[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]
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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.
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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