Determination of Regulatory Review Period for Purposes of Patent Extension; EMEND FOR INJECTION, 51159-51160 [E9-23900]
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Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices
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[FR Doc. E9–23922 Filed 10–2–09; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0057]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; EMEND FOR INJECTION
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for EMEND
FOR INJECTION 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 written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
VerDate Nov<24>2008
14:59 Oct 02, 2009
Jkt 220001
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 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 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
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human 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 a human drug 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 drug product EMEND FOR
INJECTION (fosaprepitant meglumine).
EMEND FOR INJECTION, in
combination with other antiemetic
agents, is indicated for the prevention of
acute and delayed nausea and vomiting
associated with initial and repeat
courses of highly emetogenic cancer
chemotherapy including high-dose
cisplatin, and for prevention of nausea
and vomiting associated with initial and
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
$175,000
50,000
50,000
100,000
51159
Location
San Francisco, CA.
Minneapolis, MN.
Chicago, IL.
Washington, DC.
repeat courses of moderately emetogenic
cancer chemotherapy. Subsequent to
this approval, the Patent and Trademark
Office received a patent term restoration
application for EMEND FOR INJECTION
(U.S. Patent No. 5,691,336) from Merck
& Co., 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 February 26, 2009, FDA
advised the Patent and Trademark
Office that this human drug product had
undergone a regulatory review period
and that the approval of EMEND FOR
INJECTION 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
EMEND FOR INJECTION is 4,473 days.
Of this time, 3,810 days occurred during
the testing phase of the regulatory
review period, while 663 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 (the act) (21 U.S.C.
355(i)) became effective: October 29,
1995. The applicant claims October 28,
1995, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was October 29, 1995,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: April 3, 2006. The
applicant claims March 31, 2006, as the
date the new drug application (NDA) for
Emend for Injection (NDA 22–023) was
initially submitted. However, FDA
records indicate that NDA 22–023 was
submitted on April 3, 2006.
3. The date the application was
approved: January 25, 2008. FDA has
verified the applicant’s claim that NDA
22–023 was approved on January 25,
2008.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
E:\FR\FM\05OCN1.SGM
05OCN1
51160
Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices
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 1,826 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) written or
electronic comments and ask for a
redetermination by December 4, 2009.
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
April 5, 2010. 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: June 23, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E9–23900 Filed 10–2–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0470]
Draft Guidance for Industry and FDA
Staff; the Scope of the Prohibition
Against Marketing a Tobacco Product
in Combination With Another Article or
Product Regulated Under the Federal
Food, Drug, and Cosmetic Act;
Availability
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘The Scope of the Prohibition
Against Marketing a Tobacco Product in
Combination with Another Article or
Product Regulated under the Federal
Food, Drug, and Cosmetic Act.’’ This
VerDate Nov<24>2008
14:59 Oct 02, 2009
Jkt 220001
guidance is intended for manufacturers,
retailers, importers, and FDA staff. The
Federal Food, Drug, and Cosmetic Act
(FDCA), as amended by the Family
Smoking Prevention and Tobacco
Control Act (FSPTCA), states ‘‘A
tobacco product shall not be marketed
in combination with any other article or
product regulated under this Act
(including a drug, biologic, food,
cosmetic, medical device, or a dietary
supplement).’’ The guidance discusses
certain activities that FDA believes do
or do not fall within the scope of the
prohibition. The guidance is not
intended to be an exhaustive analysis of
all activities that may or may not fall
within the scope of the prohibition.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by January 4, 2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘The Scope of the
Prohibition Against Marketing a
Tobacco Product in Combination with
Another Article or Product Regulated
under the Federal Food, Drug, and
Cosmetic Act’’ to the Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–595–7946. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit written comments concerning
this draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Michele Mital, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 0850–3229, 301–796–
4800, Michele.Mital@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President
signed the FSPTCA (Public Law 111–31)
into law. The FSPTCA amended the
FDCA (21 U.S.C. 301 et seq.) by adding
a new chapter granting FDA important
new authority to regulate the
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
manufacture, marketing, and
distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 201(rr)(4) of the FDCA, as
amended by the FSPTCA, states ‘‘A
tobacco product shall not be marketed
in combination with any other article or
product regulated under this Act
(including a drug, biologic, food,
cosmetic, medical device, or a dietary
supplement).’’
This guidance discusses certain
activities that FDA believes do or do not
fall within the scope of the prohibition.
The guidance is not intended to be an
exhaustive analysis of all activities that
may or may not fall within the scope of
the prohibition.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized will
represent the agency’s current thinking
on ‘‘The Scope of the Prohibition
Against Marketing a Tobacco Product in
Combination with Another Article or
Product Regulated under the Federal
Food, Drug, and Cosmetic Act.’’ It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. The guidance document
may be accessed at the Center for
Tobacco Products’ Web site at https://
www.fda.gov/tobaccoproducts. This
guidance document is also available at
https://www.regulations.gov. To receive
‘‘The Scope of the Prohibition Against
Marketing a Tobacco Product in
Combination with Another Article or
Product Regulated under the Federal
Food, Drug, and Cosmetic Act,’’ you
may either send an e-mail request to
michele.mital@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–595–7946 to receive
a hard copy.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 74, Number 191 (Monday, October 5, 2009)]
[Notices]
[Pages 51159-51160]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23900]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-E-0057]
Determination of Regulatory Review Period for Purposes of Patent
Extension; EMEND FOR INJECTION
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for EMEND FOR INJECTION 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 written comments and petitions to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.regulations.gov.
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 (Public Law 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Public Law 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 the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human 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 a human drug 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 drug product EMEND
FOR INJECTION (fosaprepitant meglumine). EMEND FOR INJECTION, in
combination with other antiemetic agents, is indicated for the
prevention of acute and delayed nausea and vomiting associated with
initial and repeat courses of highly emetogenic cancer chemotherapy
including high-dose cisplatin, and for prevention of nausea and
vomiting associated with initial and repeat courses of moderately
emetogenic cancer chemotherapy. Subsequent to this approval, the Patent
and Trademark Office received a patent term restoration application for
EMEND FOR INJECTION (U.S. Patent No. 5,691,336) from Merck & Co., 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 February 26, 2009, FDA advised the Patent and Trademark
Office that this human drug product had undergone a regulatory review
period and that the approval of EMEND FOR INJECTION 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
EMEND FOR INJECTION is 4,473 days. Of this time, 3,810 days occurred
during the testing phase of the regulatory review period, while 663
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 (the act) (21 U.S.C. 355(i)) became effective:
October 29, 1995. The applicant claims October 28, 1995, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was October
29, 1995, which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the act: April 3, 2006.
The applicant claims March 31, 2006, as the date the new drug
application (NDA) for Emend for Injection (NDA 22-023) was initially
submitted. However, FDA records indicate that NDA 22-023 was submitted
on April 3, 2006.
3. The date the application was approved: January 25, 2008. FDA has
verified the applicant's claim that NDA 22-023 was approved on January
25, 2008.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and
[[Page 51160]]
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 1,826 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) written or electronic comments and ask for a redetermination
by December 4, 2009. 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 April
5, 2010. 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: June 23, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-23900 Filed 10-2-09; 8:45 am]
BILLING CODE 4160-01-S
