[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]
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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.
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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
