[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493.561]

[Page 992-993]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 493_LABORATORY REQUIREMENTS--Table of Contents
 
     Subpart E_Accreditation by a Private, Nonprofit Accreditation 
  Organization or Exemption Under an Approved State Laboratory Program
 
Sec. 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.

[[Page 993]]

    (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.