[Federal Register Volume 59, Number 159 (Thursday, August 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20348]
[[Page Unknown]]
[Federal Register: August 18, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 5
Delegations 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
regulations for delegations of authority relating to functions
performed by officials in the Center for Food Safety and Applied
Nutrition (CFSAN). The reorganization of CFSAN, outlined in the Federal
Register of November 17, 1992, created a second Deputy Director,
retitled several organizational units, and transferred responsibilities
to newly created organizational units. These changes require a revision
in the related delegations of authority. In addition, new authority
delegations are made that are needed to allow the organization to
handle routine and noncontroversial matters efficiently.
EFFECTIVE DATE: August 18, 1994.
FOR FURTHER INFORMATION CONTACT:
Louis B. Brock, Office of Planning, Policy, and Strategic
Initiatives (HFS-24), Food and Drug Administration, rm. 5830, 200 C St.
SW, Washington, DC 20204, 202-205-4273; or
Ellen R. Rawlings, Division of Management Systems and Policy (HFA-
340), Food and Drug Administration, rm. 3-50, 12420 Parklawn Dr.,
Rockville, MD 20857, 301-443-4976.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 17,
1992 (57 FR 54239), FDA outlined the reorganization of CFSAN and its
new substructure. This technical amendment revises references in the
delegations of authority to CFSAN officials to conform with their
organizational placement and new titles. In some cases, authorities
that were vested in one official are now shared by two or more
officials.
The sections affected by this amendment are Sec. 5.22 Certification
of true copies and use of Department seal (21 CFR 5.22); Sec. 5.25
Research, investigation, and testing programs and health information
and health promotion programs (21 CFR 5.25); Sec. 5.26 Service
fellowships (21 CFR 5.26); Sec. 5.30 Hearings (21 CFR 5.30); Sec. 5.31
Petitions under part 10 (21 CFR 5.31); Sec. 5.37 Issuance of reports
of minor violations (21 CFR 5.37); Sec. 5.61 Food standards, food
additives, generally recognized as safe (GRAS) substances, color
additives, nutrient content claims, and health claims (21 CFR 5.61);
Sec. 5.62 Issuance of initial emergency permit orders and notices of
confirmation of effective date of final regulations on food for human
and animal consumption (21 CFR 5.62); and Sec. 5.66 Approval of
schools providing food-processing instruction (21 CFR 5.66).
FDA is also amending the regulations on delegations of authority by
adding new authority delegations from the Director and Deputy
Directors, CFSAN, to specific office and division directors. These new
authorities pertain to routine and noncontroversial matters and will
allow the organization to operate more efficiently. The sections
affected by adding these new authorities are Secs. 5.22, 5.31, 5.61,
5.62, and 5.66. 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.
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; 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 5.22 is amended by revising paragraph (a)(8) to read as
follows:
Sec. 5.22 Certification of true copies and use of Department seal.
(a) * * *
(8)(i) The Director and Deputy Directors, Center for Food Safety
and Applied Nutrition (CFSAN).
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Management Systems, CFSAN.
(iv) The Director, Office of Cosmetics and Colors, CFSAN.
(v) The Director, Office of Food Labeling, CFSAN.
(vi) The Director, Office of Premarket Approval, CFSAN.
(vii) The Director, Office of Plant and Dairy Foods and Beverages,
CFSAN.
(viii) The Director, Office of Seafood, CFSAN.
(ix) The Director, Office of Special Nutritionals, CFSAN.
(x) The Director, Office of Special Research Skills, CFSAN.
(xi) The Director, Office of Constituent Operations, CFSAN.
(xii) The Director, Office of Field Programs, CFSAN.
(xiii) The Director, Office of Scientific Analysis and Support,
CFSAN.
* * * * *
3. Section 5.25 is amended by revising paragraph (a)(4) to read as
follows:
Sec. 5.25 Research, investigation, and testing programs and health
information and health promotion programs.
(a) * * *
(4) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition.
* * * * *
4. Section 5.26 is amended by revising paragraph (e) to read as
follows:
Sec. 5.26 Service fellowships.
* * * * *
(e) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN), and Director, Office of Management Systems,
CFSAN.
* * * * *
5. Section 5.30 is amended by revising paragraphs (a)(1) and (c)(2)
to read as follows:
Sec. 5.30 Hearings.
(a) * * *
(1) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN), and the Director, Office of Policy,
Planning, and Strategic Initiatives, CFSAN.
* * * * *
(c) * * *
(2) The Director and Deputy Directors, CFSAN.
* * * * *
6. Section 5.31 is amended by revising paragraphs (c)(2) and
(e)(1) to read as follows:
Sec. 5.31 Petitions under part 10.
* * * * *
(c) * * *
(2) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN), and the Director, Office of Policy,
Planning, and Strategic Initiatives, CFSAN.
* * * * *
(e)(1) The following officials are authorized to issue 180-day
tentative responses to citizen petitions on food and cosmetic matters
under Sec. 10.30(e)(2)(iii) of this chapter that relate to the assigned
functions of that Center:
(i) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN).
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Cosmetics and Colors, CFSAN.
(iv) The Director, Office of Food Labeling, CFSAN.
(v) The Director, Office of Premarket Approval, CFSAN.
(vi) The Director, Office of Plant and Dairy Foods and Beverages,
CFSAN.
(vii) The Director, Office of Seafood, CFSAN.
(viii) The Director, Office of Special Nutritionals, CFSAN.
* * * * *
7. Section 5.37 is amended by revising paragraphs (a)(3)(i) through
(a)(3)(iii) and by adding new paragraph (a)(3)(iv) to read as follows:
Sec. 5.37 Issuance of reports of minor violations.
(a) * * *
(3)(i) The Director and Deputy Directors, Center for Food Safety
and Applied Nutrition, (CFSAN).
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Field Programs, CFSAN.
(iv) The Director, Division of Enforcement, Office of Field
Programs, CFSAN.
* * * * *
8. Section 5.61 is amended by revising paragraphs (a), (b)(1),
(b)(2), (c)(1), (d), (e), (f)(1), and (g) 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.
(a)(1) The following officials are authorized to perform all the
functions of the Commissioner of Food and Drugs under section 409 and
721 of the Federal Food, Drug, and Cosmetic Act (the act) 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 Directors, Center for Food Safety and
Applied Nutrition (CFSAN).
(ii) The Director, Office of Policy, Planning and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Premarket Approval, CFSAN.
(iv) The Director and Deputy Director, Center for Veterinary
Medicine (CVM).
(2) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN), and the Director, Office of Policy,
Planning, and Strategic Initiatives, CFSAN are authorized to perform
all the functions of the Commissioner of Food and Drugs under section
401 of the act 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 and Deputy Directors, CFSAN, and the Director,
Office of Policy, Planning, and Strategic Initiatives, CFSAN are
authorized to perform all of the functions of the Commissioner of Food
and Drugs under sections 409 and 721 of the act regarding the approval
of the use of food additives under section 409(e) of the act and the
listing of color additives under section 721(d) of the act 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 of Food and Drugs under section 401 of
the act 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 Directors, CFSAN.
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Food Labeling, CFSAN.
* * * * *
(c)(1) The following officials are authorized to issue 90-day
letters to food additive petitioners under section 409(c)(2) of the act
or to color additive petitions under section 721(d)(1) of the act that
relate to the assigned functions of the Center:
(i) The Director and Deputy Directors, CFSAN.
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, 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.
* * * * *
(d) The following officials are authorized to certify batches of
color additives under section 721 of the act:
(1) The Director and Deputy Directors, CFSAN.
(2) The Director, Office of Policy, Planning, and Strategic
Initiatives, 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 Directors, CFSAN.
(2) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(3) The Director, Office of Food Labeling, CFSAN.
(f) * * *
(1) The Director and Deputy Directors, CFSAN, and the Director,
Office of Policy, Planning, and Strategic Initiatives, CFSAN.
* * * * *
(g)(1) The following officials are authorized to perform all of the
functions of the Commissioner of Food and Drugs under section 403(r)(4)
of the act 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 Directors, CFSAN.
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(2) The following officials are authorized to perform all of the
functions of the Commissioner of Food and Drugs under section 403(r)(4)
of the act regarding the issuing of letters of filing in response to
petitions for nutrient content claims and health claims:
(i) The Director and Deputy Directors, CFSAN.
(ii) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(iii) The Director, Office of Food Labeling, CFSAN.
* * * * *
9. Section 5.62 is revised to read as follows:
Sec. 5.62 Issuance of initial emergency permit orders and notices of
confirmation of effective date of final regulations on food for human
and animal consumption.
(a) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN), the Director, Office of Field Programs,
CFSAN, and the Director, Division of Enforcement, Office of Field
Programs, CFSAN, are authorized to issue initial emergency permit
orders under Sec. 108.5 of this chapter.
(b) The following officials are authorized to issue notices of
confirmation of effective date of final regulations on food matters
promulgated under section 701(e) of the Federal Food, Drug, and
Cosmetic Act:
(1) The Director and Deputy Directors, CFSAN.
(2) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(3) The Director, Office of Food Labeling, CFSAN.
(4) The Director, Office of Special Nutritionals, CFSAN.
(5) The Director, Office of Plant and Dairy Foods and Beverages,
CFSAN.
(6) The Director, Office of Seafood, CFSAN.
(7) The Director, Office of Field Programs, CFSAN.
(8) The Director, Office of Premarket Approval, CFSAN.
10. Section 5.66 is revised to read as follows:
Sec. 5.66 Approval of schools providing food-processing instruction.
The following officials are authorized to perform all the functions
of the Commissioner of Food and Drugs under Sec. 113.10 of this chapter
regarding the approval of schools giving instruction in retort
operations, processing systems operations, aseptic processing and
packaging system operations, and container closure inspections:
(a) The Director and Deputy Directors, Center for Food Safety and
Applied Nutrition (CFSAN).
(b) The Director, Office of Policy, Planning, and Strategic
Initiatives, CFSAN.
(c) The Director, Office of Plant and Dairy Foods and Beverages,
CFSAN.
Dated: August 12, 1994.
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 94-20348 Filed 8-17-94; 8:45 am]
BILLING CODE 4160-01-F
