[Federal Register Volume 60, Number 137 (Tuesday, July 18, 1995)]
[Proposed Rules]
[Pages 36743-36744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17738]



 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 60, No. 137 / Tuesday, July 18, 1995 / 
Proposed Rules  


[[Page 36743]]


DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 101 and 113

[Docket No. 94-051-2]
RIN 0579-AA66


Viruses, Serums, Toxins, and Analogous Products; In Vitro Potency 
Testing for Serial Release

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule; extension of comment period and notice of public 
hearing.

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SUMMARY: We are extending by 30 days the comment period for our 
proposed rule that would amend the regulations regarding the use of in 
vitro potency testing for serial release. The regulations pertaining to 
in vitro testing for serial release would require that such 
immunoassays be parallel line assays based upon unexpired reference 
preparations and would specify procedures and requirements for 
qualifying reference preparations for inactivated products. This 
extension will provide interested persons with additional time to 
prepare comments on the proposed rule.
    We are also advising the producers of veterinary biologics and 
other interested persons that the Animal and Plant Health Inspection 
Service will be holding a public hearing in Ames, IA, at our Veterinary 
Biologics Public Meeting to discuss issues related to in vitro potency 
testing.

DATES: Consideration will be given only to comments received on or 
before September 14, 1995. We will also consider comments made at a 
public hearing to be held in Ames, IA, on Tuesday, August 1, 1995, from 
3:00 p.m. to 5:00 p.m.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 94-051-1, Regulatory Analysis and Development, PPD, APHIS, 
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please 
state that your comments refer to Docket No. 94-051-1. Comments 
received may be inspected at USDA, room 1141, South Building, 14th 
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 
4:30 p.m., Monday through Friday, except holidays. Persons wishing to 
inspect comments are requested to call ahead on (202) 690-2817 to 
facilitate entry into the comment reading room. The public hearing will 
be held at the Scheman Building, Iowa State Center, Ames, IA, on 
Tuesday, August 1, 1995.

FOR FURTHER INFORMATION CONTACT: Dr. David A. Espeseth, Deputy 
Director, Veterinary Biologics, BBEP, APHIS, 4700 River Road Unit 148, 
Riverdale, MD 20737-1237, telephone (301) 734-8245, fax (301) 734-8669.

SUPPLEMENTARY INFORMATION: On May 17, 1995, the Animal and Plant Health 
Inspection Service (APHIS) published in the Federal Register (60 FR 
26381-26384, Docket No. 94-051-1) a proposed rule to amend the 
regulations regarding the use of in vitro tests for serial release. The 
proposed rule would, among other things, prescribe requirements for in 
vitro immunoassays used to determine the relative antigen content of 
inactivated biological products; require that such immunoassays be 
parallel line assays based upon unexpired reference preparations; and 
specify procedures and requirements for qualifying or requalifying 
reference preparations for inactivated products. Comments on the 
proposed rule were required to be received on or before August 15, 
1995.
    So that we may consider comments received after that date, we are 
extending the public comment period on Docket No. 94-051-1 until 
September 14, 1995. During this period, interested persons may submit 
their comments for our consideration.
    APHIS is also conducting a public hearing to discuss in vitro 
potency testing on August 1, 1995, at the Scheman Building, Iowa State 
Center, Ames, IA. The public hearing is scheduled as part of the public 
meeting on veterinary biologics that is being held at the Scheman 
Building on August 1 and 2, 1995, in Ames, IA. The agenda for the 
public hearing will be limited to issues related to in vitro potency 
testing. The purpose of the hearing is to have further discussion of 
this topic by interested persons. We may also hold a second hearing on 
August 15, 1995, from 8:30 a.m. to 11 a.m. at the Holiday Inn Gateway 
Center, Ames, IA, in the event that additional time is needed for 
further discussion of the topic. We shall announce at the conclusion of 
the first hearing whether the second hearing shall be held. We will 
publish a notice in the Federal Register if we decide to hold the 
hearing on August 15, 1995. Interested persons may also call the person 
listed under FOR FURTHER INFORMATION CONTACT after August 1, 1995, to 
find out whether the second hearing will be held.
    Persons wishing either to attend or participate in the public 
hearing are requested to notify the person listed under FOR FURTHER 
INFORMATION CONTACT at least two business days before the public 
hearing. Please indicate whether you wish to make a prepared statement 
at the public hearing, the subject of your remarks, and the approximate 
amount of time you would like to speak. APHIS welcomes and encourages 
the presentation of comments at the public hearing.
    A representative of APHIS will preside at the public hearing. Any 
interested person may appear and be heard in person, by attorney, or by 
other representative. Persons who wish to speak at the public hearing 
will be asked to sign in with their name and organization, to establish 
a record for the hearing.
    The public hearing is scheduled for the times specified under 
``DATES.'' The hearing, however, may be terminated at any time after it 
begins if all persons desiring to speak have been heard. We ask that 
anyone who reads a statement provide two copies to the presiding 
officer at the hearing. If the number of speakers at the hearing 
warrants it, the presiding officer may limit the time for each 
presentation so that everyone wishing to speak has the opportunity.
    The purpose of the hearing is to give interested persons an 
opportunity for oral presentation of data, views, and arguments. 
Questions about the content of the proposed rule may be part of the 
commenters' oral presentations. Neither the presiding officer nor any 
other representative of APHIS, however, will respond to comments at the 
hearing, 

[[Page 36744]]
except to clarify or explain provisions of the proposed rule.

    Authority: 21 U.S.C. 151-159, 7 CFR 2.17, 2.51, and 371.2(d).
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-17738 Filed 7-17-95; 8:45 am]
BILLING CODE 3410-34-P