Proposed Collection; Comment Request; NIH Toolbox for Assessment of Neurological and Behavioral Function, 22596-22597 [2010-10015]
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22596
Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices
Number of
respondents
Responses
per
respondent
Average
hours per
respondent
Total
responses
Total hour
burden
Healthy Start Grantee Web Survey .....................................
102
1
102
4.0
408
Total ..............................................................................
102
1
102
4.0
408
E-mail comments to
paperwork@hrsa.gov or mail to the
HRSA Reports Clearance Officer, Room
10–33, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857. Written
comments should be received within 60
days of this notice.
Dated: April 20, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–9974 Filed 4–28–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; NIH Toolbox for Assessment
of Neurological and Behavioral
Function
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute on Aging (NIA), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: NIH-Toolbox for Assessment of
Neurological and Behavioral Function.
Type of Information Collection Request:
New. Need and Use of Information
Collection: The overall goal of the
Toolbox project is to develop unified,
integrated methods and measures of
four domains of neurological and
behavioral functioning (cognitive,
emotional, motor and sensory) for use in
large longitudinal or epidemiological
studies where functioning is monitored
over time. The current phase
(‘‘Norming’’), will involve a large sample
of 5,660 for the purpose of establishing
comparative norms. We will screen
52,800 households for members’ age,
gender and primary language to recruit
the participants. The targeted
population will be non-institutionalized
U.S. residents, aged 3–85, with 66%
English-speaking and 34% Spanishspeaking. Frequency of Response: Once
to the screener, and once or twice
(depending on subsample). Affected
Public: Individuals. Type of
Respondents: U.S. residents (persons
aged 3–85 years). The annual reporting
burden is as follows: Estimated Number
of Respondents: 52,800 for the screener
and 5,660 for the Toolbox measures;
Estimated Number of Responses per
Respondent: 1 screening and 1–2 for
selected participants; Average Burden
Hours per Response: For the screener,
0.1 and 2.49 for selected participants;
and Estimated Total Annual Burden
Hours Requested: 21,480. The
annualized cost to respondents is
estimated at: $393,250. There are no
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
Estimated
number of responses per
respondent
Average burden
hours per
response
Estimated total
annual burden
hours
requested
52,800
1
.1
5,280
1710
350
910
350
390
150
1
2
1
2
1
2
3
3
0.5
0.5
3.5
3.5
5,130
2,100
455
350
1,365
1,050
Single assessment .........................................................................................
Two assessments ..........................................................................................
1300
500
1
2
2.5
2.5
3,250
2,500
Totals ......................................................................................................
*54,600
........................
..........................
21,480
Estimated
number of
respondents
Type of respondents
Screening
Household member .......................................................................................
Adults
Not affiliated with participating child, single assessment ..............................
Not affiliated with participating child, two assessments ................................
Non-participating parent of participating child, single assessment ...............
Non-participating parent of participating child, two assessments .................
Participating parent of participating child, single assessment .......................
Participating parent of participating child, two assessments .........................
Children
mstockstill on DSKH9S0YB1PROD with NOTICES
*Includes one adult from each screened household plus selected child participants.
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
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16:19 Apr 28, 2010
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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,
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
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
E:\FR\FM\29APN1.SGM
29APN1
22597
Federal Register / Vol. 75, No. 82 / Thursday, April 29, 2010 / Notices
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 Molly Wagster,
Ph.D., Division of Neuroscience,
National Institute on Aging, NIH, DHHS,
7201 Wisconsin Avenue, Suite 350,
Bethesda, Maryland 20892–9205 or call
non-toll-free number 301–496–9350 or
e-mail your request, including your
address to: wagsterm@nia.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: April 23, 2010.
Melissa Fraczkowski,
National Institute on Aging Project Clearance
Liaison, National Institutes of Health.
[FR Doc. 2010–10015 Filed 4–28–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. Docket No. FDA–2009–N–0506]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Bar Code Label
Requirement for Human Drug and
Biological Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: 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 June 1,
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0537. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Bar Code Label Requirement for
Human Drug and Biological Products—
OMB Control Number 0910–0537—
Extension
In the Federal Register of February
26, 2004 (69 FR 9120), we issued new
regulations that required human drug
product and biological product labels to
have bar codes. The rule required bar
codes on most human prescription drug
products and on over-the-counter (OTC)
drug products that are dispensed under
an order and commonly used in health
care facilities. The rule also required
machine-readable information on blood
and blood components. For human
prescription drug products and OTC
drug products that are dispensed under
an order and commonly used in health
care facilities, the bar code must contain
the National Drug Code number for the
product. For blood and blood
components, the rule specifies the
minimum contents of the machinereadable information in a format
approved by the Director, Center for
Biologics Evaluation and Research as
blood centers have generally agreed
upon the information to be encoded on
the label. The rule is intended to help
reduce the number of medication errors
in hospitals and other health care
settings by allowing health care
professionals to use bar code scanning
equipment to verify that the right drug
(in the right dose and right route of
administration) is being given to the
right patient at the right time.
Most of the information collection
burden resulting from the final rule, as
calculated in table 1 of the final rule (69
FR 9120 at 9149), was a one-time
burden that does not occur after the
rule’s compliance date of April 26,
2006. In addition, some of the
information collection burden estimated
in the final rule is now covered in other
OMB-approved information collection
packages for FDA. However, parties may
continue to seek an exemption from the
bar code requirement under certain,
limited circumstances. Section
201.25(d) (21 CFR 201.25(d)) requires
submission of a written request for an
exemption and describes the contents of
such requests. Based on the number of
exemption requests we have received,
we estimate that approximately two
exemption requests may be submitted
annually, and that each exemption
request will require 24 hours to
complete. This would result in an
annual reporting burden of 48 hours.
In the Federal Register of November
6, 2009 FR 74 57495, FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received on the information collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
201.25(d)
mstockstill on DSKH9S0YB1PROD with NOTICES
1 There
Number of Responses
per Respodent
Number of
Respondents
2
Total Annual
Responses
1
Hours per
Response
2
24
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total Hours
29APN1
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]]>Agencies
[Federal Register Volume 75, Number 82 (Thursday, April 29, 2010)]
[Notices]
[Pages 22596-22597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10015]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; NIH Toolbox for Assessment
of Neurological and Behavioral Function
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute on Aging
(NIA), the National Institutes of Health (NIH) will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Proposed Collection
Title: NIH-Toolbox for Assessment of Neurological and Behavioral
Function. Type of Information Collection Request: New. Need and Use of
Information Collection: The overall goal of the Toolbox project is to
develop unified, integrated methods and measures of four domains of
neurological and behavioral functioning (cognitive, emotional, motor
and sensory) for use in large longitudinal or epidemiological studies
where functioning is monitored over time. The current phase
(``Norming''), will involve a large sample of 5,660 for the purpose of
establishing comparative norms. We will screen 52,800 households for
members' age, gender and primary language to recruit the participants.
The targeted population will be non-institutionalized U.S. residents,
aged 3-85, with 66% English-speaking and 34% Spanish-speaking.
Frequency of Response: Once to the screener, and once or twice
(depending on subsample). Affected Public: Individuals. Type of
Respondents: U.S. residents (persons aged 3-85 years). The annual
reporting burden is as follows: Estimated Number of Respondents: 52,800
for the screener and 5,660 for the Toolbox measures; Estimated Number
of Responses per Respondent: 1 screening and 1-2 for selected
participants; Average Burden Hours per Response: For the screener, 0.1
and 2.49 for selected participants; and Estimated Total Annual Burden
Hours Requested: 21,480. The annualized cost to respondents is
estimated at: $393,250. There are no Capital Costs, Operating Costs,
and/or Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden total annual
Type of respondents number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Screening
----------------------------------------------------------------------------------------------------------------
Household member............................... 52,800 1 .1 5,280
----------------------------------------------------------------------------------------------------------------
Adults
----------------------------------------------------------------------------------------------------------------
Not affiliated with participating child, single 1710 1 3 5,130
assessment....................................
Not affiliated with participating child, two 350 2 3 2,100
assessments...................................
Non-participating parent of participating 910 1 0.5 455
child, single assessment......................
Non-participating parent of participating 350 2 0.5 350
child, two assessments........................
Participating parent of participating child, 390 1 3.5 1,365
single assessment.............................
Participating parent of participating child, 150 2 3.5 1,050
two assessments...............................
----------------------------------------------------------------------------------------------------------------
Children
----------------------------------------------------------------------------------------------------------------
Single assessment.............................. 1300 1 2.5 3,250
Two assessments................................ 500 2 2.5 2,500
----------------------------------------------------------------
Totals..................................... *54,600 .............. ............... 21,480
----------------------------------------------------------------------------------------------------------------
*Includes one adult from each screened household plus selected child participants.
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
[[Page 22597]]
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 Molly Wagster, Ph.D., Division of Neuroscience,
National Institute on Aging, NIH, DHHS, 7201 Wisconsin Avenue, Suite
350, Bethesda, Maryland 20892-9205 or call non-toll-free number 301-
496-9350 or e-mail your request, including your address to:
wagsterm@nia.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: April 23, 2010.
Melissa Fraczkowski,
National Institute on Aging Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2010-10015 Filed 4-28-10; 8:45 am]
BILLING CODE 4140-01-P
