[Federal Register Volume 59, Number 116 (Friday, June 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14855]


[[Page Unknown]]

[Federal Register: June 17, 1994]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 5 and 821

 

Delegations of Authority and Organization; Center for Devices and 
Radiological Health

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations for delegations of authority relating to general 
redelegations of authority from the Associate Commissioner of 
Regulatory Affairs to certain FDA officials in the Center for Devices 
and Radiological Health (CDRH). The redelegation provides these 
officials with authority to grant or deny certain citizen petitions for 
exemption or variance from medical device tracking requirements. This 
action is being taken to facilitate expeditious handling of citizen 
petitions. FDA is also issuing a conforming amendment to the medical 
device tracking regulations to make the regulations consistent.

EFFECTIVE DATE: June 17, 1994.

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 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 regulations in Sec. 5.31 
Petitions under part 10 (21 CFR 5.31) by granting the authority to the 
Director and Deputy Directors, CDRH, and the Director, Office of 
Compliance (previously known as the Office of Compliance and 
Surveillance), CDRH, to issue responses to citizen petitions submitted 
in accordance with Secs. 10.30 and 821.2(b) (21 CFR 10.30 and 821.2(b)) 
requesting an exemption or variance from the provisions of part 821 
concerning medical device tracking requirements. FDA is making a 
conforming amendment to 821.2(b), which currently lists only the 
Director, Office of Compliance and Surveillance, CDRH, as authorized to 
issue such responses, to add the Director and Deputy Directors, CDRH.
    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.
    This document is issued as a final rule because the rulemaking 
requirements in 5 U.S.C. 553 do not apply to rules of agency 
organization, procedure, or practice.

List of Subjects

21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).

21 CFR Part 821

    Imports, Medical devices, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
5 and 821 are 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, 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, 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 5.31 is amended by adding new paragraph (g) to read as 
follows:


Sec. 5.31  Petitions under part 10.

* * * * *
    (g) The Director and Deputy Directors, CDRH, and the Director, 
Office of Compliance, CDRH, are authorized to grant or deny citizen 
petitions submitted under Secs. 10.30 and 821.2(b) of this chapter, 
requesting an exemption or variance from medical device tracking 
requirements in part 821 of this chapter.

PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS

    3. The authority citation for 21 CFR part 821 continues to read as 
follows:
    Authority: Secs. 301, 501, 502, 510, 515, 518, 519, 701, and 704 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351, 
352, 360, 360e, 360h, 360i, 371, and 374).

    4. Section 821.2 is amended by revising the second sentence in 
introductory text of paragraph (b) to read as follows:


Sec. 821.2  Exemptions and variances.

* * * * *
    (b) * * * The Director or Deputy Directors, CDRH, or the Director, 
Office of Compliance, CDRH, shall issue responses to requests under 
this section. * * *
* * * * *

    Dated: June 13, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-14855 Filed 6-16-94; 8:45 am]
BILLING CODE 4160-01-F