80_FR_82081 80 FR 81830 - Proposed Collection; 60 Day Comment Request; The Framingham Heart Study (NHLBI)

80 FR 81830 - Proposed Collection; 60 Day Comment Request; The Framingham Heart Study (NHLBI)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 251 (December 31, 2015)

Page Range81830-81832
FR Document2015-32940

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Federal Register, Volume 80 Issue 251 (Thursday, December 31, 2015)
[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)]
[Notices]
[Pages 81830-81832]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32940]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60 Day Comment Request; The Framingham Heart 
Study (NHLBI)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Heart, Lung, and 
Blood Institute (NHLBI), the National Institutes of Health (NIH), will 
publish periodic summaries of proposed projects to the Office of 
Management and Budget (OMB) for review and approval.
    Written comments and/or suggestions from the public and affected 
agencies are invited on one or more of the following points: (1) 
Whether the proposed collection of information is necessary for the 
proper performance of the function of the agency, including whether the 
information will have practical utility; (2) The accuracy of the 
agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) Ways to minimize the burden of the 
collection of information on those who are to respond, including the 
use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact: Paul Sorlie, 
6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892, or call non-toll-
free number (301) 435-0456, or Email your request to: 
sorliep@nhlbi.nih.gov. Formal requests for additional plans and 
instruments must be requested in writing.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: The Framingham Heart Study, Revision, 0925-
0216 Expiration Date: 10/31/2016, National Heart, Lung, and Blood 
Institute (NHLBI), the National Institutes of Health (NIH).
    Need and Use of Information Collection: This proposal is to extend 
the Framingham Study to examine the Generation Three Cohort, New 
Offspring Spouses and Omni Group 2 Cohort, as well as to continue to 
monitor the morbidity and mortality which occurs in all Framingham 
Cohorts. The contractor, with the collaborative assistance of NHLBI 
Intramural staff, will invite study participants, schedule 
appointments, administer examinations and testing, enter information 
into computer databases for editing, and prepare scientific reports of 
the information for publication in appropriate scientific journals. All

[[Page 81831]]

participants have been examined previously and thus the study deals 
with a stable, carefully described group. Data are collected in the 
form of an observational health examination involving such components 
as blood pressure measurements, venipuncture, electrocardiography and a 
health interview, including questions about lifestyles and daily living 
situations. The National Heart, Lung, and Blood Institute uses the 
results of the Framingham Study to: (1) Characterize risk factors for 
cardiovascular and lung diseases so that national prevention programs 
can be designed and implemented; (2) evaluate trends in cardiovascular 
diseases and risk factors over time to measure the impact of overall 
preventive measures; and (3) understand the etiology of cardiovascular 
and lung diseases so that effective treatment and preventive modalities 
can be developed and tested. Most of the reports of study results have 
been published in peer reviewed medical journals and books.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 8,382.

Estimated Annualized Burden Hours

                         Table A.12-1.1--Estimate of Respondent Burden, Original Cohort
                                                  [Annualized]
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
               Type of respondent                    Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
I. PARTICIPANT COMPONENTS
ANNUAL FOLLOW-UP
    a. Records Request..........................              30               1           15/60               8
    b. Health Status Update.....................              30               1           15/60               8
                                                 ---------------------------------------------------------------
        SUB-TOTAL: PARTICIPANT COMPONENTS.......            * 30  ..............  ..............              15
II. NON-PARTICIPANT COMPONENTS
    A. Informant Contact (Pre-exam and Annual                 15               1           10/60               3
     Follow-up).................................
    B. Records Request (Annual follow-up).......              30               1           15/60               8
                                                 ---------------------------------------------------------------
        SUB-TOTAL: NON-PARTICIPANT COMPONENTS...              45  ..............  ..............              10
                                                 ---------------------------------------------------------------
            TOTAL: PARTICIPANT AND NON-                       75  ..............  ..............              25
             PARTICIPANT COMPONENTS.............
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Row I.b. above.


             Table A.12-1.2--Estimate of Respondent Burden, Offspring Cohort and Omni Group 1 Cohort
                                                  [Annualized]
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
               Type of respondent                    Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
I. PARTICIPANT COMPONENTS
ANNUAL FOLLOW-UP
    a. Records Request..........................           1,500               1           15/60             375
    b. Health Status Update.....................           1,700               1           15/60             425
                                                 ---------------------------------------------------------------
        SUB-TOTAL: PARTICIPANT COMPONENTS.......         * 1,700  ..............  ..............             800
II. NON-PARTICIPANT COMPONENTS
    A. Informant contact (Pre-exam and Annual                150               1           10/60              25
     Follow-up).................................
    B. Records Request (Annual follow-up).......           1,500               1           15/60             375
                                                 ---------------------------------------------------------------
        SUB-TOTAL: NON-PARTICIPANT COMPONENTS...           1,650  ..............  ..............             400
                                                 ---------------------------------------------------------------
            TOTAL: PARTICIPANT AND NON-                    3,350  ..............  ..............           1,200
             PARTICIPANT COMPONENTS.............
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Row I.b. above.


         Table A.12-1.3--Estimate of Respondent Burden, Generation 3 Cohort, NOS and Omni Group 2 Cohort
                                                  [Annualized]
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
                                                     Number of       Number of     per response    Total annual
               Type of respondent                   respondents    responses per    (hours per      burden hour
                                                                    respondent         year)
----------------------------------------------------------------------------------------------------------------
                                            I. PARTICIPANT COMPONENTS
----------------------------------------------------------------------------------------------------------------
A. PRE-EXAM:
    1.Telephone contact for appointment.........           1,450               1           10/60             242
    2. Exam appointment, scheduling, reminder              1,270               1           35/60             741
     and instructions...........................
B. EXAM CYCLE 3:
    1. Exam at study center.....................           1,200               1          110/60           2,200

[[Page 81832]]

 
    2. Home or nursing home visit...............              35               1           60/60              35
C. POST-EXAM:
    eFHS Mobile Technology for Collection of CVD           1,100              18            9/60           2,970
     Risks......................................
D. ANNUAL FOLLOW-UP:
    1. Records Request..........................           1,200               1           15/60             300
    2. Health Status Update.....................           1,400               1           15/60             350
                                                 ---------------------------------------------------------------
        Sub-Total: Participant Components.......         * 2,850  ..............  ..............           6,830
----------------------------------------------------------------------------------------------------------------
                                II. NON-PARTICIPANT COMPONENTS--ANNUAL FOLLOW-UP
----------------------------------------------------------------------------------------------------------------
A. INFORMANT CONTACTS...........................             180               1           10/60              30
B. RECORD REQUEST...............................           1,155               1           15/60             289
                                                 ---------------------------------------------------------------
    Sub-Total: Non-Participant Components.......           1,335  ..............  ..............             319
                                                 ---------------------------------------------------------------
        Total: Participant And Non-Participant             4,185  ..............  ..............           7,157
         Components.............................
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.A.1 and I.D.2 above.


    Dated: December 22, 2015.
Valery Gheen,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-32940 Filed 12-30-15; 8:45 am]
BILLING CODE 4140-01-P



                                              81830                     Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices

                                              I. Background                                           it satisfies the requirements of the                  Institute (NHLBI), the National
                                                 All medical devices have benefits and                applicable statutes and regulations.                  Institutes of Health (NIH), will publish
                                              risks. Health care providers, patients,                                                                       periodic summaries of proposed
                                                                                                      III. Electronic Access
                                              and consumers must weigh these                                                                                projects to the Office of Management
                                                                                                         Persons interested in obtaining a copy             and Budget (OMB) for review and
                                              benefits and risks when making health
                                                                                                      of the draft guidance may do so by                    approval.
                                              care decisions. FDA weighs probable
                                                                                                      downloading an electronic copy from                      Written comments and/or suggestions
                                              benefit to health from the use of the
                                                                                                      the Internet. A search capability for all             from the public and affected agencies
                                              device against any probable risk of
                                                                                                      Center for Devices and Radiological                   are invited on one or more of the
                                              injury or illness from such use in
                                                                                                      Health guidance documents is available                following points: (1) Whether the
                                              determining the safety and effectiveness
                                                                                                      at http://www.fda.gov/MedicalDevices/                 proposed collection of information is
                                              of a device. However, not all
                                                                                                      DeviceRegulationandGuidance/                          necessary for the proper performance of
                                              information regarding benefits and risks
                                                                                                      GuidanceDocuments/default.htm.                        the function of the agency, including
                                              for a given device may be fully known
                                                                                                      Guidance documents are also available                 whether the information will have
                                              or characterized prior to the device
                                                                                                      at http://www.regulations.gov. Persons                practical utility; (2) The accuracy of the
                                              reaching the market. New information
                                                                                                      unable to download an electronic copy                 agency’s estimate of the burden of the
                                              about the safety and/or effectiveness of
                                                                                                      of ‘‘Public Notification of Emerging                  proposed collection of information,
                                              the device often becomes available once
                                                                                                      Postmarket Medical Device Signals                     including the validity of the
                                              the device is more widely distributed
                                                                                                      (‘Emerging Signals’)’’ may send an email              methodology and assumptions used; (3)
                                              and used under real-world conditions of
                                                                                                      request to CDRH-Guidance@fda.hhs.gov                  Ways to enhance the quality, utility, and
                                              actual clinical practice.
                                                                                                      to receive an electronic copy of the                  clarity of the information to be
                                                 FDA is issuing this draft guidance to
                                                                                                      document. Please use the document                     collected; and (4) Ways to minimize the
                                              describe the Agency’s policy for
                                                                                                      number 1500027 to identify the                        burden of the collection of information
                                              notifying the public about medical
                                                                                                      guidance you are requesting.                          on those who are to respond, including
                                              device ‘‘emerging signals.’’ For the
                                              purposes of this guidance, an emerging                  IV. Paperwork Reduction Act of 1995                   the use of appropriate automated,
                                              signal is new information about a                                                                             electronic, mechanical, or other
                                                                                                        This draft guidance refers to                       technological collection techniques or
                                              medical device used in clinical practice:               previously approved collections of
                                              (1) That the Agency is monitoring or                                                                          other forms of information technology.
                                                                                                      information found in FDA regulations.
                                              analyzing, (2) that has the potential to                                                                      FOR FURTHER INFORMATION CONTACT: To
                                                                                                      These collections of information are
                                              impact patient management decisions                                                                           obtain a copy of the data collection
                                                                                                      subject to review by the Office of
                                              and/or alter the known benefit-risk                                                                           plans and instruments, submit
                                                                                                      Management and Budget (OMB) under
                                              profile of the device, (3) that has not yet                                                                   comments in writing, or request more
                                                                                                      the Paperwork Reduction Act of 1995
                                              been fully validated or confirmed, and                                                                        information on the proposed project,
                                                                                                      (44 U.S.C. 3501–3520). The collections
                                              (4) for which the Agency does not yet                                                                         contact: Paul Sorlie, 6701 Rockledge
                                                                                                      of information in 21 CFR parts 801 and
                                              have specific recommendations.                                                                                Drive, MSC 7936, Bethesda, MD 20892,
                                                                                                      808, regarding labelling, have been
                                                 We believe there is a need to notify                                                                       or call non-toll-free number (301) 435–
                                                                                                      approved under OMB control number
                                              the public about emerging signals that                                                                        0456, or Email your request to: sorliep@
                                                                                                      0910–0485 and the collections of
                                              the Agency is monitoring or analyzing,                                                                        nhlbi.nih.gov. Formal requests for
                                                                                                      information in 21 CFR part 803,
                                              even when the information has not been                                                                        additional plans and instruments must
                                                                                                      regarding medical device reporting,
                                              fully analyzed, validated, or confirmed,                                                                      be requested in writing.
                                                                                                      have been approved under OMB control
                                              and for which the Agency does not yet                                                                           Comments Due Date: Comments
                                                                                                      numbers 0910–0291, 0910–0437, and
                                              have specific recommendations. Timely                                                                         regarding this information collection are
                                                                                                      0910–0471.
                                              communication about emerging signals                                                                          best assured of having their full effect if
                                              is intended to provide health care                        Dated: December 28, 2015.                           received within 60 days of the date of
                                              providers, patients, and consumers with                 Leslie Kux,                                           this publication.
                                              access to the most current information                  Associate Commissioner for Policy.                      Proposed Collection: The Framingham
                                              concerning the potential benefits and                   [FR Doc. 2015–32920 Filed 12–30–15; 8:45 am]          Heart Study, Revision, 0925–0216
                                              risks of marketed devices, so that they                 BILLING CODE 4164–01–P                                Expiration Date: 10/31/2016, National
                                              can make informed treatment choices                                                                           Heart, Lung, and Blood Institute
                                              bases on all available information.                                                                           (NHLBI), the National Institutes of
                                              Therefore, because of the evolving                      DEPARTMENT OF HEALTH AND                              Health (NIH).
                                              nature of this information, FDA would                   HUMAN SERVICES                                          Need and Use of Information
                                              be sharing it with the public at an early                                                                     Collection: This proposal is to extend
                                              stage of the Agency’s assessment and                    National Institutes of Health                         the Framingham Study to examine the
                                              evaluation of the signal.                                                                                     Generation Three Cohort, New Offspring
                                                                                                      Proposed Collection; 60 Day Comment                   Spouses and Omni Group 2 Cohort, as
                                              II. Significance of Guidance                            Request; The Framingham Heart Study                   well as to continue to monitor the
                                                 This draft guidance is being issued                  (NHLBI)                                               morbidity and mortality which occurs
                                              consistent with FDA’s good guidance                     AGENCY:    National Institutes of Health,             in all Framingham Cohorts. The
                                              practices regulation (21 CFR 10.115).                   HHS.                                                  contractor, with the collaborative
                                              The draft guidance, when finalized, will                ACTION:   Notice.                                     assistance of NHLBI Intramural staff,
tkelley on DSK3SPTVN1PROD with NOTICES




                                              represent the current thinking of FDA                                                                         will invite study participants, schedule
                                              on ‘‘Public Notification of Emerging                    SUMMARY:  In compliance with the                      appointments, administer examinations
                                              Postmarket Medical Device Signals                       requirement of Section 3506(c)(2)(A) of               and testing, enter information into
                                              (‘Emerging Signals’).’’ It does not                     the Paperwork Reduction Act of 1995,                  computer databases for editing, and
                                              establish any rights for any person and                 for opportunity for public comment on                 prepare scientific reports of the
                                              is not binding on FDA or the public.                    proposed data collection projects, the                information for publication in
                                              You can use an alternative approach if                  National Heart, Lung, and Blood                       appropriate scientific journals. All


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                                                                              Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices                                                                                 81831

                                              participants have been examined                                       Institute uses the results of the                              effective treatment and preventive
                                              previously and thus the study deals                                   Framingham Study to: (1) Characterize                          modalities can be developed and tested.
                                              with a stable, carefully described group.                             risk factors for cardiovascular and lung                       Most of the reports of study results have
                                              Data are collected in the form of an                                  diseases so that national prevention                           been published in peer reviewed
                                              observational health examination                                      programs can be designed and                                   medical journals and books.
                                              involving such components as blood                                    implemented; (2) evaluate trends in                               OMB approval is requested for 3
                                              pressure measurements, venipuncture,                                  cardiovascular diseases and risk factors                       years. There are no costs to respondents
                                              electrocardiography and a health                                      over time to measure the impact of                             other than their time. The total
                                              interview, including questions about                                  overall preventive measures; and (3)                           estimated annualized burden hours are
                                              lifestyles and daily living situations.                               understand the etiology of                                     8,382.
                                              The National Heart, Lung, and Blood                                   cardiovascular and lung diseases so that                       Estimated Annualized Burden Hours
                                                                                     TABLE A.12–1.1—ESTIMATE OF RESPONDENT BURDEN, ORIGINAL COHORT
                                                                                                                                             [Annualized]

                                                                                                                                                                                 Number of                 Average time
                                                                                                                                                               Number of                                                             Total annual
                                                                                     Type of respondent                                                                        responses per               per response
                                                                                                                                                              respondents                                                            burden hour
                                                                                                                                                                                 respondent                 (in hours)

                                              I. PARTICIPANT COMPONENTS
                                              ANNUAL FOLLOW-UP
                                                   a. Records Request ..................................................................................                  30                        1                    15/60                      8
                                                   b. Health Status Update ...........................................................................                    30                        1                    15/60                      8

                                                        SUB–TOTAL: PARTICIPANT COMPONENTS .................................                                             * 30   ........................   ........................             15
                                              II. NON-PARTICIPANT COMPONENTS
                                                   A. Informant Contact (Pre-exam and Annual Follow-up) .........................                                         15                         1                  10/60                       3
                                                   B. Records Request (Annual follow-up) ...................................................                              30                         1                  15/60                       8

                                                          SUB-TOTAL: NON-PARTICIPANT COMPONENTS ........................                                                  45   ........................   ........................             10

                                                                TOTAL: PARTICIPANT AND NON-PARTICIPANT COMPO-
                                                                 NENTS ....................................................................................               75   ........................   ........................             25
                                                 * Number of participants as reflected in Row I.b. above.

                                                          TABLE A.12–1.2—ESTIMATE OF RESPONDENT BURDEN, OFFSPRING COHORT AND OMNI GROUP 1 COHORT
                                                                                                                                             [Annualized]

                                                                                                                                                                                 Number of                 Average time
                                                                                                                                                               Number of                                                             Total annual
                                                                                     Type of respondent                                                                        responses per               per response
                                                                                                                                                              respondents        respondent                 (in hours)               burden hour

                                              I. PARTICIPANT COMPONENTS
                                              ANNUAL FOLLOW-UP
                                                   a. Records Request ..................................................................................               1,500                        1                    15/60                375
                                                   b. Health Status Update ...........................................................................                 1,700                        1                    15/60                425

                                                        SUB-TOTAL: PARTICIPANT COMPONENTS ..................................                                         * 1,700   ........................   ........................            800
                                              II. NON-PARTICIPANT COMPONENTS
                                                   A. Informant contact (Pre-exam and Annual Follow-up) ..........................                                       150                        1                   10/60                  25
                                                   B. Records Request (Annual follow-up) ...................................................                           1,500                        1                   15/60                 375

                                                          SUB-TOTAL: NON-PARTICIPANT COMPONENTS ........................                                               1,650   ........................   ........................            400

                                                                TOTAL: PARTICIPANT AND NON-PARTICIPANT COMPO-
                                                                 NENTS ....................................................................................            3,350   ........................   ........................          1,200
                                                 * Number of participants as reflected in Row I.b. above.

                                                  TABLE A.12–1.3—ESTIMATE OF RESPONDENT BURDEN, GENERATION 3 COHORT, NOS AND OMNI GROUP 2 COHORT
                                                                                                                                             [Annualized]

                                                                                                                                                                                                           Average time
                                                                                                                                                                                 Number of
                                                                                                                                                               Number of                                   per response              Total annual
                                                                                     Type of respondent                                                                        responses per
                                                                                                                                                              respondents                                   (hours per               burden hour
                                                                                                                                                                                 respondent                    year)
tkelley on DSK3SPTVN1PROD with NOTICES




                                                                                                                             I. PARTICIPANT COMPONENTS

                                              A. PRE-EXAM:
                                                  1.Telephone contact for appointment .......................................................                          1,450                        1                    10/60                242
                                                  2. Exam appointment, scheduling, reminder and instructions .................                                         1,270                        1                    35/60                741
                                              B. EXAM CYCLE 3:
                                                  1. Exam at study center ...........................................................................                  1,200                        1                 110/60                2,200



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                                              81832                           Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices

                                                TABLE A.12–1.3—ESTIMATE OF RESPONDENT BURDEN, GENERATION 3 COHORT, NOS AND OMNI GROUP 2 COHORT—
                                                                                            Continued
                                                                                                                                         [Annualized]

                                                                                                                                                                                                       Average time
                                                                                                                                                                             Number of
                                                                                                                                                           Number of                                   per response              Total annual
                                                                                     Type of respondent                                                                    responses per
                                                                                                                                                          respondents                                   (hours per               burden hour
                                                                                                                                                                             respondent                    year)

                                                  2. Home or nursing home visit .................................................................                     35                         1                   60/60                 35
                                              C. POST-EXAM:
                                                  eFHS Mobile Technology for Collection of CVD Risks ............................                                  1,100                       18                     9/60              2,970
                                              D. ANNUAL FOLLOW-UP:
                                                  1. Records Request ..................................................................................            1,200                         1                   15/60                300
                                                  2. Health Status Update ...........................................................................              1,400                         1                   15/60                350

                                                          Sub-Total: Participant Components ..................................................                   * 2,850   ........................   ........................          6,830

                                                                                                    II. NON-PARTICIPANT COMPONENTS—ANNUAL FOLLOW-UP

                                              A. INFORMANT CONTACTS ..........................................................................                       180                         1                  10/60                  30
                                              B. RECORD REQUEST ..................................................................................                 1,155                         1                  15/60                 289

                                                    Sub-Total: Non-Participant Components ..................................................                       1,335   ........................   ........................            319

                                                          Total: Participant And Non-Participant Components ........................                               4,185   ........................   ........................          7,157
                                                 * Number of participants as reflected in Rows I.A.1 and I.D.2 above.


                                                Dated: December 22, 2015.                                          Place: Intramural Research Program,                         individuals associated with the grant
                                              Valery Gheen,                                                      National Institute on Drug Abuse, NIH, Johns                  applications, the disclosure of which
                                              NHLBI Project Clearance Liaison, National                          Hopkins Bayview Campus, Baltimore, MD                         would constitute a clearly unwarranted
                                              Institutes of Health.                                              21223.                                                        invasion of personal privacy.
                                                                                                                   Contact Person: Joshua Kysiak, Program
                                              [FR Doc. 2015–32940 Filed 12–30–15; 8:45 am]                       Specialist, Biomedical Research Center,                         Name of Committee: National Institute on
                                              BILLING CODE 4140–01–P                                             Intramural Research Program, National                         Drug Abuse Special Emphasis Panel; Tools
                                                                                                                 Institute on Drug Abuse, NIH, DHHS, 251                       for Monitoring and Manipulating RNA
                                                                                                                 Bayview Boulevard, Baltimore, MD 21224,                       Modifications (R41, R42, R43, R44).
                                              DEPARTMENT OF HEALTH AND                                           443–740–2465, kysiakjo@nida.nih.gov.                            Date: February 18, 2016.
                                              HUMAN SERVICES                                                     (Catalogue of Federal Domestic Assistance                       Time: 9:00 a.m. to 4:00 p.m.
                                                                                                                 Program Nos.: 93.279, Drug Abuse and                            Agenda: To review and evaluate grant
                                              National Institutes of Health                                      Addiction Research Programs, National                         applications.
                                                                                                                 Institutes of Health, HHS)                                      Place: Hilton Garden Inn Bethesda, 7301
                                              National Institute on Drug Abuse;                                                                                                Waverly Street, Bethesda, MD 20814.
                                                                                                                   Dated: December 28, 2015.                                     Contact Person: Jagadeesh S. Rao, Ph.D.,
                                              Notice of Closed Meeting
                                                                                                                 Natasha M. Copeland,                                          Scientific Review Officer, Office of
                                                                                                                 Program Analyst, Office of Federal Advisory                   Extramural Policy and Review, National
                                                Pursuant to section 10(d) of the                                                                                               Institute on Drug Abuse, National Institutes
                                              Federal Advisory Committee Act, as                                 Committee Policy.
                                                                                                                                                                               of Health, DHHS, 6001 Executive Boulevard,
                                              amended (5 U.S.C. App.), notice is                                 [FR Doc. 2015–32939 Filed 12–30–15; 8:45 am]
                                                                                                                                                                               Room 4234, MSC 9550, Bethesda, MD 02892,
                                              hereby given of a meeting of the Board                             BILLING CODE 4140–01–P                                        301–443–9511, jrao@nida.nih.gov.
                                              of Scientific Counselors, NIDA.                                                                                                  (Catalogue of Federal Domestic Assistance
                                                The meeting will be closed to the                                                                                              Program Nos.: 93.279, Drug Abuse and
                                                                                                                 DEPARTMENT OF HEALTH AND                                      Addiction Research Programs, National
                                              public as indicated below in accordance
                                                                                                                 HUMAN SERVICES                                                Institutes of Health, HHS)
                                              with the provisions set forth in section
                                              552b(c)(6), Title 5 U.S.C., as amended                             National Institutes of Health                                   Dated: December 28, 2015.
                                              for the review, discussion, and                                                                                                  Natasha M. Copeland,
                                              evaluation of individual intramural                                National Institute on Drug Abuse;                             Program Analyst, Office of Federal Advisory
                                              programs and projects conducted by the                             Notice of Closed Meeting                                      Committee Policy.
                                              National Institute on Drug Abuse,                                                                                                [FR Doc. 2015–32937 Filed 12–30–15; 8:45 am]
                                              including consideration of personnel                                 Pursuant to section 10(d) of the
                                                                                                                                                                               BILLING CODE 4140–01–P
                                              qualifications and performance, and the                            Federal Advisory Committee Act, as
                                              competence of individual investigators,                            amended (5 U.S.C. App), notice is
                                              the disclosure of which would                                      hereby given of the following meeting.
                                                                                                                                                                               DEPARTMENT OF HEALTH AND
                                              constitute a clearly unwarranted                                     The meeting will be closed to the
                                                                                                                                                                               HUMAN SERVICES
                                              invasion of personal privacy.                                      public in accordance with the
tkelley on DSK3SPTVN1PROD with NOTICES




                                                                                                                 provisions set forth in sections                              National Institutes of Health
                                                Name of Committee: Board of Scientific                           552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                              Counselors, NIDA.
                                                Date: February 1–2, 2016.
                                                                                                                 as amended. The grant applications and                        National Institute of Allergy and
                                                Closed: 8:30 a.m. to 5:00 p.m.                                   the discussions could disclose                                Infectious Diseases; Closed Meeting
                                                Agenda: To review and evaluate personal                          confidential trade secrets or commercial
                                              qualifications and performance, and                                property such as patentable materials,                          Pursuant to section 10(d) of the
                                              competence of individual investigators.                            and personal information concerning                           Federal Advisory Committee Act, as


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Document Created: 2015-12-31 02:14:44
Document Modified: 2015-12-31 02:14:44
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
ActionNotice.
DatesComments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
ContactTo obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Paul Sorlie, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892, or call non-toll- free number (301) 435-0456, or Email your request to: [email protected] Formal requests for additional plans and instruments must be requested in writing.
FR Citation80 FR 81830 

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