[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.300]

[Page 74-75]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5_DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
        Subpart E_Food and Cosmetics; Redelegations of Authority
 
Sec. 5.300  Food standards, food additives, generally recognized as 


safe (GRAS) substances, color additives, nutrient content claims, 
and health claims.

    (a)(1) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs (Commissioner) under 
sections 409 and 721 of the act (21 U.S.C. 348 and 379e) regarding the 
issuance of notices of filing (including notices of extension of, or 
reopening of, the comment period), and of voluntary withdrawal, of 
petitions on food additives, generally recognized as safe (GRAS) 
substances, and color additives that relate to the assigned functions of 
the respective Center:
    (i) The Director and Deputy Director, Center for Food Safety and 
Applied Nutrition (CFSAN).
    (ii) The Director of Regulations and Policy, CFSAN.
    (iii) The Director, Office of Premarket Approval, CFSAN
    (iv) The Director and Deputy Director, Center for Veterinary 
Medicine (CVM).
    (2) The Director, Deputy Director, and Director of Regulations and 
Policy, CFSAN are authorized to perform all the functions of the 
Commissioner under section 401 of the act (21 U.S.C. 341) regarding the 
issuance of proposed rulemaking (including notices of extension of, or 
reopening of, the comment period) pertaining to food standards.
    (b)(1) The Director, Deputy Director, and Director of Regulations 
and Policy, CFSAN are authorized to perform all of the functions of the 
Commissioner under section 409 and 721 of the act (21 U.S.C. 348 and 
379e) regarding the approval of the use of food additives under section 
409(e) of the act (21 U.S.C. 348(e)) and the listing of color additives 
under section 721(d)(1) of the act (21 U.S.C. 379e) where the listing 
does not involve novel or controversial issues and does not involve any 
questions about the applicability of the Delaney Anti-Cancer Clause.
    (2) The following officials are authorized to perform all of the 
functions of the Commissioner under section 401 of the act (21 U.S.C. 
341) regarding the issuance of notices of temporary permits for foods 
varying from standards of identity under Sec. 130.17 of this chapter:
    (i) The Director and Deputy Director, CFSAN.
    (ii) The Director of Regulations and Policy, CFSAN.
    (iii) The Director, Office of Nutritional Products, Labeling, and 
Dietary Supplements, CFSAN.
    (3) The Director and Deputy Director, CVM, are authorized to perform 
all the functions of the Commissioner regarding approvals of the use of 
food additives under section 409(e) of the act (21 U.S.C. 348(e)), where 
these approvals do not involve novel or controversial issues, including 
any question about the applicability of the Delaney Anti-Cancer Clause.
    (c)(1) The following officials are authorized to issue 90-day 
letters to food additive petitioners under section 409(c)(2) of the act 
(21 U.S.C. 348(c)(2)) or to color additive petitions under section 
721e(d)(1) (21 U.S.C. 379e(d)(1)) of the act that relate to the assigned 
functions of the Center:
    (i) The Director and Deputy Director, CFSAN.
    (ii) The Director of Regulations and Policy, CFSAN.
    (iii) The Director, Office of Premarket Approval, CFSAN.
    (iv) The Director, Division of Product Policy, Office of Premarket 
Approval, CFSAN.
    (v) The Director, Division of Petition Control, Office of Premarket 
Approval, CFSAN.
    (2) The following officials are authorized to issue 90-day letters 
to food additive petitioners under section 409(c)(2) of the act (21 
U.S.C. 348(c)(2)) that relate to the assigned functions of the Center:
    (i) The Director and Deputy Director, CVM.
    (ii) The Director and Deputy Director, Office of Surveillance and 
Compliance, CVM.
    (iii) The Director and Deputy Director, Division of Animal Feeds, 
Office of Surveillance and Compliance, CVM.
    (d) The following officials are authorized to certify batches of 
color additives under section 721 of the act (21 U.S.C. 379e):

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    (1) The Director and Deputy Director, CFSAN.
    (2) The Director of Regulations and Policy, CFSAN.
    (3) The Director, Office of Cosmetics and Colors, CFSAN.
    (e) The following officials are authorized to issue advance notices 
of proposed rulemaking pertaining to Codex Alimentarius food standards 
and notices terminating consideration of such standards when comments 
fail to support the desirability and need for proposing their adoption, 
under Sec. 130.6 of this chapter:
    (1) The Director and Deputy Director, CFSAN.
    (2) The Director of Regulations and Policy, CFSAN.
    (3) The Director, Office of Nutritional Products, Labeling, and 
Dietary Supplements, CFSAN.
    (f) The following officials are authorized to issue notices of 
proposed rulemaking and issue or amend regulations affirming GRAS status 
of food substances under Sec. Sec. 170.35 or 570.35 of this chapter 
where the affirmations relate to the assigned functions of the 
respective Center and do not involve novel or controversial issues:
    (1) The Director, Deputy Director, and Director of Regulations and 
Policy, CFSAN.
    (2) The Director and Deputy Director, CVM.
    (g)(1) The following officials are authorized to perform all of the 
functions of the Commissioner under section 403(r)(4) of the act (21 
U.S.C. 343(r)(4)) regarding the issuance of decisions to grant or deny 
petitions for nutrient content claims and health claims that do not 
present controversial issues and regarding the issuance of any notices 
of proposed rulemaking that result from such action:
    (i) The Director and Deputy Director, CFSAN.
    (ii) The Director of Regulations and Policy, CFSAN.
    (2) The following officials are authorized to perform all of the 
functions of the Commissioner under section 403(r)(4) of the act (21 
U.S.C. 343(r)(4)) regarding the issuing of letters of filing in response 
to petitions for nutrient content claims and health claims:
    (i) The Director and Deputy Director, CFSAN.
    (ii) The Director of Regulations and Policy, CFSAN.
    (iii) The Director, Office of Nutritional Products, Labeling, and 
Dietary Supplements, CFSAN.
    (h) The following officials are authorized to issue letters 
concerning substances determined to be below the ``threshold of 
regulation'' under Sec. 170.39 of this chapter:
    (1) The Director and Deputy Director, CFSAN.
    (2) The Director of Regulations and Policy, CFSAN.
    (3) The Director, Office of Premarket Approval, CFSAN.
    (4) The Directors of the Divisions of Petition Control and Product 
Policy, Office of Premarket Approval, CFSAN.
    (i) The following officials are authorized to perform all of the 
functions of the Commissioner under section 409(h) of the act (21 U.S.C. 
348(h)), excluding the duties to set out in section 409(h)(5) of the act 
(21 U.S.C. 348(h)(5)), regarding premarket notification of food-contact 
substances:
    (1) The Director and Deputy Director, CFSAN.
    (2) The Director of Regulations and Policy, CFSAN.
    (3) The Director, Office of Premarket Approval, CFSAN.
    (j) These officials may not further redelegate these authorities.