AMEND 01 RFP 11-152 FINAL DML NOV 22 2011.pdf

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 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 DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your 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 date specified.

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

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

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

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION

NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

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.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM ONLY APPLIES TO MODIFICATION 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)

Except as 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.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

Suzanne K. Stinson

PURPOSE OF AMENDMENT:

1. Provide replacement Task Order 1.

2. Provide answers to questions received.

National Institutes of Health NIMH/NIA R&D Contracts Management Branch Office of Acquisitions, Neuroscience 6001 Executive Blvd, Rm 8154 (MSC 9661) Bethesda, MD 20892-9661

TO ALL OFFERORS

HHS-NIH-NIDA-(AG)-11-152

1 1

11/22/2011

10/07/2011

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

AMENDMENT 01: QUESTIONS AND ANSWERS

“Development and Maintenance of a Multigenotypic Caloric Restricted Rodent Colony”

MEMORANDUM TO ALL POTENTIAL OFFERORS

1. Q: Does fortified diet need to be refrigerated? (SOW requires temp & humidity control but no specs). Do we need to order refrigerators for each barrier?

A: The food does not need to be stored in a refrigerator. The temperature and humidity control requirements are the same as in the barriers.

2. Q: Is there a preferred vendor for the special feed?

A: NO

3. Q: Could an example of the documentation to be supplied by the COTR on the amount of feed to be fed to the CR animals at each week of age be provided?

A: Attached

4. Q: Could alternative services be required - i.e., surgery in CR and/or AL animals?

A: Such services are not usually required by our customers using caloric restricted animals and are not part of this contract. When a customer requests a surgical procedure on animals purchased from the NIA colonies, the purchase of the animals is a separate transaction from the request to the Contractor to perform the special service. The Contractor bills the cost of the special services directly to the customer. The ability to perform surgical procedures or other special services is not required to submit a proposal to this contract RFP.

5. Please confirm that rats will be entered into the aging colony at levels defined in the contract Statement of Work (SOW), currently a total of 1260 animals/year.

For example, please clarify the following items in the solicitation:

� Attachment 3 Task Area 3 #9. The note to offerors regarding genetic quality control ask to provide details procedures to demonstrate the ability to differentiate between rat strains however, there is no listing of rat strains to be used for this project. Please provide strain information.

� According to attachment 9 SOW Task Area 1 there are references to rat requirements with the performance beginning at the time of contract award

� Attachment 9 Task Order 1 category 2C refers to Table 2 in Task Area 3a of the SOW for the number of breeding rats to be maintained. Table 2 only lists mice strains and not rat strains.

� Attachment 9 category 2F references SOW Task Area 4a and a change in wording from "rodent" to "rat"

� Attachment 9 category 2H makes reference to SOW Task Area 3k. "K" has two entries i.e.

H,I,J,K,K,L

� Attachment 10 Task Area 2 category 2C of the SOW refers to the addition of rats to the aging colony beginning at the end of year 1 at a rate that is not listed in Table 2 of SOW Task area 3a

� Attachment 10 Task Area 2 category 2F refers to a change from "Rodents" to "Rats" in SOW Task Area 4a

� Attachment 10 Task Area 2 category 2H indicates the need of breeder rats for testing and refers to SOW Task Area 3k(?)

� Attachment 10 Task Area 2 category 3G notes the routine monitoring of rats and under Task Area 2 this begins at the end of year 1

� Attachment 10 Task Area 2 category 3K5 references the shipment of rats and refers to SOW Task Areas 6b and 6c. I believe 3K5 should reference Task Area 8b and 8c on attachment 3.

� Attachment 10 Task Area 2 category 3M begins with the collection of payments for rats but changes and lists prices for mice.

� Attachment 11 Task Area 3 category 3C notes a requirement for rats and refers to table 2 in Task 3a. Rat strain information isn't listed.

� Attachment 11 Task Area 3 category 3G indicates a need for 60 rats for monitoring at the end of year 2

� Attachment 11 Task Area 3 category 3 has 2 tasks both noted as "K" � Attachment 11 Task Area 3 category 3L begins with the collection of payments for rats but changes and lists prices for mice.

A: For “Attachment 3 Task Area 3 #9. The note to offerors regarding genetic quality control ask to provide details procedures to demonstrate the ability to differentiate between rat strains…”, this is indeed a typo, it should say mouse strains. The offerors only need to address the genetic quality assurance for the mouse strains listed in Task Area 3, section A.

The proposal for the Sample Task Order One should address only the strains listed in the SOW Task Area 3. A revised Task Order One is attached to this amendment.

Please use the attached Task Order One instead of the one issued with the solicitation.

6. Q: The solicitation clearly states that work will be performed on two lines of mice, C57BLl6 and B6D2Fl; however, there are several places in the SOW where rats are mentioned too. Could you let me know if the work will indeed include both mice and rats, and if so, which rat strains will be used?

A: At award, it is currently anticipated that a task order will be issued for two strains of mice in the new colony. However, the SOW is written to allow the addition of other strains, including rats, should the need arise in the future.

7. Q: Can we bid on the mouse portion only? Will you award the mouse portion as a standalone?

A:.At this time Offerors are only required to address the two mouse strains indicated in the SOW Task Area 3.

Attachment�9:�Proposed�Contract�Task�Order�One�

Contract:�Development�and�Maintenance�of�a�Multigenotypic�Caloric�Restricted�Rodent�Colony��

RFP:�No.�HHS�NIH�NIDA(AG)�RFP�11�152�

Task�Order�Number:�01�Modification�Number:�n/a� Date�Prepared:�March�2011�

PART I. INITIATOR'S REQUEST

I. Period of Performance: Twelve (12) months, awarded at time of contract award

II. Task Order 1 Description

[References in parentheses at the end of each paragraph refer to the section of the Statement of Work addressing the particular work in the Task.]

Category 1. Acquisition and Re-derivation of Foundation Stocks for Two (2) Inbred Strains of Laboratory Mice.

The Contractor shall:

A. Within 60 calendar days of the start date of the contract, the Contractor shall acquire the genotypes (foundation stock) described herein and as directed by the Contracting Officer’s Technical Representative (COTR). Alterations in the genotypes entered require the specific written approval of the Contracting Officer. The two genotypes are C57BL/6 and DBA/2. (SOW Task Area 2.b)

B. The foundation stock shall be re-derived by caesarean re-derivation or embryo transfer.

Discrete space within the re-derivation area shall be provided for re-derivation of the mice. No other animals shall be housed within an isolator housing the mice from this contract, other than this contract’s animals and foster mothers. The animals shall remain in the isolators until transfer to the barriers for development of the breeding colonies. Foster mothers shall be of a strain that is easily distinguished from the subject genotype by color and/or genetic markers. The choice of strains(s) to be used for foster mothers shall require approval from the COTR. Use of foster mothers with different coat color is preferred when possible. (SOW Task Area 2.b)

C. The Contractor shall provide to the COTR documentation of the health status and genetic purity of the re-derived stock within 120 calendar days after the birth of the re-derived litters. (SOW Task Area 2.d)

D. Reporting Requirements - The Contractor shall provide to the COTR a report documenting the health status and genetic purity of the re-derived foundation stock within 120 calendar days after the birth of the re-derived litters. (SOW Task Area 7.a)

Category 2. Development and Maintenance of the Breeding Colonies.

The Contractor shall:

A. After the foundation stock animals for each colony segment have been re-derived, they shall be entered from isolators into the barrier system without contamination by pathogens or parasites, and shall be maintained as such. The Contractor shall provide discrete production space for each breeding colony segment within the barrier or isolation area for that segment. The barrier system or isolation room shall be operated and constructed to effectively exclude pathogens, ecto-, endo-parasites as well as vermin. Personnel shall follow the sanitary and/or sterile practices and techniques that have been established for the maintenance of barrier-sustained animals as described in the ILAR "Guide for the Care and Use of Laboratory Animals". Environment and barriers shall be maintained as described in Task Areas 1.a., 1.b., 5.c. and 5.d. of the SOW.

(SOW Task Areas 3.b., 3.g., 6.a., 6.b., 6.c., and 6.d.)

B. All offspring, whether part of the breeding colony or the aging colony, shall be considered Government owned property. Animals shall be removed from the barrier only for shipment to investigators, for monitoring of genetic purity or colony health or for other purposes as directed by the COTR. In both colony segments no other types of animals and no other types of activity other than that defined in the work-scope shall be permitted in the barrier rooms used to rear and maintain the genotypes specified. (SOW Task Area 1.b., 2.a., 4.c., 3.b.)

C. The numbers of breeding animals to be maintained shall be at levels that permit the addition of male and female weanling animals to the aging colony at the rates listed in the Table 2 in Task Area 3.a. of the SOW.

D. Breeding and recording of pedigrees of animals shall conform to the standards established for laboratory rodent strains by the Institute for Laboratory Animal Resources (ILAR) "Guide for the Care and Use of Laboratory Animals" (http://www.nap.edu/books/0309053773/html/index.html). Records of date of birth, health, breeding, environment, and colony monitoring shall be maintained by the Contractor. (SOW Task Areas 3.d. and 3.g.)

E. Litters larger than 10 shall have the smallest pups culled within 5 calendar 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. (SOW Task Area 3.e.)

F. Rodents shall be weaned at three to four (3-4) weeks of age and entered into the aging colony. (SOW Task Area 4.a.)

G. Mating, isolation, and primary enclosures shall meet or exceed minimum floor space requirements per animal, and population size per cage as stated in the ILAR "Guide for the Care and Use of Laboratory Animals". Mating cages shall be numbered consecutively. (SOW Task Area 3.f.)

H. The Contractor shall provide for semi-annual positive assurance of genetic quality control, including histocompatibility antigen and/or micro-satellite testing of a sample of breeder animals of each genotype to detect genetic contamination. Results of semiannual genetic monitoring of the breeding colonies shall be reported to the COTR no later than 60 calendar days from the date the animals were submitted for evaluation.

(SOW Task Area 3.k.)

I. Upon obtaining pathologic or other evidence that a barrier has been breached, the Contractor shall notify the COTR and the Contracting Officer by telephone and/or email within four (4) hours of discovery of the breach. The Contracting Officer shall arrange a teleconference or meeting of the Contractor's representative, the COTR, and the Contracting Officer as soon as practicable, 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. Final determination of the appropriate course of action will be made by the COTR. Potentially affected investigators shall be notified by written notice approved by the COTR. (SOW Task Area 7.f.)

J. Reporting requirements - Results of semiannual genetic monitoring of the breeding colonies shall be reported to the COTR no later than 60 calendar days from the date the animals were submitted for evaluation. (SOW Task Area 10.e.)

K. PART II. CONTRACTOR'S RESPONSE TO TASK ORDER REQUEST

(The Contractor may attach additional sheets to this form to present requested data.)

A. Estimated Cost and Effort – See Attached

1. Labor hours - list T.O. leader, specific individuals to be assigned, labor category, and estimated hours for each.

2. Labor costs - list by labor category and total.

3. Direct materials

4. Travel

5. Subcontracts

6. Other direct costs

7. Indirect costs

8. Fee

9. Total estimated costs and fee for this Order

B. Detailed description of the approach to be used and of the deliverable(s). (Be specific.)

*APPROVAL TO PROCEED: The Contractor shall not exceed the estimated T.O. amount or change the T.O. leader without the prior written approval of the Contracting Officer’s Technical Representative and the Contracting Officer.