OMB No. 0917-0009, 60 Day FRN

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Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Notices
Pharmacology and Therapeutics,
78(6):689–96, 2005.
2. Benowitz, N.L., et al., ‘‘Suppression of
Nicotine Intake During Ad Libitum
Cigarette Smoking by High-Dose
Transdermal Nicotine,’’ Journal of
Pharmacology and Experimental
Therapeutics, 287(3):958–62, 1998.
3. Blondal, T., et al., ‘‘Nicotine Nasal Spray
With Nicotine Patch for Smoking
Cessation: Randomised Trial With Six
Year Follow Up,’’ BMJ, 318(7179):285–8,
1999.
4. Bohadana, A., et al., ‘‘Nicotine Inhaler and
Nicotine Patch as a Combination
Therapy for Smoking Cessation,’’
Archives of Internal Medicine,
160(20):3128–34, 2000.
5. Bolliger, C.T., et al, ‘‘Smoking Reduction
With Oral Nicotine Inhalers: Double
Blind, Randomised Clinical Trial of
Efficacy And Safety,’’ BMJ,
321(7257):329–33, 2000.
6. Bullen, C., et al., ‘‘Precessation Nicotine
Replacement Therapy: Pragmatic
Randomized Trial,’’ Addiction,
105(8):1474–83, 2010.
7. Dale, L.C., et al., ‘‘High-Dose Nicotine
Patch Therapy. Percentage of
Replacement and Smoking Cessation,’’
JAMA, 274(17):1353–58, 1995.
8. Etter, J.F., et al., ‘‘Nicotine Replacement to
Reduce Cigarette Consumption in
Smokers Who Are Unwilling to Quit: A
Randomized Trial,’’ Journal of Clinical
Psychopharmacology, 22(5):487–95,
2002.
9. Etter, J.F., et al., ‘‘Postintervention Effect
of Nicotine Replacement Therapy on
Smoking Reduction in Smokers Who Are
Unwilling to Quit: A Randomized Trial,’’
Journal of Clinical Psychopharmacology,
24(2):174–79, 2004.
10. Etter, J.F., et al., ‘‘Nicotine Gum
Treatment Before Smoking Cessation—A
Randomized Trial,’’ Archives of Internal
Medicine, 169(11):1028–34, 2009.
11. Hajek, P., et al., ‘‘Dependence Potential of
Nicotine Replacement Treatments:
Effects of Product Type, Patient
Characteristics, and Cost to User,’’
Preventive Medicine, 44(3):230–34, 2007.
12. Hall, S.M., et al., ‘‘Extended Treatment of
Older Cigarette Smokers,’’ Addiction,
104(6):1043–52, 2009.
13. Hatsukami, D., et al., ‘‘Effects of High
Dose Transdermal Nicotine Replacement
in Cigarette Smokers,’’ Pharmacology,
Biochemistry, and Behavior, 86(1):132–
39, 2007.
14. Horst, W.D., et al., ‘‘Extended Use of
Nicotine Replacement Therapy to
Maintain Smoking Cessation in Persons
With Schizophrenia,’’ Neuropsychiatric
Disease and Treatment, 1(4):349–55,
2005.
15. Houtsmuller, E.J., et al., ‘‘Flavor
Improvement Does Not Increase Abuse
Liability of Nicotine Chewing Gum,’’
Pharmacology, Biochemistry, and
Behavior, 72(3):559–68, 2002.
16. Hughes, J.R., et al., ‘‘A Randomized,
Controlled Trial of NRT-Aided Gradual
Vs. Abrupt Cessation in Smokers
Actively Trying to Quit,’’ Drug and
Alcohol Dependence, 111(1–2):105–13,

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19:35 Apr 01, 2013

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2010.
17. Joseph, A.M., et al., ‘‘Chronic Disease
Management for Tobacco Dependence,’’
Archives of Internal Medicine,
171(21):1894–1900, 2011.
18. Lerman, C., et al., ‘‘Genetic Variation in
Nicotine Metabolism Predicts the
Efficacy of Extended-Duration
Transdermal Nicotine Therapy,’’ Clinical
Pharmacology and Therapeutics,
87(5):553–57, 2010.
19. Lindson, N. and Aveyard, P., ‘‘An
Updated Meta-Analysis of Nicotine
Preloading for Smoking Cessation:
Investigating Mediators of the Effect,’’
Psychopharmacology, 214(3):579–92,
2011.
20. Murray, R.P., et al., ‘‘Safety of Nicotine
Polacrilex Gum Used by 3,094
Participants in the Lung Health Study.
Lung Health Study Research Group,’’
CHEST, 109(2):438–45, 1996.
21. Murray, R.P., et al., ‘‘Does Nicotine
Replacement Therapy Cause Cancer?
Evidence From the Lung Health Study,’’
Nicotine & Tobacco Research,
11(9):1076–82, 2009.
22. Newhouse, P., et al., ‘‘Nicotine Treatment
of Mild Cognitive Impairment: A 6Month Double-Blind Pilot Clinical
Trial,’’ Neurology, 78(2):91–101, 2012.
23. Piper, M.E., et al., ‘‘A Randomized
Placebo-Controlled Clinical Trial of 5
Smoking Cessation Pharmacotherapies,’’
Archives of General Psychiatry,
66(11):1253–62, 2009.
24. Rennard, S.I., et al., ‘‘Efficacy of the
Nicotine Inhaler in Smoking Reduction:
A Double-Blind, Randomized Trial,’’
Nicotine & Tobacco Research, 8(4):555–
64, 2006.
25. Rose, J.E., et al., ‘‘Mecamylamine
Combined With Nicotine Skin Patch
Facilitates Smoking Cessation Beyond
Nicotine Patch Treatment Alone,’’
Clinical Pharmacology and
Therapeutics, 56(1):86–99, 1994.
26. Rose, J.E., et al., ‘‘Nicotinemecamylamine Treatment for Smoking
Cessation: The Role of Precessation
Therapy,’’ Experimental and Clinical
Psychopharmacology, 6(3):331–43, 1998.
27. Rose, J.E., et al., ‘‘Precessation Treatment
With Nicotine Skin Patch Facilitates
Smoking Cessation,’’ Nicotine & Tobacco
Research, 8(1):89–101, 2006.
28. Rose, J.E., et al., ‘‘Precessation Treatment
With Nicotine Patch Significantly
Increases Abstinence Rates Relative to
Conventional Treatment,’’ Nicotine &
Tobacco Research, 11(9):1067–75, 2009.
29. Schuurmans, M.M., et al., ‘‘Effect of
Pretreatment With Nicotine Patch on
Withdrawal Symptoms and Abstinence
Rates in Smokers Subsequently Quitting
With the Nicotine Patch: A Randomized
Controlled Trial,’’ Addiction, 99(5):634–
40, 2004.
30. T2010

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out an agency function; (b) whether the
agency processes the information
collected in a useful and timely fashion;
(c) the accuracy of public burden
estimate (the estimated amount of time

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needed for individual respondents to
provide the requested information); (d)
whether the methodology and
assumptions used to determine the
estimate is logical; (e) ways to enhance

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Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Notices
the quality, utility, and clarity of the
information being collected; and (f)
ways to minimize the public burden
through the use of automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Send Comments and Requests for
Further Information: For the proposed
collection or requests to obtain a copy
of the data collection instrument(s) and
instructions to: Paul R. Fowler D.O.,
J.D., Risk Management Officer, 801
Thompson Avenue, TMP, Suite 331,
Rockville, MD 20852, call non-toll free
(301) 443–6372, send via facsimile to
(301) 594–6213, or send your email
requests, comments, and return address
to: paul.fowler@ihs.gov.
Comment Due Date: Your comments
regarding this information collection is
best assured of having full effect if
received within 60 days of the date of
this publication.
Dated: March 26, 2013.
Yvette Roubideaux,
Director, Indian Health Service.
[FR Doc. 2013–07596 Filed 4–1–13; 8:45 am]
BILLING CODE 4165–16–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Evaluation of the Brain
Disorders in the Developing World
Program of the John E. Fogarty
International Center
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
John E. Fogarty International Center,
National Institutes of Health (NIH), will
publish periodic summaries of proposed

SUMMARY:

International Center (FIC), National
Institutes of Health (NIH).
Need and Use of Information
Collection: This study seeks to evaluate
the management, effectiveness, and
outcomes of the Brain Disorders in the
Developing World extramural research
program administered by the John E.
Fogarty International Center of the NIH.
The purpose of the Brain Disorders in
the Developing World Program is to
develop collaborative research and
capacity building projects on brain
disorders throughout life relevant to
low- and middle-income countries.
Awardees are expected to develop
innovative projects that contribute to
the long-term goal of building
sustainable research capacity in nervous
system function and impairment
throughout life. Between FY 2003 and
2012, a total of 132 awards were made
under the Brain Disorders program, and
the total investment by Fogarty and its
partners at NIH has been approximately
$75 million. The findings of this
evaluation study will provide valuable
information concerning: (1) Whether
and how the program has met its goal
of supporting research and research
capacity-building on brain disorders in
low- and middle-income countries; (2)
the extent to which the program as
implemented functions efficiently and
effectively; (3) the extent to which the
program is consistent with the strategic
priorities of Fogarty and its partners at
NIH; (4) opportunities to improve upon
the current implementation of the
program if NIH chooses to continue
supporting it; and (5) models, best
practices, and lessons learned that may
be applicable to other NIH programs,
now and in the future.
OMB approval is requested for 1 year.
There are no costs to respondents other
than their time. The total estimated
annualized burden hours are 151.

projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
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.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Dr. Rachel Sturke,
Fogarty International Center, National
Institutes of Health, 16 Center Drive,
Building 16, Room 202, Bethesda, MD
20892, or call non-toll-free number 301–
496–1491, or Email your request,
including your address to:
sturkerachel@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comment 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.
Proposed Collection: Evaluation of the
Brain Disorders in the Developing
World Program of the John E. Fogarty
International Center, 0925–New, Fogarty

ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent

srobinson on DSK4SPTVN1PROD with NOTICES

Form name

Awardee Interviews (LMIC) ..............................................
Awardee Interviews (US) ..................................................
Trainee Interviews .............................................................
Awardee Survey (LMIC) ...................................................
Awardee Survey (US) .......................................................

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Researchers
Researchers
Researchers
Researchers
Researchers

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Number
of respondents

Number of
responses per
respondent

30
30
15
115
114

1
1
1
1
1

.....
.....
.....
.....
.....

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02APN1

Average
burden per
response
(in hours)
1
1
1
20/60
20/60

Total annual
burden hour
30
30
15
38
38