Summary Information Format For the Importation
of Veterinary Biological Products into the United States from Countries
Where Foreign Animal Diseases Exist and Other Specified Countries
I. INTRODUCTION
The purpose of this Summary Information Format (SIF) is to provide Veterinary
Biologics, APHIS, with the necessary information to conduct risk analyses for
proposals to import veterinary biological products from countries that
represent a risk for the introduction of foreign animal disease into the
United States. This includes proposals to import Master Seed microorganisms
or veterinary biological products from: 1) Countries where foreign animal
diseases exist, or 2) Other specified countries that supplement their
national meat supply by the importation of fresh, chilled, or frozen meat of
ruminants or swine from, or have common land borders with countries where
foreign animal diseases exist, as provided in 9 CFR Part 94.
This SIF should be completed and submitted to APHIS in support of applications
for: 1) A U.S. Veterinary Biological Product License Application (9 CFR Part
102.5) for a product being produced from a Master Seed microorganism(s)
imported to the United States under a U.S. Veterinary Permit for Importation
and Transportation of Controlled Materials and Organisms and Vectors (9 CFR
Part 122.2); 2) a U.S. Veterinary Biological Product Permit for Distribution
and Sale ( 9 CFR Part 104.5); 3) a U.S. Veterinary Biological Permit for
Research and Evaluation (9 CFR Part 104.4) involving a request to conduct
field studies in accordance with 9 CFR Part 103.3.
For proposals to import veterinary biological products containing more than
one antigenic fraction, a separate SIF should be completed for each Master
Seed microorganism.
A. Identify Application
B. Specific Proposal
II. RESEARCH AND DEVELOPMENT
A. Research Facility
1. Identify all facilities involved in development of Master
Seed and Master Cells from date(s) of isolation
2. Location and description of the facility or facilities
3. Biocontainment
(a) Air handling system
(b) Containment equipment
(c) Operational and validation procedures
4. Other Microorganisms Maintained in the Research Facility or
Facilities Involved in the Development of the Master Seed
and Master Cells
(a) Identity and source
(b) Location and storage conditions
(c) Purpose for maintaining and handling of these
microorganisms
(d) Procedures used to prevent cross contamination of
Master Seed and Master Cells during development
B. Characterization of the Vaccine Microorganism
1. Development of the vaccine strain
(a) Parental microorganism
(i) Identity of parental strain
(ii) Genetic markers
(b) Source and isolation of the vaccine microorganism
(c) Procedures used to attenuate the vaccine microorganism
(d) Passage history of the vaccine microorganism
(e) Potential contaminating microorganisms exotic to the
U.S.
(f) Purity and extraneous agents testing, including the
sensitivity of testing procedures for potential
contaminating microorganisms exotic to the U.S.
(g) Screening methods and protocols used in the
identification and purification of the vaccine
microorganism
(h) Characterization of the Master Seed
(i) Master Seed designation
(ii) Identification of the Master Seed, including
methods and protocols
(iii) Purity and extraneous agents testing of the
Master Seed, including the sensitivity of
testing procedures for potential contaminating
microorganisms exotic to the U.S.
(iv) Genetic stability of the Master Seed
microorganism at passage level n and the highest
passage level used in production
2. Ingredients of animal origin used during development of the
vaccine microorganism
(a) Primary cells
(i) Identity and source
(ii) Preparation
(iii) Potential contaminating microorganisms exotic to
the U.S.
(Iv) Purity and extraneous agents testing, including
the sensitivity of testing procedures for
potential contaminating microorganisms exotic to
the U.S.
(v) Sensitivity of cells to the growth or
replication of potential contaminating
microorganisms exotic to the U.S.
(b) Cell Lines
(i) Identity and source
(ii) Procedures for confirming the identity of the
cell line
(iii)Potential contaminating microorganisms exotic to
the U.S.
(Iv) Purity and extraneous agents testing, including
the sensitivity of testing procedures for
potential contaminating microorganisms exotic to
the U.S.
(v) Sensitivity of cells to the growth or
replication of potential contaminating
microorganisms exotic to the U.S.
(c) Serum and other reagents of animal origin
(i) Identity and source
(ii) Sterilization procedures
(iii)Potential contaminating microorganisms exotic to
the U.S.
(Iv) Purity and extraneous agents testing, including
the sensitivity of testing procedures for
potential contaminating microorganisms exotic to
the U.S.
III. PRODUCTION
A. Production Facility
1. Location and description of the facility
2. Blue prints, plot plans, and legends
3. Biocontainment
(a) Air handling system
(b) Containment equipment
(c) Operational procedures
4. Products produced in the facility and other microorganisms
maintained in the facility
(a) Procedures to prevent cross-contamination
(b) Decontamination procedures between production runs
(c) Validation procedures
(d) Purpose for maintaining microorganisms not used in
production
B. Production Procedures
1. Cell culture and harvest procedures
2. Procedures for preparing the product from harvested cultures
3. Inactivation procedures for killed products
(a) Validation of inactivation procedures for the product
microorganism
(b) Validation of inactivation procedures for potential
extraneous agents
4. Ingredients of animal origin and cells used in production
(a) Identity and source
(b) Quality control and/or sterilization procedures
(c) Potential contaminating microorganisms exotic to the
U.S.
(d) Purity and extraneous agents testing, including the
sensitivity of testing procedures for potential
contaminating microorganisms exotic to the U.S.
(e) Sensitivity of cells to the growth or replication of
potential contaminating microorganisms exotic to the
U.S.
5. Production media and additives used in production
(a) Identity and source
(b) Quality control and/or sterilization procedures
(c) Purity testing
6. Validation procedures during production
7. In-process testing procedures
8. Final product purity testing, including the sensitivity of
testing procedures for potential contaminating
microorganisms exotic to the U.S.
9. Packaging, labeling, and storage conditions for the final
container samples
10. Proposed shipping procedures and conditions
11. Any other procedures employed to detect, inactivate, remove
or reduce the presence of potential contaminating
microorganisms exotic to the U.S.
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