Sol_75N95024R00106_Amendment_0001__001.pdf

(x)

75N95024R00106 x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT 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.

x

NIDA

Bethesda, MD 20892-7511 National Institute on Drug Abuse National Institutes of Health

NIDA-EXEC

Bethesda, MD 20892-7511 National Institute on Drug Abuse National Institutes of Health

09/04/20240001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

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

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

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

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

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

08/24/2024

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

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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

ORDER NO. IN ITEM 10A.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

MARLENE E. MILGRAM

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

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

The PURPOSE of this amendment is to make revisions to RFP No. 75N95024R00106 and provide answers to prospective offerors' questions regarding the RFP.

This amendment consists of Parts A) and B) on pages 2 - 7 below.

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

SF-30 CONTINUATION SHEET

AMENDMENT NO. 0001

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NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

REQUEST FOR PROPOSALS (RFP) NO. 75N95024R00106

AMENDMENT NO. 0001

DATE ISSUED: September 5, 2024

The above numbered RFP is amended as set forth below. The hour and the date specified for receipt of proposals remains unchanged. Offerors must acknowledge receipt of the amendment prior to the hour and the date specified in the RFP or as amended, by one of the following methods:

I. Acknowledging receipt of this “Amendment No. 0001” in its technical proposal. Please note that this is the preferred method.

II. Send an email acknowledging receipt of “Amendment No. 0001” to the point of contract listed below.

FAILURE OF YOUR ACKNOWLEDGMENT OF THE AMENDMENT TO BE RECEIVED AT

THE PLACE DESIGNATED FOR THE RECEIPT OF PROPOSALS PRIOR TO THE HOUR

AND DATE SPECIFIED IN THE RFP MAY RESULT IN REJECTION OF YOUR PROPOSAL.

If, by virtue of this amendment, you desire to change a proposal already submitted, such change may be made by email, provided each email makes reference to the RFP number and this amendment number, and is received prior to the proposal submission due date and hour.

The purpose of this Amendment No. 001 is to A) make changes to the above numbered RFP, and B) provide answers to prospective offeror questions regarding the above numbered RFP. This amendment consists of Parts “A)” and “B)” as follows:

A) This amendment makes the following changes to the above numbered RFP:

1. Provision “Notice to Offerors of Requirements, Protection of Human Subjects, HHSAR 352.270-4(a) (DEC 2015)” (at pages 74-75 of the RFP) is replaced in its entirety with provision “Notice to Offerors of Requirements, Protection of Human Subjects, HHSAR 352.270-4(a) (DEC 2015), Alternate I (DEC 2015).”

2. As the contractor will not be developing any research protocol under the contract resulting from this RFP, Attachment 9 – “PHS Human Subjects and Clinical Trials Information Form-H Study Record” does not apply to the requirement and does not need to be submitted as part of an offeror’s proposal. Accordingly, Attachment 9 is deleted from SECTION J – LIST OF ATTACHMENTS. Additionally, the following text items pertain to Attachment 9 and are deleted in their entirety:

e. Information Required for ALL Clinical Research Proposals

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This solicitation contains a review criterion addressing the adequacy of: (1) the offeror's plans for inclusion of women and minorities in the research proposed; or

(2) the offeror's justification(s) for exclusion of one or both groups from the research proposed.

Provide information on the composition of the proposed study population in terms of sex/ gender and racial/ethnic groups and provide a rationale for selection of such subjects in response to the requirements of the solicitation. The description may include (but is not limited to) information on the population characteristics of the disease or condition being studied in the planned research, and/or described in the statement of work, national and local demography, knowledge of the racial/ethnic/cultural characteristics of the population, prior experience and collaborations in recruitment and retention of the populations and subpopulations to be studied, and the plans, arrangements and letters of commitment from relevant community groups and organizations for the planned research.

The proposal must include the following information:

A description of the subject selection criteria The proposed dates of enrollment (beginning and end) A description of the proposed outreach programs for recruiting women and minorities as subjects A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group The proposed sample composition using the "PHS Human Subjects and Clinical Trials Information Form/Planned Enrollment Report" (see Section J, Attachments)

NOTE 1: For all proposals, use the ethnic and racial categories and complete the "PHS Human Subjects and Clinical Trials Information Form/Planned Enrollment Report" in accordance with the Office of Management and Budget (OMB) Directive No. 15, which may be found at: http://www.whitehouse.gov/omb/fedreg_notice_15.

(At pages 79 – 80 of RFP.)

In addition to the above requirements, solicitations for NIH defined Phase III clinical trials* require that: a) all proposals and/or protocols provide a description of plans to conduct analyses, as appropriate, to detect significant differences in intervention effect by sex/gender, racial/ethnic groups, and relevant subpopulations, if applicable (see NIH Guide:

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm, Definitions - Significant Difference).

*The definition of an " NIH-Defined Phase III clinical trial" can also be found at this website.); and

b) all contractors to report annually cumulative subject accrual, and progress in conducting analyses for sex/gender and race/ethnicity differences.

Offerors may obtain copies of the Updated Guidelines from the sources above or from the contact person listed in the solicitation.

Also, the proposal must include one of the following plans:

AMENDMENT NO. 0001 P

age 4 of o Plans to conduct valid analysis to detect significant differences in intervention effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly support these significant differences among subgroups, OR o Plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups, OR o Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect between subgroups.

Use the form entitled, "PHS Human Subjects and Clinical Trials Information Form/ Planned Enrollment Report," when preparing your response to the solicitation requirements for inclusion of women and minorities. (See Section J-List of Documents, Exhibits and Other Attachments of the RFP)

Use the form entitled, "PHS Human Subjects and Clinical Trials Information Form/Cumulative Inclusion Enrollment Report," for reporting in the resultant contract.

(At pages numbered 80 - 81 of RFP.)

The proposal also must include one of the following plans:

Plans to conduct valid analysis to detect significant differences in intervention effect among sex/gender and/or racial/ethnic subgroups when prior studies strongly support these significant differences among subgroups, OR

Plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups (representation of sex/gender and/or racial/ethnic groups as subject selection criterion is not required; however, inclusion and analyses are encouraged), OR

Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect between subgroups.

Also, the proposal must address the proposed outreach programs for recruiting women and minorities as participants.

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Some of the issues they will evaluate include:

whether the plan proposed includes minorities and both genders in adequate representation how the offeror addresses the inclusion of women and members of minority groups and their subpopulations in the development of a proposal that is appropriate to the scientific objectives of the solicitation the description of the proposed study populations in terms of sex/gender and racial/ethnic groups and the rationale for selection of such subjects if exclusion is proposed, that the rationale is appropriate with respect to the health of the subjects and/or to the purpose of the research

In addition, for gender exclusion, the reviewers will examine the rationale to determine if it is because:

o the purpose of the research constrains the offeror's selection of study participants by gender (e.g., uniquely valuable stored specimens or existing datasets are single gender; very small numbers of subjects are involved; or o overriding factors dictate selection of subjects); or o gender representation of specimens or existing datasets cannot be accurately determined, and this does not compromise the scientific objectives of the research.

For minority group exclusion, the reviewers will examine the rationale to determine if those minority groups are excluded because:

o inclusion of those groups would be inappropriate with respect to their health; or o inclusion of those groups would be inappropriate with respect to the purpose of the research.

For NIH-defined Phase III clinical trials, reviewers will also consider whether there is an adequate description of plans to conduct analyses to detect significant differences of clinical or public health importance in intervention effect(s) by sex/gender and/or racial ethnic subgroups when the intervention effect(s) is expected in the primary analyses, or if there is an adequate description of plans to conduct valid analyses of the intervention effect in subgroups when the intervention effect(s) is not expected in the primary analyses.

If you determine that inclusion of women and minority populations is not feasible, you must submit a detailed rationale and justification for exclusion of one or both groups from the study population with the technical proposal. The Government will review the rationale to determine if it is appropriate with respect to the health of the subjects and/or the purpose of the research

Based on the evaluation of the response to this criterion, this section of the proposal may be rated "unacceptable" (i.e., no discussion can be found regarding the proposed gender/minority inclusion plans, or concerns are identified as to the gender

Page 6 of or minority representation, or the proposal does not adequately address limited representation of one gender or minority; or the plan is not in accordance with NIH policy guidelines) or "acceptable." See Section L of the solicitation for the requirements of women/minorities inclusion. If the reviewers find that this portion of the proposal is "unacceptable" they will provide a narrative supporting their finding.

(At pages 100 – 101 of RFP.)

(End of Part A) Changes to RFP)

B) This amendment provides following responses to questions received from prospective offerors regarding the above numbered RFP:

PROSPECTIVE OFFEROR

QUESTIONS

GOVERNMENT ANSWERS TO PROSPECTIVE

OFFEROR QUESTIONS

Question #1:

What is the standard government cap for physician salary support?

Answer to Question #1:

The annual salary of each proposed personnel must adhere to the Executive Schedule, Level II* limit as provided under “8. Salary Rate Limitation,” at pages 92

– 93 of RFP.

Question #2:

We noticed that the deadline is two weeks away (09/09/2024). Is there any indication that NINDS intends on extending the deadline given the timing of the RFP release?

Answer to Question #2:

Due to the need to award contracts by 9/27/2024, NINDS does not intend to extend the deadline for submitting proposals in response to this RFP.

Question #3:

Do you want the lobbying disclosure (Attachment 19) included even if we aren’t involved in lobbying and if so, do you want that in the Technical or Business Proposal? It is not clear from the RFP.

Answer to Question #3:

In determining whether it has an affirmative duty to submit a completed version of Attachment 19 – Disclosure of Lobbying Activities, the Offeror shall follow the instructions provided in paragraph (d) of FAR 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sept 2007), which states:

“(d) Disclosure. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the

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PROSPECTIVE OFFEROR

QUESTIONS

GOVERNMENT ANSWERS TO PROSPECTIVE

OFFEROR QUESTIONS

offeror to whom payments of reasonable compensation were made.”

Paragraph (d) requires the submission of OMB Standard Form LLL, Disclosure of Lobbying Activities if any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract. If the Offeror determines that it has an affirmative duty to submit Attachment 19 with its offer, then Attachment 19 should be completed and included in Offeror’s Business Proposal.

Question #4:

Regarding Attachment 9, this proposal isn’t a direct proposal for a clinical trial. Does this attachment apply? It will be hard to generate an inclusion enrollment report without specific studies in mind.

Answer to Question #4:

Please refer to Part A) of this amendment, which states in part “Attachment 9 – “PHS Human Subjects and Clinical Trials Information Form-H Study Record” does not apply to the requirement and does not need to be submitted as part of an offeror’s proposal.”

(End of Part B) Questions and Answers to Questions)