Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting, 22157 [E8-8845]
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Federal Register / Vol. 73, No. 80 / Thursday, April 24, 2008 / Notices
• Other issues and questions raised
by the workshop attendees or others.
C. Is There a Fee and How Do I Register
for the Workshop?
There is a modest fee to attend the
workshop to defray the costs of meals
provided and other expenses. The fee
for the meeting for registrants from
industry is $125, and the fee for
government registrants is $75. Fees will
be waived for invited speakers and
panelists. The registration process will
be handled by AdvaMed, which has
extensive experience in planning,
executing, and organizing educational
meetings. Register online at
www.AdvaMed.org. Although the
facility is spacious, registration will be
on a first-come, first-served basis. If you
need special accommodations because
of a disability, please contact Elizabeth
Hillebrenner at least 7 days before the
workshop.
D. Where Can I Find Out More About
This Public Workshop?
II. Electronic Access
Persons with access to the Internet
may obtain both the draft guidance
document entitled ‘‘Coronary DrugEluting Stents: Nonclinical and Clinical
Studies’’and the Companion Document
at: https://www.fda.gov/cdrh/ode/
guidance/6255.pdf.
Dated: April 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–8853 Filed 4–23–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory
Committee; Notice of Postponement of
Meeting
sroberts on PROD1PC70 with NOTICES
Food and Drug Administration,
HHS.
Notice.
The Food and Drug Administration
(FDA) is postponing the meeting of the
Obstetrics and Gynecology Devices
VerDate Aug<31>2005
16:15 Apr 23, 2008
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Report on the Performance of Drug
and Biologics Firms in Conducting
Postmarketing Commitment Studies;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
SUMMARY: The Food and Drug
Administration (FDA) is required, under
the Food and Drug Administration
Modernization Act of 1997
(Modernization Act), to report annually
in the Federal Register on the status of
postmarketing study commitments
made by applicants of approved drug
and biological products. This is the
agency’s report on the status of the
studies applicants have agreed to or are
required to conduct.
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
ACTION:
Dated: April 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–8845 Filed 4–23–08; 8:45 am]
BILLING CODE 4160–01–S
Background information on the
workshop, registration information, the
agenda, information about lodging, and
other relevant information will be
posted, as it becomes available, on the
Internet at: www.AdvaMed.org and
https://www.fda.gov/cdrh/dsma/
workshop.html.
AGENCY:
Panel of the Medical Devices Advisory
Committee scheduled for May 16, 2008.
The meeting was announced in the
Federal Register of March 27, 2008 (73
FR 16315). FDA’s Center for Devices
and Radiological Health will further
evaluate data relevant to the topic. A
future meeting date will be announced
in the Federal Register.
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
Line for up-to-date information on this
meeting.
Cathryn C. Lee, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6464,
Silver Spring, MD 20993–0002, 301–
796–0700; or
Robert Yetter, Center for Biologics
Evaluation and Research (HFM–25),
Food and Drug Administration, 1400
Rockville Pike, Rockville, MD 20852,
301–827–0373.
SUPPLEMENTARY INFORMATION:
PO 00000
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22157
I. Background
Section 130(a) of the Modernization
Act (Public Law 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(the act) by adding a new provision
requiring reports of certain
postmarketing studies (section 506B of
the act (21 U.S.C. 356b)) for human drug
and biological products. Section 506B of
the act provides FDA with additional
authority to monitor the progress of a
postmarketing study commitment that
an applicant has been required or has
agreed to conduct by requiring the
applicant to submit a report annually
providing information on the status of
the postmarketing study commitment.
This report must also include reasons, if
any, for failure to complete the
commitment. On December 1, 1999 (64
FR 67207), FDA published a proposed
rule providing a framework for the
content and format of the annual
progress report. The proposed rule also
clarified the scope of the reporting
requirement and the timing for
submission of the annual progress
reports. The final rule, published on
October 30, 2000 (65 FR 64607),
modified annual report requirements for
new drug applications (NDAs) and
abbreviated new drug applications
(ANDAs) by revising § 314.81(b)(2)(vii)
(21 CFR 314.81(b)(2)(vii)). The rule also
created a new annual reporting
requirement for biologics license
applications (BLAs) by establishing
§ 601.70 (21 CFR 601.70). These
regulations became effective on April
30, 2001. The regulations apply only to
human drug and biological products.
They do not apply to animal drug or to
biological products that also meet the
definition of a medical device.
On September 27, 2007, the President
signed Public Law 110–85, the Food and
Drug Administration Amendments Act
of 2007 (FDAAA). Section 901, in Title
IX of FDAAA, creates a new section
505(o) of the act authorizing FDA to
require certain studies and clinical trials
for prescription drugs and biological
products approved under section 505 of
the act or section 351 of the Public
Health Service Act. This new authority
became effective on March 25, 2008.
FDA is considering how this new
authority will be integrated with
postmarketing commitments. FDA
expects that next year’s report will
reflect this integration.
Sections 314.81(b)(2)(vii) and 601.70
apply to postmarketing commitments
made on or before enactment of the
Modernization Act (November 21, 1997)
as well as those made after that date.
Sections 314.81(b)(2)(vii) and 601.70
require applicants of approved drug and
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[Federal Register Volume 73, Number 80 (Thursday, April 24, 2008)]
[Notices]
[Page 22157]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-8845]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Obstetrics and Gynecology Devices Panel of the Medical Devices
Advisory Committee; Notice of Postponement of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is postponing the meeting of
the Obstetrics and Gynecology Devices Panel of the Medical Devices
Advisory Committee scheduled for May 16, 2008. The meeting was
announced in the Federal Register of March 27, 2008 (73 FR 16315).
FDA's Center for Devices and Radiological Health will further evaluate
data relevant to the topic. A future meeting date will be announced in
the Federal Register.
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 Line for up-to-date
information on this meeting.
Dated: April 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-8845 Filed 4-23-08; 8:45 am]
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