Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop, 61645-61646 [2014-24307]
Download as PDF
<![CDATA[
Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices
fluorescent or chromogenic enzymesubstrate detection methods (e.g.,
immunohistochemical stains) nor does
it cover the use of flow cytometry for
cell enrichment and cell sorting/
purification when used in cell therapy
product manufacturing.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on flow cytometric devices. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
mstockstill on DSK4VPTVN1PROD with NOTICES
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or from
CBER at https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/default.htm.
Persons unable to download an
electronic copy of ‘‘Flow Cytometric
Devices’’ may send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document.
Please use the document number 1787
to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 807,
subpart E, have been approved under
OMB control number 0910–0120, and
the collections of information in 21 CFR
part 801 and 21 CFR 809.10 have been
approved under OMB control number
0910–0485.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
VerDate Sep<11>2014
16:59 Oct 10, 2014
Jkt 235001
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: October 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24308 Filed 10–10–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Society of Clinical Research
Associates—Food and Drug
Administration: 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) is announcing an educational
conference co-sponsored with the
Society of Clinical Research Associates
(SoCRA). The public workshop
regarding 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 5 and 6, 2014,
from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Wyndham Lake Buena
Vista Hotel, 1850 Hotel Plaza Blvd.,
Lake Buena Vista, FL 32830, 407–828–
4444.
Attendees are responsible for their
own accommodations. Please mention
SoCRA to receive the hotel room rate of
$95.00 plus applicable taxes (available
until October 6, 2014, or until the
SoCRA room block is filled).
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
61645
Contact: C. Stewart Watson, Food and
Drug Administration, 555 Winderley Pl.,
Suite 200, Maitland, FL 32751, 407–
475–4756, FAX: 407–475–4768, 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:
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 workshop will
receive confirmation. The cost of the
registration is as follows: SoCRA
member—$575; SoCRA nonmember
(includes membership)—$650; Federal
Government 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 education
activity for a maximum of 13.3
continuing education (CE) credits for
SoCRA CE and continuing nursing
education (CNE). SoCRA designates this
live activity for a maximum of 13.3
American Medical Association
Physicians Recognition Award Category
1 Credit(s).TM Physicians should claim
only the credit commensurate with the
extent of their participation. Continuing
Medical Education 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 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
E:\FR\FM\14OCN1.SGM
14OCN1
mstockstill on DSK4VPTVN1PROD with NOTICES
61646
Federal Register / Vol. 79, No. 198 / Tuesday, October 14, 2014 / Notices
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 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
informed consent, clinical investigation
requirements, institutional review board
inspections, electronic record
requirements, and investigator initiated
research Topics for discussion include
the following: (1) The Role of the FDA
District Office Relative to the
Bioresearch Monitoring Program
(BIMO); (2) Modernizing FDA’s Clinical
Trials/BIMO Programs; (3) What FDA
Expects in a Pharmaceutical Clinical
Trial; (4) Medical Device Aspects of
Clinical Research; (5) Adverse Event
Reporting—Science, Regulation, Error,
and Safety; (6) Working with FDA’s
Center for Biologics Evaluation and
Research; (7) Ethical Issues in Subject
Enrollment; (8) Keeping Informed and
Working Together; (9) FDA Conduct of
Clinical Investigator Inspections; (10)
Investigator Initiated Research; (11)
Meetings with FDA—Why, When, and
How; (12) Part 11 Compliance—
Electronic Signatures; (13) IRB
Regulations and FDA Inspections; (14)
Informed Consent Regulations; (15) The
Inspection is Over—What Happens
Next? Possible FDA Compliance
Actions; (16) Question and Answer
Session/Panel Discussion.
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 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: October 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–24307 Filed 10–10–14; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:59 Oct 10, 2014
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Evaluation of
National Institutes of Health
International Bilateral Programs (FIC,
NCI, NIAAA, NIAID, NICHD, NIDA,
NINDS, NIMH, OAR)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on March 13, 2014
(Vol. 79, P. 14256) and allowed 60-days
for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Margaret Mary Bertram, Center
for Global Health, National Cancer
Institute, 9609 Medical Center Dr., Rm
3W264, Rockville MD, 20850 or call
non-toll-free number 240–276–5656 or
Email your request, including your
address to: margaret.bertram@nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Evaluation of
National Institutes of Health
International Bilateral Programs (FIC,
NCI, NIAAA, NIAID, NICHD, NIDA,
NINDS, NIMH, OAR), 0925–NEW,
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: This submission is a request
for OMB to approve the Evaluation of
National Institutes of Health (NIH)
International Bilateral Programs for
three years. The bilateral awards are
made through the Funding Opportunity
Announcement mechanism and
administrative supplements, meaning
they are funded by set-aside funds that
are separate from the general pool of
research program grant funds used to
support investigator initiated research at
NIH. The bilateral programs to be
evaluated are the U.S.-China Program
for Biomedical Research Cooperation,
U.S.-India Bilateral Collaborative
Research Partnerships on the Prevention
of HIV/AIDS and Co-morbidities, U.S.Russia Bilateral Collaborative Research
Partnerships on the Prevention and
Treatment of HIV/AIDS and Comorbidities, and U.S.-South Africa
Program for Collaborative Biomedical
Research. These programs are funded
and administered by various
combinations of the following institutes:
Fogarty International Center (FIC), the
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National Cancer
Institute (NCI), National Institute on
Alcohol Abuse and Alcoholism
(NIAAA), National Institute for Allergy
and Infectious Diseases (NIAID),
National Institute on Drug Abuse
(NIDA), National Institute of Mental
Health (NIMH), National Institute of
Neurological Disorders and Stroke
(NINDS), and the Office of AIDS
Research (OAR). While these programs
differ, their underlying concept is the
same; they require U.S. scientists to
collaborate with scientists from other
countries in order to conduct
scientifically meritorious investigations
of mutual interest to both countries. The
proposed evaluation requests
information about (1) accomplishments
of the awards, (2) unique findings or
opportunities due to the international
collaborations, and (3) successes and
challenges of these collaborations. The
information will be collected one year
into the award and at the end of the
award, when possible. This information
is needed to evaluate the effectiveness
of these programs across NIH.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
129.
E:\FR\FM\14OCN1.SGM
14OCN1
]]>Agencies
[Federal Register Volume 79, Number 198 (Tuesday, October 14, 2014)]
[Notices]
[Pages 61645-61646]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24307]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Society of Clinical Research Associates--Food and Drug
Administration: 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) is announcing an educational
conference co-sponsored with the Society of Clinical Research
Associates (SoCRA). The public workshop regarding 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 5 and
6, 2014, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Wyndham Lake
Buena Vista Hotel, 1850 Hotel Plaza Blvd., Lake Buena Vista, FL 32830,
407-828-4444.
Attendees are responsible for their own accommodations. Please
mention SoCRA to receive the hotel room rate of $95.00 plus applicable
taxes (available until October 6, 2014, or until the SoCRA room block
is filled).
Contact: C. Stewart Watson, Food and Drug Administration, 555
Winderley Pl., Suite 200, Maitland, FL 32751, 407-475-4756, FAX: 407-
475-4768, 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:
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 workshop will receive confirmation. The cost of
the registration is as follows: SoCRA member--$575; SoCRA nonmember
(includes membership)--$650; Federal Government 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 education
activity for a maximum of 13.3 continuing education (CE) credits for
SoCRA CE and continuing nursing education (CNE). SoCRA designates this
live activity for a maximum of 13.3 American Medical Association
Physicians Recognition Award Category 1 Credit(s).TM
Physicians should claim only the credit commensurate with the extent of
their participation. Continuing Medical Education 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 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
[[Page 61646]]
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 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 informed consent,
clinical investigation requirements, institutional review board
inspections, electronic record requirements, and investigator initiated
research Topics for discussion include the following: (1) The Role of
the FDA District Office Relative to the Bioresearch Monitoring Program
(BIMO); (2) Modernizing FDA's Clinical Trials/BIMO Programs; (3) What
FDA Expects in a Pharmaceutical Clinical Trial; (4) Medical Device
Aspects of Clinical Research; (5) Adverse Event Reporting--Science,
Regulation, Error, and Safety; (6) Working with FDA's Center for
Biologics Evaluation and Research; (7) Ethical Issues in Subject
Enrollment; (8) Keeping Informed and Working Together; (9) FDA Conduct
of Clinical Investigator Inspections; (10) Investigator Initiated
Research; (11) Meetings with FDA--Why, When, and How; (12) Part 11
Compliance--Electronic Signatures; (13) IRB Regulations and FDA
Inspections; (14) Informed Consent Regulations; (15) The Inspection is
Over--What Happens Next? Possible FDA Compliance Actions; (16) Question
and Answer Session/Panel Discussion.
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 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: October 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24307 Filed 10-10-14; 8:45 am]
BILLING CODE 4164-01-P
