Submission for OMB Review; Comment Request; Population Assessment of Tobacco and Health (PATH) Study, 48994-48995 [2012-20068]

Download as PDF 48994 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices Sisters of women with breast cancer are one group at increased risk for breast cancer; we would expect at least 2 times as many breast cancers to accrue in a cohort of sisters as would accrue in a cohort identified through random sampling or other means. In addition, a cohort of sisters should be enriched with regard to the prevalence of relevant genes and/or exposures, further enhancing the ability to detect geneenvironment interactions. Sisters of women with breast cancer will also be at increased risk for ovarian cancer and possibly for other hormonally-mediated diseases. From August 2003 through July 2009, we enrolled a cohort of 50,884 women who had not had breast cancer. We estimated that after the cohort was fully enrolled, approximately 300 new cases of breast cancer will be diagnosed during each year of follow-up. Thus far 1,634 participants have reported being diagnosed with breast cancer. Frequency of Response: For the remainder of the study, women will be contacted once each year (when not scheduled for ‘‘triennial’’) to update contact information and health status (10 minutes per response); and asked to complete short (75 minutes per response) follow-up interviews or questionnaires (‘‘triennial’’) every three years. Follow-up and validation of reported incident breast cancer and other health outcomes is conducted under Clinical Exemption CE 2009–09– 004. Affected Public: Study participants, next-of-kin/proxies. Type of Respondents: Participants enrolled in high-risk cohort study of risk factors for breast cancer; next-of-kin/proxies. The annual reporting burden is as follows: Estimated Number of Respondents: 50,884 study participants or next-of-kin/ proxies. Estimated Number of Responses per Respondent: See annualized table below: Activity Estimated number of responses Estimated responses per respondent Average burden hours per response Estimated total burden hours requested Annual Updates ............................................................................................... Triennial Update .............................................................................................. Total .......................................................................................................... 33,923 16,961 ........................ 1 1 ........................ 10/60 1.25 ........................ 85,654 21,202 26,856 Average Burden Hours Per Response:42 minutes; and Estimated Total Annual Burden Hours Requested: 26,856. The estimated total annualized cost to respondents $537,120 (assuming $20 hourly wage × 26,856). There are no capital, operating, or maintenance costs. 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. To request more information on the project or to obtain a copy of the data collection plans and instruments, contact Dr. Dale P. Sandler, Chief, Epidemiology Branch, NIEHS, Rall Building A3–05, PO Box 12233, Research Triangle Park, NC 27709, or call non-toll free number (919)-541–4668 or Email your request, including your address to: sandler@niehs.nih.gov. srobinson on DSK4SPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: VerDate Mar<15>2010 17:49 Aug 14, 2012 Jkt 226001 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: August 7, 2012. Joellen M. Austin, Associate Director for Management. [FR Doc. 2012–20067 Filed 8–14–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Population Assessment of Tobacco and Health (PATH) Study Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 18, 2012, pages 29667–29668 and allowed 60days for public comment. Two public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. 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 conducted under the direction of the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) and in partnership with the Food and Drug Administration (FDA). The field test is scheduled to begin in the fall of 2012 and the baseline collection is scheduled to begin in the fall of 2013. Using annual interviews and the collection of biospecimens from adults, the PATH 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, E:\FR\FM\15AUN1.SGM 15AUN1 48995 Federal Register / Vol. 77, No. 158 / Wednesday, August 15, 2012 / Notices 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: $22,993; and the annualized cost to respondents for the baseline data collection is: $1,792,156. There are no capital, operating, or maintenance costs. 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—Biospecimen Collection Forms ........................................................... Adults—Tobacco Use Form ............................................................................ Adults—Followup/Tracking Participant Information Form ............................... Youth—Extended Interview ............................................................................. Adult—Parent Interview ................................................................................... Adults—Followup/Tracking Participant Information Form for Youth (completed by parents) ........................................................................................ 1,295 840 590 590 590 590 100 100 1 1 1 1 1 2 1 1 ⁄ ⁄ 19⁄60 9⁄60 2⁄60 6⁄60 35⁄60 19⁄60 367 84 679 89 20 118 58 32 100 2 8 60 ⁄ 27 Total .......................................................................................................... ........................ ........................ ........................ 1,446 Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours requested 17 60 6 60 TABLE 2—PATH STUDY BASELINE HOUR BURDEN ESTIMATES Estimated number of respondents Type of respondents 100,983 63,000 42,730 42,730 42,730 42,730 16,857 16,857 1 1 1 1 1 2 1 1 ⁄ ⁄ 19⁄60 9⁄60 2⁄60 6⁄60 35⁄60 19⁄60 28,612 6,300 49,140 6,410 1,424 8,546 9,833 5,338 16,857 2 8 60 ⁄ 4,495 Total .......................................................................................................... srobinson on DSK4SPTVN1PROD with NOTICES Adults—Household Screener .......................................................................... Adults—Individual Screener ............................................................................ Adults—Extended Interview ............................................................................. Adults—Biospecimen Collection Forms ........................................................... Adults—Tobacco Use Form ............................................................................ Adults—Followup/Tracking Participant Information Form ............................... Youth—Extended Interview ............................................................................. Adult—Parent Interview ................................................................................... Adults—Followup/Tracking Participant Information Form for Youth (completed by parents) ........................................................................................ ........................ ........................ ........................ 115,602 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. VerDate Mar<15>2010 17:49 Aug 14, 2012 Jkt 226001 Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: Desk Officer for NIH. 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 17 60 6 60 received within 30-days of the date of this publication. Dated: August 7, 2012. Glenda J. Conroy, Executive Officer (OM Director) NIDA. [FR Doc. 2012–20068 Filed 8–14–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Draft National Toxicology Program (NTP) Monograph on Developmental Effects and Pregnancy Outcomes Associated With Cancer Chemotherapy Use During Pregnancy; Request for Comments; Peer Review Panel Meeting Division of the National Toxicology Program (DNTP), National AGENCY: E:\FR\FM\15AUN1.SGM 15AUN1

Agencies

[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48994-48995]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20068]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; Comment Request; Population Assessment
of Tobacco and Health (PATH) Study

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the
National Institutes of Health (NIH) has submitted to the Office of
Management and Budget (OMB) a request to review and approve the
information collection listed below. This proposed information
collection was previously published in the Federal Register on May 18,
2012, pages 29667-29668 and allowed 60-days for public comment. Two
public comments were received. The purpose of this notice is to allow
an additional 30 days for public comment. The National Institutes of
Health may not conduct or sponsor, and the respondent is not required
to respond to, an information collection that has been extended,
revised, or implemented on or after October 1, 1995, unless it displays
a currently valid OMB control number.
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 conducted under the direction
of the National Institutes of Health (NIH) National Institute on Drug
Abuse (NIDA) and in partnership with the Food and Drug Administration
(FDA). The field test is scheduled to begin in the fall of 2012 and the
baseline collection is scheduled to begin in the fall of 2013. Using
annual interviews and the collection of biospecimens from adults, the
PATH 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,

[[Page 48995]]

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: $22,993; and the annualized cost to
respondents for the baseline data collection is: $1,792,156. There are
no capital, operating, or maintenance costs.

Table 1--PATH Study Field Test 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...................... 1,295 1 \17/60\ 367
Adults--Individual Screener..................... 840 1 \6/60\ 84
Adults--Extended Interview...................... 590 1 1\9/60\ 679
Adults--Biospecimen Collection Forms............ 590 1 \9/60\ 89
Adults--Tobacco Use Form........................ 590 1 \2/60\ 20
Adults--Followup/Tracking Participant 590 2 \6/60\ 118
Information Form...............................
Youth--Extended Interview....................... 100 1 \35/60\ 58
Adult--Parent Interview......................... 100 1 \19/60\ 32
Adults--Followup/Tracking Participant 100 2 \8/60\ 27
Information Form for Youth (completed by
parents).......................................
---------------------------------------------------------------
Total....................................... .............. .............. .............. 1,446
----------------------------------------------------------------------------------------------------------------

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 \17/60\ 28,612
Adults--Individual Screener..................... 63,000 1 \6/60\ 6,300
Adults--Extended Interview...................... 42,730 1 1\9/60\ 49,140
Adults--Biospecimen Collection Forms............ 42,730 1 \9/60\ 6,410
Adults--Tobacco Use Form........................ 42,730 1 \2/60\ 1,424
Adults--Followup/Tracking Participant 42,730 2 \6/60\ 8,546
Information Form...............................
Youth--Extended Interview....................... 16,857 1 \35/60\ 9,833
Adult--Parent Interview......................... 16,857 1 \19/60\ 5,338
Adults--Followup/Tracking Participant 16,857 2 \8/60\ 4,495
Information Form for Youth (completed by
parents).......................................
---------------------------------------------------------------
Total....................................... .............. .............. .............. 115,602
----------------------------------------------------------------------------------------------------------------

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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH. 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 30-days
of the date of this publication.

Dated: August 7, 2012.
Glenda J. Conroy,
Executive Officer (OM Director) NIDA.
[FR Doc. 2012-20068 Filed 8-14-12; 8:45 am]
BILLING CODE 4140-01-P

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