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(6) Has failed to comply with prior inctions imposed by the agency under

U.S.C. 263b(h). (b) FDA may suspend the certificate 'a facility before holding a hearing if DA makes a finding described in paraaph (a) of this section and also deterines that; (1) The failure to comply with reuired standards presents a serious sk to human health; (2) The refusal to permit inspection akes immediate suspension necsary; or (3) There is reason to believe that the olation or aiding and abetting of the olation was intentional or associated ith fraud. (c) If FDA suspends a certificate in cordance with paragraph (b) of this ction: (1) The agency shall provide the facily with an opportunity for an informal earing under part 16 of this chapter pt later than 60 days from the effecve date of this suspension; (2) The suspension shall remain in efct until the agency determines that: (i) Allegations of violations or misonduct were not substantiated; (ii) Violations of required standards ave been corrected to the agency's atisfaction; or (iii) The facility's certificate is reoked in accordance with paragraph (d) f this section; (d) After providing a hearing in acordance with paragraph (c)(1) of this ection, the agency may revoke the faility's certificate if the agency deternines that the facility:

(1) Is unwilling or unable to correct 'iolations that were the basis for suslension; or

(2) Has engaged in fraudulent activty to obtain or continue certification. 1900.15 Appeals of adverse accredita

tion or reaccreditation decisions that preclude certification or recer

tification. (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 $ 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 $ 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 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.

$900.17 [Reserved]

(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.

$ 900.16 Appeals of denials of certifi

cation. (a) The appeals procedures described in this section are available only to facilities that are denied certification by FDA after they have been accredited by an approved accreditation body. Appeals for facilities that have failed to become accredited are governed by the procedures set forth in 8 900.15.

(b) FDA may deny the application if the agency has reason to believe that:

(1) The facility will not be operated in accordance with standards established under $ 900.12;

(2) The facility will not permit inspections or provide access to records or information in a timely fashion; or

(3) The facility has been guilty of misrepresentation in obtaining the accreditation.

(c)(1) If FDA denies an application for certification by a faciity that has received accreditation from an approved accreditation body, FDA shall provide the facility with a statement of the grounds on which the denial is based.

(2) A facility that has been denied accreditation may request reconsideration and appeal of FDA's determination in accordance with the applicable provisions of $ 900.15(d).

8 900.18 Alternative requirements for

$ 900.12 quality standards. (a) Criteria for approval of alternative standards. Upon application by a qualified party as defined in paragraph (b) of this section, FDA may approve an alternative to a quality standard under $ 900.12, when the agency determines that:

(1) The proposed alternative standard will be at least as effective in assuring quality mammography as the standard it proposes to replace, and

(2) The proposed alternative:

(i) Is too limited in its applicability to justify an amendment to the standard; or

(ii) Offers an expected benefit to human health that is so great that the time required for amending the standard would present an unjustifiable risk to the human health; and

(3) The granting of the alternative is in keeping with the purposes of 42 U.S.C. 263b.

(b) Applicants for alternatives. (11 Mammography facilities and accreditation bodies may apply for alternatives to the quality standards of $ 900.12.

(2) Federal agencies and State gorernments that are not accreditation bodies may apply for alternatives to the standards of $900.12(a).

(3) Manufacturers and assemblers op equipment used for mammography may apply for alternatives to the standards of 8 900.12(b) and (e).

(c) Applications for approval of an alternative standard. An application for approval of an alternative standard of for an amendment or extension of the alternative standard shall be submitted in an original and two copies to the Director, 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. The application for approval of an alternative standard shall include the following information:

(1) Identification of the original standard for which the alternative standard is being proposed and an esplanation of why the applicant is proposing the alternative;

(2) A description of the manner in zich the alternative is proposed to deate from the original standard; (3) A description, supported by data, the advantages to be derived from ch deviation; (4) An explanation, supported by ta, of how such a deviation would enre equal or greater quality of producon, processing, or interpretation of immograms than the original stand

5) The suggested period of time that e proposed alternative standard juld be in effect; and 6) Such other information required the Director to evaluate and act on e application. d) Ruling on applications. (1) FDA ay approve or deny, in whole or in rt, a request for approval of an altertive standard or any amendment or tension thereof, and shall inform the plicant in writing of this action. The ritten notice shall state the manner

which the requested alternative andard differs from the agency standd and a summary of the reasons for proval or denial of the request. If the quest is approved, the written notice all also include the effective date id the termination date of the ap'oval and a summary of the limitaons and conditions attached to the pproval and any other information lat may be relevant to the approved quest. Each approved alternative andard shall be assigned an identiring number. (2) Notice of an approved request for a alternative standard or any amendlent or extension thereof shall be laced in the public docket file in the ivision of Dockets Management and ay also be in the form of a notice ablished in the FEDERAL REGISTER. he notice shall state the name of the pplicant, a description of the pubshed agency standard, and a descripion of the approved alternative stand rd, including limitations and condiions attached to the approval of the Iternative standard. (3) Summaries of the approval of alernative standards, including informaion on their nature and number, shall le provided to the National Mammogaphy Quality Assurance Advisory ommittee.

(4) All applications for approval of alternative standards and for amendments and extensions thereof and all correspondence (including written notices of approval) on these applications shall be available for public disclosure in the Division of Dockets Management, excluding patient identifiers and confidential commercial information.

(e) Amendment of extension of an alternative standard. An application for amending or extending approval of an alternative standard shall include the following information:

(1) The approval number and the expiration date of the alternative standard;

(2) The amendment or extension requested and the basis for the amendment or extension; and

(3) An explanation, supported by data, of how such an amendment or extension would ensure equal or greater quality of production, processing, or interpretation of mammograms than the original standard.

(1) Applicability of the alternative standards. (1) Except as provided in paragraphs (f)(2) and (f)(3) of this section, any approval of an alternative standard, amendment, or extension may be implemented only by the entity to which it was granted and under the terms under which it was granted. Other entities interested in similar or identical approvals must file their own application following the procedures of paragraph (c) of this section.

(2) When an alternative standard is approved for a manufacturer of equipment, any facility using that equipment will also be covered by the alternative standard.

(3) The agency may extend the alternative standard to other entities when FDA determines that expansion of the approval of the alternative standard would be an effective means of promoting the acceptance of measures to improve the quality of mammography. All such determinations will be publicized by appropriate means.

(g) Withdrawal of approval of alternative requirements. FDA shall amend or withdraw approval of an alternative standard whenever the agency determines that this action is necessary to protect the human health or otherwise is justified by $ 900.12. Such action will become effective on the date specified in the written notice of the action sent to the applicant, except that it will become effective immediately upon notification of the applicant when FDA determines that such action is necessary to prevent an imminent health hazard. [62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997]

Subpart C-States as Certifiers

SOURCE: 67 FR 5467, Feb. 6, 2002, unless otherwise noted. $ 900.20 Scope.

The regulations set forth in this part implement the Mammography Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart C of this part establishes procedures whereby a State can apply to become a FDA-approved certification agency to certify facilities within the State to perform mammography seryices. Subpart C of this part further establishes requirements and standards for State certification agencies to ensure that all mammography facilities under their jurisdiction are adequately and consistently evaluated for compliance with quality standards at least as stringent as the national quality standards established by FDA.

(2) Following receipt of the written request, FDA will provide the applicant with additional information to aid in the submission of an application for approval as a certification agency.

(3) The applicant shall furnish to FDA, at the address in paragraph (bx1 of this section, three copies of an application containing the following infor mation, materials, and supporting doc umentation:

(i) Name, address, and phone number of the applicant;

(ii) Detailed description of the mam mography quality standards the applicant will require facilities to meet and for those standards different from FDA's quality standards, information substantiating that they are at least as stringent as FDA standards under $ 900.12;

(iii) Detailed description of the applicant's review and decisionmaking pros ess for facility certification, includingi

(A) Policies and procedures for nog fying facilities of certificate denials and expirations;

(B) Procedures for monitoring and enforcement of the correction of deficiencies by facilities;

(C) Policies and procedures for sus pending or revoking a facility's certifcation;

(D) Policies and procedures that will ensure processing certificates within a timeframe approved by FDA;

(E) A description of the appeals proeess for facilities contesting adverse certification status decisions;

(F) Education, experience, and training requirements of the applicant's professional and supervisory staff;

(G) Description of the applicant's electronic data management and analysis system;

(H) Fee schedules;

(I) Statement of policies and procedures established to avoid conflict of interest;

(J) Description of the applicant's mechanism for handling facility inquiries and complaints;

(K) Description of a plan to ensure that certified mammography facilities will be inspected according to MRSA (42 U.S.C. 263b) and procedures and policies for notifying facilities of inspection deficiencies;

$ 900.21 Application for approval as a

certification agency. (a) Eligibility. State agencies may apply for approval as a certification agency if they have standards at least as stringent as those of $ 900.12, qualified personnel, adequate resources to carry out the States as Certifiers' responsibilities, and the authority to enter into a legal agreement with FDA to accept these responsibilities.

(b) Application for approval. (1) An applicant seeking FDA approval as a certification agency shall inform the Division of Mammography Quality and Radiation Programs (DMQRP), Center for Devices and Radiological Health (HFZ240), Food and Drug Administration, Rockville, MD 20850, marked Attn: SAC1 Coordinator, in writing, of its desire to be approved as a certification agency.

ISAC means States as Certifiers.

(L) Policies and procedures for moniring and enforcing the correction of cility deficiencies discovered during spections or by other means; (M) Policies and procedures for addional mammography review and for questing such reviews from accredition bodies; (N) Policies and procedures for paent notification; (O) If a State has regulations that e more stringent than those of 00.12, an explanation of how adverse tions taken against a facility under e more stringent regulations will be stinguished from those taken under e requirements of $ 900.12; and (P) Any other information that FDA entifies as necessary to make a dermination on the approval of the ate as a certification agency. (c) Rulings on applications for apoval. (1) FDA will conduct a review id evaluation to determine whether le applicant substantially meets the pplicable requirements of this subpart ad whether the certification standids the applicant will require facilies to meet are the quality standards ablished under subpart B of this part pat least as stringent as those of subart B. (2) FDA will notify the applicant of ny deficiencies in the application and equest that those deficiencies be corected within a specified time period. If he deficiencies are not corrected to 'DA's satisfaction within the specified ime period, FDA may deny the appliation for approval as a certification gency. (3) FDA shall notify the applicant Thether the application has been aproved or denied. The notification shall ist any conditions associated with aproval or state the bases for any delial.

(4) The review of any application may nclude a meeting between FDA and representatives of the applicant at a time and location mutually acceptable to FDA and the applicant.

(5) FDA will advise the applicant of the circumstances under which a denied application may be resubmitted.

(d) Scope of authority. FDA may limit the scope of certification authority delegated to the State in accordance with MQSA.

$900.22 Standards for certification

agencies. The certification agency shall accept the following responsibilities in order to ensure quality mammography at the facilities it certifies and shall perform these responsibilities in a manner that ensures the integrity and impartiality of the certification agency's actions:

(a) Conflict of interest. The certification agency shall establish and implement measures that FDA has approved in accordance with $900.21(b) to reduce the possibility of conflict of interest or facility bias on the part of individuals acting on the certification agency's behalf.

(b) Certification and inspection responsibilities. Mammography facilities shall be certified and inspected in accordance with statutory and regulatory requirements that are at least as stringent as those of MQSA and this part.

(c) Compliance with quality standards. The scope, timeliness, disposition, and technical accuracy of completed inspections and related enforcement activities shall ensure compliance with facility quality standards required under $ 900.12.

(d) Enforcement actions. (1) There shall be appropriate criteria and processes for the suspension and revocation of certificates.

(2) There shall be prompt investigation of and appropriate enforcement action for facilities performing mammography without certificates.

(e) Appeals. There shall be processes for facilities to appeal inspection findings, enforcement actions, and adverse certification decision or adverse accreditation decisions after exhausting appeals to the accreditation body.

(f) Additional mammography review. There shall be a process for the certification agency to request additional mammography review from accreditation bodies for issues related to mammography image quality and clinical practice. The certification agency should request additional mammography review only when it believes that mammography quality at a facility has been compromised and may present a serious risk to human health.

(g) Patient notification. There shall be processes for the certification agency to conduct, or cause to be conducted,

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