Determination of Regulatory Review Period for Purposes of Patent Extension; CONVENIA, 24034-24035 [2011-10379]
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24034
Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Notices
Number: CMS–10388 (OMB#: 0938–
NEW); Frequency: Once; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 6; Total
Annual Hours: 270; (For policy
questions regarding this collection
contact Robin Preston at 410–786–3420.
For all other issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
at https://www.cms.gov/
PaperworkReductionActof1995/PRAL/
list.asp#TopOfPage or email your
request, including your address, phone
number, OMB number, and CMS
document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office at 410–786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by June 28, 2011:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: April 25, 2011.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2011–10370 Filed 4–28–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
srobinson on DSKHWCL6B1PROD with NOTICES
[Document Identifier: CMS–10224]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
AGENCY:
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17:39 Apr 28, 2011
Jkt 223001
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of currently approved
collection; Title of Information
Collection: Healthcare Common
Procedure Coding System (HCPCS); Use:
In October 2003, the Secretary of Health
and Human Services delegated the
Center for Medicare and Medicaid
Services (CMS) authority to maintain
and distribute HCPCS Level II Codes. As
a result, the National Panel was
delineated and CMS continued with the
decision-making process under its
current structure, the CMS HCPCS
Workgroup (herein referred to as ‘‘the
Workgroup’’. CMS’ HCPCS Workgroup
is an internal workgroup comprised of
representatives of the major components
of CMS, and private insurers, as well as
other consultants from pertinent Federal
agencies. Currently the application
intake is paper-based. However, the
process has grown and the HCPCS staff
is exploring electronic processes for the
collection and storage of applications.
We have received feedback on the
nature of the application; and have
streamlined the form into a userfriendly application. The content of the
material is the same, but the questions
have been refined in accordance with
comments received from industry
members; and the level of necessity of
the information required to render
quality coding decision as determined
by the CMS workgroup. The information
on the form is used to update the
HCPCS code set. All information is
received and distributed to CMS’
HCPCS workgroup and is reviewed and
discussed at workgroup meetings. In
turn, CMS’ HCPCS workgroup reaches a
decision as to whether a change should
be made to codes in the HCPCS code
set. The respondent who submits the
application form can be anyone who has
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an interest in obtaining a code or
modifying an existing code. However,
respondents are usually manufacturers
of products, or consultants on behalf of
the manufacturer. Form Number: CMS–
10224 (OMB#: 0938–1042); Frequency:
Occasionally; Affected Public: Private
sector, business and other for-profit and
not-for-profit institutions; Number of
Respondents: 300; Total Annual
Responses: 300; Total Annual Hours:
3300. (For policy questions regarding
this collection contact Felicia Eggleston
at 410–786–9287 or Lori Anderson at
410–786–6190. For all other issues call
410–786–1326.)
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on May 31, 2011.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395–
6974, E-mail:
OIRA_submission@omb.eop.gov.
Dated: April 25, 2011.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2011–10366 Filed 4–28–11; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0087]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CONVENIA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
CONVENIA 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 Patents and Trademarks,
Department of Commerce, for the
extension of a patent which claims that
animal drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
SUMMARY:
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29APN1
srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Notices
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: 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
Patents and Trademarks 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 approved for marketing the
animal drug product CONVENIA
(cefovecin sodium). CONVENIA is
indicated for the treatment of skin
infections (wounds and abscesses)
caused by susceptible strains of
Pasteurella multocida in cats; and the
treatment of skin infections (secondary
superficial pyoderma, abscesses and
wounds) caused by susceptible strains
of Staphylococcus intermedius and
Streptococcus canis (Group G) in dogs.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for
CONVENIA (U.S. Patent No. 6,020,329)
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17:39 Apr 28, 2011
Jkt 223001
from Pfizer, Inc., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated September 2, 2009, FDA
advised the Patent and Trademark
Office that this animal drug product had
undergone a regulatory review period
and that the approval of CONVENIA
represented the first permitted
commercial marketing or use of the
product. Thereafter, the Patent and
Trademark Office requested that FDA
determine the product’s regulatory
review period.
FDA has determined that the
applicable regulatory review period for
CONVENIA is 2,841 days. Of this time,
2,801 days occurred during the testing
phase of the regulatory review period,
while 40 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 512(j) of the FD&C Act became
effective: July 17, 2000. The applicant
claims November 16, 1999, as the date
the investigational new animal drug
application (INAD) became effective.
However, the date that a major health or
environmental effects test is begun or
the date on which the Agency
acknowledges the filing of a notice of
claimed investigational exemption for a
new animal drug, whichever is earlier,
is the effective date for the INAD.
According to FDA records, July 17,
2000, is the effective date for the INAD.
2. The date the application was
initially submitted with respect to the
animal drug product under section 512
of the FD&C Act: March 17, 2008. The
applicant claims March 15, 2008, as the
date the new animal drug Application
(NADA) for CONVENIA (NADA 141–
285) was initially submitted. However,
a review of FDA records reveals that the
date of FDA’s official acknowledgement
letter assigning a number to NADA 141–
285 was March 17, 2008, which is
considered to be the initially submitted
date for NADA 141–285.
3. The date the application was
approved: April 25, 2008. FDA has
verified the applicant’s claim that
NADA 141–285 was approved on April
25, 2008. This determination of the
regulatory review period establishes the
maximum potential length of a patent
extension. However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,462 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
24035
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by June 28, 2011.
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
October 26, 2011.
To meet its burden, the petition must
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.
Comments and petitions should be
submitted to the Division of Dockets
Management. Three copies of any
mailed information are to be submitted,
except that individuals may submit one
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. Comments and petitions may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: April 15, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2011–10379 Filed 4–28–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0381]
Generic Drug User Fee; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing a public meeting to
provide a public update and to gather
additional stakeholder input on the
development of a generic drug user fee
program. A user fee program could
provide necessary supplemental
funding, in addition to current
Congressional appropriations, to
facilitate the timely review of human
generic drug applications by FDA, and
FDA is currently in negotiations with
the regulated industry aimed at
providing a consensus proposal for
congressional consideration. In the
interest of transparency, and to assure
that all interested stakeholders’ views
are heard and considered, whether they
are present at the negotiations or not,
FDA is holding a public meeting to
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]]>Agencies
[Federal Register Volume 76, Number 83 (Friday, April 29, 2011)]
[Notices]
[Pages 24034-24035]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10379]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-E-0087]
Determination of Regulatory Review Period for Purposes of Patent
Extension; CONVENIA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for CONVENIA 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 Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that animal drug product.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food
[[Page 24035]]
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.
SUPPLEMENTARY INFORMATION: 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 Patents and
Trademarks 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 approved for marketing the animal drug product CONVENIA
(cefovecin sodium). CONVENIA is indicated for the treatment of skin
infections (wounds and abscesses) caused by susceptible strains of
Pasteurella multocida in cats; and the treatment of skin infections
(secondary superficial pyoderma, abscesses and wounds) caused by
susceptible strains of Staphylococcus intermedius and Streptococcus
canis (Group G) in dogs. Subsequent to this approval, the Patent and
Trademark Office received a patent term restoration application for
CONVENIA (U.S. Patent No. 6,020,329) from Pfizer, Inc., and the Patent
and Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
September 2, 2009, FDA advised the Patent and Trademark Office that
this animal drug product had undergone a regulatory review period and
that the approval of CONVENIA represented the first permitted
commercial marketing or use of the product. Thereafter, the Patent and
Trademark Office requested that FDA determine the product's regulatory
review period.
FDA has determined that the applicable regulatory review period for
CONVENIA is 2,841 days. Of this time, 2,801 days occurred during the
testing phase of the regulatory review period, while 40 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 512(j) of the FD&C Act
became effective: July 17, 2000. The applicant claims November 16,
1999, as the date the investigational new animal drug application
(INAD) became effective. However, the date that a major health or
environmental effects test is begun or the date on which the Agency
acknowledges the filing of a notice of claimed investigational
exemption for a new animal drug, whichever is earlier, is the effective
date for the INAD. According to FDA records, July 17, 2000, is the
effective date for the INAD.
2. The date the application was initially submitted with respect to
the animal drug product under section 512 of the FD&C Act: March 17,
2008. The applicant claims March 15, 2008, as the date the new animal
drug Application (NADA) for CONVENIA (NADA 141-285) was initially
submitted. However, a review of FDA records reveals that the date of
FDA's official acknowledgement letter assigning a number to NADA 141-
285 was March 17, 2008, which is considered to be the initially
submitted date for NADA 141-285.
3. The date the application was approved: April 25, 2008. FDA has
verified the applicant's claim that NADA 141-285 was approved on April
25, 2008. This determination of the regulatory review period
establishes the maximum potential length of a patent extension.
However, the U.S. Patent and Trademark Office applies several statutory
limitations in its calculations of the actual period for patent
extension. In its application for patent extension, this applicant
seeks 1,462 days of patent term extension.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by June 28, 2011. 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 October 26, 2011.
To meet its burden, the petition must 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.
Comments and petitions should be submitted to the Division of
Dockets Management. Three copies of any mailed information are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments and petitions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: April 15, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-10379 Filed 4-28-11; 8:45 am]
BILLING CODE 4160-01-P
