patent No. 8,487,093) from Merck Sharp & Dohme Corp., and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated January 4, 2021, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of RECARBRIO represented the first permitted commercial marketing or use of relebactam, one of the three active ingredients in the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for RECARBRIO is 3,200 days. Of this time, 2,957 days occurred during the testing phase of the regulatory review period, while 243 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: October 13, 2010. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on October 13, 2010.

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: November 16, 2018. FDA has verified the applicant's claim that the new drug application (NDA) for RECARBRIO (NDA 212819) was initially submitted on November 16, 2018.

3. The date the application was approved: July 16, 2019. FDA has verified the applicant's claim that NDA 212819 was approved on July 16, 2019.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,218 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The purpose of this draft guidance is to describe FDA's thinking on the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of the safety and effectiveness of device software functions. This thinking recognizes recent changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (Pub. L. 114-255), which amended section 520 of the FD&C Act (21 U.S.C. 360) and excludes certain software functions from the device definition. It also considers the rapidly evolving nature of digital health and recent FDA-recognized consensus standards related to software.

This draft guidance identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. The recommendations in this draft guidance also may help facilitate FDA's premarket review. This draft guidance describes information that typically would be generated and documented during software development, verification, and design validation. The least burdensome approach was applied to identify the minimum amount of information that, based on our experience, would generally be needed to support a premarket submission for a device that uses software. During premarket review, FDA may request additional information that is needed to evaluate the submission.

When final, this document will replace FDA's “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” issued on May 11, 2005, and it will update FDA's thinking related to the documentation recommended for the review of device software functions in premarket submissions.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Content of Premarket Submissions for Device Software Functions.” 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 interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download an electronic copy of “Content of Premarket Submissions for Device Software Functions” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 337 and complete title to identify the guidance you are requesting.

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 the following FDA regulations, guidance, and forms have been approved by OMB as listed in the following table:

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

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

Under section 243 of the Public Health Service Act (42 U.S.C. 243), FDA is required to cooperate with and aid State and local authorities in the enforcement of their health regulations and are authorized to assist States in the prevention and suppression of communicable diseases. Under this authority, FDA participates with State regulatory agencies, some foreign nations, and the U.S. molluscan shellfish industry in the NSSP.

The NSSP is a voluntary, cooperative program to promote the safety of molluscan shellfish by providing for the classification and patrol of shellfish growing waters and for the inspection and certification of shellfish dealers. Each participating State and foreign nation monitors its molluscan shellfish production and issues certificates for those dealers that meet the State or foreign shellfish control authority's criteria. Each participating State and nation provides a certificate of its certified shellfish dealers to FDA on Form FDA 3038, “Interstate Shellfish Dealer's Certificate” (available at https://www.fda.gov/media/72094/download ). FDA uses this information to publish the “Interstate Certified Shellfish Shippers List (ICSSL),” a monthly comprehensive listing of all molluscan shellfish dealers certified under the cooperative program (available at https://www.fda.gov/food/federalstate-food-programs/interstate-certified-shellfish-shippers-list ). If FDA did not collect the information necessary to compile this list, participating States would not be able to identify and prevent the distribution in the United States of shellfish processed by uncertified dealers. Consequently, the NSSP would not be able to control the distribution of uncertified and possibly unsafe shellfish in interstate commerce. Without the ICSSL, the effectiveness of the NSSP would be nullified. The ICSSL is also used to identify U.S. shellfish dealers eligible to obtain health certificates and export to certain countries or regions.

FDA has been collecting information to construct the ICSSL since 2001. FDA is seeking to add one new data field to the Form FDA 3038, the “FDA Establishment Identifier” (FEI number). The FEI number is a unique number assigned by FDA to identify FDA-regulated facilities. FDA will explore whether the FEI can be used to retrieve data on shellfish dealers from existing FDA systems, which could reduce the number of required data elements that firms have to submit on Form FDA 3038.

The information collection also includes providing certain documents demonstrating compliance with the NSSP. When a competent authority in another country conducts an evaluation to determine whether the U.S. food safety control measures for molluscan shellfish are equivalent to their system of controls, the competent authority may require FDA to provide information and records demonstrating compliance with the provisions of the NSSP. Only those firms that comply with the NSSP would be permitted to export molluscan shellfish to a country whose competent authority determined that the U.S. system of controls is equivalent to their own controls. If approved, FDA will use this information to support the export of U.S. shellfish to countries whose competent authorities have determined the U.S. system of food safety controls to be equivalent to their own system of controls by demonstrating that the exporter is in compliance with the U.S. system of controls specified in the NSSP.

For example, to implement the European Commission's (EC) determination that the U.S. system of food safety controls for raw bivalve molluscan shellfish is equivalent to the European Union's (EU) system of controls, the EC is requiring FDA to provide documentation collected from NSSP-participating shellfish control authorities with firms seeking to export raw molluscan shellfish to the EU. This documentation includes, but is not limited to:

• A list of growing areas with an Approved classification;

• the most recent sanitary survey for each growing area with an Approved classification; and

• the most recent inspection report for each firm seeking to export shellfish to the EU.

The examples above are illustrative. Some competent authorities may require additional information to conduct an equivalence assessment or to implement an equivalence determination, or both. We plan to provide respondents with information about the specific documentation that is required for each equivalence assessment. For those competent authorities that recognize the U.S. system as equivalent, additional documentation may be needed to implement that determination.

Description of Respondents: Respondents to this collection are participating State and local regulatory agencies and foreign nations.

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. This estimate is based on our experience with this information collection and the number of certificates received in the past 3 years, which has remained constant.