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biospecimen inventories must register
for an account.
Information will be collected from
those wishing to create an account,
sufficient to identify them as unique
Users. Those submitting or requesting
data and/or biospecimen inventories
will be required to provide additional
supporting information to ensure proper
use and security of NICHD DASH study
data and biospecimen inventories. The
information collected is limited to the
essential data required to ensure the
management of Users in NICHD DASH
is efficient and the sharing of data and

All the data collected from use of
NICHD DASH except for information
provided in the annual progress reports
are for the purposes of internal
administrative management of NICHD
DASH. Information gathered through
the annual progress reports may be used
in publications describing performance
of the DASH system.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
204.

biospecimens among investigators is
effective. The primary uses of the
information collected from Users by
NICHD will be to:
• Communicate with the Users with
regards to their data submission, data
requests and biospecimen requests
• Monitor data submissions, data
requests and biospecimen requests
• Notify interested recipients of updates
to data and biospecimen inventories
stored in NICHD DASH
• Help NICHD understand the use of
NICHD DASH study data and
biospecimen inventories by the
research community

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of form

Average time
per response
(in hours)

Total annual
burden hour

User Registration .............................................................................................
Data and Biospecimen Inventory Submission .................................................
Data Request ...................................................................................................
Biospecimen Request ......................................................................................
Data Use Annual Progress Report ..................................................................
Biospecimen Use Annual Progress Report .....................................................
Institutional Certification Template ..................................................................

200
36
60
36
60
36
36

1
1
1
1
1
1
1

5/60
2
1
1
10/60
10/60
5/60

17
72
60
36
10
6
3

Total ..........................................................................................................

200

200

........................

204

Dated: April 17, 2018.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy
Shriver, National Institute of Child Health
and Human Development, National Institutes
of Health.
[FR Doc. 2018–08901 Filed 4–26–18; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request
CTEP Branch and Support Contracts
Forms and Surveys (National Cancer
Institute)
AGENCY: National Institutes of Health,
HHS.
ACTION: Notice.
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.
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.
SUMMARY:

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Frequency of
response

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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., Shanda Finnigan, MPH, RN,
CCRC or Jacquelyn Goldberg, JD, 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: ctsucontact@
westat.com.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on February 21, 2018, page
7483 (83 FR 7483) and allowed 60 days
for public comment. No public
comments were received. The National
Cancer Institute (NCI), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
ADDRESSES:

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revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: CTEP Branch
and Support Contracts Forms and
Surveys, 0925–0753 Expiration Date 06/
30/2020, REVISION, 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 implements programs to
register clinical site investigators and
clinical site staff, and to oversee the
conduct of research at the clinical sites.
CTEP and DCP also oversee two support
programs, the NCI Central Institutional
Review Board (CIRB) and the Cancer
Trial Support Unit (CTSU). The
combined systems and processes for

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initiating and managing clinical trials is
termed the Clinical Oncology Research
Enterprise (CORE) and represents an
integrated set of information systems
and processes which support
investigator registration, trial oversight,
patient enrollment, and clinical data
collection. The information collected is
required to ensure compliance with
applicable federal regulations governing
the conduct of human subjects research
(45 CFR 46 and 21 CRF 50), and when
CTEP acts as the Investigational New
Drug (IND) holder, FDA regulations
pertaining to the sponsor of clinical

trials and the selection of qualified
investigators under 21 CRF 312.53).
Information is also collected through
surveys to assess satisfaction, provide
feedback to guide improvements with
processes and technology, and assess
health professional’s interests in clinical
trials.
To increase efficiencies, reduce
administrative burden and cost, CTEP
has requested consolidation of their
current OMB submission. Consolidation
is justified because although the various
branches and contracts are responsible
for distinct services, the processes that
support the NCI and participating

clinical sites efforts are intertwined.
This revision of the previous
submission includes changes to the NCI
CIRB and CTSU form collections and
integrates the Clinical Trials Monitoring
Branch (CTMB) and Pharmaceutical
Management Branch (PMB) form
collections related to site audit and
clinical investigator and key clinical site
staff registration.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
112,798.

daltland on DSKBBV9HB2PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Number of
respondents

Average
burden per
response
(in hours)

Total
annual
burden
hours

Form name

Type of respondent

CTSU IRB/Regulatory Approval Transmittal
Form (Attachment A01).
CTSU IRB Certification Form (Attachment
A02).
Withdrawal from Protocol Participation Form
(Attachment A03).
Site Addition Form (Attachment A04) ..............
CTSU Roster Update Form (Attachment A05)
CTSU Request for Clinical Brochure (Attachment A06).
CTSU Supply Request Form (Attachment
A07).
Site Initiated Data Update Form (Attachment
A08).
Data Clarification Form (Attachment A09) ......
RTOG 0834 CTSU Data Transmittal Form
(Attachment A10).
CTSU Generic Data Transmittal Form (Attachment A12).
CTSU Patient Enrollment Transmittal Form
(Attachment A15).
CTSU Transfer Form (Attachment A16) ..........
CTSU System Access Request Form (Attachment A17).
CTSU OPEN Rave Request Form (Attachment A18).
CTSU LPO Form Creation (Attachment A19)
CTSU Site Form Creation and PDF (Attachment A20).
CTSU PDF Signature Form (Attachment A21)
NCI CIRB AA & DOR between the NCI CIRB
and Signatory Institution (Attachment B01).
NCI CIRB Signatory Enrollment Form (Attachment B02).
CIRB Board Member Application (Attachment
B03).
CIRB Member COI Screening Worksheet (Attachment B08).
CIRB COI Screening for CIRB meetings ........
(Attachment B09) .............................................
CIRB IR Application (Attachment B10) ...........
CIRB IR Application for Exempt Studies (Attachment B11).
CIRB Amendment Review Application (Attachment B12).
CIRB Ancillary Studies Application ..................
(Attachment B13) .............................................
CIRB Continuing Review Application ..............
(Attachment B14) .............................................
Adult IR of Cooperative Group Protocol (Attachment B15).

Health Care Practitioner ....

2,444

12

2/60

978

Health Care Practitioner ....

2,444

12

10/60

4,888

Health Care Practitioner ....

279

1

10/60

47

Health Care Practitioner ....
Health Care Practitioner ....
Health Care Practitioner ....

80
600
360

12
1
1

10/60
5/60
10/60

160
50
60

Health Care Practitioner ....

90

12

10/60

180

Health Care Practitioner ....

2

12

10/60

4

Health Care Practitioner ....
Health Care Practitioner ....

150
12

24
76

10/60
10/60

600
152

Health Care Practitioner ....

5

12

10/60

10

Health Care Practitioner ....

12

12

10/60

24

Health Care Practitioner ....
Health Care Practitioner ....

360
180

2
1

10/60
20/60

120
60

Health Care Practitioner ....

30

21

10/60

105

Health Care Practitioner ....
Health Care Practitioner ....

5
400

2
10

120/60
30/60

20
2,000

Health Care Practitioner ....
Participants ........................

400
50

10
1

10/60
15/60

667
13

Participants ........................

50

1

15/60

13

Board Member ...................

100

1

30/60

50

Board Members .................

100

1

15/60

25

Board Members .................

72

1

15/60

18

Health Care Practitioner ....
Health Care Practitioner ....

80
4

1
1

60/60
30/60

80
2

Health Care Practitioner ....

400

1

15/60

100

Health Care Practitioner ....

1

1

60/60

1

Health Care Practitioner ....

400

1

15/60

100

Board Members .................

65

1

180/60

195

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daltland on DSKBBV9HB2PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent

Number of
respondents

Average
burden per
response
(in hours)

Total
annual
burden
hours

Form name

Type of respondent

Pediatric IR of Cooperative Group Protocol
(Attachment B16).
NCI Adult/Pediatric Continuing Review of Cooperative Group Protocol.
(Attachment B17) .............................................
Adult Amendment of Cooperative Group Protocol (Attachment B19).
Pediatric Amendment of Cooperative Group
Protocol (Attachment B20).
Pharmacist’s Review of a Cooperative Group
Study (Attachment B21).
Adult Expedited Amendment Review (Attachment B23).
Pediatric Expedited Amendment Review (Attachment B24).
Adult Expedited Continuing Review (Attachment B25).
Pediatric Expedited Continuing Review (Attachment B26).
Adult Cooperative Group Response to CIRB
Review (Attachment B27).
Pediatric Cooperative Group Response to
CIRB Review (Attachment B28).
Adult Expedited Study Chair Response to Required Modifications (Attachment B29).
Reviewer Worksheet- Determination of UP or
SCN (Attachment B31).
Reviewer Worksheet -CIRB Statistical Reviewer Form (Attachment B32).
CIRB Application for Translated Documents
(Attachment B33).
Reviewer Worksheet of Translated Documents (Attachment B34).
Reviewer Worksheet of Recruitment Material
(Attachment B35).
Reviewer Worksheet Expedited Study Closure
Review (Attachment B36).
Reviewer Worksheet of Expedited IR (Attachment B38).
Annual Signatory Institution Worksheet About
Local Context (Attachment B40).
Annual Principal Investigator Worksheet
About Local Context (Attachment B41).
Study-Specific Worksheet About Local Context (Attachment B42).
Study Closure or Transfer of Study Review
Responsibility (Attachment B43).
Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attachment (B44).
Change of Signatory Institution PI Form (Attachment B45).
Request Waiver of Assent Form (Attachment
B46).
CTSU OPEN Survey (Attachment C03) ..........
CIRB Customer Satisfaction Survey (Attachment C04).
Follow-up Survey (Communication Audit) (Attachment C05).
CIRB Board Member Annual Assessment
Survey (Attachment C07).
PIO Customer Satisfaction Survey (Attachment C08).
Concept Clinical Trial Survey (Attachment
C09).
Prospective Clinical Trial Survey (Attachment
C10).
Low Accrual Clinical Trial Survey (Attachment
C11).

Board Members .................

15

1

180/60

45

Board Members .................

275

1

60/60

275

Board Members .................

40

1

120/60

80

Board Members .................

25

1

120/60

50

Board Members .................

50

1

120/60

100

Board Members .................

348

1

30/60

174

Board Members .................

140

1

30/60

70

Board Members .................

140

1

30/60

70

Board Members .................

36

1

30/60

18

Health Care Practitioner ....

30

1

60/60

30

Health Care Practitioner ....

5

1

60/60

5

Board Members .................

40

1

30/60

20

Board Members .................

400

1

10/60

67

Board Members .................

100

1

15/60

25

Health Care Practitioner ....

100

1

30/60

50

Board Members .................

100

1

15/60

25

Board Members .................

20

1

15/60

5

Board Members .................

20

1

15/60

5

Board Members .................

5

1

30/60

3

Health Care Practitioner ....

400

1

40/60

267

Health Care Practitioner ....

1,800

1

20/60

600

Health Care Practitioner ....

4,800

1

20/60

1,600

Health Care Practitioner ....

1,680

1

20/60

560

Health Care Practitioner ....

360

1

20/60

120

Health Care Practitioner ....

120

1

20/60

40

............................................

60

1

20/60

20

Health Care Practitioner ....
Participants ........................

60
600

1
1

15/60
15/60

15
150

Participants/Board Members.
Board Members .................

300

1

15/60

75

60

1

15/60

15

Health Care Practitioner ....

60

1

5/60

5

Health Care Practitioner ....

500

1

5/60

42

Health Care Practitioner ....

1,000

1

1/60

17

Health Care Practitioner ....

1,000

1

1/60

17

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ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
annual
burden
hours

Type of respondent

Audit Scheduling Form (Attachment D01) .......
Preliminary Audit Findings Form (Attachment
D02).
Audit Maintenance Form (Attachment D03) ....
Final Audit Finding Report Form (Attachment
D04).
Follow-up Form (Attachment D05) ..................
Roster Maintenance Form (Attachment D06)
Final Report and CAPA Request Form (Attachment D07).
NCI/DCTD/CTEP FDA Form 1572 for Annual
Submission (Attachment E01).
NCI/DCTD/CTE Biosketch (Attachment E02)

Group/CTMS Users ...........
Auditor ...............................

152
152

5
5

21/60
10/60

266
127

Group/CTMS Users ...........
Group/CTMS Users ...........

152
75

5
11

9/60
1,098/60

114
15,098

Group/CTMS Users ...........
CTMS Users ......................
CTMS Users ......................

75
5
12

7
1
9

27/60
18/60
1,800/60

236
2
3240

Physician ...........................

23,000

1

15/60

5,750

Physician; Health Care
Practitioner.
Physician; Health Care
Practitioner.
Physician ...........................

33,000

1

120/60

66,000

33,000

1

5/60

2,750

23,000

1

10/60

3,833

............................................

136,487

207,989

........................

112,838

NCI/DCTD/CTEP Financial Disclosure Form
(Attachment E03).
NCI/DCTD/CTEP Agent Shipment Form
(ASF) (Attachment E04).
Totals ........................................................

Dated: April 12, 2018.
Karla Bailey,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2018–08902 Filed 4–26–18; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
daltland on DSKBBV9HB2PROD with NOTICES

Number of
respondents

Form name

Name of Committee: Center for Scientific
Review Special Emphasis Panel; Metabolic
Reprogramming to Improve Immunotherapy.
Date: May 22, 2018.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).

VerDate Sep<11>2014

19:43 Apr 26, 2018

Jkt 244001

Contact Person: Malaya Chatterjee, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6192,
MSC 7804, Bethesda, MD 20892, (301) 806–
2515, [email protected].
Name of Committee: Immunology
Integrated Review Group; Cellular and
Molecular Immunology—B Study Section.
Date: May 23–24, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Double Tree by Hilton Washington/
Silver Spring, 8727 Colesville Road, Silver
Spring, MD 20910.
Contact Person: Betty Hayden, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4206,
MSC 7812, Bethesda, MD 20892, 301–435–
1223, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Bioengineering Sciences and Technologies:
AREA Review.
Date: May 24, 2018.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: David Filpula, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6181,
MSC 7892, Bethesda, MD 20892, 301–435–
2902, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)

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Dated: April 23, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–08843 Filed 4–26–18; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AIDS and
Related Research Special Topics.
Date: April 26, 2018.
Time: 1:30 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).

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