
[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Proposed Rules]
[Page 17947]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07046]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

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


Draft Guidance for Industry: Prior Notice of Imported Food 
Questions and Answers (Edition 3); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance entitled ``Guidance for Industry: 
Prior Notice of Imported Food Questions and Answers (Edition 3).'' The 
draft guidance addresses questions received since the publication of 
the second edition of the guidance in May 2004 and includes information 
related to the Food Safety Modernization Act (FSMA), which amended the 
Federal Food, Drug, and Cosmetic Act, to require the name of any 
country to which an article has been refused entry be reported in a 
prior notice. The draft guidance is intended to help the food industry 
and others comply with prior notice requirements.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 30, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Regulatory Affairs, Office of Food and Feed 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.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Anthony Taube, Office of Regulatory 
Affairs, Office of Food and Feed Operations, Division of Food Defense 
Targeting (HFC-180), Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20857, 866-521-2297.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Guidance for Industry: Prior Notice of Imported Food 
Questions and Answers (Edition 3).'' In the Federal Register of May 3, 
2004 (69 FR 24070), FDA issued a notice of availability of guidance 
entitled ``Questions and Answers Regarding the Interim Final Rule on 
Prior Notice of Imported Food (Edition 2).'' Since publication of 
edition 2 of the guidance, we have 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 (73 FR 66294; 
November 7, 2008) 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 (78 FR 32359; May 30, 2013). 
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 and 2013 final rules, and include information about the new 
prior notice information requirement created by FSMA.
    The Agency continues to believe that it is reasonable to maintain 
responses to questions concerning prior notice of imported food in a 
single document that is periodically updated in response to additional 
questions and/or regulatory changes. As in the previous edition, the 
following indicators are used to help users identify revisions: (1) The 
guidance is identified as a revision of a previously issued document; 
(2) the revision date appears on the cover of the guidance; (3) the 
edition number of the guidance is included in its title; and (4) 
revised or added questions and answers are identified as such in the 
body of the guidance.
    This draft guidance is being issued consistent with our good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent our current thinking on this topic. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
the draft guidance to http://www.regulations.gov or written comments to 
the Division of Dockets Management (see ADDRESSES). It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

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 site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: March 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07046 Filed 3-28-14; 8:45 am]
BILLING CODE 4160-01-P


