Delegations of Authority and Organization; Center for Food Safety and Applied Nutrition

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