81 FR 45507 - The Food and Drug Administration Foods and Veterinary Medicine Program's Strategic Plan for Fiscal Years 2016-2025

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 135 (July 14, 2016)

Page Range		45507-45509
FR Document		2016-16684

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.

Federal Register, Volume 81 Issue 135 (Thursday, July 14, 2016)

[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Notices]
[Pages 45507-45509]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-16684]

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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.

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[[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: 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'').

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 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.

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 http://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 http://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 http://www.fda.gov/aboutfda/centersoffices/officeoffoods/ucm273269.htm.
2. Partnership for Food Protection (PFP) Strategic Plan FY 2015
through 2020, available at http://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

Federal Register / Vol. 81, No. 135 / Thursday, July 14, 2016 / Notices 45507

Place: Teleconference. SUPPLEMENTARY INFORMATION: In 1984, withdrawn from sale for reasons of
Status: The meeting will be closed to the Congress enacted the Drug Price safety or effectiveness.
public in accordance with provisions set Competition and Patent Term After considering the citizen petition
forth in section 552b(c)(4) and (6), title 5 and reviewing Agency records and
Restoration Act of 1984 (Pub. L. 98–417)
U.S.C., and the determination of the Director,
Management Analysis and Services Office, (the 1984 amendments), which based on the information we have at this
CDC, pursuant to Public Law 92–463. authorized the approval of duplicate time, FDA has determined under
Matters for Discussion: The meeting will versions of drug products under an § 314.161 that PARAFON FORTE DSC
include the initial review, discussion, and ANDA procedure. ANDA applicants (chlorzoxazone) tablets, 500 mg, were
evaluation of applications received in must, with certain exceptions, show that not withdrawn for reasons of safety or
response to ‘‘Emerging Infections Programs’’, the drug for which they are seeking effectiveness. The petitioner has
FOA CK17–1701. approval contains the same active identified no data or other information
Contact Person for More Information: ingredient in the same strength and suggesting that PARAFON FORTE DSC
Gregory Anderson, M.S., M.P.H., Scientific
dosage form as the ‘‘listed drug,’’ which (chlorzoxazone) tablets, 500 mg, were
Review Officer, CDC, 1600 Clifton Road NE.,
Mailstop E60, Atlanta, Georgia 30333, is a version of the drug that was withdrawn for reasons of safety or
Telephone: (404) 718–8833. previously approved. ANDA applicants effectiveness. We have carefully
The Director, Management Analysis and do not have to repeat the extensive reviewed our files for records
Services Office, has been delegated the clinical testing otherwise necessary to concerning the withdrawal of
authority to sign Federal Register notices gain approval of a new drug application PARAFON FORTE DSC (chlorzoxazone)
pertaining to announcements of meetings and (NDA). tablets, 500 mg, from sale. We have also
other committee management activities, for The 1984 amendments include what independently evaluated relevant
both the Centers for Disease Control and is now section 505(j)(7) of the Federal literature and data for possible
Prevention and the Agency for Toxic
Food, Drug, and Cosmetic Act (21 U.S.C. postmarketing adverse events. We have
Substances and Disease Registry.
355(j)(7)), which requires FDA to reviewed the available evidence and
Catherine Ramadei, publish a list of all approved drugs. determined that this drug product was
Acting Director, Management Analysis and FDA publishes this list as part of the not withdrawn from sale for reasons of
Services Office, Centers for Disease Control ‘‘Approved Drug Products With safety or effectiveness.
and Prevention. Therapeutic Equivalence Evaluations,’’ Accordingly, the Agency will
[FR Doc. 2016–16581 Filed 7–13–16; 8:45 am] which is known generally as the continue to list PARAFON FORTE DSC
BILLING CODE 4163–18–P ‘‘Orange Book.’’ Under FDA regulations, (chlorzoxazone) tablets, 500 mg, in the
drugs are removed from the list if the ‘‘Discontinued Drug Product List’’
Agency withdraws or suspends section of the Orange Book. The
DEPARTMENT OF HEALTH AND approval of the drug’s NDA or ANDA ‘‘Discontinued Drug Product List’’
HUMAN SERVICES for reasons of safety or effectiveness or delineates, among other items, drug
if FDA determines that the listed drug products that have been discontinued
Food and Drug Administration was withdrawn from sale for reasons of from marketing for reasons other than
[Docket No. FDA–2015–P–4224] safety or effectiveness (21 CFR 314.162). safety or effectiveness. ANDAs that refer
A person may petition the Agency to to PARAFON FORTE DSC
Determination That PARAFON FORTE determine, or the Agency may (chlorzoxazone) tablets, 500 mg, may be
DSC (Chlorzoxazone) Tablets, 500 determine on its own initiative, whether approved by the Agency as long as they
Milligrams, Was Not Withdrawn From a listed drug was withdrawn from sale meet all other legal and regulatory
Sale for Reasons of Safety or for reasons of safety or effectiveness. requirements for the approval of
Effectiveness This determination may be made at any ANDAs. If FDA determines that labeling
time after the drug has been withdrawn for this drug product should be revised
AGENCY: Food and Drug Administration, from sale, but must be made prior to to meet current standards, the Agency
HHS. approving an ANDA that refers to the will advise ANDA applicants to submit
ACTION: Notice. listed drug (§ 314.161 (21 CFR 314.161)). such labeling.
SUMMARY: The Food and Drug FDA may not approve an ANDA that
Dated: July 8, 2016.
Administration (FDA or Agency) has does not refer to a listed drug.
PARAFON FORTE DSC Leslie Kux,
determined that PARAFON FORTE DSC Associate Commissioner for Policy.
(chlorzoxazone) tablets, 500 mg, is the
(chlorzoxazone) tablets, 500 milligrams [FR Doc. 2016–16635 Filed 7–13–16; 8:45 am]
subject of NDA 011529, held by Janssen
(mg), were not withdrawn from sale for
Research & Development, LLC, and BILLING CODE 4164–01–P
reasons of safety or effectiveness. This
initially approved on August 15, 1958.
determination means that FDA will not
PARAFON FORTE DSC is indicated as
begin procedures to withdraw approval DEPARTMENT OF HEALTH AND
an adjunct to rest, physical therapy, and
of abbreviated new drug applications HUMAN SERVICES
other measures for the relief of
(ANDAs) that refer to this drug product,
discomfort associated with acute,
and this determination will allow FDA Food and Drug Administration
painful musculoskeletal conditions.
to continue to approve ANDAs for PARAFON FORTE DSC [Docket No. FDA–2016–N–1678]
chlorzoxane tablets, 500 mg, if all other (chlorzoxazone) tablets, 500 mg, is listed
legal and regulatory requirements are in the ‘‘Discontinued Drug Product List’’ The Food and Drug Administration
asabaliauskas on DSK3SPTVN1PROD with NOTICES

met. section of the Orange Book. Foods and Veterinary Medicine
FOR FURTHER INFORMATION CONTACT: Flamingo Pharmaceuticals Ltd. Program’s Strategic Plan for Fiscal
David Faranda, Center for Drug submitted a citizen petition dated Years 2016–2025
Evaluation and Research, Food and November 7, 2015 (Docket No. FDA– AGENCY: Food and Drug Administration,
Drug Administration, 10903 New 2015–P–4224), under 21 CFR 10.30, HHS.
Hampshire Ave., Bldg. 51, Rm. 6213, requesting that the Agency determine
Notice and request for
ACTION:
Silver Spring, MD 20993–0002, 301– whether PARAFON FORTE DSC
comments.
796–8767. (chlorzoxazone) tablets, 500 mg, were

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Document Created: 2016-07-14 01:55:08
Document Modified: 2016-07-14 01:55:08

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		Notices
Action		Notice and request for comments.
Dates		Submit either electronic or written comments on the strategic plan at any time.
Contact		Mia Mercer, Office of Foods and Veterinary Medicine, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8794.
FR Citation		81 FR 45507

81 FR 45507 - The Food and Drug Administration Foods and Veterinary Medicine Program's Strategic Plan for Fiscal Years 2016-2025

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 135 (July 14, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration