81_FR_68211 81 FR 68020 - Notice of Correction for Announcement of Requirements and Registration for “Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test” Challenge

81 FR 68020 - Notice of Correction for Announcement of Requirements and Registration for “Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test” Challenge

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 191 (October 3, 2016)

Page Range68020-68021
FR Document2016-23854

Federal Register, Volume 81 Issue 191 (Monday, October 3, 2016) 
[Federal Register Volume 81, Number 191 (Monday, October 3, 2016)]
[Notices]
[Pages 68020-68021]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23854]


-----------------------------------------------------------------------

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

[[Page 68021]]

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 [email protected].

    Dated: September 27, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-23854 Filed 9-30-16; 8:45 am]
 BILLING CODE 4140-01-P

68020 Federal Register / Vol. 81, No. 191 / Monday, October 3, 2016 / Notices 7W264, Rockville, MD 20892–9750, Contact Person: Yisong Wang, Ph.D., Name of Committee: National Institute on 240–276–6384, gravesr@mail.nih.gov. Scientific Review Officer, Special Aging Special Emphasis Panel; Multi–Omics Review Branch, Division of Extramural in Osteoporosis. Name of Committee: National Cancer Activities, National Cancer Institute, Date: October 25, 2016. Institute Special Emphasis Panel; NCI Time: 1:00 p.m. to 5:00 p.m. Provocative Questions—PQ4. 9609 Medical Center Drive, Room Agenda: To review and evaluate grant Date: November 3, 2016. 7W240, Rockville, MD 20892–9750, applications. Time: 12:00 p.m. to 3:00 p.m. 240–276–7157, yisong.wang@nih.gov. Place: National Institute on Aging, Agenda: To review and evaluate grant Name of Committee: National Cancer Gateway Building, 2W200, 7201 Wisconsin applications. Institute Special Emphasis Panel; Avenue, Bethesda, MD 20892, (Telephone Place: National Cancer Institute, Provocative Questions in Cancer with Conference Call). Shady Grove, 9609 Medical Center an Underlying HIV Infection. Contact Person: Nijaguna Prasad, MS, Drive, Room 7W032/034, Rockville, MD Date: November 16, 2016. Ph.D., Scientific Review Officer, Scientific 20850, (Telephone Conference Call). Time: 11:00 a.m. to 4:00 p.m. Review Branch, National Institute of Aging, Contact Person: Zhiqiang Zou, MD, Agenda: To review and evaluate grant National Institutes of Health, Bethesda, MD Ph.D., Scientific Review Officer, Special 20892, 301–496–9667, nijaguna.prasad@ applications. nih.gov. Review Branch, Division of Extramural Place: National Cancer Institute, Activities, National Cancer Institute, Shady Grove, 9609 Medical Center (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, 9609 Medical Center Drive, Room Drive, Room 4E030, Rockville, MD National Institutes of Health, HHS) 7W242, Rockville, MD 20892–9750, 20850, (Telephone Conference Call). 240–276–6372, zouzhiq@mail.nih.gov. Contact Person: Clifford W. Dated: September 27, 2016. Name of Committee: National Cancer Schweinfest, Ph.D., Scientific Review Melanie J. Gray, Institute Special Emphasis Panel; Officer, Special Review Branch, Program Analyst, Office of Federal Advisory Fundamental Mechanisms of Affective Division of Extramural Activities, Committee Policy. and Decisional Process in Cancer National Cancer Institute, 9609 Medical [FR Doc. 2016–23735 Filed 9–30–16; 8:45 am] Control. Center Drive, Room 7W108, Rockville, BILLING CODE 4140–01–P Date: November 4, 2016. MD 20892–9750, 240–276–6343, Time: 11:00 a.m. to 4:00 p.m. schweinfestcw@mail.nih.gov. Agenda: To review and evaluate grant (Catalogue of Federal Domestic Assistance DEPARTMENT OF HEALTH AND applications. Program Nos. 93.392, Cancer Construction; HUMAN SERVICES Place: National Cancer Institute, 93.393, Cancer Cause and Prevention Shady Grove, 9609 Medical Center Research; 93.394, Cancer Detection and National Institutes of Health Drive, Room 2W910, Rockville, MD Diagnosis Research; 93.395, Cancer 20850, (Telephone Conference Call). Treatment Research; 93.396, Cancer Biology Notice of Correction for Research; 93.397, Cancer Centers Support; Announcement of Requirements and Contact Person: Thomas A. Winters, 93.398, Cancer Research Manpower; 93.399, Registration for ‘‘Antimicrobial Ph.D., Scientific Review Officer, Special Cancer Control, National Institutes of Health, Review Branch, Division of Extramural Resistance Rapid, Point-of-Need HHS) Activities, National Cancer Institute, Diagnostic Test’’ Challenge Dated: September 27, 2016. 9609 Medical Center Drive, Room The National Institutes of Health 7W112, Rockville, MD 20892–9750, Melanie J. Gray, Program Analyst, Office of Federal Advisory (NIH) is correcting a notice previously 240–276–6386, twinters@mail.nih.gov. published in the Federal Register on Committee Policy. Name of Committee: National Cancer September 8, 2016 (81 FR 62150), titled [FR Doc. 2016–23734 Filed 9–30–16; 8:45 am] Institute Special Emphasis Panel; NCI ‘‘Announcement of Requirements and BILLING CODE 4140–01–P Provocative Questions—PQ6. Registration for ‘Antimicrobial Date: November 4, 2016. Resistance Rapid, Point-of-Need Time: 12:00 p.m. to 4:00 p.m. Diagnostic Test’ Challenge.’’ The notice Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND HUMAN SERVICES announced the Antimicrobial Resistance applications. Place: National Cancer Institute, Rapid, Point-of-Need challenge Shady Grove, 9609 Medical Center National Institutes of Health competition that may result in the Drive, Room 6W034, Rockville, MD awarding of $20 million dollars for the National Institute on Aging; Notice of successful development of new, 20850, (Telephone Conference Call). Closed Meeting Contact Person: Zhiqiang Zou, MD, innovative, accurate, and cost-effective Ph.D., Scientific Review Officer, Special Pursuant to section 10(d) of the in vitro diagnostic tests that would Review Branch, Division of Extramural Federal Advisory Committee Act, as rapidly inform clinical treatment Activities, National Cancer Institute, amended (5 U.S.C. App.), notice is decisions and be of significant clinical 9609 Medical Center Drive, Room hereby given of the following meeting. and public health utility to combat the 7W242, Rockville, MD 20892–9750, The meeting will be closed to the development and spread of antibiotic 240–276–6372, zouzhiq@mail.nih.gov. public in accordance with the resistant bacteria and improve antibiotic provisions set forth in sections stewardship. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., The NIH is correcting and clarifying Provocative Questions—PQ8. as amended. The grant applications and several components of the Challenge the discussions could disclose competition including: sradovich on DSK3GMQ082PROD with NOTICES Date: November 10, 2016. Time: 12:00 p.m. to 5:00 p.m. confidential trade secrets or commercial (1) The letter of intent must be Agenda: To review and evaluate grant property such as patentable material, submitted by December 23, 2016, for all applications. and personal information concerning ‘‘Solvers’’ planning to submit for the Place: National Cancer Institute, individuals associated with the grant Step 1 (Theoretical) stage of the Shady Grove, 9609 Medical Center applications, the disclosure of which competition. The September 8, 2016 Drive, Room 7W032/034, Rockville, MD would constitute a clearly unwarranted announcement incorrectly stated that 20850, (Telephone Conference Call). invasion of personal privacy. the letter of intent prior to Step 1 was VerDate Sep<11>2014 17:56 Sep 30, 2016 Jkt 241001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1

Federal Register / Vol. 81, No. 191 / Monday, October 3, 2016 / Notices 68021 required but a specific due date was not 496–2229 or by email DEPARTMENT OF HEALTH AND stated. Robert.eisinger@nih.gov. HUMAN SERVICES (2) Any Appendix submitted for Step Dated: September 27, 2016. 1 of the Challenge competition must be Substance Abuse and Mental Health limited to 5 pages or less in length. If Lawrence A. Tabak, Services Administration a longer Appendix is submitted, only Deputy Director, National Institutes of Health. the first 5 pages will be considered by [FR Doc. 2016–23854 Filed 9–30–16; 8:45 am] Current List of HHS-Certified the Technical Evaluation Panel and the BILLING CODE 4140–01–P Laboratories and Instrumented Initial Judging Panel. The September 8, 2016, Testing Facilities Which Meet Minimum announcement incorrectly stated that Standards To Engage in Urine Drug there was no page length for the DEPARTMENT OF HEALTH AND Testing for Federal Agencies Appendix material. HUMAN SERVICES AGENCY: Substance Abuse and Mental (3) Submissions for Step 1 of the Health Services Administration, HHS Challenge competition received after the National Institutes of Health deadline of January 9, 2017, at 11:59 ACTION: Notice. p.m. ET will be disqualified and not National Institute of Allergy and Infectious Diseases; Notice of Closed SUMMARY: The Department of Health and evaluated by the Technical Evaluation Human Services (HHS) notifies federal Panel or Judging Panel. Meeting (4) Solvers may submit corrections or agencies of the laboratories and additional materials in support of their Pursuant to section 10(d) of the Instrumented Initial Testing Facilities Step 1 submissions so long as the NIH Federal Advisory Committee Act, as (IITF) currently certified to meet the receives the materials by the deadline of standards of the Mandatory Guidelines amended (5 U.S.C. App.), notice is January 9, 2017, at 11:59 p.m. ET. for Federal Workplace Drug Testing hereby given of the following meeting. Corrections or additional materials for Programs (Mandatory Guidelines). The The meeting will be closed to the Mandatory Guidelines were first Step 1 will not be accepted or evaluated public in accordance with the published in the Federal Register on by the Technical Evaluation Panel or provisions set forth in sections April 11, 1988 (53 FR 11970), and Judging Panel if they are received after January 9, 2017 at 11:59 p.m. ET. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., subsequently revised in the Federal (5) The NIH will perform an initial as amended. The grant applications and Register on June 9, 1994 (59 FR 29908); review of all submissions to ensure they the discussions could disclose September 30, 1997 (62 FR 51118); are complete and within the scope of confidential trade secrets or commercial April 13, 2004 (69 FR 19644); November the Challenge competition. Submissions property such as patentable material, 25, 2008 (73 FR 71858); December 10, that are incomplete will be and personal information concerning 2008 (73 FR 75122); and on April 30, administratively disqualified and will individuals associated with the grant 2010 (75 FR 22809). not be evaluated by the Technical applications, the disclosure of which A notice listing all currently HHS- Evaluation Panel or the Judging Panel. would constitute a clearly unwarranted certified laboratories and IITFs is (6) The NIH and Assistant Secretary invasion of personal privacy. published in the Federal Register for Preparedness and Response/ during the first week of each month. If Name of Committee: National Institute of any laboratory or IITF certification is Biomedical Advanced Research and Allergy and Infectious Diseases Special suspended or revoked, the laboratory or Development Authority may determine Emphasis Panel; NIAID Clinical Trial that based on the number of IITF will be omitted from subsequent Planning Grant (R34) and NIAID Investigator submissions received for Step 1 that less lists until such time as it is restored to Initiated Program Project Applications (P01). competitive submissions will not be full certification under the Mandatory Date: October 28, 2016. discussed by the Technical Evaluation Guidelines. Time: 8:00 a.m. to 3:00 p.m. Panel during the Panel’s meeting. If any laboratory or IITF has Agenda: To review and evaluate grant (7) The ‘‘Solver’’ needs to address the applications. withdrawn from the HHS National NIH Human Subjects Protections and Place: National Institutes of Health, 5601 Laboratory Certification Program (NLCP) Inclusion of Women, Children, and Fishers Lane, Rockville, MD 20892, during the past month, it will be listed Minorities policies in their submissions (Telephone Conference Call). at the end and will be omitted from the for Step 1 of this competition. Contact Person: Zhuqing (Charlie) Li, monthly listing thereafter. (8) Members of the Technical Ph.D., Scientific Review Officer, Scientific This notice is also available on the Evaluation Panel are not eligible to Review Program, Division of Extramural Internet at http://www.samhsa.gov/ participate in or contribute to any Activities, Room # 3G41B, National Institutes workplace. proposal for Step 2 and Step 3 of the of Health/NIAID, 5601 Fishers Lane, FOR FURTHER INFORMATION CONTACT: Challenge competition. MSC9823 Bethesda, MD 20892–9823, (240) (9) Any Solver is eligible for Step 2 of Giselle Hersh, Division of Workplace 669–5068, zhuqing.li@nih.gov. Programs, SAMHSA/CSAP, 5600 this Challenge competition. For example, if a Step 1 ‘‘Solver’’ is not (Catalogue of Federal Domestic Assistance Fishers Lane, Room 16N03A, Rockville, Program Nos. 93.855, Allergy, Immunology, Maryland 20857; 240–276–2600 (voice). identified as a semifinalist, he/she may and Transplantation Research; 93.856, SUPPLEMENTARY INFORMATION: The still submit for Step 2 of this Microbiology and Infectious Diseases Mandatory Guidelines were initially competition and those who did not Research, National Institutes of Health, HHS) developed in accordance with Executive sradovich on DSK3GMQ082PROD with NOTICES submit a Step 1 proposal may still submit a proposal for Step 2. Dated: September 27, 2016. Order 12564 and section 503 of Public (10) All submissions for Step 1, 2, and Natasha M. Copeland, Law 100–71. The ‘‘Mandatory 3 must be in English. Program Analyst, Office of Federal Advisory Guidelines for Federal Workplace Drug For further information about the Committee Policy. Testing Programs,’’ as amended in the Antimicrobial Resistance Diagnostic [FR Doc. 2016–23736 Filed 9–30–16; 8:45 am] revisions listed above, requires strict Challenge competition, please contact standards that laboratories and IITFs BILLING CODE 4140–01–P Robert W. Eisinger, Ph.D., NIH, 301– must meet in order to conduct drug and VerDate Sep<11>2014 17:56 Sep 30, 2016 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\03OCN1.SGM 03OCN1


Document Created: 2018-02-13 14:11:46
Document Modified: 2018-02-13 14:11:46
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 68020 
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