
[Federal Register: June 14, 2010 (Volume 75, Number 113)]
[Notices]               
[Page 33624-33626]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jn10-60]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
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.

-----------------------------------------------------------------------

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, submission of information to a 
Master File in support of petitions, and electronic submission using 
FDA Form 3503. This notice also notifies the public of and solicits 
comments on FDA's proposed changes to Form FDA 3503 and elimination of 
Form FDA 3504.

DATES: Submit either electronic or written comments on the collection 
of information by August 13, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 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; 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 (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 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 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 of the agency's 
regulations (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.
    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 act (21 U.S.C. 321(s)), 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

[[Page 33625]]

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. 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 an 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 Form 
FDA 3504 redundant 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                         No. of     Annual Frequency    Total Annual       Hours  per          Total Operating  &
      21 CFR Section/  FDA Form       Respondents     per Response        Responses         Response           Maintenance Costs          Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CAPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
  70.25,71                                      2                   1               2               1,337                     $5,600               2,674
--------------------------------------------------------------------------------------------------------------------------------------------------------
GRAS Affirmation Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
  170.35                               1 or fewer                   1      1 or fewer               2,614                          0               2,614
--------------------------------------------------------------------------------------------------------------------------------------------------------
FAPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
  171.1                                         3                   1               3               7,093                          0              21,279
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Form 3503                                   6                   1               6                   1                          0                   6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                         $5,600              26,573
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 four 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 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 2 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 act and other specific labeling acts administered by 
FDA. Label information

[[Page 33626]]

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, 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: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14155 Filed 6-11-10; 8:45 am]
BILLING CODE 4160-01-S

