Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3); Availability, 17947 [2014-07046]

Download as PDF Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Proposed Rules § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9X, Airspace Designations and Reporting Points, dated August 7, 2013, and effective September 15, 2013, is amended as follows: ■ Paragraph 6005 Class E airspace areas extending upward from 700 feet or more above the surface of the earth. * * * AGL WI E5 * * Crandon, WI [New] Crandon/Steve Conway Municipal Airport, WI (Lat. 45°31′22″ N., long. 88°55′42″ W.) That airspace extending upward from 700 feet above the surface within a 7mile radius of Crandon/Steve Conway Municipal Airport. Issued in Fort Worth, TX, on March 21, 2014. Humberto D. Melendez, Acting Manager, Operations Support Group, ATO Central Service Center. [FR Doc. 2014–07125 Filed 3–28–14; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA–2011–N–0179] Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3); Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ‘‘Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3).’’ The draft guidance addresses questions received since the publication of the second edition of the guidance in May 2004 and includes information related to the Food Safety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 The draft guidance is intended to help the food industry and others comply with prior notice requirements.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 emcdonald on DSK67QTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 16:24 Mar 28, 2014 Jkt 232001 considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 30, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Regulatory Affairs, Office of Food and Feed Operations, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993.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 https:// 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 PO 00000 Frm 00008 Fmt 4702 Sfmt 9990 17947 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 https://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 https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://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 E:\FR\FM\31MRP1.SGM 31MRP1

Agencies

[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.

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

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 https://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 https://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 https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either https://www.fda.gov/FoodGuidances or https://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

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