30day FRN

12618

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

Dated: February 15, 2017.
Karla Bailey,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2017–04255 Filed 3–3–17; 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

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following 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
appications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PAR–14–
255: Multidisciplinary Studies of HIV and
Viral Hepatitis Co-Infection.
Date: March 28, 2017.
Time: 10:00 a.m. to 11:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Kenneth A. Roebuck,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106,
MSC 7852, Bethesda, MD 20892, (301) 435–
1166, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel,
Fellowships: Physiology and Pathobiology of
Musculoskeletal, Oral and Skin Systems.
Date: March 29, 2017.
Time: 8:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Anshumali Chaudhari,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4124,
MSC 7802, Bethesda, MD 20892, (301) 435–
1210, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Small
Business: Non-HIV Diagnostics, Food Safety,
Sterilization/Disinfection and
Bioremediation.
Date: March 30–31, 2017.

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Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Gagan Pandya, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Rm 3200, MSC 7808,
Bethesda, MD 20892, 301–435–1167,
[email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Small
Business: Cancer Biotherapeutics
Development.
Date: March 30–31, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: Nicholas J. Donato, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040,
Bethesda, MD 20817, 301–827–4810,
[email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel, RFA–GM–
17–004: Maximizing Investigators’ Research
Award for Early Stage Investigators (R35).
Date: March 30, 2017.
Time: 8:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: David Balasundaram,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5189,
MSC 7840, Bethesda, MD 20892, 301–435–
1022, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Cardiovascular Science.
Date: March 30–31, 2017.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Kimm Hamann, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118A,
MSC 7814, Bethesda, MD 20892, 301–435–
5575, [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)
Dated: February 28, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–04172 Filed 3–3–17; 8:45 am]
BILLING CODE 4140–01–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Integrative Health; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Complementary and Integrative Health
Special Emphasis Panel, NCCIH Training,
Career Development, Fellowship, and
Research Grant Review.
Date: March 22, 2017.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892, (Virtual
Meeting).
Contact Person: Ashlee Tipton, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Center for
Complementary and Integrative Health, 6707
Democracy Blvd., Suite 401, Bethesda, MD
20892, 301–451–3849, Ashlee.tipton@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Integrative Health,
National Institutes of Health, HHS)
Dated: February 28, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–04177 Filed 3–3–17; 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 Support
Contracts Forms and Surveys, NCI,
NIH
AGENCY:

National Institutes of Health,

HHS.
ACTION:

E:\FR\FM\06MRN1.SGM

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12619

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

asabaliauskas on DSK3SPTVN1PROD with NOTICES

CTSU AND NCI CIRB FORMS AND CTSU, CIRB AND CTEP SURVEYS—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Type of
respondent

CTSU IRB/Regulatory Approval Transmittal
Form (Attachment A1).
CTSU IRB Certification Form (Attachment
A2).
Withdrawal from Protocol Participation Form
(Attachment A3).
Site Addition Form (Attachment A4) .............
CTSU Roster Update Form (Attachment A5)
CTSU Request for Clinical Brochure (Attachment A6).
CTSU Supply Request Form (Attachment
A7).
Site Initiated Data Update Form (Attachment A8).
Data Clarification Form (Attachment A9) .....
RTOG 0834 CTSU Data Transmittal Form
(Attachment A10).
MC0845(8233) CTSU Data Transmittal (Attachment A11).
CTSU Generic Data Transmittal Form (Attachment A12).
TAILORx—PACCT1—Data
Transmittal
Form (Attachment A13).
Unsolicited Data Modification Form: Protocol: TAILORx/PACCT–1 (Attachment
14).
CTSU Patient Enrollment Transmittal Form
(Attachment A15).
CTSU Transfer Form (Attachment A16) .......
CTSU System Access Request Form (Attachment A17).

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 .......

5

12

10/60

10

Health Care Practitioner .......

161

96

10/60

2576

Health Care Practitioner .......

30

12

10/60

60

Health Care Practitioner .......

12

12

10/60

24

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

360
180

2
1

10/60
20/60

120
60

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respondents

Average
burden per
response
(in hours)

Form name

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12620

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

asabaliauskas on DSK3SPTVN1PROD with NOTICES

CTSU AND NCI CIRB FORMS AND CTSU, CIRB AND CTEP SURVEYS—ESTIMATED ANNUALIZED BURDEN HOURS—
Continued
Number of
responses per
respondent

Type of
respondent

NCI CIRB AA & DOR between the NCI
CIRB and Signatory Institution (Attachment B1).
NCI CIRB Signatory Enrollment Form (Attachment B2).
CIRB Board Member Biographical Sketch
Form (Attachment B3).
CIRB Board Member Contact Information
Form (Attachment B4).
CIRB Board Member NDA (Attachment B6)
CIRB Direct Deposit Form (Attachment B7)
CIRB Member COI Screening Worksheet
(Attachment B8).
CIRB COI Screening for CIRB meetings (Attachment B9).
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).
Pediatric IR of Cooperative Group Protocol
(Attachment B16).
Adult Continuing Review of Cooperative
Group Protocol (Attachment B17) Protocol.
Pediatric Continuing Review of Cooperative
Group Protocol (Attachment B18).
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).
CPC Pharmacist’s Review of Cooperative
Group Study (Attachment B22).
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 Mod (Attachment B29).
Pediatric Expedited Study Chair Response
to Required Mod (Attachment B30).
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).

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

50

1

15/60

13

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

50

1

15/60

13

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

25

1

15/60

6

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

25

1

10/60

4

Board Member ......................
Board Member ......................
Board Members ....................

25
25
12

1
1
1

10/60
15/60
30/60

4
6
6

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

72

1

15/60

18

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

80
4

1
1

1
30/60

80
2

Health Care Practitioner .......

400

1

15/60

100

Health Care Practitioner .......

1

1

1

1

Health Care Practitioner .......

400

1

30/60

200

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

65

1

180/60

195

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

15

1

180/60

45

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

275

1

1

275

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

130

1

1

130

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

40

1

120/60

80

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

25

1

120/60

50

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

10

1

120/60

20

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

20

1

120/60

40

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

1

30

Health Care Practitioner .......

5

1

1

5

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

40

1

15/60

10

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

40

1

15/60

10

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

360

1

10/60

61

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

100

1

1

100

Health Care Practitioner .......

100

1

30/60

50

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

100

1

15/60

25

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

20

1

15/60

5

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(in hours)

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12621

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
Type of
respondent

Reviewer Worksheet Expedited Study Closure Review (Attachment B36).
Reviewer Worksheet Expedited Review of
Study Chair Response to CIRB-Required
Modifications (Attachment B37).
Reviewer Worksheet of Expedited IR (Attachment B38).
Reviewer Worksheet—CPC—Determination
of UP or SCN (Attachment B39).
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 Form (Attachment B43).
UP or SCN Reporting Form (Attachment
B44).
Change of SI PI Form (Attachment B45) .....
CTSU Website Customer Satisfaction Survey (Attachment C1).
CTSU Help Desk Customer Satisfaction
Survey (Attachment C2).
CTSU OPEN Survey (Attachment C3) .........
CIRB Customer Satisfaction Survey (Attachment C4) Satisfaction Survey (Attachment
C4).
Follow-up Survey (Communication Audit)
(Attachment C5).
Website Focus Groups, Communication
Project (Attachment C6 A–D).
CIRB Board Member Annual Assessment
Survey (Attachment C7).
PIO Customer Satisfaction Survey (Attachment C8).
Concept Clinical Trial Survey (Attachment
C9).
Prospective Clinical Trial Survey (Attachment C10).
Low Accrual Clinical Trial Survey (Attachment C11).
ETCTN PI Survey (Attachment 12) ..............
ETCTN RS Survey (Attachment 13) ............

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

20

1

15/60

5

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

5

1

30/60

3

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

5

1

30/60

3

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

40

1

15/60

10

Health Care Practitioner .......

400

1

40/60

267

Health Care Practitioner .......

1800

1

20/60

600

Health Care Practitioner .......

4800

1

20/60

1600

Health Care Practitioner .......

1680

1

15/60

420

Health Care Practitioner .......

360

1

20/60

120

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

120
275

1
1

15/60
15/60

30
69

Health Care Practitioner .......

325

1

15/60

81

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

60
600

1
1

15/60
15/60

15
150

Participants/Board Members

300

1

15/60

75

Participants/Board Members

18

1

1

18

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

60

1

20/60

20

Health Care Practitioner .......

60

1

5/60

5

Health Care Practitioner .......

500

1

5/60

42

Health Care Practitioner .......

1000

1

1/60

17

Health Care Practitioner .......

1000

1

1/60

17

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

75
175

1
1

15/60
15/60

19
44

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]

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respondents

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burden hours

National Center for Complementary &
Integrative Health; Notice of Closed
Meeting

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.

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and

Name of Committee: National Center for
Complementary and Integrative Health
Special Emphasis Panel, Exploratory Clinical
Trials and Studies of Natural Products.
Date: March 30, 2017.
Time: 12:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health

BILLING CODE 4140–01–P
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response
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