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CFR > Title 42 - Public Health > CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER G—STANDARDS AND CERTIFICATION (parts 482 to 498) > PART 493—LABORATORY REQUIREMENTS > SUBPART E—Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program (§493.551 to §493.575) > 493.561—Denial of application or reapplication.

CFR

493.561—Denial of application or reapplication.

(a) Reconsideration of denial. (1) If CMS denies a request for approval, an accreditation organization or State licensure program may request, within 60 days of the notification of denial, that CMS reconsider its original application or application for renewal, in accordance with part 488, subpart D.
(2) If the accreditation organization or State licensure program requests a reconsideration of CMS's determination to deny its request for approval or reapproval, it may not submit a new application until CMS issues a final reconsideration determination.
(b) Resubmittal of a request for approval—accreditation organization. An accreditation organization may resubmit a request for approval if a final reconsideration determination is not pending and the accreditation program meets the following conditions:
(1) It has revised its accreditation program to address the rationale for denial of its previous request.
(2) It demonstrates that it can provide reasonable assurance that its accredited facilities meet condition-level requirements.
(3) It resubmits the application in its entirety.
(c) Resubmittal of request for approval—State licensure program. The State licensure program may resubmit a request for approval if a final reconsideration determination is not pending and it has taken the necessary action to address the rationale for any previous denial.
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