Determination of Regulatory Review Period for Purposes of Patent Extension; IXIARO, 54888-54889 [2010-22394]
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54888
Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices
ADDRESSES)
electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–22496 Filed 9–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0416]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; IXIARO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for IXIARO
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 electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments 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
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:24 Sep 08, 2010
Jkt 220001
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 biologic product IXIARO
(Japanese Encephalitis Virus, Vaccine
Inactivated, Adsorbed). IXIARO is
indicated for active immunization for
the prevention of disease caused by
Japanese encephalitis virus in persons
17 years of age and older. Subsequent to
this approval, the Patent and Trademark
Office received a patent term restoration
application for IXIARO (U.S. Patent No.
6,309,650) from Chiel Jedang Corp. and
Walter Reed Army Institute of Research,
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 17, 2010, FDA advised the
Patent and Trademark Office that this
human biological product had
undergone a regulatory review period
and that the approval of IXIARO
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
IXIARO is 3,461 days. Of this time,
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
2,994 days occurred during the testing
phase of the regulatory review period,
while 467 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: October 10, 1999. The
applicant claims October 9, 1999, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was October 10, 1999,
which was 30 days after FDA receipt of
the IND.
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): December 20, 2007. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for IXIARO (BLA B125280/0) was
initially submitted on December 20,
2007.
3. The date the application was
approved: March 30, 2009. FDA has
verified the applicant’s claim that BLA
B125280/0 was approved on March 30,
2009.
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 1,588 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) either
electronic or written comments and ask
for a redetermination by November 8,
2010. 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 March 8, 2011. 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.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
E:\FR\FM\09SEN1.SGM
09SEN1
Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
regulations.gov may be viewed in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2010–22394 Filed 9–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[ATSDR–265]
Development of Set 24 Toxicological
Profiles
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (DHHS).
ACTION: Notice.
AGENCY:
Profiles will be available to the
public on or about October 17, 2010.
SUMMARY: The Agency for Toxic
Substances and Disease Registry
(ATSDR) of the Department of Health
and Human Services is developing Set
24 Toxicological Profiles. Set 24
Toxicological Profiles consists of one
new draft and one updated draft.
Electronic access to these documents
will be available at the ATSDR Web site:
https://www.atsdr.cdc.gov/toxpro2.html.
DATES:
Set 24 Toxicological Profiles
The following toxicological profiles
are now being developed:
Toxicological profile
Toxaphene ............................
Trichlorobenzene*
1,2,3–Trichlorobenzene
1,2,4–Trichlorobenzene
1,3,5–Trichlorobenzene
Trichlorobenzene ....
FOR FURTHER INFORMATION CONTACT:
Commander Jessilynn B. Taylor,
Division of Toxicology and
Environmental Medicine, Agency for
CAS number
Toxic Substances and Disease Registry,
8001–35–2 1600 Clifton Road, NE., Mail Stop F–62,
Atlanta, GA 30333; telephone (770)
87–61–6 488–3313; e-mail: JBTaylor@cdc.gov.
120–82–1
108–70–3
12002–48–1
* Denotes new profile.
The
Superfund Amendments and
Reauthorization Act of 1986 (42 U.S.C.
9601 et seq.) amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA) (42 U.S.C. 9601
et seq.) by establishing certain
requirements for ATSDR and the U.S.
Environmental Protection Agency (EPA)
mstockstill on DSKH9S0YB1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
17:24 Sep 08, 2010
with regard to hazardous substances
that are most commonly found at
facilities on the CERCLA National
Priorities List. Among these statutory
requirements is a mandate for the
Administrator of ATSDR to prepare
toxicological profiles for each substance
included on the Priority List of
Hazardous Substances (https://
www.atsdr.cdc.gov/cercla/07list.html).
This list names 275 hazardous
substances that pose the most
significant potential threat to human
health as determined by ATSDR and
EPA. The availability of the revised list
of the 275 priority substances was
announced in the Federal Register on
March 6, 2008 (73 FR 12178). For prior
versions of the list of substances, see
Federal Register notices dated April 17,
1987 (52 FR 12866); October 20, 1988
(53 FR 41280); October 26, 1989 (54 FR
43619); October 17, 1990 (55 FR 42067);
October 17, 1991 (56 FR 52166); October
28, 1992 (57 FR 48801); February 28,
1994 (59 FR 9486); April 29, 1996 (61
FR 18744; November 17, 1997 (62 FR
61332); October 21, 1999 (64 FR 56792);
October 25, 2001 (66 FR 54014);
November 7, 2003 (68 FR 63098); and
December 7, 2005 (70FR 70284).
Notice of the availability of drafts of
one updated and one new toxicological
profile for public review and comment
will be published in the Federal
Register on or about October 17, 2010,
with notice of a 90-day public comment
period for each profile, starting from the
actual release date. Following the close
of the comment period, chemicalspecific comments will be addressed,
and where appropriate, revisions will be
incorporated into each profile.
Jkt 220001
Dated: September 3, 2010.
Ken Rose,
Associate Director, Office of Policy, Planning
and Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2010–22439 Filed 9–8–10; 8:45 am]
BILLING CODE 4163–70–P
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54889
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0451]
Draft Guidance for Industry on
Suicidality: Prospective Assessment of
Occurrence in Clinical Trials;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Suicidality:
Prospective Assessment of Occurrence
in Clinical Trials.’’ The purpose of this
guidance is to assist sponsors in
prospectively assessing the occurrence
of treatment-emergent suicidality in
clinical trials of drug and biological
products. Specifically, this guidance
addresses FDA’s current thinking
regarding the importance of suicidality
assessment in psychiatric and
nonpsychiatric drug trials and the
general principles for how best to
accomplish this assessment during drug
development.
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
either electronic or written comments
on the draft guidance by November 8,
2010.
SUMMARY:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Thomas Laughren, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4114,
Silver Spring, MD 20993–0002, 301–
796–2260.
ADDRESSES:
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 75, Number 174 (Thursday, September 9, 2010)]
[Notices]
[Pages 54888-54889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22394]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-E-0416]
Determination of Regulatory Review Period for Purposes of Patent
Extension; IXIARO
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for IXIARO 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 electronic comments to https://www.regulations.gov.
Submit written petitions along with three copies and written comments
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 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 biologic product
IXIARO (Japanese Encephalitis Virus, Vaccine Inactivated, Adsorbed).
IXIARO is indicated for active immunization for the prevention of
disease caused by Japanese encephalitis virus in persons 17 years of
age and older. Subsequent to this approval, the Patent and Trademark
Office received a patent term restoration application for IXIARO (U.S.
Patent No. 6,309,650) from Chiel Jedang Corp. and Walter Reed Army
Institute of Research, 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 17, 2010, FDA advised the
Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of IXIARO
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
IXIARO is 3,461 days. Of this time, 2,994 days occurred during the
testing phase of the regulatory review period, while 467 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: October 10,
1999. The applicant claims October 9, 1999, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was October 10, 1999,
which was 30 days after FDA receipt of the IND.
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): December 20, 2007. FDA has verified the
applicant's claim that the biologics license application (BLA) for
IXIARO (BLA B125280/0) was initially submitted on December 20, 2007.
3. The date the application was approved: March 30, 2009. FDA has
verified the applicant's claim that BLA B125280/0 was approved on March
30, 2009.
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 1,588 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) either electronic or written comments and ask for a
redetermination by November 8, 2010. 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 March 8, 2011. 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.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with
[[Page 54889]]
the docket number found in brackets in the heading of this document.
Comments and petitions that have not been made publicly available
on regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: August 13, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-22394 Filed 9-8-10; 8:45 am]
BILLING CODE 4160-01-S