80 FR 74115 - Proposed Collection; 60-Day Comment Request; The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NIEHS)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 228 (November 27, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 228 (November 27, 2015)
| Page Range | 74115-74116 | |
| FR Document | 2015-30219 |
[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)] [Notices] [Pages 74115-74116] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30219] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NIEHS) SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), 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. 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. 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: 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: [email protected]. Formal requests for additional plans and instruments must be requested in writing. 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. Proposed Collection: The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease 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 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. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Estimated Number of Average time Type of respondent Form name annual number responses per per response Total annual of respondents respondent (in hours) burden hours ---------------------------------------------------------------------------------------------------------------- Private and Commercial Reminder, 100 1 5/60 8 Applicators and Spouses. Missing, and Damaged Scripts for Buccal Cell. Private Applicators........... BEEA CATI 480 1 20/60 160 Eligibility Script. Private Applicators........... Mailed Consent, 160 1 20/60 53 Pre-Visit Show Card, and Paper/ Pen Dust Questionnaire. Private Applicators........... BEEA Home Visit 160 1 90/60 240 CAPI, Blood, Buccal cell, Urine & Dust. Private Applicators........... BEEA Pre-Visit 20 3 5/60 5 Scripts. Private Applicators........... BEEA Home Visit 20 3 90/60 90 CAPI, Blood, Buccal cell, Urine, & Dust x 3. Private Applicators........... BEEA Mailed 16 1 25/60 7 Consents (Home Visit & Farm Visit), Pre- Visit Show Card, and Paper/ Pen Dust Questionnaire. Private Applicators........... BEEA Home Visit 16 2 90/60 16 CAPI, Blood, Urine, Buccal cell & Dust x 2. Controls...................... BEEA CATI 215 1 20/60 72 Control Eligibility Script. [[Page 74116]] Controls...................... BEEA Mailed 67 1 20/60 22 Consent, Pre- Visit Show Card, and Paper/ Pen Dust Questionnaire. Controls...................... BEEA Control 67 1 90/60 101 Home Visit CAPI, Blood, Buccal cell, Urine, & Dust. Private Applicators........... `Life in a Day' 100 25 10/60 417 Smartphone Application x 25. Private Applicators........... Paper/pen, CAWI 13,855 1 25/60 5,773 or CATI. Spouses....................... Paper/pen, CAWI 10,201 1 25/60 4,250 or CATI. Proxy......................... Paper/pen, CAWI 635 1 15/60 159 or CATI (Attachment 26). --------------------------------------------------------------- Total..................... ................ 25,486 28,608 .............. 11,516 ---------------------------------------------------------------------------------------------------------------- OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 11,516. Dated: November 20, 2015. Chris Long, Acting Executive Officer, NIEHS. [FR Doc. 2015-30219 Filed 11-25-15; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 80, No. 228 / Friday, November 27, 2015 / Notices 74115
Health Workforce, Health Resources and Ways to enhance the quality, utility, and 2016) of the Agricultural Health Study
Services Administration, Room 12C–05, clarity of the information to be (AHS) and continue buccal cell
5600 Fishers Lane, Rockville, Maryland collected; and (4) Ways to minimize the collection. Phase IV will continue to
20857; (2) call (301) 443–0430; or (3) burden of the collection of information update the occupational and
send an email to jweiss@hrsa.gov. on those who are to respond, including environmental exposure information as
the use of appropriate automated, well as medical history information for
Jackie Painter,
electronic, mechanical, or other licensed pesticide applicators and their
Director, Division of the Executive Secretariat. technological collection techniques or spouses enrolled in the AHS. The new
[FR Doc. 2015–30073 Filed 11–25–15; 8:45 am] other forms of information technology. BEEA components are a control
BILLING CODE 4165–15–P To Submit Comments and for Further respondent group, and a smartphone
Information: To obtain a copy of the application (app), along with new
data collection plans and instruments, sample collection (buccal cell and air
DEPARTMENT OF HEALTH AND submit comments in writing, or request monitoring samples). The new
HUMAN SERVICES more information on the proposed components will use similar procedures
project, contact: Dale Sandler, Ph.D., to ones already employed on the BEEA
National Institutes of Health
Chief, Epidemiology Branch, National study, as well as other NCI studies. The
Proposed Collection; 60-Day Comment Institute of Environmental Health primary objectives of the study are to
Request; The Agricultural Health Sciences, NIH, 111 T.W. Alexander determine the health effects resulting
Study: A Prospective Cohort Study of Drive, P.O. Box 12233, MD A3–05, from occupational and environmental
Cancer and Other Disease Among Men Research Triangle Park, NC 27709, or exposures in the agricultural
and Women in Agriculture (NIEHS) call non-toll-free number 919–541– environment. Secondary objectives
4668, or email your request, including include evaluating biological markers
SUMMARY: In compliance with the your address to: sandler@niehs.nih.gov. that may be associated with agricultural
requirement of Section 3506(c)(2)(A) of Formal requests for additional plans and exposures and risk of certain types of
the Paperwork Reduction Act of 1995, instruments must be requested in cancer. Phase IV questionnaire data are
for opportunity for public comment on writing. collected by using self-administered
proposed data collection projects, the DATES: Comment Due Date: Comments computer assisted web survey (CAWI);
National Institute of Environmental regarding this information collection are self-administered paper-and-pen (Paper/
Health Sciences (NIEHS), National best assured of having their full effect if pen); or an interviewer administered
Institutes of Health (NIH) will publish received within 60 days of the date of computer assisted telephone interview
periodic summaries of proposed this publication. (CATI) and in-person interview (CAPI)
projects to be submitted to the Office of Proposed Collection: The Agricultural systems for telephone screeners and
Management and Budget (OMB) for Health Study: A Prospective Cohort home visit interviews, respectively.
review and approval. Study of Cancer and Other Disease Some respondents are also asked to
Written comments and/or suggestions Among Men and Women in Agriculture, participate in the collection of
from the public and affected agencies 0925–0406 (Expiration Date 9/30/2016, biospecimens and environmental
are invited on one or more of the REVISION), National Institute of samples, including blood, urine, buccal
following points: (1) Whether the Environmental Health Sciences cells (loose cells from the respondent’s
proposed collection of information is (NIEHS), National Institutes of Health mouth), and vacuum dust. The findings
necessary for the proper performance of (NIH). will provide valuable information
the function of the agency, including Need and Use of Information concerning the potential link between
whether the information will have Collection: The purpose of this agricultural exposures and cancer and
practical utility; (2) The accuracy of the information collection is to request new other chronic diseases among
agency’s estimate of the burden of the components as part of the ongoing Agricultural Health Study cohort
proposed collection of information, Study of Biomarkers of Exposures and members, and this information may be
including the validity of the Effects in Agriculture (BEEA), as well as generalized to the entire agricultural
methodology and assumptions used; (3) continue and complete phase IV (2013– community.
ESTIMATED ANNUALIZED BURDEN HOURS
Estimated Number of Average time Total annual
Type of respondent Form name annual number responses per per response burden hours
of respondents respondent (in hours)
Private and Commercial Ap- Reminder, Missing, and Damaged Scripts 100 1 5/60 8
plicators and Spouses. for Buccal Cell.
Private Applicators ................ BEEA CATI Eligibility Script ......................... 480 1 20/60 160
Private Applicators ................ Mailed Consent, Pre-Visit Show Card, and 160 1 20/60 53
Paper/Pen Dust Questionnaire.
Private Applicators ................ BEEA Home Visit CAPI, Blood, Buccal cell, 160 1 90/60 240
Urine & Dust.
Private Applicators ................ BEEA Pre-Visit Scripts ................................. 20 3 5/60 5
mstockstill on DSK4VPTVN1PROD with NOTICES
Private Applicators ................ BEEA Home Visit CAPI, Blood, Buccal cell, 20 3 90/60 90
Urine, & Dust x 3.
Private Applicators ................ BEEA Mailed Consents (Home Visit & Farm 16 1 25/60 7
Visit), Pre-Visit Show Card, and Paper/
Pen Dust Questionnaire.
Private Applicators ................ BEEA Home Visit CAPI, Blood, Urine, 16 2 90/60 16
Buccal cell & Dust x 2.
Controls ................................. BEEA CATI Control Eligibility Script ............ 215 1 20/60 72
VerDate Sep<11>2014 19:01 Nov 25, 2015 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1](https://thefederalregister.org/doc/80_FR_74343/page/1.svg)
![74116 Federal Register / Vol. 80, No. 228 / Friday, November 27, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Estimated Number of Average time Total annual
Type of respondent Form name annual number responses per per response burden hours
of respondents respondent (in hours)
Controls ................................. BEEA Mailed Consent, Pre-Visit Show 67 1 20/60 22
Card, and Paper/Pen Dust Questionnaire.
Controls ................................. BEEA Control Home Visit CAPI, Blood, 67 1 90/60 101
Buccal cell, Urine, & Dust.
Private Applicators ................ ‘Life in a Day’ Smartphone Application x 25 100 25 10/60 417
Private Applicators ................ Paper/pen, CAWI or CATI ........................... 13,855 1 25/60 5,773
Spouses ................................ Paper/pen, CAWI or CATI ........................... 10,201 1 25/60 4,250
Proxy ..................................... Paper/pen, CAWI or CATI (Attachment 26) 635 1 15/60 159
Total ............................... ....................................................................... 25,486 28,608 ........................ 11,516
OMB approval is requested for 3 categories of individuals, (6) categories Officer, Privacy Office, Department of
years. There are no costs to respondents of records, (7) routine uses, (8) retention Homeland Security, Washington, DC
other than their time. The total and disposal, (9) notification 20528–0655.
estimated annualized burden hours are procedures, and (10) system manager SUPPLEMENTARY INFORMATION:
11,516. and address. Additionally, this notice
includes non-substantive changes to I. Background
Dated: November 20, 2015.
simplify the formatting and text of the In accordance with the Privacy Act of
Chris Long,
previously published notice. 1974, 5 U.S.C. 552a, the Department of
Acting Executive Officer, NIEHS. Homeland Security (DHS) United States
The Coast Guard is also issuing a
[FR Doc. 2015–30219 Filed 11–25–15; 8:45 am] Coast Guard (USCG) proposes to update
Notice of Proposed Rulemaking (NPRM)
BILLING CODE 4140–01–P to clarify the exemptions for this system and reissue a current DHS system of
concurrently with this notice. This records titled, ‘‘DHS/USCG–029 Notice
updated system will be included in the of Arrival and Departure (NOAD)
DEPARTMENT OF HOMELAND Department of Homeland Security’s System of Records.’’ The collection and
SECURITY inventory of record systems. maintenance of this information assists
DATES: Submit comments on or before DHS/USCG in meeting its statutory
Office of the Secretary obligation to assign priorities while
December 28, 2015. This updated
[Docket No. DHS–2015–0078] system will be effective December 28, conducting maritime safety and security
2015. missions in accordance with
Privacy Act of 1974; Department of international and U.S. regulations. DHS/
ADDRESSES: You may submit comments, USCG is updating this system of records
Homeland Security/United States
identified by docket number DHS– to (1) clarify the authority for the
Coast Guard-029 Notice of Arrival and
2015–0078 by one of the following maintenance of the system to align with
Departure System of Records
methods: the recently published Vessel
AGENCY: Department of Homeland • Federal e-Rulemaking Portal: http:// Requirements for Notices of Arrival and
Security, Privacy Office. www.regulations.gov. Follow the Departure, and Automatic Identification
ACTION: Notice of Privacy Act system of instructions for submitting comments. System Final Rule (January 30, 2015, 80
records. • Fax: (202) 343–4010. FR 5281); (2) update the security
• Mail: Karen L. Neuman, Chief classification; (3) change the system
SUMMARY: In accordance with the Privacy Officer, Privacy Office, location to clarify that NOAD records
Privacy Act of 1974, the Department of Department of Homeland Security, may be stored on information
Homeland Security proposes to update Washington, DC 20528–0655. technology (IT) systems connected to
and reissue a current Department of Instructions: All submissions received classified networks; (4) update the
Homeland Security system of records must include the agency name and purpose(s) to align with the updated
titled, ‘‘Department of Homeland docket number for this rulemaking. All authorities for collection, pursuant to
Security/United States Coast Guard-029 comments received will be posted the newly issued Vessel Requirements
Notice of Arrival and Departure System without change to http:// for Notices of Arrival and Departure,
of Records.’’ This system of records www.regulations.gov, including any and Automatic Identification System
allows the United States Coast Guard personal information provided. Final Rule and to allow for replication
(Coast Guard) to facilitate the effective Docket: For access to the docket to of data for analysis and vetting as part
and efficient entry and departure of read background documents or of the DHS Data Framework. DHS/USCG
vessels into and from the United States, comments received, please visit http:// is also updating the categories of
and assist with assigning priorities for www.regulations.gov. individuals and categories of records to
complying with maritime safety and FOR FURTHER INFORMATION CONTACT: For clarify that individuals considered
mstockstill on DSK4VPTVN1PROD with NOTICES
security regulations. As part of the general questions, please contact: ‘‘non-crew’’ for the purposes of this
Department’s ongoing effort to promote Marilyn Scott-Perez, (202) 475–3515, system may include passenger records,
transparency regarding its collection of Privacy Officer, Commandant (CG–61), as well as organizations; and removing
information, the Coast Guard is United States Coast Guard, 2703 Martin routine use (M) because it is not
updating this system of records notice to Luther King Jr. Ave SE., Mail Stop 7710, compatible with the original purpose for
update the (1) authority for maintenance Washington, DC 20593. For privacy collection of the records. Further DHS/
of the system, (2) security classification, questions, please contact: Karen L. USCG is updating the retention period
(3) system location, (4) purpose(s), (5) Neuman, (202) 343–1717, Chief Privacy and disposal standards to reflect that
VerDate Sep<11>2014 19:01 Nov 25, 2015 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1](https://thefederalregister.org/doc/80_FR_74343/page/2.svg)
Document Created: 2015-12-14 14:05:32
Document Modified: 2015-12-14 14:05:32
| 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 | |
| FR Citation | 80 FR 74115 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR