Submission for OMB Review; 30-Day Comment Request; Population Assessment of Tobacco and Health (PATH) Study, 37754-37755 [2014-15584]
Download as PDF
<![CDATA[
37754
Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Notices
Column A—What information is requested?
Column B—put data specific to the nominated substance
Has the bulk drug substance been used previously to compound drug
product(s)?
Is there any other relevant information? ..................................................
Interested persons may submit either
electronic nominations to https://
www.regulations.gov or written
nominations to the Division of Dockets
Management (see ADDRESSES). It is only
necessary to send one set of
nominations. Identify nominations with
the docket number found in the brackets
in the heading of this document.
Received nominations 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, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15373 Filed 7–1–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK4VPTVN1PROD with NOTICES
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
67 FR 46519, as amended June 11, 2008;
73 FR 33099, as amended September 30,
2009, 78 FR 50227, as last amended
January 24, 2013, 78 FR 7436). This
Order of Succession supersedes the
Order of Succession for the
Administrator, HRSA, published at 78
FR 7436, February 1, 2013.
This notice deletes the Bureau of
Health Professions; the Bureau of
Clinician Recruitment and Services; and
Regional Division Directors from the
order of succession, and adds the
Bureau of Health Workforce and
Regional Administrators to HRSA’s
hierarchy affecting the Order of
Succession. This notice reflects the new
Order of Succession for HRSA.
Section R–30, Order of Succession
During the absence or disability of the
Administrator, or in the event of a
vacancy in the office, the officials
17:49 Jul 01, 2014
Jkt 232001
Provide any other information you would like FDA to consider in evaluating the nomination.
designated below shall act as
Administrator in the order in which
they are listed:
1. Deputy Administrator;
2. Chief Operating Officer;
3. Associate Administrator, Bureau of
Primary Health Care;
4. Associate Administrator, Bureau of
Health Workforce;
5. Associate Administrator, HIV/AIDS
Bureau;
6. Associate Administrator, Maternal
and Child Health Bureau;
7. Associate Administrator,
Healthcare Systems Bureau;
8. Associate Administrator, Office of
Regional Operations; and
9. HRSA Regional Administrators in
the order in which they have received
their permanent appointment as such.
Exceptions
Health Resources and Services
Administration
VerDate Mar<15>2010
Describe previous uses of the bulk drug substance in compounding.
(a) No official listed in this section
who is serving in acting or temporary
capacity shall, by virtue of so serving,
act as Administrator pursuant to this
section.
(b) Notwithstanding the provisions of
this section, during a planned period of
absence, the Administrator retains the
discretion to specify a different order of
succession.
Section R–40, Delegations of Authority
All delegations of authority and redelegations of authority made to HRSA
officials that were in effect immediately
prior to this action, and that are
consistent with this action, shall
continue in effect pending further redelegation, pending further redelegation, provided they are consistent
with this action.
This document is effective upon date
of signature.
Dated: June 25, 2014.
Mary K. Wakefield,
Administrator.
[FR Doc. 2014–15498 Filed 7–1–14; 8:45 am]
BILLING CODE 4165–15–P
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute on Drug Abuse (NIDA), 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 6, 2014, pages 7206–7207, 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 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, OIRA_Submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
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, submit
comments in writing, or request more
information on the proposed project
contact: Kevin P. Conway, Ph.D.,
Deputy Director, Division of
Epidemiology, Services, and Prevention
Research, National Institute on Drug
Abuse, 6001 Executive Boulevard.,
Room 5185; or call non-toll-free number
(301)-443–8755; or Email your request,
SUMMARY:
E:\FR\FM\02JYN1.SGM
02JYN1
37755
Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Notices
including your address to:
PATHprojectofficer@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Population
Assessment of Tobacco and Health
(PATH) Study—Second Wave of Data
Collection—0925–0664–Revision—
National Institutes of Health (NIH),
National Institute on Drug Abuse
(NIDA), in partnership with the Food
and Drug Administration (FDA).
Need and Use of Information
Collection: This is a revision request
(OMB 0925–0664, expires 11/30/2015)
for the Population Assessment of
Tobacco and Health (PATH) Study to
conduct the second wave of data
collection. The PATH Study is a large
behaviors and health effects within the
cohort over time. These data will help
to inform regulatory decisions and
actions by FDA.
OMB approval is requested for 3
years. There are no capital, operating, or
maintenance costs to report. There are
no costs to respondents other than their
time. The total estimated annualized
burden hours are 56,939. Factors
accounting for the difference between
the baseline and Wave 2 total hours
include the following: (1) Wave 2 does
not have a screening phase; (2) as
indicated in Supporting Statement B, a
86 percent response rate for adult
interviews and a 90 percent response
rate for youth interviews are projected
for Wave 2; and (3) fewer biological
samples will be collected in Wave 2.
national longitudinal cohort study on
tobacco use behavior and health among
the U.S. household population of adults
age 18 and older and youth ages 12 to
17. The PATH Study conducts annual
interviews and collects biospecimens
from adults to help inform the
development, implementation, and
evaluation of tobacco-product
regulations by FDA in meeting its
mission under the Family Smoking
Prevention and Tobacco Control Act
(TCA) to regulate tobacco products,
including tobacco-product advertising,
labeling, marketing, constituents,
ingredients, and additives. The
longitudinal design of the PATH Study
enables it to measure and report withinperson changes and between-person
differences in tobacco product use
ESTIMATED ANNUALIZED BURDEN HOURS
Estimated
number of
respondents
Type of respondent and
instrument
Adults—Extended Interview .............................................................................
Adults—Baseline youth respondents who age into adult cohort—Consent
for Extended Interview .................................................................................
Adults—Baseline youth respondents who age into adult cohort—Extended
Interview .......................................................................................................
Adults—Baseline youth respondents who age into the adult cohort—Consent for Biological Samples .........................................................................
Adults—Biospecimen Collection: Urine ...........................................................
Adults—Biospecimen Collection: Blood ...........................................................
Adults—Tobacco Use Form ............................................................................
Adults—Follow-up/Tracking Participant Information Form ..............................
Youth—Extended Interview .............................................................................
Youth—Shadow youth who age into youth cohort—Assent for Extended
Interview .......................................................................................................
Youth—Shadow youth who age into youth cohort—Extended Interview ........
Parent Interview ...............................................................................................
Parents of Shadow youth who age into youth cohort—Parent Permission
and Consent for Parent Interview ................................................................
Parents of Shadow youth who age into youth cohort—Parent Interview .......
Parents of youth—Follow-up/Tracking Participant Information Form for
Youth ............................................................................................................
Adults—Follow-up/Tracking Participant Information Form for sample Shadow youth (completed by parents) .................................................................
Estimated
number of
responses per
respondent
Average
burden hours
per response
Estimated
total annual
burden hours
requested
* 27,113
1
1
27,113
2,295
1
2/60
77
* 1,990
1
68/60
2,255
1,990
11,373
896
12,269
33,615
** 10,537
1
1
1
1
2
1
4/60
10/60
18/60
4/60
8/60
32/60
133
1,896
269
818
8,964
5,620
2,338
10,748
1
1
1
2/60
42/60
14/60
78
1,474
2,508
2,338
2,147
1
1
2/60
17/60
78
608
14,165
2
8/60
3,777
4,772
2
8/60
1,273
** 2,105
* Estimated
total number of adult extended interview respondents is 27,113 adults from Wave 1 + 1,990 youth from Wave 1 who turn 18 by
Wave 2 = 29,103.
**Estimated total number of youth extended interview respondents is 10,537 youth from Wave 1+ 2,105 shadow youth who turn 12 by Wave 2
= 12,642.
Dated: June 25, 2014.
Genevieve R. deAlmeida,
Project Clearance Liaison, National Institute
on Drug Abuse.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–15584 Filed 7–1–14; 8:45 am]
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4140–01–P
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
VerDate Mar<15>2010
17:49 Jul 01, 2014
Jkt 232001
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, Kidney Disease
Ancillary Studies.
E:\FR\FM\02JYN1.SGM
02JYN1
]]>Agencies
[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Notices]
[Pages 37754-37755]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15584]
-----------------------------------------------------------------------
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
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), 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
6, 2014, pages 7206-7207, 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 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, OIRA_Submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
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, submit comments in writing, or
request more information on the proposed project contact: Kevin P.
Conway, Ph.D., Deputy Director, Division of Epidemiology, Services, and
Prevention Research, National Institute on Drug Abuse, 6001 Executive
Boulevard., Room 5185; or call non-toll-free number (301)-443-8755; or
Email your request,
[[Page 37755]]
including your address to: PATHprojectofficer@mail.nih.gov. Formal
requests for additional plans and instruments must be requested in
writing.
Proposed Collection: Population Assessment of Tobacco and Health
(PATH) Study--Second Wave of Data Collection--0925-0664-Revision--
National Institutes of Health (NIH), National Institute on Drug Abuse
(NIDA), in partnership with the Food and Drug Administration (FDA).
Need and Use of Information Collection: This is a revision request
(OMB 0925-0664, expires 11/30/2015) for the Population Assessment of
Tobacco and Health (PATH) Study to conduct the second wave of data
collection. The PATH Study is a large national longitudinal cohort
study on tobacco use behavior and health among the U.S. household
population of adults age 18 and older and youth ages 12 to 17. The PATH
Study conducts annual interviews and collects biospecimens from adults
to help inform the development, implementation, and evaluation of
tobacco-product regulations by FDA in meeting its mission under the
Family Smoking Prevention and Tobacco Control Act (TCA) to regulate
tobacco products, including tobacco-product advertising, labeling,
marketing, constituents, ingredients, and additives. The longitudinal
design of the PATH Study enables it to measure and report within-person
changes and between-person differences in tobacco product use behaviors
and health effects within the cohort over time. These data will help to
inform regulatory decisions and actions by FDA.
OMB approval is requested for 3 years. There are no capital,
operating, or maintenance costs to report. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 56,939. Factors accounting for the difference between
the baseline and Wave 2 total hours include the following: (1) Wave 2
does not have a screening phase; (2) as indicated in Supporting
Statement B, a 86 percent response rate for adult interviews and a 90
percent response rate for youth interviews are projected for Wave 2;
and (3) fewer biological samples will be collected in Wave 2.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated Estimated
Estimated number of Average burden total annual
Type of respondent and instrument number of responses per hours per burden hours
respondents respondent response requested
----------------------------------------------------------------------------------------------------------------
Adults--Extended Interview...................... * 27,113 1 1 27,113
Adults--Baseline youth respondents who age into 2,295 1 2/60 77
adult cohort--Consent for Extended Interview...
Adults--Baseline youth respondents who age into * 1,990 1 68/60 2,255
adult cohort--Extended Interview...............
Adults--Baseline youth respondents who age into 1,990 1 4/60 133
the adult cohort--Consent for Biological
Samples........................................
Adults--Biospecimen Collection: Urine........... 11,373 1 10/60 1,896
Adults--Biospecimen Collection: Blood........... 896 1 18/60 269
Adults--Tobacco Use Form........................ 12,269 1 4/60 818
Adults--Follow-up/Tracking Participant 33,615 2 8/60 8,964
Information Form...............................
Youth--Extended Interview....................... ** 10,537 1 32/60 5,620
Youth--Shadow youth who age into youth cohort-- 2,338 1 2/60 78
Assent for Extended Interview..................
Youth--Shadow youth who age into youth cohort-- ** 2,105 1 42/60 1,474
Extended Interview.............................
Parent Interview................................ 10,748 1 14/60 2,508
Parents of Shadow youth who age into youth 2,338 1 2/60 78
cohort--Parent Permission and Consent for
Parent Interview...............................
Parents of Shadow youth who age into youth 2,147 1 17/60 608
cohort--Parent Interview.......................
Parents of youth--Follow-up/Tracking Participant 14,165 2 8/60 3,777
Information Form for Youth.....................
Adults--Follow-up/Tracking Participant 4,772 2 8/60 1,273
Information Form for sample Shadow youth
(completed by parents).........................
----------------------------------------------------------------------------------------------------------------
* Estimated total number of adult extended interview respondents is 27,113 adults from Wave 1 + 1,990 youth from
Wave 1 who turn 18 by Wave 2 = 29,103.
**Estimated total number of youth extended interview respondents is 10,537 youth from Wave 1+ 2,105 shadow youth
who turn 12 by Wave 2 = 12,642.
Dated: June 25, 2014.
Genevieve R. deAlmeida,
Project Clearance Liaison, National Institute on Drug Abuse.
[FR Doc. 2014-15584 Filed 7-1-14; 8:45 am]
BILLING CODE 4140-01-P
