Submission for OMB Review; Comment Request; Cancer Biomedical Informatics Grid® (caBIG®) Support Service Provider (SSP) Program (NCI), 24889-24890 [2011-10666]
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Federal Register / Vol. 76, No. 85 / Tuesday, May 3, 2011 / Notices
Web site for guidance documents with
current enforcement policies related to
premarket requirements for tobacco
products (https://www.fda.gov/
TobaccoProducts/default.htm)).
With regard to the comment that the
number of section 905(j)(1)(A)(i)
substantial equivalence reports which
FDA estimated to be submitted (150 per
year) was too low, FDA has revised its
estimate based on information it now
has from initial submissions,
interactions with industry, and other
information, such as the comment
received on the 60-day notice on the
information collection. As shown
24889
able to refine these estimates. In
addition, as discussed previously, the
commenter did not suggest an
alternative number of hours. FDA’s
estimate of 360 hours reflects an amount
of time that should provide each
submitter enough time to prepare and
submit a section 905(j)(1)(A)(i)
substantial equivalence report to the
Agency.
below, FDA is increasing the annual
estimate of the number of reports
received from 150 to 1,000.
With regard to the comment that the
number of hours to prepare and submit
each report is unrealistic, FDA
continues to believe that the currently
estimated hours (360 hours annually) is
appropriate, particularly given that the
premarket requirements for new tobacco
products (Section 910 of the FD&C Act)
are new and manufacturers’ experience
with preparing a submission is just
beginning to develop. As the
requirements and program become more
familiar to respondents, FDA may be
Estimation of Burden
FDA estimates the burden for this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FD&C Act sections
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
905(j)(a)(A)(i) and 910(a) .....................................................
Total ..............................................................................
1,000
........................
1
........................
1,000
........................
360
........................
1 There
360,000
360,000
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has based these estimates on
information it now has available from
interactions with the industry,
comments regarding the submission of
905(j)(1)(A)(i) substantial equivalence
reports, and comments on the 60-day
information collection notice request for
comments published in the Federal
Register on January 24, 2011 (76 FR
4116). Table 1 of this document
describes the annual reporting burden
as a result of the implementation of the
substantial equivalence requirements of
sections 905(j)(1)(A)(i) and 910(a) of the
FD&C Act. FDA estimates that it will
receive 1,000 section 905(j) substantial
equivalence reports each year and that
it will take a manufacturer
approximately 360 hours to prepare a
report of substantial equivalence for a
new tobacco product. Therefore, FDA
estimates the burden for submission of
substantial equivalence information will
be 360,000 hours.
Dated: April 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–10618 Filed 5–2–11; 8:45 am]
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Total hours
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Cancer Biomedical
Informatics Grid® (caBIG®) Support
Service Provider (SSP) Program (NCI)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on February 11, 2011 (76 FR
7867) 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. The 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, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title: cancer
Biomedical Informatics Grid ® (caBIG ®)
Support Service Provider (SSP) Program
(NCI). Type of Information Collection
Request: Existing Collection in Use
Without an OMB Number. Need and
Use of Information Collection: The NCI
Center for Biomedical Informatics and
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
Information Technology (CBIIT)
launched the enterprise phase of the
caBIG ® initiative in early 2007 with an
emphasis on widespread institutional
adoption of the program and tools. This
emphasis on adoption has generated an
expanding community with diverse
needs for support, which are met
through the resources available through
the caBIG ® Enterprise Support Network
(ESN), including the caBIG ® Support
Service Provider (SSP) Program. The
caBIG ® SSPs provide caBIG ® end-users
with the freedom to match what caBIG ®
has to offer to their unique
organizational goals and needs, so
having this customized support option
available is critically important to
advancing the goals of the caBIG ®
program. caBIG ® SSP applicants are
evaluated against well-defined criteria
published in the SSP Program
Announcement and must successfully
demonstrate that they have the technical
capabilities, staffing and scalability,
geographic coverage (when applicable),
and the domain expertise in
biomedicine to effectively serve caBIG ®
users. The information submitted by
SSP applicants enables NCI to
determine whether such applicants are
qualified to enter into trademark license
negotiations with NCI to use the caBIG ®
trademarks in connection with their
services and become designated as
caBIG ® SSPs. Thus, the collection of
information from SSP applicants is
critical to both ensuring that the goals
and objectives of the caBIG ® program
will be maintained and furthered by the
E:\FR\FM\03MYN1.SGM
03MYN1
24890
Federal Register / Vol. 76, No. 85 / Tuesday, May 3, 2011 / Notices
organizations designated as SSPs and
facilitating NCI’s ability to exercise
appropriate stewardship of the caBIG ®
trademarks. Sections 410 and 411 of the
Public Health Service Act (42 U.S.C. 285
and 285a) authorize the collection of the
information. Frequency of Response:
once for the applicants. caBIG ® SSP
applications are accepted on a rolling
basis and reviewed several times a year.
Affected Public: Private sector including
Business or other for-profits and not-forprofit organizations and institutions.
Type of Respondents: Technical
representatives of commercial, academic
or not-for-profit organizations. The
annual reporting burden is estimated at
360 hours.
There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to
report.
A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS
Number of
respondents
Type of respondents
Frequency of
response
14
1
Nonprofit Organizations ..................................
1
Totals .......................................................
srobinson on DSKHWCL6B1PROD with NOTICES
Commercial Organizations ..............................
15
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on 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
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.
Direct Comments to OMB: 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
Attention: NIH Desk Officer, Office of
Management and Budget, at
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact John
Speakman, NCI CBIIT Chief Program
Officer, Center for Biomedical
Informatics and Information
Technology, National Cancer Institute,
NIH, DHHS, 2115 E. Jefferson Street,
Suite 6000, Rockville, MD 20892 or call
non-toll-free number 301–451–8786 or
e-mail your request, including your
address to: john.speakman@nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
VerDate Mar<15>2010
20:39 May 02, 2011
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Average time per response
(minutes/hour)
336
1
1440/60 ..........................................................
(24 hours) .......................................................
1440/60 ..........................................................
(24 hours) .......................................................
........................
.........................................................................
360
received within 30 days of the date of
this publication.
Dated: April 26, 2011.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2011–10666 Filed 5–2–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
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
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Initial Review Group, Biological Aging
Review Committee.
Date: June 1–2, 2011.
Time: 3 p.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Guest Suites Santa
Monica, 1707 Fourth Street, Santa Monica,
CA 90401.
Contact Person: Bita Nakhai, PhD,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, Gateway
Bldg., 2c212, 7201 Wisconsin Avenue,
PO 00000
Frm 00043
Annual burden
hours
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24
Bethesda, MD 20814, 301–402–7701,
nakhaib@nia.nih.gov.
Name of Committee: National Institute on
Aging Initial Review Group, Neuroscience of
Aging Review Committee.
Date: June 2–3, 2011.
Time: 3 p.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Guest Suites Santa
Monica, 1707 Fourth Street, Santa Monica,
CA 90401.
Contact Person: William Cruce, PhD,
Scientific Review Administrator, National
Institute on Aging, Scientific Review Office,
Gateway Building 2c-212, 7201 Wisconsin
Ave., Bethesda, MD 20814, 301–402–7704,
crucew@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: April 27, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–10739 Filed 5–2–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Research
Resources; 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
E:\FR\FM\03MYN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 85 (Tuesday, May 3, 2011)]
[Notices]
[Pages 24889-24890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10666]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Cancer Biomedical
Informatics Grid[supreg] (caBIG[supreg]) Support Service Provider (SSP)
Program (NCI)
Summary: Under the provisions of Section 3507(a)(1)(D) of the
Paperwork Reduction Act of 1995, the National Cancer Institute (NCI),
the National Institutes of Health (NIH), has submitted to the Office of
Management and Budget (OMB) a request to review and approve the
information collection listed below. This proposed information
collection was previously published in the Federal Register on February
11, 2011 (76 FR 7867) 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. The 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,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: cancer Biomedical Informatics Grid
[supreg] (caBIG [supreg]) Support Service Provider (SSP) Program (NCI).
Type of Information Collection Request: Existing Collection in Use
Without an OMB Number. Need and Use of Information Collection: The NCI
Center for Biomedical Informatics and Information Technology (CBIIT)
launched the enterprise phase of the caBIG [supreg] initiative in early
2007 with an emphasis on widespread institutional adoption of the
program and tools. This emphasis on adoption has generated an expanding
community with diverse needs for support, which are met through the
resources available through the caBIG [supreg] Enterprise Support
Network (ESN), including the caBIG [supreg] Support Service Provider
(SSP) Program. The caBIG [supreg] SSPs provide caBIG [supreg] end-users
with the freedom to match what caBIG [supreg] has to offer to their
unique organizational goals and needs, so having this customized
support option available is critically important to advancing the goals
of the caBIG [supreg] program. caBIG [supreg] SSP applicants are
evaluated against well-defined criteria published in the SSP Program
Announcement and must successfully demonstrate that they have the
technical capabilities, staffing and scalability, geographic coverage
(when applicable), and the domain expertise in biomedicine to
effectively serve caBIG [supreg] users. The information submitted by
SSP applicants enables NCI to determine whether such applicants are
qualified to enter into trademark license negotiations with NCI to use
the caBIG [supreg] trademarks in connection with their services and
become designated as caBIG [supreg] SSPs. Thus, the collection of
information from SSP applicants is critical to both ensuring that the
goals and objectives of the caBIG [supreg] program will be maintained
and furthered by the
[[Page 24890]]
organizations designated as SSPs and facilitating NCI's ability to
exercise appropriate stewardship of the caBIG [supreg] trademarks.
Sections 410 and 411 of the Public Health Service Act (42 U.S.C. 285
and 285a) authorize the collection of the information. Frequency of
Response: once for the applicants. caBIG [supreg] SSP applications are
accepted on a rolling basis and reviewed several times a year. Affected
Public: Private sector including Business or other for-profits and not-
for-profit organizations and institutions. Type of Respondents:
Technical representatives of commercial, academic or not-for-profit
organizations. The annual reporting burden is estimated at 360 hours.
There are no Capital Costs, Operating Costs, and/or Maintenance
Costs to report.
A.12-1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Frequency of Average time per Annual burden
Type of respondents respondents response response (minutes/hour) hours
----------------------------------------------------------------------------------------------------------------
Commercial Organizations.............. 14 1 1440/60................. 336
(24 hours)..............
Nonprofit Organizations............... 1 1 1440/60................. 24
(24 hours)..............
--------------------------------
Totals............................ 15 .............. ........................ 360
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on 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 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.
Direct Comments to OMB: 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 Attention: NIH Desk Officer, Office of Management and
Budget, at OIRA_submission@omb.eop.gov or by fax to 202-395-6974. To
request more information on the proposed project or to obtain a copy of
the data collection plans and instruments, contact John Speakman, NCI
CBIIT Chief Program Officer, Center for Biomedical Informatics and
Information Technology, National Cancer Institute, NIH, DHHS, 2115 E.
Jefferson Street, Suite 6000, Rockville, MD 20892 or call non-toll-free
number 301-451-8786 or e-mail your request, including your address to:
john.speakman@nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: April 26, 2011.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2011-10666 Filed 5-2-11; 8:45 am]
BILLING CODE 4140-01-P
