Determination of Regulatory Review Period for Purposes of Patent Extension; RETEVASE, 14818-14819 [E7-5736]
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14818
Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Notices
TABLE 1.—TESTING RECOMMENDATIONS FOR SUBSTANCES NOMINATED TO THE NTP FOR TOXICOLOGICAL STUDIES—
Continued
Substance [CAS No.]
Nominated by 1
Nomination rationale
Preliminary study recommendations 2
Artificial butter flavoring mixture and certain components: Acetoin [513–86–0],
Diacetyl [431–03–8].
United Food and
Commercial
Workers International Union.
National Center for
Environmental
Health/Agency
for Toxic Substances and Disease Registry,
U.S. Environmental Protection Agency.
National Institute of
Environmental
Health Sciences.
Evidence of lung disease in exposed
workers and respiratory toxicity in
short-term animal toxicity studies.
—Chronic toxicity and carcinogenicity
studies via inhalation in rats.
—Mechanistic studies.
Widespread community exposure in
certain geographic locales; insufficient dose-response data to characterize risk from exposure to ‘‘unregulated’’ asbestiform mineral fibers
and naturally occurring fibrous mineral ‘‘mixtures’’.
—Mineral characterization.
—In vitro durability and toxicity studies.
—Subchronic and chronic toxicity/carcinogenicity studies via inhalation.
—Studies should utilize test materials
representative of minerals identified
in Libby, MT and at other Naturally
Occurring Asbestos (NOA) sites.
Widespread
consumer
exposure
through use in cosmetics and personal care products; insufficient toxicity data to assess potential reproductive hazard.
High production volume; potential
worker and consumer exposures;
lack of adequate toxicological data;
suspicion of toxicity based on structure.
High production volume; potential
worker exposures; lack of adequate
toxicological data; positive mutagenicity data; strong suspicion of toxicity and carcinogenicity based on
structure.
Widespread and increasing use in
drug, food and cosmetic products;
lack of adequate toxicological and
pharmacokinetic data; need to
evaluate whether the current required tests are adequate to detect
adverse biological and toxicological
events.
—Multigeneration oral reproductive
and developmental toxicity studies
—Toxicokinetic studies (oral and dermal routes).
Asbestos, naturally occurring and atypical forms [1332–21–4].
Diethyl phthalate [84–66–2] ...................
2′,2″-Dithiobisbenzanilide [135–57–9] ....
NCI ........................
2-Methoxy-4-nitroaniline [97–52–9] ........
NCI ........................
Nanoscale materials Nanoscale gold
[7440–57–5] Nanoscale silver [7440–
22–4].
U.S. Food and
Drug Administration.
Pentaethylenehexamine [4067–16–7] ....
NCI ........................
o-Phthalaldehyde [643–79–8] ................
National Institute
for Occupational
Safety and
Health.
High production volume; potential
worker exposures; lack of adequate
toxicological data; positive mutagenicity data.
Widespread and increasing use as a
disinfectant in health care settings;
lack of adequate and publicly available toxicological data; potential skin
and respiratory sensitizer.
—Genotoxicity studies.
—Metabolism studies.
—Toxicological characterization.
—Short-term mechanistic studies to
predict carcinogenic potential.
—Nanoscale materials characterization.
—Metabolism and pharmacokinetic
studies.
—Acute, subacute and subchronic toxicity studies.
—Mechanistic studies to assess the
role of size and surface coating on
biological disposition and toxicity.
No studies at this time due to the irritant and corrosive nature of this
compound.
—Toxicological characterization including studies to assess dermal irritation, dermal toxicity, and sensitization and asthmagenic potential.
1
National Cancer Institute (NCI).
The term ‘‘toxicological characterization’’ in this table includes studies for genotoxicity, subchronic toxicity, and chronic toxicity/carcinogenicity
as determined to be appropriate during the conceptualization and design of a research program to address toxicological data needs. Other types
of studies (e.g., metabolism and disposition, immunotoxicity, and reproductive and developmental toxicity) may be conducted as part of a complete toxicological characterization; however, these types of studies are not listed unless they are specifically recommended.
2
[FR Doc. E7–5831 Filed 3–28–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jlentini on PROD1PC65 with NOTICES
[Docket No. 1997E–0013]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RETEVASE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Aug<31>2005
17:20 Mar 28, 2007
Jkt 211001
PO 00000
Submit written comments
and petitions to the Division of Dockets
ADDRESSES:
Notice.
Frm 00052
Fmt 4703
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
RETEVASE 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.
Sfmt 4703
E:\FR\FM\29MRN1.SGM
29MRN1
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Notices
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:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
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 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 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 approved for marketing the
human biological product RETEVASE
(reteplase). RETEVASE is indicated in
the management of acute myocardial
infarction (AMI) in adults for the
improvement of ventricular function
following AMI, the reduction of the
incidence of congestive heart failure and
the reduction of mortality associated
with AMI. Subsequent to this approval,
the Patent and Trademark Office
received a patent term restoration
application for RETEVASE (U.S. Patent
No. 5,223,256) from Boehringer
VerDate Aug<31>2005
17:20 Mar 28, 2007
Jkt 211001
Mannheim GmbH, 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 6, 1997, FDA
advised the Patent and Trademark
Office that this human biological
product had undergone a regulatory
review period and that the approval of
RETEVASE represented the first
permitted commercial marketing or use
of the product. On September 14, 2006,
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
RETEVASE is 1,919 days. Of this time,
1,430 days occurred during the testing
phase of the regulatory review period,
while 489 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: August 1, 1991. The
applicant claims July 1, 1991, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was August 1, 1991,
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): June 30, 1995. FDA has
verified the applicant’s claim that the
product license application (PLA) for
Retevase (PLA 95–1167) was initially
submitted on June 30, 1995. The PLA
was renumbered as biologics license
application (BLA) 103632/0.
3. The date the application was
approved: October 30, 1996. The
applicant claims October 29, 1996, as
the date the PLA was approved.
However, FDA records indicate that
PLA 95–1167 (BLA 103632/0) was
approved on October 30, 1996.
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 123 days of patent
term extension.
Anyone with knowledge that any of
the dates as published is incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments and ask for a
redetermination by May 29, 2007.
Furthermore, any interested person may
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
14819
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 25, 2007. 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: March 12, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E7–5736 Filed 3–28–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006E–0354]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VAPRISOL
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
VAPRISOL 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
that claims that human drug 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:
Beverly Friedman, Office of Regulatory
Policy (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
E:\FR\FM\29MRN1.SGM
29MRN1
]]>Agencies
[Federal Register Volume 72, Number 60 (Thursday, March 29, 2007)]
[Notices]
[Pages 14818-14819]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-5736]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1997E-0013]
Determination of Regulatory Review Period for Purposes of Patent
Extension; RETEVASE
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for RETEVASE 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
[[Page 14819]]
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: Beverly Friedman, Office of Regulatory
Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2041.
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 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 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 approved for marketing the human biological product RETEVASE
(reteplase). RETEVASE is indicated in the management of acute
myocardial infarction (AMI) in adults for the improvement of
ventricular function following AMI, the reduction of the incidence of
congestive heart failure and the reduction of mortality associated with
AMI. Subsequent to this approval, the Patent and Trademark Office
received a patent term restoration application for RETEVASE (U.S.
Patent No. 5,223,256) from Boehringer Mannheim GmbH, 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 6, 1997, FDA advised the Patent and Trademark Office that this
human biological product had undergone a regulatory review period and
that the approval of RETEVASE represented the first permitted
commercial marketing or use of the product. On September 14, 2006, 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
RETEVASE is 1,919 days. Of this time, 1,430 days occurred during the
testing phase of the regulatory review period, while 489 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: August 1,
1991. The applicant claims July 1, 1991, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 1, 1991,
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): June 30, 1995. FDA has verified the
applicant's claim that the product license application (PLA) for
Retevase (PLA 95-1167) was initially submitted on June 30, 1995. The
PLA was renumbered as biologics license application (BLA) 103632/0.
3. The date the application was approved: October 30, 1996. The
applicant claims October 29, 1996, as the date the PLA was approved.
However, FDA records indicate that PLA 95-1167 (BLA 103632/0) was
approved on October 30, 1996.
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 123 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written or electronic comments and ask for a redetermination
by May 29, 2007. 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 September 25,
2007. 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: March 12, 2007.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E7-5736 Filed 3-28-07; 8:45 am]
BILLING CODE 4160-01-S
