Generic Drug User Fee; Public Meeting; Request for Comments, 24035-24036 [2011-10382]
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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)
VerDate Mar<15>2010
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
E:\FR\FM\29APN1.SGM
29APN1
srobinson on DSKHWCL6B1PROD with NOTICES
24036
Federal Register / Vol. 76, No. 83 / Friday, April 29, 2011 / Notices
provide an update on the current
process and to gather additional input
on such a program.
Date and Time: The public meeting
will be held on May 10, 2011, from 2
p.m. to 3:30 p.m.
Location: The public meeting will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 1,
Conference Rooms 4101, 4103, and
4105, Silver Spring, MD 20993–0002.
Contact Person: Mari Long, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 4237,
Silver Spring, MD 20993–0002, 301–
796–7574, Fax 301–847–3541,
mari.long@fda.hhs.gov; or
Peter C. Beckerman, Office of Policy,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
4238, Silver Spring, MD 20993–0002,
301–796–4830, Fax 301–847–3541,
peter.beckerman@fda.hhs.gov.
Registration and Requests for Oral
Presentations: If you wish to attend and/
or present at the meeting, please e-mail
your registration information to
GDUFA_Meeting2@fda.hhs.gov by May
3, 2011. Your e-mail should contain
complete contact information for each
attendee, including name, title,
affiliation, address, e-mail address, and
telephone number. Registration is free
and will be on a first-come, first-served
basis. Early registration is recommended
because seating is limited. FDA may
limit the number of participants from
each organization as well as the total
number of participants, based on space
limitations. Registrants will receive
confirmation once they have been
accepted. Onsite registration on the day
of the meeting will be based on space
availability. We will try to accommodate
all persons who wish to make a
presentation. The time allotted for
presentations may depend on the
number of persons who wish to speak,
and if the entire meeting time is not
needed for presentations, FDA reserves
the right to terminate the meeting early.
If you need special accommodations
because of disability, please contact
Mari Long or Peter Beckerman (see
Contact Person) at least 7 days before
the meeting.
Comments: Regardless of attendance
at the public meeting, interested persons
may submit either electronic or written
comments regarding this document by
June 10, 2011. To ensure consideration,
all comments must be received by June
10, 2011. Submission of comments prior
to the meeting is strongly encouraged.
Submit any comments that you plan to
present at the public meeting to the
docket by the date of the public
meeting, but note that either electronic
VerDate Mar<15>2010
17:39 Apr 28, 2011
Jkt 223001
or written comments generally may be
submitted until June 10, 2011.
Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. It
is only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing its intention to
hold a public meeting related to generic
drug user fees. The Agency continues to
solicit comment on whether to seek a
user fee program that would provide
additional resources for the review of
human generic drug applications, as
well as what such a program should
look like. New legislation would be
required for FDA to establish and collect
user fees for generic drugs, and FDA is
currently engaged in negotiations with
industry over aspects of a joint proposal
for a generic drug user fee program,
including fees and performance goals.
Because FDA can only negotiate with
trade organizations, not individual
companies, but remains interested in
hearing from non-affiliated companies
in addition to patient and consumer
stakeholders, the Agency will hold a
public meeting. The public meeting will
provide a status update and seek input
from stakeholders on generic drug user
fees. In addition, FDA continues to
encourage all interested stakeholders to
submit either electronic or written
comments to the docket (see
Comments).
II. What information should you know
about the public meeting, when and
where will the public meeting occur,
and what format will FDA use?
Through this notice, we are
announcing a public meeting to update
stakeholders and hear stakeholder views
on what features FDA should propose
for a generic drug user fee program. We
will conduct the meeting on May 10,
2011, from 2 p.m. to 3:30 p.m. at FDA’s
White Oak Campus, 10903 New
Hampshire Ave., Bldg. 1, Conference
Rooms 4101, 4103, and 4105, Silver
Spring, MD 20993–0002. In general, the
meeting format will include a
presentation by FDA and presentations
by stakeholders and members of the
public who have registered in advance
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
to present at the meeting. The amount
of time available for presentations will
be determined by the number of people
who register to make a presentation. We
will also provide an opportunity for
organizations and individuals to submit
either electronic or written comments to
the docket after the meeting (see
Comments). FDA policy issues are
beyond the scope of this initiative.
Accordingly, the presentations should
focus on process and funding issues,
and not focus on policy.
Dated: April 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–10382 Filed 4–28–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Brain
Disorders Pathology and Treatment.
Date: May 26, 2011.
Time: 11 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Dan D. Gerendasy,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3218,
MSC 7843, Bethesda, MD 20892. 301–408–
9164. gerendad@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Cancer Biology and Therapeutics.
Date: June 1–2, 2011.
Time: 11 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting.)
E:\FR\FM\29APN1.SGM
29APN1
]]>Agencies
[Federal Register Volume 76, Number 83 (Friday, April 29, 2011)]
[Notices]
[Pages 24035-24036]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10382]
-----------------------------------------------------------------------
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.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
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
[[Page 24036]]
provide an update on the current process and to gather additional input
on such a program.
Date and Time: The public meeting will be held on May 10, 2011,
from 2 p.m. to 3:30 p.m.
Location: The public meeting will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 1, Conference Rooms 4101, 4103,
and 4105, Silver Spring, MD 20993-0002.
Contact Person: Mari Long, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm.
4237, Silver Spring, MD 20993-0002, 301-796-7574, Fax 301-847-3541,
mari.long@fda.hhs.gov; or
Peter C. Beckerman, Office of Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 4238, Silver Spring, MD 20993-
0002, 301-796-4830, Fax 301-847-3541, peter.beckerman@fda.hhs.gov.
Registration and Requests for Oral Presentations: If you wish to
attend and/or present at the meeting, please e-mail your registration
information to GDUFA_Meeting2@fda.hhs.gov by May 3, 2011. Your e-mail
should contain complete contact information for each attendee,
including name, title, affiliation, address, e-mail address, and
telephone number. Registration is free and will be on a first-come,
first-served basis. Early registration is recommended because seating
is limited. FDA may limit the number of participants from each
organization as well as the total number of participants, based on
space limitations. Registrants will receive confirmation once they have
been accepted. Onsite registration on the day of the meeting will be
based on space availability. We will try to accommodate all persons who
wish to make a presentation. The time allotted for presentations may
depend on the number of persons who wish to speak, and if the entire
meeting time is not needed for presentations, FDA reserves the right to
terminate the meeting early.
If you need special accommodations because of disability, please
contact Mari Long or Peter Beckerman (see Contact Person) at least 7
days before the meeting.
Comments: Regardless of attendance at the public meeting,
interested persons may submit either electronic or written comments
regarding this document by June 10, 2011. To ensure consideration, all
comments must be received by June 10, 2011. Submission of comments
prior to the meeting is strongly encouraged. Submit any comments that
you plan to present at the public meeting to the docket by the date of
the public meeting, but note that either electronic or written comments
generally may be submitted until June 10, 2011.
Submit electronic comments to https://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing its intention to hold a public meeting related to
generic drug user fees. The Agency continues to solicit comment on
whether to seek a user fee program that would provide additional
resources for the review of human generic drug applications, as well as
what such a program should look like. New legislation would be required
for FDA to establish and collect user fees for generic drugs, and FDA
is currently engaged in negotiations with industry over aspects of a
joint proposal for a generic drug user fee program, including fees and
performance goals. Because FDA can only negotiate with trade
organizations, not individual companies, but remains interested in
hearing from non-affiliated companies in addition to patient and
consumer stakeholders, the Agency will hold a public meeting. The
public meeting will provide a status update and seek input from
stakeholders on generic drug user fees. In addition, FDA continues to
encourage all interested stakeholders to submit either electronic or
written comments to the docket (see Comments).
II. What information should you know about the public meeting, when and
where will the public meeting occur, and what format will FDA use?
Through this notice, we are announcing a public meeting to update
stakeholders and hear stakeholder views on what features FDA should
propose for a generic drug user fee program. We will conduct the
meeting on May 10, 2011, from 2 p.m. to 3:30 p.m. at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 1, Conference Rooms 4101, 4103,
and 4105, Silver Spring, MD 20993-0002. In general, the meeting format
will include a presentation by FDA and presentations by stakeholders
and members of the public who have registered in advance to present at
the meeting. The amount of time available for presentations will be
determined by the number of people who register to make a presentation.
We will also provide an opportunity for organizations and individuals
to submit either electronic or written comments to the docket after the
meeting (see Comments). FDA policy issues are beyond the scope of this
initiative. Accordingly, the presentations should focus on process and
funding issues, and not focus on policy.
Dated: April 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10382 Filed 4-28-11; 8:45 am]
BILLING CODE 4160-01-P
