Amendment_No._2_-_NIAID-DMID-NIHAI2014004.pdf

Amendment #2

Solicitation Number

NIAID-DMID-NIHAI2014004

AMENDMENT TWO (2)

OFFICE OF ACQUISITONS

National Institute of Allergy and Infectious Diseases (NIAID)

6700-B Rockledge Drive, Room 3223, MSC7612

Bethesda, MD 20892-7612

Solicitation Number: NIAID-DMID-NIHAI2014004

Date of Solicitation Issuance: 04/17/2014

Date of Amendment No.1 Issuance: 06/10/2014

Number of Pages 3

NIAID Point of Contact: PRIMARY:

Tiffany Chadwick, Contract Specialist

E-mail: tiffany.chadwick@nih.gov

Phone: 301-435-0699

SECONDARY:

George W. Kennedy, Contracting Officer

E-mail: kennedyg@mail.nih.gov

Phone: 301-451-2607

Purpose of Solicitation amendment: The purpose of Amendment #2 is to respond to questions received regarding this solicitation and to provide a final date for the submission of questions. The Government’s intention is to post at least one more Q&A amendment to this solicitation.

The hour and date specified for receipt of Offerors remains unchanged – 3:30 PM Eastern Prevailing Time on August 1, 2014.

Offerors must acknowledge receipt of this amendment (as well as all other amendments) on each copy of the proposal submitted. Failure to receive your acknowledgement of all amendments may result in rejection of your proposal.

Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

A. Final date/time to submit questions regarding this solicitation:

All questions regarding this solicitation must be submitted via e-mail to the NIAID Point of Contact listed above by 3:30 PM Eastern Prevailing Time on July 10, 2014.

mailto:kennedyg@mail.nih.gov

B. The Government’s responses to questions received regarding this solicitation are as follows:

1) ATTACHMENT 1 – Packaging and Delivery of Proposals

Question: Attachment 1, page 3 describes exclusions from the 150 page limit. Please clarify whether any of the following required documents may also be exempt from the page limit. The

Section 508 Product Assessment Templates are of particular concern as these are long templates that may need to be completed for several proposed EIT systems.

Technical Proposal Cost Summary

[required by Section J Technical Proposal Attachments, p. 34]

Summary of Related Activities

[required by Section J Technical Proposal Attachments, p. 34]

HHS Section 508 Product Assessment Template

[required by Section J Technical Proposal Attachments, p. 34]

Project Objectives (NIH Form 1688-1) [required by Attachment 5, p. 1]

Government Notice for Handling Proposals [required by Attachment 5, p. 1]

Proposal Summary and Data Record (NIH-2043) [required by Attachment 5, p. 1]

Response: Attachment 1 – Packaging and Delivery of Proposals is hereby revised to state that the page limit for the Technical Proposal is not to exceed 150 pages (inclusive of all

Attachments, with the exception of Electronic and Information Technology Accessibility, Section 508 Compliance referenced in Section L.2.b.4. and the Standard Operating

Procedures referenced in the Additional Technical Proposal Instructions). Offerors shall address Section 508 Compliance, including applicable HHS Section 508 Product Assessment

Templates, in a separately-numbered Attachment to the Technical Proposal.

All other documents referenced above shall be included in the Technical Proposal page limit.

Question: Can proposal submissions include color graphics, figures, tables, etc. within the

PDF document? If so, will color be maintained for the reviewers or will they receive black and white copies that will make color obsolete?

Response: Proposals may include color graphics, figures, tables, etc. within the PDF document. Color will be maintained during the review process.

2) ATTACHMENT 3 – Statement of Work

Question: Attachment 3 (Statement of Work) includes, “Keep DMID abreast of changes in

U.S. and international regulations and guidelines that may impact the DMID research program.”

What ex-US countries should the offerors assume regulatory support is needed for?

Response: Describe the process by which your organization will approach this issue for any ex-US country, as needed. Also, provide specific examples that demonstrate your organization’s experience in providing this service, using your professional judgment to select representative ex-countries.

3) ATTACHMENT 6 – Additional Business Proposal Instructions and

Uniform Cost Assumptions

Question: Within Attachment 6 (Uniform Cost Assumptions - Section 3.1.A.1), the RFP states that the contractor should purchase “4,000 3-inch binders and 4,500 3-inch binders, respectively.” To clarify, should we assume the purchase of 8,500 3-inch binders or did the

Government intend to include different size binders for one of the included quantities?

Response: For purposes of preparing your proposal, assume the purchase of 8,500 3-inch binders.

Question: Within Attachment 6 (Uniform Cost Assumptions – Section 3.1.A.9), the RFP states that ongoing activities at contract award will include four audits/site visits to be planned and conducted. Where should offerors assume these audits/visits will take place?

Response: For purposes of preparing your proposal, assume these audits/visits will take place in Florida, Ohio, New Mexico, and Texas.

Question: Within Attachment 6 (Uniform Cost Assumptions – Section 3.1.B.7), the RFP states that new regulatory support activities will include a total of 8 two-day audits/site visits per year.

Where should offerors assume these audits/visits will take place?

Response: For purposes of preparing your proposal, assume these audits/site visits will take place in Florida, Ohio, New Mexico, and Texas.

Question: Within Attachment 6 (Uniform Cost Assumptions – Section 3.1.B.8), the RFP states that contractors will be responsible for the planning, conduct, and logistical arrangements for 5-day regulatory training workshops, 1-day meetings of DMID-funded clinical research networks, and 1-day regulatory training workshops. Should offerors assume that these workshops and meetings will be held at NIH facilities in Bethesda, MD?

Response: For purposes of preparing your proposal, assume these workshops and meetings will be held at the NIH facilities in Bethesda, MD.