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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations
significant effect on the human environment. This rule involves a special local regulation lasting twelve hours that will prohibit entry from MM
48.5 to 52.0 on the Clinch River. It is categorically excluded from further review under paragraph L61 in Table 3
1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A Memorandum for Record supporting this determination is available in the docket where indicated under ADDRESSES.

c Enforcement period. This section will be enforced from 6 a.m. to 6 p.m.
from May 8, 2021 to May 9, 2021.
d Information broadcast. The COTP
will issue Broadcast Notices to Mariners BNMs, Local Notices to Mariners LNMs, and Marine Safety Information Bulletins MSIBs about this special local regulation so that waterway users may plan accordingly for this short restriction on transit, and the rule would allow vessels to request permission to enter the zone.

G. Protest Activities
Dated: May 4, 2021.
A.M. Beach, Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.

The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

FR Doc. 202109725 Filed 5621; 8:45 am BILLING CODE 911004P

DEPARTMENT OF VETERANS
AFFAIRS

List of Subjects in 33 CFR Part 100

38 CFR Part 17

Marine safety, Navigation water, Reporting and recordkeeping requirements, Security measures, Waterways.

RIN 2900AP64

Adopting Standards for Laboratory Requirements ACTION:

1. The authority citation for part 100
continues to read as follows:

Authority: 46 U.S.C. 70041; 33 CFR 1.05
1.

2. Add 100.T080215 to read as follows:

100.T080215 Oak Ridge, TN. Clinch River mile 48.5 to 52.0.

a Location. The regulations in this section apply to the following area: All navigable waters of the Clinch River from mile 48.5 to mile 52.0, extending the entire width of the river.
b Regulations. 1 All nonparticipants are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area described in paragraph a of this section unless authorized by the Captain of the Port Sector Ohio Valley or a designated representative.
2 To seek permission to enter, contact the COTP or the COTPs representative by Sector Ohio Valley Command Center at 5027795422.
Those in the regulated area must comply with all lawful orders or directions given to them by the COTP or the designated representative.

16:08 May 06, 2021

Jkt 253001

The Department of Veterans Affairs VA adopts as final, with changes, a proposed rule amending its medical regulations to establish standards for VA clinical laboratories.
The Department of Health and Human Services HHS has established standards for the staffing, management, procedures, and oversight of clinical laboratories that perform testing used for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. VA is required, in consultation with HHS, to establish standards equal to those applicable to other clinical laboratories. As a matter of policy and practice VA has applied HHS standards to its VA laboratory operations, and this rule formalizes this practice. In response to public comments this final rulemaking amends proposed language to more accurately reflect VAs utilization of CMS-deemed accreditation organizations in the process of inspection, oversight, and operational approval of VA clinical laboratories.
DATES: This final rule is effective June 7, 2021.
FOR FURTHER INFORMATION CONTACT:
Quynh Vantu, Health Science Specialist, Pathology and Laboratory Service 1011DIAG2, Office of Clinical Care Services, Veterans Health SUMMARY:

PART 100SAFETY OF LIFE ON
NAVIGABLE WATERS

VerDate Sep<11>2014

Department of Veterans Affairs.
Final rule.

AGENCY:

For the reasons discussed in this preamble, the Coast Guard amends 33
CFR part 100 as follows:

PO 00000

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Administration, Department of Veterans Affairs, 810 Vermont Ave NW, Washington, DC 20420, 202 6328418.
This is not a toll-free number.
SUPPLEMENTARY INFORMATION: In a document published in the Federal Register on October 17, 2018, VA
proposed to amend its medical regulations to establish standards for VA
clinical laboratories. 83 FR 52345. We provided a 60-day comment period, which ended on December 17, 2018, and we received four comments.
The Clinical Laboratory Improvement Amendments of 1988 Public Law Pub.
L. 100578 amended section 353 of the Public Health Service Act to establish legal requirements for the staffing, management, procedures, reporting of results and oversight of clinical laboratories that perform testing used for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings. These statutory requirements are codified at 42 U.S.C.
263a. The Centers for Medicare &
Medicaid Services CMS, within HHS, has primary responsibility for the administration of the Clinical Laboratory Improvement Amendments CLIA program and implementing regulations for CLIA at 42 Code of Federal Regulations CFR part 493.
Section 101 of Pub. L. 102139
enacted October 28, 1991, required VA, within a specified time-frame and in consultation with HHS, to establish standards by regulation equal to that sic applicable to other medical facility laboratories in accordance with the requirements of section 353f of the Public Health Service Act. VAs regulations must include appropriate provisions respecting compliance with such requirements set forth in section 353f of the Public Health Service Act and may include appropriate provisions respecting waivers and accreditations as described in section 353d and 353e, respectively, of the Public Health Service Act. This final rule complies with the requirement for rulemaking by amending VAs medical regulations to reference the portions of 42 CFR part 493 adopted by VA as they apply to VA
medical facility laboratories and clinics, and to clarify that these standards are subject to VA oversight and enforcement by VA only. In addition, this final rule allows VA laboratories to be accredited by an accreditation organization granted deeming authority by CMS under the CLIA program, in accordance with the accreditation requirements in the CLIA
regulations at subpart E of 42 CFR part 493, and participate in an HHS
approved proficiency testing program.

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