Document ID: FDA-2008-D-0233-0003
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Whole Blood and Blood Components Intended for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 Cells, Tissues, and Cellular and Tissue-Based Products; Request for Data
Posted Date: 2008-07-07T04:00Z

[Federal Register: July 7, 2008 (Volume 73, Number 130)]
[Notices]               
[Page 38460-38461]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jy08-100]                         

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

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Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce 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 Cells, 
Tissues, and Cellular and Tissue-Based Products; Request for Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for data.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting 
submission of data related to certain recommendations in the draft 
guidance

[[Page 38461]]

entitled, ``Draft Guidance for Industry: Use of Nucleic Acid Tests to 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 
Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' that 
published April 28, 2008. The agency is taking this action to allow 
interested persons to submit complete data from the 2008 West Nile 
Virus season concerning the criteria for converting from minipool 
nucleic acid tests (NAT) to individual donation NAT for donations of 
Whole Blood and blood components for transfusion.

DATES: Submit requested data by January 31, 2009.

ADDRESSES: Submit written data, identified by Docket No. FDA-2008-D-
0233, to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit data in electronic format to http://www.regulations.gov. For 
additional information on submitting data, see the ``Request for Data'' 
heading of the SUPPLEMENTARY INFORMATION section of this document. 
Under 21 CFR 10.115(g)(5), comments on guidance documents can be 
submitted at any time; comments may be submitted to the addresses 
specified previously.

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

    In the Federal Register of April 28, 2008 (73 FR 22958), FDA 
published a notice announcing the availability of the draft guidance 
entitled, ``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).'' The 
draft guidance 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 
requested that comments on this draft guidance be submitted within 90 
days of publication. The 90-day comment period ends on July 28, 2008.
    Based on FDA's consideration of input received to date, we believe 
that data collected during the 2008 WNV season will be important 
information that we should obtain prior to finalizing recommendations 
on criteria for converting from minipool NAT to individual donation NAT 
for donations of Whole Blood and blood components for transfusion. 
However, the 2008 WNV season will extend beyond the 90-day comment 
period for this draft guidance. We are concerned that extending the 
comment period until the end of the WNV season would significantly 
delay finalization of the draft guidance, which contains additional 
recommendations regarding testing of donations of Whole Blood and blood 
components for transfusion and HCT/P donor specimens. Based on these 
considerations, FDA is retaining the 90-day comment period for the 
draft guidance (ending July 28, 2008). However, we do not intend to 
finalize the proposed recommendations on conversion from minipool NAT 
to individual donation NAT until obtaining additional data from the 
2008 WNV season. We are requesting the submission, on or before January 
31, 2009, of complete data collected during the 2008 WNV season 
relating to the criteria for converting from minipool NAT to individual 
NAT. FDA intends to finalize the draft guidance as soon as it is 
practicable, but may finalize the criteria for conversion to individual 
donation NAT in a subsequent guidance document after reviewing the 
additional 2008 data.

II. Request for Data

    FDA requests the submission, on or before January 31, 2009, of 
complete data collected during the 2008 WNV season relating to the 
criteria for converting from minipool NAT to individual donation NAT. 
Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic data. Submit a single copy of 
electronic data or two paper copies of any mailed data, except that 
individuals may submit one paper copy. Data are to be identified with 
the docket number found in brackets in the heading of this document. 
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 data or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cber/guidelines.htm or http://
www.regulations.gov.

    Dated: June 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15368 Filed 7-3-08; 8:45 am]

BILLING CODE 4160-01-S