80_FR_20308 80 FR 20236 - Eunice Kennedy Shriver National Institute of Child Health and Human Development Notice of Closed Meeting

80 FR 20236 - Eunice Kennedy Shriver National Institute of Child Health and Human Development Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 72 (April 15, 2015)

Page Range20236-20237
FR Document2015-08572

Federal Register, Volume 80 Issue 72 (Wednesday, April 15, 2015)
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Pages 20236-20237]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-08572]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health and 
Human Development Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel PDB-P2C_Infrastructure/Center 
Grants.
    Date: June 29, 2015.
    Time: 8:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.

[[Page 20237]]

    Place: Doubletree Hotel Washington, 1515 Rhode Island Ave. NW., 
Washington, DC 20005.
    Contact Person: CARLA T. WALLS, Ph.D., Scientific Review 
Officer, Scientific Review Branch, EUNICE KENNEDY SHRIVER NATIONAL 
INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT, NIH, 6100 EXECUTIVE 
BOULEVARD, ROOM 5B01, BETHESDA, MD 20892-9304, (301) 435-6898, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.864, 
Population Research; 93.865, Research for Mothers and Children; 
93.929, Center for Medical Rehabilitation Research; 93.209, 
Contraception and Infertility Loan Repayment Program, National 
Institutes of Health, HHS)

    Dated: April 9, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-08572 Filed 4-14-15; 8:45 am]
 BILLING CODE 4140-01-P



                                              20236                                  Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices

                                                • Step 4: Authorized Organization                                         ACTION:       Notice.                                                       Information Collection Request Title:
                                              Representative (AOR) Authorization                                                                                                                      Evaluation of Pregnancy Prevention
                                                • Step 5: Track AOR Status                                                SUMMARY:   In compliance with section                                       Approaches—First Follow-up
                                                • Step 6: Register With Electronic                                        3507(a)(1)(D) of the Paperwork
                                              Research Administration (eRA)                                               Reduction Act of 1995, the Office of the                                       Abstract: The Office of Adolescent
                                              Commons                                                                     Secretary (OS), Department of Health                                        Health (OAH), U.S. Department of
                                                Steps 1 through 5, in detail, can be                                      and Human Services, has submitted an                                        Health and Human Services (HHS) is
                                              found at http://www07.grants.gov/                                           Information Collection Request (ICR),                                       requesting an extension without change
                                              applicants/organization_                                                    described below, to the Office of                                           of a currently approved information
                                              registration.jsp. Step 6, in detail, can be                                 Management and Budget (OMB) for                                             collection request by OMB. The purpose
                                              found at https://commons.era.nih.gov/                                       review and approval. The ICR is for                                         of the extension is to complete the
                                              commons/registration/                                                       renewal of the approved information                                         ongoing follow-up data collection for
                                              registrationInstructions.jsp. After you                                     collection assigned OMB control                                             the Evaluation of Adolescent Pregnancy
                                              have followed these steps, submit the                                       number 0990–0382, scheduled to expire                                       Prevention Approaches (PPA), a multi-
                                              electronic application to: http://                                          on May 31, 2015. Comments submitted                                         site random assignment evaluation of
                                              www.grants.gov.                                                             during the first public review of this ICR                                  promising approaches to teen pregnancy
                                                                                                                          will be provided to OMB. OMB will                                           prevention.
                                                Dated: April 8, 2015.
                                                                                                                          accept further comments from the                                               Need and Proposed Use of the
                                              Leslie Kux,                                                                                                                                             Information: The PPA study is being
                                                                                                                          public on this ICR during the review
                                              Associate Commissioner for Policy.                                          and approval period.                                                        conducted in seven program sites
                                              [FR Doc. 2015–08613 Filed 4–14–15; 8:45 am]                                                                                                             around the country. The proposed
                                                                                                                          DATES: Comments on the ICR must be
                                              BILLING CODE 4164–01–P
                                                                                                                          received on or before May 15, 2015.                                         extension is necessary to complete
                                                                                                                                                                                                      ongoing follow-up data collection in
                                                                                                                          ADDRESSES: Submit your comments to                                          five of the seven study sites. The
                                              DEPARTMENT OF HEALTH AND                                                    OIRA_submission@omb.eop.gov or via                                          resulting data will be used in a rigorous
                                              HUMAN SERVICES                                                              facsimile to (202) 395–5806.                                                program impact analysis to assess the
                                                                                                                          FOR FURTHER INFORMATION CONTACT:                                            effectiveness of each program in
                                              Office of the Secretary                                                     Information Collection Clearance staff,                                     reducing rates of teen pregnancy and
                                              [Document Identifier: HHS–OS–0990–0382-                                     Information.CollectionClearance@                                            associated sexual risk behaviors.
                                              30–D]                                                                       hhs.gov or (202) 690–6162.                                                     Likely Respondents: The 1484 youth
                                                                                                                          SUPPLEMENTARY INFORMATION: When                                             participants who agreed to participate in
                                              Agency Information Collection                                                                                                                           the study upon sample enrollment in 5
                                              Activities; Submission to OMB for                                           submitting comments or requesting
                                                                                                                          information, please include the OMB                                         impact study sites.
                                              Review and Approval; Public Comment
                                              Request                                                                     control number 0990–0382 and                                                   The total annual burden hours
                                                                                                                          document identifier HHS–OS–30D for                                          estimated for this ICR are summarized
                                              AGENCY:        Office of the Secretary, HHS.                                reference.                                                                  in the table below.

                                                                                                                TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                                                                                  Average
                                                                                                                                                                                                    Number of
                                                                                                                                                                         Number of                                              burden per              Total burden
                                                                                               Form name                                                                                          responses per
                                                                                                                                                                        respondents                                              response                  hours
                                                                                                                                                                                                    respondent                   (in hours)

                                              Oklahoma Institute for Child Advocacy (OICA) ...............................................                                               294                            2                  42/60                 412
                                              Ohio Health ......................................................................................................                         148                            3                  42/60                 310
                                              Children’s Hospital Los Angeles ......................................................................                                     254                            2                  36/60                 305
                                              EngenderHealth ...............................................................................................                             240                            2                  36/60                 288
                                              Princeton Center for Leadership Training .......................................................                                           548                            2                  36/60                 658

                                                    Total ..........................................................................................................   ........................   ........................   ........................          1,973



                                              Terry S. Clark,                                                             DEPARTMENT OF HEALTH AND                                                    amended. The grant applications and
                                              Assistant Information Collection Clearance                                  HUMAN SERVICES                                                              the discussions could disclose
                                              Officer.                                                                                                                                                confidential trade secrets or commercial
                                              [FR Doc. 2015–08541 Filed 4–14–15; 8:45 am]                                 National Institutes of Health                                               property such as patentable material,
                                              BILLING CODE 4150–30–P
                                                                                                                                                                                                      and personal information concerning
                                                                                                                          Eunice Kennedy Shriver National                                             individuals associated with the grant
                                                                                                                          Institute of Child Health and Human                                         applications, the disclosure of which
                                                                                                                          Development Notice of Closed Meeting                                        would constitute a clearly unwarranted
                                                                                                                                                                                                      invasion of personal privacy.
                                                                                                                            Pursuant to section 10(d) of the
                                                                                                                          Federal Advisory Committee Act, as                                            Name of Committee: National Institute of
tkelley on DSK3SPTVN1PROD with NOTICES




                                                                                                                          amended (5 U.S.C. App.), notice is                                          Child Health and Human Development
                                                                                                                          hereby given of the following meeting.                                      Special Emphasis Panel PDB–P2C_
                                                                                                                                                                                                      Infrastructure/Center Grants.
                                                                                                                            The meeting will be closed to the                                           Date: June 29, 2015.
                                                                                                                          public in accordance with the                                                 Time: 8:00 a.m. to 6:00 p.m.
                                                                                                                          provisions set forth in section 552b(c)(4)                                    Agenda: To review and evaluate grant
                                                                                                                          and 552b(c)(6), Title 5 U.S.C., as                                          applications.



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                                                                           Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices                                           20237

                                                Place: Doubletree Hotel Washington, 1515              environmentally responsive genes may                  platforms. In Phase III, the focus is on
                                              Rhode Island Ave. NW., Washington, DC                   also be useful in biomarker                           assaying chemicals in high-content
                                              20005.                                                  development and basic research efforts.               screens and mid to high throughput
                                                Contact Person: CARLA T. WALLS, Ph.D.,                This list of genes, referred to as the                transcriptomic screens. High throughput
                                              Scientific Review Officer, Scientific Review
                                              Branch, EUNICE KENNEDY SHRIVER
                                                                                                      ‘‘S1500’’ gene list, or gene set, is                  gene expression changes will be the
                                              NATIONAL INSTITUTE OF CHILD HEALTH                      available for public comment.                         primary metric that is employed in
                                              AND HUMAN DEVELOPMENT, NIH, 6100                        DATES: The deadline for receipt of                    Phase III to measure biological effects
                                              EXECUTIVE BOULEVARD, ROOM 5B01,                         comments is May 15, 2015.                             from chemical exposures.
                                              BETHESDA, MD 20892–9304, (301) 435–                     ADDRESSES: Comments on the human                         To conduct Tox21 Phase III, Tox21
                                              6898, wallsc@mail.nih.gov.                              S1500 gene set should be submitted                    partners initiated the ‘‘S1500 Genes
                                              (Catalogue of Federal Domestic Assistance               electronically in Microsoft Excel or                  High Throughput Transcriptomics’’
                                              Program Nos. 93.864, Population Research;               Word formats to Genelist@niehs.nih.gov.               project to capture information from the
                                              93.865, Research for Mothers and Children;              Nominations for genes to be added to                  whole transcriptome (i.e., the entirety of
                                              93.929, Center for Medical Rehabilitation                                                                     all expressed RNA molecules in a cell
                                                                                                      the S1500 must be accompanied with a
                                              Research; 93.209, Contraception and
                                                                                                      strong scientific justification for                   or biological sample). This project will
                                              Infertility Loan Repayment Program, National
                                              Institutes of Health, HHS)                              inclusion.                                            use a targeted subset of genes in a HTS
                                                                                                      FOR FURTHER INFORMATION CONTACT: Dr.
                                                                                                                                                            or semi-HTS platform to gain insight
                                                Dated: April 9, 2015.                                                                                       into how biological systems respond to
                                              Carolyn Baum,                                           Elizabeth Maull, NIEHS, P.O. Box 12233
                                                                                                      (MD K2–17), Research Triangle Park, NC                chemical exposures. Neither the actual
                                              Program Analyst, Office of Federal Advisory                                                                   number of genes to be utilized, nor the
                                              Committee Policy.
                                                                                                      27709; email: maull@niehs.nih.gov.
                                                                                                                                                            specific transcriptomics platform(s)
                                                                                                      SUPPLEMENTARY INFORMATION:
                                              [FR Doc. 2015–08572 Filed 4–14–15; 8:45 am]
                                                                                                         Background: In 2008, NIEHS/NTP, the                needed to carry out the project, have
                                              BILLING CODE 4140–01–P
                                                                                                      U.S. Environmental Protection Agency’s                been finalized.
                                                                                                      (EPA) National Center for                                In an effort to select an appropriate
                                                                                                      Computational Toxicology (NCCT), and                  subset of key representative or
                                              DEPARTMENT OF HEALTH AND                                                                                      ‘‘sentinel’’ genes, the NTP previously
                                              HUMAN SERVICES                                          the National Human Genome Research
                                                                                                      Institute (NHGRI)/NIH Chemical                        requested input from the scientific
                                                                                                      Genomics Center (NCGC) (now located                   community (78 FR 45542, July 29, 2013)
                                              National Institutes of Health                                                                                 on the ‘‘Nomination and Prioritization
                                                                                                      within the National Center for
                                              List of Environmentally Responsive                      Advancing Translational Sciences                      of Environmentally Responsive Genes
                                              Human Genes Selected for Use In                         (NCATS)) entered into a formal                        for Use in Screening Large Numbers of
                                              Screening Large Numbers of                              agreement to develop a vision and                     Substances Using Toxicogenomic
                                              Substances Using Toxicogenomic                          devise an implementation strategy to                  Technologies.’’ An interagency working
                                              Approaches                                              shift the assessment of chemical hazards              group composed of members of the
                                                                                                      from traditional, experimental animal,                Tox21 partnership considered the input
                                                Request for Comments: The National                    toxicology studies to target-specific,                provided in response to the Federal
                                              Institute of Environmental Health                       mechanism-based, biological                           Register notice as they developed a
                                              Sciences/National Toxicology Program                    observations largely obtained using in                consensus strategy to select appropriate
                                              requests comments on a list of                          vitro assays. In mid-2010, the U.S. Food              genes.
                                              environmentally responsive human                        and Drug Administration (FDA) joined                     The working group’s goal was to
                                              genes selected for use in screening large               the collaboration that is known                       select the most relevant and biologically
                                              numbers of substances using                             informally as Tox21.                                  diverse set of sentinel genes to represent
                                              toxicogenomic approaches.                                  Tox21 partner agencies collaborate to              transcriptomic responses to injury.
                                              SUMMARY: The National Institute of                      research, develop, validate, and                      Criteria for the selection and evaluation
                                              Environmental Health Sciences                           translate innovative testing methods for              of an appropriate gene set are: (1)
                                              (NIEHS)/National Toxicology Program                     characterization of toxicity pathways;                Representative of highly diverse gene
                                              (NTP) requests comments on a set of                     identify compounds, assays, informatic                expression changes reported to date, (2)
                                              human genes that have been identified                   analyses, and targeted testing needed to              capable of predicting the gene
                                              and prioritized as environmentally                      support the development of new                        expression changes observed across the
                                              responsive genes. These genes will be                   methods; identify patterns of                         transcriptome, and (3) coverage of all
                                              used in toxicogenomics approaches to                    compound-induced biological                           major biological pathways.
                                              screen cells or tissues obtained from                   response(s) in order to characterize                     The current version of the human
                                              humans against large numbers of                         toxicity pathways; facilitate cross-                  S1500 gene set can be found at http://
                                              chemicals. The goal was to generate a                   species and low-dose extrapolation;                   ntp.niehs.nih.gov/go/S1500. This site
                                              set of approximately 1500 human genes                   prioritize compounds for more                         will be updated as changes to the list are
                                              to evaluate transcriptional changes in                  extensive toxicological evaluation; and               made. The consensus strategy for
                                              response to chemical exposures. Similar                 develop predictive models for biological              selection of an appropriate sentinel gene
                                              gene sets will be developed for                         response in humans. The primary                       set can be accessed at the same site.
                                              screening cells or tissues from other                   activity of Tox21 Phase I was the                        Comments on the human S1500 gene
                                              species such as rats, mice, zebrafish,                  development of a quantitative high                    set should be submitted electronically
                                              and Caenorhabditis elegans. The human                   throughput screening (qHTS) approach                  in Microsoft Excel or Word format to
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                                              gene set should provide maximal                         for toxicology. The goal of Phase II was              Genelist@niehs.nih.gov.
                                              toxicogenomic information on effects                    the implementation of the qHTS                           Respondents to this request are asked
                                              from chemical exposures that reflect                    approach in screening a 10,000                        to provide their name, affiliation,
                                              general cellular responses, independent                 compound library through a variety of                 address, and contact information
                                              of cell type or species, and gene                       nuclear receptor agonist/antagonist and               (including telephone and fax numbers,
                                              expression changes that are specific by                 stress response pathway assays,                       and email address). The deadline for
                                              organ and/or cell type. Such a list of                  utilizing primarily reporter gene                     receipt of comments is May 15, 2015.


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Document Created: 2015-12-18 11:13:47
Document Modified: 2015-12-18 11:13:47
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
DatesJune 29, 2015.
FR Citation80 FR 20236 

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