30-day FRN

0925–0406 30-Day Notice PUblished.pdf

Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture

30-day FRN

OMB: 0925-0406

Document [pdf]
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Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices
Dated: April 6, 2016.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–08294 Filed 4–11–16; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Fogarty International Center; Notice of
Meeting

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Fogarty
International Center Advisory Board.
The meeting will be open to the public
as indicated below, with attendance
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
Contact Person listed below in advance
of the meeting.
The meeting will be closed to the
public in accordance with the
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 materials,
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: Fogarty International
Center Advisory Board.
Date: May 10–11, 2016.
Closed: May 10, 2016.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: Second level review of grant
applications.
Place: National Institutes of Health, Stone
House, Building 16, Conference Room, 9000
Rockville Pike, Bethesda, MD 20892.
Open: May 11, 2016.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: Update and discussion of current
and planned FIC activities, including an
overview and presentations from grantees of
our Global Environmental and Occupational
Health (GEOHealth) Program.
Place: National Institutes of Health, Stone
House, Building 16, Conference Room, 9000
Rockville Pike, Bethesda, MD 20892.
Contact Person: Kristen Weymouth,
Executive Secretary, Fogarty International
Center, National Institutes of Health, 31
Center Drive, Room B2C02, Bethesda, MD
20892, (301) 496–1415, weymouthk@
mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on

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this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: http://
www.fic.nih.gov/About/Advisory/Pages/
default.aspx, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.106, Minority International
Research Training Grant in the Biomedical
and Behavioral Sciences; 93.154, Special
International Postdoctoral Research Program
in Acquired Immunodeficiency Syndrome;
93.168, International Cooperative
Biodiversity Groups Program; 93.934, Fogarty
International Research Collaboration Award;
93.989, Senior International Fellowship
Awards Program, National Institutes of
Health HHS)
Dated: April 6, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–08292 Filed 4–11–16; 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 Agricultural
Health Study: A Prospective Cohort
Study of Cancer and Other Diseases
Among Men and Women in Agriculture
(NIEHS)
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 November 27,
2015, Pages 74115—74116, 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 Institute of Environmental
Health Sciences (NIEHS), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information

SUMMARY:

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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 or request more
information on the proposed project
contact: Dale Sandler, Ph.D., Chief,
Epidemiology Branch, National Institute
of Environmental Health Sciences, NIH,
111 T.W. Alexander Drive, P.O. Box
12233, MD A3–05, Research Triangle
Park, NC 27709, or call non-toll-free
number 919–541–4668, or email your
request, including your address to:
sandler@niehs.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Proposed Collection: The Agricultural
Health Study: A Prospective Cohort
Study of Cancer and Other Diseases
Among Men and Women in Agriculture,
0925–0406 (Expiration Date 9/30/2016,
REVISION), National Institute of
Environmental Health Sciences
(NIEHS), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The purpose of this
information collection is to request new
components as part of the ongoing
Study of Biomarkers of Exposures and
Effects in Agriculture (BEEA), as well as
continue and complete phase IV (2013–
2016) of the Agricultural Health Study
(AHS) and continue buccal cell
collection. Phase IV will continue to
update the occupational and
environmental exposure information as
well as medical history information for
licensed pesticide applicators and their
spouses enrolled in the AHS. The new
BEEA components are a control
respondent group, and a smartphone
application (app), along with new
sample collection (buccal cell and air
monitoring samples). The new
components will use similar procedures
to ones already employed on the BEEA
study, as well as other NCI studies. The
primary objectives of the study are to
determine the health effects resulting

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Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices

from occupational and environmental
exposures in the agricultural
environment. Secondary objectives
include evaluating biological markers
that may be associated with agricultural
exposures and risk of certain types of
cancer. Phase IV questionnaire data are
collected by using self-administered
computer assisted web survey (CAWI);
self-administered paper-and-pen (Paper/
pen); or an interviewer administered
computer assisted telephone interview

(CATI) and in-person interview (CAPI)
systems for telephone screeners and
home visit interviews, respectively.
Some respondents are also asked to
participate in the collection of
biospecimens and environmental
samples, including blood, urine, buccal
cells (loose cells from the respondent’s
mouth), and vacuum dust. The findings
will provide valuable information
concerning the potential link between
agricultural exposures and cancer and

other chronic diseases among
Agricultural Health Study cohort
members, and this information may be
generalized to the entire agricultural
community.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
11,440.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
per
respondent

Average
time per
response
(in hours)

Total
annual
burden
hours

Form name

Private and Commercial Applicators and Spouses.
Private and Commercial Applicators and Spouses.
Private and Commercial Applicators and Spouses.
Private Applicators ..............

IA/NC Scripts for Verbal Consent for Buccal .................

100

1

3/60

5

IA/NC Written Consent for Buccal .................................

100

1

5/60

8

30

1

2/60

1

480

1

20/60

160

196

1

5/60

16

160
160
160
160

1
1
1
1

5/60
10/60
2/60
90/60

13
27
5
240

20
20
20
20

3
3
3
3

5/60
10/60
2/60
90/60

5
10
2
90

20
16
16
16
16

1
2
2
2
2

2/60
5/60
10/60
2/60
90/60

1
3
5
1
48

16
16
215
67
67
67
67
67

1
2
1
1
1
1
1
1

5/60
2/60
20/60
5/60
5/60
10/60
2/60
90/60

3
1
72
6
6
11
2
101

Private Applicators ..............
Private Applicators ..............
Private Applicators ..............
Spouses ..............................
Proxy ...................................

Buccal Follow-up Scripts (as needed): Reminder, Missing Consent, or Damaged/Missing Sample.
BEEA CATI Screening Script for RSG, REG or AMG
Eligibility.
IA/NC BEEA Consent for RSG Home Visit or REG
Home Visit or AMG Home Visit.
IA/NC BEEA RSG Pre-Visit Show Card ........................
IA/NC BEEA RSG Paper/Pen Dust Questionnaire ........
BEEA RSG Pre-Home Visit Script .................................
BEEA RSG Home Visit CAPI, Blood, Buccal cell, Urine
& Dust.
IA/NC BEEA REG Pre-Visit Show Card ........................
IA/NC BEEA REG Paper/Pen Dust Questionnaire ........
BEEA REG Pre-Home Visit Script .................................
BEEA REG Home Visit CAPI, Blood, Buccal cell, Urine
& Dust.
IA/NC BEEA REG Post-Exposure Scheduling Script ....
IA/NC BEEA AMG Pre-Visit Show Card ........................
IA/NC BEEA AMG Paper/Pen Dust Questionnaire .......
BEEA AMG Pre-Home Visit Script .................................
BEEA AMG Home Visit CAPI, Blood, Urine, Buccal cell
& Dust.
IA/NC BEEA Consent for AMG Farm Visit ....................
BEEA Pre-Farm Visit Script ...........................................
BEEA CATI Control Eligibility Script ..............................
IA/NC BEEA Control Home Visit Consent .....................
IA/NC BEEA Pre-Visit Show Card .................................
IA/NC BEEA Paper/Pen Dust Questionnaire .................
BEEA REG Pre-Visit Script ............................................
BEEA Control Home Visit CAPI, Blood, Buccal cell,
Urine, & Dust.
‘Life in a Day’ Smartphone App Consent and Setup .....
‘Life in a Day’ Smartphone Application ..........................
Phase IV Follow-up CAWI, CATI, or Paper/pen ............
Phase IV Follow-up CAWI, CATI, or Paper/pen ............
Phase IV Follow-up CAWI, CATI, or Paper/pen ............

78
78
13,855
10,201
635

1
30
1
1
1

20/60
10/60
25/60
25/60
15/60

26
390
5,773
4,250
159

Total .............................

.........................................................................................

27,139

29,641

....................

11,440

Private Applicators ..............
Private
Private
Private
Private

Applicators
Applicators
Applicators
Applicators

..............
..............
..............
..............

Private
Private
Private
Private

Applicators
Applicators
Applicators
Applicators

..............
..............
..............
..............

Private
Private
Private
Private
Private

Applicators
Applicators
Applicators
Applicators
Applicators

..............
..............
..............
..............
..............

Private Applicators ..............
Private Applicators ..............
Controls ...............................
Controls ...............................
Controls ...............................
Controls ...............................
Controls ...............................
Controls ...............................

asabaliauskas on DSK3SPTVN1PROD with NOTICES

Number of
respondents

Type of respondent

Dated: April 4, 2016.
Jane M. Lambert,
Project Clearance Liaison, CIP, NIEHS.
[FR Doc. 2016–08397 Filed 4–11–16; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting

BILLING CODE 4140–01–P

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as

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Fmt 4703

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amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
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

E:\FR\FM\12APN1.SGM

12APN1


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