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| USDA/APHIS | RIN: 0579-AD06 | Publication ID: Fall 2010 |
| Title: ●Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serials and Subserials and Determination of Expiration Date of Product | |
| Abstract: This action would 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. It would also 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. | |
| Agency: Department of Agriculture(USDA) | Priority: Other Significant |
| RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 9 CFR 101 9 CFR 114 | |
| Legal Authority: 21 USC 151 to 159 | |
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Legal Deadline:
None |
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Timetable:
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| Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov. | |
| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Albert P. Morgan Chief of Operational Support, CVB, Licensing and Policy Development, VS Department of Agriculture Animal and Plant Health Inspection Service Unit 148, 4700 River Road, Unit 148, Riverdale, MD 20737-1231 Phone:301 734-8245 |
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