Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 32632 [05-11072]
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Federal Register / Vol. 70, No. 106 / Friday, June 3, 2005 / Notices
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Dated: June 1, 2005.
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Regulations Development Group.
[FR Doc. 05–11178 Filed 6–2–05; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005M–0005]
Medical Devices Regulated by the
Center for Biologics Evaluation and
Research; 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 by the
Center for Biologics Evaluation and
Research (CBER). This list is intended to
inform the public of the availability of
safety and effectiveness summaries of
approved PMAs through the Internet
and FDA’s Division of Dockets
Management.
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:
Nathaniel L. Geary, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
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,
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.
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
of safety and effectiveness were placed
on the Internet from October 1, 2004,
through December 31, 2004. There were
no denial actions during the 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 OCTOBER 1, 2004,
THROUGH DECEMBER 31, 2004
PMA No./Docket No.
BP 040046/02005M–0005
Applicant
Trade Name
Bio-Rad Laboratories
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cber/products.htm.
Dated: April 11, 2005.
Jesse Goodman,
Director, Center for Biologics Evaluation and
Research.
[FR Doc. 05–11072 Filed 6–2–05; 8:45 am]
Multispot HIV–1/HIV–2 Rapid Test
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, DHHS.
AGENCY:
ACTION:
Notice.
BILLING CODE 4160–01–S
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
VerDate jul<14>2003
18:03 Jun 02, 2005
Jkt 205001
PO 00000
Approval Date
Frm 00069
Fmt 4703
Sfmt 4703
November 12, 2004
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: (301)
496–7057; fax: (301) 402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
ADDRESSES:
E:\FR\FM\03JNN1.SGM
03JNN1
Agencies
[Federal Register Volume 70, Number 106 (Friday, June 3, 2005)]
[Notices]
[Page 32632]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11072]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005M-0005]
Medical Devices Regulated by the Center for Biologics Evaluation
and Research; 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 by the
Center for Biologics Evaluation and Research (CBER). This list is
intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and FDA'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 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: Nathaniel L. Geary, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, 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. 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 were placed on the Internet from
October 1, 2004, through December 31, 2004. There were no denial
actions during the 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 October 1, 2004, through
December 31, 2004
----------------------------------------------------------------------------------------------------------------
PMA No./Docket No. Applicant Trade Name Approval Date
----------------------------------------------------------------------------------------------------------------
BP 040046/02005M-0005 Bio-Rad Laboratories Multispot HIV-1/HIV-2 Rapid Test November 12, 2004
----------------------------------------------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cber/products.htm.
Dated: April 11, 2005.
Jesse Goodman,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 05-11072 Filed 6-2-05; 8:45 am]
BILLING CODE 4160-01-S