Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practices; Public Workshop, 66988-66989 [E9-30017]
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Federal Register / Vol. 74, No. 241 / Thursday, December 17, 2009 / Notices
Dated: December 11, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–30022 Filed 12–16–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Auditory Neuroscience.
Date: January 19–20, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting.)
Contact Person: John Bishop, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7844, Bethesda, MD 20892, (301) 408–
9664, bishopj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR–07–
420: Lymphatic Biology in Health and
Disease.
Date: January 27–28, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Virtual Meeting.)
Contact Person: Maqsood A. Wani, DVM,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2114,
MSC 7814, Bethesda, MD 20892. 301–435–
2270, wanimaqs@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: December 10, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–30021 Filed 12–16–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Food and Drug Administration Clinical
Trial Requirements, Regulations,
Compliance and Good Clinical
Practices; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) Florida District,
in cosponsorship with The Society of
Clinical Research Associates, Inc.
(SoCRA), is announcing a public
workshop entitled ‘‘FDA Clinical Trial
Requirements, Regulations, Compliance
and GCP.’’ This 2-day public workshop
is intended to provide information
about FDA clinical trial requirements to
the regulated industry.
Date and Time: The public workshop
will be held on Wednesday, March 3,
2010, from 8 a.m. to 5 p.m., and
Thursday, March 4, 2010, from 8 a.m. to
4:35 p.m.
Location: The public workshop will
be held at The Wyndham Orlando
Resort, 8001 International Dr., Orlando,
FL 32819, 407–351–2420.
Attendees are responsible for their
own accommodations. To make
reservations at the Wyndham Orlando
Resort, at the discounted rate of $149
per night (plus applicable taxes), contact
the hotel before February 10, 2010,
citing ‘‘SoCRA’’. The hotel’s Web site is:
https://www.wyndham.com/hotels/
MCOWD/main.wnt. (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.)
Contacts:
For FDA: C. Stewart Watson, Food
and Drug Administration, 555
Winderley Pl., suite 200, Maitland, FL
32751, 407–475–4756, FAX: 407–475–
4768, e-mail:
charles.watson@fda.hhs.gov.
For SoCRA: SoCRA Administrative
Office, 530 West Butler Ave., suite 109,
Chalfont, PA 18914, 1–800–762–7292 or
215–822–8644, FAX: 215–822–8633, email: SoCRAmail@aol.com.
Registration: You are encouraged to
register by February 26, 2010. Seats are
limited; please submit your registration
as soon as possible. Workshop space
will be filled in order of receipt of
registration. Registration will close
when the workshop is filled. Those
accepted into the workshop will receive
confirmation. Registration at the site is
not guaranteed but may be possible on
a space available basis on the day of the
public workshop beginning at 8 a.m.
The SoCRA registration fees cover the
cost of the workshop facilities,
materials, breaks, and lunches. The cost
of registration is as follows:
COST OF REGISTRATION
Affiliation
Fee
FDA Employee
Fee waived
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Government (SoCRA Member)
$450.00
Federal Government (Non-SoCRA Member)
$525.00
Non-Federal Government (SoCRA Member)
$575.00
Non-Federal Government (Non-SoCRA Member)
$650.00
If you need special accommodations
due to a disability, please contact C.
VerDate Nov<24>2008
13:19 Dec 16, 2009
Jkt 220001
Stewart Watson at least 7 days in
advance of the meeting.
PO 00000
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Fmt 4703
Sfmt 4703
Registration instructions: To register,
please submit your name, affiliation,
E:\FR\FM\17DEN1.SGM
17DEN1
Federal Register / Vol. 74, No. 241 / Thursday, December 17, 2009 / Notices
mailing address, phone/fax number, and
e-mail, along with a check or money
order payable to SoCRA. Please mail
your payment to: SoCRA Administrative
Office, 530 West Butler Ave., suite 109,
Chalfont, PA 18914. Registration may be
downloaded on the SoCRA Web site at
https://www.socra.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.)
Other payment forms accepted are
major credit cards (VISA, MasterCard, or
American Express only). For more
information on the meeting, or for
questions on registration, contact the
SoCRA Administrative Office (see
Contact).
The
public workshop helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The public
workshop will provide those engaged in
FDA-regulated (human) clinical trials
with information on a number of topics
concerning FDA requirements related to
informed consent, clinical investigation
requirements, institutional review board
investigations, electronic record
requirements, and investigator initiated
research. Topics for discussion include
the following: (1) What FDA Expects in
a Pharmaceutical Clinical Trial, (2)
Adverse Event Reporting, (3) Part 11
Compliance—electronic signatures, (4)
Informed Consent Regulations, (5) IRB
Regulations and FDA Inspections, (6)
Keeping Informed and Working
Together, (7) FDA Conduct of Clinical
Investigator Inspections, (8) Meetings
with the FDA, (9) Investigator Initiated
Research, (10) Medical Device Aspects
of Clinical Research, (11) Working with
FDA’s Center for Biologics Evaluation
and Research, (12) Ethical Issues in
Subject Enrollment, (13) The Inspection
is Over—What Happens Next? Possible
FDA Compliance Actions.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The public workshop helps to achieve
objectives set forth in section 406 of the
FDA Modernization Act of 1997 (21
U.S.C. 393) which includes working
closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. The public workshop also is
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Public Law 104–121), as outreach
activities by Government agencies to
small businesses.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
13:19 Dec 16, 2009
Jkt 220001
Dated: December 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–30017 Filed 12–16–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
Notice of Proposed Information
Collection for 1029–0089
AGENCY: Office of Surface Mining
Reclamation and Enforcement.
ACTION: Notice and request for
comments.
SUMMARY: In compliance with the
Paperwork Reduction Act of 1995, the
Office of Surface Mining Reclamation
and Enforcement (OSM) is announcing
its intention to request renewed
authority for the following collection of
information: 30 CFR Part 702 regarding
the exemption of coal extraction
incidental to the extraction of other
minerals. This information collection
activity was previously approved by the
Office of Management and Budget
(OMB), and assigned clearance number
1029–0089.
DATES: Comments on the proposed
information collection must be received
by February 16, 2010, to be assured of
consideration.
ADDRESSES: Comments may be mailed to
John Trelease, Office of Surface Mining
Reclamation and Enforcement, 1951
Constitution Ave., NW., Room 202–SIB,
Washington, DC 20240. Comments may
also be submitted electronically to
jtrelease@osmre.gov.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the information
collection request and explanatory
information contact John Trelease, at
(202) 208–2783 or e-mail at the address
provided above.
SUPPLEMENTARY INFORMATION: OMB
regulations at 5 CFR 1320, which
implement provisions of the Paperwork
Reduction Act of 1995 (Pub. L. 104–13),
require that interested members of the
public and affected agencies have an
opportunity to comment on information
collection and recordkeeping activities
[see 5 CFR 1320.8 (d)]. This notice
identifies an information collection that
OSM will be submitting to OMB for
approval. This collection is contained in
30 CFR part 702—Exemption for Coal
Extraction Incidental to the Extraction
of Other Minerals. The information
submitted by respondents is required to
obtain a benefit. OSM will request a 3-
PO 00000
Frm 00039
Fmt 4703
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66989
year term of approval for this
information collection activity.
Comments are invited on: (1) The
need for the collection of information
for the performance of the functions of
the agency; (2) the accuracy of the
agency’s burden estimates; (3) ways to
enhance the quality, utility and clarity
of the information collection; and (4)
ways to minimize the information
collection burden on respondents, such
as use of automated means of collection
of the information. A summary of the
public comments will accompany
OSM’s submission of the information
collection request to OMB.
Before including your address, phone
number, e-mail address, or other
personal identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
Title: 30 CFR Part 702 Exemption for
Coal Extraction Incidental to the
Extraction of Other Minerals.
OMB Control Number: 1029–0089.
Summary: This part implements the
requirement in Section 701(28) of the
Surface Mining Control and
Reclamation Act of 1977 (SMCRA),
which grants an exemption from the
requirements of SMCRA to operators
extracting not more than 162⁄3
percentage tonnage of coal incidental to
the extraction of other minerals. This
information will be used by the
regulatory authorities to make that
determination.
Bureau Form Number: None.
Frequency of Collection: Once and
annually thereafter.
Description of Respondents:
Producers of coal and other minerals
and State regulatory authorities.
Total Annual Responses: 120.
Total Annual Burden Hours: 535.
Total Non-wage Costs: $200.
Dated: December 11, 2009.
Dennis G. Rice,
Acting Chief, Division of Regulatory Support.
[FR Doc. E9–29933 Filed 12–16–09; 8:45 am]
BILLING CODE 4310–05–M
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 74, Number 241 (Thursday, December 17, 2009)]
[Notices]
[Pages 66988-66989]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30017]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Food and Drug Administration Clinical Trial Requirements,
Regulations, Compliance and Good Clinical Practices; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Florida District, in
cosponsorship with The Society of Clinical Research Associates, Inc.
(SoCRA), is announcing a public workshop entitled ``FDA Clinical Trial
Requirements, Regulations, Compliance and GCP.'' This 2-day public
workshop is intended to provide information about FDA clinical trial
requirements to the regulated industry.
Date and Time: The public workshop will be held on Wednesday, March
3, 2010, from 8 a.m. to 5 p.m., and Thursday, March 4, 2010, from 8
a.m. to 4:35 p.m.
Location: The public workshop will be held at The Wyndham Orlando
Resort, 8001 International Dr., Orlando, FL 32819, 407-351-2420.
Attendees are responsible for their own accommodations. To make
reservations at the Wyndham Orlando Resort, at the discounted rate of
$149 per night (plus applicable taxes), contact the hotel before
February 10, 2010, citing ``SoCRA''. The hotel's Web site is: https://www.wyndham.com/hotels/MCOWD/main.wnt. (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.)
Contacts:
For FDA: C. Stewart Watson, Food and Drug Administration, 555
Winderley Pl., suite 200, Maitland, FL 32751, 407-475-4756, FAX: 407-
475-4768, e-mail: charles.watson@fda.hhs.gov.
For SoCRA: SoCRA Administrative Office, 530 West Butler Ave., suite
109, Chalfont, PA 18914, 1-800-762-7292 or 215-822-8644, FAX: 215-822-
8633, e-mail: SoCRAmail@aol.com.
Registration: You are encouraged to register by February 26, 2010.
Seats are limited; please submit your registration as soon as possible.
Workshop space will be filled in order of receipt of registration.
Registration will close when the workshop is filled. Those accepted
into the workshop will receive confirmation. Registration at the site
is not guaranteed but may be possible on a space available basis on the
day of the public workshop beginning at 8 a.m. The SoCRA registration
fees cover the cost of the workshop facilities, materials, breaks, and
lunches. The cost of registration is as follows:
Cost of Registration
----------------------------------------------------------------------------------------------------------------
Affiliation Fee
----------------------------------------------------------------------------------------------------------------
FDA Employee Fee waived
----------------------------------------------------------------------------------------------------------------
Federal Government (SoCRA Member) $450.00
----------------------------------------------------------------------------------------------------------------
Federal Government (Non-SoCRA Member) $525.00
----------------------------------------------------------------------------------------------------------------
Non-Federal Government (SoCRA Member) $575.00
----------------------------------------------------------------------------------------------------------------
Non-Federal Government (Non-SoCRA Member) $650.00
----------------------------------------------------------------------------------------------------------------
If you need special accommodations due to a disability, please
contact C. Stewart Watson at least 7 days in advance of the meeting.
Registration instructions: To register, please submit your name,
affiliation,
[[Page 66989]]
mailing address, phone/fax number, and e-mail, along with a check or
money order payable to SoCRA. Please mail your payment to: SoCRA
Administrative Office, 530 West Butler Ave., suite 109, Chalfont, PA
18914. Registration may be downloaded on the SoCRA Web site at https://www.socra.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.)
Other payment forms accepted are major credit cards (VISA,
MasterCard, or American Express only). For more information on the
meeting, or for questions on registration, contact the SoCRA
Administrative Office (see Contact).
SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the
Department of Health and Human Services' and FDA's important mission to
protect the public health. The public workshop will provide those
engaged in FDA-regulated (human) clinical trials with information on a
number of topics concerning FDA requirements related to informed
consent, clinical investigation requirements, institutional review
board investigations, electronic record requirements, and investigator
initiated research. Topics for discussion include the following: (1)
What FDA Expects in a Pharmaceutical Clinical Trial, (2) Adverse Event
Reporting, (3) Part 11 Compliance--electronic signatures, (4) Informed
Consent Regulations, (5) IRB Regulations and FDA Inspections, (6)
Keeping Informed and Working Together, (7) FDA Conduct of Clinical
Investigator Inspections, (8) Meetings with the FDA, (9) Investigator
Initiated Research, (10) Medical Device Aspects of Clinical Research,
(11) Working with FDA's Center for Biologics Evaluation and Research,
(12) Ethical Issues in Subject Enrollment, (13) The Inspection is
Over--What Happens Next? Possible FDA Compliance Actions.
FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The public workshop helps to achieve objectives set
forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C.
393) which includes working closely with stakeholders and maximizing
the availability and clarity of information to stakeholders and the
public. The public workshop also is consistent with the Small Business
Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), as
outreach activities by Government agencies to small businesses.
Dated: December 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-30017 Filed 12-16-09; 8:45 am]
BILLING CODE 4160-01-S
