Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 51288-51289 [E9-23962]
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Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
571.1(c) moderate category
1
1
1
3,000
3,000
571.1(c) complex category
1
1
1
10,000
10,000
571.6 amendment of petition
2
2
4
1,300
5,200
21 CFR Section
Hours per
Response
Total Hours
1 There
18,200
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA derived the annual reporting
burden estimate for the different
categories as follows:
Section 571.1(c)—moderate category:
For food additive petition without
complex chemistry, manufacturing,
efficacy, or safety issues, the estimated
time requirement per petition is
approximately 3,000 hours. An average
of 1 (one) petitions of this type is
received on an annual basis, resulting in
a burden of 3,000 hours.
Section 571.1(c)—complex category:
For a food additive petition with
complex chemistry, manufacturing,
efficacy, and/or safety issues, the
estimated time requirement per petition
is approximately 10,000 hours. An
average of 1 (one) petition of this type
is received on an annual basis, resulting
in a burden of 10,000 hours.
Section 571.6: For a food additive
petition amendment, the estimated time
requirement per petition is
approximately 1,300 hours. An average
of 4 (four) petitions of this type is
received on an annual basis, resulting in
a burden of 5,200 hours.
Thus, the estimated total annual
burden for this information collection is
18,200 hours.
Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–24047 Filed 10–05–09; 8:45 am]
and Human Services to share and
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and other Federal agencies regarding
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The Committee’s primary mission is
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Duration of this committee is two
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Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. E9–23974 Filed 10–5–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
BILLING CODE 4160–01–S
[Docket Nos. FDA–2009–M–0033, FDA–
2009–M–0016, FDA–2009–M–0034, FDA–
2009–M–0049, FDA–2009–M–0071, FDA–
2009–M–0127, FDA–2009–M–0128, FDA–
2009–M–0135, FDA–2009–M–0159]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
National Institutes of Health
Food and Drug Administration,
HHS.
Notice.
Notice of Establishment
jlentini on DSKJ8SOYB1PROD with NOTICES
Total Hours
ACTION:
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
Appendix 2), the Director, National
Institutes of Health (NIH), announces
the establishment of the Interagency
Breast Cancer and Environmental
Research Coordinating Committee
(Committee).
The Committee shall coordinate all
efforts within the Department of Health
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(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.
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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 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:
Nicole Wolanski, Center for Devices and
Radiological Health (HFZ–402), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1650,
Silver Spring, MD 20993, 301–796–
6570.
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
E:\FR\FM\06OCN1.SGM
06OCN1
51289
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices
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 January 1, 2009, through
March 31, 2009. 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 JANUARY 1,
2009, THROUGH MARCH 31, 2009
PMA No.
Docket No.
Applicant
Trade Name
Approval Date
P060030
FDA–2009–M–0033
Roche Molecular Systems, Inc.
Cobas ampliprep/cobas taqman HFC
test
October 30, 2008
P950009 (S8)
FDA–2009–M–0016
BD Diagnostics
BD focal point gs imaging system
December 3, 2008
P080010
FDA–2009–M–0034
Advanced Medical Optics, Inc.
Tecnis multifocal foldable posterior
chamber intraocular lens
January 16, 2009
P080021
FDA–2009–M–0049
Advanced Vision Science, Inc.
xact foldable hydrophobic acrylic UV
light absorbing posterior chamber IOL
February 2, 2009
P030031 (S11)
FDA–2009–M–0071
Biosense Webster, Inc.
Navistar & Celsius thermo cool catheters
February 6, 2009
P070014
FDA–2009–M–0127
Bard Peripheral Vascular, Inc.
lifestent flexstar & flexstar XL vascular
stent system
February 13, 2009
P940015 (S12)
FDA–2009–M–0128
Genzyme Corp.
Synvisc-One
February 26, 2009
P070005
FDA–2009–M–0135
Synthemed Corp.
Repel-cv bioresorbable adhesion barrier
March 6, 2009
P080002
FDA–2009–M–0159
The Female Health Co.
FC2 female condom
March 10, 2009
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: September 24, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and
Radiological Health.
[FR Doc. E9–23962 Filed 10–5–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jlentini on DSKJ8SOYB1PROD with NOTICES
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
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as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Review of P01 applications
on Interdisciplinary Research on Oral
Manifestations of HIV/AIDS in Vulnerable
Populations.
Date: November 12, 2009.
Time: 9 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Victor Henriquez, PhD,
Scientific Review Officer, DEA/SRB/NIDCR,
6701 Democracy Blvd., Room 668, Bethesda,
MD 20892–4878, 301–451–2405,
henriquv@nidcr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
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Dated: September 29, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–23997 Filed 10–5–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
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Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Advisory Committee.
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[Federal Register Volume 74, Number 192 (Tuesday, October 6, 2009)]
[Notices]
[Pages 51288-51289]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23962]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2009-M-0033, FDA-2009-M-0016, FDA-2009-M-0034, FDA-
2009-M-0049, FDA-2009-M-0071, FDA-2009-M-0127, FDA-2009-M-0128, FDA-
2009-M-0135, FDA-2009-M-0159]
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 (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 data 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: Nicole Wolanski, Center for Devices
and Radiological Health (HFZ-402), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993, 301-
796-6570.
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
[[Page 51289]]
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 January 1, 2009, through March 31,
2009. 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 January 1, 2009, through March 31, 2009
------------------------------------------------------------------------
Approval
PMA No. Docket No. Applicant Trade Name Date
------------------------------------------------------------------------
P060030 Roche Molecular Cobas ampliprep/ October 30,
FDA-2009-M-0033 Systems, Inc. cobas taqman HFC 2008
test
------------------------------------------------------------------------
P950009 (S8) BD Diagnostics BD focal point gs December 3,
FDA-2009-M-0016 imaging system 2008
------------------------------------------------------------------------
P080010 Advanced Medical Tecnis multifocal January 16,
FDA-2009-M-0034 Optics, Inc. foldable posterior 2009
chamber
intraocular lens
------------------------------------------------------------------------
P080021 Advanced Vision xact foldable February 2,
FDA-2009-M-0049 Science, Inc. hydrophobic 2009
acrylic UV light
absorbing
posterior chamber
IOL
------------------------------------------------------------------------
P030031 (S11) Biosense Navistar & Celsius February 6,
FDA-2009-M-0071 Webster, Inc. thermo cool 2009
catheters
------------------------------------------------------------------------
P070014 Bard Peripheral lifestent flexstar February 13,
FDA-2009-M-0127 Vascular, Inc. & flexstar XL 2009
vascular stent
system
------------------------------------------------------------------------
P940015 (S12) Genzyme Corp. Synvisc-One February 26,
FDA-2009-M-0128 2009
------------------------------------------------------------------------
P070005 Synthemed Corp. Repel-cv March 6,
FDA-2009-M-0135 bioresorbable 2009
adhesion barrier
------------------------------------------------------------------------
P080002 The Female FC2 female condom March 10,
FDA-2009-M-0159 Health Co. 2009
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: September 24, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-23962 Filed 10-5-09; 8:45 am]
BILLING CODE 4160-01-S
