Viruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serials and Subserials and Determination of Expiration Date of Product, 21985-21987 [05-8516]
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Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Proposed Rules
etc. Finally, this rule will ensure that
employers have sufficient time to seek
a new beneficiary or beneficiaries in the
event a petition is denied.
Executive Order 13132
This rule will not have substantial
direct effects on the states, on the
relationship between the National
Government and the states, or on the
distribution of power and
responsibilities among the various
levels of government. Therefore, in
accordance with section 6 of Executive
Order 13132, it is determined that this
rule does not have sufficient federalism
implications to warrant the preparation
of a federalism summary impact
statement.
Executive Order 12988 Civil Justice
Reform
This rule meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of Executive Order 12988.
Paperwork Reduction Act
Under the Paperwork Reduction Act
of 1995, Public Law 104–13, all
Departments are required to submit to
the Office of Management and Budget
(OMB), for review and approval, any
reporting requirements inherent in a
rule. This rule does not impose any new
reporting or recordkeeping requirements
under the Paperwork Reduction Act.
§ 214.2 Special requirements for
admission, extension, and maintenance of
status.
*
*
*
*
*
(o) * * *
(2) * * *
(i) General. * * * The petition may
be filed up to one year, but not earlier
than 6 months, before the actual need
for the alien’s services. Exceptions may
be granted in emergency situations at
the discretion of the USCIS Service
Center Director, and in special filing
situations as determined by USCIS
Headquarters. * * *
*
*
*
*
*
(p) * * *
(2) * * *
(i) General. * * * The petition may
be filed up to one year, but not earlier
than 6 months before the actual need for
the alien’s services. Exceptions may be
granted in emergency situations at the
discretion of the USCIS Service Center
Director, and in special filing situations
as determined by USCIS Headquarters.
* * *
*
*
*
*
*
Dated: April 22, 2005.
Michael Chertoff,
Secretary.
[FR Doc. 05–8471 Filed 4–27–05; 8:45 am]
BILLING CODE 4410–10–P
List of Subjects in 8 CFR Part 214
DEPARTMENT OF AGRICULTURE
Administrative practice and
procedures, Aliens, Employment,
Foreign officials, Health professions,
Reporting and recordkeeping
requirements, Students.
Accordingly, part 214 of chapter I of
title 8 of the Code of Federal
Regulations is proposed to be amended
as follows:
Animal and Plant Health Inspection
Service
PART 214—NONIMMIGRANT CLASSES
1. The authority citation for part 214
continues to read as follows:
Authority: 8 U.S.C. 1101, 1102, 1103, 1182,
1184, 1186a, 1187, 1221, 1281, 1282, 1301–
1305 and 1372; sec. 643, Pub. L. 104–208,
110 Stat. 3009–708; Section 141 of the
Compacts of Free Association with the
Federated States of Micronesia and the
Republic of the Marshall Islands, and with
the Government of Palau, 48 U.S.C. 1901
note, and 1931 note, respectively, 8 CFR part
2.
2. Section 214.2 is amended by:
a. Revising the second sentence in
paragraph (o)(2)(i) and adding a new
sentence immediately thereafter; and by
b. Revising the tenth sentence in
paragraph (p)(2)(i) and adding a new
sentence immediately after.
The revisions read as follows:
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15:58 Apr 27, 2005
Jkt 205001
9 CFR Part 114
[Docket No. 04–064–1]
Viruses, Serums, Toxins, and
Analogous Products; Expiration Date
Required for Serials and Subserials
and Determination of Expiration Date
of Product
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
AGENCY:
SUMMARY: We are proposing to amend
the Virus-Serum-Toxin Act regulations
to require licensees and permittees to
confirm the proposed expiration dating
period of products by potency testing
serials on multiple occasions
throughout the proposed dating period,
rather than only at release and at the
approximate expiration date as is
currently required. We would require
that those stability test data be
submitted to the Animal and Plant
Health Inspection Service for review
and filing, and that the approval date be
specified in a filed Outline of
PO 00000
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Fmt 4702
Sfmt 4702
21985
Production. In addition, after a product
is licensed and its dating period
confirmed, the licensee or permittee
would have to submit a plan to monitor
the stability of the product and the
suitability of its dating period; that plan
would have to include regular testing of
serials for potency during and at the end
of dating. The proposed changes would
help clarify the distinction between
specifying an expiration date for an
individual serial of a product and
establishing the appropriate expiration
dating period for the product. The effect
of these proposed changes would be to
establish a single uniform standard for
determining expiration dates for
veterinary biological products.
DATES: We will consider all comments
that we receive on or before June 27,
2005.
ADDRESSES: You may submit comments
by any of the following methods:
• EDOCKET: Go to https://
www.epa.gov/feddocket to submit or
view public comments, access the index
listing of the contents of the official
public docket, and to access those
documents in the public docket that are
available electronically. Once you have
entered EDOCKET, click on the ‘‘View
Open APHIS Dockets’’ link to locate this
document.
• Postal Mail/Commercial Delivery:
Please send four copies of your
comment (an original and three copies)
to Docket No. 04–064–1, Regulatory
Analysis and Development, PPD,
APHIS, Station 3C71, 4700 River Road
Unit 118, Riverdale, MD 20737–1238.
Please state that your comment refers to
Docket No. 04–064–1.
• Federal eRulemaking Portal: Go to
https://www.regulations.gov and follow
the instructions for locating this docket
and submitting comments.
Reading Room: You may read any
comments that we receive on this
docket in our reading room. The reading
room is located in room 1141 of the
USDA South Building, 14th Street and
Independence Avenue, SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 690–2817 before
coming.
Other Information: You may view
APHIS documents published in the
Federal Register and related
information on the Internet at https://
www.aphis.usda.gov/ppd/rad/
webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr.
Albert P. Morgan, Chief of Operational
Support, Center for Veterinary
Biologics, Licensing and Policy
E:\FR\FM\28APP1.SGM
28APP1
21986
Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Proposed Rules
Development, VS, 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 114,
‘‘Production Requirements for
Biological Products’’ (referred to below
as the regulations), include
requirements applicable to designating
the expiration date of a serial or
subserial of veterinary biologics and
determining the expiration dating
period (stability) for veterinary
biologics. Currently, § 114.12 of the
regulations requires each serial or
subserial of veterinary biological
product prepared in a licensed
establishment to be given an expiration
date determined in accordance with the
requirements prescribed in § 114.13 of
the regulations. The regulations in
§ 114.13 require the expiration date
described under § 114.12 to be
computed from the date of the initiation
of the potency test.
The expiration date of a product
designates the end of the period during
which a biological product, when
properly stored and handled, can be
expected, with reasonable certainty, to
be efficacious. Thus, the most precise
determination of the expiration date
occurs when the product is tested at the
end of its predicted shelf life. However,
the typical product may be released for
distribution and sale before its dating
period is confirmed, which necessitates
a mechanism for predicting the
product’s shelf life. Prior to licensure,
the stability of each fraction of a product
must be determined by methods
acceptable to Animal and Plant Health
Inspection Service (APHIS). Typically,
such methods involve subjecting the
product to extreme temperatures and
measuring its relative strength by
conducting a potency test. Products that
pass the potency test are licensed with
the provision that such expiration dates
must be confirmed by real-time testing
as follows: For products consisting of
viable organisms each (prelicensing)
serial shall be tested for potency at
release and at the approximate
expiration date until a statistically valid
stability record has been established; for
nonviable biological products, each
(prelicensing) serial presented in
support of licensure shall be tested for
potency at release and at or after the
dating requested.
We are proposing to amend the title
of § 114.12 to read: ‘‘Expiration date
required for a serial.’’ In addition, we
propose to amend this section by adding
the wording ‘‘computed from the date of
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15:58 Apr 27, 2005
Jkt 205001
the initiation of the potency test’’ and
remove it from § 114.13 where it is
currently found. This change is
intended to clarify the fact that the
expiration date of a serial, and not the
dating period of a product, is computed
from the date of the initiation of the
potency test.
We are proposing to amend the title
of § 114.13 to read: ‘‘Determination of
the expiration dating period of a
product.’’ This change will show that it
deals with a product’s dating period
rather than the expiration date of a
serial. The proposed revision of this
section would define a single uniform
standard for determining the dating
period for all veterinary biologics;
require the expiration dating periods of
a product to be confirmed by testing
serials or subserials on multiple
occasions throughout their dating
period in place of the current
requirement which only requires testing
at the beginning and end of the dating
period in order to confirm stability;
require a report of the expiration dating
period testing to be submitted to APHIS
for review and filing and the date of
approval to be specified in section VI of
the filed Outline of Production; and
after the dating period has been
approved, require that the stability of
the product and the suitability of the
dating period be monitored by regularly
testing serials during and after their
dating period.
APHIS is proposing these
amendments because it has been shown
that the potency of most veterinary
biologics degrades in a nonlinear
fashion, which could result in their
potency reaching its lowest point during
the middle of the dating period rather
than at the end. Testing on only two
occasions would be reasonable only if
potency loss has a strictly linear pattern,
and this is usually not the case. Thus,
APHIS is proposing to evaluate a
product’s stability as a function of time
by requiring serials to be tested on
multiple occasions when confirming the
dating period, and thereafter by
monitoring stability on a regular basis.
The proposed amendment would
update and standardize testing to
establish/confirm the stability of
veterinary biologics and improve the
reliability of expiration dating periods
currently specified on the labeling of
veterinary biologics, thereby providing
greater assurance that the product, when
properly stored and handled, will be
efficacious. We are therefore proposing
to amend §§ 114.12 and 114.13 as set
forth below.
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Frm 00004
Fmt 4702
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Executive Order 12866 and Regulatory
Flexibility Act
This proposed rule has been reviewed
under Executive Order 12866. The rule
has been determined to be not
significant for the purposes of Executive
Order 12866 and, therefore, has not
been reviewed by the Office of
Management and Budget.
This proposed rule would amend the
Virus-Serum-Toxin Act regulations in
§§ 114.12 and 114.13 concerning
expiration dates and the determination
of the stability of veterinary biologics to:
Change the title of the sections; require
veterinary biologics licensees and
permittees to evaluate the stability of
veterinary biologics as a function of
time by testing serials for potency
throughout and after their proposed
dating period beginning at the date of
final formulation; require that the
expiration dating period be determined
by testing serials for potency on
multiple occasions throughout and after
the proposed dating period; require that
a report of the results of the testing to
confirm expiration dating be submitted
to APHIS for review and filing and that
the date of approval be specified in the
filed Outline of Production; and require
monitoring of the stability of the
product and the suitability of the dating
period. The overall effect of these
proposed amendments would be to
establish a single uniform standard for
confirming the expiration dating period
of veterinary biologics.
This proposed rule would affect all
licensed manufacturers of veterinary
biologics. Currently, there are
approximately 152 veterinary biologics
manufacturers, including permittees.
According to the standards of the Small
Business Administration, most
veterinary biologics establishments are
small entities. We believe that this
proposed rule would not have a
significant effect on small entities
because all veterinary biologics
manufacturers are currently required to
confirm the expiration dating of the
products that they produce and to
submit a report to APHIS for review and
filing. In addition, the proposed
requirements to test serials on multiple
occasions when confirming expiration
dating and to require post-licensing
stability monitoring are not expected to
have a significant effect, as most
veterinary biologics manufacturers
routinely test and monitor the stability
of products throughout their dating
period.
Under these circumstances, the
Administrator of the Animal and Plant
Health Inspection Service has
determined that this action would not
E:\FR\FM\28APP1.SGM
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Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Proposed Rules
have a significant economic impact on
a substantial number of small entities.
Executive Order 12372
This program/activity is listed in the
category of Federal Domestic Assistance
under No. 10.025 and is subject to
Executive Order 12372, which requires
intergovernmental consultation with
State and local officials. (See 7 CFR part
3015, subpart V.)
Executive Order 12988
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. It is not intended to
have retroactive effect. This rule would
not preempt any State or local laws,
regulations, or policies unless they
present an irreconcilable conflict with
this rule. The Virus-Serum-Toxin Act
does not provide administrative
procedures which must be exhausted
prior to a judicial challenge to the
provisions of this rule.
Paperwork Reduction Act
This proposed rule contains no new
information collection or recordkeeping
requirements under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
List of Subjects in 9 CFR Part 114
Animal biologics, Reporting and
recordkeeping requirements.
Accordingly, we propose to amend 9
CFR part 114 as follows:
PART 114—PRODUCTION
REQUIREMENTS FOR BIOLOGICAL
PRODUCTS
tested at any time during the dating
period, the potency of the product must
not be less than the minimum specified
in the filed Outline of Production.
(b) Prior to licensure, a proposed
expiration dating period for the product
should be determined by assessing the
stability of each of its fractions by
methods acceptable to Animal and Plant
Health Inspection Service. The
proposed dating period must be
confirmed by testing the serials for
potency on multiple occasions
throughout the proposed dating period
beginning at the date of final
formulation specified in the filed
Outline of Production. A report of the
study should be submitted to Animal
and Plant Health Inspection Service for
review and filing and the date of
approval should be specified in section
VI of the filed Outline of Production.
(c) After the product is licensed and
its dating period confirmed, the licensee
or permittee must submit a plan to
monitor the stability of the product and
the suitability of its dating period that
includes regularly testing serials for
potency during and at the end of dating.
(d) Subsequent changes in the dating
period for a product may be granted,
based on the submission of a study to
support a revision of the Outline of
Production.
Done in Washington, DC, this 22nd day of
April 2005.
W. Ron DeHaven,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 05–8516 Filed 4–27–05; 8:45 am]
BILLING CODE 3410–34–P
2. Section 114.12 would be revised to
read as follows:
§ 114.12
serial.
Expiration date required for a
§ 114.13 Determination of the expiration
dating period of a product.
(a) An expiration dating period shall
be assigned to each product. When
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15:58 Apr 27, 2005
Jkt 205001
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
Endangered and Threatened Wildlife
and Plants; Extension of the Comment
Period for Proposed Designation of
Critical Habitat for the Arkansas River
Basin Population of the Arkansas
River Shiner
Fish and Wildlife Service,
Interior.
ACTION: Proposed rule; extension of
public comment period.
AGENCY:
SUMMARY: We, the U.S. Fish and
Wildlife Service (Service), announce the
extension of the public comment period
for the proposal to designate critical
habitat for the Arkansas River Basin
population of the Arkansas River Shiner
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Frm 00005
Fmt 4702
Comments must be submitted
directly to the Service (see ADDRESSES
section) on or before June 17, 2005. Any
comments received after the closing
date may not be considered in the final
determination on the proposal.
ADDRESSES: If you wish to comment,
you may submit your comments and
materials concerning this proposal by
any one of several methods:
1. You may submit written comments
and information to the Field Supervisor,
Oklahoma Ecological Services Office,
U.S. Fish and Wildlife Service, 222
South Houston, Tulsa, Oklahoma
74127–8909.
2. You may hand-deliver written
comments and information to our
Oklahoma Office, at the above address,
or fax your comments to 918–581–7467.
3. You may send your comments by
electronic mail (e-mail) to
r2arshinerch@fws.gov. For directions on
how to submit electronic filing of
comments, see the ‘‘Public Comments
Solicited’’ section.
All comments and materials received,
as well as supporting documentation
used in preparation of this proposed
rule, will be available for public
inspection, by appointment, during
normal business hours at the above
address.
DATES:
Jerry
Brabander, Field Supervisor, Oklahoma
Office (telephone 918–581–7458;
facsimile 918–581–7467).
SUPPLEMENTARY INFORMATION:
Background
50 CFR Part 17
RIN 1018–AT84
Unless otherwise provided for in a
Standard Requirement or filed Outline
of Production, each serial or subserial of
biological product prepared in a
licensed establishment must be given an
expiration date computed from the date
of the initiation of the first potency test.
A licensed biological product shall be
considered worthless under the VirusSerum-Toxin Act subsequent to the
expiration date appearing on the label.
3. Section 114.13 would be revised to
read as follows:
(Notropis girardi) (October 6, 2004; 69
FR 59859). This action will allow all
interested parties an opportunity to
comment on the proposed critical
habitat designation under the
Endangered Species Act of 1973, as
amended.
FOR FURTHER INFORMATION CONTACT:
1. The authority citation for part 114
would continue to read as follows:
Authority: 21 U.S.C. 151–159; 7 CFR 2.22,
2.80, and 371.4.
21987
Sfmt 4702
On October 6, 2004 (69 FR 59859), we
proposed to designate as critical habitat
a total of approximately 2,002
kilometers (1,244 miles) of linear
distance of rivers, including 91.4 meters
(300 feet) of adjacent riparian areas
measured laterally from each bank. This
distance includes areas that we are
proposing to exclude that are discussed
below. The areas that we have
determined to be essential to the
conservation of the Arkansas River
Shiner include portions of the Canadian
River (often referred to as the South
Canadian River) in New Mexico, Texas,
and Oklahoma, the Beaver/North
Canadian River of Oklahoma, the
Cimarron River in Kansas and
Oklahoma, and the Arkansas River in
Arkansas, Kansas, and Oklahoma.
E:\FR\FM\28APP1.SGM
28APP1
]]>Agencies
[Federal Register Volume 70, Number 81 (Thursday, April 28, 2005)]
[Proposed Rules]
[Pages 21985-21987]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8516]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 114
[Docket No. 04-064-1]
Viruses, Serums, Toxins, and Analogous Products; Expiration Date
Required for Serials and Subserials and Determination of Expiration
Date of Product
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: We are proposing to amend the Virus-Serum-Toxin Act
regulations to require licensees and permittees to confirm the proposed
expiration dating period of products by potency testing serials on
multiple occasions throughout the proposed dating period, rather than
only at release and at the approximate expiration date as is currently
required. We would require that those stability test data be submitted
to the Animal and Plant Health Inspection Service for review and
filing, and that the approval date be specified in a filed Outline of
Production. In addition, after a product is licensed and its dating
period confirmed, the licensee or permittee would have to submit a plan
to monitor the stability of the product and the suitability of its
dating period; that plan would have to include regular testing of
serials for potency during and at the end of dating. The proposed
changes would help clarify the distinction between specifying an
expiration date for an individual serial of a product and establishing
the appropriate expiration dating period for the product. The effect of
these proposed changes would be to establish a single uniform standard
for determining expiration dates for veterinary biological products.
DATES: We will consider all comments that we receive on or before June
27, 2005.
ADDRESSES: You may submit comments by any of the following methods:
EDOCKET: Go to https://www.epa.gov/feddocket to submit or
view public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once you have entered
EDOCKET, click on the ``View Open APHIS Dockets'' link to locate this
document.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 04-064-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 04-064-1.
Federal eRulemaking Portal: Go to https://
www.regulations.gov and follow the instructions for locating this
docket and submitting comments.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: You may view APHIS documents published in the
Federal Register and related information on the Internet at https://
www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief of
Operational Support, Center for Veterinary Biologics, Licensing and
Policy
[[Page 21986]]
Development, VS, 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 114,
``Production Requirements for Biological Products'' (referred to below
as the regulations), include requirements applicable to designating the
expiration date of a serial or subserial of veterinary biologics and
determining the expiration dating period (stability) for veterinary
biologics. Currently, Sec. 114.12 of the regulations requires each
serial or subserial of veterinary biological product prepared in a
licensed establishment to be given an expiration date determined in
accordance with the requirements prescribed in Sec. 114.13 of the
regulations. The regulations in Sec. 114.13 require the expiration
date described under Sec. 114.12 to be computed from the date of the
initiation of the potency test.
The expiration date of a product designates the end of the period
during which a biological product, when properly stored and handled,
can be expected, with reasonable certainty, to be efficacious. Thus,
the most precise determination of the expiration date occurs when the
product is tested at the end of its predicted shelf life. However, the
typical product may be released for distribution and sale before its
dating period is confirmed, which necessitates a mechanism for
predicting the product's shelf life. Prior to licensure, the stability
of each fraction of a product must be determined by methods acceptable
to Animal and Plant Health Inspection Service (APHIS). Typically, such
methods involve subjecting the product to extreme temperatures and
measuring its relative strength by conducting a potency test. Products
that pass the potency test are licensed with the provision that such
expiration dates must be confirmed by real-time testing as follows: For
products consisting of viable organisms each (prelicensing) serial
shall be tested for potency at release and at the approximate
expiration date until a statistically valid stability record has been
established; for nonviable biological products, each (prelicensing)
serial presented in support of licensure shall be tested for potency at
release and at or after the dating requested.
We are proposing to amend the title of Sec. 114.12 to read:
``Expiration date required for a serial.'' In addition, we propose to
amend this section by adding the wording ``computed from the date of
the initiation of the potency test'' and remove it from Sec. 114.13
where it is currently found. This change is intended to clarify the
fact that the expiration date of a serial, and not the dating period of
a product, is computed from the date of the initiation of the potency
test.
We are proposing to amend the title of Sec. 114.13 to read: ``
Determination of the expiration dating period of a product.'' This
change will show that it deals with a product's dating period rather
than the expiration date of a serial. The proposed revision of this
section would define a single uniform standard for determining the
dating period for all veterinary biologics; require the expiration
dating periods of a product to be confirmed by testing serials or
subserials on multiple occasions throughout their dating period in
place of the current requirement which only requires testing at the
beginning and end of the dating period in order to confirm stability;
require a report of the expiration dating period testing to be
submitted to APHIS for review and filing and the date of approval to be
specified in section VI of the filed Outline of Production; and after
the dating period has been approved, require that the stability of the
product and the suitability of the dating period be monitored by
regularly testing serials during and after their dating period.
APHIS is proposing these amendments because it has been shown that
the potency of most veterinary biologics degrades in a nonlinear
fashion, which could result in their potency reaching its lowest point
during the middle of the dating period rather than at the end. Testing
on only two occasions would be reasonable only if potency loss has a
strictly linear pattern, and this is usually not the case. Thus, APHIS
is proposing to evaluate a product's stability as a function of time by
requiring serials to be tested on multiple occasions when confirming
the dating period, and thereafter by monitoring stability on a regular
basis.
The proposed amendment would update and standardize testing to
establish/confirm the stability of veterinary biologics and improve the
reliability of expiration dating periods currently specified on the
labeling of veterinary biologics, thereby providing greater assurance
that the product, when properly stored and handled, will be
efficacious. We are therefore proposing to amend Sec. Sec. 114.12 and
114.13 as set forth below.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be not significant for the purposes of
Executive Order 12866 and, therefore, has not been reviewed by the
Office of Management and Budget.
This proposed rule would amend the Virus-Serum-Toxin Act
regulations in Sec. Sec. 114.12 and 114.13 concerning expiration dates
and the determination of the stability of veterinary biologics to:
Change the title of the sections; require veterinary biologics
licensees and permittees to evaluate the stability of veterinary
biologics as a function of time by testing serials for potency
throughout and after their proposed dating period beginning at the date
of final formulation; require that the expiration dating period be
determined by testing serials for potency on multiple occasions
throughout and after the proposed dating period; require that a report
of the results of the testing to confirm expiration dating be submitted
to APHIS for review and filing and that the date of approval be
specified in the filed Outline of Production; and require monitoring of
the stability of the product and the suitability of the dating period.
The overall effect of these proposed amendments would be to establish a
single uniform standard for confirming the expiration dating period of
veterinary biologics.
This proposed rule would affect all licensed manufacturers of
veterinary biologics. Currently, there are approximately 152 veterinary
biologics manufacturers, including permittees. According to the
standards of the Small Business Administration, most veterinary
biologics establishments are small entities. We believe that this
proposed rule would not have a significant effect on small entities
because all veterinary biologics manufacturers are currently required
to confirm the expiration dating of the products that they produce and
to submit a report to APHIS for review and filing. In addition, the
proposed requirements to test serials on multiple occasions when
confirming expiration dating and to require post-licensing stability
monitoring are not expected to have a significant effect, as most
veterinary biologics manufacturers routinely test and monitor the
stability of products throughout their dating period.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not
[[Page 21987]]
have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the category of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. It is not intended to have retroactive effect.
This rule would not preempt any State or local laws, regulations, or
policies unless they present an irreconcilable conflict with this rule.
The Virus-Serum-Toxin Act does not provide administrative procedures
which must be exhausted prior to a judicial challenge to the provisions
of this rule.
Paperwork Reduction Act
This proposed rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR Part 114
Animal biologics, Reporting and recordkeeping requirements.
Accordingly, we propose to amend 9 CFR part 114 as follows:
PART 114--PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS
1. The authority citation for part 114 would continue to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
2. Section 114.12 would be revised to read as follows:
Sec. 114.12 Expiration date required for a serial.
Unless otherwise provided for in a Standard Requirement or filed
Outline of Production, each serial or subserial of biological product
prepared in a licensed establishment must be given an expiration date
computed from the date of the initiation of the first potency test. A
licensed biological product shall be considered worthless under the
Virus-Serum-Toxin Act subsequent to the expiration date appearing on
the label.
3. Section 114.13 would be revised to read as follows:
Sec. 114.13 Determination of the expiration dating period of a
product.
(a) An expiration dating period shall be assigned to each product.
When tested at any time during the dating period, the potency of the
product must not be less than the minimum specified in the filed
Outline of Production.
(b) Prior to licensure, a proposed expiration dating period for the
product should be determined by assessing the stability of each of its
fractions by methods acceptable to Animal and Plant Health Inspection
Service. The proposed dating period must be confirmed by testing the
serials for potency on multiple occasions throughout the proposed
dating period beginning at the date of final formulation specified in
the filed Outline of Production. A report of the study should be
submitted to Animal and Plant Health Inspection Service for review and
filing and the date of approval should be specified in section VI of
the filed Outline of Production.
(c) After the product is licensed and its dating period confirmed,
the licensee or permittee must submit a plan to monitor the stability
of the product and the suitability of its dating period that includes
regularly testing serials for potency during and at the end of dating.
(d) Subsequent changes in the dating period for a product may be
granted, based on the submission of a study to support a revision of
the Outline of Production.
Done in Washington, DC, this 22nd day of April 2005.
W. Ron DeHaven,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-8516 Filed 4-27-05; 8:45 am]
BILLING CODE 3410-34-P
