[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]
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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Draft Guidance for Industry: Nucleic Acid Testing to Reduce the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.
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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draft guidance document provides to manufacturers of plasma-derived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 The draft guidance also recommends how to report to the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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may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to the draft guidance document.
Submit written comments on the draft guidance to the Division of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]
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