[Federal Register Volume 84, Number 90 (Thursday, May 9, 2019)]
[Notices]
[Pages 20370-20371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09530]


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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; Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a final guidance for industry entitled ``Preparation of 
Food Contact Notifications for Food Contact Substances in Contact with 
Infant Formula and/or Human Milk.'' This guidance is intended to 
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: The announcement of the guidance is published in the Federal 
Register on May 9, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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 
https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to 
Division of Food Contact Notifications/Office of Food Additive Safety, 
Center for Food Safety and Applied Nutrition, 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 guidance.

FOR FURTHER INFORMATION CONTACT: Vanee Komolprasert, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-1217.

[[Page 20371]]


SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a 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 guidance consistent with our good guidance practices 
regulation (21 CFR 10.115). The guidance represents 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 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. This guidance is not subject to Executive 
Order 12866.
    Section 409 of the Federal Food, Drug, and Cosmetic Act (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.
    Pursuant to section 409(h) of the FD&C Act and FDA's implementing 
regulations \1\, 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 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 guidance, infant food is 
limited to infant formula and/or human milk, and this guidance focuses 
on infants 0-6 months in age. The guidance discusses our 
recommendations and provides information for: A. Chemistry 
Recommendations, including Migration Testing and Exposure Estimation; 
B. Toxicology Recommendations including Exposure Based Testing Tiers, 
Minimum Testing Recommendations, and Age Dependent Cancer Risk Analysis 
of Carcinogenic Constituents; and C. Administrative Recommendations 
including Acknowledgment of an FCN, Non-acceptance of an FCN, Final 
Letter, Inventory of Effective FCNs, and Premarket Notification 
Consultations (PNCs).
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    \1\ 21 CFR 170.101(a) (https://www.ecfr.gov/cgi-bin/text-idx?SID=56face021b3741c1fba7e997df53d3de&mc=true&node=pt21.3.170&rgn=div5#se21.3.170_1101).
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    In the Federal Register of December 9, 2016 (81 FR 89110), we 
announced a draft guidance for industry and gave interested parties an 
opportunity to submit comments by February 7, 2017, for us to consider 
before beginning work on the final version of the guidance. We received 
a few comments on the draft guidance and have modified the final 
guidance where appropriate. Changes to the guidance include modifying 
the Exposure Based Testing Tiers 2 and 3 to be consistent with FDA's 
``Guidance for Industry: Preparation of Food Contact Notifications for 
Food Contact Substances: Toxicology Recommendations. Specifically, the 
upper bound of Tier 2 now includes an exposure equal to or less than 
2.5 micrograms per kilogram of body weight per day ([micro]g/kg bw/day) 
and lower bound of Tier 3 is now greater than 2.5 [micro]g/kg bw/day. 
The guidance announced in this notice finalizes the draft guidance 
dated December 2016.

II. Paperwork Reduction Act of 1995

    This guidance contains 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). The 
collection of information in this guidance was approved under OMB 
control number 0910-0495.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: May 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09530 Filed 5-8-19; 8:45 am]
 BILLING CODE 4164-01-P