Amendment0001_75N95022R00003-S.pdf

PDF 375 KB Posted Jan 25, 2022

Attached to: Pharmacology and Toxicology for Therapeutics Program (PTTP)
Solicitation number: 75N95022R00003
Issued by: Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse

About this file

Written by GovTribe AI · Dec 29, 2023

This amendment modifies a solicitation for multiple award indefinite delivery/indefinite quantity contracts to support the Pharmacology and Toxicology for Therapeutics Program. The National Institute on Neurological Disorders and Stroke seeks contractors to perform all preclinical pharmacology and toxicology testing required to assess promising compounds and support their development as therapeutics. Contractors will also assist with all studies necessary for regulatory filings with the FDA to allow clinical evaluation of candidate drugs. Interested offerors should review all attachments and submit all requested information and documentation by the response date. The Department of Health and Human Services National Institutes of Health National Institute on Neurological Disorders and Stroke will award multiple IDIQ contracts for an indefinite ordering period to support pharmacology and toxicology assessment of therapeutics.

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Other files

File	Type	Posted
Attachment No. 8 Propos Summary NIH-2043_revised.pdf	PDF	Jan 25, 2022
Attachment No. 5 Technical Proposal Budget Templates_revised.xlsx	XLSX spreadsheet	Jan 25, 2022
Attachment No. 3 Statement of Work_revised.pdf	PDF	Jan 25, 2022
RFP 75N95022R00003 PTTP Ramp-On_revised.pdf	PDF	Jan 25, 2022
Attachment No. 13 Disclosure of Lobbying_revised.pdf	PDF	Jan 25, 2022
Attachment No. 15 NIH(RC)-2-2_revised.pdf	PDF	Jan 25, 2022
Attachment No. 22 Project Objectives NIH-1688-1_revised.pdf	PDF	Jan 25, 2022
Attachment No. 23 Financial Questionnaire_revised.pdf	PDF	Jan 25, 2022
Attachment No. 11 Offeror Pts of Contact.pdf	PDF	Jan 3, 2022
Attachment No. 12 Wage Determination November 2021.pdf	PDF	Jan 3, 2022
Attachment No. 23 Financial Questionnaire.pdf	PDF	Jan 3, 2022
Attachment No. 14 NIH Customer Perf Survey.pdf	PDF	Jan 3, 2022
Attachment No. 1 Pack and Delivery of Proposal.pdf	PDF	Jan 3, 2022
Attachment No. 7 VAS Contracts worksheet.pdf	PDF	Jan 3, 2022
Attachment No. 15 NIH(RC)-2-2.pdf	PDF	Jan 3, 2022
Attachment No. 5 Technical Proposal Budget Templates.xlsx	XLSX spreadsheet	Jan 3, 2022
Attachment No. 21 Electronic Invoicing Instructions 20210210.pdf	PDF	Jan 3, 2022
Attachment No. 4 Section K Reps.pdf	PDF	Jan 3, 2022
Attachment No. 10 Business Proposal Budget Templates.xlsx	XLSX spreadsheet	Jan 3, 2022
Attachment No. 16 NIH (RC)-4.pdf	PDF	Jan 3, 2022
Attachment No. 18 Nondisclosure Agreement.pdf	PDF	Jan 3, 2022
Attachment No. 3 Statement of Work.pdf	PDF	Jan 3, 2022
RFP 75N95022R00003 PTTP Ramp-On.pdf	PDF	Jan 3, 2022
Attachment No. 17 Privacy Act SORN 09-25-0124.pdf	PDF	Jan 3, 2022
Attachment No. 2 Propsal Intent Response Sheet.pdf	PDF	Jan 3, 2022
Attachment No. 9 Small Business Subcontracting Plan.pdf	PDF	Jan 3, 2022
Attachment No. 19 Suitability Roster.xlsx	XLSX spreadsheet	Jan 3, 2022
Attachment No. 6 Summary of Related Activities.pdf	PDF	Jan 3, 2022
Attachment No. 13 Disclosure of Lobbying.pdf	PDF	Jan 3, 2022
Attachment No. 8 Propos Summary NIH-2043.pdf	PDF	Jan 3, 2022
Attachment No. 22 Project Objectives NIH-1688-1.pdf	PDF	Jan 3, 2022
Attachment No. 20 Employ Sep Checklist.pdf	PDF	Jan 3, 2022

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Questions RFP 75N95022R00003

No Reference Question Response Corr Att’t No. 22 Second page is labeled Att’t No. 21.

Requesting Government make correction.

Corrected. See Attachment 22.

2. Att’t No. 22 NIH suggested font Helvetica 10-point; Arial 12-point. Would the Government confirm this is the font and size requirement for the Technical and Business Volumes?

The Technical Volume should be Font Helvetica 10-point; Arial 12-point.

The Business Volume does not need to be Helvetica 10-point; Arial 12-point.

3. Att’t No. 3 Second page forward are labeled Att’t No. 1. Requesting Government make correction.

Corrected. See Attachment 3.

4. B Att’t No. 5 Period of Performance “Date of Award – 09/12/2021” is past. (Row 10, Column E). Requesting Government update the document with an updated period of performance.

Corrected. See Attachment 5.

5. Att’t No. 5 Period of Performance “09/13/2021 – 09/12/2022 (Row 12, Column E), has a Unit count of 12. Does the Government want the Offeror to price for 12 months to include four (4) to six

(6) months that will be past at time of award?

Corrected. See Attachment 5.

6. Att’t No. 8 Second page is labeled Att’t No. 8;

Requesting Government make correction.

Corrected. See Attachment 8.

7. Att’t No. 13 Second page is labeled Att’t No. 11;

Requesting Government make correction.

Corrected. See Attachment 13.

8. Att’t No. 15 Second and third pages are labeled Att’t No. 14; Requesting Government make correction

Corrected. See Attachment 15.

9. Att’t No. 23 Second and third pages are labeled Att’t No. 20: Requesting Government make correction.

Corrected. See Attachment 23.

10.

RFP Section L.2.a.II.;

It is recommended that the proposal consist of a cover page, a table of contents, and all technical proposal documents detailed in the Technical Proposal Instructions as specified in SECTION L of this solicitation.

The Title Page is sufficient in lieu of a Cover Page.

Section L.2.b.2.a., page 82, Proposal Title Page instructions include the Cover Page requirements above.

Is the Title Page sufficient in lieu of a Cover Page for advantageous evaluation?

Does the Government want a Cover Page and a Title Page?

11. RFP Section L.2.a.14, Is the requested “list of the last five

(5) contracts completed during the past three years” the same five (5) previous clients that will complete past performance surveys (Attachment 14)?

The “list of the last (5) contracts completed during the past three years” and the “five (5) previous clients that will complete past performance surveys” are not required to be the same.

12. RFP Section L.2.a.14, Will the Government accept ongoing contracts as part of the five (5) Attachment 14 past performance client surveys?

Yes, the Government will accept ongoing contracts as a part of the five

(5) past performance client surveys, provided the contract has been ongoing for at least a year.

13. RFP Section L.2.a.14, Will the Government allow completed Task Orders on an ongoing IDIQ as a previous client past performance survey (Attachment 14)?

Yes, the Government will accept completed Task Orders on an ongoing IDIQ as a part of the five (5) past performance client surveys, provided they are relevant.

14. RFP Section L.2.b.4.b.3, . . .The technical areas, character, and extent of subcontract or consultant activity will be indicated, and the anticipated sources will be specified and qualified.

Please provide clarification on the use of the word “character” in this context.

See RFP for update. The word “character” has been replaced with “nature.”

15. RFP Section L.4., page 83 and M.3., page 105, Technical Evaluation

SECTION L.4. SECTION 3: Technical Capabilities and Discussions:

“Section 3 shall be divided into separate parts for each Performance Area and for all of the Sample Task Orders.”

No, a separate section for the Kickoff Meeting is not required.

Section M3 has been revised.

The Technical Evaluation in M.3.

instructs for separate proposal sections for

(1) the Contract Kick-off Meeting;

(2) Performance Area 1, and

(3) Performance Area 2 as well as separate technical responses for each sample Task Order under Performance Area 2.

Does the Government want a separate section for the Contract Kick-off Meeting in SECTION 3: Technical Capabilities and Discussions?

16. RFP Section L.4., page 83

Capabilities and Discussions:

“Section 3 shall be divided into separate parts for each Performance Area and for all of the Sample Task Orders.”

Are the two (2) Sample Tasks 1(a) and 1(b) for Performance Area 1 included in the instruction to provide a separate section in the technical proposal?

If no, can the Government confirm that the Performance Area 1 Sample Task Orders are included in the Performance Area 1 Section of the Technical Volume – SECTION 3:

Technical Capability and Discussions?

Yes, but the offeror can reference some of the contents if they have already mentioned in other sections.

17. Att’t 3, SOW page 29, Sample Task 2(f)e.; 28 Day GLP Toxicity Evaluation (Dog)

"e. Collect ECG but not indirect BP on definitive studies”.

Does the Government require a surface ECG or a surgically placed

ECG?

Offerors’ are expected to provide their recommended approach, considering technical and business considerations, as part of their proposal. Offeror should stage the work appropriately and follow current requirements to ensure the study reports are suitable for submission to the FDA as part of an IND package.

18. Att’t 3, SOW page 27, Sample Task 2(e): Dose- Range Finding

Does the Government require a surface ECG or a surgically placed

ECG?

Refer to response to Question 17.

Toxicity Study (NHP)

19. Att’t 3, SOW page 14, 5.a.(2)b)xiii.

5.a.(2)b)xiii. Time period from death to necropsy.

Does the Government require a board-certified pathologist?

Yes. Refer to response to Question 17.

20. Att’t 3, SOW page 14, 5.a.

(2)c)vii.

5.a.(2)c)vii. Ophthalmoscopic findings.

Does the Government require a board-certified ophthalmologist?

Yes. Refer to response to Question 17.

21. Att’t 1 SOW 4.d.1)a), “Utilize suitable analytical methods to determine concentrations of test agents in biological samples (e.g., plasma, urine, bile, saliva, brain and other tissues.

The study design is incomplete;

endpoints are required to determine how biological samples are collected.

What endpoints are evaluated for urinalysis?

The biological samples mentioned in the IDIQ SOW are just examples. It is expected that an offeror would be able to determine drug concentration in different biological samples or tissues. For the purpose of the cost proposal here, assume plasma samples are collected as an end point.

22. _______ respectfully requests that consideration is given to extending the submittal date for the subject RFP, “Pharmacology and Toxicology for Therapeutics Program (PTTP)”, to February 25, 2022. _____ is very interested in bidding and has quite an array of personnel and expertise to offer NINDS and the PTTP program.

Our reasons for this extension request are to be able to gather all needed information including subcontractors’ inputs and costs, distribution of past performance questionnaires, and high-quality responses to the Sample Task Orders. We are accustomed to seeing at least 45 days for IDIQ responses, (the original solicitation for this IDIQ RFP NIH NINDS-16-01 was issued on March 21, 2016, with a due date of May 9, 2016 - 49 days initially for proposal submission, before any extensions).

Yes.

The proposal due date has been extended to 5:00 PM EST on Friday, February 25, 2022.

The additional time will allow our organization the time required to submit a high-quality bid.

23. RFP Section L.4., page 83

“Section 3 shall be divided into separate parts for each Performance Area and for all of the “Sample Task Orders” listed in the solicitation Statement of Work. Each part shall address and provide a detailed discussion indicating how each part is to be accomplished.”

Will the Government accept references to Performance Area 2 technical approach where that information is exactly the same for the individual Sample Task Order technical approach?

Are the Sample Task Orders evaluated against all the Technical Approach evaluation factors in the Technical Evaluation Criteria table on pages 105

– 108?

If yes, does the Government require a “stand alone” section for each Sample Task Order that does not refer back to Technical Capabilities and Discussions Section, but includes Performance Area 2 content from a previous section within the Sample Task Order section?

Some of the content from Technical Capability and Discussion section will remain consistent for all Sample Task Orders, (example Quality Assurance section, Key Personnel, etc.).

Will Government favorably evaluate a repetition of the consistent, applicable Technical Capability and Discussion content within the individual Sample Task Order sections?

Yes

Yes, overall approach and study designs will be evaluated against the same criteria.

Yes, require a “stand alone” section

Quality Assurance section, Key Personnel, etc… do not need to be repeated, they can be just referenced

24 n/a Will the government consider allowing contractors to bid on a

For the purposes of this RFP, offerors must show they can satisfy all the subset of the task areas to eliminate the need for multiple subcontractors?

requirements in the statement of work.

sf30_Amendment 0001_75N95022R00003

QandA RFP 75N95022R00003

	2022-01-25T14:47:42-0500
Nancy L. Lamon-kritikos -S

File details come from the government source that posted it. Updated Jan 25, 2022.