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; Availability, 57685-57686 [E9-26870]
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Federal Register / Vol. 74, No. 215 / Monday, November 9, 2009 / Notices
involved in cancer research in any
country. Frequency of Response: Once
per initial trial registration; four
amendments per trial annually; and four
accrual updates per trial annually.
Affected Public: Individuals, business
and other for-profits, and not-for-profit
institutions. Type of Respondents:
Clinical research administrators on
behalf of clinical investigators. The
annual reporting burden is estimated at
38,500 hours.
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS
Survey
instrument
Clinical Trials .....................................
Initial Registration .............................
Amendment ......................................
Accrual Updates ...............................
5,500
5,500
5,500
Total ...........................................
mstockstill on DSKH9S0YB1PROD with NOTICES
Type of respondents
......................................................
16,500
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
For Further Information Contact: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact John Speakman,
Associate Director for Clinical Trials
Products and Programs, Center for
Biomedical Informatics and Information
Technology, National Cancer Institute,
NIH, DHHS, 2115 E. Jefferson Street,
Suite 6000, Rockville, MD 20892 or call
non-toll-free number 301–451–8786 or
e-mail your request, including your
address to: john.speakman@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: October 30, 2009.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E9–26875 Filed 11–6–09; 8:45 am]
BILLING CODE 4140–01–P
VerDate Nov<24>2008
16:52 Nov 06, 2009
Jkt 220001
Number of
respondents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0233]
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;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a 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,’’
dated November 2009. This guidance is
intended for establishments that collect
Whole Blood and blood components
intended for transfusion. The document
provides recommendations for testing of
donations of Whole Blood and blood
components 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 recommends use of a
licensed NAT to screen donors of Whole
Blood and blood components intended
for transfusion. The guidance
announced in this notice finalizes the
recommendations as to Whole Blood
and blood components contained in the
draft guidance ‘‘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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Frequency of
response
1
4
4
Average time
per response
(minutes/
hours)
120/60
60/60
15/60
Annual burden
hours
11,000.
22,000.
5,500.
38,500.
(HCT/Ps),’’ dated April 2008. The
recommendations as to HCT/P donor
specimens contained in the draft
guidance are not being finalized at this
time because FDA believes additional
public discussion is warranted.
DATES: Submit electronic or written
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (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 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 guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
´
Denise Sanchez, 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 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,’’ dated November 2009.
The guidance document provides
E:\FR\FM\09NON1.SGM
09NON1
mstockstill on DSKH9S0YB1PROD with NOTICES
57686
Federal Register / Vol. 74, No. 215 / Monday, November 9, 2009 / Notices
recommendations for testing donations
of Whole Blood and blood components
for WNV using an FDA-licensed donor
screening assay. The recommendations
in section III of the guidance apply to all
donations of Whole Blood (as defined in
21 CFR 640.1) and blood components
for transfusion.
In the Federal Register of April 28,
2008 (73 FR 22958), FDA announced the
availability of the draft guidance
‘‘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. The draft
guidance provided recommendations for
testing donations of Whole Blood and
blood components and HCT/P donor
specimens for WNV using an FDAlicensed donor screening assay. FDA
requested that comments on this draft
guidance be submitted within 90 days of
publication. The 90-day comment
period ended on July 28, 2008. In
addition, in the Federal Register of July
7, 2008 (73 FR 38460), FDA requested
the submission of data from the 2008
WNV season relating to the criteria for
converting from minipool NAT (MP–
NAT) to individual donation NAT (ID–
NAT) by January 31, 2009, and stated
that we did not intend to finalize the
proposed recommendations on
conversion from MP–NAT to ID–NAT
until we had obtained the additional
data. At this time, there is insufficient
data to recommend uniform threshold
criteria for switching from MP–NAT
screening to ID–NAT screening. Until
we have sufficient data to support the
development of suitable uniform
threshold criteria, we consider it
appropriate for each blood
establishment to define its own
threshold criteria for switching from
MP–NAT to ID–NAT screening and for
reverting to MP–NAT screening.
Additionally, at this time, FDA is
continuing to review public comment
on our recommendations for testing
HCT/P donor specimens for WNV. We
believe additional public discussion is
warranted. Therefore, we are not
finalizing our recommendations for
HCT/Ps in this guidance. We intend to
seek additional public input and to
issue guidance for testing HCT/P donor
specimens for WNV in the future.
FDA received numerous comments on
the draft guidance and those comments
were considered in finalizing the
guidance. A summary of changes
follows. The guidance announced in
this notice: (1) Finalizes only the
recommendations as to testing
VerDate Nov<24>2008
16:52 Nov 06, 2009
Jkt 220001
donations of Whole Blood and blood
components intended for transfusion for
WNV; (2) allows establishments that
collect Whole Blood and blood
components intended for transfusion
flexibility to define their own threshold
criteria for switching from MP–NAT to
ID–NAT screening; (3) recommends that
establishments that collect Whole Blood
and blood components intended for
transfusion switch from MP–NAT to ID–
NAT screening as soon as feasible with
48 hours of reaching the threshold,
instead of 24 hours; (4) recommends
that establishments notify a blood donor
of his or her deferral and counsel the
donor following an ID–NAT reactive
donation, rather than after additional
testing on the reactive index donation;
and (5) removes Table 2
(Recommendations on Additional
Testing of Blood and Blood
Components).
The guidance is being issued in
conformance with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents 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
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This 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 OMB control number 0910–0014;
the collections of information in 21 CFR
601.12 have been approved under OMB
control number 0910–0338; the
collections of information in 21 CFR
606.100 have been approved under
OMB control number 0910–0116; the
collections of information in 21 CFR
606.122 have been approved under
OMB control number 0910–0116; and
the collections of information in 21 CFR
630.6 have been approved under OMB
control number 0910–0116.
III. Comments
Interested persons may, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) electronic
or written comments regarding the
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
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
with the docket number found in
brackets in the heading of this
document. A copy of the 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: November 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26870 Filed 11–6–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of Biotechnology Activities,
Office of Science Policy, Office of the
Director; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the meeting of the
National Science Advisory Board for
Biosecurity (NSABB).
Name of Committee: National Science
Advisory Board for Biosecurity.
Date: December 3, 2009.
Time: 8:30 a.m. to 4 p.m. (Times are
approximate and subject to change).
Agenda: Presentations and discussions
regarding: (1) Introduction of new NSABB
voting members; (2) federal responses to
NSABB reports; (3) activities of the Working
Groups on Outreach and Education and on
International Engagement; (4) synthetic
biology and NSABB draft report on
biosecurity issues raised by synthetic
biology; (5) public comments; and (6) other
business of the Board.
Place: Bethesda Marriott, 5151 Pooks Hill
Rd., Bethesda, MD 20814.
Contact Person: Ronna Hill, NSABB
Program Assistant, NIH Office of
Biotechnology Activities, 6705 Rockledge
Drive, Suite 750, Bethesda, Maryland 20892,
(301) 496–9838.
Under authority 42 U.S.C. 217a, Section
222 of the Public Health Service Act, as
amended, the Department of Health and
Human Services established the NSABB to
provide advice, guidance and leadership
regarding federal oversight of dual use
research, defined as biological research that
generates information and technologies that
could be misused to pose a biological threat
to public health and/or national security.
The meeting will be open to the public,
however pre-registration is strongly
recommended due to space limitations.
E:\FR\FM\09NON1.SGM
09NON1
]]>Agencies
[Federal Register Volume 74, Number 215 (Monday, November 9, 2009)]
[Notices]
[Pages 57685-57686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26870]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0233]
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; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a 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,'' dated November 2009. This guidance is intended for
establishments that collect Whole Blood and blood components intended
for transfusion. The document provides recommendations for testing of
donations of Whole Blood and blood components 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 recommends use of a licensed NAT to
screen donors of Whole Blood and blood components intended for
transfusion. The guidance announced in this notice finalizes the
recommendations as to Whole Blood and blood components contained in the
draft guidance ``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. The recommendations as to HCT/P donor specimens
contained in the draft guidance are not being finalized at this time
because FDA believes additional public discussion is warranted.
DATES: Submit electronic or written comments on agency guidances at
any time.
ADDRESSES: Submit written requests for single copies of the guidance
to the Office of Communication, Outreach and Development (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 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 guidance document.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Denise S[aacute]nchez, 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 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,'' dated November 2009. The
guidance document provides
[[Page 57686]]
recommendations for testing donations of Whole Blood and blood
components for WNV using an FDA-licensed donor screening assay. The
recommendations in section III of the guidance apply to all donations
of Whole Blood (as defined in 21 CFR 640.1) and blood components for
transfusion.
In the Federal Register of April 28, 2008 (73 FR 22958), FDA
announced the availability of the draft guidance ``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. The
draft guidance provided recommendations for testing donations of Whole
Blood and blood components and HCT/P donor specimens for WNV using an
FDA-licensed donor screening assay. FDA requested that comments on this
draft guidance be submitted within 90 days of publication. The 90-day
comment period ended on July 28, 2008. In addition, in the Federal
Register of July 7, 2008 (73 FR 38460), FDA requested the submission of
data from the 2008 WNV season relating to the criteria for converting
from minipool NAT (MP-NAT) to individual donation NAT (ID-NAT) by
January 31, 2009, and stated that we did not intend to finalize the
proposed recommendations on conversion from MP-NAT to ID-NAT until we
had obtained the additional data. At this time, there is insufficient
data to recommend uniform threshold criteria for switching from MP-NAT
screening to ID-NAT screening. Until we have sufficient data to support
the development of suitable uniform threshold criteria, we consider it
appropriate for each blood establishment to define its own threshold
criteria for switching from MP-NAT to ID-NAT screening and for
reverting to MP-NAT screening.
Additionally, at this time, FDA is continuing to review public
comment on our recommendations for testing HCT/P donor specimens for
WNV. We believe additional public discussion is warranted. Therefore,
we are not finalizing our recommendations for HCT/Ps in this guidance.
We intend to seek additional public input and to issue guidance for
testing HCT/P donor specimens for WNV in the future.
FDA received numerous comments on the draft guidance and those
comments were considered in finalizing the guidance. A summary of
changes follows. The guidance announced in this notice: (1) Finalizes
only the recommendations as to testing donations of Whole Blood and
blood components intended for transfusion for WNV; (2) allows
establishments that collect Whole Blood and blood components intended
for transfusion flexibility to define their own threshold criteria for
switching from MP-NAT to ID-NAT screening; (3) recommends that
establishments that collect Whole Blood and blood components intended
for transfusion switch from MP-NAT to ID-NAT screening as soon as
feasible with 48 hours of reaching the threshold, instead of 24 hours;
(4) recommends that establishments notify a blood donor of his or her
deferral and counsel the donor following an ID-NAT reactive donation,
rather than after additional testing on the reactive index donation;
and (5) removes Table 2 (Recommendations on Additional Testing of Blood
and Blood Components).
The guidance is being issued in conformance with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
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 requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This 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
OMB control number 0910-0014; the collections of information in 21 CFR
601.12 have been approved under OMB control number 0910-0338; the
collections of information in 21 CFR 606.100 have been approved under
OMB control number 0910-0116; the collections of information in 21 CFR
606.122 have been approved under OMB control number 0910-0116; and the
collections of information in 21 CFR 630.6 have been approved under OMB
control number 0910-0116.
III. Comments
Interested persons may, at any time, submit to the Division of
Dockets Management (see ADDRESSES) electronic or written comments
regarding the 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 brackets in the heading of this document. A copy of the
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.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: November 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26870 Filed 11-6-09; 8:45 am]
BILLING CODE 4160-01-S
