Amendment_00001.pdf

(x)

14-250-SOL-00169

x x 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

OAMP

5600 Fishers Lane, Room 14W Management and Policy Office of Acquisition

HHS/HRSA/OO/OAMP

Rockville MD 20857

OAMP

5600 Fishers Lane, Rm 14W Management and Policy Office of Acquisition

HHS/HRSA/OO/OAMP

08/21/2014000001

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

07/30/2014

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.)

The purpose of this amendment is to: 1) provide answers to questions received, 2) revise Attachment A - Statement of

Work, and 3) correct the NAICS code in the Description field of the Notice.

1) The answers to all timely received questions are as follows:

1. Regarding the request to include a plan that compares methodologies for conducting the data collection strategies

- which dimension(s) of data collection methodology are

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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)

DAN E. MATUSIEWICZ

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

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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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required to be included in the comparison? E.g.

data source, techniques for linking data system, data entry mechanisms etc.

The requested plan would include techniques for linking the data from multiple sites into a single data system and to a smaller degree data entry mechanism.

2. Will MCHB share with applicants the approaches to data collection and "data repository" that the awarded regional sites will use at this time?

The awarded regional sites are not currently using approaches to data collection and "data repository" at this time. Each awarded regional site will work with

HRSA and the awarded contractor to develop the approaches to data collection after the contract has been awarded.

3. Can an institution applying for the regional site participate in the National Coordinating Center?

Yes.

4. Can an individual at an institution applying for the regional site be a subcontractor in the National

Coordinating Center?

Yes, an individual at an institution applying for the regional site can be part of a subcontract to the

National

Coordinating Center or a consultant to the NCC as long as the individual's job description on each of the application is distinct (different) and mechanisms are put in place to clearly distinguish the roles and financial

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Sponsored by GSA

FAR (48 CFR) 53.110

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compensation to the individual on each funding stream. (For clarification, subcontracts are usually made to companies and individuals are consultants.)

5. Is there a requirement for OMB approval of the data collection?

Yes, there is a requirement for OMB approval for the data collection.

6. Task 3.3 Base Year states that the database the contractor creates "shall also be able to collect general information about the patient population, including demography information, geographical information, and information about services delivery." Please clarify whether this information must be at the level of data protected under HIPAA, or whether it can be deidentified or less granular?

All information collected by the contractor from the regional sites will be de-identified or less granular data.

The general information obtained about the patient population should be collected in a manner to allow HRSA to understand the need of the patient population, but should be de-identified so as to limit the ability of identify individuals.

7. Does HRSA anticipate that they will convene an external review committee or will the review occur internally within

HRSA?

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Review will be conducted based on the evaluation criteria contained in the solicitation.

8. Can a representative from a federal agency serve on the oversight steering committee?

Neither the authorizing legislation nor MCHB has language that would prevent a representative from another federal agency from serving on the oversight steering committee.

9. When does MCHB anticipate announcing the funding of the awards?

This award will be funded at the end of this fiscal year.

10. Is there any requirement that the National

Coordinating

Center for the Treatment Demonstration Program should also collaborate or exchange data/resources with the

National

Coordinating Center for the New Born Screening

Program?

No, there is no requirement that the National

Coordinating

Center for the Treatment Demonstration Program should collaborate or exchange data/resources with the

National

Coordinating Center for the Newborn Screening

Program.

11. Do the regional coordinating centers have any requirements pertaining to the development of the congressional report?

No, the regional coordinating centers do not have any requirements pertaining to the development of the congressional report. The regional coordinating centers

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have requirements pertaining to developing data strategies and collecting and sending data to the National

Coordinating

Center.

12. Would it be possible to offer subcontracts to academic institutions and other individuals with unique expertise without a small business contracting plan?

Yes, if the prime contractor is a small business, a subcontracting plan is not required. However, a subcontracting plan would be required if the prime is a large business, and the proposed total contract value exceeds $650,000.

13. Under Task 6.3 Report to Congress and Task

6.4

Presentation to MCHB Staff, the

"Hemoglobinopathies Learning

Collaborative" was mentioned. This Learning

Collaborative was not mentioned previously; does it still apply?

No, the mention of the Hemoglobinopathies

Learning

Collaborative was an error. Please disregard all mention of the Hemoglobinopathies Learning Collaborative.

14. In the Schedule of Deliverables table, Clause

F.6 of the

RFP, Option Years 1 and 2, the Delivery Date of

5.1, Web-based Compendium of Tools and Materials, is 1 month prior to the end of Option Year 1 (and 2). However, in

Attachment A

- Statement of Work, Task 5 (in both option years) states that the Web-based Compendium of Tools and

Materials shall be delivered two months prior to the end of each

Option

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Year. Please clarify the schedule for submission of the

Compendium of Tools and Materials.

The correct schedule for the submission of the

Web-based

Compendium of Tools and Materials should be one month prior to the end of each Option Year. Please see the revised

Attachment A - Statement of Work attached.

2) Attachment A - Statement of Work is hereby revised in response to Question 14 above. Task 5.1 in Option

Year 1 and

Option Year 2 is corrected to reflect the correct submission date for the web-based Compendium of Tools and

Materials.

The attached, revised version should replace, in its entirety, Attachment A in the document

RFP.SCDTDP.docx included in the Base Notice.

3) The NAICS code in the Description field of the

Base

Notice is hereby changed from 611710 to 541990.

The NAICS code listed in the General Information side bar is correct, and remains unchanged.

CONTRACT SPECIALIST:

Name: Philip Senerchia

Telephone: 301-443-6065

E-mail: psenerchia@hrsa.gov

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