Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 56157-56158 [E6-15755]
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Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006E–0023 and 2006E–0345]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; MYCAMINE—New Drug
Application 21–506
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PRODPC60 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
MYCAMINE and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of patents which claim 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.
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 drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the human drug
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 drug product and continues
until FDA grants permission to market
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the drug 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 drug 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 drug product MYCAMINE
(micafungin sodium). MYCAMINE is
indicated for treatment of patients with
esophageal candidiasis and prophylaxis
of Candida infections in patients
undergoing hematopoietic stem cell
transplantation. Subsequent to this
approval, the Patent and Trademark
Office received patent term restoration
applications for MYCAMINE (U.S.
Patent Nos. 6,107,458 and 6,265,536)
from Astellas Pharma, Inc., and the
Patent and Trademark Office requested
FDA’s assistance in determining these
patents’ eligibility for patent term
restoration. In a letter dated February
24, 2006, FDA advised the Patent and
Trademark Office that this human drug
product had undergone a regulatory
review period and that the approval of
MYCAMINE 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
MYCAMINE is 2,546 days. Of this time,
1,493 days occurred during the testing
phase of the regulatory review period,
while 1,053 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 (the act) (21 U.S.C.
355(i)) became effective: March 29,
1998. The applicant claims February 26,
1998, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was March 29, 1998,
which was 30 days after FDA receipt of
the original IND.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the act: April 29, 2002. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
MYCAMINE (NDA 21–506) was initially
submitted on April 29, 2002.
3. The date the application was
approved: March 16, 2005. FDA has
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56157
verified the applicant’s claim that NDA
21–506 was approved on March 16,
2005.
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 applications for patent extension,
this applicant seeks 1,192 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 November 27, 2006.
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 26, 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 numbers 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: September 9, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–15767 Filed 9–25–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006M–0161, 2006M–0264,
2006M–0148, 2006M–0200, 2006M–0162,
2006M–0199, 2006M–0193, 2006M–0235]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
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56158
Federal Register / Vol. 71, No. 186 / Tuesday, September 26, 2006 / Notices
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
agency’s Division of Dockets
Management.
Submit written requests for
copies of summaries of safety and
effectiveness to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Please cite
the appropriate docket number as listed
in Table 1 of this document when
submitting a written request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the summaries of
safety and effectiveness.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Thinh Nguyen, Center for Devices and
Radiological Health (HFZ–402), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–594–2186, ext. 152.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register. Instead,
the agency now posts this information
on the Internet on FDA’s home page at
https://www.fda.gov. FDA believes that
this procedure expedites public
notification of these actions because
announcements can be placed on the
Internet more quickly than they can be
published in the Federal Register, and
FDA believes that the Internet is
accessible to more people than the
Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the act.
The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from April 1, 2006, through
June 30, 2006. There were no denial
actions during this period. The list
provides the manufacturer’s name, the
product’s generic name or the trade
name, and the approval date.
TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1,
2006, THROUGH JUNE 30, 2006
PMA No./Docket No.
Applicant
Trade Name
Approval Date
P050021/2006M–0161
QLT, Inc.
CERALAS I LASER & CERALINK SLIT LAMP ADAPTER
December 20, 2005
P040052/2006M–0264
MonoGen, Inc.
MONOPREP PAP TEST (MPPT)
March 3, 2006
P040028/2006M–0148
Medispectra, Inc.
LUMA CERVICAL IMAGING SYSTEM
March 16, 2006
P050012/2006M–0200
Dexcom, Inc.
DEXCOM (STS) CONTINUOUS GLUCOSE MONITORING SYSTEM
March 24, 2006
P050026/2006M–0162
QLT, Inc.
QUALTEL ACTIVIS LASER & ZSL30 ACT, ZSL120 ACT,
and HSBMBQ ACT SLIT LAMP ADAPTERS
April 4, 2006
P030008(S4)/2006M–0199
SurgiVision Refractive Consultants
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER
SYSTEM
April 19, 2006
P040033/2006M–0193
Smith & Nephew
Orthopaedics
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
May 9, 2006
P050047/2006M–0235
Inamed Corp.
JUVEDERM 24HV, JUVEDERM 30, and JUVEDERM
30HV GEL IMPLANTS
June 2, 2006
II. Electronic Access
pwalker on PRODPC60 with NOTICES
Dated: September 15, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–15755 Filed 9–25–06; 8:45 am]
ACTION:
Food and Drug Administration
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
BILLING CODE 4160–01–S
SUMMARY: This is an update to previous
notice that the Food and Drug
Administration (FDA) will hold a public
meeting October 10, 2006, on
nanotechnology as it relates to FDAregulated products. The primary
purpose of this update is to notify the
public that preregistration to attend or
speak at the public meeting will close
on September 29, 2006. The purpose of
the meeting is to help FDA further its
understanding of developments in
[Docket No. 2006N–0107]
Food and Drug AdministrationRegulated Products Containing
Nanotechnology Materials; Public
Meeting
AGENCY:
Food and Drug Administration,
HHS.
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21:03 Sep 25, 2006
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Notice of public meeting;
request for comments.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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[Federal Register Volume 71, Number 186 (Tuesday, September 26, 2006)]
[Notices]
[Pages 56157-56158]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15755]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006M-0161, 2006M-0264, 2006M-0148, 2006M-0200, 2006M-
0162, 2006M-0199, 2006M-0193, 2006M-0235]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications
[[Page 56158]]
(PMAs) that have been approved. This list is intended to inform the
public of the availability of safety and effectiveness summaries of
approved PMAs through the Internet and the agency's Division of Dockets
Management.
ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Please cite the appropriate docket number as listed in Table 1
of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.
FOR FURTHER INFORMATION CONTACT: Thinh Nguyen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead, the agency now posts this information on the
Internet on FDA's home page at https://www.fda.gov. FDA believes that
this procedure expedites public notification of these actions because
announcements can be placed on the Internet more quickly than they can
be published in the Federal Register, and FDA believes that the
Internet is accessible to more people than the Federal Register.
In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the act. The 30-day
period for requesting reconsideration of an FDA action under Sec.
10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA
begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from April 1, 2006, through June 30, 2006.
There were no denial actions during this period. The list provides the
manufacturer's name, the product's generic name or the trade name, and
the approval date.
Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs
Made Available From April 1, 2006, through June 30, 2006
------------------------------------------------------------------------
PMA No./Docket Approval
No. Applicant Trade Name Date
------------------------------------------------------------------------
P050021/2006M- QLT, Inc. CERALAS I LASER & CERALINK December
0161 SLIT LAMP ADAPTER 20, 2005
------------------------------------------------------------------------
P040052/2006M- MonoGen, Inc. MONOPREP PAP TEST (MPPT) March 3,
0264 2006
------------------------------------------------------------------------
P040028/2006M- Medispectra, LUMA CERVICAL IMAGING March 16,
0148 Inc. SYSTEM 2006
------------------------------------------------------------------------
P050012/2006M- Dexcom, Inc. DEXCOM (STS) CONTINUOUS March 24,
0200 GLUCOSE MONITORING SYSTEM 2006
------------------------------------------------------------------------
P050026/2006M- QLT, Inc. QUALTEL ACTIVIS LASER & April 4,
0162 ZSL30 ACT, ZSL120 ACT, 2006
and HSBMBQ ACT SLIT LAMP
ADAPTERS
------------------------------------------------------------------------
P030008(S4)/ SurgiVision WAVELIGHT ALLEGRETTO WAVE April 19,
2006M-0199 Refractive EXCIMER LASER SYSTEM 2006
Consultants
------------------------------------------------------------------------
P040033/2006M- Smith & Nephew BIRMINGHAM HIP RESURFACING May 9, 2006
0193 Orthopaedics (BHR) SYSTEM
------------------------------------------------------------------------
P050047/2006M- Inamed Corp. JUVEDERM 24HV, JUVEDERM June 2,
0235 30, and JUVEDERM 30HV GEL 2006
IMPLANTS
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: September 15, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-15755 Filed 9-25-06; 8:45 am]
BILLING CODE 4160-01-S
