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DEFENSE INDUSTRIAL BASE ASSESSMENT:
Healthcare and Public Health (HPH) Sector
Survey for Manufacturers
SCOPE OF ASSESSMENT
The U.S. Department of Commerce, Bureau of Industry and Security (BIS), Office of Technology Evaluation (OTE), in coordination with the
Department of Homeland Security (DHS), is conducting an assessment regarding the supply chain within the Healthcare and Public Health (HPH)
sector. The principal goal of this assessment is to identify foreign sourcing, critical dependencies and other supply chain issues that could have a
negative impact on the delivery of effective medical services in the United States.
RESPONSE TO THIS SURVEY IS REQUIRED BY LAW
A response to this survey is required by law (50 U.S.C. app. Sec. 2155). Failure to respond can result in a maximum fine of $10,000, imprisonment of
up to one year, or both. Information furnished herewith is deemed confidential and will not be published or disclosed except in accordance with
Section 705 of the Defense Production Act of 1950, as amended (50 U.S.C App. Sec. 2155). Section 705 prohibits the publication or disclosure of
this information unless the President determines that its withholding is contrary to the national defense. Information will not be shared with any nongovernment entity, other than in aggregate form. The information will be protected pursuant to the appropriate exemptions from disclosure under the
Freedom of Information Act (FOIA), should it be the subject of a FOIA request.
Not withstanding any other provision of law, no person is required to respond to nor shall a person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid
OMB Control Number.
BURDEN ESTIMATE AND REQUEST FOR COMMENT
Public reporting burden for this collection of information is estimated to average 13 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 to BIS Information Collection Officer, Room 6883,
Bureau of Industry and Security, U.S. Department of Commerce, Washington, D.C. 20230, and to the Office of Management and Budget, Paperwork
Reduction Project (OMB Control No. ), Washington, D.C. 20503.
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
1
Section I
General Instructions
Your company is required to complete this survey using an Excel template, which can be downloaded from the BIS website. At your
request, BIS staff will e-mail the Excel survey template directly to your company. For your convenience, a PDF version of the survey
A. is available on the BIS website to aid internal data collection. PLEASE DO NOT submit the PDF version of your company’s response
to BIS.
If information is not available from your records in the form requested, you may furnish estimates. Please indicate in the comment
box on the page when you use an estimate.
Questions related to this survey should be directed to:
Anna Bruse, Trade and Industry Analyst, (202) 482-7418
C.
Erika Maynard, Trade and Industry Analyst, (202) 482-5572
Michael Finucane, Trade and Industry Analyst, (202) 482-3893
B.
D. Upon completion, review and certification of the survey, transmit the survey via e-mail to [email protected].
For letter correspondence to the Office of Technology Evaluation (OTE), please write to:
Brad Botwin, Director, Industrial Studies
Office of Technology Evaluation, Room 1093
E. U.S. Department of Commerce
1401 Constitution Avenue, NW
Washington, DC 20230
Please do not submit completed surveys to this address; all surveys must be submitted electronically.
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
2
Section II
Who Must Respond
Has your company manufactured or integrated/assembled healthcare-related pharmaceutical,
A.
equipment, or device products between 2007-2010?
Identify the general product areas your company manufacturers or integrates/assembles from the list below, as applicable.
Anaesthetics
Cancer Treatments
Analgesics
Cardiovasculars
Antibacterials
Hormones
Antibiotics
Immunosupressants
B.
Anticonvulsants, Sedatives,
Stimulants
Relaxants
Anti-Inflammatories
Vaccines
Antileprosy
Surgical and Medical Instruments
Antiprotozoals
Medical Devices
Antivirals
Does your company also manufacture or integrate/assemble non-healthcare related pharmaceutical,
equipment, or device products?
C.
If 'Yes,' indicate the percentage of your business that is not related to healthcare pharmaceutical,
equipment, or device products:
Exemption From Survey
If you answered "No" to Question B above, you may be exempt from completing this U.S. Government survey. Please review the
products identified in the Critical Commodities List (Sections 2.a through 2.h on this survey). If your company does not
manufacture any of these products, complete Section 1.c and call one of the BIS contacts listed on the previous page.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
3
Section III
Definitions
A supplier of the same product or an alternative product that, in the opinion of experts qualified by scientific
training and experience to evaluate the safety and effectiveness of pharmaceuticals and/or medical
devices, it is prudent to assume or ascertain the liability of similar side effects and contraindications.
Alternate Source
Component
Disruption Clauses
Finished Product
Manufacturing Material
Sole Source/Sole Manufacturer
Surge Capacity Provisions
Any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be
included as part of the finished, packaged, and labeled device.
Contract provisions that impose penalties on suppliers to recoup losses in the advent of a delivery/service
delay or interruption.
Any device, accessory to any device, or drug product, that is suitable for use or capable of functioning,
whether or not it is packaged, labeled, or sterilized.
Any material or substance used in or used to facilitate the manufacturing process, a concomitant
constituent, or a byproduct constituent produced during the manufacturing process, which is present in or
on the finished device/product as a residue or impurity not by design or intent of the manufacturer.
A supplier that is the only manufacturer or distributor of a product. For this product, there are either 1) no
alternate products or 2) potential alternate products have substantially different levels of effectiveness
and/or potential side effects.
Contract provisions that allow the contracting party to a) increase the quantity of products or services called
for under the contract by a certain amount; and/or b) accelerate the rate of delivery established under the
contract.
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
4
Section 1.a
Company Name
Street Address
City
State
A.
Zip Code
Phone Number
Fax Number
Website
Point of Contact(s) regarding this survey:
Name
B.
Company Information
Title
E-mail
Phone Number
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
5
Section 1.b
My company is headquartered in:
My company is:
Parent Company Name
A.
Company Ownership Information
Address
City
State/Province
Country
My company is Public/Private:
My parent company is Public/Private:
Please identify the entities and/or individuals currently holding 5 percent or more of your company’s or organization’s voting rights. List
no more than 5, if applicable, and place them in descending order, the highest percentage stake listed first. This question applies to both
public and privately held companies.
Entity or Individual's Name
Stake (%)
Address
City
State/Province
Country
B. 1.
2.
3.
4.
5.
From 2007-2010, has one or more foreign governments invested, directly or indirectly, in your company and control 5
percent or more of stockholder voting shares?
If you answered "Yes," please explain the type of investment and identify the foreign government(s).
Foreign Government
Type of Investment
C. 1.
2.
3.
4.
5.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
6
Section 1.c
Manufacturing Facilities
Identify the facilities your company owns and operates in the United States for the manufacture or integration/assembly of healthcare-related
pharmaceutical, equipment, or device products. Provide the name and location for each facility.
ID #
Facility Name
Street Address
City
State
Zip Code
US - 1
US - 2
US - 3
US - 4
US - 5
US - 6
A.
US - 7
US - 8
US - 9
US - 10
US - 11
US - 12
US - 13
US - 14
US - 15
Identify the facilities your company owns and operates outside the United States for the manufacture or integration/assembly of healthcarerelated pharmaceutical, equipment, or device products. Provide the name and location for each facility.
ID #
Facility Name
Street Address
City
State/Province
Country
Non-US - 1
Non-US - 2
Non-US - 3
Non-US - 4
Non-US - 5
Non-US - 6
B.
Non-US - 7
Non-US - 8
Non-US - 9
Non-US - 10
Non-US - 11
Non-US - 12
Non-US - 13
Non-US - 14
Non-US - 15
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
7
Section 2.a
Critical Commodities List
From the product areas listed below, indicate those that your company currently manufactures or integrates/assembles. For each area, identify the top three discrete
products (by an estimate of annual sales) your company currently produces and whether your company, to the best of your knowledge, is the sole U.S.-based
manufacturer, sole global manufacturer, or not a sole manufacturer of this product. If you are not sure, select "Not Sure" from the drop-down box. Finally, indicate
the primary manufacturing facility in which each product is produced (the facility that adds the most value to the finished product) based on those identified in Section
1.c.
Differentiate products based on their unique effects or capabilities. Do not differentiate products based solely on dosage, strength, or method of delivery.
Note: If the product you manufacture does not fit the product area exactly (e.g. it is a combination of multiple product areas, your company classifies its product under
a similar, but different area, etc.) make note of this in the comments area in the far right column.
Note: For the purposes of this survey a sole manufacturer is the only manufacturer of a product of a particular use, capability, or function. For this product, there
are either 1) no alternate products or 2) potential alternate products have substantially different levels of effectiveness and/or potential side effects.
Anaesthetics
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
A1 Atropine/Atropine Sulfate
A2 Bupivacaine
A3 Halothane
A4 Ketamine
A5 Lidocaine
A6 Nitrous Oxide
A7 Pancuronium Bromide
A8 Promethazine
A9 Propofol
A10 Thiopental/Pentothal
A11 Thiopentone Sodium
Analgesics
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
B1 Acetylsalicyclic Acid (Aspirin)
B2 Allopurinol
B3 Aminophenazone
B4 Azathioprine
B5 Buprenorphine
B6 Carbamazepine
B7 Chloroquine
B8 Cinchonine
B9 Codeine
B10 Dihydrocodeine
B11 Etorphine
B12 Hydrocodone
B13 Hydromorphone
B14 Ibuprofen
B15 Levorphanol
B16 Methotrexate
B17 Morphine
B18 Nicomorphine
B19 Oxycodone
B20 Oxymorphone
B21 Paracetamol/Acetaminophen
B22 Penicillamine
B23 Pholcodine
B24 Quinine
B25 Thebacon
Antibacterials
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
C1 Furazolidone
C2 Sulferamerazine
Product Name
Product Name
Product Name
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
8
C3
C4
C5
C6
Sulphadiazine
Sulphapyridine
Sulphathiazole
Sulphathiourea
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
9
Section 2.b
Critical Commodities List
From the product areas listed below, indicate those that your company currently manufactures or integrates/assembles. For each area, identify the top three discrete
products (by an estimate of annual sales) your company currently produces and whether your company, to the best of your knowledge, is the sole U.S.-based
manufacturer, sole global manufacturer, or not a sole manufacturer of this product. If you are not sure, select "Not Sure" from the drop-down box. Finally, indicate
the primary manufacturing facility in which each product is produced (the facility that adds the most value to the finished product) based on those identified in Section
1.c.
Differentiate products based on their unique effects or capabilities. Do not differentiate products based solely on dosage, strength, or method of delivery.
Note: If the product you manufacture does not fit the product area exactly (e.g. it is a combination of multiple product areas, your company classifies its product under
a similar, but different area, etc.) make note of this in the comments area in the far right column.
Note: For the purposes of this survey a sole manufacturer is the only manufacturer of a product of a particular use, capability, or function. For this product, there
are either 1) no alternate products or 2) potential alternate products have substantially different levels of effectiveness and/or potential side effects.
Antibiotics
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
D1 Actinomycins
D2 Amoxicillin
D3 Ampicillin
D4 Azithromycin
D5 Aztreonam
D6 Bacitracin
D7 Benzylpenicillin (Penicillin G)
D8 Cefalexin
D9 Cefazolin
D10 Cefixime
D11 Cefotaxime
D12 Ceftazidime
D13 Ceftriaxone
D14 Chloramphenicol
D15 Ciprofloxacin
D16 Clarithromycin
D17 Clindamycin
D18 Cloxacillin
D19 Doripenem
D20 Doxycycline
D21 Erythromycin
D22 Gentamicin
D23 Gramicidines
D24 Imipenem
D25 Levofloxacin
D26 Metronidazole
D27 Minocycline
D28 Nitrofurantoin
D29 Phenoxymethylpenicillin
D30 Procaine Benzylpenicillin
D31 Sarkomycin
D32 Spectinomycin
D33 Streptomycin
D34 Talampicillin
D35 Tetracycline
D36 Thiamphenicol
D37 Trimethoprim
D38 Tyrocidin
D39 Vancomycin
D40 Zanamivir
Product Name
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
10
Section 2.c
Critical Commodities List
From the product areas listed below, indicate those that your company currently manufactures or integrates/assembles. For each area, identify the top three discrete
products (by an estimate of annual sales) your company currently produces and whether your company, to the best of your knowledge, is the sole U.S.-based
manufacturer, sole global manufacturer, or not a sole manufacturer of this product. If you are not sure, select "Not Sure" from the drop-down box. Finally, indicate
the primary manufacturing facility in which each product is produced (the facility that adds the most value to the finished product) based on those identified in Section
1.c.
Differentiate products based on their unique effects or capabilities. Do not differentiate products based solely on dosage, strength, or method of delivery.
Note: If the product you manufacture does not fit the product area exactly (e.g. it is a combination of multiple product areas, your company classifies its product under
a similar, but different area, etc.) make note of this in the comments area in the far right column.
Note: For the purposes of this survey a sole manufacturer is the only manufacturer of a product of a particular use, capability, or function. For this product, there
are either 1) no alternate products or 2) potential alternate products have substantially different levels of effectiveness and/or potential side effects.
Anticonvulsants, Sedatives, Relaxants
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
E1 Alprazolam
E2 Atracurium Besylate
E3 Camazepam
E4 Chlordiazepoxide
E5 Clonazepam
E6 Clorazepate
E7 Delorazepam
E8 Diazepam
E9 Estazolam
E10 Ethosuximide
E11 Ethyl Loflazepate
E12 Fludiazepam
E13 Flunitrazepam
E14 Flurazepam
E15 Halazepam
E16 Lorazepam
E17 Lormetazepam
E18 Mazindol
E19 Medazepam
E20 Midazolam
E21 Nimetazepam
E22 Nitrazepam
E23 Nordazepam
E24 Oxazepam
E25 Phenobarbital
E26 Phenytoin
E27 Pinazepam
Pralidoxime/Pralidoxime
E28
Chloride
E29 Prazepam
E30 Pyrovalerone
E31 Temazepam
E32 Tetrazepam
E33 Triazolam
E34 Valproic Acid (VPA)
E35 Vecuronium Bromide
Anti-Inflammatories
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
F1 Dexamthasone
F2 Flucinolone Acetonide
F3 Indometacin/Indomethacin
F4 Rutoside/Rutin
F5 Tolmetin
Product Name
Product Name
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
11
Section 2.d
Critical Commodities List
From the product areas listed below, indicate those that your company currently manufactures or integrates/assembles. For each area, identify the top three discrete
products (by an estimate of annual sales) your company currently produces and whether your company, to the best of your knowledge, is the sole U.S.-based
manufacturer, sole global manufacturer, or not a sole manufacturer of this product. If you are not sure, select "Not Sure" from the drop-down box. Finally, indicate
the primary manufacturing facility in which each product is produced (the facility that adds the most value to the finished product) based on those identified in Section
1.c.
Differentiate products based on their unique effects or capabilities. Do not differentiate products based solely on dosage, strength, or method of delivery.
Note: If the product you manufacture does not fit the product area exactly (e.g. it is a combination of multiple product areas, your company classifies its product under
a similar, but different area, etc.) make note of this in the comments area in the far right column.
Note: For the purposes of this survey a sole manufacturer is the only manufacturer of a product of a particular use, capability, or function. For this product, there
are either 1) no alternate products or 2) potential alternate products have substantially different levels of effectiveness and/or potential side effects.
Antileprosy
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
G1 Amikacin
G2 Capreomycin
G3 Clofazimine
G4 Cycloserine
G5 Dapsone
G6 Ethambutol
G7 Ethionamide
G8 Isoniazid
G9 Kanamycin
G10 Ofloxacin
G11 P-Aminosalicylic Acid
G12 Pyrazinamide
G13 Rifabutin
G14 Rifampicin/Rifampin
Antiprotozoals
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
H1 Amodiaquine
H2 Artemether
H3 Benznidazole
H4 Diloxanide
H5 Eflornithine
H6 Mefloquine
H7 Nicarbazin
H8 Nifurtimox
H9 Paramomycin
H10 Pentamidine
H11 Primaquine
H12 Proguanil
H13 Pyrimethamine
Antivirals
2
1
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
I1 Abacavir (ABC)
I2 Acyclovir
I3 Amantadine
I4 Atazanavir
I5 Cidofovir
I6 Didanosine (ddl)
I7 Efavirenz (EFV or EFZ)
I8 Indinavir (DIV)
I9 Lamivudine (3TC)
I10 Nevirapine (NVP)
I11 Oseltamivir (aka Tamiflu)
I12 Ribavirin
Product Name
Product Name
Product Name
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
12
I13
I14
I15
I16
Rimantadine
Ritonavir
Saquinavir (SQV)
Stavudine (d4T)
Tenofovir Disoproxil Fumarate
I17
(TDF)
I18 Zidovudine (ZDV or AZT)
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
13
Section 2.e
Critical Commodities List
From the product areas listed below, indicate those that your company currently manufactures or integrates/assembles. For each area, identify the top three discrete
products (by an estimate of annual sales) your company currently produces and whether your company, to the best of your knowledge, is the sole U.S.-based
manufacturer, sole global manufacturer, or not a sole manufacturer of this product. If you are not sure, select "Not Sure" from the drop-down box. Finally, indicate
the primary manufacturing facility in which each product is produced (the facility that adds the most value to the finished product) based on those identified in Section
1.c.
Differentiate products based on their unique effects or capabilities. Do not differentiate products based solely on dosage, strength, or method of delivery.
Note: If the product you manufacture does not fit the product area exactly (e.g. it is a combination of multiple product areas, your company classifies its product under
a similar, but different area, etc.) make note of this in the comments area in the far right column.
Note: For the purposes of this survey a sole manufacturer is the only manufacturer of a product of a particular use, capability, or function. For this product, there
are either 1) no alternate products or 2) potential alternate products have substantially different levels of effectiveness and/or potential side effects.
Cancer Treatments
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
J1 Folinic Acid/Leucovorin
J2 Thiotepa
J3 Valrubicin
J4 Vinblastine Sulfate
Cardiovasculars
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
K1 Amiodarone
K2 Amlodipine
K3 Arnolol
K4 Atenolol
K5 Digoxin
K6 Dopamine
K7 Enalapril
K8 Furosemide
K9 Glyceryl Trinitrate
K10 Hydralazine Hydrochloride
K11 Hydrochlorothiazide
K12 Isosorbide Dinitrate
K13 Mexiletine
K14 Sarpogrelate
K15 Simvastatin
K16 Streptokinase
K17 Verapamil
Hormones
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
L1 Aglepristone
L2 Estradiol
L3 Estriol
L4 Estrone
L5 Ethinyl Estradiol
L6 Fludrocortisone
L7 Glibenclamide
Granulocyte-Colony Stimulating
L8
Factor (G-CSF)
L9 Insulin
L10 Levonorgestrel
L11 Levothyroxine
L12 Liothyronine
L13 Medroxyprogesterone Acetate
L14 Mestranol
L15 Metformin
L16 Norethisterone
L17 Onapristone
Product Name
Product Name
Product Name
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
14
L18
L19
L20
L21
L22
L23
L24
L25
L26
L27
Pegvisomant
Potassium Iodide
Pregnandiol
Progesterone
Propylthiouracil
Rathyronine
Somatotropin
Somatrem
Somenopor
Testosterone (Androgen)
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
15
Section 2.f
Critical Commodities List
From the product areas listed below, indicate those that your company currently manufactures or integrates/assembles. For each area, identify the top three discrete
products (by an estimate of annual sales) your company currently produces and whether your company, to the best of your knowledge, is the sole U.S.-based
manufacturer, sole global manufacturer, or not a sole manufacturer of this product. If you are not sure, select "Not Sure" from the drop-down box. Finally, indicate
the primary manufacturing facility in which each product is produced (the facility that adds the most value to the finished product) based on those identified in Section
1.c.
Differentiate products based on their unique effects or capabilities. Do not differentiate products based solely on dosage, strength, or method of delivery.
Note: If the product you manufacture does not fit the product area exactly (e.g. it is a combination of multiple product areas, your company classifies its product under
a similar, but different area, etc.) make note of this in the comments area in the far right column.
Note: For the purposes of this survey a sole manufacturer is the only manufacturer of a product of a particular use, capability, or function. For this product, there
are either 1) no alternate products or 2) potential alternate products have substantially different levels of effectiveness and/or potential side effects.
Immunosuppressants
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
M1 Aldosterone
M2 Asparaginase
M3 Bleomycin
M4 Calcium Folinate
M5 Carboplatin
M6 Chlorambucil
M7 Ciclosporin
M8 Cortisone
M9 Cortodoxone
M10 Cyclophosphamide
M11 Cytarabine
M12 Dactinomycin
M13 Darcabazine
M14 Daunorubicin
M15 Etoposide
M16 Fluorouracil
M17 Hydrocortisone
M18 Hydrooxycarbamide
M19 Ifosfamide
M20 Mercaptopurine
M21 Mesna
M22 Prednisolone
M23 Prednisone
M24 Procarbazine
M25 Tamoxifen
M26 Vinblastine
M27 Vincristine
Stimulants
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
N1 Aminorex
N2 Brotizolam
N3 Clotiazepam
N4 Ephedrine
N5 Epinephrine (Adrenaline)
N6 Fenethylline
N7 Norepinephrine
N8 Pseudoephedrine
N9 Racepinephrine
Vaccines
1
2
Product Area
Manufacture?
Sole
Manufacturing
Sole
Manufacturing
Product Name
Product Name
Manufacturer?
Facility
Manufacturer?
Facility
Anthrax Treatments (Immune
O1 Globulin Injection, Raxibacumab,
etc.)
Product Name
Product Name
Product Name
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
16
O2 BCG Vaccine
O3 Cholera Vaccine
O4 Diphtheria Vaccine
Haemophilus Influenzae Type B
O5
Vaccine
O6 Hepatitis A Vaccine
O7 Hepatitis B Vaccine
Japanese Encephalitis Vaccine
O8
O9 Measles Vaccine
Meningococcal Meningitis
Vaccine
Modified Vaccinia Ankara (MVA)
O11
O10
O12 Mumps Vaccine
O13 Pertussis Vaccine
O14 Pneumococcal Vaccine
O15 Poliomyelitis Vaccine
O16 Rabies Vaccine
O17 Rotavirus Vaccine
O18 Rubella Vaccine
O19 Smallpox Vaccine
O20 Tetanus Vaccine
O21 Typhoid Vaccine
Vaccinia Immune Globulin (VIG)
O22
O23 Varicella Vaccine
O24 Yellow Fever Vaccine
Product Area
Manufacture?
Other Products
1
Sole
Product Name
Manufacturer?
Manufacturing
Facility
Product Name
2
Sole
Manufacturer?
Manufacturing
Facility
Product Name
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
P1 Acridine
P2 Botulinum Toxin(s)
Cyanide Treatments - Amyl
P3
Nitrate
Cyanide Treatments P4
Hydroxocabalamin
Cyanide Treatments - Sodium
P5
Nitrate
Cyanide Treatments - Sodium
P6
Thiosulfate
Diethylene Triamine Pentaacetic
P7 Acid (DTPA)/Pentetic Acid
P8 Granisetron
P9 Heparin
P10 Imipramine
P11 Lysine
P12 Probenecid
P13 Prussian Blue
Technetium Generators or other
P14 equipment for the processing of
radioisotopes
P15 Thiopen
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
17
Section 2.g
Critical Commodities List
From the product areas listed below, indicate those that your company currently manufactures or integrates/assembles. For each area, identify the top three discrete
products (by an estimate of annual sales) your company currently produces and whether your company, to the best of your knowledge, is the sole U.S.-based
manufacturer, sole global manufacturer, or not a sole manufacturer of this product. If you are not sure, select "Not Sure" from the drop-down box. Finally, indicate the
primary manufacturing facility in which each product is produced (the facility that adds the most value to the finished product) based on those identified in Section 1.c.
Differentiate products based on their unique effects or capabilities. Do not differentiate products based solely on dosage, strength, or method of delivery.
Note: If the product you manufacture does not fit the product area exactly (e.g. it is a combination of multiple product areas, your company classifies its product under a
similar, but different area, etc.) make note of this in the comments area in the far right column.
Note: For the purposes of this survey a sole manufacturer is the only manufacturer of a product of a particular use, capability, or function. For this product, there
are either 1) no alternate products or 2) potential alternate products have substantially different levels of effectiveness and/or potential side effects.
Product Area
Manufacture?
Surgical and Medical Instruments
1
Sole
Manufacturing
Product Name
Manufacturer?
Facility
Product Name
2
Sole
Manufacturer?
Manufacturing
Facility
Product Name
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
Q1
Q2
Q3
Q4
Q5
Q6
Adhesive Dressings
Aerosol Therapy Apparatus
Anaesthesia Units
Anaesthetic Apparatus
Anti-Radiation Protective Suits
Apnea Monitors
Apparatus Based on Alpha, Beta, or
Q7 Gamma Radiations for Medical Use
Q8
Q9
Argon Enhanced Coagulation Units
Artificial Kidney/Dialysis Apparatus
Q10 Artificial Respiration Apparatus
Q11 Aspirators
Q12 Auriscopes
Q13 Blood Collection Tubes
Blood Pressure Measuring
Q14
Equipment
Q15 Blood Transfusion Apparatus
Q16 Bone Nails and Screws
Q17 Bone Plates
Q18 Bronchoscopes
Q19 Capnographs
Q20 Cardioscopes
Q21 IV Catheters
Q22 Adult Central Venous Catheters
Pediatric Central Venous Catheters
Q23
Q24 Swan-Ganz Catheters
Q25 Suction Catheters
Q26 Other Catheters
Q27 Cauteries
Q28 Cephalometers
Q29 Crutches
Q30 Cutaneous Dressings
Q31 Defibrillators
Q32 Dilators
Q33 Electrocardiographs
Q34 Electroencephalographs (EEG)
Electronic Nerve Stimulation
Q35
Machines
Q36 Electrosphygmographs
Q37 Electrotonographs
Q38 Endoscopes
Endotracheal Tubes (adult and
Q39
pediatric)
18
Q40 Fetal Monitors
Q41 Forceps
Q42 Gas Masks
Q43 Gastroscopes
Q44 Gauze and Bandages
Q45 Gouges
Q46 Hyperbaric Chambers
Q47 Hysterectomy Instruments
Q48 Infant Incubators
Q49 Influenza Tests
Q50 Infusion/IV Pumps
Q51 Intubation Tubes
Q52 Keratometer
Q53 Kidney Dishes
Q54 Lancets
Q55 Laparoscopic Insufflators
Q56 Laryngoscope
Laryngoscope Handle and Blade
Q57
(Intubating)
Q58 Lensometer
Q59 Liquid Dressings
Q60 Lithotrity Instruments
Q61 Lytic Bacteriophages
Magnetic Resonance Imaging (MRI)
Q62
Apparatus
Mallets and Hammers for Medical
Q63
Use
Medical Needles/Syringes/Safety
Q64
Needle
Mirrors and Reflectors for Medical
Q65
Use
Q66 Nasal Cannula
Nasogastric Tube (adult and
Q67
pediatric)
Q68 Nebulisers
Q69 Oesophagoscopes
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
19
Section 2.h
Critical Commodities List
From the product areas listed below, indicate those that your company currently manufactures or integrates/assembles. For each area, identify the top three discrete
products (by an estimate of annual sales) your company currently produces and whether your company, to the best of your knowledge, is the sole U.S.-based
manufacturer, sole global manufacturer, or not a sole manufacturer of this product. If you are not sure, select "Not Sure" from the drop-down box. Finally, indicate the
primary manufacturing facility in which each product is produced (the facility that adds the most value to the finished product) based on those identified in Section 1.c.
Differentiate products based on their unique effects or capabilities. Do not differentiate products based solely on dosage, strength, or method of delivery.
Note: If the product you manufacture does not fit the product area exactly (e.g. it is a combination of multiple product areas, your company classifies its product under a
similar, but different area, etc.) make note of this in the comments area in the far right column.
Note: For the purposes of this survey a sole manufacturer is the only manufacturer of a product of a particular use, capability, or function. For this product, there
are either 1) no alternate products or 2) potential alternate products have substantially different levels of effectiveness and/or potential side effects.
Product Area
Q70
Q71
Q72
Q73
Q74
Q75
Q76
Q77
Q78
Q79
Q80
Q81
Q82
Q83
Q84
Q85
Q86
Q87
Q88
Q89
Q90
Q91
Q92
Q93
Q94
Q95
Q96
Q97
Q98
Q99
Q100
Q101
Q102
Q103
Q104
Q105
Q106
Q107
Q108
Q109
Q110
Q111
Q112
Manufacture?
Surgical and Medical Instruments (cont.)
1
Sole
Manufacturing
Product Name
Manufacturer?
Facility
Product Name
2
Sole
Manufacturer?
Manufacturing
Facility
Product Name
3
Sole
Manufacturer?
Manufacturing
Facility
Product Area Comments
Oropharyngeal Airway
Oscillometers
Oxygen Analyzers
Oxygen Tents
Oxygen Therapy Apparatus
Ozone Therapy Apparatus
Pacemakers
Parts for Pacemakers
Pelvimeters
Phonocardiographs
Protective Sceens/Shields for XRay Facilities
Pulse Oxymiters
Pyrometers
Radiotherapy Apparatus
Respirators
Respiratory Pumps and Filters
Resuscitator Bag Valves and
Masks
Pulmonary Resuscitators
Oxygen Resuscitators
Retractors
Rheocardiographs
Saws and Scrapers for Medical Use
Sissors and Shears for Medical Use
Spatulae
Specula
Sphygmomanometers
Spinal Needles
Spirometers
Splints
Sterilizers
Stethoscopes
Stomach Pumps
Suction Pumps
Suction Tubes
Surgical Gloves
Surgical Gowns
Surgical Knives and Scalpels
Surgical Masks
Surgical Staplers
Suture Clips
Sutures
Tensiometers
Thermometers
20
Q113
Q114
Q115
Q116
Q117
Q118
Q119
Q120
Q121
Q122
Q123
Q124
Q125
Q126
Q127
Q128
Tourniquets
Tracheal Tubes
Trocars
Trusses
Ultrasound Sensors
Ultra-Violet or Infra-Red Apparatus
for Medical Use
Urethrotomes
Vaginal Retractors/Speculums
Venous Cannula
Ventilator Circuits
Ventilators
Wire Guides
X-Ray Apparatus Used in Medical
Diagnosis
X-Ray Control Panels/Desks
X-Ray Generators/Producing
Apparatus
X-Ray Screens
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
21
Section 3.a
Critical Commodities - Non-U.S. Suppliers
Identify any components, manufacturing materials, or finished products provided by suppliers based outside the United States that are critical to the final manufacture of
the products identified in the previous section. Indicate the product area and product name(s) for which this component/material is required and the supplier's name and
location. In addition, indicate whether the component/material is supplied by an internal company supplier/subsidiary or is supplied by an outside company. Finally, identify,
to the best of your company's understanding, whether there is an alternate U.S.-based or non-U.S. based source available for each component/material.
Note: If your company does not manufacture a product in a particular product area, you may leave it blank.
Anasthetics
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
1.
2.
3.
4.
5.
A. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Analgesics
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
1.
2.
3.
4.
5.
B. 6.
7.
8.
9.
10.
11.
12.
22
13.
14.
15.
Antibacterials
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
1.
2.
3.
4.
5.
C. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Antibiotics
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
1.
2.
3.
4.
5.
D. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
23
Section 3.b
Critical Commodities - Non-U.S. Suppliers
Identify any components, manufacturing materials, or finished products provided by suppliers based outside the United States that are critical to the final manufacture of
the products identified in the previous section. Indicate the product area and product name(s) for which this component/material is required and the supplier's name and
location. In addition, indicate whether the component/material is supplied by an internal company supplier/subsidiary or is supplied by an outside company. Finally, identify,
to the best of your company's understanding, whether there is an alternate U.S.-based or non-U.S. based source available for each component/material.
Note: If your company does not manufacture a product in a particular product area, you may leave it blank.
Anticonvulsants, Sedatives, Relaxants
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
1.
2.
3.
4.
5.
A. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Anti-Inflammatories
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
1.
2.
3.
4.
5.
B. 6.
7.
8.
9.
10.
11.
12.
24
13.
14.
15.
Antileprosy
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
1.
2.
3.
4.
5.
C. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Antiprotozoals
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
1.
2.
3.
4.
5.
D. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
25
Section 3.c
Critical Commodities - Non-U.S. Suppliers
Identify any components, manufacturing materials, or finished products provided by suppliers based outside the United States that are critical to the final manufacture of
the products identified in the previous section. Indicate the product area and product name(s) for which this component/material is required and the supplier's name and
location. In addition, indicate whether the component/material is supplied by an internal company supplier/subsidiary or is supplied by an outside company. Finally, identify,
to the best of your company's understanding, whether there is an alternate U.S.-based or non-U.S. based source available for each component/material.
Note: If your company does not manufacture a product in a particular product area, you may leave it blank.
Antivirals
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
1.
2.
3.
4.
5.
A. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Cancer Treatments
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
1.
2.
3.
4.
5.
B. 6.
7.
8.
9.
10.
11.
12.
26
13.
14.
15.
Cardiovasculars
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
1.
2.
3.
4.
5.
C. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Hormones
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
1.
2.
3.
4.
5.
D. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
27
Section 3.d
Critical Commodities - Non-U.S. Suppliers
Identify any components, manufacturing materials, or finished products provided by suppliers based outside the United States that are critical to the final manufacture of
the products identified in the previous section. Indicate the product area and product name(s) for which this component/material is required and the supplier's name and
location. In addition, indicate whether the component/material is supplied by an internal company supplier/subsidiary or is supplied by an outside company. Finally, identify,
to the best of your company's understanding, whether there is an alternate U.S.-based or non-U.S. based source available for each component/material.
Note: If your company does not manufacture a product in a particular product area, you may leave it blank.
Immunosuppressants
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
1.
2.
3.
4.
5.
A. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Stimulants
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
1.
2.
3.
4.
5.
B. 6.
7.
8.
9.
10.
11.
12.
28
13.
14.
15.
Vaccines
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
1.
2.
3.
4.
5.
C. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Other Products
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
1.
2.
3.
4.
5.
D. 6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
29
Section 3.e
Critical Commodities - Non-U.S. Suppliers
Identify any components, manufacturing materials, or finished products provided by suppliers based outside the United States that are critical to the final manufacture of
the products identified in the previous section. Indicate the product area and product name(s) for which this component/material is required and the supplier's name and
location. In addition, indicate whether the component/material is supplied by an internal company supplier/subsidiary or is supplied by an outside company. Finally, identify,
to the best of your company's understanding, whether there is an alternate U.S.-based or non-U.S. based source available for each component/material.
Note: If your company does not manufacture a product in a particular product area, you may leave it blank.
Surgical and Medical Equipment
Component/Manufacturing
Material/Finished Product
Product Area
Product Name(s)
Supplier Name
Country
City
State/
Province
Internal
Supplier/
Subsidiary?
Alternate Source?
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
A. 14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28.
29.
30
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
30
Section 4.a
Critical Commodities - Utilization
Based on the products identified in the Section 2, indicate your company's manufacturing capacity utilization rate for each product area from 2007-2010. Indicate your
company's maximum annual manufacturing capacity in units for 2009. In addition, using your company's 2010 production as a baseline, estimate the lead time required to
increase production of each product area by the specified amount. For the purpose of this estimate, make the following assumptions:
1) Existing U.S. production facilities are to be operated at maximum practical productive capacity;
2) Labor availability reflects normal local market conditions;
3) Material availability reflects normal local market conditions; and
4) Facilities operate at the maximum rate possible given technological constraints.
Finally, from the drop-down list provided, select the primary factor that would prevent a production increase, if applicable.
Note: If your company does not manufacture a product in a particular product area, you may leave it blank.
Anaesthetics
Manufacturing Capacity Utilization
Maximum Production
Lead Time to
Product Area
Increase
Unit of
2007
2008
2009
2010
# of Units
Measure Production 50%
1.
2.
3.
A. 4.
5.
6.
7.
8.
9.
10.
Analgesics
Manufacturing Capacity Utilization
Maximum Production
Lead Time to
Product Area
Increase
Unit of
2007
2008
2009
2010
# of Units
Measure Production 50%
1.
2.
3.
B. 4.
5.
6.
7.
8.
9.
10.
Lead Time to
Double
Production
Factors Preventing Production
Increase
Lead Time to
Double
Production
Factors Preventing Production
Increase
31
Manufacturing Capacity Utilization
Product Area
2007
2008
2009
2010
Antibacterials
Maximum Production
Unit of
# of Units
Measure
Lead Time to
Increase
Production 50%
Lead Time to
Double
Production
Factors Preventing Production
Increase
Antibiotics
Maximum Production
Unit of
# of Units
Measure
Lead Time to
Increase
Production 50%
Lead Time to
Double
Production
Factors Preventing Production
Increase
1.
2.
3.
C. 4.
5.
6.
7.
8.
9.
10.
Manufacturing Capacity Utilization
Product Area
2007
2008
2009
2010
1.
2.
3.
D. 4.
5.
6.
7.
8.
9.
10.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
32
Section 4.b
Critical Commodities - Utilization
Based on the products identified in the Section 2, indicate your company's manufacturing capacity utilization rate for each product area from 2007-2010. Indicate your
company's maximum annual manufacturing capacity in units for 2009. In addition, using your company's 2010 production as a baseline, estimate the lead time required to
increase production of each product area by the specified amount. For the purpose of this estimate, make the following assumptions:
1) Existing U.S. production facilities are to be operated at maximum practical productive capacity;
2) Labor availability reflects normal local market conditions;
3) Material availability reflects normal local market conditions; and
4) Facilities operate at the maximum rate possible given technological constraints.
Finally, from the drop-down list provided, select the primary factor that would prevent a production increase, if applicable.
Note: If your company does not manufacture a product in a particular product area, you may leave it blank.
Anticonvulsants, Sedatives, Relaxants
Maximum Production
Manufacturing Capacity Utilization
Lead Time to
Product Area
Increase
Unit of
2007
2008
2009
2010
# of Units
Measure Production 50%
1.
2.
3.
A. 4.
5.
6.
7.
8.
9.
10.
Anti-Inflammatories
Manufacturing Capacity Utilization
Maximum Production
Lead Time to
Increase
Product Area
Unit of
2007
2008
2009
2010
# of Units
Measure Production 50%
1.
2.
3.
B. 4.
5.
6.
7.
8.
9.
10.
Lead Time to
Double
Production
Factors Preventing Production
Increase
Lead Time to
Double
Production
Factors Preventing Production
Increase
33
Manufacturing Capacity Utilization
Product Area
2007
2008
2009
2010
Antileprosy
Maximum Production
Unit of
# of Units
Measure
Lead Time to
Increase
Production 50%
Lead Time to
Double
Production
Factors Preventing Production
Increase
Antiprotozoals
Maximum Production
Unit of
# of Units
Measure
Lead Time to
Increase
Production 50%
Lead Time to
Double
Production
Factors Preventing Production
Increase
1.
2.
3.
C. 4.
5.
6.
7.
8.
9.
10.
Manufacturing Capacity Utilization
Product Area
2007
2008
2009
2010
1.
2.
3.
D. 4.
5.
6.
7.
8.
9.
10.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
34
Section 4.c
Critical Commodities - Utilization
Based on the products identified in the Section 2, indicate your company's manufacturing capacity utilization rate for each product area from 2007-2010. Indicate your
company's maximum annual manufacturing capacity in units for 2009. In addition, using your company's 2010 production as a baseline, estimate the lead time required to
increase production of each product area by the specified amount. For the purpose of this estimate, make the following assumptions:
1) Existing U.S. production facilities are to be operated at maximum practical productive capacity;
2) Labor availability reflects normal local market conditions;
3) Material availability reflects normal local market conditions; and
4) Facilities operate at the maximum rate possible given technological constraints.
Finally, from the drop-down list provided, select the primary factor that would prevent a production increase, if applicable.
Note: If your company does not manufacture a product in a particular product area, you may leave it blank.
Antivirals
Maximum Production
Manufacturing Capacity Utilization
Lead Time to
Product Area
Increase
Unit of
2007
2008
2009
2010
# of Units
Measure Production 50%
1.
2.
3.
A. 4.
5.
6.
7.
8.
9.
10.
Cancer Treatments
Maximum Production
Manufacturing Capacity Utilization
Lead Time to
Product Area
Increase
Unit of
2007
2008
2009
2010
# of Units
Measure Production 50%
1.
2.
3.
B. 4.
5.
6.
7.
8.
9.
10.
Lead Time to
Double
Production
Factors Preventing Production
Increase
Lead Time to
Double
Production
Factors Preventing Production
Increase
35
Manufacturing Capacity Utilization
Product Area
2007
2008
2009
2010
Cardiovasculars
Maximum Production
Unit of
# of Units
Measure
Lead Time to
Increase
Production 50%
Lead Time to
Double
Production
Factors Preventing Production
Increase
Hormones
Maximum Production
Unit of
# of Units
Measure
Lead Time to
Increase
Production 50%
Lead Time to
Double
Production
Factors Preventing Production
Increase
1.
2.
3.
C. 4.
5.
6.
7.
8.
9.
10.
Manufacturing Capacity Utilization
Product Area
2007
2008
2009
2010
1.
2.
3.
D. 4.
5.
6.
7.
8.
9.
10.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
36
Section 4.d
Critical Commodities - Utilization
Based on the products identified in the Section 2, indicate your company's manufacturing capacity utilization rate for each product area from 2007-2010. Indicate your
company's maximum annual manufacturing capacity in units for 2009. In addition, using your company's 2010 production as a baseline, estimate the lead time required to
increase production of each product area by the specified amount. For the purpose of this estimate, make the following assumptions:
1) Existing U.S. production facilities are to be operated at maximum practical productive capacity;
2) Labor availability reflects normal local market conditions;
3) Material availability reflects normal local market conditions; and
4) Facilities operate at the maximum rate possible given technological constraints.
Finally, from the drop-down list provided, select the primary factor that would prevent a production increase, if applicable.
Note: If your company does not manufacture a product in a particular product area, you may leave it blank.
Immunosuppresants
Maximum Production
Manufacturing Capacity Utilization
Lead Time to
Product Area
Increase
Unit of
2007
2008
2009
2010
# of Units
Measure Production 50%
1.
2.
3.
A. 4.
5.
6.
7.
8.
9.
10.
Stimulants
Manufacturing Capacity Utilization
Maximum Production
Lead Time to
Increase
Product Area
Unit of
2007
2008
2009
2010
# of Units
Measure Production 50%
1.
2.
3.
B. 4.
5.
6.
7.
8.
9.
10.
Lead Time to
Double
Production
Factors Preventing Production
Increase
Lead Time to
Double
Production
Factors Preventing Production
Increase
37
Manufacturing Capacity Utilization
Product Area
2007
2008
2009
2010
Vaccines
Maximum Production
Unit of
# of Units
Measure
Lead Time to
Increase
Production 50%
Lead Time to
Double
Production
Factors Preventing Production
Increase
Other Products
Maximum Production
Unit of
# of Units
Measure
Lead Time to
Increase
Production 50%
Lead Time to
Double
Production
Factors Preventing Production
Increase
1.
2.
3.
C. 4.
5.
6.
7.
8.
9.
10.
Manufacturing Capacity Utilization
Product Area
2007
2008
2009
2010
1.
2.
3.
D. 4.
5.
6.
7.
8.
9.
10.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
38
Section 4.e
Critical Commodities - Utilization
Based on the products identified in the Section 2, indicate your company's manufacturing capacity utilization rate for each product area from 2007-2010. Indicate your
company's maximum annual manufacturing capacity in units for 2009. In addition, using your company's 2010 production as a baseline, estimate the lead time required to
increase production of each product area by the specified amount. For the purpose of this estimate, make the following assumptions:
1) Existing U.S. production facilities are to be operated at maximum practical productive capacity;
2) Labor availability reflects normal local market conditions;
3) Material availability reflects normal local market conditions; and
4) Facilities operate at the maximum rate possible given technological constraints.
Finally, from the drop-down list provided, select the primary factor that would prevent a production increase, if applicable.
Note: If your company does not manufacture a product in a particular product area, you may leave it blank.
Surgical and Medical Instruments
Maximum Production
Manufacturing Capacity Utilization
Lead Time to
Product Area
Increase
Unit of
2007
2008
2009
2010
# of Units
Measure Production 50%
1.
2.
3.
4.
5.
6.
7.
8.
A. 9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
Lead Time to
Double
Production
Factors Preventing Production
Increase
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
39
Section 5
Global Trade and Customer Distribution
If your company imported any health-related components, manufacturing materials, or finished products from the list in Section 2 from 2007-2010,
provide the HS-10 code used, a description of the product(s), and the total value of the imported commodities. If your company utilized more than ten
HS codes, only identify the top ten by total import value.
Note: Harmonized Tariff Schedule (HTS) codes (10-digit) can be found at "HTS Online Resource Tool" located under "Research Tools" at
http://www.ustic.gov/index.htm.
2007-2010 Import Value
Product Description(s)
HS-10 Code
1.
A. 2.
3.
4.
5.
6.
7.
8.
9.
10.
Indicate the percentage of your healthcare-related products that are sold in the United States to the following entities from 2007-2010:
2007
2008
2009
2010
Hospitals
Ambulatory Services
Clinics
Pharmacies
B. Distributors/Wholesalers
State/Local Governments
Federal Government
Other (specify)
Other (specify)
Other (specify)
Total (Must Equal 100%)
0%
0%
0%
0%
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
40
Section 6.a
Supplier Selection Criteria
Cost
Domestic Source
Non-U.S. Source
Product Packages (e.g., bundles of multiple products from the
same supplier)
Delivery Logistics/Speed
Identify the top five criteria your company
Sole Supplier/Unique Products
considers when selecting suppliers for
Substitute for a Critical Product
A. healthcare-related components,
Product Quality/Manufacturing Processes
manufacturing materials, and finished
Product Effectiveness (e.g., fewer side effects, higher success
products.
rate)
Product Availability
Terms of Payment
Other (specify)
Other (specify)
Other (specify)
Does your company maintain long-term contracts with its suppliers? Explain below.
B.
If 'Yes,' indicate how long, on average, these contracts last.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
41
Section 6.b
Supplier Contracts
Does your company include "disruption clauses" in contracts with U.S.-based and non-U.S. based
suppliers? If 'Yes,' explain the details of these clauses below (see the Definitions page for an
explanation of disruption clauses).
A.
B.
Does your company include "surge capacity provisions" in contracts with U.S.-based and non-U.S.
based suppliers? If 'Yes,' explain the details of these clauses below (see the Definitions page for an
explanation of surge capacity provisions).
U.S.-Based
Non-U.S. Based
U.S.-Based
Non-U.S. Based
Does your company require production forecasting requirements in contracts with your suppliers? If 'Yes,' explain what
these requirements entail below.
C.
D.
Has your company ever been a party to a rated order? A rated order is a prime contract, a subcontract, or a purchase order
in support of an approved program issued in accordance with the provisions of the Defense Priorities and Allocations
System (DPAS) regulation (15 CFR part 700). If 'Yes,' explain the details below.
Does your company have visibility into your suppliers' operations and inventory? If 'Yes,' identify what information your
company has access to below.
Current production capacity
Identification of their suppliers
E. Company Certifications
Location of their suppliers
Maximum production capacity
Other (specify)
Inventory levels
Other (specify)
Raw material supplies
Other (specify)
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
42
Section 7.a
Inventory Information
Does your company maintain an inventory for healthcare-related components, manufacturing
materials, and/or finished products?
On average, what is the normal supply level of finished, manufactured products normally kept in
inventory?
A.
On average, what is the normal supply level of components and manufacturing materials products
normally kept in inventory?
If your company maintains an inventory of healthcare-related components, manufacturing materials, and/or finished products, explain how
certain commodities are selected for inventory over others.
B.
C.
Does your company maintain a list of approved alternate supply sources for critical components,
manufacturing materials, and/or finished products?
Does your company maintain relationships with multiple suppliers of the same product expressly
as a contingency against supply disruptions? Explain your response.
Does your company use or manufacture any critical components, manufacturing materials, or
finished products that cannot be placed in inventory for any reason? If "Yes," identify the product,
its use, and the reason why it cannot be placed in inventory.
Product
Product's Use
D. 1.
2.
3.
4.
5.
Reason It Cannot Be Placed in Inventory
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
43
Section 7.b
Supply Disruptions and Shortages
Has your company had any significant supply disruptions or shortages for critical components, manufacturing materials, and/or
finished products from 2007-2010?
If 'Yes,' identify the component/material/product, supplier, country, describe the issue, and detail how this product is used by your company.
Disruption Duration
Component/Material/Product
Explanation of Supply Disruption
Product Application
Supplier Name
Supplier Country
(In Days)
1.
2.
A. 3.
4.
5.
6.
7.
8.
9.
10.
Does your company foresee a potential risk of a supply disruption or shortages for critical components, manufacturing materials,
and/or finished products in the near future? Explain your response.
B.
Does your company believe that it is vulnerable to serious and/or prolonged supply chain disruptions? Explain your response.
C.
Is your company taking steps to reduce its vulnerability to supply chain disruptions? Explain your response.
D.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
44
Section 7.c
Supply Disruptions and Shortages
From 2007-2010, has your company experienced a supply disruption as a result of a transportation problem? If "Yes," describe
the incident(s) below, indicating the disruption duration and the effect on your company.
Incident Description
Effect on Company
Duration (in days)
1.
A.
2.
3.
4.
5.
Are there any U.S. Government regulations or processes that hinder your company's ability to maintain a secure, continuous
supply chain? If 'Yes,' identify these regulations or processes below.
B.
C.
Are there any non-U.S. Government regulations or processes that hinder your company's ability to maintain a secure,
continuous supply chain? If 'Yes,' identify these regulations or processes below.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
45
Section 8
Cross-Sector Impacts
Are there any steps the U.S. government can take to reduce foreign dependency issues for healthcare-related products?
Explain your answer.
A.
Is your company taking any steps to reduce its exposure to foreign dependency issues? Explain your answer.
B.
What factors does your company take into account when deciding to purchase and/or outsource overseas? Explain your answer.
C.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
46
Section 9.a
Financial Health
Report select line items from your company's financial statement for years 2007-2010. From the drop-down indicate whether the reported
income statement and balance sheet select line items are Business Unit/Division or Corporate/Whole Company financials.
Note: Business Unit/Division financials are preferred.
Note: Calendar year data is preferred.
Source of Financial Line Items:
Reporting Schedule:
Income Statement (Select Line Items)
A.
B.
C.
D.
E.
F.
G.
H.
I.
2007
Record in $ Thousands, e.g. $12,000.00 = survey input of $12
2008
2009
2010*
2007
Record in $ Thousands, e.g. $12,000.00 = survey input of $12
2008
2009
2010*
Net Sales (and other revenue)
Cost of Goods Sold
Total Operating Expenses
Total Operating Income (Loss)
Total Other Income (Expenses)
Earnings Before Interest and Taxes
Interest Expense
Income Tax Expense
Net Income
Balance Sheet (Select Line Items)
A. Cash
B. Marketable Securities
C. Accounts Receivable
D. Inventories
E. Total Current Assets
F. Property, Plant, and Equipment
G. Total Non-Current Assets
H. Total Assets
I. Accounts Payable
J. Total Current Liabilities
K. Long-Term Debt (less current portion)
L. Total Non-Current Liabilities
M. Total Liabilities
N. Total Owner's Equity
* If data is not available for 2010, please provide estimates.
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
47
Section 9.b
Financial Health
Use the space below to qualify with narrative any anomalies, transactions, or non-recurring events reflected in your financial
statement line items, e.g. reporting restatement, merger and acquisition, chapter 11, SEC investigation, etc.
A.
2007
B.
2008
C.
2009
D.
2010
Comments:
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
48
Section 10
Certification
The undersigned certifies that the information herein supplied in response to this questionnaire is complete and correct to the best of
his/her knowledge. It is a criminal offense to willfully make a false statement or representation to any department or agency of the United
States Government as to any matter within its jurisdiction (18 U.S.C.A. 1001 (1984 & SUPP. 1197))
Company Name
Company's Internet Address
Name of Authorizing Official
Title of Authorizing Official
E-mail Address
Phone Number and Extension
Date Certified
If POC is different from the above named, include below:
Point of Contact Name
Title of Point of Contact
E-mail Address
Phone Number and Extension
Would you like a free copy of the final report?
In the box below, please provide any additional comments or any other information you wish to include regarding this assessment.
How many hours did it take to complete this survey?
BUSINESS CONFIDENTIAL - Per Section 705(d) of the Defense Production Act
49
| File Type | application/pdf |
| File Title | HPH Manufacturers - 083010.xls |
| Author | CNelson |
| File Modified | 2010-09-03 |
| File Created | 2010-09-03 |