Proposed Collection; Comment Request; NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI), 49938-49940 [2010-20167]
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49938
Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Notices
department, and the industry and
community partners.
Industry leaders who participate on
the Mayor’s Task Force for Convenience
Store Safety will provide support and
voluntarily contact approximately 90
stores and recommend they participate.
Additionally, approximately 3
community leaders in each city will
voluntarily contact approximately 90
stores and recommend they participate.
There is no cost to respondents other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Respondents
Average
burden per
response (in
hrs)
Total burden
(in hrs)
Store manager interviews ................................................................................
Store owners/upper management approve manager interviews .....................
Stakeholders Industry leader recommend stores ............................................
Community leader recommend stores .............................................................
600
35
90
90
1
1
1
1
30/60
3
30/60
30/60
300
105
45
45
Total ..........................................................................................................
........................
........................
........................
495
Dated: August 8, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–19835 Filed 8–13–10; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; NIH NCI Central Institutional
Review Board (CIRB) Initiative (NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
SUMMARY:
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: NIH NCI
Central Institutional Review Board
(CIRB). Type of Information Collection
Request: Existing Collection in Use
Without an OMB Number. Need and
Use of Information Collection: The CIRB
was created to reduce the administrative
burden on local IRBs and investigators
while protecting human research
participants. To accomplish this, the
CIRB uses several information collection
tools to ensure that CIRB operations
occur with high level of reviewer and
board member satisfaction and is absent
of conflicts of interest with the protocols
under review. Tools utilized to
accomplish this include the new
member packets which are completed
once a new member joins the CIRB to
provide background information on
workflow and processes of CIRB
operations as well as a non-disclosure
agreement. A conflict of interest form is
completed occasionally or each time the
reviewer is requested to serve as a
reviewer for a study. CIRB helpdesk
surveys measure satisfaction of
helpdesk users and is conducted
occasionally or each time the person
contacts the helpdesk. Frequency of
Response: Once, except for the SAE
Reviewer Worksheet. Affected Public:
Includes the Federal Government,
business or other for-profits and not-forprofit institutions. Type of Respondents:
Respondents include any customer who
contacts the CIRB Helpdesk,
institutional review board members and
CIRB review participants. The annual
reporting burden is estimated at 2221
hours (see Table below for the estimated
time burden). The average annual cost
to the government over a 12 month
period is approximately $153,574 per
year for a six year contract. This
includes total annualized capital/start
up costs of $25,108 and operating costs
of $150,637.
TABLE A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS
Type of
respondents
Participants/Board
Members.
Participants .............
Participants .............
Participants .............
sroberts on DSKD5P82C1PROD with NOTICES
Participants .............
Participants .............
Participants .............
Participants .............
Participants .............
VerDate Mar<15>2010
Number of
respondents
Survey instrument
CIRB Helpdesk Survey (Attachment 1)
Jkt 220001
PO 00000
Frm 00053
Annual
burden hours
1500
10/60 (.17 hour) .....
255
1
3.5 hours ................
105
65
1
10/60 (.17 hour) .....
11
65
1
10/60 (.17 hour) .....
11
65
1
10/60 (.17 hour) .....
11
65
1
10/60 (.17 hour) .....
11
65
1
10/60 (.17 hour) .....
11
65
1
10/60 (.17 hour) .....
11
65
Fmt 4703
1
30
NCI CIRB Institution Enrollment Worksheet (Attachment 2A).
IRB Staff at Signatory Institution’s IRB
(Attachment 2B).
Investigator at Signatory Institution (Attachment 2C).
Research Staff at Signatory Institution
(Attachment 2D).
Investigator at Affiliate Institution (Attachment 2E).
Research Staff at Affiliate Institution (Attachment 2F).
IRB at Signatory Institution (Attachment
2G).
Component Institution at Signatory Institution (Attachment 2H).
18:51 Aug 13, 2010
Average time per
response
(Min/Hr)
Frequency of
response
1
10/60 (.17 hour) .....
11
Sfmt 4703
E:\FR\FM\16AUN1.SGM
16AUN1
Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Notices
49939
TABLE A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS—Continued
Type of
respondents
Survey instrument
Participants .............
IRB at Affiliate Institution (Attachment
2I).
Institution Affiliate Institution without an
IRB (Attachment 2J).
Request for 30-Day Access Form (Attachment 2K).
Facilitated Review (FR) Acceptance
Form (Attachment 2L).
Study Review Responsibility Transfer
Form (Attachment 2M).
CIRB New Board Member Biographical
Sketch Form (Attachment 3B).
CIRB New Board Member Contact Information Form (Attachment 3C).
CIRB New Board Member W–9 (Attachment 3D).
Participants .............
Participants .............
Participants .............
Participants .............
Board Members ......
Board Members ......
Board Members ......
.
Board Members ......
Board Members ......
Participants .............
Participants .............
Participants .............
Participants .............
Participants .............
Board Members ......
Board Members ......
Board Members ......
Board Members ......
Board Members ......
Board Members ......
Board Members ......
Board Members ......
Board Members ......
Board Members ......
sroberts on DSKD5P82C1PROD with NOTICES
Board Members ......
Total .................
................................................................
18:51 Aug 13, 2010
Jkt 220001
Frm 00054
Annual
burden hours
1
10/60 (.17 hour) .....
11
65
1
10/60 (.17 hour) .....
11
50
1
10/60 (.17 hour) .....
9
1450
1
10/60 (.17 hour) .....
247
120
1
10/60 (.17 hour) .....
20
16
1
30/60 (.5 hour) .......
8
16
1
15/60 (.25 hour) .....
4
16
1
15/60 (.25 hour) .....
4
16
1
15/60 (.25 hour) .....
4
16
150
1
1
15/60 (.25 hour) .....
2 hours ...................
4
300
62
1
2 hours ...................
124
10
1
2 hours ...................
20
20
1
30/60 (.5 hour) .......
10
230
1
1 hour ....................
230
20
1
4 hours ...................
80
12
1
4 hours ...................
48
25
1
1 hour ....................
25
70
1
1 hour ....................
70
130
1
1.5 hours ................
195
50
1
1.5 hours ................
75
150
1
.5 hour ...................
75
110
1
.5 hour ...................
55
20
20
1
1
2 hours ...................
2 hours ...................
40
40
10
15
30/60 (.5 hour) .......
75
............................
............................
................................
2221
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
PO 00000
Average time per
response
(Min/Hr)
Frequency of
response
65
CIRB New Board Member Non-Disclosure Agreement (NDA) (Attachment
3E).
Direct Deposit Form (Attachment 4) ......
NCI Adult CIRB Application (Attachment
5A).
NCI Pediatric CIRB Application (Attachment 5B).
Adult/Pediatric CIRB Application—Ancillary Studies (Attachment 5C).
Summary of CIRB Application Revisions
(Attachment 5D).
Adult/Pediatric CIRB Application for
Continuing Review (Attachment 5E).
Adult CIRB Reviewer Findings—Initial
Review of Cooperative Group Protocol (Attachment 6A).
Pediatric CIRB Reviewer Findings—Initial Review of Cooperative Group
Protocol (Attachment 6B).
Adult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attachment 6C).
Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB
Review (Attachment 6D).
Adult CIRB Reviewer Findings Amendment Cooperative Group Protocol (Attachment 6E).
Pediatric CIRB Reviewer Findings
Amendment to Cooperative Group
Protocol (Attachment 6F).
Adult CIRB Reviewer Findings Continuing Review of Cooperative Group
Protocol (Attachment 6G).
Pediatric CIRB Reviewer Findings Continuing Review of Cooperative Group
Protocol (Attachment 6H).
CIRB Reviewer Form (Attachment 6I) ...
CIRB Statistical Reviewer Form (Attachment 6J).
CIRB SAE Reviewer Worksheet (Attachment 6K).
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
VerDate Mar<15>2010
Number of
respondents
Fmt 4703
Sfmt 4703
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
E:\FR\FM\16AUN1.SGM
16AUN1
49940
Federal Register / Vol. 75, No. 157 / Monday, August 16, 2010 / Notices
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Michael Montello,
Pharm. D., CTEP, 6130 Executive Blvd.,
Rockville, MD 20852. At non-toll-free
number 301–435–9206 or e-mail your
request, including your address to:
montellom@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: August 9, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–20167 Filed 8–13–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: General and
Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 18, 2010, from 8 a.m.
to 6 p.m.
Location: Holiday Inn College Park,
Grand Ballroom, 10000 Baltimore Ave.,
College Park, MD.
Contact Person: Margaret McCabeJanicki, Center for Devices and
VerDate Mar<15>2010
18:51 Aug 13, 2010
Jkt 220001
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1535, Silver Spring,
MD 20993–0002, 301–796–7029, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512519. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On November 18, 2010, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application for MelaFind,
sponsored by MELA Sciences. MelaFind
is a computer-controlled multi-spectral
dermoscope that uses light, wavelengths
from 430 nanometers (nm) (blue)
through 950 nm (near infrared), to image
the skin through a thin layer of liquid
(alcohol or oil), making lesion structures
under the skin surface visible to the
observer. A complementary metal oxide
semiconductor digital camera inside the
probe captures the images and then
differentiates them among pigmented
skin lesions for melanoma risk using
predefined software statistical pattern
recognition algorithms.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before November 9, 2010.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 28, 2010. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
November 2, 2010.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Conference Management
Staff, 301–796–5966, at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 11, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–20156 Filed 8–13–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of meetings of the National
Diabetes and Digestive and Kidney
Diseases Advisory Council.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
E:\FR\FM\16AUN1.SGM
16AUN1
]]>Agencies
[Federal Register Volume 75, Number 157 (Monday, August 16, 2010)]
[Notices]
[Pages 49938-49940]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-20167]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; NIH NCI Central
Institutional Review Board (CIRB) Initiative (NCI)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NCI), the National Institutes of Health (NIH) will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Proposed Collection: Title: NIH NCI Central Institutional Review
Board (CIRB). Type of Information Collection Request: Existing
Collection in Use Without an OMB Number. Need and Use of Information
Collection: The CIRB was created to reduce the administrative burden on
local IRBs and investigators while protecting human research
participants. To accomplish this, the CIRB uses several information
collection tools to ensure that CIRB operations occur with high level
of reviewer and board member satisfaction and is absent of conflicts of
interest with the protocols under review. Tools utilized to accomplish
this include the new member packets which are completed once a new
member joins the CIRB to provide background information on workflow and
processes of CIRB operations as well as a non-disclosure agreement. A
conflict of interest form is completed occasionally or each time the
reviewer is requested to serve as a reviewer for a study. CIRB helpdesk
surveys measure satisfaction of helpdesk users and is conducted
occasionally or each time the person contacts the helpdesk. Frequency
of Response: Once, except for the SAE Reviewer Worksheet. Affected
Public: Includes the Federal Government, business or other for-profits
and not-for-profit institutions. Type of Respondents: Respondents
include any customer who contacts the CIRB Helpdesk, institutional
review board members and CIRB review participants. The annual reporting
burden is estimated at 2221 hours (see Table below for the estimated
time burden). The average annual cost to the government over a 12 month
period is approximately $153,574 per year for a six year contract. This
includes total annualized capital/start up costs of $25,108 and
operating costs of $150,637.
Table A.12-1--Estimates of Annual Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time per response Annual burden
Type of respondents Survey instrument respondents response (Min/Hr) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Participants/Board Members............. CIRB Helpdesk Survey 1500 1 10/60 (.17 hour)......... 255
(Attachment 1).
Participants........................... NCI CIRB Institution 30 1 3.5 hours................ 105
Enrollment Worksheet
(Attachment 2A).
Participants........................... IRB Staff at Signatory 65 1 10/60 (.17 hour)......... 11
Institution's IRB (Attachment
2B).
Participants........................... Investigator at Signatory 65 1 10/60 (.17 hour)......... 11
Institution (Attachment 2C).
Participants........................... Research Staff at Signatory 65 1 10/60 (.17 hour)......... 11
Institution (Attachment 2D).
Participants........................... Investigator at Affiliate 65 1 10/60 (.17 hour)......... 11
Institution (Attachment 2E).
Participants........................... Research Staff at Affiliate 65 1 10/60 (.17 hour)......... 11
Institution (Attachment 2F).
Participants........................... IRB at Signatory Institution 65 1 10/60 (.17 hour)......... 11
(Attachment 2G).
Participants........................... Component Institution at 65 1 10/60 (.17 hour)......... 11
Signatory Institution
(Attachment 2H).
[[Page 49939]]
Participants........................... IRB at Affiliate Institution 65 1 10/60 (.17 hour)......... 11
(Attachment 2I).
Participants........................... Institution Affiliate 65 1 10/60 (.17 hour)......... 11
Institution without an IRB
(Attachment 2J).
Participants........................... Request for 30-Day Access Form 50 1 10/60 (.17 hour)......... 9
(Attachment 2K).
Participants........................... Facilitated Review (FR) 1450 1 10/60 (.17 hour)......... 247
Acceptance Form (Attachment
2L).
Participants........................... Study Review Responsibility 120 1 10/60 (.17 hour)......... 20
Transfer Form (Attachment 2M).
Board Members.......................... CIRB New Board Member 16 1 30/60 (.5 hour).......... 8
Biographical Sketch Form
(Attachment 3B).
Board Members.......................... CIRB New Board Member Contact 16 1 15/60 (.25 hour)......... 4
Information Form (Attachment
3C).
Board Members.......................... CIRB New Board Member W-9 16 1 15/60 (.25 hour)......... 4
(Attachment 3D).
Board Members.......................... CIRB New Board Member Non- 16 1 15/60 (.25 hour)......... 4
Disclosure Agreement (NDA)
(Attachment 3E).
Board Members.......................... Direct Deposit Form 16 1 15/60 (.25 hour)......... 4
(Attachment 4).
Participants........................... NCI Adult CIRB Application 150 1 2 hours.................. 300
(Attachment 5A).
Participants........................... NCI Pediatric CIRB Application 62 1 2 hours.................. 124
(Attachment 5B).
Participants........................... Adult/Pediatric CIRB 10 1 2 hours.................. 20
Application--Ancillary
Studies (Attachment 5C).
Participants........................... Summary of CIRB Application 20 1 30/60 (.5 hour).......... 10
Revisions (Attachment 5D).
Participants........................... Adult/Pediatric CIRB 230 1 1 hour................... 230
Application for Continuing
Review (Attachment 5E).
Board Members.......................... Adult CIRB Reviewer Findings-- 20 1 4 hours.................. 80
Initial Review of Cooperative
Group Protocol (Attachment
6A).
Board Members.......................... Pediatric CIRB Reviewer 12 1 4 hours.................. 48
Findings--Initial Review of
Cooperative Group Protocol
(Attachment 6B).
Board Members.......................... Adult CIRB Reviewer Findings 25 1 1 hour................... 25
Cooperative Group Response to
CIRB Review (Attachment 6C).
Board Members.......................... Pediatric CIRB Reviewer 70 1 1 hour................... 70
Findings Cooperative Group
Response to CIRB Review
(Attachment 6D).
Board Members.......................... Adult CIRB Reviewer Findings 130 1 1.5 hours................ 195
Amendment Cooperative Group
Protocol (Attachment 6E).
Board Members.......................... Pediatric CIRB Reviewer 50 1 1.5 hours................ 75
Findings Amendment to
Cooperative Group Protocol
(Attachment 6F).
Board Members.......................... Adult CIRB Reviewer Findings 150 1 .5 hour.................. 75
Continuing Review of
Cooperative Group Protocol
(Attachment 6G).
Board Members.......................... Pediatric CIRB Reviewer 110 1 .5 hour.................. 55
Findings Continuing Review of
Cooperative Group Protocol
(Attachment 6H).
Board Members.......................... CIRB Reviewer Form (Attachment 20 1 2 hours.................. 40
6I).
Board Members.......................... CIRB Statistical Reviewer Form 20 1 2 hours.................. 40
(Attachment 6J).
Board Members.......................... CIRB SAE Reviewer Worksheet 10 15 30/60 (.5 hour).......... 75
(Attachment 6K).
--------------------------------------------------------------------------------
Total.............................. .............................. ................ ................ ......................... 2221
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) Evaluate the accuracy of the agency's estimate of the
burden of the proposed collection of
[[Page 49940]]
information, including the validity of the methodology and assumptions
used; (3) Enhance the quality, utility, and clarity of the information
to be collected; and (4) Minimize the burden of the collection of
information on those who are to respond, including the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Michael Montello, Pharm. D., CTEP, 6130 Executive
Blvd., Rockville, MD 20852. At non-toll-free number 301-435-9206 or e-
mail your request, including your address to: montellom@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: August 9, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-20167 Filed 8-13-10; 8:45 am]
BILLING CODE 4140-01-P
