NIH-NICHD-DIPHR-2018-12_Amendment_2_Population_Health_Research_Support_.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1

1. CONTRACT ID CODE

N/A

2. AMENDMENT/MODIFICATION NUMBER

3 EFFECTIVE DATE

07/12/2018

4 REQUISITION/PURCHASE REQUISITION NUMBER , 5. PROJECT NUMBER (If applicable) N/A N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE I Office of Acquisitions Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health 6710B Rockledge Dr., First Floor, MSC 7000 Bethesda, Maryland 20892

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

X

TO THE PROSPECTIVE OFFEROR

NIH-NICHD-DIPHR-2018-12

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

CODE I FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

[gj The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers D is extended. [gj is not extended.

Offers must acknowledge receipt of this amendment at 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 ( l ) copy of the amendment; and with the offer submitted, (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication 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 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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

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

NUMBER IN ITEM 10A,

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, 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. IMPORT ANT: Contractor D is not [gj is required to sign this document and return ___ 1 copies to the issuing office.

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

15B. CONTRACTORIOFFEROR 15C. DATE SIGNED

(Signature of person authorized to sign)

Previous edition unusable

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

16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of Contracting Officer)

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

PAGE OF

PAGES 1 4

June 25, 20l8

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

PURPOSE: To amend RFP NIH-NICHD-DIPHR-2018-12, entitled, “Population Health Research Support” by 1.) listing prospective offerors' additional questions and responses to the questions.

DUE DATE: Until July 25, 2018, 3:00 PM Local Time (Eastern Standard Time (EST) (Unchanged).

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 1 0A, as heretofore changed, remains unchanged and in full force and effect.

Jacquelin Jones

7/I2/20I8

RFP No.: NIH-NICHD-DIPHR-2018-12

July 12, 2018 Page 1 of 3

POPULATION HEALTH RESEARCH SUPPORT

OFFERORS ADDITIONAL TECHNICAL AND BUSINESS QUESTIONS AND

RESPONSES

1. Please confirm that the IDIQ Base, Task Order 1 and Task Order 2 each require their own Business Proposal? If yes, can you please confirm the 25-page limit for each Business Proposal? Do screen shots of the budget excel tabs count against the page limit?

Response: Yes, the IDIQ Base, Task Order 1 and Task Order 2 each require their own business proposal. The 25-page limit is for the IDIQ Base only. The task orders 1 (inclusive of 1 through sample 1E) and 2 (inclusive of 2 through sample 2C) will have a 15-page limit. (For example Task order 1, 1A, 1B, 1C, 1D, and 1E are limited to 15 pages for the entire series.)

2. Please confirm that attachments in the Business Proposal do not count against the 25-page limit for each business proposal? As an example, the typical Small Business Subcontracting Plan is 12 pages in length.

Response: The attachments and the appendix do not count against the 25-page limit.

3. Can you please confirm how we should budget for the EUROLyser hsCRP machines?

We did not see any US distributers of the 4 machines listed on the company website. Is there a per test price that should be assumed?

Response: Offerors may assume an estimated cost of $2200 for the EUROLyser device in addition to approximately $4 per test.

4. Can you confirm whether there is an FTE cap for the IDIQ contract?

Response: For purposes of this solicitation, there is no FTE cap for the IDIQ contract.

5. Should each task area (A, B, C etc.) have its own separate excel workbook?

Response: Yes, Each task order in the series should have it’s own separate budget excel worksheet.

6. Given the fact that responses to questions posed between now and July 9th will be available on or around July 12th on FEDBIZOPPS, will the NICHD consider extending the submission date beyond on July 25th? Currently, our institution has a 10-day routing period to allow for dept review and central office review and signature.

Response: The due date for proposals will remain July 25, 2018 by 3:00 PM Eastern. The eCPS system will block any proposals sent after the 3:00 PM Eastern deadline. At that point the proposal is considered late.

7. We have a follow-up question about using a different PI for Task Orders from the PI for the overall IDIQ. In that case would the submission of a multiple investigator plan be necessary?

Response: Please submit a plan for multiple investigators.

July 12, 2018 Page 2 of 3

8. On page 2 of Attachment 7, (page 170 of 180 of entire proposal). It states that Task 1a will be a “…Participants will be block randomized by central obesity (waist circumference ≥88 cm, waist circumference <88 cm) and the trial will be conducted in two stages.” Is any other block randomization planned for Tasks 1b-1e?

Response: Block randomization by geographic site may be applied in addition to block randomization by central obesity.

9. Does the human resources section count against the 25 (or 15) page limits for the technical proposals?

Response: Yes, the human resources section counts against the Business proposal 25-page limit.

10. In task 1, is an ultrasound required at the 12 week visit or is documentation of viability with a Doppler acceptable?

Response: Ultrasound is preferred, but either method is acceptable in Task 1.

11. Is a paper copy of the submission required or is it only electronic? One part of the RFP suggests that a paper copy is needed.

Response: Only electronic submissions through eCPS will be an acceptable form of proposal submission. Any paper copy submission required in the solicitation is considered corrected through this amendment.

12. Is a quality oral health screen acceptable in lieu of a formal dental evaluation?

Response: An oral health screen that sufficiently assesses potential sources of inflammation (e.g. the spectrum of gum health/disease, etc.) could be considered with justification of the approach providing comparable, relevant information and accompanying expertise.

13. For Task Orders 1 and 2, can you please clarify the total number of blood collection tubes for each draw, the type and the size of each tube?

Response: For Task 1, we anticipate collecting approximately 5- 10mL serum (i.e. red top) collection tubes (2 baseline, 1 of each fertility treatment cycle) and 4- 10mL EDTA (i.e. lavender top) collection tubes (1 baseline, 1 of each fertility treatment cycle). Each blood collection tube is expected to be aliquoted into 4 serum/plasma cryovial aliquots.

For Sample Task 2, these details will be decided between the site(s), NICHD DIPHR investigators, and the NICHD CO as the final Manual of Procedures is developed, taking into account Review Board guidelines for the quantities of blood that can be taken from pregnant women and best practices regarding aliquoting.

14. For Task Orders 1 and 2, can you please clarify the number of aliquots of blood from each tube and the number of aliquots from each urine sample collected?

Response: For Task 1, please see above #13.

July 12, 2018 Page 3 of 3

For Sample Task 2, these details will be decided between the site(s), NICHD DIPHR investigators, and the NICHD CO as the final Manual of Procedures is developed.

15. Will NICHD reconsider placing a page limit on the business volume due the supporting documentation required for subcontractors?

Response: The page limit for the business proposal in no more than 25 pages.

16. Amendment 1, Technical Question #14 states that NIH biosketches are preferred. NIH biosketches are formatted using 0.5 inch margins. Per the NIH-NICHD-DIPHR-2018-12 solicitation, Attachment 1, section II(A), proposals should be formatted with 1 inch margins.

Response: Since the biosketches are part of an appendix, please use the preferred formatting in the appendix of 0.5 inch margins.