RFP ATTACHMENTS 1-13 Oct 06 2011.pdf

ATTACHMENT 1

PACKAGING AND DELIVERY OF THE PROPOSAL

Your proposal shall be organized as specified in Section L.2., Instructions to Offerors.

Shipping and marking shall be as follows:

EXTERNAL PACKAGE MARKING

In addition to the address cited below, mark each package as follows:

"RFP: HHS-NI H-NIDA(AG)-RFP-11-152

TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

NUMBER OF COPIES AND SHIPPING

• TECHNICAL PROPOSAL: One (1) original*, ten (10) paper copies, and one (1) copy on DVD.

• BUSINESS PROPOSAL: One (1) original*, five (5) paper copies, and one (1) copy on DVD

PROPOSALS must be received by the Contracting officer NO LATER THAN 3:00 PM local time, on the date identified in SECTION A, Block 2 of the SOLICITATION, at the following address:

;·'ItcHan(I·'D.elive~~Of·E·xtir~S$:Sen"ic:ei"c,~~:\':;i~;:If:usillQ[fUis~tP.l:istal;;Servicej ·"·",.·,f ;"~·",,:;f " Mrs. Diane Loeb Mrs. Diane Loeb Contract Specialist Contract Specialist NIDA Neuroscience COAC NIDA Neuroscience COAC NIMH/NIA R&D Contracts Management Br NIMH/NIA R&D Contracts Management Br 6001 Executive Blvd., Room 8154 6001 Executive Blvd., Rm 8154, MSC 9661 Rockville, Maryland 20852 . Bethesda, Maryland 20892-9661

NOTE: Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address and delivery to the Bethesda, Maryland tlddress will result in a delayed delivery to our office here in Rockville, Maryland (up to 3-5 days). If a proposal is not received at the place, date and time specified herein, it will be considered a "late proposal".

*PLEASE HAVE THE ORIGINALS READILY ACCESSIBLE FOR DATE STAMPING PURPOSES.

For questions please contact Mrs. Diane Loeb, Contract Specialist Telephone: 301-443-8886; Main: 443-443-2696 e-mail: dI294p@nih.gov

Collect calls will not be acce ted

PACKAGING AND DELIVERY OF THE PROPOSAL ATIACHMENT 1 Page 1 of 1

HHS-NIH-NIDA{AG)-RFP-11-152

mailto:dI294p@nih.gov

ATTACHMENT 2

PROPOSAL INTENT RESPONSE FORM

RFP No: HHS-NIH-NIDA(AG)-RFP-11-152

RFP Title: Development and Maintenance of a Multigenotypic Caloric Restricted Rodent Colony

Please review the Request for Proposal (RFP). Furnish the information requested below and return this page to the Contracting Officer/Contract Specialist identified on Section A-Solicitation/Contract Form by the following date:

Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

Choose one of the following Options:

o Do intend to submit a proposal o Do Not intend to submit a proposal

If you are not responding to this RFP, please provide your reason(s):

Please provide the following contact information:

Name (First, Middle Initial, Last):

Title:

Organization:

E-mail:

PROPOSAL INTENT RESPONSE FORM ATTACHMENT 2

Attachment 3: STATEMENT OF WORK (added to DGS)

Development and Maintenance of a Multigenotvpic Caloric Restricted Rodent Colony RFP No. HHS-NIH-NIDA(AG)-RFP-11-152

1. BACKGROUND

NIA funded research programs using rodents to model aging processes and age-related diseases in humans require animals of defined genotype and controlled environmental and health status.

Only with the meticulous, long-term control of genetic and environmental variables is it possible to maintain animal models suitable for the study of biological and behavioral processes in aging.

Caloric restriction, in which the calories are restricted to maintain a stable adult body weight but all other nutritional needs are met, is a proven intervention to extend lifespan and improve health. Calorically restricted rodents are used to investigate the cellular and physiological biology of normal aging. A colony of aged, calorically restricted laboratory rodents, of defmed genetic backgrounds and health status, is an integral part of the NIA's program of research on agmg.

2. OBJECTIVE(S)

The objective is to develop, maintain and distribute a standing colony of aged, genetically defined, calorically restricted rodents for use by investigators in studies of aging. This colony is to be developed and maintained within controlled and defined barrier environments where animals are monitored and characterized for disease status and markers of genetic purity.

3. WORK TO BE PERFORMED

Independently, and not as an agent of the government, the Contractor shall furnish all necessary services, qualified personnel, materials, facilities and equipment not otherwise provided by the Government as needed to perform the work described below.

Specifically, the Contractor shall develop, maintain and distribute a standing colony of aged, calorically restricted rodents of defined strains for use by investigators in studies of aging. The expected duration of this colony, and therefore of this contract, is nine years. During years 1 through 2, animals shall be entered into the colony, but few animals shall be removed from the colony except for the purposes of monitoring health and genetic purity. However, if the need should arise, animals may be distributed from the colony at anytime at the direction of the Contracting Officer's Technical Representative (COTR). During years 3 through 7, animals shall continue to be entered into the colony and animals shall be distributed to investigators.

This should be a period of stable operation with young animals entering the colony at approximately the same rate as older animals leave the colony due to distribution and normal attrition. The final two-year period, years 8 and 9, will serve as the colony closeout period.

Animals shall be maintained and disbursed, but entry of animals shall cease at the beginning of year 8 or when entries begin in a renewal contract colony. Thus the population in this contract colony will decline over the two year period to a point of near zero or very few animals at the end of year rune.

Statement of Work Attachment 3 September 12,2011

The colony population at the end of each year of the nine-year period should be approximately as presented in Table 1.

Table 1. Approximate colony population by year.

YEAR I 400 R4 2800 YEAR 7 00

YEAR 2 1600 YEARS 2800 YEAR 8 1600

YEAR 3 2800 YEAR 6 2800 YEAR 9 NEAR 0

Task Area 1. Provision of barrier environment

a) This animal colony shall be divided into two, approximately equal, separate segments.

Each segment shall be maintained behind a totally independent barrier, specific pathogen and parasite free, for the entire contract period. Both segments shall specifically be in helicobacter-negative barriers. The purpose of colony division is to insure the survival of at least one half of the colony in the event of pathologic breach of a barrier, genetic contamination, mechanical failure of environmental maintenance systems, or accidental disaster such as fire, or flood. Total independence of colony segments therefore means separation of buildings, power systems and back-up systems, environmental controls (heat, air conditioning, and air filtration) and breeding stock. Each barrier shall have an independent back-up generator and alarm system in case ofloss of power.

b) Each colony segment shall be maintained solely within its barrier facility without intermingling. Entries are to be divided approximately equally between the two colony segments. Exceptions may be granted but each exception shall require the prior written approval of the COTR.

Task Area 2. Supply of the Rodent Genotvpes

a) All animals obtained for this contract and produced under this contract, including those in the breeding colony and those entered into the aging colonies, shall be the property of the government. The Contractor shall not change the strains entered into this colony without written instructions from the Contracting Officer. The Government reserves the right to alter the numbers of each strain entered and to change the strains in the colony in response to changing needs of the research community.

b) Within 60 days of the start date of the contract, the Contractor shall acquire at the direction of the COTR breeding stock and shall re-derive the stock by cesarean section or embryo transfer. The Contractor shall test by micro-satellite assays a sample of the post re-derivation foundation stock to detect genetic contamination. The Contractor shall provide to the COTR documentation of the re-derivation and genetic history of the foundation stock for the aging colony. Foster mothers shall be of a strain that is easily distinguished from the NIA strains by both color and genetic markers.

NOTE TO OFFERORS: Proposals should include a description ofthe method proposed for re-derivation ofthe foundation stock.

NOTE TO OFFERORS: The choice ofstrain(sj to be usedfor foster mothers and the procedures to be used for demonstrating the genetic purity ofall pups born ofthe foster mothers should be included in the proposal.

c) Discrete space within the re-derivation area shall be provided for re-derivation of the NIA strains. No other animals shall be housed within an isolator housing the NIA contract strains, other than the contract animals and foster mothers.

d) Health monitoring shall be performed on the colony or colonies to be used as foster mothers within 60 days before the initiation of re-derivation and the results of that monitoring shall be provided to the COTR within 10 calendar days of the receipt by the Contractor. This health monitoring shall specifically include helicobacter status.

Task Area 3. Development of Breeding Colonies & Entries for Each Colony Segment

a) The size of the breeding colonies to be maintained shall be at levels that permit entry into the aging colony of male and female weanlings at the rate directed by the COTR. Each barrier shall house approximately one half, by age and gender, of all animals entered into the aging colony. The Government may alter the number of entries as research demands change during the performance period. Alterations in the number of animals entered require the specific written approval of the Contracting Officer. The initial colony entry levels shall be as presented in Table 2.

Table 2. Initial Monthly Entry Levels into the Aging Colony for Each Strain.

Cohort (strain! gender/diet*)

Total Entered

Entered in Barrier 'A'

Entered in Barrier 'B'

C57BLl6 M AL 40 every month 20 every month 20 every month

C57BLl6 M CR 30 every month 15 every month 15 every month

B6D2F1 M AL 40 every other month

20 every other month

20 every other month

B6D2Fl M CR 30 every other month

15· every other month

15 every other month

* AL = ad libitum fed; CR calorically restricted

• Note: for cohorts entered every other month, the entire entry level of both AL and CR should be in the same month in order to provide experimental groups of sufficient size.

• Note: breeding pairs should be kept together during periods when no offspring would be . entered into the aging colony, and the offspring born should be removed at 10-14 days of age and euthanized.

September 12, 2011

b) Re-derived foundation colony animals shall be entered into the barriers without contamination by pathogens or parasites and shall be maintained as such. Discrete space shall be provided for the breeding and aging colonies within each barrier. Breeding colony animals shall be removed from the barrier only for monitoring of genetic purity or colony health, or for other purposes as directed by the COTR. In both colony segments, no animals other than mice and rats shall be housed within the barrier and no other types of activity other than colony breeding and maintenance shall be permitted in the barrier rooms used to breed and maintain the NIA colony. Breeding and maintenance of commercial colonies of mice and rats is permissible within the barrier rooms housing the NIA colonies, but activities such as surgery or euthanasia are not permissible within the same rooms as the NIA colonies. Breeding colony maintenance shall conform to the following requirements.

1. The strains or sub-strains produced under this contract shall initially be approved by the Contracting Officer, and shall not be changed except on direct written authority from the Contracting Officer.

2. Breeding and recording of pedigrees of animals shall conform to the standards established for laboratory rodents by the Institute for Laboratory Animal Resources (ILAR) "Guide for the Care and Use of Laboratory Animals" (http://www.nap.eduibooks/0309053773/htmllindex.html).

3. Litters larger than 10 shall have the smallest pups culled and euthanized within 5 days of birth to bring the litter size down to 10; animals from litters smaller than 4 shall be excluded from introduction into the aging colony and shall be euthanized.

4. Mating, isolation, and primary enclosures shall meet or exceed minimum floor space requirements and population size per cage as stated in the ILAR "Guide for the Care and Use of Laboratory Animals". Solid bottom cages with aspen bedding shall be used for all breeding and maintenance cages. All primary enclosures shall require the prior approval of the COTR. Mating cages shall be numbered consecutively.

NOTE TO OFFERORS: The size and type ofenclosures and the type ofcage bedding to be used should be included in the proposal.

5. The Contractor shall maintain records of date of birth, health, breeding, genetic monitoring, environment, and colony monitoring for the entire contract period. These records shall be supplied to the investigators upon request by the COTR.

6. All cages shall be permanently identified by their genotypes, gender, and date of birth.

7. No animal shall be medicated during any part of the breeding or maintenance period except on specific instruction of the COTR.

8. The breeders shall be replaced when they reach 9 10 months and retired breeders shall be euthanized.

Statement of Work Attachment 3 http://www.nap.eduibooks/0309053773/htmllindex.html

9. The Contractor shall provide for positive assurance of genetic quality control, by micro-satellite testing of a sample of the breeding colonies to detect genetic contamination.

Procedures for genetic quality control are subject to the prior written approval of the COTR.

This testing shall be performed on the foundation colony within sixty (60) calendar days after re derivation and on all breeding colonies semiannually thereafter, unless otherwise directed by the COTR. The Contractor shall notify the COTR immediately of any genetic monitoring results not consistent with strain purity.

NOTE TO OFFERORS: Procedures for genetic quality control should be sufficiently detailed in the proposal to demonstrate that they can distinguish between rat strains ofthis contract colony and other common strains oflaboratory rodents.

Task Area 4. Maintenance of the Aging Caloric Restriction Colony

a) Rodents shall be weaned at 3 - 4 weeks of age and shall be permanently marked by tail tattoo to identify month and year of birth. Animals born in excess of the number required to meet defined levels of entry into the aging colony shall be euthanized unless otherwise directed by the COTR.

NOTE TO OFFERORS: the method and equipment used for euthanasia should be described in the proposal. Euthanasia protocols must conform to PHS policy as described in http://grants.nih.govlgrantslguidelnotice-filesINOT-OD-02 062.html.

b) Weaned rodents shall be housed individually and fed ad libitum until the commencement of the caloric restriction regimen. Caging must meet current ILAR and Department of Health and Human Services (DHHS) (http://grants.nih.gov/grants/olaw/references/phspol.htm) standards. Cage cards shall include the strain, gender, feeding protocol (AL or CR when assigned), and date of birth.

c) All rodents entered into the aging colony shall be maintained within the barrier until scheduled for removal (shipment or sacrifice) or natural expiration of the animal.

Animals shall be removed from the barrier only for shipment to investigators at the direction of the COTR, for monitoring of genetic purity or colony health, or for other purposes as directed by the COTR.

d) The type of cage bedding is subject to review and approval by the COTR.

e) No animal shall be medicated without prior written approval of the COTR.

Task Area 5. Feeding Protocol'

a) Ad libitum (AL) fed animals assigned to the aging colony shall receive a laboratory animal feed, the formulation of which is consistent with NIH31 autoclavable diet with regard to ingredients, both in kind and amount (Rader et al., 1986, J. Nutrition 116:1777 88). The kind of ingredient shall be absolute; the percentage of the kinds of ingredients may vary dependent on nutrient content, provided the final formulation post-autoclaving

Statement of Work Attachment 3 September 12, 2011 http://grants.nih.gov/grants/olaw/references/phspol.htm http://grants.nih.govlgrantslguidelnotice-filesINOT-OD-02 remains consistent with NIH3l diet. NIH31 shall be made in random weight pellets appropriate for feeding mice and rats.

b) Calorically restricted (CR) animals shall receive a laboratory animal feed, the formulation of which is consistent with NIH3l autoclavable diet but is enriched 1.67-fold for all vitamins and minerals such that 40% restricted calorie intake provides 100% of the vitamin and mineral intake of ad libitum fed animals. This diet is called NIH31-Fortified.

NIH31-Fortified shall be provided in known-weight pellets from 2.5 to 5.0 grams in 0.5 gram increments. The diet shall be of a consistency that prevents excessive crumbling of the pellets.

NOTE TO OFFERORS: The formulation and post-autoclaving vitamin and mineral content ofthe NIH31 and NIH31-Fortified diets should be included in the proposal and subject to approval by the COTR.

c) Both NIH31 and NIH31-Fortified shall be supplied by the same manufacturer. Food shall be stored in a temperature and humidity controlled environment and shall be used within 6 months of milling.

d) The Contractor shall provide food to investigators who purchase the animals, both NIH31 and NIH31-Fortified, packaged in 1 kilogram packages. When food is ordered to be shipped with the animals, the Contractor shall determine how much food the investigator needs for the period for which they will be feeding the animals and ship the appropriate amount, plus at least 10% extra to allow for breakage, rounded up to the nearest kilogram.

e) CR animals shall be fed the prescribed daily food amount once per day. The amount of food is controlled by feeding the animals specific numbers of known-weight pellets of food. The COTR will supply documentation on the amount of food to feed the CR animals at each week of age. The CR regimen begins at 14 weeks of age, with a 10% reduction in food as compared to ad lib food intake. At 15 weeks it is increased to 25% restriction and at 16 weeks it is increased to 40% restriction (60% of ad lib intake) where it remains for the life of the animal.

1) The Contractor shall measure food intake in the first cohort (DaB) of each strain and gender. entered into the aging colony, to verify that food intake in the new colony is consistent with the levels on which the feeding protocol is based. Food intake shall be measured by providing an excess number of food pellets of known weight each day and weighing the food remaining the next day. Food intake shall be measured daily for the entire cohort from the age of 5 weeks through the age of 12 weeks. The data shall be compiled in an Excel spreadsheet and the up-dated spreadsheet shall be provided to the COTR weekly.

Task Area 6. Environmental Requirements

a) The Contractor shall provide discrete production space for each colony segment within the barrier or isolation area for that segment. This space shall be defined within each unit, and the animals held therein until the scheduled removal or expiration of the

September 12, 2011 .

animals. Facilities set aside for these colonies shall be provided with all equipment, materials, and supplies necessary to maintain these animals effectively within the barrier enclosure in a stable condition and environment.

b) The barrier system or isolation room shall be operated and constructed to effectively exclude pathogens, ecto-, endo-parasites as well as vermin.

NOTE TO OFFERORS: Floor plans for the containment of the colony should be submitted with the proposal.

c) The following items shall be controlled within the ranges specified: temperature (72 77°F), humidity (40-55%), light cycles (12112 hrs.), air circulation (0.25rn/hr/animal) and filtration (HEPA), water chlorination (7-8 PPM at discharge end) and water acidification (PH 5.8 - 6.0). A maximum of 25% re-circulated air within the barrier is allowed. The COTR shall be notified iinmediately if the ambient temperature remains outside the above noted temperature range for a period in excess of 4 hours or if there is any loss of animals due to breakdown of environmental controls.

NOTE TO OFFERORS: Description of the methods of control and monitoring oflimits should accompany the proposal.

d) Personnel shall follow the sanitary and/or sterile practices and techniques that have been established for the maintenance of barrier-sustained animal colonies as described in the ILAR "Guide for the Care and Use of Laboratory Animals". Personnel assigned to the project shall have no contact with rodent colonies other than barrier-sustained animal colonies. Staff shall not at any time be permitted to enter the area assigned to this project unless all necessary precautionary measures have been taken with respect to entry and exit from the barrier enclosure. Visitors other than the COTR or her designated representative shall not be permitted to enter the area assigned to this project.

e) Current ILAR and DHHS guidelines for breeding, care and maintenance of laboratory rodents shall apply where specifications have not been detailed.

f) The Contractor shall notify the COTR immediately if any abnormal condition(s) are detected in the colony.

g) The Contractor shall cooperate with the COTR concerning the submission of whole animals or specimens for diagnosis, use of medication, and changes in methodology which are intended as remedial measures for alleviation of undesirable conditions and/or to improve reproductive or breed characteristics of the colony.

Task Area 7. Colony Evaluation and Monitoring

a) All spontaneous deaths in the colony shall be reported by barrier, gender, diet and age in the semiannual progress reports and on the weekly census report. Necropsies shall not be performed unless there is an unusual pattern of animal deaths or upon the direction of the COTR. Postmortem findings in such cases shall be tabulated, summarized, and provided to the COTR within sixty (60) calendar days of the death. Primary and secondary lesions

September 12, 2011 possibly attributable to cause of death are to be described. Differences between colony segments shall be identified and reported in the semiannual progress report.

b) Routine monitoring for disease and post mortem examinations is to be performed by either an independent laboratory approved by the COTR or the Contractor if Contractor plans, personnel and facilities are approved by the COTR.· Selection of animals for monitoring shall be evenly divided between colony segments and represent all strains and genders present in the colony. Thirty (30) animals from the colony shall be submitted for routine health monitoring each quarter unless otherwise specified by the COTR. Animals to be submitted for routine monitoring shall be a minimum of 4 months old.

Approximately half of the animals tested each quarter shall be 4-12 months old and the other half 12-20 months old. The schedule for health monitoring shall be developed by the Contractor and shall require the approval of the COTR.

c) Additional animals, up to 160 per year, shall be designated by the COTR for shipment to an independent laboratory designated by the NIA for health monitoring.

and visible lesions and symptoms

effectiveness of the barrier system and animal health

4. histopathology of major organs and systems.

NOTE TO OFFERORS: The specific microbial, parasitological, histopathological and serological assessments should be detailed in the proposal and require approval by the COTR.

e) Animals shall be monitored for wounds, open lesions caused by excessive scratching, and for visible tumors, and shall be euthanized when wounds or tumors are extreme enough to cause pain, wasting or decreased mobility in the animal or when tumors reach 2 cm in diameter.

f) Upon obtaining pathologic or other evidence that a barrier has been breached, the Contractor shall immediately notify the COTR and the Contracting Officer by telephone.

The Contracting Officer shall arrange a meeting or teleconference of the Contractor's representative, the COTR, and the Contracting Officer as soon as practical, but in all cases within seven (7) calendar days, to determine an appropriate course of action. Such action may range from medication to reestablishment of the colony in newly constituted barrier facilities. The COTR will make final determination of the appropriate course of action.

Task AreaS. Shipment of Animals to Investigators

a) Animals from the aging calorically restricted rodent colony shall be distributed to investigators or laboratories only as directed by the COTR or the designated representative of the COTR. A copy of the most recent Health Evaluation Summary for the animals, prepared under Task Area 7.b. shall be sent with each order.

b) The animals shall be shipped in containers that are made of new materials that are non reusable and non-returnable; the design and fabrication of which are approved by the COTR; with filters for ventilation openings of a type approved by the COTR; and designed to allow stacking without interference with normal circulation of air through the container.

c) The AL and CR animals shall be shipped in compartmentalized crates, one animal per compartment. All compartments housing animals shall include food and a source of liquid. Compartments carrying CR animals shall include either 1 or 2 days of food, depending on the length of time in transit. Special provisions may be specified by the COTR as needed.

d) The Contractor shall report to the COTR or the designated representative of the COTR immediately ifthere are delays in the shipment of animals.

e) Shipment via dedicated, climate-controlled truck is the preferred method. The Contractor shall bear responsibility for the cost of animals and shipping charges for replacing animals or providing credits for animals that die during shipment or within 48 hours of delivery, or that are unacceptable to the consignee due to injury or breached shipping containers. The Contractor is also responsible for the cost of replacing orders not filled correctly according to the instructions provided by the COTR or the representative designated by the COTR.

f) When shipment by dedicated, climate-controlled truck is not possible, airfreight shall be used. The Contractor shall take all necessary precautions to assure expedient delivery of animals shipped by air freight, by advising the recipient of expected arrival time, mode of transport and carrier number, and any responsibility the consignee has for pick-up at the point of arrival. When the consignee is notified that they are required to meet animals at point of arrival, late or delayed pick up of animals shall constitute neglect by recipient and Contractor is relieved of all replacement or reimbursement obligations.

g) Title to animals shipped will be transferred to the consignee once animals are received and accepted.

h) Shipping charges shall be borne by the recipient when animals are shipped to investigators at the direction of the COTR.

i) The Contractor shall maintain all records of shipments to investigators until the end of the contract period.

Task Area 9. Cost of Animals to Investigators

a) Animals produced under this contract shall be made available to investigators under conditions as stated herein or as otherwise specified by the COTR. The cost of each animal to the investigators shall be determined by the COTR. The current charge is

$6.00 per month of age per mouse; these costs shall be subject to annual adjustment. The consignee is also responsible for all shipping costs and the cost of food ordered. Current charges for food are $2.00 per Kg for NIH31, $10.00 per Kg for NIH31-Fortified, and a flat fee of $12.00 per food type per shipment if the food is shipped by truck with the animals. If food is shipped by common. courier, the investigator will pay the prevailing rate.

b) Total cost (as charged to the consignee) of animals (animals, crate, water source and shipping charge) which are not useable when received by the consignee due to negligence on the part of the contractor or subcontractors, shall be borne by the Contractor and are not chargeable to the Government. The Contractor shall be responsible for invoicing the recipients for the animals, food and shipping charges, receiving payments, and keeping an accounting of investigator payments received.

Task Area 10. Reporting Requirements

a) Semiannual progress reports shall include any unusual developments or problems involving colony health, genetic purity, environment or environmental control, and any differences noted between barriers. The report shall include the results of routine genetic monitoring- and all laboratory tests executed either by Contractor as a routine part of the protocol or results from tests that have direct implication for colony health or development. All deaths or sacrifices from the colony shall be accounted for by barrier, gender, diet and age of the animal sacrificed or expired. Unusual problems shall be reported to the COTR immediately. Semiannual progress reports shall be submitted to the COTR within fifteen (15) calendar days of the end of each six-month period of the contract. The initial report shall be submitted for the first full six months of the contract performance including any fractional part of the initial month. Thereafter, the reporting period shall consist of six full calendar months. A semiannual report will not be required for the period when the final report is due.

b) A weekly census report shall be submitted to the COTR in accordance with a format approved by the COTR. Electronic transfer of the census in Excel spreadsheet format is the preferred means. The weekly census report is due to the COTR no later than one week (7 calendar days) from date of census. Access to a "real-time" electronic inventory would take the place of the weekly census report subject to approval by the COTR.

c) A weekly up-date of the food intake measurements during the initiation of the aging colony (Task Area 5.t) shall be provided electronically to the COTR no later than Friday of the week following the week the measurements were performed.

d) Complete quarterly health monitoring reports shall be submitted to the COTR no later than three months from the date the animals were submitted for evaluation (Task 7.b).

Semiannual summaries of these reports shall be furnished as a part of the semiannual progress reports described in Task Area 1 O.a above.

e) Reports of the results of the genetic monitoring of the foundation stock (Task Area 2.b) and semiannual genetic monitoring of the breeding colonies (Task Area 3.k) shall be provided to the COTR no later than sixty (60) calendar days from the date the animals were submitted for evaluation. Semiannual summaries of these reports shall be furnished as a part of the semiannual progress reports described in Task Area 1O.a above.

f) Complete postmortem reports on individual animals chosen for additional health monitoring independent of the quarterly health monitoring (Task Area 7.a) shall be submitted to the COTR no later than sixty (60) calendar days from the date the animals were submitted for evaluation.

g) A final report shall be submitted to the COTR upon completion of this contract. The final report shall include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be submitted on or before the contract expiration date.

Task Area 11. Proceeds From Sales

a) All proceeds from the sale of animals shall be used to offset the total estimated costs under the contract. Proceeds from the sale of animal shall be shown as a separate line item on monthly invoices. Likewise, adjustments required shall be a separate line item on the monthly invoice.

ATTACHMENT 4

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER

STATEMENTS OF OFFERORS

Updated through FAC 2005-52

Last updated: 6/10/2011

This SECTION is made up of six parts as follows:

1. Annual Representations and Certifications

2. Information Regarding Responsibility Matters, FAR 52.209-7

3. Cost Accounting Standards

4. Certification Regarding Environmental Tobacco Smoke

5. Certification of Institutional Policy on Conflict of Financial Interest

6. Disaster or Emergency Area Representation

7. Certification of Filing and Payment of Taxes

To Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications:

1. ANNUAL REPRESENTATIONS AND CERTIFICATIONS (MAY 2011), FAR Clause 52.204-8

(a) (1) The North American Industry Classification System (NAICS) code for this acquisition is 112990 [insert NAleS code].

construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b) (1) If the clause at 52.204-7, Central Contractor Registration, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the clause at 52.204-7 is not included in this solicitation, and the offeror is currently registered in CCR, and has completed the ORCA electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes:

D (i) Paragraph (d) applies.

(ii) Paragraph (d) does not apply and the offeror has completed the individual representations and D certifications in the solicitation.

(c) (1) The following representations or certifications in ORCA are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the clause at 52.204-7, Central Contractor Registration.

(iv)52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that

(A) Are not set aside for small business concerns;

REPRESENTATIONS. CERTIFiCATIONS, AND OTHER STATEMENTS OF OFFERORS ATTACHMENT 4

Page 10f9

ATIACHMENT4

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(v) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations-Representation. This provision applies to solicitations using funds appropriated in fiscal years 2008, 2009, or 2010.

(vi) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(vii) 52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(viii) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

Ox) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(x) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xi) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xii) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xiii) 52.222-38, Compliance with Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xiv) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xv) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA-designated items.

(xvi) 52.225-2, Buy American Act Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xvii)52.225-4, Buy American Act--Free Trade Agreements-Israeli Trade Act Certificate. (Basic, Alternate I, and Alternate II) This provision applies to solicitations containing the clause at 52.225 3.

(A) If the acquisition value is less than $25,000. the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50.000. the provision with its

Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $67,826, the provision with its

Alternate II applies.

(xviii) 52.225-6. Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xix) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan--Certification.

This provision applies to all solicitations.

REPRESENTATIONS. CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS ATIACHMENT4

(XX) 52.225~25, Prohibition on Engaging in Sanctioned Activities Relating to Iran-Certification. This provision applies to all solicitations.

(xxi) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to-

(A) Solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions; and

(B) For 000, NASA, and Coast Guard acquisitions, solicitations that contain the clause at 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns.

(2) The following certifications are applicable as indicated by the Contracting Officer: [Contracting Officer check as appropriate.]

_(i) 52.219-22, Small Disadvantaged Business Status.

_(A) Basic.

_(B) Alternate I.

_(ii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

_(iii) 52,222-48, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification, _(iv) 52.222-52 Exemption from Application of the Service Contract Act to Contracts for Certain Services--Certification.

_(v) 52,223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA Designated Products (Alternate I only).

_(vi)

_(vii)

52.227-6, Royalty Information.

_(A) Basic.

_(B) Alternate I.

52,227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically via the Online Representations and Certifications Application (ORCA) website at http://orca.bpn.gov. After reviewing the ORCA database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause No. Title Chan\1e

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on ORCA.

(End of Provision)

REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS ATTACHMENT 4

http:http://orca.bpn.gov

2. INFORMATION REGARDING RESPONSIBILITY MAnERS, (January 2011) FAR Provision 52.209-7

Note to Offeror: This provision is applicable when the resultant contract is expected to exceed $500,000.

(a) Definitions. As used in this provision-

Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

Federal contracts and grants with total value greater than $10,000,000 means-

quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions). .

(b) The offerorDhasDdoes not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked "has" in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAP"S) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i)ln a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1 )(i), (c)(1 )(ii), or (c)(1 )(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this proviSion, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(1 )(i) through (c)(1)(iv) of this provision in FAP"S as required through maintaining an active registration in the Central Contractor Registration database at http://www.ccr.gov (see 52.204-7).

REPRESENTATIONS. CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS ATTACHMENT 4

Page 40f9 http:http://www.ccr.gov

3. COST ACCOUNTING STANDARDS

(1) Cost Accounting Standards Notices and Certification (Oct 2008), FAR Provision 52.230-1

Note: This notice does notapply to small businesses or foreign governments. This notice is in three parts, identified by Roman numerals I through III.

Offerors shall examine each part and provide the requested information in order to determine CostAccounting Standards rCA S) requirements applicable to any resultant contract

If the offeror is an educational institution, Part II does not apply unless the contemplated contract will be subject to full or modified CAS-coverage pursuant to 48 CFR 9903.201- 2(C)(5) or 9903.201 2(c)(6), respectively.

I. Disclosure Statement -- Cost Accounting Practices and Certification

(a) Any contract in excess of $650,000 resulting from this solicitation will be subject to the requirements of the Cost Accounting Standards Board (48 CFR Chapter 99), except for those contracts which are exempt as specified in 9903.201-1.

(b) Any offeror submitting a proposal which, if accepted, will result in a contract subject to the requirements of 48 CFR Chapter 99 must, as a condition of contracting, submit a Disclosure Statement as required by 9903.202. When required, the Disclosure Statement must be submitted as a part of the offeror's proposal under this solicitation unless the offeror has already submitted a Disclosure Statement disclosing the practices used in connection with the pricing of this proposal. If an applicable Disclosure Statement has already been submitted, the offeror may satisfy the requirement for submission by providing the information requested in paragraph (c) of Part I of this provision.

CAUTION: In the absence of specific regulations or agreement, a practice disclosed in a Disclosure Statement shall not, by virtue of such disclosure, be deemed to be a proper, approved, or agreed-to practice for pricing proposals or accumulating and reporting contract performance cost data.

(c) Check the appropriate box below:

0(1) Certificate of Concurrent Submission of Disclosure Statement.

The offeror hereby certifies that, as part of the offer, copies of the Disclosure Statement have been submitted as follows:

(i) original and one copy to the cognizant Administrative Contracting Officer (ACO), or cognizant Federal agency official authorized to act in that capacity (Federal official), as applicable, and;

(ii) one copy to the cognizant Federal auditor.

(Disclosure must be on Form No. CASB DS-1 or CASB DS-2, as applicable .. Forms may be obtained from the cognizant ACO or Federal official and/or from the looseleaf version of the Federal Acquisition Regulation).

Date of Disclosure Statement: _________________

Name and Address of Cognizant ACO or Federal Official Where Filed:

The offeror further certifies that the practices used in estimating costs in pricing this proposal are consistent with the cost accounting practices disclosed in the Disclosure Statement.

REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS ATTACHMENT 4

Page 5 of9

ATIACHMENT 4

D (2) Certificate of Previously Submitted Disclosure Statement.

The offeror hereby certifies that the required Disclosure Statement was filed as follows:

Date of Disclosure Statement:

Name and Address of Cognizant ACO or Federal Official Where Filed:

The offeror further certifies that the practices used in estimating costs in pricing this proposal are consistent with the cost accounting practices disclosed in the applicable Disclosure Statement.

Certificate of Monetary Exemption.

The offeror hereby certifies that the offeror together with all divisions, subsidiaries, and affiliates under common control, did not receive net awards of negotiated prime contracts and subcontracts subject to CAS totaling more than $50 million or more in the cost accounting period immediately preceding the period in which this proposal was submitted. The offeror further certifies that if such status changes before an award resulting from this proposal, the offeror will advise the Contracting Officer immediately.

Certificate of Interim Exemption.

The offeror hereby certifies that:

(i) the offeror first exceeded the monetary exemption for disclosure, as defined in

(3) of this subsection, in the cost accounting period immediately preceding the period in which this offer was submitted, and

(ii) in accordance with 48 CFR 9903.202-1, the offeror is not yet…