0004_-_(SF30)_Amendment_to_FDA-SOL-1153590 _Multi-Center_Animal_Care.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE PAGE OF PAGES

1 4

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

0004 11/10/2016

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

CODE

FDA/OO/OFBA/OAGS/DAP

SUZANNE MARTELLA

3900 NCTR ROAD

BUILDING 50, RM 430, HFT-320

JEFFERSON AR 72079

Same as Block 6

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, county, State and ZIP: Code) (X) 9A. AMENDMENT OF SOLICITATION NO.

ALL OFFERORS

FDA-SOL-1153590

9B. DATED (SEE ITEM 11)

10/18/2016

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 Offers 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 Items 8 and 15, and returning one (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 DATA 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 data 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.

CHECK ONE 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 date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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 __1_ copies to the issuing office.

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

The purpose of this Amendment is as follows (SEE SF30 CONTINUATION PAGES):

1) SF30 Section 1: Revise RFP language referencing contract Period of Performance dates. Revised SF1449 Pages 4 and 5 are attached to allow Offerors to perform a “page-for-page swap” of affected pages.

2) SF30 Section 2:

• Revise PWS Annex 1 language referencing Personnel certifications. A revised PWS Page 4 is attached to allow Offerors to perform a “page-for-page swap” of the affected page.

• Pen and ink change the date of PWS ANNEX 1.

3) SF30 Section 3: Attach Pre-performance Site Visit Meeting Minutes (Addendum 1 and 2) which were inadvertently omitted from

Amendment 0001 (Pages 13-24).

4) Extend the date for submission of Past Performance questionnaires (as per RFP Attachment 7) FROM: NLT Nov 10, 2016 TO: NLT Dec 5, 2016, 12:00 PM CST.

5) All other terms and conditions remain unchanged.

Except at 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)

Jerry Martin, Contracting Officer

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)

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

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.243

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION 1 – SF1449 CONTINUATION PAGE(S) CHANGES

The following changes are made to the SF1449 and Continuation pages. Changes in the updated SF1449 are highlighted by a bold black line in the left margin of the page and are summarized below.

Offerors are provided revised RFP pages (Page 4 and Page 5) in order to perform a “page-for-page swap” of affected pages. This is not mandatory if Offerors prefer to make the changes in their own document copy.

1. SF1449 Page 4, Section B.2, Sub-Section B.2.2 Pricing Schedule, Phase-In period dates are changed as follows:

FROM:

Phase-In CLIN Description Total Price 0001 PHASE-IN PERIOD (20 days)

From 11 Dec 2016 – 31 Dec 2016

TO:

Phase-In CLIN Description Total Price

From 9 Feb 2017 – 28 Feb 2017

2. SF1449 Page 5, Section B, Paragraph B.2.9 Contract Period of Performance is changed as follows:

FROM:

CLIN No. Period Period of Performance 0001 Phase-In Period (20 days) 10 Dec 2016 – 31 Dec 2016 0002-0004 Base Period (10 months) 01 Jan 2017 – 31 Dec 2017 1001-1003 Option Period 1 01 Jan 2018 – 31 Dec 2018 2001-2003 Option Period 2 01 Jan 2019 – 31 Dec 2019 3001-3003 Option Period 3 01 Jan 2020 – 31 Dec 2020 4001-4003 Option Period 4 01 Jan 2021 – 31 Dec 2021

TO:

CLIN No. Period Period of Performance 0001 Phase-In Period (20 days) 9 Feb 2017 – 28 Feb 2017 0002-0004 Base Period (10 months) 01 Mar 2017 – 31 Dec 2017 1001-1003 Option Period 1 01 Jan 2018 – 31 Dec 2018 2001-2003 Option Period 2 01 Jan 2019 – 31 Dec 2019

(End of SF1449 Changes)

RFP Pages 4 and 5 follow and are not included in Amendment 0004 total page count.

SECTION 2 – PERFORMANCE WORK STATEMENT (PWS) CHANGES

As noted in Block 14, the following changes are made to PWS ANNEX 1. Changes in the PWS are highlighted by a bold black line in the left margin of the page and are summarized below. Offerors are provided a revised PWS Page 4 in order to perform a “page-for-page swap” of the affected page. This is not mandatory if Offerors prefer to make the changes in their own document copy.

1. PWS ANNEX 1, Page 4, Paragraph 4.1.8.8. Animal Health Technician I/II is changed as follows (in italics):

FROM:

“4.1.8.8. Animal Health Technician I/II. Shall be LAT-certified, CVT, or RVT at time of employment; shall be Laboratory Animal Technologist (LATG) certified at the time of employment. Lead Technician/Animal Health Technicians in addition to animal husbandry tasks, shall provide technical assistance, as requested, for animal studies as required by approved protocols. A partial list of representative examples associated with current and anticipated studies involve (1) dosing of animals by oral gavage, skin painting, and/or injection (intraperitoneal, intramuscular, and/or intravenous), (2) collection of blood by intravenous (including peripheral vessels and/or the jugular vein, aka, subclavian, or vena cava), intracardiac, or orbital sinus routes, (3) collection of physiologic data, tissues and/or necropsy information, (4) observation and recording of animal activity and/or behavior, (4) induction and maintenance of anesthesia, (5) pre-surgical preparation and post-surgical monitoring of animals,

(6) assembly, use of and disassembly of metabolic caging.”

TO:

“4.1.8.8. Animal Health Technician I/II. Shall be ALAT-certified at time of employment. Lead Technician/Animal Health Technicians in addition to animal husbandry tasks, shall provide technical assistance, as requested, for animal studies as required by approved protocols. A partial list of representative examples associated with current and anticipated studies involve (1) dosing of animals by oral gavage, skin painting, and/or injection (intraperitoneal, intramuscular, and/or intravenous), (2) collection of blood by intravenous (including peripheral vessels and/or the jugular vein, aka, subclavian, or vena cava), intracardiac, or orbital sinus routes, (3) collection of physiologic data, tissues and/or necropsy information, (4) observation and recording of animal activity and/or behavior, (4) induction and maintenance of anesthesia, (5) pre-surgical preparation and post-surgical monitoring of animals, (6) assembly, use of and disassembly of metabolic caging.”

2. PWS ANNEX 1, Page 4, Paragraph 4.1.8.9. Veterinary Technician is changed as follows (in italics):

FROM:

“4.1.8.9. Veterinary Technician. Veterinary Technician shall be at the minimum certification of LAT at the time of employment. Veterinary Technician shall provide guidance to the Animal Health Technicians ensuring that all animal health issues are managed in a timely manner, documentation is complete and filed appropriately. The Veterinary and Animal Health Technicians shall provide technical assistance to the animal care staff and researchers. Representative examples of technical procedures include daily observations of animals, injections (intraperitoneal, intramuscular, intravenous), intravenous collection of blood and medical treatments as prescribed by the veterinarian. Shall write up animal observation record sheets for health issues and notify researchers of these issues. Shall follow up on health issues with animal care staff and researchers, document and file all findings. The Animal Health Technician position will also perform routine animal husbandry.”

TO:

“4.1.8.9. Veterinary Technician. Veterinary Technician shall be at the minimum certification of LAT at the time of employment and be LATG within the first year of employment. Veterinary Technician shall provide guidance to the Animal Health Technicians ensuring that all animal health issues are managed in a timely manner, documentation is complete and filed appropriately. The Veterinary and Animal Health Technicians shall provide technical assistance to the animal care staff and researchers. Representative examples of technical procedures include daily observations of animals, injections (intraperitoneal, intramuscular, intravenous), intravenous collection of blood and medical treatments as prescribed by the veterinarian. Shall write up animal observation record sheets for health issues and notify researchers of these issues. Shall follow up on health issues with animal care staff and researchers, document and file all findings. The Animal Health Technician position will also perform routine animal husbandry.”

Pen and Ink Change:

3. PWS Annex 1, Page 1, change the date of the PWS:

FROM: October 6, 2016 TO: November 8, 2016

(End of PWS Changes) Revised PWS Page 4 follows and is not included in Amendment 0004 total page count.

SECTION 3 – MEETING MINUTES

The following Meeting Minutes Addendums were omitted from Amendment 0001 (Pages 13-24 of Amendment 0001). Addendums/omitted pages from Amendment 0001 are included in the following pages.

Addendum 1 – White Oak Campus Pre-Proposal Site Visit Meeting Minutes (Pages 13-16 of 24) Addendum 2 – Muirkirk Road Complex MOD-1 (MRC/MOD-1) Pre-Proposal Site Visit Meeting Minutes (Pages 17-24 of 24)

(End of Section 3)

(End of SF30 Continuation Pages)

Addendum Pages follow and are not included in Amendment 0004 total page count.

SF1449 (RFP/Solicitation) Pages follow:

• Page 4 of 34

• Page 5 of 34

FDA-SOL-1153590 (Revision 1) Page 4 of 34 Page Revised as of November 8, 2016

B.2 SERVICES AND PRICES/COSTS – Addendum to SF 1449, blocks 19/20 B.2.1 Description of Services The U.S. Food and Drug Administration (FDA) (specifically the Center for Biological Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and the Center for Food Safety and Applied Nutrition (CFSAN)) has a requirement for animal husbandry support services for the (CBER/CDER/CDRH) White Oak Consolidated Animal Program (WOC AP) and (CFSAN) Muirkirk Road Complex (MRC/MOD-1) Animal Care and Use Programs (ACUP), both located in Maryland.

Animal husbandry support includes but is not limited to the provision of quality care to all research animals, sanitation of all animal care and diet preparation/formulation facilities and the provision of protocol-specified technical procedures support, as well as ancillary tasks necessary to accomplish these services, i.e.: quality control, occupational safety and health, inventory control, equipment maintenance, development and maintenance of standard operating procedures, and a comprehensive training program. The need for these services is paramount as the preponderance of the FDA's research mission can only be accomplished through animal research. Animal-based research projects are highly regulated and demand exemplary execution in accordance with (IAW) Attachment 1- Performance Work Statement (PWS), Annex 1 and Annex 2.

B.2.2 Pricing Schedule Phase-In

CLIN Description Total Price

From 9 Feb 2017 – 28 Feb 2017

Base Period and Option Pricing

CLIN Description Annual Price

0002 SERVICES BASE PERIOD – WOC AP

CBER/CDER/CDRH On-Site Animal Husbandry Services IAW the PWS Annex 1.

0003 SERVICES BASE PERIOD – MRC/MOD-1

CFSAN On-Site Animal Husbandry Services IAW the PWS Annex 2.

0004 TRAVEL BASE PERIOD (Cost Reimbursement) Funds allocated for travel and training in support of services at IAW the PWS.

1001 SERVICES OPTION PERIOD 1 – WOC AP

1002 SERVICES OPTION PERIOD 1 – MRC/MOD-1

1003 TRAVEL OPTION PERIOD 1 (Cost Reimbursement)

2001 SERVICES OPTION PERIOD 2 – WOC AP

2002 SERVICES OPTION PERIOD 2 – MRC/MOD-1

2003 TRAVEL OPTION PERIOD 2 (Cost Reimbursement)

3001 SERVICES OPTION PERIOD 3 – WOC AP

3002 SERVICES OPTION PERIOD 3 – MRC/MOD-1

3003 TRAVEL OPTION PERIOD 3 (Cost Reimbursement)

4001 SERVICES OPTION PERIOD 4 – WOC AP

4002 SERVICES OPTION PERIOD 4 – MRC/MOD-1

4003 TRAVEL OPTION PERIOD 4 (Cost Reimbursement)

TOTAL (CLINs 0001-4003)

NOTE 1: The maximum dollar values for Contract Line Items 0001 through 4003 are annual ceiling amounts for each year of the contract. The contract shall not exceed the total ceiling amount for the Base year and all Option periods.

FDA-SOL-1153590 (Revision 1) Page 5 of 34 Page Revised as of November 8, 2016

NOTE 2: For the purpose of a balanced evaluation, Offerors are to insert the price of $5,000 in each of the Travel CLINs (0003, 1002, 2002, 3002 and 4002) in the Pricing Table above.

B.2.3 Pricing Breakdown See Attachment 6 – Pricing Worksheet, to provide breakdown of the above pricing.

B.2.4 Contract Payments – Labor Hour Contract Upon presentation of a proper invoice and in accordance with FAR Clause 52.232-7 Payments Under Time and Material and Labor-Hour Contracts, payment will be made monthly, in arrears, for services rendered to and accepted by the Government.

B.2.5 Travel

a. There is no routine travel anticipated under this requirement. If at a future date the Government does require one or more Contractor employees to travel (e.g.: training, conferences, national/local AALAS, etc.), the travel line item will be funded and the Contractor will be responsible for making all required travel arrangements for Contractor’s personnel. Upon completion of travel, in accordance with FAR 31.205-46, Travel Costs, Contractor will be reimbursed only for actual travel costs incurred. No additional profit, G&A or fee of any kind will be allowed on the direct travel reimbursement.

b. Travel claims/invoices shall be submitted separately from monthly service invoices. Listed below is a description of receipts required as attachments to the invoice to support travel claims:

1. Copy of common carrier ticket reflecting class of travel, dates of travel and amount of fare;

2. Lodging receipt;

3. Parking/tolls receipts;

4. Rental car receipt including receipts for gasoline;

5. Receipts for taxi travel.

B.2.6 Packing, Marking and Shipping B.2.6.1 Preparation of Delivery. All material to be delivered hereunder shall be afforded the degree of packing (preservation and packing) required to prevent deterioration and damages due to hazards of shipment, handling and storage. Best commercial practice will be accepted.

B.2.6.2 Prohibited Packaging Materials. The use of asbestos, excelsior, newspaper or shredded paper (all types including waxed paper, computer and similar hygroscopic or non-neutral material) is prohibited. In addition, loose fill polystyrene is prohibited for shipboard use.

B.2.7 Inspection and Acceptance The Contracting Officer’s Representative (COR), a duly authorized representative of the CO, shall monitor the Contractor’s performance, evaluate the quality of services and perform the final inspection and acceptance of all deliverables. Unless otherwise requested, deliverables shall be sent to the COR specified herein.

B.2.8 Deliveries or Performance B.2.8.1 Reporting Requirements and Deliverables. Deliverables required by this contract are outlined in the PWS.

B.2.8.2 Contractor Notice Regarding Late Delivery. In the event the contractor, for any reason, anticipates or encounters difficulty in complying with the contract delivery schedule or performance date or in meeting any of the requirements of the contract, the contractor shall immediately provide written notification to the CO giving pertinent details. The data shall be informational in character and its receipt by the Government shall not be construed as a waiver by the contractor or any other rights or remedies provided to the Government by law or under this contract.

B.2.9 Contract Period of Performance The anticipated performance period for the phase-in, base year and option periods are as follows:

CLIN No. Period Period of Performance 0001 Phase-In Period (20 days) 9 Feb 2017 – 28 Feb 2017 0002-0004 Base Period (10 months) 01 Mar 2017 – 31 Dec 2017 1001-1003 Option Period 1 01 Jan 2018 – 31 Dec 2018 2001-2003 Option Period 2 01 Jan 2019 – 31 Dec 2019

PWS Revised Page 4 follows

FDA-SOL-1153590 PWS ANNEX 1

4 Page Revision 1 – November 8, 2016 involving animal care, health observations and security procedures, and/or management of breeding colonies to include genotyping support and advising PIs.

4.1.8.7. IACUC Assistant. The IACUC assistant is preferred to have BS or BA degree or higher and experience in research compliance or related area; AALAS certification as an ALAT or higher; experience in administrative tasks to support the IACUC to include protocol management, preparation of agendas, scheduling of meetings/meeting space, creation of meeting documents prior to and meeting minutes following meetings, preparation and distribution of memos and notifications as required by the IACUC, proper completion of proposed protocol documentation and personnel training for animal use, maintenance of IACUC records, and tracking of animal use. Experience with Microsoft Office products to include a variety of databases to do data entry and retrieval and produce spreadsheets and tables. Support currently is for 188 active protocols, on average 12-15 protocols/ amendments per month.

4.1.8.8. Animal Health Technician I/II. Shall be ALAT-certified at time of employment. Lead Technician/Animal Health Technicians in addition to animal husbandry tasks, shall provide technical assistance, as requested, for animal studies as required by approved protocols. A partial list of representative examples associated with current and anticipated studies involve (1) dosing of animals by oral gavage, skin painting, and/or injection (intraperitoneal, intramuscular, and/or intravenous), (2) collection of blood by intravenous (including peripheral vessels and/or the jugular vein, aka, subclavian, or vena cava), intracardiac, or orbital sinus routes, (3) collection of physiologic data, tissues and/or necropsy information, (4) observation and recording of animal activity and/or behavior, (4) induction and maintenance of anesthesia, (5) pre-surgical preparation and post-surgical monitoring of animals, (6) assembly, use of and disassembly of metabolic caging.

4.1.8.9. Veterinary Technician. Veterinary Technician shall be at the minimum certification of LAT at the time of employment and be LATG within the first year of employment. Veterinary Technician shall provide guidance to the Animal Health Technicians ensuring that all animal health issues are managed in a timely manner, documentation is complete and filed appropriately. The Veterinary and Animal Health Technicians shall provide technical assistance to the animal care staff and researchers. Representative examples of technical procedures include daily observations of animals, injections (intraperitoneal, intramuscular, intravenous), intravenous collection of blood and medical treatments as prescribed by the veterinarian. Shall write up animal observation record sheets for health issues and notify researchers of these issues. Shall follow up on health issues with animal care staff and researchers, document and file all findings. The Animal Health Technician position will also perform routine animal husbandry.

4.1.8.10. Animal Caretaker I/II/III. Animal Caretaker II/III shall be Assistant Laboratory Animal Technician (ALAT) at employment and the Animal Caretaker I shall be Assistant Laboratory Animal Technician (ALAT)-certified within (1) year of employment. Animal Caretakers II shall have training and experience working in a laboratory animal facility performing animal husbandry duties. Animal Caretakers II must have demonstrated knowledge and skill in handling various animal species. They must recognize the appearance of normal animals and be able to maintain the animals in a clean environment. This position shall perform daily observations of animals for health issues and report findings to appropriate staff. Shall record animal births, deaths and health issues in a timely manner. Animal Caretaker I can be an entry-level position with on-the-job training provided, some animal experience is desirable but not necessary for employment.

4.1.9. Employee Training. As outlined in the main PWS.

4.1.10. Occupational Safety and Health. As outlined in the main PWS.

4.1.11. Medical Examinations. As outlined in the main PWS.

4.1.12. Data Management. As outlined in the main PWS.

4.1.13. Contractor Furnished Materials. Except for those items specifically stated to be Government-furnished, the Contractor shall furnish everything required to perform the services under this contract. The Contractor shall supply adequate and dedicated work shoes, boots, non-disposable eye and hearing protection and non-disposable respirators and uniforms; uniforms to be maintained and sanitized regularly.

4.1.14. Government Furnished Property (GFP). The Government reserves the right to furnish property to the Contractor for use under the contract when it determines that it is in the Government’s best interest to do so.

Meeting Minutes Addendum 1 and 2 Pages follow:

• White Oak Campus Pre-Proposal Site Visit Meeting Minutes (Pages 13-16 of 24)

• Muirkirk Road Complex MOD-1 (MRC/MOD-1) Pre-Proposal Site Visit Meeting Minutes (Pages 17-24 of 24)

Addendum 1 – White Oak Campus Site Visit Meeting Minutes

Pre-Proposal Site Visit Minutes/Summary

October 24, 2016

Location: White Oak Campus, Silver Spring Maryland

The following is a summary of the items that were discussed at the above-referenced Pre-proposal Site Visit in support of RFP No. FDA-SOL-1153590 for the provision of quality care to all research animals, sanitation of all animal care and formulation facilities and provision of protocol-specified technical procedures support to the FDA

White Oak Campus Animal Program (WOC AP), including the ancillary tasks necessary to accomplish these services (i.e.: quality control, occupational safety and health, inventory control, equipment maintenance, development and maintenance of standard operating procedures, and a comprehensive employee training program).

The meeting was called to order at approximately 9:a.m. by Mary Belcher, the designated COR, who welcomed the prospective Proposers and requested that all attendees sign the attendance roster provided. Attendees were advised that a summary of the meeting would be provided in the minutes issued by the Contracting Officer under an

Amendment to the Solicitation at fbo.gov. The COR then described the purpose of the Site Visit and discussed the

Site visit plan for the walk through. All attendees were asked if they had received and reviewed all available contract documents from the solicitation. All attendees agreed that they had reviewed applicable documents and were prepared for the site visit walk through. [A copy of the Agenda, list of attendees, and questions and responses are attached to these minutes.].

1. Administrative Notes

The Pre-proposal Site Visit is not mandatory and is intended to provide potential Offerors with an overview of the facility and insight to the work required under this effort, as well answer any site related questions Contractors may have. Attendees were notified of the Disclaimer and advised that formal written responses to all questions submitted will be issued as an amendment posted to FBO. [FDA staff] provided the following information during the Site

Visit. Description of facilities as the walk through took place and repeatedly asked if there were any questions.

There were very few questions and all attendees seemed familiar with the equipment, facilities operations and basic animal care requirements. Attached is a summary of the questions and responses that were raised during the site visit.

2. Contract Information

Attendees were advised of the NAICS code and small business set-aside for this requirement. They were advised that the Contracting Office is located in Jefferson AR and who the Contracting Officer and Contract Administrator are. The contract COR introduced herself as well as the other government staff participating in the site visit. All present are listed on the attendees sheet.

3. Review of Important Dates

[FDA Staff] advised Attendees of the following list of important dates:

EVENT DATE

Issuance of RFP October 18, 2016

Pre-Proposal Site Visit: 9:00 a.m.@ Muirkirk Road Complex October 21, 2016

Pre-Proposal Site Visit: 9:00 a.m.@ White Oak Campus October 24, 2016

Submission of Questions October 26, 2016

Submission of Past Performance (Reference RFP Attachment 7) November 10, 2016

Proposal due date November 18, 2016

Projected Contract Award TBD

Phase-In Begins December 10, 2016

Addendum 1 – White Oak Campus Site Visit Meeting Minutes

4. Review of Requirement

The COR asked if the attendees had read the requirement for the solicitation and if there were any questions or clarifications required at that time. There were no questions.

5. Q&A

6. There were no questions

7. Site Tour Details

The site visitors were then escorted to the vivarium. Starting in Section 1, we toured the clean cagewash area, walking through the corridors and not going into occupied animal rooms. Windows are available to look into each animal room and the COR encouraged all attendees to look into each room. Types of cages were described during the walk through and the attendees were given an opportunity to see all types of cages and animal housing equipment. Specialized equipment was shown to all attendees and explained that the imaging equipment is operated by a contract technician and this would be a requirement in the contract.

8. Final Questions

There were no other questions from any of the site visit attendees

9. Adjournment

At approximately 10:20a.m. the Site Visit adjourned and the group was dismissed.

10. Summary

Attendees’ oral inquiries and written questions received during the pre-proposal Site Visit and responses given are provided herein as Attachment “A”.

If you have any questions regarding these minutes, please contact the undersigned by e-mail at mart.belcher@fda.hhs.gov or at (240) 402-9390.

Respectfully submitted, /s/

Mary Belcher

White Oak Campus Contracting Officer Representative (COR)

Exhibit(s): (1) White Oak Campus Pre-Proposal Site Visit List of Attendees

(2) White Oak Campus Pre-Proposal Site Visit Agenda

WOC AP Pre-Proposal Site Visit List of Attendees (in no particular order) Oct 24, 2016 / 09:00am

PLEASE PRINT CLEARLY AND LEGIBLY

Name Company (Name/Address) Phone E-Mail

1.

Harry G. Davis Alpha Omega Bioservices Inc

15520 Woodbine Morgan Rd

4104897805 davish@aomegabiosvcs.com

2.

Melissa Marrah

SoBran Inc.

4000 Blackburn Ln

Burtonsville MD

5713263411 mmarrah@sobran-inc.com

3.

Brad Fisher SoBran Inc.

4000 Blackburn Ln, Burtonsville MD

3012339696 bfisher@sobran-inc.com

4.

Jason Clardy Priority One Services

6600 Fleet Dr. Alexandria VA. 22310

3017609381 jclardy@priorityoneservices.com

5.

Marquerite Santos Priority One Services

6600 Fleet Dr. Alexandria VA. 22310

4104935615 msantos@priorityoneservices.com

6.

Vicky Mayoral Priority One Services

6600 Fleet Dr. Alexandria VA. 22310

3014422990 vicky@priorityoneservices.com

7.

Michael Fischer 10903 New Hampshire Ave

Silver Spring MD 20993

3013483917 michael.fischer@fda.hhs.gov

8. Jenn Cookson FDA-White Oak 2026507283 jennifer.cookson@fda.hhs.gov

9. Josh Rowe 71 WO 28157 joshua.rowe@fda.hhs.gov

10. Tyson Bellany FEFA 2022662441 tbellamy@fefainc.com

11. Neil Grove FEFA 9193160188 ngrove@fefainc.com

12.

Anthony Ferrine, Facility

Manager

FDA 10903 New Hampshire Ave. Bldg.

52/G111

2404029522 anthony.ferrine@fda.hhs.gov

13.

Claudia Diaz, Scribe FDA 10903 New Hampshire Ave. Bldg.

52/G110

2404029493 claudia.diaz@fda.hhs.gov

14.

Mary Belcher, Operations

Manager and COR

FDA 10903 New Hampshire Ave. Bldg.

52/G112

2404029390 mary.belcher@fda.hhs.gov

Pre-Proposal Site Visit Meeting Agenda

Solicitation (RFP) Number: FDA-SOL-1153590 Date: 24 Oct 2016 Time: 09:00

Title: Multi-Center Animal Husbandry, Animal Care and Technical Support Services, FDA Animal

Care and Use Programs (ACUP)

Location: White Oak Campus

Center(s) Name: Center for Biological Evaluation and Research (CBER)

Center for Drug Evaluation and Research (CDER)

Center for Devices and Radiological Health (CDRH

COR: Mary Belcher

AGENDA

Sign-in All

Welcome/Introductions Mary Belcher

FDA Personnel & Attendees

Administrative Notes MB

Purpose of Pre-Proposal Site Visit

Review Contract Information

Review Important Due Dates

Review Requirement (WOC AP)

Q&A o Disclaimer (see page 3)

Site Tour

Final Questions

Contract Information MB

This requirement has been set aside for small business under NAICS Code (541711 Research in

Biometrics, Small Business. Size Standard: 1,000 employees)

Contract written and Administered from Jefferson AR but facilities located in MD

Contract Specialist is Suzanne Martella. Contracting Officer is Jerry Martin. Contact them with any questions or issues regarding this requirement.

Important Due Dates MB

White Oak Campus Site Visit: October 24, 2016 at 09:00 am

Submission of questions: October 26, 2016

Past Performance Due: (to Contracting) NLT October 10, 2016

Proposal closing date/time: November 18, 2016 at 12:00 pm (NOON) CENTRAL Time (CST)

Requirement MB

Review requirements outlined in the PWS

Location and any pertinent details (key locations, dumpster location, parking, lay down area and/or other details)

Review general and special conditions such as safety, barricades, signage, noise limitations, no access areas, hours of work, etc.

Q&A Open Forum

Site Tour MB

Final Questions Open Forum

Addendum 2 – Muirkirk Road Complex Site Visit Meeting Minutes

Solicitation FDA-SOL-1153590 MOD-1 Site Visit

Minutes of October 21, 2016 Meeting

Attendees: Kevin J.Reed (Meeting Leader), KJR Brad Fisher

Jason Clandy

Marguerite Santos

Vicky Mayoral

Tyson Bellamy

Dr.Micu (invited guest)

Meeting called to order at 9:17am.

Attendees welcomed to MOD-1and introductions of all parties. KJR provided the introduction to the meeting and stated his role and responsibilities regarding this solicitation. The introductory information included the following.

The Vivarium is a DualCorridor, Restricted Access Biocontainment Facility.

Animal welfare compliance was discussed.

The CFSAN Animal Research Program has been AAALAC accredited since 2000.

The people on the contract are the most important resource.

All Visitor Forms completed by the Attendees.

The following references were available for the Attendees to review.

Vivarium Standard Operating Procedures (SOP's)

Animal Welfare Act

The Guide for the care and use of Laboratory Animals

The PHS Policy on Humane Care and Use of Laboratory Animals

Biosafety in Microbiological and Biomedical Laboratories (BMBL)

The meeting agenda provided by the Contract Specialist was reviewed and used as the format for the discussion and the site visit. All agenda items were noted and discussed and a reminder of the important dates were noted.

Additional Facility and Program information was provided to the Attendees from the latest AAALAC Program Description. This information (highlighted) is provided as an attachment to this document.

NOTE: No questions noted from the Attendees at this time.

Site Visit:

Introductory remarks provided regarding the history of the Vivarium and the construction aspects.

Proper Vivarium attire and traffic patterns were discussed.

All functionalareas as identified in the solicitation were toured.

Use of two-way radios for communication was discussed.

Importance of cross training of personnel was discussed.

In-house laundry area and the duties of performing this task were discussed.

The different animal caging types were noted and discussed.

The use of Ventilated Racks was noted and discussed.

The Poultry room is the only animal room in the Vivarium with automatic drinking water all other animal rooms use bottles for drinking water.

Upon conclusion of the Vivarium Site Visit KJR commented to the attendees the current animal census is low but this is subject to change with minimal notice provided. The Contractor awarded this contract must be able to change accordingly and work with the COR to adjust personnel and labor categories as required to satisfy the research effort.

NOTE: No questions noted from the Attendees at this time.

KJR thanked everyone for their attendance and for being a part of the CFSAN/MOD-1 Vivarium Site Visit today. Meeting Adjourned at 11:47 am.

The minutes prepared by: Kevin J. Reed Date: 10/24/2016

Exhibit(s): (1) Muirkirk Road Complex MOD-1 (MRC/MOD-1) Pre-Proposal Site Visit List of Attendees

(2) MRC/MOD-1 Pre-Proposal Site Visit Agenda

(3) MRC/MOD-1 Additional Facility and Program Information

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Pre-Proposal Site Visit Meeting Agenda

Solicitation (RFP) Number: FDA-SOL-1153590 Date: 21 Oct 2016 Time: 09:00 Title: Multi-Center Animal Husbandry, Animal Care and Technical Support Services, FDA Animal

Care and Use Programs (ACUP) Location: Muirkirk Road Complex MOD-1 (MRC/MOD-1), Laurel MD

Center(s) Name: Center for Food Safety and Nutrition (CFSAN)

COR: Kevin Reed, LaQuia Geathers

AGENDA

Sign-in All

Welcome/Introductions Kevin Reed FDA Personnel & Attendees

Administrative Notes KR Purpose of Pre-Proposal Site Visit Review Contract Information Review Important Due Dates Review Requirement (WOC AP) Q&A o Disclaimer (see page 3) Site Tour Final Questions

Contract Information KR This requirement has been set aside for small business under NAICS Code (541711 Research in Biometrics, Small Business. Size Standard: 1,000 employees) Contract written and Administered from Jefferson AR but facilities located in MD Contract Specialist is Suzanne Martella. Contracting Officer is Jerry Martin. Contact them with any questions or issues regarding this requirement.

Important Due Dates KR White Oak Campus Site Visit: October 24, 2016 at 09:00 am Submission of questions: October 26, 2016 Past Performance Due: (to Contracting) NLT October 10, 2016 Proposal closing date/time: November 18, 2016 at 12:00 pm (NOON) CENTRAL Time (CST)

Requirement KR Review requirements outlined in the PWS Location and any pertinent details (key locations, dumpster location, parking, lay down area and/or other details) Review general and special conditions such as safety, barricades, signage, noise limitations, no access areas, hours of work, etc.

Q&A Open Forum

Site Tour KR

Final Questions Open Forum

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E.4.3 Proposal Disqualification