
[Federal Register Volume 79, Number 73 (Wednesday, April 16, 2014)]
[Notices]
[Pages 21469-21471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08590]


=======================================================================
-----------------------------------------------------------------------

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

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.

DATES: Submit either electronic or written comments on the collection 
of information by June 16, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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)--Extension

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the 
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.

[[Page 21470]]

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 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 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 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 CAPs 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 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 
FD&C Act, FDA has set forth procedures for the GRAS affirmation 
petition process in 21 CFR 170.35(c)(1) of its regulations. 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.
    Interested persons may transmit FAP or CAP regulatory submissions 
in electronic format or paper format to the Office of Food Additive 
Safety in the Center for Food Safety and Applied Nutrition using Form 
FDA 3503. Form FDA 3503 helps the respondent organize their submission 
to focus on the information needed for FDA's safety review. 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. FDA estimates 
that the amount of time for respondents to complete FDA Form 3503 will 
continue to be 1 hour.
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                             Number of       Number of     Total annual   Average burden                   operating and
                 21 CFR Section/FDA Form                    respondents    responses per     responses     per response     Total hours     maintenance
                                                                            respondent                                                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  CAPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.25, 71.1.............................................               2               1               2           1,337           2,674          $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       GRAS Affirmation Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.35..................................................      1 or fewer               1      1 or fewer           2,614           2,614               0
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  FAPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1...................................................               3               1               3           7,093          21,279               0
FDA Form 3503...........................................               6               1               6               1               6               0
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............          26,573          $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The estimate of burden for food additive, color additive, or GRAS 
affirmation petitions is based on FDA's experience with the petition 
process. FDA is retaining its prior estimate of the number of petitions 
received because the average number of petitions received annually has 
varied little over the past 10 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

[[Page 21471]]

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 Sec.  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 start-up 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.  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: April 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08590 Filed 4-15-14; 8:45 am]
BILLING CODE 4160-01-P


