[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]
BILLING CODE 4160-01-F
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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
