Proposed Information Collection; 60-day Comment Request: Population Assessment of Tobacco and Health (PATH) Study, 7206-7207 [2014-02603]

Download as PDF 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 http://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]


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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