[Federal Register Volume 64, Number 119 (Tuesday, June 22, 1999)]
[Rules and Regulations]
[Page 33194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15753]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 5
Delegation of Authority and Organization; Center for Food Safety
and Applied Nutrition
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
general redelegation of authority from the Commissioner of Food and
Drugs to other officers of FDA. The amendment delegates to the Director
and Deputy Director, Center for Food Safety and Applied Nutrition
(CFSAN); the Director, Office of Regulations and Policy, CFSAN; and the
Director, Office of Premarket Approval, CFSAN authority to implement
the Federal Food, Drug, and Cosmetic Act (the act), as amended
hereafter. This redelegation is necessary to improve the efficiency of
program operations.
EFFECTIVE DATE: June 22, 1999.
FOR FURTHER INFORMATION CONTACT:
Louis B. Brock, Regulation Coordination Staff (HFS-24), Food and
Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4273,
or
Loretta W. Davis, Division of Management Systems and Policy (HFA-
340), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-4809.
SUPPLEMENTARY INFORMATION: Section 309 of the Food and Drug
Administration Modernization Act of 1997 (Pub. L. 105-115) amended
section 409 of the act (21 U.S.C. 348). New section 409(h) of the act
requires manufacturers or suppliers of food-contact substances to
notify the Secretary of Health and Human Services (and by delegation,
the Commissioner of Food and Drugs), at least 120 days prior to the
introduction or delivery for introduction into interstate commerce, of
the identification and use of food-contact substances, and to provide
information showing that the substance is safe according to the
standards of section 409(c)(3)(A) of the act.
FDA is amending the general redelegation of authority from the
Commissioner of Food and Drugs to the Director and Deputy Director,
Center for Food Safety and Applied Nutrition (CFSAN); the Director,
Office of Regulations and Policy, CFSAN; and the Director, Office of
Premarket Approval, CFSAN authority to implement the act, as amended
hereafter. This redelegation is necessary to improve the efficiency of
program operations. Further redelegation of the authorities is not
authorized at this time. Authority delegated to a position 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, 2421, 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 5.61 is amended by adding paragraph (i) to read as
follows:
Sec. 5.61 Food standards, food additives, generally recognized as
safe (GRAS) substances, color additives, nutrient content claims, and
health claims.
* * * * *
(i) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs under section 409(h) of
the act, excluding the duties set out in section 409(h)(5) of the act,
regarding premarket notification of food-contact substances:
(1) The Director and Deputy Director, Center for Food Safety and
Applied Nutrition (CFSAN).
(2) The Director, Office of Regulations and Policy, CFSAN.
(3) The Director, Office of Premarket Approval, CFSAN.
Dated: June 11, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy Coordination.
[FR Doc. 99-15753 Filed 6-21-99; 8:45 am]
BILLING CODE 4160-01-F
