81 FR 39183 - Prior Notice of Imported Food Questions and Answers (Edition 3); Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 116 (June 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 116 (June 16, 2016)
| Page Range | 39183-39184 | |
| FR Document | 2016-14231 |
[Federal Register Volume 81, Number 116 (Thursday, June 16, 2016)] [Rules and Regulations] [Pages 39183-39184] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14231] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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] BILLING CODE P
![Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Rules and Regulations 39183
Order 7400.9Z, dated August 6, 2015, number of small entities under the DEPARTMENT OF HEALTH AND
and effective September 15, 2015, which criteria of the Regulatory Flexibility Act. HUMAN SERVICES
is incorporated by reference in 14 CFR
Environmental Review Food and Drug Administration
part 71.1. The Class E airspace
designations listed in this document The FAA has determined that this
will be published subsequently in the action qualifies for categorical exclusion 21 CFR Part 1
Order. under the National Environmental [Docket No. FDA–2011–N–0179]
Availability and Summary of Policy Act in accordance with FAA
Documents for Incorporation by Order 1050.1F, ‘‘Environmental Prior Notice of Imported Food
Reference Impacts: Policies and Procedures’’ Questions and Answers (Edition 3);
paragraph 5–6.5a. This airspace action Guidance for Industry; Availability
This document amends FAA Order is not expected to cause any potentially
7400.9Z, Airspace Designations and AGENCY: Food and Drug Administration,
significant environmental impacts, and HHS.
Reporting Points, dated August 6, 2015, no extraordinary circumstances exist
and effective September 15, 2015. FAA that warrant preparation of an ACTION: Notice of availability.
Order 7400.9Z is publicly available as environmental assessment.
listed in the ADDRESSES section of this SUMMARY: The Food and Drug
document. FAA Order 7400.9Z lists List of Subjects in 14 CFR Part 71 Administration (FDA or we) is
Class A, B, C, D, and E airspace areas, announcing the availability of a
air traffic service routes, and reporting Airspace, Incorporation by reference, guidance for industry entitled ‘‘Prior
points. Navigation (air). Notice of Imported Food Questions and
Answers (Edition 3): Guidance for
The Rule Adoption of the Amendment
Industry.’’ The guidance provides
This action amends Title 14, Code of In consideration of the foregoing, the updated information pertaining to prior
Federal Regulations (14 CFR), Part 71 by Federal Aviation Administration notice of imported food under the
amending Class E airspace at Little Rock amends 14 CFR part 71 as follows: Federal Food, Drug, and Cosmetic Act
Air Force Base (AFB), AR. The air traffic (the FD&C Act), as amended by the Food
control tower at Dennis Cantrell Field, PART 71—DESIGNATION OF CLASS A, Safety Modernization Act (FSMA) on
Conway, AR, has closed, and B, C, D, AND E AIRSPACE AREAS; AIR January 4, 2011. The guidance is
approaches cancelled. This action TRAFFIC SERVICE ROUTES; AND intended to help the food industry and
removes Dennis F. Cantrell Field, REPORTING POINTS others comply with prior notice
Conway, AR, from the airspace requirements.
designation and regulatory text for Little ■ 1. The authority citation for part 71 DATES: Submit either electronic or
Rock AFB, as they are no longer needed continues to read as follows: written comments on FDA guidances at
to define its boundaries. Additionally, Authority: 49 U.S.C. 106(f), 106(g); 40103, any time.
geographic coordinates for Little Rock 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, ADDRESSES: You may submit comments
AFB, are changed from (lat. 34°54′59″ 1959–1963 Comp., p. 389. as follows:
N., long. 92°08′47″ W.) to (lat. 34°55′03″
§ 71.1 [Amended] Electronic Submissions
N., long. 92°08′42″ W.) and Saline
County Airport, Benton, AR, ■ 2. The incorporation by reference in Submit electronic comments in the
coordinates are changed from (lat. 14 CFR 71.1 of FAA Order 7400.9Z, following way:
34°33′23″ N., long. 92°36′25″ W.) to (lat. Airspace Designations and Reporting • Federal eRulemaking Portal: http://
34°35′25″ N., long. 92°28′46″ W.). These Points, dated August 6, 2015, and www.regulations.gov. Follow the
minor adjustments reflect the current effective September 15, 2015, is instructions for submitting comments.
information in the FAA’s aeronautical amended as follows: Comments submitted electronically,
database. including attachments, to http://
Paragraph 6005 Class E Airspace Areas www.regulations.gov will be posted to
Regulatory Notices and Analyses Extending Upward From 700 Feet or More
Above the Surface of the Earth.
the docket unchanged. Because your
The FAA has determined that this comment will be made public, you are
regulation only involves an established * * * * * solely responsible for ensuring that your
body of technical regulations for which ASW AR E5 Little Rock, AR [Amended] comment does not include any
frequent and routine amendments are Little Rock AFB, AR confidential information that you or a
necessary to keep them operationally (Lat. 34°55′03″ N., long. 92°08′42″ W.) third party may not wish to be posted,
current, is non-controversial and Little Rock, Adams Field, AR such as medical information, your or
unlikely to result in adverse or negative (Lat. 34°43′46″ N., long. 92°13′29″ W.) anyone else’s Social Security number, or
comments. It, therefore: (1) Is not a Benton, Saline County Airport, AR confidential business information, such
‘‘significant regulatory action’’ under (Lat. 34°35′25″ N., long. 92°28′46″ W.) as a manufacturing process. Please note
Executive Order 12866; (2) is not a That airspace extending upward from 700 that if you include your name, contact
‘‘significant rule’’ under DOT feet above the surface bounded within a 20- information, or other information that
Regulatory Policies and Procedures (44 mile radius of Little Rock AFB, and within identifies you in the body of your
FR 11034; February 26, 1979); and (3) a 22-mile radius of Adams Field Airport and
within a 6.3-mile radius of Saline County
comments, that information will be
does not warrant preparation of a Airport. posted on http://www.regulations.gov.
jstallworth on DSK7TPTVN1PROD with RULES
regulatory evaluation as the anticipated • If you want to submit a comment
impact is so minimal. Since this is a Issued in Fort Worth, TX, on June 7, 2016. with confidential information that you
routine matter that only affects air traffic Walter Tweedy, do not wish to be made available to the
procedures and air navigation, it is Acting Manager, Operations Support Group, public, submit the comment as a
certified that this rule, when ATO Central Service Center. written/paper submission and in the
promulgated, does not have a significant [FR Doc. 2016–14071 Filed 6–15–16; 8:45 am] manner detailed (see ‘‘Written/Paper
economic impact on a substantial BILLING CODE 4910–13–P Submissions’’ and ‘‘Instructions’’).
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![39184 Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Rules and Regulations
Written/Paper Submissions electronic and written/paper comments 16, 2003, and May 3, 2004, respectively.
Submit written/paper submissions as received, go to http:// Both editions were issued as Level 1
follows: www.regulations.gov and insert the guidance documents under 21 CFR
• Mail/Hand delivery/Courier (for docket number, found in brackets in the 10.115. Consistent with FDA’s good
written/paper submissions): Division of heading of this document, into the guidance practices regulations (21 CFR
Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts 10.115(g)(2)), the Agency accepted
and Drug Administration, 5630 Fishers and/or go to the Division of Dockets comments, but implemented the
Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. documents immediately because it
• For written/paper comments 1061, Rockville, MD 20852. determined that prior public
Submit written requests for single participation was not feasible or
submitted to the Division of Dockets
copies of the guidance to the Office of appropriate.
Management, FDA will post your
Regulatory Affairs, Office of Food and In the Federal Register of March 31,
comment, as well as any attachments,
Feed Operations, Food and Drug 2014 (79 FR 17947), we made available
except for information submitted,
Administration, 10903 New Hampshire a draft guidance for industry entitled
marked and identified, as confidential,
Ave., Silver Spring, MD 20993. Send ‘‘Draft Guidance for Industry: Prior
if submitted as detailed in
two self-addressed adhesive labels to Notice of Imported Food Questions and
‘‘Instructions.’’
assist that office in processing your Answers (Edition 3)’’ and gave
Instructions: All submissions received
request. See the SUPPLEMENTARY interested parties an opportunity to
must include the Docket No. FDA–
INFORMATION section for electronic submit comments by May 30, 2014, for
2011–N–0179 for ‘‘Prior Notice of
access to the guidance. us to consider before beginning work on
Imported Food Questions and Answers
FOR FURTHER INFORMATION CONTACT: the final version of the guidance. We
(Edition 3): Guidance for Industry.’’
Received comments will be placed in Angel M. Suarez, Office of Regulatory carefully considered all comments
the docket and, except for those Affairs, Office of Food and Feed received when preparing the final
submitted as ‘‘Confidential Operations, Division of Food Defense guidance. No substantive changes were
Submissions,’’ publicly viewable at Targeting, Food and Drug made in finalizing the guidance. The
http://www.regulations.gov or at the Administration, Element Bldg., HFC– guidance announced in this notice
180, 12420 Parklawn Dr., Rockville, MD finalizes the draft guidance dated March
Division of Dockets Management
20857–20993, 866–521–2297. 2014.
between 9 a.m. and 4 p.m., Monday
through Friday. SUPPLEMENTARY INFORMATION:
II. Electronic Access
• Confidential Submissions—To I. Background Persons with access to the Internet
submit a comment with confidential
FDA is announcing the availability of may obtain the guidance at either http://
information that you do not wish to be
a guidance for industry entitled ‘‘Prior www.fda.gov/Food/Guidance
made publicly available, submit your
Notice of Imported Food Questions and Regulation/GuidanceDocuments
comments only as a written/paper
Answers (Edition 3): Guidance for RegulatoryInformation/default.htm or
submission. You should submit two Industry.’’ We are issuing this guidance http://www.regulations.gov. Use the
copies total. One copy will include the consistent with our good guidance FDA Web site listed in the previous
information you claim to be confidential practices regulation (21 CFR 10.115). sentence to find the most current
with a heading or cover note that states The guidance represents the current version of the guidance.
‘‘THIS DOCUMENT CONTAINS thinking of FDA on this topic. It does
CONFIDENTIAL INFORMATION.’’ The Dated: June 10, 2016.
not establish any rights for any person
Agency will review this copy, including Leslie Kux,
and is not binding on FDA or on the
the claimed confidential information, in public. You can use an alternative Associate Commissioner for Policy.
its consideration of comments. The approach if it satisfies the requirements [FR Doc. 2016–14231 Filed 6–15–16; 8:45 am]
second copy, which will have the of the applicable statutes and BILLING CODE P
claimed confidential information regulations.
redacted/blacked out, will be available Since publication of edition two of
for public viewing and posted on http:// the guidance, FDA has issued a final DEPARTMENT OF HOMELAND
www.regulations.gov. Submit both rule requiring the submission to FDA of SECURITY
copies to the Division of Dockets prior notice of food, including animal
Management. If you do not wish your feed, imported or offered for import into Coast Guard
name and contact information to be the United States (November 7, 2008, 73
made publicly available, you can FR 66294) and, in accordance with 33 CFR Part 100
provide this information on the cover section 304 of FSMA, a final rule [Docket Number USCG–2016–0322]
sheet and not in the body of your requiring the name of any country to
comments and you must identify this which an article has been refused entry RIN 1625–AA08
information as ‘‘confidential.’’ Any be reported in prior notices (May 30,
information marked as ‘‘confidential’’ Special Local Regulation; Cumberland
2013, 78 FR 32359). FDA is issuing a
will not be disclosed except in third edition of its prior notice guidance River, Mile 190.5 to 194.0; Nashville, TN
accordance with 21 CFR 10.20 and other to address questions received since AGENCY:Coast Guard, DHS.
applicable disclosure law. For more publication of the second edition, Temporary final rule; request for
ACTION:
information about FDA’s posting of clarify previous responses, update comments.
jstallworth on DSK7TPTVN1PROD with RULES
comments to public dockets, see 80 FR previous responses as appropriate to
56469, September 18, 2015, or access reflect the 2008 final rule, and include SUMMARY: The Coast Guard is
the information at: http://www.fda.gov/ information about the new prior notice establishing a special local regulation
regulatoryinformation/dockets/ information requirement created by for all waters of the Cumberland River
default.htm. FSMA. beginning at mile marker 190.5 and
Docket: For access to the docket to FDA issued the first and second ending at mile marker 194.0. This
read background documents or the editions of this guidance on December special local regulation is necessary to
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Document Created: 2016-06-16 00:37:25
Document Modified: 2016-06-16 00:37:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on FDA guidances at any time. | |
| 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. | |
| FR Citation | 81 FR 39183 |
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