GUIDELINES
FOR THE
Step 1 –
REVIEWING THE APPLICATION PACKAGE
The application package contains five forms that must = be completed and returned before USAID/Washington can process the application. A sixth form is provided for reporting the results of your activities.
Note: F= orms marked with “*” c= an be filed on-line.
A.
B.
Ø The cargo will be used solely for humanitari= an purposes
Ø The cargo will not be distributed to persons engaged in military/paramilitary activities
Ø The cargo is in useable condition and suitab= le for transport
Ø The beneficiaries have a legitimate need for= the cargo and the ability to use the cargo safely
Ø General compliance with program guidelines, instructions, and reporting requirements.
C.
D.
E.
F.
A.&n= bsp; Contact USAID/Washington to determine whether t= he proposed activity may be undertaken in the destination country. The USAID/Washington point of cont= act information is provided at the end of these guidelines.
B.&n= bsp; Identify an in-country consignee and/or local contact that will:
Ø Secure host country government WRITTEN approval for the shipment (with English translation)
Ø Arrange with the destination country’s customs officials for formal duty-free entry or to provide tariffs and fees= for entry (with English translation)
Ø Ensure compliance with any and all additional legal requirements of the destination country
Ø Receive and take possession of cargo on arri= val
Ø Distribute the cargo to the beneficiaries.
Note:
Donors are advised that in many nations consignees must be recognized and
approved by the host country government to be eligible to receive the donat=
ed
cargo, particularly when duty-free entry is assigned.
A. CARGO<= /b> -- Requests to transport less than 2,000 or more than 100,000 lbs. cannot be accepted. The total number= of pieces, the total gross weight (pounds) and total gross volume (cubic feet)= of the cargo must be included on the application to permit DoD to determine transportation requirements. The total gross weight number is extremely important and needs to be as accurate as possible (within +/- 2%) -- transportation of your cargo may be delayed bec= ause of weight inaccuracies and any additional weight could be eliminated from y= our shipment. You must also attach a complete itemized inventory of the cargo to be shipped, including a detailed listing by item of quantity, size (volume), and weight. It is recommended that you develop and maintain an itemized contents list per box/container/crate -- this will expedite the U.S. Government's inspection process and customs clearance in the destination country (in certain countries/instances, an itemized listing by container has been required).
Where transportation is requested for vehicles, additional preparatio=
ns
for shipment are required and these are addressed in Step 4.
Note: Very large shipments should be separated into several smaller shipm=
ents
that can be more easily handled, on a space available basis. Very large shipments, and those
including vehicles, take significantly longer to find transport and you, the
donor, must be ready to determine a priority, if partial shipments are made=
.
You may not add new items to the inventory or increase the wei=
ght
of the cargo to be shipped once the application has been submitted. Both U.=
S.
Government and host country approval for these shipments are based on the
information in the application. Shipping unapproved items or even additional
quantities of approved items has caused embarrassment in the past and puts =
the
entire
The following items will <= u>not be approved for shipment:
Ø Passengers or livestock (of any sort)
Ø Hazardous cargo (e.g., explosives, fuels, ot= her highly flammable materials, pressurized gas commodities, alcohol, peroxide, batteries). A list of hazardo= us materials is at the end of these guidelines.
Ø Perishable food commodities
Ø Medical supplies (e.g. pharmaceuticals) with expiration date less than 12 months from the date of application.
Ø Any cargo not categorized as humanitarian re= lief supplies of equipment. Political or religious material is not considered humanitarian cargo.
B.
USAID
GUIDELINES FOR DRUG DONATIONS
1. Drug donations will only be recomm=
ended
for clearance if documentation of the consignee’s review and acceptan=
ce,
denoted by consignee initialing of product manifest and a letter of accepta=
nce
and ability to utilize is included with the
2. All donated drugs or their generic
equivalents should be approved for use in the recipient country and appear =
on
the national list of essential drugs, or if a national list is not availabl=
e,
on the World Health Organization (WHO) Model List of Essential Drugs, unless
specifically requested otherwise by the recipient. Exceptions may be made for products
needed for outbreaks of uncommon or newly emerging diseases when products a=
re
not approved for use in country.
3. The presentation, strength and
formulation of donated drugs should, as much as possible, be similar to tho=
se
commonly used in the recipient country.
4. All donated drugs should be obtain=
ed
from a reliable source and comply with quality standards in both donor and
recipient countries. The majority of pharmaceutical products requested to be
transported to a recipient country from a donor in the United States are
Federal Drug Administration (FDA) approved; hence USAID does not require
documentation certifying safety and effectiveness from donors wanting to se=
nd
US-FDA approved products. Don=
ors
should specify that the products are FDA approved. For non-FDA approved products, the=
WHO
Certification Scheme on the Quality of Pharmaceutical Products Moving in
International Commerce should be submitted.
5. No drugs should be donated that ha= ve been issued to patients and then returned to a pharmacy or elsewhere, or we= re given to health professionals as free samples.
6. After arrival in the recipient cou=
ntry,
all donated drugs should have remaining a shelf life of at least one year. =
For
emergency situations (disaster declared countries, etc.), an exception may =
be
made for direct donations to specific health facilities, provided a respons=
ible
professional at the receiving end is aware of the limited shelf life; and t=
hat
the quantity and remaining shelf life allow for proper administration prior=
to
expiration. In all cases, it =
is
important that the date of arrival and the expiry dates of the drugs be
communicated to the recipient well in advance. In such cases, written
confirmation from the in-country recipient (via e-mail or facsimile
transmission) documenting knowledge of the product’s limited dating b=
ut
validating the need and ability to use the product prior to its expiration =
will
be required. Otherwise, all
products must have a minimum of one-year expiration dating upon arrival in =
the
recipient country.
7. All drugs should be labeled in a
language that is easily understood by health professionals in the recipient
country; the label on each individual container should at least contain the
International Nonproprietary Name (INN) or generic name, batch number, dosa=
ge
form, strength, name of manufacturer, quantity in the container, storage
conditions and expiration date.
USAID requir= es the submission of a subset of the information cited above. The required information should be provided in the manifest in a matrix/table format in the initial application requesting assistance with transport.
8. As much as possible, donated drugs
should be presented in larger quantity units and hospital packs. This depends tremendously on the c=
ountry
and emergency situation. In m=
any
instances, unit-of-use containers may be a much more useful form of packagi=
ng
for the health care providers to use.
In other cases, if the product is going to a consignee (e.g. hospita=
l)
with the capabilities of repackaging, bulk containers may be appropriate
(depending on if the consignee also has materials needed for repackaging).<=
span
style=3D'mso-spacerun:yes'> Documentation attesting to the
consignee’s desires and needs is very important in determining
appropriateness of container sizes.
9. All drug donations should be packe=
d in
accordance with international shipping regulations and be accompanied by a
detailed packing list which specifies the contents of each numbered carton =
by
EXTREMELY
IMPORTANT! This packing list also serves as t=
he
manifest reviewed by OFDA pharmacists.&nbs=
p;
A copy should be provided with submission of the
10. Donations will not be recommended =
for
clearance until an in-country consignee capable of accepting, managing, and
distributing the drug donation has been named and consignee states
willingness to perform said functions.&nbs=
p;
If consignee is not a direct member/associate of the health facility,
which will receive and use the donation, the consignee should obtain this
concurrence from the health facility.
11. In the recipient country, the decl= ared value of a drug donation should be based upon the wholesale price of its generic equivalent in the recipient country, or, if such information is not available, on the wholesale world market price for its generic equivalent.<= /span>
A.
The Department of Defense will make every reasonable attempt to
identify space available transportation in a timely manner. The Department =
of
Defense, however, will not be responsible for transporting by a certain date
because of a need to vacate a storage facility. In this regard, please note that
transportation schedules are subject to change with little or no notice.
B. INSPEC= TION: All cargo will be inspected by an authorized U.S. Government representative, after which the containers shall= be sealed. The US Government will inspect and certify the cargo for quality and/= or serviceability (typically, a sample set) and will inspect all cargo = to the extent necessary to ensure transportability and safety. Inspection wil= l be arranged by USAID prior to final approval of the application. You will be notified of the time a= nd date of the inspection.
C.
D.
A.&n=
bsp; =
;
GENE=
RAL
CARGO: The donor must ensure th=
at
general cargo is placed in strong, durable, unsealed boxes or crates. Since
cargo awaiting DoD transportation is often placed outside, containers shoul=
d be
prepared to prevent mildew, water damage, and insect infestation. All containers must be palletized =
for
handing by forklift. Ideally,=
the
pallets should have length/width/height dimensions of 48" x 48" x
48”. Specially built crates for larger pieces must be built for forkl=
ift
handling. No specially built
containers can exceed the dimensions outlined above. Containers secured on pallets shou=
ld be
built up to a height as specified by the Department of Defense officials on=
ly
after the cargo is inspected and final approval by USAID is received.
B.=
=
VEHI=
CLES: V=
ehicles
and other motorized items (generators, etc.) require special preparation for
shipment by DoD. These items =
must
be clean and in good operable condition.&n=
bsp;
Dirty, inoperable, or leaking equipment will not be accepted for
transport. To ensure maximum utility to the beneficiaries, vehicles should =
have
less than 80,000 miles of service.
Vehicles with more than 80,000 miles of service may not be accepted =
for
shipment. Vehicles that requi=
re a
specially trained operator will not be accepted for transport. Specific regulations for the
transportation of vehicles are developed by the U.S. Air Force and are
dependent on exact method of transportation, safety of flight, and security
concerns. You will be contact=
ed by
a U.S. Government representative, before you deliver the vehicle(s) to the =
port
of embarkation (
C. &nb= sp; LABELI= NG: Each and every container must be m= arked sequentially by number, for example: Container 1 of 20, Container 2 of 20, etc. A final inventory using = this numbering system, as an index, must be submitted to the Department of Defense prior to pick up of the cargo. When final approval has been granted, USAID will requ= est the Department of Defense to make transportation arrangements. The
Department of Defense will=
provide
you a Transportation Control Number (TCN) number that is unique to that
shipment. This number is assigned to assist the Defense Transportation Syst=
em
in tracking the cargo as it is transported to its destination. The TCN must be stenciled or marked
clearly on each box or item of the cargo in indelible ink.
Note: You should labe=
l all
containers and secure them, as necessary, on pallets with shrink-wrap or
banding only after receiving instructions from the DoD on the
Transportation Control Number (TCN).
Container Labeling Require= ments: All containers must be stenciled or marked in indelible ink with the follow= ing information:
FROM: (Donor Name and Organization, if applicable)
DONOR TELEPHONE NUMBER:
TO: (Consignee Name and Organization and Telephone Number)
CONTAINER __________ of_______________
You should submit an application only after the actions Steps 1 through 4 have been completed.&nbs= p; The application (if not done electronically) should be mailed to:
DCHA/PVC/PDM Attn: Denton = Program Officer
Telephone: (301) 424-6888<= /p>
E-mail: dalzouma@usaid.gov
Once your application is received, USAID will determine
whether the application is consistent with
Note: Applicat=
ion
approval does not obligate the
The Department of Defense will notify you regarding the estimated date, time and location of departure. Cargo must be transported, = at your expense to the departure location, within the timeframe specified by t= he Department of Defense.
Prior to cargo arrival in the destination country, the= DoD will inform you of its Estimated Time of Arrival (ETA). You must communicate this ETA to t= he consignee to ensure that the consignee will attend to the cargo without del= ay, after it has arrived.
The consignee must take possession of the cargo and en= sure that the cargo clears customs and other legal requirements of the destinati= on country after the cargo’s arrival. The consignee must arrange for sufficient vehicles, on-load equipment, and personnel to fulfill this responsibility. The U.S. Embassy in the country will be informed of schedul= ed arrival of cargo at the port of debarkation and will also be provided with information regarding the consignee and his responsibilities.
The consignee will remove the cargo from the port of debarkation and distribute the items to the targeted beneficiaries. The consignee and the donor must be aware that the program has no funding for w= arehousing in the destination country. Expeditious removal of the cargo from the seaport/airport area is required. Failure to claim cargo promptly prevents other shipments from entering the port, and can lead to confiscation by loc= al officials and/or destruction.
Once the consignee takes possession of the cargo, the consignee is responsible for the timely distribution of the cargo to the targeted beneficiaries in accordance with the distribution plan. Cargoes mu= st be distributed on a non-commercial basis, free of cost to the person or per= sons receiving the goods.
You must submit an After Action Report (AAR) to USAID =
within
30 days after the cargoes are distributed describing, in detail, how the ca=
rgo
was distributed, to whom, and how the humanitarian assistance supplies were
used. The
Note: Failure to submit an AAR in a time=
ly manner
may result in your disqualification from future participation in the
Each
application and all required forms must be submitted and approved by the
Note: Incomplete applica=
tions
and forms will be returned.
Please submit=
the
application and all required forms to:
DCHA/PVC/PDM Attn: Denton = Program Officer
Tel: (301) 424-6888
E-mail: = dalz= ouma@usaid.gov
Required form=
s:
Denton Program Application= (available electronically)
Certification of Complianc= e (available electronically)
Release from Liability (available electronically)
Certification of Country A= pproval
Consignee Affidavit (requi= red to be notarized)
Packing list (available electronically)
After Action Report (available electronically)
Hazardous
Materials
This list of hazardous materials covers most of the ma= jor categories, but is not all inclusive.
- Any substance or article (includin=
g a
device) that is designed to function by explosion. Example: Fire works, blasting caps,
explosive charges of any type.
- Any material that is a gas (boiling
point) at 68 degrees F or less and has a pressure of 14.7 pounds per square
inch. Example: Propane cookin=
g gas.
- A flammable liquid is any liquid h=
aving
a flash point equal to or below 141 degrees F. Example: Cigarette lighter fluid.<=
span
style=3D'font-size:12.0pt;mso-bidi-font-size:10.0pt'>
- Flammable Solids consist of solids,
which are readily combustible under conditions encountered in transport, or=
may
cause or contribute to fire through friction. Example: Book, card or strike-on-t=
he-box
matches.
- Liquids or solids that are prone to
spontaneous heating under normal conditions encountered in transport or hea=
ting
with air and thus are liable to ignite.
- Solids liable to become spontaneou=
sly
flammable or emit flammable gases when they come into contact with water.
.
- A refrigerated liquefied gas havin=
g a
boiling point colder than –130 degrees F at 14.7 pounds per inch. Example: Medial chemicals used for
freezing.
- A material that may cause or enhan=
ce the
combustion of other material, generally by yielding oxygen. Example: Washing detergent.
- A substance prone to explosive
decomposition or rapid burning; be sensitive to impact or friction; reacts
dangerously with other material; or cause damage to the eyes.
- A material, other than gas, which =
is
known to be so toxic to humans as to afford a hazard to health during
transportation. Example: Rat =
and
mice poisons, insect poisons.
- A substance that has a microorgani=
sm, or
toxin, which may cause disease in humans or animals. Example: Bio-medical samples.
- Any manufactured instrument or art=
icle
such as clocks, electronic tube or apparatus, or similar instrument or arti=
cle
having radioactive material as a component part.
- A liquid or solid that causes
destruction or irreversible alterations to human skin. Example: Vehicle battery acid.
- Magnets of any type.
- Compress gas of any type. Example: Oxygen tanks used for med=
ical
treatments.
- Refrigerant gas used in home type
refrigerators.
- Any type of batteries, wet or dry =
cell.