RFQ Amendment 01 SF-30.pdf

NSN 7540 - 01 - 152 – 8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48CFR) 53.243

OMB No. 0990-0115

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

1 6

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

01 See Block 16C

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

NIDA Section, Contracts Management Branch Red Office of Acquisition, NIDA c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, Maryland 20892-9559

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

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION NO.

RFQ No. 75N95020Q00228

9B. DATED (SEE ITEM 11)

August 13, 2020

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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 Offer is extended 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 Item 8 and 15, and returning 1 copies of the amendment; (b) 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 ACKNOWLEDG- MENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR 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 hours and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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: (Specify authority) 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 data, etc.) SET FORTH IN ITEM 14, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF

D. OTHER (Specify type of modification and authority)

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

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

PURPOSE: To respond to formal questions submitted in response to the solicitation.

Proposal Due Date: 3:00 p.m. (Eastern) on September 2, 2020 (UNCHANGED)

Note: The offeror should acknowledge on the cover page or first page of its business and technical proposals receipt of the RFP and this Amendment.

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 (Type or print)

Joshua T. Lazarus, Contracting Officer, NIDA Section, CMB Red

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

(Signature of person authorized to sign)

BY

(Signature of Contracting Officer)

August 25, 2020

Request for Proposal Amendment No. 01 75N95020Q00228 Page 2 of 6

Page # Section Title Question Response

3 Project Requirement

Can NIH provide an estimate of how many studies the contractors should be prepared to recruit for annually? Will recruitment studies overlap?

Can NIH provide an estimate for the total number of participants that the contractors should be prepared to recruit annually?

The number of active studies recruiting at any given time varies but is approximately 10. Studies close when they reach their individual recruitment goals, which are different for each study.

However, most studies (on average) aim to enroll 10-15 new subjects per month.

There are often participants who are eligible for more than one study, depending on the study criteria. Study staff will work with each other to determine priority which is based on various factors.

Project Requirement – Statement of

Understanding

Will contractors be responsible for conducting telephone screenings of potential participants, including those for inclusion/exclusion factors such as age, gender, socio-economic status, IQ, and other health conditions?

Will contractors be responsible for conducting in-person screenings of participants (e.g., for biometric confirmation of drug-use status or health conditions)?

NIDA IRP conducts phone and in-person screening. The Contractor may be asked to assist with identifying an online screening platform to facilitate scheduling of phone screens and in-person screens or to work with the NIDA IRP to develop online screens that are linked to specific ads for tracking interest/success of those ads.

75N95020Q00228 Page 3 of 6

5 Statement of Work

Can NIH provide more information regarding what mental health disorders will count as an exclusion criterion (e.g., in addition to schizophrenia, bipolar disorder, etc., would a diagnosis of depression or anxiety exclude an individual from being eligible to participate in the study)? Furthermore, does this mental health disorder diagnosis refer to those who have been specifically diagnosed by a physician, or would it also pertain to those who have self-diagnosed?

Each study will list specific information and allow for varying levels of comorbidities. Some will not allow any DSM diagnosis except a substance use disorder (SUD). Some studies exclude mood disorders, anxiety disorders, and psychotic disorders and others do not. An official diagnosis is what we would ask about although typically, we also administer the DSM-V during screening and exclude based on results and study Inclusion/Exclusion criteria.

For the purpose of responding to the Sample Recruitment Plan, assume the sample protocol only allows for the single SUD (alcohol, nicotine, cocaine and/or opioid use disorder) and that it would exclude those with any other current (in the past 12 months) official DSM diagnosis.

5 Statement of Work

Can NIH provide more information regarding what types of “significant physical illness” would count as exclusion criteria (e.g., cancer, heart conditions, recent major surgery, chronic illness)?

Each study will list specific information.

Some studies will allow the use of medications to stabilize a condition (e.g.

high blood pressure), others do not. For the purpose of responding to the Sample Recruitment Plan, assume the sample protocol will not accept any current illness requiring the use of regular prescription or OTC medications.

8 Technical Evaluation Criteria

Can NIH confirm that there is no page limit for contractor submissions?

NIDA requests that the Technical Quote not exceed 30 pages. However, Past performance references for same or similar work, Approach to and Compliance with HHS Security and Privacy Language for Information and Information Technology, and Section 508 Compliance (if applicable) will not count towards the page limit. Resumes and an organizational chart can be included as an attachment and will not count towards the page limit. Technical Quotes should be descriptive yet concise.

75N95020Q00228 Page 4 of 6

8 Technical Evaluation Criteria

If a page limit is determined, can NIH confirm that resumes, past performances, and the Product Accessibility template are excluded from that page limit?

Past performance references for same or similar work, Approach to and Compliance with HHS Security and Privacy Language for Information and Information Technology, and Section 508 Compliance (if applicable) will not count towards the page limit. Resumes and an organizational chart can be included as an attachment and will not count towards the page limit.

12 Technical Evaluation Criteria

Can NIH confirm the maximum file size allowed for email submission?

Incoming messages from non-NIH addresses shall not exceed 100 megabytes (MB).

12 Technical Evaluation Criteria

May contractors submit their proposal in zipped files?

The NIH email system usually blocks .ZIP files, therefore submitting .ZIP files is not advised.

12 Technical Evaluation Criteria

Could NIH confirm whether the Section 508 Product Assessment Template should be included as part of Section H of Other Non-Cost/Price Factors or in an appendix to the technical quote?

Section 508 Product Assessment Template should be included as part of Section H of Other Non-Cost/Price Factors.

19 General Requirements

Could NIH confirm whether the contractor is expected to create landing pages for each protocol? Or will contractors maintain existing landing pages?

The IRP is open to options regarding who will maintain the one main recruitment website for NIDA studies.

The IRP may be able to grant access to the contractor to maintain the main website which can also serve as a connection to multiple landing pages that the contractor creates for each study or campaign.

20 General Requirements

Can NIH confirm what the approval process will be for each proposed advertising campaign?

First, the study team will confirm that the proposed campaign aligns with the study and budget. Then, all images and text must receive two different institutional approvals (first from our Office of Science Policy/Digital Communications Branch then from the

IRB).

75N95020Q00228 Page 5 of 6 and

Technical Evaluation Criteria

Can NIH confirm that the given base price of the contract is inclusive of the labor and ODCs included in the Transition-In and Transition-Out services and the $350,000 of optional advertising and marketing support?

As stated on page 14 of the Solicitation:

“The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. NIDA estimates that the total cost of this contract (inclusive of Option Quantities) is between $665,000 and $815,000 for the Base Period, between $670,000 and $820,000 for Option Period 1, between $675,000 and $825,000 for Option Period 2.”

Please also note that beginning on page 8 of the Statement of Work it states:

“Options for additional marketing and advertising support include the following:

1. If exercised, the Contractor shall provide up to $5,000 in optional marketing and advertising support as described above. NIDA may exercise this Option Quantity Task up to 10 times in each period of performance.

2. If exercised, the Contractor shall provide up to $10,000 in optional marketing and advertising support as described above. NIDA may exercise this Option Quantity Task up to 10 times in each period of performance.

3. If exercised, the Contractor shall provide up to $20,000 in optional marketing and advertising support as described above. NIDA may exercise this Option Quantity Task up to 10 times in each period of performance.”

and

Technical Evaluation Criteria

Is there is an established advertising budget per year outside of options?

What is their expected advertising budget per protocol?

Please refer to the response above.

N/A General Inquiries

Are there any changes in this project due to COVID?

Offerors should prepare and submit their quotes in accordance with the description and instructions detailed in Solicitation number 75N95020Q00228.

75N95020Q00228 Page 6 of 6

N/A General Inquiries

Is the contractor permitted to transport participants to the BRC location in East Baltimore? How many can be transported at a time? Are there updated guidelines for your agency due to the pandemic?

Transportation varies across protocols.

More than one participant is not typically transported at a time as each study team has different start and end times.

Limitations to how many participants will be allowed in the building will change over time and will be communicated to the contractor as needed. The IRP is currently closed to participants and is expected to slowly begin in September with a limited number of studies (~2).

N/A General Inquiries Is there a ceiling on the incentives that can be provided to each participant?

Each protocol has a set approved remuneration. Incentives are usually based on performance completion within the study. Most studies do not and cannot include referral incentives (e.g.

participant A cannot receive financial benefit based on something participant B does)

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