80_FR_60887 80 FR 60693 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting

80 FR 60693 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 194 (October 7, 2015)

Page Range60693-60694
FR Document2015-25439

Federal Register, Volume 80 Issue 194 (Wednesday, October 7, 2015)
[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)]
[Notices]
[Pages 60693-60694]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25439]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Diabetes and Digestive and Kidney Diseases; 
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 sections 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 Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel, Look AHEAD Brain MRI-2.
    Date: December 1, 2015.
    Time: 1:00 p.m. to 2:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Two Democracy Plaza, 6707 
Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference 
Call).
    Contact Person: Paul A. Rushing, Ph.D., Scientific Review 
Officer, Review Branch, DEA, NIDDK, National Institutes of Health, 
Room 747, 6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 
594-8895, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.847, 
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive 
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology 
and Hematology Research, National Institutes of Health, HHS)


[[Page 60694]]


    Dated: October 1, 2015.
David Clary,
 Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-25439 Filed 10-6-15; 8:45 am]
 BILLING CODE 4140-01-P



                                                                               Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices                                                 60693

                                                    FOR FURTHER INFORMATION CONTACT:     RoC                • Mountaintop removal mining (health                  physical substances, or mixtures
                                                    Nominations: Dr. Ruth Lunn, Director,                     impacts on surrounding communities)                 (collectively referred to as ‘‘substances’’)
                                                    ORoC; telephone (919) 316–4637; lunn@                   • Neonicotinoid pesticides                            cause adverse non-cancer health
                                                    niehs.nih.gov. OHAT Nominations: Dr.                    • Fluoride (developmental                             outcomes. As part of these evaluations,
                                                    Kristina Thayer, Director, OHAT,                          neurotoxicity and endocrine                         NTP may also provide opinions on
                                                    telephone (919) 541–5021; thayer@                         disruption)                                         whether these substances might be of
                                                    niehs.nih.gov. Address for Dr. Lunn and                    Information on RoC nominations                     concern for causing adverse effects on
                                                    Dr. Thayer: DNTP, NIEHS, 111 T.W.                       should be submitted electronically on                 human health given what is known
                                                    Alexander Drive, P.O. Box 12233,                        the ORoC nomination page                              about toxicity and current human
                                                    Research Triangle Park, NC 27709.                       (http://ntp.niehs.nih.gov/go/rocnom) or               exposure levels.
                                                    SUPPLEMENTARY INFORMATION: Request                      by email to lunn@niehs.nih.gov.                         Dated: October 1, 2015.
                                                    for Information: The NTP requests                       Information on OHAT nominations                       John R. Bucher,
                                                    information on nine substances: Six                     should be submitted electronically on                 Associate Director, National Toxicology
                                                    substances have been nominated for                      the OHAT nominated topics page                        Program.
                                                    possible review for future editions of the              (http://ntp.niehs.nih.gov/go/763346) or               [FR Doc. 2015–25434 Filed 10–6–15; 8:45 am]
                                                    RoC (see http://ntp.niehs.nih.gov/go/                   to thayer@niehs.nih.gov. Public                       BILLING CODE 4140–01–P
                                                    rocnom) and three are under                             comments should include the
                                                    consideration by OHAT for evaluation                    submitter’s name, affiliation, sponsoring
                                                    of non-cancer health outcomes. (see                     organization (if any) along with                      DEPARTMENT OF HEALTH AND
                                                    http://ntp.niehs.nih.gov/go/763346).                    appropriate contact information                       HUMAN SERVICES
                                                    Specifically, NTP requests information                  (telephone and email). Written
                                                    on each substance regarding: (1) Data on                information received in response to this              National Institutes of Health
                                                    current production, use patterns, and                   notice will be posted on the NTP Web
                                                    human exposure; (2) published,                          site, and the submitter identified by                 National Institute of Diabetes and
                                                    ongoing, or planned studies related to                  name, affiliation, and/or sponsoring                  Digestive and Kidney Diseases; Notice
                                                    evaluating adverse health outcomes                      organization.                                         of Closed Meeting
                                                    (e.g., cancer, development,                                Responses to this request for
                                                    reproductive, or immunological                          information are voluntary. This request                 Pursuant to section 10(d) of the
                                                    disorders); (3) scientific issues                       for information is for planning purposes              Federal Advisory Committee Act, as
                                                    important for prioritizing and assessing                only and is not a solicitation for                    amended (5 U.S.C. App.), notice is
                                                    adverse health outcomes; and (4) names                  applications or an obligation on the part             hereby given of the following meeting.
                                                    of scientists with expertise or                         of the U.S. Government to provide                       The meeting will be closed to the
                                                    knowledge about the substance—please                    support for any ideas identified in                   public in accordance with the
                                                    include any bibliographic citations                     response to it. Please note that the U.S.             provisions set forth in sections
                                                    when available. NTP will use this                       Government will not pay for the                       552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                    information in determining which                        preparation of any information                        as amended. The grant applications and
                                                    substances to propose for formal health                 submitted or for its use. No proprietary,             the discussions could disclose
                                                    hazard evaluations.                                     classified, confidential, or sensitive                confidential trade secrets or commercial
                                                                                                            information should be included in your                property such as patentable material,
                                                    Six Substances Nominated for Possible
                                                                                                            response.                                             and personal information concerning
                                                    Review for the RoC *
                                                                                                               Background Information on ORoC: On                 individuals associated with the grant
                                                    Flame Retardants                                        behalf of NTP, ORoC manages                           applications, the disclosure of which
                                                                                                            preparation of the RoC following an
                                                    • Pentabromodiphenyl ether mixture                                                                            would constitute a clearly unwarranted
                                                                                                            established, four-part process (http://               invasion of personal privacy.
                                                      (DE–71)
                                                                                                            ntp.niehs.nih.gov/go/rocprocess). The
                                                    • Tetrabromobisphenol A, CASRN 79–                                                                              Name of Committee: National Institute of
                                                                                                            RoC is a congressionally mandated,
                                                      94–7                                                                                                        Diabetes and Digestive and Kidney Diseases
                                                                                                            science-based, public health report that              Special Emphasis Panel, Look AHEAD Brain
                                                    Water Disinfection Byproducts                           identifies agents, substances, mixtures,              MRI–2.
                                                                                                            or exposures (collectively called
                                                    • Dibromoacetonitrile, CASRN 3252–                                                                              Date: December 1, 2015.
                                                                                                            ‘‘substances’’) in our environment that                 Time: 1:00 p.m. to 2:00 p.m.
                                                      43–5
                                                                                                            pose a cancer hazard for people in the                  Agenda: To review and evaluate grant
                                                    • Di- and tri-haloacetic acids (as a
                                                                                                            United States. Published biennially,                  applications.
                                                      class); specifically, those haloacetic
                                                                                                            each edition of the RoC is cumulative                   Place: National Institutes of Health, Two
                                                      acids with similar functional or
                                                                                                            and consists of substances newly                      Democracy Plaza, 6707 Democracy
                                                      structural properties that may cause                                                                        Boulevard, Bethesda, MD 20892, (Telephone
                                                                                                            reviewed in addition to those listed in
                                                      similar health hazards                                                                                      Conference Call).
                                                                                                            previous editions. Newly reviewed
                                                    Other                                                   substances with their recommended                       Contact Person: Paul A. Rushing, Ph.D.,
                                                                                                            listing are reviewed and approved by                  Scientific Review Officer, Review Branch,
                                                    • Fluoride, CASRN 7681–49–4                                                                                   DEA, NIDDK, National Institutes of Health,
                                                                                                            the Secretary of Health and Human
                                                    • Vinylidene chloride, CASRN 5–35–4                                                                           Room 747, 6707 Democracy Boulevard,
                                                                                                            Services. The 13th RoC, the latest
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                       * Evaluations for the RoC may seek to                                                                      Bethesda, MD 20892–5452, (301) 594–8895,
                                                                                                            edition, was published on October 2,                  rushingp@extra.niddk.nih.gov.
                                                    list a new substance in the report,                     2014 (available at http://
                                                    reclassify the listing status of a                                                                            (Catalogue of Federal Domestic Assistance
                                                                                                            ntp.niehs.nih.gov/go/roc13). The 14th                 Program Nos. 93.847, Diabetes,
                                                    substance already listed, or remove a                   RoC is under development.                             Endocrinology and Metabolic Research;
                                                    listed substance.                                          Background Information on OHAT:                    93.848, Digestive Diseases and Nutrition
                                                       Three substances are being considered                On behalf of NTP, OHAT conducts                       Research; 93.849, Kidney Diseases, Urology
                                                    for OHAT evaluation of non-cancer                       literature-based evaluations to assess the            and Hematology Research, National Institutes
                                                    health outcomes.                                        evidence that environmental chemicals,                of Health, HHS)



                                               VerDate Sep<11>2014   18:12 Oct 06, 2015   Jkt 238001   PO 00000   Frm 00083   Fmt 4703   Sfmt 4703   E:\FR\FM\07OCN1.SGM   07OCN1


                                                    60694                      Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices

                                                      Dated: October 1, 2015.                               aggregate findings from program                       GLS program foci differ by grantee type,
                                                    David Clary,                                            activities (e.g., Condron et al., 2014;               some instruments will apply to either
                                                    Program Analyst, Office of Federal Advisory             Walrath et al., 2015). As a result of the             State/Tribal or Campus programs only.
                                                    Committee Policy.                                       vast body of information collected and                Of the 11 instruments, 2 will be
                                                    [FR Doc. 2015–25439 Filed 10–6–15; 8:45 am]             analyzed through the cross-site                       administered with State/Tribal and
                                                    BILLING CODE 4140–01–P                                  evaluation of the two GLS Suicide                     Campus grantees (tailored to grantee
                                                                                                            Prevention Programs components—the                    type), 6 are specific to State/Tribal
                                                                                                            GLS State/Tribal Program and the GLS                  grantees, and 3 pertain only to Campus
                                                    DEPARTMENT OF HEALTH AND                                Campus Program—SAMHSA has                             grantees.
                                                    HUMAN SERVICES                                          identified areas for additional
                                                                                                            investigation and the types of inquiry                Instrument Removals
                                                    Substance Abuse and Mental Health                       needed to move the evaluation into its                  Due to the fulfillment of data
                                                    Services Administration                                 next phase.                                           collection goals, six currently-approved
                                                                                                               The NOE aims to address the field’s                instruments and their associated burden
                                                    Agency Information Collection                           need for additional evidence on the                   will be removed. The combined
                                                    Activities: Proposed Collection;                        impacts of the GLS Suicide Prevention                 estimated annual burden for these
                                                    Comment Request                                         Program in three areas: (1) Suicide                   instruments is 4,300 hours. These
                                                                                                            prevention training effectiveness, (2)                include the State/Tribal Training
                                                      In compliance with Section                            early identification and referral on                  Utilization and Preservation Survey.
                                                    3506(c)(2)(A) of the Paperwork                          subsequent care follow-up and
                                                    Reduction Act of 1995 concerning                        adherence, and (3) suicide safer care                 (TUP–S) Adolescent Version, Coalition
                                                    opportunity for public comment on                       practices within health care settings.                Profile, and Coalition Survey, and the
                                                    proposed collections of information, the                The evaluation comprises three distinct,              Campus Training Exit Survey (TES)
                                                    Substance Abuse and Mental Health                       but interconnected core studies—                      Interview Forms, Life Skills Activities
                                                    Services Administration (SAMHSA)                        Training, Continuity of Care (COC), and               Follow-up Interview, and the Student
                                                    will publish periodic summaries of                      Suicide Safer Environment (SSE). The                  Awareness Intercept Survey
                                                    proposed projects. To request more                      Training and SSE studies also have                    Instrument Continuations
                                                    information on the proposed projects or                 ‘‘enhanced’’ study components. Core
                                                    to obtain a copy of the information                     study data align with required program                   Three instruments will be
                                                    collection plans, call the SAMHSA                       activities across the State/Tribal and                administered only in OMB Year 1 to
                                                    Reports Clearance Officer on (240) 276–                 Campus programs and provide                           finalize data collection for the current
                                                    1243.                                                   continuity with and utility of data                   cross-site evaluation protocol. Each
                                                      Comments are invited on: (a) Whether                  previously collected (implementation                  instrument was previously approved as
                                                    the proposed collections of information                 and proximal outcomes). Enhanced                      part of the four-stage approach (OMB
                                                    are necessary for the proper                            components use experimental and                       No. 0930–0286; Expiration, January
                                                    performance of the functions of the                     quasi-experimental methods                            2017) and no changes are being made.
                                                    agency, including whether the                           (randomized controlled trial [RCT] and                These include the State/Tribal Referral
                                                    information shall have practical utility;               retrospective cohort study designs) to                Network Survey (RNS), TUP–S Campus
                                                    (b) the accuracy of the agency’s estimate               truly assess program impacts on distal                Version, and Campus Short Message
                                                    of the burden of the proposed collection                outcomes (e.g., identifications and                   Service Survey (SMSS). Each
                                                    of information; (c) ways to enhance the                 referrals, hospitalizations, and suicide              instrument will be discontinued once
                                                    quality, utility, and clarity of the                    attempts and deaths) without undue                    the associated data collection
                                                    information to be collected; and (d)                    burden on grantees and youth. This                    requirement has been fulfilled.
                                                    ways to minimize the burden of the                      outcome- and impact-focused design                    Instrument Revisions
                                                    collection of information on                            reflects SAMHSA’s desire to assess the
                                                    respondents, including through the use                  implementation, outcomes, and impacts                    Six currently-approved instruments
                                                    of automated collection techniques or                   of the GLS program.                                   will be revised for the NOE. Each of the
                                                    other forms of information technology.                     The NOE builds on information                      instruments, or an iteration thereof, has
                                                                                                            collected through the four-stage cross-               received approval through multiple
                                                    Proposed Project: National Outcomes                                                                           cross-site evaluation packages cleared
                                                                                                            site evaluation approach (context,
                                                    Evaluation of the Garrett Lee Smith                                                                           by OMB. As such, the information
                                                                                                            product, process, and impact) to further
                                                    Suicide Prevention Program—Revision                                                                           gathered has been, and will continue to
                                                                                                            the field of suicide prevention and
                                                      The Substance Abuse and Mental                        mental health promotion. Of notable                   be, crucial to this effort and to the field
                                                    Health Services Administration                          importance, the design now accounts for               of suicide prevention and mental health
                                                    (SAMHSA) Center for Mental Health                       differences in State/Tribal and Campus                promotion.
                                                    Services (CMHS) is requesting clearance                 program grant funding cycles (i.e., 5-                   D Prevention Strategies Inventory
                                                    for the revision of data collection                     year State/Tribal and 3-year Campus                   (PSI): The PSI has been updated to
                                                    associated with the previously-approved                 programs), while also establishing                    enhance the utility and accuracy of the
                                                    cross-site evaluation of the Garrett Lee                continuity with and maximizing utility                data collected. Changes capture
                                                    Smith (GLS) Youth Suicide Prevention                    of data previously collected. Further,                different strategies implemented and
                                                    and Early Intervention Program (GLS                     the evaluation meets the legislative                  products distributed by grantee
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    Suicide Prevention Program), now                        requirements outlined in the GLSMA to                 programs, the population of focus for
                                                    entitled National Outcomes Evaluation                   inform performance and                                each strategy, total GLS budget
                                                    (NOE). The NOE is a proposed redesign                   implementation of programs.                           expenditures, and the percent of funds
                                                    of the currently-approved cross-site                       Eleven data collection activities                  allocated by the activity type.
                                                    evaluation (OMB No. 0930–0286;                          compose the NOE—two new                                  D Training Activity Summary Page
                                                    Expiration, January 2017) that builds on                instruments, three previously-approved                (TASP): New items on the TASP gather
                                                    prior published GLS evaluation                          instruments, and six previously-                      information about the use of behavioral
                                                    proximal and distal training and                        approved and improved instruments. As                 rehearsal and/or role-play and resources


                                               VerDate Sep<11>2014   18:12 Oct 06, 2015   Jkt 238001   PO 00000   Frm 00084   Fmt 4703   Sfmt 4703   E:\FR\FM\07OCN1.SGM   07OCN1



Document Created: 2015-12-15 08:49:00
Document Modified: 2015-12-15 08:49:00
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
DatesDecember 1, 2015.
FR Citation80 FR 60693 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR