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[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]
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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Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce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.
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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submission of data related to certain recommendations in the draft
guidance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entitled, ``Draft Guidance for Industry: Use of Nucleic Acid Tests to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]
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