80 FR 37276 - Submission for OMB Review; 60-Day Comment Request; Population Assessment of Tobacco and Health Study

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 125 (June 30, 2015)

Page Range		37276-37277
FR Document		2015-15844

In compliance with the requirements 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.

Federal Register, Volume 80 Issue 125 (Tuesday, June 30, 2015)

[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37276-37277]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15844]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 60-Day Comment Request; Population 
Assessment of Tobacco and Health Study

AGENCY: National Institute on Drug Abuse (NIDA), the National 
Institutes of Health (NIH), Department of Health and Human Services.

SUMMARY: In compliance with the requirements 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.

DATES: 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.

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: 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.

SUPPLEMENTARY INFORMATION: 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.
    Proposed Collection: Cognitive Interviews and Focus Groups for the 
Population Assessment of Tobacco and Health (PATH) Study (NIDA), 0925-
0663-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 0925-0663, expires 11/30/2015) for the Population Assessment of 
Tobacco and Health (PATH) Study to conduct cognitive interviews and 
focus groups, to support the development of the Study's questionnaires 
and other materials. 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 inform FDA's regulatory actions under the Family Smoking Prevention 
and Control Act. Cognitive interviews and focus groups are qualitative 
methods to assess how people interpret, process, retrieve, and respond 
to phrases, questions, response options, and product images that may be 
used in the development of the PATH Study's questionnaires and other 
materials. These methods have previously been used to help the PATH 
Study improve the comprehensibility of its materials for Study 
participants, and to increase efficiencies in data collection and 
reduce duplication and its associated burden on participants and the 
public.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total annualized burden hours 
are 2,400.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
         Activity name               Type of         Number of     responses per   per response    Total annual
                                   respondent       respondents     respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
Completing eligibility          Youth...........           1,200               1           10/60             200
 screener.
                                Adults..........           2,400               1           10/60             400
Examining concepts to be        Adults..........             200               1           90/60             300
 measured in PATH Study.

[[Page 37277]]

 
Examining assent forms for      Youth...........             200               1           90/60             300
 participation in PATH Study.
Examining consent forms for     Adults..........             200               1           90/60             300
 participation in PATH Study.
Examining other forms and       Adults..........             200               1           90/60             300
 materials to support PATH
 Study data collection.
Examining PATH Study            Youth...........             100               1           90/60             150
 questionnaires.
                                Adults..........             300               1           90/60             450
----------------------------------------------------------------------------------------------------------------


    Dated: June 23, 2015.
Genevieve deAlmeida-Morris,
Project Clearance Liaison, NIDA, NIH.
[FR Doc. 2015-15844 Filed 6-29-15; 8:45 am]
 BILLING CODE 4140-01-P

37276 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices

Requirements Concerning Gowns DEPARTMENT OF HEALTH AND estimate of the burden of the proposed
Intended for Use in Health Care HUMAN SERVICES collection of information, including the
Settings’’ may send an email request to validity of the methodology and
CDRH-Guidance@fda.hhs.gov to receive National Institutes of Health assumptions used; (3) Ways to enhance
an electronic copy of the document. the quality, utility, and clarity of the
Submission for OMB Review; 60-Day information to be collected; and (4)
Please use the document number
Comment Request; Population Ways to minimize the burden of the
1500025 to identify the guidance you
Assessment of Tobacco and Health collection of information on those who
are requesting.
Study are to respond, including the use of
IV. Paperwork Reduction Act of 1995 AGENCY: National Institute on Drug appropriate automated, electronic,
Abuse (NIDA), the National Institutes of mechanical, or other technological
This guidance refers to previously
Health (NIH), Department of Health and collection techniques or other forms of
approved collections of information
Human Services. information technology.
found in FDA regulations. These
collections of information are subject to SUMMARY: In compliance with the Proposed Collection: Cognitive
review by the Office of Management and requirements of the Paperwork Interviews and Focus Groups for the
Budget (OMB) under the Paperwork Reduction Act of 1995, for opportunity Population Assessment of Tobacco and
Reduction Act of 1995 (44 U.S.C. 3501– for public comment on proposed data Health (PATH) Study (NIDA), 0925–
3520). The collections of information in collection projects, the National 0663–Revision, National Institute on
Institute on Drug Abuse (NIDA), the Drug Abuse (NIDA), National Institutes
21 CFR part 807, subparts A through D
National Institutes of Health (NIH) will of Health (NIH), in partnership with the
have been approved under OMB control
publish periodic summaries of proposed Food and Drug Administration (FDA).
number 0910–0625; the collections of
projects to be submitted to the Office of Need and Use of Information
information in 21 CFR part 807, subpart
Management and Budget (OMB) for Collection: This is a revision request
E have been approved under OMB review and approval.
control number 0910–0120; the (OMB 0925–0663, expires 11/30/2015)
DATES: Comment Due Date: Comments for the Population Assessment of
collections of information in 21 CFR
regarding this information collection are Tobacco and Health (PATH) Study to
part 803 have been approved under
best assured of having their full effect if conduct cognitive interviews and focus
OMB control number 0910–0437; the received within 60 days of the date of groups, to support the development of
collections of information in 21 CFR this publication. the Study’s questionnaires and other
part 820 have been approved under
FOR FURTHER INFORMATION CONTACT: To materials. The PATH Study is a national
OMB control number 0910–0073; and
Submit Comments and for Further longitudinal cohort study of tobacco use
the collections of information in 21 CFR Information: To obtain a copy of the behavior and health among the U.S.
part 801 have been approved under data collection plans and instruments, household population of adults age 18
OMB control number 0910–0485. submit comments in writing, or request and older and youth ages 12 to 17; the
V. Comments more information on the proposed Study conducts annual interviews and
project, contact: Dr. Kevin P. Conway, collects biospecimens from adults to
Interested persons may submit either Deputy Director, Division of inform FDA’s regulatory actions under
written comments regarding this Epidemiology, Services, and Prevention the Family Smoking Prevention and
document to the Division of Dockets Research, NIDA, NIH, 6001 Executive Control Act. Cognitive interviews and
Management (see ADDRESSES) or Boulevard, Room 5185, Rockville, MD focus groups are qualitative methods to
electronic comments to http:// 20852; or call non-toll-free number (301) assess how people interpret, process,
www.regulations.gov. It is only 443–8755 or Email your request, retrieve, and respond to phrases,
necessary to send one set of comments. including your address to: questions, response options, and
Identify comments with the docket PATHprojectofficer@mail.nih.gov. product images that may be used in the
number found in brackets in the Formal requests for additional plans and development of the PATH Study’s
heading of this document. Received instruments must be requested in questionnaires and other materials.
comments may be seen in the Division writing. These methods have previously been
of Dockets Management between 9 a.m. SUPPLEMENTARY INFORMATION: Written used to help the PATH Study improve
and 4 p.m., Monday through Friday, and comments and/or suggestions from the the comprehensibility of its materials
will be posted to the docket at http:// public and affected agencies are invited for Study participants, and to increase
www.regulations.gov. on one or more of the following points: efficiencies in data collection and
(1) Whether the proposed collection of reduce duplication and its associated
Dated: June 25, 2015.
information is necessary for the proper burden on participants and the public.
Leslie Kux,
performance of the function of the OMB approval is requested for 3
Associate Commissioner for Policy. agency, including whether the years. There are no costs to respondents
[FR Doc. 2015–16011 Filed 6–29–15; 8:45 am] information will have practical utility; other than their time. The total
BILLING CODE 4164–01–P (2) The accuracy of the agency’s annualized burden hours are 2,400.

ESTIMATED ANNUALIZED BURDEN HOURS
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Average
Number of
Number of burden per Total annual
Activity name Type of respondent responses per
respondents response burden hours
respondent (in hours)

Completing eligibility screener ...................... Youth .................................... 1,200 1 10/60 200
Adults .................................... 2,400 1 10/60 400
Examining concepts to be measured in Adults .................................... 200 1 90/60 300
PATH Study.

VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

Document Created: 2018-02-22 11:17:05
Document Modified: 2018-02-22 11:17:05

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		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.
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: 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
FR Citation		80 FR 37276

80 FR 37276 - Submission for OMB Review; 60-Day Comment Request; Population Assessment of Tobacco and Health Study

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 125 (June 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health