Viruses, Serums, Toxins, and Analogous Products; Records and Reports, 48325-48329 [05-16266]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 70, Number 158 (Wednesday, August 17, 2005)]
[Proposed Rules]
[Pages 48325-48329]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16266]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

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

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Federal Register / Vol. 70, No. 158 / Wednesday, August 17, 2005 / 
Proposed 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.

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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 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. 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 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, 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