82_FR_18379 82 FR 18306 - Request for Information on Input on Opportunities of Engagement of External Stakeholders With the “Illuminating the Druggable Genome” (IDG) Program

82 FR 18306 - Request for Information on Input on Opportunities of Engagement of External Stakeholders With the “Illuminating the Druggable Genome” (IDG) Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 73 (April 18, 2017)

Page Range18306-18307
FR Document2017-07795

NIH seeks input from the biomedical research community, biotechnology and pharmaceutical companies and other members of the public on interest and opportunities of engagement with the Illuminating the Druggable Genome (IDG) Program. The purpose of this Request for Information (RFI) is to identify and obtain comments on strategies for sharing potential data, tools, and other resources of common interest generated by the IDG Program and by external stakeholders to maximize the impact of the IDG Program.

Federal Register, Volume 82 Issue 73 (Tuesday, April 18, 2017)
[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Pages 18306-18307]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Request for Information on Input on Opportunities of Engagement 
of External Stakeholders With the ``Illuminating the Druggable Genome'' 
(IDG) Program

SUMMARY: NIH seeks input from the biomedical research community, 
biotechnology and pharmaceutical companies and other members of the 
public on interest and opportunities of engagement with the 
Illuminating the Druggable Genome (IDG) Program. The purpose of this 
Request for Information (RFI) is to identify and obtain comments on 
strategies for sharing potential data, tools, and other resources of 
common interest generated by the IDG Program and by external 
stakeholders to maximize the impact of the IDG Program.

DATES: The IDG Program Request for Information is open for public 
comment for a period of 30 days. Comments must be received by May 18, 
2017 to ensure consideration. After the public comment period has 
closed, the comments received by the IDG Program will be considered in 
a timely manner by the National Center for Advancing

[[Page 18307]]

Translational Sciences (NCATS) and the National Institute of Diabetes 
and Digestive and Kidney Diseases (NIDDK).

ADDRESSES: Submissions may be sent electronically to [email protected] or by mail to Dr. Karlie Sharma, National Center for 
Advancing Translational Sciences, National Institutes of Health, 6701 
Democracy Blvd., Suite 900, Bethesda, MD 20892.

FOR FURTHER INFORMATION CONTACT: Questions about this request for 
information should be directed to Dr. Karlie Sharma, National Center 
for Advancing Translational Sciences, National Institutes of Health, 
6701 Democracy Blvd., Suite 900, Bethesda, MD 20892, [email protected], 301-451-4965.

SUPPLEMENTARY INFORMATION: Out of the nearly 30,000 genes in the human 
genome, approximately 3,000 genes are estimated to be part of the 
druggable genome--the subset of genes expressing proteins with the 
ability to bind drug-like molecules. Yet, only about ten percent of 
druggable proteins are targeted by Food and Drug Administration (FDA)-
approved drugs. Many proteins that comprise the druggable genome are 
members of the G-protein coupled receptor (GPCR), ion channel, and 
kinase families. A significant number of proteins within these classes 
are understudied and are the focus of the data and resource generation 
initiative of the IDG Program.

1. Goals and Requirements

    The IDG Program was originally funded as a three-year pilot program 
in 2014 with two overarching goals: (1) Integrate information about 
understudied druggable proteins from disparate sources into a single 
informatics site and (2) foster technology development to enable the 
determination of function and therapeutic potential of understudied 
druggable proteins. Having successfully achieved these goals, the IDG 
Program is currently transitioning to a new implementation phase 
intended to:
     Expand the informatics tools developed in the pilot phase 
to include additional data and allow users to access, analyze, and 
visualize a wide range of information on sets of proteins.
     Facilitate the elucidation of the function of understudied 
proteins from the three key druggable protein families (GPCR, ion 
channels, and kinases) by generating new reagents and new data.
     Disseminate the IDG-generated resources and data to the 
greater scientific community.

2. Information Requested

    NIH is seeking input from national and international experts and 
interested members of the public that includes, but is not limited to, 
the following areas:
     Resources that an outside organization (biotechnology or 
pharmaceutical company; non-profit organization; academic institution 
and national/international consortia) might be willing to share with 
the IDG Program and may:
[cir] Strategize development of chemical probes against proteins drawn 
from the IDG focused list
[cir] develop assays and platforms that can help to answer questions 
about understudied protein function
[cir] identify reagents that may be useful in annotation efforts
[cir] provide data or knowledge on any understudied protein
     Potential resources of the IDG Program that are of 
interest to an outside organization of the broader biomedical research 
community including:
[cir] Sharable databases of relevant subsets of data on understudied 
proteins
[cir] data analysis and query tools
[cir] links between protein target and disease pathologies
[cir] new methods of analysis to accelerate collection of data
    This RFI is for planning purposes only and should not be construed 
as a solicitation for applications or proposals, or as an obligation in 
any way on the part of the United States Federal government. The 
Federal government will not pay for the preparation of any information 
submitted or for the government's use. Additionally, the government 
cannot guarantee the confidentiality of the information provided.

    Dated: April 12, 2017.
Christopher P. Austin,
Director, NCATS.
Griffin P. Rodgers,
Director, NIDDK, Illuminating the Druggable Genome Program, National 
Center for Advancing Translational Sciences, National Institute of 
Diabetes and Digestive and Kidney Diseases.
[FR Doc. 2017-07795 Filed 4-17-17; 8:45 am]
 BILLING CODE 4140-01-P



                                                18306                          Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices

                                                Development, 31 Center Drive, Room 2A03,                Vascular Diseases Research; 93.838, Lung              DEA, NIDDK, National Institutes of Health,
                                                MSC 2425, Bethesda, MD 20892, (301) 496–                Diseases Research; 93.839, Blood Diseases             Room 7349, 6707 Democracy Boulevard,
                                                0536, kaeserl@mail.nih.gov.                             and Resources Research, National Institutes           Bethesda, MD 20892–5452, (301) 594–8894,
                                                   Any interested person may file written               of Health, HHS)                                       begumn@niddk.nih.gov.
                                                comments with the committee by forwarding                 Dated: April 12, 2017.                                Name of Committee: National Institute of
                                                the statement to the Contact Person listed on           Michelle Trout,                                       Diabetes and Digestive and Kidney Diseases
                                                this notice. The statement should include the                                                                 Special Emphasis Panel; NIDDK Diabetes
                                                name, address, telephone number and when                Program Analyst, Office of Federal Advisory           Research Centers (P30).
                                                applicable, the business or professional                Committee Policy.                                       Date: May 24–25, 2017.
                                                affiliation of the interested person.                   [FR Doc. 2017–07740 Filed 4–17–17; 8:45 am]             Time: 8:00 a.m. to 6:00 p.m.
                                                   In the interest of security, NIH has                 BILLING CODE 4140–01–P                                  Agenda: To review and evaluate grant
                                                instituted stringent procedures for entrance                                                                  applications.
                                                onto the NIH campus. All visitor vehicles,                                                                      Place: DoubleTree by Hilton, Ballroom C,
                                                including taxicabs, hotel, and airport shuttles         DEPARTMENT OF HEALTH AND                              8120 Wisconsin Avenue, Bethesda, MD
                                                will be inspected before being allowed on                                                                     20814.
                                                                                                        HUMAN SERVICES
                                                campus. Visitors will be asked to show one                                                                      Contact Person: Najma Begum, Ph.D.,
                                                form of identification (for example, a                                                                        Scientific Review Officer, Review Branch,
                                                                                                        National Institutes of Health
                                                government-issued photo ID, driver’s license,                                                                 DEA, NIDDK, National Institutes of Health,
                                                or passport) and to state the purpose of their                                                                Room 7349, 6707 Democracy Boulevard,
                                                                                                        National Institute of Diabetes and                    Bethesda, MD 20892–5452, (301) 594–8894,
                                                visit.
                                                                                                        Digestive and Kidney Diseases; Notice                 begumm@niddk.nih.gov.
                                                  Dated: April 12, 2017.                                of Closed Meetings                                    (Catalogue of Federal Domestic Assistance
                                                Michelle Trout,
                                                                                                          Pursuant to section 10(d) of the                    Program Nos. 93.847, Diabetes,
                                                Program Analyst, Office of Federal Advisory                                                                   Endocrinology and Metabolic Research;
                                                Committee Policy.                                       Federal Advisory Committee Act, as
                                                                                                                                                              93.848, Digestive Diseases and Nutrition
                                                                                                        amended (5 U.S.C. App.), notice is
                                                [FR Doc. 2017–07739 Filed 4–17–17; 8:45 am]                                                                   Research; 93.849, Kidney Diseases, Urology
                                                                                                        hereby given of the following meetings.               and Hematology Research, National Institutes
                                                BILLING CODE 4140–01–P
                                                                                                          The meetings will be closed to the                  of Health, HHS)
                                                                                                        public in accordance with the
                                                                                                        provisions set forth in sections                        Dated: April 12, 2017.
                                                DEPARTMENT OF HEALTH AND                                                                                      David Clary,
                                                                                                        552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                HUMAN SERVICES                                                                                                Program Analyst, Office of Federal Advisory
                                                                                                        as amended. The grant applications and
                                                                                                        the discussions could disclose                        Committee Policy.
                                                National Institutes of Health
                                                                                                        confidential trade secrets or commercial              [FR Doc. 2017–07736 Filed 4–17–17; 8:45 am]
                                                National Heart, Lung, and Blood                         property such as patentable material,                 BILLING CODE 4140–01–P
                                                Institute; Notice of Closed Meeting                     and personal information concerning
                                                                                                        individuals associated with the grant
                                                  Pursuant to section 10(d) of the                      applications, the disclosure of which                 DEPARTMENT OF HEALTH AND
                                                Federal Advisory Committee Act, as                      would constitute a clearly unwarranted                HUMAN SERVICES
                                                amended (5 U.S.C. App.), notice is                      invasion of personal privacy.
                                                hereby given of the following meeting.                                                                        National Institutes of Health
                                                  The meeting will be closed to the                       Name of Committee: National Institute of
                                                public in accordance with the                           Diabetes and Digestive and Kidney Diseases            Request for Information on Input on
                                                provisions set forth in sections                        Special Emphasis Panel; NIDDK Central                 Opportunities of Engagement of
                                                                                                        Biorepositories Non-renewable Sample                  External Stakeholders With the
                                                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              Access (X01) PAR–14–301.
                                                as amended. The grant applications and                    Date: May 11, 2017.
                                                                                                                                                              ‘‘Illuminating the Druggable Genome’’
                                                the discussions could disclose                            Time: 1:00 p.m. to 2:30 p.m.                        (IDG) Program
                                                confidential trade secrets or commercial                  Agenda: To review and evaluate grant                SUMMARY:    NIH seeks input from the
                                                property such as patentable material,                   applications.                                         biomedical research community,
                                                and personal information concerning                       Place: National Institutes of Health, Two
                                                                                                        Democracy Plaza, 6707 Democracy
                                                                                                                                                              biotechnology and pharmaceutical
                                                individuals associated with the grant                                                                         companies and other members of the
                                                applications, the disclosure of which                   Boulevard, Bethesda, MD 20892 (Telephone
                                                                                                        Conference Call).                                     public on interest and opportunities of
                                                would constitute a clearly unwarranted                                                                        engagement with the Illuminating the
                                                                                                          Contact Person: Najma Begum, Ph.D.,
                                                invasion of personal privacy.                           Scientific Review Officer, Review Branch,             Druggable Genome (IDG) Program. The
                                                  Name of Committee: National Heart, Lung,              DEA, NIDDK, National Institutes of Health,            purpose of this Request for Information
                                                and Blood Institute Special Emphasis Panel;             Room 7349, 6707 Democracy Boulevard,                  (RFI) is to identify and obtain comments
                                                Genetic Basis and/or Omics Phenotypes of                Bethesda, MD 20892–5452, (301) 594–8894,              on strategies for sharing potential data,
                                                Heart, Lung and Blood Disorders.                        begumn@niddk.nih.gov.                                 tools, and other resources of common
                                                  Date: May 12, 2017.                                     Name of Committee: National Institute of
                                                  Time: 8:00 a.m. to 5:00 p.m.
                                                                                                                                                              interest generated by the IDG Program
                                                                                                        Diabetes and Digestive and Kidney Diseases            and by external stakeholders to
                                                  Agenda: To review and evaluate grant                  Special Emphasis Panel; PAR–16–034:
                                                applications.                                           NIDDK Ancillary Studies to Major Ongoing
                                                                                                                                                              maximize the impact of the IDG
                                                  Place: Residence Inn Bethesda, 7335                   Clinical Studies (R01).                               Program.
                                                Wisconsin Avenue, Bethesda, MD 20814.                     Date: May 15, 2017.                                 DATES: The IDG Program Request for
                                                  Contact Person: Chang Sook Kim, Ph.D.,                  Time: 2:00 p.m. to 4:00 p.m.                        Information is open for public comment
sradovich on DSK3GMQ082PROD with NOTICES




                                                Scientific Review Officer, Office of Scientific           Agenda: To review and evaluate grant
                                                Review/DERA, National Heart, Lung, and
                                                                                                                                                              for a period of 30 days. Comments must
                                                                                                        applications.                                         be received by May 18, 2017 to ensure
                                                Blood Institute, 6701 Rockledge Drive, Room               Place: National Institutes of Health, Two
                                                7188, Bethesda, MD 20892–7924, 301–435–                 Democracy Plaza, 6707 Democracy
                                                                                                                                                              consideration. After the public comment
                                                0287, carolko@mail.nih.gov.                             Boulevard, Bethesda, MD 20892 (Telephone              period has closed, the comments
                                                (Catalogue of Federal Domestic Assistance               Conference Call).                                     received by the IDG Program will be
                                                Program Nos. 93.233, National Center for                  Contact Person: Najma Begum, Ph.D.,                 considered in a timely manner by the
                                                Sleep Disorders Research; 93.837, Heart and             Scientific Review Officer, Review Branch,             National Center for Advancing


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                                                                               Federal Register / Vol. 82, No. 73 / Tuesday, April 18, 2017 / Notices                                            18307

                                                Translational Sciences (NCATS) and the                  2. Information Requested                              DEPARTMENT OF HEALTH AND
                                                National Institute of Diabetes and                                                                            HUMAN SERVCES
                                                Digestive and Kidney Diseases (NIDDK).                     NIH is seeking input from national
                                                                                                        and international experts and interested              Substance Abuse and Mental Health
                                                ADDRESSES:    Submissions may be sent                   members of the public that includes, but              Services Administration
                                                electronically to DK-IDG-Phase2-RFI@                    is not limited to, the following areas:
                                                mail.nih.gov or by mail to Dr. Karlie                                                                         Agency Information Collection
                                                Sharma, National Center for Advancing                      • Resources that an outside
                                                                                                                                                              Activities: Proposed Collection;
                                                Translational Sciences, National                        organization (biotechnology or
                                                                                                                                                              Comment Request
                                                Institutes of Health, 6701 Democracy                    pharmaceutical company; non-profit
                                                Blvd., Suite 900, Bethesda, MD 20892.                   organization; academic institution and                   In compliance with Section
                                                                                                        national/international consortia) might               3506(c)(2)(A) of the Paperwork
                                                FOR FURTHER INFORMATION CONTACT:
                                                                                                        be willing to share with the IDG                      Reduction Act of 1995 concerning
                                                Questions about this request for                                                                              opportunity for public comment on
                                                                                                        Program and may:
                                                information should be directed to Dr.                                                                         proposed collections of information, the
                                                Karlie Sharma, National Center for                      Æ Strategize development of chemical
                                                                                                                                                              Substance Abuse and Mental Health
                                                Advancing Translational Sciences,                          probes against proteins drawn from
                                                                                                                                                              Services Administration (SAMHSA)
                                                National Institutes of Health, 6701                        the IDG focused list
                                                                                                                                                              will publish periodic summaries of
                                                Democracy Blvd., Suite 900, Bethesda,                   Æ develop assays and platforms that can               proposed projects. To request more
                                                MD 20892, DK-IDG-Phase2-RFI@                               help to answer questions about                     information on the proposed project or
                                                mail.nih.gov, 301–451–4965.                                understudied protein function                      to obtain a copy of the information
                                                SUPPLEMENTARY INFORMATION:     Out of the               Æ identify reagents that may be useful                collection plans, call the SAMHSA
                                                nearly 30,000 genes in the human                           in annotation efforts                              Reports Clearance Officer at (240) 276–
                                                genome, approximately 3,000 genes are                                                                         1243.
                                                                                                        Æ provide data or knowledge on any                       Comments are invited on: (a) Whether
                                                estimated to be part of the druggable
                                                genome—the subset of genes expressing                      understudied protein                               the proposed collection of information
                                                proteins with the ability to bind drug-                    • Potential resources of the IDG                   is necessary for the proper performance
                                                like molecules. Yet, only about ten                     Program that are of interest to an outside            of the functions of the agency, including
                                                percent of druggable proteins are                       organization of the broader biomedical                whether the information shall have
                                                targeted by Food and Drug                               research community including:                         practical utility; (b) the accuracy of the
                                                Administration (FDA)-approved drugs.                    Æ Sharable databases of relevant subsets              agency’s estimate of the burden of the
                                                Many proteins that comprise the                            of data on understudied proteins                   proposed collection of information; (c)
                                                druggable genome are members of the G-                                                                        ways to enhance the quality, utility, and
                                                protein coupled receptor (GPCR), ion                    Æ data analysis and query tools                       clarity of the information to be
                                                channel, and kinase families. A                         Æ links between protein target and                    collected; and (d) ways to minimize the
                                                significant number of proteins within                      disease pathologies                                burden of the collection of information
                                                these classes are understudied and are                  Æ new methods of analysis to accelerate               on respondents, including through the
                                                the focus of the data and resource                                                                            use of automated collection techniques
                                                                                                           collection of data
                                                generation initiative of the IDG Program.                                                                     or other forms of information
                                                                                                           This RFI is for planning purposes                  technology.
                                                1. Goals and Requirements                               only and should not be construed as a
                                                                                                        solicitation for applications or                      Proposed Project: Strategic Prevention
                                                  The IDG Program was originally                                                                              Framework for Prescription Drugs
                                                funded as a three-year pilot program in                 proposals, or as an obligation in any
                                                                                                                                                              (SPF-Rx)—New
                                                2014 with two overarching goals: (1)                    way on the part of the United States
                                                Integrate information about                             Federal government. The Federal                          The Substance Abuse and Mental
                                                understudied druggable proteins from                    government will not pay for the                       Health Services Administration
                                                disparate sources into a single                         preparation of any information                        (SAMHSA)’s Center for Substance
                                                informatics site and (2) foster                         submitted or for the government’s use.                Abuse Prevention (CSAP) aims to
                                                technology development to enable the                    Additionally, the government cannot                   conduct a cross-site evaluation of the
                                                determination of function and                           guarantee the confidentiality of the                  Strategic Prevention Framework for
                                                therapeutic potential of understudied                   information provided.                                 Prescription Drugs (SPF-Rx) program.
                                                druggable proteins. Having successfully                                                                       The SPF-Rx program is designed to
                                                                                                          Dated: April 12, 2017.                              address nonmedical use of prescription
                                                achieved these goals, the IDG Program is
                                                currently transitioning to a new                        Christopher P. Austin,                                drugs (as well as opioid overdoses) by
                                                implementation phase intended to:                       Director, NCATS.                                      raising awareness about the dangers of
                                                                                                                                                              sharing medications. and by working
                                                  • Expand the informatics tools                        Griffin P. Rodgers,
                                                                                                        Director, NIDDK, Illuminating the Druggable
                                                                                                                                                              with pharmaceutical and medical
                                                developed in the pilot phase to include
                                                                                                        Genome Program, National Center for                   communities. The SPF-Rx program aims
                                                additional data and allow users to
                                                                                                        Advancing Translational Sciences, National            to promote collaboration between states/
                                                access, analyze, and visualize a wide
                                                                                                        Institute of Diabetes and Digestive and Kidney        tribes and pharmaceutical and medical
                                                range of information on sets of proteins.
                                                                                                        Diseases.                                             communities to understand the risks of
                                                  • Facilitate the elucidation of the                                                                         overprescribing to youth ages 12–17 and
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                        [FR Doc. 2017–07795 Filed 4–17–17; 8:45 am]
                                                function of understudied proteins from                                                                        adults 18 years of age and older. The
                                                the three key druggable protein families                BILLING CODE 4140–01–P
                                                                                                                                                              program also aims to enhance capacity
                                                (GPCR, ion channels, and kinases) by                                                                          for, and access to, Prescription Drug
                                                generating new reagents and new data.                                                                         Monitoring Program (PDMP) data for
                                                  • Disseminate the IDG-generated                                                                             prevention purposes.
                                                resources and data to the greater                                                                                The SPF-Rx program aims to address
                                                scientific community.                                                                                         SAMHSA’s priorities on prevention and


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Document Created: 2017-04-17 23:59:51
Document Modified: 2017-04-17 23:59:51
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
DatesThe IDG Program Request for Information is open for public comment for a period of 30 days. Comments must be received by May 18, 2017 to ensure consideration. After the public comment period has closed, the comments received by the IDG Program will be considered in a timely manner by the National Center for Advancing Translational Sciences (NCATS) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
ContactQuestions about this request for information should be directed to Dr. Karlie Sharma, National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Blvd., Suite 900, Bethesda, MD 20892, DK-IDG-Phase2- [email protected], 301-451-4965.
FR Citation82 FR 18306 

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