[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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