[Federal Register Volume 74, Number 215 (Monday, November 9, 2009)]
[Notices]
[Pages 57685-57686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26870]
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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.
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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draft guidance ``Guidance for Industry: Use of Nucleic Acid Tests to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contained in the draft guidance are not being finalized at this time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 http://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 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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