Proposed Collection; 30-day Comment Request: The Hispanic Community Health Study/Study of Latinos (HCHS/SOL), 41293-41295 [2014-16528]

Download as PDF 41293 Federal Register / Vol. 79, No. 135 / Tuesday, July 15, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; Special Volunteer and Guest Researcher Assignment, Office of the Director (OD) 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 April 1, 2014 (Volume 79, Number 62), page 18300, 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 Office of Intramural Research (OIR), National Institutes of Health (NIH), may not conduct or sponsor, and the respondent is not required to respond to, an information SUMMARY: 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 sent 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, to submit comments in writing, or to request more information on the proposed project, contact Mr. Larry Chloupek, Management Liaison Director, OIR, OD, NIH, 2 Center Drive MSC 0235, Bethesda, MD 20892–0235; or call nontoll-free number 301–594–3992; or email your request, including your address to larry.chloupek@nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Special Volunteer and Guest Researcher Assignment, 0925–0177, Expiration Date 07/31/2014, Extension, Office of Intramural Research (OIR), National Institutes of Health (NIH). Need and Use of Information Collection: Form Number: NIH–590 is a single form completed by an NIH official for each Guest Researcher or Special Volunteer prior to his/her arrival at the NIH. The information on the form is necessary for the approving official to reach a decision on whether to allow a Guest Researcher to use NIH facilities or whether to accept volunteer services offered by a Special Volunteer. If the original assignment is extended, another form notating the extension is completed to update the file. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 166. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Special Volunteers ........................................................................................... Guest Researchers .......................................................................................... Dated: July 9, 2014. Lawrence A. Tabak, Deputy Director, NIH. [FR Doc. 2014–16527 Filed 7–14–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 30-day Comment Request: The Hispanic Community Health Study/Study of Latinos (HCHS/ SOL) 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 March 25, 2014 (Vol. 79, No. 57, pages 16345–16347). Three comments were received. The purpose of this notice is to allow an mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:46 Jul 14, 2014 Jkt 232001 1,250 410 additional 30 days for public comment. The National Heart, Lung and Blood Institute (NHLBI), 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. DATES: To obtain a copy of the data collection plans and instruments or request more FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Frequency of response 1 1 Average time per response 6/60 6/60 Annual hour burden 125 41 information on the proposed project contact either: Dr. Larissa Aviles-Santa, 6701 Rockledge, Epidemiology Branch, Program in Prevention and Population Sciences, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Dr, MSC 7936, Bethesda, MD 20892–7936, or call nontoll-free number 301–435–0450, or Email your request, including your address to avilessantal@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: The Hispanic Community Health Study/Study of Latinos (HCHS/SOL), Revision, National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose and use of the information collection for this project is to study the prevalence of cardiovascular and pulmonary disease and other chronic diseases, and their risk and protective factors, understand their relationship to all-cause, E:\FR\FM\15JYN1.SGM 15JYN1 41294 Federal Register / Vol. 79, No. 135 / Tuesday, July 15, 2014 / Notices cardiovascular and pulmonary morbidity and mortality, and understand the role of sociocultural factors (including acculturation) on the prevalence or onset of disease among over 16,400 Hispanics/Latinos of diverse origins, aged 18–74 years at enrollment, living in four U.S. communities: San Diego, California; Chicago, Illinois; Miami, Florida, and the Bronx, New York. In order to achieve these objectives, the HCHS/SOL had two integrated components: events (including fatal and non-fatal myocardial infarction and heart failure; fatal and non-fatal stroke; and exacerbation of asthma and chronic obstructive pulmonary disease). This component also includes contact with physicians and informants to obtain medical information about participants. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 75,305. 1. Examination of the cohort following a standardized protocol, which consisted of interviews and clinical measurements to assess physiological and biochemical measurements including DNA/RNA extraction for ancillary genetic research studies. 2. Follow-up of the cohort, which consists of an annual telephone interview to assess vital status, changes in health status and medication intake, and new cardiovascular and pulmonary ESTIMATED ANNUALIZED BURDEN HOURS A.12.1 ESTIMATES OF HOUR BURDEN [Appendices 11, 14 and 15] Number of respondents Type of respondents Survey instrument Participants Visit 2 Examination (Appendices 11 and 14). Pre-visit scheduling & safety screening (Appendix 14 —Procedures— ELE bilingual). Reception, informed consent (Appendix 11), medical releases. Ppt. disability screening ................... Ppt. safety update and routing (Appendix 14—Procedures—PSE bilingual). Change clothes, urine specimen (Appendix 14 — Procedures —BIO)*. Updated personal information .......... Anthropometry .................................. Determination of fasting & blood draw (Appendix 14 — Procedures—BIO)*. Determination of blood glucose, OGTT (Appendix 14 — Procedures—BIO)*. Seated BP ........................................ Echocardiography ............................ 2-hour blood draw, snack (Appendix 14—Procedures—BIO)*. Personal Medical History ................. Reproductive Medical History .......... Pregnancy Complications History .... Socio-economic Status—Occupation Health Care Access and Utilization Chronic Stress .................................. Family Cohesion .............................. Social Support .................................. Acculturation ..................................... Well Being ........................................ Abbreviated Medication Use ............ Tobacco Use .................................... Alcohol Use ...................................... Participant Feedback ....................... Number of responses per respondent Average time per response (in hours) Total burden hours 13878 1 2/60 463 13878 1 20/60 4626 13878 13878 1 1 4/60 2/60 925 463 13878 1 10/60 2313 13878 13878 13878 1 1 1 5/60 7/60 11/60 1157 1619 2544 13878 1 6/60 1388 13878 8000 13878 1 1 1 9/60 30/60 12/60 2082 4000 2776 13878 9000 9000 13878 13878 13878 13878 13878 13878 13878 13878 13878 13878 13878 1 1 1 1 1 1 1 1 1 1 1 1 1 1 10/60 9/60 6/60 3/60 15/60 4/60 5/60 3/60 3/60 4/60 4/60 7/60 3/60 12/60 2313 1350 900 694 3470 925 1157 694 694 925 925 1619 694 2776 mstockstill on DSK4VPTVN1PROD with NOTICES Total ........................................... ........................................................... ........................ 206/60 43492 ........................ Participants AFU Phone Interview (Appendix 15). AFU Year 3 ...................................... 3146 1 15/60 787 9033 14259 16222 16222 16222 16222 16222 1 1 1 1 1 1 1 15/60 15/60 15/60 15/60 15/60 15/60 15/60 2258 3565 4055 4055 4055 4055 4055 AFU AFU AFU AFU AFU AFU AFU VerDate Mar<15>2010 19:09 Jul 14, 2014 Jkt 232001 Year Year Year Year Year Year Year 4 ...................................... 5 ...................................... 6 ...................................... 7 ...................................... 8 ...................................... 9 ...................................... 10 .................................... PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\15JYN1.SGM 15JYN1 41295 Federal Register / Vol. 79, No. 135 / Tuesday, July 15, 2014 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued A.12.1 ESTIMATES OF HOUR BURDEN [Appendices 11, 14 and 15] Type of respondents Number of responses per respondent Number of respondents Survey instrument Average time per response (in hours) Total burden hours AFU Year 11 .................................... 16222 1 15/60 4055 Total ........................................... ........................................................... ........................ 120/60 30940 ........................ Physicians and/or other health care providers. Informants ......................................... Hospitalization records/physician interview (Appendix 16, PQE). Informant Interview Deaths (Appendix 16, IIE/IIS). 1591 1 30/60 796 154 1 30/60 77 Total ........................................... ........................................................... ........................ ........................ 60/60 873 Dated: June 18, 2014. Michael Lauer, Director, DCVS, NHLBI, NIH. Dated: June 18, 2014. Lynn Susulske, NHLBI Project Clearance Liaison, National Institutes of Health. [FR Doc. 2014–16528 Filed 7–14–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health mstockstill on DSK4VPTVN1PROD with NOTICES Proposed Collection; 60-Day Comment Request; Evaluation of Cancer Control Leadership Forums at the Center for Global Health 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 Cancer Institute (NCI), 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, VerDate Mar<15>2010 17:46 Jul 14, 2014 Jkt 232001 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, or request more information on the proposed project, contact: Brenda Kostelecky, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W276, Rockville MD, 20850 or call non-tollfree number 240–276–5585 or Email your request, including your address to: brenda.kostelecky@nih.gov. Formal requests for additional plans and instruments must be requested in writing. 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: Evaluation of Cancer Control Leadership Forums at the Center for Global Health (CGH) (NCI), 0925–NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This submission is a request for OMB to approve the Cancer Control Leadership Forums. These workshops are organized and funded by the National Cancer Institute’s CGH in PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 conjunction with various partners ranging from foreign Ministries of Health and research institutions, to international non-governmental organizations (NGOs) and U.S. academic institutions. The goal of the U.S. National Cancer Institute (NCI) Cancer Control Leadership Forums is to increase the capacity of participating countries to initiate or enhance cancer control planning and implementation in their respective countries. The Forums are an opportunity for countries to exchange experiences and ideas about creating and implementing comprehensive cancer control plans. The proposed evaluation requests information about the outcomes of the forums including (1) status of cancer control planning and implementation in each participating country, (2) outcomes related to the action plans (e.g. developing written materials, completion of action items, resources and support acquired),(3) successes and challenges related to the action plans, and (4) new cancer control partnerships and networks. Baseline information regarding the status of cancer control planning and implementation will be collected 3 months prior to the Forums in order to inform the development of each Forum. The evaluation information will be collected 3–24 months after each forum and is needed to evaluate the effectiveness of these workshops in order to inform future programming and funding decisions. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 108. E:\FR\FM\15JYN1.SGM 15JYN1

Agencies

[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Notices]
[Pages 41293-41295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16528]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 30-day Comment Request: The Hispanic 
Community Health Study/Study of Latinos (HCHS/SOL)

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 for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on March 25, 2014 (Vol. 79, No. 57, pages 16345-16347). Three 
comments were received. The purpose of this notice is to allow an 
additional 30 days for public comment. The National Heart, Lung and 
Blood Institute (NHLBI), 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.

DATES: 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 either: Dr. Larissa Aviles-Santa, 6701 
Rockledge, Epidemiology Branch, Program in Prevention and Population 
Sciences, Division of Cardiovascular Sciences, National Heart, Lung, 
and Blood Institute, National Institutes of Health, 6701 Rockledge Dr, 
MSC 7936, Bethesda, MD 20892-7936, or call non-toll-free number 301-
435-0450, or Email your request, including your address to 
avilessantal@nhlbi.nih.gov. Formal requests for additional plans and 
instruments must be requested in writing.
    Proposed Collection: The Hispanic Community Health Study/Study of 
Latinos (HCHS/SOL), Revision, National Heart, Lung and Blood Institute 
(NHLBI), National Institutes of Health (NIH).
    Need and Use of Information Collection: The purpose and use of the 
information collection for this project is to study the prevalence of 
cardiovascular and pulmonary disease and other chronic diseases, and 
their risk and protective factors, understand their relationship to 
all-cause,

[[Page 41294]]

cardiovascular and pulmonary morbidity and mortality, and understand 
the role of sociocultural factors (including acculturation) on the 
prevalence or onset of disease among over 16,400 Hispanics/Latinos of 
diverse origins, aged 18-74 years at enrollment, living in four U.S. 
communities: San Diego, California; Chicago, Illinois; Miami, Florida, 
and the Bronx, New York. In order to achieve these objectives, the 
HCHS/SOL had two integrated components:
    1. Examination of the cohort following a standardized protocol, 
which consisted of interviews and clinical measurements to assess 
physiological and biochemical measurements including DNA/RNA extraction 
for ancillary genetic research studies.
    2. Follow-up of the cohort, which consists of an annual telephone 
interview to assess vital status, changes in health status and 
medication intake, and new cardiovascular and pulmonary events 
(including fatal and non-fatal myocardial infarction and heart failure; 
fatal and non-fatal stroke; and exacerbation of asthma and chronic 
obstructive pulmonary disease). This component also includes contact 
with physicians and informants to obtain medical information about 
participants.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 75,305.

                                        Estimated Annualized Burden Hours
                                         A.12.1 Estimates of Hour Burden
                                           [Appendices 11, 14 and 15]
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
      Type of respondents            Survey          Number of     responses per   per response    Total burden
                                   instrument       respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Participants Visit 2            Pre-visit                  13878               1            2/60             463
 Examination (Appendices 11      scheduling &
 and 14).                        safety
                                 screening
                                 (Appendix 14 --
                                 Procedures--ELE
                                 bilingual).
                                Reception,                 13878               1           20/60            4626
                                 informed
                                 consent
                                 (Appendix 11),
                                 medical
                                 releases.
                                Ppt. disability            13878               1            4/60             925
                                 screening.
                                Ppt. safety                13878               1            2/60             463
                                 update and
                                 routing
                                 (Appendix 14--
                                 Procedures--PSE
                                 bilingual).
                                Change clothes,            13878               1           10/60            2313
                                 urine specimen
                                 (Appendix 14 --
                                 Procedures --
                                 BIO)*.
                                Updated personal           13878               1            5/60            1157
                                 information.
                                Anthropometry...           13878               1            7/60            1619
                                Determination of           13878               1           11/60            2544
                                 fasting & blood
                                 draw (Appendix
                                 14 --
                                 Procedures--BIO
                                 )*.
                                Determination of           13878               1            6/60            1388
                                 blood glucose,
                                 OGTT (Appendix
                                 14 --
                                 Procedures--BIO
                                 )*.
                                Seated BP.......           13878               1            9/60            2082
                                Echocardiography            8000               1           30/60            4000
                                2-hour blood               13878               1           12/60            2776
                                 draw, snack
                                 (Appendix 14--
                                 Procedures--BIO
                                 )*.
                                Personal Medical           13878               1           10/60            2313
                                 History.
                                Reproductive                9000               1            9/60            1350
                                 Medical History.
                                Pregnancy                   9000               1            6/60             900
                                 Complications
                                 History.
                                Socio-economic             13878               1            3/60             694
                                 Status--Occupat
                                 ion.
                                Health Care                13878               1           15/60            3470
                                 Access and
                                 Utilization.
                                Chronic Stress..           13878               1            4/60             925
                                Family Cohesion.           13878               1            5/60            1157
                                Social Support..           13878               1            3/60             694
                                Acculturation...           13878               1            3/60             694
                                Well Being......           13878               1            4/60             925
                                Abbreviated                13878               1            4/60             925
                                 Medication Use.
                                Tobacco Use.....           13878               1            7/60            1619
                                Alcohol Use.....           13878               1            3/60             694
                                Participant                13878               1           12/60            2776
                                 Feedback.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............          206/60           43492  ..............
----------------------------------------------------------------------------------------------------------------
Participants AFU Phone          AFU Year 3......            3146               1           15/60             787
 Interview (Appendix 15).
                                AFU Year 4......            9033               1           15/60            2258
                                AFU Year 5......           14259               1           15/60            3565
                                AFU Year 6......           16222               1           15/60            4055
                                AFU Year 7......           16222               1           15/60            4055
                                AFU Year 8......           16222               1           15/60            4055
                                AFU Year 9......           16222               1           15/60            4055
                                AFU Year 10.....           16222               1           15/60            4055

[[Page 41295]]

 
                                AFU Year 11.....           16222               1           15/60            4055
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............          120/60           30940  ..............
----------------------------------------------------------------------------------------------------------------
Physicians and/or other health  Hospitalization             1591               1           30/60             796
 care providers.                 records/
                                 physician
                                 interview
                                 (Appendix 16,
                                 PQE).
Informants....................  Informant                    154               1           30/60              77
                                 Interview
                                 Deaths
                                 (Appendix 16,
                                 IIE/IIS).
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............           60/60             873
----------------------------------------------------------------------------------------------------------------


    Dated: June 18, 2014.
Michael Lauer,
Director, DCVS, NHLBI, NIH.

    Dated: June 18, 2014.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-16528 Filed 7-14-14; 8:45 am]
BILLING CODE 4140-01-P
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