[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
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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