Proposed Collection; 60-Day Notice Request: Application Process for Clinical Research Training and Medical Education at the Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness, 60885-60886 [2013-24074]

Download as PDF tkelley on DSK3SPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Notices cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On November 13, 2013, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Retroviruses and Laboratory of Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Review, FDA. FDA intends to make background material available to the public no later than 2 business days before the meeting. 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[FR Doc. 2013–24025 Filed 10–1–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Notice Request: Application Process for Clinical Research Training and Medical Education at the Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness 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 application information collection, the Clinical Center (CC), 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. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 60885 Written comments and/or suggestions from the public and affected agencies are invited to address 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) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Robert M. Lembo, MD, Deputy Director, Office of Clinical Research Training and Medical Education, NIH Clinical Center, 10 Center Drive, MSC 1158, Bethesda, MD 20892–1352, or call non-toll-free number (301)–594–4193, or Email your request, including your address to: lembor@mail.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: Application Process for Clinical Research Training and Medical Education at the Clinical Center and its Impact on Course and Training Program Enrollment and Effectiveness, 0925–NEW, Clinical Center, National Institutes of Health (CC), National Institutes of Health (NIH). Need and Use of Information Collection: The primary objective of the application process is to allow OCRTME to evaluate applicants’ qualifications to determine applicants’ eligibility for courses and training programs managed by the office. Applicants must provide the required information requested in the respective applications to be considered a candidate for participation. Information submitted by candidates for training programs is reviewed initially by OCRTME administrative staff to establish eligibility for participation. Eligible candidates are then referred to the designated training program director or training program selection committee for review and decisions regarding E:\FR\FM\02OCN1.SGM 02OCN1 60886 Federal Register / Vol. 78, No. 191 / Wednesday, October 2, 2013 / Notices acceptance for participation. A secondary objective of the application process is to track enrollment in courses and training programs over time. OMB approval is requested for 3 years. There are capital, operating, and/ or maintenance costs of $98,022. The total estimated annualized burden hours are 2,210. ESTIMATED ANNUALIZED BURDEN HOURS Doctoral Level .................................................................................................. Students ........................................................................................................... Other ................................................................................................................ Dated: September 25, 2013. Laura Lee, Project Clearance Liaison, Clinical Center, National Institutes of Health. [FR Doc. 2013–24074 Filed 10–1–13; 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; Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), 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 29, 2013, Vol.78, No.61, pages 19273–19274, and allowed 60-days for public comment. No public comments were received. The purpose of this SUMMARY: Estimated number of applications per applicant Estimated number of applicants Type of applicants 6,488 82 59 1 1 1 notice is to allow an additional 30 days for public comment. The National Institute on Drug Abuse (NIDA), the 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: Comments 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, submit comments in writing, or request more information on the proposed project contact: Dr. Steve Gust, National Institute on Drug Abuse, 6001 Executive Blvd., Bethesda, MD 20892, or call non- Maximum burden hours per application 20/60 20/60 20/60 Estimated total annual burden hours requested 2,163 27 20 toll-free number (301) 443–6480 or Email your request, including your address to: sgust@nida.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Quantification of Behavioral and Physiological Effects of Drugs Using a Mobile Scalable Device, 0925-New, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH). Need and Use of Information Collection: This study will examine the effectiveness of a mobile scalable device to detect the impairing effects of different drugs. The primary purpose of the data collected is to determine eligibility in a driving simulation study and to verify the effectiveness of the experimental manipulations. The findings will provide valuable information concerning the utility and effectiveness of mobile, smartphone/ tablet-based neurocognitive assessment that can provide a multifactorial evaluation of cognitive functioning associated with impaired driving. OMB approval is requested for 18 months. There are no costs to respondents other than their time. The total estimated annualized burden hours are 859. ESTIMATED ANNUALIZED BURDEN HOURS tkelley on DSK3SPTVN1PROD with NOTICES Form name Phone Screening .................................................. Consent Process, In-Person Screening Adderall Consent Process, In-Person Screening Xanax .... Consent Process, In-Person Screening Cannabis Driving Survey ...................................................... Realism Survey ..................................................... Sleep and Intake Questionnaire ........................... Stanford Sleepiness Scale ................................... Wellness Survey ................................................... Dosing/Driving/Waiting .......................................... VerDate Mar<15>2010 17:48 Oct 01, 2013 Number of respondents Type of respondent Jkt 232001 PO 00000 Adults Adults Adults Adults Adults Adults Adults Adults Adults Adults ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ Frm 00071 Fmt 4703 Number of responses per respondent 100 ........................ 100 ........................ ........................ ........................ ........................ 72 ........................ ........................ 1 ........................ ........................ ........................ 1 1 2 6 2 2 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1 Average burden per response (in hours) 10/60 45/60 45/60 45/60 15/60 3/60 3/60 1/60 2/60 4 Per annual hour burden 17 75 75 75 18 4 7 7 5 576

Agencies

[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Notices]
[Pages 60885-60886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Notice Request: Application Process 
for Clinical Research Training and Medical Education at the Clinical 
Center and Its Impact on Course and Training Program Enrollment and 
Effectiveness

    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 application information collection, the 
Clinical Center (CC), 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 to address 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) The quality, utility, and clarity of the information to be 
collected; and (4) Minimize the burden of the collection of information 
on those who are to respond, including the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology.
    To Submit Comments and For Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Robert M. 
Lembo, MD, Deputy Director, Office of Clinical Research Training and 
Medical Education, NIH Clinical Center, 10 Center Drive, MSC 1158, 
Bethesda, MD 20892-1352, or call non-toll-free number (301)-594-4193, 
or Email your request, including your address to: lembor@mail.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: Application Process for Clinical Research 
Training and Medical Education at the Clinical Center and its Impact on 
Course and Training Program Enrollment and Effectiveness, 0925-NEW, 
Clinical Center, National Institutes of Health (CC), National 
Institutes of Health (NIH).
    Need and Use of Information Collection: The primary objective of 
the application process is to allow OCRTME to evaluate applicants' 
qualifications to determine applicants' eligibility for courses and 
training programs managed by the office. Applicants must provide the 
required information requested in the respective applications to be 
considered a candidate for participation. Information submitted by 
candidates for training programs is reviewed initially by OCRTME 
administrative staff to establish eligibility for participation. 
Eligible candidates are then referred to the designated training 
program director or training program selection committee for review and 
decisions regarding

[[Page 60886]]

acceptance for participation. A secondary objective of the application 
process is to track enrollment in courses and training programs over 
time.
    OMB approval is requested for 3 years. There are capital, 
operating, and/or maintenance costs of $98,022. The total estimated 
annualized burden hours are 2,210.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated                       Estimated
                                                     Estimated       number of    Maximum burden   total annual
               Type of applicants                    number of     applications      hours per     burden hours
                                                    applicants     per applicant    application      requested
----------------------------------------------------------------------------------------------------------------
Doctoral Level..................................           6,488               1           20/60           2,163
Students........................................              82               1           20/60              27
Other...........................................              59               1           20/60              20
----------------------------------------------------------------------------------------------------------------


    Dated: September 25, 2013.
Laura Lee,
Project Clearance Liaison, Clinical Center, National Institutes of 
Health.
[FR Doc. 2013-24074 Filed 10-1-13; 8:45 am]
BILLING CODE 4140-01-P