The Food and Drug Administration Foods and Veterinary Medicine Program's Strategic Plan for Fiscal Years 2016-2025, 45507-45509 [2016-16684]
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Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in section 552b(c)(4) and (6), title 5
U.S.C., and the determination of the Director,
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CDC, pursuant to Public Law 92–463.
Matters for Discussion: The meeting will
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FOA CK17–1701.
Contact Person for More Information:
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The Director, Management Analysis and
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Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2016–16581 Filed 7–13–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–P–4224]
Determination That PARAFON FORTE
DSC (Chlorzoxazone) Tablets, 500
Milligrams, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that PARAFON FORTE DSC
(chlorzoxazone) tablets, 500 milligrams
(mg), were not withdrawn from sale for
reasons of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and this determination will allow FDA
to continue to approve ANDAs for
chlorzoxane tablets, 500 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT:
David Faranda, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213,
Silver Spring, MD 20993–0002, 301–
796–8767.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:33 Jul 13, 2016
Jkt 238001
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
PARAFON FORTE DSC
(chlorzoxazone) tablets, 500 mg, is the
subject of NDA 011529, held by Janssen
Research & Development, LLC, and
initially approved on August 15, 1958.
PARAFON FORTE DSC is indicated as
an adjunct to rest, physical therapy, and
other measures for the relief of
discomfort associated with acute,
painful musculoskeletal conditions.
PARAFON FORTE DSC
(chlorzoxazone) tablets, 500 mg, is listed
in the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Flamingo Pharmaceuticals Ltd.
submitted a citizen petition dated
November 7, 2015 (Docket No. FDA–
2015–P–4224), under 21 CFR 10.30,
requesting that the Agency determine
whether PARAFON FORTE DSC
(chlorzoxazone) tablets, 500 mg, were
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
45507
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that PARAFON FORTE DSC
(chlorzoxazone) tablets, 500 mg, were
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that PARAFON FORTE DSC
(chlorzoxazone) tablets, 500 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
PARAFON FORTE DSC (chlorzoxazone)
tablets, 500 mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list PARAFON FORTE DSC
(chlorzoxazone) tablets, 500 mg, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to PARAFON FORTE DSC
(chlorzoxazone) tablets, 500 mg, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: July 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16635 Filed 7–13–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1678]
The Food and Drug Administration
Foods and Veterinary Medicine
Program’s Strategic Plan for Fiscal
Years 2016–2025
AGENCY:
Food and Drug Administration,
HHS.
Notice and request for
comments.
ACTION:
E:\FR\FM\14JYN1.SGM
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45508
Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices
The Food and Drug
Administration (FDA or we) is
announcing the availability of the
‘‘Foods and Veterinary Medicine (FVM)
Program’s Strategic Plan for Fiscal Years
2016–2025’’ that covers activities of the
Office of Foods and Veterinary
Medicine, the Center for Food Safety
and Applied Nutrition, and the Center
for Veterinary Medicine, as well as
related efforts by the Office of Global
Regulatory Operations and Policy and
the Office of Regulatory Affairs. Our
strategic plan includes goals and
objectives for the next 10 years
including our mission to implement the
FDA Food Safety Modernization Act
(FSMA) enacted in 2011, as well as
details on our goals of protecting and
enhancing the health of both people and
animals. We invite public comment on
the plan.
DATES: Submit either electronic or
written comments on the strategic plan
at any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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’’).
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.
VerDate Sep<11>2014
19:33 Jul 13, 2016
Jkt 238001
• 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–
2016–N–1678 for ‘‘FDA Foods and
Veterinary Medicine (FVM) Program’s
Strategic Plan for Fiscal Years 2016–
2025.’’ 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.
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Mia
Mercer, Office of Foods and Veterinary
Medicine, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301–796–
8794.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
We are announcing the availability of
the FVM Program’s Strategic Plan for
Fiscal Years 2016–2025 in order to
inform the public of our goals for the
next 10 years. We are implementing the
modernization of FDA’s regulatory
framework for the FVM Program. We are
focused on continuing to drive toward
a more proactive, preventive, riskinformed approach to food and feed
safety, nutrition, and animal health.
The FVM Program works to ensure
the American public has food that is
safe and nutritious and that animal drug
products are safe and effective. Our
priority is to obtain high rates of
compliance with standards necessary to
protect public health and meet
consumer and other stakeholder
expectations. Recognizing the unique
challenges we face in the area of food
safety in the 21st century, Congress
enacted FSMA which requires (among
other things):
• Comprehensive prevention-oriented
food safety standards across the food
system;
• mandated domestic inspection
frequency, based on risk, to ensure high
rates of compliance;
• a national integrated food safety
system based on full partnership with
States; and
• a new import safety system based
on food safety accountability for
importers, increased foreign presence,
and increased collaboration with foreign
governments.
Our FVM Program Strategic Plan takes
this statutory framework into account,
places high priority on the
implementation of FSMA, and focuses
on how we plan to modernize our food
safety work including:
• An increased focus on obtaining
compliance with preventive control
standards rather than finding and
responding to legal violations after an
illness or outbreak has occurred;
• strengthening our technical
expertise and capacity to support FDA,
industry, and other stakeholders in
implementing the new prevention
standards;
• furthering federal, State, local, and
territorial partnerships, and investing in
training and capacity to ensure efficient,
high quality, and consistent oversight
nationwide; and
• broadening interaction with foreign
partners and increasing oversight of
E:\FR\FM\14JYN1.SGM
14JYN1
Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices
importers, who will have more
responsibility for the safety of imported
foods.
Beyond FSMA’s implementation, the
FVM Program Strategic Plan provides
details on our goals of protecting and
enhancing the health of people and
animals. The active engagement of all
stakeholders and partners, both internal
and external, is critical to the successful
implementation of this plan.
II. Electronic Access
Persons with access to the Internet
may obtain the FVM Program Strategic
Plan at https://www.regulations.gov.
Treatment.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for the
treatment of bacterial vaginosis (BV).
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 October 12,
2016.
ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
III. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
the Web site addresses in this reference
section, but we are not responsible for
any subsequent changes to the Web sites
after this document publishes in the
Federal Register.)
1. FDA Foods and Veterinary Medicine
Program Strategic Plan, FY 2016–2025,
available at https://www.fda.gov/
aboutfda/centersoffices/officeoffoods/
ucm273269.htm.
2. Partnership for Food Protection (PFP)
Strategic Plan FY 2015 through 2020,
available at https://www.fda.gov/
downloads/ForFederalStateand
LocalOfficials/FoodSafetySystem/
PartnershipforFoodProtectionPFP/
UCM423834.pdf.
Dated: July 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16684 Filed 7–13–16; 8:45 am]
BILLING CODE 4164–01–P
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’’).
Written/Paper Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1659]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Bacterial Vaginosis: Developing Drugs
for Treatment; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Bacterial
Vaginosis: Developing Drugs for
SUMMARY:
VerDate Sep<11>2014
19:33 Jul 13, 2016
Jkt 238001
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–
2016–D–1659 for ‘‘Bacterial Vaginosis:
Developing Drugs for Treatment; Draft
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
45509
Guidance for Industry; Availability.’’
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 draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
E:\FR\FM\14JYN1.SGM
14JYN1
]]>Agencies
[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Notices]
[Pages 45507-45509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1678]
The Food and Drug Administration Foods and Veterinary Medicine
Program's Strategic Plan for Fiscal Years 2016-2025
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice and request for comments.
-----------------------------------------------------------------------
[[Page 45508]]
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of the ``Foods and Veterinary Medicine (FVM) Program's
Strategic Plan for Fiscal Years 2016-2025'' that covers activities of
the Office of Foods and Veterinary Medicine, the Center for Food Safety
and Applied Nutrition, and the Center for Veterinary Medicine, as well
as related efforts by the Office of Global Regulatory Operations and
Policy and the Office of Regulatory Affairs. Our strategic plan
includes goals and objectives for the next 10 years including our
mission to implement the FDA Food Safety Modernization Act (FSMA)
enacted in 2011, as well as details on our goals of protecting and
enhancing the health of both people and animals. We invite public
comment on the plan.
DATES: Submit either electronic or written comments on the strategic
plan 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'').
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-2016-N-1678 for ``FDA Foods and Veterinary Medicine (FVM) Program's
Strategic Plan for Fiscal Years 2016-2025.'' 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.
FOR FURTHER INFORMATION CONTACT: Mia Mercer, Office of Foods and
Veterinary Medicine, 10903 New Hampshire Ave., Silver Spring, MD 20993,
301-796-8794.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of the FVM Program's Strategic
Plan for Fiscal Years 2016-2025 in order to inform the public of our
goals for the next 10 years. We are implementing the modernization of
FDA's regulatory framework for the FVM Program. We are focused on
continuing to drive toward a more proactive, preventive, risk-informed
approach to food and feed safety, nutrition, and animal health.
The FVM Program works to ensure the American public has food that
is safe and nutritious and that animal drug products are safe and
effective. Our priority is to obtain high rates of compliance with
standards necessary to protect public health and meet consumer and
other stakeholder expectations. Recognizing the unique challenges we
face in the area of food safety in the 21st century, Congress enacted
FSMA which requires (among other things):
Comprehensive prevention-oriented food safety standards
across the food system;
mandated domestic inspection frequency, based on risk, to
ensure high rates of compliance;
a national integrated food safety system based on full
partnership with States; and
a new import safety system based on food safety
accountability for importers, increased foreign presence, and increased
collaboration with foreign governments.
Our FVM Program Strategic Plan takes this statutory framework into
account, places high priority on the implementation of FSMA, and
focuses on how we plan to modernize our food safety work including:
An increased focus on obtaining compliance with preventive
control standards rather than finding and responding to legal
violations after an illness or outbreak has occurred;
strengthening our technical expertise and capacity to
support FDA, industry, and other stakeholders in implementing the new
prevention standards;
furthering federal, State, local, and territorial
partnerships, and investing in training and capacity to ensure
efficient, high quality, and consistent oversight nationwide; and
broadening interaction with foreign partners and
increasing oversight of
[[Page 45509]]
importers, who will have more responsibility for the safety of imported
foods.
Beyond FSMA's implementation, the FVM Program Strategic Plan provides
details on our goals of protecting and enhancing the health of people
and animals. The active engagement of all stakeholders and partners,
both internal and external, is critical to the successful
implementation of this plan.
II. Electronic Access
Persons with access to the Internet may obtain the FVM Program
Strategic Plan at https://www.regulations.gov.
III. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov. (FDA
has verified the Web site addresses in this reference section, but we
are not responsible for any subsequent changes to the Web sites after
this document publishes in the Federal Register.)
1. FDA Foods and Veterinary Medicine Program Strategic Plan, FY
2016-2025, available at https://www.fda.gov/aboutfda/centersoffices/officeoffoods/ucm273269.htm.
2. Partnership for Food Protection (PFP) Strategic Plan FY 2015
through 2020, available at https://www.fda.gov/downloads/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/UCM423834.pdf.
Dated: July 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16684 Filed 7-13-16; 8:45 am]
BILLING CODE 4164-01-P
