Amendment 1 to NHLBI-PB-(EB)-2009-206-TK.doc

National Institute of Biomedical Imaging and Bioengineering (NIBIB) and National Institute of Environmental and Health Sciences (NIEHS)

REQUEST FOR PROPOSAL NUMBER NHLBI-PB-(EB)-2009-206-TK

TITLED: RECOVERY - Development and Launch of an Interoperable and Curated Nanomaterial Registry

AMENDMENT NO. 1

DATE OF ISSUANCE: September 18, 2009 SEQ CHAPTER \h \r 1The above numbered solicitation is amended as set forth below. The hour and the date specified for receipt of proposals remains unchanged. Offerors must acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by one of the following methods:

I. By acknowledging receipt of this amendment on each copy of the proposal submitted. Please note that this is the preferred method.

II. By separate letter or email which includes a reference to the solicitation and amendment number.

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF PROPOSALS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR PROPOSAL. If by virtue of this amendment you desire to change a proposal already submitted, such change may be made by letter, provided each letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

This amendment revises the RFP as stated below.

1.

SECTION C, ARTICLE C.2. REPORTING REQUIREMENTS, paragraph a. Technical Progress Reports, Item 1. Program Plan Report is hereby renamed Program Plan.

2.

SECTION C, ARTICLE C.2. REPORTING REQUIREMENTS, paragraph c. Web-based Registry Software Deliverable, is hereby revised to add the HHS Section 508 Product Assessment Template to the reporting requirements and shall read as follows:

“The contractor shall provide the following web-based registry software and related document deliverables. The registry website, database and software shall be hosted and operated at the contractor's facility during the period of performance.

In the initial development and implementation phase, the contractor shall release a prototype within one year after the contract award. A first version of a full functional registry shall be publicly-released 18 months after the contract award . After the first full functional release, two releases should be planned each year for enhancements and upgrades.

The contractor shall provide the following web-based registry software deliverables to the Contracting Officer's Technical Representative (COTR) during the initial development and implementation phase and in each subsequent release:

• Web-based registry software

Software source code and executable (hosted and operated at the contractor's facility during the period of the contract)

Installation guide

User guide

• Curated content (stored in the registry database)

• Website and user interface design specifications (intended for initial phase. It may need to modify in each subsequent release)

• Database and system architecture of the registry (intended for initial phase. It may need to modify in each subsequent release)

• Use cases document

• Design document

• Software performance evaluation matrix. The contractor shall develop a registry software performance evaluation matrix for major functions of the registry as defined in the technical requirements and specifications in section 1.3.1. The software performance evaluation shall be submitted to the NIH as part of the combined technical and software performance report.

• Registry release and functionality testing report

• Technical requirements and specifications compliance report

• Web content specifications and development report

• HHS Section 508 Product Assessment Template. The contractor shall prepare the HHS Section 508 Product Assessment Template, in accordance with its completion instructions, and provide a binding statement of conformance. The purpose of the template is to assist HHS acquisition and program officials in determining that EIT products and services proposed support applicable Section 508 accessibility standards. The template allows vendors or developers to self-evaluate their products or services and document in detail how they door do not conform to a specific Section 508 standard. Instructions for preparing the HHS Section 508 Product Assessment Template may be found at http://508.hhs.gov. The template will be submitted with the Web-based Registry Software – Prototype.

3.

SECTION F, ARTICLE F.2. DELIVERIES, paragraph a. Technical Progress Reports Delivery Schedule, Item 1. Program Plan Report has been renamed Program Plan.

4.

SECTION F, ARTICLE F.2. DELIVERIES, paragraph c. Web-based Registry Software Deliverables and Delivery Schedule, Item 1. Web-based Registry Software – Prototype is hereby revised to add the HHS Section 508 Product Assessment Template and shall read as follows:

Description

Quantity

*Delivery Schedule

1. Web-based registry software – Prototype includes the Section 508 Template.

Due the 15th calendar day after the end of the 12th month

* Delivery times are relative to the start date of the contract.

5.

SECTION L, PART 1. GENERAL INFORMATION, subparagraph d. ESTIMATE OF EFFORT is hereby revised to read as follows:

“It is expected that a completion type contract will be awarded as a result of this RFP. To assist you in the preparation of your proposal, the Government considers the effort to be approximately 5.5 Full Time Equivalents (FTEs) annually for the Base Period and each Option Period. This information is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes.”

6.

SECTION L, PART 2. INSTRUCTIONS TO OFFERORS, Item a. GENERAL INSTRUCTIONS, subparagraph 14. Electronic and Information Technology Accessibility, HHSAR 352.270-19(a) (January 2008), the HHS Section 508 Product Assessment Template is not required to be submitted with the proposal. The template shall be submitted with the Web-based Registry Software – Prototype.

7.

SECTION L, PART 2. INSTRUCTIONS TO OFFERORS, Item a. GENERAL INSTRUCTIONS, subparagraph 5. Page and Formatting Limitations is revised to delete the substudy proposal and replace it with program plan. Page and Formatting Limitations shall read as follows:

“The Technical Plan (objectives, approach, methods and procedures, and program plan) of the technical proposal shall not exceed 30 single-sided pages or 15 double-sided pages. This page limitation does not include the cover sheet, abstract, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, and literature cited. The program plan is included within the 30 page limit. Appendices shall not exceed a total of 50 single-sided pages or 25 double-sided pages. Pages in excess of the limitation will be deleted and will be neither read nor evaluated. Each page of the technical proposal must be numbered sequentially. Offerors are encouraged to limit the overall size of the technical proposal, inclusive of appendices, attachments, etc. Although no page limit has been placed on the business proposal, offerors are encouraged to limit its content to only those documents necessary to provide adequate support for the proposed costs.

Type density and size must be 10 to 12 points. If constant spacing is used, 15 cpi (characters per inch) or fewer shall be used, whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch. Margins must be no less than ½ inch around, exclusive of headers and footers.”

8.

SECTION L, PART 2. INSTRUCTIONS TO OFFERORS, Item b. TECHNICAL PROPOSAL INSTRUCTIONS, subparagraph 4. Obtaining and Disseminating Biomedical Research Resources is revised to delete subparagraph

a. Sharing Research Data in its entirety.

9.

SECTION L, PART 2. INSTRUCTIONS TO OFFERORS, Item b. TECHNICAL PROPOSAL INSTRUCTIONS, subparagraph 6. ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS, subparagraphs 1, 2, 3, and 4 are revised to correct the referenced Sections of the Statement of Work (SOW). The SOW sections shall read as:

1. The contractor shall develop a program plan as part of the proposal see Section 1.3.1 item a. of the SOW.

2. There are challenges, barriers, and tensions associated with attempts at collaboration with ongoing efforts for development of the MIAN and ontology, and with nurturing and sustaining them these collaborations. The contractor shall identify them and provide solutions and approaches to mitigate them in the proposal see Section 1.3.2 item d. of the SOW.

3. A high level architecture diagram of the Nanomaterials Registry should be included in the proposal see Section 1.3.3 of the SOW.

4. The contractor shall develop a plan and rationale for selecting the data sources to be curated as part of the proposal see Section 1.3.4 of the SOW.

The attached Questions and Answers are provided as clarifications:

1. Page 1 of SOW Attachment 3 and page 7 of RFP.

Would the government please clarify who has the final approval authority on the criteria for gold, silver and bronze compliance (the advisory panel, the government or somebody else)?

A: This has been stated in the section 1.3.2, e) of SOW (page 4 of SOW). Please see the reproduced text below.

e) The contractor shall develop the MIAN and ontology for nanomaterials used in the registry. The contractor shall develop, with the NIH and the advisory board approval, the following documents for the registry based on the collaborative community effort described in the above section:

· MIAN

· Ontology

· the evaluation criteria and level of compliance (gold, silver and bronze) for curated nanomaterial data

· curation process

· the nanomaterial identification and matching system for identifying same nanomaterials in different databases

In addition, to what is stated above, the advisory board will review and approve the criteria compliance first, and then the NIH will review and approve them. The advisory board should be composed of representatives from the community.

2. Page 42 The government has provided an estimated level of effort of 5.5 FTE. Please clarify is this an annual estimated level of effort?

A: The Government considers the effort to be approximately 5.5 Full Time Equivalents (FTEs) annually for the Base Period and each Option Period. This information is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes. See Item 5 of Amendment 1.

3. Page 2-3 of SOW Attachment 3 Is there any software that the government would prefer to be used?

A:

Please refer to section “1.3.3 Section 3: Development of a Nanomaterial Registry” of SOW for details. There is no preferred software. The software needs to meet all the technical requirements specified in this section of SOW.

4. Page 44.

There is mention of a substudy to be included in the page limit. There was no reference in the SOW to a substudy. Please clarify the intent.

A: There is no substudy and it has been replaced with the program plan in the Page and Formatting Limitations instructions. Please see Item 7 of Amendment 1 for the revision.

5. Page 5 – Article C.2. REPORTING REQUIREMENTS – a. Technical Progress Reports –Item 1: The “Quarterly”, “Annually”, and “Final” checkboxes have been “checked” and then 11 different reports have been specified and described with each report having a frequency/timeline specified.

a. This is to request clarification that the individual frequency/timeline specified under each report is the correct frequency timeline and that the “checkboxes” are a generalization across all of the reports described.

A: This is correct. Please see Articles C.2. REPORTING REQUIREMENTS and

F.2. DELIVERIES of the solicitation for the delivery schedule.

b. Will the government provide templates for these reports for the respondents review?

A: No, the Government will not provide templates for these reports.

6. Page 6 - Article C.2. REPORTING REQUIREMENTS – a. Technical Progress Reports – Item 1 (Second one) Program Plan Report:

a. Is this report/deliverable the “same” as the draft Program Plan that is requested to be provided with the proposal – referenced on page 55 of the solicitation under “ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS”?

A: They are the same document however the Program Plan will be submitted as a part of the proposal and a final Program Plan will be due 30 days after contract award. As the work performed under the contract progresses the Program Plan may need to be updated and shall be submitted annually to reflect any changes that may have occurred during the reporting period.

b. Is the Program Plan the same as the Technical Plan that is referenced on page 44 – under GENERAL INSTRUCTIONS – INTRODUCTION – 5. Page and Formatting Limitations?

A: No, the Program Plan is not the same as the Technical Plan. The program plan is part of the technical plan. In accordance with Item 7 in Amendment 1, the Technical Plan consists of objectives, approach, methods and procedures, and the program plan.

c. Is the Program Plan the same as the work plan that is requested on page 48 in the first paragraph under TECHNICAL PROPOSAL INSTRUCTIONS?

A: No, the “work plan” on page 48 is not the same as the technical plan, of which the program plan is a part of.

7. Page 6 - Article C.2. REPORTING REQUIREMENTS – a. Technical Progress Reports – Item 1 (Second one) Program Plan Report:

Please provide guidance on the use of one page charts within the Program Plan report (also reference on page 4 of 10 of the SOW). Is it anticipated that each proposed activity will be represented by a single “chart” with the following information: Task description, method/timeline for achieving the task, etc. Is it expected that the order of the charts will represent (in general) the order/sequence of activities?

A: The utilization of one page charts are encouraged whenever possible but are not required. Multiple activities could be, but is not required to be, represented by one chart. The purpose for recommending the utilization of one page charts is for simple presentation and easy understanding. The offeror should determine the logical order/sequence of the charts.

8. Page 7 - Article C.2. REPORTING REQUIREMENTS – a. Technical Progress Reports – Item 8 Annual Web system Usage Tracking Report.

a. It was requested that the number of registered users will be provided in this report – is there a requirement that users of the system be registered with the system or is the system to be generally available to anybody in the public?

A: The data and information that is curated in nanomaterial registry is expected to be generally available to anybody in the public. It also encourages users to register as registered users (please see question 18 for cross reference). This reporting requirement asks for the number of registered users. There is another requirement in the same section for the number of unique visitors (most likely be IP addresses), who may or may not registered.

b. It was requested that the number of downloads be provided as a statistic – please provide guidance and information on the nature of the information that is expected to be downloaded from the registry website.

A: The expected downloads include, but are not limited to, files, data, etc.

9. Page 6 - Article C.2. REPORTING REQUIREMENTS – a. Technical Progress Reports – Item 11 Other Reports:

Will the government please provide additional guidance on the expected number of additional reports that may be requested as well as guidance on the nature of, and estimated effort required for, the analysis that might be expected?

A: At this time we cannot estimate the number of Other NIH Required Reports or the nature of the reports. Accommodations to create these reports most likely can be achieved by adding a few additional elements to already specified and/or existing reports. In rare cases, the contractor may be required to provide ad hoc reports. It is anticipated that no significant effort will be required to prepare these reports.

10. Page 7 - Article C.2 REPORTING REQUIREMENTS, b. Document Deliverables: The RFP calls for the delivery of nanomaterial identification, matching system, and criteria. Can more details be provided in regards to the expectation for a “matching system”?

A: Please see section 1.3.2 e. of the SOW. In addition, the “matching system” is a set of evaluation and curation criteria based on the MIAN and Ontology that allows curators and users to either identify equivalent (but differently named) nanomaterials from different databases and/or to determine how close the nanomaterials are related to each other. For example, this “matching system” will be used to determine if two nanomaterials from different sources are identical in all physical and biological characteristics. For similar materials, the matching system would determine, for example, if they belonged to same category (based on the ontology), or have the same structure, physicochemical properties, or functions. The matching system should compare mode of manufacture as there are often residual artifacts of manufacturing that affect nanomaterial behavior.

11. Page 13 - Article F.2 Deliveries: Request clarification in regards to the expectation of the prototype web-based registry software being due month 12 which is one month after the required due date for the minimal required information about nanomaterials.

A: Yes, this is correct. The software prototype is due on the 15th calendar day after the end of the 12th month. As indicated in this RFP, this nanomaterials registry project is expected to leverage as much as possible other community efforts, especially the MIAN and Ontology. It is expected that the prototype development of the registry and the development of MIAN and Ontology used for this registry are parallel efforts. As specified in the SOW, the architecture of the registry should be flexible and extensible to accommodate any future changes of MIAN and Ontology. The “First full functional version”, which is due on the 15th calendar day after the end of the 18th month, should reflect the MIAN and Ontology that are due 7 months earlier.

12. Page 16 – Article G.4. CONTRACT FINANCIAL REPORT

The solicitation calls for a financial report to be delivered on 30th working days after the close of the reporting period and that the first financial report shall consists of the first three full months plus any fractional portion of the first month. They are then due on a quarterly basis.

a. Is it accurate to assume that a reporting period is a three month period of a calendar year?

A:

No, in accordance with Article G.4. CONTRACT FINANCIAL REPORT of the solicitation, the first quarter consists of the first three months following the date of the contract award. Therefore the quarters are in the contract year, not calendar year.

13. For technical and business proposal preparation purposes, please provide guidance on the expected Place of Performance of a resulting contract.

A: The resulting contract place of performance will be where the successful offeror is located or the location proposed.

14. Page 44 – Item 5 – Page and Formatting Limitations

a. It is assumed that the draft Information System Security Plan (ISSP) and the completed self assessment are not part of the Technical Plan that has a 30 page limitation. Please provide confirmation that these items are not included in the 30 page limitation

A: This is correct, the draft Information System Security Plan (ISSP) and the completed self assessment are not part of the Technical Plan that has the 30 page limitation.

b. It is assume that the data sharing plan requested as a part of the proposal (page 51 – a.

Sharing Research Data) is not part of the Technical Plan that has a 30 page limitation. Please provide confirmation that this item is not included in the 30 page limitation.

A: The Sharing Research Data requirement has been deleted from the solicitation and is no longer a requirement. See Item 8 of Amendment 1.

c. It is assumed that the resumes associated with proposed personnel are not included in the 30 page limitation of the Technical Plan since personnel are not included in the page limitation. Please confirm this assumption.

A: This is correct.

15. Page 47 – Item 14 Electronic and Information Technology Accessibility, HHSAR 352.270- 19a (January 2008).

a. Please note that the standards were not specified in the SOW as are indicated in this section as well as previous sections.

A: Please see page 7 of the SOW, Section 1.3.3 item g. It states “……… The registry website shall be Section 508 compliant (under 29 U.S.C. 794d).” Please see the web links provided on page 47, item 14 Electronic and Information Technology Accessibility, HHSAR 352.270- 19a (January 2008) of the solicitation for the specific standards.

b. Please confirm that it is required to submit a completed Section 508 Product

Assessment Template as part of the proposal. Please provide guidance in completing this form in the absence of applicable standards being specified in the solicitation. It is assumed that, if required, the completed Product Assessment Template is not included in the 30 page limitation of the Technical Plan. Please confirm this assumption.

A: This template is not required with the submission of the proposal since the Registry will not be delivered until after contract award. See Item 2 of Amendment 1.

16. Page 48 – b. TECHNICAL PROPOSAL INSTRUCTIONS –

It is assumed that the 4 items listed: (1) Technical Discussions, (2) Approach, (3) Methods, and (4) Schedule make up the Technical Plan that is required from the Technical Proposal Instructions and is the portion of the Technical Proposal that is limited to 30 pages.

A: This is correct. The four items are a portion of the technical plan. The technical plan is limited to 30 pages as stated on page 44.

17. Page 54/55 – ADDTIIONAL TECHNICAL PROPOSAL INSTRUCTIONS.

It is assumed that the items listed in this section are not constrained by the 30 page limited of the technical Plan. Please confirm this assumption.

A: The program plan and the rest of the items are subject to the 30 page limitation. The only exception is the letter(s) of support from the potential collaborators, which could be on a separate section other than the 30 pages limitation.

18. Attachment 3, Statement of Work, Page 6 - Section 3 Development of a Nanomaterial Registry: Are there any requirements for user authentication and authorization in the web based registry or is the intent to provide access to only publicly available information?

A: It is expected that the curated data and information should be freely accessible (query download, etc.) to the general public. However, the curated data should only be entered by the designated curators only. Registered users should be able to submit feedbacks and comments regarding data, MIAN, Ontology, evaluation criteria, etc.

19. What is the anticipated usage volume (number of users, average number of downloads, etc.) with the nanomaterial registry?

A: The answer will depend upon the number of databases made interoperable and how successful users will find the registry. In the research community alone, there are thousands of nanomaterials researchers, but few are familiar with more than a single database. A goal of the registry to create a unique resource for all nanomaterials researchers, but also provide information for the regulatory community and other stakeholder groups.

20. Please explain the current interoperability readiness of the nanomaterial databases listed in the SOW Appendix.

A: This is one of the major questions that this project will have to address. On page 8 of the

SOW, it stated that the contractor shall describe aspects of nanomaterial data compatibility and database software interoperability. The contractor shall negotiate and implement a stable solution for connections with the planned nanomaterial databases. It should be a practical solution that provides functional linkages to the databases with query features that allow users to obtain information from various portals and databases in the system. The technical solutions and specifications of the interoperability will be continually enhanced over time. Please see the section on page 8 for details.

21. Attachment 4, Statement of Work, Page 5 - Three workshops are mentioned - Please provide additional information on the nature of these workshops, the items that were discussed, and any outcomes that were pertinent to the purposes of this solicitation.

A: The pertinent information resulting from these workshops has already been incorporated in the SOW.

22. Page 54/55 – ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS – Number 1 at the top of the page – Section 2.3.1 Item a. of the SOW is referenced regarding the program plan. However, there is no section 2.3.1 in the SOW.

A: “Section 2.3.1 item a. of the SOW.” in this section should read “Section 1.3.1 item a of the SOW.” See Item 9 of Amendment 1.

23. Page 54/55 – ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS – Number 2 at the top of the page – Section 2.3.2 Item b. of the SOW is referenced regarding the program plan. However, there is no section 2.3.2 in the SOW.

A: “Section 2.3.2 item d. of the SOW.” in this section should read “Section 1.3.2 item d. of the

SOW.” See Item 9 of Amendment 1.

24. Page 53 – TECHNICAL PROPOSAL INSTRUCTIONS – 5 Information Security – Item f – NIST SP 800 53 Self Assessment – It is stated that contractors are required to submit a self assessment as required by NIST 800-53 rev 3. The NIST SP 800-53 (Recommended Security Controls for Federal Information Systems and Organizations) provides guidelines for performing a full security assessment, while NIST 800-26 (Security Self-Assessment Guide for Information Technology Systems) provides the format for a self-assessment checklist. We are not sure of the specific format required for the self-assessment since the 800-53 does not appear to contain a specific self-assessment format. Can you provide a sample of the specific format you require for the self assessment since the time required may vary significantly between formats?

A: There is no specific format required for the NIST SP 800 53 Self Assessments.

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