RFP-2012144 - Amendment 3.1.pdf

RFP NIAID-DMID-NIHAI2012144

Amendment #3 (09/07/2012) Page 1 of 3

Amendment #3

“VACCINE AND TREATMENT EVALUATION UNITS (VTEU)”

Amendment Issue Date: September 07, 2012

Proposal Due Date/Time:

September 27, 2012., at 3:00 P.M., local time

[Unchanged]

Issued By: Michael C. Finn

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

6700-B Rockledge Drive, Room 3214, Bethesda, Maryland 20892-7612

Points of Contact: PRIMARY:

ryanes@niaid.nih.gov

E. Shane Ryan, Contract Specialist Phone: 301-451-3692

SECONDARY:

aileene.mitchellford@nih.gov Aileene Mitchell Ford, Contracting Officer

Phone: 301-496-7288

Offerors must acknowledge receipt of this Amendment 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.

General Notes;

1. The NIAID has established a cutoff date for offerors to send in questions for a response of September

12, 2012.

2. Note- The NIAID is requiring detailed budgets for the Sample Task Orders as stated in the Solicitation.

FAQ’s and RESPONSES

1. The Business proposal Instructions for Task Order A-1 indicate to assume one GCP audit per year.

The SOW indicates the audit will be conducted by DMID or a designee. Should an audit be conducted by a designee or should we assume the contractor will be billed for the audit?

Response: The contractor will not be billed for the audit.

mailto:ryanes@niaid.nih.gov mailto:aileene.mitchellford@nih.gov

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2. What is meant by “collection ‘equipment’ for immunogenicity studies” since the contract specifies that equipment cannot be procured?

Response: This phrase should refer to all materials necessary to collect the samples (needle and collection tube, appropriate vials for freezing/storing samples, etc.).

3. In Attachment 8, the Table on page 5 of 11 lists populations – Should this include the populations that we access by age (e.g., pediatric, adult, elderly), and international as well as U.S.? If we are using different populations, is it expected that the total numbers given in the RFP should be attained overall, or by each age/geographic group?

Response: The offeror is expected to demonstrate how they are planning to have access to each of the specific populations listed under ‘3.A’, including those populations listed in the Table.

4. Can funds be used for construction/facilities and purchasing/maintenance of equipment? There seems to be conflicting information in different parts of the RFP about what the contract will cover.

How about meals, refreshments, promotional items, etc.? See Part 1, Article B, page 6. For some of the items mentioned there, elsewhere it says the contract will not pay for them.

Response: No funds may be used for the construction/facilities and purchasing/maintenance of equipment unless authorized prior to occurring expense is given by the Contracting Officer. In addition, no funds may be used for meals, refreshments, promotional items unless otherwise authorized by the Contracting Officer.

5. With regard to the numbers of subjects to be enrolled on an annual basis (populations; page 5 of Attachment 8): Should budgets be built around the numbers provided in 1. General population? Or do we add the numbers of subjects described in 2. Access to additional populations, or just describe our access to these additional populations? When added up, there are 1350 subjects per year in 1, and if you add to that 200 from international sites and 3 special populations, it gets quite large

Response: Each offeror should propose budgets based on task order (A) and the sample task orders given in the RFP. The annual enrollment estimates were only provided to give offerors a potential idea of the amount of work that might be done under the Parent contract.

6. Are 2a. and 2b. overlapping or mutually exclusive? For example, if we have access to 400 subjects in a malaria-endemic area, then we already have at least 200 subjects form an international setting, correct?

Response: 2a and 2b are not mutually exclusive. Depending on the sites proposed, the same site/population access may meet both criteria.

7. How will the HHS controlled information systems or database be accessed (web portal, direct connection)?

Response: Offerors IT management is responsible for these types of decisions

8. Does the IT risk assessment have an NIH form or template?

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Response: Yes, there are Federal Information Processing Standards (FIPS) and National

Institute of Standards and Technology (NIST) special publications for this purpose. They are used to assess the level of data security and systems security that manage the data. NIH uses security templates from these, and other, sources. For example, the FIPS-199 standard requires risk assessments use NIST SP 800-60 guidance and NIH developed templates that use this guidance.

9. Do the IT requirements as they pertain to the institution also apply to international sites and subcontractor sites?

Response: Yes. The contractor is responsible to manage subcontractor FISMA compliance specified in the contract.

10. Does the requirement for key card security apply to all computers in the institution or can it apply to a subset of computers that are designated to access the federal data?

Response: The requirement is mandated by HHS?

11. How does the NACI requirement apply to personnel at international sites?

Response: Background checks are required by law, irrespective of location.

The contractor is responsible to manage subcontractor FISMA compliance specified in the contract.

12. Can the Government clarify if reps and certs for international sites will need to be completed?

Response: The prime is responsible for making sure all subcontracts including international site are adhering to the requirements as stated in the FAR and section K of the solicitation concerning reps and certs. NOTE- That while the Contractor’s Representations and Certifications are due at the time of award, the subcontractor’s Representations and Certifications are not due until the time of approval of the subcontract.