[Federal Register Volume 64, Number 169 (Wednesday, September 1, 1999)]
[Rules and Regulations]
[Page 47669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22676]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 5
Delegations of Authority and Organization; Redelegation to
Officials Within the Center for Biologics Evaluation and Research
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
statements of redelegations of authority to reflect a new redelegation
that enables the Director and Deputy Directors of the Center for
Biologics Evaluation and Research (CBER) to issue license suspension
notifications under the authority given to the Commissioner of Food and
Drugs (the Commissioner). This amendment is intended to reflect those
redelegations.
EFFECTIVE DATE: September 1, 1999.
FOR FURTHER INFORMATION CONTACT:
Anita F. Richardson, Center for Biologics Evaluation and Research
(HFM-610), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20850, 301-827-6206, 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 redelegations of
authority statement in Sec. 5.67 (21 CFR 5.67) by revising the section
heading and adding an authority to certain FDA officials. In order to
ensure efficient program operations, the Commissioner has further
redelegated this authority to the Center Director and the Deputy Center
Directors, CBER, the authority to issue license suspensions under
section 351(a)(2)(A) of the Public Health Service Act (42 U.S.C.
262(a)(2)(A)), as amended. The Commissioner's authority is currently
codified under 21 CFR 5.10(a)(5) and the associated regulation is
currently codified under 21 CFR 60l.6. This authority may 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, 1997 Comp., p. 124-131; E.O.
12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223.
2. Section 5.67 is amended by revising the section heading and the
introductory paragraph, and by adding paragraph (e) to read as follows:
Sec. 5.67 Issuance of notices of opportunity for a hearing on
proposals for denial of approval of applications for licenses,
suspension of licenses, or revocation of licenses and certain notices
of revocation of licenses.
The Center Director and Deputy Center Directors, Center for
Biologics Evaluation and Research are authorized to issue:
* * * * *
(e) Notice of license suspensions under Sec. 601.6 of this chapter.
Dated: August 25, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-22676 Filed 8-31-99; 8:45 am]
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