United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 1996_register executive 2010-09-24 article Rules and Regulations D09002ee1be02cd30 D09002ee1be02cdf2 United States Department of Agriculture originator org United States Government Agency or Subagency United States Animal and Plant Health Inspection Service originator org United States Government Agency or Subagency We are amending the regulations under the Virus-Serum-Toxin Act to clarify certain provisions concerning licenses, inspections, records, and reports. The effect of the rule is to ensure that licensees are aware of the fact that licenses are issued on the condition that the licensee permit inspection of establishments, products, and records, and that a licensee must have at least one product license in order to maintain a valid establishment license. Failure to permit inspection will make the license subject to suspension or revocation. We are also amending the regulations to specify the types of records and reports that must be available for inspection including records describing product development and preparation and market suspensions and recalls. Finally, we are amending the regulations to require that APHIS receive notification immediately if there are indications which raise questions regarding purity, safety, potency, or efficacy of a product, or if it appears there may be a problem regarding the preparation, testing, or distribution of a product. The rule is necessary to clarify and simplify certain provisions of the regulations and to describe required records with greater specificity. 61 FR 52871 https://www.govinfo.gov/app/details/FR-1996-10-09/96-25931 96-25931 fr09oc96-1 3410-34-P Docket No. 93-072-2 https://www.govinfo.gov/app/details/FR-1996-10-09/96-25931 https://www.govinfo.gov/content/pkg/FR-1996-10-09/html/96-25931.htm https://www.govinfo.gov/content/pkg/FR-1996-10-09/pdf/96-25931.pdf 5 p. 52871 52875 61 FR 52871 Title 9 Part 102 9 CFR Part 102 Title 9 Part 104 9 CFR Part 104 Title 9 Part 105 9 CFR Part 105 Title 9 Part 116 9 CFR Part 116 Viruses, Serums, Toxins, and Analogous Products; Licenses, Inspections, Records, and Reports; Federal Register Vol. 61, Issue RULE 96-25931 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service Docket No. 93-072-2 3410-34-P 96-25931 Final rule.

We are amending the regulations under the Virus-Serum-Toxin Act to clarify certain provisions concerning licenses, inspections, records, and reports. The effect of the rule is to ensure that licensees are aware of the fact that licenses are issued on the condition that the licensee permit inspection of establishments, products, and records, and that a licensee must have at least one product license in order to maintain a valid establishment license. Failure to permit inspection will make the license subject to suspension or revocation. We are also amending the regulations to specify the types of records and reports that must be available for inspection including records describing product development and preparation and market suspensions and recalls. Finally, we are amending the regulations to require that APHIS receive notification immediately if there are indications which raise questions regarding purity, safety, potency, or efficacy of a product, or if it appears there may be a problem regarding the preparation, testing, or distribution of a product. The rule is necessary to clarify and simplify certain provisions of the regulations and to describe required records with greater specificity.

November 8, 1996. Dr. David A. Espeseth, Deputy Director, Veterinary Biologics, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737 1237; 301-734-8245. Vol. 61, no. 197 Office of the Federal Register, National Archives and Records Administration 1996-10-09 continuing daily deposited born digital 173 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1996-10-09 P0b002ee180a23ceb 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr09oc96 https://www.govinfo.gov/app/details/FR-1996-10-09 https://www.govinfo.gov/content/pkg/FR-1996-10-09/pdf/FR-1996-10-09.pdf fdlp 52871 53034 DGPO 2010-09-24 2023-05-06 FR-1996-10-09 machine generated eng FR FR-1996-10-09 61 197