[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]
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