Mitigation Strategies To Protect Food Against Intentional Adulteration: What You Need To Know About the Food and Drug Administration Regulation: Small Entity Compliance Guide; Availability, 40484-40485 [2017-18028]
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Federal Register / Vol. 82, No. 164 / Friday, August 25, 2017 / Rules and Regulations
(viii) Messier-Bugatti-Dowty Service
Bulletin 631–32–219, dated March 3, 2014,
which was incorporated by reference on
December 29, 2015 (80 FR 73096, November
24, 2015).
(ix) Messier-Bugatti-Dowty Service Bulletin
631–32–220, dated March 3, 2014, which was
incorporated by reference on December 29,
2015 (80 FR 73096, November 24, 2015).
(x) Messier-Bugatti-Dowty Service Bulletin
631–32–232, dated December 8, 2014, which
is not incorporated by reference in this AD.
pmangrum on DSK3GDR082PROD with RULES
(r) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Section, Transport Standards Branch, FAA,
has the authority to approve AMOCs for this
AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal
inspector or local Flight Standards District
Office, as appropriate. If sending information
directly to the manager of the International
Branch, send it to the attention of the person
identified in paragraph (s)(2) of this AD.
Information may be emailed to: 9-ANM-116AMOC-REQUESTS@faa.gov.
(i) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(ii) AMOCs approved previously for AD
2015–23–12 are approved as AMOCs for the
corresponding provisions of this AD.
(2) Contacting the Manufacturer: As of the
effective date of this AD, for any requirement
in this AD to obtain corrective actions from
a manufacturer, the action must be
accomplished using a method approved by
the Manager, International Section, Transport
Standards Branch, FAA; or the EASA; or
´
ATR—GIE Avions de Transport Regional’s
EASA DOA. If approved by the DOA, the
approval must include the DOA-authorized
signature.
(s) Related Information
(1) Refer to Mandatory Continuing
Airworthiness Information (MCAI) EASA
Airworthiness Directive 2016–0135, dated
July 8, 2016, for related information. This
MCAI may be found in the AD docket on the
Internet at https://www.regulations.gov by
searching for and locating Docket No. FAA–
2017–0516.
(2) For more information about this AD,
contact Shahram Daneshmandi, Aerospace
Engineer, International Section, Transport
Standards Branch, FAA, 1601 Lind Avenue
SW., Renton, WA 98057–3356; telephone
425–227–1112; fax 425–227–1149.
(3) Service information identified in this
AD that is not incorporated by reference is
available at the addresses specified in
paragraphs (t)(5) and (t)(6) of this AD.
(t) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
VerDate Sep<11>2014
13:35 Aug 24, 2017
Jkt 241001
(2) You must use this service information
as applicable to do the actions required by
this AD, unless this AD specifies otherwise.
(3) The following service information was
approved for IBR on September 29, 2017.
(i) Messier-Bugatti-Dowty Service Bulletin
631–32–213, Revision 2, dated March 15,
2016.
(ii) Messier-Bugatti-Dowty Service Bulletin
631–32–214, Revision 1, dated March 15,
2016.
(iii) Messier-Bugatti-Dowty Service
Bulletin 631–32–215, Revision 1, dated
March 15, 2016.
(iv) Messier-Bugatti-Dowty Service Bulletin
631–32–216, Revision 3, dated March 15,
2016.
(v) Messier-Bugatti-Dowty Service Bulletin
631–32–219, Revision 1, dated March 15,
2016.
(vi) Messier-Bugatti-Dowty Service Bulletin
631–32–220, Revision 1, dated March 15,
2016.
(vii) Messier-Bugatti-Dowty Service
Bulletin 631–32–224, dated March 15, 2016.
(viii) Messier-Bugatti-Dowty Service
Bulletin 631–32–231, dated March 15, 2016.
(ix) Messier-Bugatti-Dowty Service Bulletin
631–32–232, Revision 1, dated March 15,
2016.
(x) Messier-Bugatti-Dowty Service Bulletin
631–32–233, dated March 15, 2016.
(xi) Messier-Bugatti-Dowty Service Bulletin
631–32–234, dated March 15, 2016.
(xii) Messier-Bugatti-Dowty Service
Bulletin 631–32–235, dated March 15, 2016.
(4) The following service information was
approved for IBR on December 29, 2015 (80
FR 73096, November 24, 2015).
(i) Messier-Bugatti-Dowty Service Bulletin
631–32–213, dated December 16, 2013.
(ii) Messier-Bugatti-Dowty Service Bulletin
631–32–214, dated January 13, 2014.
(iii) Messier-Bugatti-Dowty Service
Bulletin 631–32–215, dated January 13, 2014.
(iv) Messier-Bugatti-Dowty Service Bulletin
631–32–216, Revision 1, dated December 17,
2013. Pages 4, 5, and 8 of this service bulletin
are the original issue and are dated October
30, 2013.
(v) Messier-Bugatti-Dowty Service Bulletin
631–32–219, dated March 3, 2014.
(vi) Messier-Bugatti-Dowty Service Bulletin
631–32–220, dated March 3, 2014.
(5) For service information identified in
this AD, contact ATR–GIE Avions de
´
´
Transport Regional, 1, Allee Pierre Nadot,
31712 Blagnac Cedex, France; telephone +33
(0) 5 62 21 62 21; fax +33 (0) 5 62 21 67 18;
email continued.airworthiness@atr.fr;
Internet https://www.aerochain.com.
(6) You may view this service information
at the FAA, Transport Standards Branch,
1601 Lind Avenue SW., Renton, WA. For
information on the availability of this
material at the FAA, call 425–227–1221.
(7) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
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Fmt 4700
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Issued in Renton, Washington, on August
8, 2017.
Dionne Palermo,
Acting Director, System Oversight Division,
Aircraft Certification Service.
[FR Doc. 2017–17398 Filed 8–24–17; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 121
[Docket No. FDA–2013–N–1425]
Mitigation Strategies To Protect Food
Against Intentional Adulteration: What
You Need To Know About the Food
and Drug Administration Regulation:
Small Entity Compliance Guide;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
guidance for industry entitled
‘‘Mitigation Strategies to Protect Food
Against Intentional Adulteration: What
You Need To Know About the FDA
Regulation: Small Entity Compliance
Guide.’’ The small entity compliance
guide (SECG) is intended to help small
entities comply with the final rule
entitled ‘‘Mitigation Strategies to Protect
Food Against Intentional Adulteration.’’
DATES: The announcement of the
guidance is published in the Federal
Register on August 25, 2017.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time
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
E:\FR\FM\25AUR1.SGM
25AUR1
Federal Register / Vol. 82, No. 164 / Friday, August 25, 2017 / Rules and Regulations
pmangrum on DSK3GDR082PROD with RULES
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’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2013–N–1425 for ‘‘What You Need To
Know About the FDA Regulation:
Mitigation Strategies to Protect Food
Against Intentional Adulteration—Small
Entity Compliance Guide.’’ 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 Dockets Management Staff
office 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 Dockets Management
Staff. 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
VerDate Sep<11>2014
13:35 Aug 24, 2017
Jkt 241001
40485
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 Dockets Management
Staff office, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of the SECG to the Office of
Analytics and Outreach, Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT:
Ryan Newkirk, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–3712.
SUPPLEMENTARY INFORMATION:
that a small entity must take to comply
with the rule.
We are issuing the SECG consistent
with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The
SECG 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 the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations. This is not a
significant regulatory action subject to
Executive Order 12866 and does not
impose any additional burden on
regulated entities.
I. Background
Dated: August 21, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
In the Federal Register of May 27,
2016 (81 FR 34166), we issued a final
rule titled ‘‘Mitigation Strategies to
Protect Food Against Intentional
Adulteration’’ (the final rule) in which
we require domestic and foreign food
facilities that are required to register
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to address
hazards that may be introduced with the
intention to cause wide scale public
health harm. The final rule, which is
codified at part 121 (21 CFR part 121),
became effective July 26, 2016, but has
compliance dates staggered starting 3
years after publication of the final rule.
We examined the economic
implications of the final rule as required
by the Regulatory Flexibility Act (5
U.S.C. 601–612) and determined that
the final rule will have a significant
economic impact on a substantial
number of small entities. In compliance
with section 212 of the Small Business
Regulatory Enforcement Fairness Act
(Pub. L. 104–121, as amended by Pub.
L. 110–28), we are making available the
SECG to reduce the burden of
determining how to comply by further
explaining and clarifying the actions
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
part 121 have been approved under
OMB control number 0910–0812.
III. Electronic Access
Persons with access to the Internet
may obtain the SECG 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.
[FR Doc. 2017–18028 Filed 8–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2017–0317]
Safety Zones; Recurring Annual
Events Held in Coast Guard Sector
Boston Captain of the Port Zone
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
The Coast Guard will enforce
two safety zones within the Captain of
the Port Boston zone on August 31,
2017. This action is necessary to ensure
the safety of vessels, spectators, and
participants from hazards associated
with fireworks displays. During the
SUMMARY:
E:\FR\FM\25AUR1.SGM
25AUR1
Agencies
[Federal Register Volume 82, Number 164 (Friday, August 25, 2017)]
[Rules and Regulations]
[Pages 40484-40485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18028]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 121
[Docket No. FDA-2013-N-1425]
Mitigation Strategies To Protect Food Against Intentional
Adulteration: What You Need To Know About the Food and Drug
Administration Regulation: Small Entity Compliance Guide; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a guidance for industry entitled
``Mitigation Strategies to Protect Food Against Intentional
Adulteration: What You Need To Know About the FDA Regulation: Small
Entity Compliance Guide.'' The small entity compliance guide (SECG) is
intended to help small entities comply with the final rule entitled
``Mitigation Strategies to Protect Food Against Intentional
Adulteration.''
DATES: The announcement of the guidance is published in the Federal
Register on August 25, 2017.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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
[[Page 40485]]
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'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2013-N-1425 for ``What You Need To Know About the FDA Regulation:
Mitigation Strategies to Protect Food Against Intentional
Adulteration--Small Entity Compliance Guide.'' 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 Dockets Management Staff office 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 Dockets Management Staff. 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 Dockets Management Staff office, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the SECG to the Office
of Analytics and Outreach, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the SECG.
FOR FURTHER INFORMATION CONTACT: Ryan Newkirk, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-3712.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 27, 2016 (81 FR 34166), we issued a
final rule titled ``Mitigation Strategies to Protect Food Against
Intentional Adulteration'' (the final rule) in which we require
domestic and foreign food facilities that are required to register
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to
address hazards that may be introduced with the intention to cause wide
scale public health harm. The final rule, which is codified at part 121
(21 CFR part 121), became effective July 26, 2016, but has compliance
dates staggered starting 3 years after publication of the final rule.
We examined the economic implications of the final rule as required
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined
that the final rule will have a significant economic impact on a
substantial number of small entities. In compliance with section 212 of
the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-
121, as amended by Pub. L. 110-28), we are making available the SECG to
reduce the burden of determining how to comply by further explaining
and clarifying the actions that a small entity must take to comply with
the rule.
We are issuing the SECG consistent with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The SECG 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 the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This is not a significant regulatory action
subject to Executive Order 12866 and does not impose any additional
burden on regulated entities.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 121 have been approved under OMB
control number 0910-0812.
III. Electronic Access
Persons with access to the Internet may obtain the SECG 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: August 21, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18028 Filed 8-24-17; 8:45 am]
BILLING CODE 4164-01-P