Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop, 33311 [E6-8896]
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Federal Register / Vol. 71, No. 110 / Thursday, June 8, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Industry Exchange Workshop on Food
and Drug Administration Clinical Trial
Requirements; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC66 with NOTICES
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) Minneapolis
District, in cooperation with the
Association of Clinical Research
Professionals (ACRP), is announcing a
workshop on FDA clinical trial statutory
and regulatory requirements. This 2-day
workshop for the clinical research
community targets sponsors, monitors,
clinical investigators, institutional
review boards, and those who interact
with them for the purpose of conducting
FDA regulated clinical research. The
workshop will include both industry
and FDA perspectives on proper
conduct of clinical trials regulated by
FDA.
Date and Time: The public workshop
is scheduled for Wednesday, August 23,
2006, from 8 a.m. to 5 p.m. and
Thursday, August 24, 2006, from 8:30
a.m. to 12 noon.
Location: The public workshop will
be held at The Northland Inn, 7025
Northland Dr., Brooklyn Park, MN
55428, 800–441–6422 or 763–536–8300,
FAX: 763–536–8790.
Contact: Amy C. Johnson, Public
Affairs Specialist, Food and Drug
Administration, 212 3rd Ave. South
Minneapolis, MN 55401, 612–758–7131,
FAX: 612–334–4134, e-mail:
amy.johnson@fda.hhs.gov.
Registration: Send registration
information (including name, title, firm
name, address, telephone, and fax
number) and the registration fee of $220
(ACRP Minnesota chapter member),
$280 (nonmember), or $220
(Government employee). Make
registration fee payable to ACRP, and
mail to the attention of Paul Below, 441
Timberland Dr., Burnsville, MN 55337.
To register via the Internet please go to
https://mnacrp.org/ or contact the ACRP
webmaster at webmaster@mnacrp.org.
(FDA has verified the Web site address,
but is not responsible for subsequent
changes to the Web site after this
document publishes in the Federal
Register). The registrar will also accept
payment by major credit cards.
For more information on the meeting,
or for questions on registration, contact
Paul Below for ACRP at 441 Timberland
Dr., Burnsville, MN 55337, 952–882–
VerDate Aug<31>2005
15:37 Jun 07, 2006
Jkt 208001
4083, FAX: 952–223–1665, e-mail:
webmaster@mnacrp.org.
Attendees are responsible for their
own accommodations. To make
reservations at the Northland Inn at a
rate of $119.00 plus tax, please contact
the Northland Inn (see Location).
The registration fee will be used to
offset the expenses of hosting the
conference, including meals,
refreshments, meeting rooms, and
materials. Space is limited, therefore
interested parties are encouraged to
register early. Limited onsite registration
may be available. Please arrive early to
ensure prompt registration.
If you need special accommodations
due to a disability, please contact Amy
Johnson (see Contact) at least 7 days in
advance of the workshop.
SUPPLEMENTARY INFORMATION: The
workshop on FDA clinical trials
statutory and regulatory requirements
helps fulfill the Department of Health
and Human Services’ and FDA’s
important mission to protect the public
health by educating researchers on
proper conduct of clinical trials. Topics
for discussion at the workshop include
the following:
1. Medical device and drug aspects of
clinical research requirements,
2. Pre-investigational device and preinvestigational drug meetings with FDA,
3. Investigator initiated research,
4. Electronic documentation and data
capture,
5. Ethical issues in subject
enrollment,
6. Informed consent requirements,
7. Adverse event reporting,
8. FDA regulation of institutional
review boards,
9. How FDA conducts bioresearch
inspections,
10. FDA Enforcement actions
associated with clinical research, and
11. How FDA promotes confidence in
clinical research.
FDA has made education of the
research community a high priority to
ensure the quality of clinical data and
protect research subjects. The workshop
will also help to implement the
objectives of section 903 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393) and the FDA Plan for Statutory
Compliance, which includes working
more closely with stakeholders and
ensuring access to needed scientific and
technical expertise. The workshop also
furthers the goals of the Small Business
Regulatory Enforcement Fairness Act
(Public Law 104–121) by providing
outreach activities by Government
agencies directed to small businesses.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
33311
Dated: May 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–8896 Filed 6–7–06; 8:45 am]
BILLING CODE 4160–01–S
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Periodically, the Substance Abuse and
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Chapter 35). To request a copy of these
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Clearance Officer on (240) 276–1243.
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0110)—Revision
The National Survey on Drug Use and
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The data are used to determine the
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(Respondents who report use of
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only a small subset of the sample will
receive them.
As with all NSDUH/NHSDA surveys
conducted since 1999, the sample size
of the survey for 2007 will be sufficient
to permit prevalence estimates for each
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[Federal Register Volume 71, Number 110 (Thursday, June 8, 2006)]
[Notices]
[Page 33311]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-8896]
[[Page 33311]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Industry Exchange Workshop on Food and Drug Administration
Clinical Trial Requirements; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Minneapolis District,
in cooperation with the Association of Clinical Research Professionals
(ACRP), is announcing a workshop on FDA clinical trial statutory and
regulatory requirements. This 2-day workshop for the clinical research
community targets sponsors, monitors, clinical investigators,
institutional review boards, and those who interact with them for the
purpose of conducting FDA regulated clinical research. The workshop
will include both industry and FDA perspectives on proper conduct of
clinical trials regulated by FDA.
Date and Time: The public workshop is scheduled for Wednesday,
August 23, 2006, from 8 a.m. to 5 p.m. and Thursday, August 24, 2006,
from 8:30 a.m. to 12 noon.
Location: The public workshop will be held at The Northland Inn,
7025 Northland Dr., Brooklyn Park, MN 55428, 800-441-6422 or 763-536-
8300, FAX: 763-536-8790.
Contact: Amy C. Johnson, Public Affairs Specialist, Food and Drug
Administration, 212 3rd Ave. South Minneapolis, MN 55401, 612-758-7131,
FAX: 612-334-4134, e-mail: amy.johnson@fda.hhs.gov.
Registration: Send registration information (including name, title,
firm name, address, telephone, and fax number) and the registration fee
of $220 (ACRP Minnesota chapter member), $280 (nonmember), or $220
(Government employee). Make registration fee payable to ACRP, and mail
to the attention of Paul Below, 441 Timberland Dr., Burnsville, MN
55337. To register via the Internet please go to https://mnacrp.org/ or
contact the ACRP webmaster at webmaster@mnacrp.org. (FDA has verified
the Web site address, but is not responsible for subsequent changes to
the Web site after this document publishes in the Federal Register).
The registrar will also accept payment by major credit cards.
For more information on the meeting, or for questions on
registration, contact Paul Below for ACRP at 441 Timberland Dr.,
Burnsville, MN 55337, 952-882-4083, FAX: 952-223-1665, e-mail:
webmaster@mnacrp.org.
Attendees are responsible for their own accommodations. To make
reservations at the Northland Inn at a rate of $119.00 plus tax, please
contact the Northland Inn (see Location).
The registration fee will be used to offset the expenses of hosting
the conference, including meals, refreshments, meeting rooms, and
materials. Space is limited, therefore interested parties are
encouraged to register early. Limited onsite registration may be
available. Please arrive early to ensure prompt registration.
If you need special accommodations due to a disability, please
contact Amy Johnson (see Contact) at least 7 days in advance of the
workshop.
SUPPLEMENTARY INFORMATION: The workshop on FDA clinical trials
statutory and regulatory requirements helps fulfill the Department of
Health and Human Services' and FDA's important mission to protect the
public health by educating researchers on proper conduct of clinical
trials. Topics for discussion at the workshop include the following:
1. Medical device and drug aspects of clinical research
requirements,
2. Pre-investigational device and pre-investigational drug meetings
with FDA,
3. Investigator initiated research,
4. Electronic documentation and data capture,
5. Ethical issues in subject enrollment,
6. Informed consent requirements,
7. Adverse event reporting,
8. FDA regulation of institutional review boards,
9. How FDA conducts bioresearch inspections,
10. FDA Enforcement actions associated with clinical research, and
11. How FDA promotes confidence in clinical research.
FDA has made education of the research community a high priority to
ensure the quality of clinical data and protect research subjects. The
workshop will also help to implement the objectives of section 903 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393) and the FDA
Plan for Statutory Compliance, which includes working more closely with
stakeholders and ensuring access to needed scientific and technical
expertise. The workshop also furthers the goals of the Small Business
Regulatory Enforcement Fairness Act (Public Law 104-121) by providing
outreach activities by Government agencies directed to small
businesses.
Dated: May 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8896 Filed 6-7-06; 8:45 am]
BILLING CODE 4160-01-S
