Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent Nos. 5,759,580 and 6,545,040, 34749-34750 [2010-14814]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices
annualized cost to respondents is
estimated at $3,793.00. There are no
capital costs to report. There are no
operating or maintenance costs to
report.
Direct Comments to OMB
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the:
Office of Management and Budget,
Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
reports and instrument, contact Kathy
Kranzfelder, Director, NIDDK Office of
Communications and Public Liaison,
Building 31, Room 9A06, MSC2560,
Bethesda, MD 20852 or e-mail your
request, including your address to:
KranzfelderK@mail.nih.gov. To request
more information on the proposed
project or to obtain a copy of the data
collection reports and instrument,
contact Kathy Kranzfelder, Director,
NIDDK Office of Communications and
Public Liaison, Building 31, Room
9A06, MSC2560, Bethesda, MD 20852.
You may also submit comment and data
by electronic mail (e-mail) at
KranzfelderK@mail.nih.gov.
Dated: June 14, 2010.
Lynell Nelson,
NIDDK Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–14793 Filed 6–17–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2008–E–0268 and FDA–
2008–E–0267]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BYSTOLIC; U.S. Patent
Nos. 5,759,580 and 6,545,040
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSKHWCL6B1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
BYSTOLIC and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of Patents
and Trademarks, Department of
VerDate Mar<15>2010
16:17 Jun 17, 2010
Jkt 220001
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. 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.
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 human drug
product 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 BYSTOLIC
(nebivolol hydrochloride). BYSTOLIC is
indicated for the treatment of
hypertension. Subsequent to this
approval, the Patent and Trademark
Office received two patent term
restoration applications for BYSTOLIC
(U.S. Patent Nos. 5,759,580 and
6,545,040) from Forest Laboratories,
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
34749
Inc., and the Patent and Trademark
Office requested FDA’s assistance in
determining the patents’ eligibilities for
patent term restoration. In a letter dated
June 10, 2008, FDA advised the Patent
and Trademark Office that this human
drug product had undergone a
regulatory review period and that the
approval of BYSTOLIC 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
BYSTOLIC is 6,790 days. Of this time,
5,463 days occurred during the testing
phase and 1,327 days occurred during
the approval phase. These periods of
time were derived from the following
dates:
1. The date an exemption under
subsection 505(i) of the Federal Food,
Drug, and Cosmetic Act (the act) (U.S.C.
355 (i)) involving this drug product
became effective: May 17, 1989. The
applicant claims July 6, 2000, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND originally became effective on May
17, 1989, which was 30 days after FDA
receipt of the original IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the Federal Food, Drug, and
Cosmetic Act: April 30, 2004. The
applicant claims April 29, 2004, as the
date the new drug application (NDA) for
BYSTOLIC (NDA 21–742) was initially
submitted. However, FDA records
indicate that NDA 21–742 was
submitted on April 30, 2004.
3. The date the application was
approved: December 17, 2007. FDA has
verified the applicant’s claim that NDA
21–742 was approved on December 17,
2007. 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 1,828 days of patent
term extension for U.S. Patent No.
5,759,580 and 619 days of patent term
extension for U.S. Patent No. 6,545,040.
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 August 17, 2010.
Furthermore, any interested person may
petition FDA for a determination
E:\FR\FM\18JNN1.SGM
18JNN1
34750
Federal Register / Vol. 75, No. 117 / Friday, June 18, 2010 / Notices
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 15, 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: May 10, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: J.
Felix Rogers, Ph.D., M.P.H., NCIPC/ERPO,
CDC, 4770 Buford Highway, NE., M/S F63,
Atlanta, Georgia 30341–3724, Telephone
(770) 488–4334. The Director, Management
Analysis and Services Office has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities for both
CDC and the Agency for Toxic Substances
and Disease Registry.
Dated: June 10, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–14772 Filed 6–17–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2010–14814 Filed 6–17–10; 8:45 am]
BILLING CODE 4160–01–S
[Docket No. FDA–2010–N–0295 ]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Web-Based Public Meeting To Discuss
Issues Related to the Development of
an Enforcement Action Plan; Request
for Data, Information, and Views
Centers for Disease Control and
Prevention
AGENCY:
HHS.
Disease, Disability, and Injury
Prevention and Control
srobinson on DSKHWCL6B1PROD with NOTICES
Special Emphasis Panel (SEP):
Cooperative Agreement Program for the
National Academic Centers of
Excellence in Youth Violence
Prevention (U01), Funding Opportunity
Announcement (FOA) CE10–004, Initial
Review
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Times and Dates: 8 a.m.–5 p.m., July 22,
2010 (Closed). 8 a.m.–5 p.m., July 23, 2010
(Closed).
Place: Embassy Suites Atlanta—Buckhead,
3285 Peachtree Road, NE., Atlanta, Georgia
30305, Telephone: 404–261–7733.
Status: The meetings will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5,
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Section 10(d) of Public Law
92–463.
Matters to be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Cooperative Agreement Program
for the National Academic Centers of
Excellence in Youth Violence Prevention
(U01), FOA CE10–004.’’
VerDate Mar<15>2010
16:17 Jun 17, 2010
Jkt 220001
Food and Drug Administration,
ACTION: Notice of Web-based public
meeting; request for data, information,
and views.
SUMMARY: The Food and Drug
Administration (FDA), Center for
Tobacco Products is announcing that it
is hosting a Web-based public meeting
to discuss issues regarding the
development of an enforcement action
plan to enforce restrictions on
promotion and advertising of menthol
and other cigarettes to youth, including
youth in minority communities. FDA is
seeking participation in the Web-based
public meeting and data, information,
and views from all interested parties,
including, but not limited to, public
health organizations, minority
community groups and leaders, other
stakeholders with demonstrated
expertise and experience in serving
minority communities, groups serving
youth, patient groups, advertising
agencies, the regulated industry, and
other interested parties. This Web-based
public meeting and the data,
information, and views we receive are
intended to help FDA in developing an
enforcement action plan. FDA is seeking
input on a number of specific issues, but
is interested in other pertinent
information as well.
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
DATES: The Web-based public meeting
will be held on June 30, 2010, from 9
a.m. to 5 p.m. EDT. Persons interested
in participating in the Web-based public
meeting must submit written or
electronic registration by close of
business on June 23, 2010. Submit
written and electronic data, information,
and views by August 2, 2010.
ADDRESSES: Submit data, information,
and views electronically to https://
www.regulations.gov. Submit written
data, information, and views to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic
registration to
CTPCompliance@fda.hhs.gov. Submit
written registration to Anthony W. Lee,
Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850.
FOR FURTHER INFORMATION CONTACT:
Anthony W. Lee, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 877–287–
1373, email:
AnthonyW.Lee@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act) (Public Law 111–31; 123 Stat.
1776) was enacted on June 22, 2009,
providing FDA with the authority to
regulate tobacco products in order to
protect the public health generally and
to reduce tobacco use by minors.
Tobacco products are responsible for
more than 440,000 deaths each year in
the United States (Ref. 1). In enacting
the Tobacco Control Act, Congress
found, among other things, that the use
of tobacco products by children is a
pediatric disease and virtually all new
users of tobacco products are under the
minimum legal age to purchase such
products (sections 2(1) and (4) of the
Tobacco Control Act). Advertising,
marketing, and promotion of tobacco
products have been ‘‘especially directed
to attract young persons to use tobacco
products, and these efforts have resulted
in increased use of such products by
youth’’ (section 2(15) of the Tobacco
Control Act).
Additionally, the rates of tobacco use
and tobacco-related mortality are higher
among certain racial and ethnic groups,
including American Indian and Alaska
Natives, and African-American men. As
the National Cancer Institute (NCI)
noted in Monograph 19, ‘‘[t]argeting of
various population groups—including
* * * specific racial and ethnic
E:\FR\FM\18JNN1.SGM
18JNN1
]]>Agencies
[Federal Register Volume 75, Number 117 (Friday, June 18, 2010)]
[Notices]
[Pages 34749-34750]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-14814]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2008-E-0268 and FDA-2008-E-0267]
Determination of Regulatory Review Period for Purposes of Patent
Extension; BYSTOLIC; U.S. Patent Nos. 5,759,580 and 6,545,040
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for BYSTOLIC and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications 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 comments and petitions 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 (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 human drug product 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 BYSTOLIC
(nebivolol hydrochloride). BYSTOLIC is indicated for the treatment of
hypertension. Subsequent to this approval, the Patent and Trademark
Office received two patent term restoration applications for BYSTOLIC
(U.S. Patent Nos. 5,759,580 and 6,545,040) from Forest Laboratories,
Inc., and the Patent and Trademark Office requested FDA's assistance in
determining the patents' eligibilities for patent term restoration. In
a letter dated June 10, 2008, FDA advised the Patent and Trademark
Office that this human drug product had undergone a regulatory review
period and that the approval of BYSTOLIC 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
BYSTOLIC is 6,790 days. Of this time, 5,463 days occurred during the
testing phase and 1,327 days occurred during the approval phase. These
periods of time were derived from the following dates:
1. The date an exemption under subsection 505(i) of the Federal
Food, Drug, and Cosmetic Act (the act) (U.S.C. 355 (i)) involving this
drug product became effective: May 17, 1989. The applicant claims July
6, 2000, as the date the investigational new drug application (IND)
became effective. However, FDA records indicate that the IND originally
became effective on May 17, 1989, which was 30 days after FDA receipt
of the original IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the Federal Food, Drug,
and Cosmetic Act: April 30, 2004. The applicant claims April 29, 2004,
as the date the new drug application (NDA) for BYSTOLIC (NDA 21-742)
was initially submitted. However, FDA records indicate that NDA 21-742
was submitted on April 30, 2004.
3. The date the application was approved: December 17, 2007. FDA
has verified the applicant's claim that NDA 21-742 was approved on
December 17, 2007. 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 1,828 days of patent term extension for U.S. Patent No. 5,759,580
and 619 days of patent term extension for U.S. Patent No. 6,545,040.
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 August 17, 2010. Furthermore, any interested person may petition FDA
for a determination
[[Page 34750]]
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by December 15, 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: May 10, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-14814 Filed 6-17-10; 8:45 am]
BILLING CODE 4160-01-S
