Submission for OMB Review; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study, 12913-12914 [2016-05431]

Download as PDF 12913 Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices alive in the 1940s via focus groups and key informant interviews and will be used to derive means and ranges of exposure-related parameters, such as consumption of contaminated foodstuffs, collection and use of water, time spend outdoors, and building materials. These parameter values will be used with historical fallout deposition data in fallout dose assessment models to estimate external and internal radiation doses to typical persons in all counties in New Mexico by ethnicity and age. The estimated doses will be used with literaturederived risk and parameter values on risk/unit dose to project the excess cancers expected (per 1,000 persons within each stratum) including uncertainty on each estimate. Endpoints are leukemia, thyroid cancer, stomach cancer, colon cancer, and all solid cancers combined. This data collection is needed to accomplish the overall Trinity Study goals, which are to: (1) Estimate external and internal radiation dose to the four primary organs/tissues of interest (thyroid, stomach, colon, and red bone marrow) from primary radionuclides in nuclear testing fallout in each county of New Mexico as a result of the Trinity test, stratified by age, gender, ethnicity, and conditions of exposure (low, medium, high); (2) in each county, estimate the number of excess cancer cases to organs of interest per 1,000 (hypothetical) persons stratified by age, gender, ethnicity, and conditions of exposure (low, medium, high). The study data will be collected via focus group and individual interview. Between 10 and 15 focus groups with up to 8 participants are planned. These participants will be 70 years old and older, living in New Mexico, who were alive at the time of the Trinity nuclear test and living in any of 19 Native American pueblos/tribes or Hispanic/ Latino and non-Hispanic white communities in or near the fallout region in New Mexico. Additionally, up to 30 individual interviews are planned with key informants chosen to represent a variety of experiences and expertise. Individuals who prefer not to take part in a focus group will be interviewed individually as key informants. The investigators will collaborate with community representatives who will recommend potential participants for either the focus groups or interviews. The objective of the focus groups and interviews is to collect information directly from community members who were alive at the time of the Trinity test, or with direct knowledge of specific life circumstances, cultural patterns, and dietary practices of Native Americans, Hispanics/Latinos, or non-Hispanic whites living in New Mexico at this time. In this study, two interviewers, including one with extensive experience working with tribal communities, will moderate the focus groups and conduct in-depth interviews. Translators and interpreters with experience in the study populations will be presented when needed. Each focus group and interview will be scheduled for no more than two hours and will take place in office settings, community facilities, or municipal facilities. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 395. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Average time per response (in hours) Frequency of response Annual burden hours Type of respondents Instrument Individuals ...................... Screener .............................................................. Consent Form ...................................................... Focus Groups ...................................................... Pre-Focus Group Guide ...................................... Key Informants and Academics Interview ........... 300 150 120 120 30 1 1 1 1 1 10/60 10/60 120/60 10/60 120/60 50 25 240 20 60 Totals ...................... .............................................................................. 300 720 ........................ 395 Dated: March 1, 2016. Karla Bailey, Project Clearance Liaison, National Cancer Institute, NIH. [FR Doc. 2016–05426 Filed 3–10–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES asabaliauskas on DSK3SPTVN1PROD with NOTICES National Institutes of Health Submission for OMB Review; 60-Day 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 VerDate Sep<11>2014 17:56 Mar 10, 2016 Jkt 238001 (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) 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, PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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. Kevin P. Conway, Deputy Director, Division of Epidemiology, Services, and Prevention Research, National Institute on Drug Abuse, NIH, 6001 Executive Boulevard, Room 5185, Rockville, MD 20852; 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. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if E:\FR\FM\11MRN1.SGM 11MRN1 12914 Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices received within 60 days of the date of this publication. Proposed Collection: Methodological Studies for the Population Assessment of Tobacco and Health (PATH) Study (NIDA), 0925–0675, expiration date 5/ 31/2016—EXTENSION—NIDA, NIH, in partnership with the Food and Drug Administration (FDA). Need and Use of Information Collection: This is a request to continue the Population Assessment of Tobacco and Health (PATH) Study’s conduct of Control Act. The methodological studies under this extension will continue to enhance the approaches used by the PATH Study for data and biospecimen collections to obtain high quality and useful data; minimize respondent burden; and achieve and maintain high response, retention, and follow-up rates. methodological studies in support of improvements in the Study’s approaches for data and biospecimen collection. The PATH Study is a national longitudinal cohort study of tobacco use behavior and health among the U.S. household population of adults age 18 and older and youth ages 12 to 17; the Study conducts annual or biannual interviews and collects biospecimens from adults and youth to inform FDA’s regulatory actions under the Family Smoking Prevention and OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total annualized burden hours are 29,750. ESTIMATED ANNUALIZED BURDEN HOURS Data collection activity Number of respondents Type of respondent In-person surveys ......................................... Web surveys ................................................. Focus groups and individual in-depth qualitative interviews. Biospecimen collection ................................. Adults Youth Adults Youth Adults [FR Doc. 2016–05431 Filed 3–10–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health asabaliauskas on DSK3SPTVN1PROD with NOTICES Proposed Collection; 60-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI) 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 Cancer Institute, 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 to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of VerDate Sep<11>2014 17:56 Mar 10, 2016 Jkt 238001 Total annual burden hours .................................... .................................... .................................... .................................... .................................... 5,000 3,500 5,000 3,500 1,000 1 1 1 1 1 90/60 90/60 90/60 90/60 2 7,500 5,250 7,500 5,250 2,000 Youth .................................... Adults .................................... 1,000 1,000 1 1 2 15/60 2,000 250 20,000 20,000 ........................ 29,750 Total ....................................................... Dated: March 7, 2016. Genevieve deAlmeida-Morris, Project Clearance Liaison. NIDA, NIH. Average burden per response (in hours) Number of responses per respondent 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) 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: Jose Galvez, MD, Office of the Director, National Cancer Institute, 9609 Medical Center Drive, 1W468, Rockville, MD 20852 or call non-toll-free number 240–276–5206 or Email your request, including your address to: jose.galvez@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database, 0925–0600, Expiration Date 05/31/2016—EXTENSION, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Clinical Trials Reporting Program (CTRP) Database is an electronic resource that serves as a single, definitive source of information about all NCI-supported clinical research. This resource allows the NCI to consolidate reporting, aggregate information and reduce redundant submissions. Information is submitted by clinical research administrators as designees of clinical investigators who conduct NCI-supported clinical research. The designees can electronically access the CTRP Web site to complete the initial trial registration. Subsequent to registration, four amendments and four study subject accrual updates occur per trial annually. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hours are 18,000. E:\FR\FM\11MRN1.SGM 11MRN1

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[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12913-12914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05431]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 60-Day 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.
    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. Kevin 
P. Conway, Deputy Director, Division of Epidemiology, Services, and 
Prevention Research, National Institute on Drug Abuse, NIH, 6001 
Executive Boulevard, Room 5185, Rockville, MD 20852; 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.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if

[[Page 12914]]

received within 60 days of the date of this publication.
    Proposed Collection: Methodological Studies for the Population 
Assessment of Tobacco and Health (PATH) Study (NIDA), 0925-0675, 
expiration date 5/31/2016--EXTENSION--NIDA, NIH, in partnership with 
the Food and Drug Administration (FDA).
    Need and Use of Information Collection: This is a request to 
continue the Population Assessment of Tobacco and Health (PATH) Study's 
conduct of methodological studies in support of improvements in the 
Study's approaches for data and biospecimen collection. The PATH Study 
is a national longitudinal cohort study of tobacco use behavior and 
health among the U.S. household population of adults age 18 and older 
and youth ages 12 to 17; the Study conducts annual or biannual 
interviews and collects biospecimens from adults and youth to inform 
FDA's regulatory actions under the Family Smoking Prevention and 
Control Act. The methodological studies under this extension will 
continue to enhance the approaches used by the PATH Study for data and 
biospecimen collections to obtain high quality and useful data; 
minimize respondent burden; and achieve and maintain high response, 
retention, and follow-up rates.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total annualized burden hours 
are 29,750.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Type of         Number of       Number of      burden per     Total annual
   Data collection activity        respondent       respondents    responses per   response  (in   burden hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
In-person surveys.............  Adults..........           5,000               1           90/60           7,500
                                Youth...........           3,500               1           90/60           5,250
Web surveys...................  Adults..........           5,000               1           90/60           7,500
                                Youth...........           3,500               1           90/60           5,250
Focus groups and individual in- Adults..........           1,000               1               2           2,000
 depth qualitative interviews.
                                Youth...........           1,000               1               2           2,000
Biospecimen collection........  Adults..........           1,000               1           15/60             250
                                                 ---------------------------------------------------------------
    Total.....................                            20,000          20,000  ..............          29,750
----------------------------------------------------------------------------------------------------------------


    Dated: March 7, 2016.
Genevieve deAlmeida-Morris,
Project Clearance Liaison. NIDA, NIH.
[FR Doc. 2016-05431 Filed 3-10-16; 8:45 am]
 BILLING CODE 4140-01-P