Viruses, Serums, Toxins, and Analogous Products; Suspension, Revocation, or Termination of Biological Licenses or Permits; Inspections, 17795-17798 [E7-6700]
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Federal Register / Vol. 72, No. 68 / Tuesday, April 10, 2007 / Rules and Regulations
access to Government information and
services, and for other purposes.
As noted in the initial regulatory
flexibility analysis, USDA has not
identified any relevant Federal rules
that duplicate, overlap or conflict with
this final rule.
In addition, the Committee’s meeting
was widely publicized throughout the
Washington potato industry and all
interested persons were invited to
attend and participate in Committee
deliberations on all issues. Like all
Committee meetings, the February 9,
2006, meeting was a public meeting and
all entities, both large and small, were
able to express views on this issue.
A proposed rule concerning this
action was published in the Federal
Register on January 16, 2007 (72 FR
1685). Copies of the rule were sent to all
Committee members and were made
available for all attendees at the
February 7, 2007, Committee meeting.
Finally, the rule was made available
through the Internet by USDA and the
Office of the Federal Register. A 60-day
comment period ending March 19, 2007,
was provided to allow interested
persons to respond to the proposal. No
comments were received.
A small business guide on complying
with fruit, vegetable, and specialty crop
marketing agreements and orders may
be viewed at: https://www.ams.usda.gov/
fv/moab.html. Any questions about the
compliance guide should be sent to Jay
Guerber at the previously mentioned
address in the FOR FURTHER INFORMATION
CONTACT section.
After consideration of all relevant
matter presented, including the
information and recommendation
submitted by the Committee and other
available information, it is hereby found
that this rule, as hereinafter set forth,
will tend to effectuate the declared
policy of the Act.
It is further found that good cause
exists for not postponing the effective
date of this rule until 30 days after
publication in the Federal Register (5
U.S.C. 553) because the Committee
needs adequate time to conduct
nominations and a mail vote to elect
new Committee members and alternates
prior to the fiscal period beginning on
July 1, 2007. Further, Committee
members and alternates are aware of
this rule, which was recommended at a
public meeting. Also, a 60-day comment
period was provided for in the proposed
rule.
List of Subjects in 7 CFR Part 946
For the reasons set forth in the
preamble, 7 CFR part 946 is amended as
follows:
I
PART 946—IRISH POTATOES GROWN
IN WASHINGTON
1. The authority citation for 7 CFR
part 946 continues to read as follows:
I
Authority: 7 U.S.C. 601–674.
2. Section 946.103 is revised to read
as follows:
I
§ 946.103
Reestablishment of districts.
Pursuant to § 946.22, on and after July
1, 2007, the following districts are
reestablished:
(a) District No. 1—the counties of
Douglas, Chelan, Okanogan, Grant,
Adams, Ferry, Stevens, Pend Oreille,
Spokane, Whitman, and Lincoln.
(b) District No. 2—the counties of
Kittitas, Yakima, Klickitat, Benton,
Franklin, Walla Walla, Columbia,
Garfield, and Asotin.
(c) District No. 3—all of the remaining
counties in the State of Washington, not
included in Districts No. 1 and No. 2 of
this paragraph.
3. Section 946.104 is revised to read
as follows:
I
§ 946.104 Reestablishment and
reapportionment of committee.
(a) Pursuant to § 946.22, on and after
July 1, 2007, the State of Washington
Potato Committee consisting of nine
members, of whom six shall be
producers and three shall be handlers,
is hereby reestablished. For each
member of the committee there shall be
an alternate who shall have the same
qualifications as the member.
(b) Pursuant to § 946.22, on and after
July 1, 2007, membership representation
of the State of Washington Potato
Committee shall be reapportioned
among the districts of the production
area so as to provide that each of the
three districts as defined in § 946.103
are represented by two producer
members and one handler member and
their respective alternates.
Dated: April 5, 2007.
Lloyd C. Day,
Administrator, Agricultural Marketing
Service.
[FR Doc. 07–1794 Filed 4–6–07; 12:20 pm]
BILLING CODE 3410–02–P
Marketing agreements, Potatoes,
Reporting and recordkeeping
requirements.
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17795
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 105 and 115
[Docket No. 02–107–2]
RIN 0579–AC29
Viruses, Serums, Toxins, and
Analogous Products; Suspension,
Revocation, or Termination of
Biological Licenses or Permits;
Inspections
Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
AGENCY:
SUMMARY: We are amending the VirusSerum-Toxin Act regulations to specify
the actions to be taken by veterinary
biologics licensees and permittees upon
receipt of notice from the Animal and
Plant Health Inspection Service (APHIS)
to stop the preparation, distribution,
sale, barter, exchange, shipment, or
importation of any worthless,
contaminated, dangerous, harmful, or
unsatisfactory veterinary biological
product. After receiving notice from
APHIS, licensees and permittees must
notify each wholesaler, dealer, jobber,
consignee, or other recipient known to
have any such product in their
possession to stop the preparation,
distribution, sale, barter, exchange,
shipment, or importation of such
product. In addition, licensees and
permittees must provide a complete
accounting of the remaining inventory
of affected serials or subserials of such
product in the current possession of
known wholesalers, dealers, jobbers,
consignees, or other known recipients
and provide written documentation
concerning the required notification(s)
as directed by the Administrator of
APHIS. These changes are necessary in
order to clarify the regulations, provide
for the most expeditious means of
disseminating stop distribution and sale
notices, and to mitigate the risk that any
worthless, contaminated, dangerous,
harmful, or unsatisfactory veterinary
biological product may cause harm to
animals, the public health, or to the
environment.
Effective Date: May 10, 2007.
Dr.
Albert P. Morgan, Chief of Operational
Support, Center for Veterinary
Biologics, Licensing and Policy
Development, VS, APHIS, 4700 River
Road Unit 148, Riverdale, MD 20737–
1231, (301) 734–8245.
SUPPLEMENTARY INFORMATION:
DATES:
FOR FURTHER INFORMATION CONTACT:
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17796
Federal Register / Vol. 72, No. 68 / Tuesday, April 10, 2007 / Rules and Regulations
Background
Parts 105 and 115 of the Virus-SerumToxin Act regulations (9 CFR parts 105
and 115, referred to below as the
regulations) provide, respectively, for
the suspension, revocation, or
termination of biological licenses or
permits and for the inspection of
veterinary biologics establishments and
veterinary biological products. These
regulations also contain provisions that
address the actions to be taken by the
manufacturer or importer, and any
jobbers, wholesalers, dealers, or other
persons known to have veterinary
biologics in their possession, upon their
receipt of notice from the Animal and
Plant Health Inspection Service (APHIS)
to stop the preparation, distribution,
sale, barter, exchange, shipment, or
importation of worthless, contaminated,
dangerous, harmful, or unsatisfactory
veterinary biological product.
Section 105.3 of the regulations
provides, in relevant part, that APHIS
may notify a licensee or permittee to
stop the preparation, sale, barter,
exchange, shipment, or importation of
any veterinary biological product if at
any time it appears that such product
may be dangerous in the treatment of
domestic animals or unsatisfactory
according to applicable Standard
Requirements.
Similarly, § 115.2 provides, in
relevant part, that if as a result of any
inspection it appears that any veterinary
biological product is worthless,
contaminated, dangerous, or harmful,
the Secretary will give notice of that
finding to the manufacturer or importer
and to any jobbers, wholesalers, dealers,
or other persons known to have any of
such product in their possession. After
receiving such notice, no person may
sell, barter, or exchange any such
product in any place under the
jurisdiction of the United States or ship
or deliver for shipment any such
product in or from any State, Territory,
or the District of Columbia.
Typically, before stop distribution
and sale notifications provided for by
§§ 105.3 and 115.2 can be given, APHIS
must obtain from the licensees and
permittees (manufacturers or importers)
the names and addresses of the
wholesalers, dealers, jobbers,
consignees, or other persons known to
have any of such unsatisfactory product
in their possession. Any delay in
obtaining the names and addresses of
persons in possession of biological
products subject to a stop distribution
and sale notification increases the risk
that such product may cause harm to
animals, the public health, or to the
environment. We believe that it is
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prudent to use the most expeditious
means available to notify wholesalers,
dealers, jobbers, foreign consignees, or
other persons concerning the stop
distribution and sale action.
On April 9, 2003, we published in the
Federal Register (68 FR 17327–17330,
Docket No. 02–107–1) a proposal to
amend the regulations to require
veterinary biologics licensees and
permittees (instead of APHIS) to: (1)
Notify wholesalers, dealers, jobbers, or
other persons concerning APHISdirected stop distribution and sale
notifications pertaining to worthless,
contaminated, dangerous, harmful, or
unsatisfactory veterinary biological
product; (2) account for any remaining
quantity of such product in the current
possession of persons involved in the
distribution or sale of said product; and
(3) to provide written documentation
concerning the required notifications as
directed by the Administrator of APHIS.
We solicited comments concerning
our proposal for 60 days ending June 9,
2003. We received one comment by that
date, from a trade association
representing veterinary biologics
manufacturers. We carefully considered
this comment before we reached a
decision concerning our proposal. The
comment is discussed below.
The commenter stated that the
proposed rule could be subject to
multiple interpretations and would
require licensees and permittees to be
accountable for activities beyond their
ability to control, and requested
clarification regarding the proposed
provisions that would require licensees
and permittees to account for the
quantity for each serial or subserial of
unsatisfactory product at each location
in the distribution channel (i.e., the
provisions of proposed §§ 105.3(c)(3)
and 115.2(b)(3)). The commenter
inquired as to whether this meant
accounting only for the quantity of
product shipped from the manufacturer
directly to primary (presumably,
known) distributors (wholesalers, etc.)
or, in addition, accounting for product
shipped from primary distributors to
secondary and/or tertiary recipients
who may not be known to the
manufacturer or importer.
In proposed §§ 105.3(c)(2) and
115.2(b)(2), we specified that stop sale
notifications should be issued to all
wholesalers, jobbers, dealers, foreign
consignees, or other persons known to
have the product in their possession.
However, we agree that the wording of
proposed §§ 105.3(c)(3) and 115.2(b)(3)
could be interpreted as requiring
licensees and permittees to account for
product in the possession of persons
that are not known to the manufacturer
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or importer. To clarify those provisions,
we have amended §§ 105.3(c)(3) and
115.2(b)(3) in this final rule to refer to
accounting for the quantity of product at
each location known to the
manufacturer or importer. As amended,
§§ 105.3(c)(3) and 115.2(b)(3) now read:
‘‘Account for the remaining quantity of
each serial(s) or subserial(s) of any such
veterinary biological product at each
location in the distribution channel
known to the manufacturer or
importer.’’
The commenter also inquired as to the
meaning of ‘‘immediately’’ as used in
§§ 105.3(c)(2) and 115.2(b)(2) of the
proposed rule, and identified several
situations where ‘‘rapid notification’’
may not be in the best interest of the
consumer or manufacturer.
The purpose of the typical stop
distribution and sale action is to
mitigate the possibility that any
worthless, dangerous, harmful, or
unsatisfactory veterinary biological
product may cause harm to animals, the
public health, or to the environment.
We realize that a hasty decision may not
be in the best interest of the health of
animals or the manufacturer, and would
exercise great caution before issuing a
stop distribution and sale notification.
However, we believe that stop
distribution and sale notifications
should be carried out as expeditiously
as possible once the determination has
been made that suspension of
distribution and sale of the product is
the best means to limit harm to animals,
the public health, or the environment.
To clarify the meaning of
‘‘immediately,’’ we have amended
§§ 105.3(c)(2) and 115.2(b)(2) in this
final rule to read as follows:
‘‘Immediately, but no later than 2 days,
send stop distribution and sale
notifications to any wholesalers,
jobbers, dealers, foreign consignees, or
other persons known to have any such
veterinary biological product in their
possession, which instruct them to stop
preparation, distribution, sale, barter,
exchange, shipment, or importation of
any such veterinary biological product.
All such notifications shall be
documented in writing by the licensee
or permittee.’’
The commenter agreed with the
estimate of burden in the proposed
rule’s Paperwork Reduction Act section
of 1.7666 hours per response for
respondents affected by stop
distribution and sale notifications,
provided that such notifications are
only applicable to ‘‘parties that are a
single business transaction away from
the licensee or permittee’’ (i.e., known
to the manufacturer or importer).
However, the commenter opined that
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1.7666 hours per response may be an
underestimate for firms that market
directly to veterinarians, or if such
notifications must ‘‘include all
participants in each distribution chain,’’
(i.e., known and unknown participants).
Regarding the commenter’s concern
that notification must include all
participants in each distribution chain,
APHIS has amended §§ 105.3(c)(3) and
115.2(b)(3) in this final rule to specify
that licensees and permittees are only
required to notify wholesalers, jobbers,
dealers, foreign consignees, or other
persons known to be in possession of
product subject to the stop distribution
and sale action. In addition, APHIS
believes that available technological
tools such as electronic mail, facsimile,
and the telephone help lower the
burden of notification in all cases,
including for those who market directly
to veterinarians. Given these facts,
APHIS believes that the estimated
burden of 1.7666 hours per response
stated in the proposed rule is not
unreasonable.
Therefore, for the reasons given in the
proposed rule and in this document, we
are adopting the proposed rule as a final
rule, with the changes discussed in this
document.
Executive Order 12866 and Regulatory
Flexibility Act
This rule has been determined to be
not significant for purposes of Executive
Order 12866, and, therefore, has not
been reviewed by the Office of
Management and Budget.
We are amending §§ 105.3 and 115.2
of our regulations under the VirusSerum-Toxin Act concerning actions
that veterinary biologics licensees and
permittees must take after receiving
notice from APHIS to stop distribution
and sale of a serial(s) or subserial(s) of
veterinary biological product that is
found to be unsatisfactory according to
applicable standard requirements, or if
it appears that such product is
worthless, contaminated, dangerous, or
harmful. Licensees and permittees are
required to notify wholesalers, jobbers,
dealers, foreign consignees, or other
persons known to be in possession of
such product immediately, but no later
than 2 days after being contacted by
APHIS, to stop further distribution and
sale of such serial(s) or subserial(s)
pending further instructions. This final
rule also requires veterinary biologics
licensees and permittees to document,
in writing, their communications with
wholesalers, jobbers, dealers, foreign
consignees, or other persons concerning
such stop distribution and sale
notifications; determine the remaining
inventory of such product in the current
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possession of such wholesalers, jobbers,
dealers, consignees, or other persons;
and, as directed by the Administrator,
submit reports of all such notifications
to APHIS.
The primary effect of this rule will be
to provide for the most expeditious
means of disseminating information
concerning stop distribution and sale
notices pertaining to veterinary
biological product found unsatisfactory
according to applicable standard
requirements, and to mitigate the risk
that such unsatisfactory veterinary
biological product may cause harm to
animals, the public health, or the
environment. The rule also clarifies the
regulations with regard to whom
licensees and permittees should contact
concerning stop distribution and sale
notification, and what information
APHIS may require to be reported
concerning such notification.
There are approximately 125
veterinary biologics establishments,
including permittees, that may be
affected by this rule. According to the
standards of the Small Business
Administration, most veterinary
biologics establishments would be
classified as small entities.
It is anticipated that no undue
recordkeeping burden will be added to
licensees and permittees since §§ 116.2
and 116.5 of the regulations currently
require the maintenance of detailed
disposition records and the submission
of reports concerning each biological
product that is prepared and/or
shipped. We further anticipate that the
only economic effects that may result
from this amendment to the regulations
would be related to the costs incurred
by licensees and permittees in
connection with the notification process
itself. This final rule does not specify
the means by which licensees and
permittees are required to give
notification, only that notification be
given immediately, but no later than 2
days of receipt of the stop distribution
and sale notification from APHIS. We
expect that licensees and permittees
would use electronic mail, telephone,
and facsimile to notify wholesalers,
jobbers, dealers, consignees, or other
persons known to be in possession of
the product. These methods are
inexpensive, so the actual costs of
transmitting notifications required by
this amendment would be minimal. The
amendment will benefit manufacturers
of veterinary biologics by clarifying the
actions they must take should they
receive notification from APHIS
concerning a serial(s) or subserial(s) of
biological product found to be
unsatisfactory according to applicable
standard requirements.
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17797
Under these circumstances, the
Administrator of the Animal and Plant
Health Inspection Service has
determined that this action will not
have a significant economic impact on
a substantial number of small entities.
Executive Order 12372
This program/activity is listed in the
Catalog 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 final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. It is not intended to
have retroactive effect. This rule will
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
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), the information collection or
recordkeeping requirements included in
this rule have been approved by the
Office of Management and Budget
(OMB) under OMB control number
0579–0318.
E-Government Act Compliance
The Animal and Plant Health
Inspection Service is committed to
compliance with the E-Government Act
to promote the use of the Internet and
other information technologies, to
provide increased opportunities for
citizen access to Government
information and services, and for other
purposes. For information pertinent to
E-Government Act compliance related
to this rule, please contact Mrs. Celeste
Sickles, APHIS’ Information Collection
Coordinator, at (301) 734–7477.
List of Subjects
9 CFR Part 105
Animal biologics, Exports, Imports,
Labeling, Packaging and containers,
Reporting and recordkeeping
requirements.
9 CFR Part 115
Animal biologics, Exports, Imports,
Reporting and recordkeeping
requirements.
Accordingly, we are amending 9 CFR
parts 105 and 115 as follows:
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Federal Register / Vol. 72, No. 68 / Tuesday, April 10, 2007 / Rules and Regulations
PART 105—SUSPENSION,
REVOCATION, OR TERMINATION OF
BIOLOGICAL LICENSES OR PERMITS
1. The authority citation for part 105
continues to read as follows:
I
Authority: 21 U.S.C. 151–159; 7 CFR 2.22,
2.80, and 371.4.
2. Section 105.3 is amended by adding
a new paragraph (c) and an OMB control
number citation to read as follows:
I
§ 105.3 Notices re: worthless,
contaminated, dangerous, or harmful
biological products.
*
*
*
*
*
(c) When notified to stop distribution
and sale of a serial or subserial of a
veterinary biological product under the
provisions of paragraph (a) or (b) of this
section, veterinary biologics licensees or
permittees shall:
(1) Stop the preparation, distribution,
sale, barter, exchange, shipment, or
importation of the affected serial(s) or
subserial(s) of any veterinary biological
product pending further instructions
from APHIS.
(2) Immediately, but no later than 2
days, send stop distribution and sale
notifications to any wholesalers,
jobbers, dealers, foreign consignees, or
other persons known to have any such
veterinary biological product in their
possession, which instruct them to stop
the preparation, distribution, sale,
barter, exchange, shipment, or
importation of any such veterinary
biological product. All notifications
shall be documented in writing by the
licensee or permittee.
(3) Account for the remaining
quantity of each serial(s) or subserial(s)
of any such veterinary biological
product at each location in the
distribution channel known to the
manufacturer (licensee) or importer
(permittee).
(4) When required by the
Administrator, submit complete and
accurate reports of all notifications
concerning stop distribution and sale
actions to the Animal and Plant Health
Inspection Service pursuant to § 116.5
of this subchapter.
(Approved by the Office of Management and
Budget under control number 0579–0318.)
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PART 115—INSPECTIONS
3. The authority citation for part 115
continues to read as follows:
I
Authority: 21 U.S.C. 151–159; 7 CFR 2.22,
2.80, and 371.4.
4. Section 115.2 is revised to read as
follows:
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§ 115.2
Inspections of biological products.
(a) Any biological product, the
container of which bears a United States
veterinary license number or a United
States veterinary permit number or
other mark required by these
regulations, may be inspected at any
time or place. If, as a result of such
inspection, it appears that any such
product is worthless, contaminated,
dangerous, or harmful, the Secretary
shall give notice to stop distribution and
sale to the manufacturer (licensee) or
importer (permittee) and may proceed
against such product pursuant to the
provisions of part 118 of this
subchapter.
(b) When notified to stop distribution
and sale of a serial or subserial of a
veterinary biological product by the
Secretary, veterinary biologics licensees
or permittees shall:
(1) Stop the preparation, distribution,
sale, barter, exchange, shipment, or
importation of the affected serial(s) or
subserial(s) of any such veterinary
biological product pending further
instructions from APHIS.
(2) Immediately, but no later than 2
days, send stop distribution and sale
notifications to any jobbers,
wholesalers, dealers, foreign consignees,
or other persons known to have any
such veterinary biological product in
their possession, which instruct them to
stop the preparation, distribution, sale,
barter, exchange, shipment, or
importation of any such veterinary
biological product. All notifications
shall be documented in writing by the
licensee or permittee.
(3) Account for the remaining
quantity of each serial(s) or subserial(s)
of any such veterinary biological
product at each location in the
distribution channel known to the
manufacturer (licensee) or importer
(permittee).
(4) When required by the
Administrator, submit complete and
accurate reports of all notifications
concerning stop distribution and sale
actions to the Animal and Plant Health
Inspection Service pursuant to § 116.5
of this subchapter.
(c) Unless and until the Secretary
shall otherwise direct, no persons so
notified shall thereafter sell, barter, or
exchange any such product in any place
under the jurisdiction of the United
States or ship or deliver for shipment
any such product in or from any State,
Territory, or the District of Columbia.
However, failure to receive such notice
shall not excuse any person from
compliance with the Virus-Serum-Toxin
Act. (Approved by the Office of
Management and Budget under control
number 0579–0318).
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Done in Washington, DC, this 4th day of
April 2007.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E7–6700 Filed 4–9–07; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF THE TREASURY
Office of the Comptroller of the
Currency
12 CFR Part 4
[Docket ID OCC–2007–0007]
FEDERAL RESERVE SYSTEM
12 CFR Parts 208 and 211
[Docket No. R–1279]
FEDERAL DEPOSIT INSURANCE
CORPORATION
12 CFR Parts 337 and 347
RIN 3064–AD17
DEPARTMENT OF THE TREASURY
Office of Thrift Supervision
12 CFR Part 563
[Docket ID OTS–2007–0006]
Expanded Examination Cycle for
Certain Small Insured Depository
Institutions and U.S. Branches and
Agencies of Foreign Banks
Office of the Comptroller of
the Currency (OCC); Board of Governors
of the Federal Reserve System (Board);
Federal Deposit Insurance Corporation
(FDIC); and Office of Thrift Supervision
(OTS), Treasury.
ACTION: Interim rules with request for
comment.
AGENCIES:
SUMMARY: The OCC, Board, FDIC, and
OTS (collectively, the Agencies) are
jointly issuing and requesting public
comment on these interim rules to
implement the Financial Services
Regulatory Relief Act of 2006 (FSRRA)
and related legislation (collectively the
Examination Amendments). The
Examination Amendments permit
insured depository institutions
(institutions) that have up to $500
million in total assets, and that meet
certain other criteria, to qualify for an
18-month (rather than 12-month) on-site
examination cycle. Prior to enactment of
FSRRA, only institutions with less than
$250 million in total assets were eligible
for an 18-month on-site examination
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]]>Agencies
[Federal Register Volume 72, Number 68 (Tuesday, April 10, 2007)]
[Rules and Regulations]
[Pages 17795-17798]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6700]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 105 and 115
[Docket No. 02-107-2]
RIN 0579-AC29
Viruses, Serums, Toxins, and Analogous Products; Suspension,
Revocation, or Termination of Biological Licenses or Permits;
Inspections
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the Virus-Serum-Toxin Act regulations to
specify the actions to be taken by veterinary biologics licensees and
permittees upon receipt of notice from the Animal and Plant Health
Inspection Service (APHIS) to stop the preparation, distribution, sale,
barter, exchange, shipment, or importation of any worthless,
contaminated, dangerous, harmful, or unsatisfactory veterinary
biological product. After receiving notice from APHIS, licensees and
permittees must notify each wholesaler, dealer, jobber, consignee, or
other recipient known to have any such product in their possession to
stop the preparation, distribution, sale, barter, exchange, shipment,
or importation of such product. In addition, licensees and permittees
must provide a complete accounting of the remaining inventory of
affected serials or subserials of such product in the current
possession of known wholesalers, dealers, jobbers, consignees, or other
known recipients and provide written documentation concerning the
required notification(s) as directed by the Administrator of APHIS.
These changes are necessary in order to clarify the regulations,
provide for the most expeditious means of disseminating stop
distribution and sale notices, and to mitigate the risk that any
worthless, contaminated, dangerous, harmful, or unsatisfactory
veterinary biological product may cause harm to animals, the public
health, or to the environment.
DATES: Effective Date: May 10, 2007.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief of
Operational Support, Center for Veterinary Biologics, Licensing and
Policy Development, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD
20737-1231, (301) 734-8245.
SUPPLEMENTARY INFORMATION:
[[Page 17796]]
Background
Parts 105 and 115 of the Virus-Serum-Toxin Act regulations (9 CFR
parts 105 and 115, referred to below as the regulations) provide,
respectively, for the suspension, revocation, or termination of
biological licenses or permits and for the inspection of veterinary
biologics establishments and veterinary biological products. These
regulations also contain provisions that address the actions to be
taken by the manufacturer or importer, and any jobbers, wholesalers,
dealers, or other persons known to have veterinary biologics in their
possession, upon their receipt of notice from the Animal and Plant
Health Inspection Service (APHIS) to stop the preparation,
distribution, sale, barter, exchange, shipment, or importation of
worthless, contaminated, dangerous, harmful, or unsatisfactory
veterinary biological product.
Section 105.3 of the regulations provides, in relevant part, that
APHIS may notify a licensee or permittee to stop the preparation, sale,
barter, exchange, shipment, or importation of any veterinary biological
product if at any time it appears that such product may be dangerous in
the treatment of domestic animals or unsatisfactory according to
applicable Standard Requirements.
Similarly, Sec. 115.2 provides, in relevant part, that if as a
result of any inspection it appears that any veterinary biological
product is worthless, contaminated, dangerous, or harmful, the
Secretary will give notice of that finding to the manufacturer or
importer and to any jobbers, wholesalers, dealers, or other persons
known to have any of such product in their possession. After receiving
such notice, no person may sell, barter, or exchange any such product
in any place under the jurisdiction of the United States or ship or
deliver for shipment any such product in or from any State, Territory,
or the District of Columbia.
Typically, before stop distribution and sale notifications provided
for by Sec. Sec. 105.3 and 115.2 can be given, APHIS must obtain from
the licensees and permittees (manufacturers or importers) the names and
addresses of the wholesalers, dealers, jobbers, consignees, or other
persons known to have any of such unsatisfactory product in their
possession. Any delay in obtaining the names and addresses of persons
in possession of biological products subject to a stop distribution and
sale notification increases the risk that such product may cause harm
to animals, the public health, or to the environment. We believe that
it is prudent to use the most expeditious means available to notify
wholesalers, dealers, jobbers, foreign consignees, or other persons
concerning the stop distribution and sale action.
On April 9, 2003, we published in the Federal Register (68 FR
17327-17330, Docket No. 02-107-1) a proposal to amend the regulations
to require veterinary biologics licensees and permittees (instead of
APHIS) to: (1) Notify wholesalers, dealers, jobbers, or other persons
concerning APHIS-directed stop distribution and sale notifications
pertaining to worthless, contaminated, dangerous, harmful, or
unsatisfactory veterinary biological product; (2) account for any
remaining quantity of such product in the current possession of persons
involved in the distribution or sale of said product; and (3) to
provide written documentation concerning the required notifications as
directed by the Administrator of APHIS.
We solicited comments concerning our proposal for 60 days ending
June 9, 2003. We received one comment by that date, from a trade
association representing veterinary biologics manufacturers. We
carefully considered this comment before we reached a decision
concerning our proposal. The comment is discussed below.
The commenter stated that the proposed rule could be subject to
multiple interpretations and would require licensees and permittees to
be accountable for activities beyond their ability to control, and
requested clarification regarding the proposed provisions that would
require licensees and permittees to account for the quantity for each
serial or subserial of unsatisfactory product at each location in the
distribution channel (i.e., the provisions of proposed Sec. Sec.
105.3(c)(3) and 115.2(b)(3)). The commenter inquired as to whether this
meant accounting only for the quantity of product shipped from the
manufacturer directly to primary (presumably, known) distributors
(wholesalers, etc.) or, in addition, accounting for product shipped
from primary distributors to secondary and/or tertiary recipients who
may not be known to the manufacturer or importer.
In proposed Sec. Sec. 105.3(c)(2) and 115.2(b)(2), we specified
that stop sale notifications should be issued to all wholesalers,
jobbers, dealers, foreign consignees, or other persons known to have
the product in their possession. However, we agree that the wording of
proposed Sec. Sec. 105.3(c)(3) and 115.2(b)(3) could be interpreted as
requiring licensees and permittees to account for product in the
possession of persons that are not known to the manufacturer or
importer. To clarify those provisions, we have amended Sec. Sec.
105.3(c)(3) and 115.2(b)(3) in this final rule to refer to accounting
for the quantity of product at each location known to the manufacturer
or importer. As amended, Sec. Sec. 105.3(c)(3) and 115.2(b)(3) now
read: ``Account for the remaining quantity of each serial(s) or
subserial(s) of any such veterinary biological product at each location
in the distribution channel known to the manufacturer or importer.''
The commenter also inquired as to the meaning of ``immediately'' as
used in Sec. Sec. 105.3(c)(2) and 115.2(b)(2) of the proposed rule,
and identified several situations where ``rapid notification'' may not
be in the best interest of the consumer or manufacturer.
The purpose of the typical stop distribution and sale action is to
mitigate the possibility that any worthless, dangerous, harmful, or
unsatisfactory veterinary biological product may cause harm to animals,
the public health, or to the environment. We realize that a hasty
decision may not be in the best interest of the health of animals or
the manufacturer, and would exercise great caution before issuing a
stop distribution and sale notification. However, we believe that stop
distribution and sale notifications should be carried out as
expeditiously as possible once the determination has been made that
suspension of distribution and sale of the product is the best means to
limit harm to animals, the public health, or the environment. To
clarify the meaning of ``immediately,'' we have amended Sec. Sec.
105.3(c)(2) and 115.2(b)(2) in this final rule to read as follows:
``Immediately, but no later than 2 days, send stop distribution and
sale notifications to any wholesalers, jobbers, dealers, foreign
consignees, or other persons known to have any such veterinary
biological product in their possession, which instruct them to stop
preparation, distribution, sale, barter, exchange, shipment, or
importation of any such veterinary biological product. All such
notifications shall be documented in writing by the licensee or
permittee.''
The commenter agreed with the estimate of burden in the proposed
rule's Paperwork Reduction Act section of 1.7666 hours per response for
respondents affected by stop distribution and sale notifications,
provided that such notifications are only applicable to ``parties that
are a single business transaction away from the licensee or permittee''
(i.e., known to the manufacturer or importer). However, the commenter
opined that
[[Page 17797]]
1.7666 hours per response may be an underestimate for firms that market
directly to veterinarians, or if such notifications must ``include all
participants in each distribution chain,'' (i.e., known and unknown
participants).
Regarding the commenter's concern that notification must include
all participants in each distribution chain, APHIS has amended
Sec. Sec. 105.3(c)(3) and 115.2(b)(3) in this final rule to specify
that licensees and permittees are only required to notify wholesalers,
jobbers, dealers, foreign consignees, or other persons known to be in
possession of product subject to the stop distribution and sale action.
In addition, APHIS believes that available technological tools such as
electronic mail, facsimile, and the telephone help lower the burden of
notification in all cases, including for those who market directly to
veterinarians. Given these facts, APHIS believes that the estimated
burden of 1.7666 hours per response stated in the proposed rule is not
unreasonable.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been determined to be not significant for purposes of
Executive Order 12866, and, therefore, has not been reviewed by the
Office of Management and Budget.
We are amending Sec. Sec. 105.3 and 115.2 of our regulations under
the Virus-Serum-Toxin Act concerning actions that veterinary biologics
licensees and permittees must take after receiving notice from APHIS to
stop distribution and sale of a serial(s) or subserial(s) of veterinary
biological product that is found to be unsatisfactory according to
applicable standard requirements, or if it appears that such product is
worthless, contaminated, dangerous, or harmful. Licensees and
permittees are required to notify wholesalers, jobbers, dealers,
foreign consignees, or other persons known to be in possession of such
product immediately, but no later than 2 days after being contacted by
APHIS, to stop further distribution and sale of such serial(s) or
subserial(s) pending further instructions. This final rule also
requires veterinary biologics licensees and permittees to document, in
writing, their communications with wholesalers, jobbers, dealers,
foreign consignees, or other persons concerning such stop distribution
and sale notifications; determine the remaining inventory of such
product in the current possession of such wholesalers, jobbers,
dealers, consignees, or other persons; and, as directed by the
Administrator, submit reports of all such notifications to APHIS.
The primary effect of this rule will be to provide for the most
expeditious means of disseminating information concerning stop
distribution and sale notices pertaining to veterinary biological
product found unsatisfactory according to applicable standard
requirements, and to mitigate the risk that such unsatisfactory
veterinary biological product may cause harm to animals, the public
health, or the environment. The rule also clarifies the regulations
with regard to whom licensees and permittees should contact concerning
stop distribution and sale notification, and what information APHIS may
require to be reported concerning such notification.
There are approximately 125 veterinary biologics establishments,
including permittees, that may be affected by this rule. According to
the standards of the Small Business Administration, most veterinary
biologics establishments would be classified as small entities.
It is anticipated that no undue recordkeeping burden will be added
to licensees and permittees since Sec. Sec. 116.2 and 116.5 of the
regulations currently require the maintenance of detailed disposition
records and the submission of reports concerning each biological
product that is prepared and/or shipped. We further anticipate that the
only economic effects that may result from this amendment to the
regulations would be related to the costs incurred by licensees and
permittees in connection with the notification process itself. This
final rule does not specify the means by which licensees and permittees
are required to give notification, only that notification be given
immediately, but no later than 2 days of receipt of the stop
distribution and sale notification from APHIS. We expect that licensees
and permittees would use electronic mail, telephone, and facsimile to
notify wholesalers, jobbers, dealers, consignees, or other persons
known to be in possession of the product. These methods are
inexpensive, so the actual costs of transmitting notifications required
by this amendment would be minimal. The amendment will benefit
manufacturers of veterinary biologics by clarifying the actions they
must take should they receive notification from APHIS concerning a
serial(s) or subserial(s) of biological product found to be
unsatisfactory according to applicable standard requirements.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog 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 final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. It is not intended to have retroactive effect.
This rule will 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
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this rule have been approved by the Office of Management
and Budget (OMB) under OMB control number 0579-0318.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the Internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this rule, please contact Mrs. Celeste Sickles,
APHIS' Information Collection Coordinator, at (301) 734-7477.
List of Subjects
9 CFR Part 105
Animal biologics, Exports, Imports, Labeling, Packaging and
containers, Reporting and recordkeeping requirements.
9 CFR Part 115
Animal biologics, Exports, Imports, Reporting and recordkeeping
requirements.
0
Accordingly, we are amending 9 CFR parts 105 and 115 as follows:
[[Page 17798]]
PART 105--SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL
LICENSES OR PERMITS
0
1. The authority citation for part 105 continues to read as follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
0
2. Section 105.3 is amended by adding a new paragraph (c) and an OMB
control number citation to read as follows:
Sec. 105.3 Notices re: worthless, contaminated, dangerous, or harmful
biological products.
* * * * *
(c) When notified to stop distribution and sale of a serial or
subserial of a veterinary biological product under the provisions of
paragraph (a) or (b) of this section, veterinary biologics licensees or
permittees shall:
(1) Stop the preparation, distribution, sale, barter, exchange,
shipment, or importation of the affected serial(s) or subserial(s) of
any veterinary biological product pending further instructions from
APHIS.
(2) Immediately, but no later than 2 days, send stop distribution
and sale notifications to any wholesalers, jobbers, dealers, foreign
consignees, or other persons known to have any such veterinary
biological product in their possession, which instruct them to stop the
preparation, distribution, sale, barter, exchange, shipment, or
importation of any such veterinary biological product. All
notifications shall be documented in writing by the licensee or
permittee.
(3) Account for the remaining quantity of each serial(s) or
subserial(s) of any such veterinary biological product at each location
in the distribution channel known to the manufacturer (licensee) or
importer (permittee).
(4) When required by the Administrator, submit complete and
accurate reports of all notifications concerning stop distribution and
sale actions to the Animal and Plant Health Inspection Service pursuant
to Sec. 116.5 of this subchapter.
(Approved by the Office of Management and Budget under control
number 0579-0318.)
PART 115--INSPECTIONS
0
3. The authority citation for part 115 continues to read as follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
0
4. Section 115.2 is revised to read as follows:
Sec. 115.2 Inspections of biological products.
(a) Any biological product, the container of which bears a United
States veterinary license number or a United States veterinary permit
number or other mark required by these regulations, may be inspected at
any time or place. If, as a result of such inspection, it appears that
any such product is worthless, contaminated, dangerous, or harmful, the
Secretary shall give notice to stop distribution and sale to the
manufacturer (licensee) or importer (permittee) and may proceed against
such product pursuant to the provisions of part 118 of this subchapter.
(b) When notified to stop distribution and sale of a serial or
subserial of a veterinary biological product by the Secretary,
veterinary biologics licensees or permittees shall:
(1) Stop the preparation, distribution, sale, barter, exchange,
shipment, or importation of the affected serial(s) or subserial(s) of
any such veterinary biological product pending further instructions
from APHIS.
(2) Immediately, but no later than 2 days, send stop distribution
and sale notifications to any jobbers, wholesalers, dealers, foreign
consignees, or other persons known to have any such veterinary
biological product in their possession, which instruct them to stop the
preparation, distribution, sale, barter, exchange, shipment, or
importation of any such veterinary biological product. All
notifications shall be documented in writing by the licensee or
permittee.
(3) Account for the remaining quantity of each serial(s) or
subserial(s) of any such veterinary biological product at each location
in the distribution channel known to the manufacturer (licensee) or
importer (permittee).
(4) When required by the Administrator, submit complete and
accurate reports of all notifications concerning stop distribution and
sale actions to the Animal and Plant Health Inspection Service pursuant
to Sec. 116.5 of this subchapter.
(c) Unless and until the Secretary shall otherwise direct, no
persons so notified shall thereafter sell, barter, or exchange any such
product in any place under the jurisdiction of the United States or
ship or deliver for shipment any such product in or from any State,
Territory, or the District of Columbia. However, failure to receive
such notice shall not excuse any person from compliance with the Virus-
Serum-Toxin Act. (Approved by the Office of Management and Budget under
control number 0579-0318).
Done in Washington, DC, this 4th day of April 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-6700 Filed 4-9-07; 8:45 am]
BILLING CODE 3410-34-P
