Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop, 49448-49449 [2012-19851]
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49448
Federal Register / Vol. 77, No. 159 / Thursday, August 16, 2012 / Notices
used to evaluate patient and allograft
outcome in clinical trials of kidney
transplantation. The meeting will
include a discussion of measure of
patient and graft survival, evaluation of
the allograft by histology and
biomarkers, glomerular filtration rate or
other measures of renal function,
evaluation of safety, and other topics.
The input from this public workshop
will help in developing topics for
further discussion and may serve to
inform recommendations on potential
endpoints in clinical trials of kidney
transplantation.
Date and Time: The public workshop
will be held on September 10, 2012,
from 9 a.m. to 6 p.m., and on September
11, 2012, from 8 a.m. to 3 p.m.
Location: The public workshop will
be held at the Sheraton Silver Spring
Hotel, 8777 Georgia Ave., Silver Spring,
MD 20910, 301–589–0800. Seating is
limited and available only on a firstcome, first-served basis.
CONTACT PERSON FOR MORE INFORMATION:
Christine Moser or Ramou Mauer,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6209, Silver Spring,
MD 20993–0002, 301–796–1300 or 301–
796–1600.
Registration: Registration is free for
the public workshop. Interested parties
are encouraged to register early because
space is limited. Seating will be
available on a first-come, first-served
basis. To register electronically, email
registration information (including
name, title, firm name, address,
telephone, and fax number) to
endpoints@fda.hhs.gov. Persons without
access to the Internet can call Christine
Moser, 301–796–1300, or Ramou Mauer,
301–796–1600, to register.
Persons needing a sign language
interpreter or other special
accommodations should notify
Christine Moser or Ramou Mauer (see
CONTACT PERSON FOR MORE INFORMATION)
at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is
announcing a public workshop
regarding potential clinical or surrogate
endpoints and biomarkers for clinical
trials of drugs and therapeutic biologics
in kidney transplantation. This public
workshop will include scientific
discussion on the following topics:
• Patient and graft survival;
• Allograft rejection, both cellular
and antibody-mediated, injury, and
recurrent disease;
• Glomerular filtration rate,
proteinuria, and other measures of renal
function;
• Proteomic, genomic, and
immunologic biomarkers;
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16:38 Aug 15, 2012
Jkt 226001
• Measures of safety, including
cardiovascular and metabolic outcomes;
• Medication adherence; and
• Consideration of composite
endpoints.
The Agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be
available on the Internet at https://
www.fda.gov/Drugs/NewsEvents/
ucm305308.htm approximately 45 days
after the workshop.
Dated: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–20105 Filed 8–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
discuss the informed consent process
and informed consent documents;
regulation, relating to drugs, devices,
and biologics; as well as inspections of
clinical investigators, of IRB, and
research sponsors.
Date and Time: The public workshop
will be held on November 14 and 15,
2012, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Radisson Plaza Lord
Baltimore Hotel, 20 West Baltimore St.,
Baltimore, MD 21201, 410–539–8400.
Attendees are responsible for their own
accommodations. Please mention
SoCRA to receive the hotel room rate of
$129.00 plus applicable taxes (available
until October 13, 2012, or until the
SoCRA room block is filled).
Contact: Cynthia A. Harris, Food and
Drug Administration, 6000 Metro Dr.,
Suite 101, Baltimore, MD 21215, 410–
779–5133, FAX: 410–779–5705; or
Society of Clinical Research Associates
(SoCRA), 530 West Butler Ave., Suite
109, Chalfont, PA 18914, 800–762–7292
or 215–822–8644; Fax: 215–822–8633,
email: SoCRAmail@aol.com, Web site:
https://www.socra.org.
Registration: The registration fee will
cover actual expenses including
refreshments, lunch, materials, and
speaker expenses. Seats are limited;
please submit your registration as soon
as possible. Workshop space will be
filled in order of receipt of registration.
Those accepted into the public
workshop will receive confirmation.
The cost of the registration is as follows:
COST OF REGISTRATION
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Food and Drug Administration Clinical
Trial Requirements, Compliance, and
Good Clinical Practice; Public
Workshop
AGENCY:
Food and Drug Administration,
SoCRA member ...............
SoCRA nonmember (includes membership).
Federal Government
SoCRA member.
Federal Government
SoCRA nonmember.
FDA Employee .................
$575.00.
$650.00.
$525.00.
$450.00.
Fee Waived.
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Baltimore District Office, in
cosponsorship with the Society of
Clinical Research Associates (SoCRA), is
announcing a public workshop. The
public workshop on FDA’s clinical trial
requirements is designed to aid the
clinical research professional’s
understanding of the mission,
responsibilities, and authority of the
FDA and to facilitate interaction with
FDA representatives. The program will
focus on the relationships among FDA
and clinical trial staff, investigators, and
institutional review boards (IRB).
Individual FDA representatives will
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
If you need special accommodations
due to a disability, please contact
SoCRA or Cynthia Harris (see Contact)
at least 21 days in advance.
Extended periods of question and
answer and discussion have been
included in the program schedule.
SoCRA designates this education
activity for a maximum of 13.3
Continuing Education (CE) Credits for
SoCRA CE and continuing nurse
education (CNE). SoCRA designates this
educational activity for a maximum of
13.3 American Medical Association
Physician’s Recognition Award Category
1 Credit(s)TM. Physicians should claim
only the credit commensurate with the
extent of their participation. SoCRA is
E:\FR\FM\16AUN1.SGM
16AUN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 159 / Thursday, August 16, 2012 / Notices
accredited by the Accreditation Council
for Continuing Medical Education to
provide continuing medical education
for physicians. SoCRA is an approved
provider of CNE by the Pennsylvania
State Nurses Association (PSNA), an
accredited approver by the American
Nurses Credentialing Center’s
Commission on Accreditation (ANCC).
ANCC/PSNA Provider Reference
Number: 205–3–1–09.
Registration Instructions: To register,
please submit a registration form with
your name, affiliation, mailing address,
telephone, fax number, and email, along
with a check or money order payable to
‘‘SoCRA’’. Mail to: SoCRA (see Contact
for address). To register via the Internet,
go to https://socra.org/html/
FDA_Conference.htm. (FDA has verified
the Web site addresses throughout this
document, but we are not responsible
for any subsequent changes to the Web
sites after this document is published in
the Federal Register.)
Payment by major credit card is
accepted (Visa/MasterCard/AMEX
only). For more information on the
meeting registration, or for questions on
the public workshop, contact SoCRA
(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, IRB inspections,
electronic record requirements, and
investigator initiated research. Topics
for discussion include the following: (1)
Are We There Yet?; (2) What FDA
Expects in a Pharmaceutical Clinical
Trial; (3) Medical Device Aspects of
Clinical Research; (4) Adverse Event
Reporting—Science, Regulation, Error,
and Safety; (5) Working With FDA’s
Center for Biologics Evaluation and
Research; (6) Ethical Issues in Subject
Enrollment; (7) Keeping Informed and
Working Together; (8) FDA Conduct of
Clinical Investigator Inspections; (9)
Investigator Initiated Research; (10)
Meetings with FDA—Why, When, and
How; (11) Part 11 Compliance—
Electronic Signatures; (12) IRB
Regulations and FDA Inspections; (13)
Informed Consent Regulations; and (14)
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
VerDate Mar<15>2010
16:38 Aug 15, 2012
Jkt 226001
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 (Pub. L. 104–121) as outreach
activities by Government Agencies to
small businesses.
Dated: August 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–19851 Filed 8–15–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Food and Drug Administration Clinical
Trial Requirements, Compliance, and
Good Clinical Practice; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Office of Regulatory Affairs
(ORA), Dallas District Office, in cosponsorship with the Society of Clinical
Research Associates (SoCRA) is
announcing a public workshop. The
public workshop on FDA’s clinical trial
requirements is designed to aid the
clinical research professional’s
understanding of the mission,
responsibilities, and authority of FDA
and to facilitate interaction with FDA
representatives. The program will focus
on the relationships among FDA and
clinical trial staff, investigators, and
institutional review boards (IRBs).
Individual FDA representatives will
discuss the informed consent process
and informed consent documents;
regulations relating to drugs, devices,
and biologics; as well as inspections of
clinical investigators, IRBs, and research
sponsors.
Date and Time: The public workshop
will be held on March 6 and 7, 2013,
from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Sheraton Dallas Hotel,
400 North Olive St., Dallas, TX 75201,
214–922–8000.
Attendees are responsible for their
own accommodations. Please mention
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
49449
SoCRA to receive the hotel room rate of
$145 plus applicable taxes (available
until February 3, 2013, or until the
SoCRA room block is filled).
Contact: David Arvelo, Office of
Regulatory Affairs, Food and Drug
Administration, Southwest Regional
Office, 4040 North Central Expressway,
Suite 900, Dallas, TX 75204, 214–253–
4952, Fax: 214–253–4970, email:
david.arvelo@fda.hhs.gov or SoCRA,
530 West Butler Ave., Suite 109,
Chalfont, PA 18914, 800–762–7292,
FAX: 215–822–8633, email:
SoCRAmail@aol.com, Web site: https://
www.SoCRA.org.
Registration: The registration fee
covers the cost of actual expenses,
including refreshments, lunch,
materials, and speaker expenses. Seats
are limited; please submit your
registration as soon as possible.
Workshop space will be filled in order
of receipt of registration. Those accepted
into the workshop will receive
confirmation. The cost of registration is
as follows:
SoCRA member, $575.00
SoCRA nonmember (includes membership),
$650.00
Federal Government SoCRA member,
$450.00
Federal Government SoCRA nonmember,
$525.00
FDA Employee, Fee Waived
If you need special accommodations
due to a disability, please contact
SoCRA (see Contact) at least 21 days in
advance.
Extended periods of question and
answer and discussion have been
included in the program schedule.
SoCRA designates this educational
activity for a maximum of 13.3
Continuing Education (CE) credits for
SoCRA CE and Nurse continuing
nursing education (CNE). SoCRA
designates this educational activity for a
maximum of 13.3 American Medical
Association Physicians Recognition
Award Category 1 Credit(s)TM.
Physicians should claim credit
commensurate with the extent of their
participation. SoCRA is accredited by
the Accreditation Council for
Continuing Medical Education to
provide continuing medical education
for physicians. SoCRA is an approved
provider of CNE by the Pennsylvania
State Nurses Association (PSNA), an
accredited approver by the American
Nurses Credentialing Center’s
Commission on Accreditation (ANCC).
ANCC/PSNA Provider Reference
Number: 205–3–A–09.
Registration Instructions: To register,
please submit a registration form with
your name, affiliation, mailing address,
phone, fax number, and email, along
E:\FR\FM\16AUN1.SGM
16AUN1
]]>Agencies
[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Notices]
[Pages 49448-49449]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19851]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Food and Drug Administration Clinical Trial Requirements,
Compliance, and Good Clinical Practice; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA), Baltimore District Office,
in cosponsorship with the Society of Clinical Research Associates
(SoCRA), is announcing a public workshop. The public workshop on FDA's
clinical trial requirements is designed to aid the clinical research
professional's understanding of the mission, responsibilities, and
authority of the FDA and to facilitate interaction with FDA
representatives. The program will focus on the relationships among FDA
and clinical trial staff, investigators, and institutional review
boards (IRB). Individual FDA representatives will discuss the informed
consent process and informed consent documents; regulation, relating to
drugs, devices, and biologics; as well as inspections of clinical
investigators, of IRB, and research sponsors.
Date and Time: The public workshop will be held on November 14 and
15, 2012, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Radisson Plaza
Lord Baltimore Hotel, 20 West Baltimore St., Baltimore, MD 21201, 410-
539-8400. Attendees are responsible for their own accommodations.
Please mention SoCRA to receive the hotel room rate of $129.00 plus
applicable taxes (available until October 13, 2012, or until the SoCRA
room block is filled).
Contact: Cynthia A. Harris, Food and Drug Administration, 6000
Metro Dr., Suite 101, Baltimore, MD 21215, 410-779-5133, FAX: 410-779-
5705; or Society of Clinical Research Associates (SoCRA), 530 West
Butler Ave., Suite 109, Chalfont, PA 18914, 800-762-7292 or 215-822-
8644; Fax: 215-822-8633, email: SoCRAmail@aol.com, Web site: https://www.socra.org.
Registration: The registration fee will cover actual expenses
including refreshments, lunch, materials, and speaker expenses. Seats
are limited; please submit your registration as soon as possible.
Workshop space will be filled in order of receipt of registration.
Those accepted into the public workshop will receive confirmation. The
cost of the registration is as follows:
Cost of Registration
------------------------------------------------------------------------
------------------------------------------------------------------------
SoCRA member.............................. $575.00.
SoCRA nonmember (includes membership)..... $650.00.
Federal Government SoCRA member........... $525.00.
Federal Government SoCRA nonmember........ $450.00.
FDA Employee.............................. Fee Waived.
------------------------------------------------------------------------
If you need special accommodations due to a disability, please
contact SoCRA or Cynthia Harris (see Contact) at least 21 days in
advance.
Extended periods of question and answer and discussion have been
included in the program schedule. SoCRA designates this education
activity for a maximum of 13.3 Continuing Education (CE) Credits for
SoCRA CE and continuing nurse education (CNE). SoCRA designates this
educational activity for a maximum of 13.3 American Medical Association
Physician's Recognition Award Category 1 Credit(s)TM.
Physicians should claim only the credit commensurate with the extent of
their participation. SoCRA is
[[Page 49449]]
accredited by the Accreditation Council for Continuing Medical
Education to provide continuing medical education for physicians. SoCRA
is an approved provider of CNE by the Pennsylvania State Nurses
Association (PSNA), an accredited approver by the American Nurses
Credentialing Center's Commission on Accreditation (ANCC). ANCC/PSNA
Provider Reference Number: 205-3-1-09.
Registration Instructions: To register, please submit a
registration form with your name, affiliation, mailing address,
telephone, fax number, and email, along with a check or money order
payable to ``SoCRA''. Mail to: SoCRA (see Contact for address). To
register via the Internet, go to https://socra.org/html/FDA_Conference.htm. (FDA has verified the Web site addresses throughout
this document, but we are not responsible for any subsequent changes to
the Web sites after this document is published in the Federal
Register.)
Payment by major credit card is accepted (Visa/MasterCard/AMEX
only). For more information on the meeting registration, or for
questions on the public workshop, contact SoCRA (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, IRB inspections,
electronic record requirements, and investigator initiated research.
Topics for discussion include the following: (1) Are We There Yet?; (2)
What FDA Expects in a Pharmaceutical Clinical Trial; (3) Medical Device
Aspects of Clinical Research; (4) Adverse Event Reporting--Science,
Regulation, Error, and Safety; (5) Working With FDA's Center for
Biologics Evaluation and Research; (6) Ethical Issues in Subject
Enrollment; (7) Keeping Informed and Working Together; (8) FDA Conduct
of Clinical Investigator Inspections; (9) Investigator Initiated
Research; (10) Meetings with FDA--Why, When, and How; (11) Part 11
Compliance--Electronic Signatures; (12) IRB Regulations and FDA
Inspections; (13) Informed Consent Regulations; and (14) 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 (Pub. L. 104-121) as
outreach activities by Government Agencies to small businesses.
Dated: August 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19851 Filed 8-15-12; 8:45 am]
BILLING CODE 4160-01-P
