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FROM David G. Groves

 

INSTRUCTIONS FOR USING TEMPLATE FOR THE

USDA FORM VS16-3 - Updated March 6, 1999

Please bear with me and help as you can. I’ve never attempted to work "cross platform" and "cross operating systems" for hard print documents before and I will need your questions and points of clarification to make it work.

Please note the added certifications in Blocks 6 and 7. These may (should?) replace potentially needed signed statements that, the insulin is for your personal use, is in quantities that do not indicate commercial distribution and a written statement from your MD that porcine and human insulins available in the US do not effectively control your diabetes mellitus. These are a CP requirement from the UK and I believe that simply providing CP a copy of the application form can reduce paperwaste and work.

Here is the current US problem.

To legally obtain a working substitute for Iletin® I (85% beef, 15% pork) insulins, you must have a permit from the US Department of Agriculture. Now that the JDF and Representatives Nethercutt and DeBette’s House Diabetes Caucus have intervened in our behalf, approval for "personal use importation" permits through the USDA should be fast, straightforward and simple. This form is my personal effort to assist my fellow diabetics in obtaining the appropriate permit. Since most diabetics do not have computers and many who have computers cannot reach the internet, we have multiple distribution problems.

Information. Many US MDs and diabetics do not yet know of the many differences between bovine, porcine, synthetic and semi-synthetic human and totally synthetic designer analog insulins. I am working on a piece to outline the differences for diabetics to share with each other and their medical care teams. It is beyond the scope of this effort but your help is needed in the matter and you can start by getting the LONG FORM letter from http://members.tripod.com/diabetics_world/longform.htm mailing it and sharing copies with your medical team and the diabetics you know.

Personal use Permit Application Forms. The attached form I’ve built from the USDA PDF format form vs163.pdf available through http://compassionateuse.com or the FDA’s web site. Many of you do not have the needed Adobe PDF applications software to fill the form out and the form is not devised for "personal use importation" use. I’ve restructured it to build in answers to the 16 blocks that must be filled in. It is in Word for Window 6.0 format and should be useable by most diabetics online. I’ve used Linda’s approved application so it should work with FDA and USDA.

Beef Insulin. There are other suppliers of beef insulin aside from CP in the UK, a company called "Biobras" in Brazil, and Eli Lilly in Mexico. (As of 3/4/99 we confirmed Lilly Bovina R, N and L production for Mexico had been suspended in September, 1998. ) CP likely does not yet have production capacity to supply the whole US market of human diabetics who are currently on Iletin® I beef-pork and can’t get it anymore, much less the dogs and cats who need beef too. In addition, we are hearing rumors "shortages" and price-gouging for Iletin®II pork insulins. If you have found someone besides CP who will export bovine or porcine to you, PLEASE let us know. (dggroves@csi.com) We should have details on pricing and such and contacts at CP for you shortly. We will address the rumored Pork shortage as soon as we can.

Filling out the Form 16-3 Template

There are 16 Blocks of information on the attached Application Form. I’ve filled in blocks 1, 2, 4, 8-12, 15 and 16 for you, so here’s the skinny on the 6 blocks you need to fill out.

Block 3: Mouse click on the individual blocks until the whole block highlights and type in the information that was requested in the block, your full legal name or the name of your delivery agent (your pharmacy or MD if you’ve decided to accept delivery through them), the mailing address to which the insulin is to be delivered (this cannot be a PO Box as the insulin will not be delivered unless prompt retrieval is assured), the city, state and zip code of the delivery address, and the phone and fax of the party to whom the insulin is to be delivered (you or your delivery agent). DONE. (You can delete all the blocks and the Phone: and FAX: text and print this neatly and should do this for the forms for those who don’t have computers.)

Block 5: Mouse click on each applicable check box until it highlights. Some of you will be able to get a menu on which you can set it to be checked, others of you will just have to overtype it with an X this doesn’t matter. Mark all of the insulin types which you think you will be needing. Also mark all of the insulin packages you may wish to have delivered, even if you are not on a pen, you may wish to use one, so mark not only the 10cc Vials block but at least the 1.5cc and 3cc Cartridge blocks as well. (I don’t think there is a 2.5cc cartridge, but it was on the form that I saw so I included it). Alternatively, you can mark the blocks in pen on the finished print.

Block 6: Mouse click on each applicable check box until it highlights. I would recommend quarterly or semi-annual order periods to minimize delivery charges while minimizing the risk of stale-date insulin. The markings for insulin types should be identical to those for insulin types marked in Block 5. On the , make the estimate in number of vials and/or number of cartridges for each type of insulin you’ve checked, delete these blocks for the unchecked insulins. Remember that your insulin requirements will almost certainly change over the course of the year and that you will lose some insulin to spillage, breakage, etc so estimate close but at least a vial a quarter high of your current needs. Alternatively, you can highlight each delete them all and print in pen on the finished print.

Block 7: Mouse click the block and type in your full legal name or delete and print in in pen.

Block 13: Sign your legal signature or have your delivery agent sign in ink.

Block 14: Mouse click the and type in your name and the title personal use or the name and title of your agent.

Any of the material on the form can be altered to suit your needs. All should be deleted but a copy of the form with the blocks as on the template provided to instruct those without computers on how to fill it out. The following page is the USDA instructions for the form, and the third page is the form template in its final form. The date in block 15 should set to the date of printing.

United States Animal and Veterinary Services

Department of Plant Health National Center For Import And Export

Agriculture Inspection Import/Export Products

Service 4700 River Road, Unit 40

Riverdale MD 20737-1231

Procedures to Follow to Obtain a USDA Permit to Import Controlled Material or Import or Transport Organisms and Vectors:

The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS), regulates the importation of all animal-origin materials, that could represent a disease risk to U.S. livestock, and the import and transport of infectious organisms and vectors of disease agents. This includes not only animal products and byproducts but also biological materials that contain or have been in contact with certain organisms and animal materials (including cell cultures).

The individual at the company/research facility to which the material is to be imported, and who will be responsible for the material, must apply for a USDA veterinary permit by completing an application (VS Form 16-3 and VS Form 16-7 when applicable).

Application forms, along with payment of fee, should be mailed to the address shown above.

Original application review $27.50

Application for renewal of previous permit $15.00

Application for amendment of existing permit $11.50

Import compliance assistance $24.00

*** User fees increased, effective June 6, 1996.

*** Application fees are non-refundable.

POINTS TO CONSIDER WHEN COMPLETING APPLICATION FOR PERMIT ---- FORMS SHOULD BE TYPED. Illegible forms result in significant delays. Include your telephone and FAX numbers.

---- Complete the application thoroughly; provide details sufficient to allow us to evaluate the disease risk associated with the material.

---- Information required in item 10 of VS Form 16-3 about product processing/production prior to importation is critical and should be continued on a separate page if necessary.

---- For all cell lines and cell culture products, such as monoclonal antibodies and recombinant proteins, complete VS Form 16-7 in addition to VS Form 16-3. Item #7 on VS Form 16-7 is criticial; information must be supplied. The nutrient factor (protein source) must be described.

To reach us by telephone, please refer to the following:

APPLICATION FORMS mailed (301) 734-7885

Importation of MEAT PRODUCTS (301) 734-7834

Importation of materials in

COMMERCIAL quantities, to be distributed (301) 734-4401

Importation of materials to

be used for RESEARCH (301) 734-8695

USER FEE questions and payments (301) 734-3584

It is the importer's responsibility to ensure that a USDA veterinary permit is obtained before shipment.

June 6, 1996

 

 

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

ANIMAL AND PLANT HEALTH INSPECTION SERVICE

VETERINARY SERVICES

National Center for Import-Export, Products Program

4700 River Road, Unit 40

Riverdale, MD 20737-1231

APPLICATION FOR PERMIT TO:

IMPORT CONTROLLED MATERIAL

IMPORT OR TRANSPORT ORGANISMS OR VECTORS

FORM APPROVED – OMB NO. 0579-0015

MODE OF TRANSPORTATION (Please Check):

AIR SEA LAND ANY

1. U.S Ports of Entry

New York, NY (JFK International Airport)
Chicago, IL (Ohare International Airport)
Determined by Shipper

3 IMPORTER (Name, complete address, telephone and fax number)

,

Phone: FAX:

4. SHIPPER: (Name and Address of foreign producer)

CP Pharmaceuticals Limited,

Ash Road North, Wrexham Industrial Estate,

Wrexham, LL 13 9 UF, United Kingdom

Phone: +44-1979-6611261 FAX: +44-1978-660130

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)

Country of Origin: United Kingdom

Animal Source: Highly purified pharmaceutical grade Bovine Pancreatic Extract as described above – (*Eli Lilly Iletin® designations below are provided for information as to which UK names have the most similar actions.)

Description of items to be imported: Strength and Packaging:

Hypurin® Bovine Neutral (*US Iletin® I Regular) Insulin 100 IU/CC – 10CC Vials

Hypurin® Bovine Isophane (*US Iletin® I NPH) Insulin 100 IU/CC – 1.5 to 3CC Cartridges should such become available

Hypurin® Bovine Lente (*US Iletin® I Lente®) Insulin

Hypurin® Bovine Protamine Zinc (*US Iletin® I UL or PZI) Insulin

6. QUANTITY AND FREQUENCY OF IMPORTATIONS (estimate))

Monthly Quarterly

Hypurin® Bovine Neutral Insulin

Hypurin® Bovine Isophane Insulin

Hypurin® Bovine Lente Insulin

Hypurin® Bovine Protamine Zinc Insulin
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)

Expected Completion Date: Duration of personal uses natural life of patient or return of licensed distribution for the needed insulins to the US market.

Final Disposition: Medications will be injected as instructed by US medical team treating patient.

I certify that Doctor practicing at , 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 crystalization 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

4. "HYPOGLYCEMIA UNAWARENESS IN DIABETICS TRANSFERRED FROM BEEF/PORCINE INSULIN TO HUMAN INSULIN" A. Teuscher and W. G. Berger, LANCET, p. 382-85, August 15,1987

5. "Failure of warning in insulin induced hypoglycemic reactions" K. E. Sussman, et al, DIABETES, 1963; 12: 38-45

6. "'HUMAN' INSULIN LOSES ITS CLEAN APPEAL~ Frank Lesser, N~W SCIENTIST, p. 30, April 15, 1989

7. "HUMAN INSULIN COMES UNDER CLOSE SCRUTINY AS NUMBER OF DEATHS RISE" Frank Lesser, NEW SCIENTIST, p. 22 August 19, 1989

8. "REPORTS OF DEATHS AMONG U.K. DIABETICS USING HUMAN INSULIN STIR CONCERN HERE" Bill Richards, WALL STREET JOURNAL, Metro DC edition sometime in or near the week of 10/23-30/89

9. "RESPONSES TO HUMAN AND PORCINE INSULIN IN HEALTHY SUBJECTS" R.J. Heine, et al, LANCET, p. 946-49, October 21,1989

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

 

5. TYPED NAME AND TITLE

14. Date

6. APHIS USE CREDIT ACCOUNT NO.

Not applicable, $27.50 Check/Money Order Enclosed