E9-17965. 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.

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 The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2008.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://www.fda.gov/​cber/​guidelines.htm or http://www.regulations.gov.

Dated: July 20, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.