Proposed Collection; 60-Day Comment Request: The Framingham Heart Study (FHS), 26639-26641 [2013-10771]

Download as PDF 26639 Federal Register / Vol. 78, No. 88 / Tuesday, May 7, 2013 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request: Financial Sustainability of Human Tissue Biobanking (NCI) 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, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and based survey is to collect information regarding the challenges that human tissue biobanks encounter in achieving financially sustainable operations. The information will be used to assist the National Cancer Institute (NCI) in strategizing program plans to provide increased and tailored support for national and international biobanks. The survey will collect a combination of structured, quantitative, and free-text descriptive data that characterize the type and maturity of respondent biobanks, their sources of funding, and their usage of funding in conducting operations. The survey will also collect information describing the difficulties in maintaining funding sources and establishing new ones. Finally, the survey will elicit descriptions of techniques used to overcome the difficulties. It is expected that the information generated by this survey will be used to inform published guidance to biobanks regarding the financial hazards to sustained operations and the means by which these hazards can be avoided or overcome. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 822. 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: Chana Rabiner, Ph.D., Biorepositories and Biospecimen Research Branch, Cancer Diagnosis Program, 9609 Medical Center Drive, Rockville, MD 20892 or call nontoll-free number 240–276–5715 or Email your request, including your address to: chana.rabiner@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: Financial Sustainability of Human Tissue Biobanking, 0925–NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this web- ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Category of respondents Average time per response (in hours) Frequency of response Total burden hours Estimates of Annualized Burden Hours Private Sector .................................................................................................. 548 1 90/60 822 Totals ........................................................................................................ 548 ........................ ........................ 822 Dated: May 1, 2013. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, NCI, NIH. [FR Doc. 2013–10772 Filed 5–6–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health tkelley on DSK3SPTVN1PROD with NOTICES Proposed Collection; 60-Day Comment Request: The Framingham Heart Study (FHS) 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 Heart, Lung, and Blood VerDate Mar<15>2010 18:51 May 06, 2013 Jkt 229001 Institute (NHLBI), the 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 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 request more information on the proposed project or to obtain a copy of data collection plans and instruments, contact Dr. Gina Wei, Division of Cardiovascular Sciences, NHLBI, NIH, Two Rockledge Center, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892–7936, or call nontoll-free number (301) 435–0456, or email your request, including your address to: weig@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing. E:\FR\FM\07MYN1.SGM 07MYN1 26640 Federal Register / Vol. 78, No. 88 / Tuesday, May 7, 2013 / Notices 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 Framingham Heart Study, 0925–0216, Extension, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Need and Use of Information Collection: The Framingham Heart Study will continue to conduct morbidity and mortality follow-up, as well as examinations, for the purpose of studying the determinants of cardiovascular disease. Morbidity and mortality follow-up will continue to occur in all of the cohorts (Original, Offspring, Third Generation, Omni Group 1, and Omni Group 2). Examinations will continue to be conducted on the Original, Offspring, and Omni Group 1 Cohorts. OMB approval is requested for 3 years. There is no cost to the respondents other than their time. The total estimated annualized burden hours are 4264. ESTIMATED ANNUALIZED BURDEN HOURS, ORIGINAL COHORT Number of respondents Type of respondent I. Participant Components A. Pre-Exam: a. Telephone contact to set up appointment ............................................ b. Exam Appointment, Scheduling, Reminder, and Instructions .............. B. Exam—Cycle 32: a. Clinic exam ........................................................................................... b. Home or nursing home visit ................................................................. C. Annual Follow-up: a. Records Request .................................................................................. b. Health Status Update ........................................................................... Number of responses per respondent Average time per response (in hours) Total annual burden hour 60 55 1 1 10/60 35/60 10 32 25 25 1 1 45/60 65/60 19 27 60 45 1 1 15/60 15/60 15 11 Sub-Total: Participant Components .................................................. * 60 ........................ ........................ 114 II. Non-Participant Components A. Informant Contact (Pre-exam and Annual Follow-up) ................................ B. Records Request (Annual follow-up) .......................................................... ........................ 25 50 ........................ 1 1 ........................ 10/60 15/60 ........................ 4 13 Sub-Total: Non-Participant Components ........................................... 75 ........................ ........................ 17 * Number of participants as reflected in Rows I.A.a and I.C.a. above. ESTIMATED ANNUALIZED BURDEN HOURS, OFFSPRING COHORT AND OMNI GROUP 1 COHORT Number of respondents Type of respondent I. Participant Components: A. Pre-Exam: a. Telephone contact to set up apt or Health status update ................... b. Appt. or update Confirmation ............................................................... c. Food Frequency Form .......................................................................... B. Exam: a. Clinic Exam .......................................................................................... b. Home or nursing home visit ................................................................. c. Consent Forms ..................................................................................... C. Annual Follow-Up: a. Records Request .................................................................................. b. Health Status Update ........................................................................... Number of responses per respondent Average time per response (in hours) Total annual burden hour 300 250 250 1 1 1 10/60 10/60 10/60 50 42 42 100 100 200 1 1 1 175/60 60/60 20/60 292 100 67 2292 1833 1 1 15/60 15/60 573 458 Sub-Total: Participant Components .................................................. * 2292 ........................ ........................ 1624 II. Non-Participant Components: A. Informant contact (Pre-exam and Annual Follow-up) ................................. B. Records Request (Annual follow-up) .......................................................... 229 2292 1 1 10/60 15/60 38 573 Sub-Total: Non-Participant Components: .......................................... 2521 ........................ ........................ 611 * Number of participants as reflected in Rows I.C.a. above. tkelley on DSK3SPTVN1PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS, GENERATION 3 COHORT AND OMNI GROUP 2 COHORT Type of respondent Number of respondents I. Participant Components Annual Follow-up: A. Records Request ................................................................................. VerDate Mar<15>2010 15:24 May 06, 2013 Jkt 229001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Number of responses per respondent 3212 E:\FR\FM\07MYN1.SGM 1 1 07MYN1 Average time per response (in hours) 15/60 Total annual burden hour 803 26641 Federal Register / Vol. 78, No. 88 / Tuesday, May 7, 2013 / Notices ESTIMATED ANNUALIZED BURDEN HOURS, GENERATION 3 COHORT AND OMNI GROUP 2 COHORT—Continued Type of respondent Number of responses per respondent Number of respondents Average time per response (in hours) Total annual burden hour B. Health Status Update ........................................................................... 3212 1 15/60 803 Sub-Total: Participant Components .................................................. * 3212 ........................ ........................ 1606 Annual Follow-up: A. Informant contacts ............................................................................... B. Records Request ................................................................................. ........................ 160 1060 ........................ 1 1 ........................ 10/60 15/60 ........................ 27 265 Sub-Total: Non-Participant Components ........................................... 1220 ........................ ........................ 292 II. Non-Participant Components * Number of participants as reflected in Rows I.A. and I.B. above. SUMMARY OF 3 TABLES COMBINED—TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Number of responses per respondent Number of respondents Average time per response (in hours) Total annual burden hour Participants ...................................................................................................... Non-Participants .............................................................................................. 5564 3816 1 1 36/60 14.5/60 3344 920 Totals ........................................................................................................ 9380 ........................ ........................ 4264 (Note: reported and calculated numbers differ slightly due to rounding.) Dated: April 25, 2013. Lynn Susulske, NHLBI Project Clearance Liaison, National Institutes of Health. Michael Lauer, Director, DCVS, National Institutes of Health. [FR Doc. 2013–10771 Filed 5–6–13; 8:45 am] BILLING CODE 4140–01–P Mellitus Interagency Coordinating Committee, National Institute of Diabetes and Digestive and Kidney Diseases, 31 Center Drive, Building 31A, Room 9A19, MSC 2560, Bethesda, MD 20892–2560, telephone: 301–496–6623; FAX: 301–480–6741; email: dmicc@mail.nih.gov. The DMICC facilitates cooperation, communication, and collaboration on diabetes among government entities. The June 6–7, 2013, DMICC workshop will discuss new and emerging opportunities for type 1 diabetes research supported by the Special Statutory Funding Program for Type 1 Diabetes Research. An agenda for the DMICC workshop will be available by contacting Mary Allen, The Scientific Consulting Group, Inc. (mallen@scgcorp.com; please put ‘‘Agenda Request for DMICC T1D Meeting’’ in the subject line). Any interested person may file written comments with the Committee by forwarding their statement to the contact person listed on this notice. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person. Because of time constraints for the workshop, there will not be time on the agenda for oral comments from members of the public. Members of the public who would like to receive email notification about future DMICC meetings may register on SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health tkelley on DSK3SPTVN1PROD with NOTICES National Institute of Diabetes and Digestive and Kidney Diseases, Diabetes Mellitus Interagency Coordinating Committee Notice of Workshop SUMMARY: The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a 2-day workshop on June 6–7, 2013. The workshop will be open to the public, with attendance limited to space available. DATES: The workshop will be held on June 6, 2013 from 8:15 a.m. to 6:00 p.m., and June 7, 2013 from 8:15 a.m. to 4:00 p.m. ADDRESSES: The workshop will be held at the National Institutes of Health Neuroscience Center, Conference Room B1/B2, 6001 Executive Boulevard, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: For further information concerning this workshop, contact Dr. B. Tibor Roberts, Executive Secretary of the Diabetes VerDate Mar<15>2010 15:24 May 06, 2013 Jkt 229001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 a listserv on the DMICC Web site: www.diabetescommittee.gov. Please note that seating is limited and attendance will be first-come, firstserved. Non-federal individuals planning to attend the workshop should register by email to Mary Allen, The Scientific Consulting Group, Inc. (mallen@scgcorp.com; please put ‘‘Registration DMICC T1D Meeting’’ in the subject line) at least 7 days prior to the workshop. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the Contact Person listed below at least 10 days in advance of the workshop. Dated: April 26, 2013. B. Tibor Roberts, Executive Secretary, DMICC, Office of Scientific Program and Policy Analysis, NIDDK, National Institutes of Health. [FR Doc. 2013–10770 Filed 5–6–13; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. E:\FR\FM\07MYN1.SGM 07MYN1

Agencies

[Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)]
[Notices]
[Pages 26639-26641]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10771]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request: The Framingham Heart 
Study (FHS)

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 Heart, Lung, and 
Blood Institute (NHLBI), the 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 request more 
information on the proposed project or to obtain a copy of data 
collection plans and instruments, contact Dr. Gina Wei, Division of 
Cardiovascular Sciences, NHLBI, NIH, Two Rockledge Center, 6701 
Rockledge Drive, MSC 7936, Bethesda, MD 20892-7936, or call non-toll-
free number (301) 435-0456, or email your request, including your 
address to: weig@nhlbi.nih.gov. Formal requests for additional plans 
and instruments must be requested in writing.

[[Page 26640]]

    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 Framingham Heart Study, 0925-0216, 
Extension, National Heart, Lung, and Blood Institute (NHLBI), National 
Institutes of Health (NIH).
    Need and Use of Information Collection: The Framingham Heart Study 
will continue to conduct morbidity and mortality follow-up, as well as 
examinations, for the purpose of studying the determinants of 
cardiovascular disease. Morbidity and mortality follow-up will continue 
to occur in all of the cohorts (Original, Offspring, Third Generation, 
Omni Group 1, and Omni Group 2). Examinations will continue to be 
conducted on the Original, Offspring, and Omni Group 1 Cohorts.
    OMB approval is requested for 3 years. There is no cost to the 
respondents other than their time. The total estimated annualized 
burden hours are 4264.

                               Estimated Annualized Burden Hours, Original Cohort
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
               Type of respondent                    Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
            I. Participant Components
A. Pre-Exam:
    a. Telephone contact to set up appointment..              60               1           10/60              10
    b. Exam Appointment, Scheduling, Reminder,                55               1           35/60              32
     and Instructions...........................
B. Exam--Cycle 32:
    a. Clinic exam..............................              25               1           45/60              19
    b. Home or nursing home visit...............              25               1           65/60              27
C. Annual Follow-up:
    a. Records Request..........................              60               1           15/60              15
    b. Health Status Update.....................              45               1           15/60              11
                                                 ---------------------------------------------------------------
        Sub-Total: Participant Components.......            * 60  ..............  ..............             114
 
         II. Non-Participant Components           ..............  ..............  ..............  ..............
A. Informant Contact (Pre-exam and Annual Follow-             25               1           10/60               4
 up)............................................
B. Records Request (Annual follow-up)...........              50               1           15/60              13
                                                 ---------------------------------------------------------------
        Sub-Total: Non-Participant Components...              75  ..............  ..............              17
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.A.a and I.C.a. above.


                   Estimated Annualized Burden Hours, Offspring Cohort and Omni Group 1 Cohort
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
               Type of respondent                    Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
           I. Participant Components:
A. Pre-Exam:
    a. Telephone contact to set up apt or Health             300               1           10/60              50
     status update..............................
    b. Appt. or update Confirmation.............             250               1           10/60              42
    c. Food Frequency Form......................             250               1           10/60              42
B. Exam:
    a. Clinic Exam..............................             100               1          175/60             292
    b. Home or nursing home visit...............             100               1           60/60             100
    c. Consent Forms............................             200               1           20/60              67
C. Annual Follow-Up:
    a. Records Request..........................            2292               1           15/60             573
    b. Health Status Update.....................            1833               1           15/60             458
                                                 ---------------------------------------------------------------
        Sub-Total: Participant Components.......          * 2292  ..............  ..............            1624
 
         II. Non-Participant Components:
A. Informant contact (Pre-exam and Annual Follow-            229               1           10/60              38
 up)............................................
B. Records Request (Annual follow-up)...........            2292               1           15/60             573
                                                 ---------------------------------------------------------------
        Sub-Total: Non-Participant Components:..            2521  ..............  ..............             611
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.C.a. above.


                 Estimated Annualized Burden Hours, Generation 3 Cohort and Omni Group 2 Cohort
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
               Type of  respondent                   Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
            I. Participant Components
Annual Follow-up:                                                              1
    A. Records Request..........................            3212               1           15/60             803

[[Page 26641]]

 
    B. Health Status Update.....................            3212               1           15/60             803
                                                 ---------------------------------------------------------------
        Sub-Total: Participant Components.......          * 3212  ..............  ..............            1606
 
         II. Non-Participant Components
Annual Follow-up:                                 ..............  ..............  ..............  ..............
    A. Informant contacts.......................             160               1           10/60              27
    B. Records Request..........................            1060               1           15/60             265
                                                 ---------------------------------------------------------------
        Sub-Total: Non-Participant Components...            1220  ..............  ..............             292
----------------------------------------------------------------------------------------------------------------
* Number of participants as reflected in Rows I.A. and I.B. above.


                      Summary of 3 Tables Combined--Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
               Type of respondent                    Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
Participants....................................            5564               1           36/60            3344
Non-Participants................................            3816               1         14.5/60             920
                                                 ---------------------------------------------------------------
    Totals......................................            9380  ..............  ..............            4264
----------------------------------------------------------------------------------------------------------------
(Note: reported and calculated numbers differ slightly due to rounding.)


    Dated: April 25, 2013.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013-10771 Filed 5-6-13; 8:45 am]
BILLING CODE 4140-01-P
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