HHS is committed to advancing its mission in part through strong regulatory stewardship, including regularly reviewing and modernizing its regulations, in accordance with the principles, inter alia, established in Executive Order 13563 (Jan. 18, 2011). Section 6 of E.O. 13563 (76 FR 3821) guides the process of the retrospective review of existing regulations by agencies. While retrospective regulatory review and reform has until now been a largely manual process, new technologies exist that can support policy subject matter experts (SMEs) in their efforts to review large amounts of regulatory text. As part of HHS's pioneering efforts to pilot the use of Artificial Intelligence (AI) and other advanced analyses, HHS recently applied AI and Natural Language Processing (NLP) technology to support and accelerate SME reviews in cognizant divisions of HHS of unstructured text in the Code of Federal Regulations (CFR), facilitating the identification of opportunities to improve HHS's regulations.

In conjunction with, and following validation by, human SMEs, this AI-augmented analysis indicated that HHS has a number of “incorrect citations,” in which a current regulation cites a regulation that may have moved or may no longer exist. In response to these findings, HHS is amending the identified “incorrect citations.” The amendments detailed in this rule correct these citations, remove erroneous language, or correct misspellings and other typographical errors.

HHS is committed to the Administration's vision of reducing regulatory burden and modernizing the CFR. Executive Order 13771 (Jan. 30, 2017) (82 FR 9339) and E.O. 13563 both emphasize the importance of retrospectively reviewing existing regulations in order to achieve these objectives. In particular, section 6 of E.O. 13563 asks agencies to “consider how best to promote retrospective analyses of rules that may be outmoded . . .” (76 FR 3822). HHS has continued to execute regulatory reform through new and innovative methods. In the past, regulatory analysis and reform has been a largely manual process, limited by each expert's experience with a particular subset of agency regulations, and it has been labor-intensive and time-consuming to find regulatory reform opportunities through this manual review. In addition, unless a portfolio of minor changes can occur through a consolidated regulatory vehicle, it is often administratively impractical to implement many results of retrospective review; this relative infeasibility of implementation may in turn discourage the identification and correction of many small but valuable refinements to existing regulations.

However, HHS has piloted a new method of regulatory analysis, using an AI-driven tool that analyzed HHS's regulations using NLP as applied to the regulatory text in the CFR. This NLP analysis is designed to accelerate and augment expert review, by highlighting “candidate” provisions that could be outmoded, allowing HHS SMEs to focus on these provisions as potential areas of opportunity for modernization. The NLP analysis revealed numerous reform opportunities, including instances where a regulation citation is now incorrect. Combined with the policy expertise of HHS SMEs, this NLP analysis method has yielded promising results towards reforming and modernizing regulations at HHS. The revisions outlined in this rule represent a portion of the results from this effort, and are focused on administrative, non-substantive changes that will clean up HHS's regulations. For efficiency, a consolidated regulatory vehicle is being used to implement these numerous non-substantive changes across multiple HHS regulations. Future uses of these technologies to promote comprehensive and systematic retrospective review will continue to algorithmically refine identification of potentially “outmoded” regulations and will seek algorithmic characterization of other regulatory targets of E.O. 13563—regulations which are “ineffective, insufficient, or excessively burdensome”, as candidates for SME review and potential reform.

• Deletion. In 2 CFR 376.10, this rule removes the incorrect references to 3 CFR 1986 Comp., p. 189 and 3 CFR 1989 Comp., p. 235 as these references no longer exist. Although 3 CFR 1986 and 3 CFR 1989 are referenced as sources for Executive Order 12549 “Debarment and Suspension” (signed February 18, 1986) and Executive Order 12689 “Debarment and Suspension (signed august 18, 1989), removal of these references ensure consistency with 2 CFR 276.10 as currently written.

• Correct Reference. In 21 CFR 1.24(a)(6)(ii) and (8)(ii), this rule removes the incorrect reference 21 CFR 101.105 and replaces it with the correct reference 21 CFR 101.7 as 21 CFR 101.105 was redesignated in 2016 as part of a technical amendment (81 FR 59130).

• Correct an Omission. In 21 CFR 5.1100, a footnote “*” next to the “Office of Chief Counsel,” that had appeared in earlier editions and was inadvertently omitted, should be inserted to read as it had in prior editions, as follows: “*The Office of the Chief Counsel (also known as the Food and Drug Division, Office of the General Counsel, Department of Health and Human Services), while administratively within the Office of the Commissioner, is part of the Office of the General Counsel of the Department of Health and Human Services.”

• Correct an Omission. In 21 CFR 5.1105, a footnote “*” next to the “Office of Chief Counsel,” that had appeared in earlier editions and was inadvertently omitted, should be inserted to read as it had in prior editions, as follows: “*The Office of the Chief Counsel (also known as the Food and Drug Division, Office of the General Counsel, Department of Health and Human Services), while administratively within the Office of the Commissioner, is part of the Office of the General Counsel of the Department of Health and Human Services.”

• Deletion. In 21 CFR 12.21(a)(2), this rule deletes the phrase “514.2 for applications for animal feeds” as 21 CFR 514.2 was removed in 1999 (64 FR 63195) to provide for feed mill licensing in accordance with the Animal Drug Availability Act (ADAA) of 1996.

• Correct Reference. In 21 CFR 14.7(b), this rule removes the incorrect reference 45 CFR 5.34 and replaces it with the correct reference 45 CFR 5.61—45 CFR 5.64 (subpart F Appeals) as 45 CFR 5.34 was removed when the Freedom of Information regulations were reorganized in 2016 (81 FR 74930).

• Deletion. This rule deletes and reserves 21 CFR 25.33(a)(7), which reads “(7) Approval of a drug for use in animal feeds if such drug has been approved under § 514.2 or 514.9 of this chapter for other uses,” as 21 CFR 514.2 and 21 CFR 514.9 were removed in 1999 (64 FR 63195) to provide for feed mill licensing in accordance with the Animal Drug Availability Act (ADAA) of 1996.

• Deletion. In 21 CFR 81.30(s)(2), this rule deletes the sentence “Ingested drug lip products, however, are regulated for use in 74.1308 and 74.1309” in order to remove the incorrect references to 21 CFR 74.1308 and 21 CFR 74.1309. This language is no longer needed because 21 CFR 74.1308 and 21 CFR 74.1309 were removed in 1988 (53 FR 26766).

• Deletion. This rule deletes 21 CFR 81.32. This language is no longer needed because it cross-references a section, 21 CFR 81.25, that was removed in 1988 (53 FR 33110).

• Deletion. This rule deletes 21 CFR 133.116(d), which reads “(d) Low sodium cheddar cheese is subject to § 105.69 of this chapter” as 21 CFR 105.69 was revoked in 1996 (61 FR 27771).

• Deletion. This rule deletes 21 CFR 133.121(f) which reads “(f) Low sodium colby cheese is subject to § 105.69 of this chapter” as 21 CFR 105.69 was revoked in 1996 (61 FR 27771).

• Deletion. In 21 CFR 172.840(c)(13), this rule deletes “and 133.131” as this section was revoked in 1996 (61 FR 58991) after FDA determined that lowfat cottage cheese was more appropriately covered by the general standard in 21 CFR 130.10.

• Correct Reference. In 21 CFR 178.3730, this rule removes the incorrect references to 21 CFR 193.390, 21 CFR 561.310, and 21 CFR 561.340 and replaces them with the correct references 40 CFR 180.127 and 40 CFR 180.128. This change reflects a renumbering of the CFR in 1988 (53 FR 24666) and a consolidation of certain tolerance regulations in 2000 (65 FR 33703).

• Deletion. In 21 CFR 178.3730, this rule removes the incorrect reference to 21 CFR 193.60 as this rule was renumbered in 1988 (53 FR 24666) and revoked in 1989 (54 FR 43424).

• Correct Reference. In 21 CFR 184.1097, this rule removes the incorrect reference to 9 CFR 318.7 and replaces it with the correct reference 9 CFR 424.21. This change reflects a renumbering of the CFR in 1999 (64 FR 72168).

• Correct Reference. In 21 CFR 184.1143, this rule removes the incorrect reference to 21 CFR 170.1 and replaces it with the correct reference 21 CFR 170.3(n)(22) as the definition for “gelatins and puddings” was moved in 1977 (42 FR 14302).

• Correct Reference. In 21 CFR 184.1924(c)(1), this rule removes the incorrect reference to 27 CFR 2.5 and replaces it with the correct reference 27 CFR 1.10 as the definition reference was moved in 1996 (61 FR 26096) and moved again in 1999 (64 FR 49985).

• Deletion. This rule removes a clause in 21 CFR 201.317(c) that cross-references 21 CFR 310.500, which was revoked in 2002 (67 FR 42992, 42997).

• Deletion. This rule removes 21 CFR 310.303 as it concerns procedures to list a drug in 21 CFR 310.304, which was revoked as obsolete or no longer necessary to achieve public health goals in 1996 (61 FR 29476, 29477).

• Correct Reference. In 21 CFR 369.3, this rule removes the incorrect reference to 21 CFR 369.22, which was removed in 2002 (67 FR 4904, 4907).

• Deletion. In 21 CFR 501.105(t), this rule removes the incorrect reference to 21 CFR 564.14(b) as 21 CFR part 564 was removed in 1999 (64 FR 4293) as an unnecessary regulation.

• Correct Reference. In 21 CFR 582.99, this rule removes the incorrect references to 40 CFR 180.1001(c) and (d) and replaces them with the correct references of 40 CFR 180.910 and 40 CFR 180.920 as these references were renumbered in 2004 (69 FR 23113).

• Correct Reference. This rule amends § 23.9 to remove the phrase “the most recent `CSA Income Poverty Guidelines' (45 CFR 1060.2) issued by the Community Services Administration;” and replace it with “the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. 9902(2);”. The Secretary of HHS is required to update the poverty guidelines at least annually, adjusting them based on the Consumer Price Index for All Urban Consumers. 45 CFR 1060.2 no longer exists; rather, updates are published at least annually in the Federal Register .

• Correct Reference. Section 51c.107(5) is amended to remove the phrase “the most recent `CSA Income Poverty Guidelines' (45 CFR 1060.2) issued by the Community Services Administration;” and replace it with “the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. 9902(2);”. The Secretary of HHS is required to update the poverty guidelines at least annually, adjusting them based on the Consumer Price Index for All Urban Consumers. 45 CFR 1060.2 no longer exists; rather, updates are published at least annually in the Federal Register .

• Correct Reference. Section 51c.303 is amended to remove the phrase “the most recent `CSA Income Poverty Guidelines' (45 CFR 1060.2) issued by the Community Services Administration;” and replace it with “the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. 9902(2);”. The Secretary of HHS is required to update the poverty guidelines at least annually, adjusting them based on the Consumer Price Index for All Urban Consumers. 45 CFR 1060.2 no longer exists; rather, updates are published at least annually in the Federal Register .

• Correct Reference. In § 52i.11b, this rule removes the incorrect reference to 45 CFR 74.53 and replaces it with the correct reference 45 CFR 75.361. This change reflects an update to the referenced citation.

• Correct Reference. In § 52i.11c, this rule removes the incorrect reference to 45 CFR 74.53e and replaces it with the correct reference 45 CFR 75.364. This change reflects an update to the referenced citation.

• Correct Reference. In § 52i.11d, this rule removes the incorrect reference to 45 CFR 74.52 and replaces it with the correct reference 45 CFR 75.341. This change reflects an update to the referenced citation.

• Correct Reference. Section 56.108 is amended to remove the phrase “the most recent `CSA Income Poverty Guidelines' (45 CFR 1060.2) issued by the Community Services Administration;” and replace it with “the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. 9902(2);”. The Secretary of HHS is required to update the poverty guidelines at least annually, adjusting them based on the Consumer Price Index for All Urban Consumers. 45 CFR 1060.2 no longer exists; rather, updates are published at least annually in the Federal Register .

• Correct Reference. Section 56.303 is amended to remove the phrase “the most recent `CSA Income Poverty Guidelines' (45 CFR 1060.2) issued by the Community Services Administration;” and replace it with “the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. 9902(2);”. The Secretary of HHS is required to update the poverty guidelines at least annually, adjusting them based on the Consumer Price Index for All Urban Consumers. 45 CFR 1060.2 no longer exists; rather, updates are published at least annually in the Federal Register .

• Deletion. Section 57.1505 is amended to remove the incorrect reference to 57.110 as it no longer exists.

• Correct Reference. In § 63.2, this rule removes the incorrect reference to 50.102 and replaces it with the correct reference 42 CFR part 93.103. This rule also amends the language to remove the outdated phrase “misconduct of science” and replaces it with the correct, current terminology “research misconduct”.

• Revised Nomenclature. In § 63.9(b), this rule removes the outdated phrase “misconduct of science” and replaces it with the correct, current terminology “research misconduct”.

• Correct Reference. In § 124.511, this rule removes the incorrect reference to 42 CFR 125.510 as this regulation no longer exists.

• Correct Reference. In § 124.602, this rule removes the incorrect reference to 42 CFR 53.1 as it is no longer necessary. This citation references Title VI of the Public Health Service Act, which was repealed in 1979 and has not received Congressional funding since the late 1980's.

• Correct Reference. In § 411.353(d), this rule removes the incorrect reference to § 1003.101 and replaces it with the correct reference § 1003.110. This change is necessary as HHS OIG re-designated the section referenced in this citation in a December 7, 2016 regulation (81 FR 88334). The December 7, 2016 regulation made no substantive changes to this provision.

• Correct Reference. In § 412.42, this rule removes all incorrect references to § 405.310 and replaces them with the correct references § 411.15. These changes are necessary as § 405.310 was renumbered in the early 1980's, and the reference needs to be updated accordingly.

• Correct Reference. In § 422.304(f), this rule removes the incorrect reference to § 495.220 and replaces it with the correct reference § 495.204. The Medicare and Medicaid Programs; Electronic Health Record Incentive Program final rule (75 FR 44314), published July 28, 2010, states that 42 CFR 422.304 would be amended to add a new paragraph (f), which would “act as a cross-reference to MA EHR incentive payment rules in subpart C of part 495 of this chapter” (75 FR 44481). Section 422.304(f), as added by the July 28, 2010 final rule, erroneously references § 495.220. This citation was incorrect at the time final rule was adopted; the regulations subpart C of part 495 do not include a § 495.220. Section 422.304(f) should instead have cross-referenced § 495.204 (“Incentive payments to qualifying MA organizations for MA-EPs and MA-affiliated eligible hospitals”).

• Correct Reference. In § 422.322(b), this rule removes the incorrect reference to 413.86(d) and replaces it with the correct reference § 413.76. Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2005 Rates; Final Rule (69 FR 48916), published on August 11, 2004 states that § 413.86(d) would be redesignated into nine separate sections (§ § 413.75, 413.76, 413.77, 413.78, 413.79, 413.80, 413.81, 413.82, and 413.83). Section 422.322 of “The Medicare Program; Establishment of the Medicare Advantage Program; Final Rule (70 FR 4729), published Jan 28, 2005, incorrectly cited § 413.86(d) which existed before the Final Rule 69 FR 48916 split the section into nine separate sections. Section 422.322(b) should have cross-referenced § 413.76 (Direct GME payments: Calculation of payments for GME costs) in place of § 413.86(d).

• Correct Reference. In § 422.324(b)(2), this rule removes the incorrect reference to § 413.86(b) and replaces it with the correct reference § 413.75(b). In a final rule published on August 11, 2004, § 413.86 was removed because the size of the section had grown too voluminous. The contents of the section were redesignated into nine individual sections (§ § 413.75 through 413.83). At that time however, the agency failed to update this reference to the section in § 422.324(b)(2).

• Correct Reference. In § 422.1094(b)(2), this rule removes the incorrect reference to § 422.858 and replaces it with the correct reference § 422.1088. Subpart T (consisting of § § 422.1000 through 422.1094) was added to part 422 on December 5, 2007 (72 FR 68727). The reference to § 423.858 was a typographical error in that document as that section did not exist at that time and was not otherwise mentioned in the document. The change is necessary to make this technical correction.

• Correct Reference. In § 423.1094(b)(2), this rule removes the incorrect reference to § 423.858 and replaces it with the correct reference § 423.1088. Subpart T (consisting of § § 423.1000 through 423.1094), was added on December 5, 2007 (72 FR 68736). At that time, the reference to § 423.858 in § 423.1094 was a typographical error in that document as that section did not exist at that time and was not otherwise mentioned in the document adding subpart T. The change is necessary to make this technical correction.

• Correct Reference. In § 423.2330(c)(3), this rule removes the incorrect reference to § 423.2306(b)(4) and replaces it with the correct reference § 423.2315(b)(4). Subpart W (consisting of 423.2300 through 423.2345) was added to part 423 on April 12, 2012 (71 FR 22172). In that document, the reference to § 423.2306 was a typographical error as that section did not exist at that time and was not included in the subpart being added. The change is necessary to make this technical correction.

• Correct Reference. In § 426.110, paragraph 1 of the definition of “Proprietary data and Privileged information”, this rule removes the incorrect reference to 45 CFR 5.65 and replaces it with the correct reference 45 CFR 5.31(d) and (e). This reference has been included in § 426.110 since it was adopted on November 7, 2003 (68 FR 63716), however, on October 28, 2016 (81 FR 74939), the Department published a final rule revising part 5. That revision moved the substantive text which had been in § 5.65 to 45 CFR 5.31(d) and (e). This change is necessary to make this technical correction.

• Correct Reference. In § 440.20(b) introductory text, this rule removes the incorrect reference to § 481.1 and replaces it with the correct reference § 491.2. There is no citation § 481.1 in the CFR. § 491.2 defines Nurse Practitioners and Physician Assistants for Rural Health Clinics and is the appropriate reference for § 440.20(b).

• Correct Reference. In § 441.17(a)(1), (a)(4), and (b), this rule removes the incorrect references to § 405.1316, § 405.1128(a), and § 405.1316(f), respectively, and replaces them with the correct reference “part 493 of this chapter”. These citations have been rescinded and updated under Medicare regulations but the corresponding Medicaid regulations that reference them were not updated.

• Correct Reference. In § 441.18(c) introductory text, this rule removes the incorrect reference to § 441.169 and replaces it with the correct reference § 440.169. This reference was correct in the October 1, 2008 edition on the CFR, however on June 30, 2009 at 74 FR 31196, CMS revised paragraph (c) and this amendment contained a typographical error that resulted in this reference being incorrectly changed.

• Correct Reference. In § 447.299(c), this rule removes the incorrect reference to § 455.204 and replaces it with the correct reference “§ 455.304 of this chapter”. The current reference is a typographical error and does not exist. This change is necessary to make this technical correction.

• Correct Reference. In 42 CFR 482.27(b)(3)(iii) and 482.27(b)(4)(iii), this rule removes the incorrect references to 21 CFR 610.48 as, effective December 28, 2015, the FDA issued a final rule that removed and reserved 21 CFR 610.48 in its entirety, along with any reference to this requirement in the FDA's other requirements. This rule also revises the remaining text of our provisions at 42 CFR 482.27(b)(3)(iii) and 482.27(b)(4)(iii), which contained references to 21 CFR 610.48(b)(3) and 610.48(c)(2), respectively.

• Correct Reference. In § 485.639(c)(1)(vii), this rule removes the incorrect reference to 42 CFR 413.86 as it no longer exists and adds in its place, a reference to § § 413.76 through 413.83. In a previous group of technical amendments (FY 2005 IPPS final rule) (69 FR 49234), CMS redesignated the contents of §  413.86 as § §  413.75 through 413.83. They also updated cross-references to §  413.86 that were located in various sections under 42 CFR parts 400 through 499. They inadvertently did not capture all of the needed cross-reference changes.

• Correct Reference. In § 1004.40, this rule removes the incorrect reference to 476.139 and replaces it with the correct reference 480.139. This non-substantive technical change is necessary to reference the correct regulation section that was moved.

• Correct Reference. In § 1008.36, this rule removes the incorrect reference to 45 CFR 5.65 and replaces it with the correct reference 45 CFR 5.41. This non-substantive technical change is necessary to reference the correct regulation section that was moved.

• Correct Reference. In § 3.1, this rule removes the incorrect reference to 40 United States Code section 318 or 318d and replaces it with the correct reference U.S. Public Law 107-296, Homeland Security Act of 2002. This amendment reflects a change in the referenced statutory authority.

• Correct Reference. In § 3.2(f), this rule removes the incorrect reference to Article 27, Sec. 36 in row 5 the table and replaces it with the correct reference Criminal Law, Sec. 4-202; removes the incorrect reference to Article 27, Sec. 36B in row 6 of the table and replaces it with the correct reference Sec. 4-202; removes the incorrect reference to Article 27, Sec. 36B in row 7 of the table and replaces it with the correct reference Criminal Law, Sec. 4-204; removed the incorrect reference to Article 27, Sec. 122 in row 8 of the table and replaces it with the correct reference Criminal Law, Sec. 6-409; removes the incorrect reference to Article 27, Secs. 240, 245 in row 9 of the table and replaces it with the correct reference Criminal Law, Sec. 12-102. These changes update the citations in the referenced Maryland codes.

• Correct Reference. In § 3.5, this rule removes the incorrect reference to 41 CFR 101-45.304 and replaces it with the correct reference 41 CFR part 102-41; removes the incorrect reference to 41 CFR part 101-48 and replaces it with the correct reference 41 CFR 102; removed the incorrect reference to 41 CFR 101-48.305 and replaces it with the correct reference 41 CFR 102-41. These changes reflect updates to the referenced General Services Administration regulations.

• Correct Reference. In § 3.61, this rule removes the incorrect reference to 40 United States Code section 318 or 318d and replaces it with the correct reference U.S. Public Law 107-296, Homeland Security Act of 2002. This amendment reflects a change in the referenced statutory authority.

• Correct Reference. In § 63.1, this rule removes the incorrect reference to 41 CFR 3-1.53 (which was not implemented into a final rule and is obsolete) and replaces it with the correct reference 45 CFR 75.201(a), and removes the incorrect reference to 41 CFR Chapters 1 and 3 (which is obsolete and has been replaced by the Federal Acquisition Regulations System (FAR) at 48 CFR) and replaces it with the correct reference 48 CFR Chapter 3.

• Correct Reference. In § 75.372, this rule removes the incorrect reference to 45 CFR 75.390 and replaces it with the correct reference 45 CFR 75.386, so that the sentence now reads “the requirements of 75.381 and 75.386”. The current citation of “the requirements of 75.381 through 75.390” is no longer accurate as § § 75.382 through 75.485 and § § 75.387 through 75.390 are now reserved.

• Correct Reference. Section 305.0 is amended in the beginning of the last sentence by replacing “Sections 305.40 through 305.42 . . .” with “Sections 305.40, 305.42 . . .” which removes the first instance of “through” in the sentence and replaces with a comma. This change is not substantive and clarifies the sentence.

• Correct Reference. In § 307.5(d)(3), this rule removes the incorrect reference to 45 CFR 305.99 and replaces it with the correct reference 45 CFR 305.66. This change is not substantive and is necessary to make this technical correction.

• Correct Reference. In § 1324.11, this rule removes the incorrect reference to 45 CFR 1327.13(e) and replaces it with the correct reference 45 CFR 1324.13(e); removes two incorrect references to 45 CFR 1327.19(b)(5) and replaces them with the correct reference 1324.19(b)(5) through (8); removes the incorrect reference to 45 CFR 1327.21 and replaces it with the correct reference 45 CFR 1324.21. 45 CFR 1327 was moved to 45 CFR 1324 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Reference. In § 1324.15, this rule removes the incorrect reference to 45 CFR 1327.13(e) and replaces it with the correct reference 1324.13(e); removes the incorrect reference to 45 CFR 1327.13(g) and replaces it with the correct reference 45 CFR 1324.13(g); removes the incorrect reference to 45 CFR 1327.13(c)(2) and replaces it with the correct reference 1324.13(c)(2). 45 CFR 1327 was moved to 45 CFR 1324 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Reference. In § 1324.19(b)(6), this rule removes the incorrect reference to 45 CFR 1327.11(e)(3) and replaces it with the correct reference 45 CFR 1324.11(e)(3). 45 CFR 1327 was moved to 45 CFR 1324 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Reference. In § 1324.19(b)(7), this rule removes the incorrect reference to 45 CFR 1327.11(e)(3) and replaces it with the correct reference 45 CFR 1324.11(e)(3). 45 CFR 1327 was moved to 45 CFR 1324 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Reference. In § 1324.19(b)(8), this rule removes the incorrect reference to 45 CFR 1327.11(e)(3) and replaces it with the correct reference 45 CFR 1324.11(e)(3). 45 CFR 1327 was moved to 45 CFR 1324 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Deletion. In § 1324.21(b)(3), this rule amends the language “(3) Where a State agency is unable to adequately remove or remedy a conflict, it shall carry out the Ombudsman program by contract or other arrangement with a public agency or nonprofit private organization, pursuant to section 712(a)(4) of the Act. The State agency may not enter into a contract or other arrangement to carry out the Ombudsman program if the other entity, and may not operate the Office directly if it” to remove the erroneous phrase “if the other entity.” 45 CFR 1324.21(b)(3) contains a grammatical typo. The earlier version at Federal Register Number 2015-01914, July 1, 2016 was referred to identify the correct grammatical language.

• Correct Reference. In § 1325.4, this rule removes the incorrect reference to 45 CFR 1386.30 and replaces it with the correct reference 45 CFR 1326.30(f). 45 CFR 1386 was moved to 45 CFR 1326 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Heading. In 45 CFR 1326, this rule removes the incorrect heading of “Formula Grant Program” and replaces it with the correct heading “Developmental Disabilities Formula Grant Programs”. This heading was changed in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Reference. In § 1326.103, this rule removes the incorrect reference to 45 CFR 1386.90 and replaces it with the correct reference 45 CFR 1326.90. 45 CFR 1386 was moved to 45 CFR 1326 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Reference. In § 1326.112, this rule removes the incorrect reference to 45 CFR 1386.84 and replaces it with the correct reference 45 CFR 1326.84. 45 CFR 1386 was moved to 45 CFR 1326 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Reference. In § 1326.93, this rule removes the incorrect reference to 45 CFR 1386.94 and replaces it with the correct reference 45 CFR 1326.94. 45 CFR 1386 was moved to 45 CFR 1326 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Reference. In § 1328.2, this rule removes the incorrect reference to 45 CFR 1385.3 and replaces it with the correct reference 45 CFR 1325.3; removes the incorrect reference to 45 CFR 1388.3 and replaces it with the correct reference 45 CFR 1328.3; and removes the incorrect reference to 45 CFR 1388.4 and replaces it with the correct reference to 45 CFR 1328.4. 45 CFR 1385 was moved to 45 CFR 1325 and 45 CFR 1388 was moved to 45 CFR 1328 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Reference. In § 1328.3, this rule removes the incorrect reference to 45 CFR 1388.2 and replaces it with the correct reference 45 CFR 1328.2. 45 CFR 1388 was moved to 45 CFR 1386 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Reference. In § 1328.5, this rule removes the incorrect reference to 45 CFR 1385.3 and replaces it with the correct reference 45 CFR 1325.3; removes the incorrect reference to 45 CFR 1388.2 and replaces it with the correct reference 45 CFR 1328.2; removes the incorrect reference to 45 CFR 1388.3 and replaces it with the correct reference to 45 CFR 1328.3. 45 CFR 1385 was moved to 45 CFR 1325 and 45 CFR 1388 was moved to 45 CFR 1328 in 2016 by 81 FR 35644 reflecting the Administration for Community Living's 2012 reorganization in a single subchapter of the regulations. The text of statutes was not completely updated to align with this final rule.

• Correct Reference. In § 302.101, this rule removes the incorrect reference to 48 CFR 301.604 and replaces it with the correct reference PGI Part 301.604.

• Correct Reference. In § 326.603(d), this rule removes the incorrect reference to `326.2' and replaces it with `326.6'. This change is not substantive as it only reflects the renumbering of the reference and the content has not been changed.

Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive publication in the Federal Register of a notice of proposed rulemaking and opportunity for comment requirements if it finds, for good cause, that they are impractical, unnecessary, or contrary to the public interest. As authorized by 5 U.S.C. 553(b)(3)(B), HHS finds good cause to waive notice and opportunity for comment on these amendments, as notice and opportunity for comment are unnecessary. These amendments will have no substantive impact and are of an administrative nature as they deal with correcting incorrect references and misspellings. HHS is exercising its authority under 5 U.S.C. 553(b)(3)(B) to publish these amendments as a final rule. The amendments are effective 30 days after date of publication in the Federal Register . These amendments do not require action by any person or entity regulated by HHS, and do not change the substantive responsibilities of any person or entity regulated by HHS.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in th[e] Executive Order.”

A regulatory impact analysis must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). HHS submits that this final rule is not economically significant as measured by the $100 million threshold, and hence not a major rule under the Congressional Review Act. This rule has not been designated as a significant regulatory action as defined by Executive Order 12866. As such, it has not been reviewed by the Office of Management and Budget.

Executive Order 13771, titled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017. It has been determined that this rule is not significant and thus is exempt from regulatory or deregulatory action for the purposes of Executive Order 13771.

On February 24, 2017, the President issued Executive Order 13777 titled “Enforcing the Regulatory Reform Agenda”. As required by Section 3 of the Executive Order, HHS established a Regulatory Reform Task Force (HHS Task Force) to review existing regulations and make recommendations regarding their repeal, replacement, or modification. It has been determined that this rule is not significant and thus is exempt for the purposes of Executive Order 13777.

This action will not have a significant impact on a substantial number of small entities. Therefore, the regulatory flexibility analysis provided for under the Regulatory Flexibility Act is not required.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

We have analyzed this final rule in accordance with the principles set forth in E.O. 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.

For reasons described in the preamble, the Department of Health and Human Services amends 2 CFR part 376; 21 CFR parts 1, 5, 12, 14, 25, 81, 133, 172, 178, 184, 201, 310, 369, 501, and 582; 42 CFR parts 23, 51c, 52i, 56, 57, 63, 124, 411, 412, 422, 423, 426, 440, 441, 447, 482, 485, 1004, and 1008; 45 CFR parts 3, 63, 75, 305, 307, 1324, 1325, 1326, and 1328; and 48 CFR parts 302 and 326 as follows:

The regulations in 2 CFR chapter IV set forth the United States Department of Agriculture's (USDA) regulations for grants and agreements. In a final rule published December 19, 2014 (79 FR 75982), USDA's Office of the Chief Financial Officer adopted 2 CFR part 200, along with an agency-specific addendum in a new 2 CFR part 400. The regulations in 2 CFR parts 415, 416, 418, and 422 were established. The regulations in 2 CFR chapter IV updated and replaced provisions that had previously been found in 7 CFR parts 3015, 3016, 3018, 3019, 3022, and 3052.

The regulations of several USDA agencies in title 7 refer to and cite the grants and agreements regulations. Following the publication of the various final rules establishing the regulations in 2 CFR chapter IV, those agencies updated their regulations so that they referred to the new grants and agreements regulations in title 2 rather than the predecessor regulations in title 7. As a result of the August 13, 2020, publication of the Office of Management and Budget's “Guidance for Grants and Agreements” (85 FR 49506), we have identified a number of instances where technical corrections are necessary. This final rule makes those technical corrections where needed.

This rule relates to internal agency management and makes various nonsubstantive changes to the regulations in titles 2 and 7 of the Code of Federal Regulations to make technical corrections to the Department's grants and agreements regulations. Accordingly, notice and other public procedure on this rule are unnecessary and contrary to the public interest. Therefore, pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity to comment are not required and this rule may be made effective less than 30 days after publication in the Federal Register . Further, since this rule relates to internal agency management, it is exempt from the provisions of Executive Orders 12866, 12988, and 13771. Finally, this action is not a rule as defined by the Regulatory Flexibility Act (5 U.S.C. 501) and, thus, is exempt from the provisions of that Act.

This final rule contains no new reporting, recordkeeping, or third-party disclosure requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Accordingly, 2 CFR parts 415 and 416 and 7 CFR parts 1780 and 3430 are amended as follows:

The FRTIB administers the Thrift Savings Plan (TSP), which was established by the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514. The TSP provisions of FERSA are codified, as amended, largely at 5 U.S.C. 8351 and 8401-79. The TSP is a tax-deferred retirement savings plan for federal civilian employees and members of the uniformed services. The TSP is similar to cash or deferred arrangements established for private-sector employees under section 401(k) of the Internal Revenue Code (IRC)(26 U.S.C. 401(k)).

Normally, a TSP participant's contributions to his or her account cannot exceed the statutory limits set forth in IRC section 402(g) (limiting the amount of traditional and Roth contributions to $19,500 for calendar year 2021) and IRC section 415(c) (limiting the total amount of traditional, Roth, tax-exempt, matching, and automatic 1% contributions to the lesser of 100% of the participant's compensation or $58,000 for calendar year 2021). However, a TSP participant who is age 50 or older is permitted to make catch-up contributions to his or her TSP account beyond these statutory limits up to the dollar limit in IRC section 414(v), which is $6,500 for calendar year 2021.

On January 23, 2020, the FRTIB published a proposed rule with request for comments in the Federal Register (85 FR 3857) to simplify the catch-up contribution process by no longer requiring participants to submit separate catch-up contribution election forms. The FRTIB received five comments on the proposed rule. Three comments expressed strong support for reducing the burden on participants by eliminating the separate catch-up contribution election forms. Two of the comments did not address the substance of the regulations. Therefore the FRTIB, is publishing the proposed rule as final without change.

Although the regulatory text is being published without change, in order to avoid confusion, the FRTIB wishes to clarify the effect of the simplified catch-up contribution process on the rules set forth at 5 CFR 1605.13 regarding back pay awards and other retroactive pay adjustments. If a TSP participant was age 50 or older during the year(s) to which a back pay award or other retroactive pay adjustment is attributable and the corrective contributions or make-up contributions exceed the IRC section 402(g) or 415(c) limit, then corrective contributions or make-up contributions will spill over toward the catch-up limit for those years, even if the contributions are attributable to years before 2021. However, catch-up contributions attributable to years before 2021 are not eligible for matching.

I certify that this regulation will not have a significant economic impact on a substantial number of small entities. This regulation will affect federal employees, members of the uniformed services who participate in the Thrift Savings Plan, and their beneficiaries. The TSP is a federal defined contribution retirement savings plan created by FERSA and is administered by the FRTIB.

I certify that these regulations do not require additional reporting under the Paperwork Reduction Act.

Pursuant to the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 602, 632, 653, 1501-1571, the effects of this regulation on state, local, and tribal governments and the private sector have been assessed. This regulation will not compel the expenditure in any one year of $100 million or more by state, local, and tribal governments, in the aggregate, or by the private sector. Therefore, a statement under 1532 is not required.

For the reasons stated in the preamble, the FRTIB amends 5 CFR chapter VI as follows:

This action, pursuant to 5 U.S.C. 553, finalizes amendments to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This rule is issued under Marketing Order No. 966, as amended (7 CFR part 966), regulating the handling of tomatoes grown in Florida. Part 966 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of tomato producers operating within the area of production. The applicable rules of practice and procedure governing the formulation of Marketing Agreements and Orders (7 CFR part 900) authorize amendment of the Order through this informal rulemaking action.

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this rule does not meet the definition of a significant regulatory action, it does not trigger the requirements contained in Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, titled ‘Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule shall not be deemed to preclude, preempt, or supersede any State program covering tomatoes grown in Florida.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 8c(15)(A) of the Act (7 U.S.C. 608 (15)(A)), any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed no later than 20 days after the date of entry of the ruling.

Section 1504 of the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill) (Pub. L. 110-246) amended section 8c(17) of the Act, which in turn required the addition of supplemental rules of practice to 7 CFR part 900 (73 FR 49307; August 21, 2008). The amendment of section 8c(17) of the Act and the supplemental rules of practice authorize the use of informal rulemaking (5 U.S.C. 553) to amend Federal fruit, vegetable, and nut marketing agreements and orders. USDA may use informal rulemaking to amend marketing orders depending upon the nature and complexity of the proposed amendments, the potential regulatory and economic impacts on affected entities, and any other relevant matters.

The Agricultural Marketing Service (USDA-AMS) considered the nature and complexity of the proposed amendments, the potential regulatory and economic impacts on affected entities, and other relevant matters, and determined that amending the Order as proposed by the Committee could appropriately be accomplished through informal rulemaking.

The Committee unanimously recommended the amendments following deliberations at two public meetings held on November 1, 2018, and February 27, 2019. This final rule will amend the Order by changing the Committee's size, the length of term of office, and quorum requirements.

A proposed rule and referendum order was issued on February 14, 2020, and published in the Federal Register on February 21, 2020 (85 FR 10096). That document also directed that a referendum among Florida tomato growers be conducted May 11, 2020, through June 1, 2020, to determine whether they favored the proposals. To become effective, the amendments had to be approved by either two-thirds of the growers voting in the referendum or by those representing at least two-thirds of the volume of tomatoes produced by those voting in the referendum.

The results of the referendum show that 78 percent of the eligible producers who voted and 91 percent of the volume voted favored amendment number 1. Also, 89 percent of the eligible producers who voted and 98 percent of the volume voted favored amendments number 2 and 3. The producer vote met the requirement of being favored by two-thirds of the producers voting, or by two-thirds of the volume voted in the referendum for all three amendments. Consequently, all three amendments passed and will change the Committee's size, the length of term of office, and quorum requirements.

Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 75 producers of Florida tomatoes in the production area and 37 handlers subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $1,000,000, and small agricultural service firms are defined as those whose annual receipts are less than $30,000,000 (13 CFR 121.201).

According to industry and Committee data, the average annual price for fresh Florida tomatoes during the 2017-18 season was approximately $12.56 per 25-pound container, and total fresh shipments were 25.9 million containers. Using the average price and shipment information, the number of handlers, and assuming a normal distribution, the majority of handlers have average annual receipts of less than $30,000,000 ($12.56 times 25.9 million containers equals $325,304,000 divided by 37 handlers equals $8,792,000 per handler).

With an estimated producer price of $6.00 per 25-pound container, the number of Florida tomato producers, and assuming a normal distribution, the average annual producer revenue is above $1,000,000 ($6.00 times 25.9 million containers equals $155,400,000 divided by 75 producers equals $2,072,000 per producer). Thus, the majority of producers of Florida tomatoes may be classified as large entities.

The Committee unanimously recommended the proposed amendments at public meetings on November 1, 2018, and February 27, 2019.

Since 1995, the number of producers and handlers operating in the industry has decreased, which makes it difficult to find enough members to fill positions on the Committee. Decreasing the Committee's size will make it more reflective of today's industry. No economic impact is expected from these amendments because they will not establish any new regulatory requirements on handlers, nor will they have any assessment or funding implications. There will be no change in financial costs, reporting, or recordkeeping requirements because of this action.

Alternatives to this proposal, including making no changes at this time, were considered by the Committee. Due to changes in the industry, AMS believes the proposals are justified and necessary to ensure the Committee's ability to locally administer the program. Reducing the size of the Committee will enable it to satisfy membership and quorum requirements fully, thereby ensuring a more efficient and orderly flow of business.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178 (Vegetable and Specialty Crops). No changes in those requirements are necessary because of this action. Should any changes become necessary, they would be submitted to OMB for approval.

This action will not impose any additional reporting or recordkeeping requirements on either small or large Florida tomato handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public-sector agencies.

AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this action.

The Committee's meetings were widely publicized throughout the Florida tomato production area. All interested persons were invited to attend the meetings and encouraged to participate in Committee deliberations on all issues. Like all Committee meetings, the November 1, 2018, and February 27, 2019, meetings were public, and all entities, both large and small, were encouraged to express their views on the proposals.

A proposed rule concerning this action was published in the Federal Register on October 1, 2019 (84 FR 52042). Copies of the rule were mailed or sent via facsimile to all Committee members and Florida tomato handlers. The proposed rule was made available through the internet by USDA and the Office of the Federal Register. A 60-day comment period ending December 2, 2019, was provided to allow interested persons to respond to the proposal. No comments were received, so no changes were made to the proposed amendments.

A proposed rule and referendum order was then issued on February 14, 2020, and published in the Federal Register on February 21, 2020 (85 FR 10096). That document directed that a referendum among Florida tomato growers be conducted during the period of May 11, 2020, through June 1, 2020, to determine whether they favored the proposed amendments to the Order. To become effective, the amendments had to be approved by at least two-thirds of the growers voting, or two-thirds of the volume of Florida tomatoes represented by voters in the referendum. The results show that 78 percent of the eligible producers who voted and 91 percent of the volume voted favored amendment number 1. Also, 89 percent of the eligible producers who voted and 98 percent of the volume voted favored amendments number 2 and 3.

The producer vote met the requirement of being favored by two-thirds of the producers voting, or by two-thirds of the volume voted in the referendum for all three amendments. All three amendments passed.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

(a) Findings and Determinations Upon the Basis of the Rulemaking Record.

The findings hereinafter set forth are supplementary to the findings and determinations which were previously made in connection with the issuance of the Order; and all said previous findings and determinations are hereby ratified and affirmed, except insofar as such findings and determinations may be in conflict with the findings and determinations set forth herein.

1. The Order, as amended, and as hereby further amended, and all the terms and conditions thereof, will tend to effectuate the declared policy of the Act;

2. The Order, as amended, and as hereby further amended, regulates the handling of tomatoes grown in Florida in the same manner as, and is applicable only to, persons in the respective classes of commercial and industrial activity specified in the Order;

3. The Order, as amended, and as hereby further amended, is limited in application to the smallest regional production area which is practicable, consistent with carrying out the declared policy of the Act, and the issuance of several orders applicable to subdivisions of the production area would not effectively carry out the declared policy of the Act;

4. The Order, as amended, and as hereby further amended, prescribes, insofar as practicable, such different terms applicable to different parts of the production area as are necessary to give due recognition to the differences in the production and marketing of onions produced in the production area; and

5. All handling of tomatoes produced or packed in the production area as defined in the Order is in the current of interstate or foreign commerce or directly burdens, obstructs, or affects such commerce.

(b) Determinations.

It is hereby determined that:

1. The issuance of this amendatory Order, amending the aforesaid Order, is favored or approved by producers representing at least two-thirds of the volume of tomatoes produced by those voting in a referendum on the question of approval and who, during the period of October 1, 2018, through September 31, 2019, have been engaged within the production area in the production of such tomatoes.

2. The issuance of this amendatory Order advances the interests of growers of tomatoes in the production area pursuant to the declared policy of the Act.

It is therefore ordered, that on and after the effective date hereof, all handling of tomatoes grown in Florida shall be in conformity to, and in compliance with, the terms and conditions of the said Order as hereby proposed to be amended as follows:

The provisions amending the Order contained in the proposed rule issued by the Administrator on September 23, 2019, and published in the Federal Register (84 FR 52042) on October 1, 2019, will be and are the terms and provisions of this order amending the Order and are set forth in full herein.

For the reasons set forth in the preamble, 7 CFR part 966 is amended as follows:

In FR Doc. 2020-19428, appearing on page 66146 in the Federal Register of Friday, October 16, 2020, the following corrections are made:

 1. On page 66180, in the third column, in § 121.103, in paragraph (h)(1)(ii), “Except for sole source 8(a) awards, the joint venture must meet the requirements of §  124.513(c) and (d), §  125.8(b) and (c), §  125.18(b)(2) and (3), §  126.616(c) and (d), or §  127.506(c) and (d) of this chapter, as appropriate, at the time it submits its initial offer including price. For a sole source 8(a) award, the joint venture must demonstrate that it meets the requirements of §  124.513(c) and (d) prior to the award of the contract.” is corrected to read, “Except for sole source 8(a) awards, the joint venture must meet the requirements of § 124.513(c) and (d), § 125.8(b) and (c), § 125.18(b)(2) and (3), § 126.616(c) and (d), or § 127.506(c) and (d) of this chapter, as appropriate, as of the date of the final proposal revision for negotiated acquisitions and final bid for sealed bidding. For a sole source 8(a) award, the joint venture must demonstrate that it meets the requirements of § 124.513(c) and (d) prior to the award of the contract.”

 2. On page 66180, in the third column, in § 121.404, in amendment 4, instruction (a) “i. Revising paragraphs (a) introductory text and (a)(1); and ii. Adding a paragraph heading to paragraph (a)(2);” is corrected to read, “i. Adding a paragraph heading to paragraphs (a) and (a)(2); and ii. Revising paragraph (a)(1);”.

 3. On page 66180, in the third column, in § 121.404, in paragraph (a), “ Time of size—” is corrected to read “ Time of size * * *”.

 4. On page 66181, in the third column, in § 121.404, in paragraph (d), “ Nonmanufacturer rule, ostensible subcontractor rule, and joint venture agreements. Size status is determined as of the date of the final proposal revision for negotiated acquisitions and final bid for sealed bidding for the following purposes: compliance with the nonmanufacturer rule set forth in §  121.406(b)(1), the ostensible subcontractor rule set forth in §  121.103(h)(4), and the joint venture agreement requirements in §  124.513(c) and (d), §  125.8(b) and (c), §  125.18(b)(2) and (3), §  126.616(c) and (d), or §  127.506(c) and (d) of this chapter, as appropriate.” is corrected to read, “ Nonmanufacturer rule, ostensible subcontractor rule, and joint venture agreements. Compliance with the nonmanufacturer rule set forth in § 121.406(b)(1), the ostensible subcontractor rule set forth in § 121.103(h)(4), and the joint venture agreement requirements in § 124.513(c) and (d), § 125.8(b) and (c), § 125.18(b)(2) and (3), § 126.616(c) and (d), or § 127.506(c) and (d) of this chapter, as appropriate, is determined as of the date of the final proposal revision for negotiated acquisitions and final bid for sealed bidding for the following purposes.”

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code (U.S.C.). Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the Class E airspace extending upward from 700 feet AGL at Bear Lake County Airport, Paris, ID in support of IFR operations.

The FAA published a notice of proposed rulemaking in the Federal Register (85 FR 53308; August 28, 2020) for Docket No. FAA-2020-0751 to modify the Class E airspace extending upward from 700 feet above the earth at Bear Lake County Airport, Paris, ID, in support of IFR operations. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No substantive comments were received.

Class D and Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020 and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is amending 14 CFR part 71 by modifying Class E airspace extending upward from 700 feet above the surface at Bear Lake County Airport, Paris, ID. The area east of the airport is being reduced from 15.3 miles wide (from east to west), and 28.1 miles tall (from north to south) to 2 miles each side of the 115° bearing from the airport from the 6.6-mile radius to 11 miles southeast from the airport, and the trapezoidal area west of the airport extending approximately 10.5 miles wide (from east to west) and 33.8 miles tall (from north to south) is being reduced to 2 miles each side of the airport 315° bearing extending from the 6.6-mile radius to 17 miles northwest from the airport, as the additional airspace is no longer required for operations.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order (E.O.) 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA published a final rule in the Federal Register for Docket No. FAA-2020-0497 (85 FR 67649, October 26, 2020) amending Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying VOR Federal airways V-5 and V-178 in the vicinity of New Hope, KY, and removing V-513 in its entirety due to the planned decommissioning of the New Hope, KY, VOR. Subsequent to publication, the FAA determined that the New Hope, KY, VOR navigation aid will not be decommissioned at this time. As a result, the final rule is being withdrawn.

NASA has determined this rulemaking meets the criteria for a direct final rule because it makes nonsubstantive changes to remove information on NASA's Cooperative Agreements with Commercial Firms codified in 14 CFR part 1274 because this information is already available in 2 CFR part 1800 and in NASA's GCAM. NASA's GCAM is accessible at https://prod.nais.nasa.gov/pub/pub_library/srba/documents/Grant_and_CooperativeAgreementManual.pdf. No opposition to the changes and no significant adverse comments are expected. However, if NASA receives any significant adverse comments, it will withdraw this direct final rule by publishing a document in the Federal Register . A significant adverse comment is one that explains: (1) Why the direct final rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the direct final rule will be ineffective or unacceptable without a change. In determining whether a comment necessitates withdrawal of this direct final rule, NASA will consider whether such comment warrants a substantive response through a notice and comment process.

Title 14 CFR part 1274, last amended June 3, 2016 [81 FR 35584], sets forth policy guidelines to establish uniform requirements for NASA cooperative agreements awarded to commercial firms. It is amended to remove information on NASA's Cooperative Agreements with Commercial Firms because this information is already available in other documents.

Executive Orders (E.O.) 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated as “not significant” under section 3(f) of E.O. 12866.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) requires an agency to prepare an initial regulatory flexibility analysis to be published at the time the proposed rule is published. This requirement does not apply if the agency “certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities” (5 U.S.C. 603). This rule removes 14 CFR part 1274, therefore, does not have a significant economic impact on a substantial number of small entities.

This direct final rule does not contain any information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

E.O. 13132, “Federalism,” 64 FR 43255 (August 4, 1999) requires regulations be reviewed for federalism effects on the institutional interest of states and local governments, and if the effects are sufficiently substantial, preparation of the Federal assessment is required to assist senior policy makers. Removal of 14 CFR part 1274 will not have any substantial direct effects on state and local governments within the meaning of the E.O. Therefore, no federalism assessment is required.

This rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

This rule will not result in the expenditure by state, local, and Tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments.

Electronic Access and Filing

This document, as well as the advance notice of proposed rulemaking (ANPRM), supporting materials, and all comments received may be viewed online through the Federal eRulemaking portal at: http://www.regulations.gov. An electronic copy of this document may also be downloaded from the Office of the Federal Register's home page at: http://www.archives.gov/federal-register and the Government Publishing Office's web page at: http://www.gpo.gov/fdsys.

The FHWA is adding a new subpart F under 23 CFR part 635 to allow States to useproje the ID/IQ method of contracting, including JOC, on Federal-aid highway projects, under certain circumstances, on a permanent basis. Currently, this contracting technique is only authorized on an experimental basis under FHWA's Special Experimental Project No. 14 (SEP-14). Allowing ID/IQ contracting on a permanent basis provides benefits to State departments of transportation (State DOT) and other contracting agencies, including expediting project delivery, increasing administrative efficiency, reducing project costs, and increasing flexibility for State DOTs to use Federal-aid funds on certain projects.

The FHWA is issuing this IFR pursuant to 5 U.S.C. 553(b)(3)(B) to allow States to realize immediately the benefits and cost savings associated with the ID/IQ method of contracting. The FHWA has conducted a preliminary cost-benefit analysis on this rulemaking and anticipates a cost savings of $3.4 million per year at a 7 percent discount rate.

The ID/IQ method of contracting allows an IQ of supplies or services for a fixed time. The Federal Government uses this method when agencies cannot determine, above a specified minimum, the precise quantities of supplies or services that the Government will require during the contract period. For construction ID/IQ contracts, contractors bid unit prices for estimated quantities of standard work items, and work orders are used to define the location and quantities for specific work. The ID/IQ contracts may be awarded to the lowest responsive bidder based on an invitation for bids or the best-value proposer based on responses to Requests for Proposals. Contracting agencies use other names for these types of contracts, including JOC contracts, master contracts, on-call contracts, area-wide contracts, continuing contracts, design-build push-button contracts, push-button contracts, stand-by contracts, and task order contracts. The JOC method is a form of ID/IQ contracting that uses a unit price book with pre-priced work item descriptions in the solicitation. Contract awards under this method use the bidder's adjustment factors or multipliers to establish contract prices. The contract is awarded to the lowest responsive bidder determined by their rates.

Although ID/IQ contracts are specifically authorized in the Federal procurement process (48 CFR subpart 16.5) and for the contracting of architecture and engineering services in the Federal-aid highway program (FAHP) (23 CFR part 172), FAHP authorization and procurement laws for construction do not address the possible use of ID/IQ contracts. The FAHP construction procurement statute, 23 U.S.C. 112(b)(1), requires contracts to be awarded by a competitive bidding process to the lowest responsive bidder (traditional design-bid-build project delivery method based upon the premise of a 100 percent-complete design and a well-defined scope of work). Typically, ID/IQ contracts are awarded based upon a general, but not completely defined, scope of work for a geographic area and limited time period (but not specific locations, designs, or quantities) and are often awarded based upon specific evaluation criteria.

The FHWA used its authority in 23 U.S.C. 502(b)(1) to test the use of ID/IQ contracts for the construction of FAHP projects through the SEP-14 Program for innovative contracting techniques under authority of 23 U.S.C. 502(b)(2). Under the SEP-14 Program, contracting agencies interested in testing an innovative contracting technique submit project-specific (or programmatic) work plans to FHWA for implementation. The FHWA Division Office evaluates the work plan, coordinates with FHWA Headquarters, and, if it finds the work plan to be acceptable, FHWA approves the use of the technique on a temporary basis for a project or group of pilot projects. Over time, FHWA Headquarters staff assess the initiative to determine if it is a technique that should be operationalized for the FAHP on a permanent basis without the need for individual requests, work plans, and evaluation reports. More information on SEP-14 can be found at https://www.fhwa.dot.gov/construction/cqit/sep14.cfm.

From 2007 to the present, FHWA, State DOTs, and Local Public Agencies (LPA) through the State DOTs, have experimented with the use of ID/IQ and JOC contracts for construction. The FHWA has approved the use of this contracting method under SEP-14 for 19 different State DOTs and 6 LPAs. Evaluation reports indicate that ID/IQ and JOC contracts allow for cost-effective contracting for small value contracts and preventive maintenance programs. Specifically, the reports indicate that these contracts eliminate the need for contracting agencies to advertise and award numerous small contracts and provide contracting agencies with wide flexibility in programming and addressing preventive maintenance needs.

Having evaluated the use of ID/IQ and JOC contracts for construction in the FAHP for over a decade, FHWA determined that they were suitable for operationalization. This is consistent with Senate report language accompanying fiscal years 2017 and 2018 appropriations to operationalize JOC. See S. Rept. No. 114-243, 43 (April 21, 2016); S. Rept. No. 115-138, 52 (July 27, 2017). The approach is also consistent with the U.S. Department of Justice Office of Legal Counsel opinion regarding competition and contracting requirements, which found that “FHWA may reasonably conclude, consistent with 23 U.S.C. 112, that certain state or local requirements [that may have the effect of reducing the number of potential bidders for a particular contract still] promote the efficient and effective use of federal funds or protect the integrity of the competitive bidding process.” See Competitive Bidding Requirements Under the Federal-Aid Highway Program, 23 U.S.C. 112 (Aug. 23, 2013), at 24. 1 As discussed further below, including in relation to provisions on securing competition and selection of contractors, ID/IQ and JOC contracts are consistent with the opinion because they promote “the efficient and effective use of federal funds.”

The FHWA is proceeding with two phases to operationalize ID/IQ contracting and JOC for construction in the FAHP. The first phase was the issuance of an FHWA Notice  2 on how FHWA will allow ID/IQ and JOC contracts for low-cost construction contracts in the FAHP without the need for project-specific work plans from contracting agencies. The second phase was the initiation of this rulemaking.

Under the first phase, FHWA published a Federal Register Notice requesting public comment on allowing contracting agencies to establish ID/IQ contracting and JOC for low-cost construction contracts at 83 FR 19393 on May 2, 2018, and subsequently published FHWA Notice N5060.2, titled “Indefinite Delivery/Indefinite Quantity Contracting for Low-Cost Federal-Aid Construction Contracts,” on January 18, 2019. 3 Notice N5060.2 set forth FHWA's policy for the use of ID/IQ contracting for low-cost FAHP construction contracts and clarified under what conditions ID/IQ contracts are allowed for Federal-aid construction.

Under Notice N5060.2, an ID/IQ contract not requiring advance approval under the SEP-14 Program should satisfy certain conditions, including that the contract be: Low-cost (the total value of task or work orders may not exceed $2,000,000 per year on average over the contract term); short-term (a base contract of 1 to 2 years); awarded by competitive bidding to the lowest responsive bidder; a single-award contract; qualified for a National Environmental Policy Act (NEPA) categorical exclusion listed under 23 CFR 771.117; awarded and performed in compliance with applicable Disadvantaged Business Enterprise (DBE) provisions of 49 CFR part 26; and compliant with certain other laws and regulations related to Federal-aid construction. Additional details can be found in FHWA Notice N5060.2. Although Notice N5060.2 allows ID/IQ contracting without advance SEP-14 Program approval on a project-by-project basis, the contracts continue to be administered under the SEP-14 Program on an experimental basis. The ID/IQ contracts not meeting the conditions of Notice N5060.2, such as multiple-award contracts, continue to require advance approval under the SEP-14 Program.

After the publication of this Interim Final Rule, Notice N5060.2, Indefinite Delivery/Indefinite Quantity Contracting for Low-Cost Federal-aid Construction Contracts, January 18, 2019, will expire effective November 16, 2021.

Under the second phase of operationalizing ID/IQ contracting and JOC for construction in the FAHP, FHWA published the ANPRM titled, “Indefinite Delivery and Indefinite Quantity Contracts for Federal-Aid Construction,” at 83 FR 29713 on June 26, 2018. The ANPRM sought comment on how to expand ID/IQ contracting and allow it on a permanent basis. The FHWA received 11 comments to the docket, 9 of which were responsive to the questions posed in the ANPRM. Comments were provided by six State DOTs, two municipalities, one business, and two individuals who responded to the wrong Federal Register notice. The comments are available for examination in the docket (FHWA-2018-0017) at http://www.regulations.gov.

After consideration of the responsive comments, and based on its ongoing experience with ID/IQ contracting under the SEP-14 Program, FHWA is authorizing ID/IQ contracting on Federal-aid highway projects on a permanent basis as set forth in this IFR. The FHWA believes that this approach will benefit State DOTs by expediting project delivery, increasing administrative efficiency, reducing project costs, and increasing flexibility for State DOTs to use Federal-aid funds on certain projects. The FHWA considered responsive comments related to the benefits of ID/IQ contracting and other topics in developing the regulation set forth in this IFR.

Commenters argued ID/IQ contracting expedites the delivery of highway construction projects and increases administrative efficiency. In making this argument, commenters cited as reasons the reduced time necessary to prepare, advertise, and procure highway construction projects; the ability to consolidate design assignments; the reduced time and resources necessary to administer highway construction projects; and the reduced administrative burden in working with fewer contractors and on fewer contracts.

For example, one State DOT indicated that, based on its experience under the SEP-14 Program, ID/IQ contracting reduces the time necessary to prepare projects for construction and reduces the administrative burden associated with advertising projects. Another State DOT indicated that ID/IQ contracting allows States to quickly obligate Federal funds for needed work, consolidate design assignments, and reduce their administrative burden in administering projects by working with fewer contractors. This commenter indicated that ID/IQ contracts reduce procurement time for each work order by approximately 8 weeks. Another State DOT argued that ID/IQ contracting reduces the time and resources necessary to administer individual work orders. This commenter also explained that ID/IQ contracts reduce the administrative burden associated with pre-qualification procedures because quality is accounted for in the initial award. Another State DOT noted that certain tasks can be completed more quickly using ID/IQ contracting compared to its traditional reliance on in-house resources.

The FHWA agrees with the commenters and believes that ID/IQ contracting is likely to expedite project delivery of certain highway projects and increase administrative efficiency.

Commenters also said that ID/IQ contracting reduces the overall costs of certain highway projects and work orders. Commenters cited as reasons reduced costs associated with expedited project delivery; reduced costs associated with gains in administrative efficiency; the reduced time and resources that contactors must spend on bid preparation, which results in reduced costs for States; increased competition for larger contracts, which can reduce overall cost; and reduced costs on emergency maintenance contracts because prices are established in advance.

For example, one State DOT stated that ID/IQ contracting reduces overall construction costs. This commenter said that because ID/IQ contracting reduces the time and resources that contactors must spend on bid preparation, it also reduces contract prices and the overall costs incurred by States. Another State DOT indicated that under the SEP-14 Program it received twice as many bids for tasks relative to traditional design-bid-build contracting. The increased competition resulted in lower prices. This commenter also reported that its contractors are highly satisfied with ID/IQ contracting under the SEP-14 Program. Another State DOT stated that it anticipates cost savings on emergency maintenance contracts because predetermined prices will be in place.

The only business that commented provided several examples of the efficiency and effectiveness of JOC contracts used by States, municipalities, and other government agencies, mostly at educational facilities. The examples indicated that JOC can reduce overall project costs by 5 to 10 percent.

The FHWA agrees with the commenters and believes that ID/IQ contracting is likely to reduce the overall cost of certain highway projects.

Commenters also argued that operationalizing ID/IQ contracting will increase flexibility for State DOTs by allowing them to use ID/IQ contracting on a broader range of projects and on a permanent basis. As discussed above, the added flexibility provided to States by operationalizing ID/IQ through rulemaking may also provide associated gains in expedited project delivery, administrative efficiency, and reduced project costs. One State DOT indicated that experimenting with ID/IQ contracts under the SEP-14 Program allowed for competitive bidding on projects that otherwise would have been awarded non-competitively under State emergency procedures.

Considering the comments, FHWA believes that ID/IQ contracting increases flexibility for State DOTs and that expanding ID/IQ contracting and allowing it on a permanent basis provides needed flexibility to the States to manage Federal financial assistance under 23 U.S.C. 145.

A common theme in several comments was that FHWA should raise or eliminate the annual expenditure cap of $2 million existing under Notice N5060.2.

Commenters in favor of eliminating the cap, including multiple State DOTs, argued that a $2 million cap would limit their flexibility and reduce the benefits of ID/IQ contracting. For example, one State DOT argued that a $2 million cap would limit the usability of ID/IQ contracting. Eliminating the cap, it argued, would expand opportunity to use this method and realize its benefits on a broader scale. Another State DOT argued that a $2 million cap would quickly limit the ability of State DOTs to use the best contractors, which would create inefficiency and result in awards to less competitive contractors. Another State DOT argued that eliminating the cap or making it significantly higher would maximize flexibility for State DOTs to use and realize the benefits of ID/IQ contracting. Another commenter argued that States should be allowed the flexibility to set their own caps. This commenter also argued that setting a cap in this context would be inconsistent with the practices and regulations of certain other Federal agencies.

No commenters supported retaining the annual expenditure cap of $2 million existing under Notice N5060.2. The FHWA agrees with the arguments put forth by the commenters opposing a cap and is not establishing an annual expenditure cap for contracts authorized under this regulation. Section G below discusses a 12-month phase-out period for authorizing low-cost ID/IQ contracts under Notice N5060.2, as well as ID/IQ contracts authorized under an approved SEP-14 work plan.

Commenters also addressed whether “on-ramp” procedures should be used to allow new contractors to be considered for the award pool after the initial award of an ID/IQ and “off-ramp” procedures be used to discontinue the use of contractors who are not performing satisfactorily.

One State DOT agreed that such procedures should be used. It further stated that it already uses on-ramp procedures under the SEP-14 Program. The commenter argued that these procedures give contracting agencies flexibility to expand the pool of contractors when necessary as well as the ability to remove unresponsive, non-competitive contractors. This tool motivates contractors to be and remain competitive. This commenter is in the process of developing off-ramp criteria for its State.

A municipality opposed on-ramp procedures outside of a competitive process and recommends new contractors be added via new procurements. This commenter recommended using termination clauses for convenience or default to remove contractors. Another commenter opposed on-ramp procedures because, it argued, they undermine the initial competitive process. This commenter recommended using existing processes to address non-performing contractors.

Contracting agencies may use appropriate methods to address contractor performance by removing contractors through State DOT “off-ramp” or contract termination procedures. The FHWA believes that procedures introducing new contractors into an existing ID/IQ contract after the initial solicitation and award could undermine the competitive process required by statute and the regulation. Accordingly, FHWA has not established “on-ramp” procedures in this rulemaking, nor is FHWA establishing additional contract termination procedures.

Two commenters also recommended clarifying some of the language that FHWA uses in referring to ID/IQ contracts in this rulemaking. As discussed above, one commenter suggested that FHWA align its terminology about contract extensions with the industry standard, using “contract extension” or “contract renewal” instead of “time extension.” The same commenter recommended using terminology consistent with industry standards for contractor “adjustment factors” in JOC. In the ANPRM, FHWA referred to “mark-up rates.” Relative to the meaning of a unit price book or construction task catalog used by JOC, the same commenter recommended changing the phrase “with pre-priced work item descriptions” from the ANPRM to “which includes a list of defined construction tasks, and for each task, includes a unit of measure and a preset unit price.”

Another commenter observed that it is unclear how time limits for contract length are defined—calendar year, Federal fiscal year, or start of work. The same commenter also observed that it is unclear how $2 million annual contract limit applies—estimated work, scheduled or planned work, or invoiced work. Another State DOT recommended clarifying whether the maximum contract limit is total contract value or Federal funds only.

The FHWA has attempted to address these comments in this regulation. The comments regarding the annual contract value limit no longer apply because such a limit is not provided in the regulation.

Some commenters also recommended clarifying certain elements of ID/IQ procedures. For example, one State DOT recommended minimizing reporting requirements and focusing on critical areas. Another commenter recommended clarifying what contracting agencies must do to use ID/IQ or JOC beyond providing assurances to FHWA regarding implementation and reporting. It suggested that FHWA align reporting requirements for ID/IQ with other standard contracting techniques. Regarding comments concerning reporting requirements, as this IFR operationalizes the ID/IQ method, FHWA intends to cancel Notice N5060.2 and FHWA is not establishing reporting requirements for contracts authorized under this regulation.

To provide flexibility to State DOTs and ease of transition, during a period of no more than 12 months following publication of this IFR, FHWA Division Administrators may continue to concur in the use of ID/IQ for low-cost contracts per the terms of the Notice and other ID/IQ contracts authorized under an approved SEP-14 work plan. Division Administrators may continue to allow extensions of contracts authorized under the Notice or applicable SEP-14 work plan for the duration of these contracts. For low-cost contracts authorized under the Notice or ID/IQ contracts authorized under an approved SEP-14 work plan, State DOTs may continue to administer the contracts per the requirements of the Notice or applicable SEP-14 work plan for the duration of these contracts. However, the reporting requirements described in Question and Answer No. 9 of the Notice or applicable SEP-14 work plan would no longer apply to these projects after the effective date of this IFR. The FHWA may continue to use SEP-14 to authorize and evaluate contracting methods that are outside the scope of this regulation.

Another commenter proposed using “Fixed Price/Variable Scope or Fixed Budget/Best Value contracts,” an alternative contracting method. Another commenter referred to certain best practices including partnering, use of software to promote transparency, training, use of a task catalog tailored to the specific contracting agency, detailed scopes of work, and transparent proposal review process. As discussed above, FHWA believes that sufficient benefits will result if ID/IQ contracting is operationalized under this rulemaking on a permanent basis. The FHWA is not considering other alternative contracting methods in the context of this rulemaking.

The FHWA makes several amendments in 23 CFR parts 630 and 635 to address the application of various Federal requirements to ID/IQ projects. In addition, FHWA replaces the terms “State transportation department” and “STD” with the more commonly used terms “State department of transportation” and “State DOT” throughout 23 CFR part 630 and 635. Finally, FHWA also corrects certain outdated citations in 23 CFR parts 630 and 635.

The FHWA amends 23 CFR 630.106(a)(9) to provide for the execution and modification of the project agreement for ID/IQ projects. This amendment is similar to the existing language for design-build projects at 23 CFR 630.106(a)(7) and Construction Manager/General Contractor projects at 23 CFR 630.106(a)(8) in that this amendment makes clear that FHWA execution or modification of a project agreement for final design or physical construction, and authorization to proceed, shall not occur until after the completion of the NEPA process. This language conforms with 23 CFR 771.113(a) regarding the relationship between the completion of required environmental reviews and the obligation of funds for final design and construction.

The FHWA amends 23 CFR 630.112(c)(3) and (4) to correct outdated citations. The changes to 23 CFR 630.112(c)(3) are intended to update the drug-free workplace requirements to reflect the new DOT regulations. The changes to 23 CFR 630.112(c)(4) are intended to update the suspension and debarment requirements to reflect the new Office of Management and Budget regulations at 2 CFR part 180, as adopted by the DOT at 2 CFR part 1200. The requirements of the previous 49 CFR part 29 have been updated and moved to these new regulations. The updates to these cross references in 23 CFR 630.112(c)(3) and (4) do not impose any new requirements or burdens under this part.

The FHWA amends 23 CFR 630.205(e) to provide an exception from the standard contracting approval process for contracts that conform to the requirements of the revised 23 CFR part 635 subpart F. In addition, FHWA amends 23 CFR 630.205(d) by revising the term “State Highway Agency” to conform with the more commonly used term, “State DOT.”

The FHWA amends the definitions in 23 CFR 635.102 by adding a definition for “ID/IQ project” and “State DOT.”

The FHWA amends 23 CFR 635.104 to state that the applicable regulations pertaining to the ID/IQ contracting process found in this rule apply to ID/IQ projects. In addition, no justification of cost effectiveness is necessary in selecting projects for this method of construction.

The FHWA amends 23 CFR 635.107 to clarify that the disadvantaged business enterprise program requirement will also apply to ID/IQ projects.

The FHWA amends 23 CFR 635.109 to provide that State DOTs are strongly encouraged to use “suspensions of work ordered by the engineer” clauses, and may consider “differing site condition” clauses and “significant changes in the character of work” clauses, as appropriate, for contracts for ID/IQ projects.

Commenters addressed what changed conditions clause would be appropriate for ID/IQ and JOC contracts including for significant changes in the character of work. One State DOT recommended that the content of this clause be left to the discretion of the State or local contracting agency. Another State DOT recommended standard specifications. Another State DOT stated that changes should be minimal due to nature of work. It supports use of existing standard changed conditions clauses with additional specificity left to the States. A municipality recommended that the nature of any extra work should relate to a specific work order. It recommended a 10 percent threshold for higher authority approval. Another municipality provided its local job order specification, which is tailored for ID/IQ. Another commenter supported use of the standard changed condition clause of 23 CFR 635.109 and issuing a supplemental job order with pre-established prices in the contract when changed conditions are encountered. Finally, another State DOT recommended adjustments related to geography and changes due to unknown utilities, design ambiguity, and other factors. This commenter also suggested limiting the amount of changes in scope from the original contract, such as to 30 percent of the original contract.

Considering the comments, FHWA is not establishing specific requirements relating to standardized changed conditions clauses. The regulation amends 23 CFR 635.109 to allow contracting agencies a choice regarding the inclusion of clauses in that section or clauses developed locally, as may be appropriate for the ID/IQ method. Consistent with the design-build project delivery method, the regulation encourages contracting agencies to incorporate the “suspensions of work ordered by the engineer” clauses.

The FHWA amends 23 CFR 635.110(f) to clarify that State DOTs may use their own bonding, insurance, licensing, qualification or prequalification procedure for any phase of ID/IQ procurement.

The FHWA amends 23 CFR 635.112 to indicate that the FHWA Division Administrator's approval of the solicitation document constitutes FHWA's approval to use the ID/IQ contracting method and approval to release the solicitation document. The amendment also provides that the State DOT must obtain the approval of the FHWA Division Administrator before issuing addenda which result in major changes to the solicitation document.

The FHWA amends 23 CFR 635.114 to clarify that the award of a contract for an ID/IQ project and FHWA's concurrence in such award are subject to the requirements in 23 CFR part 635 subpart F.

The FHWA amends 23 CFR 635.309(q) to clarify what certification is required as a prerequisite to FHWA authorization of physical construction and final design activities. Since ID/IQ contracts may be awarded before the completion of the NEPA process, FHWA establishes specific certification requirements to apply to ID/IQ contracts.

The FHWA adds a new subpart F to 23 CFR part 635 to provide the policies, requirements, and procedures relating to the use of ID/IQ contracting. With the exception of approval of State DOT ID/IQ procedures, all FHWA approval requirements established in this new subpart would be subject to assumption by the State DOT in accordance with 23 U.S.C. 106(c).

In 23 CFR 635.601, FHWA adds a paragraph describing that the general purpose of subpart F is to prescribe the policies, requirements, and procedures for the use of the ID/IQ contracting method.

In 23 CFR 635.602, FHWA establishes definitions for certain terms used in subpart F. The FHWA has found that contracting agencies and practitioners use a variety of terms to describe the components of the ID/IQ contracting method.

For clarity and simplicity of use, FHWA establishes eight definitions associated with this regulation. Best value selection is used to describe a process using both price and qualitative components as a basis of award of contracts. Contracting agency means the State DOTs, and any State or local government agency, public-private partnership, or Indian Tribe (as defined in 2 CFR part 200) that is the acting under the supervision of the State DOT and is awarding and administering an ID/IQ contract. The term ID/IQ refers to a method of contracting that allows an IQ of services for a fixed time. An ID/IQ contract is used to describe the principal contract between the contracting agency and the contractor under the ID/IQ method of contracting. The term JOC refers to a specific form of ID/IQ contracting, distinguished by its use of a unit price book in the solicitation and the bidder's adjustment factors or multipliers to establish contract prices. A JOC contract means a type of ID/IQ contract delivered using the JOC method. The term NEPA process refers to the applicable environmental reviews and has the same meaning as defined in Subpart E. Unit price book is used to describe the document that lists construction tasks, units of measure, and unit prices in the JOC method of contracting. Work order is used to describe the contract document issued for a definite scope of work under an ID/IQ contract.

In 23 CFR 635.603, FHWA establishes that the requirements of this subpart apply to all Federal-aid construction projects except engineering and design service contracts, to which 23 CFR part 172 applies, and Federal Lands Highway contracts, to which 48 CFR subpart 16.5 applies. The requirements do not apply to other non-construction activities, such as the procurement of supplies, to which 2 CFR part 200 applies.

In 23 CFR 635.604, FHWA establishes requirements related to ID/IQ solicitations, contracts, and the ID/IQ procurement process.

In 23 CFR 635.604(a)(1), FHWA clarifies that the contracting agency may procure the ID/IQ contract using applicable State or local competitive selection procurement procedures if those procedures: (i) Comply with 23 CFR 635.604; (ii) are effective in securing competition; and (iii) do not conflict with applicable Federal laws and regulations. The requirement for free and open competition is a fundamental principle under 23 U.S.C. 112 for the procurement of all Federal-aid highway projects.

Other requirements that apply to contracting agencies' ID/IQ procedures are discussed below. Beyond these requirements, FHWA believes that preserving contracting flexibility for contracting agencies is consistent with contracting practices used by participants in the ID/IQ SEP-14 experiments approved by FHWA and provides needed flexibility to the States to manage Federal financial assistance under 23 U.S.C. 145.

In 23 CFR 635.604(a)(2) through 635.604(a)(4), FHWA establishes several requirements that apply to contracting agencies' ID/IQ procedures. In FHWA's experience, the information required under 23 CFR 635.604(a)(2)-(4) is needed to have an effective, fair, and transparent procurement process. In addition, this information is typical of what many of the contracting agencies that have utilized ID/IQ under SEP-14 have included in their solicitation documents.

Responding to the ANPRM, commenters suggested procedures to ensure fairness and transparency in the selection and implementation of multiple-award ID/IQ contracts. Suggestions related to work order awards included considering contractor performance and work-load; requiring secondary bidding (or bidding for individual work orders) from all contractors in the contract pool; or offering the work order to the lowest cost contractor, subject to the contractor's availability.

In addition, commenters recommended the solicitations and contracts clearly identify the procedures and criteria to be used by the contracting agency to award work. Commenters also recommended public posting of solicitations, selection criteria, bidder questions and answers, bids, contract awards, and work order awards.

Commenters also addressed how authorizations to proceed with work should be given for individual work orders. One commenter recommended that the process should follow the applicable stewardship and oversight plan with FHWA. Multiple commenters indicated that in practice they issue notices to proceed once the work order is authorized. Another commenter uses a signed contract modification with the work order.

The FHWA believes the provisions established in this rulemaking enable contracting agencies to ensure fairness and transparency in the selection and implementation of both single-award and multiple-award ID/IQ contracts. Section 635.604(a)(2) requires solicitations for ID/IQ contracts to state the procedures and criteria the contracting agency will use to award an ID/IQ contract. In addition, 23 CFR 635.604(a)(3) requires that an ID/IQ contract, and any solicitation for an ID/IQ contract, include: The period of the contract; whether optional contract extensions will be used and for what period; the basis for adjusting prices in optional contract extensions; the estimated minimum and maximum quantity of services to be acquired; appropriate statements of work generally describing the services to be acquired; the procedures and selection criteria to be used to issue work orders; and the dispute resolution procedures available to awardees in cases where multiple awards are made.

To further ensure fairness and transparency, 23 CFR 635.604(a)(3)(ii) prohibits the use of Federal-aid funds for negotiated contract price adjustments on optional contract extensions.

In addition to the general requirements for ID/IQ solicitations and contracts, additional requirements for JOC solicitations and contracts are listed in 23 CFR 635.604(a)(4). The FHWA believes these requirements specific to JOC are necessary to ensure transparency and consistency.

Regarding authorizations to proceed with work for individual work orders, the comments responding to the ANPRM exhibited a variety of locally developed procedures that agencies considered successful during the SEP-14 Program. Considering this, FHWA is not requiring specific methodology for the issuance of work orders under the IFR.

Section 635.604(a)(5) allows a contracting agency's procurement procedures to include selection of one or multiple contractors based on competitive low bid or best value selection under a single solicitation. Other than specifying that price must be included in the analysis, FHWA neither specifies nor limits the best value factors an agency may consider. For contracts awarded to multiple contractors under a single solicitation, the issuance of work orders must be based on lowest cost or lowest cost-plus time to the Government for the specified work. The FHWA requires that work orders must not be issued to contractors on a rotating basis or other non-competitive method.

Several commenters recommended that FHWA should permit multiple awards under ID/IQ contracts, which is not allowed under Notice N5060.2. One State DOT commented that multiple awards allow for greater efficiency and require competition both at contract level and the work order level, which increases competition overall. This commenter explained that robust competition existed when it experimented with this method under the SEP-14 Program. It also explained that multiple-award contracts provide flexibility to States to use certain innovative bidding practices. With multiple-award ID/IQ contracts, this commenter explained that it achieved certain efficiencies in work order transactions, increased contractor participation and competition, and completed projects more quickly. Another State DOT also supported multiple awards based on its experience and success with that method on an experimental basis under the SEP-14 Program. Another State DOT supported multiple-award contracts with individual work orders awarded based on lowest bid using prices in the initial solicitation from awarded contractors.

Another commenter argued that multiple-award contracts should be allowed to maximize the flexibility of agencies to address project-specific needs and requirements. This commenter also argued, however, that secondary bidding for individual work orders should not be required since competition on price will have already occurred at time of initial bid. This commenter argued that secondary bidding would be redundant, slow project delivery, allow for variance from the contract pricing structure, and increase administrative burden.

Other commenters supporting multiple-award contracts cited reasons that FHWA believes could potentially harm competition or violate requirements of Title 23, U.S.C. For example, one municipality stated that multiple-award contracts allow for “spreading work evenly.” Another municipality referred to the ability to use rotating and round- robin selection methods under multiple-award contracts. Another commenter referred to agencies issuing orders on a rotating basis or equally distributing work to contractors. The FHWA believes these objectives are inconsistent with the statutory competition requirements under 23 U.S.C. 112.

Considering the comments, FHWA believes these provisions provide a balance of allowing flexibility to contracting agencies on procurement and selection procedures while also requiring contracting agencies to secure free and open competition. The FHWA is not prohibiting secondary bidding or bidding on individual work orders on multiple-award contracts under this IFR, but FHWA agrees it could defeat certain benefits and efficiencies gained by ID/IQ contracting. The FHWA will also not require secondary bidding for individual work orders under multiple-award contracts, provided that another competitive method of selection is used based on prices and other terms set forth in the contract.

Although FHWA is allowing multiple-award contracts, they must not be used in non-competitive ways that are inconsistent with the requirements of Title 23, U.S.C. When administering multiple-award contracts, State DOTs and other contracting agencies must continue to ensure that they comply with the requirement to secure competition effectively under 23 U.S.C. 112. To address this, the regulation provides that work orders shall not be issued to contractors on a rotating basis or other non-competitive method.

In addition to recommending FHWA permit multiple-award ID/IQ contracts, commenters also addressed whether FHWA should allow best value considerations in awarding ID/IQ contracts. All responsive comments supported allowing best value considerations.

Considering the comments, FHWA allows, but does not require, best value considerations in awarding ID/IQ contracts. Under the IFR, contracting agencies may determine the appropriate best value factors or considerations to use in combination with price. The FHWA neither specifies nor limits the best value factors an agency may consider—except that price must be included. The FHWA also notes that best value considerations must not restrict competition.

The FHWA is aware that many contracting agencies utilize a method that monetizes construction completion time and uses that value as a factor in analyzing and awarding bids, commonly known as “A+B” bidding. The FHWA anticipates that this or similar contracting methods may be used in soliciting and awarding ID/IQ contracts in a manner consistent with the procedures set forth in the IFR.

In 23 CFR 635.604(a)(6), FHWA prohibits the sum of the duration of the initial ID/IQ contract and any optional contract extensions from exceeding 5 years. The contracting agency may include a provision in the ID/IQ contract to exercise an option to extend the contract for a term that does not exceed the initial duration of the ID/IQ contract. Provided that the duration of the base contract and extension periods do not exceed 5 years, the ID/IQ contract may include multiple options and extension periods.

Most commenters argued in favor of allowing base contracts of 1-5 years with various extension options. They believed that longer contract terms and the availability of extensions allow flexibility and reduce administrative burden on States. Another State DOT argued that minimum and maximum contract lengths should not be pre-determined by regulation, and that States should be allowed to use their own processes to make those determinations. The FHWA believes the provisions in this IFR provide a balance of allowing flexibility to contracting agencies on the length of contract terms and extensions while also setting reasonable limits to account for risk, inflation, and transparency.

Section 635.604(a)(6)(i) establishes that, prior to granting a contract extension, the contracting agency must receive concurrence from the Division Administrator. The FHWA believes requiring this concurrence is consistent with the requirements of 23 U.S.C. 112. In addition, for ID/IQ contracts where prevailing wages apply under 23 U.S.C. 113, 23 CFR 635.604(a)(6)(ii) establishes that the current prevailing wage rate determination, as determined by the U.S. Department of Labor (DOL), to be in effect on the date of the execution of the contract extension shall apply to work covered under the contract extension. The FHWA believes this provision is necessary to conform with DOL policy as outlined in its All Agency Memorandum No. 157, as clarified in the Federal Register on November 20, 1998, at 63 FR 64542.

Section 635.604(a)(6)(iii) provides that, for ID/IQ contracts exceeding 1 year in duration, the contracting agency may use price escalation methods, such as referring to a published index, to adjust the payment for items of work in the issuance of work orders. Such price escalation methods, however, shall not be applied to items of work when those items are separately covered under commodity price escalation clauses in the ID/IQ contract. The FHWA believes this provision is necessary to avoid improper compounding of overlapping escalation factors. For example, if a contracting agency normally applies a commodity price escalation clause based upon a published index for steel and iron items, this index would account for changes in the material's cost relative to the time the contract was bid. The FHWA believes it would be improper and duplicative also to apply a price escalation method based on the duration of the ID/IQ contract or optional extension to steel and iron items, in this example, because changes in material costs have already been accounted for.

Section 635.604(a)(7) clarifies that a contracting agency's payment to a contractor to satisfy a minimum award provision that is not supported by eligible work is not eligible for Federal-aid participation. The FHWA recognizes some State and local procurement rules may require a minimum award provision. The FHWA anticipates rare situations where a contracting agency executes an ID/IQ contract but does not receive work from a contractor and is required to make payment to the contractor to satisfy the agency's minimum award provision. The FHWA believes it would be improper for Federal-aid funds to participate in such a payment if insufficient eligible work is performed to support the payment.

Section 635.604(b) clarifies that the requirements of 49 CFR part 26 and the State's approved DBE plan apply to ID/IQ contracts. The ID/IQ contracting method by its nature is less predictable regarding the total amount of procured work, as compared to traditional contracting methods. Thus, FHWA believes the regulation should provide State DOTs the option of how to apply DBE contract or project goal setting and goal attainment, either to ID/IQ contracts in their entirety, or to individual work orders for ID/IQ contracts with single or multiple awards, or both.

Section 635.604(c) clarifies that, at the option of the State DOT, the minimum prime contractor participation requirement set forth at 23 CFR 635.116 may be applied over the entirety of the ID/IQ contract or applied to each individual work order. The solicitation shall specify the applicable requirements.

Commenters addressed how the 30 percent self-performance requirement in 23 CFR 635.116(a) would apply to ID/IQ contracts and JOC contracts. Commenters appear to believe that contracting agencies should have the discretion to determine how to meet the minimum self-performance requirement under 23 CFR 635.116(a) in this context. The FHWA agrees with these comments and establishes that the minimum self-performance requirement will continue to apply to ID/IQ contracts, but it may be applied either over the entirety of the ID/IQ contract or to each individual work order. To ensure transparency, the regulation also requires the solicitation to specify the applicable requirements related to satisfying 23 CFR 635.116(a).

In 23 CFR 635.604(d), FHWA requires that when a contracting agency's processes or procedures use project cost to establish the assessed rate of liquidated damages under 23 CFR part 635.127, the work order cost must be used to determine the rate when liquidated damages are assessed. Since an individual work order is a smaller part of a larger ID/IQ contract, FHWA believes this clarification is necessary to reduce confusion and the disproportionate application of liquidated damages.

In 23 CFR 635.604(e), FHWA clarifies that nothing in this subpart shall be construed as prohibiting a State DOT from adopting more restrictive policies and procedures than contained herein regarding ID/IQ contracts.

Section 635.605 outlines requirements to establish the relationship between the ID/IQ procurement process and the NEPA process. The requirements in this section are designed to protect the integrity of the NEPA decision-making process because the solicitation and award of an ID/IQ contract will often occur before the completion of the NEPA process.

Through ID/IQ projects under the SEP-14 process, FHWA found that the NEPA process often cannot be completed until specific work locations are identified. The FHWA believes certain requirements preclude FHWA from authorizing final design and construction to proceed, or from obligating funds for final design and construction work, prior to completing the NEPA decision-making process; these requirements include 23 U.S.C. 112(c), 23 CFR 630.106, and 23 CFR 771.113(a). The FHWA thus establishes the requirements set forth in the following sections.

To call attention to the indefinite nature of the ID/IQ contracting method, 23 CFR 635.605(a)(1) stipulates that the solicitation for an ID/IQ contract may identify all, some, or none of the specific locations where construction is to be required under the contract.

To expedite project delivery, 23 CFR 635.605(a)(2) and (a)(3) allow a contracting agency to solicit and award an ID/IQ contract prior to completion of the NEPA process or processes, as applicable. In addition, FHWA requires prior concurrence of the Division Administrator for these actions, which FHWA believes is consistent with other project delivery methods and is necessary to conform with the requirements of 23 U.S.C. 112.

To protect the NEPA decision-making process, 23 CFR 635.605(a)(4) prohibits the execution of an authorization to proceed and formal project agreement under 23 CFR 630.106 for final design and construction for the portion of an ID/IQ contract for work until the NEPA process has been completed for said work.

The FHWA anticipates that, through the duration of an ID/IQ contract, additional work locations will be identified by the contracting agency and the NEPA process will be completed for these locations. To address this, 23 CFR 635.605(a)(5) allows for modifications to the formal project agreement to accommodate the additional work.

In the ANPRM, FHWA solicited input regarding the agreement estimates required under 23 CFR 635.115, which must be submitted to FHWA Division Offices for use in the preparation of project agreements. The FHWA asked whether the estimate should be of the minimum value provided under the contract, the estimate for the base contract, or the estimated maximum value under the contract including contract extensions.

The FHWA considered the widely varied responses the commenters provided as well as the requirements of 23 CFR 771.113(a) regarding the relationship between the completion of required environmental reviews and the obligation of funds for final design and construction. Section 635.605(a)(6) establishes that the agreement estimate for final design or physical construction of an ID/IQ contract must not exceed the actual or best estimated costs of items necessary to complete the scope of work considered in applicable work orders and in the completed NEPA processes since the estimate serves as the basis for the obligation of funds pursuant to 23 CFR 630.106(a)(3), and to satisfy the requirements of 23 CFR 771.113(a). The estimate also must be adjusted as necessary as set forth under 23 CFR 630.106(a)(4).

The FHWA recognizes that a contracting agency may use a project estimate developed for planning purposes under 23 CFR part 450 as it develops its ID/IQ solicitation. However, for projects to which NEPA applies, the allowable amount of an agreement estimate for final design or physical construction of an ID/IQ contract is determined after the NEPA process is complete.

In 23 CFR 635.605(b)(1), subject to the requirements in subpart F, the contracting agency may request Federal participation in the costs associated with an ID/IQ contract, or portion of a contract. In such cases, FHWA's construction contracting requirements will apply to all ID/IQ contract work orders if any ID/IQ contract work orders are funded with Title 23, U.S.C. funds. This provision is consistent with other project delivery methods. The FHWA believes this provision is necessary to ensure the ID/IQ contract is compliant with applicable Federal requirements, even if some portion of that contract's expenses are funded with non-Federal-aid funds. Further, any expenses incurred before FHWA authorization shall not be eligible for reimbursement except as may be determined in accordance with 23 CFR 1.9.

The FHWA anticipates contracting agencies may use an ID/IQ contract for multiple purposes during the contract period, such as for both planned work and emergency work. These situations may include separate Federal funding sources with differing Federal share payable requirements. Section 635.605(b)(2) permits contracting agencies such flexibility while also requiring the applicable Federal share requirements for each work order be specified in the relevant project agreements.

In 23 CFR 635.606(a), a State DOT must submit its proposed ID/IQ procurement procedures to the Division Administrator for review and approval. Following approval by the Division Administrator, any subsequent changes in procedures and requirements are also subject to approval by the Division Administrator before they are implemented. This review and approval is consistent with 23 U.S.C. 112(a), and is necessary to facilitate efficient administrative oversight of a State DOT's ID/IQ procurement process for compliance with Federal requirements. The FHWA's approval of the State DOT's process will eliminate the need for FHWA to review and evaluate the State DOT's ID/IQ procurement process on a project-by-project basis, subject to the terms of the Stewardship and Oversight Agreement between FHWA and the State DOT. This review and approval is consistent with other project delivery methods. Other contracting agencies may follow approved State DOT procedures in their State or their own procedures if approved by both the State DOT and FHWA. The Division Administrator's approval of ID/IQ procurement procedures is a program-level action and may not be delegated or assigned to the State DOT.

The FHWA establishes the parameters for the Division Administrator's approval of the State DOT's ID/IQ procedures. Under 23 CFR 635.606(b), the Division Administrator would be required to review a State DOT's ID/IQ procedures to verify that the procedures do not operate to restrict competition and conform to the requirements of applicable Federal regulations.

In 23 CFR 635.606(c), FHWA requires that ID/IQ procurement procedures document several procedures and responsibilities. The procedures and responsibilities listed relate to changes in this regulation and have been identified by FHWA as being sufficiently different under ID/IQ procurement when compared to other project delivery methods. As such, FHWA believes these procedures and responsibilities warrant having a documented and approved process to ensure compliance with applicable Federal requirements.

The FHWA is aware that some agencies combine the design-build contracting method with ID/IQ contracting. One commenter recommended that FHWA should allow a small percentage of design work to be performed under ID/IQ contracts when needed. In 23 CFR 635.606(d), FHWA clarifies that, subject to the approval of the Division Administrator as described in 23 CFR 635.606(a), contracting agencies may incorporate the design-build contracting method with ID/IQ contracts. In addition to the requirements of subpart F, the contracting agency must include procedures as needed to ensure compliance with 23 CFR part 636 and related requirements.

Amendments to FHWA's current policies for reviewing and approving ID/IQ projects are necessary to allow this contracting technique on a permanent basis. To assist the Agency in this effort, FHWA seeks public comments on the following specific questions in addition to comments on its attempt to quantify cost savings from the regulation and the regulatory text:

1. Section 635.604(a)(3)(iii): To ensure transparency and effective competition, should FHWA require contracting agencies to provide estimated minimum and maximum quantities of services in both ID/IQ solicitations and contracts? Or should FHWA require such estimates for any other reason?

2. Section 635.604(a)(3)(iii): Should FHWA require contracting agencies to specify in ID/IQ solicitations and contracts the estimated maximum or minimum quantities that may be expected under each work order?

3. Section 635.604(a)(5): When using multiple-award contracts, what criteria should, or should not be used, to issue work orders?

4. Section 635.604(a)(5): When using multiple-award contracts, are typical cause and convenience termination clauses sufficient to remove contractors from the pool of those to be considered when issuing work orders, when those contractors are not meeting the terms of the contract?

5. Section 635.605: What procedures can be implemented to review efficiently and approve small, preventive maintenance projects that provide for a very limited scope of work at numerous locations ( e.g., impact attenuator repair, guardrail repair, pavement marking projects, etc.)?

6. Section 635.606(d): When using ID/IQ procedures within a design-build contract, what procedures should be in place to ensure compliance with this subpart, 23 CFR part 636, and related requirements?

7. In this IFR, FHWA attempted to quantify cost savings resulting from increasing administrative efficiency but lacked sufficient data to quantify cost savings based on: (a) Expediting project delivery; and (b) reducing project or construction costs. Compared to a baseline scenario under which ID/IQ contracting is not allowed, and apart from cost savings based on increasing administrative efficiency (as addressed in this IFR), do you expect State DOTs to achieve additional cost savings based on (a) or (b)? If so, how much? What is your estimate based on? What data, if any, is available and may be used to support and quantify any such cost savings?

8. Assuming ID/IQ contracting was not allowed (either experimentally or operationally), approximately how many traditional construction contracts would a State DOT process in a typical year? Of those contracts, what percentage do you anticipate the State DOT in your State would process using the ID/IQ contracting method if allowed in the form required by this IFR?

9. Approximately how long does it take State DOTs to administer a traditional contract as discussed in Question 8?

10. Approximately how long does it take to administer an ID/IQ contract as discussed in Question 8?

All comments received before the close of business on the comment closing date indicated above will be considered and will be available for examination in the docket at the above address. Comments received after the closing date will be filed in the docket and will be considered to the extent practicable, but FHWA may issue a final rule at any time after the close of the comment period. In addition to late comments, FHWA will also continue to file relevant information in the docket as it becomes available after the comment closing date, and interested persons should continue to examine the docket for new material.

The FHWA has determined that prior notice and opportunity for comment are unnecessary under 5 U.S.C. 553(b)(3)(B) because this IFR does not impose any new obligation or requirement on the States or highway contractors. Instead it simply enables ID/IQ contracting for Federal-aid highway construction on a permanent basis and thus provides benefits to State DOTs and other contracting agencies including expediting project delivery, increasing administrative efficiency, reducing project costs, and increasing flexibility for State DOTs to use Federal-aid funds on certain projects. Furthermore, prior notice and an opportunity for public comment is contrary to the public interest because allowing States DOTs to utilize this method of contracting as soon as possible would promote economic recovery. Because of the Coronavirus Disease (COVID-19) public health emergency, and in response to E.O. 13924, “Regulatory Relief to Support Economic Recovery” (issued on May 22, 2020), FHWA believes this IFR would promote job creation and economic growth. Many State DOTs and Local Public Agencies are already familiar with this method of contracting and could begin using it in a very short period of time. ID/IQ contracting also offers an opportunity to streamline procurement through bundling similar-type projects, which reduces the contracting agencies' administrative overhead by having fewer contracts to prepare, advertise, and award. In addition, ID/IQ would provide more flexibility to States that are struggling with reduced budgets and programming of projects due to COVID-19 issues.

For these reasons, FHWA finds good cause to forgo further procedures for notice and opportunity for comment under 5 U.S.C. 553(b)(3)(B). For these same reasons, this IFR is effective upon its date of publication under 5 U.S.C. 553(d)(3) and, therefore, is exempt from the 30-day delayed effective date requirement of that section for these same reasons. Nonetheless, this IFR includes a 60-day comment period. The FHWA will consider and address any submitted comments in a final rule that will follow this IFR.

The FHWA has determined that this action would not be a significant regulatory action within the meaning of Executive Order (E.O.) 12866, and within the meaning of DOT's Policies and Procedures for Rulemaking (49 CFR part 5, subpart B). This action complies with EOs 12866, 13563, and 13771 to improve regulation. The FHWA anticipates that the economic impact of this rulemaking would be minimal. The FHWA anticipates that the rule would not adversely affect, in a material way, any sector of the economy. In addition, these changes would not interfere with any action taken or planned by another agency and would not materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs.

Although FHWA has determined that this action would not be a significant regulatory action, this action is expected to be an E.O. 13771 deregulatory action because it would generate cost savings. These cost savings, measured in 2019 dollars and discounted at 7 percent, are expected to be $3.4 million per year. These cost savings are generated by allowing ID/IQ contracting on a permanent basis. States' experience shows that ID/IQ contracting can lead to cost savings due to increased administrative efficiency, faster project delivery, and reduced project costs. By granting States the flexibility to use ID/IQ contracting, they can achieve the associated cost savings.

Currently, as explained in more detail above, there are two methods available to approve ID/IQ contracts for use on Federal-aid highway construction projects:

1. Special Experimental Project Number 14: Under the SEP-14 Program, contracting agencies interested in testing an innovative contracting technique submit project-specific (or programmatic) work plans to FHWA for their implementation. The FHWA Division Office evaluates the work plan, coordinates with FHWA Headquarters, and, if it finds the work plan to be acceptable, FHWA approves the use of the technique on a temporary basis for a project or group of pilot projects.

2. FHWA Notice N5060.2: Under Notice N5060.2, an ID/IQ contract not requiring advance approval under the SEP-14 Program must satisfy certain conditions, including that the contract must be: Low-cost (the total value of task or work orders may not exceed $2,000,000 per year on average over the contract term); short-term (a base contract of 1 to 2 years); awarded by competitive bidding to the lowest responsive bidder; a single-award contract; qualified for a NEPA categorical exclusion listed under 23 CFR 771.117; and compliant with certain other laws and regulations related to Federal-aid construction. Additional requirements are detailed in FHWA Notice 5060.2.

These approval methods are only authorized experimentally and on a temporary basis. To estimate the cost savings from operationalizing ID/IQ contracting on a permanent basis, FHWA compared a baseline scenario under which ID/IQ contracting is undertaken for 32 contracts per year under the SEP-14 Program, based on the historical record, with the scenario established by the rule. The SEP-14 Program historical average assumes that approximately two to three States actively use ID/IQ contracting each year. Some States have also sought approval for individual contracts. 4

To conduct the analysis, FHWA used the evaluations of ID/IQ contracts required under the SEP-14 Program, ANPRM comments, and responses to NCHRP Synthesis 473: Indefinite Delivery/Indefinite Quality Contracting Practices. The estimates used within the analysis are based on this small sample of data. The FHWA welcomes additional feedback on potential impacts of using ID/IQ contracts.

The FHWA estimated cost savings over an 11-year analysis period, with year one modeled as an implementation year, assuming lower than normal contracting volume as contracting processes take time to plan and initiate in general, and two 5-year contract cycles. Elapsed contracting times, based on agency estimates, were converted to labor hours, assuming a standard 40-hour work week. These labor hours were monetized using a mix of State employee wage rates. 5 To account for the cost of employer provided benefits, wage rates were multiplied by a factor of 1.43. 6

The NCHRP Synthesis 473 included survey responses for how many new ID/IQ contracts are awarded each year by each State agency. The average of these responses was multiplied by 50 States, assuming all States will implement ID/IQ contracting using the rule. 7 One major advantage of ID/IQ contracting is the ability to issue a work order instead of making a separate, time-intensive traditional contract. The average number of work orders per contract (9) reported by agencies was multiplied by expected domestic ID/IQ contracts annually to estimate total work orders issued per year. Based on data presented within NCHRP Synthesis 473, approximately 4 percent of work orders will be processed separately using ID/IQ, rather than with traditional contracts. 8 Furthermore, the number of work orders was further scaled down by 30 percent because FHWA assumes smaller work orders would not have been done as traditional contracts. The cost savings associated with avoided traditional contracts was monetized using this conversion rate, and the estimated elapsed time difference between issuing a work order versus a new traditional contract. The estimate incorporates a modest assumed growth rate of 1 percent for contracts and work orders per contract annually.

The FHWA estimates that an average traditional contract takes 911 hours to complete, whereas an ID/IQ contract takes 272 hours, leading to total time savings of 639 hours per contract. The FHWA assumes administrative time savings from this action will account for approximately 25 percent, or 160 hours (639 hours × 0.25), of the shortened contract time. In addition to the administrative savings per contract, a small amount of time savings is estimated to avoid the need for new contracts altogether, based on having ID/IQ contracts in place. The FHWA estimates administrative time savings of approximately 25 percent of the traditional contract time, or 228 hours saved per avoided contract (911 hours × 0.25).

The per contract time savings were multiplied by the number of contracts and wage rates to determine total savings. For example, in 2021, FHWA assumes 499 ID/IQ contracts will lead to 79,695 hours saved (499 contracts × 160 hours) and 57 avoided traditional contracts will lead to 12,980 hours saved (57 contracts × 228 hours), for total administrative time savings of 92,675 hours (79,695 hours + 12,980 hours). Dollars saved were calculated in a similar manner by applying wage rates to the administrative time savings. In 2021 this led to approximately $3.0 million in savings generated by using ID/IQ contracts and $505,000 in savings, leading to total 2021 cost savings of approximately $3.5 million. In future years FHWA assume the number of contracts will grow by approximately 1 percent.

Aggregating over the 11-year analysis period leads to total time savings of approximately 1.0 million hours from the use of ID/IQ contracts. This leads to total undiscounted cost saving of $38.8 million. When discounted at 7 percent and 3 percent present value, the cost savings equal approximately $25.8 million and $32.3 million, respectively. Table 1 shows these costs savings for the analysis period.

In addition to the cost savings that have been quantified here, there may be additional positive impacts from the rulemaking related to allowing ID/IQ contracts. Many of the SEP-14 evaluations claim that, along with administrative savings, the agencies saw savings in the construction phase, getting lower prices than they were quoted with traditional contracting. These construction cost savings were not quantified but are likely to be significant and will lead to increased efficiency and quickened construction timelines.

Although FHWA has undertaken various efforts to grant States the flexibility to use ID/IQ contracts, specifically through the SEP-14 Program, to the extent that the current rules and guidance discourage their use, this rule removes those barriers.

In compliance with the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601-612), FHWA has evaluated the effects of this action on small entities and has determined that the action is not anticipated to have a significant economic impact on a substantial number of small entities. The amendment addresses obligation of Federal funds to States for Federal-aid highway projects. As such, it affects only States and States are not included in the definition of small entity set forth in 5 U.S.C. 601. Therefore, FHWA certifies that the action will not have a significant economic impact on a substantial number of small entities.

This rule would not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48, March 22, 1995) as it will not result in the expenditure by State, local, Tribal governments, in the aggregate, or by the private sector, of $155 million or more in any 1 year (2 U.S.C. 1532 et seq. ). In addition, the definition of “Federal mandate” in the Unfunded Mandates Reform Act excludes financial assistance of the type in which State, local, or Tribal governments have authority to adjust their participation in the program in accordance with changes made in the program by the Federal Government. The Federal-aid highway program permits this type of flexibility.

This action has been analyzed in accordance with the principles and criteria contained in E.O. 13132 dated August 4, 1999, and FHWA has determined that this action would not have a substantial direct effect or sufficient federalism implications on the States. The FHWA has also determined that this action would not preempt any State law or regulation or affect the States' ability to discharge traditional State governmental functions.

Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program. Local entities should refer to the Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction, for further information.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et. seq. ), Federal agencies must obtain approval from OMB for each collection of information they conduct, sponsor, or require through regulations. The FHWA has determined that the rule does not contain collection of information requirements for the purposes of the PRA.

The FHWA has analyzed this action for the purpose of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 et seq. ), and has determined that this action would not have any effect on the quality of the environment and meets the criteria for the categorical exclusion at 23 CFR 771.117(c)(20).

The FHWA has analyzed this action under E.O. 13175, dated November 6, 2000, and believes that the action would not impose substantial direct compliance costs on Indian Tribal governments; and would not preempt Tribal laws. The rulemaking addresses obligations of Federal funds to States for Federal-aid highway projects and would not impose any direct compliance requirements on Indian Tribal governments. To the extent that Tribes utilize these regulations, they would be expected to derive the same benefits identified above. Therefore, a Tribal summary impact statement is not required.

A regulation identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.

For the reasons stated in the preamble, FHWA amends title 23, Code of Federal Regulations, parts 630 and 635 as follows:

The final regulations (TD 9909) that are the subject of this correction are issued under sections 245A, 954(c)(6), and 6038 of the Internal Revenue Code.

As published on August 27, 2020 (85 FR 53068) the final regulations (TD 9909) contain errors that need to be corrected.

Under ERISA, an employee benefit plan (whether a pension plan or a welfare plan) must be sponsored by an employer, by an employee organization, or by both. Section 3(5) of ERISA defines the term “employer” for this purpose as “any person acting directly as an employer, or indirectly in the interest of an employer, in relation to an employee benefit plan, and includes a group or association of employers acting for an employer in such capacity.” These definitional provisions of ERISA have been interpreted as permitting a multiple employer plan (MEP) to be established or maintained by a bona fide group or association of employers that is controlled by the employer members and that acts in the interests of its employer members to provide benefits to their employees. 1 This approach is based on the premise that the person or group that maintains the plan is tied to the employers and employees that participate in the plan by some common economic or representational interest or genuine organizational relationship unrelated to the provision of benefits. The Department of Labor (Department) has taken steps, through a final rule on “association retirement plans” at 29 CFR 2510.3-55, to clarify and expand the types of arrangements that can be treated as multiple employer plans under Title I of ERISA. That final rule did not, however, extend to so-called “open MEPs.”  2

The Setting Every Community Up for Retirement Enhancement Act of 2019 (SECURE Act)  3 removed possible legal barriers to the broader use of multiple employer plans by authorizing a new type of ERISA-covered defined contribution plan—a “pooled employer plan” operated by a “pooled plan provider.” The SECURE Act amended section 3(2) of ERISA to authorize these pooled employer plans, which offer benefits to the employees of multiple unrelated employers without the need for any commonality among the participating employers or other genuine organizational relationship unrelated to participation in the plan, thus enabling a type of open MEP. A pooled employer plan arrangement allows most of the administrative and fiduciary responsibilities of sponsoring a retirement plan to be transferred to a pooled plan provider. Therefore, a pooled employer plan can offer employers, especially small employers, a workplace retirement savings option with reduced burdens and costs compared to sponsoring their own separate retirement plan. New section 3(44) of ERISA establishes requirements for pooled plan providers, including a requirement to register with the Department and the Department of the Treasury (Treasury Department) before beginning operations as a pooled plan provider. The effective date for these provisions allows “pooled employer plans” to begin operating on January 1, 2021.

Under section 3(2) of ERISA, a pooled employer plan is treated for purposes of ERISA as a single plan that is a multiple employer plan. A pooled employer plan is generally defined in section 3(43) as a qualified retirement plan that is an individual account plan or a plan that consists of individual retirement accounts described in Internal Revenue Code (Code) section 408 that is established or maintained for the purpose of providing benefits to the employees of two or more employers, the terms of which meet certain requirements set forth in the statute. 4 Specifically, the terms of the plan must:

• Designate a pooled plan provider and provide that the pooled plan provider is a named fiduciary of the plan;

• designate one or more trustees (other than an employer in the plan) to be responsible for collecting contributions to, and holding the assets of, the plan, and require the trustees to implement written contribution collection procedures that are reasonable, diligent, and systematic;

• provide that each employer in the plan retains fiduciary responsibility for the selection and monitoring, in accordance with ERISA fiduciary requirements, of the person designated as the pooled plan provider and any other person who is designated as a named fiduciary of the plan, and the investment and management of the portion of the plan's assets attributable to the employees of that employer (or beneficiaries of such employees) in the plan to the extent not delegated to another fiduciary by the pooled plan provider and subject to the ERISA rules relating to self-directed investments;

• provide that employers in the plan, and participants and beneficiaries, are not subject to unreasonable restrictions, fees, or penalties with regard to ceasing participation, receipt of distributions, or otherwise transferring assets of the plan in accordance with applicable rules for plan mergers and transfers;

• require the pooled plan provider to provide to employers in the plan any disclosures or other information that the Secretary of Labor may require, including any disclosures or other information to facilitate the selection or monitoring of the pooled plan provider by employers in the plan;

• require each employer in the plan to take any actions that the Secretary of Labor or pooled plan provider determines are necessary to administer the plan or to allow for the plan to meet the ERISA and Code requirements applicable to the plan, including providing any disclosures or other information that the Secretary of Labor may require or which the pooled plan provider otherwise determines are necessary to administer the plan or to allow the plan to meet such ERISA and Code requirements; and

• provide that any disclosure or other information required to be provided to participating employers may be provided in electronic form and will be designed to ensure only reasonable costs are imposed on pooled plan providers and employers in the plan.

The fidelity bonding requirements in ERISA section 412 apply to fiduciaries and other persons handling the assets of a pooled employer plan, but the maximum bond amount for each such plan official is $1,000,000, as compared to the $500,000 maximum that applies in the case of other ERISA-covered plans that do not hold employer securities. 5

A pooled plan provider with respect to a pooled employer plan is defined in ERISA section 3(44) to mean a person that—

• is designated by the terms of the plan as a named fiduciary under ERISA, as the plan administrator, and as the person responsible to perform all administrative duties (including conducting proper testing with respect to the plan and the employees of each employer in the plan) that are reasonably necessary to ensure that the plan meets the Code requirements for tax-favored treatment and the requirements of ERISA and to ensure that each employer in the plan takes such actions as the Secretary or the pooled plan provider determines necessary for the plan to meet Code and ERISA requirements, including providing to the pooled plan provider any disclosures or other information that the Secretary may require or that the pooled plan provider otherwise determines are necessary to administer the plan or to allow the plan to meet Code and ERISA requirements;

• acknowledges in writing its status as a named fiduciary under ERISA and as the plan administrator;

• is responsible for ensuring that all persons who handle plan assets or are plan fiduciaries are bonded in accordance with ERISA requirements; and

• registers as a pooled plan provider.

The SECURE Act specifies that the Secretary may perform audits, examinations, and investigations of pooled plan providers as may be necessary to enforce and carry out the purposes of the provision. The SECURE Act also directs the Department to issue such guidance as it determines appropriate to carry out the pooled employer plan and pooled plan provider provisions, including guidance (1) to identify the administrative duties and other actions required to be performed by a pooled plan provider; and (2) that provides, in appropriate cases involving a noncompliant employer, for transfer of plan assets attributable to employees of the noncompliant employer (or beneficiaries of such employees) to (a) a plan maintained only by that employer (or its successor), (b) a tax-favored retirement plan for each individual whose account is transferred, or (c) any other arrangement that the Department determines is appropriate. The SECURE Act further provides such guidance must provide for the noncompliant employer (and not the plan with respect to which the failure occurred or any other employer in the plan) to be liable for any plan liabilities attributable to employees of the noncompliant employer (or beneficiaries of such employees), except to the extent provided in the guidance. An employer or pooled plan provider is not treated as failing to meet a requirement of guidance issued by the Secretary if, before the issuance of such guidance, the employer or pooled plan provider complies in good faith with a reasonable interpretation of the provisions to which the guidance relates.

The SECURE Act also provides that the Form 5500 annual return/report of employee benefit plan (Form 5500) filing for a multiple employer plan subject to section 210 of ERISA, including a pooled employer plan, must include a list of the employers in the plan, a good faith estimate of the percentage of total contributions made by such employers during the plan year, the aggregate account balances attributable to each employer in the plan (determined as the sum of the account balances of the employees of each employer and the beneficiaries of such employees) and, with respect to a pooled employer plan in particular, the identifying information for the person designated under the terms of the plan as the pooled plan provider. In addition, the provision authorizes the Department to prescribe simplified reporting for pooled employer plans that cover fewer than 1,000 participants, but only if no single employer in the plan has 100 or more participants covered by the plan.

The SECURE Act does not limit the class of persons who can act as pooled plan providers, but it is expected that many financial services companies (such as insurance companies, banks, trust companies, consulting firms, record keepers, and third-party administrators) will be pooled plan providers. As noted above, however, section 3(44) does require as a condition of being a pooled plan provider that the person “registers as a pooled plan provider with the Secretary, and provides to the Secretary such other information the Department may require, before beginning operations as a pooled plan provider.”  6

In March 2019, the U.S. Supreme Court in Sturgeon v. Frost (139 S. Ct. 1066, March 26, 2019) unanimously determined the National Park Service's (NPS) ordinary regulatory authority over National Park System units in Alaska only applies to federally owned “public lands” (as defined in section 102 of the Alaska National Interest Lands Conservation Act, 16 U.S.C. 3102)—and not to State, Native, or private lands—irrespective of unit boundaries on a map. Lands not owned by the federal government, including submerged lands beneath navigable waters, are not deemed to be a part of the units (slip op. 17). More specifically, the Court held that the NPS could not enforce a System-wide regulation prohibiting the operation of a hovercraft on part of the Nation River that flows through the Yukon-Charley Rivers National Preserve (the Preserve). A brief summary of the factual background and Court opinion follow, as they are critical to understanding the purpose of this rulemaking.

The Preserve is a conservation system unit established by the 1980 Alaska National Interest Lands Conservation Act (ANILCA) and administered by the NPS as a unit of the National Park System. The State of Alaska owns the submerged lands underlying the Nation River, a navigable waterway. In late 2007, John Sturgeon was using his hovercraft on the portion of the Nation River that passes through the Preserve. NPS law enforcement officers encountered him and informed him such use was prohibited within the boundaries of the Preserve under 36 CFR 2.17(e), which states that “[t]he operation or use of a hovercraft is prohibited.” According to NPS regulations at 36 CFR 1.2(a)(3), this rule applies to persons within “[w]aters subject to the jurisdiction of the United States located within the boundaries of the National Park System, including navigable waters” without any regard to ownership of the submerged lands. See 54 U.S.C. 100751(b) (authorizing the Secretary of the Interior to regulate “boating and other activities on or relating to water located within System units”).

Mr. Sturgeon disputed that NPS regulations could apply to his activities on the Nation River, arguing that the river is not public land and is therefore exempt from NPS rules pursuant to ANILCA section 103(c) (16 U.S.C. 3103(c)), which provides that only the public lands within the boundaries of a System unit are part of the unit, and that State-owned lands are exempt from NPS regulations, including the hovercraft rule. Mr. Sturgeon appealed his case through the federal court system.

In its March 2019 opinion, the Court agreed with Mr. Sturgeon. The questions before the Court were: (1) Whether the Nation River in the Preserve is public land for the purposes of ANILCA, making it indisputably subject to NPS regulation; and (2) if not, whether NPS has an alternative source of authority to regulate Mr. Sturgeon's activities on that portion of the Nation River. The Court answered “no” to both questions.

Resolution turned upon several definitions in ANILCA section 102 and the aforementioned section 103(c). Under ANILCA, 16 U.S.C. 3102, “land” means “lands, waters, and interests therein”; “Federal land” means “lands the title to which is in the United States”; and “public lands” are “Federal lands,” subject to several statutory exclusions that were not at issue in the Sturgeon case. As such, the Court found “public lands” are “most but not quite all [lands, waters, and interests therein] that the Federal Government owns” (slip op. 10). The Court held that the Nation River did not meet the definition of “public land” because: (1) “running waters cannot be owned”; (2) “Alaska, not the United States, has title to the lands beneath the Nation River”; and, (3) federal reserved water rights do not “give the Government plenary authority over the waterway” (slip op. 12-14).

Regarding the second question, the Court found no alternative basis to support applying NPS regulations to Mr. Sturgeon's activities on the Nation River, concluding that, pursuant to ANILCA section 103(c), “only the federal property in system units is subject to the Service's authority” (slip op. 19). As stated by the Court, “non-federally owned waters and lands inside system units (on a map) are declared outside them (for the law),” and “those `non-federally owned waters and lands inside system units' are no longer subject to the Service's power over `System units' and the `water located within' them” (slip op. 18) (quoting 54 U.S.C. 100751(a), (b)).

There are four additional aspects of the Sturgeon opinion and ANILCA that inform this rulemaking. First, by incorporating the provisions of the Submerged Lands Act of 1953, the Alaska Statehood Act gave the State “title to and ownership of the lands beneath navigable waters” effective as of the date of Statehood. The Court recognized that a State's title to lands beneath navigable waters brings with it regulatory authority over public uses of those waters (slip op. 12-13). While the specific example cited by the Court involved the State of Alaska, the conclusion logically extends to any submerged lands owner. Thus, in cases where the United States holds title to submerged lands within the external boundaries of a System unit, the NPS maintains its ordinary regulatory authority over the waters.

Second, the Court noted but expressly declined to address Ninth Circuit precedent finding that “public lands” in ANILCA's subsistence fishing provisions include navigable waters with a reserved water right held by the federal government. Alaska v. Babbitt, 72 F. 3d 698 (1995); John v. United States, 247 F. 3d 1032 (2001) (en banc); John v. United States, 720 F. 3d 1214 (2013) ( Katie John cases). Because the Ninth Circuit precedent remains valid law for purposes of NPS's subsistence regulations, the revised definition of federally owned lands does not upset the application of the Katie John cases to the waters listed in 36 CFR 242.3 and 50 CFR 100.3. Regulations at 36 CFR part 13, subpart F, will be applied accordingly. The NPS primarily participates in regulating subsistence fisheries as part of the Federal Subsistence Management Program, a joint effort between the Departments of the Interior and Agriculture implementing Title VIII of ANILCA. Applicable regulations can be found at 36 CFR part 242 and 50 CFR part 100 and are unaffected by the Sturgeon decision or this rulemaking.

Third, the Court acknowledged that NPS maintains its authority to acquire lands, enter into cooperative agreements, and propose needed regulatory action to agencies with jurisdiction over non-federal lands (slip op. 20, 28). Cooperative agreements with the State, for example, could stipulate that certain NPS regulations would apply to activities on the waters and that NPS would have authority to enforce those regulations under the terms of the agreement.

Fourth, ANILCA section 906(o)(2) contains an administrative exemption relative to State and Native corporation land selections, which are excluded from the definition of “public land” in section 102. This exemption did not feature in the Sturgeon case and will not be affected by this rulemaking. The Final Rule section below provides more detail.

The NPS published a proposed rule in the Federal Register on April 30, 2020 (85 FR 23935). The NPS accepted comments on the rule through the mail, by hand delivery, and through the Federal eRulemaking Portal at www.regulations.gov. The comment period closed on June 29, 2020. A summary of the pertinent issues raised in the comments and NPS responses are provided below.

The overwhelming majority of comments expressed support for the proposed regulatory changes, along with opposition to or concern over the way the Federal government is implementing ANILCA and/or managing Federal lands and waters in Alaska. Many commenters included proposals for changes or clarifications to the wording in the proposed rule. The NPS believes it is administering National Park System areas in Alaska in accordance with ANILCA and other applicable laws. If it is determined otherwise, prompt action will be taken to make any necessary changes, as illustrated by this process. After considering public comments and after additional review, the NPS made several changes in the final rule, as explained below.

1. Comment: Several commenters expressed concern that the proposed language for 36 CFR 1.2(f) focused too heavily on the concept of “boundaries” or was otherwise not clear on the extent of NPS regulatory authority (or lack thereof) over non-federal lands and waters surrounded by National Park System units established or expanded by ANILCA. Commenters suggested modifying the proposed text in several different ways.

NPS Response: After considering these comments, the NPS has revised 36 CFR 1.2(f) to read as follows: “In Alaska, unless otherwise provided, only the public lands (federally owned lands) within Park area boundaries are deemed a part of that Park area, and non-public lands (including state, Native, and other non-federally owned lands and waters) shall not be regulated in this chapter as part of the National Park System.” This language is consistent with the original intent of the proposed rule and the Court's decision in Sturgeon.

Focusing the language in paragraph (f) on which lands and waters are regulated as part of the National Park System, rather than which lands and waters are included within the boundary, will also help to resolve a question raised by other commenters about whether persons living on private lands within national parks or monuments would still be considered within a resident zone for purposes of eligibility to engage in subsistence activities within that National Park System unit. Commenters raised this question because NPS regulations at 36 CFR 13.430 define a resident zone as including the “area within a national park or monument” and “areas near a national park or monument” that meet certain criteria. The concern appears to be that the proposed modifications would make privately owned lands that are within a national park or monument outside the resident zone for purposes of determining eligibility to engage in subsistence.

The NPS does not intend this rule to make any changes to resident zone determinations or to eligibility requirements for engaging in subsistence activities. Under ANILCA, as outlined by the Supreme Court in Sturgeon, non-federal lands and waters within the external boundaries of a park unit in Alaska are “deemed” outside of the unit and thus, may not be regulated as if they were a part of the surrounding National Park System lands. But nothing in the Sturgeon decisions or ANILCA would correspondingly deem local residents on those lands to be outside the resident zone. To remove any potential ambiguity in the regulations, in concert with the changes to paragraph (f), a clarifying amendment has been added to § 13.430(a)(1) in this final rule responding to concerns that the language could otherwise be interpreted to mean that private land within the external boundaries of an NPS unit would no longer be located “within a national park or monument” for purposes of this section.

2. Comment: Multiple commenters suggested use of the Supreme Court's phrase “ordinary regulatory authority” in the preamble to the proposed rule was too vague, calling the Court's use of the phrase “offhand” and proposing NPS instead limit the scope of its regulatory authority to that contained in the NPS Organic Act. This was based on a stated presumption that NPS would, in the future, seek to impose regulations on non-federal lands in Alaska by claiming they were not based on any “ordinary” regulatory authority.

NPS Response: There are numerous statutes that expressly provide the NPS with regulatory authority which are not part of the Organic Act (see 54 U.S.C. 100101 note, explaining which statutory provisions are referred to as the “NPS Organic Act”). Limiting this phrase just to the Organic Act itself, as suggested in the comments, could open the very door the commenters seek to keep closed, because it might suggest that the NPS could use these other statutory authorities to apply its regulations to non-federally owned lands in Alaska. The NPS does not believe such action would be consistent with ANILCA under the Supreme Court's ruling.

The preamble uses the phrase “ordinary regulatory authority” since that was the term repeatedly used by the Court, which spent a considerable part of its opinion in Sturgeon discussing and analyzing NPS authorities, not just the NPS Organic Act, and thus meant “ordinary regulatory authority” to include all existing NPS regulatory authorities applicable to National Park System units as of the date of the Court's decision, not just authority expressly derived from the NPS Organic Act. The phrase is not used in the regulatory text.

3. Comment: The NPS received several comments opposing or questioning the merits of the Sturgeon decision or recommending certain uses and activities be prohibited in Alaska park areas, particularly mechanized means of access and transportation.

NPS Response: As a Federal agency, the NPS has no discretion when it comes to promptly and reasonably implementing federal statutes and Supreme Court decisions that affect its management authorities. In addition to ensuring NPS regulations reflect the outcome of the Sturgeon litigation, particularly with respect to non-federally owned lands, ANILCA expressly requires Federal land managers permit the use of snowmachines, motorboats, airplanes, and other mechanized means of transportation in all conservation system units in Alaska for a variety of purposes, including to engage in traditional activities and for travel to and from villages and homesites. Accordingly, NPS has no ability to respond positively to these comments.

4. Comment: Comments were supportive of language in the proposed rule stating that the NPS participates in the regulation of subsistence fisheries through its participation in the Federal Subsistence Management Program, and that applicable regulations at 36 CFR part 242 and 50 CFR part 100 are unaffected by the Sturgeon decision. Comments requested the NPS clarify that those regulations are additionally unaffected by this regulatory change, and others requested confirmation that regulations at 36 CFR part 13 are affected and apply only to federally owned lands and waters in Alaska park areas.

NPS Response: Both suggested clarifications are consistent with the Supreme Court's decision and the effect of the regulatory changes being made here, which is limited to and includes 36 CFR parts 1-199. This response serves to affirm those understandings. The revised definition of federally owned lands does not upset the application of the Katie John cases to the waters listed in 36 CFR 242.3 and 50 CFR 100.3. Regulations at 36 CFR part 13, subpart F, will be applied accordingly.

5. Comment: Several commenters suggested that the NPS limit regulatory changes in response to the Supreme Court's decision to implementing the final order of the U.S. District Court, or otherwise narrowing the scope of this rule to exempt only the Nation River within the Preserve from the Service's hovercraft prohibition at 36 CFR 2.17(e), or alternatively, to adopt language making it clear that Wild and Scenic Rivers are not affected by the regulatory changes.

NPS Response: The NPS disagrees with the suggestions that regulatory changes should be limited to the Yukon-Charley Rivers National Preserve, or to the Nation River, or to the hovercraft transiting it. While that was the specific issue in the case, it remains the NPS's duty to enforce the laws applicable to the lands it manages as part of the National Park System, and the Supreme Court's decision in Sturgeon has a broader effect on how those laws apply in Alaska, as explained above. Regulatory changes that are limited to the applicability of the hovercraft ban on the Nation River would be inconsistent with the intent of this rulemaking and fail to implement the Court's holding in Sturgeon. The final rule ensures NPS regulations are consistent with that holding. Inasmuch as the Court expressly declined to address how Wild and Scenic Rivers in Alaska are impacted by its analysis of NPS authorities (slip op. 27, n. 10), these regulations do not address that issue.

6. Comment: Several commenters questioned the effect of this rule on waters within National Park System units where navigability has not yet been determined or that overlay submerged lands where ownership is in question. Some commenters recommended that the NPS recognize or presume that title resides with the State, while others recommended the NPS assert title, until adjudicated otherwise. Extensive commentary was also provided on the issue of navigability and determining ownership of submerged lands, and on the purposes for which conservation system units in Alaska were established vis-à-vis the protection of lakes, rivers, and streams within the units.

NPS Response: In response to both sets of comments, the NPS notes that the existing and proposed regulations at 36 CFR Chapter I do not address or determine, and have no impact on, whether waters in Alaska are navigable or who maintains title to the submerged lands. Those are not decisions that can be made by the National Park Service. As noted in some of the comments, those decisions are made by Congress, the Bureau of Land Management, or the courts.

7. Comment: Many commenters asked that the NPS work cooperatively with the State of Alaska in the management of waterways, particularly those used by commercial service providers and the public for access to and across park areas.

NPS Response: The NPS is working to develop cooperative agreements with the State on this and other matters and remains committed to working closely with its partners and neighbors to promote healthy ecosystems and provide for public use and enjoyment in Alaska park areas.

8. Comment: Several commenters recommended additional changes to NPS regulations to reflect the outcome of the Sturgeon litigation, including modifying 36 CFR 1.4 to limit the “legislative jurisdiction” of the NPS over private lands, or to confirm the role of “boundaries” in determining regulatory authority in Alaska, and further requested the NPS clarify the relationship between the regulations in 36 CFR part 13 and the other NPS regulations in Title 36.

NPS Response: The NPS agrees that it could clarify the language in 36 CFR 13.2(a) consistent with the intent of this rulemaking. The revised paragraph (a) will now read: “The regulations contained in part 13 are prescribed for the proper use and management of park areas in Alaska and supersede any inconsistent provisions of the general regulations of this chapter, which apply only on federally owned lands within the boundaries of any park area in Alaska.”

Regarding the remaining suggested edits, once ownership is taken into account, as directed by the Supreme Court, we believe the scope of authority in the final rule is consistent with ANILCA.

9. Comment: The State of Alaska brought to our attention that the authorities cited in support of the proposed rule failed to include relevant sections of ANILCA.

NPS Response: The NPS appreciates the opportunity to make the necessary corrections and has updated the statement of authorities in the final rule.

10. Comment: Two commenters requested that the NPS explain the decision to use and define the term “federally owned lands” instead of the terms “Federal lands” or “public lands” or other terms used and defined in ANILCA.

NPS Response: As the commenters accurately note, the term “federally owned lands” is not used in ANILCA, and the relevant distinction between the terms that are used in the statute—“Federal lands” and “public lands”—will collapse over time as land selections are conveyed and relinquished in Alaska park units. In the interim, the NPS believed the use of the term “federally owned lands” would be clearer to the general public than the statutorily-defined “public lands”. Due to the many comments and questions we have received on the issue, we are revising the provision to use “public lands (federally owned lands)” as a way of better communicating our meaning to the general public. The definitions are not changed. More detail on how the terms are defined in relation to ANILCA is provided in the “Final Rule” section, below.

This rule modifies NPS regulations at 36 CFR parts 1 and 13 to conform to the U.S. Supreme Court's decision in Sturgeon. In the interest of clarifying NPS regulations, and in response to a petition for rulemaking filed by the State of Alaska, the NPS is promulgating a set of targeted amendments to ensure its regulations reflect the outcome of the Sturgeon case and provide fair notice of where regulations in 36 CFR Chapter I apply and where they do not in System units in Alaska.

Regulations at 36 CFR 1.2 address the “Applicability and Scope” of regulations found in 36 CFR Chapter I, which “provide for the proper use, management, government, and protection of persons, property, and natural and cultural resources within areas under the jurisdiction of the National Park Service” (36 CFR 1.1(a)). Section 1.2(a) identifies where the regulations apply unless otherwise stated. In order to reflect the Court's holding in Sturgeon, the NPS amends 36 CFR 1.2(a)(3) to add the words “except in Alaska” before “without regard to the ownership of submerged lands, tidelands, or lowlands.” This ensures that, consistent with the Court's holding, NPS regulations “will apply exclusively to public lands (meaning federally owned lands and waters) within system units” (slip op. 19).

The NPS adds a new 36 CFR 1.2(f) to clarify that, under ANILCA, “ `[o]nly the `public lands' (essentially, the federally owned lands)” within unit boundaries in Alaska are “ `deemed' a part of that unit,” and lands (including waters) not federally owned “may not be regulated as part of the park” (slip op. 16-17). As stated by the Court, “[g]eographic inholdings thus become regulatory outholdings, impervious to the Service's ordinary authority” (slip op. 19). The new paragraph (f) in this final rule states that, in Alaska, unless otherwise provided, only the public lands (federally owned lands) within National Park System unit boundaries are deemed a part of that unit, whereas the lands, waters, and interests therein which are not federally owned (including those owned by the State, Native corporations, and other parties) are not a part of the unit and will not be regulated as part of the National Park System. The language has been modified from the proposed rule in response to public comments for the reasons explained above (see comments 1 and 10). The definition of “boundary” in 36 CFR 1.4 has limited operation in Alaska, as NPS published legal descriptions for each unit boundary in 1992 and modifications must be consistent with ANILCA sections 103(b) and 1302(c) and (h).

The NPS also changes its regulations at 36 CFR part 13, which “are prescribed for the proper use and management of park areas in Alaska.” In section 13.1, “park areas” is currently defined as “lands and waters administered by the National Park Service within the State of Alaska.” The NPS modifies this definition and adds a definition of “federally owned lands” (incorporating and relocating the description formerly at 36 CFR 13.2(f)), to reflect ANILCA's limitations on the lands and waters that are administered by the NPS in Alaska, as outlined in the Sturgeon decision. This will not affect NPS administration under a valid cooperative agreement, which would be governed by the terms of the agreement. In response to public comments and for the reasons explained above (see comment 8), the final rule also changes the language in section 13.2(a) to clarify that part 13 regulations supersede general regulations found elsewhere in Title 36 where inconsistent.

The term “federally owned lands” is used instead of “public lands” to account for the authority granted by ANILCA section 906(o)(2) over validly-selected “Federal lands within the boundaries of a conservation system unit,” an exception to the definition of “public lands” in section 102 of ANILCA (16 U.S.C. 3102(3)). That section notes that definitions in Title IX are governed by the Alaska Native Claims Settlement Act (ANCSA) and the Alaska Statehood Act. Section 3(e) of ANCSA defines “public lands” as “all Federal lands and interests therein located in Alaska” with certain exceptions which, like the definition in ANILCA, predominantly relate to satisfaction of outstanding land entitlements, including section 6(g) of the Alaska Statehood Act.

However, ANILCA section 906(o)(2) uses the term “Federal lands,” which is not separately defined in either ANCSA or the Alaska Statehood Act, meaning it is as defined in ANILCA section 102 to include those lands, waters, and interests therein the title to which is in the United States. As before, selected lands are not considered “federally owned lands” once they are subject to a tentative approval or an interim conveyance; title has been transferred although it is not recordable until the lands are surveyed. Until statutory entitlements are satisfied in Alaska and land selections in National Park System units are adjudicated or relinquished, the definitions in part 13, as amended here, ensure NPS regulations are applied consistent with direction from Congress in Alaska-specific legislation and from the Supreme Court in Sturgeon.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. The OIRA has determined that the final rule is a significant regulatory action as defined by Executive Order 12866.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. The NPS has developed this rule in a manner consistent with these requirements.

Enabling regulations are considered deregulatory under guidance implementing E.O. 13771 (M-17-21). This rule clarifies that activities on lands in Alaska which are not federally owned, including submerged lands under navigable waters, are not subject to the NPS's ordinary regulatory authority.

This rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The costs and benefits of a regulatory action are measured with respect to its existing baseline conditions. Regarding the applicability of NPS regulations within the external boundaries of National Park System units in Alaska, the baseline conditions will be unchanged by this rule. The Supreme Court settled this legal question when it announced the Sturgeon decision in March 2019. Compared to baseline conditions, this regulatory change will benefit the general public by clarifying regulatory language in 36 CFR describing where NPS regulations apply, specifically that fewer areas in Alaska are subject to NPS regulations. In addition, this action will not impose restrictions on local businesses in the form of fees, training, record keeping, or other measures that would increase costs. Given those findings, the agency certifies that this regulatory action will not impose a significant economic impact on a substantial number of small entities.

This rule is not a major rule under 5 U.S.C. 804(2). This rule:

(a) Does not have an annual effect on the economy of $100 million or more.

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

This rule does not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. It addresses the use of and jurisdiction over lands and waters within the external boundaries of NPS units as determined by the U.S. Supreme Court in a March 2019 decision and imposes no requirements on other agencies or governments. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq. ) is not required.

This rule does not effect a taking of private property or otherwise have takings implications under Executive Order 12630. A takings implication assessment is not required.

Under the criteria in section 1 of Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. This rule clarifies that the NPS may not regulate non-public lands within the external boundaries of NPS units in Alaska. It has no outside effects on other areas. A Federalism summary impact statement is not required.

This rule complies with the requirements of Executive Order 12988. This rule:

(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

The Department of the Interior strives to strengthen its government-to-government relationship with Tribes and Alaska Native corporations through a commitment to consultation and recognition of their right to self-governance and tribal sovereignty. The NPS has evaluated this rule under the criteria in Executive Order 13175 and under the Department's Tribal consultation policy and has determined that consultation is not required because the rule will have no substantial direct effect on federally recognized Tribes or Alaska Native corporations.

This rule does not contain information collection requirements, and a submission to the Office of Management and Budget under the Paperwork Reduction Act is not required. The NPS may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because the rule is covered by a categorical exclusion. The NPS has determined the rule is categorically excluded under 43 CFR 46.210(i) which applies to “policies, directives, regulations, and guidelines: That are of an administrative, financial, legal, technical, or procedural nature; or whose environmental effects are too broad, speculative, or conjectural to lend themselves to meaningful analysis and will later be subject to the NEPA process, either collectively or case-by-case.” This rule is legal in nature. The Sturgeon decision has governed how the NPS administers lands and waters in Alaska since it was issued in March 2019. This rule will have no legal effect beyond what was announced by the Court. It will revise NPS regulations to be consistent with the decision and make no additional changes. The NPS has determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

This rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects in not required.

For the reasons set forth in the preamble, the National Park Service amends 36 CFR parts 1 and 13 as set forth below:

Throughout this document “we,” “us,” and “our” refer to the EPA.

The EPA is approving the removal of 10 Code of State Regulation (CSR) 10-5.455, Control of Emission from Solvent Cleanup Operations, from the Missouri SIP.

As explained in detail in EPA's proposed rule, Missouri has demonstrated that removal of 10 CSR 10-5.455 will not interfere with attainment of the NAAQS, reasonable further progress  1 or any other applicable requirement of the CAA because the only three sources subject to the rule are no longer subject and the removal of the rule from the SIP will not cause VOC emissions to increase. (85 FR 56193, September 11, 2020). The EPA solicited but did not receive any comments on this proposed rule. Therefore, the EPA is finalizing its proposal to remove 10 CSR 10-5.455 from the SIP.

The State submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The State provided public notice on this SIP revision from May 15, 2018, to August 2, 2018, and received twelve comments from the EPA that related to Missouri's lack of an adequate demonstration that the rule could be removed from the SIP in accordance with section 110(l) of the CAA, whether the rule applied to new sources and other implications related to rescinding the rule. Missouri's July 11, 2019 letter and December 3, 2018 response to comments on the state rescission rulemaking addressed the EPA's comments. In addition, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.

The EPA is taking final action to approve Missouri's request to remove 10 CSR 10-5.455 from the SIP.

In this document, the EPA is amending regulatory text that includes incorporation by reference. As described in the amendments to 40 CFR part 52 set forth below, the EPA is removing provisions of the EPA-Approved Missouri Regulation from the Missouri State Implementation Plan, which is incorporated by reference in accordance with the requirements of 1 CFR part 51.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 24, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

For the reasons stated in the preamble, the EPA amends 40 CFR part 52 as set forth below:

Section 553 of the APA, 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedures are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. The EPA has determined that there is good cause for making this final agency action without prior proposal and opportunity for comment because no significant EPA judgment is involved in making findings of failure to submit SIPs, or elements of SIPs, required by the CAA, where states have made no submissions to meet the requirement. Thus, notice and public procedures are unnecessary to take this action. The EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

The EPA has established a docket for this action under Docket ID No. EPA- HQ-OAR-2020-0485. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the EPA Docket Center, EPA/DC, William Jefferson Clinton Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC. Out of an abundance of caution for members of the public and our staff, the EPA Docket Center and Reading Room are closed to the public, with limited exceptions, to reduce the risk of transmitting COVID-19. Our Docket Center staff will continue to provide remote customer service via email, phone, and webform. The telephone number for the Public Reading Room is (202) 566-1744 and the telephone number for the Office of Air and Radiation Docket and Information Center is (202) 566-1742. For further information on EPA Docket Center services and the current status, please visit us online at https://www.epa.gov/dockets.

For questions related to specific states mentioned in this document, please contact the appropriate EPA Regional Office:

On March 27, 2008, the EPA revised the NAAQS for ozone to establish new 8-hour standards. 1 In that action, the EPA promulgated identical revised primary and secondary ozone standards, designed to protect public health and welfare, of 0.075 parts per million (ppm). Those standards are met when the 3-year average of the annual fourth highest daily maximum 8-hour average ozone concentration is less than or equal to 0.075 ppm. 2

Promulgation of revised NAAQS triggers a requirement for the EPA to designate areas of the country as nonattainment, attainment, or unclassifiable for the standards; for the ozone NAAQS, this also involves classifying any nonattainment areas at the time of initial area designation. 3 Ozone nonattainment areas are classified based on the severity of their ambient ozone levels (as determined based on an area's “design value,” which represents air quality in the area for the most recent 3 years). The possible classifications for ozone nonattainment areas are Marginal, Moderate, Serious, Severe, and Extreme. 4 Nonattainment areas with a “lower” classification ( e.g., Marginal) have ozone levels that are closer to the standards than areas with a “higher” classification ( e.g., Severe). 5

On May 21 and June 11, 2012, respectively, the EPA issued two separate rules which cumulatively designated 46 areas throughout the country as nonattainment for the 2008 ozone NAAQS, effective July 20, 2012, and established classifications for the designated nonattainment areas. 6 Areas designated nonattainment for the ozone NAAQS are subject to the general nonattainment area planning requirements of CAA section 172 and also to the ozone-specific planning requirements of CAA section 182. States in an OTR are subject to the requirements outlined in CAA section 184. 7 CAA section 172(c)(1) provides that SIPs for nonattainment areas must include reasonably available control technology (RACT), including RACT for existing sources of emissions. CAA section 182(b)(2)(A) requires states in which a nonattainment area classified as Moderate is located to amend their SIP “to include provisions to require the implementation of [RACT] . . . with respect to. . .[e]ach category of VOC sources in the area covered by a CTG document . . . ” CAA sections 182(c) through (e) apply this requirement to states with designated ozone nonattainment areas classified as Serious, Severe, or Extreme. CAA section 184(b) provides that states in the OTR must submit a SIP revision addressing RACT with respect to all sources of VOCs in the OTR covered by a CTG document.

On October 27, 2016, the EPA announced a final CTG document for reducing VOC emissions from existing oil and natural gas industry equipment and processes. 8 As stated in that announcement, “[s]ection 182(b)(2)(A) of the CAA requires that for areas designated nonattainment for an ozone [NAAQS]. . .and classified as Moderate [or above], states must revise their SIP to include provisions to implement RACT for each category of VOC sources covered by a CTG document.” Id. “The CAA also imposes the same requirement on states in Ozone Transport Regions.” Id. The EPA provided a two-year period starting from October 27, 2016, for states to submit SIP revisions addressing RACT for VOC sources covered by the CTG ( i.e., SIP submissions were due from affected states to the EPA by October 27, 2018). On March 9, 2018, for reasons explained in the Federal Register (83 FR 10478), the EPA proposed to withdraw the CTG. However, the EPA did not finalize the proposal to withdraw the CTG. The EPA announced in the U.S. Office of Management and Budget's Spring 2020 Unified Agenda and Regulatory Plan that “the CTG will remain in place as published on October 27, 2016.”  9

Therefore, in response to the 2016 oil and natural gas industry CTG, RACT SIP revisions were due for EPA review and approval from states with nonattainment areas classified as Moderate or higher for the 2008 ozone NAAQS (a total of 25 SIP revisions for 21 nonattainment areas, some of which are multistate nonattainment areas), as well as the 12 states and the District of Columbia that comprise the OTR. Nonattainment areas and/or states subject to this RACT SIP requirement without any oil and natural gas sources covered by the CTG in their jurisdictions were required to make a SIP submission that could be comprised of a “negative declaration” stating as much.

Pursuant to CAA section 110(k)(1)(B), the EPA must determine no later than 6 months after the date by which a state is required to submit a SIP whether a state has made a submission that meets the minimum completeness criteria established pursuant to CAA section 110(k)(1)(A). These criteria are set forth at 40 CFR part 51, appendix V. The EPA refers to the determination that a state has not submitted a SIP submission that meets the minimum completeness criteria as a “finding of failure to submit.”

The following Table 1 provides the names of states with nonattainment areas and/or OTR states that this action finds failed to submit the SIP revision required for the CTG for reducing VOC emissions from existing oil and natural gas industry equipment and processes as of the date of this action.

If the EPA finds that a state has failed to make the required SIP submittal or that a submitted SIP is incomplete, then CAA section 179(a) establishes specific consequences, after a period of time, including the imposition of mandatory sanctions for the affected area or state (as appropriate in the case of the OTR). Additionally, such a finding triggers an obligation under CAA section 110(c) for the EPA to promulgate a FIP no later than 2 years after issuance of the finding of failure to submit if the affected state has not submitted, and the EPA has not approved, the required SIP submittal.

If the EPA has not affirmatively determined that a state has made the required complete SIP submittal for an area or OTR state within 18 months of the effective date of this action, then, pursuant to CAA section 179(a) and (b) and 40 CFR 52.31, the offset sanction identified in CAA section 179(b)(2) will apply in the affected nonattainment area or OTR state. If the EPA has not affirmatively determined that the state has made the required complete SIP submittal within 6 months after the offset sanction is imposed, then the highway funding sanction will apply in the affected nonattainment area, in accordance with CAA section 179(b)(1) and 40 CFR 52.31. 10 The sanctions will not take effect if, within 18 months after the effective date of these findings, the EPA affirmatively determines that the state has made a complete SIP submittal addressing the deficiency for which the finding was made. Additionally, if the state makes the required SIP submittal and the EPA takes final action to approve the submittal within 2 years of the effective date of these findings, the EPA is not required to promulgate a FIP for the affected nonattainment area or OTR state.

Based on a review of SIP submittals received and deemed complete as of the date of signature of this action, the EPA finds that the states listed in Table 1 above failed to submit the 2016 Oil and Gas CTG RACT SIP revisions required under subpart 2 of part D of Title I of the CAA and that were due no later than October 27, 2018, for the listed nonattainment areas and OTR states.

The EPA believes that the human health or environmental risks addressed by this action will not have disproportionately high or adverse human health or environmental effects on minority, low-income, or indigenous populations because it does not directly affect the level of protection provided to human health or the environment under the 2008 ozone NAAQS. The purpose of this action is to make findings that the named states failed to provide the identified SIP submissions to the EPA that are required per the CAA. As such, this action does not directly affect the level of protection provided for human health or the environment. Moreover, it is intended that the actions and deadlines resulting from this document will in fact lead to greater protection for U.S. citizens, including minority, low-income, or indigenous populations, by ensuring that states meet their statutory obligation to develop and submit SIPs to ensure that areas make progress toward reducing ozone pollution.

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

This action is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866

This action does not impose an information collection burden under the provisions of the PRA. This final action does not establish any new information collection requirement apart from what is already required by law. This action relates to the requirement in the CAA for states to submit SIPs under sections 172, 182, and 184 which address the statutory requirements that apply to areas designated as nonattainment for the ozone NAAQS and to states within the Ozone Transport Region, respectively.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This action is a finding that the named states have not made the necessary SIP submission for certain nonattainment areas and/or states in the OTR to meet the requirements of part D of Title I of the CAA.

This action does not contain any unfunded mandate as described in UMRA 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the National Government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. This action finds that several states have failed to submit SIP revisions that satisfy the nonattainment area planning requirements under sections 172 and 182 of the CAA, and/or the OTR requirements under section 184 of the CAA. No tribe is subject to the requirement to submit an implementation plan under section 172 or under subpart 2 of part D of Title I of the CAA. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it is a finding that several states failed to submit SIP revisions that satisfy the nonattainment area planning requirements under sections 172 and 182 of the CAA, and/or the OTR requirements under Section 184, and does not directly or disproportionately affect children.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This action does not involve technical standards.

The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations. In finding that several states have failed to submit SIP revisions that satisfy the nonattainment area planning requirements under sections 172 and 182 of the CAA, and/or the OTR requirements under section 184 of the CAA, this action does not directly affect the level of protection provided to human health or the environment.

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Section 307(b)(1) of the CAA indicates which Federal Courts of Appeal have venue for petitions of review of final actions by the EPA under the CAA. This section provides, in part, that petitions for review must be filed in the United States Court of Appeals for the District of Columbia Circuit if (i) the agency action consists of “nationally applicable regulations promulgated, or final actions taken, by the Administrator,” or (ii) such action is locally or regionally applicable, but “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”

This final action is nationally applicable. To the extent a court finds this final action to be locally or regionally applicable, the EPA finds that this action is based on a determination of “nationwide scope or effect” within the meaning of CAA section 307(b)(1). This final action consists of findings of failure to submit required SIPs from five states with nonattainment areas and/or in the OTR, located in five of the 10 EPA Regions, and in four different Federal judicial circuits. This final action is also based on a common core of factual findings concerning the receipt and completeness of the relevant SIP submittals. For these reasons, this final action is nationally applicable or, alternatively, to the extent a court finds this action to be locally or regionally applicable, the Administrator has determined that this final action is based on a determination of nationwide scope or effect for purposes of CAA section 307(b)(1).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the District of Columbia Circuit within 60 days from the date this final action is published in the Federal Register . Filing a petition for reconsideration by the Administrator of this final action does not affect the finality of the action for the purposes of judicial review, nor does it extend the time within which a petition for judicial review must be filed, and shall not postpone the effectiveness of such rule or action.

Throughout this document “we,” “us,” and “our” means the EPA.

The background for this action is discussed in detail in our August 11, 2020, proposal (85 FR 48485). In that document we proposed to accept the negative declarations for incinerators subject to the CISWI EG from the Arkansas Department of Environmental Quality (ADEQ), New Mexico Environment Department (NMED), and City of Albuquerque Environmental Health Department (AEHD), and to amend the CFR in accordance with the requirements of the CAA.

We received one comment on our proposal. We have determined that this comment is not relevant to this rulemaking and no further response is required.

The EPA is amending 40 CFR part 62 to reflect receipt of the negative declaration letters from ADEQ, NMED and AEHD certifying that there are no existing incinerators subject to the CISWI EG subject to 40 CFR part 60, subpart DDDD, in in their respective jurisdictions in accordance with 40 CFR 60.2510, 40 CFR 60.2530, 40 CFR 60.23(b), 40 CFR 62.06, and sections 111(d) and 129 of the CAA.

If a designated facility is later found within the mentioned jurisdictions after publication of the final action, then the overlooked facility will become subject to the requirements of the federal plan for that designated facility, including the compliance schedule. The federal plan will no longer apply if we subsequently receive and approve the section 111(d)/129 plan from the jurisdiction with the overlooked facility.

Under the CAA, the Administrator is required to approve a CAA section 111(d)/129 submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7411(d); 42 U.S.C. 7429; 40 CFR part 60, subparts B and DDDD; and 40 CFR part 62, subpart A. With regard to negative declarations for designated facilities received by the EPA from states, the EPA's role is to notify the public of the receipt of such negative declarations and revise 40 CFR part 62 accordingly. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because this action is not significant under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

This rule also does not have Tribal implications because it will not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 62 as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2019-0384 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before January 15, 2021. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2019-0384, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of February 11, 2020 (85 FR 7708) (FRL-10005-02), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9F8774) by FMC Corporation, 2929 Walnut Street, Philadelphia, PA 19104. The petition requested that 40 CFR 180.564 be amended by establishing tolerances for residues of the insecticide indoxacarb, [(S)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)-phenyl]amino]carbonyl]indeno[1,2e][1,3,4]oxadiazine-4a(3H)-carboxylate], and its R-enantiomer [(R)-methyl 7 chloro-2,5-dihydro-2[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl] amino]carbonyl]indeno [1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate], in or on Almond, hulls at 9 parts per million (ppm) and Nut, tree, group 14-12 at 0.07 ppm. That document referenced a summary of the petition prepared by FMC Corporation, the registrant, which is available in the docket, http://www.regulations.gov. No public comments were received in response to the notice of filing.

Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is establishing tolerances that vary from what the petitioners sought. The reasons for these changes are explained in detail in Unit IV.C.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”

Consistent with FFDCA section 408(b)(2)(D) and the factors specified therein, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for indoxacarb in or on almond, hulls and nut, tree, group 14-12.

In the Federal Register on December 8, 2017 (82 FR 57860) (FRL-9970-39), EPA published a final rule establishing a tolerance for residues of the insecticide indoxacarb in or on corn, field, forage; corn, field, grain; and corn, field, stover based on the Agency's determination that aggregate exposure to indoxacarb is safe for the U.S. general population, including infants and children. Because certain elements of EPA's assessment of exposures and risks associated with indoxacarb have not changed since the 2017 rule was published, EPA is incorporating the following portions of the 2017 rule as part of this rulemaking: the toxicological profile and points of departure/levels of concern.

EPA has updated the exposure assessments of indoxacarb to estimate exposures that will result from the current and proposed new uses of indoxacarb in or on almond, hulls and nut, tree, group 14-12, as described below. Based on the current and proposed uses of indoxacarb, exposures can occur both from dietary sources (food + water) and in residential settings. An updated 2020 drinking water assessment utilized a total residue modeling approach to account for the environmental fate and transport of indoxacarb plus its degradation products of concern. Notwithstanding the updated 2020 drinking water assessment, the exposure estimates generated in the 2017 drinking water assessment are protective of the estimates generated from the proposed use of indoxacarb on tree nuts. Surface water estimated drinking water concentrations (EDWCs) were lower than the corresponding ground water EDWCs (acute EDWC of 131 parts per billion (ppb) and a chronic EDWC of 123 ppb), which were used in the partially refined acute probabilistic and chronic dietary exposure assessments of indoxacarb, respectively. In addition, for food commodities, residue distribution files were constructed from field trial residues for the probabilistic acute dietary exposure assessment as appropriate, and average residues were computed for blended commodities and for the chronic dietary exposure assessment.

An updated occupational and residential exposure assessment found no residential handler risk estimates of concern and there are no proposed changes to the use pattern which will impact the residential exposure or aggregate assessments for indoxacarb. For the currently registered products of indoxacarb: (1) Residential handler inhalation MOEs are ≥92 (LOC = 30) and are not of concern; and (2) there is potential for residential post-application exposure for individuals entering an environment previously treated with indoxacarb and/or contact with treated pets; however, residential post-application MOEs are ≥170 (LOC = 100) and are not of concern.

Section 408(b)(2)(C) of the FFDCA provides that EPA shall apply an additional tenfold (10x) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10 times, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

EPA determined reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1x because: (1) The hazard and exposure databases are complete; (2) there is no susceptibility in fetuses or offspring in any of the in utero or postnatal toxicity studies; (3) there are no residual uncertainties with regard to pre- and/or postnatal toxicity; (4) the acute neurotoxicity, subchronic neurotoxicity, and developmental neurotoxicity studies are available and all endpoints used in this risk assessment are protective of neurotoxic effects; and (5) exposure estimates will not underestimate actual exposures.

For aggregate risk assessment, risk estimates resulting from food, drinking water, and residential uses are combined. Acute, short- and intermediate-term, and long-term (chronic) aggregate assessments were performed for indoxacarb. Partially refined acute probabilistic and chronic dietary exposure assessments were conducted for all current and proposed new uses of indoxacarb and were found to not be of concern at the 99.9th percentile for the U.S. general population and all population subgroups: 54% of the acute population adjusted dose (aPAD) for children 1 to 2 years old, the group with the highest exposure level; and 35% of the chronic population adjusted dose (cPAD) for all infants, the group with the highest exposure level. Moreover, there are no acute, short-, intermediate- or long-term (chronic) aggregate risk estimates of concern for adult or child aggregate exposures to indoxacarb as a result of the current and proposed new uses of indoxacarb. For children 1 to 2 years old, the group expected to be the most highly exposed, the short-term aggregate margin of exposure (MOE) is 120 and the intermediate-/long-term aggregate MOE is 260. Because EPA's LOC for indoxacarb is an MOE of 100 or below, these MOEs are not of concern.

Indoxacarb is classified as not likely to be carcinogenic to humans. Therefore, cancer risk is not a concern and cancer risks are not quantified.

Based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the U.S. general population, or to infants and children, from aggregate exposure to indoxacarb residues. More detailed information on the subject action to establish tolerances in or on almond, hulls and nut, tree, group 14-12 can be found at http://www.regulations.gov in the document entitled “Indoxacarb. Human Health Risk Assessment for Indoxacarb to Support the Proposed New Use on Almond Hulls and Tree Nut Group 14-12,” dated August 20, 2020. This document can be found in docket ID number EPA-HQ-OPP-2019-0384.

Several adequate methods are available for enforcing indoxacarb tolerances on both plant and livestock commodities. Because these methods do not distinguish the indoxacarb enantiomers, they give a total measure of indoxacarb concentration. For the enforcement of tolerances established on crops, two high-performance liquid chromatograph/ultraviolet detection (HPLC/UV) methods are available for use. The limits of quantitation (LOQs) for these methods range from 0.01 to 0.05 ppm for a variety of plant commodities. A third gas chromatograph/mass-selective detection (GC/MSD), DuPont method AMR 3493-95 Supplement No. 4, is also available for the confirmation of residues in plants. In addition, a liquid chromatograph/mass spectrometer/mass spectrometer (LC/MS/MS) method has been developed and is considered an improvement to the previously approved enforcement method, Method DuPont-AMR-2712-93. Method DuPont-36189 has been determined to be adequate for enforcing tolerances established on crops and is reported to provide an LOQ of 0.01 ppm.

These methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). Codex is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. Although EPA may establish a tolerance that is different from a Codex MRL, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established MRLs for residues of indoxacarb in or on almond hulls or tree nuts.

The petitioned-for tolerance levels are different from those being established by EPA. These differences are attributable to the petitioned-for levels not being consistent with Organization for Economic Cooperation and Development (OECD) rounding class practice. The almond, hulls tolerance level is somewhat lower than the petitioned-for level due to the level calculated with the OECD MRL calculation procedures. As a result, EPA is establishing a lower tolerance for almond hulls at 8 ppm based on the FMC data, rather than the tolerance level of 9 ppm proposed by FMC Corporation.

A tolerance level of 0.07 ppm was proposed by FMC Corporation for the tree nut group. EPA is establishing a tolerance level for the tree nut group at 0.08 ppm based on the MRL calculated for pistachios. The submitted field trial data for the representative tree nut crops of almond and pecan also included a full dataset for pistachios, which yielded the highest MRL in comparison to the almond and pecan representative crop data. In this instance, EPA considers the pistachio data acceptable for setting the recommended crop group tolerance on tree nuts because pistachios are analogous to almonds and share the same weed and pest pressures, are grown in the same geographic regions as almonds, and are a leading tree nut production crop based on total acreage as reported in the 2017 USDA Census of Agriculture report.

Tolerances are established for residues of the insecticide indoxacarb in or on Almond, hulls at 8 parts per million (ppm) and Nut, tree group 14-12 at 0.08 ppm.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

In FR Doc. 2020-21695, published in the Federal Register at 85 FR 67613, on October 23, 2020, make the following correction:

This final rule establishes metrics and minimum standards for measuring the performance and service quality of Amtrak's intercity passenger train operations (Metrics and Standards). The Metrics and Standards are organized into four categories: On-time performance (OTP) and train delays, customer service, financial, and public benefits. With respect to on-time performance and train delays, this final rule sets forth a customer on-time performance metric, defined as the percentage of all customers on an intercity passenger rail train who arrive at their detraining point no later than 15 minutes after their published scheduled arrival time, reported by train and by route. This final rule establishes a customer on-time performance minimum standard of 80 percent for any 2 consecutive calendar quarters, and sets forth when the standard begins to apply. In addition, this final rule includes the following related metrics: Ridership data, certified schedule, train delays, train delays per 10,000 train miles, station performance, and host running time.

By notice of proposed rulemaking (NPRM) published on March 31, 2020 (85 FR 17835), FRA proposed metrics and minimum standards for measuring the performance and service quality of intercity passenger train operations. FRA held a telephonic public hearing on April 30, 2020. Written comments on the proposed rule were required to be submitted no later than June 1, 2020.

FRA received more than 320 comments, including comments from: Alabama State Port Authority, Alaska Railroad, American Association of State Highway and Transportation Officials, Association of American Railroads, Association of Independent Passenger Rail Operators, BNSF Railway Company, California State Transportation Agency, Canadian National Railway Company, Canadian Pacific, Capitol Corridor Joint Powers Authority, CSX Transportation, Environmental Law and Policy Center, Metropolitan Transportation Authority, Midwest Interstate Passenger Rail Commission, New York State Department of Transportation (DOT), NJ Transit, Norfolk Southern Railway Company, North Carolina DOT, Rail Passengers Association, San Joaquin Regional Rail Commission, Southeastern Pennsylvania Transportation Authority, Southern Rail Commission, States for Passenger Rail Coalition, Surface Transportation Board (STB), Transportation for America, Union Pacific Railroad Company, Utah Rail Passengers Association, Virginia Department of Rail and Public Transportation, Virginia Railway Express, Washington State DOT, the Honorable U.S. Representative Sam Graves, the Honorable U.S. Representative Rick Crawford, and more than 290 other individuals. Comments are addressed in the preamble.

All costs of this final rule are expected to be incurred during the first year. The following table shows the total 10-year costs of this final rule.

This final rule may result in lower operational costs for Amtrak to the extent it results in improved OTP, which may reduce labor costs, fuel costs, and expenses related to passenger inconvenience, and provide benefits to riders from improved travel times and service quality. Due to the difficulty in quantifying future benefits to rail routes from improved OTP, combined with the inability to quantify the potential synergistic effects that improved OTP reliability could have across Amtrak's network, FRA has not quantified any potential benefits from lower operational costs or improved service that may result from the final rule.

On October 16, 2008, President George W. Bush signed the Passenger Rail Investment and Improvement Act of 2008, Public Law 110-432, 122 Stat. 4907 (PRIIA) into law. Section 207 of PRIIA requires FRA and Amtrak to develop jointly new or improved metrics and minimum standards for measuring the performance and service quality of intercity passenger train operations, including: Cost recovery, on-time performance and minutes of delay, ridership, on-board services, stations, facilities, equipment, and other services.

Section 207 also calls for consultation with STB, rail carriers over whose rail lines Amtrak trains operate, States, Amtrak employees, and groups representing Amtrak passengers, as appropriate.

Section 207 further provides that the metrics, at a minimum, must include: The percentage of avoidable and fully allocated operating costs covered by passenger revenues on each route; ridership per train mile operated; measures of on-time performance and delays incurred by intercity passenger trains on the rail lines of each rail carrier; and, for long-distance routes, measures of connectivity with other routes in all regions currently receiving Amtrak service and the transportation needs of communities and populations that are not well-served by other forms of intercity transportation. Section 207 requires Amtrak to provide reasonable access to FRA to carry out its duty under section 207.

Section 207 provides that the Federal Railroad Administrator must collect the necessary data and publish a quarterly report on the performance and service quality of intercity passenger train operations, including: Amtrak's cost recovery, ridership, on-time performance and minutes of delay, causes of delay, on-board services, stations, facilities, equipment, and other services.

Finally, section 207 provides that, to the extent practicable, Amtrak and its host rail carriers shall incorporate the Metrics and Standards into their access and service agreements (also referred to as operating agreements).

The Metrics and Standards also relate to section 213 of PRIIA (codified at 49 U.S.C. 24308(f)). Section 213 states that if the on-time performance of any intercity passenger train averages less than 80 percent for any 2 consecutive calendar quarters, or the service quality of intercity passenger train operations for which minimum standards are established under section 207 fails to meet those standards for 2 consecutive calendar quarters, STB may initiate an investigation. Under section 213, STB shall also initiate such an investigation upon the filing of a complaint by Amtrak, an intercity passenger rail operator, a host freight railroad over which Amtrak operates, or an entity for which Amtrak operates intercity passenger rail service. Section 213 further describes STB's investigation and STB's related authority to identify reasonable measures and make recommendations to improve the service, quality, and on-time performance of the train and to award damages and prescribe other relief.

In March 2009, FRA published proposed Metrics and Standards, which were jointly developed with Amtrak. After receiving and considering comments, FRA published final Metrics and Standards in May 2010. However, the 2010 Metrics and Standards were subject to a legal challenge on the basis that section 207 of PRIIA was unconstitutional. In 2016, the United States Court of Appeals for the District of Columbia Circuit found that paragraph (d) of section 207 was unconstitutional, and this holding had the effect, in part, of voiding the 2010 Metrics and Standards. Following additional litigation, that Court also found that paragraphs (a) through (c) of section 207 were constitutional and remained in effect (this decision became final upon the U.S. Supreme Court's denial of certiorari on June 3, 2019). As a result, in July 2019, FRA and Amtrak once again began the process of developing joint Metrics and Standards under section 207(a).

Consistent with section 207(a), FRA and Amtrak consulted with many stakeholders to develop the Metrics and Standards.

Specifically, in August and September, 2019, FRA met individually with representatives of the following Class I railroads that host Amtrak trains: BNSF Railway, Canadian National Railway, Canadian Pacific Railway, CSX Transportation, Norfolk Southern Railway Company, and Union Pacific Railroad. On September 5, 2019, FRA and Amtrak met with representatives of the Rail Passengers Association. On September 10, 2019, FRA and Amtrak met with representatives of the Metro-North Railroad. On September 12, 2019, FRA and Amtrak met with representatives of the Transport Workers Union. On September 13, 2019, FRA and Amtrak met with Surface Transportation Board staff. On September 18, 2019, FRA and Amtrak convened a meeting with members of the State-Amtrak Intercity Passenger Rail Committee, whose members include: Caltrans, Capitol Corridor Joint Powers Authority, Connecticut DOT, Illinois DOT, Los Angeles-San Diego-San Luis Obispo Joint Powers Authority, Massachusetts DOT, Michigan DOT, Missouri DOT, New York State DOT, North Carolina DOT, Northern New England Passenger Rail Authority, Oklahoma DOT, Oregon DOT, Pennsylvania DOT, San Joaquin Joint Powers Authority, Texas DOT, Vermont Agency of Transportation, Virginia Department of Rail and Public Transportation, Washington State DOT, and Wisconsin DOT. On September 20, 2019, Amtrak met separately with representatives of the Union Pacific Railroad. On September 24, 2019, FRA and Amtrak met with representatives of the Vermont Railway. On November 15, 2019, Amtrak met separately with representatives of the BNSF Railway. On November 19, 2019, in two different meetings, FRA met separately with, first, representatives of the International Association of Sheet Metal, Air, Rail, and Transportation Workers, Transportation Division, and, second, with members of the Surface Transportation Board. 1 FRA and Amtrak also sought input from other potentially interested entities who did not express interest in consulting at that time. 2

After publishing the NPRM, FRA invited each of the stakeholders to meet again. As a result of this invitation, on April 23, 2020, FRA met via telephone with representatives of the following Class I railroads that host Amtrak trains: BNSF Railway; Canadian National Railway; Canadian Pacific Railway; CSX Transportation; Norfolk Southern Railway Company; and Union Pacific Railroad. Representatives of the Association of American Railroads and Amtrak also attended this meeting. On May 6, 2020, FRA met via telephone with representatives of the American Association of State Highway Transportation Officials, Capitol Corridor Joint Powers Authority, Connecticut DOT, California DOT, Illinois DOT, Michigan DOT, Missouri DOT, North Carolina DOT, New York State DOT, Northern New England Passenger Rail Authority, Oklahoma DOT, Oregon DOT, San Joaquin Joint Powers Authority, Vermont Agency of Transportation, Virginia Department of Rail and Public Transportation, Washington State DOT, Wisconsin DOT, State Amtrak Intercity Passenger Rail Committee, and States for Passenger Rail Coalition. Representatives of Amtrak also attended this meeting. Lastly, on May 8, 2020, FRA met with representatives of STB. Representatives of Amtrak also attended this meeting. FRA placed summaries of each of these meetings, including the presentation material, in the NPRM's rulemaking docket (FRA-2019-0069-0013, FRA-2019-0069-0022, and FRA-2019-0069-0028).

In addition, on June 17, 2020, FRA met individually via telephone with BNSF Railway, Canadian National Railway, CSX Transportation, Norfolk Southern Railway Company, and Union Pacific Railroad. Representatives of Amtrak attended each of these meetings. On June 19, 2020, FRA met via telephone with Canadian Pacific Railway. Representatives of Amtrak attended this meeting. In these six meetings, FRA sought collaborative commitment to affirm or adjust the intercity passenger train schedules published for stations served across the railroad's network, and continued discipline to maintaining schedules, in order to expand the growing data pool that would support any necessary schedule change. Subsequent FRA letters to these parties summarizing the discussion were placed in the NPRM's rulemaking docket (FRA-2019-0069-0379). On July 31, 2020, FRA met collectively via telephone with Amtrak, BNSF Railway, Canadian National Railway, Canadian Pacific Railway, CSX Transportation, Norfolk Southern Railway Company, and Union Pacific Railroad regarding reaffirmation or reconciliation of Amtrak's published train schedules. FRA's subsequent letter to those parties summarizing the discussion was placed in the NPRM's rulemaking docket (FRA-2019-0069-0382).

Beginning in July 2019, FRA and Amtrak began the process of developing the Metrics and Standards under section 207(a) of PRIIA. FRA and Amtrak held an executive kick-off meeting to initiate the effort, which was followed by a regular cadence of staff level meetings. As described above, FRA and Amtrak then conducted an extensive consultation process with many stakeholders to develop the Metrics and Standards. After the conclusion of the consultation process, FRA worked with Amtrak to develop the Metrics and Standards, which included extensive Amtrak input that was reflected in the Metrics and Standards NPRM. After publication of the NPRM, FRA met with various stakeholders (Class I railroads, States, and the STB) together with Amtrak, as described above. FRA then sought (and received) Amtrak's input on the draft Metrics and Standards final rule, considered Amtrak's input, and then, as the agency with rulemaking authority, FRA ultimately determined the contents of this final rule.

As proposed in the NPRM, this final rule measures the OTP element of intercity passenger train performance using a customer OTP metric, defined as the percentage of all customers on an intercity passenger rail train who arrive at their detraining point no later than 15 minutes after their published scheduled arrival time, reported by train and by route. 3 The customer OTP metric focuses on intercity passenger train performance as experienced by the customer. Customer OTP measures the on-time arrival of every intercity passenger customer, including those who detrain at intermediate stops along a route and those who ride the entire route.

The customer OTP metric is calculated as follows: The total number of customers on an intercity passenger rail train who arrive at their detraining point no later than 15 minutes after their published scheduled arrival time, divided by the total number of customers on the intercity passenger rail train. 4 For example:

The following table provides a hypothetical customer OTP calculation for a single train on two separate days. The table provides the minutes late, arrival status (“OT” for on-time, “LT” for late), total number of customer arrivals, and number of on-time customer arrivals, by station, for each day of operation and the two days overall.

Pacific whiting ( Merluccius productus ) is a very productive species with highly variable recruitment (the biomass of fish that mature and enter the fishery each year) and a relatively short life span compared to other groundfish species. Pacific whiting has the largest annual allowable harvest levels (by volume) of the more than 90 groundfish species managed under the Pacific Coast Groundfish Fishery Management Plan (FMP), which governs the groundfish fishery off Washington, Oregon, and California. The coastwide Pacific whiting stock is managed jointly by the United States and Canada, and mature Pacific whiting are commonly available to vessels operating in U.S. waters from April through December. Background on the stock assessment, and the establishment of the 2020 Total Allowable Catch (TAC), for Pacific whiting was provided in the final rule for the 2020 Pacific whiting harvest specifications, published June 18, 2020 (85 FR 36803). Pacific whiting is allocated to the Pacific Coast treaty tribes (tribal fishery) and to three non-tribal commercial sectors: The catcher/processor cooperative (C/P Coop), the mothership cooperative (MS Coop), and the Shorebased Individual Fishery Quota (IFQ) Program.

This notice announces the reapportionment of 40,000 metric tons (mt) of Pacific whiting from the tribal allocation to the non-tribal commercial sectors on September 16, 2020. Regulations at 50 CFR 660.131(h) contain provisions that allow the Regional Administrator to reapportion Pacific whiting from the tribal allocation, specified at 50 CFR 660.50, that will not be harvested by the end of the fishing year to other sectors.

For 2020, the Pacific Coast treaty tribes were allocated 74,342 mt of Pacific whiting. The best available information on September 16, 2020, indicated that at least 40,000 mt of the tribal allocation would not be harvested by December 31, 2020. As required under the 2017 Endangered Species Act (ESA) Section 7(a)(2) biological opinion on the effects of the Pacific Coast Groundfish Fishery Management Plan on listed salmonids, NMFS considered the number and bycatch rate of Chinook salmon taken by the Pacific whiting fishery sectors prior to reapportionment. Based on the best available information in early September 2020, NMFS determined there was little risk that the reapportionment would cause the Pacific whiting sector fisheries to exceed the guideline limit of 11,000 Chinook salmon under current regulations and practices. In early September, incidental take of Chinook salmon by the non-tribal sector was 15 percent of the guideline limit. While the incidental take of Chinook salmon was higher compared to the same period in the previous year, the total take this year is still well below the guideline limit.

To allow for increased utilization of the resource, on September 16, 2020, NMFS reapportioned 40,000 mt from the Tribal sector to the Shorebased IFQ Program, C/P Coop, and MS Coop in proportion to each sector's original allocation. Reapportioning this amount is expected to allow for greater attainment of the TAC while not limiting tribal harvest opportunities for the remainder of the year. NMFS provided notice of the reapportionment on September 16, 2020, via emails sent directly to fishing businesses and individuals. Reapportionment was effective the same day as the notice.

The amounts of Pacific whiting available for 2020 before and after the reapportionment are described in the table below.

NOAA's Assistant Administrator for Fisheries (AA) finds that good cause exists for this notification to be issued without affording prior notice and opportunity for public comment pursuant to 5 U.S.C. 553(b)(B), because such notification would be impracticable and contrary to the public interest. As previously noted, NMFS provided actual notice of the reapportionment to fishery participants at the time of the action. Prior notice and opportunity for public comment on this reapportionment was impracticable because NMFS had insufficient time to provide prior notice between the time the information about the progress of the fishery needed to make this determination became available and the time at which fishery modifications had to be implemented in order to allow fishery participants access to the available fish during the remainder of the fishing season. For the same reasons, the AA also finds good cause to waive the 30-day delay in effectiveness for these actions, required under 5 U.S.C. 553(d)(3).

These actions are authorized by §§ 660.55(i), 660.60(d) and 660.131(h) and are exempt from review under Executive Order 12866.

NMFS and the Western Pacific Fishery Management Council (Council) manage the bottomfish fishery in the U.S. Exclusive Economic Zone (Federal waters) around American Samoa under the FEP and the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Most of the management measures for the fishery are found at 50 CFR 665.

In 2019, the NMFS Pacific Islands Fisheries Science Center (PIFSC) completed a benchmark stock assessment that indicated that the multi-species bottomfish stock complex in American Samoa is overfished and experiencing overfishing. Consistent with Magnuson-Stevens Act sections 304(e)(6) and 305(c), the Council requested that NMFS implement an interim measure to reduce overfishing of the stock while the Council develops management measures required by section 304(e)(3). This temporary rule implements an interim catch limit (ICL) of 13,000 lb of American Samoa bottomfish for the fishing year. We originally proposed the rule would be effective only during fishing year 2020. This final rule revises the proposed effective period of this measure so that it will remain in effect for 180 days or until replaced, consistent with Magnuson-Stevens Act section 305(c), to ensure that the measure is continuous with any subsequent extension. Thus, the catch limit of 13,000 lb will apply for fishing year 2020, and for fishing year 2021 until the measure expires or is replaced.

As an in-season accountability measure, if NMFS projects that the fishery will reach the ICL, we would close the fishery in Federal waters through the end of the fishing year in which the ICL is reached, or the end of the effective period of this rule, whichever comes first. To maintain consistency with the timeframe of catch projections from the stock assessment and the bottomfish fishing year (January-December), NMFS will monitor catches of bottomfish management unit species (MUS) made in both territorial and Federal waters during the fishing year and will count the combined catch toward the ICL for that year. Under the interim measure, overfishing will be reduced relative to the status quo, and socio-economic impacts to the community will be minimized relative to measures that would have ended overfishing immediately.

You may find additional background information on this action in the preamble to the proposed temporary rule published on September 11, 2020 (85 FR 56208).

On September 11, 2020, NMFS published a proposed rule, an EA, and regulatory impact review for public comment (85 FR 56208). The comment period ended September 28, 2020. NMFS received comments from three individuals, the American Samoa Department of Marine and Wildlife Resources (DMWR) and the Western Pacific Fishery Management Council, and responds below.

Comment 1: The temporary catch limit and accountability measures are reasonable to balance the need to reduce overfishing while minimizing the impact to economic, cultural, and subsistence fishing. One of the regulatory conditions for implementing interim measures is that following the recommendations for ending overfishing immediately would be “expected to result in severe social and/or economic impacts.” This condition is met, and is evidenced by the comments made by American Samoan fishermen and council members at public Council meetings, which indicated that even the higher ICL of 13,000 lb would inhibit subsistence fishing. Their comments also indicated that the potential closure of the Federal offshore banks as a result of reaching the 13,000 lb ICL would further inhibit subsistence fishing and cultural practices due to the lack of access to “important fishing grounds for deep-water snappers that are critical for cultural ceremonies.” Overall, the proposed rule would have positive impacts on American Samoa bottomfish stocks, while not completely inhibiting the livelihood of American Samoan fishermen and residents.

Response: NMFS agrees.

Comment 2: The calculation methods used to assess the condition of the bottomfish stocks are not accurate, and new methods are needed to monitor fish catches and collect fishery data, including a self-reporting device developed by the Council.

Response: The methods and data used to assess the condition of the American Samoa bottomfish fishery and to develop the interim measure are the best available scientific and commercial information on the status of the stocks. The 2019 benchmark stock assessment completed by NMFS PIFSC used all available information about the fishery and applied the overfishing status determination criteria established in the FEP to evaluate stock status, and all components of the assessment were evaluated and analyzed for applicability and appropriateness for use. Moreover, consistent with the Magnuson-Stevens Act and regulations at 50 CFR 600.315 for scientific information, the assessment was independently peer reviewed through the Western Pacific Stock Assessment Review (WPSAR) process, which found that the results and conclusions were reliable and useful for management purposes based on information available at the time.

Fishermen's concerns regarding the stock assessment methodologies and reliability of the fisheries data were presented and discussed at the October 2019 meeting of the Council's Scientific and Statistical Committee (SSC) in Honolulu, Hawaii, and October 2019 Council meeting in Pago Pago, American Samoa. The SSC and Council, nonetheless, accepted the stock assessment as providing the best scientific information available for management purposes. Accordingly, in January 2020, PIFSC determined the 2019 assessment is the best scientific information available for the fishery.

NMFS recognizes that the Council is exploring new and other methodologies to improve fisheries data in American Samoa and other U.S. territories. As part of a coordinated approach to improve fisheries information, NMFS, in collaboration with the Council, DMWR, and other resource management agencies have developed a Marine Recreational Implementation Plan for the Pacific Islands Region (MRIP-PIR). This plan identifies priority needs and actions associated with understanding and management of the non-commercial fishery in the state/territorial and Federal waters in 2018-2022. These include:

1. A programmatic review of the Territory creel surveys;

2. Full funding for the surveys that meets the minimum survey standards for Hawaii, American Samoa, and the Mariana Archipelago, including expansion of spatial and temporal surveys, and additional technical support for data entry and database management;

3. Improved timeliness of non-commercial catch estimates;

4. Development of an algorithm that extracts the non-commercial component of the total creel survey catch estimates; and

5. Development of mobile data entry system to support near-real time reporting.

Comment 3: The DMWR noted that the previous stock assessment before the current one indicated that bottomfish stocks were healthy, and questioned how the fishery can be subject to overfishing and overfished with low numbers of fishery participants. The DMWR does not feel that the assessment accurately captured the nature of the fishery, and requested that NMFS re-examine the assessment methodology, including whether the DMWR data collection systems are appropriate for such methods.

Response: The previous assessment completed by PIFSC in 2016 was replaced by a new benchmark assessment in 2019. Several changes relative to the previous assessment were incorporated into the 2019 benchmark assessment. These include using new species lists, calculating the percentage of catch reported at the family or species-group level and believed to contain bottomfish management unit species, filtering catch per unit effort (CPUE) based on gear, standardizing the CPUE for covariates that may affect the catch rate, removing independently-estimated maximum sustainable yield values from the model fitting process, and including an improved production model parameterization. An independent panel of fisheries scientists reviewed the 2019 assessment and concluded that it is superior to the previous assessment. PIFSC, the Council and its SSC concluded that the 2019 assessment represents the best scientific information available for the American Samoa bottomfish fishery. The DMWR has not identified any superior information that NMFS failed to consider when it determined the stock assessment was the best scientific information available, so based on the best scientific information available NMFS determined that the fishery is subject to overfishing and is overfished, and developed the interim measure to reduce overfishing while the Council develops and NMFS implements long-term management measures to end overfishing and rebuild the stock. For the next assessment, NMFS anticipates that MRIP-PIR will improve fishery data to allow consideration of alternative methods for assessing the condition of the fishery. See also response to Comment 2.

Comment 4: The DMWR believes that the 13,000 lb ICL is too low for American Samoa fishermen to subsist, and does not support closing Federal waters to bottomfish fishing, especially the productive offshore banks, which the DMWR asserts are important fishing grounds for deepwater snappers that are critical for American Samoan cultural ceremonies and fa`alavelave. Instead, they propose that DMWR develop a territorial bottomfish management plan in coordination with NMFS that includes data workshops to fully understand the fishery and incorporates cultural aspects of the fishery. They also requested flexibility in the national guidelines.

Response: The best scientific information available indicates that the fishery is subject to overfishing and is overfished. This temporary action, which includes a potential closure of Federal waters to prevent the fishery from exceeding the limit, is needed to reduce overfishing while the Council and NMFS develop a plan that ends overfishing and rebuilds the stock. NMFS expects that the level of catch under this temporary action will still allow American Samoan bottomfish fishermen to continue to provide enough fish for subsistence, cultural, and religious purposes. Overall, the interim action provides a balance between the statutory requirement to reduce overfishing and the needs of the fishery and dependent communities for continued access to bottomfish. NMFS is committed to working with DMWR and the Council to address the condition of the fishery, which may include consideration of a bottomfish management plan for territorial waters. See also response to Comments 1-3.

Comment 5: The DMWR also requested that NMFS examine whether changes in the priority species of management and other aspects of the analysis have changed the status of the fishery.

Response: The 2019 assessment evaluated species that remained as management unit species after the ecosystem reclassification action. The WPSAR panel investigated the impact of changes in the management unit species and found that it did not have significant effects on the assessment results. The panel concluded that changes in the assessment were improvements over the previous assessment, which supported the determination that the assessment is the best scientific information available for management.

Comment 6: The Council expressed general support for the action, but noted concerns about the data used in the 2019 stock assessment, how the WPSAR review addressed data uncertainty, and suggested options for improving data used for future assessments.

Response: The data used for the assessment comes from two programs conducted by the DMWR in collaboration with the NMFS Western Pacific Fisheries Information Network (WPacFIN): Creel surveys and the commercial purchase database program. The stock assessment authors considered, but rejected, using other data sources, such as the WPacFIN biosampling program and the Federal permit logbook dataset, due to insufficient years of data or low reporting rates. The SSC expressed concern about the reliability of data from the creel surveys and commercial dealer program, but did not identify a superior data source. Thus, the data relied on for the assessment are considered the best scientific information available. Moreover, the assessment was reviewed by an independent panel of experts under the WPSAR process and the SSC, and was endorsed by these groups and NMFS as the best scientific information available. NMFS looks forward to working with the Council and the DMWR to develop a long-term plan to end overfishing and rebuild the stock. See also responses to Comments 1-4.

Comment 7: Implementation of the interim measure will be challenging, given that the majority of fishing activity is believed to take place in territorial waters, and that existing monitoring was not designed for in-season tracking. The Council is working with the DMWR to develop a Territorial Bottomfish Fishery Management Plan, which would allow parallel management of the bottomfish management unit species between territorial and Federal waters.

Response: NMFS will work with DMWR to encourage timely processing of data, and will track all catches in Federal and territorial waters toward any applicable limit when data are provided to NMFS. While NMFS cannot implement a closure in territorial waters, we will still monitor and account for catch that comes from territorial waters. NMFS agrees that the efficacy of the measure could be improved if the Territory implemented parallel management. See also response to Comment 8.

Comment 8: There should be an additional proposal to monitor species of fish, especially those that have been over-fished, in territorial waters to gain a better estimate for catch limits, and to assess the costs and benefits regarding economics and biological sustainability.

Response: The creel surveys and commercial receipt program conducted by DMWR in collaboration with NMFS collect fisheries data in both territorial and Federal waters, so current management already includes the suggested measures. The information is used in stock assessments that evaluate the effects of fishing and management on the bottomfish stock as a whole, and are also used to assess potential social, cultural, and economic impacts in the EA.

Comment 9: While a catch limit is appropriate for American Samoa bottomfish for the remainder of 2020, the limit of 13,000 lb may be inappropriate because, although this number may be regulated in Federal waters, most (85%) bottomfish live in territorial waters, which are unregulated by the NMFS.

Response: The bottomfish stock in American Samoa is assessed as a single unit across the archipelago, including territorial and Federal waters. Similarly, the 13,000 lb catch limit covers bottomfish in both areas. NMFS will monitor catch in territorial and Federal waters relative to the 13,000 lb ICL, but does not have jurisdiction to restrict catch in territorial waters. NMFS agrees that the efficacy of the measure could be improved if the Territory implemented parallel management.

Comment 10: The effects of overfishing need to be mitigated, especially for a species that has previously been recorded to experience overfishing.

Response: NMFS agrees that the effects of overfishing need to be mitigated, and developed this rule to accomplish that goal. We note, however, that previous stock assessments did not conclude that the stock is experiencing overfishing; the current overfishing status was first determined by NMFS in 2020.

The proposed rule would have been effective during fishing year 2020 only. This final rule is effective for 180 days. We are making this change under Section 305(c) of the Magnuson-Stevens Act so that this rule is effective for 180 days, or until replaced, to ensure that the measure is continuous with any subsequent extension.

NMFS is issuing this temporary rule pursuant to section 304(e)(6) and section 305(c) of the Magnuson-Stevens Act, which provide specific authority for implementing this action to address overfishing in response to a request from the Council. The NMFS Assistant Administrator has determined that this temporary rule is consistent with the FEP, the Magnuson-Stevens Act, and other applicable law.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. NMFS did not receive any comments regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.

The Assistant Administrator Fisheries, NOAA (AA) finds it is contrary to the public interest to provide for a 30-day delay in effectiveness of this temporary rule. The need to implement the interim rule in a timely manner to reduce overfishing constitutes “good cause” under authority contained in 5 U.S.C. 553(d)(3) to make the rule effective immediately upon publication in the Federal Register . The fishery is experiencing overfishing, and management measures are needed to reduce catch to mitigate immediate effects of fishing on the stock and long-term effects on the fishing community while the stock is rebuilding. Specifically, the temporary action needs to be implemented immediately to establish thresholds that would minimize adverse biological effects to the stock and adverse long-term socioeconomic effects to fishermen and communities that utilize bottomfish in American Samoa.

This final rule has been determined to be not significant for purposes of Executive Order 12866. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.

This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995.

For the reasons set out in the preamble, NMFS amends 50 CFR part 665 as follows: