[Federal Register Volume 64, Number 21 (Tuesday, February 2, 1999)]
[Rules and Regulations]
[Pages 4964-4965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2357]


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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 redelegations to 
other officials within the Center for Devices and Radiological Health 
(CDRH) pertaining to: Certifying true copies and using the Department 
seal, disclosing official records, issuing reports of minor violations, 
and medical device reporting procedures. This amendment is intended to 
reflect those redelegations.

EFFECTIVE DATE: February 2, 1999.


[[Page 4965]]



FOR FURTHER INFORMATION CONTACT:

     Deb 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 
under Sec. 5.22 Certification of true copies and use of the Department 
seal (21 CFR 5.22); Sec. 5.23 Disclosure of official records (21 CFR 
5.23); Sec. 5.37 Issuance of reports of minor violations (21 CFR 5.37); 
and Sec. 5.98 Authority relating to medical device reporting procedures 
(21 CFR 5.98) to reflect redelegations to other officials within CDRH. 
These redelegations will improve the efficiency of operations for the 
center.
     Further redelegation of the authorities 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; 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 5.22 is amended by revising paragraph (a)(10)(v) and by 
adding paragraph (a)(10)(vi) to read as follows:


Sec. 5.22   Certification of true copies and use of Department seal.

     (a) * * *
     (10) * * *
    (v) The Director and Deputy Director, Office of Surveillance and 
Biometrics (OSB), CDRH, and the Director and Deputy Director, Division 
of Surveillance Systems (DSS), OSB, CDRH.
     (vi) Freedom of Information Officers, CDRH.
* * * * *
     3. Section 5.23 is amended by adding paragraph (c)(5) to read as 
follows:


Sec. 5.23   Disclosure of official records.

* * * * *
     (c) * * *
     (5) The Director and Deputy Director, Office of Surveillance and 
Biometrics (OSB), CDRH, the Director and Deputy Director, Division of 
Surveillance Systems (DSS), OSB, CDRH, and the Chief Reporting Systems 
Monitoring Branch, DSS, OSB, CDRH.
* * * * *
     3. Section 5.37 is amended by adding paragraphs (a)(2)(iv) and 
(b)(4) to read as follows:


Sec. 5.37   Issuance of reports of minor violations.

    (a) * * *
    (2) * * *
     (iv) The Director and Deputy Director, Office of Surveillance and 
Biometrics (OSB), CDRH, and the Director and Deputy Director, Division 
of Surveillance Systems (DSS), OSB, CDRH.
* * * * *
     (b) * * *
     (4) The Director and Deputy Director, OSB, CDRH, and the Director 
and Deputy Director, DSS, OSB, CDRH.
* * * * *
     5. Section 5.98 is revised to read as follows:


Sec. 5.98   Authority relating to medical device reporting procedures.

     (a) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), the Director and Deputy Director, Office of 
Surveillance and Biometrics, (OSB), CDRH and the Director and Deputy 
Director, Division of Surveillance Systems (DSS), OSB, CDRH, are 
authorized to approve electronic reporting under Sec. 803.14 of this 
chapter.
     (b) The Director and Deputy Directors, CDRH, the Director and 
Deputy Director, OSB, CDRH, and the Director and Deputy Director, DSS, 
OSB, CDRH, are authorized to request the submission of additional 
information under Sec. 803.15 of this chapter.
     (c) The Director and Deputy Directors, CDRH, the Director and 
Deputy Director, OSB, CDRH, and the Director and Deputy Director, DSS, 
OSB, CDRH, are authorized to grant or revoke exemptions and variances 
from reporting requirements under Sec. 803.19 of this chapter.

    Dated: January 22, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-2357 Filed 2-1-99; 8:45 am]
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