[Federal Register Volume 63, Number 95 (Monday, May 18, 1998)]
[Rules and Regulations]
[Pages 27207-27208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13046]


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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 to reflect a new delegation 
that authorizes the Division Directors, Office of Device Evaluation 
(ODE), Center for Devices and Radiological Health (CDRH) to approve, 
disapprove, or withdraw approval of product development protocols and 
applications for premarket approval for medical devices.

EFFECTIVE DATE: May 18, 1998.
FOR FURTHER INFORMATION CONTACT:
    Debra A. Baclawski, Center for Devices and Radiological Health 
(HFZ-026), Food and Drug Administration, 1350 Piccard Dr., Rockville, 
MD 20850, 301-443-1060, or
    Donna G. Page, Division of Management Systems and Policy (HFA-340), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-4816.

SUPPLEMENTARY INFORMATION: FDA is amending the delegations of authority 
regulation in subpart B of part 5 (21 CFR part 5) by adding authorities 
to additional officials within CDRH under Sec. 5.53 Approval, 
disapproval, or withdrawal of approval of product development protocols 
and applications for premarket approval for medical devices. As a 
result of reengineering initiatives within CDRH, for the Premarket 
Approval and Product Development Protocol Programs, this delegation 
will improve the efficiency of operations for these programs.
    These authorities will not be further redelegated at this time.

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; 15 U.S.C. 1451-1461; 21 U.S.C. 
41-50, 61-63, 141-149, 321-394, 467f, 679(b), 801-886, 1031-1309; 35 
U.S.C. 156; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 
264, 265, 300u-300u-5, 300aa-1, 1395y, 3246b, 4332, 4831(a), 10007-
10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O. 
12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223.

    2. Section 5.53 is amended by revising paragraphs (a)(1) and 
(b)(1)(i) to read as follows:


Sec. 5.53  Approval, disapproval, or withdrawal of approval of product 
development protocols and applications for premarket approval for 
medical devices.

    (a) * * *
    (1) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), the Director and Deputy Directors, Office 
of Device Evaluation (ODE), CDRH, and the Division Directors, ODE, 
CDRH.
* * * * *
    (b)(1) * * *

[[Page 27208]]

    (i) The Director and Deputy Directors, CDRH, the Director and 
Deputy Directors, ODE, CDRH, and the Division Directors, ODE, CDRH.
* * * * *

    Dated: May 7, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-13046 Filed 5-15-98; 8:45 am]
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