
[Federal Register: August 30, 2010 (Volume 75, Number 167)]
[Notices]               
[Page 52954-52956]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au10-70]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0258]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Submission of 
Petitions: Food Additive, Color Additive (Including Labeling), and 
Generally Recognized as Safe Affirmation; Submission of Information to 
a Master File in Support of Petitions; Electronic Submission Using Food 
and Drug Administration Form 3503

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: Fax written comments on the collection of information by 
September 29, 2010.

ADDRESSES:  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: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0016. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 Generally Recognized as Safe Affirmation; Submission of 
Information to a Master File in Support of Petitions; Electronic 
Submission Using FDA Form 3503--21 CFR 70.25, 71.1, 170.35, 171.1, 172, 
173, 179, and 180 (OMB Control Number 0910-0016)--Revision

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C 
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 
FD&C 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 FD&C 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 of FDA's regulations (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 FD&C 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 FD&C 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 of the agency's 
regulations (21 CFR 71.1) specifies the information that a

[[Page 52955]]

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.
    FDA scientific personnel review FAPs to ensure the safety of the 
intended use of the additive in or on food or that may be present in 
food as a result of its use in articles that contact food. Likewise, 
FDA personnel review color additive petitions to ensure the safety of 
the color additive prior to its use in food, drugs, cosmetics, or 
medical devices.
    Under section 201(s) of the FD&C Act (21 U.S.C. 321(s)), a 
substance is Generally Recognized as Safe (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 FD&C 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 FD&C 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) of its regulations (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 and is not expecting any during the period covered 
by this proposed extension of collection of information.
    Currently, interested persons may transmit regulatory submissions 
to the Office of Food Additive Safety in the Center for Food Safety and 
Applied Nutrition using Form FDA 3503 for FAP and Form FDA 3504 for 
CAP. FDA is revising Form FDA 3503 to better enable its use for 
electronic submission and to permit its use for multiple types of 
submissions, which eliminates the need for Form FDA 3504. Because Form 
FDA 3503 helps the respondent organize their submission to focus on the 
information needed for FDA's safety review, FDA now recommends that 
this form be used for FAPs and CAPs, whether submitted in electronic 
format or paper format. FDA estimates that the amount of time for 
respondents to complete the revised FDA Form 3503 will continue to be 1 
hour. The revised Form FDA 3503 can be used to submit information to 
FDA in electronic format using the Electronic Submission Gateway 
portal. The revised Form FDA 3503 can be used to substitute for the 
``Dear Sir'' section of 21 CFR 71.1(c) for a CAP and 21 CFR 171.1(c) 
for a FAP. The revised Form FDA 3503 provides for submitters to 
indicate the date of their most recent presubmission consultation 
activity with FDA. The revised Form FDA 3503 can also be used to 
organize information within a Master File submitted in support of 
petitions according to the items listed on the form. Master Files can 
be used as repositories for information that can be referenced in 
multiple submissions to the Agency, thus minimizing paperwork burden 
for food and color additive approvals. The revised Form FDA 3503 is 
formatted to accept submissions for both FAP and CAP, thus making 
redundant Form FDA 3504 for collecting CAP submissions. Therefore, FDA 
is eliminating Form FDA 3504.
    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.
    In the Federal Register of June 14, 2010 (75 FR 33624), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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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70.25, 71.1                                                2                     1               2           1,337                $5,600           2,674
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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                                                      3                     1               3           7,093                     0          21,279
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FDA Form 3503                                              6                     1               6               1                     0               6
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Total                                                                                                                             $5,600          26,573
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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 2006, 2007, 2008, 
and 2009, 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 4 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

[[Page 52956]]

$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 one Category A and one Category B color additive 
petition is 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. Because an average of 
two color additive petitions are expected per calendar year, the 
estimated total annual cost burden to petitioners for this startup cost 
would be less than or equal to $5,600 (1 x $2,600 + 1 x $3,000 listing 
fees = $5,600). There are no capital costs associated with color 
additive petitions.
    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 FD&C 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, 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.

    Dated: August 19, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-21388 Filed 8-27-10; 8:45 am]
BILLING CODE 4160-01-S

