[Federal Register Volume 59, Number 60 (Tuesday, March 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7248]


[[Page Unknown]]

[Federal Register: March 29, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5

 

Delegations of Authority and Organization; Office of the 
Commissioner

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
delegations of authority regulations that cover general redelegations 
of authority from the Commissioner of Food and Drugs to other officers 
of FDA. The amendment delegates the FDA Chief Mediator and Ombudsman 
authority to consider and decide requests under certain circumstances 
for waivers or reduction of user fees and the Deputy Commissioner for 
Operations is delegated authority to hear and decide appeals related to 
user fee waivers or reductions. This action sets forth the agency's 
procedures that govern requests for waivers or reductions as well as 
for reconsideration or appeals.

EFFECTIVE DATE: March 29, 1994.

FOR FURTHER INFORMATION CONTACT: Ellen Rawlings, Division of Management 
Systems and Policy (HFA-340), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-4976.

SUPPLEMENTARY INFORMATION: FDA is amending the delegations of authority 
under Sec. 5.20 General redelegations of authority from the 
Commissioner to other officers of the Food and Drug Administration (21 
CFR 5.20) in order to redelegate under Sec. 5.20(h) the Commissioner's 
authorities under the Prescription Drug User Fee Act of 1992, as 
amended hereafter, under section 736(d) (21 U.S.C. 379h(d)) dealing 
with authority to waive or reduce user fees. The Chief Mediator and 
Ombudsman will serve as User Fee Waiver Officer to consider and decide 
requests under certain circumstances for waivers of or reductions in 
user fees. The User Fee Waiver Officer's authority may be redelegated 
to the Deputy, Chief Mediator and Ombudsman, without further 
redelegation. The Deputy Commissioner for Operations will serve as the 
User Fee Appeals Officer to hear and decide appeals under certain 
circumstances of the User Fee Waiver Officer's decisions.
    FDA has established procedures governing requests for waivers or 
reductions as well as for reconsideration or appeal within the agency 
of an adverse decision relating to a waiver or reduction request. If 
the User Fee Waiver Officer fully or partially denies a request for a 
fee waiver or reduction, the requestor may ask the User Fee Waiver 
Officer to reconsider the decision. As an additional safeguard, if the 
request is denied again on reconsideration, the requestor may appeal 
the denial to the User Fee Appeals Officer. The User Fee Appeals 
Officer's decision will constitute final agency action on that request.
    Further redelegation of these authorities 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 5.20 is amended by redesignating paragraph (h) as 
paragraph (i) and by adding a new paragraph (h) to read as follows:

Sec. 5.20  General redelegations of authority from the Commissioner to 
other officers of the Food and Drug Administration.

* * * * *
    (h) The Chief Mediator and Ombudsman is designated as User Fee 
Waiver Officer and is authorized to perform all of the functions of the 
Commissioner under the Prescription Drug User Fee Act of 1992 (21 
U.S.C. 379h(d)), as amended hereafter, relating to waiver or reduction 
of user fees. The User Fee Waiver Officer's authority may be 
redelegated to the Deputy, Chief Mediator and Ombudsman, without 
further redelegation. The Deputy Commissioner for Operations is 
designated as User Fee Appeals Officer and authorized to hear and 
decide user fee waiver appeals. The decision of the User Fee Appeals 
Officer will constitute final agency action on such matters.
* * * * *

    Dated: March 23, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-7343 Filed 3-28-94; 8:45 am]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 21 CFR Parts 172, 176, 177, 178, 179, and 184

 [Docket No. 94F-0042]

 Food Additives; Substances Generally Recognized as Safe; Technical 
Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive and generally recognized as safe (GRAS) regulations to correct 
certain typographical and other inadvertent errors. This action is 
being taken to improve the accuracy and clarity of the regulations.

EFFECTIVE DATE: March 29, 1994.

FOR FURTHER INFORMATION CONTACT: Linda S. Kahl, Center for Food Safety 
and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-254-9523.

SUPPLEMENTARY INFORMATION:  FDA has discovered that certain errors have 
become incorporated into the agency's codified regulations on food 
additives and direct food substances affirmed as GRAS. FDA is 
correcting these errors. These corrections are nonsubstantive, and 
therefore no new rulemaking is necessary. This final rule addresses the 
following errors in the regulations:
     1. In 21 CFR 172.320(b)(1), in the list of amino acids, the entry 
``L-Methionine'' appears twice. The correct list should include one 
entry for ``DL-Methionine'' and one entry for ``L-Methionine.'' This 
error was inadvertently introduced in the 1985 edition of title 21 of 
the Code of Federal Regulations (title 21). FDA is correcting this 
error.
     2. In the table in 21 CFR 176.170(a)(5), the entry ``N,N-Bis(2-
hydroxyethyl)alkyl (C12-C16)amide'' is incorrect. The correct 
entry is ``N,N-Bis(2-hydroxyethyl)alkyl (C12-C18)amide.'' 
This error was inadvertently introduced in the 1977 edition (and 
recodification) of title 21. FDA is correcting this error.
     3. In 21 CFR 177.1610(a), the second sentence reads ``* * * as 
determined by the method in contact with all types of food, except that 
when used in contact with fatty food of Types III, IV-A, V, VII-A, and 
IX described in Table 1 of Sec. 176.170(c) of this chapter, chlorinated 
polyethylene is limited to use only as a modifier admixed at levels not 
exceeding 15 weight percent in plastic articles prepared from polyvinyl 
chloride and/or from vinyl chloride copolymers complying with 
Sec. 177.1980.'' The second sentence in paragraph (a) should read: ``* 
* * as determined by the method described in Sec. 177.1520(d)(3)(ii).'' 
In addition, this sentence should be followed by paragraph (b), which 
reads:
    Chlorinated polyethylene may be used in contact with all types 
of food, except that when used in contact with fatty food of Types 
III, IV-A, V, VII-A, and IX described in Table 1 of Sec. 176.170(c) 
of this chapter, chlorinated polyethylene is limited to use only as 
a modifier admixed at levels not exceeding 15 weight percent in 
plastic articles prepared from polyvinyl chloride and/or from vinyl 
chloride copolymers complying with Sec. 177.1980.
This error was inadvertently introduced in the 1979 edition of title 
21. FDA is correcting this error.
     4. In the table in 21 CFR 178.3570(a)(3), the entry for 
``Phosphoric acid, mono- and diisooctyl esters, reacted with tert-alkyl 
and (C11-C14) primary amines'' is incorrect. The correct 
entry is ``Phosphoric acid, mono- and diisooctyl esters, reacted with 
tert-alkyl (C12-C14) primary amines.'' This error was 
inadvertently introduced when an amendment to 21 CFR 178.3570, which 
was published in the Federal Register of December 11, 1985 (50 FR 50611 
at 50612), and added this entry, was incorporated into the 1986 edition 
of title 21. FDA is correcting this error.
     5. In 21 CFR 179.45(b)(4)(i), (b)(6)(i), and (d)(2)(ii) through 
(d)(2)(iv), the cross-reference to ``paragraph (c)(2)(i) of this 
section'' is incorrect. The correct cross-reference is ``paragraph 
(d)(2)(i) of this section.'' This error was inadvertently introduced 
when an amendment to 21 CFR 179.45, which was published in the Federal 
Register of February 21, 1989 (54 FR 7404 at 7405), and redesignated 
paragraphs (c) and (d) as paragraphs (d) and (e), respectively, and 
added a new paragraph (c), was incorporated into the 1990 edition of 
title 21. FDA is correcting this error.
     6. In 21 CFR 184.1139, in the second sentence in paragraph (c)(2), 
the word ``good'' was inadvertently added between ``water'' and 
``additive'' when FDA amended the agency's GRAS regulations by adding a 
new Sec. 184.1139, which was published in the Federal Register of 
November 18, 1983 (48 FR 52438 at 52440). FDA is correcting this error.
     Publication of this document constitutes final action on these 
changes. FDA has determined that notice and public comment under 
section 409 of the Federal Food, Drug, and Cosmetic Act are unnecessary 
because these amendments to the agency's regulations simply correct 
various inadvertent errors introduced during the publication or 
republication process. By correcting these inadvertent errors, those 
who rely on these regulations (including the regulated industry) will 
be better able to understand and adhere to the requirements of the 
regulations. Accordingly, FDA concludes that good cause exists for 
proceeding directly to final rules here.

List of Subjects

21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.

21 CFR Parts 176, 177, and 178

    Food additives, Food packaging.

21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and recordkeeping requirements, Signs and 
symbols.

21 CFR Part 184

    Food ingredients.

     Therefore, under the Federal Food, Drug, and Cosmetic Act and 
under authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR parts 172, 176, 177, 178, 179, and 184 are amended as 
follows:

 PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

     1. The authority citation for 21 CFR part 172 continues to read as 
follows:

     Authority: Secs. 201, 401, 402, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 
379e).

Sec. 172.320  [Amended]

     2. Section 172.320 Amino acids is amended in paragraph (b)(1) by 
removing the first entry for ``L-Methionine'' and adding in its place 
``DL-Methionine''.

 PART 176--INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

     3. The authority citation for 21 CFR part 176 continues to read as 
follows:

     Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).

Sec. 176.170  [Amended]

     4. Section 176.170 Components of paper and paperboard in contact 
with aqueous and fatty foods is amended in the table in paragraph 
(a)(5), under the heading ``List of Substances,'' in the entry for 
``N,N-Bis(2-hydroxyethyl)alkyl (C12-C16)amide'' by removing 
the ``C16'' and adding in its place ``C18''.

 PART 177--INDIRECT FOOD ADDITIVES: POLYMERS

     5. The authority citation for 21 CFR part 177 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

Sec. 177.1610  [Amended]

     6. Section 177.1610 Polyethylene, chlorinated is amended in 
paragraph (a), in the second sentence, by removing the phrase ``as 
determined by the method in contact with all types of food, except that 
when used in contact with fatty food of Types III, IV-A, V, VII-A, and 
IX described in Table 1 of Sec. 176.170(c) of this chapter, chlorinated 
polyethylene is limited to use only as a modifier admixed at levels not 
exceeding 15 weight percent in plastic articles prepared from polyvinyl 
chloride and/or from vinyl chloride copolymers complying with 
Sec. 177.1980.'' and adding in its place the phrase ``as determined by 
the method described in Sec. 177.1520(d)(3)(ii).''; and by adding new 
paragraph (b) to read as follows:


Sec. 177.1610  Polyethylene, chlorinated.

 * * * * *
     (b) Chlorinated polyethylene may be used in contact with all types 
of food, except that when used in contact with fatty food of Types III, 
IV-A, V, VII-A, and IX described in Table 1 of Sec. 176.170(c) of this 
chapter, chlorinated polyethylene is limited to use only as a modifier 
admixed at levels not exceeding 15 weight percent in plastic articles 
prepared from polyvinyl chloride and/or from vinyl chloride copolymers 
complying with Sec. 177.1980.

 PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
SANITIZERS

     7. The authority citation for 21 CFR part 178 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 721 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 379e).

Sec. 178.3570   [Amended]

     8. Section 178.3570 Lubricants with incidental food contact is 
amended in the table in paragraph (a)(3), under the heading 
``Substances,'' in the entry for ``Phosphoric acid, mono- and 
diisooctyl esters, reacted with tert-alkyl and (C11-C14) 
primary amines'' by removing ``and (C11-C14)'' and adding in 
its place ``(C12-C14)''.

PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF 
FOOD

     9. The authority citation for 21 CFR part 179 continues to read as 
follows:

    Authority: Secs. 201, 402, 403, 409, 703, 704 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 348, 373, 
374).

Sec. 179.45  [Amended]

     10. Section 179.45 Packaging materials for use during the 
irradiation of prepackaged foods is amended in paragraphs (b)(4)(i), 
(b)(6)(i), and (d)(2)(ii) through (d)(2)(iv) by removing ``(c)(2)(i)'' 
and adding in its place ``(d)(2)(i)''wherever it appears.

PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

     11. The authority citation for 21 CFR part 184 continues to read 
as follows:

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

Sec. 184.1139  [Amended]

     12. Section 184.1139 Ammonium hydroxide is amended in paragraph 
(c)(2), in the second sentence, by removing the word ``good'' the first 
time it appears.

    Dated: March 22, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-7248 Filed 3-28-94; 8:45 am]
BILLING CODE 4160-01-F