Federal Register: January 31, 2002 (Volume 67, Number 21)
DOCID: FR Doc 02-2321
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. 01D-0584]
NOTICE: NOTICES
ACTION: Reports and guidance documents; availability, etc.:
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Draft ``Guidance for Industry: Use of Nucleic Acid Tests on Pooled Samples From Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV-1 and HCV''; Availability
DATES: Submit written or electronic comments on the draft guidance to ensure their adequate consideration in preparation of the final document by May 1, 2002. General comments on agency guidance documents are welcome at any time.
DOCUMENT SUMMARY:
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Nucleic Acid Tests on Pooled Samples From Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV1 and HCV'' dated December 2001. The draft guidance document, when finalized, would inform all establishments that manufacture Source Plasma that FDA has approved nucleic acid tests (NAT) to identify human immunodeficiency virus type 1 (HIV1) and hepatitis C virus (HCV) in Source Plasma donations. The draft document recommends that manufacturers submit a prior approval supplement to a biologics license application (BLA) to implement HIV1 and HCV NAT by a specified date.
SUMMARY:
Nucleic acid tests use on pooled samples from source plasma donors to adequately and appropriately reduce HIV-1 and HCV transmission risk,
SUPPLEMENTAL INFORMATION
I. Background
FDA is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Nucleic Acid Tests on Pooled Samples From Source Plasma Donors to Adequately and Appropriately Reduce the Risk of Transmission of HIV1 and HCV'' dated December 2001. FDA's final rule (66 FR 31146, June 11, 2001) entitled ``Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Diseases'' became effective on December 10, 2001. The provision in 21 CFR 610.40(b) of the rule provides that manufacturers ``must perform one or more screening tests to adequately and appropriately reduce the risk of transmission of communicable disease agents'' (66 FR 31146 at 31162). As we noted in the preamble to the final rule, the standard for adequate and appropriate testing will change as new testing technology is approved by FDA. We explained, ``we intend to regularly issue guidance describing those tests that we believe would adequately and appropriately reduce the risk of transmission of communicable disease agents'' (66 FR 31146 at 31149).
The availability of NAT to identify HIV1 and HCV will change the testing protocol that should be used to adequately and appropriately reduce the risk of transmission of those diseases. The draft document recommends that manufacturers submit a prior approval supplement to a BLA to implement HIV1 and HCV NAT by a specified date.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This draft guidance document represents the agency'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. Comments
This draft document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Dockets Management Branch (address above) written or electronic comments regarding this draft guidance document. Submit written or electronic comments to ensure adequate consideration in preparation of the final document by May 1, 2002. Two copies of any comments are to be submitted, except individuals may submit one copy. Comments should be identified with the docket number found in the brackets in the heading of this document. A copy of the document and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/ ohrms/dockets/default.htm.
[[Page 4720]]
Dated: January 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 022321 Filed 13002; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Nathaniel L. Geary, Center for Biologics Evaluation and Research (HFM17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 208521448, 301827
6210.