000005.pdf

OMB No. 0990-0115

(x)

FDA-SOL-08-00653

x x

5 copies 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 ACKNOWLEDGEMENT 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 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 date specified.

x

ROCKVILLE MD 20857

DCSC

ROOM 2081, HFA-500

5630 FISHERS LANE

ATTN: Patricia Pemberton

DHHS/FDA/OAGS/DCSC

ROCKVILLE MD 20857

DCSC

ROOM 2081, HFA-500

5630 FISHERS LANE

ATTN: Patricia Pemberton

DHHS/FDA/OAGS/DCSC

06/18/2008000005

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

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

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

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

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

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

06/27/2008

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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

ORDER NO. IN ITEM 10A.

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

FDA Document Control Room Program

The purpose of this Amendment 000005 is to:

1. Incorporate a complete revision of Part E and F of solicitation FDA-SOL-08-00653.

2.Incorprate Response to questions.

3.Incorporate Document Control Room Pre-Proposal Attendees.

4.Incorporate Pre-Proposal Conference Transcript.

Continued ...

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

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

(Signature of person authorized to sign) (Signature of Contracting Officer)

PATRICIA D. PEMBERTON

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

NSN 7540-01-152-8070

Previous edition unusable

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.

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

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CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

FDA-SOL-08-00653/000005

5.Incorporate Critical Processing Time

Constraints.

6. Incorporate Document Control Room Pre-proposal

Conferences Slide Presentation.

7. Incorporate page 110 revision which ellminates the need for the Offerors to provide resumes for the entire Offeror staff. The revision identifies the key employees resumes is required.

Minimum Education: High School Diploma.

PERSONNEL AND RESUMES

Resumes shall be provided for each proposed individual to cover the labor resources required under the first year of the contract. The following additional number of resumes shall be submitted:

Labor Category

Resume(s) Required

Program manager

Yes

Project Team Manager

Yes

Project Team Supervisor

Yes

IT Technician-IV

Yes

Senior Task Leader provide (3)separate resumes

Offerors should take care to insure that resumes for proposed personnel clearly identity's the proposed candidate's pertinent qualification

(education and experience) required for the applicable labor category. Individuals whose resumes do not clearly show the required qualifications and availability will be considered unqualified and the proposed hours for that person will not be counted toward meeting the RFQ maximum resource requirements. Describe

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

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CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

FDA-SOL-08-00653/000005

current status and work assignment of each proposed person. A "Letter of Intent" to participate in the project, indicating the type of employment relationship, should be affixed to the resume of each person who is not a current full-time employee of the offeror or a proposed subcontractor. Resumes should be arranged in alphabetical order. A chart shall be provided which indicates the line item for which each individual is proposed.

The Contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person, and an alternate or alternates, who shall act for the

Contractor when the manager is absent, shall be designated in writing to the contracting officer.

All management staff proposed shall be identified as key and resumes provided.

Management staff is defined as Contractor staff having the autonomy and authority to provide guidance and direction to the Contractor staff and interact with CDER management. At a minimum, the contract manager and alternate will be designated as key staff.

The contract manager or alternate shall have full authority to act on behave of the Contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available during normal duty hours within 30 minutes to meet on the installation with government personnel

(designated by the project officer) to discuss problem areas.

After normal duty hours, the manager or alternate shall be available within one hour. The contract manager and alternate or alternates must be able to read, write, speak and understand English.

Contractor Personnel - The Contractor shall not employ persons for work on this contract if such employee is identified to the Contractor by the project officer as a potential threat to the health, safety, security, general well being or operational mission of the installation and its population. Contractor personnel shall present a neat appearance and be easily recognized as

Continued ...

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

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CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

FDA-SOL-08-00653/000005

Contractor employees. The FDA shall furnish an identifying badge, which shall include at a minimum the person?s name and photograph. Each employee shall wear the badge on the outer garments at all times.

The Contractor shall not employ any person who is an employee of the US Government if employing that person would create a conflict of interest.

The Contractor shall be required to provide preliminary security background checks for all proposed staff. Additionally, all Contractor staff must pass a preliminary FDA security background check prior to being assigned to the contract. Contract staff shall complete a SF 85

Form within 5 workdays upon assignment to contract.

8. Extend the closing date to July 2nd, 2008 at

3:30 pm ET

All other terms and conditions remains the same.

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)