Submission for OMB review; comment request; NCCAM Office of Communications and Public Liaison Communications Program Planning and Evaluation Research, 69086-69088 [2010-28290]
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69086
Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices
organization or other affiliation, full
address and phone, fax, and e-mail
information or e-mail this information
to FindYouthInfo@air.org. Additional
identification documents may be
required.
Dated: November 4, 2010.
Sherry Glied,
Assistant Secretary for Planning and
Evaluation.
Authority: Division F, Pub. L. 111–8; E.O.
13459, 73 FR 8003, February 12, 2008.
[FR Doc. 2010–28396 Filed 11–9–10; 8:45 am]
BILLING CODE 4154–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–10–10DE]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC), Agency for Toxic
Substances and Disease Registry
(ATSDR) publishes a list of information
collection requests under review by the
Office of management and Budget
(OMB) in compliance with the
Paperwork Reduction Act (33 U.S.C.
chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer, at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to ATSDR Desk Officer,
Office of Management and Budget,
Washington, DC 20503 or by fax to (202)
395–5806. Written comments should be
received within 30 days of this notice.
Proposed Project
Creation of State and Metropolitan
Area-based Surveillance Projects for
Amyotrophic Lateral Sclerosis (ALS)—
New—Agency for Toxic Substances and
Disease Registry (ATSDR).
Background and Brief Description
On October 10, 2008, President Bush
signed S. 1382: ALS Registry Act which
amended the Public Health Service Act
to provide for the establishment of an
Amyotrophic Lateral Sclerosis (ALS)
Registry. The activities described are
part of the effort to create the National
ALS Registry. The purpose of the
registry is to: (1) Better describe the
incidence and prevalence of ALS in the
United States; (2) examine appropriate
factors, such as environmental and
occupational, that might be associated
with the disease; (3) better outline key
demographic factors (such as age, race
or ethnicity, gender, and family history
of individuals diagnosed with the
disease); and (4) better examine the
connection between ALS and other
motor neuron disorders that can be
confused with ALS, misdiagnosed as
ALS, and in some cases progress to ALS.
The registry will collect personal health
information that may provide a basis for
further scientific studies of potential
risks for developing ALS.
This project purposes to collect
information-specific data related to
ALS. The objective of this project is to
develop state-based and metropolitan
area-based surveillance projects for
ALS. The primary goal of the state-based
and metropolitan area-based
surveillance project is to use these data
to evaluate the completeness of the
National ALS Registry. The secondary
goal of the surveillance project is to
obtain reliable and timely information
on the incidence and prevalence of ALS
and to better describe the demographic
characteristics (e.g., age, race, sex, and
geographic location) of those with ALS.
Neurologists or their staff will
complete an ALS Case Reporting Form
on each of their ALS patients. This will
be transmitted to the state or
metropolitan health department. The
contract surveillance staff assigned to
the state and metropolitan area health
departments will train medical
personnel how to complete the ALS
Case Reporting Form (Attachment 3)
and assist with abstracting records as
requested. An ALS Medical Record
Verification Form will be collected on a
subset of cases reported. Each medical
provider reporting source should keep a
line listing of individuals diagnosed
with or thought to have ALS along with
information on whether or not the case
was reported and if not, the reason.
Surveillance items to be collected
include information to make sure that
there are no duplicates. There are no
costs to the respondents other than their
time. The estimated annualized burden
hours are 703.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of data collection instrument
Type of respondent
Training ...........................................................
ALS Case Reporting Form .............................
ALS Medical Record Verification Form ..........
Line Listing (record keeping) ..........................
Medical Personnel/Neurologist ......................
Medical Personnel/Neurologist ......................
Neurologist .....................................................
Medical Personnel ..........................................
Dated: November 4, 2010.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention/Agency for
Toxic Substances and Disease Registry.
emcdonald on DSK2BSOYB1PROD with NOTICES
[FR Doc. 2010–28337 Filed 11–9–10; 8:45 am]
BILLING CODE 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
SUMMARY:
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243
2,250
450
243
Number of
responses per
respondent
1
1
1
1
Average
burden per
response
(in hours)
30/60
5/60
20/60
1
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 August 25, 2010
(Vol. 75, No. 164, p. 52349) and allowed
60-days for public comment. There was
one public comments 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
E:\FR\FM\10NON1.SGM
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69087
Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices
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 test 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
.25
.50
.25
23
30
475
75
25
50
Total ..........................................................................................................
emcdonald on DSK2BSOYB1PROD with NOTICES
In-depth interviews with general public ...........................................................
Focus groups ...................................................................................................
Omnibus surveys .............................................................................................
Intercept interviews with public and healthcare professionals ........................
In-depth interviews 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
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
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Jkt 223001
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
PO 00000
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Fmt 4703
Sfmt 4703
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,
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.
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69088
Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices
Dated: November 1, 2010.
Christy Thomsen,
Director, Office of Communications and
Public Liaison, National Center for
Complementary and Alternative Medicine,
National Institutes of Health.
OMB No.: New Collection.
Description: This proposed
information collection activity is to
obtain information from participants in
two Strengthening Communities Fund
(SCF) programs: The Nonprofit Capacity
Building Program and the State, Local,
and Tribal Government Capacity
Building Program. Both programs are
designed to contribute to the economic
recovery as authorized in the American
Recovery and Reinvestment Act of 2009
(ARRA). The SCF evaluation is an
important opportunity to examine
outcomes achieved by the Strengthening
Communities Fund and progress toward
the objective of improving the capacity
of organizations served by program
grantees to address broad economic
recovery issues in their communities.
[FR Doc. 2010–28290 Filed 11–9–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Strengthening Communities
Fund (SCF) Evaluation.
The evaluation will be designed to
assess progress and measure increased
organizational capacity of each
participating organization. The purpose
of this request is to receive approval of
the data collection instruments that will
be used in this study.
A significant amount of information is
already being collected through
program-specific OMB-approved PPR
forms or is available through secondary
sources. Proposed surveys and phone
interviews are very brief to reduce the
burden on respondents.
Respondents: SCF grantees,and faithbased and Community Organizations
(FBCOs).
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
emcdonald on DSK2BSOYB1PROD with NOTICES
An on-line survey of SCF grantees .................................................................
Telephone interview of SCF grantees .............................................................
On-line survey of faith-based and community organizations (FBCOs) that
received capacity building services from the SCF grantees .......................
Estimated Total Annual Burden
Hours: 647
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
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18:25 Nov 09, 2010
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0.25
1.50
21
126
1,000
1
0.50
500
[FR Doc. 2010–28304 Filed 11–9–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–P–0273]
Determination That Amphetamine
Sulfate, 5 and 10 Milligram Tablets,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) has determined
that Amphetamine sulfate, 5 and 10
milligram (mg) tablets, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Total burden
hours
1
1
Dated: November 4, 2010.
Robert Sargis,
Reports Clearance Officer.
ACTION:
Average
burden hours
per response
84
84
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
AGENCY:
Number of
responses per
respondent
applications (ANDAs) for Amphetamine
sulfate, 5 mg and 10 mg tablets, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of a new
drug application (NDA). The only
clinical data required in an ANDA are
data to show that the drug that is the
subject of the ANDA is bioequivalent to
the listed drug.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\10NON1.SGM
10NON1
]]>Agencies
[Federal Register Volume 75, Number 217 (Wednesday, November 10, 2010)]
[Notices]
[Pages 69086-69088]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28290]
-----------------------------------------------------------------------
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 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 comments 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
[[Page 69087]]
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 test 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 total annual
Type of respondents number of responses per burden hours burden hours
respondents respondent per 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 .25 75
professionals..................................
In-depth interviews 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, 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.
[[Page 69088]]
Dated: November 1, 2010.
Christy Thomsen,
Director, Office of Communications and Public Liaison, National Center
for Complementary and Alternative Medicine, National Institutes of
Health.
[FR Doc. 2010-28290 Filed 11-9-10; 8:45 am]
BILLING CODE 4140-01-P
