Federal Register/Vol. 85, No. 211/Friday, October 30, 2020/Rules
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68758 Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Rules and Regulations clinical trials for COVID–19. For the (3) TRICARE will not provide limitations for certain process lines at duration of the President’s national reimbursement for care rendered in the the Accel Group, Incorporated (Accel) emergency regarding the COVID–19 NIH Clinical Center or costs associated facility in Wadsworth, Ohio. EPA outbreak, TRICARE will cover cost- with non-treatment research activities proposed to approve this action on July sharing for those TRICARE-eligible associated with the clinical trials. 22, 2020, and received no adverse patients selected to participate in (4) Cost-shares and deductibles comments. NIAID-sponsored Phase I, II, III, and IV applicable to TRICARE will also apply DATES: This final rule is effective on studies examining the treatment or under the NIAID-sponsored clinical November 30, 2020. trials. prevention of COVID–19 and its ADDRESSES: EPA has established dockets associated sequelae (e.g., cardiac and (5) The Director, Defense Health for this action under Docket ID Nos. pulmonary issues). TRICARE will Agency (or designee), shall issue EPA–R05–OAR–2019–0302 (pertaining continue to cover cost-sharing for any procedures and guidelines establishing to amendments to OAC Chapter 3745– eligible beneficiary enrolled in such a NIAID-sponsorship of clinical trials and 21) and EPA–R05–OAR–2019–0676 study until the conclusion of that study, the administrative process by which (pertaining to site-specific alternate even if the national emergency ends individual patients apply for and VOC SIP limits for the Accel facility). before the conclusion of the study. receive cost-sharing under NIAID- All documents in the dockets are listed (1) TRICARE will cost-share all sponsored COVID–19 clinical trials. on the www.regulations.gov website. medical care (including associated * * * * * Although listed in the index, some health complications) and testing Dated: October 27, 2020. information is not publicly available, required to determine eligibility for an i.e., Confidential Business Information NIAID-sponsored trial, including the Aaron T. Siegel, Alternate OSD Federal Register Liaison (CBI) or other information whose evaluation for eligibility at the disclosure is restricted by statute. institution conducting the NIAID- Officer, Department of Defense. [FR Doc. 2020–24114 Filed 10–28–20; 11:15 am] Certain other material, such as sponsored study. TRICARE will cost- copyrighted material, is not placed on share all medical care required as a BILLING CODE 5001–06–P the internet and will be publicly result of participation in NIAID- available only in hard copy form. sponsored studies. This includes Publicly available docket materials are purchasing and administering all ENVIRONMENTAL PROTECTION available either through approved pharmaceutical agents (except AGENCY www.regulations.gov or at the for NIAID-funded investigational drugs), 40 CFR Part 52 Environmental Protection Agency, all inpatient and outpatient care, Region 5, Air and Radiation Division, 77 including diagnostic, laboratory, [EPA–R05–OAR–2019–0302, EPA–R05– West Jackson Boulevard, Chicago, rehabilitation, and home health services OAR–2019–0676; FRL–10015–49–Region 5] Illinois 60604. This facility is open from not otherwise reimbursed under an 8:30 a.m. to 4:30 p.m., Monday through NIAID grant program if the following Air Plan Approval; Ohio; Volatile Friday, excluding Federal holidays and conditions are met: Organic Compounds facility closures due to COVID–19. We (i) Such treatments are NIAID- AGENCY: Environmental Protection recommend that you telephone Anthony sponsored Phase I, Phase II, Phase III, or Agency (EPA). Maietta, Environmental Protection Phase IV protocols; ACTION: Final rule. Specialist, at (312) 353–8777 before (ii) The patient continues to meet visiting the Region 5 office. entry criteria for said protocol; SUMMARY: The Environmental Protection (iii) The institutional and individual FOR FURTHER INFORMATION CONTACT: Agency (EPA) is approving under the providers are TRICARE-authorized Anthony Maietta, Environmental Clean Air Act, a State Implementation providers; and Protection Specialist, Control Strategies (iv) The requirements for Phase I Plan (SIP) submittal from the Ohio Section, Air Programs Branch (AR–18J), protocols in paragraph (e)(26)(iii)(B)(2) Environmental Protection Agency Environmental Protection Agency, of this section are met. (OEPA). This SIP revision request, Region 5, 77 West Jackson Boulevard, (2) Requirements for Phase I protocols submitted on April 5, 2019, and Chicago, Illinois 60604, (312) 353–8777, are: supplemented on November 21, 2019, [email protected]. (i) Standard treatment has been or consists of amendments and additions SUPPLEMENTARY INFORMATION: would be ineffective, does not exist, or to the volatile organic compound (VOC) Throughout this document whenever there is no superior non-investigational rules in the Ohio Administrative Code ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean treatment alternative; (OAC). These changes provide clarity to EPA. (ii) The available clinical or facilities that are subject to multiple I. Background Information preclinical data provide a reasonable VOC requirements in the SIP, or whose expectation that the treatment will be at applicable requirements have been On July 22, 2020, EPA proposed to least as effective as the non- moved to other sections within the OAC approve amendments and additions to investigational alternative; as a result of a previous revision. The the VOC rules located at OAC Chapter (iii) The facility and personnel changes also correct errors and provide 3745–21, including an alternative providing the treatment are capable of general administrative cleanup. An monitoring, recordkeeping, and doing so by virtue of their experience, alternative monitoring, recordkeeping, reporting program for the BP-Husky training, and volume of patients treated and reporting program was added to the Refining LLC, Toledo Refinery at OAC to maintain expertise; and requirements for the BP-Husky Refining 3745–21–09(T)(4), and alternate site- (iv) The referring physician has LLC, Toledo Refinery. In addition, the specific limitations for the Accel facility concluded that the enrollee’s SIP submittal adds a mechanism for contained in its September 19, 2019, participation in such a trial would be Ohio to approve alternate limitations for operating permit (85 FR 44255). An appropriate based upon the satisfaction site-specific miscellaneous industrial explanation of the applicable Clean Air of paragraphs (e)(26)(iii)(B)(2)(i) through adhesive and sealant facilities and Act requirements, a detailed analysis of (iii) of this section. includes alternate site-specific the revisions, and EPA’s reasons for VerDate Sep<11>2014 16:11 Oct 29, 2020 Jkt 253001 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 E:\FR\FM\30OCR1.SGM 30OCR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Rules and Regulations 68759 proposing approval were provided in not impose additional requirements agency promulgating the rule must the notice of proposed rulemaking beyond those imposed by state law. For submit a rule report, which includes a (NPRM) and will not be restated here. that reason, this action: copy of the rule, to each House of the The public comment period for this • Is not a significant regulatory action Congress and to the Comptroller General proposed rule ended on August 21, subject to review by the Office of of the United States. EPA will submit a 2020. EPA received one supportive Management and Budget under report containing this action and other comment (from BP-Husky) on the Executive Orders 12866 (58 FR 51735, required information to the U.S. Senate, proposal. Therefore, we are finalizing October 4, 1993) and 13563 (76 FR 3821, the U.S. House of Representatives, and our action as proposed. January 21, 2011); the Comptroller General of the United • Is not an Executive Order 13771 (82 II. Final Action States prior to publication of the rule in FR 9339, February 2, 2017) regulatory the Federal Register. A major rule EPA is approving the revisions to action because it is not a significant cannot take effect until 60 days after it OAC Chapter 3745–21, specifically to regulatory action under Executive Order is published in the Federal Register. the following rules: 3745–21–09, 3745– 12866; This action is not a ‘‘major rule’’ as 21–10, 3745–21–25, 3745–21–26, 3745– • Does not impose an information defined by 5 U.S.C. 804(2). 21–28, and 3745–21–29, as contained in collection burden under the provisions Under section 307(b)(1) of the Clean Ohio’s April 5, 2019 submittal. EPA is of the Paperwork Reduction Act (44 Air Act, petitions for judicial review of also approving into the SIP the addition U.S.C. 3501 et seq.); this action must be filed in the United • of paragraphs B.4, B.6, B.8, B.9.c), Is certified as not having a States Court of Appeals for the C.1.b)(1)d, C.1.b)(2)a, C.1.d)(2), significant economic impact on a appropriate circuit by December 29, C.1.d)(3), C.1.e)(3), C.1.f)(1)c, C.2.b)(1)d, substantial number of small entities 2020. Filing a petition for C.2.b)(2)a, C.2.d)(2), C.2.d)(3), C.2.e)(3), under the Regulatory Flexibility Act (5 reconsideration by the Administrator of and C.2.f)(1)e as listed in the September U.S.C. 601 et seq.); • this final rule does not affect the finality 19, 2019 operating permit for the Accel Does not contain any unfunded of this action for the purposes of judicial facility. mandate or significantly or uniquely review nor does it extend the time affect small governments, as described III. Incorporation by Reference within which a petition for judicial in the Unfunded Mandates Reform Act In this rule, EPA is finalizing review may be filed, and shall not of 1995 (Pub.