Proposed Information Collection; 60-day Comment Request: Population Assessment of Tobacco and Health (PATH) Study, 7206-7207 [2014-02603]
Download as PDF
<![CDATA[
7206
Federal Register / Vol. 79, No. 25 / Thursday, February 6, 2014 / Notices
For those without Internet access, please
contact Denise Pica-Branco (see
Contact) to register. Onsite registration
will not be available.
If you need special accommodations
due to a disability, please contact
Denise Pica-Branco (see Contact) at least
7 days in advance.
II. Transcripts
Transcripts of the workshop will be
available for review at the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
and at https://www.regulations.gov
approximately 30 days after the
workshop. A transcript will also be
available in either hard copy or on CD–
ROM, after submission of a Freedom of
Information request. Send written
requests to the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857. Send faxed requests to 301–827–
9267.
Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–02552 Filed 2–5–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICE
National Institutes of Health
Proposed Information Collection; 60day Comment Request: Population
Assessment of Tobacco and Health
(PATH) Study
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
SUMMARY:
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.
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)
The quality, utility, and clarity of the
information to be collected; and (4) The
approaches used 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.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received by April 7, 2014.
FOR FURTHER INFORMATION CONTACT: 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: Kevin P. Conway,
Ph.D., Deputy Director, Division of
Epidemiology, Services, and Prevention
Research, National Institute on Drug
Abuse, 6001 Executive Boulevard, Room
5185; or call non-toll-free number (301)
443–8755; or Email your request,
including your address to:
PATHprojectofficer@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION:
Proposed Collection: Population
Assessment of Tobacco and Health
(PATH) Study—Second Wave of Data
Collection–0925–0664–Revision—
National Institutes of Health (NIH),
National Institute on Drug Abuse
(NIDA), in partnership with the Food
and Drug Administration (FDA).
Need and Use of Information
Collection: This is a revision request
(OMB 0925–0664, expires 11/30/2015)
for the Population Assessment of
Tobacco and Health (PATH) Study to
conduct the second wave of data
collection. The PATH Study is a large
national longitudinal cohort study on
tobacco use behavior and health among
the U.S. household population of adults
age 18 and older and youth ages 12 to
17. The PATH Study conducts annual
interviews and collects biospecimens
from adults to help inform the
development, implementation, and
evaluation of tobacco-product
regulations by FDA in meeting its
mission under the Family Smoking
Prevention and Tobacco Control Act
(TCA) to regulate tobacco products,
including tobacco-product advertising,
labeling, marketing, constituents,
ingredients, and additives. The
longitudinal design of the PATH Study
provides it with the capacity to measure
and report within-person changes and
between-person differences in tobacco
product use behaviors and health effects
within the cohort over time. These data
will help to inform regulatory decisions
and actions by FDA and FDA’s
evaluations of associations between its
regulations and tobacco use behaviors
and health indicators in the population.
OMB approval is requested for 3
years. There are no capital, operating, or
maintenance costs to report. There are
no costs to respondents other than their
time. The total estimated annualized
burden hours are 75,124.
ESTIMATED ANNUALIZED BURDEN HOURS
Estimated
number of
respondents
mstockstill on DSK4VPTVN1PROD with NOTICES
Type of respondent and instrument
Adults—Extended Interview .............................................................................
Adults—Baseline youth respondents who age into adult cohort—Consent
for Extended Interview .................................................................................
Adults—Baseline youth respondents who age into adult cohort—Extended
Interview .......................................................................................................
Adults—Adult respondents who refused biospecimen collection at Baseline
but who consent for Wave 2—Consent for Biological Samples ..................
Adults—Baseline youth respondents who age into the adult cohort—Consent for Biological Samples .........................................................................
Adults—Biospecimen Collection: Urine ...........................................................
Adults—Biospecimen Collection: Buccal Cell ..................................................
VerDate Mar<15>2010
18:18 Feb 05, 2014
Jkt 232001
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Estimated
number of
responses per
respondent
Average
burden hours
per response
(in hours)
Estimated total
annual burden
hours
requested
38,740
1
1
38,740
2,717
1
2/60
91
2,500
1
68/60
2,833
1,452
1
4/60
97
2,500
12,387
2,387
1
1
1
4/60
10/60
18/60
167
2,065
716
E:\FR\FM\06FEN1.SGM
06FEN1
7207
Federal Register / Vol. 79, No. 25 / Thursday, February 6, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Estimated
number of
respondents
Type of respondent and instrument
Adults—Biospecimen Collection: Blood ...........................................................
Adults—Tobacco Use Form ............................................................................
Adults—Follow-up/Tracking Participant Information Form ..............................
Youth—Extended Interview .............................................................................
Youth—Shadow youth who age into youth cohort—Assent for Extended
Interview .......................................................................................................
Youth—Shadow youth who age into youth cohort—Extended Interview ........
Adult—Parent Interview ...................................................................................
Adults—Parents of Shadow youth who age into youth cohort—Parent Permission and Consent for Parent Interview ...................................................
Adults—Parents of Shadow youth who age into youth cohort—Parent Interview ..............................................................................................................
Adults—Follow-up/Tracking Participant Information Form for Youth (completed by parents) ........................................................................................
Adults—Follow-up/Tracking Participant Information Form for sample Shadow youth (completed by parents) .................................................................
18/60
4/60
8/60
32/60
691
1,138
10,997
6,609
2,734
2,515
12,392
1
1
1
2/60
42/60
14/60
91
1,761
2,891
2,734
1
2/60
91
2,515
1
17/60
713
14,907
2
8/60
3,975
5,468
2
8/60
1,458
[FR Doc. 2014–02603 Filed 2–5–14; 8:45 am]
Description of Technology: This CDC
developed invention is a simple enzyme
immunoassay that detects increasing
levels of anti-HIV-IgG after
seroconversion and can be used for
detection of HIV–1 infection. The assay,
termed IgG-Capture BED–EIA,
incorporates a branched peptide derived
from 3 different subtypes to allow
equivalent detection of antibodies of
different subtypes. The competitive
format of the assay allows detection of
increasing proportion of HIV–1 IgG for
almost 2 years after seroconversion.
This is different from what is normally
observed in a conventional EIA (with
antigen coated plates) that plateaus soon
after seroconversion. This assay will be
important for HIV prevention activities,
targeting resources, and evaluation of
ongoing interventions.
Potential Commercial Applications:
• HIV clinical serodiagnostics
• Informing clinical decision-making
• Public health/HIV monitoring
programs and incidence surveillance
Competitive Advantages:
• Ready for commercialization
• Simple and high-throughput capable
• Detects HIV–1 subtypes prevalent in
N. America, Europe, Japan, Thailand,
Australia, and also central and E.
Africa
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 209 and 37 CFR Part 404 to
achieve expeditious commercialization
of results of federally-funded research
and development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
VerDate Mar<15>2010
18:18 Feb 05, 2014
Jkt 232001
Development Stage: In vitro data
available
Inventors: Bharat S. Parekh and J.
Steven McDougal (CDC)
Publications:
1. Parekh BS, et al. Determination of mean
recency period for estimation of HIV
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Estimated total
annual burden
hours
requested
1
1
2
1
HIV–1 BED: A Simple Serological Assay
for Detecting Recent Infection and
Estimating Incidence of Multiple,
Worldwide HIV–1 Subtypes
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Average
burden hours
per response
(in hours)
2,303
17,077
41,239
12,392
Dated: January 31, 2014.
Glenda J. Conroy,
Executive Officer (OM Director), National
Institute on Drug Abuse, NIH.
BILLING CODE 4140–01–P
Estimated
number of
responses per
respondent
type 1 Incidence with the BED-capture
EIA in persons infected with diverse
subtypes. AIDS Res Hum Retroviruses.
2011 Mar;27(3):265–73. [PMID
20954834]
2. Dobbs T, et al. A comprehensive
evaluation of the proficiency testing
program for the HIV–1 BED incidence
assay. J Clin Microbiol. 2011
Oct;49(10):3470–3. [PMID 21832016]
3. Parekh BS, et al. Quantitative detection of
increasing HIV type 1 antibodies after
seroconversion: a simple assay for
detecting recent HIV infection and
estimating incidence. AIDS Res Hum
Retroviruses. 2002 Mar 1;18(4):295–307.
[PMID 11860677]
4. Dobbs T, et al. Performance characteristics
of the immunoglobulin G-capture BEDenzyme immunoassay, an assay to detect
recent human immunodeficiency virus
type 1 seroconversion. J Clin Microbiol.
2004 Jun;42(6):2623–8. [PMID 15184443]
5. Nesheim S, et al. Temporal trends in HIV
Type 1 incidence among inner-city
childbearing women in Atlanta: use of
the IgG-capture BED-enzyme
immunoassay. AIDS Res Hum
Retroviruses. 2005 Jun;21(6):537–44.
[PMID 15989458]
Intellectual Property: HHS Reference
No. E–555–2013/0—Research Tool.
Patent protection is not being pursued
for this technology.
Related Technologies:
• HHS Reference No. E–357–2013/0—
Research Tool. Patent protection is
not being pursued for this technology.
• HHS Reference No. E–358–2013/0—
Research Tool. Patent protection is
not being pursued for this technology.
Licensing Contact: Whitney Blair, J.D.,
M.P.H.; 301–435–4937; whitney.blair@
nih.gov
Improved Botulism, Botulinum
Neurotoxin Type-E Diagnostics
Description of Technology: CDC
researchers have improved upon a prior,
E:\FR\FM\06FEN1.SGM
06FEN1
]]>Agencies
[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7206-7207]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02603]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICE
National Institutes of Health
Proposed Information Collection; 60-day Comment Request:
Population Assessment of Tobacco and Health (PATH) Study
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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.
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) The quality, utility, and clarity of the information to be
collected; and (4) The approaches used 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.
DATES: Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received by April 7,
2014.
FOR FURTHER INFORMATION CONTACT: 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: Kevin P. Conway, Ph.D., Deputy Director,
Division of Epidemiology, Services, and Prevention Research, National
Institute on Drug Abuse, 6001 Executive Boulevard, Room 5185; or call
non-toll-free number (301) 443-8755; or Email your request, including
your address to: PATHprojectofficer@mail.nih.gov. Formal requests for
additional plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION:
Proposed Collection: Population Assessment of Tobacco and Health
(PATH) Study--Second Wave of Data Collection-0925-0664-Revision--
National Institutes of Health (NIH), National Institute on Drug Abuse
(NIDA), in partnership with the Food and Drug Administration (FDA).
Need and Use of Information Collection: This is a revision request
(OMB 0925-0664, expires 11/30/2015) for the Population Assessment of
Tobacco and Health (PATH) Study to conduct the second wave of data
collection. The PATH Study is a large national longitudinal cohort
study on tobacco use behavior and health among the U.S. household
population of adults age 18 and older and youth ages 12 to 17. The PATH
Study conducts annual interviews and collects biospecimens from adults
to help inform the development, implementation, and evaluation of
tobacco-product regulations by FDA in meeting its mission under the
Family Smoking Prevention and Tobacco Control Act (TCA) to regulate
tobacco products, including tobacco-product advertising, labeling,
marketing, constituents, ingredients, and additives. The longitudinal
design of the PATH Study provides it with the capacity to measure and
report within-person changes and between-person differences in tobacco
product use behaviors and health effects within the cohort over time.
These data will help to inform regulatory decisions and actions by FDA
and FDA's evaluations of associations between its regulations and
tobacco use behaviors and health indicators in the population.
OMB approval is requested for 3 years. There are no capital,
operating, or maintenance costs to report. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 75,124.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated Average Estimated
Estimated number of burden hours total annual
Type of respondent and instrument number of responses per per response burden hours
respondents respondent (in hours) requested
----------------------------------------------------------------------------------------------------------------
Adults--Extended Interview...................... 38,740 1 1 38,740
Adults--Baseline youth respondents who age into 2,717 1 2/60 91
adult cohort--Consent for Extended Interview...
Adults--Baseline youth respondents who age into 2,500 1 68/60 2,833
adult cohort--Extended Interview...............
Adults--Adult respondents who refused 1,452 1 4/60 97
biospecimen collection at Baseline but who
consent for Wave 2--Consent for Biological
Samples........................................
Adults--Baseline youth respondents who age into 2,500 1 4/60 167
the adult cohort--Consent for Biological
Samples........................................
Adults--Biospecimen Collection: Urine........... 12,387 1 10/60 2,065
Adults--Biospecimen Collection: Buccal Cell..... 2,387 1 18/60 716
[[Page 7207]]
Adults--Biospecimen Collection: Blood........... 2,303 1 18/60 691
Adults--Tobacco Use Form........................ 17,077 1 4/60 1,138
Adults--Follow-up/Tracking Participant 41,239 2 8/60 10,997
Information Form...............................
Youth--Extended Interview....................... 12,392 1 32/60 6,609
Youth--Shadow youth who age into youth cohort-- 2,734 1 2/60 91
Assent for Extended Interview..................
Youth--Shadow youth who age into youth cohort-- 2,515 1 42/60 1,761
Extended Interview.............................
Adult--Parent Interview......................... 12,392 1 14/60 2,891
Adults--Parents of Shadow youth who age into 2,734 1 2/60 91
youth cohort--Parent Permission and Consent for
Parent Interview...............................
Adults--Parents of Shadow youth who age into 2,515 1 17/60 713
youth cohort--Parent Interview.................
Adults--Follow-up/Tracking Participant 14,907 2 8/60 3,975
Information Form for Youth (completed by
parents).......................................
Adults--Follow-up/Tracking Participant 5,468 2 8/60 1,458
Information Form for sample Shadow youth
(completed by parents).........................
----------------------------------------------------------------------------------------------------------------
Dated: January 31, 2014.
Glenda J. Conroy,
Executive Officer (OM Director), National Institute on Drug Abuse, NIH.
[FR Doc. 2014-02603 Filed 2-5-14; 8:45 am]
BILLING CODE 4140-01-P
