Determination of Regulatory Review Period for Purposes of Patent Extension; CERVARIX, 12975-12976 [2011-5310]
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Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices
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.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 14, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2011–5312 Filed 3–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0332]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CERVARIX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
CERVARIX 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 human biological
product.
SUMMARY:
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
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,
Emcdonald on DSK2BSOYB1PROD with NOTICES
ADDRESSES:
VerDate Mar<15>2010
18:04 Mar 08, 2011
Jkt 223001
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 human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological becomes effective and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the human biological product and
continues until FDA grants permission
to market the biological 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 a human biological product
will include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human biological product
CERVARIX (human papillomavirus
bivalent (types 16 and 18) vaccine).
CERVARIX is indicated for prevention
of the following diseases caused by
oncogenic human papillomavirus types
16 and 18: cervical cancer; cervical
intraepithelial neoplasia grade 2 or sores
and adenocarcinoma in situ; and
cervical intraepithelial neoplasia grade
1. Subsequent to this approval, the
Patent and Trademark Office received a
patent term restoration application for
CERVARIX (U.S. Patent No. 7,351,533)
from MedImmune, LLC., and the Patent
and Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated October 26, 2010, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
12975
CERVARIX 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
CERVARIX is 4,027 days. Of this time,
3,094 days occurred during the testing
phase of the regulatory review period,
while 933 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 Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: October 9, 1998. The
applicant claims September 8, 1998, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was October 9, 1998,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): March 29, 2007. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
CERVARIX (BLA 125259/0) was
submitted on March 29, 2007.
3. The date the application was
approved: October 16, 2009. FDA has
verified the applicant’s claim that BLA
125259/0 was approved on October 16,
2009.
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 562 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 May 9, 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
September 5, 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.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
E:\FR\FM\09MRN1.SGM
09MRN1
12976
Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Notices
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
https://www.regulations.gov may be
viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: February 14, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2011–5310 Filed 3–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Supplemental
Information Request for the Submission
of the Updated State Plan for the Home
Visiting Program (OMB No. 0915–
0336)—[Extension]
On March 23, 2010, the President
signed into law the Patient Protection
and Affordable Care Act of 2010 (Pub.
L. 111–148), historic and transformative
legislation designed to make quality,
affordable health care available to all
Americans, reduce costs, improve
health care quality, enhance disease
prevention, and strengthen the health
care workforce. Through a provision
authorizing the creation of the Maternal,
Infant, and Early Childhood Home
Visiting Program, (https://frwebgate.
access.gpo.gov/cgi-bin/
getdoc.cgi?dbname=111_cong_bills&
docid=f:h3590enr.txt.pdf, pages 216–
225), the Act responds to the diverse
needs of children and families in
communities at risk and provides an
unprecedented opportunity for
collaboration and partnership at the
Federal, State, and community levels to
improve health and development
outcomes for at-risk children through
evidence-based home visiting programs.
The Maternal, Infant, and Early
Childhood Home Visiting (MIECHV)
Program is designed: (1) To strengthen
and improve the programs and activities
carried out under Title V; (2) to improve
coordination of services for at-risk
communities; and (3) to identify and
provide comprehensive services to
improve outcomes for families who
reside in at-risk communities.
To achieve the legislative
requirements of the MIECHV program,
the following application steps were
required:
Number of
respondents
Emcdonald on DSK2BSOYB1PROD with NOTICES
Instrument
Section 1: Identification of the State’s Targeted At-Risk
Community(ies) ................................................................
Section 2: State Home Visiting Program Goals and Objectives ..................................................................................
Section 3: Selection of Proposed Home Visiting Model(s)
and Explanation of How the Model(s) Meet the Needs of
Targeted Community(ies) .................................................
Section 4: Implementation Plan for Proposed State Home
Visiting Program ...............................................................
VerDate Mar<15>2010
18:04 Mar 08, 2011
Jkt 223001
PO 00000
Frm 00045
Responses
per respondent
The first step was submission of an
application for funding: the Funding
Opportunity Announcement (FOA)
HRSA–10–275 was issued on June 10,
2010, and State applications were due
July 9, 2010. These applications were to
include plans for completing the
statewide needs assessment and initial
State plans for developing the program
in order to meet the criteria identified
in the legislation. Submission of the
needs assessments in the form and
manner required by the Secretary is also
a required condition for States to receive
FY 2011 Title V Block Grant allotments.
On September 20, 2010, all 50 States,
the District of Columbia, and five U.S.
territories submitted needs assessments
that identified communities at risk. The
needs assessments submitted were
approved, and all 56 applicants have
received FY 2011 Title V Block Grant
funds.
As a condition of receiving the
remaining grant award made to States in
July 2010, each of the 56 applicants is
also required to develop an Updated
State Plan for a State Home Visiting
Program. The Secretary of Health and
Human Services must approve the
Updated State Plan before the release of
the remaining grant funds.
The information requested for the
Updated State Plan is intended to help
States view their proposed State Home
Visiting Program as a service strategy
aimed at developing a comprehensive,
high-quality early childhood system that
promotes maternal, infant, and early
childhood health, safety and
development, and strong parent-child
relationships in the targeted
community(ies) at risk. Ultimately, the
information provided will help States
develop a comprehensive plan that
addresses community risk factors,
builds on strengths identified in the
targeted community(ies), and responds
to the specific characteristics and needs
of families in each of these
communities.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
56
56
30
1,680
56
1
56
30
1,680
56
1
56
30
1,680
56
Fmt 4703
1
1
56
60
3,360
Sfmt 4703
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 12975-12976]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5310]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-E-0332]
Determination of Regulatory Review Period for Purposes of Patent
Extension; CERVARIX
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for CERVARIX 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 human biological 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 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 human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological 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 a human biological product will include all of the testing
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing the human biological product
CERVARIX (human papillomavirus bivalent (types 16 and 18) vaccine).
CERVARIX is indicated for prevention of the following diseases caused
by oncogenic human papillomavirus types 16 and 18: cervical cancer;
cervical intraepithelial neoplasia grade 2 or sores and adenocarcinoma
in situ; and cervical intraepithelial neoplasia grade 1. Subsequent to
this approval, the Patent and Trademark Office received a patent term
restoration application for CERVARIX (U.S. Patent No. 7,351,533) from
MedImmune, LLC., and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated October 26, 2010, FDA advised the Patent
and Trademark Office that this human biological product had undergone a
regulatory review period and that the approval of CERVARIX 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
CERVARIX is 4,027 days. Of this time, 3,094 days occurred during the
testing phase of the regulatory review period, while 933 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 Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: October 9,
1998. The applicant claims September 8, 1998, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was October 9, 1998,
which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): March 29, 2007. FDA has verified the
applicant's claim that the biologics license application (BLA) for
CERVARIX (BLA 125259/0) was submitted on March 29, 2007.
3. The date the application was approved: October 16, 2009. FDA has
verified the applicant's claim that BLA 125259/0 was approved on
October 16, 2009.
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 562 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 May 9, 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 September 5, 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.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written
[[Page 12976]]
comments and written petitions. It is only necessary to send one set of
comments. It is no longer necessary to send three copies of mailed
comments. However, if you submit a written petition, you must submit
three copies of the petition. Identify comments with the docket number
found in brackets in the heading of this document.
Comments and petitions that have not been made publicly available
on https://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 14, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-5310 Filed 3-8-11; 8:45 am]
BILLING CODE 4160-01-P
