Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 35920-35921 [E6-9898]
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35920
Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Notices
21–368 was approved on November 21,
2003.
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 679 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 August 21, 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
December 19, 2006. 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: May 17, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. E6–9899 Filed 6–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006M–0075, 2006M–0009,
2006M–0014, 2006M–0015, 2006M–0163]
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.
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:
ADDRESSES:
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 January 1, 2006, through
March 31, 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 JANUARY 1,
2006, THROUGH MARCH 31, 2006
PMA No./Docket No.
Applicant
Trade Name
Approval Date
AGA Medical Corp.
AMPLATZER DUCT OCCULUDER
AND 180 DELIVERY SYSTEM
P020001/2006M–0009
Neoventa Medical AB
STAN S31 FETAL HEART MONITOR
November 1, 2005
P040001/2006M–0014
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P020024/2006M–0075
St. Francis Medical Technologies, Inc.
X STOP INTERSPINOUS PROCESS DECROMPRESSION SYSTEM
November 21, 2005
P050009/2006M–0015
Biomet, Inc.
C2 A-TAPER ACETABULAR SYSTEM
December 16, 2005
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May 14, 2003
Federal Register / Vol. 71, No. 120 / Thursday, June 22, 2006 / Notices
35921
TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2006, THROUGH MARCH 31, 2006—Continued
PMA No./Docket No.
Applicant
Trade Name
P050007/2006M–0016
Abbott Vascular Devices (AVD)
STARCLOSE VASCULAR CLOSURE SYSTEM
H040005/2006M–0163
Karl Storz Endoscopy-America,
Inc.
KARL STORZ RIGID TTTS
FETOSCOPY INSTRUMENT
SET WITH 0 AND 12 DEGREE
SCOPE, KARL STORZ RIGID
TTTS FETOSCOPY INSTRUMENT SET WITH 30 DEGREE
SCOPE, AND KARL STORZ
SEMI-RIGID TTTS FETOSCOPY
INSTRUMENT SET
II. Electronic Access
Proposed Collection
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Title: 0917–0009, ‘‘Indian Health
Service Medical Staff’’
Typed of Information Collection
Request: Extension, without revision, of
currently approved information
collection, 0917–0009, ‘‘Indian Health
Service Medical Staff Credentials and
Privileges Files.’’
Form Numbers(s): None.
Need and Use of Information
Collection: This collection of
information is used to evaluate
individual health care providers
applying for medical staff privileges at
IHS health care facilities. The HHS
operates health care facilities that
provide health care services to
American Indians and Alaska Natives.
To provide these services, the IHS
employs (directly and under contract)
several categories of health care
providers including: Physicians (M.D.
and D.O.), dentists, psychologists,
optometrists, podiatrists, audiologists,
physician assistants, certified registered
nurse anesthetists, nurse practitioners,
and certified nurse midwives. The IHS
policy specifically requires physicians
and dentists to be members of the health
care facility medical staff where they
practice. Health care providers become
medical staff members, depending on
the local health care facility’s
capabilities and medical staff bylaws.
There are three types of IHS medical
staff applicants: (1) Health care
providers applying for direct
employment with IHS; (2) contractors
who will not seek to become IHS
employees; and (3) employed IHS health
care providers who seek to transfer
between IHS health care facilities.
National health care standards
developed by the Center for Medicare
and Medicaid Services (formerly the
Health Care Financing Administration),
the Joint Commission on the
Accreditation of Healthcare
Organizations (JCAHO), and other
Dated: June 13, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–9898 Filed 6–21–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 60-Day
Proposed Information Collection:
Indian Health Service Medical Staff
Credentials and Privileges Files
Indian Health Service, HHS.
The Indian Health Service
(IHS), as part of its continuing effort to
reduce paperwork and respondent
burden, conducts a pre-clearance
consultation program to provide the
general public and Federal agencies
with an opportunity to comment on
proposed and/or continuing collections
of information in accordance with the
Paperwork Reduction Act of 1995
continuing collections of information in
accordance with the Paperwork
Reduction Act of 1995 (PRA95) (44
U.S.C. 3506(c)(2)(A)). This program
helps to ensure that requested data can
be provided in the desired format,
reporting burden (time and financial
resources) is minimized, collection
instruments are clearly understood, and
the impact of collection requirements on
respondents can be properly assessed.
Currently, the IHS is providing a 60-day
advance opportunity for public
comment on a proposed new collection
of information to be submitted to the
Office of Management and Budget for
review.
AGENCY:
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SUMMARY:
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Approval Date
December 21, 2005
March 31, 2006
accrediting organizations required
health care facilities to review, evaluate
and verify the credentials, training and
experience of medical staff applicants
prior to granting medical staff
privileges. To meet these standards, IHS
health care facilities require all medical
staff applicants to provide information
concerning their education, training,
licensure, and work experience and any
adverse disciplinary actions taken
against them. This information is then
verified with references supplied by the
applicant and may include: Former
employers, educational institutions,
licensure and certification boards, the
American Medical Association, the
Federation of State Medical Boards, the
National Practitioner Data Bank, and the
applicants themselves.
In addition to the initial granting of
medical staff membership and clinical
privileges, JCAHO standards require
that a review of the medical staff be
conducted not less than every two years.
This review evaluates the current
competence of the medical staff and
verifies whether they are maintaining
the licensure or certification
requirements of their specialty.
The medical staff credentials and
privileges records are maintained at the
health care facility where the health
care provider is a medical staff member.
The establishment of these records at
IHS health care facilities is not optional;
such records must be established and
maintained at all health care facilities in
the United States that are accredited by
JCAHO. Prior to the establishment of
this JCAHO requirement, the degree to
which medical staff applications were
verified for completeness and accuracy
varied greatly across America.
Affected Public: Individuals and
households.
Type of Respondents: Individuals.
Burden Hours: The table below
provides the estimated burden hours for
this information collection:
E:\FR\FM\22JNN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 120 (Thursday, June 22, 2006)]
[Notices]
[Pages 35920-35921]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9898]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006M-0075, 2006M-0009, 2006M-0014, 2006M-0015, 2006M-
0163]
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 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 January 1, 2006, through March 31,
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 January 1, 2006, through March 31, 2006
------------------------------------------------------------------------
PMA No./Docket
No. Applicant Trade Name Approval Date
------------------------------------------------------------------------
P020024/2006M- AGA Medical AMPLATZER DUCT May 14, 2003
0075 Corp. OCCULUDER AND
180 DELIVERY
SYSTEM
------------------------------------------------------------------------
P020001/2006M- Neoventa STAN S31 FETAL November 1, 2005
0009 Medical AB HEART MONITOR
------------------------------------------------------------------------
P040001/2006M- St. Francis X STOP November 21, 2005
0014 Medical INTERSPINOUS
Technologie PROCESS
s, Inc. DECROMPRESSIO
N SYSTEM
------------------------------------------------------------------------
P050009/2006M- Biomet, Inc. C2 A-TAPER December 16, 2005
0015 ACETABULAR
SYSTEM
------------------------------------------------------------------------
[[Page 35921]]
P050007/2006M- Abbott STARCLOSE December 21, 2005
0016 Vascular VASCULAR
Devices CLOSURE
(AVD) SYSTEM
------------------------------------------------------------------------
H040005/2006M- Karl Storz KARL STORZ March 31, 2006
0163 Endoscopy- RIGID TTTS
America, FETOSCOPY
Inc. INSTRUMENT
SET WITH 0
AND 12 DEGREE
SCOPE, KARL
STORZ RIGID
TTTS
FETOSCOPY
INSTRUMENT
SET WITH 30
DEGREE SCOPE,
AND KARL
STORZ SEMI-
RIGID TTTS
FETOSCOPY
INSTRUMENT
SET
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: June 13, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-9898 Filed 6-21-06; 8:45 am]
BILLING CODE 4160-01-S
