Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop, 11434-11435 [E6-3229]
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11434
Federal Register / Vol. 71, No. 44 / Tuesday, March 7, 2006 / Notices
sroberts on PROD1PC70 with NOTICES
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[FR Doc. E6–3088 Filed 3–6–06; 8:45 am]
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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), Baltimore
District, in cooperation with the Society
of Clinical Research Associates
(SoCRA), 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, May 17,
2006, from 8:30 a.m. to 5 p.m. and
Thursday, May 18, 2006, from 8:30 a.m.
to 4 p.m.
Location: The public workshop will
be held at the Radisson Plaza Lord
Baltimore, 20 West Baltimore St.,
Baltimore, MD 21201, 410–539–8400,
FAX: 410–625–1060.
Contact: Marie Falcone, Food and
Drug Administration, U.S.
Customhouse, 200 Chestnut St., rm. 900,
Philadelphia, PA 19106, 215–717–3703,
FAX: 215–597–5798, e-mail:
Marie.Falcone@fda.hhs.gov.
Registration: Send registration
information (including name, title, firm
name, address, telephone, and fax
number) and the registration fee of $550
(member), $625 (nonmember), or $500
(Government employee nonmember).
(The registration fee for nonmembers
includes a 1-year membership.) The
registration fee for FDA employees is
waived. Make the registration fee
payable to SoCRA, P.O. Box 101,
Furlong, PA 18925. To register via the
Internet go to https://www.socra.org/
FDA_Conference.htm. (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 800–
SoCRA92 (800–762–7292), or 215–822–
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
8644, or e-mail: socramail@aol.com.
Attendees are responsible for their own
accommodations. To make reservations
at the Radisson Plaza Lord Baltimore
hotel at the reduced conference rate,
contact the Radisson Plaza Lord
Baltimore hotel (see LOCATION) before
April 17, 2006. 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 Marie Falcone (see
CONTACT) at least 7 days in advance of
the workshop.
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) FDA regulation of the
conduct of clinical research;
(2) Medical device, drug, biological
product and food aspects of clinical
research;
(3) Investigator initiated research;
(4) Preinvestigational new drug
application meetings and FDA meeting
process;
(5) Informed consent requirements;
(6) Ethics in subject enrollment;
(7) FDA regulation of institutional
review boards;
(8) Electronic records requirements;
(9) Adverse event reporting;
(10) How FDA conducts bioresearch
inspections; and
(11) What happens after the FDA
inspection.
FDA has made education of the
research community a high priority to
ensure the quality of clinical data and
protect research subjects. The workshop
helps 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.
SUPPLEMENTARY INFORMATION:
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11435
Federal Register / Vol. 71, No. 44 / Tuesday, March 7, 2006 / Notices
Dated: March 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–3229 Filed 3–6–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995,
Public Law 104–13), the Health
Resources and Services Administration
(HRSA) will publish periodic
summaries of proposed projects being
developed for submission to the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995. To request more information on
the proposed project or to obtain a copy
of the data collection plans, call the
HRSA Reports Clearance Officer on
(301) 443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
of other forms of information
technology.
Proposed Project: Sentinel Centers
Network Technical Assistance Needs
Assessment (NEW)
HRSA’s Bureau of Primary Health
Care (BPHC) established the Sentinel
Centers Network (SCN) to assist in
addressing critical quality,
programmatic, and policy issues. Health
centers submit core data periodically
that is extracted from existing
information systems. In order to assess
needs for technical assistance (TA),
information will be requested from
centers regarding current information
systems, updates/changes to
information systems, and other TA
needs. This information will be
collected periodically via a project Web
site and will be used to manage the
ongoing needs of network participants.
The burden estimate for this project is
as follows:
Form
Number of
respondents
Number of
responses per
respondent
Total
responses
Hours per
response
Total burden
hours
TA Inventory .........................................................................
38
4
152
.25
38
Send comments to Susan G. Queen,
Ph.D., HRSA Reports Clearance Officer,
Room 10–33 Parklawn Building, 5600
Fishers Lane, Rockville, Maryland
20857. Written comments should be
received with 60 days of this notice.
Dated: March 1, 2006.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. E6–3167 Filed 3–6–06; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
sroberts on PROD1PC70 with NOTICES
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with requirement for
opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to OMB under the
Paperwork Reduction Act of 1995. To
VerDate Aug<31>2005
16:39 Mar 06, 2006
Jkt 208001
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer at 301–443–1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Women’s Physical
Activity and Eating Tools Assessment:
NEW
The HRSA Office of Women’s Health
(OWH) developed the Bright Futures for
Women’s Health and Wellness
(BFWHW) Initiative to help expand the
scope of women’s preventive health
activities, particularly related to
nutrition and physical activity. Building
upon a previous pilot study, an
intermediate assessment of the BFWHW
health promotion tools and materials
related to physical activity and healthy
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
eating will be conducted in order to
identify characteristics of both
individual and organizational change
toward health and wellness associated
with the uptake and use of the BFWHW
tools. This data collection effort will
ensure that the BFWHW tools are
disseminated and utilized in the most
effective ways, used to inform future
BFWHW programming, and added to
the literature regarding evidence-based
women’s health and wellness
initiatives.
Towards this end, questionnaires will
be used to collect data from adolescent
and adult women clients, providers, and
administrators of community health
provider organizations. Data collected
will include process, impact, and
outcome measures. Data domains
include the implementation and use of
the BFWHW tools, including
distribution and use; provider training;
organizational characteristics related to
successful implementation; client and
provider awareness; attitudes about the
importance of physical activity,
nutrition and self-efficacy to take steps
to make effective changes; increase in
knowledge and intent to change
behavior after exposure; and short-term
outcomes related to improved
preventive healthcare for women. A
total of six organizations, which may
include HHS Centers of Excellence and
Community Centers of Excellence in
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[Federal Register Volume 71, Number 44 (Tuesday, March 7, 2006)]
[Notices]
[Pages 11434-11435]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3229]
-----------------------------------------------------------------------
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), Baltimore District, in
cooperation with the Society of Clinical Research Associates (SoCRA),
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, May
17, 2006, from 8:30 a.m. to 5 p.m. and Thursday, May 18, 2006, from
8:30 a.m. to 4 p.m.
Location: The public workshop will be held at the Radisson Plaza
Lord Baltimore, 20 West Baltimore St., Baltimore, MD 21201, 410-539-
8400, FAX: 410-625-1060.
Contact: Marie Falcone, Food and Drug Administration, U.S.
Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215-
717-3703, FAX: 215-597-5798, e-mail: Marie.Falcone@fda.hhs.gov.
Registration: Send registration information (including name, title,
firm name, address, telephone, and fax number) and the registration fee
of $550 (member), $625 (nonmember), or $500 (Government employee
nonmember). (The registration fee for nonmembers includes a 1-year
membership.) The registration fee for FDA employees is waived. Make the
registration fee payable to SoCRA, P.O. Box 101, Furlong, PA 18925. To
register via the Internet go to https://www.socra.org/FDA_
Conference.htm. (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 800-SoCRA92 (800-762-7292), or 215-822-8644, or e-mail:
socramail@aol.com. Attendees are responsible for their own
accommodations. To make reservations at the Radisson Plaza Lord
Baltimore hotel at the reduced conference rate, contact the Radisson
Plaza Lord Baltimore hotel (see Location) before April 17, 2006. 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 Marie Falcone (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) FDA regulation of the conduct of clinical research;
(2) Medical device, drug, biological product and food aspects of
clinical research;
(3) Investigator initiated research;
(4) Preinvestigational new drug application meetings and FDA
meeting process;
(5) Informed consent requirements;
(6) Ethics in subject enrollment;
(7) FDA regulation of institutional review boards;
(8) Electronic records requirements;
(9) Adverse event reporting;
(10) How FDA conducts bioresearch inspections; and
(11) What happens after the FDA inspection.
FDA has made education of the research community a high priority to
ensure the quality of clinical data and protect research subjects. The
workshop helps 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.
[[Page 11435]]
Dated: March 1, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3229 Filed 3-6-06; 8:45 am]
BILLING CODE 4160-01-S
