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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations We agree with the suggestion provided by HHS because a validation inspection is performed by CMS whereas VA
performs inspections on VA
laboratories. We are amending the phrase by removing the term validation.
Fifth, HHS noted that the language provided in m2 was not clear and suggested we revise the sentence.
Proposed m2 stated Due process protections afforded by CMS-certified for laboratories facing sanctions are not applicable to laboratories operating under this section. We agree that this sentence is unclear and have amended it to state, Due process protections afforded by CMS to CMS certified laboratories facing sanctions are not applicable to laboratories operating under this section.
Based on the rationale set forth in the proposed rule and in this document, VA
is adopting the provisions of the proposed rule as a final rule with the changes noted above.
Paperwork Reduction Act This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 44 U.S.C. 35013521.
Regulatory Flexibility Act The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act 5 U.S.C. 601612. It would affect only the operations of VA medical facility laboratories and any small entity which chooses to enter into a contract with VA
to provide laboratory services. VA
estimates that this final rule potentially impacts 37 small entities within NAICS
Code 621511 Medical Laboratories, which represents 1.3 percent of small entities covered by NAICS Code 621511.
The small medical laboratories impacted by this rulemaking provide contracted medical laboratory services at various VA medical facilities, to include VA outpatient clinics and VA
Community Based Outpatient Clinics.
This rulemaking decreases the regulatory burden for the 37 small entities who provide contract medical laboratory services to VA. Under this rulemaking functions and responsibilities assigned to the Centers for Medicare & Medicaid Services CMS
in 42 CFR part 493 are assumed by VA, and provisions that are specific to oversight by state licensure programs are not applicable. For services performed under a VA contract for medical laboratory services the contractors would not be subject to
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potential CMS sanctions under subpart R of 42 CFR part 493 because VA does not participate in Medicare or Medicaid programs, and VA is responsible for both oversight and enforcement of clinical laboratory standards. In addition, state onsite monitoring and monetary penalties imposed by CMS as an alternate sanction are not applicable.
However, VA may cease laboratory testing immediately at any site subject to this section upon notification of immediate jeopardy to patients.
Therefore, pursuant to 5 U.S.C. 605b, the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603
and 604 do not apply.
Executive Order 12866 and 13563
Executive Orders 12866 and 13563
direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects, and other advantages;
distributive impacts; and equity.
Executive Order 13563 Improving Regulation and Regulatory Review emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866.
VAs impact analysis can be found as a supporting document at http
www.regulations.gov, usually within 48
hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VAs website at http
www.va.gov/orpm/, by following the link for VA Regulations Published from FY 2004 Through Fiscal Year to Date.
Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more adjusted annually for inflation in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.
Congressional Review Act Pursuant to the Congressional Review Act 5 U.S.C. 801 et seq., the Office of Information and Regulatory Affairs
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designated this rule as not a major rule, as defined by 5 U.S.C. 8042.
Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.008Veterans Domiciliary Care;
64.011Veterans Dental Care; 64.029
Purchase Care Program; 64.033VA
Supportive Services for Veteran Families Program; 64.040VA Inpatient Medicine; 64.041VA Outpatient Specialty Care; 64.042VA Inpatient Surgery; 64.043VA Mental Health Residential; 64.044VA Home Care;
64.045VA Outpatient Ancillary Services; 64.046VA Inpatient Psychiatry; 64.047VA Primary Care;
64.048VA Mental Health clinics;
64.049VA Community Living Center;
64.050VA Diagnostic Care; 64.054
Research and Development.
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Government contracts, Grant programs-health, Grant programsveterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and Dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans.
Signing Authority Denis McDonough, Secretary of Veterans Affairs, approved this document on March 22, 2021 and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.
Jeffrey M. Martin, Assistant Director, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.

For the reasons set forth in the preamble, VA amends 38 CFR part 17 as follows:
PART 17MEDICAL
1. The general authority citation for part 17 continues, and an entry for 17.3500 is added in numerical order, to read as follows:

Authority: 38 U.S.C. 501, and as noted in specific sections:

Section 17.3500 is also issued under Pub.
L. 102139 sec. 101.

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