Prior Notice of Imported Food Questions and Answers (Edition 3); Guidance for Industry; Availability, 39183-39184 [2016-14231]
Download as PDF
Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Rules and Regulations
Order 7400.9Z, dated August 6, 2015,
and effective September 15, 2015, which
is incorporated by reference in 14 CFR
part 71.1. The Class E airspace
designations listed in this document
will be published subsequently in the
Order.
Availability and Summary of
Documents for Incorporation by
Reference
This document amends FAA Order
7400.9Z, Airspace Designations and
Reporting Points, dated August 6, 2015,
and effective September 15, 2015. FAA
Order 7400.9Z is publicly available as
listed in the ADDRESSES section of this
document. FAA Order 7400.9Z lists
Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting
points.
jstallworth on DSK7TPTVN1PROD with RULES
The Rule
This action amends Title 14, Code of
Federal Regulations (14 CFR), Part 71 by
amending Class E airspace at Little Rock
Air Force Base (AFB), AR. The air traffic
control tower at Dennis Cantrell Field,
Conway, AR, has closed, and
approaches cancelled. This action
removes Dennis F. Cantrell Field,
Conway, AR, from the airspace
designation and regulatory text for Little
Rock AFB, as they are no longer needed
to define its boundaries. Additionally,
geographic coordinates for Little Rock
AFB, are changed from (lat. 34°54′59″
N., long. 92°08′47″ W.) to (lat. 34°55′03″
N., long. 92°08′42″ W.) and Saline
County Airport, Benton, AR,
coordinates are changed from (lat.
34°33′23″ N., long. 92°36′25″ W.) to (lat.
34°35′25″ N., long. 92°28′46″ W.). These
minor adjustments reflect the current
information in the FAA’s aeronautical
database.
Regulatory Notices and Analyses
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current, is non-controversial and
unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that only affects air traffic
procedures and air navigation, it is
certified that this rule, when
promulgated, does not have a significant
economic impact on a substantial
VerDate Sep<11>2014
13:07 Jun 15, 2016
Jkt 238001
39183
number of small entities under the
criteria of the Regulatory Flexibility Act.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Environmental Review
Food and Drug Administration
The FAA has determined that this
action qualifies for categorical exclusion
under the National Environmental
Policy Act in accordance with FAA
Order 1050.1F, ‘‘Environmental
Impacts: Policies and Procedures’’
paragraph 5–6.5a. This airspace action
is not expected to cause any potentially
significant environmental impacts, and
no extraordinary circumstances exist
that warrant preparation of an
environmental assessment.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for part 71
continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9Z,
Airspace Designations and Reporting
Points, dated August 6, 2015, and
effective September 15, 2015, is
amended as follows:
■
Paragraph 6005 Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
*
*
*
*
*
ASW AR E5 Little Rock, AR [Amended]
Little Rock AFB, AR
(Lat. 34°55′03″ N., long. 92°08′42″ W.)
Little Rock, Adams Field, AR
(Lat. 34°43′46″ N., long. 92°13′29″ W.)
Benton, Saline County Airport, AR
(Lat. 34°35′25″ N., long. 92°28′46″ W.)
That airspace extending upward from 700
feet above the surface bounded within a 20mile radius of Little Rock AFB, and within
a 22-mile radius of Adams Field Airport and
within a 6.3-mile radius of Saline County
Airport.
Issued in Fort Worth, TX, on June 7, 2016.
Walter Tweedy,
Acting Manager, Operations Support Group,
ATO Central Service Center.
[FR Doc. 2016–14071 Filed 6–15–16; 8:45 am]
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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.
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:
SUMMARY:
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’’).
E:\FR\FM\16JNR1.SGM
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39184
Federal Register / Vol. 81, No. 116 / Thursday, June 16, 2016 / Rules and Regulations
jstallworth on DSK7TPTVN1PROD with RULES
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
https://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 https://
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: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
VerDate Sep<11>2014
13:07 Jun 15, 2016
Jkt 238001
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 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
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
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 https://
www.fda.gov/Food/Guidance
Regulation/GuidanceDocuments
RegulatoryInformation/default.htm 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: June 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–14231 Filed 6–15–16; 8:45 am]
BILLING CODE P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket Number USCG–2016–0322]
RIN 1625–AA08
Special Local Regulation; Cumberland
River, Mile 190.5 to 194.0; Nashville, TN
Coast Guard, DHS.
Temporary final rule; request for
comments.
AGENCY:
ACTION:
The Coast Guard is
establishing a special local regulation
for all waters of the Cumberland River
beginning at mile marker 190.5 and
ending at mile marker 194.0. This
special local regulation is necessary to
SUMMARY:
E:\FR\FM\16JNR1.SGM
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Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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: 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'').
[[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 https://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 https://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: https://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 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 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 https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm 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: June 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14231 Filed 6-15-16; 8:45 am]
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