80_FR_71049 80 FR 70829 - Submission for OMB Review; 30-Day Comment Request Scientific Information Reporting System (SIRS) NIGMS [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication."> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication." /> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication." />

80 FR 70829 - Submission for OMB Review; 30-Day Comment Request Scientific Information Reporting System (SIRS) NIGMS

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 220 (November 16, 2015)

Page Range70829-70830
FR Document2015-29085

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 23, 2015, page 48549 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of General Medical Sciences (NIGMS), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

Federal Register, Volume 80 Issue 220 (Monday, November 16, 2015)
[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Pages 70829-70830]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29085]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request Scientific 
Information Reporting System (SIRS) NIGMS

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH) has 
submitted to the Office of Management and Budget (OMB) a request for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on August 23, 2015, page 48549 and allowed 60-days for public 
comment. One public comment was received. The purpose of this notice is 
to allow an additional 30 days for public comment. The National 
Institute of General Medical Sciences (NIGMS), National Institutes of 
Health, may not conduct or sponsor, and the respondent is not required 
to respond to, an information collection that has been extended, 
revised, or implemented on or after October 1, 1995, unless it displays 
a currently valid OMB control number.
    Direct Comments To OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, [email protected] or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30-days 
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments or request more information on the 
proposed project contact: Dr. W. Fred Taylor Ph.D., Branch Chief, 
Capacity-Building Branch (CBB), Division of Training, Workforce 
Development, and Diversity (TWD), NIGMS, NIH, 45 Center Drive, Room 
2AS43S, Bethesda MD 20892, or call non-toll-free number (301) 435-0760 
or Email your request, including your address to: 
[email protected]. Formal requests for additional plans and 
instruments must be requested in writing.
    Proposed Collection: Scientific Information Reporting System 
(SIRS), 0925-In Use Without OMB Control Number, National Institute of 
General Medical Sciences (NIGMS), National Institutes of Health (NIH).
    Need and Use of Information Collection: The SIRS is an online data 
collection system whose purpose is to obtain supplemental information 
to the annual Research Performance Progress Report (RPPR) submitted by 
grantees of the Institutional Development Award (IDeA) Program and the 
Native American Research Center for Health (NARCH) Program. The SIRS 
will collect program-specific data not requested in the RPPR data 
collection system. The IDeA Program is a congressionally mandated, 
long-term interventional program administered by NIGMS aimed at 
developing and/or enhancing the biomedical research competitiveness of 
States and Jurisdictions that lag in NIH funding. The NARCH Program is 
an interagency initiative that provides support to American Indian and 
Alaska Native (AI/AN) tribes and organizations for conducting research 
in their communities in order to address health disparities, and to 
develop a cadre of competitive AI/AN scientists and health 
professionals. The data collected by SIRS will provide valuable 
information for the following purposes: (1) Evaluation of progress by 
individual grantees towards achieving grantee-designated and program-
specified goals and objectives, (2) evaluation of the overall program 
for effectiveness, efficiency, and impact in building biomedical 
research capacity and capability, and (3) analysis of outcome measures 
to determine need for refinements and/or adjustments of different 
program features including but not limited to initiatives and 
eligibility criteria. Data collected from SIRS will be used for various 
regular or ad hoc reporting requests from interested stakeholders that 
include members of Congress, state and local officials, other federal 
agencies, professional societies, media, and other parties.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 613.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
         Form name               Respondents         Number of     responses per     hours per     Total annual
                                                    respondents     respondent       response      burden hours
----------------------------------------------------------------------------------------------------------------
SIRS......................  Principal                         37               1             3.5             130
                             Investigators,
                             COBRE Phase I.
SIRS......................  Principal                         36               1             3.5             126
                             Investigators,
                             COBRE Phase II.
SIRS......................  Principal                         35               1             3.5             122
                             Investigators,
                             COBRE Phase III.
SIRS......................  Principal                         24               1             5.5             132
                             Investigators,
                             INBRE.
SIRS......................  Principal                          5               1             3.5              18
                             Investigators, IDeA-
                             CTR.
SIRS......................  Principal                         19               1             4.5              85
                             Investigators,
                             NARCH.
----------------------------------------------------------------------------------------------------------------



[[Page 70830]]

    Dated: November 10, 2015.
Tammy Dean-Maxwell,
Project Clearance Branch Liaison, NIGMS, NIH.
[FR Doc. 2015-29085 Filed 11-13-15; 8:45 am]
BILLING CODE 4140-01-P



                                                                              Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices                                                          70829

                                              property such as patentable materials,                           comment was received. The purpose of                        obtain supplemental information to the
                                              and personal information concerning                              this notice is to allow an additional 30                    annual Research Performance Progress
                                              individuals associated with the grant                            days for public comment. The National                       Report (RPPR) submitted by grantees of
                                              applications, the disclosure of which                            Institute of General Medical Sciences                       the Institutional Development Award
                                              would constitute a clearly unwarranted                           (NIGMS), National Institutes of Health,                     (IDeA) Program and the Native
                                              invasion of personal privacy.                                    may not conduct or sponsor, and the                         American Research Center for Health
                                                Name of Committee: National Institute on                       respondent is not required to respond                       (NARCH) Program. The SIRS will
                                              Minority Health and Health Disparities                           to, an information collection that has                      collect program-specific data not
                                              Special Emphasis Panel, TCC Precision                            been extended, revised, or implemented                      requested in the RPPR data collection
                                              Medicine Face-to-Face Review Meeting.                            on or after October 1, 1995, unless it                      system. The IDeA Program is a
                                                Date: December 8–December 9, 2015.                             displays a currently valid OMB control                      congressionally mandated, long-term
                                                Time: 8:00 a.m. to 5:00 p.m.                                   number.                                                     interventional program administered by
                                                Agenda: To review and evaluate grant                             Direct Comments To OMB: Written
                                              applications.                                                                                                                NIGMS aimed at developing and/or
                                                Place: Bethesda North Conference Center,
                                                                                                               comments and/or suggestions regarding                       enhancing the biomedical research
                                              Marriott at Marinelli Road, 5701 Marinelli                       the item(s) contained in this notice,                       competitiveness of States and
                                              Road, North Bethesda, MD 20852.                                  especially regarding the estimated                          Jurisdictions that lag in NIH funding.
                                                Contact Person: Maryline Laude-Sharp,                          public burden and associated response                       The NARCH Program is an interagency
                                              Ph.D., Scientific Review Officer, National                       time, should be directed to the: Office                     initiative that provides support to
                                              Institute on Minority Health and Health                          of Management and Budget, Office of                         American Indian and Alaska Native (AI/
                                              Disparities, National Institutes of Health,                      Regulatory Affairs, OIRA_submission@
                                              6707 Democracy Blvd., Suite 800, Bethesda,                                                                                   AN) tribes and organizations for
                                                                                                               omb.eop.gov or by fax to 202–395–6974,                      conducting research in their
                                              MD 20892, (301) 451–9536, mlaudesharp@
                                              nih.gov.
                                                                                                               Attention: NIH Desk Officer.                                communities in order to address health
                                                                                                                 Comment Due Date: Comments                                disparities, and to develop a cadre of
                                                Dated: November 9, 2015.                                       regarding this information collection are                   competitive AI/AN scientists and health
                                              David Clary,                                                     best assured of having their full effect if                 professionals. The data collected by
                                              Program Analyst, Office of Federal Advisory                      received within 30-days of the date of                      SIRS will provide valuable information
                                              Committee Policy.                                                this publication.                                           for the following purposes: (1)
                                              [FR Doc. 2015–28833 Filed 11–13–15; 8:45 am]                     FOR FURTHER INFORMATION CONTACT: To                         Evaluation of progress by individual
                                              BILLING CODE 4140–01–P                                           obtain a copy of the data collection                        grantees towards achieving grantee-
                                                                                                               plans and instruments or request more                       designated and program-specified goals
                                                                                                               information on the proposed project                         and objectives, (2) evaluation of the
                                              DEPARTMENT OF HEALTH AND                                         contact: Dr. W. Fred Taylor Ph.D.,
                                              HUMAN SERVICES                                                                                                               overall program for effectiveness,
                                                                                                               Branch Chief, Capacity-Building Branch                      efficiency, and impact in building
                                                                                                               (CBB), Division of Training, Workforce                      biomedical research capacity and
                                              National Institutes of Health
                                                                                                               Development, and Diversity (TWD),                           capability, and (3) analysis of outcome
                                              Submission for OMB Review; 30-Day                                NIGMS, NIH, 45 Center Drive, Room                           measures to determine need for
                                              Comment Request Scientific                                       2AS43S, Bethesda MD 20892, or call                          refinements and/or adjustments of
                                              Information Reporting System (SIRS)                              non-toll-free number (301) 435–0760 or                      different program features including but
                                              NIGMS                                                            Email your request, including your                          not limited to initiatives and eligibility
                                                                                                               address to: taylorwf@mail.nih.gov.                          criteria. Data collected from SIRS will
                                              SUMMARY:   Under the provisions of                               Formal requests for additional plans and
                                              Section 3507(a)(1)(D) of the Paperwork                                                                                       be used for various regular or ad hoc
                                                                                                               instruments must be requested in                            reporting requests from interested
                                              Reduction Act of 1995, the National                              writing.
                                              Institutes of Health (NIH) has submitted                                                                                     stakeholders that include members of
                                                                                                                 Proposed Collection: Scientific
                                              to the Office of Management and Budget                                                                                       Congress, state and local officials, other
                                                                                                               Information Reporting System (SIRS),
                                              (OMB) a request for review and                                   0925-In Use Without OMB Control                             federal agencies, professional societies,
                                              approval of the information collection                           Number, National Institute of General                       media, and other parties.
                                              listed below. This proposed information                          Medical Sciences (NIGMS), National                             OMB approval is requested for 3
                                              collection was previously published in                           Institutes of Health (NIH).                                 years. There are no costs to respondents
                                              the Federal Register on August 23,                                 Need and Use of Information                               other than their time. The total
                                              2015, page 48549 and allowed 60-days                             Collection: The SIRS is an online data                      estimated annualized burden hours are
                                              for public comment. One public                                   collection system whose purpose is to                       613.

                                                                                                             ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                           Number of           Average
                                                                                                                                                         Number of                                          Total annual
                                                 Form name                                        Respondents                                                            responses per       burden hours
                                                                                                                                                        respondents                                         burden hours
                                                                                                                                                                           respondent        per response

                                              SIRS   .................   Principal   Investigators,   COBRE Phase I ..........................                      37                1               3.5            130
                                              SIRS   .................   Principal   Investigators,   COBRE Phase II .........................                      36                1               3.5            126
                                              SIRS   .................   Principal   Investigators,   COBRE Phase III ........................                      35                1               3.5            122
                                              SIRS   .................   Principal   Investigators,   INBRE .........................................               24                1               5.5            132
tkelley on DSK3SPTVN1PROD with NOTICES




                                              SIRS   .................   Principal   Investigators,   IDeA–CTR ...................................                   5                1               3.5             18
                                              SIRS   .................   Principal   Investigators,   NARCH .......................................                 19                1               4.5             85




                                         VerDate Sep<11>2014       19:47 Nov 13, 2015    Jkt 238001    PO 00000      Frm 00083      Fmt 4703      Sfmt 4703   E:\FR\FM\16NON1.SGM   16NON1


                                              70830                      Federal Register / Vol. 80, No. 220 / Monday, November 16, 2015 / Notices

                                                Dated: November 10, 2015.                             DSLD to determine total nutrient intakes                  Name of Committee: National Institute of
                                              Tammy Dean-Maxwell,                                     from food and supplements in                            Allergy and Infectious Diseases Special
                                                                                                      populations they study. Health care                     Emphasis Panel, NIAID Clinical Trial
                                              Project Clearance Branch Liaison, NIGMS,
                                                                                                      providers can learn the content of                      Planning Grant (R34) and Implementation
                                              NIH.
                                                                                                                                                              Cooperative Agreement (U01).
                                              [FR Doc. 2015–29085 Filed 11–13–15; 8:45 am]            products their patients are taking.                       Date: December 9, 2015.
                                              BILLING CODE 4140–01–P                                  Consumers might use the DSLD to                           Time: 1:30 p.m. to 3:30 p.m.
                                                                                                      search for and compare products of                        Agenda: To review and evaluate grant
                                                                                                      interest.                                               applications.
                                              DEPARTMENT OF HEALTH AND                                   The DSLD currently contains 50,000                     Place: National Institutes of Health, Room
                                              HUMAN SERVICES                                          labels, and it is expected to grow rapidly              3C100, 5601 Fishers Lane, Rockville, MD
                                                                                                      over the next three years to include                    20892, (Telephone Conference Call).
                                              National Institutes of Health                           most of the estimated 75,000+ dietary                     Contact Person: Frank S. De Silva, Ph.D.,
                                                                                                      supplement products sold to American                    Scientific Review Officer, Scientific Review
                                              Notice of Opportunity for Public                                                                                Program, Division of Extramural Activities,
                                                                                                      consumers. The DSLD is updated                          Room #3E72A, National Institutes of Health/
                                              Comment on the Dietary Supplement                       regularly to include any formulation
                                              Label Database                                                                                                  NIAID, 5601 Fishers Lane, MSC 9823,
                                                                                                      changes and label information in a                      Bethesda, MD 20892–9823, (240) 669–5023,
                                              SUMMARY:   This document, originally                    product. It also includes the labels of                 fdesilva@niaid.nih.gov.
                                              published on October 29, 2015 (80 FR                    products that have been discontinued                    (Catalogue of Federal Domestic Assistance
                                              66549), has been amended to extend the                  and are no longer sold. More                            Program Nos. 93.855, Allergy, Immunology,
                                              comment receipt date to December 31,                    information about the DSLD and its                      and Transplantation Research; 93.856,
                                              2015. The Office of Dietary                             current capabilities is available at http://            Microbiology and Infectious Diseases
                                              Supplements (ODS) at the National                       www.dsld.nlm.nih.gov and at Dwyer et                    Research, National Institutes of Health, HHS)
                                              Institutes of Health, in partnership with               al., 2014.1                                               Dated: November 9, 2015.
                                              the National Library of Medicine (NLM),                   ODS would like to receive ideas and                   Natasha Copeland,
                                              has developed a Dietary Supplement                      suggestions for how the DSLD might                      Program Analyst, Office of Federal Advisory
                                              Label Database (DSLD) that is compiling                 evolve. What features might be added,                   Committee Policy.
                                              all information from the labels of dietary              improved, or enhanced—for example, in                   [FR Doc. 2015–28835 Filed 11–13–15; 8:45 am]
                                              supplements marketed in the United                      capabilities related to search, sorting,                BILLING CODE 4140–01–P
                                              States. ODS welcomes comments about                     organization, and downloading of
                                              features to add and functionality                       information—that would make it a more
                                              improvements to make so the DSLD may                    valuable tool for users?                                DEPARTMENT OF HEALTH AND
                                              become a more useful tool to users.                       Dated: November 5, 2015.                              HUMAN SERVICES
                                                 A federal stakeholder panel for the                  Lawrence A. Tabak,
                                              DSLD will consider all comments                                                                                 National Institutes of Health
                                                                                                      Deputy Director, National Institutes of Health.
                                              received. The ODS requests input from
                                                                                                      [FR Doc. 2015–29177 Filed 11–13–15; 8:45 am]            Prospective Grant of Exclusive
                                              academic researchers, government
                                              agencies, the dietary supplement                        BILLING CODE 4140–01–P                                  License: Development of Cripto-1
                                              industry, and other interested parties,                                                                         Point of Care (POC) Tests and Kits for
                                              including consumers. The DSLD can be                                                                            the Detection of Cancer
                                                                                                      DEPARTMENT OF HEALTH AND
                                              accessed online at http://                              HUMAN SERVICES                                          AGENCY: National Institutes of Health,
                                              dsld.nlm.nih.gov.                                                                                               Public Health Service, HHS.
                                              DATES:  To ensure full consideration, all               National Institutes of Health                           ACTION: Notice.
                                              comments must be received by 11:59
                                              p.m. EST, December 31, 2015.                            National Institute of Allergy and                       SUMMARY:   This notice, in accordance
                                                                                                      Infectious Diseases; Notice of Closed                   with 35 U.S.C. 209 and 37 CFR part 404,
                                              ADDRESSES: Interested individuals and
                                                                                                      Meeting                                                 that the National Cancer Institute,
                                              organizations should submit their
                                                                                                                                                              National Institutes of Health,
                                              responses to ODS@nih.gov.                                 Pursuant to section 10(d) of the
                                                                                                                                                              Department of Health and Human
                                              FOR FURTHER INFORMATION CONTACT:                        Federal Advisory Committee Act, as
                                                                                                                                                              Services, is contemplating the grant of
                                              Richard Bailen MBA, MHA, Office of                      amended (5 U.S.C. App.), notice is
                                                                                                                                                              an exclusive patent license to practice
                                              Dietary Supplements, National                           hereby given of the following meeting.
                                                                                                                                                              the inventions embodied in the
                                              Institutes of Health, 6100 Executive                      The meeting will be closed to the
                                                                                                                                                              following U.S. Patents and Patent
                                              Boulevard, Room 3B01, Bethesda, MD                      public in accordance with the
                                                                                                                                                              Applications to Beacon Biomedical, Inc.
                                              20892–7517, Phone: 301–435–2920,                        provisions set forth in sections
                                                                                                                                                              (‘‘Beacon’’) located in Scottsdale, AZ,
                                              Fax: 301–480–1845, Email: ODS@                          552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                                                                              USA. A notice was previously
                                              nih.gov.                                                as amended. The grant applications and
                                                                                                                                                              published on December 6, 2013 in
                                                                                                      the discussions could disclose
                                              SUPPLEMENTARY INFORMATION:     The DSLD                                                                         Volume 78, Number 235 for a period of
                                                                                                      confidential trade secrets or commercial
                                              is a free resource that captures all                                                                            thirty (30) days. Herein, the National
                                                                                                      property such as patentable material,
                                              information present on dietary                                                                                  Cancer Institute, National Institutes of
                                                                                                      and personal information concerning
                                              supplement labels as provided by the                                                                            Health, Department of Health and
                                                                                                      individuals associated with the grant
                                              seller, including contents, ingredient                                                                          Human Services, is proposing a
                                                                                                      applications, the disclosure of which
tkelley on DSK3SPTVN1PROD with NOTICES




                                              amounts, and any health-related                                                                                 modification to the contents of the
                                                                                                      would constitute a clearly unwarranted
                                              product statements, claims, and                                                                                 previous notice regarding the following
                                                                                                      invasion of personal privacy.
                                              cautions. It also provides a                                                                                    intellectual property:
                                              downloadable photo of each label. Users                   1 Dwyer JT, Saldanha LG, Bailen RA, et al. A free     U.S. Provisional Patent Application No. 60/
                                              can search for and organize this                        new dietary supplement label database for                   264,643 filed January 26, 2001 entitled
                                              information in various ways. Research                   registered dietitian nutritionists. J Acad Nutr Diet.       ‘‘Detection and Quantification of Cripto-
                                              scientists, for example, could use the                  2014;114(10):1512–7.                                        1’’ [HHS Ref. No. E–290–2000/0–US–01];



                                         VerDate Sep<11>2014   19:47 Nov 13, 2015   Jkt 238001   PO 00000   Frm 00084   Fmt 4703   Sfmt 4703   E:\FR\FM\16NON1.SGM    16NON1



Document Created: 2015-12-14 14:13:34
Document Modified: 2015-12-14 14:13:34
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
DatesComments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
ContactTo obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Dr. W. Fred Taylor Ph.D., Branch Chief, Capacity-Building Branch (CBB), Division of Training, Workforce Development, and Diversity (TWD), NIGMS, NIH, 45 Center Drive, Room 2AS43S, Bethesda MD 20892, or call non-toll-free number (301) 435-0760
FR Citation80 FR 70829 

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