[Federal Register Volume 59, Number 134 (Thursday, July 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17074]


[[Page Unknown]]

[Federal Register: July 14, 1994]


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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 for delegations of authority relating to the authority of 
the Commissioner of Food and Drugs (the Commissioner) to issue 
certificates to mammography facilities. This authority is being 
redelegated to the Director and Deputy Director for Regulations and 
Policy, Center for Devices and Radiological Health (CDRH), the 
Director, Office of Health Information Programs (OHIP), CDRH, and the 
Director, Division of Mammography Quality and Radiation Programs, OHIP, 
CDRH. This delegation excludes the authority to submit reports to the 
Congress.

EFFECTIVE DATE: July 14, 1994.

FOR FURTHER INFORMATION CONTACT: Ellen Rawlings, Division of Management 
Systems and Policy (HFA-340), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-4976.

SUPPLEMENTARY INFORMATION: On June 10, 1993, the Acting Assistant 
Secretary for Health delegated to the Commissioner certain authorities 
under the Mammography Quality Standards Act of 1992 (Pub. L. 102-539), 
which amends Title III of the Public Health Service Act (42 U.S.C. 
263b). As provided for in the delegation from the Acting Assistant 
Secretary for Health, the Commissioner is further redelegating to CDRH 
the authority to issue certificates to mammography facilities.
    FDA is amending the delegations of authority under 21 CFR part 5 by 
adding new Sec. 5.85 Authority to issue certificates to mammography 
facilities (21 CFR 5.85), which will give the Director and Deputy 
Director for Regulations and Policy, CDRH, the Director, OHIP, CDRH, 
and the Director, Division of Mammography Quality and Radiation 
Programs, OHIP, CDRH, authority to issue certificates relating to the 
certification of mammography facilities. This authority is directly 
related to current CDRH operations and programs.
    Further redelegation of the authority delegated is not authorized. 
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 is revised 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. New Sec. 5.85 is added to subpart B to read as follows:


Sec. 5.85  Authority to issue certificates to mammography facilities.

    The following officials are authorized to issue certificates to 
mammography facilities under the relevant provisions of the Public 
Health Service Act (as amended by the Mammography Quality Standards Act 
of 1992 (Pub. L. 102-539)). The delegation excludes the authority to 
submit reports to Congress.
    (a) The Director and Deputy Director for Regulations and Policy, 
Center for Devices and Radiological Health (CDRH).
    (b) The Director, Office of Health Information Programs (OHIP), 
CDRH.
    (c) The Director, Division of Mammography Quality and Radiation 
Programs, OHIP, CDRH.

    Dated: July 5, 1994.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 94-17074 Filed 7-13-94; 8:45 am]
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