Blood Products Advisory Committee; Notice of Meeting, 43941-43942 [E8-17359]
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jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 146 / Tuesday, July 29, 2008 / Notices
I. Background
FDA is announcing the availability of
a draft information sheet guidance for
sponsors, clinical investigators, and
IRBs entitled ‘‘Frequently Asked
Questions—Statement of Investigator
(Form FDA 1572).’’ This guidance is
intended to assist IRBs, clinical
investigators, and sponsors involved in
clinical investigations of investigational
drugs and biologics in complying with
the requirement that each investigator
complete and sign a Form FDA 1572
before participating in an investigation.
It describes how to complete the
Statement of Investigator form (Form
FDA 1572).
FDA developed this draft information
sheet guidance in response to numerous
questions from the research community
regarding Form FDA 1572. In this draft
guidance, we provide answers to
frequently asked questions concerning
the purpose of this form, when this form
needs to be completed and signed by the
investigator, how to best complete the
various blocks within the form, and
when the form might need to be
updated. In addition, we clarify
questions related to the use of Form
FDA 1572 by clinical investigators
participating in studies conducted
outside the United States that may or
may not be under an investigational
new drug application.
This information sheet guidance is
part of the Information Sheet Guidance
Initiative announced in the Federal
Register of February 3, 2006 (71 FR
5861), which describes FDA’s intention
to update the process for developing,
issuing, and making available guidances
intended for IRBs, clinical investigators,
and sponsors. Known as ‘‘Information
Sheets,’’ these guidances have provided
recommendations to IRBs, clinical
investigators, and sponsors to help them
fulfill their responsibilities to protect
human subjects who participate in
research regulated by the FDA since the
early 1980s. The Information Sheet
Guidance Initiative is intended to
ensure that the Information Sheets are
consistent with the FDA’s good
guidance practices (GGPs). As part of
the initiative, which will be ongoing,
the agency plans to rescind Information
Sheets that are obsolete, revise and
reissue Information Sheet Guidances
that address current issues, and develop
new Information Sheet Guidances as
needed.
This draft information sheet guidance
is being issued consistent with FDA’s
GGPs regulation (21 CFR 10.115). The
draft information sheet guidance, when
finalized, will represent the agency’s
current thinking on completing Form
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16:12 Jul 28, 2008
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FDA 1572. 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 statutes
and regulations.
II. The 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 for Form FDA 1572 have
been approved under OMB Control No.
0910–0014.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The guidance
and received comments may be seen in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/oc/gcp/draft.html or
https://www.regulations.gov.
Dated: July 21, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17305 Filed 7–28–08; 8:45 am]
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43941
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Blood Products
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 10, 2008, from 8 a.m.
to 5:45 p.m. and on September 11, 2008,
from 8 a.m. to 3 p.m.
Location: Hilton Hotel, Washington,
DC/Rockville Executive Meeting Center,
1750 Rockville Pike, Rockville, MD
20852.
Contact Person: Donald W. Jehn or
Pearline K. Muckelvene, Center for
Biologics Evaluation and Research
(CBER) (HFM–71), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–827–0314, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014519516. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On the morning of
September 10, 2008, the Committee will
hear an update on the May 29 to 30,
2008, meeting of the Department of
Health and Human Services Advisory
Committee on Blood Safety and
Availability. Following this update, the
Committee will discuss strategies to
enhance bacterial safety of 7 day
platelets for transfusion. In the
afternoon, the Committee will discuss
iron status in blood donors. On
September 11, 2008, the Committee will
hear updates on the following topics: (1)
E:\FR\FM\29JYN1.SGM
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jlentini on PROD1PC65 with NOTICES
43942
Federal Register / Vol. 73, No. 146 / Tuesday, July 29, 2008 / Notices
April 29 to 30, 2008, workshop on
hemoglobin based oxygen carriers; (2)
July 10 to 11, 2008, blood establishment
computer software conference; (3) the
development of an automated Biologics
License Application submission system;
and (4) Draft Guidance for Industry: Requalification Method for Re-entry of
Blood Donors Deferred Because of
Reactive Test Results for Antibody to
Hepatitis B Core Antigen (Anti-HBc).
Following these updates, the Committee
will discuss options for blood donor
screening and re-entry for malaria. FDA
intends to make background material
available to the public no later than 2
business days before the meeting. If
FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before September 2, 2008.
Oral presentations from the public will
be scheduled between approximately
10:45 a.m. and 11:30 a.m. and between
approximately 4 p.m. and 4:30 p.m. on
September 10, 2008, and between
approximately 9:15 a.m. and 9:45 a.m.
and between approximately 1:30 p.m.
and 2 p.m. on September 11, 2008.
Those desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before August
22, 2008. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 25, 2008.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
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meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Donald W.
Jehn or Pearline K. Muckelvene at least
7 days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–17359 Filed 7–28–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Risk Communication Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public. All attendees should bring some
form of government-issued photo
identification, such as a driver’s license.
Name of Committee: Risk
Communication Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
effective risk communication.
Date and Time: The meeting will be
held on August 14, 2008, from 8 a.m. to
5 p.m. and August 15, 2008, from 8 a.m.
to 2 p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Lee L. Zwanziger,
Office of the Commissioner, Office of
Policy, Planning and Preparedness,
Office of Planning (HFP–60), Food and
Drug Administration, 5600 Fishers Lane
(for express delivery: rm 15–22),
Rockville, MD 20857, 301–827–2895,
FAX: 301–827–3285, Food and Drug
PO 00000
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Administration, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
8732112560. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On August 14 and 15, 2008,
the committee will meet for
presentations and discussion of the
scientific basis for translating principles
of risk communication into practice in
situations of emerging and uncertain
risk.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is or
will be available at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 11, 2008.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on August 14th and
10:30 to 11:30 on August 15th. Those
desiring to make formal oral
presentations should notify the contact
person and should submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 7, 2008. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
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]]>Agencies
[Federal Register Volume 73, Number 146 (Tuesday, July 29, 2008)]
[Notices]
[Pages 43941-43942]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17359]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
Blood Products Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Blood Products Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on September 10, 2008, from
8 a.m. to 5:45 p.m. and on September 11, 2008, from 8 a.m. to 3 p.m.
Location: Hilton Hotel, Washington, DC/Rockville Executive Meeting
Center, 1750 Rockville Pike, Rockville, MD 20852.
Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center
for Biologics Evaluation and Research (CBER) (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014519516. Please call the
Information Line for up-to-date information on this meeting. A notice
in the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On the morning of September 10, 2008, the Committee will
hear an update on the May 29 to 30, 2008, meeting of the Department of
Health and Human Services Advisory Committee on Blood Safety and
Availability. Following this update, the Committee will discuss
strategies to enhance bacterial safety of 7 day platelets for
transfusion. In the afternoon, the Committee will discuss iron status
in blood donors. On September 11, 2008, the Committee will hear updates
on the following topics: (1)
[[Page 43942]]
April 29 to 30, 2008, workshop on hemoglobin based oxygen carriers; (2)
July 10 to 11, 2008, blood establishment computer software conference;
(3) the development of an automated Biologics License Application
submission system; and (4) Draft Guidance for Industry: Re-
qualification Method for Re-entry of Blood Donors Deferred Because of
Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-
HBc). Following these updates, the Committee will discuss options for
blood donor screening and re-entry for malaria. FDA intends to make
background material available to the public no later than 2 business
days before the meeting. If FDA is unable to post the background
material on its Web site prior to the meeting, the background material
will be made publicly available at the location of the advisory
committee meeting, and the background material will be posted on FDA's
Web site after the meeting. Background material is available at https://
www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2008 and
scroll down to the appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
September 2, 2008. Oral presentations from the public will be scheduled
between approximately 10:45 a.m. and 11:30 a.m. and between
approximately 4 p.m. and 4:30 p.m. on September 10, 2008, and between
approximately 9:15 a.m. and 9:45 a.m. and between approximately 1:30
p.m. and 2 p.m. on September 11, 2008. Those desiring to make formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before August 22, 2008. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by August
25, 2008.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Donald W. Jehn or
Pearline K. Muckelvene at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-17359 Filed 7-28-08; 8:45 am]
BILLING CODE 4160-01-S
