[Federal Register Volume 60, Number 4 (Friday, January 6, 1995)]
[Rules and Regulations]
[Page 2014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-359]



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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 in order to redelegate 
authorities relating to determining the classification of devices first 
marketed after May 28, 1976, to additional officials in the Center for 
Devices and Radiological Health (CDRH).

EFFECTIVE DATE: January 6, 1995.

FOR FURTHER INFORMATION CONTACT:

Joseph M. Sheehan, Center for Devices and Radiological Health (HFZ-84), 
Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 
301-594-4765, 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. 5.51 Determination of 
classification of devices (21 CFR 5.51) by extending the authority in 
Sec. 5.51(b)(1) to determine the classification of a medical device 
first intended for commercial distribution after May 28, 1976, pursuant 
to section 513(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act, to 
Deputy Division Directors, Associate Division Directors, and Branch 
Chiefs, Office of Device Evaluation, CDRH. The expanded delegation will 
ensure greater efficiency in making these classification decisions.
    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).

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 5.51 is amended by revising paragraph (b)(1) to read as 
follows:


Sec. 5.51  Determination of classification of devices.

* * * * *
    (b) * * *
    (1) The Director and Deputy Director, CDRH, and the Director, 
Deputy Director, Associate Director, Chief of the Premarket 
Notification Section, Division and Deputy Division Directors, Associate 
Division Directors, and Branch Chiefs, Office of Device Evaluation, 
CDRH.
* * * * *
    Dated: December 29, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 95-359 Filed 1-5-95; 8:45 am]
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