Click here to download your blank USDA VS16-3 form
Word 97 USDA VS16-3 documentRequired to obtain USDA Permit
(one of 4 FDA required documents)
PLEASE PRINT OR TYPE CLEARLY
| No controlled material, organisms or vectors may be imported or moved interstate unless the data requested on this form is furnished and certified (9 CFR 94, 95 and 122). | Public reporting burden for this collection of information is estimated to average between 1.6 and 3 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Department of Agriculture, Clearance Officer, OIRM, Room 404-W, Washington, DC 20250; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503. | |
|
U.S.
DEPARTMENT
OF
AGRICULTURE APPLICATION
FOR
PERMIT
TO: |
FORM APPROVED – OMB NO. 0579-0015 1. MODE OF TRANSPORTATION (Please Check): _X_ AIR ___ SEA ___ LAND ___ ANY 2. U.S Ports of Entry _X_
New
York,
NY (JFK
International
Airport) |
|
| 4.
SHIPPER:
(Name
and
Address
of
foreign
producer)
Wockhardt Ltd. UK |
||
| 5.
DESCRIPTION:
(material,
country
of
origin,
animal
source,
recombinant
system
&
genetic
inserts
conditions
of
imported
preparation,
antibody
immunogens,
etc.)
(COMPLETE
VS
FORM
16-7
for
cell
cultures
&
their
products)
This application is for permit to import insulin pharmaceutical products for the treatment of Diabetes Mellitus on a "personal use basis" as follows: Material:
Highly
Purified,
Pharmaceutical
Grade
Bovine
Insulin
(certified
from
BSE-Free
sources
recognized
by
the
European
Union) Description
of
items
to
be
imported:
-------------------------------------------
Strength
and
Packaging: |
||
| 6.
QUANTITY
AND
FREQUENCY
OF
IMPORTATIONS
(estimate))
___
Monthly
___
Quarterly I certify that the amounts above are for personal use only and are insufficient quantities for any non-personal or commercial use and 3mos or less supply. |
||
| 7.
PROPOSED
USE
OF
MATERIAL,
EXPECTED
COMPLETION
DATE,
AND
FINAL
DISPOSITION
(method)
Proposed
use:
Personal
use
importation
of
insulin
medication
for
treatment
of
Diabetes
Mellitus,
Patient
Name(s) I certify that Doctor ________________ practicing at ______________________, Phone:___________, has indicated that available porcine and human insulins are not appropriate to control the diabetes mellitus condition of __________________________. |
||
| 8.
DESCRIPTION
OF
APPLICANT’S
FACILITIES
AND
EQUIPMENT
FOR
HANDLING
MATERIALS:
Insulin will be used in the personal use’s home for the personal treatment of diabetes mellitus as directed by patients medical doctor. |
||
| 9.
QUALIFICATIONS
OF
TECHNICAL
PERSONNEL
WORKING
WITH
THIS
MATERIAL
(if
applicable) Not applicable, personal use on medical need basis. |
||
| 10.
TREATMENT
OF
MATERIAL
PRIOR
TO
IMPORTATION
(Processing/purification
methods,
treatments,
disease
safeguards) Purification process consists of solvent/chemical extraction from pancreatic tissue with crude eluate fractionated by gel chromatography and crystallization. The insulin crystals are then dissolved and purified by filtration followed by anion chromatography and subsequent crystallization to produce highly purified monocomponent insulin. Cattle pancreas material used for the production of Bovine insulin is certified by the producer to come from countries recognized by the European Union as BSE-free. Insulin is refrigerated as it is diluted to appropriate designated bioactivity and activity type and while in storage and transit. |
||
| 11.
WORK
OBJECTIVES,
PROPOSED
PLAN
OR
WORK,
AND
ADDITIONAL
PERTINENT
INFORMATION
(animal
model,
use
of
derivatives,
etc.) Maintenance of reasonable glycemic control with minimal hypoglycemia and other problems for the personal use of the patient. Not applicable. |
||
| 12.
PERTINENT
PUBLISHED
PAPER/ABSTRACT
REGARDING
MATERIAL
TO
BE
IMPORTED
–
ATTACH
COPY
IF
AVAILABLE
1.
"Biologic
Activities
of
Biosynthetic
Human
Insulin
in
Healthy
Volunteers
and
Insulin-dependent
Diabetic
Patients
Monitored
by
the
Artificial
Endocrine
Pancreas"
Sotos
Raptis,
et
al,
DIAB
CARE,
Vol.
4,
No.
2,
p.
161,
March-April
1981 |
||
| I CERTIFY THIS MATERIAL WILL BE USED IN ACCORDANCE WITH ALL RESTRICTIONS AND PRECAUTIONS AS MAY BE SPECIFIED IN THE PERMIT | ||
| 13.
SIGNATURE
OF
APPLICANT
|
14. TYPED NAME AND TITLE | |
| 15. DATE | 16.
APHIS
USE
CREDIT
ACCOUNT
NUMBER
and
EXPIRATION
DATE:
|
|
|
You may now apply for permits and renew permits online at: https://web01.aphis.usda.gov/ias.nsf/Mainform?OpenForm
IMPORTANT! The address you use on the application for permit must be the same as where your insulin will be sent to. NO P.O. boxes are allowed. *Be sure to include your social security number beside your name. As of this writing there is no fee for beef or pork insulin permit applications, but this could change. So, you might want to check with the USDA. The USDA issued insulin permit is good for 5 years and as of this time there is no fee for renewals. You may now apply for permits and renew permits online at: https://web01.aphis.usda.gov/ias.nsf/Mainform?OpenForm What goes in mode of transportation? AIR Port of entry? Determined by shipper Description? Beef Insulin Quantity, Frequency? Personal Use, ~2 shipments per year, ~20 10cc vials each shipment, Proposed use? Treatment of diabetes in importer Item 8 doesn't apply? Insulin will be used in the personal user’s home for the personal treatment of diabetes mellitus as directed by patients medical doctor. Treatment of material? Purification process consists of solvent/chemical extraction from pancreatic tissue with crude eluate fractionated by liquid or gel chromatography and crystallization. The insulin crystals are then dissolved and purified by filtration followed by anion chromatography and subsequent crystallization to produce highly purified monocomponent insulin. Cattle pancreas material used for the production of Bovine insulin is certified by the producer to come from countries recognized by the European Union as BSE-free. Insulin is refrigerated as it is diluted to appropriate designated bioactivity and activity type and while in storage and transit. Method of Final Disposition? Injected into importer. |
Resulting USDA Permit (Form 16-6A)
USDA Import Permit, Doctor’s Certificate of Medical Necessity, CP Pharmaceuticals/Wockhardt, Ltd. UK ADR form, and Personal Certificate of personal use and 6 month, or less supply
