Determination of Regulatory Review Period for Purposes of Patent Extension; HUMIRA, 5342-5343 [E6-1313]
Download as PDF
<![CDATA[
5342
Federal Register / Vol. 71, No. 21 / Wednesday, February 1, 2006 / Notices
Register of February 2, 2005 (70 FR
5452).
II. Advance Notice of Termination
Under section 564(b)(3) of the act, the
FDA Commissioner provided advance
notice of the termination of the former
HHS Secretary’s declaration of
emergency to the Department of
Defense.
The January 2006 letter notifying the
Department of Defense of the
termination of the declaration of
emergency follows:
William Winkenwerder, Jr., M.D.,
Assistant Secretary of Defense for Health
Affairs,
The Pentagon,
Washington, D.C. 20301–1200
Dear Dr. Winkenwerder:
This letter is to provide advance notice of
the termination of the above-referenced
declaration of emergency that was issued by
Secretary of Health and Human Services
Tommy G. Thompson on January 14, 2005,
pursuant to section 564(b)(1) of the Federal
Food, Drug, and Cosmetic Act (the Act), 21
U.S.C. § 360bbb–3.
In accordance with section 564(b)(2)(A)(ii)
of the Act, the declaration of emergency will
terminate by expiration on January 14, 2006,
which is the end of the one year period that
began on the date that the declaration was
made. This advance notice of termination
will be published in the Federal Register,
pursuant to section 564(b)(4) of the Act.
Sincerely,
Andrew C. von Eschenbach, M.D.
Acting Commissioner of Food and Drugs
Dated: January 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–1311 Filed 1–31–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E–0445]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; HUMIRA
AGENCY:
Food and Drug Administration,
HHS.
cchase on PROD1PC60 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
HUMIRA 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
VerDate Aug<31>2005
19:42 Jan 31, 2006
Jkt 208001
Commerce, for the extension of a patent
which claims that human biological
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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Claudia V. Grillo, Office of Regulatory
Policy (HFD–013), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 240–453–6681.
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
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 HUMIRA
(adalimumab). HUMIRA is indicated for
reducing signs and symptoms, including
major clinical response, inhibiting the
progression of structural damage and
improving physical function in adult
patients with moderately to severely
active rheumatoid arthritis. Subsequent
to this approval, the Patent and
PO 00000
Frm 00111
Fmt 4703
Sfmt 4703
Trademark Office received a patent term
restoration application for HUMIRA
(U.S. Patent No. 6,090,382) from Abbott
Biotechnology Ltd., and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated April 8, 2005, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
HUMIRA represented the first permitted
commercial marketing or use of the
product. Shortly 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
HUMIRA is 1,722 days. Of this time,
1,443 days occurred during the testing
phase of the regulatory review period,
while 279 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: April 16, 1998. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
April 16, 1998.
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 28, 2002. FDA has
verified the applicant’s claim that the
product license application (BLA) for
HUMIRA (BLA 125057) was initially
submitted on March 28, 2002.
3. The date the application was
approved: December 31, 2002. FDA has
verified the applicant’s claim that BLA
125057 was approved on December 31,
2002.
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 326 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 April 3, 2006.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
E:\FR\FM\01FEN1.SGM
01FEN1
Federal Register / Vol. 71, No. 21 / Wednesday, February 1, 2006 / Notices
during the regulatory review period by
July 31, 2006. 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 (see ADDRESSES). 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: January 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–1313 Filed 2–1–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
cchase on PROD1PC60 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues. The committee
also advises and makes
recommendations to the Secretary of
Health and Human Services under 45
CFR 46.407 on research involving
children as subjects that is conducted or
supported by the Department of Health
and Human Services, when that
research is also regulated by FDA.
Date and Time: The meeting will be
held on Wednesday, March 22, 2006,
from 8 a.m. to 6 p.m.
Location: Washington DC North/
Gaithersburg Hilton, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: Jan N. Johannessen,
Office of Science and Health
Coordination, Office of the
Commissioner (HF–33), Food and Drug
Administration, 5600 Fishers Lane, (for
VerDate Aug<31>2005
17:49 Jan 31, 2006
Jkt 208001
express delivery, rm. 14C–06) Rockville,
MD 20857, 301–827–6687, e-mail:
Jan.Johannessen@fda.hhs.gov or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
8732310001. Please call the Information
Line for up to date information on this
meeting.
Agenda: The Pediatric Advisory
Committee will hear and discuss a
report by the agency, as mandated in
Section 17 of the Best Pharmaceuticals
for Children Act (BPCA), on adverse
event reports possibly related to
clofarabine (CLOLAR), irbesartan
(AVAPRO), sibutramine (MERIDIA), and
the mixed salts amphetamine product
(ADDERALL). In continuation of a prior
committee discussion of adverse events
for the class of methylphenidate
products used to treat attention deficit
hyperactivity disorder (ADHD), the
committee will hear and discuss
neuropsychiatric adverse events
possibly related to other approved
ADHD medications. The presentations
will focus on neuropsychiatric adverse
event reports and clinical trial data from
approved ADHD medications. The
committee will also receive an update
on efforts to better understand
cardiovascular adverse events possibly
related to ADHD medications.
The background material will become
available no later than the day before
the meeting and will be posted under
the Pediatric Advisory Committee
Docket site at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm. (Click
on the year 2006 and scroll down to
Pediatric Advisory Committee
meetings.)
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person by March 8, 2006. Oral
presentations from the public will be
scheduled on March 22, 2006, between
approximately 1 p.m. and 2 p.m. Time
allotted for each presentation may be
limited. Those desiring to make formal
oral presentations should notify the
contact person by March 8, 2006, and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
PO 00000
Frm 00112
Fmt 4703
Sfmt 4703
5343
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please notify Jan N.
Johannessen at least 7 days in advance
of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: January 24, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–1223 Filed 1–31–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Psychopharmacologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the of the Food and Drug
Administration (FDA). The meeting will
be open to the public.
Name of Committee:
Psychopharmacologic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 23, 2006, from 8 a.m. to
5 p.m.
Location: Hilton Washington DC
North/Gaithersburg,The Ballrooms, 620
Perry Pkwy, Gaithersburg, MD. The
hotel phone number is 301–977–8900.
Contact Person: Cicely Reese, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093) Rockville,
MD 20857, 301–827–7001, Fax: 301–
827–6776, e-mail:
ReeseCi@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512544. Please call the Information
Line for up-to-date information on this
meeting. The background material will
become available no later than the day
before the meeting and will be posted
on FDA’s Web site at https://
www.fda.gov/ohrms/dockets/ac/
acmenu.htm. Click on the year 2006 and
scroll down to the
E:\FR\FM\01FEN1.SGM
01FEN1
]]>Agencies
[Federal Register Volume 71, Number 21 (Wednesday, February 1, 2006)]
[Notices]
[Pages 5342-5343]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1313]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004E-0445]
Determination of Regulatory Review Period for Purposes of Patent
Extension; HUMIRA
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for HUMIRA 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 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.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of
Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 240-453-6681.
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 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
HUMIRA (adalimumab). HUMIRA is indicated for reducing signs and
symptoms, including major clinical response, inhibiting the progression
of structural damage and improving physical function in adult patients
with moderately to severely active rheumatoid arthritis. Subsequent to
this approval, the Patent and Trademark Office received a patent term
restoration application for HUMIRA (U.S. Patent No. 6,090,382) from
Abbott Biotechnology Ltd., and the Patent and Trademark Office
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated April 8, 2005, FDA advised
the Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of HUMIRA
represented the first permitted commercial marketing or use of the
product. Shortly 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
HUMIRA is 1,722 days. Of this time, 1,443 days occurred during the
testing phase of the regulatory review period, while 279 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: April 16,
1998. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on April 16,
1998.
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 28, 2002. FDA has verified the
applicant's claim that the product license application (BLA) for HUMIRA
(BLA 125057) was initially submitted on March 28, 2002.
3. The date the application was approved: December 31, 2002. FDA
has verified the applicant's claim that BLA 125057 was approved on
December 31, 2002.
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 326 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 April 3, 2006. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence
[[Page 5343]]
during the regulatory review period by July 31, 2006. 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 (see ADDRESSES). 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: January 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-1313 Filed 2-1-06; 8:45 am]
BILLING CODE 4160-01-S
