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), 74115-74116 [2015-30219]

Download as PDF 74115 Federal Register / Vol. 80, No. 228 / Friday, November 27, 2015 / Notices Health Workforce, Health Resources and Services Administration, Room 12C–05, 5600 Fishers Lane, Rockville, Maryland 20857; (2) call (301) 443–0430; or (3) send an email to jweiss@hrsa.gov. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015–30073 Filed 11–25–15; 8:45 am] BILLING CODE 4165–15–P 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) 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) SUMMARY: 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: sandler@niehs.nih.gov. 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 annual number of respondents Type of respondent Form name Private and Commercial Applicators and Spouses. Private Applicators ................ Private Applicators ................ 100 1 5/60 8 480 160 1 1 20/60 20/60 160 53 160 1 90/60 240 20 20 3 3 5/60 90/60 5 90 16 1 25/60 7 16 2 90/60 16 215 1 20/60 72 Reminder, Missing, and Damaged Scripts for Buccal Cell. BEEA CATI Eligibility Script ......................... Mailed Consent, Pre-Visit Show Card, and Paper/Pen Dust Questionnaire. BEEA Home Visit CAPI, Blood, Buccal cell, Urine & Dust. BEEA Pre-Visit Scripts ................................. BEEA Home Visit CAPI, Blood, Buccal cell, Urine, & Dust x 3. BEEA Mailed Consents (Home Visit & Farm Visit), Pre-Visit Show Card, and Paper/ Pen Dust Questionnaire. BEEA Home Visit CAPI, Blood, Urine, Buccal cell & Dust x 2. BEEA CATI Control Eligibility Script ............ Private Applicators ................ mstockstill on DSK4VPTVN1PROD with NOTICES Number of responses per respondent Private Applicators ................ Private Applicators ................ Private Applicators ................ Private Applicators ................ Controls ................................. 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 Average time per response (in hours) Total annual burden hours 74116 Federal Register / Vol. 80, No. 228 / Friday, November 27, 2015 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Estimated annual number of respondents Type of respondent Form name Controls ................................. Private Applicators ................ Private Applicators ................ Spouses ................................ Proxy ..................................... 1 20/60 22 67 1 90/60 101 100 13,855 10,201 635 25 1 1 1 10/60 25/60 25/60 15/60 417 5,773 4,250 159 25,486 28,608 ........................ 11,516 ....................................................................... Controls ................................. 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 DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [Docket No. DHS–2015–0078] Privacy Act of 1974; Department of Homeland Security/United States Coast Guard-029 Notice of Arrival and Departure System of Records Department of Homeland Security, Privacy Office. ACTION: Notice of Privacy Act system of records. AGENCY: In accordance with the Privacy Act of 1974, the Department of Homeland Security proposes to update and reissue a current Department of Homeland Security system of records titled, ‘‘Department of Homeland Security/United States Coast Guard-029 Notice of Arrival and Departure System of Records.’’ This system of records allows the United States Coast Guard (Coast Guard) to facilitate the effective and efficient entry and departure of vessels into and from the United States, and assist with assigning priorities for complying with maritime safety and security regulations. As part of the Department’s ongoing effort to promote transparency regarding its collection of information, the Coast Guard is updating this system of records notice to update the (1) authority for maintenance of the system, (2) security classification, (3) system location, (4) purpose(s), (5) SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES 67 BEEA Mailed Consent, Pre-Visit Show Card, and Paper/Pen Dust Questionnaire. BEEA Control Home Visit CAPI, Blood, Buccal cell, Urine, & Dust. ‘Life in a Day’ Smartphone Application x 25 Paper/pen, CAWI or CATI ........................... Paper/pen, CAWI or CATI ........................... Paper/pen, CAWI or CATI (Attachment 26) Total ............................... Number of responses per respondent VerDate Sep<11>2014 19:01 Nov 25, 2015 Jkt 238001 categories of individuals, (6) categories of records, (7) routine uses, (8) retention and disposal, (9) notification procedures, and (10) system manager and address. Additionally, this notice includes non-substantive changes to simplify the formatting and text of the previously published notice. The Coast Guard is also issuing a Notice of Proposed Rulemaking (NPRM) to clarify the exemptions for this system concurrently with this notice. This updated system will be included in the Department of Homeland Security’s inventory of record systems. DATES: Submit comments on or before December 28, 2015. This updated system will be effective December 28, 2015. You may submit comments, identified by docket number DHS– 2015–0078 by one of the following methods: • Federal e-Rulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Fax: (202) 343–4010. • Mail: Karen L. Neuman, Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528–0655. Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received will be posted without change to https:// www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received, please visit https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: For general questions, please contact: Marilyn Scott-Perez, (202) 475–3515, Privacy Officer, Commandant (CG–61), United States Coast Guard, 2703 Martin Luther King Jr. Ave SE., Mail Stop 7710, Washington, DC 20593. For privacy questions, please contact: Karen L. Neuman, (202) 343–1717, Chief Privacy ADDRESSES: PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 Average time per response (in hours) Total annual burden hours Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528–0655. SUPPLEMENTARY INFORMATION: I. Background In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS) United States Coast Guard (USCG) proposes to update and reissue a current DHS system of records titled, ‘‘DHS/USCG–029 Notice of Arrival and Departure (NOAD) System of Records.’’ The collection and maintenance of this information assists DHS/USCG in meeting its statutory obligation to assign priorities while conducting maritime safety and security missions in accordance with international and U.S. regulations. DHS/ USCG is updating this system of records to (1) clarify the authority for the maintenance of the system to align with the recently published Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System Final Rule (January 30, 2015, 80 FR 5281); (2) update the security classification; (3) change the system location to clarify that NOAD records may be stored on information technology (IT) systems connected to classified networks; (4) update the purpose(s) to align with the updated authorities for collection, pursuant to the newly issued Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System Final Rule and to allow for replication of data for analysis and vetting as part of the DHS Data Framework. DHS/USCG is also updating the categories of individuals and categories of records to clarify that individuals considered ‘‘non-crew’’ for the purposes of this system may include passenger records, as well as organizations; and removing routine use (M) because it is not compatible with the original purpose for collection of the records. Further DHS/ USCG is updating the retention period and disposal standards to reflect that E:\FR\FM\27NON1.SGM 27NON1

Agencies

[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Pages 74115-74116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: sandler@niehs.nih.gov. 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
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