Amendment_0001_(SF30)_to_FDA-SOL-1153590.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE PAGE OF PAGES

1 24

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

0001 10/27/2016

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 to:

1) Change or update specific solicitation language (Section 1). A revised SF1449 with Continuation Pages (Solicitation

Revision 1) supersedes the previous posting. Offerors shall use only the updated Solicitation (Revision 1) and are advised to understand the Summary of Changes outlined in the attached pages.

2) Update specific PWS Annex 2 language (Section 2). An updated PWS (Revision 1) supersedes the previous posting.

Offerors are to replace the specified PWS pages and take note of the information referenced in the Summary of Changes.

3) Address Questions and Answers (Section 3).

4) Post Site Visit Meeting Minutes (Section 4).

SEE THE FOLLOWING SF30 CONTINUATION PAGES

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 document and are summarized below. Offerors, as of the date in Block 3 of this SF1449, shall use only the Solicitation Revision 1 document.

1. SF1449 Page 1, Block 15 is changed FROM FDA/NCTR, 3900 NCTR Road, Jefferson AR, 72079 TO

FDA White Oak Campus, Silver Spring MD and Muirkirk Road Complex, Laurel MD (as in PWSs).

2. SF1449 Page 4, Section B, Paragraph B.2.2 under the Pricing Table, “NOTE:” is changed

TO “NOTE 1:”

3. SF1449 Page 5, Section B, Paragraph B.2.2 under NOTE 1:, “NOTE 2:” is added as follows:

“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.”

4. SF1449 Page 5, Section B, Paragraph B.2.5 Sub-paragraph a., second sentence is changed to read:

FROM: “If at a future date the Government does require one or more Contractor employees to travel (training, conferences, etc.)…” TO: “If at a future date the Government does require one or more Contractor employees to travel (training, conferences, national/local AALAS, etc.)…”

5. SF1449 Page 8, Section B, Paragraph B.4.3, Paragraph Title is changed:

FROM: “Occupational Health & Safety and Employee Medical Examinations” TO: “Occupational Health & Safety”

6. SF1449 Page 2, Table of Contents, Paragraph B.4.3 Title is changed:

FROM: “Occupational Health & Safety and Employee Medical Examinations” TO: “Occupational Health & Safety”

7. SF1449 Page 16, Section D, in the “List of Attachments”, Attachment 8 name is changed:

FROM: “Past and Present Performance Evaluation Questionnaire” TO: “Past Performance Evaluation Questionnaire”

8. SF1449 Page 17, Section E, Table of FAR Clauses, the following FAR clause is added with fill-ins:

FAR NUMBER TITLE DATE

52.209-7 Information Regarding Responsibility Matters

“(b)… The offeror has does not have current active Federal contracts and grants with total value greater than $10,000,000.”

Jul 2013

9. SF1449 Page 17, Section E, Table of FAR Clauses, the fill-in information has been added to the following FAR Clause:

FAR NUMBER TITLE DATE

52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony

Conviction under any Federal Law “(b)(1) It is is not a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is is not a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.”

Feb 2016

*NOTE FOR CLAUSE ADDITIONS: Offerors need only submit the fill-ins using the updated SF1449 (Solicitation). There is no need to check the boxes on this Amendment document.

10. F1449 Page 17, Section E, Table of FAR Clauses, the following FAR clause is added:

FAR NUMBER TITLE DATE

52.237-10 Identification of Uncompensated Overtime Mar 2015

11. SF1449 Page 19, Section E, Paragraph E.4, Sub-paragraph E.4.1.1.e.1, first sentence in the paragraph is changed to read:

FROM: “1. All Volumes submitted in response to this RFP shall be placed in 3-ring binders, presented on 8.5 x 11 inch paper with standard one-inch margins on each border, single-spaced using a minimum of 12-point font size, printed front and back, and furnished in the number of copies stated below.”

TO: “1. All Volumes submitted in response to this RFP shall be placed in 3-ring binders, presented on

8.5 x 11 inch paper with standard one-inch margins on each border, single-spaced using a minimum of 12-point body text font size (table and graph font may be smaller, but must be clearly legible), printed front and back, and furnished in the number of copies stated below...”

12. SF1449 Page 20, top of the page, paragraph c. is changed to read:

FROM: “Rodent Production Colony Operation” TO: “Rodent Production Colony Management”

13. SF1449 Page 20, Sub-factor B, Paragraph 1, Subparagraph 3, second sentence is changed to read:

FROM: “While the labor union and the Executive Order are real factors that must be considered…” TO: “While the Executive Order must be considered…”

14. SF1449 Page 22, Section E, Paragraph E.4.1.4, 4th bullet is changed to read:

FROM: “Representations and Certifications.”

TO: “Representations and Certifications and other Clauses with required fill-in information.”

15. SF1449 Page 23, Section E, Paragraph E.4.3 entitled “Proposal Disqualification,” first sentence in the paragraph is changed to read:

FROM: “Failure to address the information required by the instructions provided herein will result in technical disqualification and will not be evaluated further.”

TO: “Failure to adequately address the information required by the instructions provided herein may result in technical disqualification whereby the proposal will not be evaluated further.”

16. SF1449 Page 24, seventh paragraph Under Factor 3 – Price, first sentence is changed to read:

FROM: “…same rates and terms as the last option period (CLINs 4001 and 4002) being extended.”

TO: “…same rates and terms as the last option period (CLINs 4001-4003) being extended.”

(End of SF1449 Changes)

SECTION 2 – Performance Work Statement (PWS) CHANGES

As noted in Block 14, a Revised PWS Annex 2 (8 pages) supersedes the previous version. Offerors shall use only the updated PWS Annex 2 Revision 1 dated October 27, 2016 and note the changes below:

1. PWS Annex 2, Page 2, Paragraph 4.1.1. Hours of Operation, paragraph is added after the first paragraph that reads:

“Weekend work is required to provide routine animal husbandry and animal observations for both Saturday and Sunday. Two Contract personnel are required to work together on the weekends for safety reasons and the amount of time anticipated per weekend day is two hours per person per day.”

2. PWS ANNEX 2, Page 3, fifth sub-paragraph under Paragraph 4.1.1., DELETE second sentence.

Paragraph is changed to read:

FROM: “For on-site support at the FDA facility, unless otherwise directed, the Contractor should adhere to standard work hours, working no more than forty (40) hours per week. If more than forty

(40) hours per week are required, then the hours should be billed at normal rates/straight time. Any necessary overtime shall be authorized in advance by the COR or Contracting Officer.”

TO: “For on-site support at the FDA facility, unless otherwise directed, the Contractor should adhere to standard work hours, working no more than forty (40) hours per week. Any necessary overtime shall be authorized in advance by the COR or Contracting Officer.”

3. PWS Annex 2, Paragraph 4.1.8.4., top of Page 5. Add sentence to the end of paragraph which reads:

“Cage Wash Attendant Ancillary duties include laundering of soiled cloth lab clothing (scrubs and lab coats) as necessary (average is twice per week).”

(End of PWS Changes)

SECTION 3 – QUESTIONS AND ANSWERS

The following are the questions submitted prior to receipt of proposals and their corresponding answers.

General Questions Question 1: SF1449 Page 1 says “Page 1 of 35”; however there are only 34 pages throughout the rest of the document. Is a page missing or is this an error?

Answer 1: SF1449 Page 1 incorrectly listed that there were 35 pages. There were no missing pages.

Question 2: RFP Page 19 under Volume Preparation, it states, “….using a minimum of 12-point font size.” This font size is fine for proposal body text but is very restrictive for graphical notations, diagrams, tables and similar graphics. Will the government modify this font requirement to allow smaller fonts for tables and graphics?

Answer 2: Yes. Language is updated to reference 12-point font for body text only. See updated language in the SF1449, Revision 1.

Question 3: Do we submit Key Personnel resumes with proposals?

Answer 3: Yes. RFP/Solicitation/SF1449 page 20, Sub-Factor B, fourth Sub-paragraph under Paragraph

1. “Staffing Plan/Recruiting Plan.” Paragraph states: “…including a listing of detailed resumes for key personnel committed to work directly on this contract…”

Question 4: Upon review of the Performance Work Statement, we noticed the number of positions that were noted as key Personnel. Is this intended to be key positions for some of the listed positions or are they all truly Key personnel? In addition, if they are all key personnel, are resumes required?

Answer 4: All positions listed as key personnel are truly key personnel and resumes are required with proposals. See previous question above.

Question 5: Confirm Supervisor position – listed as key, but is not listed as position in PWS.

Answer 5: See PWS Annex 1 & Annex 2, paragraph(s) 4.1.8.3. Supervisors are listed at both locations.

WOC Supervisor is Key Personnel, as listed in WOC Key Personnel list.

Question 6: The NCTR Animal Care Solicitation (16-223-SOL-00036), Page 19, proposal instructions require Offerors to address major areas of responsibility. With respect to item “c. Rodent Production Colony Operation,” the NCTR Attachment 1 – PWS has a corresponding Task Section outlining required support (Section 4.4, Rodent Production Colony Support). Similarly, the Multi-Center Solicitation (FDA- SOL-1153590) RFP also includes, on Page 20, the requirement for Offerors to address major areas of responsibility, and also includes item “c. Rodent Production Colony Operation.” This task, however, is not discussed or represented in the Multi-Center (FDA-SOL-1153590) Attachment 1 – Performance Work Statement or Annexes.

Q: Is there a designated Rodent Production Colony task/requirement for this solicitation or is it typical small level in-house breeding supported by specific Animal Study Protocols?

Answer 6: SF1449 Page 19 Paragraph c. is changed to read FROM: “Rodent Production Colony Operation” TO: “Rodent Production Colony Management (as applicable)” (as in change #12 above).

Offerors are advised that the Multi-Center requirement does include only small level in-house breeding driven by specific animal study protocols. Further, the following information is provided as clarification to the applicable Task Requirements:

Attachment 1 (Main PWS) Page 8, Paragraph 4.1.8. Personnel, Second sentence states: “The management and technical positions presented in each requirement reflect the required organizational structure for project management, animal care and technical procedures. Quality control, training, occupational safety and health, inventory, and equipment maintenance support tasks are currently positioned at or above the technical specialist level.” Rodent Breeding Colony Management would be included under the project management and technical procedures.

White Oak Campus:

PWS Annex 1, Page 15 of 47, and PWS Annex II, Page 33 of 47, Paragraph(s) 1.2. Objective states:

“The purpose of this contract is to provide animal husbandry services to (facility’s) animal research program specifically 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.” The statement "provision of protocol-specified technical procedures support" includes protocols involving animal research, regulatory studies and rodent breeding protocols.

PWS Annex 1, Page 17 of 47 (WOC Annex), Paragraph 4.1.8.6. Research Assistant I and Research Assistant II, last sentence in the paragraph: “…work with non-human primates, immunocompromised humanized/gnotobiotic mice and/or BSL 3 work involving animal care, health observations and security procedures, and/or management of breeding colonies to include genotyping support and advising PIs.”

The Rodent Colony Production Management is carried out by the RA I/II.

PWS Annex 1, Page 21 of 47, Paragraph 4.2.2.3 “Provide technical laboratory animal services, such as injections, bleeding, treatment, breeding management, weaning, record keeping, animal observations, assisting researchers, report generation, and distribution.”

MRC/MOD-1:

CFSAN/MOD-1 does not maintain stock breeding colonies. Any rodent breeding colony management activity is Protocol driven and the duties are shared between the FDA Research Staff and the Contractor.

To date there have been only a few (three) Protocols requiring the breeding of animals since the facility opened in 1990.

(End of Answer 6)

Question 7: SF1449 page 20, Paragraph 1, sub-paragraph 3 includes a reference to the Union. Is there a Union at this site?

Answer 7: These sites are not represented by a Union. Reference to the Union has been removed. See #13 in PWS changes, above.

Question 8: Early dismissal, etc. – are hours billable?

Answer 8: Only exact hours worked can be billed.

Question 9: Do you want OT rates proposed?

Answer 9: See WOC Question and Answer #8 and MRC/MOD-1 Question and Answer #1.

Question 10: What ODCs are billable (shoes, scrubs, etc.)?

Answer 10: Reference PWS Paragraphs 4.1.13. which states the Contractor is responsible for furnishing everything (notwithstanding items furnished by the Government) required to safely perform services under this contract. This is a Labor Hour contract which means you will bill for Direct Labor hours actually worked. Refer to Attachment 6 – Pricing Worksheet and build your labor hours as a fully burdened rate.

Question 11: Clarify onsite laundry?

Answer 11: WOC AP: As per PWS Annex 1, page 4, Paragraph 4.1.13. “Contractor Furnished Materials” “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.” Accordingly, Contractor is responsible for providing clean uniforms to their employees. There is no onsite laundry facility at WOC. MRC/MOD-1: As per PWS Annex 2, Paragraph 4.2.1.12. Contractor employees “provide laundry services for the Government-furnished clothing provided for use in the animal facility.” At MRC there is an on-site laundry facility. This was discussed during MRC/MOD-1’s site visit.

Language has been added to Annex 2 PWS, Personnel Paragraph 4.1.8.4. to clarify which position performs this ancillary duty. See PWS Annex 2, Revision 1.

Question 12: Client Authorization Letters and Past Performance Evaluation Questionnaires are requested for both solicitations (16-223-SOL-00036 & FDA-SOL-1153590). Can just one authorization letter and questionnaire be submitted from our clients combining both solicitations?

Answer 12: The above-mentioned Solicitations are individual and independent requirements and the government will evaluate them as such. Offerors are to follow the requirements outlined in each RFP and submit documentation independently.

Question 13: Animal Health Technician 3: confirm ALAT or LAT?

Answer 13: See PWS Annex 1, Paragraph 4.1.8.8. and PWS Annex 2, Paragraph 4.1.8.6. “Animal Health Technician I/II” (that’s “AHT 1 or 2”, not “AHT3”). Certification is stated clearly for AHT I/II.

The following questions and their associated responses are Center (site)-specific.

White Oak Campus Questions Question 1: How frequently are empty animal rooms sanitized?

Answer 1: All facilities are sanitized quarterly and Section 1 that is under construction at this time will be decontaminated after construction is finished and prior to animal occupancy.

Question 2: What types of isolators are used in the germ free animal room?

Answer 2: 1 Soft Wall flexible isolator made by Class Biologically Clean Ltd. and 2 semi-ridged isolators manufactured by Park Biosciences are utilized in the germ free room.

Question 3: Are vehicles maintained by the FDA?

Answer 3: GSA and FDA maintain all government vehicles. Contractors are required to provide driving recorded for any contractors that will be driving government vehicles. Insurance coverage by the contractor is also required.

Question 4: What is the water system?

Answer 4: The watering system consists of an Edstrom Automated watering system that is purified and chlorinated by a reverse osmosis (RO) system. This provides water to 90 percent of the animal population with the remaining water being RO water in drinking bottles that are autoclave-sterilized prior to placing on animal caging.

Question 5: Who maintains the water system?

Answer 5: The Edstrom watering system is covered for all repairs and maintenance by the Government Services Administration (GSA) on the above standard equipment contract.

Question 6: What species are held in the BSL3 rooms?

Answer 6: In the BSL3 facility mice are maintain in Allentown Bio Containment Racks. Other species such as guinea pigs have been used but there are no other plans to use this species in BSL3 studies.

Rats and ferrets are planned for use in BSL3 work and these species would be maintained in Allentown positive/negative ventilated racks. All BSL3 animals are provided with sterilized water bottles.

Question 7: During the site visit at the White Oak site, there was mention of a contract veterinarian, however there is no mention of this in the PWS 4.1.8 section. Please clarify?

Answer 7: A Contract Veterinarian is not required for the contract. We do have a contract veterinarian but it is a government position separate from the animal care contract.

Question 8: Are overtime pay rates an option for weekend and holiday hours noted in Attachment 1, PWS Annex 1, page 2, paragraph 4.1.1? (There is not a place on Attachment 6 – Pricing Worksheet, for bidders to provide OT rates.)

Answer 8: Yes, White Oak Campus will require overtime and holiday work, as authorized by the COR.

Contractor employees will be paid the standard overtime rate. As per RFP Page 22, Paragraph “b. Pricing Worksheets,” second subparagraph instructs that the Attachment 6 – Pricing Worksheet “…shall be used as a guide when determining labor mix and number of personnel… the pricing worksheet may be altered…” The fourth Subparagraph also discusses the number of hours a FTE is expected to work depending tenure, and does state that Offerors should explain any deviation an Offeror proposes to that FTE position. Thus if an Offeror proposes to use Overtime, Offerors are expected to alter the Worksheet to include OT categories to present a clear picture of both how the fully burdened hourly rate has been developed, as well as how the overall contract pricing (which is then carried forward into the SF1449 Section B Pricing tables) has been developed.

Muirkirk Road Complex (MRC/MOD-1) Questions Question 1: Are overtime pay rates an option for weekend and holiday hours noted in Attachment 1, PWS, Annex 2, page 3, paragraphs 4.1.1 and 4.1.2?

Answer 1: MRC/MOD-1 has not previously and does not provide for overtime or Holiday pay. Contractor employees have historically been provided compensated time off for weekend and Holiday work. Note response to MOD-1 question #8, above in that if Offerors wish to propose an alternative method to what has been done in the past, explain the rationale and “show the work” using Attachment 6 – Pricing Worksheet. In other words: clearly present your proposed solution, leaving no question as to why or how you have proposed that solution.

Question 2: What are weekend hours for MOD-1?

Answer 2: Weekend work is required to provide routine animal husbandry and animal observations for both Saturday and Sunday. Two Contract personnel are required to work together on the weekends for safety reasons and the amount of time anticipated per weekend day is two hours per person per day.

This language has been included in Annex 2 PWS, Revision 1 and has been addressed in the PWS changes outlined in Section 2 of this document.

Question 3: MRC/MOD-1 PWS page 5, Paragraph 4.1.10. reference to buddy system. Does that put two animal caretakers per room, etc.? How is this managed?

Answer 3: No, there are two Contract personnel present in the Vivarium on the weekends but not two Contract personnel per animal room. “How is this managed?” See response to Question #2, above.

Question 4: Please clarify rodent cage changing frequency for both locations?

Answer 4: As follows:

White Oak Campus Sanitization and Cage Changing Water: Most animals are supplied water via an Edstrom Automated Watering System (AWS). The Edstrom RO system is capable of storing 1550 gallons of chlorinated contaminant free drinking water providing chlorinated water.

Animal drinking water is processed through the Edstrom RO system, distributed to animal rooms’ pressure reducing stations and bottle filling stations. The AWS is automatically flushed twice daily. The Edstrom AWS consists of water pressure stations that have 5.0-micron filtration cartridge which is changed every other month.

Some animals are provided water bottles. If the contents of a water bottle are low, or if the contents are contaminated with feed or bedding, it is immediately replaced with a new bottle. Bottles, stoppers and sipper tubes are replaced once per week for rodents. All replacement bottles are filled at a water bottle filler in clean cage wash and autoclaved.

Animal Racks: IVCS are sanitized every six months; Primate racks are sanitized every 2 weeks;

Conventional racks (rabbit and guinea pig) are sanitized every 2 weeks.

Edstrom A-160 drinking values integral to the cage are sanitized with cages by tunnel washer, rack washer and autoclaved. Each drinking valve is primed with a cage charging station in the animal room before being plugged into the rack manifold.

Cage changing and washing: Section 1 and 2: Contact cage bedding for mice and hamsters is changed a minimum of once a week with daily spot checks. Contact cage bedding for rats and guinea pigs is changed a minimum of twice a week with daily spot checks. Spot changing is done as needed.

Non-contact catch pan bedding is changed twice a week for rabbits and ferrets in plastic perforated or expanded flat wire-bottom cages.

NHP Section 3: NHP Hardwood chip and paperchip bedding is changed daily. NHP non-bedding catch pans are flushed daily to room drain troughs.

Germ-Free Isolator Cage Changing -The cage change rotation for mice on germ-free studies will be once every 2 or 3 weeks. This is permissible, because germ-free mice are not colonized with bacteria that are able to breakdown urinary nitrogenous wastes to ammonia; thus cages remain ammonia-free.

Excessively wet or flooded cages will be changed immediately.

Section 2: Aquatic housing consists of two independent Xenopus laevis systems with recirculated, de-chlorinated conditioned water by passing it through a carbon tank filter with a weekly back wash cycle, coarse filters, carbon filters, fluidized bed biofilter (FBB), UV light, and a water exchange rate of 5-10% per day depending on population load. Also utilized is constant flow quarantine rack system with five individual 17 liter tanks. Quality assurance of stable water parameters is assessed daily during the week, using 5-1 or 6-1 chemical test strips and a pH/conductivity meter. The maximum housing densities for Xenopus laevis is one frog per 3 liters or more of water. All aquatic frog housing systems water is tested for bacterial pathogens monthly. The frog housing systems are tested annually for preventive maintenance, and technical support service is provided by Aquaneering Inc.

Feeding: Sections 1 and 2: Feed is provided ad libitum to all species except rabbits and primates that are on a controlled caloric intake for health purposes and aquatic frogs for reasons of good husbandry. Frogs are fed twice weekly. Rodent feed pellets are placed in the wire cage lids for shoebox caging and J feeders for rabbits, ferrets, and guinea pigs, unless the protocol requires that feed be placed in stainless steel cups inside the cages. Feed is placed in feeders in metabolism caging. Feed is checked daily and added as needed.

Section 3: NHP’s are fed a standard diet twice per day. Each animal is fed according to his weight with rations being adjusted on occasion according to their body condition score that is documented during semiannual physical exams.

Cleaning and Disinfection of the Micro- and Macro-Environment Area Washing/Sanitizing Frequency Other Comments Solid-bottom cages (static) 1-3 time per week Rodent Caging Solid-bottom cages (IVC) 1-2 times per week Rodent caging Suspended perforated bottom or slotted floor cages

1 time a week Rabbit and Primate racks with cages

Cage Wire lids Every 2 weeks Filter tops Once per month Wipe with Quatricide PV disinfectant weekly Cage racks and shelves Once every 2 weeks Cage pans under suspended cages Primate-Daily pans only

Primates-Every 2 weeks rack w/pans Rabbits-2 times a week

Play pens, floor pens, stalls, etc. Hand washing Rabbits-weekly Aquatic, amphibian, and reptile tanks and enclosures

Hand washing Every 6 months

Feeders Every 2 weeks Watering Devices (rodent) bottles/stoppers w/lixits Racks with lixits Racks with removal lixits Cages with attached lixits

1 time a week Monthly Every 6 months Once per week

Watering Devices (rabbit) Once every 2 weeks Exercise devices and manipulanda used in environmental enrichment programs, etc.

(rodent)

Once weekly and every 2 weeks

Exercise devices and manipulanda used in environmental enrichment programs, etc.

(rabbit)

1 time every 2 weeks

Transport cages After each use (End White Oak Campus (WOC) Sanitization and Cage Changing Response)

MRC/MOD-1 Cage Changing

1. The following minimum frequencies have been established for the changing of animal cages in the MOD-1 animal facility.

Species Cage Type Minimum Frequency of Change Mouse Polycarbonate shoebox cages Cage change - twice weekly Wire lid change – once weekly Water bottle change - twice weekly Micro isolator lid change - monthly Shelf rack wipe down – once weekly Shelf rack change - quarterly

Lab Products Ventilated cages

Cage change - once weekly Wire lid change - once weekly Water bottle change – once weekly Micro isolator lid change - monthly Shelf rack wipe down - once weekly Rack change - bi-annually

Rat Polycarbonate shoebox cages

Cage change - twice weekly Wire lid change - once weekly Water bottle change - twice weekly Micro isolator lid change - monthly Shelf rack wipe down – once weekly Shelf rack change - quarterly

Wire cages Cage change - twice monthly Feeder change - twice weekly Water bottle change- twice weekly Excreta pan - twice weekly

Guinea pig Polycarbonate shoebox cages

Cage change - thrice weekly Wire lid change - thrice weekly Feeder change - thrice weekly Water bottle change – thrice weekly Micro isolator lid change – monthly Shelf rack wipe down – once weekly Shelf rack change - quarterly

Rabbit Molded plastic hanging cages

Rack and cage change - once weekly Excreta pan liner change - thrice weekly Excreta pan change -thrice weekly Feeder change - once weekly Water bottle change- thrice weekly Water bottle daily - fill out bottles by using 5gal carboy

Poultry Wire Cages Rack change – once monthly Feeder – add feed daily/sanitize monthly Water lixit – spot check daily Flush water line – daily Excreta pan liner – thrice weekly Excreta pan change - once monthly

Miniature Swine

Pen floor Water check lixit daily/sanitize weekly add water daily Feeder – add feed daily/sanitize weekly Excreta - daily twice a day/on weekends and holidays once daily Spray floor mat - daily Floor Mat- once monthly

2. Cages and Cage Rack Care

A. Cages and Components

1) Shoebox cages are to be changed according to the minimum frequencies described above.

These changes constitute the transfer of the animals from a soiled cage to a dry, freshly sanitized cage with clean bedding. Soiled cages are to be promptly placed on the floor or on carts provided adjacent to the animal room return door for transport to the return cage wash area for processing. Soiled cages are not to be left stacked overnight in the animal rooms or in the corridors of the facility.

2) Diversion from the minimum cage changing frequency will be acceptable only with the approval of the CFSAN COTR or Study Director/Principal Investigator. Single house mice cage must be changed on the first cage change of the week and spot check for the second cage change.

3) The bedding of the animal cages is to be checked daily. Excessively soiled cages or cages with wet bedding are to be changed immediately in addition to the scheduled cage changes.

4) Shelf type cages with wire lids are to have their wire cage lids changed a minimum of once weekly and their micro isolator lids changes monthly.

5) All cage and component changes will be documented by the animal technician on the

DARC Form (Form F-001) upon completion of the task.

NOTE: Enrichment toys are changed weekly.

B. Racks

1) Shelf racks are to be damp dusted with a paper towel moistened with an approved disinfectant weekly to control dust buildup and accumulation of bedding material and feces.

2) Racks are to be replaced with freshly sanitized units every three months and labeled with the sanitation date when introduced into the animal room. Use an indelible marker on a disposable tag and attached with a cable tie to a rack support (out of reach of animal cages).

3) Clean racks are stored on the clean side of the cagewash area and transferred from this clean area directly to the animal room. Clean racks are not stored in the corridors of the facility unless they are placed there temporary to be utilized in a room change within 72 hours.

4) Excreta trays for suspended caging must be exchanged for freshly sanitized pans with fresh tray liners a minimum of twice weekly.

5) All rack changes will be documented by the animal technician on the DARC Form (Form F-

001) upon completion of the task.

NOTE: Refer to the study for metabolic cages and supplies.

(End White Oak Campus (WOC) Sanitization and Cage Changing Response)

(End of Questions and Answers)

SECTION 4 – MEETING MINUTES

Meeting Minutes are included as Addendums to this Amendment and are on the pages that follow.

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)