Proposed Collection; Comment Request; Population Assessment of Tobacco and Health (PATH) Study, 29667-29668 [2012-12017]
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Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Blood Products
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 12, 2012, from 12 p.m. to
4:30 p.m.
Location: National Institutes of Health
(NIH), Bldg. 29, Conference Room 121,
9000 Rockville Pike, Bethesda, MD
20892. The public is welcome to attend
the meeting at the specified location
where a speakerphone will be provided.
Public participation in the meeting is
limited to the use of the speakerphone
in the conference room. Important
information about transportation and
directions to the NIH campus, parking,
and security procedures is available on
the Internet at https://www.nih.gov/
about/visitor/index.htm. Visitors must
show two forms of identification, one of
which must be a government-issued
photo identification such as a Federal
employee badge, driver’s license,
passport, green card, etc. Detailed
information about security procedures is
located at https://www.nih.gov/about/
visitorsecurity.htm. Due to the limited
available parking, visitors are
encouraged to use public transportation.
Contact Person: LCDR Bryan Emery or
Rosanna Harvey, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), to find out
further information regarding FDA
advisory committee information. A
notice in the Federal Register about last
minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
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18:21 May 17, 2012
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call the advisory committee information
line, or visit our Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm to learn about possible
modifications before coming to the
meeting.
Agenda: On June 12, 2012, the
Committee will meet in open session to
hear updates on the research programs
of the Laboratory of Emerging Pathogens
and the Laboratory of Bacterial and
Transmissible Spongiform
Encephalopathy Agents, Division of
Emerging and Transfusion Transmitted
Diseases, Office of Blood Research and
Review, Center for Biologics Evaluation
and Research, FDA.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: On June 12, 2012, from
12 p.m. to approximately 3:45 p.m., the
meeting is open to the public. Interested
persons may present data, information,
or views, orally or in writing, on issues
pending before the committee. Written
submissions may be made to the contact
person on or before June 1, 2012. Oral
presentations from the public will be
scheduled between approximately
2:30 p.m. and 3:30 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before May 24, 2012. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by May 25, 2012.
Closed Committee Deliberations: On
June 12, 2012, from approximately
3:45 p.m. to 4:30 p.m., the meeting will
be closed to permit discussion where
disclosure would constitute a clearly
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29667
unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss the site visit
report of the intramural research
programs and make recommendations
regarding personnel staffing decision.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact LCDR Bryan
Emery or Rosanna Harvey at least 7 days
in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 15, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–12164 Filed 5–17–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Population Assessment of
Tobacco and Health (PATH) Study
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 Drug Abuse
(NIDA), 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: Population
Assessment of Tobacco and Health
(PATH) Study. Type of Information
Collection Request: NEW. Need and Use
of Information Collection: This is a large
national longitudinal cohort study on
tobacco use behavior and health in the
United States. It is scheduled to begin
in the fall of 2013 under the direction
of the National Institutes of Health
SUMMARY:
E:\FR\FM\18MYN1.SGM
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29668
Federal Register / Vol. 77, No. 97 / Friday, May 18, 2012 / Notices
(NIH) National Institute on Drug Abuse
(NIDA), and in partnership with the
Food and Drug Administration (FDA).
Using annual interviews and the
collection of bio-specimens from adults,
the study is designed to establish a
population-based framework for
monitoring and evaluating the
behavioral and health impacts of
regulatory provisions by FDA as it meets
its mandate under the Family Smoking
Prevention and Tobacco Control Act
(FSPTCA) to regulate tobacco-product
advertising, labeling, marketing,
constituents, ingredients, and additives.
These regulatory changes are expected
to influence tobacco-product risk
perceptions, exposures, and use patterns
in the short term, and to reduce tobaccorelated morbidity and mortality in the
long term. By measuring and accurately
reporting tobacco product use behaviors
and health effects associated with these
regulatory changes, this study will
provide an empirical evidence base to
inform the development,
implementation, and evaluation of
tobacco-product regulations in the U.S.
Frequency of Response: Annually.
Affected Public: Individuals or
households. Type of Respondents:
Youth (ages 12–17) and Adults (ages
18+). The annual reporting burden for
the field test is presented in Table 1,
and the annual reporting burden for the
baseline data collection is presented in
Table 2. The annualized cost to
respondents for the field test is
estimated at: $24,495; and the
annualized cost to respondents for the
baseline data collection is: $1,947,567.
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report.
TABLE 1—PATH STUDY FIELD TEST HOUR BURDEN ESTIMATES
Estimated
number of
respondents
Type of respondents
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
Adults—Household Screener ..........................................................................
Adults—Individual Screener ............................................................................
Adults—Extended Interview .............................................................................
Adults—Tobacco Use Form ............................................................................
Youth—Extended Interview .............................................................................
Adult—Parent Interview ...................................................................................
1,295
840
590
590
100
100
1
1
1
1
1
1
22/60
6/60
1 26/60
2/60
55/60
24/60
479
84
844
18
92
40
Total ..........................................................................................................
3,515
1
........................
1,557
TABLE 2—PATH STUDY BASELINE HOUR BURDEN ESTIMATES
Estimated
number of
respondents
Type of respondents
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated total
annual burden
hours
requested
100,983
63,000
42,730
42,730
16,857
16,857
1
1
1
1
1
1
22/60
6/60
1 26/60
2/60
55/60
24/60
37,364
6,300
61,104
1,282
15,508
6,743
Total ..........................................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Adults—Household Screener ..........................................................................
Adults—Individual Screener ............................................................................
Adults—Extended Interview .............................................................................
Adults—Tobacco Use Form ............................................................................
Youth—Extended Interview .............................................................................
Adult—Parent Interview ...................................................................................
283,157
1
........................
128,301
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
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18:21 May 17, 2012
Jkt 226001
collection techniques or other forms of
information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Kevin P. Conway,
Ph.D., Deputy Director, Division of
Epidemiology, Services, and Prevention
Research, National Institute on Drug
Abuse, 6001 Executive Blvd., Room
5185; 301–443–8755; email
PATHprojectofficer@mail.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.
FOR FURTHER INFORMATION CONTACT:
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Dated: May 11, 2012.
Helio Chaves,
Deputy Executive Officer (OM Director),
NIDA.
[FR Doc. 2012–12017 Filed 5–17–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
SUMMARY:
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]]>Agencies
[Federal Register Volume 77, Number 97 (Friday, May 18, 2012)]
[Notices]
[Pages 29667-29668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12017]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Population Assessment of
Tobacco and Health (PATH) Study
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 Drug
Abuse (NIDA), 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: Population Assessment of Tobacco and
Health (PATH) Study. Type of Information Collection Request: NEW. Need
and Use of Information Collection: This is a large national
longitudinal cohort study on tobacco use behavior and health in the
United States. It is scheduled to begin in the fall of 2013 under the
direction of the National Institutes of Health
[[Page 29668]]
(NIH) National Institute on Drug Abuse (NIDA), and in partnership with
the Food and Drug Administration (FDA). Using annual interviews and the
collection of bio-specimens from adults, the study is designed to
establish a population-based framework for monitoring and evaluating
the behavioral and health impacts of regulatory provisions by FDA as it
meets its mandate under the Family Smoking Prevention and Tobacco
Control Act (FSPTCA) to regulate tobacco-product advertising, labeling,
marketing, constituents, ingredients, and additives. These regulatory
changes are expected to influence tobacco-product risk perceptions,
exposures, and use patterns in the short term, and to reduce tobacco-
related morbidity and mortality in the long term. By measuring and
accurately reporting tobacco product use behaviors and health effects
associated with these regulatory changes, this study will provide an
empirical evidence base to inform the development, implementation, and
evaluation of tobacco-product regulations in the U.S.
Frequency of Response: Annually. Affected Public: Individuals or
households. Type of Respondents: Youth (ages 12-17) and Adults (ages
18+). The annual reporting burden for the field test is presented in
Table 1, and the annual reporting burden for the baseline data
collection is presented in Table 2. The annualized cost to respondents
for the field test is estimated at: $24,495; and the annualized cost to
respondents for the baseline data collection is: $1,947,567. There are
no Capital Costs to report. There are no Operating or Maintenance Costs
to report.
Table 1--PATH Study Field Test Hour Burden Estimates
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average total annual
Type of respondents number of responses per burden hours burden hours
respondents respondent per response requested
----------------------------------------------------------------------------------------------------------------
Adults--Household Screener...................... 1,295 1 22/60 479
Adults--Individual Screener..................... 840 1 6/60 84
Adults--Extended Interview...................... 590 1 1 26/60 844
Adults--Tobacco Use Form........................ 590 1 2/60 18
Youth--Extended Interview....................... 100 1 55/60 92
Adult--Parent Interview......................... 100 1 24/60 40
---------------------------------------------------------------
Total....................................... 3,515 1 .............. 1,557
----------------------------------------------------------------------------------------------------------------
Table 2--PATH Study Baseline Hour Burden Estimates
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden total annual
Type of respondents number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Adults--Household Screener...................... 100,983 1 22/60 37,364
Adults--Individual Screener..................... 63,000 1 6/60 6,300
Adults--Extended Interview...................... 42,730 1 1 26/60 61,104
Adults--Tobacco Use Form........................ 42,730 1 2/60 1,282
Youth--Extended Interview....................... 16,857 1 55/60 15,508
Adult--Parent Interview......................... 16,857 1 24/60 6,743
---------------------------------------------------------------
Total....................................... 283,157 1 .............. 128,301
----------------------------------------------------------------------------------------------------------------
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.
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 Kevin P. Conway, Ph.D., Deputy Director, Division
of Epidemiology, Services, and Prevention Research, National Institute
on Drug Abuse, 6001 Executive Blvd., Room 5185; 301-443-8755; email
PATHprojectofficer@mail.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: May 11, 2012.
Helio Chaves,
Deputy Executive Officer (OM Director), NIDA.
[FR Doc. 2012-12017 Filed 5-17-12; 8:45 am]
BILLING CODE 4140-01-P
