**Amendment #4 (Questions & Answers)**

RFP-NIH-NIAID-DMID-08-05

"Division of Microbiology and Infectious Diseases: Regulatory Affairs
Support"

**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.**

+------------------------------+---------------------------------------+
| **Amendment to Solicitation  | RFP NIH-NIAID-DMID-08-05              |
| No.**                        |                                       |
+------------------------------+---------------------------------------+
| **Amendment No.:**           | 4                                     |
+------------------------------+---------------------------------------+
| **Amendment Issue Date:**    | September 20, 2007                    |
+------------------------------+---------------------------------------+
| **Proposal Due Date/Time:**  | October 29, 2007, 4:00 P.M., EST      |
+------------------------------+---------------------------------------+
| **Issued By:**               | Yvette Brown                          |
|                              |                                       |
|                              | Contracting Officer                   |
|                              |                                       |
|                              | OA/DEA/NIAID/NIH/DHHS                 |
|                              |                                       |
|                              | 6700-B Rockledge Drive, Room 3214     |
|                              |                                       |
|                              | Bethesda, Maryland 20892-7612         |
+------------------------------+---------------------------------------+
| **Points of Contact:**       | Gehmelle L. Johnson, Contract         |
|                              | Specialist                            |
|                              |                                       |
|                              | 301-451-3689                          |
|                              |                                       |
|                              | gj73g@nih.gov                         |
+------------------------------+---------------------------------------+

![](media/image1.png){width="6.25in" height="0.10416666666666667in"}

**Offerors must acknowledge receipt of [Amendment #4]{.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.

Please note that the Question and Answer period has ended and this is
the last amendment posting

for Questions and Answers.

![](media/image1.png){width="6.25in" height="0.10416666666666667in"}

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

> **[Question 1]{.underline}**
>
> On p. 32, under e. ESTIMATE OF EFFORT, it states, **"...**the
> Government considers the effort to be approximately 9.2 full time
> equivalents." Is this estimate 9.2 full time equivalents for each
> year?

**[Response 1]{.underline}**

Yes

> **[Question 2]{.underline}**
>
> Does NIAID anticipate having any full time equivalents onsite at any
> NIH facility; if so, please clarify the location(s) and requirement?

**[Response 2]{.underline}**

> For proposal purposes, assume 1 FTE on site at DMID/NIAID to provide
> regulatory support. Location is: 6610 Rockledge Drive, Bethesda, MD
> 20892.
>
> **[Question 3]{.underline}**
>
> Reference Attachment 6, Section 3, 1. A, no. 9. For pricing purposes
> can you provide the CONUS/ONCONUS locations for the audit/site visits,
> duration of visit, and number of people expected to conduct the
> audit/site visits?
>
> **[Response 3]{.underline}**
>
> For 3.1.A.9 assume 2 individuals will be on site for two days for each
> audit/visit. Two audits/visits will occur in Vienna, Austria; one
> audit/visit will occur in San Diego, CA; the audit/visit for Durham,
> NC is in the preparation stages.
>
> **[Question 4]{.underline}**
>
> Reference Attachment 6, Section 3, 1. B, no. 7. For pricing purposes
> can you provide the CONUS/ONCONUS locations of the audit/site visits,
> duration of visits and the number of people expected to conduct the
> audit/site visits?
>
> **[Response 4]{.underline}**
>
> Assume 2 individuals per audit/visit. Audits/visits will be for two
> days on site. Two audits/visits will occur in Vienna, Austria; one
> audit/visit will occur in San Diego, CA; one audit /visit will occur
> in Durham, NC.
>
> **[Question 5]{.underline}**
>
> Is there a reading room under this requirement?
>
> **[Response 5]{.underline}**
>
> No.
>
> **[Question 6]{.underline}**
>
> What is the current contract value for the incumbent?
>
> **[Response 6]{.underline}**
>
> Please refer to Freedom of Information Act website at
> http://www.usdoj.gov/oip/index.html.
>
> **[Question 7]{.underline}**
>
> Does the Government anticipate a Cost-Plus-Fixed-Fee (CPFF) contract?
>
> **[Response 7]{.underline}**
>
> It is anticipated that the award from this solicitation will be a
> multiple-year cost reimbursement type completion contract.
>
> **[Question 8]{.underline}**
>
> *Section L.1.c.(2) (page 32): The small business size standard is 500
> employees.* Could you please clarify the size standard for the
> applicable NAICS code for this acquisition (541990), i.e., is it
> \$6.5M or 500 employees?

**[Response 8]{.underline}**

The NAICS code for this acquisition is 541990 with a size standard of \$
6.5M.

**[Question 9]{.underline}**

> *Attachment 6, Section 3.1.B.(7) (page 102): Regulatory Audits: A
> total of 4 two-day audits/site visits per year*. Could you please
> clarify whether it is 4 two-day audits total per year or 4 two-day
> audits, per site, per year?
>
> **[Response 9]{.underline}**
>
> A total of 4-two day audits/visits will occur per year.
>
> **[Question 10]{.underline}**
>
> *Attachment 6, Section 3.1.B.(8) (page 102): Regulatory Educational
> and Training Activities.* What percentages of the activities are
> international?
>
> **[Response 10]{.underline}**
>
> Assume each year that 1 of the protocol-specific clinical investigator
> meetings (Attachment 6, Section 3.1.B.(8.ii) will be international.
> All other activities will be within the U.S.
>
> **[Question 11]{.underline}**
>
> *Attachment 6, Section 4(1) (page 104): Small Business Subcontracting
> Plan. Section L of the RFP specifies the minimum documentation
> requirements for completing a subcontracting plan. **This plan should
> be turned in with the original proposal.***
>
> *Section L.1.b (page 32): Subcontracting Plan*. ***The offeror's Small
> Business Subcontracting Plan shall not be submitted with the initial
> business proposal**. Only the apparent successful offeror will be
> required to submit an acceptable subcontracting plan.*
>
> Could you please clarify when the Small Business Subcontracting Plan
> should be submitted?

**[Response 11]{.underline}**

The Subcontracting plan should not be submitted with the initial
business proposal.

**[Question 12]{.underline}**

> *Section 3 of Uniform Cost Assumptions, part 3:* The RFP describes
> hardware and software required to "accept data" for the system.  It
> specifies both "CTi.Crypto20.DLL" and "CTi FolderWatcher" in software.
>  These are not common Commercial Off The Shelf (COTS) server
> applications.  Should the Contractor assume they are custom modules
> provided by OTIS or a third party vendor?  If so, please clarify
> whether the Contractor is expected to cost out the purchase price of
> this software or handle this in another way.
>
> **[Response 12]{.underline}**
>
> "CTi.Crypto20.DLL" and "CTi FolderWatcher" are custom modules that
> will be provided to the offerors by DMID. Offerors should not propose
> costs associated with purchase of this software.
>
> **[Question 13]{.underline}**
>
> *Technical Requirements Section  4.A.1 (pp 77) "DMID Regulatory
> Management Database System**"**:*
>
> This section details the maintenance of the existing HSROAD
> application and specifies that the Contractor will provide technical
> support and equipment to maintain archival, coding, reporting, backup
> and compatibility with other systems but does not specify if the
> Contractor will assume hosting responsibilities for the production web
> application.  The HSROAD System Description document notes that "DMID,
> via Fisher BioServices Inc, is providing the necessary server hardware
> and software licenses required for the project."  Therefore, we assume
> that hosting development, testing and production versions of the
> application are included in the scope.  However, as many systems are
> developed off-site then installed for production use inside NIAID
> under the direction of OTIS, please confirm this assumption or
> clarify.
>
> **[Response 13]{.underline}**
>
> The assumption is correct-since HSROAD is a web-based database, the
> contractor, rather than OTIS, is responsible for hosting development,
> testing and production versions of HSROAD.
>
> **[Question 14]{.underline}**
>
> There is no description of current or anticipated load/usage of the
> database system.  The hardware requirements specified under Section 3
> of the Uniform Cost Assumptions will be used for initial cost of
> materials and purchased items, but load and performance metrics or
> benchmarks will assist in evaluating other hardware requirements
> implied in Section 4 of the Technical Requirements (e.g. a system with
> heavy usage or high performance requirements might require a dedicated
> T1 or additional network infrastructure).  Please provide anticipated
> usage/load if available.
>
> **[Response 14]{.underline}**
>
> Please see below regarding user information for the last 12 months.
> Offerors should assume similar user usage during the course of the
> contract.

  --- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- ----------------- --- --- --- --- ---
                                                                                                                                                              

               **Sep    **Oct    **Nov    **Dec    **Jan    **Feb    **Mar    **Apr    **May    **Jun    **Jul    **Aug                                      
               2006**   2006**   2006**   2006**   2007**   2007**   2007**   2007**   2007**   2007**   2007**   2007**                                     

      Users    33       35       38       42       41       35       40       45       35       36       43       41                                         

                                                                                                                                                             

      **Sep                                                                                                                                                  
      2006 \~                                                                                                                                                
      Aug                                                                                                                                                    
      2007**                                                                                                                                                 

      Visit                                                                                                                                                  
      Users:                                                                                                                                                 
      103                                                                                                                                                    
  --- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- -------- ----------------- --- --- --- --- ---

**[Question 15]{.underline}**

Will the computer equipment that the current HSROAD system resides on
transfer to the awardee and, if so, what are the technical
specifications of that equipment?  

**[Response 15]{.underline}**

For the purpose of this solicitation, offerors should assume that the
equipment will not transfer, and as such should propose to purchase
equipment as outlined in Attachment 6, Section 3.1.3. The exception is
"CTi.Crypto20.DLL"and "CTi FolderWatcher", which are custom modules that
will be provided to the offerors by DMID. Offerors should not propose
costs associated with purchase of this software "CTi.Crypto20.DLL" and
"CTi FolderWatcher".

**[ Question 16]{.underline}**

Please provide information regarding the need to provide additional
cabinets to accommodate growth. 

**[Response 16]{.underline}**

Offeror should provide sufficient space to meet the IND storage
requirements as outlined in the SOW.

**[Question 17]{.underline}**

Please clarify paragraph C.4 on page 75: \"Provide on-site staff
assistance at the DMID offices to update the DMID Regulatory Management
Database System, file hard copies of IND, IDE, MF and other regulatory
documents, and maintain on-site document control of the movement of
regulatory document between DMID and the Contractor\".   What is the
current time spent by the incumbent staff at the DMID office?  Do the
staff have a permanent office on-site at DMID? 

**[Response  17]{.underline}**

For proposal purposes, assume 1 FTE on site to provide regulatory
support.  Staff are provided an office.    

**[Question 18]{.underline}**

In reference to Attachment 6, Section 3, 1.A.1., please confirm the
assumption the 8,500 hard copy binders at DMID\'s office will physically
remain at DMID throughout the contract period.  Is there a similar
number of \"working or duplicate\" hard copy files at the incumbent that
are expected to be transferred if a new contractor is awarded the
contract?   Is there any government- owned equipment that will be
transferred with the duplicate files?  

**[Response 18]{.underline}**

The new contractor will need to assume responsibility for storage of
approximately 2000 3-inch binders at the time of contract award. The
equipment that is to transfer, Copier (Xerox 5855CA),

Konica Minolta bizhub C450, HP Deskjet 55 printer.

**[Question 19]{.underline}**

Was an Interested Vendors List created for this procurement, and is it
available? I would like to contact the other prospective offerors for
teaming purposes as we have determined not to submit a prime proposal.

**[Response 19]{.underline}**

No.

**[Question 20]{.underline}**

> For competitive costing purposes, we request the Government consider
> allowing bidders to provide transition costs separately from other
> business proposal items. How, otherwise, will the Government consider
> the advantage that the incumbent has in not needing to cost transition
> activities that new bidders must (such as, but not limited to,
> hardware, other equipment)?
>
> **[Response 20]{.underline}**
>
> Offerors should submit one business proposal.
>
> **[Question 21]{.underline}**
>
> Please provide a list of Government-Furnished property and equipment
> for this contract.
>
> **[Response 21]{.underline}**

The government-furnished property and equipment is: (1) Copier (Xerox
5855CA),

\(2\) Konica Minolta bizhub C450, and (3) HP Deskjet 55 printer.

> **[Question 22]{.underline}**

**[Section L, Instructions, Conditions, and Notices to
Offerors]{.underline}**

> *Section L.2 (a)(11), General Instructions to Offerors, Past
> Performance Information, Page 39*: "For the purposes of this
> solicitation, a "major subcontract" is defined as any subcontract over
> \$650,000. Later, *Section L.(c)(7), Instructions to Offerors,
> Business Proposal Instructions, Small Business Subcontracting Plan,
> Page 51*, references the need for submittal of a plan if the proposed
> contract exceed a total estimated cost of \$550,000 for the period of
> performance.
>
> Please clarify what is considered a "major subcontract:"\$550,000 or
> \$650,000. Also, in referencing a "major subcontract," is the figure
> tied to per year or per the life of the contract?
>
> **[Response22]{.underline}**
>
> As stated in Section L.2 (a) (11) General Insrtuctions to Offerors ,
> Past Performance a major subcontract is defined as any subcontract
> over \$650,000 for the duration of the contract.

**[Question 23]{.underline}**

**[Attachment 1, Packaging and Delivery of the Proposal]{.underline}**

> *Page 68*: "Total page count does not include title and back page,
> NIH-2043, Table of Contents, Section dividers that do not contain
> information other than title of Section."
>
> Are other front-end required elements also excluded from the page
> count? (Other front-end requirements include required NIH 1688-1 form,
> and required elements as cited in Attachment 1.a.(c) (2) on page
> 27-28; the latter elements traditionally included in a cover letter.)
>
> **[Response 23]{.underline}**
>
> Total page count does not include: Title and Back Page; NIH-2043;
> Table of Contents; Section Dividers that do not contain information
> other than title of Section.
>
> **[Question 24]{.underline}**
>
> *Page Limits, Page 69*: Page limits "Not to exceed 200 pages
> (inclusive of all Attachments and Appendices)." We request and
> recommend that subcontractor agreements and consultant letters of
> commitment be excluded from the page count to support open and fair
> competition.
>
> Otherwise, those offerors with multiple subcontractor and/or
> consultant agreements are more limited in space to provide discussions
> of other technical elements of their solution than those offerors who
> do not subcontract out services or do not propose to do so to the
> extent of other bidders.
>
> **[Response 24]{.underline}**
>
> Total page count does not include: Title and Back Page; NIH-2043;
> Table of Contents; Section Dividers that do not contain information
> other than title of Section.

**[Question 25]{.underline}**

**[Attachment 3, Statement of Work]{.underline}**

> *Background, Page 71: "Currently, DMID sponsors approximately 100 INDs
> or MFs which span more than 200 clinical trials. This includes both
> multicenter trials and single center studies, and encompasses Phase 1,
> 2, and 3 clinical trials performed at both domestic and international
> sites."*
>
> Regarding international sites, please provide detail about what
> countries and related foreign languages the offeror is required to
> support now and throughout the life of the contract. Will the offeror
> be required to provide foreign language translation services to
> support mailings to study sites, including the general correspondence
> and other communications required in SOW 1.A.7 (page 74)?
>
> **[Response 25]{.underline}**
>
> Currently, DMID supports clinical trials throughout the world,
> including Africa, South America, Europe and Asia. Locations of
> clinical trials conducted by DMID are constantly changing. As such, it
> is not possible to predict where clinical trials might be performed
> during the period of performance of the contract. Per the statement of
> work, offerors should provide a plan to support international clinical
> studies throughout the world. Foreign language translation service
> capabilities are required.
>
> **[Question 26]{.underline}**
>
> *Section 1.A.7, Review, Preparation, and Submission of Regulatory
> Documents, Reports, and Other Agreements, Regulatory Submission, Page
> 74: "Provide cost-efficient courier service for same day transfer of
> documents between DMID and the contractor."* What type of documents
> will be transferred that cannot be delivered via email or otherwise
> electronically?
>
> **[Response 26]{.underline}**
>
> A variety of documents require transfer, including regulatory filings
> which require original signatures and IND books which have to be
> transferred between the contractor and DMID.
>
> **[Question 27]{.underline}**
>
> *Section 1.A.7, Review, Preparation, and Submission of Regulatory
> Documents, Reports, and Other Agreements, Regulatory Submission, Page
> 74: "Provide cost-efficient courier service for same day transfer of
> documents between DMID and the contractor."* How frequently is courier
> service used? Also, is a daily round-trip run required between DMID
> and the contractor?
>
> **[Response 27]{.underline}**
>
> Courier service is used daily.
>
> **[Question 28]{.underline}**
>
> *Section 1.C.4, Review, Preparation, and Submission of Regulatory
> Documents, Reports, and Other Agreements, Regulatory Affairs Tracking
> and Reporting, Page 75: "Provide on-site staff assistance at the DMID
> offices..."* Please provide more information on level of effort
> required for providing on-site staff. Does the government anticipate
> on-site, full-time assistance? If so, will the government provide
> workspace for this person, including the necessary telephone and
> computer equipment?
>
> **[Response 28]{.underline}**
>
> For proposal purposes, assume 1 FTE on site to provide regulatory
> support.  Staff are provided an office. 
>
> **[Question 29]{.underline}**
>
> *Section 4.A, Electronic Information Systems, Data Management, and
> System Security, Page 77:* Where is HSROAD currently hosted?
>
> **[Response 29]{.underline}**
>
> HSROAD is a web-based database. Hosting the system is the
> responsibility of the contractor.
>
> **[Question 30]{.underline}**
>
> *Section 4., Electronic Information Systems, Data Management, and
> System Security, Page 77:* Does HSROAD have all the needed
> functionality to meet all RFP requirements in SOW 4.A.1, 4.B.2, *and*
> SOW 1.C *(Regulatory Affairs Tracking and Reporting)*?
>
> **[Response 30]{.underline}**
>
> HSROAD should be assumed to have the functionality necessary to meet
> the minimum requirements in SOW 4.A.1 and 4.B.2. Offerors are
> reminded, however, that following contract award, the successful
> offeror will be required to re-asses HSROAD in light of DMID's needs
> as detailed in the SOW, and determine if HSROAD can be enhanced to
> meet the Division's needs.
>
> **[Question 31]{.underline}**
>
> If not, what other systems exist to meet those requirements? What
> other systems exist that the contractor will be required to maintain?
> Please provide information about their structure.
>
> **[Response 31]{.underline}**
>
> For SOW 1.C, HSROAD performs the 'track' function of these activities.
> Offeror is expected to propose system(s) for the 'collect' and
> 'archive' functions. Offerors are expected to propose
> systems/structures to meet all activities requested in the SOW.
> Offerors will only be required to maintain those systems specifically
> listed in the SOW, such as HSROAD.
>
> **[Question 32]{.underline}**
>
> *Section 4.A(d), Electronic Information Systems, Data Management, and
> System Security, Page 77:* *"Compatibility with information systems
> used by DMID and DMID clinical research contractors..."* Please
> provide information about DMID and DMID clinical research contractors'
> systems with which a new contractor must have compatibility.
>
> **[Response 32]{.underline}**
>
> This sub-heading of the SOW is discussing compatibility in terms of
> HSROAD. HSROAD is currently compatible with the required DMID systems,
> which, like HSROAD, are web-based databases. It is not possible to
> predict future changes to compatibility needs. Therefore, Offerors
> should propose general capabilities as outlined in section 4.A(d).
>
> **[Question 33]{.underline}**
>
> *Section 4.A.3, Electronic Information Systems, Data Management, and
> System Security, Page 77: "Investigate new and improved
> technologies..."* Please provide any enhancement plans already
> approved but not yet implemented.
>
> **[Response 33]{.underline}**
>
> There are none.

**[Question 34]{.underline}**

**[Attachment 6, Additional Business Proposal Instructions and Uniform
Cost Assumptions]{.underline}**

> *Section 3.1.A and 3.1.B, Technical Cost Assumptions (ongoing and new,
> page 101 and 102)* provide information about the number of site visits
> for regulatory audits (see 3.1.A.9; 3.1.B.7). However, there are no
> assumptions for where these are, nor is information provided in
> *Section 3.2, Travel,* regarding travel for audits. Please provide
> information about the number of domestic site visits and the number of
> international site visits (and where CONUS or OCONUS they are) for
> competitive costing purposes.
>
> **[Response 34]{.underline}**
>
> For 3.1.A.9 assume 2 individuals will be on site for two days for each
> audit/visit. Two audits/visits will occur in Vienna, Austria; one
> audit/visit will occur in San Diego, CA; the audit/visit that is in
> the stages of preparation will occur in Durham, NC. For 3.1.B7, on a
> yearly basis, assume 2 individuals per audit/visit (4 visits/audits
> per year). Audits/visits will be for two days on site. Two
> audits/visits will occur in Viewnna, Austria; one audit/visit will
> occur in San Diego, CA; one audit/visit will occur in Durham, NC.
>
> **[Question 35]{.underline}**
>
> *Section 3.3, Other, Page 103:* The Government has asked the offeror
> to provide costs for purchasing the hardware and software listed in
> this section. Does the incumbent contractor already provide this
> hardware and software? What, if any, hardware and software will convey
> to the new contractor as GFE?
>
> **[Response 35]{.underline}**
>
> For the purposes of this solicitation, offerors should assume that the
> equipment is not available for the new contract, and as such all
> offerors should propose to purchase equipment as outlined in
> Attachment 6, Section 3.1.3. The exception is "CTi.Crypto20.DLL" and
> "CTi FolderWatcher", which are custom modules that will be provided to
> the offerors by DMID. Offerors should not propose costs associated
> with purchase of this software "CTi.Crypto20.DLL" and "CTi
> FolderWatcher".

**[Question 36]{.underline}**

**[Attachment 8, DMID-Funded Clinical Research Support Services
Contracts]{.underline}**

> *DMID Regulatory Affairs Support Contract, Page 108: "The current DMID
> Regulatory Affairs Support contractor utilizes two DMID-owned database
> management systems, CARIM and HSROAD."*
>
> However, *Attachment 3, SOW 4, Electronic Information Systems, Data
> Management, and System Security, Page 77,* does not mention CARIM. Is
> the offeror expected to maintain, operate, and/or improve CARIM? Which
> DMID contractor is responsible for CARIM?
>
> **[Response 36]{.underline}**
>
> The repository contractor will be responsible for maintaining,
> operating and/or improving CARIM.

**[Question 37]{.underline}**

The Technical Evaluation Criteria for Section B.1 on page 62 describe a
\"Proposed plan for the conduct of a one-day training workshop to
***clinical site staff*** at domestic and international sites on
compliance with GMP and GLP with respect to regulatory requirements and
guidelines governing research involving human subject.\"  This statement
does not appear to be consistent with the information in section 3.B.1
of the Technical Approach on page 96.  Is the statement on page 62
correct?  If it is correct, can you provide additional clarification on
the focus of the GMP and GLP training as it relates to clinical site
staff versus DMID staff and DMID investigators? 

**[Response 37]{.underline}**

 The use of \'GLP\' and \'GMP\' is not correct in this context.  The
paragraph should read:

 

\"Proposed plan for the conduct of a one-day training workshop to
***clinical site staff*** at domestic and international sites on
compliance with GCP and FDA IND requirements with respect to regulatory
requirements and guidelines governing research involving human
subject.\"  

**[Question 38]{.underline}**

**REVIEW, PREPARATION, AND SUBMISSION OF REGULATORY DOCUMENTS, REPORTS
AND OTHER AGREEMENTS**

[Regulatory Submissions]{.underline}

How many new IND submissions does the Government anticipate per annum?
How many IND

supplements are anticipated per annum?

How many new IDE submissions and supplements are anticipated per annum?

How many MF submissions are anticipated per annum?

**[Response 38]{.underline}**

**This information is provided in Attachment 6, Section 3.1.B.1-2-A
total of 15 new original IND and IDE filings, a total of 2 new MF
filings, and a combined total of 150 amendment filings to IND, IDE and
MF.**

**[Question 39]{.underline}**

How many Investigator Brochures does the Government anticipate will be
prepared per annum. How many will require updating per annum?

**[Response 39]{.underline}**

**This information is provided in Attachment 6, Section 3.1.B.3, but for
clarification assume 5 IBs will be prepared and 5 IBs will be reviewed
each year, and no IBs will require updating**

**[Question 40]{.underline}**

[FDA Meetings, teleconferences and Correspondence]{.underline}

How many pre-IND, pre-IDE and other meetings and teleconferences are
anticipated with FDA per annum?

**[Response 40]{.underline}**

**This information is provided in Attachment 6, section 3.1.B.5.**

**[Question 41]{.underline}**

**REGULATORY EDUCATIONAL AND TRAINING ACTIVITIES**

> How many training activities are anticipated per annum and what is the
> anticipated duration of each activity? Will the training be held in
> the Bethesda/Rockville/Washington, DC Metropolitan area?

**[Response 41]{.underline}**

**Training activities are detailed in Attachment 6, section 3.1.B.8. In
terms of location, Assume each year that 1 of the protocol-specific
clinical investigator meetings (Attachment 6, Section 3.1.B.(8.ii) will
be international. All other activities will be within the U.S.**

**[Question 42]{.underline}**

**SPECIALIZED EXPERTISE AND REGULATORY AUDITS**

[A. Specialized Expertise]{.underline}

> What type investigational products will be moved through the
> regulatory pathway toward licensure?

**[Response 42]{.underline}**

**The Division works on all types of products, including biologicals,
drugs, and devices. Offerors should be capable of providing expertise in
all areas as needed.**

**[Question 43]{.underline}**

For how many investigational products with specialized regulatory
consultations [will]{.underline} be required per

year?

**[Response 43]{.underline}**

**Specialized experience requirements are not based on product, but
rather report reviewing. Specialized experience requirements are
detailed in Attachment 6, Section 3.1.B.6.**

**[Question 44]{.underline}**

[B. Regulatory Audits]{.underline}

What are the geographic locations of contract sites that will be
audited; e.g., Will audits be conducted in Europe or at other foreign
sites? Will audits be conducted in the U.S.?

**[Response 44]{.underline}**

**For 3.1.B.7, on a yearly basis, assume 2 auditors/visit (4
visits/audits per year). Audits will be for three days on site. Two
audits will occur in Vienna, Austria; one audit will occur in San Diego,
CA; one audit will occur in Durham, NC**

**[Question 45]{.underline}**

How many GLP and cGMP audits are anticipated per year?

**[Response 45]{.underline}**

**GLP, cGMP, and Clinical Assay audits all fall under the audits
requested under 3.1.B.7. For the purposes**

**of the proposal, assume 2 cGMP audits, 1 GLP audit, and 1 Clinical
Assay audit/year.**

**[Question 46]{.underline}**

How many clinical assay audits are anticipated per year?

**[Response 46]{.underline}**

**GLP, cGMP, and Clinical Assay audits all fall under the audits
requested under 3.1.B.7. For the purposes of the proposal, assume 2 cGMP
audits, 1 GLP audit, and 1 Clinical Assay audit/year.**

**[Question 47]{.underline}**

On page 33 -- Section L, i. Comparative Importance of Proposals says
"All evaluation factors other than cost or price, when combined, are
[significantly more important]{.underline} than cost or price" while
Page 61 -- Section M., 1, Evaluation Factors, General says "All
evaluation factors other than cost or price, when combined, are
[approximately equal to]{.underline} cost or price." Can you please
clarify which evaluation factor will be used for the proposal
evaluations?

**[Response 47]{.underline}**

**All evaluation factors other than cost or price, when combined are
significantly more important than cost or price.**

**[Question 48]{.underline}**

Reference page 32 "Just In Time", Cost/Pricing Information -- refers to
Section L.2.c.(1) for basic cost/pricing information to be provided in
the proposal. There is no Section L.2.c.(1) in the RFP. Can you please
provide the correct reference?

**[Response 48]{.underline}**

**Section L. 2. c 1 is found on page 45.**

**[Question 49]{.underline}**

Reference L.2.c.1) through L.2.c.11 (pages 45 & 46) and L.2.c.1 through
L.2.c.5 (pages 47 -- 50.) Both referenced sections contain data that
seem to be the same in some respects, but different in others. Is it
your intent that the data on pages 45 & 46 represent what we would
submit with our initial proposal under the "just in time" procedures and
that later we would provide the additional data required on pages 47 &
50? Please clarify

**[Response 49]{.underline}**

**Offerors should submit data as specified in Section L-Instructions,
Conditions and Notices to Offerors.**

**[Question 50]{.underline}**

Reference Alternate 1 of FAR Clause 52.215-20 (page 51). The second
paragraph identifies paragraph L.2.c(4) as the location for the format
for Cost and Pricing Data. Can you please provide the correct reference
since there is no Section L.2.c(4) in the RFP?

**[Response 50]{.underline}**

**See number 3. on page 50 of the RFP.**