Submission for OMB Review; 60-Day Comment Request; Population Assessment of Tobacco and Health Study, 37276-37277 [2015-15844]
Download as PDF
<![CDATA[
37276
Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
Requirements Concerning Gowns
Intended for Use in Health Care
Settings’’ may send an email request to
CDRH-Guidance@fda.hhs.gov to receive
an electronic copy of the document.
Please use the document number
1500025 to identify the guidance you
are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subparts A through D
have been approved under OMB control
number 0910–0625; the collections of
information in 21 CFR part 807, subpart
E have been approved under OMB
control number 0910–0120; the
collections of information in 21 CFR
part 803 have been approved under
OMB control number 0910–0437; the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073; and
the collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485.
V. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: June 25, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–16011 Filed 6–29–15; 8:45 am]
BILLING CODE 4164–01–P
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.
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
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:
PATHprojectofficer@mail.nih.gov.
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
AGENCY:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Activity name
Type of respondent
Completing eligibility screener ......................
Youth ....................................
Adults ....................................
Adults ....................................
Examining concepts to be measured in
PATH Study.
VerDate Sep<11>2014
17:34 Jun 29, 2015
Jkt 235001
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1,200
2,400
200
E:\FR\FM\30JNN1.SGM
1
1
1
30JNN1
Average
burden per
response
(in hours)
10/60
10/60
90/60
Total annual
burden hours
200
400
300
37277
Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
Activity name
Type of respondent
Examining assent forms for participation in
PATH Study.
Examining consent forms for participation in
PATH Study.
Examining other forms and materials to
support PATH Study data collection.
Examining PATH Study questionnaires .......
Youth ....................................
200
1
90/60
300
Adults ....................................
200
1
90/60
300
Adults ....................................
200
1
90/60
300
Youth ....................................
Adults ....................................
100
300
1
1
90/60
90/60
150
450
Dated: June 23, 2015.
Genevieve deAlmeida-Morris,
Project Clearance Liaison, NIDA, NIH.
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: NIH Desk
Officer.
[FR Doc. 2015–15844 Filed 6–29–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; The Effectiveness
of Donor Notification, HIV Counseling,
and Linkage of HIV Positive Donors to
Health Care in Brazil
National Heart, Lung and Blood
Institute (NHLBI), National Institutes of
Health (NIH), Department of Health and
Human Services.
SUMMARY: Under the provisions 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
April 8, 2015, page 18853 and allowed
60-days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institutes of Health (NIH) 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.
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.
ADDRESSES: Direct Comments to OMB:
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
AGENCY:
VerDate Sep<11>2014
17:34 Jun 29, 2015
Jkt 235001
To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Simone Glynn, MD, Project
Officer/ICD Contact, Two Rockledge
Center, Suite 9142, 6701 Rockledge
Drive, Bethesda, MD 20892, or call 301435–0065, or Email your request,
including your address to: glynnsa@
nhlbi.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
SUPPLEMENTARY INFORMATION:
Proposed Collection: The
effectiveness of donor notification, HIV
counseling, and linkage of HIV positive
donors to health care in Brazil, 0925New, National Heart, Lung and Blood
Institute (NHLBI).
Need and Use of Information
Collection: The prevention of
transfusion-associated transmission of
HIV is one of the greatest success stories
in the fight against the HIV epidemic;
however, the job is unfinished. In some
middle-and low-income countries,
blood transfusion may account for up to
6% of HIV infections (1). Currently, all
blood donors who test positive or
inconclusive for HIV or other sexually
transmitted diseases are notified (donor
notification) and requested to follow-up
with the blood bank for potential
confirmatory testing and referral to
specific health services, such as
monitoring and treatment. Little is
known about the consequences of blood
donor notification and subsequent
monitoring and counseling on efforts to
control the HIV epidemic in the United
States and internationally. The Brazil
Notification Study team proposed to
addresses this significant information
gap by enrolling all former blood donors
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
who participated in the REDS–II HIV
case-control study (OMB 0925- 0597,
expired on February 29, 2012) and those
enrolled during the REDS–III HIV case
surveillance risk factor study (OMB
0925–0597, expiration date, July 31,
2015), between 2012 and 2014. Donor
enrollees at any of the four blood
centers participating in these studies
completed an audio computer-assisted
structured interview (ACASI) that
elicited responses on demographics, risk
factors/behaviors, and HIV knowledge.
At the same time, a blood sample was
drawn and tested for HIV genotype and
drug resistance. In addition, recent
infection status was determined using
detuned antibody testing of samples
from the original blood donation. All
enrolled participants received
counseling by a blood bank physician
and were referred to HIV counseling and
testing centers (HCT).
New information gathered from these
enrollees will serve the three aims
proposed for this proposed study. The
first aim of this study will be to analyze
the actual percentage of blood donors
who are successfully notified of their
infection testing results. In this aim, we
will expand the notification focus to
include all infections that blood centers
in Brazil test for because differences in
rates of notification by type of infection
are unknown. The second aim will
assess the effectiveness of HIV
notification and counseling. HIVpositive donors will be interviewed to
evaluate their follow-up activities with
regard to HIV infection treatment and
infection transmission prevention
behavior after notification by the blood
center. This will be accomplished using
a new audio computer-assisted
structured interview (ACASI) (See
Attachment 1, Brazil HIV Follow up
ACASI Survey). The third aim will
consist of asking HIV-positive blood
donors about ways to improve the
disclosure of HIV risks during donor
eligibility assessment to better
understand the motivating factors that
E:\FR\FM\30JNN1.SGM
30JNN1
]]>Agencies
[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37276-37277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: PATHprojectofficer@mail.nih.gov. 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
