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Rules and Regulations Federal Register Vol 57607 Rules and Regulations Federal Register Vol. 68, No. 193 Monday, October 6, 2003 This section of the FEDERAL REGISTER Unit 148, Riverdale, MD 20737–1231; that a firm does not have the equipment contains regulatory documents having general (301) 734–8245. necessary to conduct the test. applicability and legal effect, most of which In this final rule, we are adopting the SUPPLEMENTARY INFORMATION: are keyed to and codified in the Code of gravimetric method as the standard Federal Regulations, which is published under Background procedure for determining moisture 50 titles pursuant to 44 U.S.C. 1510. content. As a Standard Requirement The Virus-Serum-Toxin Act test, the gravimetric method should be The Code of Federal Regulations is sold by regulations in 9 CFR part 113 (referred the Superintendent of Documents. Prices of used whenever the test for moisture new books are listed in the first FEDERAL to below as the regulations) prescribe content is performed. However, we note REGISTER issue of each week. standard requirements for the that exemptions to the use of the preparation and testing of veterinary gravimetric method, like exemptions to biological products. Standard any test prescribed in the various DEPARTMENT OF AGRICULTURE requirements consist of test methods, standard requirements found in part procedures, and criteria that define the 113, may be granted for any valid reason Animal and Plant Health Inspection standards for purity, safety, potency, in accordance with § 113.4, Service and efficacy for a given type of ‘‘Exemptions to tests.’’ Exemption veterinary biologic product. When a requests are evaluated on a product-by- 9 CFR Part 113 standard procedure for testing product basis, and in our review of such [Docket No. 01–067–2 ] veterinary biological products is requests, we focus on the methods, validated and approved by the Animal equipment, and procedures that would Viruses, Serums, Toxins, and and Plant Health Inspection Service be used in place of those prescribed in Analogous Products; Determination of (APHIS) for general use, it is proposed the Standard Requirement. It is the Moisture Content in Desiccated for codification in the regulations. validity of the alternative methods and Biological Products Section 113.29 of the regulations sets procedures that serves as the basis for forth the requirement for determination the granting of an exemption. AGENCY: Animal and Plant Health of moisture content in desiccated Therefore, for the reasons given in the Inspection Service, USDA. biological products. proposed rule and in this document, we ACTION: Final rule. On August 5, 2002, we published in are adopting the proposed rule as a final rule, without change. SUMMARY: We are amending the Virus- the Federal Register (67 FR 50606– Serum-Toxin Act regulations for the 50608, Docket No. 01–067–1) a proposal Executive Order 12866 and Regulatory determination of moisture content in to amend the regulations for Flexibility Act determination of moisture content in desiccated biological products to require This rule has been reviewed under that such determinations be made using desiccated biological products to specify that such determinations be made using Executive Order 12866. The rule has a gravimetric method that expresses been determined to be not significant for moisture content as the percentage of a gravimetric method, and to require that the maximum percentage of the purposes of Executive Order 12866 weight a product loses during a drying and, therefore, has not been reviewed by moisture permitted for a satisfactory test cycle, and to require that the maximum the Office of Management and Budget. must be specified in a filed Outline of percentage of moisture permitted for a We are amending the Virus-Serum- satisfactory test must be specified in a Production. The proposed rule was Toxin Act regulations for determination filed Outline of Production. The intended to update the regulations by of moisture content in desiccated gravimetric method has been adopted as providing a uniform method of biological products to require that such an international standard by scientific determining moisture content in moisture determinations be made using experts and regulatory authorities in the desiccated products and ensure the a gravimetric method that determines United States, Canada, Japan, and the stability of that product during its residual moisture by measuring the European Union. In addition, we are dating period. percentage of weight a product loses amending the regulations pertaining to We solicited comments on our during a product drying cycle. In general requirements for live bacterial proposed rule for 60 days ending on addition, this rule provides that the vaccines and general requirements for October 4, 2002. We received two maximum percentage of moisture live virus vaccines to specify the comments by that date, from a permitted for a satisfactory test must be gravimetric method when testing for veterinary biologics manufacturer and a specified in a filed Outline of moisture content. These actions will national trade association representing Production. The effect of this action will update the regulations by providing a veterinary biologics manufacturers. Both be to provide a standardized method for uniform method of determining commenters supported the proposed the determination of moisture content in moisture content in desiccated products rule. One commenter did, however, desiccated biological products that has and ensure the stability of that product request that we ‘‘clarify the exceptions been adopted internationally and ensure during its dating period. to the use of the proposed method.’’ The that such moisture determinations are EFFECTIVE DATE: November 5, 2003. commenter recommended that if we uniform and reproducible. FOR FURTHER INFORMATION CONTACT: Dr. intend to handle such instances via This rule will affect all licensed Albert P. Morgan, Chief of Operational outline exemptions, then that should be manufacturers of veterinary biologics Support, Licensing and Policy stated. Additionally, the commenter that test desiccated vaccines for Development, Center for Veterinary asked that we indicate whether one moisture content. Currently, there are Biologics, VS, APHIS, 4700 River Road valid reason for an exemption would be approximately 135 veterinary biologics VerDate jul<14>2003 16:17 Oct 03, 2003 Jkt 203001 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 E:\FR\FM\06OCR1.SGM 06OCR1 57608 Federal Register / Vol. 68, No. 193 / Monday, October 6, 2003 / Rules and Regulations establishments, including permittees. ■ 2. Section 113.29 is revised to read as (4) After a minimum of 3 hours of According to the standards of the Small follows: drying time, turn off the vacuum pump Business Administration, most and allow dry air to bleed into the oven veterinary biologics establishments § 113.29 Determination of moisture until the pressure inside the oven is content in desiccated biological products. would be classified as small entities. equalized with the prevailing We do not expect that this rule will Methods provided in this section atmospheric pressure. must be used when a determination of impose any additional testing or (5) While the bottle is still warm, moisture content in desiccated economic burden on these replace the stopper in its normal biological products is prescribed in an manufacturers because manufacturers position and transfer the weighing bottle applicable Standard Requirement or in currently test their products for to the desiccator. moisture content by methods specified the filed Outline of Production for the product. Firms currently using methods (i) Allow a minimum of 2 hours for in their filed Outline of Production and the weighing bottle to cool to room the reagents and equipment necessary to other than those provided in this section for determining the moisture content in temperature or for its weight to reach perform the gravimetric test for moisture equilibrium. content that will be required under this desiccated biological products have rule are expected to be comparable in until November 5, 2004 to update their (ii) Weigh, and record the weight as cost. Outlines of Production to be in ‘‘C.’’ compliance with this requirement. Under these circumstances, the (6) Calculate the percentage of (a) Final container samples of Administrator of the Animal and Plant moisture in the original sample as completed product shall be tested. The Health Inspection Service has follows: weight loss of the sample due to drying determined that this action will not ¥ ¥ × in a vacuum oven shall be determined. (B C)/(B A) (100) = Percentage of have a significant economic impact on All procedures should be performed in residual moisture, where: a substantial number of small entities. an environment with a relative A = tare weight of weighing bottle Executive Order 12372 humidity less than 45 percent. The B¥A = weight of sample before drying equipment necessary to perform the test This program/activity is listed in the B¥C = weight of sample after drying is as follows: catalog of Federal Domestic Assistance (1) Cylindrical weighing bottles with (7) The results are considered under No. 10.025 and is subject to airtight glass stoppers. satisfactory if the percentage of residual Executive Order 12372, which requires (2) Vacuum oven equipped with moisture is less than or equal to the intergovernmental consultation with manufacturer’s specification. State and local officials. (See 7 CFR part validated thermometer and thermostat. 3015, subpart V.) A suitable air-drying device should be ■ 3. In § 113.64, paragraph (e) is attached to the inlet valve. amended by adding a new paragraph Executive Order 12988 (3) Balance, accurate to 0.1 mg (rated (e)(3) to read as follows: ± This final rule has been reviewed precision 0.01mg). (4) Desiccator jar equipped with § 113.64 General requirements for live under Executive Order 12988, Civil bacterial vaccines. Justice Reform. It is not intended to phosphorous pentoxide, silica gel, or * * * * * have retroactive effect. This rule will equivalent. not preempt any State or local laws, (5) Desiccated vaccine in original (e) * * * regulations, or policies, unless they sealed vial.
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