Submission for OMB Review; Comment Request; Resource for the Collection and Evaluation of Human Tissues and Cells From Donors With an Epidemiology Profile (NCI), 52351-52352 [2010-21098]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Request; OMB No. 0925–0177
‘‘Special Volunteer and Guest
Researcher Assignment,’’ Form 590
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 information collection, the
Office of Human Resources, 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: Special
Volunteer and Guest Researcher
Assignment for use in NIH facilities.
Type of Information Collection
Request: Reinstatement, OMB 0925–
0177, Expiration Date July 31, 2005.
Need and Use of Information
Collection Request:
Form Number: NIH–590. A single
Form NIH–590 is completed by an NIH
official for each Guest Researcher or
Special Volunteer prior to his/her
arrival at NIH. The information on the
form is necessary for the approving
official to reach a decision on whether
to allow a Guest Researcher to use NIH
facilities, or whether to accept volunteer
services offered by a Special Volunteer.
If the original assignment is extended,
another form notating the extension is
completed to update the file.
Frequency of Response: Once.
Affected Public: Individuals.
Type of Respondents: Non-federal
scientific professionals and/or
individuals.
The annual Reporting burden is as
follows:
Estimated Number of Respondents:
1660;
Estimated Number of Responses per
Respondent: 1.0;
Average Burden Hours per Response:
0.1; and
Estimated Total Annual Burden
Hours Requested: 166. The estimated
annualized cost to respondents is
$2,275.
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) 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;
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:02 Aug 24, 2010
Jkt 220001
(2) 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) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to 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 Mrs. Wanda
Darwin, Office of Human Resources,
Office of The Director, NIH, Building 31,
Room 1C31E, One Center Drive,
Bethesda, MD 20892–2269, or call nontoll-free number 301–402–2820, or
E-mail your request, including your
address to: [darwinw@od.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 18, 2010.
Wanda R. Darwin,
Human Resources Specialist, Office of
Human Resources, National Institutes of
Health.
[FR Doc. 2010–21099 Filed 8–24–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Resource for the
Collection and Evaluation of Human
Tissues and Cells From Donors With
an Epidemiology Profile (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 June 16, 2010 (75 FR 34146)
and allowed 60-days for public
comment. One public comment was
received on 7/16/2010 from a business
informing us that they are able to
provide a time-saving ‘‘batch processing
service’’ to locate and verify ‘‘the most
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
52351
current addresses and phone numbers’’
of survey respondents. A response was
sent on 7/26/2010 to the business which
indicated the existence of similar
devices and/or procedures in the
current design of the project. 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: Resource
for the Collection and Evaluation of
Human Tissues and Cells from Donors
with an Epidemiology Profile (NCI).
Type of Information Collection Request:
New: Need and Use of Information
Collection: Under the auspices of three
NCI IRB-approved protocols and
instruments, the Laboratory of Human
Carcinogenesis conducts case-control
studies to investigate the relations
between biomarkers, the environment,
and human cancer. Human subjects
recruited from the general population
are needed as controls (Population
Controls) for bio-specimens and
personal histories (social, occupational
and health) that serve as references for
the significance of the frequency and
prevalence of bio-markers found in
cancer patients and thought to be
important in the development,
progression, and/or response to
treatment of the malignant growths in
cancer patients. The questionnaires will
be used to obtain the personal histories
to compare to the life styles and
exposures and the biospecimens will
serve as controls for the assay results
obtained from cancer patients. The
collection of information and specimens
from the cancer cases received NIH
Clinical Exemption (Request #2009–09–
002) on October 28, 2009. Frequency of
Response: Once. Affected Public: Adult
and senior members of the licensed
driver population in Baltimore,
Maryland and eleven near-by counties,
including the Eastern Shore. Type of
Respondents: Responders will be
English speaking, male and female,
Caucasian, African-American and
Asian. The total annual reporting
burden is estimated to be 692 (see table
below). There are no Capital Costs,
Operating Costs, and/or Maintenance
Costs to report.
E:\FR\FM\25AUN1.SGM
25AUN1
52352
Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices
TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS
Average time
per response
(minutes/hour)
Annual burden
hours
1
1
1
10/60 (0.17)
60/60 (1)
30/60 (0.5)
283
225
63
225
225
1
1
30/60 (0.5)
2/60 (0.03)
113
8
2500
........................
........................
692
Number of
respondents
Type of respondents
Survey instrument
Adults (40–79 years old)
Telephone Screener (Attachment 16) .................
Main Questionnaire (Attachment 6) .....................
Prostate Supplemental Questionnaire (Attachment 7).
Liver Supplement (Attachment 8) ........................
Refusal Questionnaire Form (Attachment 21) .....
1700
225
125
..............................................................................
Totals .....................
srobinson on DSKHWCL6B1PROD with NOTICES
Frequency of
response
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
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
Glenwood E. Trivers or Elise Bowman,
Center for Cancer Research, NCI, NIH,
37 Convent Drive Room 3060–C or
3060–A, Building 37, Bethesda,
Maryland 30893–4258 or call non-tollfree number 301–496–2094 or 301–496–
2090 or e-mail your request, including
your address to triversg@mail.nih.gov or
bowmane@mail.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.
VerDate Mar<15>2010
17:48 Aug 24, 2010
Jkt 220001
Dated: August 18, 2010.
Vivian Horovitch-Kelley
NCI Project Clearance Liaison, National
Institutes of Health.
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
[FR Doc. 2010–21098 Filed 8–24–10; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0079]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study of Graphic Cigarette Warning
Labels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
24, 2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Experimental Study of Graphic
Cigarette Warning Labels.’’ Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Experimental Study of Graphic
Cigarette Warning Labels—(OMB
Control Number 0910–NEW)
Tobacco products are responsible for
more than 440,000 deaths each year.
The Centers for Disease Control and
Prevention report that approximately 46
million U.S. adults smoke cigarettes in
the United States, even though this
behavior will result in death or
disability for half of all regular users.
Paralleling this enormous health burden
is the economic burden of tobacco use,
which is estimated to total $193 billion
annually in medical expenditures and
lost productivity. Curbing the
significant adverse consequences of
tobacco use is one of the most important
public health goals of our time. One way
to do this is through health warnings
that describe and graphically depict the
harm caused by cigarette use.
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (Tobacco
Control Act) (Public Law 111–31) into
law. The Tobacco Control Act granted
FDA important new authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 201 of the Tobacco Control Act,
which amends section 4 of the Federal
Cigarette Labeling and Advertising Act
(15 U.S.C. 1333), requires FDA to issue
‘‘regulations that require color graphics
depicting the negative health
consequences of smoking to accompany
the label statements specified in
subsection (a)(1).’’ FDA conducts
research relating to tobacco products
under its statutory authority in section
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 75, Number 164 (Wednesday, August 25, 2010)]
[Notices]
[Pages 52351-52352]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21098]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Resource for the
Collection and Evaluation of Human Tissues and Cells From Donors With
an Epidemiology Profile (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 June 16,
2010 (75 FR 34146) and allowed 60-days for public comment. One public
comment was received on 7/16/2010 from a business informing us that
they are able to provide a time-saving ``batch processing service'' to
locate and verify ``the most current addresses and phone numbers'' of
survey respondents. A response was sent on 7/26/2010 to the business
which indicated the existence of similar devices and/or procedures in
the current design of the project. 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: Resource for the Collection and
Evaluation of Human Tissues and Cells from Donors with an Epidemiology
Profile (NCI). Type of Information Collection Request: New: Need and
Use of Information Collection: Under the auspices of three NCI IRB-
approved protocols and instruments, the Laboratory of Human
Carcinogenesis conducts case-control studies to investigate the
relations between biomarkers, the environment, and human cancer. Human
subjects recruited from the general population are needed as controls
(Population Controls) for bio-specimens and personal histories (social,
occupational and health) that serve as references for the significance
of the frequency and prevalence of bio-markers found in cancer patients
and thought to be important in the development, progression, and/or
response to treatment of the malignant growths in cancer patients. The
questionnaires will be used to obtain the personal histories to compare
to the life styles and exposures and the biospecimens will serve as
controls for the assay results obtained from cancer patients. The
collection of information and specimens from the cancer cases received
NIH Clinical Exemption (Request 2009-09-002) on October 28,
2009. Frequency of Response: Once. Affected Public: Adult and senior
members of the licensed driver population in Baltimore, Maryland and
eleven near-by counties, including the Eastern Shore. Type of
Respondents: Responders will be English speaking, male and female,
Caucasian, African-American and Asian. The total annual reporting
burden is estimated to be 692 (see table below). There are no Capital
Costs, Operating Costs, and/or Maintenance Costs to report.
[[Page 52352]]
Table 1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Survey Number of Frequency of per response Annual burden
instrument respondents response (minutes/hour) hours
----------------------------------------------------------------------------------------------------------------
Adults (40-79 years old)...... Telephone 1700 1 10/60 (0.17) 283
Screener
(Attachment 16).
Main 225 1 60/60 (1) 225
Questionnaire
(Attachment 6).
Prostate 125 1 30/60 (0.5) 63
Supplemental
Questionnaire
(Attachment 7).
Liver Supplement 225 1 30/60 (0.5) 113
(Attachment 8).
Refusal 225 1 2/60 (0.03) 8
Questionnaire
Form
(Attachment 21).
---------------------------------------------------------------
Totals.................... ................ 2500 .............. .............. 692
----------------------------------------------------------------------------------------------------------------
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 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 Glenwood E. Trivers
or Elise Bowman, Center for Cancer Research, NCI, NIH, 37 Convent Drive
Room 3060-C or 3060-A, Building 37, Bethesda, Maryland 30893-4258 or
call non-toll-free number 301-496-2094 or 301-496-2090 or e-mail your
request, including your address to triversg@mail.nih.gov or
bowmane@mail.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: August 18, 2010.
Vivian Horovitch-Kelley
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-21098 Filed 8-24-10; 8:45 am]
BILLING CODE 4140-01-P
