[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)]
[Rules and Regulations]
[Pages 39183-39184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14231]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0179]


Prior Notice of Imported Food Questions and Answers (Edition 3); 
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 guidance for industry entitled ``Prior Notice of 
Imported Food Questions and Answers (Edition 3): Guidance for 
Industry.'' The guidance provides updated information pertaining to 
prior notice of imported food under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), as amended by the Food Safety 
Modernization Act (FSMA) on January 4, 2011. The guidance is intended 
to help the food industry and others comply with prior notice 
requirements.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

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'').

[[Page 39184]]

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-2011-N-0179 for ``Prior Notice of Imported Food Questions and 
Answers (Edition 3): Guidance for Industry.'' 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 guidance to the 
Office of Regulatory Affairs, Office of Food and Feed Operations, Food 
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 
20993. 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: Angel M. Suarez, Office of Regulatory 
Affairs, Office of Food and Feed Operations, Division of Food Defense 
Targeting, Food and Drug Administration, Element Bldg., HFC-180, 12420 
Parklawn Dr., Rockville, MD 20857-20993, 866-521-2297.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Prior Notice of Imported Food Questions and Answers (Edition 
3): Guidance for Industry.'' We are issuing this 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 on 
the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    Since publication of edition two of the guidance, FDA has issued a 
final rule requiring the submission to FDA of prior notice of food, 
including animal feed, imported or offered for import into the United 
States (November 7, 2008, 73 FR 66294) and, in accordance with section 
304 of FSMA, a final rule requiring the name of any country to which an 
article has been refused entry be reported in prior notices (May 30, 
2013, 78 FR 32359). FDA is issuing a third edition of its prior notice 
guidance to address questions received since publication of the second 
edition, clarify previous responses, update previous responses as 
appropriate to reflect the 2008 final rule, and include information 
about the new prior notice information requirement created by FSMA.
    FDA issued the first and second editions of this guidance on 
December 16, 2003, and May 3, 2004, respectively. Both editions were 
issued as Level 1 guidance documents under 21 CFR 10.115. Consistent 
with FDA's good guidance practices regulations (21 CFR 10.115(g)(2)), 
the Agency accepted comments, but implemented the documents immediately 
because it determined that prior public participation was not feasible 
or appropriate.
    In the Federal Register of March 31, 2014 (79 FR 17947), we made 
available a draft guidance for industry entitled ``Draft Guidance for 
Industry: Prior Notice of Imported Food Questions and Answers (Edition 
3)'' and gave interested parties an opportunity to submit comments by 
May 30, 2014, for us to consider before beginning work on the final 
version of the guidance. We carefully considered all comments received 
when preparing the final guidance. No substantive changes were made in 
finalizing the guidance. The guidance announced in this notice 
finalizes the draft guidance dated March 2014.

II. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: June 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14231 Filed 6-15-16; 8:45 am]
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