[Federal Register: August 17, 2005 (Volume 70, Number 158)]
[Proposed Rules]
[Page 48325-48329]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au05-26]
========================================================================
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.
========================================================================
[[Page 48325]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 101 and 116
[Docket No. 00-071-2]
RIN 0579-AB90
Viruses, Serums, Toxins, and Analogous Products; Records and
Reports
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule; withdrawal and reproposal.
-----------------------------------------------------------------------
SUMMARY: We are proposing to amend the Virus-Serum-Toxin Act
regulations concerning records and reports to require veterinary
biologics licensees and permittees to record specific information
concerning adverse events associated with the use of biological
products that they produce or distribute and to compile and submit
those records in a summary report to the Animal and Plant Health
Inspection Service (APHIS) every 12 months for products licensed for 1
year or more; for newly licensed products, a summary report would have
to be submitted at 6-month intervals during the first year of the
product license and at 12-month intervals thereafter. The summary
report would also have to identify the number of doses, or the average
number of doses, of the product in distribution channels, if available.
These records and reports would help ensure that APHIS will be able to
provide complete and accurate information to consumers regarding
adverse reactions or other problems associated with the use of licensed
biological products. This proposed rule replaces a previously published
proposed rule, which we are withdrawing as part of this document, that
contained fewer specifics concerning the information that would have to
be recorded in adverse event reports associated with the use of
veterinary biologics that are submitted to the Agency.
DATES: We will consider all comments that we receive on or before
October 17, 2005.
ADDRESSES: You may submit comments by any of the following methods:
EDOCKET: Go to http://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. 00-071-2,
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. 00-071-2.
Federal eRulemaking Portal: Go to http://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 http://www.aphis.usda.gov/ppd/rad/webrepor.html
.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Section Leader,
Operational Support Section, Policy, Evaluation, and Licensing, Center
for Veterinary Biologics, 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 116 (referred
to below as the regulations) contain requirements for maintaining
detailed records of information necessary to give a complete accounting
of all the activities within a veterinary biologics establishment. In
Sec. 116.1, paragraph (a) states that such reports must include, but
are not limited to, the items enumerated in the regulations, including
inventory and disposition records (Sec. 116.2), information concerning
product development and preparation and market suspension and recalls
(Sec. 116.5), animal records (Sec. 116.6), and test records (Sec.
116.7).
In Sec. 116.5, paragraph (b) states that if at any time there are
indications that raise questions regarding the purity, safety, potency,
or efficacy of a product, or if it appears that there may be a problem
regarding the preparation, testing, or distribution of a product, the
licensee, permittee, or foreign manufacturer must immediately notify
the Animal and Plant Health Inspection Service (APHIS) concerning the
circumstances and the action taken, if any.
However, the regulations in Sec. 116.1 do not explicitly require
licensees and permittees to maintain records of adverse events
associated with the use of veterinary biologics, nor do the regulations
in Sec. 116.5 provide specific guidance in determining whether an
adverse event should be considered an indication that raises questions
regarding the purity, safety, potency, efficacy, preparation, testing,
or distribution (PSPEPTD) of such product. Consequently, each
veterinary biologics manufacturer makes an independent determination
concerning (1) whether an adverse event report raises PSPEPTD questions
and (2) when and in what manner such report of the adverse event will
be provided to APHIS.
To limit the harm to animals posed by unsatisfactory veterinary
biologics, APHIS must rely on adverse event reports provided by
veterinary biologics licensees and permittees. However, without any
explicit guidance in the regulations as to the form those reports
should take, licensees and permittees are using nonstandardized methods
to record and submit reports regarding adverse events to APHIS.
Similarly, without explicit reporting requirements concerning adverse
events, reports that may signal problems concerning the use of
veterinary biological products are not all being submitted to APHIS in
a timely manner.
[[Page 48326]]
To address this situation, on January 15, 2002, we published in the
Federal Register (67 FR 1910-1913, Docket No. 00-071-1) a proposed rule
to amend the regulations concerning records and reports to require
veterinary biologics licensees and permittees to record and submit
reports to APHIS concerning adverse events associated with the use of
veterinary biological products that they produce or distribute. The
proposed rule would have required veterinary biologics licensees and
permittees to report to APHIS the number of doses of each licensed
product that they distribute. The proposed rule also would have amended
the regulations in 9 CFR part 101 to provide definitions for the terms
adverse event and adverse event report.
We solicited comments on our proposal for 60 days ending on March
18, 2002. We received 13 comments by that date. The comments were from
10 veterinary biologics manufacturers, 2 trade associations
representing veterinary biologics manufacturers, and a veterinary
association. Six commenters expressed conceptual support for the
proposed rule, but were concerned that parts of the proposed
regulations were overly broad or ambiguous and would increase the
regulatory burden on the industry and possibly compromise confidential
business information. Four commenters were opposed to the rule, stating
that it was unnecessary and that APHIS had underestimated the
regulatory burden that would be imposed on the industry. The remaining
three commenters neither supported nor opposed the rule, but instead
either asked for clarification of certain aspects of the proposed rule
or suggested alternative wording that they believed would provide
greater clarity.
In response to these comments, we believe it is necessary to
clarify those provisions that could be subject to multiple
interpretations and to provide more specifics concerning the
information that should be included in adverse event reports associated
with the use of veterinary biologics that are submitted to the Agency.
Therefore, we are withdrawing the January 15, 2002, proposed rule
referenced above and are replacing it with the proposed changes
described in this document. The proposed recordkeeping and reporting
requirements regarding adverse events that would apply to each
licensee, permittee, and foreign establishment that prepares and
distributes biological products are described below.
Definitions
The regulations in 9 CFR part 101 contain definitions of terms used
in the regulations concerning veterinary biologics. The proposed
changes to part 116 of the regulations would make it necessary for us
to add definitions in Sec. 101.2 for two terms used in the proposed
regulations: Adverse event and adverse event report. We would define
adverse event as any observation in animals, whether or not the cause
of the event is known, that is unfavorable and unintended and that
occurs after any use (on or off label) of a biological product. For
products administered to animals, this would include events related to
a suspected lack of expected efficacy. For products intended to
diagnose disease, adverse events would refer to anything that hinders
discovery of the correct diagnosis. We would define adverse event
report as a communication concerning the occurrence of an adverse event
from an identifiable first-hand reporter that includes at least the
following information: An identifiable reporter; an identifiable
animal; an identifiable biological product; and one or more adverse
events.
Adverse Event Records
In this document we are proposing to add to the regulations a new
Sec. 116.9 for adverse event records, reports, and summary reports.
New Sec. 116.9 would require licensees and permittees to record
reports of all adverse events that they receive concerning the use of
biological products they produce or distribute and to submit a summary
of such reports to APHIS on an annual (for products licensed for more
than 1 year) or semiannual (for products licensed less than 1 year)
basis. For each event, licensees and permittees would be required to
record the following information: (1) The date of the report; (2) the
identification of the person initiating the report; (3) the product
code number as it appears on the product license or permit and the
product trade name; (4) the product serial number(s), if available; (5)
a description of the adverse event; (6) a description of the animal(s)
involved in the event, including the number dead, number affected,
number exposed to the product, species, breed, age, sex, and
physiological status; (7) the opinion of the person reporting the event
as to whether the event is product-related (i.e., probable, possible,
unknown, unlikely, no assessment); (8) route and site of vaccination
for products administered parenterally; (9) identity of the person
administering the product (veterinarian, animal owner, other, unknown);
(10) the date the event occurred; and (11) the outcome of the event
(recovered, death, euthanized, alive with side effects, ongoing event).
Summary Reports
We are proposing to require that licensees and permittees submit to
APHIS a summary report of all adverse event reports received during the
reporting period. For products licensed for 1 year or more, the summary
report would have to be submitted at 12-month intervals; for newly
licensed products, a summary report would have to be submitted at 6-
month intervals during the first year of the product license and at 12-
month intervals thereafter. For new products, we had considered an
alternative proposal that would also have allowed summary reports for
new products to also be submitted every 12 months. However, we believe
that more frequent reporting for new products will enable us to
identify trends more quickly and thereby resolve any problems sooner.
We specifically request that you comment on the merit of 6-month as
compared to 12-month reporting of adverse events concerning new
products.
The summary report would have to include the following information:
(1) The name, address, and U.S. Veterinary License or Permit number of
the producer or permittee; (2) copies of any individual adverse event
report record(s); and (3) the number of doses, or the average number of
doses, of the product in distribution channels, if available. For
products licensed for 1 year or more, firms would be allowed 1 year
after the effective date of the final rule to come into compliance with
the proposed amendment and submit their first summary report, with
subsequent summary reports being submitted at 12-month intervals
thereafter. For the reasons explained above, the first summary report
for newly licensed products would have to be submitted 6 months after
the effective date of the final rule and a second report submitted 6
months later, after which summary reports would have to be submitted at
12-month intervals. We would require all summary reports to be received
by APHIS within 60 days after the reporting date (semiannual or annual,
as the case may be) that would be established by the licensee or
permittee and approved by APHIS.
We would require the submission of summary reports at 12-month
intervals (6-month intervals for new products) because we believe that
frequent reporting of adverse events concerning veterinary biologicals
would ensure that
[[Page 48327]]
we have adequate data to support a decision, if necessary, to take
regulatory action against products that are associated with an unusual
number of adverse event reports.
In order to provide an objective measure of when it may be
necessary to take action against a veterinary biologic to limit harm in
animals, and as a component of the adverse event reporting system, we
would use the number of doses of product distributed or the average
number of doses of the product in distribution channels, if available,
instead of the number of doses of product administered to animals to
calculate the incidence of adverse events associated with a particular
product. Typically, the number of doses of product administered to
animals would be used to calculate incidence. However, because we must
take timely action and may not know precisely how many animals have
been treated with a product, we would use the number of distributed
doses of a product as representative of the number of doses that were
administered to animals.
Completion of Records
The regulations in Sec. Sec. 116.1(a)(3) and 116.8 provide that
all records (other than disposition records) required under part 116
shall be completed by the licensee, permittee, or foreign manufacturer
before any portion of a serial of any product may be marketed in the
United States or exported. We are proposing to amend those provisions
to also allow adverse event records to be excluded from the list of
records that must be completed before a product may be marketed or
exported. Like disposition records, adverse event records could not be
expected to have been completed prior to the marketing or exportation
of a product.
Miscellaneous
We would also make several minor, nonsubstantive editorial changes
to the regulations to improve their clarity.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be significant for purposes of Executive Order
12866, and, therefore, has been reviewed by the Office of Management
and Budget.
We are proposing to amend the Virus-Serum-Toxin Act regulations for
records and reports to require veterinary biologics licensees and
permittees to record and submit reports to APHIS concerning adverse
events associated with the use of veterinary biologics that they
produce or distribute. The proposed regulations would specify the
information to be included in adverse event records and would require
the submission, at 12-month intervals (6-month intervals for new
products), of summary reports that would include, among other things,
compilations of individual adverse event records and information
concerning the number of doses, or the average number of doses, of the
product in distribution channels, if available. These proposed
requirements would assist us in providing complete and accurate
information concerning adverse reactions or other problems associated
with the use of licensed veterinary biologics.
For this rule, we have prepared an economic analysis. The economic
analysis provides a cost-benefit analysis as required by Executive
Order 12866, as well as an analysis of the potential economic effects
of this proposed rule on small entities, as required under the
Regulatory Flexibility Act. The economic analysis is set forth below.
We do not expect that the proposed recordkeeping requirements would
have a significant economic impact on most veterinary biologics
manufacturers. This is because most manufacturers already maintain
recordkeeping systems for adverse event reports that capture most, if
not all, of the information that would be required to be recorded under
the proposal. The information that would be required is basic in
nature; it is the type of information that most manufacturers record
anyway, in order to improve their product or reduce their potential
legal liability. Furthermore, the proposed regulations would not
restrict manufacturers from using their discretion to choose the most
appropriate recordkeeping system for maintaining records of these
reports; the proposal, therefore, should not result in veterinary
biologics manufacturers having to alter their current recordkeeping
systems or create new recordkeeping systems. It should also be noted
that the vast majority of licensed products are not likely to be
associated with adverse events. It is estimated, for example, that
reports of adverse events are received for no more than 10 percent of
the approximately 2,000 currently licensed products.
The proposed requirement for the submission of summary reports to
APHIS should not have a significant economic impact on most veterinary
biologics manufacturers. As indicated above, most manufacturers already
maintain recordkeeping systems for adverse event reports that capture
most, if not all, of the information that would be required to be
recorded under the proposal. For most manufacturers that receive
adverse reports, therefore, the proposed requirement for the submission
of annual summary reports to APHIS should involve no more than
packaging and assembling information that has already been captured, a
task that should have only minimal economic consequences. The current
regulations do not require veterinary biologics licensees or permittees
to report to APHIS on the number of doses of each licensed or permitted
product that has been distributed, but that information, too, is
currently being captured by most manufacturers.
Effect on Small Entities
The proposed rule would affect all of the approximately 125 U.S.
veterinary biologics manufacturers, including permittees. This is
because, at the present time, none of the licensees and permittees is
in full compliance with the proposed requirements on a voluntary basis;
they would all have to take at least some additional action, even if
that additional action simply involved establishing a formal system for
recording adverse event reports that they receive.
We do not have definitive information on the size of all
potentially affected entities. However, it is reasonable to assume that
most are small in size, under the U.S. Small Business Administration's
(SBA) standards. This assumption is based on composite data for
providers of the same and similar services in the United States. In
2002, there were 296 U.S. establishments in North American Industry
Classification System (NAICS) subsector 325414, a classification
comprised of establishments primarily engaged in manufacturing
vaccines, toxoids, blood fractions, and culture media of plant or
animal origin (except diagnostic). Of the 296 establishments, 285 (or
96 percent) had fewer than 500 employees, the SBA's small entity
threshold for establishments in that NAICS category. Similarly, in
2002, there were 236 U.S. establishments in NAICS 325413, a
classification comprised of establishments primarily engaged in
manufacturing in-vitro diagnostic substances, including biological
substances. Of the 236 establishments, 223 (or 95 percent) had fewer
than 500 employees, the SBA's small entity threshold for establishments
in NAICS 325413.
Alternatives
Alternatives to the proposed rule would be to either leave the
regulations unchanged, or to require a different set
[[Page 48328]]
of criteria than is proposed. Leaving the regulations unchanged would
be unsatisfactory, because it would perpetuate the current situation,
i.e., one that may not allow APHIS to take expeditious action to limit
the harm to animals caused by harmful or dangerous veterinary
biologics. The current regulations have resulted in licensees and
permittees using non-standardized methods to record and submit reports
regarding adverse events to APHIS. In addition, adverse event reports
that may signal problems concerning the use of veterinary biological
products are not all being submitted to APHIS in a timely manner.
Without complete information and timely reports, APHIS may not be able
to take prompt action to limit the harm to animals posed by
unsatisfactory veterinary biologics.
APHIS considers the proposed set of criteria to be the minimum
necessary to accomplish the rule's objectives. The submission of
reports to APHIS at longer than 12-month intervals was considered but
rejected; we believe that longer reporting intervals would not ensure
that we have adequate data to support a decision to take regulatory
action against products that are associated with an unusual number of
adverse event reports.
Costs and Benefits
The proposed rule has the potential to benefit animals and their
owners, to the extent that it allows APHIS to act quickly to limit the
harm to animals posed by unsatisfactory veterinary biologics. For
animal owners, the monetary benefits are difficult to estimate, because
they would depend on several factors that are currently unknown--the
significance, or gravity, of the harm that would be avoided with the
rule in effect, and the number, and value, of animals that would avoid
harm with the rule in effect. For some animal owners, especially those
with large numbers of high-value animals, the potential monetary
benefits of avoided harm could be large. For the reasons discussed
above, manufacturer costs to comply with the rule should be minimal in
most cases. Thus, we expect that the benefits of this proposed action
would outweigh its costs.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not 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
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
The information collection and recordkeeping requirements described in
the January 2002 proposed rule withdrawn by this document were approved
by OMB under control number 0579-0209, and we will request that OMB
approve the information collection or recordkeeping requirements
included in this proposed rule under that same number. Please send
written comments to the Office of Information and Regulatory Affairs,
OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please
state that your comments refer to Docket No. 00-071-2. Please send a
copy of your comments to: (1) Docket No. 00-071-2, Regulatory Analysis
and Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118,
Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, room
404-W, 14th Street and Independence Avenue SW., Washington, DC 20250. A
comment to OMB is best assured of having its full effect if OMB
receives it within 30 days of publication of this proposed rule.
This proposed rule would require manufacturers of veterinary
biological products to maintain records of adverse event reports that
they receive concerning the use of veterinary biological products that
they produce or distribute for 2 years. In addition, licensees and
permittees would have to submit summary reports of adverse events to
APHIS every 12 months for products licensed for 1 year or more; for
newly licensed products, a summary report would have to be submitted at
6-month intervals during the first year of the product license and at
12-month intervals thereafter. These information collection and
recordkeeping requirements would allow us to monitor and provide the
appropriate level of regulatory oversight.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses).
Estimate of burden: The public reporting burden for this collection
of information is estimated to average 0.5 hour per response.
Respondents: Veterinary biologics licensees and permittees.
Estimated annual number of respondents: 125.
Estimated annual number of responses per respondent: 4.
Estimated annual number of responses: 1,000.
Estimated total annual burden on respondents: 500 hours. (Due to
averaging, the total annual burden hours may not equal the product of
the annual number of responses multiplied by the reporting burden per
response.)
Copies of this information collection can be obtained from Mrs.
Celeste Sickles, APHIS' Information Collection Coordinator, at (301)
734-7477.
Government Paperwork Elimination Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the Government Paperwork Elimination Act (GPEA), which
requires Government agencies in general to provide the public the
option of submitting information or transacting business electronically
to the maximum extent possible. For information pertinent to GPEA
compliance related to this proposed rule, please contact Mrs.
[[Page 48329]]
Celeste Sickles, APHIS' Information Collection Coordinator, at (301)
734-7477.
List of Subjects
9 CFR Part 101
Animal biologics.
9 CFR Part 116
Animal biologics, Reporting and recordkeeping requirements.
Accordingly, we propose to amend 9 CFR parts 101 and 116 as
follows:
PART 101--DEFINITIONS
1. The authority citation for part 101 would continue to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
2. In Sec. 101.2, definitions of adverse event and adverse event
report would be added in alphabetical order to read as follows:
Sec. 101.2 Administrative terminology.
* * * * *
Adverse event. Any observation in animals, whether or not the cause
of the event is known, that is unfavorable and unintended and that
occurs after any use (off label or on label) of a biological product.
Included are events related to a suspected lack of expected efficacy.
For products intended to diagnose disease, adverse events refer to
anything that hinders discovery of the correct diagnosis.
Adverse event report. Any communication concerning the occurrence
of an adverse event from an identifiable first-hand reporter which
includes at least the following information:
(1) An identifiable reporter;
(2) An identifiable animal;
(3) An identifiable biological product; and
(4) One or more adverse events.
* * * * *
PART 116--RECORDS AND REPORTS
3. The authority citation for part 116 would continue to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
4. In Sec. 116.1, paragraph (a)(3) would be revised to read as
follows:
Sec. 116.1 Applicability and general considerations.
(a) * * *
(3) Records (other than disposition records and adverse event
records) required by this part must be completed by the licensee,
permittee, or foreign manufacturer, as the case may be, before any
portion of a serial of any product may be marketed in the United States
or exported.
* * * * *
5. Section 116.8 would be revised to read as follows:
Sec. 116.8 Completion and retention of records.
All records (other than disposition records and adverse event
records) required by this part must be completed by the licensee,
permittee, or foreign manufacturer before any portion of a serial of
any product may be marketed in the United States or exported. All
records must be retained at the licensed or foreign establishment or
permittee's place of business for a period of 2 years after the
expiration date of a product or longer as may be required by the
Administrator. (Approved by the Office of Management and Budget under
control number 0579-0013)
6. A new Sec. 116.9 would be added to read as follows:
Sec. 116.9 Adverse event report records and summary reports.
(a) A detailed record must be maintained for every adverse event
report the licensee or permittee receives for any biological product it
produces or distributes. Each record must include:
(1) The date of the report;
(2) The identification of the person initiating the report;
(3) The product code number as it appears on the product license or
permit, and product trade name;
(4) The serial number(s) of the product, if available;
(5) A description of the adverse event;
(6) A description of the animal(s) involved, including the number
dead, number affected, number exposed to the product, species, breed,
age, sex, and physiological status;
(7) The opinion (probable, possible, unknown, unlikely, no
assessment) of the person initiating the report as to whether the event
is product-related;
(8) The route and site of vaccination for products administered
parenterally;
(9) The identity of the person administering the product
(veterinarian, animal owner, other, unknown);
(10) The date of the event; and
(11) The outcome of the event (recovered, death, euthanized, alive
with side effects, ongoing event).
(b) A summary report of all adverse event reports received by a
licensee or permittee must be compiled and submitted to the Animal and
Plant Health Inspection Service. For products licensed for 1 year or
more, such summary reports must cover intervals of 12 months; for
products licensed for less than 1 year, the summary reports must be
submitted at 6-month intervals. All summary reports must be received
within 60 days after the end of the reporting date that will be
determined by the licensee or permittee and approved by the Animal and
Plant Health Inspection Service. Each summary report must include:
(1) The name, address, and U.S. Veterinary License or Permit number
of the producer, permittee, or foreign manufacturer;
(2) Copies of any individual adverse event reports for the product
maintained as prescribed in paragraph (a) of this section; and
(3) The number of doses, or the average number of doses, of the
product in distribution channels, if available.
Done in Washington, DC, this 11th day of August 2005.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 05-16266 Filed 8-16-05; 8:45 am]
BILLING CODE 3410-34-P