75F40123R00001 Amendment 01 - Q and A.pdf

(x) x x

1 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

HFT-323

FDA/OO/OFBA/OAGS/DAP

OAGS - Field Operations Branch Tim Walbert

3900 NCTR ROAD

JEFFERSON AR 72079

03/14/2023

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

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION

NO.75F40123R00001

CODE

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. 0001

5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

02/22/2023

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.

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

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)

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

REGINA WILLIAMS

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

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 .

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), requires on-site Animal Care and Technical Procedures in accordance with the attached Performance Work Statement (PWS) and appendices.

The purpose of this amendment is to (1) post answers to contractor-posed questions received through March 8, 2023, and (2) post revised Solicitation and Attachments 1, 2, and 7.

FDA Solicitation No.: 75F40123R00001 Amendment No.: 01 Date: March 14, 2023

The purpose of this amendment is as follows:

1. Answer questions submitted in accordance with Section E.2.1.6 of the solicitation;

2. Provide additional information for all offerors.

New text is underlined. Revised text is in boldface font. Deleted text is in strike-through.

Q1: Reference: Solicitation, Section E.2(a) General Instructions Will the following requirement be acceptable? “The text of the proposal should be typed and prepared on standard 8-1/2” by 11” paper, single-spaced 11-point font or greater. Charts, tables, or diagrams may be used on 17” by 11”pages and pages will count as one page each towards the page limitation.

Minimum of 9-point font for charts and tables only. Title pages will not be included for page counts limitation purposes unless information regarding the proposal is included on the title page.”

A1: Section E.2.1.1 Part I – Technical Proposal Instructions, paragraph 1, has been revised as follows:

The written Technical Proposal is limited to forty (40) pages. Pages exceeding the forty-page limit will not be evaluated. The text of the proposal should be electronically formatted in Microsoft Word as follows: 8-1/2” by 11” paper, single -spaced (double-spaced preferred) 11-point font or greater.

Page margins shall be 1” top, bottom, left and right. Charts, tables, or diagrams maybe be used, however, the offeror may use no more than two (2) sized 17” by 11” pages and shall count as one page each towards the page limitation. Title pages, indexes and/or appendices will not count towards the 40-page total unless information instrumental to the proposal is included on them.

Q2: Reference: FAR 52.222-46 – Evaluation of Compensation for Professional Employees The government has included FAR 52.222-46 as a part of the contract but not indicated where in the proposal volumes to include this information. Where in the proposal offerors’ are to include the total compensation plan?

A2: The purpose of the Pricing Worksheets (Attachment 2) are to accurately capture the total compensation plan for each professional labor category. An offeror may supplement these worksheets with attachments to them, but there is no specified location required within a proposal.

Q3: Reference: Attachment 2 – Pricing Worksheet-Labor Categories There are two tabs titled ‘Phase-In Period” and ‘Phase-In (30 days)’. This is different than the Schedule B CLIN structure. Are both tabs to be completed or is one tab redundant?

A3: Attachment 2 – Pricing Worksheet-Labor Categories has been revised to eliminate the duplicate Tab titled “Phase-In Period.”

Q4: Reference: Attachment 2 - Pricing Worksheet Labor Categories; Schedule B.2.3 Table Column 1 of the Attachment 2 worksheet and Schedule B pricing table indicate offerors are to “indicate “A” if service contract Act applies or “E” if exempt”. Column 2 of the same table indicates whether the positions are one of three options “SCA, Exempt, CBA” creating a redundancy. Can the requirement be removed from column 1 so offerors indicate the labor class in column 2 of these tables?

A4: The Pricing Worksheet Labor Categories and Schedule B.2.3 Table in the solicitation have been revised to strike the redundant classification language.

Q5: Reference: Attachment 1 - PWS and Appendices 1 Appendix 1: Historical and Estimated Workload and Attachment 2 - Pricing Worksheet Labor Categories Is there any way the Government can provide historical information on hours expended by LCAT on the current contract?

A5: See table below:

Labor Category Hours per Option Year Monthly Billing Cycle

OY2 OY3 OY4

Average Average Average Assistant Animal Care Technician (NHP) 428.38 316.92 185.52 Assistant Animal Care Technician 814.14 1000.33 1138.76 Animal Care Technician 2626.34 2759.48 3018.02 Animal Care Technician (NHP) 1555.83 1543.93 1063.64 Administrative Assistant 143.16 165.89 120.59 Building Supervisor 667.50 592.17 426.67 Behaviorist 147.73 152.97 143.00 Cage Processing Area Lead 326.88 314.54 282.42 Equipment Support Specialist 145.54 154.78 154.94 Formulation Supervisor 137.00 151.00 163.33 Formulation Technician 272.74 292.88 300.86 Internal Quality Assurance Manager 153.29 147.97 149.50 Project Director 145.78 157.80 167.43 Program Manager 157.50 116.25 152.50 Production Aide 196.71 239.03 277.38 Quality Control Specialist 160.19 147.71 161.07 Technical Specialist 748.28 451.02 399.70 Training Coordinator 112.96 148.98 148.67

NOTE: This is historical data that may not represent future conditions. The Offeror should base their bid on the information in the PWS, the solicitation, and their proposed labor distribution.

Q6: Attachment 1 - PWS and Appendices 1 Appendix 1: Historical and Estimated Workload;

Attachment 2 - Pricing Worksheet Labor Categories.

Can the Government provide rough estimates of the percentages of the workforce (as percentages of total hours expended per year) covered by 1) the CBA and 2) SCA?

A6: See table below:

Labor Category Hours per Option Year

OY2 OY3 OY4

Total Hours

Total Hours

Total Hours

Assistant Animal Care Technician

(NHP) 5140.60 3803.00 2226.20

Assistant Animal Care Technician 9769.70 12003.90 13665.10 Animal Care Technician 31516.10 33113.70 36216.20 Animal Care Technician (NHP) 18670.00 18527.10 12763.70

Administrative Assistant 1717.90 1990.70 1447.10 Building Supervisor 8010.00 7106.00 5120.00 Behaviorist 1772.80 1835.60 1716.00 Cage Processing Area Lead 3922.50 3774.50 3389.00 Equipment Support Specialist 1746.50 1857.30 1859.30 Formulation Supervisor 1644.00 1812.00 1960.00 Formulation Technician 3272.90 3514.60 3610.30 Internal Quality Assurance Manager 1839.50 1775.60 1794.00 Project Director 1749.30 1893.60 2009.10 Program Manager 1890.00 1395.00 1830.00 Production Aide 2360.50 2868.30 3328.50 Quality Control Specialist 1922.30 1772.50 1932.80 Technical Specialist 8979.40 5412.20 4796.40 Training Coordinator 1355.50 1787.80 1784.05 Total Hours for OY 107279.50 106243.40 101447.75

NOTE: Percentages can be calculated using the labor hour information. However, this is historical data that may not represent future conditions. The Offeror should base their bid on the information in the PWS, the solicitation, and their proposed labor distribution.

Q7: Reference: Staffing Plan/Recruiting Plan. Pg 38 paragraph 1 Could we obtain the incumbent company name and total award value of the current contract?

A7: The incumbent is The Bionetics Corporation; current total contract value is $26,133,911.91.

Q8: Reference: Attachment 1 pg. 7, B.2.3 Pricing Detail; Attachment 2 – Pricing Worksheet Labor Categories Both indicate 17 position titles. However, Attachment 8 – SCA Incumbents - Length of Service indicates 28 employees. Could you please confirm the number of FTEs for each labor category? Also, could you confirm the number of open positions that need to be filled and which specific positions that need to currently be filled?

A8: See table below:

Labor Category Personnel Classification FTE

Project Director Management 1

Administrative Assistant Professional 0

Internal Quality Assurance Manager Management 1

Quality Control Specialist Professional 1

Training Coordinator Professional 1

Equipment Support Specialist Professional 1

Behaviorist Professional 1

Program Manager Management 1

Supervisor Management 3

Technical Specialist Technical 2

Animal Care Technician Technical Union 28

Assistant Animal Care Technician Technical Union 9

Cage Processing Area Lead Technical SCA 1

Production Aide Technical Union 3

Formulation Supervisor Management 1

Formulation Technician Technical Union 2

Contract Total 56

There are 2 Technical Specialists, 1 Cage Processing Area Lead, and an HR Admin position open.

However, this is historical data that may not represent future conditions. The Offeror should base their bid on the information in the PWS, the solicitation, and their proposed labor distribution.

Q9: Reference: Section B.3.2 Contractor Personnel… Key Personnel Only those positions described and listed in the PWS are key personnel applicable to this contract and are as follows: Project Director, Program Manager, Supervisors (3), Behaviorist, and Internal Quality Assurance (IQA) Manager (see PWS Paragraph 4.1.4 et seq.), Although they are key personnel, can you confirm if you would like to see resumes for the SCA and CBA positions?

A9: The government is not requesting the resumes for any personnel other than the Key Personnel listed in the Solicitation.

Q10: Reference: Attachment 4, Wage Determination Should we provide open market pricing for all of the exempt positions which include Project Director, Animal Care Manager, Supervisor, Quality Assurance Manager, QC & Safety Specialist, Behaviorist, Training Manager, and Diet Prep Manager?

A10: The Wage Determination provided is a baseline for the positions listed therein. Offerors should conduct their own market research to determine their own pricing. If the proposed pricing for a position is higher or lower than your market research indicates, offerors should include supporting documentation.

Q11: Reference: Attachment 4, Wage Determination Should we use the below Wage Determination categories to price the following positions or if we should use another occupational code.

A11: See listing below:

SCA - HR Administrator WD-01020 - Administrative Assistant (correct) SCA - Technical Specialist WD-99251 - Lab Animal Caretaker I/99252 Lab Animal

Caretaker II 12305 Radiologic Technologist SCA - Cage Processing Foreman WD-99251 - Lab Animal Caretaker I/99252 Lab Animal

Caretaker II SCA - Equipment Specialist WD-14150 - Peripheral Equipment Operator 21030 Material

Coordinator

Q12: Reference: Attachment 3 – CBA Please confirm the CBA wage rate for the Animal Care Technician, Asst Animal Care Technician and Diet Prep Technician from attachment 3 CBA.PDF pg. 32.

1. CBA - Animal Care Technician (rodent)

2. CBA - Asst Animal Care Technician (rodent)

3. CBA - Animal Care Technician (NHP)

4. CBA - Asst Animal Care Technician (NHP)

5. CBA - Diet Prep Technician

Attachment 3 CBA.PDF pg. 32.

Schedule A - Wage Rates –

Classification Current 2/26/2022 2/26/2023 2/26/2024

1. Technician $20.62 $21.87 $22.62 $23.17

2. Assistant Technician $17.08 $18.33 $19.08 $19.63

3. Production Aide $15.76 $17.01 $17.76 $18.31

A12: The wage rates in the question are the current wage rates for those positions in the CBA. Please note, the CBA has a premium rate added to the NHP positions. Those are only charged/paid when personnel are supporting NHP. There are currently no NHP onsite and none are planned during the large animal renovation.

Q13: When will renovation of the large animal space begin and how long will it last?

A13: Renovation of the large animal space commences in March of 2023 and is anticipated to last 18- 24 months. The PWS has been updated to reflect this information.

Q14: During large animal renovation, what species will be housed in the 62A 177 quarantine area?

A14: During renovation of the large animal space, the 62A Quarantine area (formerly NHP Quarantine) will be set up with mini swine caging to support up to 6 pens of mini swine at any one time. The PWS has been updated to reflect this information.

Q15: Reference: Attachment 1 – PWS, Paragraph 4.1.4 In the Performance Work Statement (PWS) on page 7, paragraph 4.1.4 is labeled Baseline Security Requirements. The next paragraph number on page 12 is also 4.1.4 Key and Access Card Control, followed by 4.1.1 Standard Operating Procedures. Is the numbering system going to be changed to correct the duplication and sequence of the SOW?

A15: The PWS has been updated to correct this numbering issue.

Q16: Reference: Solicitation, Section. E.2.1.1 PART 1, Sub-factor B, EO 14055 "Nondisplacement of Qualified Workers Under"…. For senior employees (10+ years), what is their current salary range?

A16: Executive Order 14055 does not address salaries, only the obligation of a follow-on contractor to honor the right of first refusal for employment opportunities for which they are qualified under the new contract.

Q17: Reference: Attachment 1 – PWS, Section 4, Subsection 4.1, 2nd paragraph, pg. 5 – “5) provide psychological well-being programs for the NHP colony primarily, and for other species secondarily.”

Will past records of enrichment/the psychological well-being program be made available for review?

A17: Past records will not be made available prior to the time of award. There are currently no NHP onsite; however, the Psychological Well-being plan is archived in the IACUC files and will be made available after award. The enrichment program is outlined via SOP for the rodents. For rats and mice, the enrichment items consist of nestlets, crinkle paper, rodent tunnels, nylon bones, gummy bones, fat rat hut, mouse tunnel, rat tunnel, mouse igloos, rat retreats, and mouse safe harbor retreats.

For guinea pigs, the enrichment items include guinea pig huts, hay hangers, hay, and apples. The enrichment program for other species is under development (mini swine, rabbits).

Q18: Reference: PWS, Section 4, subsection 4.1, 3rd paragraph, pg.6 “…equipment and expendable supplies are provided by NCTR.” Is there a procurement system that the Contractor will access to submit order requests?

A18: The procurement process for these supplies is strictly an internal function between the contractor and DVS. The contractor obtains quotes and submits a request on a standardized form to Veterinary Services. Veterinary Services handles the procurement process/systems after that point.

For items that must be ordered by contract, Veterinary Services or the research group initiate the contract process and engage the contractor for information including the need to reorder items.

Q19: Reference: PWS, Section 4, subsection 4.1.1, 7th paragraph, pg. 6. “Core hours are Monday through Friday 6:00 a.m. to 6:00 p.m. Central Time. Continuous service shall be provided as required during the core hours by using staggered start times with the normal animal facility workday scheduled from 7am – 3:30pm and the normal non-animal facility workday scheduled from 8:00 a.m. to 4:30 p.m.” What are the requirements and responsibilities outside of the "normal workday" hours listed?

A19: On weekends and holidays, the animals will still require their normal care (twice daily health checks, feed, watering) and any required medical care. Study dependent activities such as scheduled technical procedures (body weight, blood collection, dosing, clinical observations, operant test battery, etc…) may occur after hours or on weekends dependent on study requirements. Orphaned infants, if present, would require additional after-hours work.

Q20: Reference: PWS, Section 4, subsection 4.1.12, 1st paragraph, pg. 20 Equipment Maintenance Support: Please provide information on NCTR’s monitoring system for environmental controls.

Other than the contractor, are there any other parties [present] on-site monitoring for errors and/or alarms?

A20: The animal housing room and procedure room lighting, temperature, humidity, and ventilation rates are monitored 24/7 using an Environmental Monitoring and Control System by the maintenance contractor with onsite personnel 24/7. The animal care contractor is expected to monitor the zebrafish and automatic watering systems during working hours. The automatic watering system in 5A has a call out text function that can notify the area supervisor in case of emergency after hours.

Q21: Reference: 21. PWS, Appendix 4, pg. 82, QASP - USDA covered species.

Which contract employees are responsible for meeting with the USDA inspector?

A21: As a federal agency, NCTR is not inspected by the USDA. However, OLAW can perform ‘not for cause’ and ‘for cause’ inspections and AAALAC performs a site visit every three years. The government expects the relevant personnel for the area inspected to participate with the government employees in the inspection process including answering OLAW or AAALAC questions.

Q22: Reference: PWS, Section 4, subsection 4.1.9, 2nd paragraph, pg. 19 “…shall furnish transportation for animals….”

Will the government provide specifications regarding the transport vehicle currently utilized for this task?

A22: For the transportation of animals, the vehicle must have a temperature-controlled ventilated compartment separate from the personnel compartment that can be disinfected between shipments.

The temperature-controlled area must have ventilation and temperatures that comply with the applicable Animal Welfare Regulations and the Guide for the Care and Use of Laboratory Animals.

Q23: Reference: Attachment 7 – Sample Client Authorization Letter, 2nd paragraph: Deadline for receipt of letters is “TBD.” What is the correct date by which past performance references need to be received by?

A23: The deadline for receipt of past performance references is March 23, 2023 by 2:00 pm CDT.

Attachment 7 has been revised to reflect this date and has been uploaded to the Contract Opportunities site on SAM.gov. The solicitation has been revised as follows to include this information in paragraph “a),” last sentence: All PPEQ’s shall be received electronically by 2:00 pm CDT on March 23, 2023. Subject line of e-mails containing a PPEQ shall include “75F40123R00001 PPEQ: (name of Offeror).”

Q24: Reference: FAR Clause 52.232-7 Payments under Time-and-Materials and Labor-Hour Contracts (Nov 2021). We didn’t see this clause listed in the solicitation; does it apply to this requirement?

A24: No; however, FAR Clause 52.212-4 Alternate I applies to this requirement and similarly addresses those points. . Particular attention is directed to Alternate I replacement paragraphs (a), (e), (i), (l), and (m) for those in the basic clause with particular emphasis on paragraph (e) and (i).

Offerors are reminded that under (2(i(i) (A) above “direct labor” is defined as “the hours of the work performing labor directly related to a service,” or work required by the Government. Fixed hourly rates are defined as separate fixed hourly rates for each labor category that include wages, overhead, general and administrative expenses, and profit for each category of labor.

END OF AMENDMENT NO.: 0001