[Federal Register Volume 60, Number 237 (Monday, December 11, 1995)]
[Rules and Regulations]
[Pages 63606-63607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29905]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 5


Delegations of Authority; Medical Device Reporting Procedures

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 redelegate to certain 
officials in the Center for Devices and Radiological Health (CDRH) 
authorities relating to medical device reporting procedures.

EFFECTIVE DATE: December 11, 1995.

FOR FURTHER INFORMATION CONTACT:
    Kerry G. Rothschild, Center for Devices and Radiological Health 
(HFZ-84), Food and Drug Administration, 2094 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 the delegations of authority 
under part 5 (21 CFR part 5) by adding new Sec. 5.98 Authority relating 
to medical device reporting procedures. In conjunction with CDRH's 
issuance of a medical device reporting final rule under section 519 of 
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i), 
the Commissioner of Food and Drugs (the Commissioner) has decided to 
delegate to certain officials in CDRH the authority to approve 
electronic reporting under 21 CFR 803.14, to request the submission of 
additional information under 21 CFR 803.15, and to grant or revoke 
exemptions and variances from reporting requirements under 21 CFR 
803.19. Delegation of these authorities to the directors and deputy 
directors of the Office of the Director and the Office of Surveillance 
and Biometrics, CDRH, 

[[Page 63607]]
will increase the efficiency of the medical device reporting process.
     The authority delegated may be redelegated further only with the 
Commissioner's approval. 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. New Sec. 5.98 is added to subpart B 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), and the Director and Deputy Director, 
Office of Surveillance and Biometrics, CDRH, are authorized to approve 
electronic reporting under Sec. 803.14 of this chapter.
     (b) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Director, 
Office of Surveillance and Biometrics, CDRH, are authorized to request 
the submission of additional information under Sec. 803.15 of this 
chapter.
     (c) The Director and Deputy Directors, Center for Devices and 
Radiological Health (CDRH), and the Director and Deputy Director, 
Office of Surveillance and Biometrics, CDRH, are authorized to grant or 
revoke exemptions and variances from reporting requirements under 
Sec. 803.19 of this chapter.

    Dated: September 1, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-29905 Filed 12-8-95; 8:45 am]
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