**Amendment #2 (Questions & Answers)**

"NIAID Division of Microbiology and Infectious Diseases: Clinical Agent
and Specimen Repository"

**This Amendment provides questions submitted by potential offerors and
the responses provided by the NIAID. The responses are offered for
information only and do not modify or become part of this solicitation.
The cutoff date for questions has been set at November 30, 2007.**

+----------------------+-----------------------------------------------+
| **Amendment No.:**   | 2 (1^st^ Posting)                             |
+----------------------+-----------------------------------------------+
| **Amendment Issue    | November 15, 2007 (Questions 1 -- 22)         |
| Date:**              |                                               |
+----------------------+-----------------------------------------------+
| **Proposal Due       | December 21, 2007, at 4:00 P.M., EST          |
| Date/Time:**         | **(UNCHANGED)**                               |
+----------------------+-----------------------------------------------+
| **Issued By:**       | Brian Jamieson                                |
|                      |                                               |
|                      | Contract Specialist                           |
|                      |                                               |
|                      | OA/DEA/NIAID/NIH/DHHS                         |
|                      |                                               |
|                      | 6700-B Rockledge Drive, MSC 7612              |
|                      |                                               |
|                      | Bethesda, Maryland 20892-7612                 |
+----------------------+-----------------------------------------------+
| **Points of          | Brian Jamieson, Contract Specialist           |
| Contact:**           |                                               |
|                      | e-mail: <bjamieson@niaid.nih.gov>             |
|                      |                                               |
|                      | Yvette Brown, Contracting Officer             |
|                      |                                               |
|                      | e-mail: <ybrown@niaid.nih.gov>                |
+----------------------+-----------------------------------------------+

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**Offerors must acknowledge receipt of the [final posting of Amendment
#2]{.underline}, on each copy of the proposal submitted. Failure to
receive your acknowledgment of this Amendment may result in the
rejection of your proposal.**

**The hour and date specified for receipt of proposals HAS NOT been
extended.**

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THE FOLLOWING PAGES PROVIDE ANSWERS CONCERNING A NUMBER OF INQUIRIES WE
HAVE RECEIVED FOR THE ABOVE NUMBERED ACQUISITION:

[Question 1]{.underline}

Will the Government provide an inventory of existing supplies for
clinical trials materials (CTM)?

[Response]{.underline}

***The requirements set forth in the RFP outline the amount and type of
space needed to store all material, and should be the basis for the
offerors proposal. The Government will provide a CTM inventory to the
successful offeror upon award.***

[Question 2]{.underline}

Will the anticipated scope of services require working with select agent
samples or clinical specimens that might contain viable, highly
hazardous, etiologic agent(s)? What bio-safety level (BSL) practices,
equipment, or specialized engineering controls will be needed to store,
aliquot, or otherwise work with such specimens, BSL 2, 3, 4?

[Response]{.underline}

***Select agent handling under this contract will be minimal and limited
to shipping. It is anticipated that no more than 1-2 shipments per year
will include select agents, and it is unlikely that anything over BSL-2
will be shipped. Note that the repository will not be required to have
BSL-2 space on site, nor is inclusion of BSL-2 space a requirement for
this RFP.***

[Question 3]{.underline}

The RFP does not mention transition of Government property. In order to
adequately determine the scope of the project, will the Government
please identify what, if any, equipment will be provided to the
successful offeror, and when will that equipment be provided?

[Response]{.underline}

***There will not be any Government property transitioned under this
RFP.***

[Question 4]{.underline}

Does the Government's 60-day transition period include the transfer of
Government property other than specimens and samples? Additionally, the
volume of specimens and samples, as well as the preparation of the
successful offeror's facilities may require a longer transition period
than 60 days. It is recommended that the Government consider a
transition period of 120 days.

[Response]{.underline}

***Transfer will include specimens and samples. There will be no
government property transferred. Due to the critical nature of this
repository in supporting clinical trials throughout the world, the
transition must occur as rapidly as possible in order to minimize the
time during which specimens and samples are located at two different
storage facilities. Therefore, the transition period will remain at
60-days, and Offerors should propose accordingly.***

[Question 5]{.underline}

Section M.2. PRE-AWARD SITE VISIT OR SITE AUDIT states, "If audits are
performed during the negotiations, the results of the audits will be a
factor in final selection for award of a contract."  Can the government
please clarify how plans to bring an existing repository to sufficient
capacity contingent on contract award would be factored in the
evaluation?

[Response]{.underline}

***In those instances where the offeror plans to bring an existing
repository to sufficient capacity contingent on contract award, the
audit will focus on details of the plans for how the offeror plans to
ensure that the repository design is feasible and will meet all
requirements as outlined in the contract. Details include specific
IQ/OQ/PQ plans, back-up generator plans, room designs, etc.***

[Question 6]{.underline}

What is the acceptable timeframe for obtaining FISMA certification of
information systems used for the DMID repository.

[Response]{.underline}

***The following link provides guidance regarding FISMA
certification:***
<http://csrc.nist.gov/drivers/documents/FISMA-final.pdf>***. Offerors
should have a basic plan of their general infrastructure and policy at
the time of proposal. A complete plan is not required until 60-90 days
after award.***

[]{.mark}

[Question 7]{.underline}

The contract requires testing of acquired clinical agents as outlined in
Federal Regulations 21CFR610 and 21CFR211. Please specify: What are the
tests? How many and what categories of agents need testing?

[Response]{.underline}

***During the course of the contract, a variety of different types of
products are likely to require this type of testing, including biologics
and small molecules.*** ***For proposal purposes, please assume three
biological products each year will be obtained that require the
following testing: sterility, mycoplasma, and PCR for HCMV. Also assume
one lot of Guanadrel Sulfate which must be tested according to USP each
year.***

[Question 8]{.underline}

How many and what categories of agents will need additional in vitro and
in vivo safety testing?

[Response]{.underline}

***A variety of different types of products are likely to require this
type of testing, including cell banks and biologics. For proposal
purposes, please assume two cell banks each year will require both in
vivo and in vitro adventitious agent testing as outlined in the Sept.
2006 FDA Draft Guidance for Industry: Characterization and Qualification
of Cell Substrates and Other Biological Starting Materials Used in the
Production of Viral Vaccines for the Prevention and Treatment of
Infectious Diseases***.

[Question 9]{.underline}\
What classification of clean rooms are required for aliquoting?

[Response]{.underline}\
***For clinical specimens, a classified clean room is not a requirement.
Offerors should describe where/how they will aliquote material to
minimize chance of contamination.\
***

[Question 10]{.underline}\
How are clinical agents, clinical samples, and clinical trial materials
presently labeled?

[Response]{.underline}

***These items are currently labeled according to cGMP. Offerors should
propose to label materials as outlined in the RFP according to cGMP
requirements***.

[Question 11]{.underline}

Concerning shipment and distribution of clinical agents:

-   What is the monthly shipment frequency, and how many requests are
    normally required to be processed concurrently?

[Response]{.underline}

***These items are currently labeled according to cGMP. Offerors should
propose to label materials as outlined in the RFP according to cGMP
requirements***.

-   What is the monthly shipment frequency, and how many requests are
    normally required to be processed concurrently?

[Response]{.underline}

***On average, 15 shipments are made per month. Number of shipments
processed concurrently will vary significantly, but can range from 0-5,
with 1-2 being most common.***

-   Are there seasonal variations in shipment frequency; if so, please
    characterize the variability.

[Response]{.underline}

***While there can be significant month-to-month variability in
shipping, it is not seasonal***.

Concerning clinical specimens:

-   How many shipments are received each month, if there are seasonal
    variations, will the government please characterize the variability?

[Response]{.underline}

***For the purposes of this question, a shipment is defined as 1 9x9
grid box. Approximately 80 shipments are received per month. While there
can be significant month-to-month variability, it is not seasonal***.

-   What is the required monthly frequency for shipment and distribution
    (RFP Attachment 3,

page 11, 3) and if there are seasonal variations, will the government
please characterize the variability?

[Response]{.underline}

***For the purposes of this question, a shipment is defined as 1 9x9
grid box. Approximately 35 shipments are sent per month. While there can
be significant month-to-month variability, it is not seasonal.***

-   Attachment 3, page 10 of 24, B.1.d. requires specimen confirmation
    at the vial level. Is this confirmation based solely on labels or is
    other testing required?

[Response]{.underline}

***Label verification is sufficient.***

[Question 12]{.underline}

In attachment 3, Section A. part 1, statement F, it is stated that 4 --
6 -194º C tanks with a capacity to hold approximately 50,000 vials is
needed. Please clarify vial size? Also, is 50,000 the total capacity
needed overall, or per tank?

[Response]{.underline}

***There was an error in this sentence. The capacity should be 25,000
vials per tank. Vial size is 2.0ml cryovials.***

[Question 13]{.underline}

A.2.e, Provide and maintain the necessary clean room(s) and equipment
for packaging and repackaging of clinical agents, as well as facility
space to label under cold chain conditions in compliance with cGMP. For
costing purposes, please clarify the term "clean". Additionally in
section B.2.a, what standards of clean are expected?

[Response]{.underline}

***Packaging and re-packaging of clinical agents should be done
according to cGMP, including use of appropriate facilities. For proposal
purposes, assume the task is over-encapsulation of caplets and
subsequent packaging in blister packs for the purposes of blinding a
study. For clinical specimens (B.2.a), a classified clean room is not a
requirement. Offerors should describe where/how they will aliquot
clinical specimens to minimize chance of contamination.***

[Question 14]{.underline}

A.2.g, Provide one sample, if requested, of each of the repackaged,
labeled clinical agents to the Project Officer for approval prior to
completion of labeling functions and prior to the distribution to the
DMID-funded clinical research sites and DMID approved testing
laboratories. These samples shall be submitted to the Project Officer
for review either the same day they are generated or, at the latest, the
day following receipt of the request from the Project Officer. The
Project Officer will provide comments within 2 business days of receipt
of the sample. If samples are not approved by the Project Officer,
corrections shall be made until the Project Officer approves the sample.
Please clarify if this approval requirement is applicable for label
proofs or actual clinical product samples?

[Response]{.underline}

***This requirement is for label proofs.***

[Question 15]{.underline}

A.3.a. Within 10 business days of receipt of request from the Project
Officer, conduct validation testing of the procedures for the packaging
and shipping of clinical agents under appropriate temperature conditions
ranging from -194°C to controlled room temperature, U.S. Pharmacopeia
(USP) specified conditions, as well as the conditions required for
controlled substances (as defined by the U.S. Drug Enforcement Agency),
biologics, ethanol-containing products, electronic devices, infectious
agents, hazardous goods, and for products sensitive to air pressure,
humidity, vibrations, and carbon dioxide.

A.5.e., Possess and maintain appropriate licenses and permits required
by local, state, province, domestic, and non-domestic, country-specific
government authorities for the safe import, storage, handling,
transportation, and distribution of drugs, biologics, controlled
substances and devices. Process any document requiring embassy approval
through the appropriate embassy. Obtain the appropriate

interstate, intrastate and non-domestic import/export shipping licenses
and permits for transporting drugs, biologics, controlled substances,
and devices. References are made to handling controlled substances,
which schedules will be included?

[Response]{.underline}

***It is estimated that very few shipments of only small amounts of
Schedule II-V substances will be performed under this contract.***

[Question 16]{.underline}

A.8.a and A.8.b, a. Acquire clinical agents manufactured in compliance
with cGMP regulations from product manufacturers approved by the Project
Officer. The acquisition shall include clinical agents at all stages of
development, such as: i. Pilot lot material; ii. Bulk substance; iii.
Master and working cell banks; and iv. Final drug product.

b\. Carry out all necessary testing of acquired clinical agents as
outlined in Federal Regulations 21CFR610 and 21CFR211 and as requested
by the Project Officer. Our understanding is that most clinical agents
acquired have been manufactured in compliance with cGMP regulations and
therefore all necessary testing as outlined in Federal Regulations
21CFR610 and 21CFR211 has been completed, prior to arrival at the
repository; please clarify the contractor's responsibility for this
testing beyond this point.

[Response]{.underline}

***In most instances, products will have been tested prior to delivery;
in some cases, the testing may be included as part of the contract to
procure the items. However, there will be exceptions. For proposal
purposes, please assume three biological products each year will be
obtained that require the following testing: sterility, mycoplasma, and
PCR for HCMV. Also assume one lot of Guanadrel Sulfate which must be
tested according to USP each year. Offerors are reminded that
capabilities required under this RFP may be proposed via
subcontracts.***

[Question 17]{.underline}

B.1.f. Track and record contents and condition of the shipments.
Electronically document chain of custody, shipment receipt date,
condition and inspection of specimens and shipments, storage and
monitoring of clinical specimens from DMID-funded clinical research
sites. Provide a summary report of shipments received in the Monthly
Progress Reports. Please clarify the depth of chain of custody.

[Response]{.underline}

***They need to document back to the organization that produced the
material and all the parties along the way.  It would be expected that
this information would be provided by the sender.***

[Question 18]{.underline}

C.1.b. Where applicable, ensure the conduct of work in accordance with
DHHS regulations regarding the transfer of Select Agents (U.S. Code of
Federal Regulations 42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R.
Part 121 (http://www.cdc.gov/od/sap/index.htm)). Please define what
volume and level of select agents will be handled under this contract?

[Response]{.underline}

***Select agent handling under this contract will be minimal. It is
anticipated that no more than 1-2 shipments per years will include
select agents, and it is unlikely that anything over BSL-2 will be
shipped. Note that the repository will not be required to have BSL-2
space on site, nor is BSL-2 space required as part of the proposal.***

[Question 19]{.underline}

C.1.f. Provide complete back-up equipment for maintaining storage
conditions for both clinical agents and clinical specimens at: -194°C,
-80°C, -20°C, or 2°C to 8°C. Please define the term "complete".

[Response]{.underline}

***Offerors should propose back-up system(s) that they think are
sufficient to meet the needs as outlined in the proposal. As indicated
in the RFP, a minimum requirement is a back-up generator. Offerors
should detail plans for how back-up system(s) will be activated, period
of time that the back-up generator can supply power without additional
fuel, as well as what plans will be put in place to ensure generators
can continue to operate for longer periods of time in the event of an
extended electrical power outage.***

[Question 20]{.underline}

C.1.i., Provide a clean agent fire suppression system that is
environmentally acceptable and leaves no residues. Please define what
functional areas are to be covered under the residue-free, fire
suppression system, i.e. ambient temperature storage areas, entire
facility, or other?

[Response]{.underline}

***Areas sufficient to allow complete recovery of operations should be
covered, including storage areas, and any areas which contain key
documentation or other items that would be necessary to track/trace all
material either in the repository or which has been shipped out of the
repository***.

[Question 21]{.underline}

Attachment 5, Section 3.B.5, 5. Training for CASR personnel include
\$4000 per year for training of CASR personnel. Please clarify if the
\$4,000 is per person, per year or for all personnel per year?

[Response]{.underline}

***It is \$4,000 per person per year***.

[Question 22]{.underline}

As referred to in the proposal submission instructions (on page 32,
Section J, List of Attachments) Under Attachment 1: is the number of CDs
requested a typo? And if so, how many are needed?

[Response]{.underline}

***It is correct; you are to furnish 30 CD's.***