Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Proposed Rules 21985

etc. Finally, this rule will ensure that § 214.2 Special requirements for . In addition, after a product employers have sufficient time to seek admission, extension, and maintenance of is licensed and its dating period a new beneficiary or beneficiaries in the status. confirmed, the licensee or permittee event a petition is denied. * * * * * would have to submit a plan to monitor (o) * * * the stability of the product and the Executive Order 13132 (2) * * * suitability of its dating period; that plan This rule will not have substantial (i) General. * * * The petition may would have to include regular testing of direct effects on the states, on the be filed up to one year, but not earlier serials for potency during and at the end relationship between the National than 6 months, before the actual need of dating. The proposed changes would Government and the states, or on the for the alien’s services. Exceptions may help clarify the distinction between distribution of power and be granted in emergency situations at specifying an expiration date for an responsibilities among the various the discretion of the USCIS individual serial of a product and levels of government. Therefore, in Center Director, and in special filing establishing the appropriate expiration accordance with section 6 of Executive situations as determined by USCIS dating period for the product. The effect Order 13132, it is determined that this Headquarters. * * * of these proposed changes would be to rule does not have sufficient federalism * * * * * establish a single uniform standard for implications to warrant the preparation (p) * * * determining expiration dates for of a federalism summary impact (2) * * * veterinary biological products. statement. (i) General. * * * The petition may DATES: We will consider all comments be filed up to one year, but not earlier Executive Order 12988 Civil Justice that we receive on or before June 27, than 6 months before the actual need for 2005. Reform the alien’s services. Exceptions may be ADDRESSES: You may submit comments This rule meets the applicable granted in emergency situations at the by any of the following methods: standards set forth in sections 3(a) and discretion of the USCIS Service Center • EDOCKET: Go to http:// 3(b)(2) of Executive Order 12988. Director, and in special filing situations www.epa.gov/feddocket to submit or as determined by USCIS Headquarters. Paperwork Reduction Act view public comments, access the index *** listing of the contents of the official Under the Paperwork Reduction Act * * * * * of 1995, Public Law 104–13, all public docket, and to access those Departments are required to submit to Dated: April 22, 2005. documents in the public docket that are the Office of Management and Budget Michael Chertoff, available electronically. Once you have (OMB), for review and approval, any Secretary. entered EDOCKET, click on the ‘‘View Open APHIS Dockets’’ link to locate this reporting requirements inherent in a [FR Doc. 05–8471 Filed 4–27–05; 8:45 am] document. rule. This rule does not impose any new BILLING CODE 4410–10–P • Postal Mail/Commercial Delivery: reporting or recordkeeping requirements Please send four copies of your under the Paperwork Reduction Act. comment (an original and three copies) List of Subjects in 8 CFR Part 214 DEPARTMENT OF to Docket No. 04–064–1, Regulatory Administrative practice and Animal and Plant Health Inspection Analysis and Development, PPD, procedures, Aliens, Employment, Service APHIS, Station 3C71, 4700 River Road Foreign officials, Health professions, Unit 118, Riverdale, MD 20737–1238. Reporting and recordkeeping 9 CFR Part 114 Please state that your comment refers to requirements, Students. Docket No. 04–064–1. [Docket No. 04–064–1] • Federal eRulemaking Portal: Go to Accordingly, part 214 of chapter I of http://www.regulations.gov and follow title 8 of the Code of Federal Viruses, Serums, Toxins, and the instructions for locating this docket Regulations is proposed to be amended Analogous Products; Expiration Date and submitting comments. as follows: Required for Serials and Subserials Reading Room: You may read any and Determination of Expiration Date PART 214—NONIMMIGRANT CLASSES comments that we receive on this of Product docket in our reading room. The reading 1. The authority citation for part 214 room is located in room 1141 of the AGENCY: Animal and Plant Health continues to read as follows: Inspection Service, USDA. USDA South Building, 14th Street and Independence Avenue, SW., Authority: 8 U.S.C. 1101, 1102, 1103, 1182, ACTION: Proposed rule. 1184, 1186a, 1187, 1221, 1281, 1282, 1301– Washington, DC. Normal reading room 1305 and 1372; sec. 643, Pub. L. 104–208, SUMMARY: We are proposing to amend hours are 8 a.m. to 4:30 p.m., Monday 110 Stat. 3009–708; Section 141 of the the Virus-Serum-Toxin Act regulations through Friday, except holidays. To be Compacts of Free Association with the to require licensees and permittees to sure someone is there to help you, Federated States of Micronesia and the please call (202) 690–2817 before Republic of the Marshall Islands, and with confirm the proposed expiration dating period of products by potency testing coming. the Government of Palau, 48 U.S.C. 1901 Other Information: You may view note, and 1931 note, respectively, 8 CFR part serials on multiple occasions 2. throughout the proposed dating period, APHIS documents published in the 2. Section 214.2 is amended by: rather than only at release and at the Federal Register and related a. Revising the second sentence in approximate expiration date as is information on the Internet at http:// paragraph (o)(2)(i) and adding a new currently required. We would require www.aphis.usda.gov/ppd/rad/ sentence immediately thereafter; and by that those stability test data be webrepor.html. b. Revising the tenth sentence in submitted to the Animal and Plant FOR FURTHER INFORMATION CONTACT: Dr. paragraph (p)(2)(i) and adding a new Health Inspection Service for review Albert P. Morgan, Chief of Operational sentence immediately after. and filing, and that the approval date be Support, Center for Veterinary The revisions read as follows: specified in a filed Outline of Biologics, Licensing and Policy

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Development, VS, APHIS, 4700 River the initiation of the potency test’’ and Executive Order 12866 and Regulatory Road Unit 148, Riverdale, MD 20737– remove it from § 114.13 where it is Flexibility Act 1231; (301) 734–8245. currently found. This change is This proposed rule has been reviewed SUPPLEMENTARY INFORMATION: intended to clarify the fact that the under Executive Order 12866. The rule expiration date of a serial, and not the Background has been determined to be not dating period of a product, is computed significant for the purposes of Executive The Virus-Serum-Toxin Act from the date of the initiation of the Order 12866 and, therefore, has not regulations in 9 CFR part 114, potency test. been reviewed by the Office of ‘‘Production Requirements for We are proposing to amend the title Management and Budget. Biological Products’’ (referred to below This proposed rule would amend the as the regulations), include of § 114.13 to read: ‘‘Determination of the expiration dating period of a Virus-Serum-Toxin Act regulations in requirements applicable to designating §§ 114.12 and 114.13 concerning the expiration date of a serial or product.’’ This change will show that it expiration dates and the determination subserial of veterinary biologics and deals with a product’s dating period of the stability of veterinary biologics to: determining the expiration dating rather than the expiration date of a Change the title of the sections; require period (stability) for veterinary serial. The proposed revision of this veterinary biologics licensees and biologics. Currently, § 114.12 of the section would define a single uniform permittees to evaluate the stability of regulations requires each serial or standard for determining the dating veterinary biologics as a function of subserial of veterinary biological period for all veterinary biologics; time by testing serials for potency product prepared in a licensed require the expiration dating periods of throughout and after their proposed establishment to be given an expiration a product to be confirmed by testing dating period beginning at the date of date determined in accordance with the serials or subserials on multiple requirements prescribed in § 114.13 of occasions throughout their dating final formulation; require that the the regulations. The regulations in period in place of the current expiration dating period be determined by testing serials for potency on § 114.13 require the expiration date requirement which only requires testing multiple occasions throughout and after described under § 114.12 to be at the beginning and end of the dating the proposed dating period; require that computed from the date of the initiation period in order to confirm stability; a report of the results of the testing to of the potency test. require a report of the expiration dating confirm expiration dating be submitted The expiration date of a product period testing to be submitted to APHIS to APHIS for review and filing and that designates the end of the period during for review and filing and the date of which a biological product, when the date of approval be specified in the approval to be specified in section VI of filed Outline of Production; and require properly stored and handled, can be the filed Outline of Production; and expected, with reasonable certainty, to monitoring of the stability of the after the dating period has been product and the suitability of the dating be efficacious. Thus, the most precise approved, require that the stability of determination of the expiration date period. The overall effect of these the product and the suitability of the proposed amendments would be to occurs when the product is tested at the dating period be monitored by regularly end of its predicted shelf life. However, establish a single uniform standard for testing serials during and after their the typical product may be released for confirming the expiration dating period dating period. distribution and sale before its dating of veterinary biologics. period is confirmed, which necessitates APHIS is proposing these This proposed rule would affect all a mechanism for predicting the amendments because it has been shown licensed manufacturers of veterinary product’s shelf life. Prior to licensure, that the potency of most veterinary biologics. Currently, there are the stability of each fraction of a product biologics degrades in a nonlinear approximately 152 veterinary biologics must be determined by methods fashion, which could result in their manufacturers, including permittees. acceptable to Animal and Plant Health potency reaching its lowest point during According to the standards of the Small Inspection Service (APHIS). Typically, the middle of the dating period rather Administration, most such methods involve subjecting the than at the end. Testing on only two veterinary biologics establishments are product to extreme temperatures and occasions would be reasonable only if small entities. We believe that this measuring its relative strength by potency loss has a strictly linear pattern, proposed rule would not have a conducting a potency test. Products that and this is usually not the case. Thus, significant effect on small entities pass the potency test are licensed with APHIS is proposing to evaluate a because all veterinary biologics the provision that such expiration dates product’s stability as a function of time manufacturers are currently required to must be confirmed by real-time testing by requiring serials to be tested on confirm the expiration dating of the as follows: For products consisting of multiple occasions when confirming the products that they produce and to viable organisms each (prelicensing) dating period, and thereafter by submit a report to APHIS for review and serial shall be tested for potency at monitoring stability on a regular basis. filing. In addition, the proposed release and at the approximate requirements to test serials on multiple expiration date until a statistically valid The proposed amendment would occasions when confirming expiration stability record has been established; for update and standardize testing to dating and to require post-licensing nonviable biological products, each establish/confirm the stability of stability monitoring are not expected to (prelicensing) serial presented in veterinary biologics and improve the have a significant effect, as most support of licensure shall be tested for reliability of expiration dating periods veterinary biologics manufacturers potency at release and at or after the currently specified on the labeling of routinely test and monitor the stability dating requested. veterinary biologics, thereby providing of products throughout their dating We are proposing to amend the title greater assurance that the product, when period. of § 114.12 to read: ‘‘Expiration date properly stored and handled, will be Under these circumstances, the required for a serial.’’ In addition, we efficacious. We are therefore proposing Administrator of the Animal and Plant propose to amend this section by adding to amend §§ 114.12 and 114.13 as set Health Inspection Service has the wording ‘‘computed from the date of forth below. determined that this action would not

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have a significant economic impact on tested at any time during the dating (Notropis girardi) (October 6, 2004; 69 a substantial number of small entities. period, the potency of the product must FR 59859). This action will allow all not be less than the minimum specified interested parties an opportunity to Executive Order 12372 in the filed Outline of Production. comment on the proposed critical This program/activity is listed in the (b) Prior to licensure, a proposed habitat designation under the category of Federal Domestic Assistance expiration dating period for the product Endangered Species Act of 1973, as under No. 10.025 and is subject to should be determined by assessing the amended. Executive Order 12372, which requires stability of each of its fractions by DATES: Comments must be submitted intergovernmental consultation with methods acceptable to Animal and Plant directly to the Service (see ADDRESSES State and local officials. (See 7 CFR part Health Inspection Service. The 3015, subpart V.) section) on or before June 17, 2005. Any proposed dating period must be comments received after the closing Executive Order 12988 confirmed by testing the serials for date may not be considered in the final potency on multiple occasions determination on the proposal. This proposed rule has been reviewed throughout the proposed dating period under Executive Order 12988, Civil beginning at the date of final ADDRESSES: If you wish to comment, Justice Reform. It is not intended to formulation specified in the filed you may submit your comments and have retroactive effect. This rule would Outline of Production. A report of the materials concerning this proposal by not preempt any State or local laws, study should be submitted to Animal any one of several methods: regulations, or policies unless they and Plant Health Inspection Service for 1. You may submit written comments present an irreconcilable conflict with review and filing and the date of and information to the Field Supervisor, this rule. The Virus-Serum-Toxin Act approval should be specified in section Oklahoma Ecological Services Office, does not provide administrative VI of the filed Outline of Production. U.S. Fish and Wildlife Service, 222 procedures which must be exhausted (c) After the product is licensed and South Houston, Tulsa, Oklahoma prior to a judicial challenge to the its dating period confirmed, the licensee 74127–8909. provisions of this rule. or permittee must submit a plan to 2. You may hand-deliver written Paperwork Reduction Act monitor the stability of the product and comments and information to our Oklahoma Office, at the above address, This proposed rule contains no new the suitability of its dating period that includes regularly testing serials for or fax your comments to 918–581–7467. information collection or recordkeeping 3. You may send your comments by requirements under the Paperwork potency during and at the end of dating. (d) Subsequent changes in the dating electronic mail (e-mail) to Reduction Act of 1995 (44 U.S.C. 3501 [email protected]. For directions on et seq.). period for a product may be granted, based on the submission of a study to how to submit electronic filing of List of Subjects in 9 CFR Part 114 support a revision of the Outline of comments, see the ‘‘Public Comments Solicited’’ section. Animal biologics, Reporting and Production. All comments and materials received, recordkeeping requirements. Done in Washington, DC, this 22nd day of as well as supporting documentation Accordingly, we propose to amend 9 April 2005. used in preparation of this proposed CFR part 114 as follows: W. Ron DeHaven, rule, will be available for public Administrator, Animal and Plant Health PART 114—PRODUCTION inspection, by appointment, during Inspection Service. normal business hours at the above REQUIREMENTS FOR BIOLOGICAL [FR Doc. 05–8516 Filed 4–27–05; 8:45 am] PRODUCTS address. BILLING CODE 3410–34–P FOR FURTHER INFORMATION CONTACT: Jerry 1. The authority citation for part 114 Brabander, Field Supervisor, Oklahoma would continue to read as follows: Office (telephone 918–581–7458; DEPARTMENT OF THE INTERIOR Authority: 21 U.S.C. 151–159; 7 CFR 2.22, facsimile 918–581–7467). 2.80, and 371.4. Fish and Wildlife Service SUPPLEMENTARY INFORMATION: 2. Section 114.12 would be revised to Background read as follows: 50 CFR Part 17 On October 6, 2004 (69 FR 59859), we § 114.12 Expiration date required for a RIN 1018–AT84 serial. proposed to designate as critical habitat a total of approximately 2,002 Unless otherwise provided for in a Endangered and Threatened Wildlife kilometers (1,244 miles) of linear Standard Requirement or filed Outline and Plants; Extension of the Comment distance of rivers, including 91.4 meters of Production, each serial or subserial of Period for Proposed Designation of (300 feet) of adjacent riparian areas biological product prepared in a Critical Habitat for the Arkansas River measured laterally from each bank. This licensed establishment must be given an Basin Population of the Arkansas distance includes areas that we are expiration date computed from the date River Shiner proposing to exclude that are discussed of the initiation of the first potency test. AGENCY: below. The areas that we have A licensed biological product shall be Fish and Wildlife Service, determined to be essential to the considered worthless under the Virus- Interior. conservation of the Arkansas River Serum-Toxin Act subsequent to the ACTION: Proposed rule; extension of Shiner include portions of the Canadian expiration date appearing on the label. public comment period. 3. Section 114.13 would be revised to River (often referred to as the South read as follows: SUMMARY: We, the U.S. Fish and Canadian River) in New Mexico, Texas, Wildlife Service (Service), announce the and Oklahoma, the Beaver/North § 114.13 Determination of the expiration extension of the public comment period Canadian River of Oklahoma, the dating period of a product. for the proposal to designate critical Cimarron River in Kansas and (a) An expiration dating period shall habitat for the Arkansas River Basin Oklahoma, and the Arkansas River in be assigned to each product. When population of the Arkansas River Shiner Arkansas, Kansas, and Oklahoma.

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