N02CP11003-49 Amendment 2.pdf

OMB No 0990-0115

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 16

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

2 June 29, 2011 N/A

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

CODE N/A

National Institutes of Health National Cancer Institute Office of Acquisitions Executive Plaza South, Suite 600 6120 Executive Blvd, MSC 7193 Bethesda, Maryland 20892-7193

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) (4 ) 9A. AMENDMENT OF SOLICITATION NO.

TO ALL POTENTIAL OFFERORS

N02CP11003-49

9B. DATED (SEE ITEM 11)

June 29, 2011

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.

(4 ) 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: 1) To provide clarification to questions received by the deadline for questions, June 24, 2011, on RFP N02CP11003- 49, “Multidisciplinary Studies of Nutrition and Cancer” and subsequently revised Section 3.1 of Attachment 7, Additional Business Proposal Instructions and Section A.(1) of Attachment 6, Additional Technical Proposal Instructions.

Deadline for Questions: June 24, 2011; 4pm (EDT) (Unchanged) Proposal Due Date: July 14, 2011; 4pm (EDT) (Unchanged)

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)

Lisa Coleman Contracting Officer, ETSB Branch, NCI OA, NIH

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)

June 29, 2011

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

Solicitation N02CP11003-49; “Multidisciplinary Studies of Nutrition and Cancer” Page 1 of 4 Amendment #2 –Questions/Responses

Solicitation N02CP11003-49

“Multidisciplinary Studies of Nutrition and Cancer”

1. In Section 3.3 of Attachment 7 – Additional Business Proposal Instructions, bidders are asked to “assume monthly sample shipments per study (includes packaging of samples for shipment) and for payment of duties.” The RFP does not include information on monthly shipping volume (domestic and international) or the nature of the items to be shipped each month. Please provide these guidelines so that all bidders make the same assumptions in their submissions to the govt.

Answer to #1: Biospecimens such as blood, urine, feces, saliva, and tissue may be shipped from a study center to a designated biorepository. On average for all active studies, a monthly shipment of 2 boxes (approximately 14x12x12 size) of samples is expected. 70% of shipment is domestic ((17) boxes per contract year) and 30% is international ((7) boxes per contract year). Domestic applies to the US only.

Studies conducted outside of the US will send the biospecimens to the US or another designated country, in which case the monthly shipment will be considered 100% international.

2. The labor hours per year implied by the table in Section 3.1 on page one of Attachment 7 – Additional Business Proposal Instructions appear to be in disagreement with those specified in the table in Section 4B on page three of the same attachment. Should the table containing direct labor estimates group the estimated percent of effort for the increased services options in the same way as they are in the Section 4B table. That is, should the options be grouped 5-7, 8-10, 11-13, 14-16, and 17-19 so that the hours for the increased services option total 4,701 per year?

Answer to #2: Please see Attachment 6, Additional Technical Proposal Instructions and Attachment 7, Additional Business Proposal Instructions attached to Amendment #2 for revised direct labor estimate tables that now correlate with the option groupings in the Section 4B table in Attachment 7.

3. Can the government offer guidance on what projects are anticipated to occur in the contract base year and in options 1-4?

Answer to #3: The NIH-AARP Diet and Healthy study will be continued throughout the entire contracting years while others will start at different time. Multiple studies, at least 5 or more studies of various sizes are likely to be conducted in each contracting year.

4. Can the government offer guidance on the qualifications required, such as training, certification, degrees and years of work experience, for each of the following positions: Biospecimen expert, Physical activity expert, and Research nutritionist?

Answer to #4:

Biospecimen Specialist: Masters level or above

The Biospecimen Specialist should have at least 5 years of professional experience in:

1. laboratory analysis

2. the analysis and/or monitoring of analyses of specimens such as blood, urine, feces, saliva, etc

Solicitation N02CP11003-49; “Multidisciplinary Studies of Nutrition and Cancer” Page 2 of 4

3. the monitoring of biospecimen collection including, collection, tracking, analytic methods, transport, storage, quality control, standard procedures, and sample variation

Physical Activity Expert: Masters level or above

The Physical Activity Expert should have 5 years of experience in:

1. administration of multiple physical activity assessment methods, such as physical activity questionnaires, logs/records, and physical activity monitors

2. the use of activity measures and their appropriate modification for population surveys or epidemiologic research studies

3. the editing of responses to physical activity assessment methods, particularly for questionnaire and physical activity monitor data

4. the use of Compendium of Physical Activities in the analysis of physical activity questionnaires and physical activity logs/records

Research Nutritionist: Masters level or above

The Nutritionist should have at least 5 years of experience in:

1. administration of multiple dietary assessment instruments including food frequency questionnaires, the 24-hour recalls, and food records

2. the use of such instruments and their appropriate modification for population surveys or epidemiologic research studies

3. the editing of responses to dietary assessment instruments, particularly the food frequency questionnaires, the 24-hour recalls, and food records

4. the use of the national nutritional survey data and nutrient databases in the analysis of both 24-hour dietary recalls, food records, and food frequency questionnaires

5. On page 52 of the RFP, item 12 outlines the past performance information that offerors should provide as a part of the business proposal. IT reads, “Include the following information for each contract or subcontract listed:1) Name of Contracting Organization, 2) Contract Number (for subcontracts, provide the prime contract number and the subcontract number), 3) Contract Type,

4) Total Contract Value, 5) Description of Requirement, 6) Contracting Officer's Name and Telephone Number, 7) Program Manager's Name and Telephone Number, 8) North American Industry Classification System (NAICS) Code.” The information requested here is slightly different than the information requested in the business proposal instructions on page 88, item 10d which reads, “The listing should include: 1) the contract number; 2) contracting agency; 3) contract dollar value; 4) dates contract began and ended (or ends); 5) description of contract work; 6) explanation of relevance of work to this RFP; 7) actual delivery and cost performance versus delivery and cost agreed to in the contract(s). For award fee contracts, separately state in dollars the base fee and award fee available and the award fee actually received.” Can the government clarify what information should be provided on the performance of pertinent contracts?

Answer to #5: Please provide information for all seven (7) requirements listed in paragraph 10.d on page 88. Please address item 12 on page 52 and Item 10.d on page 88 individually despite that the requirements stipulated for each seem duplicative.

Solicitation N02CP11003-49; “Multidisciplinary Studies of Nutrition and Cancer” Page 3 of 4

6. Attachment 6, Additional Technical Proposal Instructions and Format indicates that the page limit is 75 pages. In Section D of these instructions, item 5 indicates that the offeror must include a draft Information System Security Plan (ISSP). May this be included as an SOP and therefore not count against the page limit of 75 pages or must it be included within the technical proposal and associated page limit?

Answer to #6: The draft Information System Security Plan (ISSP).shall be addressed in a separate section of the Technical Proposal and will not be included as part of the page count limitation for the Technical Proposal.

7. Likewise, may issues addressing Human Subjects, Obtaining and Disseminating Biomedical Research Resources and the Sharing Research Data be addressed as SOPs and therefore not count against the page limit of 75 pages?

Answer to #7: The section entitled “Human Subjects” shall be addressed in a separate section of the Technical Proposal and will not be included as part of the page count limitation for the Technical Proposal.

8. In Section L, on page 66, the section discussing Sharing Research Data is a subsection of Obtaining and Disseminating Biomedical Research Resources. May these topics be addressed together as one topic or must they be addressed as separate topics as outlined in Attachment 6?

Answer to #8: The sections Obtaining and Disseminating Biomedical Research Resources and Sharing Research Data shall be discussed as separate topics as outlined in Attachment 6, Additional Technical Proposal Instructions.

9. In Section L, on page 76, it is indicated that Section 508 Compliance information be included in the technical proposal. May this information be included as an SOP? Inclusion of this information is not addressed in Attachment 6 as part of the Technical Proposal Instructions and Format, but we want to make sure to meet this requirement.

Answer to #9: The section 508 Compliance information in Section L on page 76 shall be addressed in a separate section of the Technical Proposal and will not be included as part of the page count limitation for the Technical Proposal.

10. Attachment 6 indicates that a detailed technical plan must be submitted in the Offeror’s Technical Proposal indicating how each aspect of the Statement of Work is to be accomplished.

However, in the template outlined in the alphanumeric sections of Attachment 6, a section associated with a description of the Offeror’s technical approach is not included. Which of the following formats is recommended: 1) that the detailed technical plan be included as an additional section in the Technical Proposal (and count towards the page limit); 2) that the plan be included as part of Section B, Organizational Experience in Documenting and Simultaneously Managing Concurrent, Multiple, Large (Including International) Investigations As Described in This RFP (and count towards the page limit); or, 3) included as an SOP and not counted towards the page limit?

If you have a different recommendation, I would welcome that response as well.

Answer to #10: The detailed technical plan shall be included as an additional section in the Technical Proposal and will count towards its page limit.

Solicitation N02CP11003-49; “Multidisciplinary Studies of Nutrition and Cancer” Page 4 of 4

11.On page 15 and in Attachment 7, p. 3 of the RFP, the hours for each year include an amount for each base/term option and then three incremental amounts of hours for each incremental option within each year, described in five columns in total (for each of the potential contract years).

However, on Attachment 6, page 1 and Attachment 7, page 1, the percentage FTE is provided for the base/term option years and then percentage FTEs for four additional periods that include options 5-8 (three increments in year 1 and first increment of year 2, or 4 increments altogether), options 9-12 (last 2 increments in year 2 and first 2 increments in year 3, or 4 increments altogether), options 13-15 (last increment in year 3 and first 2 increments in year 4, or 3 increments altogether) and options 16-19 (last increment in year 4 and three increments in year 5, or 4 increments altogether). Should we apply the FTE percentages instead to reflect the incremental percentages listed as Options 5-7 (Base Year), Options 8-10 (Year 2), Options 11-13 (Year 3), Options 14-16 (Year 4) and Options 17-19 (Year 5) so that the FTE percentages match the increments of hours by year?

Answer to #11: Please see Attachment 6, Additional Technical Proposal Instructions and Attachment 7, Additional Business Proposal Instructions attached to Amendment #2 for revised direct labor estimate tables that now correlate with the option groupings in the Section 4B table in Attachment 7.

End of Solicitation N02CP11003-49 Amendment #2 –Questions/Responses

Attachment 6 – Additional Technical Proposal Instructions Page 1 of 7

RFP N02-CP-11003-49

Solicitation N02-CP-11003-49; “Multidisciplinary Studies of Nutrition and Cancer”

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS and FORMAT for:

TECHNICAL PROPOSAL – TABLE OF CONTENTS

THE BELOW TEMPLATE MUST BE USED AS THE TABLE OF CONTENTS FOR YOUR

TECHNICAL PROPOSAL AND ALL INFORMATION IN YOUR TECHNICAL PROPOSAL

SHOULD BE PRESENTED IN THE ORDER SPECIFIED BELOW.

OFFERORS ARE REMINDED THAT THE TOTAL PAGE LIMITATION FOR THE ENTIRE

TECHNICAL PROPOSAL PACKAGE IS (75) PAGES INCLUDING APPENDICES AND

ATTACHMENTS, BUT EXCLUDING KEY STANDARD OPERATING PROCEDURE (SOPs).

THESE ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS REFLECT THE

REQUIREMENTS OF THE RFP AND ARE MEANT TO PROVIDE A CLEAR UNDERSTANDING

OF THE INTENT OF THIS SOLICITATION.

OFFERORS ARE ADVISED TO GIVE CAREFUL CONSIDERATION TO THE STATEMENT OF

WORK, ALL REFERENCE MATERIAL PROVIDED AS APPENDICES AND ATTACHMENTS,

AND THE TECHNICAL EVALUATION CRITERIA IN THE DEVELOPMENT OF YOUR

PROPOSAL.

TECHNICAL PROPOSAL – TABLE OF CONTENTS

GENERAL NOTES:

1. All Offerors must adhere to the following page limitations:

a. TECHNICAL PROPOSAL: Not-to-exceed a total of (75) pages

b. APPENDICES AND ATTACHMENTS: Not-to-exceed (20) pages of the (75) total pages

2. A detailed technical plan must be submitted in the Offeror’s Technical Proposal indicating how each aspect of the Statement of Work (SOW) is to be accomplished. Your technical approach should be in as much detail as necessary to fully explain your proposed technical approach or method. The Technical Proposal should reflect a clear understanding of the nature of the work being undertaken.

3. It is recognized that a single institution may not have the expertise and facilities required to perform all requirements of the Statement of Work. Therefore, the Offeror may propose to subcontract a portion of the work. If a subcontractor is proposed, similar technical information must be provided in the Technical Proposal as that required for the Offeror, i.e., technical approach, methods, experience, personnel qualifications, facilities, resources, etc. The relationship between the proposed subcontractor and the Offeror must be clearly delineated.

Attachment 6 – Additional Technical Proposal Instructions Page 2 of 7

NEB seeks to establish a contract with an organization highly experienced in providing technical support services for both methodologic and substantive research projects in the nutritional epidemiology of cancer.

A. Experience, Capabilities, and Availability of Personnel

(1) Personnel The Government estimates that, as a baseline, the labor mix of the key personnel required to provide the level-of-effort required for this contract shall include approximately:

*Other field personnel as needed to fulfill the Statement of Work (interviewers, coders, phlebotomists and abstractors).

a) Project Director (Key Personnel)

Should have extensive experience with oversight of large, complex, interdisciplinary, international studies. A doctoral degree is not required. Previous experience with oversight of

Direct Labor Estimate

Estimated Percent of Effort for Base Year and Term

Years, Options 1-

Estimated Percent of Effort for Options 5-7 for

Increased Services

Estimated Percent of Effort for Options 8-10 for

Increased Services

Estimated Percent of Effort for Options 11-13 for Increased Services

Estimated Percent of Effort for Options 14-16 for Increased Services

Estimated Percent of Effort for Options 17-19 for Increased Services

Project Director 25% 15% 15% 15% 15% 15% Professional Support

Computer systems manager 10% 10% 10% 10% 10% 10% Computer programmer/analyst 10% 10% 10% 10% 10% 10%

Study manager 10% 25% 25% 25% 25% 25% Study manager 35% 35% 35% 35% 35% 35% Biospecimen specialist 5% 5% 5% 5% 5% 5% Web developer 3% 5% 5% 5% 5% 5% Statistician 3% N/A N/A N/A N/A N/A Research assistant 55% 80% 80% 80% 80% 80% Research nutritionist 5% 5% 5% 5% 5% 5% Physical activity expert 2% 5% 5% 5% 5% 5% Clinical study coordinator 3% 5% 5% 5% 5% 5% Nurse 1% N/A N/A N/A N/A N/A Senior Systems Analyst 5% 5% 5% 5% 5% 5% Technicians and Support

Medical technician 3% N/A N/A N/A N/A N/A Interviewer 3% N/A N/A N/A N/A N/A Data coding/entry 2% N/A N/A N/A N/A N/A Medical record abstractor 1% N/A N/A N/A N/A N/A Data manager 3% 10% 10% 10% 10% 10% SAS Programmer N/A 10% 10% 10% 10% 10%

Non-Professional & Support

Supporting staff * 10% 25% 25% 25% 25% 25%

Attachment 6 – Additional Technical Proposal Instructions Page 3 of 7

Solicitation N02-CP-11003-49; “Multidisciplinary Studies of Nutrition and Cancer” Amendment #2 –Questions/Responses large complex contracts is desirable. Demonstrated capability for providing the necessary expertise to conduct complex interdisciplinary studies with biospecimen collections. The Project Director shall have ultimate responsibility for overseeing the professional, epidemiological, administrative, budgetary, and personnel management of the Contract, as well as management of subcontracts. Experience is required in the conduct of studies that have involved multiple centers and non US centers. The Project Director should be experienced in: 1) supervising the conduct, management and maintenance of quality control of multiple epidemiologic studies being conducted simultaneously 2) training interviewers and abstractors; 3) coordinating other aspects of field studies such as obtaining cancer validation, death certificates and medical records; 4) tracing study subjects to conduct interviews and to determine vital status; 5) arranging for the collection and shipment of biologic samples ; 6) managing subcontracts; and 7) managing budgets and allocating resources and personnel to meet changing requirements. He/she may also function as a Senior Project Manager. A doctoral degree is neither requested nor required, but it is anticipated that the Senior Project Manager may have a Master’s degree in Public Health or Epidemiology or a Bachelor’s degree plus a substantial length and breadth of relevant experience.

b) Study Managers

Should have previous experience in managing clinical and/or interdisciplinary epidemiologic studies with biologic specimen collections. The Offeror should also be able to present a plan to meet the requirement of frequent face-to-face meetings with NCI personnel. Should be experienced in developing data management systems and relational databases to edit and monitor data acquisition and study progress for epidemiologic case-control and cohort studies. In addition, this person should be experienced in manipulating large and/or complex data sets for epidemiologic analysis.

c) Other Personnel

The Offeror should demonstrate the appropriate mix and experience of other personnel necessary to conduct simultaneous studies in different areas.

B. Organizational Experience in Documenting and Simultaneously Managing Concurrent, Multiple, Large (Including International) Investigations As Described In This RFP

(1) The Offeror should provide evidence of experience and successful completion of the following tasks:

a. Concurrent international and large prospective epidemiologic studies of cancer involving the collection of data and biologic specimens from subjects.

b. Link the information collected from subjects to deaths and/or medical diagnosis.

c. Internet based studies that recruit participants through web and collect data using online research tools.

(2) The Offeror should provide details of Q/A and Q/C approaches used in recent studies.

(3) The Offeror should provide examples of previous recent experience in recruiting study subjects from population-based and clinic-based surveys.

(4) The Offeror should provide evidence of capability for rapid response to request for initiating a new study to address urgent public health need.

(5) The Offeror must outline potential biohazard protection for employees and steps to be taken to minimize the risk.

Attachment 6 – Additional Technical Proposal Instructions Page 4 of 7

C. Managerial Approach

(1) The Offeror should describe corporate plans to use modifiable data management and tracking systems that can be applied across studies. Describe plans for limiting the number of datafiles and for managing, storing, and documenting large numbers of datafiles. Present an approach for insuring that files related to a single investigation are clearly linked to that investigation.

(2) The Offeror should describe a comprehensive corporate approach to minimizing errors in deliverables. Include in the description the measures that the Offeror intends to undertake to minimize errors and the policy on charges if work must be produced a second time, due to errors in the initial deliverables.

(3) The Offeror should provide the plan of where this project and the proposed team would be in the organizational structure of the corporation.

(4) The Offeror should provide examples of how they have developed cost-effective means of conducting tasks.

(5) The plan for monitoring the progress of subcontracted work.

(6) The approach to providing temporary support to meet increased personnel requirements for unexpected emergent demands.

(7) A management plan to retain key personnel.

(8) Frequent Face to Face Discussions:

The complex nature of our interdisciplinary epidemiologic studies requires that NCI scientists closely monitor activities to be able to make critical epidemiologic decisions. Frequent face-to-face discussions between the NCI COTR, the Project Director, and Study Managers are required to monitor and review the progress on project activities. Simultaneous conduct of widespread studies under this contract dictates that NCI researchers and Contract Study Managers be in close contact regarding the completion of study tasks. Failure to adequately monitor or coordinate study activities can compromise the scientific quality of a study. Studies conducted under this contract require in-person meetings on a nearly daily basis between NCI and Contractor staff to review study progress, plan new activities, and correct problems. Documents, forms, protocols, and descriptive statistics must be reviewed at these meetings. Since multiple studies may be underway at any point in time, meetings between some members of the NCI and Contractor staff will take place on a nearly daily basis.

The Offeror must demonstrate how it will accomplish the task of attendance at face-to-face discussions, on a nearly daily basis, between the NCI COTR and the Contractor’s Project Director and Study Managers in Rockville, Maryland, in order to monitor and review progress of project activities.

(9) Any agreements and/or arrangements with subcontractor(s). Provide as much detail as necessary to explain how the statement of work will be accomplished within this working relationship.

Attachment 6 – Additional Technical Proposal Instructions Page 5 of 7

Solicitation N02-CP-11003-49; “Multidisciplinary Studies of Nutrition and Cancer”

D.

Facilities and Equipment

(1) The Offeror should present information documenting the provision of a secure storage area for study materials.

(2) The Offeror should present a plan for the security of data processing and storage.

(3) The Offeror should provide evidence of telephone interviewing center capability and computer assisted interview capability.

(4) Equipment and unusual operating procedures established to protect personnel from hazards associated with this project.

(5) Draft Information System Security Plan:

The offeror must include a draft Information System Security Plan (ISSP) using the current template in Appendix A of NIST SP 800-18, Guide to Developing Security Plans for Federal Information Systems (http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf). The details contained in the offeror's draft ISSP must be commensurate with the size and complexity of the requirements of the SOW based on the System Categorization determined above in subparagraph (b) Security Categories and Levels.

Subcontracts: The offeror must include similar information for any proposed subcontractor that will perform under the SOW with the offeror whenever the submission of an ISSP is required.

Note to Offeror: The resultant contract will require the draft ISSP to be finalized in coordination with the Project Officer no later than 90 calendar days after contract award.

Also, a contractor is required to update and resubmit its ISSP to NIH every three years following award or when a major modification has been made to its internal system.

(6) Computer Facilities:

Although the Government anticipates that most work will be done on personal computers, the facilities of the National Institutes of Health (NIH), Division of Computer Information Technology (CIT) may be used for computer processing. If so, programmers shall access the CIT computer via remote terminals provided by the contractor. The current systems of programs use the NIH/CIT IBM and Convex systems, WYLBUR text-editor and SAS, including its graphics capability. The offeror must display either a working knowledge of these facilities or similar large computer systems, their high-level associated languages, interactive text-editing and graphics systems.

For protocols, data collection instruments, manuals, and all other documents that may need to be revised by NEB personnel, the Contractor shall use word processing and graphics software that is compatible with that in use in NEB.

E. Other Considerations

Attachment 6 – Additional Technical Proposal Instructions Page 6 of 7

Solicitation N02-CP-11003-49; “Multidisciplinary Studies of Nutrition and Cancer” Amendment #2 –Questions/Responses

Record and discuss specific factors not included elsewhere which support your proposal. Using specifically titled subparagraphs, items may include:

a) Unique arrangements, equipment, etc., which none or very few organizations are likely to have which is advantageous for effective implementation of this project.

b) Other factors you feel are important and support your proposal.

c) Recommendations for changing reporting requirements if such changes would be more compatible with the offeror's proposed schedules.

d) Discussion of Methods for Protection of Human Subjects:

Describe approach to protecting human subjects, including: 1) the circumstances under which informed consent is required; 2) policies governing review of protocols to assure protection of human subjects; and 3) plans to protect privacy and confidentiality of data from human subjects.

This research project involves human subjects. NIH Policy requires that women, members of minority groups and the subpopulations, and children must be included in the study population of research involving human subjects, unless a clear and compelling rationale and justification is provided with respect to the health of the subjects or the purpose of the research.

Where inclusion of women, children, and minorities is feasible, the offeror shall demonstrate how they will ensure that women and minorities are included in the study populations.

Where inclusion of women, children, and minority populations is not feasible, a detailed rationale and justification for exclusion of the group from the study population must be submitted with the technical proposal. The NCI will review the rationale to determine if it is appropriate with respect to the health of the subjects and/or the purpose of the research. If the rationale is not considered acceptable by the Government and the offeror is included in the competitive range, the offeror will be afforded the opportunity to further discuss and/or clarify their position during discussions or include women, children, and minorities in the Final Proposal Revision (FPR). If the exclusion position is still considered unacceptable by the Government after discussions, the proposal may not be considered further for award.

e) Obtaining and Disseminating Biomedical Research Resources:

As a public sponsor of biomedical research, the National Institutes of Health (NIH) has a dual interest in accelerating scientific discovery and facilitating product development. Intellectual property restrictions can stifle the broad dissemination of new discoveries and limit future avenues of research and product development. At the same time, reasonable restrictions on the dissemination of research tools are sometimes necessary to protect legitimate proprietary interests and to preserve incentives for commercial development. To assist NIH contractors achieve an appropriate balance, the NIH has provided guidance in the form of a two-part document, consisting of Principles setting forth the fundamental concepts and Guidelines that provide specific information to patent and license professionals and sponsored research administrators for implementation.

The purpose of these Principles and Guidelines is to assist NIH funding recipients in determining: 1) Reasonable terms and conditions for making NIH-funded research resources available to scientists in other institutions in the public and private sectors (disseminating research tools); and 2) Restrictions to accept as a condition of receiving access to research tools for use in NIH-funded research (acquiring

Attachment 6 – Additional Technical Proposal Instructions Page 7 of 7

Solicitation N02-CP-11003-49; “Multidisciplinary Studies of Nutrition and Cancer” Amendment #2 –Questions/Responses research tools). The intent is to help recipients ensure that the conditions they impose and accept on the transfer of research tools will facilitate further biomedical research, consistent with the requirements of the Bayh-Dole Act and NIH funding policy.

This policy, entitled, "Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts," (Federal Register Notice, December 23, 1999 [64 FR 72090] will be included in any contract awarded from this solicitation. It can be found at the following website: http://ott.od.nih.gov/NewPages/64FR72090.pdf.

f) Sharing Research Data:

Section L of the RFP specifies the minimum documentation requirements for Data Sharing. All related documentation should be included in the proposal in this clearly marked section. The Technical Proposal should include a plan for Data Sharing as required by this RFP. Information Technology (IT) Systems Security Section L of the RFP specifies the minimum documentation requirements for IT Systems security. All related documentation should be included in the Technical Proposal in this clearly marked section. The Technical Proposal should include a plan for IT Systems security as required by this RFP.

Attachment 7 – Additional Business Proposal Instructions Page 1 of 4

Solicitation N02-CP-11003-49; “Multidisciplinary Studies of Nutrition and Cancer”

Appendix 7. BUSINESS PROPOSAL INSTRUCTIONS

BUSINESS PROPOSAL – TABLE OF CONTENTS

SECTION 1 – PROPOSAL COVER SHEET (use form NIH 2043 identified in Section J)

SECTION 2 – COST OR PRICE SUPPORT

Section L of the RFP specifies the minimum documentation requirements for cost data and all cost related support. All related documentation should be included in the proposal in a clearly marked section.

SECTION 3 – UNIFORM COST ASSUMPTIONS

For proposal purposes, the offerer shall propose based on the following budget assumptions:

1) Labor: As a baseline, the labor mix required to provide the level-of-effort required for this contract shall include the following estimates:

Direct Labor Estimate

Estimated Percent of Effort for Base Year and Term

Years, Options 1-

Estimated Percent of Effort for Options 5-7 for

Increased Services

Estimated Percent of Effort for Options 8-10 for

Increased Services

Estimated Percent of Effort for Options 11-13 for Increased Services

Estimated Percent of Effort for Options 14-16 for Increased Services

Estimated Percent of Effort for Options 17-19 for Increased Services

Project Director 25% 15% 15% 15% 15% 15% Professional Support

Computer systems manager 10% 10% 10% 10% 10% 10% Computer programmer/analyst 10% 10% 10% 10% 10% 10%

Study manager 10% 25% 25% 25% 25% 25% Study manager 35% 35% 35% 35% 35% 35% Biospecimen specialist 5% 5% 5% 5% 5% 5% Web developer 3% 5% 5% 5% 5% 5% Statistician 3% N/A N/A N/A N/A N/A Research assistant 55% 80% 80% 80% 80% 80% Research nutritionist 5% 5% 5% 5% 5% 5% Physical activity expert 2% 5% 5% 5% 5% 5% Clinical study coordinator 3% 5% 5% 5% 5% 5% Nurse 1% N/A N/A N/A N/A N/A Senior Systems Analyst 5% 5% 5% 5% 5% 5% Technicians and Support

Medical technician 3% N/A N/A N/A N/A N/A

Attachment 7 – Additional Business Proposal Instructions Page 2 of 4

*Other field personnel as needed to fulfill the Statement of Work (interviewers, coders, phlebotomists and abstractors).

2) Travel and Meetings

The following General Cost Assumptions apply to travel:

a. Assume all airfare to be economy class.

b. Assume two days of travel time for travel destinations outside of the traveler’s country of origin.

c. Assume hotel and per diem at U.S. government rates for the applicable city/location.

Specific Activity Cost Assumptions

1. Weekly Progress Status

Teleconferences During the active phase of study (less than 15 participants per call).

2. Contract Initiation Meeting One (1) 1-day Contract Initiation Meeting at the Contractor’s site within four (4) weeks of the effective date of the contract; to be attended by three (3) Contractor staff.

3. Initial Contract Transition Meetings Two (2) 2-day Initial Contract Transition Meetings with incumbent Contractor, to be held at the offices of NCI in Bethesda, MD within six (6) weeks of the effective date of the contract; to be attended by 3 Contractor staff.

3) Special Shipping and Packaging

Please assume monthly sample shipments per study (includes packaging of samples for shipment) and for payment of duties.

4) Materials and Supplies

Interviewer 3% N/A N/A N/A N/A N/A Data coding/entry 2% N/A N/A N/A N/A N/A Medical record abstractor 1% N/A N/A N/A N/A N/A Data manager 3% 10% 10% 10% 10% 10% SAS Programmer N/A 10% 10% 10% 10% 10%

Non-Professional & Support

Supporting staff * 10% 25% 25% 25% 25% 25%

Attachment 7 – Additional Business Proposal Instructions Page 3 of 4

Solicitation N02-CP-11003-49; “Multidisciplinary Studies of Nutrition and Cancer” Amendment #2 –Questions/Responses

Please assume, for proposal purposes, an annual cost of $10,000 for materials and supplies to support the performance of the Statement of Work, e.g. such as printing medical record abstract forms and questionnaires.

5) Government Furnished Equipment (GFE)

Government Furnished Equipment available to be transferred from incumbent contractor.

The purchase of Government Furnished Equipment will not be authorized as a direct charge under this contract without the prior written approval of the Contracting Officer.

SECTION 4 – OPTIONS

Offerors are requested to submit cost estimates for each Option.

As stated in the Statement of Work, in addition to the functions and services to be provided for in the Base period, the Government may exercise, at its discretion, Options for additional level of effort as follows: (1) Options to extend the term of the contract, (2) Options to accommodate significant increases in work:

A. Options 1 through 4: Extension of Term of Performance If the Government elects to exercise these Options to extend the period of the contract beyond the base period, assume that the scope and types of activities as outlined herein (i.e., for year one of the contract) would be continued for each succeeding annual contract period up to 5 total years.

B. Options 5 through 19: Increase In Service The Government may elect to exercise these Options to increase the level of effort to accommodate Program’s increased demand for more scope and types of activities as outlined herein.

Contract Base Year

Contract Year 2

Contract Year 3

Contract Year 4

Contract Year 5

Total

Base Year 3,647 hrs Option 1, Term 3,647 hrs Option 2, Term 3,647 hrs Option 3, Term 3,647 hrs Option 4, Term 3,647 hrs Option 5, Incr. Serv. 1,567 hrs Option 6, Incr. Serv. 1,567 hrs Option 7, Incr. Serv. 1,567 hrs Option 8, Incr. Serv. 1,567 hrs Option 9, Incr. Serv. 1,567 hrs Option 10, Incr. Serv. 1,567 hrs Option 11, Incr. Serv. 1,567 hrs Option 12, Incr. Serv. 1,567 hrs Option 13, Incr. Serv. 1,567 hrs Option 14, Incr. Serv. 1,567 hrs Option 15, Incr. Serv. 1,567 hrs

Attachment 7 – Additional Business Proposal Instructions Page 4 of 4

Solicitation N02-CP-11003-49; “Multidisciplinary Studies of Nutrition and Cancer” Amendment #2 –Questions/Responses

Option 16, Incr. Serv. 1,567 hrs Option 17, Incr. Serv. 1,567 hrs Option 18, Incr. Serv. 1,567 hrs Option 19, Incr. Serv. 1,567 hrs

Total 8,348 hrs 8,348 hrs 8,348 hrs 8,348 hrs 8,348 hrs 41,740 hrs

SECTION 5 - TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED

UNDER SECTION L OF THE SOLICITATION

1) Small Business Subcontracting Plan

Section L of the RFP specifies the minimum documentation requirements for completing a subcontracting plan. This plan should be turned in with the original proposal. All related documentation should be included in the proposal in a clearly marked section.

2) Extent of Small Disadvantaged Business Participation

Section L of the RFP specifies the minimum documentation requirements for small disadvantaged business utilization. This information should be turned in with the original proposal. All related documentation should be included in the proposal in a clearly marked section.

3) Past Performance Data, including references

Section L of the RFP specifies the minimum documentation requirements for providing past performance information. This information should be turned in with the original proposal. All related documentation should be included in the proposal in a clearly marked section.