Viruses, Serums, Toxins, and Analogous Products; Standard Requirement for Escherichia Coli Bacterins, 12813-12814 [05-5155]

Download as PDF Federal Register / Vol. 70, No. 50 / Wednesday, March 16, 2005 / Proposed Rules Executive Order 12866, Regulatory Review This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866. List of Subjects in 5 CFR Part 213 Government employees, Reporting and recordkeeping requirements. Education. The definition of half-time is the definition provided by the school in which the student is enrolled. Students need not be in actual physical attendance, so long as all other requirements are met. An individual who needs to complete less than the equivalent of half an academic/vocational or technical course-load in the class enrollment period immediately prior to graduating is still considered a student for purposes of this program. * because it affects only certain Federal employees. Office of Personnel Management. Dan G. Blair, Acting Director. Accordingly, OPM proposes to amend 5 CFR Part 213 as follows: PART 213—EXCEPTED SERVICE 1. The authority citation for part 213 is revised to read as follows: Authority: 5 U.S.C. 3161; 5 U.S.C. 3301 and 3302; E.O. 10577, 3 CFR 1954–1958 Comp., p. 218; Sec. 213.101 also issued under 5 U.S.C. 2103; Sec. 213.3102 also issued under 5 U.S.C. 3301, 3302, 3307, 8337(h) and 8456; E.O. 13318, 68 FR 66317, Nov. 25, 2003; 38 U.S.C. 4301 et seq.; Pub. L. 105–339, 112 Stat 3182–83; and E.O. 13162, 65 FR 43211, July 12, 2000. 2. Revise § 213.3202, paragraphs (a)(2), (b)(2), and (b)(11) to read as follows: § 213.3202 Entire executive civil service. (a) * * * (2) Definition of student: A student is an individual who has been accepted for enrollment or who is enrolled and seeking a degree (diploma, certificate, etc.) in a high school whose curriculum has been approved by a State or local governing body, or in a technical or vocational school, 2-year or 4year college or university, or graduate or professional school, that has been accredited by an accrediting body recognized by the Secretary of the U.S. Department of Education. The definition of half-time is the definition provided by the school in which the student is enrolled. Students need not be in actual physical attendance, so long as all other requirements are met. An individual who needs to complete less than the equivalent of half an academic/vocational or technical course-load in the class enrollment period immediately prior to graduating is still considered a student for purposes of this program. * * * * * (b) * * * (2) Definition of student: A student is an individual who has been accepted for enrollment or who is enrolled and seeking a degree (diploma, certificate, etc.) in a high school whose curriculum has been approved by a State or local governing body, or in a technical or vocational school, 2-year or 4year college or university, or graduate or professional school, that has been accredited by an accrediting body recognized by the Secretary of the U.S. Department of VerDate jul<14>2003 15:05 Mar 15, 2005 Jkt 205001 * * * * (11) Program requirements for noncompetitive conversion. (i) A student who is a U.S. citizen may be noncompetitively converted from the Student Career Experience Program to a term, career or career-conditional appointment under Executive Order 12015 (as amended by Executive Order 13024) when the student has: (A) Completed at least 640 hours of careerrelated work experience acquired through a Federal work-study program while otherwise enrolled as a full-time or part-time, degreeseeking student. Up to 320 hours acquired through a comparable non-Federal workstudy program meeting the criteria set forth in paragraph (b)(11)(ii) of this section may be credited toward the 640-hour minimum for students pursuing degrees under paragraphs (b)(1)(i)(D) through (F) of this section; (B) Completed a course of academic study from an accredited school conferring a diploma, certificate, or degree, within the 120-day period preceding the appointment; (C) Received a favorable recommendation regarding such an appointment by an official of the agency or agencies in which the jobrelated work experience was acquired; and (D) Met the qualification standards for the position to which the student will be appointed. (ii) To be creditable under paragraph (b)(11)(i)(A) of this section, work experience must be in a field or functional area that is generally related to the student’s target position/career field and must be acquired either under a Student Educational Employment Program appointment or while the student: (A) Worked in, but not for, a Federal agency, pursuant to a formal work-study agreement between the agency and the accredited academic institution; (B) Worked in, but not for, a Federal agency, pursuant to a written contract between the agency and an organization officially established to provide internship experiences to students; or (C) Served as a member in good standing of the armed forces of the United States (including the National Guard and Reserves), as defined in 5 U.S.C. 2101. (iii) Agencies may waive up to one-half (i.e., 320 hours) of the 640-hour minimum service requirement in paragraph (b)(11)(i)(A) of this section if a student enrolled in an accredited college or university completes 320 hours of career-related work experience under a Student Educational Employment Program appointment and has demonstrated high potential, as evidenced by outstanding academic achievement and exceptional job performance. (A) Outstanding academic achievement must be demonstrated by an overall grade PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 12813 point average of 3.5 or better, on a 4.0 scale; standing in the top 10 percent of the student’s graduating class; and/or induction into a nationally-recognized scholastic honor society (see the definition of superior academic achievement in OPM’s Qualifications Standards for General Schedule Positions available on the OPM Web site at https://www.opm.gov). (B) Exceptional job performance must be demonstrated by a formal evaluation conducted by the student’s work-study supervisor(s), in a manner consistent with the applicable performance appraisal program established under an approved performance appraisal system. (iv) Service credited under paragraphs (b)(ii)(A) and (B) of this section is not creditable for any other purpose of this chapter. Student volunteer service under part 308 of this chapter may not be credited under this section. (v) Noncompetitive conversion may be to a position within the same agency or any other agency within the Federal Government but must be to an occupation related to the student’s academic training and work-study experience. (vi) Agencies that noncompetitively convert a Student Career Experience Program graduate to a term appointment may also noncompetitively convert that individual to a career or career-conditional appointment before the term appointment expires. * * * * * [FR Doc. 05–5179 Filed 3–15–05; 8:45 am] BILLING CODE 6325–39–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 113 [Docket No. 93–039–4] Viruses, Serums, Toxins, and Analogous Products; Standard Requirement for Escherichia Coli Bacterins Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule; withdrawal. AGENCY: SUMMARY: We are withdrawing a proposed rule to amend the VirusSerum-Toxin Act regulations by adding a Standard Requirement for Escherichia coli bacterins. The proposed rule would have provided uniform test methods, procedures, and criteria to be used by manufacturers of E. coli bacterins to ensure that such bacterins were immunogenic and potent. We are withdrawing the proposed rule after considering the comments we received following its publication. FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader, Operational Support Section, Center for E:\FR\FM\16MRP1.SGM 16MRP1 12814 Federal Register / Vol. 70, No. 50 / Wednesday, March 16, 2005 / Proposed Rules Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737– 1231; (301) 734–8245. On October 11, 1994, we published in the Federal Register (59 FR 51390–51392, Docket No. 93–039–1) a proposed rule to amend the regulations in 9 CFR part 113 to include a Standard Requirement for Escherichia coli bacterins. We solicited comments on the proposed rule for 60 days ending on December 12, 1994. We subsequently reopened the comment period, then extended the comment period again: The first notice, published in the Federal Register on May 17, 1995 (60 FR 26384, Docket No. 93–039–2), reopened the comment period until August 15, 1995, and the second notice, published in the Federal Register on August 22, 1995 (60 FR 43573–43574, Docket No. 93–039–3), extended the comment period until September 14, 1995. We received a total of nine comments by the close of the extended comment period. The comments were from veterinary biologics manufacturers and a trade association representing veterinary biologics manufacturers. One commenter supported the concept of a standard test procedure for E. coli bacterin, but remarked that the proposed standard lacked sufficient detail concerning the test method. Another commenter identified provisions in the proposed rule that he believed conflicted with the provisions in an interrelated proposed rule concerning in vitro testing, and requested an indefinite extension of the comment period pending resolution of the conflicting provisions. The remaining commenters requested clarification of the various technical provisions of the rule and suggested alternative wording for our consideration. After considering all of the comments that we received, we have concluded that we will withdraw the proposed rule. Therefore, we are withdrawing the October 11, 1994, proposed rule referenced above. The concerns and recommendations of all of the commenters will be considered if any new proposed regulations concerning a Standard Requirement for E. coli bacterins are developed. SUPPLEMENTARY INFORMATION: Authority: 21 U.S.C. 151–159; 7 CFR 2.22, 2.80, and 371.4. VerDate jul<14>2003 15:05 Mar 15, 2005 Jkt 205001 Done in Washington, DC, this 10th day of March 2005. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 05–5155 Filed 3–15–05; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 113 [Docket No. 03–054–2] Viruses, Serums, Toxins, and Analogous Products; Standard Requirements for Bovine Virus Diarrhea and Bovine Rhinotracheitis Vaccines Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule; withdrawal. AGENCY: SUMMARY: We are withdrawing a proposed rule to amend the VirusSerum-Toxin Act regulations concerning Standard Requirements for Bovine Virus Diarrhea Vaccine, Killed Virus, and Bovine Rhinotracheitis Vaccine, Killed Virus. The proposed rule would have required vaccines to elicit specific antibody titer that is at least 80 percent of the geometric mean antibody titer obtained in the vaccinates in the host animal protection study to pass the potency test. We are taking this action after considering the comments we received following the publication of the proposed rule. FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737–1231; (301) 734–8245. SUPPLEMENTARY INFORMATION: Background The Virus-Serum-Toxin Act regulations in 9 CFR part 113 (referred to below as the regulations) prescribe standard requirements for the preparation and testing of veterinary biological products. On October 6, 2003, we published in the Federal Register (68 FR 57638–57639, Docket No. 03– 054–1) a proposed rule to amend the regulations concerning Standard Requirements for Bovine Virus Diarrhea Vaccine, Killed Virus, and Bovine Rhinotracheitis Vaccine, Killed Virus, to require that those vaccines elicit specific antibody titer that is at least 80 percent of the geometric mean antibody PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 titer obtained in the vaccinates in the host animal protection study to pass the potency test. The proposed action would have established potency test requirements for these vaccines that were based on the host animal protection study performed by the licensee. We solicited comments concerning our proposal for 60 days ending on December 5, 2003. We received nine comments by that date. The comments were from veterinary biologics manufacturers, trade associations representing veterinary biologics manufacturers, a microbiologist, and a veterinary association. One commenter supported the proposed rule. Another commenter expressed support for the proposal in principle, but urged delay in its implementation pending the completion of additional studies. The remaining commenters were opposed to the proposed rule. Some of those commenters stated that the proposed rule was scientifically flawed, and suggested that it be withdrawn lest it have a negative impact on the industry and future availability of vaccine. Other commenters stated that the proposed rule was inconsistent with the requirements for vaccine evaluated by other test methods and suggested that the Agency address the disparity in requirements. After considering all of the comments that we received, we have concluded that we will withdraw the proposed rule. Therefore, we are withdrawing the October 6, 2003, proposed rule referenced above. The concerns and recommendations of all of the commenters will be considered if any new proposed regulations concerning Standard Requirements for Bovine Virus Diarrhea Vaccine, Killed Virus, and Bovine Rhinotracheitis Vaccine, Killed Virus, are developed. Authority: 21 U.S.C. 151–159; 7 CFR 2.22, 2.80, and 371.4. Done in Washington, DC, this 10th day of March 2005. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 05–5156 Filed 3–15–05; 8:45 am] BILLING CODE 3410–34–P E:\FR\FM\16MRP1.SGM 16MRP1

Agencies

[Federal Register Volume 70, Number 50 (Wednesday, March 16, 2005)]
[Proposed Rules]
[Pages 12813-12814]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5155]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 113

[Docket No. 93-039-4]


Viruses, Serums, Toxins, and Analogous Products; Standard 
Requirement for Escherichia Coli Bacterins

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule; withdrawal.

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SUMMARY: We are withdrawing a proposed rule to amend the Virus-Serum-
Toxin Act regulations by adding a Standard Requirement for Escherichia 
coli bacterins. The proposed rule would have provided uniform test 
methods, procedures, and criteria to be used by manufacturers of E. 
coli bacterins to ensure that such bacterins were immunogenic and 
potent. We are withdrawing the proposed rule after considering the 
comments we received following its publication.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader, 
Operational Support Section, Center for

[[Page 12814]]

Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 
4700 River Road, Unit 148, Riverdale, MD 20737-1231; (301) 734-8245.

SUPPLEMENTARY INFORMATION: On October 11, 1994, we published in the 
Federal Register (59 FR 51390-51392, Docket No. 93-039-1) a proposed 
rule to amend the regulations in 9 CFR part 113 to include a Standard 
Requirement for Escherichia coli bacterins. We solicited comments on 
the proposed rule for 60 days ending on December 12, 1994. We 
subsequently reopened the comment period, then extended the comment 
period again: The first notice, published in the Federal Register on 
May 17, 1995 (60 FR 26384, Docket No. 93-039-2), reopened the comment 
period until August 15, 1995, and the second notice, published in the 
Federal Register on August 22, 1995 (60 FR 43573-43574, Docket No. 93-
039-3), extended the comment period until September 14, 1995.
    We received a total of nine comments by the close of the extended 
comment period. The comments were from veterinary biologics 
manufacturers and a trade association representing veterinary biologics 
manufacturers. One commenter supported the concept of a standard test 
procedure for E. coli bacterin, but remarked that the proposed standard 
lacked sufficient detail concerning the test method. Another commenter 
identified provisions in the proposed rule that he believed conflicted 
with the provisions in an interrelated proposed rule concerning in 
vitro testing, and requested an indefinite extension of the comment 
period pending resolution of the conflicting provisions. The remaining 
commenters requested clarification of the various technical provisions 
of the rule and suggested alternative wording for our consideration.
    After considering all of the comments that we received, we have 
concluded that we will withdraw the proposed rule. Therefore, we are 
withdrawing the October 11, 1994, proposed rule referenced above. The 
concerns and recommendations of all of the commenters will be 
considered if any new proposed regulations concerning a Standard 
Requirement for E. coli bacterins are developed.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 10th day of March 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-5155 Filed 3-15-05; 8:45 am]
BILLING CODE 3410-34-P
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