NIDA_RFP_N02DA-17-9916_Amendment_01.pdf

Request for Proposal Amendment No. 01 N02DA-17-9916 Page 2 of 9

Request for Proposal (RFP) No. N02DA-9916 is modified to remove the requirement that offerors submit a Vertebrate Animal Section (VAS) as part of the Technical Proposal and to remove Attachment 08 from the RFP.

RESPONSES TO QUESTIONS

QUESTION 1: The cover letter states proposal is to be submitted electronically via https://secureemail.nih.gov – later the RFP lists via https://ecps.nih.gov. Will the Government please confirm that proposal is to be submitted via the ecps website?

ANSWER 1: All proposals must be submitted via the eCPS website.

QUESTION 2: The RFP requests that a Vertebrate Animals Section (VAS) be submitted.

Will the Government please confirm that it is required for submission with this proposal?

ANSWER 2: Offerors do not need to submit a VAS and the VAS requirement has been removed. However, Offerors must be compliant with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy), as well as all federal laws and regulations. See ARTICLE H.5. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015) and ARTICLE H.6. ANIMAL WELFARE of the RFP. The National Institutes of Health Intramural Research Program’s current Office of Laboratory Animal Welfare (OLAW) Assurance Number is D16-00602 (A4149-01).

QUESTION 3: Will the Government please confirm that the Technical Training Plan should be submitted with the Technical Proposal at the time of initial proposal submission.

ANSWER 3: For proposal purposes, the Technical Training Plan should be submitted with the Technical Proposal at the time of the initial proposal submission. See Section II.E.2.b. of the Statement of Work. An updated schedule for implementation of the Technical Training Plan must be submitted within 30 days after initiation. See ARTICLE

F.2 DELIVERIES.

QUESTION 4: Will the Government please confirm that offerors should submit information to help establish price reasonableness or cost realism, but that such information will not be required to be certified?

ANSWER 4: Certified cost or pricing data is not required; however, information to help establish price reasonableness or cost realism is necessary. Offerors should submit such information pursuant to SECTION L.2.c.3 Data Other than Certified Cost or Pricing Data and SECTION L.2.c.4 Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause 52.215-20 (October 2010) of the

RFP.

https://secureemail.nih.gov/ https://ecps.nih.gov/

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QUESTION 5: Will the Government please confirm which positions are covered by SCA?

ANSWER 5: Section III.B.1.d of the Statement of Work states that “The number of staff, when a minimum is required, by category and job titles, as an example reflective of common functional task assignments and abilities, with minimum qualifications are listed below. The Contractor may propose different categories and job titles from these;

however, contractor proposed categories shall include a description of position complexity, qualifications, requirements and proficiencies for each category or title.”

Offerors should review ARTICLE I.5 SERVICE CONTRACT LABOR STANDARDS and Attachment 12 to the RFP to ensure that proposed positions are in compliance with the Service Contract Act (SCA).

QUESTION 6: For this contract, what contractor owned systems will contain HHS data for which the following apply?

a. The Contractor shall configure its computers that contain HHS data with the latest applicable United States Government Configuration Baseline (USGCB) and/or other approved HHS IT Security Configurations. (See: https://usgcb.nist.gov/)

b. The Contractor shall apply approved security configurations to information technology (IT) that is used to process information on behalf of HHS and must adhere to all NIH configuration standards and policies See:

https://ocio.nih.gov/InfoSecurity/Policy/Pages/CM.aspx.. The following security configuration requirements apply: USGCB

ANSWER 6: The Government cannot identify potential offeror’s owned systems.

Offerors should review ARTICLE H.13. INFORMATION AND PHYSICAL ACCESS SECURITY for more information.

QUESTION 7: For this contract, what applications is the contractor responsible for designing that the following apply?

a. The Contractor shall ensure IT applications operated on behalf of HHS are fully functional and operate correctly on systems configured in accordance with the above configuration requirements. The Contractor shall use Security Content Automation Protocol (SCAP)-validated tools with USGCB Scanner capability to ensure its products operate correctly with USGCB configurations and do not alter USCGB settings - (See:

http://scap.nist.gov/validation). The Contractor shall test applicable product versions with all relevant and current updates and patches installed. The Contractor shall ensure currently supported versions of information technology products met the latest USGCB major version and subsequent major versions.

b. The Contractor shall ensure IT applications designed for end users run in the standard user context without requiring elevated administrative privileges.

ANSWER 7: The Government does not currently plan for the Contractor to be responsible for designing applications. However, the Contractor must ensure any IT applications operated are in compliance with ARTICLE H.13. INFORMATION AND

PHYSICAL ACCESS SECURITY.

https://usgcb.nist.gov/

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QUESTION 8: For this contract what IT systems will need to be purchased by the contractor?

The Contractor shall (1) include Federal Information Processing Standard (FIPS) 201-compliant (See: http://csrc.nist.gov/publications/fips/fips201-1/FIPS-201-1-chng1.pdf), Homeland Security Presidential Directive 12 (HSPD-12) card readers with the purchase of servers, desktops, and laptops; and (2) comply with FAR Subpart 4.13, Personal Identity Verification.

ANSWER 8: The Government does not currently plan for the Contractor to be purchasing IT systems; however, the Contractor’s employees will be required comply with the personal identity verification and investigations procedures discussed in

ARTICLE H.13. INFORMATION AND PHYSICAL ACCESS SECURITY.

QUESTION 9: For this contract, please confirm that the Government assumes that HHS data will be transferred and stored on Contractor owned equipment in or outside of HHS facilities.

The Contractor shall use Federal Information processing Standard (FIPS) 140-2-compliant encryption (Security) Requirements for Cryptographic Module, as amended) to protect all instances of HHS sensitive information during storage and transmission. (Note: The Government has determined that HHS information under this contract is considered "sensitive" in accordance with FIPS 199, Standards for Security Categorization of Federal Information and Information Systems, dated February 2004).

ANSWER 9: The Contractor may have access to HHS data on Government owned equipment in and/or outside of HHS facilities. It is not anticipated that the Contractor will transfer or store HHS data on Contractor owned equipment.

QUESTION 10: For this contract, what IT system is the contractor responsible for providing under for which the following would apply?

a. Providing security of any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor, regardless of location, on behalf of HHS. Adopting, and implementing, at a minimum, the policies, procedures, controls and standards of the HHS Information Security Program to ensure the integrity, confidentiality, and availability of Federal information and Federal information systems for which the Contractor is responsible under this contract or to which it may otherwise have access under this contract. The HHS Information Security Program is outlined in the HHS Information Security Program Policy, which is available on the HHS Office of the Chief Information Officer's (OCIO) Web site.

b. IT Security Plan (IT-SP) - due within 30 days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

c. IT Risk Assessment (IT-RA) - due within 30 days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the

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HHS-OCIO Information Systems Security and Privacy Policy. After resolution of any comments provided by the Government on the draft IT-RA, the Contracting Officer shall accept the IT-RA and incorporate the Contractor's final version into the contract for Contractor implementation and maintenance. The Contractor shall update the IT-RA on an annual basis.

d. IT Security Certification and Accreditation (IT-SC&A) - due within 3 months after contract award. The Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed for applicable information systems - see paragraph (a) of this clause. The Contractor shall perform the IT-SC&A in accordance with the HHS Chief Information Security Officer's Certification and Accreditation Checklist; NIST SP 800-37, Guide for the Security, Certification and Accreditation of Federal Information Systems; and NIST 800-53, Recommended Security Controls for Federal Information Systems. An authorized senior management official shall sign the draft IT-SC&A and provided it to the Contracting Officer for review, comment, and acceptance.

ANSWER 10: The Government does not currently plan for the Contractor to provide new IT systems; however, the Contractor is required to maintain current IT systems and IT Security in compliance with ARTICLE H.13. INFORMATION AND PHYSICAL

ACCESS SECURITY.

QUESTION 11: On page 62 the RFP states under Additional Personnel: List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis. Our question is: are resumes required for all personnel or are resumes only required for Key Personnel listed in the SOW on page 13

ANSWER 11: Resumes are required for all Key Personnel. See ARTICLE L.2.b.1.b.4 of the RFP. The Offeror may propose different categories and job titles for its personnel, including for Key Personnel. See Section III.B.1.d of the Statement of Work.

QUESTION 12: On page 20 under ARTICLE H.5. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015) the RFP states: the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. Our question is if we are using the government owned facility are we still required to register as a contractor/register the government’s facility?

ANSWER 12: The Government facility is registered with USDA-APHIS. The Contractor is not required to independently register; however, the Contractor will be required comply with all laws and regulations associated with registration. See also Answer to Question 2.

QUESTION 13: On page 21 RFP states Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. Our question is if we using the government owned facility are we still required to register as a contractor/register the government’s facility?

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ANSWER 13: See Answer to Question 12.

QUESTION 14: Will subcontractors be authorized to submit their cost data, including Fringe Benefits, Indirect Cost and other proprietary information to the government directly via sealed submission or some other format?

ANSWER 14: Offerors must submit their entire proposal through the eCPS website.

Therefore, subcontractors cannot independently submit cost data directly to the government. Offerors may include the total cost and labor estimate for subcontractors, excluding proprietary information, in their proposals. The Government reserves its right to request such information from the Offeror during discussions after the establishment of the competitive range. At such time, the subcontractor may submit their cost data directly to the Government via sealed submission.

QUESTION 15: To help eliminate a degree of future risk to the government and to potential small business vendors we would like to request a site visit. This would also help ensure the government receives the most competitive proposals from the small business vendors.

ANSWER 15: Site visits will not be provided.

QUESTION 16: Page 65 of the RFP indicates the requirement for offerors to include in the Technical Proposal a "Vertebrate Animal Section" (VAS), addressing the criteria highlighted below. This criteria appears to be more in line with an animal study proposal, or other document justifying the use of animals and associated procedures, which are not decisions that would be proposed by contractors to fulfill the requirements of a contract of this nature. Please clarify this requirement

ANSWER 16: See Answer to Question 2.

QUESTION 17: On Page 64 the RFP states: The letters of commitment for consultants shall specify the number of hours that each will be available throughout each year of the projected performance. Our question is, as consultants are often utilized on an as needed basis, would it be sufficient to list in the letter of commitment that the consultant will be available on an as needed basis. Depending on their specialty a consultant may be available for 10 hours per year, which might seem to be a low number of hours but because of their unique specialty 10 hours might be sufficient.

ANSWER 17: Offerors may state that consultants will be available on an as needed basis; however, Offerors should include in their proposal a best estimate of the costs associated with each consultant.

QUESTION 18: On page 65 Research Involving Live Vertebrate Animals. It is intended that live vertebrate animals will be used during performance of this contract. The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (authority derived from the Health Research Extension Act of 1985) specifies that certain information is required from offerors in contract proposals submitted to the NIH that will use live vertebrate animals.

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ANSWER 18: See Answer to Question 2.

QUESTION 19: One page 65 of the RFP under a. Description of Procedures. This information seems to request information on a specific study, as we assume there will be potentially a variety of vertebrate animals in the work including a variety of species, strains, ages, sex and total number of animals by species to be used. Is there additional information available in relation to this question (question a), as well as questions b, c, and d.

ANSWER 19: See Answer to Question 2.

QUESTION 20: ARTICLE H.5. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR

352.270-5(b) (December 2015), it states: "a. Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.” Does the contractor need to provide this certification as we will only be supporting the research at NIDA?

ANSWER 20: See Answer to Question 12.

QUESTION 21: In Article H.6. Animal Welfare, it discusses the Vertebrate Animal Section requirement that must be addressed in the technical proposal and Attachment 8: VAS Worksheet.

Question: Is the inclusion of this information necessary as the contractor will be supporting NIDA research?

ANSWER 21: See Answer to Question 2.

QUESTION 22: Past Performance: It states in L.2.a.12 that “we are to submit a list of the last 3 contracts completed during the past 3 years.” Question: Do the 3 past performance references need to have been completed or can they include current contracts?

ANSWER 22: ARTICLE L.2.a.12. requires the submission of a “list of the last 3 contracts completed during the past Three years and ALL CONTRACTS AWARDED currently being performed that are similar in nature to the solicitation workscope.”

QUESTION 23: Breeding Production Assistants: It states in the Breeding Production Assistants role that they receive instruction from the Transgenic Breeding Core Manager.

Question: Is the Transgenic Breeding Core Manager a government or contract position?

ANSWER 23: The Transgenic Breeding Core Manager is a government position. (This person provides guidance as the Principal Investigator on the protocol covering centralized breeding services).

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QUESTION 24: Emergency Veterinarian Services: Task 12 discusses that backup emergency coverage for the NIDA veterinarian will be 24 hours a day, 365 days a year. Question: On average, how many times a year have backup services been needed in the past?

ANSWER 24: On-call backup emergency coverage for the NIDA veterinarian with ability to provide prompt on-site service if needed, is required 24 hours a day, 365 days a year. Historically, actual use of back-up services is infrequent (less than 5 times a year), but a veterinarian must be available to provide clinical instructions and on-site direct care if needed.

QUESTION 25: Upon being notified that emergency veterinary coverage is needed, how soon must the veterinarian report to NIDA?

ANSWER 25: The Contractor is expected to provide a telephonic response within 30 minutes and on-site service, if needed, within one hour.

QUESTION 26: Task 12 also states: The contractor shall retain consulting services of an independent laboratory animal veterinarian for services as requested by the COR. Services may be requested for up to 10 calendar days per year and will be reimbursed for fee as well as travel, hotel, and per diem cost as applicable. How many days in advance would we be informed that the backup veterinarian is needed?

ANSWER 26: For consulting services, 14 days’ notice will be provided and may be requested for up to 10 calendar days per year. Consulting services include, but are not limited to, subjects of veterinary care, laboratory animal husbandry, vivarium design and renovation, ACUC consultation, and AAALAC accreditation. Backup emergency veterinarian coverage for the NIDA veterinarian is required 24 hours a day, 365 days a year without advanced notice. See also Answers to Question 24 and Question 25.

QUESTION 27: Section L.2 provides instructions for hard copy submittal. This contradicts instructions provided Attachment 1 and Section J of the RFP which instruct us to submit our response electronically. Question: Please confirm that this is an electronic submittal only through the eCPS.

ANSWER 27: All proposals must be electronically submitted through eCPS. Proposals submitted by facsimile, e-mail, or hard-copy will not be accepted.

QUESTION 28: Reference Section L.1.e. (Page 45), entitled ‘Level of Effort’, “The Government’s requirement for the work set forth in the Statement of Work of this solicitation is 63,960 direct labor hours. It is estimated that the labor hours are constituted as specified below and will be expended approximately as follows:” Question: Can the contractor propose an alternate number of hours per period for this effort?

ANSWER 28: The Level of Effort identified in ARTICLE F.3. LEVEL OF EFFORT and ARTICLE L.1.e LEVEL OF EFFORT are Government estimates of the amount of effort required to satisfy the Statement of Work. The Offeror may propose alternate labor

N02DA-17-9916 Page 9 of 9 hours; however, the Offeror should provide justification if the proposed level of effort deviates substantially from the RFP.

QUESTION 29: Is the 63,960 direct labor hours, specified for the base period, a solicitation requirement or a Government estimate?

ANSWER 29: See Answer to Question 28.