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5342 Federal Register / Vol. 71, No.

21 / Wednesday, February 1, 2006 / Notices

Register of February 2, 2005 (70 FR Commerce, for the extension of a patent Trademark Office received a patent term
5452). which claims that human biological restoration application for HUMIRA
product. (U.S. Patent No. 6,090,382) from Abbott
II. Advance Notice of Termination
ADDRESSES: Submit written comments Biotechnology Ltd., and the Patent and
Under section 564(b)(3) of the act, the and petitions to the Division of Dockets Trademark Office requested FDA’s
FDA Commissioner provided advance Management (HFA–305), Food and Drug assistance in determining this patent’s
notice of the termination of the former Administration, 5630 Fishers Lane, rm. eligibility for patent term restoration. In
HHS Secretary’s declaration of 1061, Rockville, MD 20852. Submit a letter dated April 8, 2005, FDA
emergency to the Department of electronic comments to http:// advised the Patent and Trademark
Defense. www.fda.gov/dockets/ecomments. Office that this human biological
The January 2006 letter notifying the product had undergone a regulatory
Department of Defense of the review period and that the approval of
Claudia V. Grillo, Office of Regulatory
termination of the declaration of Policy (HFD–013), Food and Drug HUMIRA represented the first permitted
emergency follows: Administration, 5600 Fishers Lane, commercial marketing or use of the
William Winkenwerder, Jr., M.D., Rockville, MD 20857, 240–453–6681. product. Shortly thereafter, the Patent
Assistant Secretary of Defense for Health SUPPLEMENTARY INFORMATION: The Drug
and Trademark Office requested that
Price Competition and Patent Term FDA determine the product’s regulatory
Restoration Act of 1984 (Public Law 98– review period.
The Pentagon, FDA has determined that the
Washington, D.C. 20301–1200 417) and the Generic Animal Drug and
Patent Term Restoration Act (Public applicable regulatory review period for
Dear Dr. Winkenwerder:
Law 100–670) generally provide that a HUMIRA is 1,722 days. Of this time,
This letter is to provide advance notice of
the termination of the above-referenced patent may be extended for a period of 1,443 days occurred during the testing
declaration of emergency that was issued by up to 5 years so long as the patented phase of the regulatory review period,
Secretary of Health and Human Services item (human drug product, animal drug while 279 days occurred during the
Tommy G. Thompson on January 14, 2005, product, medical device, food additive, approval phase. These periods of time
pursuant to section 564(b)(1) of the Federal or color additive) was subject to were derived from the following dates:
Food, Drug, and Cosmetic Act (the Act), 21 1. The date an exemption under
U.S.C. § 360bbb–3.
regulatory review by FDA before the
item was marketed. Under these acts, a section 505(i) of the Federal Food, Drug,
In accordance with section 564(b)(2)(A)(ii) and Cosmetic Act (21 U.S.C. 355(i))
of the Act, the declaration of emergency will product’s regulatory review period
terminate by expiration on January 14, 2006, forms the basis for determining the became effective: April 16, 1998. FDA
which is the end of the one year period that amount of extension an applicant may has verified the applicant’s claim that
began on the date that the declaration was receive. the date the investigational new drug
made. This advance notice of termination A regulatory review period consists of application became effective was on
will be published in the Federal Register, two periods of time: A testing phase and April 16, 1998.
pursuant to section 564(b)(4) of the Act. an approval phase. For human 2. The date the application was
Sincerely, biological products, the testing phase initially submitted with respect to the
Andrew C. von Eschenbach, M.D. begins when the exemption to permit human biological product under section
Acting Commissioner of Food and Drugs the clinical investigations of the 351 of the Public Health Service Act (42
Dated: January 25, 2006. biological becomes effective and runs U.S.C. 262): March 28, 2002. FDA has
Jeffrey Shuren, until the approval phase begins. The verified the applicant’s claim that the
approval phase starts with the initial product license application (BLA) for
Assistant Commissioner for Policy.
submission of an application to market HUMIRA (BLA 125057) was initially
[FR Doc. E6–1311 Filed 1–31–06; 8:45 am]
the human biological product and submitted on March 28, 2002.
continues until FDA grants permission 3. The date the application was
to market the biological product. approved: December 31, 2002. FDA has
Although only a portion of a regulatory verified the applicant’s claim that BLA
review period may count toward the 125057 was approved on December 31,
actual amount of extension that the 2002.
Food and Drug Administration Director of Patents and Trademarks may This determination of the regulatory
award (for example, half the testing review period establishes the maximum
[Docket No. 2004E–0445] potential length of a patent extension.
phase must be subtracted as well as any
time that may have occurred before the However, the U.S. Patent and
Determination of Regulatory Review
patent was issued), FDA’s determination Trademark Office applies several
Period for Purposes of Patent
of the length of a regulatory review statutory limitations in its calculations
Extension; HUMIRA
period for a human biological product of the actual period for patent extension.
AGENCY: Food and Drug Administration, will include all of the testing phase and In its application for patent extension,
HHS. approval phase as specified in 35 U.S.C. this applicant seeks 326 days of patent
ACTION: Notice. 156(g)(1)(B). term extension.
FDA recently approved for marketing Anyone with knowledge that any of
SUMMARY: The Food and Drug the human biological product HUMIRA the dates as published are incorrect may
Administration (FDA) has determined (adalimumab). HUMIRA is indicated for submit to the Division of Dockets
the regulatory review period for reducing signs and symptoms, including Management (see ADDRESSES) written or
HUMIRA and is publishing this notice major clinical response, inhibiting the electronic comments and ask for a
cchase on PROD1PC60 with NOTICES

of that determination as required by progression of structural damage and redetermination by April 3, 2006.
law. FDA has made the determination improving physical function in adult Furthermore, any interested person may
because of the submission of an patients with moderately to severely petition FDA for a determination
application to the Director of Patents active rheumatoid arthritis. Subsequent regarding whether the applicant for
and Trademarks, Department of to this approval, the Patent and extension acted with due diligence

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Federal Register / Vol. 71, No. 21 / Wednesday, February 1, 2006 / Notices 5343

during the regulatory review period by express delivery, rm. 14C–06) Rockville, accommodate persons with physical
July 31, 2006. To meet its burden, the MD 20857, 301–827–6687, e-mail: disabilities or special needs. If you
petition must contain sufficient facts to Jan.Johannessen@fda.hhs.gov or FDA require special accommodations due to
merit an FDA investigation. (See H. Advisory Committee Information Line, a disability, please notify Jan N.
Rept. 857, part 1, 98th Cong., 2d sess., 1–800–741–8138 (301–443–0572 in the Johannessen at least 7 days in advance
pp. 41–42, 1984.) Petitions should be in Washington, DC area), code of the meeting.
the format specified in 21 CFR 10.30. 8732310001. Please call the Information Notice of this meeting is given under
Comments and petitions should be Line for up to date information on this the Federal Advisory Committee Act (5
submitted to the Division of Dockets meeting. U.S.C. app. 2).
Management (see ADDRESSES). Three Agenda: The Pediatric Advisory
Dated: January 24, 2006.
copies of any mailed information are to Committee will hear and discuss a
report by the agency, as mandated in Jason Brodsky,
be submitted, except that individuals
may submit one copy. Comments are to Section 17 of the Best Pharmaceuticals Acting Associate Commissioner for External
for Children Act (BPCA), on adverse Relations.
be identified with the docket number
found in brackets in the heading of this event reports possibly related to [FR Doc. E6–1223 Filed 1–31–06; 8:45 am]
document. Comments and petitions may clofarabine (CLOLAR), irbesartan BILLING CODE 4160–01–S

be seen in the Division of Dockets (AVAPRO), sibutramine (MERIDIA), and

Management between 9 a.m. and 4 p.m., the mixed salts amphetamine product
Monday through Friday. (ADDERALL). In continuation of a prior DEPARTMENT OF HEALTH AND
committee discussion of adverse events HUMAN SERVICES
Dated: January 5, 2006.
for the class of methylphenidate
Jane A. Axelrad, products used to treat attention deficit Food and Drug Administration
Associate Director for Policy, Center for Drug hyperactivity disorder (ADHD), the
Evaluation and Research. Psychopharmacologic Drugs Advisory
committee will hear and discuss Committee; Notice of Meeting
[FR Doc. E6–1313 Filed 2–1–06; 8:45 am] neuropsychiatric adverse events
BILLING CODE 4160–01–S possibly related to other approved AGENCY: Food and Drug Administration,
ADHD medications. The presentations HHS.
will focus on neuropsychiatric adverse ACTION: Notice.
DEPARTMENT OF HEALTH AND event reports and clinical trial data from
HUMAN SERVICES approved ADHD medications. The This notice announces a forthcoming
committee will also receive an update meeting of a public advisory committee
Food and Drug Administration on efforts to better understand of the of the Food and Drug
Pediatric Advisory Committee; Notice cardiovascular adverse events possibly Administration (FDA). The meeting will
of Meeting related to ADHD medications. be open to the public.
The background material will become Name of Committee:
AGENCY: Food and Drug Administration, available no later than the day before Psychopharmacologic Drugs Advisory
HHS. the meeting and will be posted under Committee.
ACTION: Notice. the Pediatric Advisory Committee
General Function of the Committee:
Docket site at http://www.fda.gov/
This notice announces a forthcoming To provide advice and
ohrms/dockets/ac/acmenu.htm. (Click
meeting of a public advisory committee recommendations to the agency on
on the year 2006 and scroll down to
of the Food and Drug Administration FDA’s regulatory issues.
Pediatric Advisory Committee
(FDA). The meeting will be open to the meetings.) Date and Time: The meeting will be
public. Procedure: Interested persons may held on March 23, 2006, from 8 a.m. to
Name of Committee: Pediatric present data, information, or views, 5 p.m.
Advisory Committee. orally or in writing, on issues pending Location: Hilton Washington DC
General Function of the Committee: before the committee. Written North/Gaithersburg,The Ballrooms, 620
To provide advice and submissions may be made to the contact Perry Pkwy, Gaithersburg, MD. The
recommendations to the agency on person by March 8, 2006. Oral hotel phone number is 301–977–8900.
FDA’s regulatory issues. The committee presentations from the public will be Contact Person: Cicely Reese, Center
also advises and makes scheduled on March 22, 2006, between for Drug Evaluation and Research (HFD–
recommendations to the Secretary of approximately 1 p.m. and 2 p.m. Time 21), Food and Drug Administration,
Health and Human Services under 45 allotted for each presentation may be 5600 Fishers Lane (for express delivery,
CFR 46.407 on research involving limited. Those desiring to make formal 5630 Fishers Lane, rm. 1093) Rockville,
children as subjects that is conducted or oral presentations should notify the MD 20857, 301–827–7001, Fax: 301–
supported by the Department of Health contact person by March 8, 2006, and 827–6776, e-mail:
and Human Services, when that submit a brief statement of the general ReeseCi@cder.fda.gov, or FDA Advisory
research is also regulated by FDA. nature of the evidence or arguments Committee Information Line, 1–800–
Date and Time: The meeting will be they wish to present, the names and 741–8138 (301–443–0572 in the
held on Wednesday, March 22, 2006, addresses of proposed participants, and Washington, DC area), code
from 8 a.m. to 6 p.m. an indication of the approximate time 3014512544. Please call the Information
Location: Washington DC North/ requested to make their presentation. Line for up-to-date information on this
Gaithersburg Hilton, 620 Perry Pkwy., Persons attending FDA’s advisory meeting. The background material will
Gaithersburg, MD. committee meetings are advised that the become available no later than the day
cchase on PROD1PC60 with NOTICES

Contact Person: Jan N. Johannessen, agency is not responsible for providing before the meeting and will be posted
Office of Science and Health access to electrical outlets. on FDA’s Web site at http://
Coordination, Office of the FDA welcomes the attendance of the www.fda.gov/ohrms/dockets/ac/
Commissioner (HF–33), Food and Drug public at its advisory committee acmenu.htm. Click on the year 2006 and
Administration, 5600 Fishers Lane, (for meetings and will make every effort to scroll down to the

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