[Federal Register Volume 72, Number 12 (Friday, January 19, 2007)]
[Notices]
[Pages 2533-2535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-681]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0014]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Submission of Petitions: Food Additive, Color Additive 
(Including Labeling), and Generally Recognized as Safe Affirmation; 
Electronic Submission Using Food and Drug Administration 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 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 the information collection 
provisions of FDA's regulations for submission of petitions, including 
food and color additive petitions (including labeling) and generally 
recognized as safe (GRAS) affirmations, and electronic submission using 
FDA Forms 3503 and 3504. This notice also notifies the public of, and 
solicits comments on, FDA's proposal to transfer the collection of 
information and burden associated with petitions submitted to amend the 
indirect food additive regulations from the subject collection of 
information Office of Management and Budget (OMB) control number 0910-
0016 to the collection of information for the Food Contact Substances 
Notification System (OMB control number 0910-0495).

DATES: Submit written or electronic comments on the collection of 
information by March 20, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(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: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from 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 these topics: (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--21 CFR 70.25, 71.1, 170.35, 171.1, 172, 173, 179, and 
180 (OMB Control Number 0910-0016)--Extension

    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. 
Food additive petitions (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, 179, and 180 (21 CFR parts 172, 173, 179, 
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. Color additive petitions (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 71.1) specifies 
the information that a petitioner must submit 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 section 201(s) of the act (21 U.S.C. 321(s)), a substance is 
GRAS if it is generally recognized among experts

[[Page 2534]]

qualified by scientific training and experience to evaluate its safety, 
to be safe through either scientific procedures or common use in food. 
The act historically has been interpreted to permit food manufacturers 
to make their own initial determination that use of a substance in food 
is GRAS and thereafter seek affirmation of GRAS status from FDA. FDA 
reviews petitions for affirmation of GRAS status that are submitted on 
a voluntary basis by the food industry and other interested parties 
under authority of sections 201, 402, 409, and 701 of the act (21 
U.S.C. 321, 342, 348, and 371). To implement the GRAS provisions of the 
act, FDA has set forth procedures for the GRAS affirmation petition 
process in Sec.  170.35(c)(1) (21 CFR 170.35(c)(1)). While the GRAS 
affirmation petition process still exists, FDA has not received a GRAS 
affirmation petition since the establishment of the voluntary GRAS 
notification program.
    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 3503 and FDA Form 
3504, respectively.
    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).
    Description of respondents: 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                           No. of       Annual Frequency   Total Annual    Hours per    Total Operating and
               21 CFR Section/FDA Form                  Respondents       per Response       Responses     Response      Maintenance Costs   Total Hours
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CAPs
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70.25, 71.1                                                         3                   1             3         1,337                $8,200        4,010
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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 or fewer                   1    1 or fewer         2,614                     0        2,614
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FAPs
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171.1                                                               6                   1             6         7,093                     0       42,560
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FDA Form 3503                                                       1                   1             1             1                     0            1
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Total                                                                                                                                $8,200       49,186
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\1\There are no capital costs associated with this collection of information.

    The estimate of burden for food additive, color additive, or GRAS 
affirmation petitions is based on FDA's experience and the average 
number of new petitions received in calendar years 2003, 2004, and 
2005, and the total hours expended in preparing the petitions. In 
compiling these estimates, FDA consulted its records of the number of 
petitions received in the past 3 years. The figures for hours per 
response are based on estimates from experienced persons in the agency 
and in industry. Although the estimated hour burden varies with the 
type of petition submitted, an average 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.
    Color additives are subjected to payment of fees for the 
petitioning process. The listing fee for a color additive petition 
ranges from $1,600 to $3,000, depending on the intended use of the 
color and the scope of the requested amendment. A complete schedule of 
fees is set forth in 21 CFR 70.19. An average of two category A and one 
category B color additive petitions are expected per year. The maximum 
color additive petition fee for a category A petition is $2,600 and the 
maximum color additive petition fee for a category B petition is 
$3,000. Since an average of three color additive petitions are expected 
per calendar year, the estimated total annual cost burden to 
petitioners for this start-up cost would be less than or equal to 
$8,200 ((2 x $2,600) + (1 x $3,000) = $8,200). There are no capital 
costs associated with color additive petitions.
    The estimated burden reported in table 1 of this document does not 
include the previously estimated burden for the preparation of FAPs 
submitted to amend parts 175 throuhg 178 (21 CFR parts 175 through 
178). The burden to respondents is similar between the preparation of 
petitions submitted to amend parts 175 through 178 and the preparation 
of a food contact substance notification. In this request for extension 
of OMB approval for the collection of information for FAPs, FDA 
proposes to transfer the collection of information and burden 
associated with petitions submitted to amend the indirect food additive 
regulations (parts 175 through 178) from this collection of information 
(OMB control number 0910-0016) to the existing collection of 
information for the Food Contact Substances Notification System (OMB 
control number 0910-0495).
    FDA estimates the annual reporting burden associated with petitions 
submitted to amend parts 175 through 178 to be transferred from OMB 
control number 0910-0016 to OMB control number 0910-0495. An average of 
two indirect food additive petitions are expected per calendar year. 
The estimated total annual hour burden to

[[Page 2535]]

petitioners per petition is 10,995 hours, for a total burden of 21,990 
hours. There are no capital costs or operating and maintenance costs 
associated with the burden hours being transferred from OMB control 
number 0910-0016 to OMB control number 0910-0495.
    Electronic submissions of petitions contain the same petition 
information required for paper submissions. The agency estimates that 
one petitioner for both food and color additives will take advantage of 
the electronic submission process per year. 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 under 
Sec.  70.25, labeling requirements 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, 179, 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.
    In cases where a regulation implements a statutory information 
collection requirement, only the additional burden attributable to the 
regulation, if any, has been included in FDA's burden estimate.

    Dated: January 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-681 Filed 1-18-07; 8:45 am]
BILLING CODE 4160-01-S