Determination of Regulatory Review Period for Purposes of Patent Extension; STELARA, 75678-75679 [2010-30512]
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Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices
Administration, 1350 Piccard Dr., PI50–
410B, Rockville, MD 20850, 301–796–
3794, E-mail:
Jonnalynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes Agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal Agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility, (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Exports: Notification and
Recordkeeping Requirements—21 CFR
Part 1 (OMB Control Number 0910–
0482)—Extension
The respondents to this information
collection are exporters who have
notified FDA of their intent to export
unapproved products that may not be
sold or marketed in the United States as
allowed under section 801(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 381). In
general, the notification identifies the
product being exported (e.g., name,
description, and in some cases, country
of destination) and specifies where the
notification should be sent. These
notifications are sent only for an initial
export; subsequent exports of the same
product to the same destination (or, in
the case of certain countries identified
in section 802(b) of the FD&C Act (21
U.S.C. 382)) would not result in a
notification to FDA.
The recordkeepers for this
information collection export human
drugs, biologics, devices, animal drugs,
foods, and cosmetics that may not be
sold in the United States and maintain
records demonstrating their compliance
with the requirements in section
801(e)(1) of the FD&C Act.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Annual
frequency
per response
Total
annual
responses
Hours per
response
Total hours
1.101 (d) to (e) .....................................................................
400
3
1,200
15
18,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
Number of
recordkeepers
Annual
frequency per
recordkeeping
Total annual
records
Hours per
record
Total
hours
1.101 (b) to (c) ...........................................................
320
3
960
22
21,120
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30433 Filed 12–3–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jdjones on DSK8KYBLC1PROD with NOTICES
[Docket Nos. FDA–2010–E–0032 and FDA–
2010–E–0036]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; STELARA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
15:27 Dec 03, 2010
Jkt 223001
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
STELARA 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.
ADDRESSES:
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
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.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06DEN1.SGM
06DEN1
jdjones on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 75, No. 233 / Monday, December 6, 2010 / Notices
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 biologic product STELARA
(ustekinumab). STELARA is indicated
for treatment of adult patients with
severe plaque psoriasis who are
candidates for phototherapy or systemic
therapy. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for STELARA (U.S. Patent
No. 6,902,734 and 7,166,285) from
Centocor Ortho Biotech Inc., and the
Patent and Trademark Office requested
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated March 24,
2010, FDA advised the Patent and
Trademark Office that this human
biological product had undergone a
regulatory review period and that the
approval of STELARA 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
STELARA is 3,165 days. Of this time,
2,498 days occurred during the testing
phase of the regulatory review period,
while 667 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: January 27, 2001. The
applicant claims December 28, 2000 as
the date the investigational new drug
application (IND) became effective.
VerDate Mar<15>2010
15:27 Dec 03, 2010
Jkt 223001
However, FDA records indicate that the
IND effective date was January 27, 2001,
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): November 29, 2007. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for STELARA (BLA 125261/0) was
initially submitted on November 29,
2007.
3. The date the application was
approved: September 25, 2009. FDA has
verified the applicant’s claim that BLA
125261/0 was approved on September
25, 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 applications for patent extension,
this applicant seeks 425 or 510 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 February 4,
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 June 6, 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
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
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
75679
Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–30512 Filed 12–3–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0584]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BESIVANCE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
BESIVANCE 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 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
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 drug
products, the testing phase begins when
SUMMARY:
E:\FR\FM\06DEN1.SGM
06DEN1
]]>Agencies
[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75678-75679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30512]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-E-0032 and FDA-2010-E-0036]
Determination of Regulatory Review Period for Purposes of Patent
Extension; STELARA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for STELARA 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
[[Page 75679]]
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 biologic product
STELARA (ustekinumab). STELARA is indicated for treatment of adult
patients with severe plaque psoriasis who are candidates for
phototherapy or systemic therapy. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for STELARA (U.S. Patent No. 6,902,734 and 7,166,285) from
Centocor Ortho Biotech Inc., and the Patent and Trademark Office
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated March 24, 2010, FDA advised
the Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of STELARA
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
STELARA is 3,165 days. Of this time, 2,498 days occurred during the
testing phase of the regulatory review period, while 667 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: January 27,
2001. The applicant claims December 28, 2000 as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was January 27, 2001,
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): November 29, 2007. FDA has verified the
applicant's claim that the biologics license application (BLA) for
STELARA (BLA 125261/0) was initially submitted on November 29, 2007.
3. The date the application was approved: September 25, 2009. FDA
has verified the applicant's claim that BLA 125261/0 was approved on
September 25, 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
applications for patent extension, this applicant seeks 425 or 510 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 February 4, 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 June 6, 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 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 regulations.gov may be viewed in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-30512 Filed 12-3-10; 8:45 am]
BILLING CODE 4160-01-P
