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
<![CDATA[
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 https://
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.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: On November 13, 2013,
from 12:30 p.m. to approximately 3:10
p.m., the meeting is open to the public.
Interested persons may present data,
information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
November 6, 2013. Oral presentations
from the public will be scheduled
between approximately 2:10 p.m. and
approximately 3:10 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 29, 2013. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 30, 2013.
VerDate Mar<15>2010
17:48 Oct 01, 2013
Jkt 232001
Closed Committee Deliberations: On
November 13, 2013, between
approximately 3:10 p.m. and
approximately 3:45 p.m., the meeting
will be closed to permit discussion
where disclosure would constitute a
clearly unwarranted invasion of
personal privacy (5 U.S.C. 552b(c)(6)).
The committee will discuss the report of
the intramural research programs and
make recommendations regarding
personnel staffing decisions.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Donald W.
Jehn or Denise Royster at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 26, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[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]
-----------------------------------------------------------------------
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
