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Federal Register / Vol. 71, No.

196 / Wednesday, October 11, 2006 / Notices 59797

D. Technical Electronic Product The document announced that FDA had Director of Patents and Trademarks may
Radiation Safety Standards Committee determined the regulatory review period award (for example, half the testing
Persons nominated should be for BONIVA. The notice provided that phase must be subtracted as well as any
technically qualified by training and on or before August 21, 2006, anyone time that may have occurred before the
experience in one or more fields of with knowledge that any of the dates as patent was issued), FDA’s determination
science or engineering applicable to published are incorrect may submit a of the length of a regulatory review
electronic product radiation safety. The request for a redetermination of the period for a human drug product will
particular needs at this time for this regulatory review period. A request for include all of the testing phase and
revision of the regulatory review period approval phase as specified in 35 U.S.C.
committee are listed in section I of this
was filed for the product on July 25, 156(g)(1)(B).
document. The term of office is up to 4 FDA recently approved for marketing
2006. FDA reviewed its records and
years, depending on the appointment the human drug product BONIVA
found that the effective date of the
date. (ibandronate sodium). BONIVA is
investigational new drug application
IV. Nomination Procedures (IND) was incorrect because of a clerical indicated for treatment and prevention
error. Therefore, FDA is republishing a of osteoporosis in postmenopausal
Any interested person may nominate
determination of the regulatory review women. Subsequent to this approval,
one or more qualified persons for
period to reflect the corrected effective the Patent and Trademark Office
membership on one or more of the
date for the IND. FDA has made a received a patent term restoration
advisory panels or advisory committees.
determination of the regulatory review application for BONIVA (U.S. Patent
Self-nominations are also accepted.
period because of the submission of an No. 4,927,814) from Hoffmann-La
Nominations will include complete
application to the Director of Patents Roche, Inc., and the Patent and
curriculum vitae of each nominee,
and Trademarks, Department of Trademark Office requested FDA’s
current business address and telephone assistance in determining this patent’s
number. Nominations will specify the Commerce, for the extension of a patent
which claims that human drug product. eligibility for patent term restoration. In
advisory panel(s) or advisory a letter dated October 19, 2004, FDA
committee(s) for which the nominee is ADDRESSES: Submit written comments
and petitions to the Division of Dockets advised the Patent and Trademark
recommended. Nominations will Office that this human drug product had
include confirmation that the nominee Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm. undergone a regulatory review period
is aware of the nomination, is willing to and that the approval of BONIVA
serve as a member of the advisory 1061, Rockville, MD 20852. Submit
electronic comments to http:// represented the first permitted
committee if selected, and appears to commercial marketing or use of the
have no conflict of interest that would www.fda.gov/dockets/ecomments.
product. Shortly thereafter, the Patent
preclude membership. Potential FOR FURTHER INFORMATION CONTACT:
and Trademark Office requested that
candidates will be required to provide Beverly Friedman, Office of Regulatory FDA determine the product’s regulatory
detailed information concerning such Policy (HFD–007), Food and Drug review period.
matters as financial holdings, Administration, 5600 Fishers Lane, FDA has determined that the
employment, and research grants and/or Rockville, MD 20857, 301–594–2041. applicable adjusted regulatory review
contracts to permit evaluation of SUPPLEMENTARY INFORMATION: The Drug period for BONIVA is 3,122 days. Of
possible sources of conflict of interest. Price Competition and Patent Term this time, 2,817 days occurred during
This notice is issued under the Restoration Act of 1984 (Public Law 98– the testing phase of the regulatory
Federal Advisory Committee Act (5 417) and the Generic Animal Drug and review period, while 305 days occurred
U.S.C. app. 2) and 21 CFR part 14 Patent Term Restoration Act (Public during the approval phase. These
relating to advisory committees. Law 100–670) generally provide that a periods of time were derived from the
Dated: October 3, 2006. patent may be extended for a period of following dates:
Randall W. Lutter, up to 5 years so long as the patented 1. The date an exemption under
item (human drug product, animal drug section 505(i) of the Federal Food, Drug,
Associate Commissioner for Policy and
Planning. product, medical device, food additive, and Cosmetic Act (the act) (21 U.S.C.
or color additive) was subject to 355(i)) became effective: October 30,
[FR Doc. E6–16679 Filed 10–10–06; 8:45 am]
regulatory review by FDA before the 1994. FDA has verified the applicant’s
item was marketed. Under these acts, a claim that the date the IND became
product’s regulatory review period effective was on October 30, 1994.
DEPARTMENT OF HEALTH AND forms the basis for determining the 2. The date the application was
HUMAN SERVICES amount of extension an applicant may initially submitted with respect to the
receive. human drug product under section
Food and Drug Administration A regulatory review period consists of 505(b) of the act: July 16, 2002. FDA has
two periods of time: A testing phase and verified the applicant’s claim that the
[Docket No. 2004E–0444] an approval phase. For human drug new drug application (NDA) for
products, the testing phase begins when BONIVA (NDA 21–455) was initially
Redetermination of Regulatory Review
the exemption to permit the clinical submitted on July 16, 2002.
Period for Purposes of Patent
investigations of the drug becomes 3. The date the application was
Extension; BONIVA; Correction
effective and runs until the approval approved: May 16, 2003. FDA has
AGENCY: Food and Drug Administration, phase begins. The approval phase starts verified the applicant’s claim that NDA
HHS. with the initial submission of an 21–455 was approved on May 16, 2003.
ACTION: Notice; correction. application to market the human drug This redetermination of the regulatory
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product and continues until FDA grants review period establishes the maximum
SUMMARY: The Food and Drug permission to market the product. potential length of a patent extension.
Administration (FDA) is correcting a Although only a portion of a regulatory However, the U.S. Patent and
notice that appeared in the Federal review period may count toward the Trademark Office applies several
Register of June 22, 2006 (71 FR 35918). actual amount of extension that the statutory limitations in its calculations

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59798 Federal Register / Vol. 71, No. 196 / Wednesday, October 11, 2006 / Notices

of the actual period for patent extension. unwarranted invasion of personal Name of Committee: Interagency
In its application for patent extension, privacy. Autism Coordinating Committee.
this applicant seeks 1,713 days of patent Name of Committee: Board of Scientific Date: November 17, 2006.
term extension. Counselors of the NIH Clinical Center. Time: 9 a.m.–4 p.m.
Anyone with knowledge that any of Date: October 16, 2006. Agenda: Discussion of autism
the dates as published are incorrect may Time: 3 p.m. to 5 p.m. activities across Federal agencies.
submit to the Division of Dockets Agenda: To review and evaluate the Place: National Institutes of Health,
Management (see ADDRESSES) written or Rehabilitation Medicine Program. Building 31, Conference Room 10 (6th
Place: National Institutes of Health, floor), 31 Center Drive, Bethesda,
electronic comments and ask for a Building 10, 10 Center Drive, Bethesda, MD
redetermination by December 11, 2006. Maryland 20892.
20892, (Telephone Conference Call). Contact Person: Ann Wagner, Ph.D.,
Furthermore, any interested person may Contact Person: David K. Henderson, MD,
petition FDA for a determination Division of Pediatric Translational
Deputy Director for Clinical Care, Office of
regarding whether the applicant for the Director, Clinical Center, National
Research and Treatment Development,
extension acted with due diligence Institutes of Health, Building 10, Room 6– National Institute of Mental Health,
during the regulatory review period by 1480, Bethesda, MD 20892, 301/402–0244. NIH, 6001 Executive Boulevard, Room
April 9, 2007. To meet its burden, the This notice is being published less than 15 6184, MSC 9617, Bethesda, Maryland
petition must contain sufficient facts to days prior to the meeting due to the urgent 20892. E-mail: awagner@mail.nih.gov.
need to meet timing limitations imposed by Phone: 301–443–5944.
merit an FDA investigation. (See H. the intramural research review cycle. Any member of the public interested
Rept. 857, part 1, 98th Cong., 2d sess., Any interested person may file written in presenting oral comments to the
pp. 41–42, 1984.) Petitions should be in comments with the committee by forwarding Committee may notify the contact
the format specified in 21 CFR 10.30. the statement to the Contact Person listed on
person listed on this notice at least 5
Comments and petitions should be this notice. The statement should include the
name, address, telephone number and when days in advance of the meeting.
submitted to the Division of Dockets Interested individuals and
Management. Three copies of any applicable, the business or professional
affiliation of the interested person. representatives of organizations may
mailed information are to be submitted, submit a letter of intent, a brief
except that individuals may submit one Dated: October 4, 2006.
description of the organization
copy. Comments are to be identified Anna Snouffer,
represented, and a short description of
with the docket number found in Acting Director, Office of Federal Advisory the oral presentation. Presentations may
brackets in the heading of this Committee Policy.
be limited to 5 minutes; both printed
document. [FR Doc. 06–8602 Filed 10–10–06; 8:45 am] and electronic copies are requested for
Comments and petitions may be seen BILLING CODE 4140–01–M the record. In addition, any interested
in the Division of Dockets Management person may file written comments with
between 9 a.m. and 4 p.m., Monday the Committee by forwarding his/her
through Friday. DEPARTMENT OF HEALTH AND statement to the contact person listed on
Dated: September 22, 2006.
HUMAN SERVICES this notice. The statement should
Jane A. Axelrad, National Institutes of Health include the name, address, telephone
Associate Director for Policy, Center for Drug number, and, when applicable, the
Evaluation and Research. Notice of Meeting; Interagency Autism business or professional affiliation of
[FR Doc. E6–16816 Filed 10–10–06; 8:45 am] Coordinating Committee the interested person.
Information about the meeting and
The National Institutes of Health online registration forms are also
(NIH) hereby announces a meeting of available on-line on the NIMH
DEPARTMENT OF HEALTH AND the Interagency Autism Coordinating homepage at http://www.nimh.nih.gov/
HUMAN SERVICES Committee (IACC) to be held on autismiacc/index.cfm.
November 17, 2006, on the NIH campus
Dated: September 29, 2006.
National Institutes of Health in Bethesda, Maryland.
The Children’s Health Act of 2000 Raynard S. Kington, M.D., Ph.D.,
Clinical Center; Notice of Closed (Pub.L. 106–310), Title I, Section 104, Deputy Director, National Institutes of Health.
Meeting mandated the establishment of an [FR Doc. E6–16721 Filed 10–10–06; 8:45 am]
Interagency Autism Coordinating BILLING CODE 4167–01–P
Pursuant to section 10(d) of the Committee (IACC) to coordinate autism
Federal Advisory Committee Act, as research and other efforts within the
amended (5 U.S.C. Appendix 2), notice Department of Health and Human DEPARTMENT OF HEALTH AND
is hereby given of a meeting of the Services (DHHS). In April 2001, the HUMAN SERVICES
Board of Scientific Counselors of the HHS Secretary delegated the authority
NIH Clinical Center. to establish the IACC to the National National Institutes of Health
The meeting will be closed to the Institutes of Health (NIH). The National National Cancer Institute; Notice of
public as indicated below in accordance Institute of Mental Health (NIMH) at the Closed Meeting
with the provisions set forth in section NIH has been designated the lead for
552b(c)(6), Title 5 U.S.C., as amended this activity. Pursuant to section 10(d) of the
for the review, discussion, and The IACC meeting will be open to the Federal Advisory Committee Act, as
evaluation of individual intramural public, with attendance limited to space amended (5 U.S.C. Appendix 2), notice
programs and projects conducted by the available. Individuals who plan to is hereby given of the following
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Clinical Center, including consideration attend and need special assistance, such meeting.
of personnel qualifications and as sign language interpretation or other The meeting will be closed to the
performance, and the competence of reasonable accommodations, should public in accordance with the
individual investigators, the disclosure notify the contact person listed below in provisions set forth in sections
of which would constitute a clearly advance of the meeting. 552b(c)(4) and 522b(c)(6), Title 5 U.S.C.,

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