Federal Register Vol. 83, No.148,

Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), the regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered “regulated articles.”

The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. APHIS received a petition (APHIS Petition Number 17-292-01p) from Texas A&M AgriLife Research of College Station, TX (Texas A&M), seeking a determination of nonregulated status of cotton (Gossypium hirsutum) designated as event TAM66274, which has been genetically engineered for ultra-low gossypol levels in the cottonseed. The Texas A&M petition states that information collected during field trials and laboratory analyses indicates that TAM66274 cotton is not likely to be a plant pest and therefore should not be a regulated article under APHIS' regulations in 7 CFR part 340.

According to our process 1 for soliciting public comment when considering petitions for determinations of nonregulated status of GE organisms, APHIS accepts written comments regarding a petition once APHIS deems it complete. In a notice 2 published in the Federal Register on December 5, 2017 (82 FR 57426-57427, Docket No. APHIS-2017-0097), APHIS announced the availability of the Texas A&M petition for public comment. APHIS solicited comments on the petition for 60 days ending on February 5, 2018, in order to help identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition. APHIS received 47 comments on the petition. Of those, 44 were supportive, two opposed, and one was not related to the petition. APHIS has evaluated the issues raised during the comment period and, where appropriate, has provided a discussion of these issues in our draft environmental assessment (EA).

After public comments are received on a completed petition, APHIS evaluates those comments and then provides a second opportunity for public involvement in our decisionmaking process. According to our public review process (see footnote 1), the second opportunity for public involvement follows one of two approaches, as described below.

If APHIS decides, based on its review of the petition and its evaluation and analysis of comments received during the 60-day public comment period on the petition, that the petition involves a GE organism that raises no substantive new issues, APHIS will follow Approach 1 for public involvement. Under Approach 1, APHIS announces in the Federal Register the availability of APHIS' preliminary regulatory determination along with its draft EA, preliminary finding of no significant impact (FONSI), and its draft plant pest risk assessment (PPRA) for a 30-day public review period. APHIS will evaluate any information received related to the petition and its supporting documents during the 30-day public review period.

If APHIS decides, based on its review of the petition and its evaluation and analysis of comments received during the 60-day public comment period on the petition, that the petition involves a GE organism that raises substantive new issues, APHIS will follow Approach 2. Under Approach 2, APHIS first solicits written comments from the public on a draft EA and draft PPRA for a 30-day comment period through the publication of a Federal Register notice. Then, after reviewing and evaluating the comments on the draft EA and draft PPRA and other information, APHIS will revise the PPRA as necessary and prepare a final EA and, based on the final EA, a National Environmental Policy Act (NEPA) decision document (either a FONSI or a notice of intent to prepare an environmental impact statement). For this petition, we are using Approach 2.

As part of our decisionmaking process regarding a GE organism's regulatory status, APHIS prepares a PPRA to assess the plant pest risk of the article. APHIS also prepares the appropriate environmental documentation—either an EA or an environmental impact statement—in accordance with NEPA, to provide the Agency and the public with a review and analysis of any potential environmental impacts that may result if the petition request is approved.

APHIS has prepared a draft PPRA and has concluded that cotton designated as event TAM66274, which has been genetically engineered for ultra-low gossypol levels in the cottonseed, is unlikely to pose a plant pest risk. In section 403 of the Plant Protection Act, “plant pest” is defined as any living stage of any of the following that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product: A protozoan, a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or viroid, an infectious agent or other pathogen, or any article similar to or allied with any of the foregoing.

APHIS has also prepared a draft EA in which we present two alternatives based on our analysis of data submitted by Texas A&M, a review of other scientific data, field tests conducted under APHIS oversight, and comments received on the petition. APHIS is considering the following alternatives: (1) Take no action, i.e., APHIS would not change the regulatory status of cotton designated as event TAM66274, or (2) make a determination of nonregulated status of cotton designated as event TAM66274.

The draft EA was prepared in accordance with (1) NEPA, as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) U.S. Department of Agriculture regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

In accordance with our process for soliciting public input when considering petitions for determinations of nonregulated status for GE organisms, we are publishing this notice to inform the public that APHIS will accept written comments on our draft EA and our draft PPRA regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 30 days from the date of this notice. Copies of the draft EA and the draft PPRA, as well as the previously published petition, are available as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.

After the 30-day comment period closes, APHIS will review and evaluate any information received during the comment period and any other relevant information. After reviewing and evaluating the comments on the draft EA and the draft PPRA and other information, APHIS will revise the PPRA as necessary and prepare a final EA. Based on the final EA, APHIS will prepare a NEPA decision document (either a FONSI or a notice of intent to prepare an environmental impact statement). If a FONSI is reached, APHIS will furnish a response to the petitioner, either approving or denying the petition. APHIS will also publish a notice in the Federal Register announcing the regulatory status of the GE organism and the availability of APHIS' final EA, PPRA, FONSI, and our regulatory determination.

The original corrected notice of intent for public comment on the greater sage-grouse plan amendments was published in the Federal Register on July 2, 2018 (83 FR 30909). The original notice of intent provided a 30 day comment period, which may be insufficient for comment preparation from all interested parties. As such, the comment period for the original notice is being extended by 14 days.

If the Forest Service amends land management plans, we hereby give notice that substantive requirements of the 2012 Planning Rule (36 CFR part 219) that are likely to be directly related, and therefore applicable, to the amendments are in sections 219.8(a) and (b) (ecological and social and economic sustainability), 219.9 (diversity of plant and animal communities), and 219.10(a) (integrated resource management for ecosystem services and multiple use).

The public is encouraged to help identify any issues, management questions, or concerns that should be addressed in plan amendment(s) or policy or administrative action. The Forest Service will work collaboratively with interested parties to identify the management direction that is best suited to local, regional, and national needs and concerns. The Forest Service will use an interdisciplinary approach as it considers the variety of resource issues and concerns.

Background

On June 11, 2018, the Department of Commerce (Commerce) initiated a countervailing duty (CVD) investigation of imports of steel propane cylinders from the People's Republic of China (China).1 Currently, the preliminary determination is due no later than August 15, 2018.

Section 703(b)(1) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in a countervailing duty investigation within 65 days after the date on which Commerce initiated the investigation. However, section 703(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 130 days after the date on which Commerce initiated the investigation if: (A) The petitioner 2 makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination. Under 19 CFR 351.205(e), the petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reasons for the request. Commerce will grant the request unless it finds compelling reasons to deny the request.

On July 20, 2018, the petitioners submitted a timely request that Commerce postpone the preliminary CVD determination.3 The petitioners stated that the purpose of their request is to provide Commerce with adequate time to analyze fully questionnaire responses from the Government of China and the mandatory respondents and to determine the extent to which the respondents received countervailable subsidies.4 In accordance with 19 CFR 351.205(e), the petitioners have stated the reasons for requesting a postponement of the preliminary determination, and Commerce finds no compelling reason to deny the request. Therefore, in accordance with section 703(c)(1)(A) of the Act, Commerce is postponing the deadline for the preliminary determination to no later than 130 days after the date on which this investigation was initiated, i.e., October 19, 2018. Pursuant to section 705(a)(1) of the Act and 19 CFR 351.210(b)(1), the deadline for the final determination of this investigation will continue to be 75 days after the date of the preliminary determination.

This notice is issued and published pursuant to section 703(c)(2) of the Act and 19 CFR 351.205(f)(1).

Background

Commerce's procedures for the conduct of Sunset Reviews are set forth in its Procedures for Conducting Five-Year (Sunset) Reviews of Antidumping and Countervailing Duty Orders, 63 FR 13516 (March 20, 1998) and 70 FR 62061 (October 28, 2005). Guidance on methodological or analytical issues relevant to Commerce's conduct of Sunset Reviews is set forth in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Duty Proceedings; Final Modification, 77 FR 8101 (February 14, 2012).

In accordance with section 751(c) of the Act and 19 CFR 351.218(c), we are initiating the Sunset Reviews of the following antidumping and countervailing duty order(s):

As a courtesy, we are making information related to sunset proceedings, including copies of the pertinent statute and Commerces's regulations, Commerce's schedule for Sunset Reviews, a listing of past revocations and continuations, and current service lists, available to the public on Commerce's website at the following address: http://enforcement.trade.gov/sunset/. All submissions in these Sunset Reviews must be filed in accordance with Commerce's regulations regarding format, translation, and service of documents. These rules, including electronic filing requirements via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS), can be found at 19 CFR 351.303.1

Any party submitting factual information in an AD/CVD proceeding must certify to the accuracy and completeness of that information.2 Parties must use the certification formats provided in 19 CFR 351.303(g).3 Commerce intends to reject factual submissions if the submitting party does not comply with applicable revised certification requirements.

On April 10, 2013, Commerce modified two regulations related to AD/CVD proceedings: the definition of factual information (19 CFR 351.102(b)(21)), and the time limits for the submission of factual information (19 CFR 351.301).4 Parties are advised to review the final rule, available at http://enforcement.trade.gov/frn/2013/1304frn/2013-08227.txt, prior to submitting factual information in these segments. To the extent that other regulations govern the submission of factual information in a segment (such as 19 CFR 351.218), these time limits will continue to be applied. Parties are also advised to review the final rule concerning the extension of time limits for submissions in AD/CVD proceedings, available at http://enforcement.trade.gov/frn/2013/1309frn/2013-22853.txt, prior to submitting factual information in these segments.5

Pursuant to 19 CFR 351.103(d), Commerce will maintain and make available a public service list for these proceedings. Parties wishing to participate in any of these five-year reviews must file letters of appearance as discussed at 19 CFR 351.103(d)). To facilitate the timely preparation of the public service list, it is requested that those seeking recognition as interested parties to a proceeding submit an entry of appearance within 10 days of the publication of the Notice of Initiation. Because deadlines in Sunset Reviews can be very short, we urge interested parties who want access to proprietary information under administrative protective order (APO) to file an APO application immediately following publication in the Federal Register of this notice of initiation. Commerce's regulations on submission of proprietary information and eligibility to receive access to business proprietary information under APO can be found at 19 CFR 351.304-306.

Domestic interested parties, as defined in section 771(9)(C), (D), (E), (F), and (G) of the Act and 19 CFR 351.102(b), wishing to participate in a Sunset Review must respond not later than 15 days after the date of publication in the Federal Register of this notice of initiation by filing a notice of intent to participate. The required contents of the notice of intent to participate are set forth at 19 CFR 351.218(d)(1)(ii). In accordance with Commerce's regulations, if we do not receive a notice of intent to participate from at least one domestic interested party by the 15-day deadline, Commerce will automatically revoke the order without further review.6

If we receive an order-specific notice of intent to participate from a domestic interested party, Commerce's regulations provide that all parties wishing to participate in a Sunset Review must file complete substantive responses not later than 30 days after the date of publication in the Federal Register of this notice of initiation. The required contents of a substantive response, on an order-specific basis, are set forth at 19 CFR 351.218(d)(3). Note that certain information requirements differ for respondent and domestic parties. Also, note that Commerce's information requirements are distinct from the Commission's information requirements. Consult Commerce's regulations for information regarding Commerce's conduct of Sunset Reviews. Consult Commerce's regulations at 19 CFR part 351 for definitions of terms and for other general information concerning antidumping and countervailing duty proceedings at Commerce.

This notice of initiation is being published in accordance with section 751(c) of the Act and 19 CFR 351.218(c).

Background

In accordance with sections 735(d) and 777(i)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.210(c), on June 18, 2018, Commerce published its affirmative final determination in the less-than-fair-value (LTFV) investigation of ripe olives from Spain.1 On July 25, 2018, the ITC notified Commerce of its final determination pursuant to section 735(b)(1)(A) of the Act that an industry in the United States is materially injured by reason of the LTFV imports of ripe olives from Spain.2

The merchandise covered by this order is ripe olives. For a complete description of the scope of the order, see the Appendix to this notice.

On July 25, 2018, in accordance with sections 735(b)(1)(A) and 735(d) of the Act, the ITC notified Commerce of its final determination in this investigation, in which it found that an industry in the United States is materially injured by reason of imports of ripe olives from Spain that are sold in the United States at LTFV.3 Therefore, in accordance with section 735(c)(2) of the Act, we are issuing this antidumping duty order. Because the ITC determined that imports of ripe olives from Spain are materially injuring a U.S. industry, unliquidated entries of such merchandise from Spain, entered or withdrawn from warehouse for consumption, are subject to the assessment of antidumping duties.

Therefore, in accordance with section 736(a)(1) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, antidumping duties equal to the amount by which the normal value of the merchandise exceeds the export price (or constructed export price) of the merchandise, for all relevant entries of ripe olives from Spain. Antidumping duties will be assessed on unliquidated entries of ripe olives from Spain entered, or withdrawn from warehouse, for consumption on or after January 26, 2018, the date of publication of the Preliminary Determination, 4 but will not be assessed on entries occurring after the expiration of the provisional measures period and before publication of the ITC's final injury determination as further described below.

In accordance with section 735(c)(1)(B) of the Act, Commerce will instruct CBP to continue to suspend liquidation of all appropriate entries of ripe olives from Spain as described in the Appendix to this notice, which were entered, or withdrawn from warehouse, for consumption on or after January 26, 2018, the date of publication of the preliminary determination of this investigation in the Federal Register. These instructions suspending liquidation will remain in effect until further notice.

Pursuant to section 735(c)(1)(B) of the Act and 19 CFR 351.210(d), Commerce will instruct CBP to require cash deposits equal to the amounts indicated below. Accordingly, effective on the date of publication of the ITC's final affirmative injury determination, CBP will require, at the same time as importers would normally deposit estimated antidumping duties on this subject merchandise, a cash deposit equal to the cash deposit rates listed below.5 The all-others rate applies to producers or exporters not specifically listed, as appropriate. For the purpose of determining cash deposit rates, the estimated weighted-average dumping margins for imports of subject merchandise have been adjusted, as appropriate, for estimated domestic subsidy pass-through rates calculated based on the final determination of the companion countervailing duty investigation of ripe olives from Spain.6

Section 733(d) of the Act states that suspension of liquidation pursuant to an affirmative preliminary determination may not remain in effect for more than four months, except where exporters representing a significant proportion of exports of the subject merchandise request Commerce to extend that four-month period to no more than six months. At the request of exporters that account for a significant proportion of ripe olives from Spain, Commerce extended the four-month period to six months.7 In the underlying investigation, Commerce published the preliminary determination on January 26, 2018. Therefore, the extended period, beginning on the date of publication of the Preliminary Determination, ended on July 24, 2018. Furthermore, section 737(b) of the Act states that definitive duties are to begin on the date of publication of the ITC's final injury determination.

Therefore, in accordance with section 733(d) of the Act and our practice,8 we will instruct CBP to terminate the suspension of liquidation and to liquidate, without regard to antidumping duties, unliquidated entries of ripe olives from Spain entered, or withdrawn from warehouse, for consumption after July 24, 2018, the date the provisional measures expired, through the day preceding the date of publication of the ITC's final injury determination in the Federal Register. Suspension of liquidation will resume on the date of publication of the ITC's final determination in the Federal Register.

Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. Section 302(b)(1) of the Export Trading Company Act of 1982 and 15 CFR 325.6(a) require the Secretary to publish a notice in the Federal Register identifying the applicant and summarizing its proposed export conduct.

Interested parties may submit written comments relevant to the determination whether an amended Certificate should be issued. If the comments include any privileged or confidential business information, it must be clearly marked and a nonconfidential version of the comments (identified as such) should be included. Any comments not marked as privileged or confidential business information will be deemed to be nonconfidential.

An original and five (5) copies, plus two (2) copies of the nonconfidential version, should be submitted no later than 20 days after the date of this notice to: Office of Trade and Economic Analysis, International Trade Administration, U.S. Department of Commerce, Room 21028, Washington, DC 20230.

Information submitted by any person is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552). However, nonconfidential versions of the comments will be made available to the applicant if necessary for determining whether or not to issue the amended Certificate. Comments should refer to this application as “Export Trade Certificate of Review, application number 01-1A001.”

A summary of the current application follows.

Applicant: Ginseng & Herb Cooperative, 3899 Co Rd B, Marathon, WI 54448.

Contact: Glenn Heier, President, (715) 443-3355.

Application No.: 01-1A001.

Date Deemed Submitted: July 18, 2018.

Proposed Amendment: GBW (the Certificate holder) and Ginseng & Herb Cooperative (“GHC”; currently a Member) seek to amend the Certificate as follows:

1. Remove GBW as the Certificate holder and issue the Certificate to GHC,

2. Remove all references to GBW and the GBW Seal,

3. Remove all references to Members,

4. Remove all references to Mechthild Handke,

5. Remove all references to Ginseng Research Institute of America, Inc. (“GRIA”), and

6. Remove reference to the supplier lottery.

Additionally, GHC seeks to change the list of Products under the Export Trade section of the Certificate from “cultivated ginseng and cultivated ginseng products; cultivated golden seal and cultivated golden seal products; cultivated echinacea and cultivated echinacea products” to “cultivated ginseng and cultivated ginseng products, including wholesale ginseng roots, ginseng capsules 500 mg, ginseng slices, ginseng tea, ginseng powder and fiber, and ginseng retail root.”

The Export Trade Activities and Methods of Operation currently covered by the Certificate as published in the Federal Register on January 31, 2001 (66 FR 8386) will be amended consistent with the above listed proposed changes.

In accordance with section 735(d) and 777(i)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.210(c), on June 11, 2018, Commerce published its affirmative Final Determination in the less than fair value (LTFV) investigation of stainless steel flanges from China.1 On July 25, 2018, the ITC notified Commerce of its final determination pursuant to section 735(d) of the Act, that an industry in the United States is materially injured by reason of LTFV imports of stainless steel flanges from China, within the meaning of section 735(b)(1)(A) of the Act.2

The products covered by this order are stainless steel flanges from China. For a complete description of the scope of the order, see the Appendix to this notice.

In accordance with sections 735(b)(1)(A) and 735(d) of the Act, the ITC has notified Commerce of its final determination in this investigation, in which it found that imports of stainless steel flanges from China are materially injuring a U.S. industry.3 Therefore, in accordance with sections 735(c)(2) and 736(a) of the Act, we are publishing this antidumping duty order.

As a result of the ITC's final determination, in accordance with section 736(a)(1) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, antidumping duties equal to the amount by which the normal value of the merchandise exceeds the export price (or constructed export price) of the merchandise, for all relevant entries of stainless steel flanges from China. These antidumping duties will be assessed on unliquidated entries of stainless steel flanges from China entered, or withdrawn from warehouse, for consumption on or after March 28, 2018, the date on which Commerce published the Preliminary Determination, 4 but will not include entries occurring after the expiration of the provisional measures period and before publication of the ITC's final injury determination, as further described below.

In accordance with section 735(c)(1)(B) of the Act, we will instruct CBP to continue to suspend liquidation on entries of subject merchandise from China. We will also instruct CBP to require cash deposits equal to the estimated amount by which the normal value exceeds the U.S. price as indicated in the chart below. These instructions suspending liquidation will remain in effect until further notice.

Accordingly, effective on the date of publication of the ITC's final affirmative injury determination, CBP will require, at the same time as importers would normally deposit estimated duties on this subject merchandise, a cash deposit equal to the estimated antidumping duty margin.5 The “China-wide” rate applies to all exporters of subject merchandise not specifically listed in the table below.

Section 733(d) of the Act states that instructions to suspend liquidation issued pursuant to an affirmative preliminary determination may not remain in effect for more than four months, except where exporters representing a significant proportion of exports of subject merchandise request to extend the four-month period to six months. Therefore, the four-month period beginning on March 28, 2018, the date of publication of the Preliminary Determination, ended on July 25, 2018. Furthermore, section 737(b) of the Act states that definitive duties are to begin on the date of publication of the ITC's final injury determination.

Therefore, in accordance with section 733(d) of the Act and our practice, we will instruct CBP to terminate the suspension of liquidation and to liquidate, without regard to antidumping duties, unliquidated entries of stainless steel flanges from China entered, or withdrawn from warehouse, for consumption on or after July 26, 2018, the day after which the provisional measures expired, until and through the day preceding the date of publication of the ITC's final injury determination in the Federal Register. Suspension of liquidation will resume on the date of publication of the ITC's final determination in the Federal Register.

Commerce determines that the estimated final weighted-average dumping margins are as follows:

This notice constitutes the antidumping duty order with respect to stainless steel flanges from China, pursuant to section 736(a) of the Act. Interested parties can find a list of antidumping duty orders currently in effect at http://enforcement.trade.gov/stats/iastats1.html.

This order is issued and published in accordance with section 736(a) of the Act and 19 CFR 351.211(b).

Background

In accordance with sections 705(a), 705(d), and 777(i)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.210(c), on June 18, 2018, Commerce published in the Federal Register an affirmative final determination in the CVD investigation of ripe olives from Spain.1 Interested parties submitted timely filed allegations that Commerce made certain ministerial errors in the final CVD determination of ripe olives from Spain. Section 705(e) of the Act and 19 CFR 351.224(f) define ministerial errors as errors in addition, subtraction, or other arithmetic function, clerical errors resulting from inaccurate copying, duplication, or the like, and any other type of unintentional error which the Commerce considers ministerial. We reviewed the allegations and determined that we made certain ministerial errors. See “Amendment to the Final Determination” section below for further discussion.

On July 25, 2018, the ITC notified Commerce of its affirmative determination pursuant to sections 705(b)(1)(A)(i) and 705(d) of the Act, that an industry in the United States is materially injured by reason of subsidized imports of ripe olives from Spain.2

The merchandise covered by this order is ripe olives from Spain. For a complete description of the scope of this order, see the Appendix to this notice.

On June 19, 2018, the petitioner,3 Aceitunas Guadalquivir S.L.U. (Aceitunas Guadalquivir), and Angel Camacho Alimentación, S.L. (Angel Camacho) timely alleged that the Final Determination contained certain ministerial errors and requested that Commerce correct such errors. On June 25, 2018, the petitioner filed rebuttal comments.

Commerce reviewed the record and, on July 12, 2018, agreed that certain errors referenced in the petitioner's and Angel Camacho's allegations constitute ministerial errors within the meaning of section 705(e) of the Act and 19 CFR 351.224(f).4 Commerce did not agree that the error alleged in Aceitunas Guadalquivir's submission constituted a ministerial error. Commerce found that it made errors in calculating Angel Camacho's benefit under the European Union Common Agricultural Policy Pillar I: Basic Payment Scheme—Greening program, and in attributing to Angel Camacho subsidies received by its cross-owned input suppliers.5 Pursuant to 19 CFR 351.224(e), Commerce is amending the Final Determination to reflect the correction of the ministerial errors described above. Based on our correction of the ministerial errors in Angel Camacho's calculation, the subsidy rate for Angel Camacho increased from 13.22 percent ad valorem to 13.76 percent ad valorem. 6 Because in the Final Determination we based the “all-others” rate, in part, on Angel Camacho's ad valorem subsidy rate,7 the correction described above also required that we recalculate the “all-others” rate. This recalculation increases the “all-others” rate determined in the Final Determination from 14.75 percent ad valorem to 14.97 percent ad valorem. 8

On July 25, 2018, in accordance with sections 705(b)(1)(A)(i) and 705(d) of the Act, the ITC notified Commerce of its final determination in this investigation, in which it found that an industry in the United States is materially injured by reason of subsidized imports of ripe olives from Spain. Therefore, in accordance with section 705(c)(2) of the Act, we are issuing this CVD order. Because the ITC determined that imports of ripe olives from Spain are materially injuring a U.S. industry, unliquidated entries of such merchandise from Spain, entered or withdrawn from warehouse for consumption, are subject to the assessment of countervailing duties.

Therefore, in accordance with section 706(a) of the Act, Commerce will direct United States Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, countervailing duties equal to the net countervailable subsidy rates, for all relevant entries of ripe olives from Spain. Upon further instruction by Commerce, countervailing duties will be assessed on unliquidated entries of ripe olives from Spain entered, or withdrawn from warehouse, for consumption on or after November 28, 2017, the date of publication of the Preliminary Determination. 9

In accordance with section 706 of the Act, we will instruct CBP to suspend liquidation on all relevant entries of ripe olives from Spain, as further described below. These instructions suspending liquidation will remain in effect until further notice. Commerce will also instruct CBP to require cash deposits equal to the amounts as indicated below. Accordingly, effective on the date of publication of the ITC's final affirmative injury determination, CBP will require, at the same time as importers would normally deposit estimated duties on this subject merchandise, a cash deposit equal to the subsidy rates listed below.10 The all-others rate applies to all producers or exporters not specifically listed, as appropriate.

Section 703(d) of the Act states that the suspension of liquidation pursuant to an affirmative preliminary CVD determination may not remain in effect for more than four months. In the underlying investigation, Commerce published the Preliminary Determination on November 28, 2017. Therefore, the four-month period beginning on the date of the publication of the Preliminary Determination ended on March 27, 2018, the final day on which provisional measures were in effect. Furthermore, section 707(b) of the Act states that definitive duties are to begin on the date of publication of the ITC's final injury determination. Therefore, in accordance with section 703(d) of the Act and our practice, we instructed CBP to terminate the suspension of liquidation of and to liquidate, without regard to duties, unliquidated entries of ripe olives from Spain made on or after March 28, 2018. Suspension of liquidation will resume on the date of publication of the ITC's final determination in the Federal Register.

This notice constitutes the CVD order with respect to ripe olives from Spain pursuant to section 706(a) of the Act. Interested parties can find a list of CVD orders currently in effect at http://enforcement.trade.gov/stats/iastats1.html.

This order and amended final determination are published in accordance with section 705(d)-(e), 706(a), and 777(i)(1) of the Act and 19 CFR 351.211(b).

Background

On May 1, 2018, Commerce published a notice of opportunity to request an administrative review of the antidumping duty order on PSF from Korea for the POR of May 1, 2017, through April 30, 2018.1 On May 31, 2018, pursuant to 19 CFR 351.213, Commerce received a timely-filed request from DAK Americas LLC and Auriga Polymers, Inc. (collectively, the petitioners) for an administrative review of, among others, Huvis Corporation (Huvis).2 Also on May 31, 2018, Huvis Corporation (Huvis) requested an administrative review of its POR sales.3 On July 12, 2018, in accordance with 19 CFR 351.221(c)(1)(i), Commerce published a notice of initiation of an administrative review of Huvis.4 On July 17 and 18, 2018, respectively, pursuant to 19 CFR 351.213(d)(1), both the petitioners and Huvis timely withdrew their requests for an administrative review of Huvis.5

Pursuant to 19 CFR 351.213(d)(l), Commerce will rescind an administrative review, in whole or in part, if the party, or parties, that requested a review withdraw(s) the request(s) within 90 days of the publication date of the notice of initiation of the requested review. As noted above, both the petitioners and Huvis withdrew their requests for review of Huvis within 90 days of the publication date of the notice of initiation. No other parties requested an administrative review of the antidumping duty order on PSF from Korea. Therefore, in response to the timely withdrawal of requests for review and, in accordance with 19 CFR 351.213(d)(l), Commerce is rescinding this review.

Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries of PSF from Korea during the POR. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption in accordance with 19 CFR 351.212(c)(l)(i). Commerce intends to issue appropriate assessment instructions to CBP 15 days after publication of this notice in the Federal Register.

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

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

This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).

Exempted Fishing Permits (EFP) that waive monkfish landing limits for designated Research Set-Aside (RSA) days-at-sea (DAS) have been routinely issued since 2007 to increase operational efficiency and to optimize research funds generated under the Monkfish RSA Program. Amendment 2 to the Monkfish Fishery Management Plan (FMP) (70 FR 21929; April 28, 2005) specifies that 500 RSA DAS are set aside each year to support approved monkfish research projects. Award recipients receive an allocation of those 500 RSA DAS, and their EFP limits the maximum weight of monkfish that may be landed under their allocated RSA DAS. Projects are constrained to the total DAS, maximum landing weight, or EFP expiration date, whichever is reached first. Since the origination of the RSA program in 2007, no project has reached the total DAS or maximum landing weight.

Allowing vessels an exemption from monkfish landing limits provides an incentive for vessel owners to participate in the Monkfish RSA Program. Constraining each project to a maximum harvest limit ensures that the overall Monkfish RSA catch will be consistent with DAS effort and total mortality controls established for the fishery as a whole. To calculate the maximum weight allocation for each year's 500 RSA DAS, we assign each RSA DAS to be equal to twice the limit for a Permit Category A or C monkfish vessel fishing in the Southern Fishery Management Area (i.e., the highest permissible landing limit within the fishery). This means that annually, a maximum weight of 500 times this calculated RSA DAS pound value may be harvested under the Monkfish RSA program, and each project is limited to this assigned weight value multiplied by their allocated number of RSA DAS.

On April 28, 2017, we issued RSA compensation fishing EFPs to the Cornell Cooperative Extension (Cornell) and the University of Massachusetts School for Marine Science and Technology (SMAST) for their 2017 Monkfish RSA projects. At the time, the associated monkfish landing weight for each 2017 RSA DAS was 3,552 lb (1,611 kg). Cornell was allocated 300 DAS for a maximum weight limit of 1,065,600 lb (483,348 kg) to fund their research. SMAST was allocated the remaining 200 DAS, allowing 710,400 lb (322,232 kg) to be caught for their project. However, on July 12, 2017, Framework Adjustment 10 to the Monkfish FMP (82 FR 32145) increased the industry's DAS allocation and trip limits across the whole monkfish fishery. As a part of the Framework 10 changes, the possession limit for Category A and C vessels in the Southern Area increased from 1,776 lb (806 kg) to 2,037 lb (924 kg).

On June 8 and July 12, 2018, we received requests from Cornell and SMAST, to increase assigned pound value of the 2017 RSA DAS from 3,552 lb (1,611 kg) to 4,074 lb (1,848 kg), commensurate with the Framework 10 possession limit increase already implemented in the fishery. The adjusted total weight limit of each project under this higher DAS valuation would be 1,222,200 lb (554,381 kg) for Cornell and 814,800 lb (369,587 kg) for SMAST. Investigators from Cornell and SMAST have stated there is less incentive for industry to buy RSA DAS now that the possession limits in the fishery have increased through the Framework 10 measures. The requested weight adjustment to RSA DAS would help maintain the relative value of the Monkfish RSA Program, and potentially attract and maintain participants from the fishing industry.

The revised EFPs would not alter the previously approved exemptions, and all participating vessels and allocated RSA DAS would remain the same. The only revision would be the maximum total weight that may be landed under each project. This adjustment would be consistent with changes implemented in the monkfish fishery under Framework 10, and the minimal additional effort that may occur within the RSA program is negligible and within the scope of the analysis originally conducted. The proposed adjustment does not change any of the determinations made during the review and approval of the original 2017 Monkfish RSA EFPs. These EFPs are scheduled to expire April 30, 2019. Because the RSA program is a unique entitlement within the monkfish fishery, we are soliciting public input on the increase in per RSA DAS weight requested by the participating research institutions.

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.

NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

On February 13, 2018, NMFS received a request from the KDC for an IHA to take marine mammals incidental to construction activities associated with the Ketchikan Berth IV Expansion Project. The IHA application was determined adequate and complete on March 28, 2018. The KDC's request is for take of eight species of marine mammals by Level B harassment and Level A harassment of a small number of harbor porpoises and harbor seals. Neither the KDC nor NMFS expect serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.

The KDC will expand Berth IV, its dock adjacent to downtown Ketchikan, Alaska, located in East Tongass Narrows, in order to accommodate a new fleet of large cruise ships that are expected to reach Alaska in the summer of 2019.

The expansion will include the removal of some existing piles and structures and the installation of new piles and structures. All pile driving and removal will take place at the existing dock facility and is expected to occur over the course of 29 days (not necessarily consecutive). The project will occur in marine waters that support several marine mammal species. The pile driving, pile removal, and drilling activities associated with the project may result in behavioral harassment (Level B harassment and small numbers of Level A harassment) of marine mammal species.

The purpose of this project is to reconfigure Berth IV so that it can accommodate larger cruise ships. This project is needed because the existing Berth IV cannot support the modern fleet of larger cruise ships. Once the project is constructed Berth IV will be able to accommodate these large cruise ships.

Construction activities associated with impact pile driving, vibratory pile driving/removal, and drilling are expected to take three to four months beginning in Fall 2018. The project is likely to begin in October of 2018 and complete in January of 2019, depending on the start date, construction could extend into March of 2019. Regardless of start date, construction will occur within a four-month (maximum) work window. The total number of days for pile removal, pile installation and drilling is expected to occur over 29 days (not necessarily consecutive days). The total construction duration accounts for the time required to mobilize materials and resources and construct the project. The duration also accounts for potential delays in material deliveries, equipment maintenance, inclement weather, and shutdowns that may occur to prevent impacts to marine mammals. Please see Table 1 below for the specific amount of time required to install and remove piles.

A detailed description of the planned activities is provided in the proposed IHA for this action found in the following Federal Register notice (83 FR 22009, May 11, 2018). Since that time, the only alteration that has been made to the planned activities is the activity duration for impact piling of the 48-inch piles. The number of strikes per pile will be no more than 50 strikes per pile (See Table 1). As a result of this change in duration, the Level A zone for the activity and take numbers were also modified. In addition, take will now be authorized for anchor drilling. The new Level A zones for impact piling of 48-inch piles, the modeled zones for anchor drilling, and the revised take numbers are presented and discussed further in the Estimated Take Section. Due to only slight changes in the activity duration for impact piling, a detailed description of the action is not provided here. Please refer to the Federal Register notice (83 FR 22009, May 11, 2018) for the proposed IHA for the description of the specific activity.

A notice of NMFS's proposal to issue an IHA was published in the Federal Register on May 11, 2018 (83 FR 22009). During the 30-day public comment period, the Marine Mammal Commission (Commission) submitted a letter on April 2, 2018. The Commission recommended that NMFS issue the IHA, subject to inclusion of the mitigation, monitoring, and reporting measures.

Comment 1: The Commission recommends that NMFS review more thoroughly both the applications prior to deeming them complete and its notices prior to submitting them for publication in the Federal Register. For example, the Commission stated that NMFS incorrectly assumed a pile casing would inhibit sound transmission during drilling of 30-in anchors into bedrock, which underestimated the numbers of Level B harassment takes for harbor seals and Steller sea lions.

Response: NMFS thanks the Commission for pointing out the errors in the Federal Register notice for the proposed authorization. NMFS has addressed those errors in this notice of issuance of the authorization. NMFS makes every effort to read notices thoroughly prior to publication and will continue this effort to publish the best possible product for public comment. In addition, NMFS notes that recent drilling techniques which have not been authorized in the past require further review due to the novelty of such actions. Due to this, NMFS continues to welcome suggestions from the Commission on how to approach new drilling techniques until acoustic monitoring data is available for such actions.

Comment 2: The Commission recommends that NMFS refrain from implementing its proposed renewal process and instead use abbreviated Federal Register notices and reference existing documents to streamline the incidental harassment authorization process. The Commission also suggested that NMFS should discuss the possibility of renewals through a more general route, such as a rulemaking, instead of notice in a specific authorization. The Commission further recommended that if NMFS did not pursue a more general route, that the agency provide the Commission and the public with a legal analysis supporting our conclusion that this process is consistent with the requirements of section 101(a)(5)(D) of the MMPA.

Response: The process of issuing a renewal IHA does not bypass the public notice and comment requirements of the MMPA. The notice of the proposed IHA expressly notifies the public that under certain, limited conditions an applicant could seek a renewal IHA for an additional year. The notice describes the conditions under which such a renewal request could be considered and expressly seeks public comment in the event such a renewal is sought. Additional reference to this solicitation of public comment has recently been added at the beginning of FR notices that consider renewals. NMFS appreciates the streamlining achieved by the use of abbreviated FR notices and intends to continue using them for proposed IHAs that include minor changes from previously issued IHAs, but which do not satisfy the renewal requirements. We believe our proposed method for issuing renewals meets statutory requirements and maximizes efficiency. Importantly, such renewals would be limited to circumstances where: the activities are identical or nearly identical to those analyzed in the proposed IHA; monitoring does not indicate impacts that were not previously analyzed and authorized; and, the mitigation and monitoring requirements remain the same, all of which allow the public to comment on the appropriateness and effects of a renewal at the same time the public provides comments on the initial IHA. NMFS has, however, modified the language for future proposed IHAs to clarify that all IHAs, including renewal IHAs, are valid for no more than one year and that the agency would consider only one renewal for a project at this time. In addition, notice of issuance or denial of a renewal IHA would be published in the Federal Register, as they are for all IHAs. Last, NMFS will publish on our website a description of the renewal process before any renewal is issued utilizing the new process.

A detailed description of the of the species likely to be affected by the construction project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice for the proposed IHA (83 FR 22009, May 11, 2018); since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not provided here. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' website (https://www.fisheries.noaa.gov/topic/population-assessments/marine-mammals) for generalized species accounts. All species that could potentially occur in the planned survey area are included in Table 2.

The effects of underwater noise from pile driving/removal and drilling activities for the Ketchikan Berth IV Expansion project have the potential to result in Level A and Level B harassment of marine mammals in the vicinity of the action area. The Federal Register notice for the proposed IHA (83 FR 22009, May 11, 2018) included a discussion of the effects of anthropogenic noise on marine mammals and their habitat in the action area, therefore that information is not repeated here; please refer to the Federal Register notice (83 FR 22009, May 11, 2018) for that information.

This section provides an estimate of the number of incidental takes for authorization through this IHA, which will inform both NMFS's consideration of “small numbers” and the negligible impact determination.

Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

Authorized takes would primarily be by Level B harassment, as use of impact pile driving, vibratory pile driving/removal, and drilling has the potential to result in disruption of behavioral patterns for individual marine mammals. There is also some potential for auditory injury (Level A harassment) to result, primarily for harbor seals and harbor porpoises due to larger predicted auditory injury zones. Auditory injury is unlikely to occur for other species. The mitigation and monitoring measures are expected to minimize the severity of such taking to the extent practicable.

As described previously, no mortality or serious injury is anticipated or authorized for this activity. Below we describe how the take is estimated.

Described in the most basic way, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) the number of days of activities. Below, we describe these components in more detail and present the take estimate.

Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed or experience TTS (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).

Level B Harassment for non-explosive sources—Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (e.g., frequency, predictability, duty cycle), the environment (e.g., bathymetry), and the receiving animals (hearing, motivation, experience, demography, behavioral context) and can be difficult to predict (Southall et al., 2007, Ellison et al., 2011). Based on what the available science indicates and the practical need to use a threshold based on a factor that is both predictable and measurable for most activities, NMFS uses a generalized acoustic threshold based on received level to estimate the onset of behavioral harassment. NMFS predicts that marine mammals are likely to be behaviorally harassed in a manner we consider Level B harassment when exposed to underwater anthropogenic noise above received levels of 120 dB re 1 μPa rms for continuous (e.g., vibratory pile-driving, drilling) and above 160 dB re 1 μPa rms for non-explosive impulsive (e.g., impact pile driving) or intermittent (e.g., scientific sonar) sources.

KDC's construction activity includes the use of continuous (vibratory pile driving and drilling) and impulsive (impact pile driving) sources, and therefore the 120 and 160 dB re 1 μPa rms thresholds for Level B behavioral harassment are applicable.

Level A harassment for non-explosive sources—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Technical Guidance, 2016) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). KDC's activity includes the use of impulsive (impact pile driving) and non-impulsive (vibratory pile driving and drilling) sources.

These thresholds are provided in the table below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2016 Technical Guidance, which may be accessed at: http://www.nmfs.noaa.gov/pr/acoustics/guidelines.htm.

Effective September 16, 2011, with the passage of the AIA, the USPTO is authorized under Section 10 of the AIA to set or adjust by rule all patent and trademark fees established, authorized, or charged under Title 35 of the United States Code and the Trademark Act of 1946, respectively. Patent and trademark fees set or adjusted by rule under Section 10 of the AIA may only recover the aggregate estimated costs to the Office for processing, activities, services, and materials relating to patents and trademarks, respectively, including administrative costs of the Office with respect to each as the case may be. Congress set forth the process for the USPTO to follow in setting or adjusting patent and trademark fees by rule under Section 10 of the AIA, including additional procedural steps in the rulemaking proceeding for the issuance of regulations under this section. In particular, Congress requires the relevant advisory committee to hold a public hearing about the USPTO fee proposals after receiving them from the agency. Congress likewise requires the relevant advisory committee to prepare a written report on the proposed fees and the USPTO to consider the relevant advisory committee's report before finally setting or adjusting the fees.

Presently, the USPTO is planning to exercise its fee setting authority to set or adjust patent fees. As part of the rulemaking proceeding for the issuance of regulations under Section 10, the USPTO will publish a proposed patent fee schedule and related supplementary information for public viewing no later than August 29, 2018, on the USPTO internet website (address: www.uspto.gov/about-us/performance-and-planning/fee-setting-and-adjusting). In turn, the PPAC will hold a public hearing about the proposed patent fee schedule on the date indicated herein. The USPTO will assist the PPAC in holding the hearing by providing resources to organize the hearing and by notifying the public about the hearing, such as through this notice. Following the PPAC public hearing, the USPTO will publish a Notice of Proposed Rulemaking in the Federal Register, setting forth its proposed patent fees.

Interested members of the public are invited to testify at the PPAC hearing about the proposed patent fees and the questions posed on PPAC's website about the proposed fees. Those wishing to present oral testimony at the hearing must submit a request in writing no later than August 29, 2018. Requests to testify should indicate the following: (1) The name of the person wishing to testify; (2) the person's contact information (telephone number and email address); (3) the organization(s) the person represents, if any; and (4) an indication of the amount of time needed for the testimony. Requests to testify must be submitted by email to Jennifer Lo at [email protected]. Speakers providing testimony at the hearing should submit a written copy of their testimony for inclusion in the record of the proceedings no later than September 13, 2018.

Based upon the requests received, an agenda for witness testimony will be sent to testifying requesters and posted on the USPTO internet website (address: www.uspto.gov/about-us/performance-and-planning/fee-setting-and-adjusting). If time permits, the PPAC may permit unscheduled testimony as well.

Purpose of the Board: To make recommendations to the Assistant Secretary for the Office of Energy Efficiency and Renewable Energy regarding goals and objectives, programmatic and administrative policies, and to otherwise carry out the Board's responsibilities as designated in the State Energy Efficiency Programs Improvement Act of 1990 (Pub. L. 101-440).

Tentative Agenda: Welcome new STEAB members. Discuss recommendations from STEAB to the Assistant Secretary for the Office of Energy Efficiency and Renewable Energy.

Public Participation: The meeting is open to the public. Written statements may be filed with the Board either before or after the meeting. Members of the public who wish to make oral statements pertaining to agenda items should contact Michael Li at the address or telephone number listed above. Requests to make oral comments must be received five days prior to the meeting; reasonable provision will be made to include requested topic(s) on the agenda. The Chair of the Board is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business.

The purpose of this RFI is to solicit feedback from industry, academia, research laboratories, government agencies, and other stakeholders on issues related to national offshore wind test facilities. WETO is specifically interested in information on: The facilities in the U.S. that are available for offshore wind-specific experimentation and testing; facilities upgrades or new facilities that are required in the U.S. for offshore wind testing in order to perform cutting edge R&D; and, the most pressing R&D needs that would utilize existing, upgraded, or new U.S. offshore wind specific facilities. The RFI is available at: https://eere-exchange.energy.gov/

Because information received in response to this RFI may be used to structure future programs, funding and/or otherwise be made available to the public, respondents are strongly advised to not include any information in their responses that might be considered business sensitive, proprietary, or otherwise confidential. If, however, a respondent chooses to submit business sensitive, proprietary, or otherwise confidential information, it must be clearly and conspicuously marked as such in the response as detailed in the RFI [DE-FOA-0001963] at: https://eere-exchange.energy.gov/.

Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person that would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.

The purpose of this RFI is to solicit feedback from industry, academia, research laboratories, government agencies, and other stakeholders on energy efficiency and renewable energy R&D testing needs and the associated equipment, facilities and infrastructure needed to ensure continued world class energy technology development at the NWTC. This is solely a request for information and NOT a Funding Opportunity Announcement (FOA). EERE is not accepting applications. The RFI is available at: https://eere-exchange.energy.gov/.

Because information received in response to this RFI may be used to structure future programs, funding and/or otherwise be made available to the public, respondents are strongly advised to not include any information in their responses that might be considered business sensitive, proprietary, or otherwise confidential. If, however, a respondent chooses to submit business sensitive, proprietary, or otherwise confidential information, it must be clearly and conspicuously marked as such in the response as detailed in the RFI [DE-FOA-0001959] at: https://eere-exchange.energy.gov/.

Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person that would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

• Welcome and Announcements

• Introduction of New Members

• Comments from the Deputy Designated Federal Officer

• Presentations from the DOE, Tennessee Department of Environment and Conservation, and Environmental Protection Agency Liaisons

• Discussion of Board Mission, Accomplishments and Operations

• Presentation of Slate of Candidates for FY19 Officers

• Motions/Approval of June 13, 2018 Meeting Minutes

• Motions/Approval of Two Proposed Recommendations to DOE

• Public Comment Period

• Follow-on Discussion

• Adjourn

Public Participation: The EM SSAB, Oak Ridge, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Melyssa P. Noe at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to the agenda item should contact Melyssa P. Noe at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

Minutes: Minutes will be available by writing or calling Melyssa P. Noe at the address and phone number listed above. Minutes will also be available at the following website: https://energy.gov/orem/listings/oak-ridge-site-specific-advisory-board-meetings.

Purpose of Meeting: To develop advice and guidance that promotes research and development leading to the production of biobased fuels and biobased products.

Tentative Agenda: Agenda will include the following:

Public Participation: In keeping with procedures, members of the public are welcome to observe the business of the Biomass Research and Development Technical Advisory Committee. To attend the meeting and/or to make oral statements regarding any of the items on the agenda, you must contact Dr. Mark Elless at (202) 586-6501 or Email: [email protected] at least 5 business days prior to the meeting. Members of the public will be heard in the order in which they sign up at the beginning of the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Co-chairs of the Committee will make every effort to hear the views of all interested parties. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. The Co-chairs will conduct the meeting to facilitate the orderly conduct of business.

Minutes: The summary of the meeting will be available for public review and copying at http://biomassboard.gov/committee/meetings.html.

Table of Contents I. Background II. Overview of the Proposed National Model Family Foster Home Licensing III. Standards Summary of the Proposed National Model Foster Care Licensing Standards I. Background (1) Legislative Context

The President signed the Bipartisan Budget Act of 2018, Public Law (Pub. L.) 115-123 into law on February 9, 2018. Public Law 115-123 includes the FFPSA in Division E, Title VII. Section 50731 of the FFPSA directs HHS to “identify reputable model licensing standards with respect to the licensing of foster family homes (as defined in section 472(c)(1) of the Social Security Act).”

By April 1, 2019, title IV-E agencies, which include all states and 12 tribes, must provide the HHS specific and detailed information about:

○ Whether the state or tribal agency foster family home licensing standards are consistent with the model licensing standards identified by HHS, and if not, the reason; and

○ Whether the state or tribal agency waives non-safety licensing standards for relative foster family homes (pursuant to waiver authority provided by section 471(a)(10)(D) of the Act), and if so, how caseworkers are trained to use the waiver authority and whether the agency has developed a process or provided tools to assist caseworkers in waiving these non-safety standards to quickly place children with relatives.

States and tribes have a long history of developing and implementing their own foster family home licensing standards. These standards are typically included in statutes, codes, or regulations, but may also be included in policy documents or guidance. In reference to the title IV-E program, section 471(a)(10) of the Act requires title IV-E agencies to develop plans that provide for the establishment and maintaining of standards for foster family homes and child care institutions. These standards must be reasonably in accord with related standards developed by national organizations, including standards related to admission policies, safety, sanitation, protection of civil rights, and permit the use of the reasonable prudent parent standard.

We are proposing one set of standards for comment to apply to relatives and non-relatives, as well as state and tribal title IV-E agencies.

Prior to drafting these standards, CB:

• Reviewed several state and tribal foster family licensing standards that represented a mix of population densities, state and county administered states, and a range of geographic locations;

• examined the “Model Family Foster Home Licensing Standards” published by the National Association for Regulatory Administration (NARA Standards);

• reviewed the “Development and Implementation of Tribal Foster Care Standards” published by the National Indian Child Welfare Association (NICWA); and

• consulted guidelines, recommendations, and best practices for foster care services including the following:

• Council on Accreditation Family Foster Care and Kinship Care Program Accreditation Guidelines; and

• Child Welfare League of America (CWLA) Standards of Excellence for Family Foster Care Services.

The CB relied heavily upon the NARA standards in drafting the proposed National Model Family Foster Home Licensing Standards. The NARA standards were developed by attorneys at Generations United and the American Bar Association who researched family foster care licensing standards in state codes, regulations, and policies for each state and the District of Columbia.1 The current NARA standards use model language from state licensing standards and language from the CWLA and the Council on Accreditation with the goal to create reasonable and achievable safety standards for family foster home licensing. NICWA assisted the Council on Accreditation with developing foster care and kinship care standards used to accredit public and private agencies that address the unique needs of Native children and account for the protections of the Indian Child Welfare Act.

CB assessed whether these materials shared purposes, standards, and categories to support the conclusion that the NARA standards were appropriate to use as a main source for the National Model Family Foster Home Licensing Standards. Through this review, CB determined that while it is important for standards to be flexible for title IV-E agency implementation, overall, the standards reviewed shared many commonalities. Further, the NARA standards are based in significant research and input from experts in the field; therefore, we consider them the best available resource to base a federal standard on, and reasonably flexible for title IV-E agency implementation.

CB did not examine the following subject areas because this was outside the scope of the legislative requirement:

• Foster home licensing procedures;

• Emergency placement procedures;

• Re-licensure procedures;

• Procedures for pre-service training;

• Care of children after placement in a licensed foster home; and

• Post-licensing requirements, such as foster parent recordkeeping and reporting.

The proposed standards are categorized into eight categories that closely resemble the NARA standards:

These categories cover the essential components of licensing a foster family in terms of ensuring the applicant's capacity to care for a child in foster care, and also provide parameters for licensing the physical home of the family to ensure it is appropriate and safe for a child in foster care.

The National Model Family Foster Home Licensing Standards, based on the NARA Standards, are designed to be broad and flexible enough to respond to individual circumstances, state and tribal jurisdictions, and help ensure children in out-of-home care have safe and appropriate homes. The standards do not include the many other agency practices for how to conduct assessments, good practice standards, guidelines on re-licensing, or other requirements that must be undertaken with licensing foster family homes. In addition, there are numerous state and federal laws that agencies must consider when licensing foster family homes that we did not address. We encourage agencies to utilize best practices, such as engaging tribal communities or others as appropriate in licensing families; however, these standards do not address such practices.

The Drug Quality and Security Act (DQSA) contains important provisions relating to the oversight of compounding human drugs. Title I of this law, the Compounding Quality Act, created a new section 503B in the FD&C Act (21 U.S.C. 353b). Under section 503B of the FD&C Act, a human drug compounder can become an “outsourcing facility.”

Outsourcing facilities, as defined in section 503B(d)(4) of the FD&C Act, are facilities that meet all of the conditions described in section 503B(a), including registering with FDA as an outsourcing facility and paying an annual establishment fee. If the conditions of section 503B are met, a drug compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from three sections of the FD&C Act: (1) Section 502(f)(1) (21 U.S.C. 352(f)(1)) concerning the labeling of drugs with adequate directions for use; (2) section 505 (21 U.S.C. 355) concerning the approval of human drug products under new drug applications (NDAs) or abbreviated new drug applications (ANDAs); and (3) section 582 (21 U.S.C. 360eee-1) concerning drug supply chain security requirements. Drugs compounded in outsourcing facilities are not exempt from the requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) concerning current good manufacturing practice requirements for drugs.

Section 744K of the FD&C Act (21 U.S.C. 379j-62) authorizes FDA to assess and collect the following fees associated with outsourcing facilities: (1) An annual establishment fee from each outsourcing facility and (2) a re-inspection fee from each outsourcing facility subject to a re-inspection (see section 744K(a)(1) of the FD&C Act). Under statutorily defined conditions, a qualified applicant may pay a reduced small business establishment fee (see section 744K(c)(4) of the FD&C Act).

FDA announced in the Federal Register of November 24, 2014 (79 FR 69856), the availability of a final guidance for industry entitled “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.” The guidance provides additional information on the annual fees for outsourcing facilities and adjustments required by law, re-inspection fees, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee. This guidance can be accessed on FDA's website at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf.

Section 744K(c)(2) of the FD&C Act specifies the annual inflation adjustment for outsourcing facility fees. The inflation adjustment has two components: One based on FDA's payroll costs and one based on FDA's non-payroll costs for the first 3 of the 4 previous fiscal years. The payroll component of the annual inflation adjustment is calculated by taking the average change in FDA's per-full time equivalent (FTE) personnel compensation and benefits (PC&B) in the first 3 of the 4 previous fiscal years (see section 744K(c)(2)(A)(ii) of the FD&C Act). FDA's total annual spending on PC&B is divided by the total number of FTEs per fiscal year to determine the average PC&B per FTE.

Table 1 summarizes the actual cost and FTE data for the specified fiscal years, and provides the percent change from the previous fiscal year and the average percent change over the first 3 of the 4 fiscal years preceding FY 2019. The 3-year average is 2.4152 percent.

Section 744K(c)(2)(A)(ii) of the FD&C Act specifies that this 2.4152 percent should be multiplied by the proportion of PC&B to total costs of an average FDA FTE for the same 3 fiscal years.

The payroll adjustment is 2.4152 percent multiplied by 50.6043 percent, or 1.2222 percent.

Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that the portion of the inflation adjustment for non-payroll costs for FY 2019 is equal to the average annual percent change in the Consumer Price Index (CPI) for urban consumers (U.S. City Average; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data, multiplied by the proportion of all non-PC&B costs to total costs of an average FDA FTE for the same period.

Table 2 provides the summary data for the percent change in the specified CPI for U.S. cities. These data are published by the Bureau of Labor Statistics and can be found on its website: https://data.bls.gov/cgi-bin/surveymost?cu. The data can be viewed by checking the box marked “U.S. All items, 1982-84 = 100—CUUR0000SA0” and then selecting “Retrieve Data.”

Section 744K(c)(2)(A)(iii) of the FD&C Act specifies that this 1.1702 percent should be multiplied by the proportion of all non-PC&B costs to total costs of an average FTE for the same 3 fiscal years. The proportion of all non-PC&B costs to total costs of an average FDA FTE for FYs 2015 to 2017 is 49.3957 percent (100 percent − 50.6043 percent = 49.3957 percent). Therefore, the non-pay adjustment is 1.1702 percent times 49.3957 percent, or 0.5780 percent.

The PC&B component (1.2222 percent) is added to the non-PC&B component (0.5780 percent), for a total inflation adjustment of 1.8002 percent (rounded). Section 744K(c)(2)(A)(i) of the FD&C Act specifies that one is added to that figure, making the inflation adjustment 1.018002.

Section 744K(c)(2)(B) of the FD&C Act provides for this inflation adjustment to be compounded after FY 2015. This factor for FY 2019 (1.8002 percent) is compounded by adding one to it, and then multiplying it by one plus the inflation adjustment factor for FY 2018 (7.2835 percent), as published in the Federal Register of August 2, 2017 (82 FR 35962 at 35965). The result of this multiplication of the inflation factors for the 4 years since FY 2015 (1.018002 × 1.072835) becomes the inflation adjustment for FY 2019. For FY 2019, the inflation adjustment is 9.2148 percent (rounded). We then add one, making the FY 2019 inflation adjustment factor 1.092148.

Section 744K(c)(3) of the FD&C Act specifies that in addition to the inflation adjustment factor, the establishment fee for non-small businesses is to be further adjusted for a small business adjustment factor. Section 744K(c)(3)(B) of the FD&C Act provides that the small business adjustment factor is the adjustment to the establishment fee for non-small businesses that is necessary to achieve total fees equaling the amount that FDA would have collected if no entity qualified for the small business exception in section 744K(c)(4) of the FD&C Act. Additionally, section 744K(c)(5)(A) states that in establishing the small business adjustment factor for a fiscal year, FDA shall provide for the crediting of fees from the previous year to the next year if FDA overestimated the amount of the small business adjustment factor for such previous fiscal year.

Therefore, to calculate the small business adjustment to the establishment fee for non-small businesses for FY 2019, FDA must estimate: (1) The number of outsourcing facilities that will pay the reduced fee for small businesses for FY 2019 and (2) the total fee revenue it would have collected if no entity had qualified for the small business exception (i.e., if each entity that registers as an outsourcing facility for FY 2019 were to pay the inflation-adjusted fee amount of $16,382).

With respect to (1), FDA estimates that 14 entities will qualify for small business exceptions and will pay the reduced fee for FY 2019. With respect to (2), to estimate the total number of entities that will register as outsourcing facilities for FY 2019, FDA used data submitted by outsourcing facilities through the voluntary registration process, which began in December 2013. Accordingly, FDA estimates that 82 outsourcing facilities, including 14 small businesses, will be registered with FDA in FY 2019.

If the projected 82 outsourcing facilities paid the full inflation-adjusted fee of $16,382, this would result in total revenue of $1,343,324 in FY 2019 ($16,382 × 82). However, 14 of the entities that are expected to register as outsourcing facilities for FY 2019 are projected to qualify for the small business exception and to pay one-third of the full fee ($5,461 × 14), totaling $76,454 instead of paying the full fee ($16,382 × 14), which would total $229,348. This would leave a potential shortfall of $152,894 ($229,348 − $76,454).

Additionally, section 744K(c)(5)(A) of the FD&C Act states that in establishing the small business adjustment factor for a fiscal year, FDA shall provide for the crediting of fees from the previous year to the next year if FDA overestimated the amount of the small business adjustment factor for such previous fiscal year. FDA has determined that it is appropriate to credit excess fees collected from the last completed fiscal year, due to the inability to conclusively determine the amount of excess fees from the fiscal year that is in progress at the time this calculation is made. This crediting is done by comparing the small business adjustment factor for the last completed fiscal year, FY 2017 ($1,137), to what would have been the small business adjustment factor for FY 2017 ($892) if FDA had estimated perfectly.

The calculation for what the small business adjustment would have been if FDA had estimated perfectly begins by determining the total target collections (15,000 × [inflation adjustment factor] × [number of registrants]). For the most recent complete fiscal year, FY 2017, this was $1,219,449 ($15,837 × 77). The actual FY 2017 revenue from the 77 total registrants (i.e., 71 registrants paying FY 2017 non-small business establishment fee and six small business registrants) paying establishment fees is $1,156,101. $1,156,101 is calculated as follows: (FY 2017 Non-Small Business Establishment Fee adjusted for inflation only) × (total number of registrants in FY 2017 paying Non-Small Business Establishment Fee) + (FY 2017 Small Business Establishment Fee) × (total number of small business registrants in FY 2017 paying Small Business Establishment Fee). $15,837 × 71 + $5,279 × 6 = $1,156,101. This left a shortfall of $63,348 from the estimated total target collection amount ($1,219,449 − $1,156,101). $63,348 divided by the total number of registrants in FY 2017 paying Standard Establishment Fee (71) equals $892.

The difference between the small business adjustment factor used in FY 2017 and the small business adjustment factor that would have been used had FDA estimated perfectly; is $245 ($1,137 − $892). The $245 (rounded to the nearest dollar) is then multiplied by the number of actual registrants who paid the standard fee for FY 2017 (71), which provides us a total excess collection of $17,380 in FY 2017.

Therefore, to calculate the small business adjustment factor for FY 2019, FDA subtracts $17,380 from the projected shortfall of $152,894 for FY 2019 to arrive at the numerator for the small business adjustment amount, which equals $135,514. This number divided by 68 (the number of expected non-small businesses for FY 2019) is the small business adjustment amount for FY 2019, which is $1,993 (rounded to the nearest dollar).

The amount of the establishment fee for a qualified small business is equal to $15,000 multiplied by the inflation adjustment factor for that fiscal year, divided by three (see section 744K(c)(4)(A) and (c)(1)(A) of the FD&C Act). The inflation adjustment factor for FY 2019 is 1.092148. See section II.A.1 for the methodology used to calculate the FY 2019 inflation adjustment factor. Therefore, the establishment fee for a qualified small business for FY 2019 is one third of $16,382, which equals $5,461 (rounded to the nearest dollar).

Under section 744K(c) of the FD&C Act, the amount of the establishment fee for a non-small business is equal to $15,000 multiplied by the inflation adjustment factor for that fiscal year, plus the small business adjustment factor for that fiscal year, and plus or minus an adjustment factor to account for over- or under-collections due to the small business adjustment factor in the prior year. The inflation adjustment factor for FY 2019 is 1.092148. The small business adjustment amount for FY 2019 is $1,993. See section II.A.2 for the methodology used to calculate the small business adjustment factor for FY 2019. Therefore, the establishment fee for a non-small business for FY 2019 is $15,000 multiplied by 1.092148 plus $1,993, which equals $18,375 (rounded to the nearest dollar).

Section 744K(c)(1)(B) of the FD&C Act provides that the amount of the FY 2019 re-inspection fee is equal to $15,000, multiplied by the inflation adjustment factor for that fiscal year. The inflation adjustment factor for FY 2019 is 1.092148. Therefore, the re-inspection fee for FY 2019 is $15,000 multiplied by 1.092148, which equals $16,382 (rounded to the nearest dollar). There is no reduction in this fee for small businesses.

Once an entity submits registration information and FDA has determined that the information is complete, the entity will incur the annual establishment fee. FDA will send an invoice to the entity, via email to the email address indicated in the registration file, or via regular mail if email is not an option. The invoice will contain information regarding the obligation incurred, the amount owed, and payment procedures. A facility will not be registered as an outsourcing facility until it has paid the annual establishment fee under section 744K of the FD&C Act. Accordingly, it is important that facilities seeking to operate as outsourcing facilities pay all fees immediately upon receiving an invoice. If an entity does not pay the full invoiced amount within 15 calendar days after FDA issues the invoice, FDA will consider the submission of registration information to have been withdrawn and adjust the invoice to reflect that no fee is due.

Outsourcing facilities that registered in FY 2018 and wish to maintain their status as an outsourcing facility in FY 2019 must register during the annual registration period that lasts from October 1, 2018, to December 31, 2018. Failure to register and complete payment by December 31, 2018, will result in a loss of status as an outsourcing facility on January 1, 2019. Entities should submit their registration information no later than December 10, 2018, to allow enough time for review of the registration information, invoicing, and payment of fees before the end of the registration period.

FDA will issue invoices for each re-inspection after the conclusion of the re-inspection, via email to the email address indicated in the registration file or via regular mail if email is not an option. Invoices must be paid within 30 days.

1. The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay. (Note: only full payments are accepted. No partial payments can be made online.) Once you search for your invoice, click “Pay Now” to be redirected to Pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S bank accounts as well as U.S. credit cards.

2. If paying with a paper check: Checks must be in U.S. currency from a U.S. bank and made payable to the Food and Drug Administration. Payments can be mailed to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000. If a check is sent by a courier that requests a street address, the courier can deliver the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only. If you have any questions concerning courier delivery, contact the U.S. Bank at 314-418-4013).

3. When paying by wire transfer, the invoice number must be included. Without the invoice number the payment may not be applied. Regarding re-inspection fees, if the payment amount is not applied, the invoice amount will be referred to collections. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire transfer fee, it is required that the outsourcing facility add that amount to the payment to ensure that the invoice is paid in full. Use the following account information when sending a wire transfer: New York Federal Reserve Bank, U.S. Dept of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No. 75060099, Routing No. 021030004, SWIFT: FRNYUS33. If needed, FDA's tax identification number is 53-0196965.

I. Background

Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h, respectively) establish two different kinds of user fees. Fees are assessed as follows: (1) Application fees are assessed on certain types of applications for the review of human drug and biological products; and (2) prescription drug program fees are assessed on certain approved products (section 736(a) of the FD&C Act). When specific conditions are met, FDA may waive or reduce fees (section 736(d) of the FD&C Act).

For FY 2018 through FY 2022, the base revenue amounts for the total revenues from all PDUFA fees are established by PDUFA VI. The base revenue amount for FY 2019 is $935,903,507. The FY 2019 base revenue amount is adjusted for inflation and for the resource capacity needs for the process for the review of human drug applications (the capacity planning adjustment). An additional dollar amount specified in the statute (see section 736(b)(1)(F) of the FD&C Act) is then added to provide for additional full-time equivalent (FTE) positions to support PDUFA VI initiatives. The FY 2019 revenue amount may be adjusted further, if necessary, to provide for sufficient operating reserves of carryover user fees. Finally, the amount is adjusted to provide for additional direct costs to fund PDUFA VI initiatives. Fee amounts are to be established each year so that revenues from application fees provide 20 percent of the total revenue, and prescription drug program fees provide 80 percent of the total revenue.

This document provides fee rates for FY 2019 for an application requiring clinical data ($2,588,478), for an application not requiring clinical data ($1,294,239), and for the prescription drug program fee ($309,915). These fees are effective on October 1, 2018, and will remain in effect through September 30, 2019. For applications that are submitted on or after October 1, 2018, the new fee schedule must be used.

The base revenue amount for FY 2019 is $935,903,507 prior to adjustments for inflation, capacity planning, additional FTE, operating reserve, and additional direct costs (see section 736(b)(1) of the FD&C Act).

PDUFA VI specifies that the $935,903,507 is to be adjusted for inflation increases for FY 2019 using two separate adjustments—one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (see section 736(c)(1) of the FD&C Act).

The component of the inflation adjustment for payroll costs shall be one plus the average annual percent change in the cost of all PC&B paid per FTE positions at FDA for the first 3 of the preceding 4 FYs, multiplied by the proportion of PC&B costs to total FDA costs of the process for the review of human drug applications for the first 3 of the preceding 4 FYs (see section 736(c)(1)(A) and (c)(1)(B) of the FD&C Act).

Table 1 summarizes the actual cost and FTE data for the specified FYs and provides the percent changes from the previous FYs and the average percent changes over the first three of the four FYs preceding FY 2019. The 3-year average is 2.4152 percent.

The statute specifies that this 2.4152 percent be multiplied by the proportion of PC&B costs to the total FDA costs of the process for the review of human drug applications. Table 2 shows the PC&B and the total obligations for the process for the review of human drug applications for the first three of the preceding four FYs.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); April 30, 2010 (75 FR 22809); and on January 23, 2017 (82 FR 7920).

The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100-71. The “Mandatory Guidelines for Federal Workplace Drug Testing Programs,” as amended in the revisions listed above, requires strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on urine specimens for federal agencies.

To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections.

Laboratories and IITFs in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that it has met minimum standards.

In accordance with the Mandatory Guidelines dated January 23, 2017 (82 FR 7920), the following HHS-certified laboratories and IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens: