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Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serials and Subserials and Determination of Expiration Date of Product

Document ID: APHIS-2009-0028-0001
Document Type: Proposed Rule
Agency: Animal And Plant Health Inspection Service
Topics: Animal Biologics, Reporting and Recordkeeping Requirements
Federal Register Number: 2010-23186
CFR Citation: 9 CFR Parts 101 and 114
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Details Information

Abstract: We are proposing to amend the Virus-Serum-Toxin Act regulations concerning expiration dating to clarify that the expiration date of a serial or subserial of a veterinary biologic should be computed from the date of the initiation of the first potency test. We also propose to require the expiration dating period (stability) of a product to be confirmed by conducting a real-time stability study with a stability-indicating assay; require stability monitoring of products after licensing; and specify a single standard for determining the expiration date for veterinary biologics in place of the current standard that specifies different procedures for products contingent upon whether they consist of viable or nonviable organisms. These amendments would update and clarify the regulations concerning expiration dating and establish a single uniform standard for determining the stability of veterinary biological products. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document.
Document Subtype: Proposed rule
Received Date: September 17 2010, at 12:00 AM Eastern Daylight Time
Start-End Page: 56916 - 56919
Comment Start Date: September 17 2010, at 12:00 AM Eastern Standard Time
Comment Due Date: November 16 2010, at 11:59 PM Eastern Standard Time

Comments

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Total: 8
Comment from JEAN PUBLIC
Submitter: PUBLIC, JEAN    Posted: 11/16/2010     ID: APHIS-2009-0028-0002

Nov 16,2010 11:59 PM ET
Comment from Joseph O'Donnell
Submitter: O'Donnell, Joseph    Posted: 11/16/2010     ID: APHIS-2009-0028-0003

Nov 16,2010 11:59 PM ET
Comment from Tom Evans
Submitter: Evans, Tom    Posted: 11/16/2010     ID: APHIS-2009-0028-0005

Nov 16,2010 11:59 PM ET
Comment from Tracy Olsen
Submitter: Olsen, Tracy    Posted: 11/16/2010     ID: APHIS-2009-0028-0006

Nov 16,2010 11:59 PM ET
Comment from John Thomas
Submitter: Thomas, John    Posted: 11/16/2010     ID: APHIS-2009-0028-0007

Nov 16,2010 11:59 PM ET

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