[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR900.15]

[Page 552-553]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 900--MAMMOGRAPHY--Table of Contents
 
             Subpart B--Quality Standards and Certification
 
Sec. 900.15  Appeals of adverse accreditation or reaccreditation decisions that preclude certification or recertification.

    (a) The appeals procedures described in this section are available 
only for adverse accreditation or reaccreditation decisions that 
preclude certification or recertification by FDA. Agency decisions to 
suspend or revoke certificates that are already in effect will be 
handled in accordance with Sec. 900.14.
    (b) Upon learning that a facility has failed to become accredited or 
reaccredited, FDA will notify the facility that the agency is unable to 
certify that facility without proof of accreditation.
    (c) A facility that has been denied accreditation or reaccreditation 
is entitled to an appeals process from the accreditation body, in 
accordance with Sec. 900.7. A facility must avail itself of the 
accreditation body's appeal process before requesting reconsideration 
from FDA.
    (d) A facility that cannot achieve satisfactory resolution of an 
adverse

[[Page 553]]

accreditation decision through the accreditation body's appeal process 
is entitled to further appeal in accordance with procedures set forth in 
this section and in regulations published in 42 CFR part 498.
    (1) References to the Health Care Financing Administration (HCFA) in 
42 CFR part 498 should be read as the Division of Mammography Quality 
and Radiation Programs (DMQRP), Center for Devices and Radiological 
Health, Food and Drug Administration.
    (2) References to the Appeals Council of the Social Security 
Administration in 42 CFR part 498 should be read as references to the 
Departmental Appeals Board.
    (3) In accordance with the procedures set forth in subpart B of 42 
CFR part 498, a facility that has been denied accreditation following 
appeal to the accreditation body may request reconsideration of that 
adverse decision from DMQRP.
    (i) A facility must request reconsideration by DMQRP within 60 days 
of the accreditation body's adverse appeals decision, at the following 
address: Division of Mammography Quality and Radiation Programs (HFZ-
240), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, Attn: Facility 
Accreditation Review Committee.
    (ii) The request for reconsideration shall include three copies of 
the following records:
    (A) The accreditation body's original denial of accreditation.
    (B) All information the facility submitted to the accreditation body 
as part of the appeals process;
    (C) A copy of the accreditation body's adverse appeals decision; and
    (D) A statement of the basis for the facility's disagreement with 
the accreditation body's decision.
    (iii) DMQRP will conduct its reconsideration in accordance with the 
procedures set forth in subpart B of 42 CFR part 498.
    (4) A facility that is dissatisfied with DMQRP's decision following 
reconsideration is entitled to a formal hearing in accordance with 
procedures set forth in subpart D of 42 CFR part 498.
    (5) Either the facility or FDA may request review of the hearing 
officer's decision. Such review will be conducted by the Departmental 
Appeals Board in accordance with subpart E of 42 CFR part 498.
    (6) A facility cannot perform mammography services while an adverse 
accreditation decision is being appealed.