[Federal Register Volume 73, Number 147 (Wednesday, July 30, 2008)]
[Notices]
[Pages 44272-44273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17431]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0379]


Draft Guidance for Industry: Nucleic Acid Testing to Reduce the 
Possible Risk of Parvovirus B19 Transmission by Plasma-Derived 
Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus 
B19 Transmission by Plasma-Derived Products,'' dated July 2008. The 
draft guidance document provides to manufacturers of plasma-derived 
products recommendations for performing parvovirus B19 NAT as an in-
process test for Source Plasma and recovered plasma to identify and 
help to prevent the use of plasma units containing high levels of 
parvovirus B19. The draft guidance also recommends how to report to the 
FDA implementation of parvovirus B19 NAT.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115 (g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by October 28, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (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 The draft guidance may 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to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., 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:

[[Page 44273]]

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the 
Possible Risk of Parvovirus B19 Transmission by Plasma-Derived 
Products'' dated July 2008. Parvovirus B19 is a small, non-enveloped 
single strand DNA virus that is highly resistant to all commonly used 
inactivation methods. The parvovirus B19 can be transmitted by blood 
components and certain plasma derivatives and may cause morbidity to 
susceptible recipients such as pregnant women, persons with underlying 
hemolytic disorders, and immune compromised individuals. The disease 
transmission from transfusion of blood components is rare; however, 
extremely high levels of parvovirus B19 in plasma of acutely infected 
but asymptomatic donors may present a greater risk in plasma 
derivatives due to pooling of large numbers of plasma units in the 
manufacture of these products.
    The draft guidance provides recommendations for performing 
parvovirus B19 NAT as an in-process test for Source Plasma and 
recovered plasma used in the further manufacturing of plasma-derived 
products to identify and help to prevent the use of plasma units 
containing high levels of parvovirus B19. The draft guidance also 
recommends how to report to the FDA implementation of parvovirus B19 
NAT.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 draft 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 211.165 and 211.194 have been 
approved under 0910-0139; the collections of information in 21 CFR 
600.12 have been approved under 0910-0308.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft 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 the brackets in 
the heading of this document. A copy of the draft 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.
    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 comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

IV. 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: July 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17431 Filed 7-29-08; 8:45 am]
BILLING CODE 4160-01-S