[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Notices]
[Pages 37330-37332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15384]


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

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 Regarded 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 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 July 
31, 2014.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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; Submission of Information to a Master 
File in Support of Petitions; Electronic Submission Using Form FDA 
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. 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

[[Page 37331]]

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 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 generally regarded 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 FD&C Act, FDA has set forth procedures for 
the GRAS affirmation petition process in Sec.  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 Form FDA 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.
    In the Federal Register of April 16, 2014 (79 FR 21469) 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                                   Number of                              Average burden                   operating and
       21 CFR Section/FDA Form          Number of respondents    responses per   Total annual 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
Form FDA 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 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

[[Page 37332]]

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.  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 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15384 Filed 6-30-14; 8:45 am]
BILLING CODE 4164-01-P