Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Availability, 22958-22959 [E8-9253]
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Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Notices
D. Other Submission Requirements and
Information
Several additional separate actions are
required before an applicant institution/
organization can submit an application.
Organizational DUNS—As of October
1, 2003, applicants are required to have
a DUNS number to apply for a grant or
cooperative agreement from the Federal
Government. The DUNS number is a
nine-digit identification number, which
uniquely identifies business entities.
Obtaining a DUNS number is easy and
there is no charge. To obtain a DUNS
number applicants should go to https://
www.grants.gov/RequestaDUNS.
Central Contractor Registration—
Applicants must register with the CCR
database. This database is a governmentwide warehouse of commercial and
financial information for all
organizations conducting business with
the Federal Government. The preferred
method for completing a registration is
at https://www.ccr.gov. This Web site
provides a CCR handbook with detailed
information on data you will need prior
to beginning the online preregistration
as well as steps to walk you through the
registration process. You must have a
DUNS number to begin your
registration. For foreign entities the Web
site is https://www.grants.gov/
RequestaDUNS.gov. In order to access
Grants.gov an applicant will be required
to register with the Credential Provider.
Information about this is available at
https://apply.grants.gov/OrcRegister.
A copy of the complete RFA can also
be viewed on FDA’s Center for Food
Safety and Applied Nutrition Web site
at https://www.cfsan.fda.gov/list.html.
Foreign Applications (Non-domestic
(non-U.S.) Entity)
• Indicate how the proposed project
has specific relevance to the mission
and objectives of FDA and has the
potential for significantly advancing
sciences in the United States.
• Research grant applications from
foreign or international organizations
may not be funded unless approved by
the National Cancer Institute National
Advisory Board.
IV. Agency Contacts
pwalker on PROD1PC71 with NOTICES
A. Scientific/Research Contacts
For issues regarding the programmatic
aspects of this document, contact Susan
E. Carberry at 301–436–1269 or by email: susan.carberry@fda.hhs.gov.
B. Financial or Grants Management
Contacts
For issues regarding the
administrative and financial
management aspects, contact Gladys
Melendez-Bohler at 301–827–7168 or by
VerDate Aug<31>2005
18:22 Apr 25, 2008
Jkt 214001
e-mail: gladys.melendezbohler@fda.hhs.gov.
Dated: April 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–9251 Filed 4–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0233]
Draft Guidance for Industry: Use of
Nucleic Acid Tests to Reduce the Risk
of Transmission of West Nile Virus
from Donors of Whole Blood and
Blood Components Intended for
Transfusion and Donors of Human
Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps);
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Use of Nucleic
Acid Tests to Reduce the Risk of
Transmission of West Nile Virus from
Donors of Whole Blood and Blood
Components Intended for Transfusion
and Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products
(HCT/Ps)’’ dated April 2008. This draft
guidance is intended for establishments
that collect Whole Blood and blood
components intended for transfusion
and establishments that make donor
eligibility determinations for donors of
human cells, tissues, and cellular and
tissue-based products (HCT/Ps). The
document provides recommendations
for testing of donations of Whole Blood
and blood components and HCT/P
donor specimens for West Nile Virus
(WNV) using an FDA-licensed donor
screening assay. FDA believes that the
use of a licensed nucleic acid test (NAT)
will reduce the risk of transmission of
WNV, and therefore recommend use of
a licensed NAT to screen donors of
Whole Blood and blood components
intended for transfusion and for testing
donors of HCT/Ps for infection with
WNV. FDA recommends the use of
licensed NAT testing for WNV within 6
months after a final guidance is issued.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by July 28, 2008.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Use of Nucleic Acid Tests to
Reduce the Risk of Transmission of
West Nile Virus from Donors of Whole
Blood and Blood Components Intended
for Transfusion and Donors of Human
Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps)’’ dated April
2008. This draft guidance is intended
for establishments that collect Whole
Blood and blood components intended
for transfusion and establishments that
make donor eligibility determinations
for donors of human cells, tissues, and
cellular and tissue-based products HCT/
Ps. The document provides
recommendations for testing of
donations of Whole Blood and blood
components and HCT/P donor
specimens for WNV using an FDAlicensed donor screening assay. FDA
believes that the use of a licensed NAT
will reduce the risk of transmission of
WNV, and therefore recommend use of
a licensed NAT to screen donors of
Whole Blood and blood components
intended for transfusion and for testing
donors of HCT/Ps for infection with
WNV. FDA recommends the use of
licensed NAT testing for WNV within 6
months after a final guidance is issued.
E:\FR\FM\28APN1.SGM
28APN1
Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Notices
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. 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 requirement
of the applicable statutes and
regulations.
Dated: April 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–9253 Filed 4–25–08; 8:45 am]
II. Paperwork Reduction Act of 1995
[Docket No. FDA–2008–N–0226]
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 312 have
been approved under 0910–0014; 21
CFR part 601 have been approved under
0910–0338; CFR part 606 have been
approved under 0910–0116; and 21 CFR
part 7, subpart C, have been approved
under 0910–0249.
Risk Communication Advisory
Committee; Notice of Meeting
III. Comments
pwalker on PROD1PC71 with NOTICES
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the draft
guidance. 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 the
brackets in the heading of this
document. A copy of the draft guidance
and received comments are available for
public examination 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 draft guidance at either
https://www.fda.gov/cber/guidelines.htm
or https://www.regulations.gov.
VerDate Aug<31>2005
18:22 Apr 25, 2008
Jkt 214001
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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: 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 May 15, 2008, from 8 a.m. to 5
p.m. and May 16, 2008, from 8 a.m. to
2 p.m.
Addresses: Submit electronic
comments and information to https://
www.regulations.gov . Comments are to
be identified with the docket number
found in brackets in the heading of this
document. Written comments should be
submitted to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, by close of
business on June 16, 2008. All
comments received will be posted
without change, including any personal
information provided. Comments
received on or before May 8, 2008, will
be provided to the committee before or
at the meeting; comments received after
that time will still be considered in
preparing the report that was specified
in the FDA Amendments Act of 2007
(see docket and committee background
for further information).
Location: Hilton Washington DC/
Rockville Hotel & Executive Meeting
Center, 1750 Rockville Pike, Rockville,
MD, 20852–1699.
Contact Person: Lee L. Zwanziger,
Office of the Commissioner, 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–
827–5340, Food and Drug
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
22959
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 affect 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 May 15, 2008, the
committee will meet for presentations
and discussion of direct-to-consumer
(DTC) advertising, including how it
relates to communicating to subsets of
the general population, such as the
elderly, children, and racial and ethnic
minority communities, and increased
access to health information and
decreased health disparities for these
populations. On May 16, 2008, the
committee will discuss studying the
appropriateness of including, in
televised DTC ads, a statement
encouraging consumers to report
negative side effects of prescription
drugs to MedWatch, as is currently
required for print DTC prescription drug
ads.
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 May 8, 2008.
Written submissions may also be made
to the docket at the address above (see
the docket for further information on
topics of particular interest for comment
in connection with this meeting). Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. on May 15th and
between 10:30 a.m. and 11:30 a.m. on
May 16th. Those desiring to make
formal oral presentations should notify
the contact person on or before May 8,
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 73, Number 82 (Monday, April 28, 2008)]
[Notices]
[Pages 22958-22959]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9253]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0233]
Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce
the Risk of Transmission of West Nile Virus from Donors of Whole Blood
and Blood Components Intended for Transfusion and Donors of Human
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft document entitled ``Guidance for Industry: Use
of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile
Virus from Donors of Whole Blood and Blood Components Intended for
Transfusion and Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)'' dated April 2008. This draft guidance
is intended for establishments that collect Whole Blood and blood
components intended for transfusion and establishments that make donor
eligibility determinations for donors of human cells, tissues, and
cellular and tissue-based products (HCT/Ps). The document provides
recommendations for testing of donations of Whole Blood and blood
components and HCT/P donor specimens for West Nile Virus (WNV) using an
FDA-licensed donor screening assay. FDA believes that the use of a
licensed nucleic acid test (NAT) will reduce the risk of transmission
of WNV, and therefore recommend use of a licensed NAT to screen donors
of Whole Blood and blood components intended for transfusion and for
testing donors of HCT/Ps for infection with WNV. FDA recommends the use
of licensed NAT testing for WNV within 6 months after a final guidance
is issued.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by July 28, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers
Assistance (HFM-40), Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist the office in processing your requests. The draft guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for electronic access
to the draft guidance document.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk
of Transmission of West Nile Virus from Donors of Whole Blood and Blood
Components Intended for Transfusion and Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products (HCT/Ps)'' dated April 2008.
This draft guidance is intended for establishments that collect Whole
Blood and blood components intended for transfusion and establishments
that make donor eligibility determinations for donors of human cells,
tissues, and cellular and tissue-based products HCT/Ps. The document
provides recommendations for testing of donations of Whole Blood and
blood components and HCT/P donor specimens for WNV using an FDA-
licensed donor screening assay. FDA believes that the use of a licensed
NAT will reduce the risk of transmission of WNV, and therefore
recommend use of a licensed NAT to screen donors of Whole Blood and
blood components intended for transfusion and for testing donors of
HCT/Ps for infection with WNV. FDA recommends the use of licensed NAT
testing for WNV within 6 months after a final guidance is issued.
[[Page 22959]]
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. 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 requirement of the applicable statutes
and regulations.
II. 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 312 have been approved under
0910-0014; 21 CFR part 601 have been approved under 0910-0338; CFR part
606 have been approved under 0910-0116; and 21 CFR part 7, subpart C,
have been approved under 0910-0249.
III. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft guidance. 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 the brackets in
the heading of this document. A copy of the draft guidance and received
comments are available for public examination 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 draft guidance
at either https://www.fda.gov/cber/guidelines.htm or https://
www.regulations.gov.
Dated: April 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9253 Filed 4-25-08; 8:45 am]
BILLING CODE 4160-01-S
