Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop, 78933-78934 [2011-32435]
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Federal Register / Vol. 76, No. 244 / Tuesday, December 20, 2011 / Notices
78933
TABLE 1—Continued
Committee name
Tentative date(s) of meeting(s)
Medical Devices Dispute Resolution Panel .............................................
Microbiology Devices Panel .....................................................................
Molecular and Clinical Genetics Panel ....................................................
Neurological Devices Panel .....................................................................
Obstetrics and Gynecology Devices Panel ..............................................
Ophthalmic Devices Panel .......................................................................
Orthopedic and Rehabilitation Devices Panel ..........................................
Radiological Devices Panel ......................................................................
National Mammography Quality Assurance Advisory Committee ...........
Technical Electronic Product Radiation Safety Standards Committee ....
Date(s), if needed, to be determined.
Date(s), if needed, to be determined.
June 27.
Date(s), if needed, to be determined.
July 5–6.
November 8–9.
September 13–14, November 16, December 6–7.
November 2.
October 18.
June 14.
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
Food Advisory Committee ........................................................................
December 13–14.
CENTER FOR TOBACCO PRODUCTS
Tobacco Products Scientific Advisory Committee ...................................
January 18–20, March 1–2.
CENTER FOR VETERINARY MEDICINE
Veterinary Medicine Advisory Committee ................................................
Date(s), if needed, to be determined.
NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR)
Science Advisory Board to NCTR ............................................................
Dated: December 14, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–32469 Filed 12–19–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Food and Drug Administration Clinical
Trial Requirements, Regulations,
Compliance, and Good Clinical
Practice; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSK4TPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Los Angeles 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
VerDate Mar<15>2010
16:28 Dec 19, 2011
Jkt 226001
October 23–24.
and informed consent documents;
regulations 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 March 7 and 8, 2012,
from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Hyatt Regency Newport
Beach, 1107 Jamboree Rd., Newport
Beach, CA 92660, 1 (949) 729–1234.
Attendees are responsible for their
own accommodations. Please mention
SoCRA to receive the hotel room rate of
$145.00 plus applicable taxes (available
until February 14, 2012, or until the
SoCRA room block is filled).
Contact: Linda Hartley, Office of
Regulatory Affairs, Food and Drug
Administration, 19701 Fairchild, Irvine,
CA 92612, (949) 608–4413, FAX: (949)
608–4417; or Society of Clinical
Research Associates (SoCRA), 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, Web site:
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:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
COST OF REGISTRATION
SoCRA
nonmember
(includes
membership) ...............................
Federal Government SoCRA member ...............................................
Federal Government SoCRA nonmember .......................................
FDA Employee ...............................
650.00
450.00
525.00
[*]
* Fee Waived.
If you need special accommodations
due to a disability, please contact
SoCRA or Linda Hartley (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 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).
E:\FR\FM\20DEN1.SGM
20DEN1
jlentini on DSK4TPTVN1PROD with NOTICES
78934
Federal Register / Vol. 76, No. 244 / Tuesday, December 20, 2011 / Notices
ANCC/PSNA Provider Reference
Number: 205–3–A–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://www.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 publishes 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)
What FDA Expects in a Pharmaceutical
Clinical Trial; (2) Adverse Event
Reporting—Science, Regulation, Error,
and Safety; (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 FDA: Why, When, and How; (9)
Investigator Initiated Research; (10)
Medical Device Aspects of Clinical
Research; (11) Working With FDA’s
Center for Biologics Evaluation and
Research; and (12) 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
VerDate Mar<15>2010
16:28 Dec 19, 2011
Jkt 226001
1996 (Public Law 104–121) as outreach
activities by Government Agencies to
small businesses.
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 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Dated: December 13, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–32435 Filed 12–19–11; 8:45 am]
BILLING CODE 4160–01–P
[FR Doc. 2011–32520 Filed 12–19–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HOMELAND
SECURITY
National Institutes of Health
Office of the Secretary
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 RFA Panel:
Challenge on the Transition from Acute to
Chronic Neuropathic Pain
Date: January 9–10, 2012.
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, Ph.D.,
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 Member
Conflict: Topics in Infectious Diseases and
Microbiology
Date: January 12, 2012.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Liangbiao Zheng, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3202,
MSC 7808, Bethesda, MD 20892, (301) 996–
5819, zhengli@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Published Privacy Impact
Assessments on the Web
Privacy Office, DHS.
Notice of Publication of Privacy
Impact Assessments (PIA).
AGENCY:
ACTION:
The Privacy Office of DHS is
making available seven PIAs on various
programs and systems in DHS. These
assessments were approved and
published on the Privacy Office’s web
site between September 1, 2011 and
November 30, 2011.
DATES: The PIAs will be available on the
DHS Web site until February 21, 2012,
after which they may be obtained by
contacting the DHS Privacy Office
(contact information below).
FOR FURTHER INFORMATION CONTACT:
Mary Ellen Callahan, Chief Privacy
Officer, Department of Homeland
Security, Washington, DC 20528, or
email: pia@hq.dhs.gov.
SUPPLEMENTARY INFORMATION: Between
September 1, 2011 and November 30,
2011, the Chief Privacy Officer of the
DHS approved and published seven
Privacy Impact Assessments (PIAs) on
the DHS Privacy Office web site,
www.dhs.gov/privacy, under the link for
‘‘Privacy Impact Assessments.’’ These
PIAs cover seven separate DHS
programs. Below is a short summary of
those programs, indicating the DHS
component responsible for the system,
and the date on which the PIA was
approved. Additional information can
be found on the web site or by
contacting the Privacy Office.
System: DHS/FEMA/PIA–018
Suspicious Activity Reporting (SAR).
Component: Federal Emergency
Management Agency (FEMA).
Date of approval: September 9, 2011.
FEMA, a component of DHS, manages
a process for SAR. This process,
assigned to FEMA’s Office of the Chief
Security Officer, is designed to collect,
investigate, analyze, and report
suspicious activities to the Federal
Bureau of Investigation’s (FBI) Joint
SUMMARY:
E:\FR\FM\20DEN1.SGM
20DEN1
]]>Agencies
[Federal Register Volume 76, Number 244 (Tuesday, December 20, 2011)]
[Notices]
[Pages 78933-78934]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32435]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Food and Drug Administration Clinical Trial Requirements,
Regulations, Compliance, and Good Clinical Practice; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA), Los Angeles 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;
regulations 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 March 7 and 8,
2012, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Hyatt Regency
Newport Beach, 1107 Jamboree Rd., Newport Beach, CA 92660, 1 (949) 729-
1234.
Attendees are responsible for their own accommodations. Please
mention SoCRA to receive the hotel room rate of $145.00 plus applicable
taxes (available until February 14, 2012, or until the SoCRA room block
is filled).
Contact: Linda Hartley, Office of Regulatory Affairs, Food and Drug
Administration, 19701 Fairchild, Irvine, CA 92612, (949) 608-4413, FAX:
(949) 608-4417; or Society of Clinical Research Associates (SoCRA), 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, Web site:
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.................. 450.00
Federal Government SoCRA nonmember............... 525.00
FDA Employee..................................... [*]
------------------------------------------------------------------------
* Fee Waived.
If you need special accommodations due to a disability, please
contact SoCRA or Linda Hartley (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 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).
[[Page 78934]]
ANCC/PSNA Provider Reference Number: 205-3-A-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://www.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 publishes 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) What FDA Expects in a
Pharmaceutical Clinical Trial; (2) Adverse Event Reporting--Science,
Regulation, Error, and Safety; (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 FDA:
Why, When, and How; (9) Investigator Initiated Research; (10) Medical
Device Aspects of Clinical Research; (11) Working With FDA's Center for
Biologics Evaluation and Research; and (12) 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 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32435 Filed 12-19-11; 8:45 am]
BILLING CODE 4160-01-P
