Amendment_No._1_RFP_16-01.doc

OMB No.: 0990-0115

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

04/22/2016

4. REQUISITION/PURCHASE REQ. NO.

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

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

NINDS R&D Contracts Management Branch

National Institute on Drug Abuse, NIH

6001 Executive Blvd, Suite 3287, MSC 9135

Rockville, MD 20852

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

RFP NIH-NINDS-16-01

X

9B. DATED (SEE ITEM 11)

March 21, 2016

10A. MODIFICATION OF CONTRACT/ORDER NO.

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 extended, is not X 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; (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)

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

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

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, is required to sign this document and return ___________ copy to the issuing office.

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

Purpose of this Solicitation Amendment: To share Government’s response to questions received under the solicitation; to amend the chart for Sample Task 2d: Sample Dose-Range Finding Toxicity Study (Rat) under the Statement of Work for Performance Area 2, Sample Task Orders 2(a) through 2(g); and to include HHSAR Provision 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015). This provision is included in full text and is hereby made a part of the RFP under Section L.2., entitled: “Instructions to Offerors.”

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

Kirkland L. Davis, Chief, NINDS R&D Contracts Management Branch, NIDA, NIH

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

BY ________________________________________

(Signature of Contracting Officer)

16C.DATE SIGNED

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

RFP No. NIH-NINDS-16-01

AMENDMENT No. 0001 The following is a list of questions and the Government’s response to those questions for which the Government has determined should be shared with all potential offerors.

1. Question: Will the study data provided for non-GLP studies be required to be in SEND (Standard for Exchange of Nonclinical Data) format?

Response: Non-GLP studies will generally not require data to be in SEND format, though that may be required for particular projects. Specific reporting requirements will be specified for each task order.

2. Question: The 28-day studies for both rat and dog specify full histopathology on control and high-dose groups and target organs in low and mid groups. Does this apply to both the Main and Recovery groups, or should the Recovery groups have different requirements (e.g., evaluation of only target organs and gross lesions)?

Response: For purposes of preparation of the technical and cost proposal, full histopathology applies to both Main and Recovery groups. Requirements under the contract may vary based on the needs of particular projects and will be specified in task order Statements of Work.

3. Question: Can additional endpoints common to GLP 28-day toxicity studies that were not described in the RFP be added? Examples include food consumption, ophthalmology, and organ weights at necropsy.

Response: Sample task outlines are not intended to be comprehensive, but to give an overview of the desired study design. Offerors should use the outline as the basis of their proposed protocol, however the protocol should be comprehensive including the offerors recommended approach for meeting the goals of the study. Proposals must include all aspects described in the RFP, however additional endpoints may be proposed based on an organization’s experience. Any additions should be noted in the proposal.

4. Question: How often should ECG tests be conducted in the 28-day dog study?

Response: Offerors should propose the timing and number of ECG evaluations based on their experience with non-rodent toxicology studies for submission as part of an IND.

5. Question: Will all test articles be small molecules or will there be biologics tested?

Response: Test articles may include both small molecules and biologics.

6. Question: Confirm that for Sample Task 2d, the number of rats for Group 3 is correct as described in the RFP (i.e., 5M/3F for the Main Study Group and 5M and 5F for the TK Satellite Group).

Response: This was a typographic error, the groups should be 5M/5F for both groups. Offerors are instructed to acknowledge receipt of this amendment as stated on the SF-30.

7. Question: For Sample Task 2a-c: the RFP explicitly calls for calculation of PK parameters on Task 2c, but not in Tasks 2a or 2b. Should PK parameters be calculated for those two tasks also, or is plasma drug level determination sufficient?

Response: PK parameters should be calculated for all sample PK studies.

RFP No. NIH-NINDS-16-01

AMENDMENT No. 0001

8. Question: For Sample Task 2c: The requested number of blood collections (21 from each rat) may limit the volume available for each sample, due to total volume limits. This volume limitation may prevent plasma drug level determination. Does NIH have a preferred alternative approach to address the potential issue?

Response: Offerors should discuss possible limitations of a study design in their proposal and should include options for alternatives, based on their prior experience that would best meet the goals of the study.

9. Question: For Sample Tasks 2d and 2e; The RFP indicates that blood samples for TK analysis will be collected pretreatment and predose and 5-7 times after treatment on Days 1 and 7. Are the pretreatment and predose samples separate samples or are they the same?

Response: Predose and pretreatment refer to the same sample.

10. Question: Sample Task 2d: please clarify whether organ weights should be collected on the ovaries since female rats are only included for Group 3?

Response: Organ weights should be collected on ovaries.

11. Question: Sample Task 2d and 2e: The RFP states that samples (i.e., tissue) collected but not used for slide preparation will be stored frozen for 30 days after the final report. Storage of formalin fixed tissues at room temperature is an alternative approach. Is storage of frozen tissue required or would alternatives be acceptable?

Response: Offerors should propose based on the study outline provided, however alternatives may be proposed in addition. This may include alternatives for sample maintenance.

12. Question: Please clarify the scope to comply with Section 508 accessibility standards required.

Response: All electronic reports/deliverables as stated in the RFP (Statement of Work, Attachment No. 3), shall be submitted in accordance with HHS Section 508. Any electronic reporting, any web base application/website/database/software application, any video/audio, any documentation of the system or other documentation an offeror delivers shall be 508 compliant. Offerors shall submit a PAT/EPAT with their proposal which is detailed at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-th-section-508-standards/guide-to-th-section-508-standards as stated in ARTICLE H.17. of the solicitation.

ADMET related questions

13. Question: Metabolic stability: Is the test using liver microsomes, S9 or expressed recombinant enzymes?

Response: Metabolic stability may be required in any of those preparations, based on the need of the project. This will be specified in the individual task orders. Proposals should describe capabilities with each of those assay formats.

14. Question: MDCK permeability assay: Is this single concentration of test article or multiple dose?

Response: Projects may require either single dose or multiple dose concentrations. For cost proposal purposes, assume single dose.

RFP No. NIH-NINDS-16-01

AMENDMENT No. 0001

15. Question: P450: Is this for CYP inhibition assays alone or will it include induction and/or phenotyping?

Response: Inhibition, induction, or phenotyping may be required based on the needs of each project and will be specified in individual task orders. Technical proposals should describe the offeror’s capabilities for each. For cost proposal purposes for the sample task, assume CYP inhibition only.

16. Question: Cytotoxicity: Is there a preferred test system?

Response: Offerors should propose the test system based on their prior experience.

Change to RFP Statement of Work, Attachment No. 3 – The Statement of Work section entitled Performance Area 2 - Pharmacology and Toxicology Studies, Sample Task Orders 2(a) through 2(g) - The chart for Sample Task 2d: Dose-Range Finding Toxicity Study (Rat) is amended to reflect the correction cited in Question/Response Number 6 above and the chart below supersedes and replaces the chart provided in the original solicitation, and read as follows:

Sample Task 2d: Dose-Range Finding Toxicity Study (Rat)

The following HHSAR Provision No. 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015), is hereby added and made a part of this solicitation, as paragraph number 16, under Section L.2., “Instructions to Offerors.” The full text of this paragraph is as follows:

16.

352.239-73 Electronic Information and Technology Accessibility Notice (December 18, 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have

RFP No. NIH-NINDS-16-01

AMENDMENT No. 0001 access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

INFORMATIONAL REMINDERS

Offerors are reminded to acknowledge receipt of this amendment per instructions in Block 11 of the

SF-30.

The due date for receipt of proposals is NOT extended by issuance of this amendment. Proposal are due by 4:30 p.m. EST on May 9, 2016.