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Federal Register/Vol. 70, No. 81/Thursday, April 28, 2005 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 Production. 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 Service 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 AGRICULTURE 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 VerDate jul<14>2003 15:58 Apr 27, 2005 Jkt 205001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 E:\FR\FM\28APP1.SGM 28APP1 21986 Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Proposed Rules 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.
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