80 FR 34684 - Submission for OMB Review; 30-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study-3rd Wave (NIDA)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 116 (June 17, 2015)

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on February 11, 2015, pages 7619-7620 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute on Drug Abuse (NIDA), 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. 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, [email protected] or by fax to (202) 395-6974, Attention: NIH Desk Officer.

[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34684-34685]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14902]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; Population 
Assessment of Tobacco and Health (PATH) Study--3rd Wave (NIDA)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH) has 
submitted to the Office of Management and Budget (OMB) a request for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on February 11, 2015, pages 7619-7620 and allowed 60-days for 
public comment. One public comment was received. The purpose of this 
notice is to allow an additional 30 days for public comment. The 
National Institute on Drug Abuse (NIDA), 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.
    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, [email protected] or by fax to (202) 395-6974, 
Attention: NIH Desk Officer.

DATES: Comment 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.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments or request more information on the 
proposed project, contact: Dr. Kevin P. Conway, Deputy Director, 
Division of Epidemiology, Services, and Prevention Research, NIDA, 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.
    Proposed Collection: Population Assessment of Tobacco and Health 
(PATH) Study--Third Wave of Data Collection--0925-0664--Revision, 
National Institute on Drug Abuse (NIDA), National Institutes of Health 
(NIH), in partnership with the Food and Drug Administration (FDA).
    Need and Use of Information Collection: This is a revision request 
(OMB 0925-0664, expires 9/30/2016) for the Population Assessment of 
Tobacco and Health (PATH) Study to conduct the third wave of data 
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 interviews and collects biospecimens from adults to assess 
within-person changes and between-person differences in tobacco-product 
use behaviors and related health conditions over time. Its 
longitudinal, population-based data will help to enhance the evidence 
base that informs FDA's regulatory actions under the Family Smoking 
Prevention and Control Act to protect the Nation's public health and 
reduce its burden of tobacco-related morbidity and mortality.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 54,434.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
    Form or activity name           Type of          Number of     responses per   per  response   Total annual
                                   respondent       respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Adult Extended Interview.....  Adults...........          25,444               1               1          25,444
Consent for Adult Extended     Adults...........           2,046               1            4/60             136
 Interview.

[[Page 34685]]

 
Adult Extended Interview       Adults...........           1,780               1           68/60           2,017
 (Aged-up).
Consent for Biological         Adults...........           1,780               1            5/60             148
 Samples.
Biospecimen Collection: Urine  Adults...........          13,805               1           10/60           2,301
Biospecimen Collection: Blood  Adults...........             765               1           18/60             230
Tobacco Use Form.............  Adults...........          14,570               1            5/60           1,214
Follow-up/Tracking             Adults...........          27,224               2            8/60           7,260
 Participant Information Form
 for Adults.
Youth Extended Interview.....  Youth............           9,625               1           35/60           5,615
Assent for Youth Extended      Youth............           1,923               1            3/60              96
 Interview.
Youth Extended Interview       Youth............           1,923               1           45/60           1,442
 (Aged-up).
Parent Interview.............  Parents..........           9,818               1           16/60           2,618
Parent Permission and Consent  Parents..........           2,161               1            5/60             180
 for Parent Interview.
Parent Interview (Aged-up)...  Parents..........           1,961               1           19/60             621
Verification Interview.......  Adults...........          35,564               1            2/60           1,185
Validation Interview.........  Adults...........           3,579               1            4/60             239
Follow-up/Tracking             Parents..........          11,548               2            8/60           3,079
 Participant Information Form
 for Youth.
Follow-up/Tracking             Parents..........           2,282               2            8/60             609
 Participant Information Form
 for Sample Shadow Youth.
----------------------------------------------------------------------------------------------------------------


    Dated: June 12, 2015.
Genevieve deAlmeida-Morris,
Project Clearance Liaison, NIDA, NIH.
[FR Doc. 2015-14902 Filed 6-16-15; 8:45 am]
 BILLING CODE 4140-01-P