82_FR_12660 82 FR 12618 - Submission for OMB Review; 30-Day Comment Request; CTEP Support Contracts Forms and Surveys, NCI, NIH

82 FR 12618 - Submission for OMB Review; 30-Day Comment Request; CTEP Support Contracts Forms and Surveys, NCI, NIH

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 82, Issue 42 (March 6, 2017)

Page Range12618-12621
FR Document2017-04253

Federal Register, Volume 82 Issue 42 (Monday, March 6, 2017)
[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12618-12621]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04253]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; CTEP Support 
Contracts Forms and Surveys, NCI, NIH

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

[[Page 12619]]

    In compliance with the Paperwork Reduction Act of 1995, the 
National Institutes of Health (NIH) has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on December 
13, 2016, page 89955 (81 FR 89955) and allowed 60 days for public 
comment. No public comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30-days of the date of 
this publication.

ADDRESSES: Written comments and/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden and associated response time, should be directed to the: Office 
of Management and Budget, Office of Regulatory Affairs, 
[email protected] or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Michael Montello, Pharm.D., Cancer Therapy 
Evaluation Program, Division of Cancer Treatment and Diagnosis, 9609 
Medical Center Drive, Rockville, MD 20850 or call non-toll-free number 
(240-276-6080) or Email your request, including your address to: 
[email protected].
    Proposed Collection: CTEP Support Contracts Forms and Surveys, NCI, 
0925-New, National Cancer Institute (NCI), National Institutes of 
Health (NIH).
    Need and Use of Information Collection: The National Cancer 
Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and the 
Division of Cancer Prevention (DCP) fund an extensive national program 
of cancer research, sponsoring clinical trials in cancer prevention, 
symptom management and treatment for qualified clinical investigators. 
As part of this effort, CTEP and DCP oversee two support programs, the 
NCI Central Institutional Review Board (CIRB) and the Cancer Trial 
Support Unit (CTSU). The purpose of the support programs is to increase 
efficiency and minimizing burden. The NCI CIRB provides trial oversight 
satisfying the requirements of 45 CFR part 45 and 21 CFR part 56 for 
review of NCI supported studies. The CTSU provides program and systems 
support for regulatory document collection, membership, data management 
and patient enrollment. The two programs use integrated systems and 
processes for managing participant information and documentation of 
regulatory review.
    To meet the responsibilities of each program, information is 
collected from the sites for purposes of membership, enrollment, 
opening of IRB approved studies, documenting IRB review, regulatory 
approval (for sites not using the CIRB), patient enrollment, and 
routing of case report forms.
    Several surveys are collected to assess satisfaction and provide 
feedback to guide improvements with processes and technology. Other 
Surveys have been developed to assess health professional's interests 
in clinical trials.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 15,525.

           CTSU and NCI CIRB Forms and CTSU, CIRB and CTEP Surveys--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondent       respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
CTSU IRB/Regulatory Approval    Health Care                2,444              12            2/60             978
 Transmittal Form (Attachment    Practitioner.
 A1).
CTSU IRB Certification Form     Health Care                2,444              12           10/60           4,888
 (Attachment A2).                Practitioner.
Withdrawal from Protocol        Health Care                  279               1           10/60              47
 Participation Form              Practitioner.
 (Attachment A3).
Site Addition Form (Attachment  Health Care                   80              12           10/60             160
 A4).                            Practitioner.
CTSU Roster Update Form         Health Care                  600               1            5/60              50
 (Attachment A5).                Practitioner.
CTSU Request for Clinical       Health Care                  360               1           10/60              60
 Brochure (Attachment A6).       Practitioner.
CTSU Supply Request Form        Health Care                   90              12           10/60             180
 (Attachment A7).                Practitioner.
Site Initiated Data Update      Health Care                    2              12           10/60               4
 Form (Attachment A8).           Practitioner.
Data Clarification Form         Health Care                  150              24           10/60             600
 (Attachment A9).                Practitioner.
RTOG 0834 CTSU Data             Health Care                   12              76           10/60             152
 Transmittal Form (Attachment    Practitioner.
 A10).
MC0845(8233) CTSU Data          Health Care                    5              12           10/60              10
 Transmittal (Attachment A11).   Practitioner.
CTSU Generic Data Transmittal   Health Care                    5              12           10/60              10
 Form (Attachment A12).          Practitioner.
TAILORx--PACCT1--Data           Health Care                  161              96           10/60            2576
 Transmittal Form (Attachment    Practitioner.
 A13).
Unsolicited Data Modification   Health Care                   30              12           10/60              60
 Form: Protocol: TAILORx/PACCT-  Practitioner.
 1 (Attachment 14).
CTSU Patient Enrollment         Health Care                   12              12           10/60              24
 Transmittal Form (Attachment    Practitioner.
 A15).
CTSU Transfer Form (Attachment  Health Care                  360               2           10/60             120
 A16).                           Practitioner.
CTSU System Access Request      Health Care                  180               1           20/60              60
 Form (Attachment A17).          Practitioner.

[[Page 12620]]

 
NCI CIRB AA & DOR between the   Participants....              50               1           15/60              13
 NCI CIRB and Signatory
 Institution (Attachment B1).
NCI CIRB Signatory Enrollment   Participants....              50               1           15/60              13
 Form (Attachment B2).
CIRB Board Member Biographical  Board Member....              25               1           15/60               6
 Sketch Form (Attachment B3).
CIRB Board Member Contact       Board Member....              25               1           10/60               4
 Information Form (Attachment
 B4).
CIRB Board Member NDA           Board Member....              25               1           10/60               4
 (Attachment B6).
CIRB Direct Deposit Form        Board Member....              25               1           15/60               6
 (Attachment B7).
CIRB Member COI Screening       Board Members...              12               1           30/60               6
 Worksheet (Attachment B8).
CIRB COI Screening for CIRB     Board Members...              72               1           15/60              18
 meetings (Attachment B9).
CIRB IR Application             Health Care                   80               1               1              80
 (Attachment B10).               Practitioner.
CIRB IR Application for Exempt  Health Care                    4               1           30/60               2
 Studies (Attachment B11).       Practitioner.
CIRB Amendment Review           Health Care                  400               1           15/60             100
 Application (Attachment B12).   Practitioner.
CIRB Ancillary Studies          Health Care                    1               1               1               1
 Application (Attachment B13).   Practitioner.
CIRB Continuing Review          Health Care                  400               1           30/60             200
 Application (Attachment B14).   Practitioner.
Adult IR of Cooperative Group   Board Members...              65               1          180/60             195
 Protocol (Attachment B15).
Pediatric IR of Cooperative     Board Members...              15               1          180/60              45
 Group Protocol (Attachment
 B16).
Adult Continuing Review of      Board Members...             275               1               1             275
 Cooperative Group Protocol
 (Attachment B17) Protocol.
Pediatric Continuing Review of  Board Members...             130               1               1             130
 Cooperative Group Protocol
 (Attachment B18).
Adult Amendment of Cooperative  Board Members...              40               1          120/60              80
 Group Protocol (Attachment
 B19).
Pediatric Amendment of          Board Members...              25               1          120/60              50
 Cooperative Group Protocol
 (Attachment B20).
Pharmacist's Review of a        Board Members...              10               1          120/60              20
 Cooperative Group Study
 (Attachment B21).
CPC Pharmacist's Review of      Board Members...              20               1          120/60              40
 Cooperative Group Study
 (Attachment B22).
Adult Expedited Amendment       Board Members...             348               1           30/60             174
 Review (Attachment B23).
Pediatric Expedited Amendment   Board Members...             140               1           30/60              70
 Review (Attachment B24).
Adult Expedited Continuing      Board Members...             140               1           30/60              70
 Review (Attachment B25).
Pediatric Expedited Continuing  Board Members...              36               1           30/60              18
 Review (Attachment B26).
Adult Cooperative Group         Health Care                   30               1               1              30
 Response to CIRB Review         Practitioner.
 (Attachment B27).
Pediatric Cooperative Group     Health Care                    5               1               1               5
 Response to CIRB Review         Practitioner.
 (Attachment B28).
Adult Expedited Study Chair     Board Members...              40               1           15/60              10
 Response to Required Mod
 (Attachment B29).
Pediatric Expedited Study       Board Members...              40               1           15/60              10
 Chair Response to Required
 Mod (Attachment B30).
Reviewer Worksheet--            Board Members...             360               1           10/60              61
 Determination of UP or SCN
 (Attachment B31).
Reviewer Worksheet--CIRB        Board Members...             100               1               1             100
 Statistical Reviewer Form
 (Attachment B32).
CIRB Application for            Health Care                  100               1           30/60              50
 Translated Documents            Practitioner.
 (Attachment B33).
Reviewer Worksheet of           Board Members...             100               1           15/60              25
 Translated Documents
 (Attachment B34).
Reviewer Worksheet of           Board Members...              20               1           15/60               5
 Recruitment Material
 (Attachment B35).

[[Page 12621]]

 
Reviewer Worksheet Expedited    Board Members...              20               1           15/60               5
 Study Closure Review
 (Attachment B36).
Reviewer Worksheet Expedited    Board Members...               5               1           30/60               3
 Review of Study Chair
 Response to CIRB-Required
 Modifications (Attachment
 B37).
Reviewer Worksheet of           Board Members...               5               1           30/60               3
 Expedited IR (Attachment B38).
Reviewer Worksheet--CPC--       Board Members...              40               1           15/60              10
 Determination of UP or SCN
 (Attachment B39).
Annual Signatory Institution    Health Care                  400               1           40/60             267
 Worksheet About Local Context   Practitioner.
 (Attachment B40).
Annual Principal Investigator   Health Care                 1800               1           20/60             600
 Worksheet About Local Context   Practitioner.
 (Attachment B41).
Study-Specific Worksheet About  Health Care                 4800               1           20/60            1600
 Local Context (Attachment       Practitioner.
 B42).
Study Closure or Transfer of    Health Care                 1680               1           15/60             420
 Study Review Responsibility     Practitioner.
 Form (Attachment B43).
UP or SCN Reporting Form        Health Care                  360               1           20/60             120
 (Attachment B44).               Practitioner.
Change of SI PI Form            Health Care                  120               1           15/60              30
 (Attachment B45).               Practitioner.
CTSU Website Customer           Health Care                  275               1           15/60              69
 Satisfaction Survey             Practitioner.
 (Attachment C1).
CTSU Help Desk Customer         Health Care                  325               1           15/60              81
 Satisfaction Survey             Practitioner.
 (Attachment C2).
CTSU OPEN Survey (Attachment    Health Care                   60               1           15/60              15
 C3).                            Practitioner.
CIRB Customer Satisfaction      Participants....             600               1           15/60             150
 Survey (Attachment C4)
 Satisfaction Survey
 (Attachment C4).
Follow-up Survey                Participants/                300               1           15/60              75
 (Communication Audit)           Board Members.
 (Attachment C5).
Website Focus Groups,           Participants/                 18               1               1              18
 Communication Project           Board Members.
 (Attachment C6 A-D).
CIRB Board Member Annual        Board Members...              60               1           20/60              20
 Assessment Survey (Attachment
 C7).
PIO Customer Satisfaction       Health Care                   60               1            5/60               5
 Survey (Attachment C8).         Practitioner.
Concept Clinical Trial Survey   Health Care                  500               1            5/60              42
 (Attachment C9).                Practitioner.
Prospective Clinical Trial      Health Care                 1000               1            1/60              17
 Survey (Attachment C10).        Practitioner.
Low Accrual Clinical Trial      Health Care                 1000               1            1/60              17
 Survey (Attachment C11).        Practitioner.
ETCTN PI Survey (Attachment     Physician.......              75               1           15/60              19
 12).
ETCTN RS Survey (Attachment     Health Care                  175               1           15/60              44
 13).                            Practitioner.
                                                 ---------------------------------------------------------------
    Totals....................  ................          24,100         100,337  ..............          15,525
----------------------------------------------------------------------------------------------------------------


    Dated: February 15, 2017.
Karla Bailey,
PRA OMB Liaison, Office of Management Policy and Compliance, National 
Cancer Institute (NCI) National Institutes of Health (NIH).
[FR Doc. 2017-04253 Filed 3-3-17; 8:45 am]
 BILLING CODE 4140-01-P



                                                    12618                          Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices

                                                      Dated: February 15, 2017.                               Time: 8:00 a.m. to 6:00 p.m.                        DEPARTMENT OF HEALTH AND
                                                    Karla Bailey,                                             Agenda: To review and evaluate grant                HUMAN SERVICES
                                                    Project Clearance Liaison, National Cancer              applications.
                                                    Institute, National Institutes of Health.                 Place: Residence Inn Bethesda, 7335                 National Institutes of Health
                                                                                                            Wisconsin Avenue, Bethesda, MD 20814.
                                                    [FR Doc. 2017–04255 Filed 3–3–17; 8:45 am]
                                                                                                              Contact Person: Gagan Pandya, Ph.D.,                National Center for Complementary &
                                                    BILLING CODE 4140–01–P                                  Scientific Review Officer, National Institutes        Integrative Health; Notice of Closed
                                                                                                            of Health, Center for Scientific Review, 6701         Meeting
                                                                                                            Rockledge Drive, Rm 3200, MSC 7808,
                                                    DEPARTMENT OF HEALTH AND                                Bethesda, MD 20892, 301–435–1167,                       Pursuant to section 10(d) of the
                                                    HUMAN SERVICES                                          pandyaga@mail.nih.gov.                                Federal Advisory Committee Act, as
                                                                                                              Name of Committee: Center for Scientific            amended (5 U.S.C. App.), notice is
                                                    National Institutes of Health                           Review Special Emphasis Panel, Small                  hereby given of the following meeting.
                                                    Center for Scientific Review; Notice of                 Business: Cancer Biotherapeutics                        The meeting will be closed to the
                                                                                                            Development.                                          public in accordance with the
                                                    Closed Meetings                                           Date: March 30–31, 2017.                            provisions set forth in sections
                                                      Pursuant to section 10(d) of the                        Time: 8:00 a.m. to 5:00 p.m.                        552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                    Federal Advisory Committee Act, as                        Agenda: To review and evaluate grant                as amended. The grant applications and
                                                    amended (5 U.S.C. App.), notice is                      applications.
                                                                                                                                                                  the discussions could disclose
                                                                                                              Place: Courtyard by Marriott, 5520
                                                    hereby given of the following meetings.                                                                       confidential trade secrets or commercial
                                                                                                            Wisconsin Avenue, Chevy Chase, MD 20815.
                                                      The meetings will be closed to the                                                                          property such as patentable material,
                                                                                                              Contact Person: Nicholas J. Donato, Ph.D.,
                                                    public in accordance with the                           Scientific Review Officer, Center for                 and personal information concerning
                                                    provisions set forth in sections                        Scientific Review, National Institutes of             individuals associated with the grant
                                                    552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,              Health, 6701 Rockledge Drive, Room 4040,              applications, the disclosure of which
                                                    as amended. The grant applications and                  Bethesda, MD 20817, 301–827–4810,                     would constitute a clearly unwarranted
                                                    the discussions could disclose                          nick.donato@nih.gov.                                  invasion of personal privacy.
                                                    confidential trade secrets or commercial                  Name of Committee: Center for Scientific              Name of Committee: National Center for
                                                    property such as patentable material,                   Review Special Emphasis Panel, RFA–GM–                Complementary and Integrative Health
                                                    and personal information concerning                     17–004: Maximizing Investigators’ Research            Special Emphasis Panel, NCCIH Training,
                                                    individuals associated with the grant                   Award for Early Stage Investigators (R35).            Career Development, Fellowship, and
                                                    appications, the disclosure of which                      Date: March 30, 2017.                               Research Grant Review.
                                                    would constitute a clearly unwarranted                    Time: 8:00 a.m. to 6:30 p.m.                          Date: March 22, 2017.
                                                    invasion of personal privacy.                             Agenda: To review and evaluate grant                  Time: 12:00 p.m. to 4:00 p.m.
                                                                                                            applications.                                           Agenda: To review and evaluate grant
                                                      Name of Committee: Center for Scientific                Place: Hyatt Regency Bethesda, One                  applications.
                                                    Review Special Emphasis Panel, PAR–14–                  Bethesda Metro Center, 7400 Wisconsin                   Place: National Institutes of Health, Two
                                                    255: Multidisciplinary Studies of HIV and               Avenue, Bethesda, MD 20814.                           Democracy Plaza, 6707 Democracy
                                                    Viral Hepatitis Co-Infection.                                                                                 Boulevard, Bethesda, MD 20892, (Virtual
                                                                                                              Contact Person: David Balasundaram,
                                                      Date: March 28, 2017.                                                                                       Meeting).
                                                                                                            Ph.D., Scientific Review Officer, Center for
                                                      Time: 10:00 a.m. to 11:00 p.m.                                                                                Contact Person: Ashlee Tipton, Ph.D.,
                                                      Agenda: To review and evaluate grant                  Scientific Review, National Institutes of
                                                                                                            Health, 6701 Rockledge Drive, Room 5189,              Scientific Review Officer, Division of
                                                    applications.                                                                                                 Extramural Activities, National Center for
                                                      Place: National Institutes of Health, 6701            MSC 7840, Bethesda, MD 20892, 301–435–
                                                                                                            1022, balasundaramd@csr.nih.gov.                      Complementary and Integrative Health, 6707
                                                    Rockledge Drive, Bethesda, MD 20892                                                                           Democracy Blvd., Suite 401, Bethesda, MD
                                                    (Virtual Meeting).                                        Name of Committee: Center for Scientific
                                                                                                                                                                  20892, 301–451–3849, Ashlee.tipton@
                                                      Contact Person: Kenneth A. Roebuck,                   Review Special Emphasis Panel, Member
                                                                                                                                                                  mail.nih.gov.
                                                    Ph.D., Scientific Review Officer, Center for            Conflict: Cardiovascular Science.
                                                    Scientific Review, National Institutes of                 Date: March 30–31, 2017.                            (Catalogue of Federal Domestic Assistance
                                                    Health, 6701 Rockledge Drive, Room 5106,                  Time: 1:00 p.m. to 5:00 p.m.                        Program Nos. 93.213, Research and Training
                                                    MSC 7852, Bethesda, MD 20892, (301) 435–                                                                      in Complementary and Integrative Health,
                                                                                                              Agenda: To review and evaluate grant
                                                    1166, roebuckk@csr.nih.gov.                                                                                   National Institutes of Health, HHS)
                                                                                                            applications.
                                                      Name of Committee: Center for Scientific                Place: National Institutes of Health, 6701            Dated: February 28, 2017.
                                                    Review Special Emphasis Panel,                          Rockledge Drive, Bethesda, MD 20892                   Michelle Trout,
                                                    Fellowships: Physiology and Pathobiology of             (Virtual Meeting).                                    Program Analyst, Office of Federal Advisory
                                                    Musculoskeletal, Oral and Skin Systems.                   Contact Person: Kimm Hamann, Ph.D.,                 Committee Policy.
                                                      Date: March 29, 2017.                                 Scientific Review Officer, Center for
                                                      Time: 8:00 a.m. to 6:30 p.m.                                                                                [FR Doc. 2017–04177 Filed 3–3–17; 8:45 am]
                                                                                                            Scientific Review, National Institutes of
                                                      Agenda: To review and evaluate grant                  Health, 6701 Rockledge Drive, Room 4118A,             BILLING CODE 4140–01–P
                                                    applications.                                           MSC 7814, Bethesda, MD 20892, 301–435–
                                                      Place: Hyatt Regency Bethesda, One                    5575, hamannkj@csr.nih.gov.
                                                    Bethesda Metro Center, 7400 Wisconsin                                                                         DEPARTMENT OF HEALTH AND
                                                                                                            (Catalogue of Federal Domestic Assistance
                                                    Avenue, Bethesda, MD 20814.                                                                                   HUMAN SERVICES
                                                      Contact Person: Anshumali Chaudhari,                  Program Nos. 93.306, Comparative Medicine;
                                                    Ph.D., Scientific Review Officer, Center for            93.333, Clinical Research, 93.306, 93.333,
                                                                                                            93.337, 93.393–93.396, 93.837–93.844,
                                                                                                                                                                  National Institutes of Health
                                                    Scientific Review, National Institutes of
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    Health, 6701 Rockledge Drive, Room 4124,                93.846–93.878, 93.892, 93.893, National
                                                                                                                                                                  Submission for OMB Review; 30-Day
                                                    MSC 7802, Bethesda, MD 20892, (301) 435–                Institutes of Health, HHS)
                                                                                                                                                                  Comment Request; CTEP Support
                                                    1210, chaudhaa@csr.nih.gov.                               Dated: February 28, 2017.                           Contracts Forms and Surveys, NCI,
                                                      Name of Committee: Center for Scientific              Natasha M. Copeland,                                  NIH
                                                    Review Special Emphasis Panel, Small
                                                                                                            Program Analyst, Office of Federal Advisory
                                                    Business: Non-HIV Diagnostics, Food Safety,
                                                                                                            Committee Policy.
                                                                                                                                                                  AGENCY:   National Institutes of Health,
                                                    Sterilization/Disinfection and                                                                                HHS.
                                                    Bioremediation.                                         [FR Doc. 2017–04172 Filed 3–3–17; 8:45 am]
                                                                                                                                                                  ACTION:   Notice.
                                                      Date: March 30–31, 2017.                              BILLING CODE 4140–01–P




                                               VerDate Sep<11>2014   19:24 Mar 03, 2017   Jkt 241001   PO 00000   Frm 00086   Fmt 4703   Sfmt 4703   E:\FR\FM\06MRN1.SGM   06MRN1


                                                                                   Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices                                                 12619

                                                       In compliance with the Paperwork                     proposed project or to obtain a copy of                burden. The NCI CIRB provides trial
                                                    Reduction Act of 1995, the National                     the data collection plans and                          oversight satisfying the requirements of
                                                    Institutes of Health (NIH) has submitted                instruments, contact: Michael Montello,                45 CFR part 45 and 21 CFR part 56 for
                                                    to the Office of Management and Budget                  Pharm.D., Cancer Therapy Evaluation                    review of NCI supported studies. The
                                                    (OMB) a request for review and                          Program, Division of Cancer Treatment                  CTSU provides program and systems
                                                    approval of the information collection                  and Diagnosis, 9609 Medical Center                     support for regulatory document
                                                    listed below. This proposed information                 Drive, Rockville, MD 20850 or call non-                collection, membership, data
                                                    collection was previously published in                  toll-free number (240–276–6080) or                     management and patient enrollment.
                                                    the Federal Register on December 13,                    Email your request, including your                     The two programs use integrated
                                                    2016, page 89955 (81 FR 89955) and                      address to: montellom@mail.nih.gov.                    systems and processes for managing
                                                    allowed 60 days for public comment. No                     Proposed Collection: CTEP Support                   participant information and
                                                    public comments were received. The                      Contracts Forms and Surveys, NCI,                      documentation of regulatory review.
                                                    purpose of this notice is to allow an                   0925-New, National Cancer Institute                      To meet the responsibilities of each
                                                    additional 30 days for public comment.                  (NCI), National Institutes of Health                   program, information is collected from
                                                    DATES: Comments regarding this                          (NIH).                                                 the sites for purposes of membership,
                                                    information collection are best assured                    Need and Use of Information                         enrollment, opening of IRB approved
                                                    of having their full effect if received                 Collection: The National Cancer                        studies, documenting IRB review,
                                                    within 30-days of the date of this                      Institute (NCI) Cancer Therapy                         regulatory approval (for sites not using
                                                    publication.                                            Evaluation Program (CTEP) and the                      the CIRB), patient enrollment, and
                                                    ADDRESSES: Written comments and/or                      Division of Cancer Prevention (DCP)                    routing of case report forms.
                                                    suggestions regarding the item(s)                       fund an extensive national program of                    Several surveys are collected to assess
                                                    contained in this notice, especially                    cancer research, sponsoring clinical                   satisfaction and provide feedback to
                                                    regarding the estimated public burden                   trials in cancer prevention, symptom                   guide improvements with processes and
                                                    and associated response time, should be                 management and treatment for qualified                 technology. Other Surveys have been
                                                    directed to the: Office of Management                   clinical investigators. As part of this                developed to assess health
                                                    and Budget, Office of Regulatory Affairs,               effort, CTEP and DCP oversee two                       professional’s interests in clinical trials.
                                                    OIRA_submission@omb.eop.gov or by                       support programs, the NCI Central                        OMB approval is requested for 3
                                                    fax to 202–395–6974, Attention: Desk                    Institutional Review Board (CIRB) and                  years. There are no costs to respondents
                                                    Officer for NIH.                                        the Cancer Trial Support Unit (CTSU).                  other than their time. The total
                                                    FOR FURTHER INFORMATION CONTACT: To                     The purpose of the support programs is                 estimated annualized burden hours are
                                                    request more information on the                         to increase efficiency and minimizing                  15,525.

                                                         CTSU AND NCI CIRB FORMS AND CTSU, CIRB AND CTEP SURVEYS—ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                      Average
                                                                                                                                                                   Number of
                                                                                                                     Type of                    Number of                           burden per     Total annual
                                                                      Form name                                                                                  responses per
                                                                                                                   respondent                  respondents                           response      burden hours
                                                                                                                                                                   respondent        (in hours)

                                                    CTSU IRB/Regulatory Approval Transmittal             Health Care Practitioner .......               2,444               12              2/60            978
                                                      Form (Attachment A1).
                                                    CTSU IRB Certification Form (Attachment              Health Care Practitioner .......               2,444               12             10/60          4,888
                                                      A2).
                                                    Withdrawal from Protocol Participation Form          Health Care Practitioner .......                 279                1             10/60             47
                                                      (Attachment A3).
                                                    Site Addition Form (Attachment A4) .............     Health Care Practitioner .......                  80               12             10/60            160
                                                    CTSU Roster Update Form (Attachment A5)              Health Care Practitioner .......                 600                1              5/60             50
                                                    CTSU Request for Clinical Brochure (At-              Health Care Practitioner .......                 360                1             10/60             60
                                                      tachment A6).
                                                    CTSU Supply Request Form (Attachment                 Health Care Practitioner .......                  90               12             10/60            180
                                                      A7).
                                                    Site Initiated Data Update Form (Attach-             Health Care Practitioner .......                    2              12             10/60              4
                                                      ment A8).
                                                    Data Clarification Form (Attachment A9) .....        Health Care Practitioner .......                 150               24             10/60            600
                                                    RTOG 0834 CTSU Data Transmittal Form                 Health Care Practitioner .......                  12               76             10/60            152
                                                      (Attachment A10).
                                                    MC0845(8233) CTSU Data Transmittal (At-              Health Care Practitioner .......                    5              12             10/60             10
                                                      tachment A11).
                                                    CTSU Generic Data Transmittal Form (At-              Health Care Practitioner .......                    5              12             10/60             10
                                                      tachment A12).
                                                    TAILORx—PACCT1—Data              Transmittal         Health Care Practitioner .......                 161               96             10/60           2576
                                                      Form (Attachment A13).
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    Unsolicited Data Modification Form: Pro-             Health Care Practitioner .......                  30               12             10/60             60
                                                      tocol: TAILORx/PACCT–1 (Attachment
                                                      14).
                                                    CTSU Patient Enrollment Transmittal Form             Health Care Practitioner .......                  12               12             10/60             24
                                                      (Attachment A15).
                                                    CTSU Transfer Form (Attachment A16) .......          Health Care Practitioner .......                 360                2             10/60            120
                                                    CTSU System Access Request Form (At-                 Health Care Practitioner .......                 180                1             20/60             60
                                                      tachment A17).



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                                                    12620                          Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices

                                                        CTSU AND NCI CIRB FORMS AND CTSU, CIRB AND CTEP SURVEYS—ESTIMATED ANNUALIZED BURDEN HOURS—
                                                                                                 Continued
                                                                                                                                                                                           Average
                                                                                                                                                                        Number of
                                                                                                                       Type of                       Number of                           burden per        Total annual
                                                                      Form name                                                                                       responses per
                                                                                                                     respondent                     respondents                           response         burden hours
                                                                                                                                                                        respondent        (in hours)

                                                    NCI CIRB AA & DOR between the NCI                    Participants ...........................               50                1             15/60                13
                                                      CIRB and Signatory Institution (Attach-
                                                      ment B1).
                                                    NCI CIRB Signatory Enrollment Form (At-              Participants ...........................               50                1             15/60                13
                                                      tachment B2).
                                                    CIRB Board Member Biographical Sketch                Board Member ......................                    25                1             15/60                 6
                                                      Form (Attachment B3).
                                                    CIRB Board Member Contact Information                Board Member ......................                    25                1             10/60                 4
                                                      Form (Attachment B4).
                                                    CIRB Board Member NDA (Attachment B6)                Board Member ......................                    25                1             10/60                 4
                                                    CIRB Direct Deposit Form (Attachment B7)             Board Member ......................                    25                1             15/60                 6
                                                    CIRB Member COI Screening Worksheet                  Board Members ....................                     12                1             30/60                 6
                                                      (Attachment B8).
                                                    CIRB COI Screening for CIRB meetings (At-            Board Members ....................                     72                1             15/60                18
                                                      tachment B9).
                                                    CIRB IR Application (Attachment B10) ........        Health Care Practitioner .......                       80                1                 1                80
                                                    CIRB IR Application for Exempt Studies (At-          Health Care Practitioner .......                        4                1             30/60                 2
                                                      tachment B11).
                                                    CIRB Amendment Review Application (At-               Health Care Practitioner .......                      400                1             15/60               100
                                                      tachment B12).
                                                    CIRB Ancillary Studies Application (Attach-          Health Care Practitioner .......                         1               1                    1              1
                                                      ment B13).
                                                    CIRB Continuing Review Application (At-              Health Care Practitioner .......                      400                1             30/60               200
                                                      tachment B14).
                                                    Adult IR of Cooperative Group Protocol (At-          Board Members ....................                     65                1            180/60               195
                                                      tachment B15).
                                                    Pediatric IR of Cooperative Group Protocol           Board Members ....................                     15                1            180/60                45
                                                      (Attachment B16).
                                                    Adult Continuing Review of Cooperative               Board Members ....................                    275                1                    1            275
                                                      Group Protocol (Attachment B17) Pro-
                                                      tocol.
                                                    Pediatric Continuing Review of Cooperative           Board Members ....................                    130                1                    1            130
                                                      Group Protocol (Attachment B18).
                                                    Adult Amendment of Cooperative Group                 Board Members ....................                     40                1            120/60                80
                                                      Protocol (Attachment B19).
                                                    Pediatric Amendment of Cooperative Group             Board Members ....................                     25                1            120/60                50
                                                      Protocol (Attachment B20).
                                                    Pharmacist’s Review of a Cooperative                 Board Members ....................                     10                1            120/60                20
                                                      Group Study (Attachment B21).
                                                    CPC Pharmacist’s Review of Cooperative               Board Members ....................                     20                1            120/60                40
                                                      Group Study (Attachment B22).
                                                    Adult Expedited Amendment Review (At-                Board Members ....................                    348                1             30/60               174
                                                      tachment B23).
                                                    Pediatric Expedited Amendment Review                 Board Members ....................                    140                1             30/60                70
                                                      (Attachment B24).
                                                    Adult Expedited Continuing Review (Attach-           Board Members ....................                    140                1             30/60                70
                                                      ment B25).
                                                    Pediatric Expedited Continuing Review (At-           Board Members ....................                     36                1             30/60                18
                                                      tachment B26).
                                                    Adult Cooperative Group Response to CIRB             Health Care Practitioner .......                       30                1                    1             30
                                                      Review (Attachment B27).
                                                    Pediatric Cooperative Group Response to              Health Care Practitioner .......                         5               1                    1              5
                                                      CIRB Review (Attachment B28).
                                                    Adult Expedited Study Chair Response to              Board Members ....................                     40                1             15/60                10
                                                      Required Mod (Attachment B29).
                                                    Pediatric Expedited Study Chair Response             Board Members ....................                     40                1             15/60                10
                                                      to Required Mod (Attachment B30).
                                                    Reviewer Worksheet—Determination of UP               Board Members ....................                    360                1             10/60                61
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                      or SCN (Attachment B31).
                                                    Reviewer Worksheet—CIRB Statistical Re-              Board Members ....................                    100                1                    1            100
                                                      viewer Form (Attachment B32).
                                                    CIRB Application for Translated Documents            Health Care Practitioner .......                      100                1             30/60                50
                                                      (Attachment B33).
                                                    Reviewer Worksheet of Translated Docu-               Board Members ....................                    100                1             15/60                25
                                                      ments (Attachment B34).
                                                    Reviewer Worksheet of Recruitment Mate-              Board Members ....................                     20                1             15/60                 5
                                                      rial (Attachment B35).



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                                                                                            Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices                                                                            12621

                                                        CTSU AND NCI CIRB FORMS AND CTSU, CIRB AND CTEP SURVEYS—ESTIMATED ANNUALIZED BURDEN HOURS—
                                                                                                 Continued
                                                                                                                                                                                                                 Average
                                                                                                                                                                                              Number of
                                                                                                                                        Type of                            Number of                           burden per              Total annual
                                                                          Form name                                                                                                         responses per
                                                                                                                                      respondent                          respondents                           response               burden hours
                                                                                                                                                                                              respondent        (in hours)

                                                    Reviewer Worksheet Expedited Study Clo-                             Board Members ....................                           20                 1                 15/60                   5
                                                      sure Review (Attachment B36).
                                                    Reviewer Worksheet Expedited Review of                              Board Members ....................                              5               1                 30/60                   3
                                                      Study Chair Response to CIRB-Required
                                                      Modifications (Attachment B37).
                                                    Reviewer Worksheet of Expedited IR (At-                             Board Members ....................                              5               1                 30/60                   3
                                                      tachment B38).
                                                    Reviewer Worksheet—CPC—Determination                                Board Members ....................                           40                 1                 15/60                  10
                                                      of UP or SCN (Attachment B39).
                                                    Annual Signatory Institution Worksheet                              Health Care Practitioner .......                            400                 1                  40/60                267
                                                      About Local Context (Attachment B40).
                                                    Annual Principal Investigator Worksheet                             Health Care Practitioner .......                          1800                  1                  20/60                600
                                                      About Local Context (Attachment B41).
                                                    Study-Specific Worksheet About Local Con-                           Health Care Practitioner .......                          4800                  1                  20/60               1600
                                                      text (Attachment B42).
                                                    Study Closure or Transfer of Study Review                           Health Care Practitioner .......                          1680                  1                  15/60                420
                                                      Responsibility Form (Attachment B43).
                                                    UP or SCN Reporting Form (Attachment                                Health Care Practitioner .......                            360                 1                 20/60                 120
                                                      B44).
                                                    Change of SI PI Form (Attachment B45) .....                         Health Care Practitioner .......                            120                 1                 15/60                  30
                                                    CTSU Website Customer Satisfaction Sur-                             Health Care Practitioner .......                            275                 1                 15/60                  69
                                                      vey (Attachment C1).
                                                    CTSU Help Desk Customer Satisfaction                                Health Care Practitioner .......                            325                 1                  15/60                 81
                                                      Survey (Attachment C2).
                                                    CTSU OPEN Survey (Attachment C3) .........                          Health Care Practitioner .......                             60                 1                  15/60                 15
                                                    CIRB Customer Satisfaction Survey (Attach-                          Participants ...........................                    600                 1                  15/60                150
                                                      ment C4) Satisfaction Survey (Attachment
                                                      C4).
                                                    Follow-up Survey (Communication Audit)                              Participants/Board Members                                  300                 1                  15/60                 75
                                                      (Attachment C5).
                                                    Website Focus Groups, Communication                                 Participants/Board Members                                   18                 1                         1              18
                                                      Project (Attachment C6 A–D).
                                                    CIRB Board Member Annual Assessment                                 Board Members ....................                           60                 1                 20/60                  20
                                                      Survey (Attachment C7).
                                                    PIO Customer Satisfaction Survey (Attach-                           Health Care Practitioner .......                             60                 1                   5/60                  5
                                                      ment C8).
                                                    Concept Clinical Trial Survey (Attachment                           Health Care Practitioner .......                            500                 1                    5/60                42
                                                      C9).
                                                    Prospective Clinical Trial Survey (Attach-                          Health Care Practitioner .......                          1000                  1                    1/60                17
                                                      ment C10).
                                                    Low Accrual Clinical Trial Survey (Attach-                          Health Care Practitioner .......                          1000                  1                    1/60                17
                                                      ment C11).
                                                    ETCTN PI Survey (Attachment 12) ..............                      Physician ..............................                     75                 1                  15/60                 19
                                                    ETCTN RS Survey (Attachment 13) ............                        Health Care Practitioner .......                            175                 1                  15/60                 44

                                                         Totals .....................................................   ...............................................          24,100          100,337    ........................         15,525



                                                      Dated: February 15, 2017.                                            DEPARTMENT OF HEALTH AND                                           the discussions could disclose
                                                    Karla Bailey,                                                          HUMAN SERVICES                                                     confidential trade secrets or commercial
                                                    PRA OMB Liaison, Office of Management                                                                                                     property such as patentable material,
                                                    Policy and Compliance, National Cancer                                 National Institutes of Health                                      and personal information concerning
                                                    Institute (NCI) National Institutes of Health                                                                                             individuals associated with the grant
                                                    (NIH).                                                                 National Center for Complementary &                                applications, the disclosure of which
                                                                                                                           Integrative Health; Notice of Closed                               would constitute a clearly unwarranted
                                                    [FR Doc. 2017–04253 Filed 3–3–17; 8:45 am]
                                                                                                                           Meeting                                                            invasion of personal privacy.
                                                    BILLING CODE 4140–01–P
                                                                                                                             Pursuant to section 10(d) of the
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                                                                                                Name of Committee: National Center for
                                                                                                                           Federal Advisory Committee Act, as                                 Complementary and Integrative Health
                                                                                                                           amended (5 U.S.C. App.), notice is                                 Special Emphasis Panel, Exploratory Clinical
                                                                                                                           hereby given of the following meeting.                             Trials and Studies of Natural Products.
                                                                                                                                                                                                Date: March 30, 2017.
                                                                                                                             The meeting will be closed to the                                  Time: 12:00 p.m. to 4:30 p.m.
                                                                                                                           public in accordance with the                                        Agenda: To review and evaluate grant
                                                                                                                           provisions set forth in sections                                   applications.
                                                                                                                           552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                           Place: National Institutes of Health, Two
                                                                                                                           as amended. The grant applications and                             Democracy Plaza, 6707 Democracy



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Document Created: 2017-03-04 00:06:40
Document Modified: 2017-03-04 00:06:40
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 30-days of the date of this publication.
ContactTo request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Michael Montello, Pharm.D., Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number
FR Citation82 FR 12618 

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