80 FR 76701 - Determination of Regulatory Review Period for Purposes of Patent Extension; VERAFLOX

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 237 (December 10, 2015)

Page Range		76701-76702
FR Document		2015-31099

The Food and Drug Administration (FDA) has determined the regulatory review period for VERAFLOX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.

Federal Register, Volume 80 Issue 237 (Thursday, December 10, 2015)

[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76701-76702]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-31099]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-1573]

Determination of Regulatory Review Period for Purposes of Patent
Extension; VERAFLOX

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for VERAFLOX and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that animal drug product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 8, 2016. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 7, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

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-2013-E-1573 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; VERAFLOX''. 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.

[[Page 76702]]

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background

The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For animal drug products, the
testing phase begins on the earlier date when either a major
environmental effects test was initiated for the drug or when an
exemption under section 512(j) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the animal drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for an animal
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(4)(B).
FDA has approved for marketing the animal drug product VERAFLOX
(pradofloxacin). VERAFLOX is indicated for treatment of skin infections
in cats caused by susceptible strains of Pasteurella multocide,
Streptococcus canis, Staphylococcus aureus, Staphylococcus felis, and
Staphylococcus pseudintermedius. Subsequent to this approval, the USPTO
received a patent term restoration application for VERAFLOX (U.S.
Patent No. 6,323,213) from Bayer Animal Health GmbH, and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated March 26, 2014, FDA advised
the USPTO that this animal drug product had undergone a regulatory
review period and that the approval of VERAFLOX represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

FDA has determined that the applicable regulatory review period for
VERAFLOX is 3,285 days. Of this time, 3,235 days occurred during the
testing phase of the regulatory review period, while 50 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505(i) of the FD&C Act (21
U.S.C. 355(i)) became effective: November 12, 2003. The applicant
claims July 31, 2002, as the date the investigational new animal drug
application (INAD) became effective. However, FDA records indicate that
the INAD effective date was November 12, 2003, which was the date on
which the agency acknowledges the filing of a notice of claimed
investigational exemption for a new animal drug.
2. The date the application was initially submitted with respect to
the animal drug product under section 512 of the FD&C Act (21 U.S.C.
360b): September 19, 2012. FDA has verified the applicant's claim that
the new animal drug Application (NADA) for VERAFLOX (NADA 141-344) was
submitted on September 19, 2012.
3. The date the application was approved: November 7, 2012. FDA has
verified the applicant's claim that NADA 141-344 was approved on
November 7, 2012.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,901 days of patent term extension.

III. Petitions

Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

Dated: December 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31099 Filed 12-9-15; 8:45 am]
BILLING CODE 4164-01-P

76702 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices

FOR FURTHER INFORMATION CONTACT: patent term restoration. In a letter dated must be timely (see DATES) and contain
Beverly Friedman, Office of Regulatory March 26, 2014, FDA advised the sufficient facts to merit an FDA
Policy, Food and Drug Administration, USPTO that this animal drug product investigation. (See H. Rept. 857, part 1,
10903 New Hampshire Ave. Bldg. 51, had undergone a regulatory review 98th Cong., 2d sess., pp. 41–42, 1984.)
Rm. 6250, Silver Spring, MD 20993, period and that the approval of Petitions should be in the format
301–796–3600. VERAFLOX represented the first specified in 21 CFR 10.30.
SUPPLEMENTARY INFORMATION: permitted commercial marketing or use Submit petitions electronically to
of the product. Thereafter, the USPTO http://www.regulations.gov at Docket
I. Background requested that FDA determine the No. FDA–2013–S–0610. Submit written
The Drug Price Competition and product’s regulatory review period. petitions (two copies are required) to the
Patent Term Restoration Act of 1984 Division of Dockets Management (HFA–
II. Determination of Regulatory Review
(Pub. L. 98–417) and the Generic 305), Food and Drug Administration,
Animal Drug and Patent Term Period
5630 Fishers Lane, Rm. 1061, Rockville,
Restoration Act (Pub. L. 100–670) FDA has determined that the MD 20852. Petitions that have not been
generally provide that a patent may be applicable regulatory review period for made publicly available on http://
extended for a period of up to 5 years VERAFLOX is 3,285 days. Of this time, www.regulations.gov may be viewed in
so long as the patented item (human 3,235 days occurred during the testing the Division of Dockets Management
drug product, animal drug product, phase of the regulatory review period, between 9 a.m. and 4 p.m., Monday
medical device, food additive, or color while 50 days occurred during the through Friday.
additive) was subject to regulatory approval phase. These periods of time
Dated: December 4, 2015.
review by FDA before the item was were derived from the following dates:
1. The date an exemption under Leslie Kux,
marketed. Under these acts, a product’s
regulatory review period forms the basis section 505(i) of the FD&C Act (21 Associate Commissioner for Policy.
for determining the amount of extension U.S.C. 355(i)) became effective: [FR Doc. 2015–31099 Filed 12–9–15; 8:45 am]
an applicant may receive. November 12, 2003. The applicant BILLING CODE 4164–01–P
A regulatory review period consists of claims July 31, 2002, as the date the
two periods of time: A testing phase and investigational new animal drug
an approval phase. For animal drug application (INAD) became effective. DEPARTMENT OF HEALTH AND
products, the testing phase begins on However, FDA records indicate that the HUMAN SERVICES
the earlier date when either a major INAD effective date was November 12,
environmental effects test was initiated 2003, which was the date on which the Viral Hepatitis Action Plan—
for the drug or when an exemption agency acknowledges the filing of a Community Stakeholder Activities
under section 512(j) of the Federal Food, notice of claimed investigational Request for Information
Drug, and Cosmetic Act (the FD&C Act) exemption for a new animal drug. AGENCY: Office of the Assistant
(21 U.S.C. 360b(j)) became effective and 2. The date the application was Secretary for Health, Office of the
runs until the approval phase begins. initially submitted with respect to the Secretary, Department of Health and
The approval phase starts with the animal drug product under section 512 Human Services.
initial submission of an application to of the FD&C Act (21 U.S.C. 360b): ACTION: Notice.
market the animal drug product and September 19, 2012. FDA has verified
continues until FDA grants permission the applicant’s claim that the new SUMMARY: The Department of Health and
to market the drug product. Although animal drug Application (NADA) for Human Services (HHS) is seeking public
only a portion of a regulatory review VERAFLOX (NADA 141–344) was input from state and local governments,
period may count toward the actual submitted on September 19, 2012. community based organizations,
amount of extension that the Director of 3. The date the application was academic institutions, professional
USPTO may award (for example, half approved: November 7, 2012. FDA has organizations, advocacy groups, private
the testing phase must be subtracted as verified the applicant’s claim that industry, and other non-federal
well as any time that may have occurred NADA 141–344 was approved on stakeholders on activities undertaken in
before the patent was issued), FDA’s November 7, 2012. 2014–2015 in support of the goals of the
determination of the length of a This determination of the regulatory national Action Plan for the Prevention,
regulatory review period for an animal review period establishes the maximum Care, and Treatment of Viral Hepatitis.
drug product will include all of the potential length of a patent extension. DATES: All responses must be received
testing phase and approval phase as However, the USPTO applies several at the address provided below, no later
specified in 35 U.S.C. 156(g)(4)(B). statutory limitations in its calculations than 5:00 p.m. ET on February 8, 2016.
FDA has approved for marketing the of the actual period for patent extension.
ADDRESSES: Electronic responses are
animal drug product VERAFLOX In its application for patent extension,
(pradofloxacin). VERAFLOX is strongly preferred and may be addressed
this applicant seeks 1,901 days of patent
indicated for treatment of skin to Corinna.Dan@hhs.gov. Written
term extension.
infections in cats caused by susceptible responses should be addressed to: U.S.
strains of Pasteurella multocide, III. Petitions Department of Health and Human
Streptococcus canis, Staphylococcus Anyone with knowledge that any of Services, 200 Independence Ave. SW.,
aureus, Staphylococcus felis, and the dates as published are incorrect may Room 443H, Washington, DC 20201.
Attention: VHAP—2015RFI
mstockstill on DSK4VPTVN1PROD with NOTICES

Staphylococcus pseudintermedius. submit either electronic or written
Subsequent to this approval, the USPTO comments and ask for a redetermination FOR FURTHER INFORMATION CONTACT:
received a patent term restoration (see DATES). Furthermore, any interested Corinna Dan, RN, MPH, Office of HIV/
application for VERAFLOX (U.S. Patent person may petition FDA for a AIDS and Infectious Disease Policy,
No. 6,323,213) from Bayer Animal determination regarding whether the (202) 401–9581.
Health GmbH, and the USPTO applicant for extension acted with due SUPPLEMENTARY INFORMATION: The
requested FDA’s assistance in diligence during the regulatory review updated comprehensive national action
determining this patent’s eligibility for period. To meet its burden, the petition plan, Combating the Silent Epidemic of

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Document Created: 2015-12-14 13:28:49
Document Modified: 2015-12-14 13:28:49

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.
Dates		Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 8, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 7, 2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
Contact		Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation		80 FR 76701

80 FR 76701 - Determination of Regulatory Review Period for Purposes of Patent Extension; VERAFLOX

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 237 (December 10, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration