[Federal Register Volume 68, Number 144 (Monday, July 28, 2003)]
[Notices]
[Pages 44342-44344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19075]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0106]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES:  Submit written comments on the collection of information by 
August 27, 2003.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974. 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 Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

[[Page 44343]]

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 (21 CFR part 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 part 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 for industry entitled 
``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.
    In the Federal Register of April 4, 2003 (68 FR 16517) FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the reporting 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        Annual Frequency     Total Annual        Hours per       and Maintenance      Total Hours
                                           Respondents        per Response        Responses           Response            Costs
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CAPS
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  70.25                                                 0                  1                  0                  0                  0                  0
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  71.1                                                  2                  1                  2              1,652             $5,600              3,304
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  FDA Form 3504                                         1                  1                  1                  1                  0                  1
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GRAS Affirmation Petitions
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  170.35                                                1                  1                  1              2,598  .................              2,598
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FAPs
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  171.1                                                 7                  1                  7              3,640  .................             25,480
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  FDA Form 3503                                         2                  1                  2                  1  .................                  2
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Total                                                                                                                          $5,600             31,385
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\1\ There are no capital costs associated with this collection of information.


[[Page 44344]]

    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. Sec.  70.25 and 
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: July 21, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-19075 Filed 7-25-03; 8:45 am]
BILLING CODE 4160-01-S