Amendment 1.pdf

OMB No 0990-0115

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1 2

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

1 April 7, 2009

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE N/A Office of Acquisitions NICHD, Contracts Management Branch National Institute of Health Executive Building, Suite 7A07 6100 Executive Blvd MSC 7510 Bethesda MD 20892-7510

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

NIH-NICHD-CDBPM-09-11

9B. DATED (SEE ITEM 11)

March 27, 2009

10A. MODIFICATION OF CONTRACT/ORDER NO.

TO ALL POTENTIAL OFFERORS

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.

(�) 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 copy to the issuing office.

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

PURPOSE: To provide further clarifications to questions submitted by potential Offerors

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.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Seena Mathews Contracting Officer, NICHD, CMB

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY ______________________/S/_______________________

(Signature of Contracting Officer)

04/7/09

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

FAR (48 CFR) 53.243

NIH-NICHD-CDBPM-09-11

Amendment 1

The following clarifications are provided as a response to questions submitted by the public to the above referenced Request for Proposal for the benefit of all potential Offerors. No further questions will be entertained after April 20, 2009.

1. Is there a dollar limit for subcontracts?

Answer: There is no dollar limit for subcontracts.

Questions for Option 5:

2. Besides isolating DNA and RNA for integrity studies, should we address the potential of isolating sufficient DNA and RNA from tissue in the Bank for distribution?

Answer: It is highly encouraged to address isolating DNA and RNA for integrity studies and for distribution purposes. The highest priority would be for creation of an adequate, high-quality stock sample of DNA from a portion of brain (or other tissue) that could be used for genotyping or other DNA-based testing purposes. It would be impractical to request RNA isolation from all potentially relevant areas of brain (or other tissue) since the RNA needs for any particular tissue cannot be anticipated. However, sampling of several brain regions (or other tissues) for RNA extraction and documentation of its integrity (RIN or other means) to ensure that it is of high quality would be desirable.

3. Elaborate on the term “protein quality”.

Answer: The government is looking for measures of objective tissue and specimen integrity. A description of a range of objective integrity measures for both protein quality and molecular characterization is encouraged. For example, it would be helpful to provide a basic level for general documentation purposes with capabilities to perform an increased level of testing and objective documentation depending on the needs of investigators.

4. Elaborate on the term “molecular characterization”.

Answer: For some samples, there may be the need to confirm the diagnosis via molecular means (e.g., array CGH for copy number variants, DNA-based testing such as Fragile X repeat length, etc.). While this should not be a requirement for all samples, the capacity to do this testing under such special circumstances (or to identify an appropriate molecular laboratory that would do such testing) would be highly desirable. The ability to perform such molecular testing would be predicated on having high quality DNA, as described above.

5. Does the term “accurate neuroanatomic mapping” refer to qualification of staff to identify specific brain regions being requested by researchers or does it refer to some specific procedure?

Answer: The government is looking for a protocol/procedure that the staff uses to identify specific brain regions.

The contractor must be able to assure (using such a protocol) that his or her staff can accomplish this task reproducibly, and can record and catalogue the various regions in a manner useful for investigators.