Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop, 51040-51041 [2011-20858]
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51040
Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices
for CDER (35 FR 3685, February 25,
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August 30, 2007; and 76 FR 19376,
April 7, 2011) is amended to reflect the
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includes the establishment of the
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Dated: August 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–20859 Filed 8–16–11; 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.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) Philadelphia District Office, in
co-sponsorship 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 (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, IRB, and research
sponsors.
Date and Time: The public workshop
will be held on November 16 and 17,
2011, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Sheraton Philadelphia
City Center Hotel, 201 North 17th St.,
Philadelphia, PA 19103, 1–215–448–
2000.
Attendees are responsible for their
own accommodations. Please mention
SoCRA to receive the hotel room rate of
$159 plus applicable taxes (available
until November 1, 2011, or until the
SoCRA room block is filled).
Contact: Anne Johnson, Food and
Drug Administration, Philadelphia
District, 900 U.S. Customhouse, Second
& Chestnut Streets, Philadelphia, PA
19106, 215–597–4390, FAX: 215–597–
4660, e-mail: anne.johnson@fda.hhs.
gov; 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, e-mail: SoCRAmail@aol.
com, Web site: https://www.SoCRA.org.
(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.)
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:
COST OF REGISTRATION
Emcdonald on DSK2BSOYB1PROD with NOTICES
SoCRA member ....................................................................................................
SoCRA nonmember (includes membership) .........................................................
Federal Government member ...............................................................................
Federal Government nonmember .........................................................................
FDA Employee ......................................................................................................
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 Credits for
SoCRA CE and Nurse CNE. SOCRA
designates this live activity for a
maximum of 13.3 AMA PRA Category 1
Credit(s) TM. Physicians should claim
only the credit commensurate with the
VerDate Mar<15>2010
18:13 Aug 16, 2011
Jkt 223001
($575.00)
($650.00)
($450.00)
($525.00)
(free) Fee Waived
extent of their participation. CME for
Physicians: SoCRA is accredited by the
Accreditation Council for Continuing
Medical Education to provide
continuing medical education for
physicians. CNE for Nurses: SoCRA is
an approved provider of continuing
nursing education 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.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Registration Instructions: To register,
please submit a registration form with
your name, affiliation, mailing address,
telephone, fax number, and e-mail,
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. Payment by
major credit card is accepted (Visa/
MasterCard/AMEX only). For more
information on the meeting registration,
or for questions on the workshop,
contact SoCRA (see Contacts).
E:\FR\FM\17AUN1.SGM
17AUN1
Federal Register / Vol. 76, No. 159 / Wednesday, August 17, 2011 / Notices
The
public workshop helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
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; (12) The Inspection is Over—
What Happens Next? Possible FDA
Compliance Actions; (13) Ethical Issues
in Subject Enrollment; (14) Medical
Device Aspects of Clinical Research);
(15) Are We There Yet? An Overview of
the FDA GCP Program.
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.
SUPPLEMENTARY INFORMATION:
Emcdonald on DSK2BSOYB1PROD with NOTICES
Dated: August 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–20858 Filed 8–16–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
18:13 Aug 16, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Hemoglobin Standards and
Maintaining Adequate Iron Stores in
Blood Donors; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Hemoglobin Standards and
Maintaining Adequate Iron Stores in
Blood Donors.’’ The purpose of this
public workshop is to discuss blood
donor hemoglobin and hematocrit
qualification standards in the United
States, its impact on donor safety and
blood availability, and potential
measures to maintain adequate iron
stores in blood donors. The public
workshop has been planned in
partnership with the Department of
Health and Human Services (HHS)
Office of the Assistant Secretary for
Health, the National Heart, Lung and
Blood Institute, America’s Blood
Centers, AABB, and the Plasma Protein
Therapeutics Association. This public
workshop will include presentations
and panel discussions by experts
knowledgeable in the field from
academic institutions, government
agencies, and industry.
Dates and Times: The public
workshop will be held on November 8,
2011, from 8 a.m. to 5:30 p.m. and
November 9, 2011, from 8 a.m. to 3 p.m.
Location: The public workshop will
be held at the Natcher Conference
Center, Main Auditorium, Building 45,
National Institutes of Health, 45 Center
Dr., Bethesda, MD 20892.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843,
e-mail: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or email your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to Rhonda
Dawson (see Contact Person) by October
14, 2011. There is no registration fee for
the public workshop. Early registration
is recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at
7:30 a.m.
If you need special accommodations
due to a disability, please contact
PO 00000
Frm 00051
Fmt 4703
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51041
Rhonda Dawson (see Contact Person) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION:
Under FDA’s current regulations,
allogeneic blood donors must have a
hemoglobin level of no less than 12.5
grams of hemoglobin per 100 milliliters
of blood or a hematocrit value of 38
percent prior to donation (21 CFR
640.3(b)(3) and 640.63(c)(3)).
Hemoglobin and hematocrit
measurements are typically obtained
from a small sample of blood drawn
from a finger or vein. New technologies
that potentially allow for less invasive,
faster, and more convenient methods of
measuring blood donor hemoglobin and
hematocrit levels are being studied. A
low donor hemoglobin and hematocrit
level is the most common reason that
prospective blood donors, particularly
women, are deferred.
Allogeneic donors of a unit of red
blood cells generally may not donate
more than once in an 8 week period to
ensure recovery of their red blood cells
and iron stores (21 CFR 640.3).
Nonetheless, some donors, especially
repeat and premenopausal female
donors, can develop iron deficiency,
with or without anemia, from blood
donation. Improved understanding of
iron loss in blood donors may help
reduce donor deferrals due to low
hemoglobin and hematocrit levels and
reduce iron deficiency that can result
from blood donation. Different strategies
to minimize iron deficiency in blood
donors (e.g., testing for iron stores,
adjusting the donation interval, or
providing iron replacement) have been
explored in the past. Changes in
qualifying hemoglobin levels have been
discussed in various forums for both
men and women to bring these levels
into closer concordance with population
norms. However, the potential risks and
benefits of these strategies require
further discussion.
This public workshop will serve as a
forum for discussion of hemoglobin and
hematocrit donation standards, current
methods for hemoglobin measurement,
iron loss and iron measurement
methods in blood donors, and strategies
to maintain adequate donor iron stores.
The first day of the public workshop
will include presentations and panel
discussions on the following topics: (1)
Hemoglobin standards for blood donors
in the United States; (2) studies of
hemoglobin distribution and deferral
patterns in blood donors; and (3)
measurement of hemoglobin and
hematocrit and iron levels in blood
donors. The second day of the public
workshop will include a discussion of
the following topics: (1) Iron
E:\FR\FM\17AUN1.SGM
17AUN1
]]>Agencies
[Federal Register Volume 76, Number 159 (Wednesday, August 17, 2011)]
[Notices]
[Pages 51040-51041]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20858]
-----------------------------------------------------------------------
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) Philadelphia District
Office, in co-sponsorship 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 (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, IRB, and research sponsors.
Date and Time: The public workshop will be held on November 16 and
17, 2011, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Sheraton
Philadelphia City Center Hotel, 201 North 17th St., Philadelphia, PA
19103, 1-215-448-2000.
Attendees are responsible for their own accommodations. Please
mention SoCRA to receive the hotel room rate of $159 plus applicable
taxes (available until November 1, 2011, or until the SoCRA room block
is filled).
Contact: Anne Johnson, Food and Drug Administration, Philadelphia
District, 900 U.S. Customhouse, Second & Chestnut Streets,
Philadelphia, PA 19106, 215-597-4390, FAX: 215-597-4660, e-mail:
anne.johnson@fda.hhs.gov; 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, e-mail: SoCRAmail@aol.com,
Web site: https://www.SoCRA.org. (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.)
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:
Cost of Registration
------------------------------------------------------------------------
------------------------------------------------------------------------
SoCRA member............................. ($575.00)
SoCRA nonmember (includes membership).... ($650.00)
Federal Government member................ ($450.00)
Federal Government nonmember............. ($525.00)
FDA Employee............................. (free) 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 Credits for SoCRA
CE and Nurse CNE. SOCRA designates this live activity for a maximum of
13.3 AMA PRA Category 1 Credit(s) TM. Physicians should
claim only the credit commensurate with the extent of their
participation. CME for Physicians: SoCRA is accredited by the
Accreditation Council for Continuing Medical Education to provide
continuing medical education for physicians. CNE for Nurses: SoCRA is
an approved provider of continuing nursing education 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,
telephone, fax number, and e-mail, 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. Payment by major credit card is accepted (Visa/
MasterCard/AMEX only). For more information on the meeting
registration, or for questions on the workshop, contact SoCRA (see
Contacts).
[[Page 51041]]
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 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; (12) The Inspection is Over--What
Happens Next? Possible FDA Compliance Actions; (13) Ethical Issues in
Subject Enrollment; (14) Medical Device Aspects of Clinical Research);
(15) Are We There Yet? An Overview of the FDA GCP Program.
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 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20858 Filed 8-16-11; 8:45 am]
BILLING CODE 4160-01-P
