Submission for OMB review; 30-day Comment Request: The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI), 43215-43216 [2013-17362]

Download as PDF 43215 Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices Dated: July 10, 2013. Ruby N. Akomeah, Project Clearance Liaison, NIDDK, NIH. [FR Doc. 2013–17365 Filed 7–18–13; 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 Disease Among Men and Women in Agriculture (NCI) 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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 23, 2013, Vol. 78, page 23942 and allowed 60-days for public comment. One public comment was received on April 23, 2013, that questioned spending taxpayer money for this research. An email response was sent on April 24, 2013, stating, ‘‘We received your comment. We will take your comments into consideration’’. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), 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 SUMMARY: 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: Jane Hoppin, Sc.D., Epidemiology Branch, National Institute of Environmental Health Sciences, NIH, 111 T.W. Alexander Drive, PO Box 12233, MD A3–05, Research Triangle Park, NC 27709, or call non-toll-free number 919–541–7622, or email your request, including your address to: hoppin1@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 Disease Among Men and Women in Agriculture, 0925–0406—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 initiation of a new dust specimen component as part of the ongoing Study of Biomarkers of Exposures and Effects in Agriculture (BEEA) as well as continue and complete phase IV (2013– 2015) 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 dust component will include a brief paper-and-pen questionnaire mailed to the participant in advance of the home visit; at the home visit, the study phlebotomist will to collect and review the questionnaire, and collect the participant’s disposable vacuum bag (or empty the dust from vacuums without disposable bags). The dust component will use similar procedures to ones that have been employed on other NCI studies to obtain information about the dust specimen and to collect and ship the dust specimen. 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. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 10,679. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total annual burden hours emcdonald on DSK67QTVN1PROD with NOTICES Form name Type of respondent 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, Urine, & Dust x 1. BEEA Schedule Home Visit Scripts .. BEEA Home Visit CAPI, Blood, & Urine x 3. Paper/pen, CAWI or CATI ................. 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 Private Applicators ........................... 160 1 90/60 240 Private Applicators ........................... Private Applicators ........................... 20 20 3 3 5/60 30/60 5 30 Private Applicators ........................... 13,855 1 25/60 5,773 VerDate Mar<15>2010 15:33 Jul 18, 2013 Jkt 229001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\19JYN1.SGM 19JYN1 43216 Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Form name Type of respondent Paper/pen, CAWI or CATI ................. Paper/pen, CAWI or CATI ................. Spouses ........................................... Proxy ................................................ Dated: July 10, 2013. Rick Woychik, Deputy Director, NIEHS. [FR Doc. 2013–17362 Filed 7–18–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, HHS. ACTION: Notice. The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. FOR FURTHER INFORMATION CONTACT: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301– 496–7057; fax: 301–402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: Use of Cysteamine to Treat Metastatic Cancer Description of Technology: Cysteamine is an aminothiol and antioxidant that has potential for the treatment of radiation sickness, neurological disorders and cancer. Cysteamine has FDA approval for use in humans, and produces few side-effects as a natural degradation product of an essential amino acid. It is mostly used for treatment of cystinosis. The inventors on this technology have demonstrated that cysteamine also VerDate Mar<15>2010 15:33 Jul 18, 2013 Jkt 229001 10,201 635 suppresses the activity of matrix metalloproteinases (MMPs). Because MMPs have been implicated in tumor invasion and metastasis, cysteamine has potential as an effective therapeutic for metastatic cancer. Administration of cysteamine was able to reduce invasion and metastasis in mouse xenograft tumor models and prolong survival of the mice without significant adverse side effects. This suggests that cysteamine could represent a novel therapeutic agent for treatment of metastatic cancer. Potential Commercial Applications: Therapeutic for metastatic cancer as monotherapy or combined with other drugs. Competitive Advantages: • Cysteamine does not produce adverse side-effects when administered to humans. • Cysteamine has already been approved for use in humans, providing a clearer path to clinical approval. Development Stage: • Pre-clinical. • In vitro data available. • In vivo data available (animal). Inventors: Raj K. Puri and Bharat Joshi (CBER/FDA). Publication: Fujisawa T, et al. Cysteamine suppresses invasion, metastasis and prolongs survival by inhibiting matrix metalloproteinases in a mouse model of human pancreatic cancer. PLoS One. 2012;7(4):e34437. [PMID 22532830] Intellectual Property: HHS Reference No. E–219–2013/0— • US Provisional Application No. 61/ 814,010. • Canadian Application No. 2813514. • Australian Application No. 2013205350. • Korean Application No. 10–2013– 43713. Licensing Contact: David A. Lambertson, Ph.D.; 301–435–4632; lambertsond@mail.nih.gov. Encircling Suture Delivery System Description of Technology: The invention provides a novel delivery system for delivering an encircling suture which includes two separate hollow limbs held together at an articulation by the suture to be PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 Average burden per response (in hours) 25/60 15/60 Total annual burden hours 4,250 159 delivered. The suture can extend through the hollow limbs, which slide along the suture. The distal ends of the limbs can be compressed into a desired delivery shape that allows the limbs to be advanced through the lumen of a delivery catheter (e.g., a transcutaneous, transvascular or intraluminal catheter) into any body cavity. As the distal portions of the limbs move out of the delivery catheter, the limbs cooperatively assume a loop shape complementary to the shape of the target around the encircling suture to leave only the suture in the desired delivery position while maintaining desired suture tension and position. The delivery device can be placed around a variety of anatomical structures (e.g., heart, arterial appendage, cecal appendix, gall bladder, neoplasm, uterus, hemorrhoid, uvula, aneurysm, transected blood vessel, folded or looped lumen, intraocular crystalline lens or implated intraocular lens or haptic, urinary bladder, kidney, prostate, intestine, or liver, etc.). Potential Commercial Applications: • Surgery. • Suturing. • Catheterization. • Cardiac valve repair. Competitive Advantages: • Formable suturing. • Circumferential suturing. • Flexible. • Easy to use. Development Stage: Prototype. Inventors: Toby Rogers, Robert Lederman, Merdim Sonmez, Dominique Franson, Ozgur Kocaturk (all of NHLBI). Intellectual Property: HHS Reference No. E–115–2013/0—US Provisional Patent Application 61/834,357 filed June 12, 2013. Related Technologies: • HHS Reference No. E–027–2013/ 0—Devices and Methods for Treating Functional Tricuspid Valve Regurgitation. • HHS Reference No. E–112–2010/ 0—Target and Capture Device for Transcatheter Cerclage Annuloplasty. • HHS Reference No. E–108–2010/ 0—An Expandable Mesh Target and Capture Device for Transcatheter Cerciage Annuloplasty. E:\FR\FM\19JYN1.SGM 19JYN1

Agencies

[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43215-43216]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17362]


-----------------------------------------------------------------------

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 Disease Among Men and Women in Agriculture (NCI)

SUMMARY: 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 to 
review and approve the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on April 23, 2013, Vol. 78, page 23942 and allowed 60-days for 
public comment. One public comment was received on April 23, 2013, that 
questioned spending taxpayer money for this research. An email response 
was sent on April 24, 2013, stating, ``We received your comment. We 
will take your comments into consideration''. The purpose of this 
notice is to allow an additional 30 days for public comment. The 
National Cancer Institute (NCI), 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 or request more information on the 
proposed project contact: Jane Hoppin, Sc.D., Epidemiology Branch, 
National Institute of Environmental Health Sciences, NIH, 111 T.W. 
Alexander Drive, PO Box 12233, MD A3-05, Research Triangle Park, NC 
27709, or call non-toll-free number 919-541-7622, or email your 
request, including your address to: hoppin1@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 Disease Among Men and Women in 
Agriculture, 0925-0406--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 initiation of a new dust specimen 
component as part of the ongoing Study of Biomarkers of Exposures and 
Effects in Agriculture (BEEA) as well as continue and complete phase IV 
(2013-2015) 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 dust component will include a brief 
paper-and-pen questionnaire mailed to the participant in advance of the 
home visit; at the home visit, the study phlebotomist will to collect 
and review the questionnaire, and collect the participant's disposable 
vacuum bag (or empty the dust from vacuums without disposable bags). 
The dust component will use similar procedures to ones that have been 
employed on other NCI studies to obtain information about the dust 
specimen and to collect and ship the dust specimen. 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.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 10,679.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total annual
                   Form name                                Type of respondent              respondents    responses per   response  (in   burden hours
                                                                                                            respondent        hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reminder, Missing, and Damaged Scripts for       Private and Commercial Applicators and              100               1            5/60               8
 Buccal Cell.                                     Spouses.
BEEA CATI Eligibility Script...................  Private Applicators....................             480               1           20/60             160
Mailed Consent, Pre-Visit Show Card, and Paper/  Private Applicators....................             160               1           20/60              53
 Pen Dust Questionnaire.
BEEA Home Visit CAPI, Blood, Urine, & Dust x 1.  Private Applicators....................             160               1           90/60             240
BEEA Schedule Home Visit Scripts...............  Private Applicators....................              20               3            5/60               5
BEEA Home Visit CAPI, Blood, & Urine x 3.......  Private Applicators....................              20               3           30/60              30
Paper/pen, CAWI or CATI........................  Private Applicators....................          13,855               1           25/60           5,773

[[Page 43216]]

 
Paper/pen, CAWI or CATI........................  Spouses................................          10,201               1           25/60           4,250
Paper/pen, CAWI or CATI........................  Proxy..................................             635               1           15/60             159
--------------------------------------------------------------------------------------------------------------------------------------------------------


     Dated: July 10, 2013.
Rick Woychik,
Deputy Director, NIEHS.
[FR Doc. 2013-17362 Filed 7-18-13; 8:45 am]
BILLING CODE 4140-01-P
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