[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]


-----------------------------------------------------------------------

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draft guidance ``Guidance for Industry: Use of Nucleic Acid Tests to 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contained in the draft guidance are not being finalized at this time 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 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