Submission For OMB Review; 30-Day Comment Request: Gulf Long-Term Follow-Up Study (GuLF STUDY), 3391-3392 [2014-01038]

Download as PDF Federal Register / Vol. 79, No. 13 / Tuesday, January 21, 2014 / Notices bound by the list of nominees in selecting a candidate. However, if no individual is selected within the 60 days, the Commissioner will select the nonvoting member to represent industry interests. IV. Application Procedure Individuals may self nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Contact information, a current curriculum vitae, and the name of the committee of interest should be sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the panel. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore encourages nominations of appropriately qualified candidates from these groups. Specifically, in this document, nominations for nonvoting representatives of industry interests are encouraged from the device manufacturing industry. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. App. 2) and 21 CFR part 14, relating to advisory committees. Dated: January 13, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–01003 Filed 1–17–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission For OMB Review; 30-Day Comment Request: Gulf Long-Term Follow-Up Study (GuLF STUDY) Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:42 Jan 17, 2014 Jkt 232001 Sciences (NIEHS), the National Institutes of Health, 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 November 7, 2013 on pages 66945–66946 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 National Institute of Environmental Health Sciences (NIEHS), 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. To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Dr. Dale P. Sandler, Chief, Epidemiology Branch, NIEHS, Rall Building A3–05, P.O. Box 12233, 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. Proposed Collection: Gulf Long-Term Follow-Up Study (GuLF STUDY), 0925– 0626, Expiration Date 01/31/2014— REVISION, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 3391 The purpose of the GuLF STUDY is to investigate potential short- and longterm health effects associated with oil spill clean-up activities and exposures related to the Deepwater Horizon disaster, and to create a resource for additional collaborative research on focused hypotheses or subgroups. Exposures range from negligible to potentially significant; however, potential long-term human health consequences are largely unknown due to insufficient research in this area. The study has enrolled 32,762 participants with a range of jobs/ exposures, including participants who performed various types of clean-uprelated work (‘‘exposed’’) and other who did not (‘‘unexposed’’ controls). Of the 32,762 enrolled into the Full Cohort, 20,000 have been assigned to the Active Follow-up Sub-cohort, and 6,000 of these have been assigned to the Biomedical Surveillance Sub-cohort. In order to minimize loss to followup, updated contact information will be collected yearly for the Full Cohort. Follow-up questionnaires will be administered biennially to the Active Follow-up Sub-Cohort to assess changes in health status and factors that could confound associations between exposures and outcomes. A supplemental mental health questionnaire will be administered repeatedly over a 2-year period to a subset of 4,600 participants in the Active Follow-up Sub-cohort to assess mental health trajectories among those affected by the oil spill and utilization of mental health services in the Gulf region. Participants in the Biomedical Surveillance Sub-cohort will be invited to take part in a comprehensive research-based clinical examination. The clinical exam provides an opportunity to carry out more comprehensive clinical testing and mental health evaluations than could be completed during the baseline home visit. The exams will allow for a much more in-depth assessment of pulmonary, neurological, and mental health outcomes that may be associated with the Deepwater Horizon oil spill exposures and experiences. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 21,724. E:\FR\FM\21JAN1.SGM 21JAN1 3392 Federal Register / Vol. 79, No. 13 / Tuesday, January 21, 2014 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Cleanup & non-Cleanup Workers. Cleanup & non-Cleanup Workers. Cleanup & non-Cleanup Workers. Cleanup & non-Cleanup Workers. Annual Recontact Questionnaire. Supplemental Mental Health Telephone Questionnaire. Follow-up Telephone Questionnaire. Clinical Exam ..................... Dated: January 9, 2014. Joellen M. Austin, Associate Director for Management. [FR Doc. 2014–01038 Filed 1–17–14; 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 Meetings tkelley on DSK3SPTVN1PROD with NOTICES 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 meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Member Conflict SEP. Date: February 5, 2014. Time: 2:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Xiaodu Guo, MD, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 761, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–4719, guox@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; The NIDDK–KUR Fellowship Review Committee. Date: February 5, 2014. VerDate Mar<15>2010 16:42 Jan 17, 2014 Number of respondents Form/activity Jkt 232001 Number of responses per respondent Frm 00049 Total burden hour (for 3 years) Annualized burden hour 32,762 3 15/60 24,572 8,191 4,600 4 15/60 4,600 1,533 20,000 2 30/60 20,000 6,667 4,000 1 4 16,000 5,333 Time: 8:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Xiaodu Guo, MD, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 761, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–4719, guox@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; R13 Conference Applications. Date: February 24, 2014. Time: 1:00 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Jian Yang, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 755, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7799, yangj@ extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; R24 Collaborative Interdisciplinary Team Science Applications. Date: March 6, 2014. Time: 11:00 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Jian Yang, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 755, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7799, yangj@ extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; P20 Developmental Centers in Benign Urology—RFA–DK–13– 019. Date: March 13, 2014. Time: 8:00 a.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. PO 00000 Average time per response (in hours) Fmt 4703 Sfmt 4703 Place: Hyatt Regency Bethesda, One Metro Center, Bethesda, MD 20814. Contact Person: Najma Begum, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 749, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–8894, begumn@niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: January 14, 2014. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–00970 Filed 1–17–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NIEHS. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Environmental Health Sciences, including E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 79, Number 13 (Tuesday, January 21, 2014)]
[Notices]
[Pages 3391-3392]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01038]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission For OMB Review; 30-Day Comment Request: Gulf Long-Term 
Follow-Up Study (GuLF STUDY)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institute of Environmental Health 
Sciences (NIEHS), the National Institutes of Health, 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 November 7, 2013 on pages 66945-66946 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 National 
Institute of Environmental Health Sciences (NIEHS), 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: Dr. Dale P. Sandler, Chief, Epidemiology 
Branch, NIEHS, Rall Building A3-05, P.O. Box 12233, 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.
    Proposed Collection: Gulf Long-Term Follow-Up Study (GuLF STUDY), 
0925-0626, Expiration Date 01/31/2014--REVISION, National Institute of 
Environmental Health Sciences (NIEHS), National Institutes of Health 
(NIH).
    Need and Use of Information Collection:
    The purpose of the GuLF STUDY is to investigate potential short- 
and long-term health effects associated with oil spill clean-up 
activities and exposures related to the Deepwater Horizon disaster, and 
to create a resource for additional collaborative research on focused 
hypotheses or subgroups. Exposures range from negligible to potentially 
significant; however, potential long-term human health consequences are 
largely unknown due to insufficient research in this area.
    The study has enrolled 32,762 participants with a range of jobs/
exposures, including participants who performed various types of clean-
up-related work (``exposed'') and other who did not (``unexposed'' 
controls). Of the 32,762 enrolled into the Full Cohort, 20,000 have 
been assigned to the Active Follow-up Sub-cohort, and 6,000 of these 
have been assigned to the Biomedical Surveillance Sub-cohort.
    In order to minimize loss to follow-up, updated contact information 
will be collected yearly for the Full Cohort. Follow-up questionnaires 
will be administered biennially to the Active Follow-up Sub-Cohort to 
assess changes in health status and factors that could confound 
associations between exposures and outcomes. A supplemental mental 
health questionnaire will be administered repeatedly over a 2-year 
period to a subset of 4,600 participants in the Active Follow-up Sub-
cohort to assess mental health trajectories among those affected by the 
oil spill and utilization of mental health services in the Gulf region. 
Participants in the Biomedical Surveillance Sub-cohort will be invited 
to take part in a comprehensive research-based clinical examination. 
The clinical exam provides an opportunity to carry out more 
comprehensive clinical testing and mental health evaluations than could 
be completed during the baseline home visit. The exams will allow for a 
much more in-depth assessment of pulmonary, neurological, and mental 
health outcomes that may be associated with the Deepwater Horizon oil 
spill exposures and experiences.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 21,724.

[[Page 3392]]



                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of     Average time    Total burden
           Type of respondent                     Form/activity              Number of     responses per   per response     hour (for 3     Annualized
                                                                            respondents     respondent      (in hours)        years)        burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cleanup & non-Cleanup Workers..........  Annual Recontact Questionnaire.          32,762               3           15/60          24,572           8,191
Cleanup & non-Cleanup Workers..........  Supplemental Mental Health                4,600               4           15/60           4,600           1,533
                                          Telephone Questionnaire.
Cleanup & non-Cleanup Workers..........  Follow-up Telephone                      20,000               2           30/60          20,000           6,667
                                          Questionnaire.
Cleanup & non-Cleanup Workers..........  Clinical Exam..................           4,000               1               4          16,000           5,333
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: January 9, 2014.
Joellen M. Austin,
Associate Director for Management.
[FR Doc. 2014-01038 Filed 1-17-14; 8:45 am]
BILLING CODE 4140-01-P
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