Submission for OMB Review; Comment Request; NCCAM Office of Communications and Public Liaison Communications Program Planning and Evaluation Research, 61763-61765 [2010-25170]
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61763
Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices
Dated: September 30, 2010.
Carol Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–25198 Filed 10–5–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission of OMB Review; Comment
Request; Drug Accountability Record
(Form NIH 2564) (NCI)
In compliance with the
requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute, the National
Cancer Institute (NIH) has submitted to
the Office of Management and Budget
(OMB) a request for review and
approval of the information collected
below. This proposed information
collection was previously published in
the Federal Register on August 4, 2010
(75 FR 46945) and allowed 60 days for
SUMMARY:
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
March 1, 2011, unless it displays a valid
OMB control number.
Proposed Collection: Title: Drug
Accountability Record (NCI) (Form NIH
2564) (OMB No.0925–0240). Type of
Information Collection Request:
Extension with changes. Need and Use
of Information Collection: Food and
Drug Administration (FDA) regulations
require investigators to establish a
record of the receipt, use and
disposition of all investigational agents.
The National Cancer Institute (NCI), as
a sponsor of investigational drug trials,
has the responsibility to assure the FDA
that investigators in its clinical trials
program are maintaining systems for
drug accountability. In order to fulfill
these requirements, a standard
Investigational Drug Accountability
Report Form (NIH 2564) was designed
to account for drug inventories and
usage by protocols. The data obtained
from the drug accountability record will
be used to keep track of the dispensing
of investigational anticancer agents to
patients. It is used by NCI management
to ensure that investigational drug
supplies are not diverted for
inappropriate protocol or patient use.
The information is also compared to
patient flow sheets (protocol reporting
forms) during site visits conducted for
each investigator once every three years.
All comparisons are done with the
intention of ensuring protocol, patient
and drug compliance for patient and
drug compliance for patient safety and
protections. Frequency of Response:
Approximately 16 times per year.
Affected Public: Private sector including
businesses, other for-profit
organizations, and non-profit
institutions. Type of Respondents:
Investigators, pharmacists, nurses,
pharmacy technicians, and data
managers. The annualized respondents’
burden is estimated to require 6,714
hours (Table 1). There are no capital
costs, operating costs, and maintenance
cost to report.
TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS
Number of
respondents
Type of respondents
mstockstill on DSKH9S0YB1PROD with NOTICES
Investigators, or Designees .............................................................................
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;
(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.
Direct Comments to OMB: Written
comments or suggestions regarding the
item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
VerDate Mar<15>2010
19:00 Oct 05, 2010
Jkt 223001
4,196
times, 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 Charles
L. Hall, Jr., Chief, Pharmaceutical
Management Branch, Cancer Therapy
Evaluation Program, Division of the
Cancer Treatment and Diagnosis, and
Centers, National Cancer Institute,
Executive Plaza North, Room 7148, 9000
Rockville Pike, Bethesda, MD 20892 or
call non-toll-free number 301–496–5725
or e-mail your request, including your
address to: Hallch@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days following the
date of this publication.
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Frequency of
response
Average time
per response
16
Annnual
burden
hours
6/60
(0.1)
6,714
Dated: September 27, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010–25190 Filed 10–5–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; NCCAM Office of
Communications and Public Liaison
Communications Program Planning
and Evaluation Research
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Center for Complementary and
Alternative Medicine (NCCAM), 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
SUMMARY:
E:\FR\FM\06OCN1.SGM
06OCN1
61764
Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices
listed below. This proposed information
collection was previously published in
the Federal Register on August 25, 2010
(Vol. 75, No. 164, p. 52349) and allowed
60 days for public comment. There was
one public comment received during
this time. 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: NCCAM
Office of Communications and Public
Liaison Communications Program
Planning and Evaluation Research. Type
of Information Collection Request:
Extension.
Need and Use of Information
Collection: To carry out NCCAM’s
legislative mandate to educate and
disseminate information about
complementary and alternative
medicine (CAM) to a wide variety of
audiences and organizations, the
NCCAM Office of Communications and
Public Liaison (OCPL) requests
clearance to carry out (1) formative and
(2) evaluative research of a variety of
print and online materials, outreach
activities, and messages to maximize
their impact and usefulness.
OCPL wishes to continue to carry out
formative research to further understand
the knowledge, attitudes, and behaviors
of its core constituent groups: Members
of the general public, researchers, and
providers of both conventional and
CAM health care. In addition, it seeks to
test newly formulated messages and
identify barriers and impediments to the
effective communication of those
messages. With this formative audience
research, OCPL tests audience responses
to NCCAM’s fact sheets, Web content,
and other materials and messages.
Clearance is also requested to
continue evaluative research on existing
materials and messages, as part of
OCPL’s ongoing effort to develop a
comprehensive program of testing and
evaluation of all of its communications
strategies. This evaluative research will
include pilot testing of recently
developed messages and information
products such as consumer fact sheets
and brochures. It will address the need
to evaluate the processes by which new
materials and messages were developed,
the effectiveness of an outreach activity
or the extent to which behaviors were
changed by the message, and the impact
of a message on health knowledge and
behaviors.
The tools to collect this information
have been selected to minimize burden
on NCCAM’s audiences, produce or
refine messages that have the greatest
potential to influence target audience
attitudes and behavior in a positive
manner, and to use Government
resources efficiently. They may include
individual in-depth interviews, focus
group interviews, intercept interviews,
self-administered questionnaires,
gatekeeper reviews, and omnibus
surveys.
The data will enhance OCPL’s
understanding of the unique
information needs and distinct healthinformation-seeking behaviors of its
core constituencies, and the segments
within these constituencies with special
information needs (for example, among
the general public these segments
include cancer patients, the chronically
ill, minority and ethnic populations, the
elderly, users of dietary supplements,
and patients integrating complementary
therapies with conventional medical
treatments).
Frequency of Response: On occasion.
Affected Public: Individuals and
households; non-profit institutions;
Federal Government; State, Local, or
Tribal Government. Type of
Respondents: Adult patients; members
of the public; health care professionals;
organizational representatives. The
annual reporting burden is as follows:
Estimated Number of Respondents:
2,500; Estimated Number of Responses
per Respondent: 1; Average Burden
Hours per Response: 0.58; and
Estimated Total Burden Hours
Requested: 2,109 for the 3-year
clearance period (approximately 703
hours annually). The annualized cost to
respondents is estimated at $18,123.
There are no Capital Costs, Operating
Costs, or Maintenance Costs to report.
TABLE 1—ANNUAL BURDEN HOURS
Estimated
number of
respondents
Type of respondents
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
30
20
1,900
300
50
200
1
1
1
1
1
1
.75
1.5
0.25
0.25
.50
.25
23
30
475
75
25
50
TOTAL ......................................................................................................
mstockstill on DSKH9S0YB1PROD with NOTICES
In-depth interviews with general public ...........................................................
Focus groups ...................................................................................................
Omnibus surveys .............................................................................................
Intercept interviews with public and healthcare professionals ........................
In-depth interviews with health professionals ..................................................
Self-administered questionnaires with health professionals ............................
2,500
........................
........................
678
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;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
VerDate Mar<15>2010
19:00 Oct 05, 2010
Jkt 223001
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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
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 Christy
Thomsen, Director, Office of
Communications and Public Liaison,
NCCAM, 31 Center Drive, Room 2B11,
E:\FR\FM\06OCN1.SGM
06OCN1
61765
Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Notices
Bethesda, MD 20892, or fax your request
to 301–402–4741, or e-mail
thomsenc@mail.nih.gov. Ms. Thomsen
can be contacted by telephone at 301–
451–8876.
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: September 29, 2010.
Christy Thomsen,
Director, Office of Communications and
Public Liaison, National Center for
Complementary and Alternative Medicine,
National Institutes of Health.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Correction in Burden Table.
AGENCY:
The Health Resources and
Services Administration published an
Agency Information Collection
document in the Federal Register of
September 17, 2010 (FR Doc. 201–
SUMMARY:
[FR Doc. 2010–25170 Filed 10–5–10; 8:45 am]
BILLING CODE 4140–01–P
023260), on page 57037, regarding the
Black Lung Clinics Program Database
(OMB No. 0915–0292). In the burden
table, the Total responses, Hours per
response and Total burden hours are
incorrect.
Correction
In the Federal Register issue of
September 17, 2010, FR Doc. 201–
023260, on page 57037, correct the Total
responses, Hours per response and Total
burden hours as follows:
Instrument
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Database ..............................................................................
15
1
15
20
300
Dated: September 28, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2010–25113 Filed 10–5–10; 8:45 am]
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases;
Amended Notice of Meeting
mstockstill on DSKH9S0YB1PROD with NOTICES
Notice is hereby given of a change in
the meeting of the Diabetes,
Endocrinology and Metabolic Diseases B
Subcommittee, October 20, 2010, 5 p.m.
to October 22, 2010, 5 p.m., Hyatt
Regency Bethesda, One Bethesda Metro
Center, 7400 Wisconsin Avenue,
Bethesda, MD 20814 which was
published in the Federal Register on
September 15, 2010, 75 FR 56117.
The meeting has been changed to
October 20, 2010, 5 p.m. to October 21,
2010, 5 p.m. The location remains the
same. The meeting is partially closed to
the public.
Dated: September 30, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–25175 Filed 10–5–10; 8:45 am]
BILLING CODE 4140–01–P
VerDate Mar<15>2010
19:00 Oct 05, 2010
Jkt 223001
National Institutes of Health
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: Eunice Kennedy
Shriver National Institute of Child Health
and Human Development Special Emphasis
Panel; ‘‘Reproductive Panel’’.
Date: November 3–5, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, Montgomery County
Conference Center Facility, 5701 Marinelli
Road, North Bethesda, MD 20852.
Contact Person: Dennis E. Leszczynski,
PhD, Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Blvd., Room 5B01, Bethesda, MD 20892,
301–435–6884, leszczyd@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: September 30, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–25178 Filed 10–5–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; 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.
E:\FR\FM\06OCN1.SGM
06OCN1
]]>Agencies
[Federal Register Volume 75, Number 193 (Wednesday, October 6, 2010)]
[Notices]
[Pages 61763-61765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25170]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; NCCAM Office of
Communications and Public Liaison Communications Program Planning and
Evaluation Research
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Center for Complementary and
Alternative Medicine (NCCAM), 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
[[Page 61764]]
listed below. This proposed information collection was previously
published in the Federal Register on August 25, 2010 (Vol. 75, No. 164,
p. 52349) and allowed 60 days for public comment. There was one public
comment received during this time. 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: NCCAM Office of Communications and
Public Liaison Communications Program Planning and Evaluation Research.
Type of Information Collection Request: Extension.
Need and Use of Information Collection: To carry out NCCAM's
legislative mandate to educate and disseminate information about
complementary and alternative medicine (CAM) to a wide variety of
audiences and organizations, the NCCAM Office of Communications and
Public Liaison (OCPL) requests clearance to carry out (1) formative and
(2) evaluative research of a variety of print and online materials,
outreach activities, and messages to maximize their impact and
usefulness.
OCPL wishes to continue to carry out formative research to further
understand the knowledge, attitudes, and behaviors of its core
constituent groups: Members of the general public, researchers, and
providers of both conventional and CAM health care. In addition, it
seeks to test newly formulated messages and identify barriers and
impediments to the effective communication of those messages. With this
formative audience research, OCPL tests audience responses to NCCAM's
fact sheets, Web content, and other materials and messages.
Clearance is also requested to continue evaluative research on
existing materials and messages, as part of OCPL's ongoing effort to
develop a comprehensive program of testing and evaluation of all of its
communications strategies. This evaluative research will include pilot
testing of recently developed messages and information products such as
consumer fact sheets and brochures. It will address the need to
evaluate the processes by which new materials and messages were
developed, the effectiveness of an outreach activity or the extent to
which behaviors were changed by the message, and the impact of a
message on health knowledge and behaviors.
The tools to collect this information have been selected to
minimize burden on NCCAM's audiences, produce or refine messages that
have the greatest potential to influence target audience attitudes and
behavior in a positive manner, and to use Government resources
efficiently. They may include individual in-depth interviews, focus
group interviews, intercept interviews, self-administered
questionnaires, gatekeeper reviews, and omnibus surveys.
The data will enhance OCPL's understanding of the unique
information needs and distinct health-information-seeking behaviors of
its core constituencies, and the segments within these constituencies
with special information needs (for example, among the general public
these segments include cancer patients, the chronically ill, minority
and ethnic populations, the elderly, users of dietary supplements, and
patients integrating complementary therapies with conventional medical
treatments).
Frequency of Response: On occasion. Affected Public: Individuals
and households; non-profit institutions; Federal Government; State,
Local, or Tribal Government. Type of Respondents: Adult patients;
members of the public; health care professionals; organizational
representatives. The annual reporting burden is as follows: Estimated
Number of Respondents: 2,500; Estimated Number of Responses per
Respondent: 1; Average Burden Hours per Response: 0.58; and Estimated
Total Burden Hours Requested: 2,109 for the 3-year clearance period
(approximately 703 hours annually). The annualized cost to respondents
is estimated at $18,123. There are no Capital Costs, Operating Costs,
or Maintenance Costs to report.
Table 1--Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden total annual
Type of respondents number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
In-depth interviews with general public......... 30 1 .75 23
Focus groups.................................... 20 1 1.5 30
Omnibus surveys................................. 1,900 1 0.25 475
Intercept interviews with public and healthcare 300 1 0.25 75
professionals..................................
In-depth interviews with health professionals... 50 1 .50 25
Self-administered questionnaires with health 200 1 .25 50
professionals..................................
---------------------------------------------------------------
TOTAL....................................... 2,500 .............. .............. 678
----------------------------------------------------------------------------------------------------------------
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; (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.
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 Christy Thomsen,
Director, Office of Communications and Public Liaison, NCCAM, 31 Center
Drive, Room 2B11,
[[Page 61765]]
Bethesda, MD 20892, or fax your request to 301-402-4741, or e-mail
thomsenc@mail.nih.gov. Ms. Thomsen can be contacted by telephone at
301-451-8876.
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: September 29, 2010.
Christy Thomsen,
Director, Office of Communications and Public Liaison, National Center
for Complementary and Alternative Medicine, National Institutes of
Health.
[FR Doc. 2010-25170 Filed 10-5-10; 8:45 am]
BILLING CODE 4140-01-P
