Notices. DEPARTMENT OF HEALTH AND HUMAN SERVICES

615 words·~3 min read·/register/2016/10/03/2016-23854·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Correction for Announcement of Requirements and Registration for “Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test” Challenge The National Institutes of Health

(NIH)is correcting a notice previously published in the **Federal Register** on September 8, 2016 (81 FR 62150), titled “Announcement of Requirements and Registration for ‘Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test’ Challenge.” The notice announced the Antimicrobial Resistance Rapid, Point-of-Need challenge competition that may result in the awarding of $20 million dollars for the successful development of new, innovative, accurate, and cost-effective in vitro diagnostic tests that would rapidly inform clinical treatment decisions and be of significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria and improve antibiotic stewardship. The NIH is correcting and clarifying several components of the Challenge competition including:

(1)The letter of intent must be submitted by December 23, 2016, for all “Solvers” planning to submit for the Step 1 (Theoretical) stage of the competition. The September 8, 2016 announcement incorrectly stated that the letter of intent prior to Step 1 was required but a specific due date was not stated.

(2)Any Appendix submitted for Step 1 of the Challenge competition must be limited to 5 pages or less in length. If a longer Appendix is submitted, only the first 5 pages will be considered by the Technical Evaluation Panel and the Judging Panel. The September 8, 2016, announcement incorrectly stated that there was no page length for the Appendix material.

(3)Submissions for Step 1 of the Challenge competition received after the deadline of January 9, 2017, at 11:59 p.m. ET will be disqualified and not evaluated by the Technical Evaluation Panel or Judging Panel.

(4)Solvers may submit corrections or additional materials in support of their Step 1 submissions so long as the NIH receives the materials by the deadline of January 9, 2017, at 11:59 p.m. ET. Corrections or additional materials for Step 1 will not be accepted or evaluated by the Technical Evaluation Panel or Judging Panel if they are received after January 9, 2017 at 11:59 p.m. ET.

(5)The NIH will perform an initial review of all submissions to ensure they are complete and within the scope of the Challenge competition. Submissions that are incomplete will be administratively disqualified and will not be evaluated by the Technical Evaluation Panel or the Judging Panel.

(6)The NIH and Assistant Secretary for Preparedness and Response/Biomedical Advanced Research and Development Authority may determine that based on the number of submissions received for Step 1 that less competitive submissions will not be discussed by the Technical Evaluation Panel during the Panel's meeting.

(7)The “Solver” needs to address the NIH Human Subjects Protections and Inclusion of Women, Children, and Minorities policies in their submissions for Step 1 of this competition.

(8)Members of the Technical Evaluation Panel are not eligible to participate in or contribute to any proposal for Step 2 and Step 3 of the Challenge competition.

(9)Any Solver is eligible for Step 2 of this Challenge competition. For example, if a Step 1 “Solver” is not identified as a semifinalist, he/she may still submit for Step 2 of this competition and those who did not submit a Step 1 proposal may still submit a proposal for Step 2.

(10)All submissions for Step 1, 2, and 3 must be in English. For further information about the Antimicrobial Resistance Diagnostic Challenge competition, please contact Robert W. Eisinger, Ph.D., NIH, 301-496-2229 or by email *Robert.eisinger@nih.gov.* Dated: September 27, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2016-23854 Filed 9-30-16; 8:45 am]