Clinical_Monitoring_Q_and_A_NIHAO2017058_12-22-16_FBO.pdf

Reference Page Question

Section E 92 1. Please confirm whether the HIV Antiviral Treatment trials requirement is applicable to this RFP

This is not applicable for the monitoring contract.

Attachment 03: Base Contract

Statement of Work

2. Does full clinical monitoring include 100% source data verification?

Answer If you are asking if 100% source data verification has to be done for each trial monitored the answer is "No". Historically, VRC's monitoring has been somewhat risk based monitoring.

Attachment 03: Base Contract

Statement of Work

3. Approximately how many protocols per year will require monitoring?

Answer This will be dependent on what products are in the pipeline and what the VRC is asked to respond to in terms issue of public health importance. In general, the Contractor should expect 3-5 protocols requiring monitoring.

Attachment 03: Base Contract

Statement of Work

4. 1.3 References monitoring visits to "domestic and international clinical sites." Are these already identified, if so which countries and states?

Answer No

Section M - Item 4 5. Please confirm whether the Human Subjects Evaluation within Section M is required for this submission?

This is not required for the monitoring contract.

Section L - Item

2.a.2/Attachment 01

55 6. Section L mentions double-sided printing and paper type. Please confirm that this is an electronic submission requirement as referenced in Attachment 01 Answer This is not applicable because of electronic submission requirements.

Attachment 03: Base Contract

Statement of Work

7. For budgeting purposes how many sites should be included in the budget and in what cities?

Answer For budgeting purposes utilize 10 sites - 5 sites in US cities and 5 sites outside the US. The offeror can pick the city and country (ies).

Attachment 03: Base Contract

Statement of Work

8. Should we include any risk-based monitoring?

Answer Yes

Attachment 03: Base Contract

Statement of Work - Section A2 iii

9. Who will determine if "specialized" or "for-cause site visits" need to be conducted and should we budget for these? If yes, how many should be included in the budget? How many days should we plan on? In what location?

Answer VRC as the Sponsor will request "specialized" or "for-cause site" visits or the monitoring or site management team can provide recommendations based on findings during visits or upon review of reports.

Attachment 03: Base Contract

Statement of Work

10. Who will be maintaining the Trial Master File?

Answer The Contractor may collect or upload items that will be part of the TMF but the Contractor awarded the complementary contract will be responsibile for compiling and maintaining the documents prior to transfer to the VRC as the Sponsor.

Attachment 03: Base Contract

Statement of Work - Section A3 i

11. Will all sites require a site assessment (pre-study) visit or can visits be waived if the site is known to the sponsor or the CRO?

Technical Questions - NIHAO2017058 - Clinical Monitoring

Answer Site assessments can be waived by the Sponsor.

Attachment 03: Base Contract

Statement of Work - Section A3 iii and Attachment 08

Additional business proposal instructions Section 3.2.c

12. How many days should be budgeted for the Site initiation visits?

Answer That will depend on variables such as site location, study team experience and the protocol complexity.

Attachment 03: Base Contract

Statement of Work - Section A3 v

13. Are Specialized Pharmacy Visits separate from the routine/interim visits and if so how many per site/study? How many days?

Answer Pharmacy visits should occur during routine and interim visits.

Attachment 03: Base Contract

Statement of Work - Section A3 vi

14. Are Specialized Regulatory Review Visits separate from the routine/interim visits and if so how many per site/study? How many days?

Answer No

Attachment 05: Sample Task

Order: Supplemental: Activities per Protocol Task 9

15. In order to provide source documents will the CRO have access the CRFs created for the study?

Answer In general, the VRC team creates the source documents and the Contractor would assist with formatting. Additionally, the source are most often created before the eCRF is available.

Attachment 05: Sample Task

Order: Supplemental: Activities per Protocol Task 9

16. Approximately how many CRF pages will be included in the sample protocol

Answer Please provide assumptions based on the study schedule of evaluations and subjects to be enrolled.

Attachment 05: Sample Task

Order: Supplemental: Activities per Protocol Task 13

17. Is the data management piece part of this RFP?

Answer No. VRC has a separate contract for Data Mgmt services.

Attachment 03: Base Contract

Statement of Work

18. Will there be an investigators meeting and if so how many days should be planned for and in what location?

Answer Structure, content, allotted time/days and location for investigator meetings will be decided based on the protocol and PI experience.

Attachment 03: Base Contract

Statement of Work

19. Will there be a central IRB (CIRB)? Will this be the responsibility of the CRO to implement?

Answer Yes and no the CRO will not be responsible for implementation

Attachment 03: Base Contract

Statement of Work

20. Who will be responsible for filing Safety Reports to the sites, the CIRB and FDA if required?

Answer The site and contractor provide site mgmt will be responsible for filing Safety Reports for their specific site. VRC will fill reports to CIRB and FDA support from the complementary contract will be utilize to draft reports on a case by case basis.

Attachment 03: Base Contract

Statement of Work - Section 3

21. Task Order Requirements A.1.vi.k: Who will be responsible for obtaining and shipping the vaccine to the sites?

Answer These activities will be covered under the complementary RFP solicitation NIHAO2017059.

Attachment 03: Base Contract

Statement of Work - Section

A4i

22. Please provide the detailed information regarding the CDMS and vendor providing the CDMS. This information can not be found in the Technical Proposal Instructions as referenced under Attachment 03 section 4i.

Answer EMMES Corporation is the Contractor providing the CDMS. Additional information pertaining to this requirement can be found on fedbizopps Attachment 03: Base Contract

Statement of Work - Section B, D1ia1, and D1ib2

23. Please clarify the Key Personnel role for "Program Manager//Project Manager" is the same as the Project Manager noted under

D1ib2 and confirm that the "Project Director" noted under D1ia1 is not a Key Personnel role.

Answer Confirmed

Attachment 01: Packaging and

Delivery

24. Please confirm that Attachment 01 should reference "Clinical Trial Monitoring Initiative" and not "General Clinical Research Support

Services" as noted in the title. The Solicitation number appears to be correct Answer Confirmed

General Question 25. How many active studies does the VRC anticipate will require concurrent monitoring support?

Answer Two (2) to four (4) are anticipated

General Question 26. Will subject injury costs be allowable under the awarded contracts?

Answer The Government does not provide subject indemnification. However, site may chose to purchase insurance at their cost.

General Question 27. Does NIAID anticipate contractors will access government facilities or IT systems as part of awarded services? Will such information and requisite security clearances be referenced in TORFPs?

Answer YES if needed.

SOW 3.A.1.vi.d 28. Would the Site Monitoring Contractor be required to do more than ensure timely reporting to sponsor (NIAID), e.g., be involved in processing and/or tracking of protocol violation and deviations?

Answer If the contractor has a method or provides support for theexample provided, VRC would be interested in reviewing that in the proposal.

Processing, tracking and categorizing violations and deviations would be of great benefit to mitigating risk and the resolution process.

SOW 3.A.1.vi.f 29. To prevent misinterpretations of SOW 3.A.1.vi.f, could the Government please provide VRC’s definition of “protocol exemptions”?

Answer In general protocol exemptions are situations where eligibility criteria or other aspects of the protocol need to be excused in order to enroll or follow a subject. VRC has not done protocol exemptions. In the case where eligibility criteria or other aspects of the protocol affect the study process and the issue is not safety related, VRC would amend the protocol and proceed with all required regulatory reviews

SOW 3.B 30. There is an inconsistency between Personnel requirements and Project Management requirements. In SOW 3.B. Scientific and

Technical Personnel under Key Personnel there is a requirement for a Program Manager/Project Manager, while in D.1.i.a and D.1.i.b both a Project Director and a Project Manager are requested (i.e., as separate individuals). Please clarify if VRC expects one or two individuals for these positions Answer The Contractor should decide is the activities required can be fulfilled by one person performing both roles or two people with separate roles.

SOW Section D.1(ii) – Project

Management

31. Project Management. Can the VRC provide the typical regions (US) and countries (OCONUS) used for VRC protocols?

Answer No, to date we have utilized sites across the US many have been Vaccine Trial Units (VTU) and/or HIV Vaccine Trial Units (HVTU). VRC currently is utilizing a site at Upenn, UMD and Emory for two separate protocols and six sites in the Carribbean for a multi-site study. We have collaborated with the military to active sites in several African countries. Regions in the US and specific countries will be based on such items as the protocol, infectious agent and public health needs.

SOW Section 4 of Attachment 3 32. Section 4 of Attachment 3 notes “the contractor shall utilize the web based CDMS for review of trial data entered as electronic case report forms (eCRF’s) for each clinical trial” and then notes to “(See additional Technical Proposal Instructions for specifications of the system)”. However, the specifications of the CDMS are not included in the Additional Technical Proposal Instructions. Can VRC please provide, as this is important for adequate staff selection and training planning?

Answer The information in the additional tech proposal instructions provides IT specifications needed for the system. The system is a sequel server web-based data system. All eCRF will be provided for each protocol via the data system. Training will be provided to

Contractor Team and subs at no cost to the Contractor.

Sample Task Order 33. Does the VRC wish for offerors to provide a technical response and estimated cost for all contractor activities delineated in the responsibility matrix in the Sample Task Order, or only those activities under clinical monitoring (Task 17)?

Answer Clinical Monitoring activities only. Also, to clarify, the Supplemental: Activities per Protocol page was designed to give the offeror a general idea of how the roles are divided and the complementary nature in which tasks are employed to complete the work.

Sample Task Order 34. Does the VRC have a specific location/site proposed/required for the Phase I trial or should the offeror propose a location?

Answer Offeror should propose a location

Sample Task Order 35. Attachment 05 (Sample Task Order); SOW. II.A states that “The protocol and schedule of evaluations will be provided to facilitate development of the clinical monitoring plan.” Since there is no additional information in this RFP, should we use the Phase I part of the

Clinical Trial information provided in RFP NIHAO2017059, or can the Government provide a protocol synopsis?

Answer A Precis and Schedule of Evaluations will be uploaded and/or you may refer the Precis and SOE listed in the Clinical Research solicitation which is the same. The current Sample TO list Part 1 of the study plan on the Precis, please provide responses for Part 1 and Part 2 of the uploaded documents Sample Task Order 36. Please provide clarification on the timelines (if possible first subject randomized, last subject randomized, last subject out) and whether the 9 visits include the screening or not.

Answer Subjects should assume 3-6 month for screening and enrollment and 1 of the 9 visits can be used as a screening visit.

Attachment 5 Task Order, Appendix A

37. Attachment 5 Task Order, Appendix A, Study Plan part 1 is a 20-subject study. Attachment 8 instructs offerers to price out the Task

Order over 7 years. Would you please clarify the duration of Part 1 of the study?

Answer See Response to Question#35. The duration of Part 1 and 2 is approximately 2 years based on 2-6 month screening and enrollment.

Sample Task Order 38. In the task order, approximately 6 visits are planned for the 20 participants at 1 site. The assumed level of effort far exceeds this level of monitoring activity even in the first year. Pricing can be done off of the SOW or off of the assumptions for level of effort, please advise.

Answer A Precis and Schedule of Evaluations will be uploaded and/or you may refer the Precis and SOE listed in the Clinical Research solicitation which is the same. The current Sample TO list Part 1 of the study plan on the Precis, please provide responses for Part 1 and Part 2 of the uploaded documents. Pricing should be based off the SOW Sample Task Order 39. In the “Supplemental: Activities per Protocol” for the task order, Number 6 - “Site Initiation Visit” is in blue but is listed as a responsibility for the monitoring RFP as well. Which contract is the lead for this activity?

Answer The Clinical Research Trial Support Contract will be the lead.

Attachment 03 40. Should we assume that all the tasks listed under Clinical site monitoring in Attachment 03, part 1 GENERAL TASK ORDER

REQUIREMENTS A.CLINICAL MONITORING, are included in the sample Task Order Scope of Work (SOW), even though they are not specifically listed in Attachment 05? OR, is the sample Task Order SOW limited to site initiation, interim monitoring and close out, plus a clinical monitoring plan?

Answer The later.

Sample Task Order 41. Please supply more details about the sample task order, for example:

a. What is the location of the site(s)?

b. What is the patient selection criteria?

c. What is the schedule of the 9 evaluation visits?

d. What is the timeline for the study activities?

Please see the attached précis and schedule of evaluations for answers

N/A 42. Is there an education requirement for the Program Manager, Project Manager or Lead Clinical Associate?

Answer No, however, personnel performing these roles should have the education and experience to allow performance of the duties effectively, efficiently and at full capacity. Personnel descriptions and CV's should have pertinent and accurate information to provides ample evidence that the duties can be performed.

N/A 43. Will contractor be required to Provide staff to administer vaccines to subjects?

Answer No, this is a reqirement for the Conractor(s) awarded under the clinical research trial support RFP.

N/A 44. Has a PI been selected for the clinical trial and if not is the contractor required to furnish one?

Answer No PI has been selected. Site PI's will be selected during site selection and the lead for the activity with be VRC as the Sponsor and the

Contractor under the complementary solicitation (Clinical Research Support Services)

N/A 45. Is the contractor required to process, test, and store the subject samples? This includes phlebotomy, sample processing, quantifying viral load if necessary, statistical analysis of results, etc.

Answer No, this is a reqirement for the Conractor(s) awarded under the clinical research trial support RFP.

N/A 46. Are there any geographical requirements for clinical trial sites?

Answer No

N/A 47. The RFP states that The Intent to Bid response sheet is to be submitted with the proposal. Is there also the expectation that it should be submitted with the questions tomorrow as well or only with the submission of the final proposal?

Answer Intent to Bid sheets may be provided submitted before the proposal due date or with the submission of final proposals

N/A N/A

1. Who is the current Incumbent for this contract? please provide the contractor name and the contract number that was awarded

ANSWER This information can be found on fedbizopps RFP page 53 1 2. Please confirm only small businesses are eligible for this opportunity.

ANSWER Correct N/A 6 3. Please confirm FAR 52.228-7 will be included in the awarded contract(s)?

ANSWER FAR 52.228-7 is not applicable per our HHS policies and procedures N/A 7 4. Is there an incumbent who is currently performing these activities for the VRC ?

ANSWER This information can be found on fedbizopps

General/Overall

5. PRIME Contractor: as a prime contractor, do all subcontractors need to be identified at the time of RFP submission, or is there the ability to secure new subcontractors based on the scope of individual task orders?

ANSWER

Ideally, at least one sub should be identified at time of RFP submission that would have the capacity to collaborate with the prime in order to meet critical timelines and requirements and logistics of large scale trials (>5000 subjects) implemented for public health emergencies.

Other subs can be identified based on scope of ind. task orders.

General/Overall

6. Can the government confirm who the current incumbent is for this contract? If this vehicle combines multiple contracts, can the government provide the incumbent information for all contracts being merged into this VRC solicitation?

ANSWER This information can be found on fedbizopps. Multiple Contracts are not being used for the existing contract.

RFP Section L (Instructions, Conditions, and Notices to

Offerors)

P53

(of 120)

7. Under section D (Type of Contract and Number of Awards), it is unclear whether this will be multiple awards or single award IDIQ. Please confirm that this is a multi-award IDIQ vehicle.

ANSWER Confirmed. This will be a multiple-award IDIQ Contract RFP Section L (Instructions, Conditions, and Notices to

Offerors)

P61

(of 120)

8. Under item #14 (Past Performance Information), can the government clarify whether the clinical trials requested must be conducted by the small business prime, or whether the trials can be conducted by a qualified teaming partner?

ANSWER A qualified partner can be utilized.

RFP Section L (Instructions, Conditions, and Notices to

Offerors)

P61

(of 120)

9. Under item #14 (Past Performance Information), can the government confirm that the some or all of clinical trials can be from the same contract? In other words, the 5 clinical trials do not need to come from 5 separate contracts, correct?

ANSWER Confirmed. Either scenario is acceptable.

RFP Section L (Instructions, Conditions, and Notices to

Offerors)

P76

(of 120)

10. Within Section C (Business Proposal Instructions), can the government confirm that Offeror(s) total evaluated price will consist solely of the estimated price of ‘associated costs’ offerors’ are instructed to provide for the “Ebola Clinical Trial” Sample Task Order described in

Attachment 5?

ANSWER That is correct RFP Section L (Instructions, Conditions, and Notices to

Offerors)

P76

(of 120)

11. Within Section C (Business Proposal Instructions), can the government confirm that offerors do not need to submit a small business plan for the sample task order since the STO is not intended for award in the business proposal submission?

ANSWER That is correct since this Contract and subsequent task orders will be awarded to a small business

Business Questions - NIHAO2017059 - General Clinical Research Support Services

RFP Attachment 01 – Packaging and Delivery of Proposals

P97

(of 120)

12. Proposal Submission: can the government confirm if technical volumes are required for both the base statement of work (Attachment

03, beginning on page 100) and the sample task order (Attachment 05, beginning on page 105), or just a response to the sample task order?

ANSWER Technical volumes shall be provided for the SOW and will need to incorporate the sample Task Order response

RFP Attachment 01 – Packaging and Delivery of Proposals

P98

(of 120)

13. Section II Formatting: for graphics and tables used in a response, will the government allow font size that is less than 10 point, provided it is considered appropriately legible and readable?

ANSWER The government will not allow for font size less than 10 point font.

RFP Attachment 01 – Packaging and Delivery of Proposals

P98

(of 120)

14. Section II Page Limitations: if additional attachments are required (e.g., SOPs and or work product examples), can these be included in an

Appendix and not be subject to the overall 200-page count limitation?

ANSWER Additional attachments must be apart of the overall 200 page limitation

RFP Attachment 08 - Sample Task

Order, Additional Business

Proposal Instructions:

15. Please clarify reference to solicitation # NIHAO201652 & NIHAO201603

ANSWER The reference number provided is not relevant for this acquisition and was a typo. Please Disregard

Section 3, 1

16. Section 3, 1 – table shows time line for four (4) years. Can offeror assume the duration of the sample study is four (4) years?

ANSWER

The ordering period will be determined by the activity required. For example, Task Orders may have a max period of performance up to five

(5) years which may include a base year/period and four (4) option years/periods

B2. 5

17. We note that B2. (pg. 5) indicates “multiple award” (as do parts of G.3 and G.4 pertaining to method of ordering and task order procedures). But, Section L.1.d. – Type of Contract (pg. 53) – anticipates “one/multiple” awards. Please confirm, will the resultant contract be multiple award?

ANSWER The resultant contract will be a multiple award IDIQ type Contract Attachment 8 – Section 3

“Uniform Cost Assumptions”

18. Attachment 8 – Section 3 “Uniform Cost Assumptions” lists labor categories and LOE for years 1-4, but the anticipated contract is 7 year duration (per RFP pg. 53). Please clarify if LOE pricing is to be provided for 4 years, or 7.

ANSWER

Pricing for options will only need to be identified for the individual task orders since the base contract will not have options. A revised table has been uploaded under "Revised Business Plan"

N/A

19. The same LOE table (Attachment 8) lists some positions that are for services typically provided (and billed) on a unit-cost basis by laboratories or sites (e.g. for example study coordinators, pharmacist, or phlebotomist). Can the offeror instead provide unit prices for representative services/procedures that these labor positions would provide under a resultant task order, as well as the equivalent estimated costs for the sample task order?

ANSWER

The Offeror can provide a response in order to meet the requirements. The Government has not requirements for how the pricing is structured.

N/A

20. The positions for “Program/Project Manager” and “Principal Investigator”, and the percentage LOE for “Medical Officer” are shown with a *, but there is no corresponding notation. Please clarify. For example, do these asterisks indicate any difference in these positions or levels of effort?

ANSWER Answered in technical section.

Attachment 8 – Section 3

22. Attachment 8 – Section 3 – UNIFORM COST ASSUMPTIONS – The RFP states the Contractor is responsible for writing any CSRs, but no

Medical Writer is included in the table of required personnel? Can the Contractor include additional labor categories beyond what is included in the Level of Effort table?

ANSWER Labor categories provide a guide. The Offeror can suggest personnel as needed to complete the requirements of the contract.

Attachment - 79

23. On page 79 of the Business Proposal Instructions, Section c.4 provides for the submission of Cost and Pricing Data. Please confirm whether the Government expects to receive adequate price competition such that cost or pricing data is not required per FAR 15.403-1?

ANSWER Cost and Pricing data is required

Attachment 8

24. Attachment 8 - Uniform Business Proposal assumptions: Are the various labor categories/levels of effort specified in Attachment 8 intended to relate to the anticipated costs of performing the sample Ebola task order in Attachment 5 (note: the instructions in bold at the beginning of Attachment 5 refer offerors to the Additional Business Proposal Instructions for guidance … but is not clear that the

Government intends the levels of effort specified in Attachment 8 to be appropriate for the sample task order)?

ANSWER

The Uniform Cost Assumptions shall be used for the sample task order. The Cost Assumptions shall also be used to determine pricing for the

IDIQ contract

N/A

25. If not, because the RFP is written to support an ID/IQ contract with Task Orders according to the ordering instructions in Section G.4, are the specified labor categories/levels of effort in Attachment 8 just intended to allowing for pricing comparisons between offerors, or will the resulting contract be based on these pricing values?

ANSWER The levels of efforts are to be used as a guide and allow for pricing comparisons

N/A

26. To clarify, please confirm whether the business proposal will have one set of costs/prices for the sample Ebola task order and different set of prices covering the base year and options years based on the levels of effort specified in Attachment 8?

ANSWER

The business proposal shall have one set of costs/prices for the sample Task Order and a separate set of prices/costs covering the IDIQ

Contract. There will be no option years for for the IDIQ Contract. Only the Task Orders may have option years, which shall be based and determinied on the individual studies Attachment 8 – Section 4

–Options

27. Regarding Attachment 8 – Section 4 –Options - indicates each Option must be priced separately. Please confirm whether this means a

Base Year and 6 Option Years or some variation?

ANSWER

Pricing for options will only need to be identified and priced separately for the individual task orders. The base IDIQ contract will not have options

N/A

28. Two different solicitation numbers are used in Attachment 08 (NIHAO2016053 and NIHAO2016052), while the solicitation number in

Section A is NIHAO2017059. Please clarify the solicitation numbers and whether the statement “This solicitation is offered in conjunction with solicitation #NIHAO2016052. Offers may propose on both, but may only win an award under one solicitation” applies to this solicitation.

ANSWER The reference number provided is not relevant for this acquisition and was a typo. Please Disregard

N/A

29. Please confirm the level of effort percentages in Section 3 of Attachment 8 are must-hit ceilings and whether they are relevant under just the sample Task Order vs. the entire IDIQ.

ANSWER LOE percentages are estimates and not must-hit ceilings.

N/A

30. Similarly, please clarify the period of performance on this IDIQ is seven years. Section 3, Part 1 of Attachment 8 “Level of Effort” indicates

4 years. Please confirm that the sample Task Order has a 4 year period of performance.

ANSWER

The period of performance for the IDIQ Contract is seven (7) years. However, the ordering period for each individual Task Order will be determined by the activity required. Task Orders may have a max period of performance up to five (5) years. A revised table has been uploaded under "Revised Business Plan" N/A 31. Does the VRC intend for VRC 207 to take place at VRC facilities (as per VRC 206) or at a different site?

ANSWER Please make assumptions to complete the Sample Task Order.

N/A 32. Please confirm site personnel will be direct labor vs ODC costs.

ANSWER Site personnel will be direct labor

On Page 33 Section I.2.g.

33. On Page 33 Section I.2.g., the RFP states that FAR 52.227-14 is deleted, and then on page 36 Section I.3.a.21. the RFP adds Alt V to that clause. It isn’t clear how Alt V can be included if the main clause has been deleted. Is there a modified Rights in Data – General clause that replaced the deleted clause?

ANSWER FAR 52.227-14 is not deleted and there remains applicable to the requirement

Attachment 06 Attachment 06: TASK ORDER REPORTING REQUIREMENTS AND DELIVERABLES, TASK ORDER DELIVERABLES, 2. Other Reports and

Deliverables (Delivery Schedule), h. Clinical Monitoring Plan, i. Monitoring Reports are not included in ATTACHMENT 03: BASE CONTRACT

STATEMENT OF WORK. Please confirm that clinical monitoring is not required for this contract.

ANSWER Clinical Monitoring Reports/Plan are not required for this contract

N/A pg. 80

34. The reference states “Conduct cost analyses for all subcontracts when certified cost or pricing data are submitted by the subcontractor” and “Submit the subcontractor certified cost or pricing data as part of your own certified cost or pricing data as required in paragraph A.2.

below.” On page 89 it requires a sub’s cost proposal to be submitted in the same format (cost build). Please confirm that subcontract offerors may submit cost or pricing data, or other than cost or pricing data directly to the Government by means of sealed submissions, given that this information is proprietary data subject to the requirements of FAR 3.104-5 Disclosure, protection, and marking of proprietary and source selection information.

ANSWER

Subcontractors may send certfied cost or pricing data directly to the CS, Sharee Richardson sharee.richardson@nih.gov or to the following mailing address 5601 Fishers Lane 3B27, MSC 9822, Bethesda, MD 20892