Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications, 63616-63617 [E7-21986]
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63616
Federal Register / Vol. 72, No. 217 / Friday, November 9, 2007 / Notices
common application form is intended to
complement, not to supersede, the
relevant regulatory frameworks
currently in effect. The sponsor must
comply with all applicable regulatory
requirements in each jurisdiction in
which it seeks designation when using
this common application form.
To use the common application form,
the sponsor must provide the required
information in each applicable section
as instructed in the explanatory notes.
Certain information elements are
identified in the form as required
exclusively by either FDA or EMEA
regulations, and as such they must be
included only in the application to that
jurisdiction. Where additional
explanations and/or supportive
documents are necessary, the sponsor
should sequentially append them at the
end of the common application form in
the order they appear in the form. The
sponsor must also complete the
declaration and signature page. For
FDA, the completed common
application form and required appended
documents must be submitted to the
Office of Orphan Products Development
(HF–35), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. For EMEA, the
completed documents must be
submitted to European Medicines
Agency, 7 Westferry Circus, Canary
Wharf, London E14 4HB, United
Kingdom.
FDA estimates the reporting burden of
this common application form as
follows. Between January 2000 and May
2006, FDA and EMEA received 226
comparable orphan designation
requests/applications of the same drugs
for the same diseases or conditions, or
an average of 35 per year. With the ease
of a common application form, FDA
anticipates the number of such requests/
applications may increase over time.
Therefore, generally there is one
request/application per respondent and
as, at the extreme, all respondent are
U.S.-based, FDA believes up to 40 such
respondents may use the common
application form each year. The
respondents will be primarily
pharmaceutical companies or other forprofit organizations. The collection of
information for sponsors requesting
orphan drug designation from FDA is
currently covered by the Orphan Drug
Regulations (21 CFR Part 316) and
approved under OMB No. 0910–0167
(expires August 31, 2010). For
applications submitted exclusively to
FDA, we do not believe the new form
will result in any increased burden on
the respondents and therefore we
estimate no additional burden for those
respondents. FDA believes the
information required for the EMEA
submission, for the most part, is very
similar to that in the FDA submission,
which is already in the respondents’
possession. The respondents, however,
may have to search existing data sources
or gather additional needed data, such
as on the prevalence or the availability
of alternative methods of diagnosis,
prevention, and treatment of the rare
disease or condition of interest in the
European Community, to complete the
EMEA submission. FDA estimates that it
will take an additional 32 hours (16
hours of professional time and 16 hours
of support time) to compile information
required for the EMEA submission.
Hence, the estimated total annual
human resource hours, at most, would
be 1,280 hours.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual No. of
Respondents
FDA Form No.
FDA 3671
1There
40
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007M–0366]
Medical Devices Regulated by the
Center for Biologics Evaluation and
Research; Availability of Summaries of
Safety and Effectiveness Data for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
Total Annual
Responses
1
Hours per
Response
40
Total Hours
32
1,280
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–21988 Filed 11–8–07; 8:45 am]
ACTION:
Annual Frequency
per Response
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved by the
Center for Biologics Evaluation and
Research (CBER). This list is intended to
VerDate Aug<31>2005
23:48 Nov 08, 2007
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inform the public of the availability
through the Internet and FDA’s Division
of Dockets Management of summaries of
safety and effectiveness data of
approved PMAs.
ADDRESSES: Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please include 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 data.
FOR FURTHER INFORMATION CONTACT:
Pamela Pope, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, suite
200N, 1401 Rockville Pike, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
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,
providing instead to post this
information on the Internet at https://
www.fda.gov. In addition, the
regulations provide that FDA publish a
quarterly list of available safety and
effectiveness summaries of PMA
approvals and denials that were
announced during the quarter. 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.
E:\FR\FM\09NON1.SGM
09NON1
Federal Register / Vol. 72, No. 217 / Friday, November 9, 2007 / Notices
The 30-day period for requesting
administrative 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 following is a list of PMAs
approved by CBER for which summaries
63617
of safety and effectiveness data were
placed on the Internet from July 1, 2007,
through September 30, 2007. 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 SUMMARIES OF SAFETY AND EFFECTIVENESS DATA FOR APPROVED PMAS MADE AVAILABLE JULY 1,
2007, THROUGH SEPTEMBER 30, 2007.
PMA No./Docket No.
Applicant
Trade Name
BP060001/0/2007M–0366
ThermoGenesis Corp.
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cber/products.htm.
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On December 13, 2007, the
committee will discuss, make
recommendations, and vote on a
premarket approval application for the
Adiana Transcervical Sterilization
System, sponsored by Cytyc Surgical
Products. This device is indicated to be
used as a permanent method for female
sterilization. On December 14, 2007, the
committee will have a general topic
discussion of clinical trial design issues
for endometrial ablation devices
indicated for pre-menopausal women in
whom childbearing is complete and
who no longer desire menses (i.e.,
monthly period). The committee will
also hear and discuss a post-approval
study update for the ExAblate 2000
System from InSightec, Inc. The system
is indicated for ablation of uterine
fibroid tissue in pre- or peri-menopausal
women with symptomatic uterine
fibroids who desire a uterine sparing
procedure.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Dated: October 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–21986 Filed 11–8–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Obstetrics and
Gynecology Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 13, 2007, from 8 a.m.
to 5 p.m., and on December 14, 2007,
from 8 a.m. to 1:15 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Michael Bailey,
Center for Devices and Radiological
Health (HFZ–470), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240–276–4100, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512524. Please call the Information
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Fmt 4703
CryoSeal FS System
Sfmt 4703
Approval Date
7/26/2007
Procedure: On December 13, 2007,
from 8 a.m. to 5 p.m., and on December
14, 2007, from 9 a.m. to 1:15 p.m., the
meeting is open to the public. Interested
persons may present data, information,
or views, orally or in writing, on issues
pending before the committee. Written
submissions may be made to the contact
person on or before November 29, 2007.
Oral presentations from the public will
be scheduled on December 13, 2007,
between approximately 8:15 a.m. and
8:45 a.m. and between approximately
3:30 p.m. and 4 p.m., and on December
14, 2007, between approximately 10
a.m. and 10:15 a.m. and between
approximately 11:15 a.m. and 12:15
p.m. Those desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
November 21, 2007. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 23, 2007.
Closed Presentation of Data: On
December 14, 2007, from 8 a.m. to 9
a.m., the meeting will be closed to
permit discussion and review of trade
secret and/or confidential information
(5 U.S.C. 552b(c)(4)). The committee
will hear an update on device
submissions currently under review.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
E:\FR\FM\09NON1.SGM
09NON1
]]>Agencies
[Federal Register Volume 72, Number 217 (Friday, November 9, 2007)]
[Notices]
[Pages 63616-63617]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21986]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007M-0366]
Medical Devices Regulated by the Center for Biologics Evaluation
and Research; Availability of Summaries of Safety and Effectiveness
Data 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 (PMAs) that have been approved by the
Center for Biologics Evaluation and Research (CBER). This list is
intended to inform the public of the availability through the Internet
and FDA's Division of Dockets Management of summaries of safety and
effectiveness data of approved PMAs.
ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please include 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 data.
FOR FURTHER INFORMATION CONTACT: Pamela Pope, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, suite
200N, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.
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, providing instead to post this information on the
Internet at https://www.fda.gov. In addition, the regulations provide
that FDA publish a quarterly list of available safety and effectiveness
summaries of PMA approvals and denials that were announced during the
quarter. 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.
[[Page 63617]]
The 30-day period for requesting administrative 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 following is a list of PMAs approved by CBER for which
summaries of safety and effectiveness data were placed on the Internet
from July 1, 2007, through September 30, 2007. 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 Summaries of Safety and Effectiveness Data for Approved
PMAs Made Available July 1, 2007, through September 30, 2007.
------------------------------------------------------------------------
PMA No./Docket No. Applicant Trade Name Approval Date
------------------------------------------------------------------------
BP060001/0/2007M- ThermoGenesis CryoSeal FS 7/26/2007
0366 Corp. System
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cber/products.htm.
Dated: October 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-21986 Filed 11-8-07; 8:45 am]
BILLING CODE 4160-01-S
