
[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Notices]
[Pages 60911-60913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25625]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0294]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Contact Substance Notification Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) 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 collection of information 
associated with the Food Contact Substance Notification Program.

DATES: Submit either electronic or written comments on the collection 
of information by December 7, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2012-N-0294 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Contact Substance 
Notification Program.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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, we are publishing this notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information

[[Page 60912]]

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.

Food Contact Substance Notification Program--21 CFR 170.101, 170.106, 
and 171.1

OMB Control Number 0910-0495--Extension

    Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 348(h)) establishes a premarket notification 
process for food contact substances. Section 409(h)(6) of the FD&C Act 
defines a ``food contact substance'' as ``any substance intended for 
use as a component of materials used in manufacturing, packing, 
packaging, transporting, or holding food if such use is not intended to 
have any technical effect in such food.'' Section 409(h)(3) of the FD&C 
Act requires that the notification process be used for authorizing the 
marketing of food contact substances except when: (1) We determine that 
the submission and premarket review of a food additive petition (FAP) 
under section 409(b) of the FD&C Act is necessary to provide adequate 
assurance of safety, or (2) we and the manufacturer or supplier agree 
that an FAP should be submitted. Section 409(h)(1) of the FD&C Act 
requires that a notification include: (1) Information on the identity 
and the intended use of the food contact substance, and (2) the basis 
for the manufacturer's or supplier's determination that the food 
contact substance is safe under the intended conditions of use.
    Sections 170.101 and 170.106 of FDA's regulations (21 CFR 170.101 
and 170.106) specify the information that a notification must contain 
and require that: (1) A food contact substance notification (FCN) 
includes Form FDA 3480, and (2) a notification for a food contact 
substance formulation includes Form FDA 3479. These forms serve to 
summarize pertinent information in the notification. The forms 
facilitate both preparation and review of notifications because the 
forms will serve to organize information necessary to support the 
safety of the use of the food contact substance. The burden of filling 
out the appropriate form has been included in the burden estimate for 
the notification.
    Currently, interested persons transmit an FCN submission to the 
Office of Food Additive Safety in the Center for Food Safety and 
Applied Nutrition using Form FDA 3480 whether it is submitted in 
electronic or paper format. We estimate that the amount of time for 
respondents to complete Form FDA 3480 will continue to be the same.
    In addition to its required use with FCNs, Form FDA 3480 is 
recommended to be used to organize information within a Pre-
notification Consultation or Master File submitted in support of an FCN 
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 FDA, thus minimizing paperwork burden for food contact 
substance authorizations. We estimate that the amount of time for 
respondents to complete the Form FDA 3480 for these types of 
submissions is 0.5 hours.
    Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the 
information that a petitioner must submit in order to: (1) Establish 
that the proposed use of an indirect food additive is safe, and (2) 
secure the publication of an indirect food additive regulation in parts 
175 through 178 (21 CFR parts 175 through 178). Parts 175 through 178 
describe the conditions under which the additive may be safely used.
    In addition, FDA's guidance document entitled ``Use of Recycled 
Plastics in Food Packaging: Chemistry Considerations,'' provides 
assistance to manufacturers of food packaging in evaluating processes 
for producing packaging from post-consumer recycled plastic. The 
recommendations in the guidance address the process by which 
manufacturers certify to us that their plastic products are safe for 
food contact.
    Description of Respondents: The respondents to this information 
collection are manufacturers of food contact substances.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                 Number of       Total       Average
   21 CFR section or other       FDA form No.     Number of    responses per     annual     burden per    Total
           category                              respondents    respondent     responses     response     hours
----------------------------------------------------------------------------------------------------------------
170.106 \2\ (Category A).....  FDA 3479........           10               2           20            2        40
170.101 \3 7\ (Category B)...  FDA 3480........            6               1            6           25       150
170.101 \4 7\ (Category C)...  FDA 3480........            6               2           12          120     1,440
170.101 \5 7\ (Category D)...  FDA 3480........           42               2           84          150    12,600
170.101 \6 7\ (Category E)...  FDA 3480........           38               1           38          150     5,700
Pre-notification Consultation  FDA 3480........          190               1          190          0.5        95
 or Master File (concerning a
 food contact substance)\8\.
Amendment to an existing       FDA 3480A.......          100               1          100          0.5        50
 notification (170.101),
 amendment to a Pre-
 notification Consultation,
 or amendment to a Master
 File (concerning a food
 contact substance)\9\.
171.1 Indirect Food Additive   N/A.............            1               1            1       10,995    10,995
 Petitions.
Use of Recycled Plastics in    N/A.............           10               1           10           25       250
 Food Packaging: Chemistry
 Considerations.
                              ----------------------------------------------------------------------------------
    Total....................  ................  ...........  ..............  ...........  ...........    31,320
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Notifications for food contact substance formulations and food contact articles. These notifications require
  the submission of Form FDA 3479 (``Notification for a Food Contact Substance Formulation'') only.
\3\ Duplicate notifications for uses of food contact substances.
\4\ Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive
  petitions.
\5\ Notifications for uses that are the subject of moderately complex food additive petitions.
\6\ Notifications for uses that are the subject of very complex food additive petitions.
\7\ These notifications require the submission of Form FDA 3480.

[[Page 60913]]

 
\8\ These notifications recommend the submission of Form FDA 3480.
\9\ These notifications recommend the submission of Form FDA 3480A.

    The estimates in table 1 are based on our current experience with 
the food contact substance notification program and informal 
communication with industry.
    Beginning in row 1, we estimate 10 respondents will submit 2 
notifications annually for food contact substance formulations (Form 
FDA 3479), for a total of 20 responses. We calculate a reporting burden 
of 2 hours per response, for a total of 40 hours. In row 2 we estimate 
six respondents. We believe the hourly burden for preparing these 
notifications will primarily consist of the manufacturer or supplier 
completing Form FDA 3480, verifying that a previous notification is 
effective, and preparing necessary documentation. We estimate one 
submission for each respondent, for a total of six responses. We 
calculate a reporting burden of 25 hours per response, for a total of 
150 hours.
    In rows 3, 4, and 5, we identify three tiers of FCNs that reflect 
different levels of burden applicable to the respective information 
collection items (denoted as Categories C, D, and E). We estimate 6 
respondents will submit 2 Category C submissions annually, for a total 
of 12 responses. We calculate a reporting burden of 120 hours per 
response, for a total burden of 1,440 hours. We estimate 42 respondents 
will submit 2 Category D submissions annually, for a total of 84 
responses. We calculate a reporting burden of 150 hours per response, 
for a total burden of 12,600 hours. We estimate 38 respondents will 
submit 1 Category E submission annually, for a total of 38 responses. 
We calculate a reporting burden of 150 hours per response, for a total 
burden of 5,700 hours.
    In row 6, we estimate 190 respondents will submit information to a 
pre-notification consultation or a master file in support of FCN 
submission using Form FDA 3480. We calculate a reporting burden of 0.5 
hours per response, for a total burden of 95 hours. In row 7 we 
estimate 100 respondents will submit an amendment (Form FDA 3480A) to a 
substantive or non-substantive request of additional information to an 
incomplete FCN submission, an amendment to a pre-notification 
consultation, or an amendment to a master file in support of an FCN. We 
calculate a reporting burden of 0.5 hours per response, for a total 
burden of 50 hours.
    In row 8, we estimate one respondent will submit one indirect food 
additive petition under Sec.  171.1, for a total of one response. We 
calculate a reporting burden of 10,995 hours per response, for a total 
burden of 10,995 hours.
    Finally, in row 9, we estimate 10 respondents will utilize the 
recommendations in the guidance document entitled, ``Use of Recycled 
Plastics in Food Packaging: Chemistry Considerations,'' to develop the 
additional information for one such submission annually, for a total of 
10 responses. We calculate a reporting burden of 25 hours per response, 
for a total burden of 250 hours.

    Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25625 Filed 10-7-15; 8:45 am]
 BILLING CODE 4164-01-P


