81_FR_12961 81 FR 12913 - Submission for OMB Review; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study [email protected] 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 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."> [email protected] 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 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." /> [email protected] 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 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." />

81 FR 12913 - Submission for OMB Review; 60-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 48 (March 11, 2016)

Page Range12913-12914
FR Document2016-05431

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: [email protected] 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 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.

Federal Register, Volume 81 Issue 48 (Friday, March 11, 2016) 
[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12913-12914]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05431]


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

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: [email protected]. 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

Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices 12913 alive in the 1940s via focus groups and nuclear testing fallout in each county of recommend potential participants for key informant interviews and will be New Mexico as a result of the Trinity either the focus groups or interviews. used to derive means and ranges of test, stratified by age, gender, ethnicity, The objective of the focus groups and exposure-related parameters, such as and conditions of exposure (low, interviews is to collect information consumption of contaminated medium, high); (2) in each county, directly from community members who foodstuffs, collection and use of water, estimate the number of excess cancer were alive at the time of the Trinity test, time spend outdoors, and building cases to organs of interest per 1,000 materials. These parameter values will (hypothetical) persons stratified by age, or with direct knowledge of specific life be used with historical fallout gender, ethnicity, and conditions of circumstances, cultural patterns, and deposition data in fallout dose exposure (low, medium, high). dietary practices of Native Americans, assessment models to estimate external The study data will be collected via Hispanics/Latinos, or non-Hispanic and internal radiation doses to typical focus group and individual interview. whites living in New Mexico at this persons in all counties in New Mexico Between 10 and 15 focus groups with time. In this study, two interviewers, by ethnicity and age. The estimated up to 8 participants are planned. These including one with extensive experience doses will be used with literature- participants will be 70 years old and working with tribal communities, will derived risk and parameter values on older, living in New Mexico, who were moderate the focus groups and conduct risk/unit dose to project the excess alive at the time of the Trinity nuclear in-depth interviews. Translators and cancers expected (per 1,000 persons test and living in any of 19 Native interpreters with experience in the within each stratum) including American pueblos/tribes or Hispanic/ study populations will be presented uncertainty on each estimate. Endpoints Latino and non-Hispanic white when needed. Each focus group and are leukemia, thyroid cancer, stomach communities in or near the fallout interview will be scheduled for no more cancer, colon cancer, and all solid region in New Mexico. Additionally, up than two hours and will take place in cancers combined. to 30 individual interviews are planned office settings, community facilities, or This data collection is needed to with key informants chosen to represent municipal facilities. accomplish the overall Trinity Study a variety of experiences and expertise. goals, which are to: (1) Estimate external Individuals who prefer not to take part OMB approval is requested for 3 and internal radiation dose to the four in a focus group will be interviewed years. There are no costs to respondents primary organs/tissues of interest individually as key informants. The other than their time. The total (thyroid, stomach, colon, and red bone investigators will collaborate with estimated annualized burden hours are marrow) from primary radionuclides in community representatives who will 395. ESTIMATED ANNUALIZED BURDEN HOURS Average time Number of Frequency of Annual burden Type of respondents Instrument per response respondents response hours (in hours) Individuals ...................... Screener .............................................................. 300 1 10/60 50 Consent Form ...................................................... 150 1 10/60 25 Focus Groups ...................................................... 120 1 120/60 240 Pre-Focus Group Guide ...................................... 120 1 10/60 20 Key Informants and Academics Interview ........... 30 1 120/60 60 Totals ...................... .............................................................................. 300 720 ........................ 395 Dated: March 1, 2016. (NIDA), the National Institutes of Health electronic, mechanical, or other Karla Bailey, (NIH) will publish periodic summaries technological collection techniques or Project Clearance Liaison, National Cancer of proposed projects to be submitted to other forms of information technology. Institute, NIH. the Office of Management and Budget To Submit Comments and For Further [FR Doc. 2016–05426 Filed 3–10–16; 8:45 am] (OMB) for review and approval. Information: To obtain a copy of the Written comments and/or suggestions BILLING CODE 4140–01–P data collection plans and instruments, from the public and affected agencies submit comments in writing, or request are invited on one or more of the more information on the proposed DEPARTMENT OF HEALTH AND following points: (1) Whether the project, contact: Dr. Kevin P. Conway, HUMAN SERVICES proposed collection of information is necessary for the proper performance of Deputy Director, Division of the function of the agency, including Epidemiology, Services, and Prevention National Institutes of Health Research, National Institute on Drug whether the information will have practical utility; (2) The accuracy of the Abuse, NIH, 6001 Executive Boulevard, Submission for OMB Review; 60-Day agency’s estimate of the burden of the Room 5185, Rockville, MD 20852; or Comment Request; Population proposed collection of information, call non-toll-free number (301) 443– asabaliauskas on DSK3SPTVN1PROD with NOTICES Assessment of Tobacco and Health including the validity of the 8755 or Email your request, including (PATH) Study methodology and assumptions used; (3) your address, to: PATHprojectofficer@ Summary: In compliance with the Ways to enhance the quality, utility, and mail.nih.gov. Formal requests for requirement of Section 3506(c)(2)(A) of clarity of the information to be additional plans and instruments must the Paperwork Reduction Act of 1995, collected; and (4) Ways to minimize the be requested in writing. for opportunity for public comment on burden of the collection of information Comment Due Date: Comments proposed data collection projects, the on those who are to respond, including regarding this information collection are National Institute on Drug Abuse the use of appropriate automated, best assured of having their full effect if VerDate Sep<11>2014 17:56 Mar 10, 2016 Jkt 238001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 methodological studies in support of Control Act. The methodological studies this publication. improvements in the Study’s under this extension will continue to Proposed Collection: Methodological approaches for data and biospecimen enhance the approaches used by the Studies for the Population Assessment collection. The PATH Study is a PATH Study for data and biospecimen of Tobacco and Health (PATH) Study national longitudinal cohort study of collections to obtain high quality and (NIDA), 0925–0675, expiration date 5/ tobacco use behavior and health among useful data; minimize respondent 31/2016—EXTENSION—NIDA, NIH, in the U.S. household population of adults burden; and achieve and maintain high partnership with the Food and Drug age 18 and older and youth ages 12 to response, retention, and follow-up rates. Administration (FDA). 17; the Study conducts annual or Need and Use of Information biannual interviews and collects OMB approval is requested for 3 Collection: This is a request to continue biospecimens from adults and youth to years. There are no costs to respondents the Population Assessment of Tobacco inform FDA’s regulatory actions under other than their time. The total and Health (PATH) Study’s conduct of the Family Smoking Prevention and annualized burden hours are 29,750. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total annual Data collection activity Type of respondent responses per respondents response burden hours respondent (in 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-depth quali- Adults .................................... 1,000 1 2 2,000 tative 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. the function of the agency, including best assured of having their full effect if Genevieve deAlmeida-Morris, whether the information will have received within 60 days of the date of Project Clearance Liaison. NIDA, NIH. practical utility; (2) The accuracy of the this publication. [FR Doc. 2016–05431 Filed 3–10–16; 8:45 am] agency’s estimate of the burden of the Proposed Collection: The Clinical BILLING CODE 4140–01–P proposed collection of information, Trials Reporting Program (CTRP) including the validity of the Database, 0925–0600, Expiration Date methodology and assumptions used; (3) 05/31/2016—EXTENSION, National DEPARTMENT OF HEALTH AND The quality, utility, and clarity of the Cancer Institute (NCI), National HUMAN SERVICES information to be collected; and (4) Institutes of Health (NIH). Minimize the burden of the collection of Need and Use of Information National Institutes of Health information on those who are to Collection: The Clinical Trials Reporting respond, including the use of Program (CTRP) Database is an Proposed Collection; 60-Day Comment appropriate automated, electronic, electronic resource that serves as a Request; The Clinical Trials Reporting mechanical, or other technological single, definitive source of information Program (CTRP) Database (NCI) collection techniques or other forms of about all NCI-supported clinical Summary: In compliance with the information technology. research. This resource allows the NCI requirement of Section 3506(c)(2)(A) of To Submit Comments and For Further to consolidate reporting, aggregate the Paperwork Reduction Act of 1995, Information: To obtain a copy of the information and reduce redundant for opportunity for public comment on data collection plans and instruments, submissions. Information is submitted proposed data collection projects, the submit comments in writing, or request by clinical research administrators as National Cancer Institute, the National more information on the proposed designees of clinical investigators who Institutes of Health (NIH) will publish project, contact: Jose Galvez, MD, Office conduct NCI-supported clinical periodic summaries of proposed of the Director, National Cancer research. The designees can projects to be submitted to the Office of Institute, 9609 Medical Center Drive, electronically access the CTRP Web site Management and Budget (OMB) for 1W468, Rockville, MD 20852 or call to complete the initial trial registration. review and approval. non-toll-free number 240–276–5206 or Subsequent to registration, four Written comments and/or suggestions Email your request, including your amendments and four study subject address to: jose.galvez@nih.gov. Formal asabaliauskas on DSK3SPTVN1PROD with NOTICES from the public and affected agencies accrual updates occur per trial annually. are invited to address one or more of the requests for additional plans and OMB approval is requested for 3 following points: (1) Whether the instruments must be requested in years. There are no costs to respondents proposed collection of information is writing. other than their time. The estimated necessary for the proper performance of Comment Due Date: Comments annualized burden hours are 18,000. regarding this information collection are VerDate Sep<11>2014 17:56 Mar 10, 2016 Jkt 238001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\11MRN1.SGM 11MRN1


Document Created: 2016-03-11 01:51:11
Document Modified: 2016-03-11 01:51:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesComments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
FR Citation81 FR 12913 
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