Document ID: FDA-2008-D-0379-0013
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Nucleic Acid Testing To Reduce the Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived Products; Availability
Posted Date: 2009-07-28T04:00Z

[Federal Register: July 28, 2009 (Volume 74, Number 143)]
[Notices]               
[Page 37231-37232]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jy09-47]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Guidance for Industry: Nucleic Acid Testing To Reduce the 
Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived 
Products; 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: Nucleic 
Acid Testing (NAT) to Reduce the Possible Risk of Human Parvovirus B19 
Transmission by Plasma-Derived Products,'' dated July 2009. The 
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 
guidance also recommends how to report to FDA implementation of 
parvovirus B19 NAT. The guidance announced in this notice finalizes the 
draft guidance of the same title, dated July 2008.

DATES: Submit written or electronic 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 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. 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:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the 
Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived 
Products,'' dated July 2009. Parvovirus B19 is a small, non-enveloped 
single stranded DNA virus. Virus clearance studies, using non-human 
parvoviruses as models for parvovirus B19, have indicated that this 
virus is highly resistant to all commonly used inactivation methods, 
including heat and solvent/detergent (S/D) treatment, and is also 
difficult to remove by filtration because of its small size. More 
recent studies have demonstrated that human parvovirus B19 may be more 
readily cleared than certain model animal parvoviruses. 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 
units of these products in the manufacturing process.
    The 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 guidance also recommends how to report to FDA 
implementation of parvovirus B19 NAT.
    In the Federal Register of July 30, 2008 (73 FR 44272), FDA 
announced the availability of the draft guidance of the same title, 
dated July 2008. FDA received a few comments on the draft guidance and 
those comments were considered as the guidance was finalized. In 
addition to minor editorial changes made to improve clarity, changes to 
the draft guidance include the addition of 4 references to reflect 
recent studies that show B19 may be less resistant to inactivation than 
animal-derived parvoviruses that have been used as models; and removal 
of the recommendation on the acceptable limit for B19 DNA titer in 
individual plasma units. The guidance announced in this notice 
finalizes the draft guidance dated July 2008.
    The guidance is being issued consistent 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 
requirement 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 601.12(a)(2) and 601.12(c)(5), 
have been approved under OMB No. 0910-0338.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic 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://

[[Page 37232]]

www.fda.gov/cber/guidelines.htm or http://www.regulations.gov.

    Dated: July 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-17965 Filed 7-27-09; 8:45 am]

BILLING CODE 4160-01-S