RFP_Amendment_02_2022-06-17.pdf

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 or (c) By separate letter or electronic communication 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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

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

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

D. OTHER (Specify type of modification and authority)

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.

15C. DATE SIGNED

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

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

Purpose: To distribute RFP questions and answers.

National Institutes of Health National Institute on Drug Abuse Office of Acquisition NCATS Section

6303180

75N95022R00054

1 4

06/17/2022

06/03/2022

RFP Number 75N95022R00054 Amendment Number 02

RFP Questions and Answers

1. Attachment 1, Section B, Page Limitations, page 2 of 2. Considering the 35-page limit for the technical volume, would the government consider excluding the Resumes/CVs (2-pg limit) from the total page count?

Curriculum Vitae (CV) and other relevant attachments are not included in the 35-page limit for the technical proposal. RFP Attachment 1 is updated to reflect this.

2. Attachment 1, Section A, Formatting of Proposals, page 2 of 2. Will the government consider allowing graphics to contain text in 8-point font?

Yes, the Government will allow graphics to contain text in 8-point font. RFP Attachment 1 is updated to reflect this.

3. RFP, Article F.3, Level of Effort, page 15. The RFP states “these labor hours exclude subcontractor labor hours.” Can the government confirm that the overall hours to be expended by year should include subcontractor labor hours?

Yes, the Government confirms the overall hours to be expended by year should include subcontractor labor hours. The RFP is updated to reflect this.

4. "RFP, Section 14, Past Performance Information, page 68. The RFP states:

"- Three Past Performance (Federal Contracts) References that are either active contracts or have expired within no more than two years.

- Two Past Performances as a prime contractor…” Can the Government confirm that this corresponds to 5 total past performances requested, of which at least two must be as the prime contractor?"

The Government confirms this corresponds to five (5) total past performances requested, of which, at least two must be as a prime contractor. The RFP is updated to reflect this.

5. Attachment 1, Section A, Packaging and Delivery of Proposals, page 1 of 2. Please confirm that proposed subcontractors may submit their company-proprietary cost/price supporting documentation directly via eCPS. If not, please advise on the preferred method for subcontractors to submit their unsanitized cost proposals directly to the Government.

If subcontractors are proposed, please include a commitment letter from the subcontractor in your proposal detailing information in accordance with “RFP SECTION L.

paragraph 2.c.11. Subcontractors.” Subcontractors may not submit their company-proprietary cost/price supporting documentation directly via eCPS.

6. The RFP Cover Page, SOW page 62, and Attachment 3 list different dates for the period of performance. Could the government confirm that the initial performance period will start on or around August 25, 2022?

The Government confirms the initial performance period will start on or around August 25, 2022. RFP Attachment 3 is updated to reflect this.

7. A small number of bibliographical references may be necessary to illustrate the scientific state of the art in our technical response. Would the government consider allowing a Bibliography Appendix with a 1-page limit that is excluded from page count?

Yes. RFP Attachment 1 is updated to reflect this.

8. RFP, Section H, Article H.18, Use of funds for conferences, meetings, and food, page 35. Can the government please list in this table the Annual Fall and Spring CTSA Program Meetings to indicate that they are pre-approved for this contract?

The Government anticipates the Annual Fall and Spring CTSA Program Meetings will be approved at the time of award, and the contract award will include both meetings in the Table under the subject ARTICLE.

9. RFP, Section H, Article H.21, Use of Funds for Promotional Items, page 36. Please confirm that the government will responsible for all promotional items and associated expenses for the two bi-annual conferences.

NIH considers promotional items to be an extraneous expense. Therefore, ICs shall not use appropriated funds to purchase promotional items. Promotional items include, but are not limited to: Clothing and commemorative items such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are sometimes provided to visitors, employees, grantees or conference attendees.

Typically, items or tokens to be given to individuals are considered personal gifts for which appropriated funds may not be expended. Refer to the NIH Policy on Promoting Efficient Spending, 2.1 Use of Appropriated Funds for Promotional Items, pg. 22, viewable here:

https://oamp.od.nih.gov/sites/default/files/ContractToolbox/confpolrewrite20151101_508re v.pdf

10. RFP, Section b.1.a.2, Technical Proposal Instructions - Statement of Work - Approach, page 70.

It is our understanding that the effort does not require research to be conducted. As such, please confirm that under the Technical Proposal Instructions, Section b.1.a.2, the following is not applicable: "Discuss phasing of research and, if appropriate, include experimental design and possible or probable outcome of approaches proposed."

The Government confirms that under the Technical Proposal Instructions, Section b.1.a.2, the following is not applicable: "Discuss phasing of research and, if appropriate, include experimental design and possible or probable outcome of approaches proposed." The RFP is updated to strikethrough this sentence.

11. Are there any tools already in existence that are being used to collect, analyze, and manage CTSA data, or will all tools necessary need to be developed by the contractor?

CTSA Consortium-wide tools such as REDCap can be utilized for data collection and data management. Existing tools for such as Excel, SPSS, SAS, R, or XML can be used for data analytics, visualization and reporting depending on the types of data and analytical needs.

In addition tools such as NIH RePORTER, clinicaltrials.gov, pubmed and other publicly available data sources can be used for data extraction and for further analysis using one or more of the above tools.

12. What data types can be expected to be used by CTSA Program participants?

Data related to the impact of the CTSA program, including data from publicly available sources such as RePORTER, clinicaltrials.gov, pubmed, and others; and non-publicly available such as data from prospective and retrospective surveys and specific data queries from CTSA hubs to evaluate their impact locally and nationally.

https://oamp.od.nih.gov/sites/default/files/ContractToolbox/confpolrewrite20151101_508rev.pdf https://oamp.od.nih.gov/sites/default/files/ContractToolbox/confpolrewrite20151101_508rev.pdf https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.project-redcap.org%2F&data=05%7C01%7Cmark.mcnally%40nih.gov%7Cbe90698bbf034c1fb47c08da4e1753ca%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C637908159333933459%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=exnVRFhpGOB5VCmFEJoILQ71jD9VQ3snf2vxaaAyBLE%3D&reserved=0 https://reporter.nih.gov/ https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C01%7Cmark.mcnally%40nih.gov%7Cbe90698bbf034c1fb47c08da4e1753ca%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C637908159334089687%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=HBCDb26ubSTdfNj70VdpeZY2VvzgACnuoNDcGAVkbb4%3D&reserved=0 https://pubmed.ncbi.nlm.nih.gov/

13. In the case hubs utilize different data types, is it required that all data is to be harmonized into a standardized format before storage?

No, data does not need to be harmonized before submission to the contractor. Data harmonization and curation will be required before storage within the NCATS cloud.

14. Can you provide an estimate regarding how large the anticipated data to be stored is?

It is expected that all data collected will be stored in the NCATS cloud. It is estimated in the low terabyte range.

15. Regarding the web portal, will the contractor be responsible for creating a custom authentication solution, or to utilize an authentication solution already in use within the NCATS web environment?

The contractor will utilize an existing authentication system in use within the NCATS web environment.

16. Does the Principal Investigator need to have previous CTSA experience?

The Principal Investigator is not required to have previous CTSA experience; however, the qualifications of proposed personnel, including key personnel, will be evaluated for appropriateness of credentials, training, qualifications, experience, and competence to perform the work contemplated in the Statement of Work in accordance with RFP SECTION M. paragraph 4.b.

17. Please provide page count for the technical proposal, business proposal, past performances, and key personnel resumes.

Technical Proposal: page limit shall not exceed 35 pages. Refer to RFP Attachment 1, paragraph II.B., items 1-4. The total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section;

b. Resumes/Curricula Vitae (CVs) and other relevant attachments;

c. A one-page bibliography appendix; and

d. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

Business Proposal: no page limit.

Past performance information shall be submitted as part of the Technical Proposal. Refer to RFP, SECTION L., paragraph 2.a.14.

Each Curriculum Vitae (CV) shall not exceed 2 pages. Refer to RFP Attachment 1, paragraph II.B., item 3.