Amendment 2-RFP NIH-NICHD-CDP-2020-2.pdf

OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

04/01/2020

4. REQUISITION/PURCHASE

REQ. NO.

N/A

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5) CODE

National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development Contracts Management Branch 6710B Rockledge Drive, MSC 7000

BETHESDA, MD 20892-7000

8. NAME AND ADDRESS OF CONTRACTOR (No., street, city, county, State and ZIP Code)

TO ALL POTENTIAL OFFERORS

9A. AMENDMENT OF SOLICITATION NO.

RFP NIH-NICHD-CDP-2020-2

X

9B. DATED (SEE ITEM 11)

1/28/2020

10A. MODIFICATION OF CONTRACT/ORDER

NO.

CODE

FACILITY CODE

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in item 14. The hour and date specified for receipt of Offers is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning __1___ copy of the amendment in your business proposal; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (if required)

N/A

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO FAR 52.243-2. THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

ORDER NO. IN ITEM 10A.

B.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b) and Contract ARTICLE B.4.

C.THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D.OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor __ is not, X is required to sign this document and return _1_ copy in your business proposal to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PURPOSE: To provide clarifications based on inquiries received, and to provide a link to the Attachments.

DUE DATE: April 28, 2020, 3:00 PM Eastern Standard Time (Unchanged)

Except as provided herein, all terms and conditions of the document referenced in item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER

NICHD Contracts Management Branch, NIH

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY ________________________________________

(Signature of Contracting Officer)

16C.DATE

SIGNED

RFP-NIH-NICHD-CDP-2020-2

AMENDMENT NO.: 01

CONTINUATION PAGE

1. Below are the answers to questions received regarding this RFP; please note that individual questions may have been combined or reworded. The responses to inquiries are as follows:

1. In light of the on-going covid-19 pandemic, is NICHD planning to postpone the due date of this

RFP for other mission-critical RFPs in the agency.

Answer: No.

2. On Page 4, of Amendment 1, under Organizational Experience- since this is for male sites, is the correct sentence there….”recruit a target population and timeline of reproductive age women”..men instead of women ?

Answer: This sentence is revised to read: “The ability to identify and recruit a target population who are eligible for the study will be evaluated.” There was/is no mention of “timeline” in this sentence.

3. On Page 4, of Amendment 1, under Technical Factor #4, Management Plan – can you explain in greater detail what you mean by the statement “In the case of the both the Core Function Task and the Clinical Trial Task Order, the offeror’s detailed management plan organizing the work, including staff hours or days planned per task and scheduling of deliverables will be evaluated for reasonableness and timelines…” based on our understanding only incumbents with prior knowledge of the TORFP will be able to adequately answer this section as protocol have not been provided in this RFP. Please clarify evaluation criteria.

Answer: All proposals will be evaluated using the technical evaluation factors set forth in the solicitation. For IDIQ/Task Order 1, Technical Factor 4 – Management Plan: The offerors must demonstrate their ability to perform both Task Order 1 and Sample Task Order 2, which includes an outline for the clinical trial task to be performed. The information contained in the Task Orders should be used as the basis to develop the corresponding management plan. As part of the evaluation of the offeror’s ability, “a detailed management plan organizing the work, including staff hours or days planned per task and scheduling of deliverables will be evaluated for reasonableness and timelines”. No knowledge of a prior TORFP (Task Order Request for Proposal) is needed to propose and be evaluated under this RFP.

4. Subjects will be instructed on daily application of testosterone gel -- How many days is the testosterone gel applied? (This appears in the RFP in the SOW for TO2, item c. Treatment Phase 1.a.)

Answer: The gel is applied daily for the duration of the treatment phase (9 months).

5. Phase II/III study, documentation of the ability to recruit and plans for the recruitment of 100 -- Only 100 subjects for Phase III seems small. Is this number correct?

Answer: This is not a Phase III study. It is Phase IIa.

6. "Understanding of the Sample Task Order No. 2 Technical Approach 20 Points" -- this seems mislabeled since it is under "CCTN IDIQ Contract and Task Order No. 1 Male Sites" Answer: It is not mislabeled. Please note that the total score for Sample Task Order 2 will be used to calculate IDIQ/TO1 factor #3. See the additional note in Technical Evaluation Criteria Sample Task Order No. 2: “Twenty percent (20%) of the total points will comprise the points for the IDIQ contract and Task Order No. 1’s technical criterion number 3: “Understanding of the Task Order No. 2 Technical Approach.” For example, a score of 90 points on Sample Task 2 equates to 18 points for Task Order No. 1’s technical criterion number 3 (90 x .20 = 18).

RFP-NIH-NICHD-CDP-2020-2

AMENDMENT NO.: 01

CONTINUATION PAGE

7. "...accessibility to special populations, including a range of ethnic/minority groups" // "diversity of proposed population if the protocol requires that population" -- Is the ethnic population at the our hospital sites (predominately Blacks ethnicity, non-Hispanic minority group) acceptable?

Answer: Please include an explanation of the population anticipated and efforts that would be made to include different ethnic/minority groups.

8. HHS Security and Privacy Language for Information and IT procurements Items :Homeland Security Directive 1-10, Contract Initiation and Expiration (security1-8) and pages 85-95 in the RFA: May we have some guidance on the extent to which these requirements apply to the specifically to the Contracted Activities in this Opportunity, and the priority of these requirements in relation to one another?

Answer: The Information Security and/or Physical Access Security requirements are in place for FISMA (Federal Information Security Modernization Act of 2014) compliance. For proposal purposes, Offerors must describe how all sensitive information, including any Personal Identifiable Information (PII) (e.g. name, social security number, driver's license number, bank account number, passport number, and address/email address), collected, stored, or transmitted during the performance of this contract will be protected. Specific documents will be required after award.

9. Business Proposal: Confirming that the budget format, as clarified in Amendment 1, will be as "Data other than Certified Cost or Pricing Data (#3/Pg 119). The information is included within the PDF of the business proposal. The excel sheet is also to be uploaded in the excel format, not as a PDF in Attachment 11. Is this the complete format of the Business proposal Cost data?

Answer: Offerors must provide Data Other that Certified Cost or Pricing Data as specified on pages 118-119 of the RFP. The information in the Business Proposal PDF document shall provide a budget narrative to support any data provided with explanations and supporting rationale of the proposed cost elements. For the cost proposal, Offerors must use the excel spreadsheet provided in Attachment 11 – “Breakdown of Proposed Estimated Costs w/Excel Spreadsheet”. Below is a link directly to the excel spreadsheet template:

https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx

2. Link to all solicitation attachments: Here is a direct link to the attachments:

https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files