[Federal Register Volume 60, Number 176 (Tuesday, September 12, 1995)]
[Rules and Regulations]
[Pages 47267-47269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22578]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5


Delegations of Authority and Organization; Center for Devices and 
Radiological Health

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations that delegate authority of the Commissioner of Food and 
Drugs (the Commissioner) to ensure that mammography facilities meet 
quality standards under the Mammography Quality Standards Act of 1992 
(the MQSA) (Pub. L. 102-593). The authorities being redelegated include 
responsibilities under the MQSA that have not previously been 
redelegated by the Commissioner. The title of the delegation is being 
revised to reflect the expansion of authorities.

EFFECTIVE DATE:September 12, 1995.

FOR FURTHER INFORMATION CONTACT:

Richard E. Gross, Center for Devices and Radiological Health (HFZ-200), 
Food and Drug Administration, Piccard Bldg., 1350 Piccard Dr., 
Rockville, MD 20850, 301-443-2845, or
Ellen R. Rawlings, Division of Management Systems and Policy (HFA-340), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-443-4976.

SUPPLEMENTARY INFORMATION: FDA is amending Sec. 5.85 (21 CFR 5.85) to 
redelegate authorities under the MQSA that were delegated to the 
Commissioner by the Acting Assistant Secretary for Health on June 10, 
1993. That delegation gave the Commissioner authority to implement 15 
sections of the MQSA (58 FR 32543). The Commissioner's authority to 
issue facility certificates was subsequently redelegated to officials 
of the Center for Devices and Radiological Health in 21 CFR 5.85 (59 FR 
35849, July 14, 1994). That section is now being amended to redelegate 
the Commissioner's additional authority under the MQSA to 

[[Page 47268]]
do the following: Issue and renew certificates to mammography 
facilities; receive applications for certificates; approve, withdraw 
approval from, and evaluate accreditation bodies; evaluate individual 
facility compliance with quality standards by conducting inspections; 
impose sanctions; suspend and revoke facility certificates; make 
information available to physicians and the general public useful in 
evaluating the performance of facilities; and authorize States to carry 
out certification requirements and implement quality standards. The 
heading for Sec. 5.85 is being revised to reflect the expansion of 
authorities being redelegated. These authorities are redelegated to the 
Director and Deputy Director for Regulations and Policy, Center for 
Devices and Radiological Health (CDRH), the Director, Office of Health 
and Industry Programs (OHIP), CDRH, and the Director, Division of 
Mammography Quality and Radiation Programs, OHIP, CDRH, as set forth in 
the regulation. These authorities are directly related to current CDRH 
operations and programs.
    Further redelegation of the authority delegated is not authorized 
at this time. Authority delegated to a position by title may be 
exercised by a person officially designated to serve in such position 
in an acting capacity or on a temporary basis.

List of Subjects in 21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
5 is amended as follows:

PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION

    1. The authority citation for 21 CFR part 5 continues to read as 
follows:

    Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15 
U.S.C. 638, 1261-1282, 3701-3711a; secs. 2-12 of the Fair Packaging 
and Labeling Act (15 U.S.C. 1451-1461); 21 U.S.C. 41-50, 61-63, 141-
149, 467f, 679(b), 801-886, 1031-1309; secs. 201-903 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321-394); 35 U.S.C. 156; 
secs. 301, 302, 303, 307, 310, 311, 351, 352, 354, 361, 362, 1701-
1706, 2101, 2125, 2127, 2128 of the Public Health Service Act (42 
U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b, 264, 265, 
300u-300u-5, 300aa-1, 300aa-25, 300aa-27, 300aa-28); 42 U.S.C. 
1395y, 3246b, 4332, 4831(a), 10007-10008; E.O. 11490, 11921, and 
12591; secs. 312, 313, 314 of the National Childhood Vaccine Injury 
Act of 1986, Pub. L. 99-660 (42 U.S.C. 300aa-1 note).

    2. Section 5.85 is revised to read as follows:


Sec. 5.85  Authority to ensure that mammography facilities meet quality 
standards.

     (a) The following officials are authorized to issue, renew, and 
extend certificates to mammography facilities under section 354(c) of 
the Public Health Service Act (42 U.S.C. 263b):
    (1) The Director and Deputy Director for Regulations and Policy, 
Center for Devices and Radiological Health (CDRH).
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (b) The following officials are authorized to accept an application 
for a certificate under section 354(d)(1) of the Public Health Service 
Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (c) The following officials are authorized to approve accreditation 
bodies to accredit mammography facilities under section 354(e)(1)(A) of 
the Public Health Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (d) The following officials are authorized to ensure that 
accreditation bodies provide satisfactory assurances of compliance 
under section 354(e)(1)(C) of the Public Health Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (e) The Director, CDRH, is authorized to promulgate regulations 
under which the Director may withdraw approval of accreditation bodies 
under section 354(e)(2) of the Public Health Service Act.
    (f) The following officials are authorized to determine the 
applicable standards for a facility for accreditation under section 
354(e)(3) of the Public Health Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (g) The following officials are authorized to ensure that 
accreditation bodies make on site visits and to determine whether other 
measures are appropriate under section 354(e)(4)(A) and (e)(4)(B) of 
the Public Health Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (h) The following officials are authorized to evaluate annually the 
performance of each approved accreditation body as provided by section 
354(e)(6)(A) of the Public Health Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (i) The following officials are authorized to determine the 
compliance of certified facilities with established standards through 
facility inspections as provided by section 354(g) of the Public Health 
Service Act:
    (1) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (2) The Director, Office of Health and Industry Programs, CDRH.
    (3) The Director, Division of Mammography Quality and Radiation 
Programs, Office of Health and Industry Programs, CDRH.
    (j) The Director and Deputy Director for Regulations and Policy, 
CDRH, are authorized to impose sanctions under section 354(h)(1) and 
(h)(2) of the Public Health Service Act.
    (k) The Director and Deputy Director for Regulations and Policy, 
CDRH, are authorized to suspend or revoke individual facility 
certificates under section 354(i)(1) and (i)(2)(A) of the Public Health 
Service Act.
    (l) The Director and Deputy Director for Regulations Policy, CDRH, 
are authorized to compile and make available to physicians and the 
general public information the Director determines is useful in 
evaluating the performance of mammography facilities as provided by 
section 354(l) of the Public Health Service Act.

[[Page 47269]]

    (m)(1) The following officials may authorize a State to carry out 
certification program requirements and implement quality standards 
under section 354(q)(1) and (q)(2) of the Public Health Service Act:
    (i) The Director and Deputy Director for Regulations and Policy, 
CDRH.
    (ii) The Director, Office of Health and Industry Programs, CDRH.
    (2) The Director, CDRH, is authorized, after providing notice and 
opportunity for corrective action, to withdraw the approval of a 
State's authority to carry out certification requirements and implement 
quality standards under section 354(q)(4) of the Public Health Service 
Act.

    Dated: September 1, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-22578 Filed 9-11-95; 8:45 am]
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