[Federal Register Volume 68, Number 65 (Friday, April 4, 2003)]
[Notices]
[Pages 16517-16519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-8265]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0106]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Submission of Petitions: Food Additive, Color Additive 
(Including Labeling), and Generally Recognized as Safe Affirmation; and 
Electronic Submission Using FDA Forms 3503 and 3504

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the

[[Page 16518]]

Paperwork Reduction Act of 1995 (the PRA), Federal agencies are 
required to publish notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
of an existing collection of information, and to allow 60 days for 
public comment in response to the notice. This notice solicits comments 
on a proposed consolidation of four existing submissions of petitions.

DATES: Submit written or electronic comments on the collection of 
information by June 3, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Submission of Petitions: Food Additive, Color Additive (Including 
Labeling), and GRAS Affirmation; Electronic Submission Using FDA Forms 
3503 and 3504 (OMB Control Number 0910-0016)--Extension

    This notice solicits comments on a proposed collection of the 
following four existing submissions of petitions: (1) Food Additive and 
Food Additive Petitions (FAPs) (OMB Control Number 0910-0016), (2) 
Affirmation of Generally Recognized as Safe (GRAS) Status (OMB Control 
Number 0910-0132), (3) Labeling Requirements for Color Additives (Other 
Than Hair Dyes) and Petitions (CAPs) (OMB Control Number 0910-0185), 
and (4) Electronic Submission of Food and Color Additive Petitions (OMB 
Control Number 0910-0480).
    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed 
to be unsafe, unless: (1) The additive and its use, or intended use, 
are in conformity with a regulation issued under section 409 of the act 
that describes the condition(s) under which the additive may be safely 
used; (2) the additive and its use, or intended use, conform to the 
terms of an exemption for investigational use; or (3) a food contact 
notification submitted under section 409(h) of the act is effective. 
FAPs are submitted by individuals or companies to obtain approval of a 
new food additive or to amend the conditions of use permitted under an 
existing food additive regulation. Section 171.1 (21 CFR 171.1) 
specifies the information that a petitioner must submit in order to 
establish that the proposed use of a food additive is safe and to 
secure the publication of a food additive regulation describing the 
conditions under which the additive may be safely used. Parts 172, 173, 
175 through 178, and 180 (21 CFR parts 172, 173, 175 through 178, and 
180) contain labeling requirements for certain food additives to ensure 
their safe use.
    Section 721(a) of the act (21 U.S.C. 379e(a)) provides that a color 
additive shall be deemed to be unsafe unless the additive and its use 
are in conformity with a regulation that describes the condition(s) 
under which the additive may safely be used, or the additive and its 
use conform to the terms of an exemption for investigational use issued 
under section 721(f) of the act. CAPs are submitted by individuals or 
companies to obtain approval of a new color additive or a change in the 
conditions of use permitted for a color additive that is already 
approved. Section 71.1 specifies the information that a petitioner must 
submit in order to establish the safety of a color additive and to 
secure the issuance of a regulation permitting its use. FDA's color 
additive labeling requirements in Sec.  70.25 (21 CFR 70.25) require 
that color additives that are to be used in food, drugs, devices, or 
cosmetics be labeled with sufficient information to ensure their safe 
use.
    Under authority of sections 201, 402, 409, and 701 of the act (21 
U.S.C. 321, 342, 348, and 371), FDA reviews petitions for affirmation 
as GRAS that are submitted on a voluntary basis by the food industry 
and other interested parties. Specifically under section 201(s) of the 
act, a substance is GRAS if it is generally recognized among experts 
qualified by scientific training and experience to evaluate its safety, 
to be safe through either scientific procedures or common use in food. 
The act has historically been interpreted to permit food manufacturers 
to make their own determination that use of a substance in food is 
GRAS. To implement the GRAS provisions of the act, FDA has issued 
procedural regulations under 21 CFR 170.35(c)(1).
    In the Federal Register of July 31, 2001 (66 FR 39517), FDA 
announced the availability of a draft guidance entitled ``Draft 
Guidance for Industry on Providing Regulatory Submissions to Office of 
Food Additive Safety in Electronic Format for Food Additive and Color 
Additive Petitions.'' This guidance describes the procedures for 
electronic submission of FAPs and CAPs using FDA Form No. 3503 entitled 
``Food Additive Petition Submission Application'' and FDA Form No. 3504 
entitled ``Color Additive Petition Submission Application.''
    FDA scientific personnel review food and color additive and GRAS 
affirmation petitions to ensure the safety of the intended use of the 
substance in or on food, or of a food additive that may be present in 
food as a result of its use in articles that contact food (or for color 
additives, its use in food, drugs, cosmetics, or medical devices). 
Respondents are businesses engaged in the manufacture or sale of food, 
food ingredients, color additives, or substances used in materials that 
come into contact with food.

[[Page 16519]]

    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                                                       Total Operating
        21 CFR Section/FDA Form         No. of Respondents  Annual Frequency      Total Annual        Average Hours     & Maintenance      Total Hours
                                                              per Response          Responses         per Response          Costs
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CAPs                                    ..................  ................  ....................  ................  ................  ................
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  70.25                                          0                 1                   0                   0                 0                 0
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                                                 2                 1                   2               1,652            $5,600             3,304
  71.1
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                                                 1                 1                   1                   1                 0                 1
  FDA Form 3504
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GRAS Affirmation Petitions              ..................  ................  ....................  ................  ................  ................
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                                                 1                 1                   1               2,598          ................     2,598
  170.35
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FAPs                                    ..................  ................  ....................  ................  ................  ................
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                                                 7                 1                   7               3,640          ................    25,480
  171.1
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                                                 2                 1                   2                   1          ................         2
  FDA Form 3503
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Total                                   ..................  ................  ....................  ................    $5,600            31,385
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimate of burden for FAPs and CAPs is based on the average 
number of new FAPs and CAPs received in calendar years 2000 through 
2002 and the total hours expended in preparing the petitions. Although 
the burden varies with the type of petition submitted, an average FAP 
or CAP, or GRAS affirmation petition, involves analytical work and 
appropriate toxicological studies, as well as the work of drafting the 
petition itself. The burden varies depending on the complexity of the 
petition, including the amount and types of data needed for scientific 
analysis.
    Electronic submissions of petitions contain the same petition 
information required for paper submission. The agency estimates that up 
to 30 percent of the petitioners for both food and color additives will 
take advantage of the electronic submission process. By using the 
guidelines and forms that FDA is providing, the petitioner will be able 
to organize the petition to focus on the information needed for FDA's 
safety review. Therefore, we estimate that petitioners will only need 
to spend approximately 1 hour completing the electronic submission 
application form (Form 3503 or 3504, as appropriate) because they will 
have already used the guidelines to organize the petition information 
needed for the submission.
    The labeling requirements for food and color additives were 
designed to specify the minimum information needed for labeling in 
order that food and color manufacturers may comply with all applicable 
provisions of the act and other specific labeling acts administered by 
FDA. Label information does not require any additional information 
gathering beyond what is already required to assure conformance with 
all specifications and limitations in any given food or color additive 
regulation. Label information does not have any specific recordkeeping 
requirements unique to preparing the label. Therefore, because labeling 
requirements under Sec.  70.25 for a particular color additive involve 
information required as part of the CAP safety review process, the 
estimate for number of respondents is the same for Sec.  70.25 and 
Sec.  71.1, and the burden hours for labeling are included in the 
estimate for Sec.  71.1. Also, because labeling requirements under 
parts 172, 173, 175 through 178, and 180 for particular food additives 
involve information required as part of the FAP safety review process 
under Sec.  171.1, the burden hours for labeling are included in the 
estimate for Sec.  171.1.

    Dated: March 31, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-8265 Filed 4-3-03; 8:45 am]
BILLING CODE 4160-01-S