
[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89110-89112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29587]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1814]


Preparation of Food Contact Notifications for Food Contact 
Substances in Contact With Infant Formula and/or Human Milk; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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[[Page 89111]]

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Preparation of 
Food Contact Notifications for Food Contact Substances in Contact with 
Infant Formula and/or Human Milk.'' The draft guidance, when finalized, 
will provide industry with our current thinking on how to prepare a 
food contact notification (FCN) submission for our review and 
evaluation of the safety of food contact substances (FCSs) used in 
contact with infant formula and/or human milk.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on the draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
February 7, 2017.

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-2016-D-1814 for ``Preparation of Food Contact Notifications for 
Food Contact Substances in Contact with Infant Formula and/or Human 
Milk.'' 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.
    Submit written requests for single copies of the draft guidance to 
the Division of Food Contact Notifications, Office of Food Additive 
Safety, Center for Food Safety and Applied Nutrition (HFS-275), Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Kelly Randolph, Center for Food Safety 
and Applied Nutrition (HFS-275), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740, 240-402-1188.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Preparation of Food Contact Notifications for Food Contact 
Substances in Contact with Infant Formula and/or Human Milk.'' We are 
issuing the draft guidance consistent with our good guidance practices 
regulation (21 CFR 10.115). The draft guidance, when finalized, will 
represent the current thinking of FDA on this topic. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternate approach if it satisfies the 
requirements of the applicable statutes and regulations.
    Section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 348) establishes an FCN process as the primary method 
by which we regulate food additives that are FCSs. As defined in 
section 409(h)(6) of the FD&C Act, the term ``food contact substance'' 
means 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.
    Under section 409(h) of the FD&C Act and FDA's implementing 
regulations, FCN submissions must contain a comprehensive discussion of 
the basis for the manufacturer's or supplier's determination that the 
use of the FCS that is the subject of the notification is safe. This 
draft guidance contains recommendations regarding how the scientific 
information in FCNs for infant food use should demonstrate that the FCS 
is safe for the specific intended use in contact with infant food. For 
purposes of the draft guidance, infant food is limited to infant 
formula and/or human milk, and this draft guidance focuses on infants 
0-6 months in age. The draft guidance discusses our

[[Page 89112]]

recommendations and provides information for: Chemistry 
recommendations, including migration testing and exposure estimation; 
toxicology recommendations including exposure-based testing tiers, 
minimum testing recommendations, and age-dependent cancer risk analysis 
of carcinogenic constituents; and administrative recommendations 
including acknowledgment of an FCN, non-acceptance of an FCN, final 
letter, inventory of effective FCNs, and premarket notification 
consultations.

II. Paperwork Reduction Act of 1995

    This draft guidance contains proposed information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). ``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. Federal law at 44 U.S.C. 3506(c)(2)(A) 
requires Federal Agencies to publish a 60-day notice in the Federal 
Register for each proposed collection of information before submitting 
the collection to OMB for approval. To comply with this requirement, we 
will publish a 60-day notice of the proposed collection of information 
in a future issue of the Federal Register.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web sites listed in the previous 
sentence to find the most current version of the guidance.

    Dated: December 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29587 Filed 12-8-16; 8:45 am]
 BILLING CODE 4164-01-P


