National Institute on Drug Abuse; Notice of Closed Meetings, 22579 [2012-9055]
Download as PDF
<![CDATA[
emcdonald on DSK29S0YB1PROD with NOTICES
Federal Register / Vol. 77, No. 73 / Monday, April 16, 2012 / Notices
to be 7 hours (including time to extract,
reformat and submit information which
has already been produced for other
purposes). This estimate is consistent
with that used on the previous PRA
clearance and incorporates 4 hours for
data extraction and 3 hours for
reformatting. Based on previous
experience, we estimate that each
registration record will be updated an
average of eight times and that each
update takes approximately 2 hours.
Applying these figures to the estimated
number of trials to be registered per year
produces an annual burden estimate of
391,000 hours. Of this total, 126,500
hours are associated with the mandatory
registration of trials subject to FDAAA,
and 264,500 hours are associated with
voluntary registrations. The burden of
results submission consists of the time
and effort needed to summarize
information from a clinical trial, format
it, and enter it into the databank. We
estimate that of the 5,500 applicable
clinical trials that are registered each
year, approximately 1,845 will be
required to submit results each year
(1,500 trials of drugs and biological
products, and 345 trials of devices). We
estimate that each results record will
submitted once and updated twice to
reflect changes in the data analysis,
additional results of subsequent prespecified outcome measures, or
additional adverse event information.
Based on information available from
various organizations about results
submission times, comments made at a
public meeting held in April 2009,
responses to estimates in previous OMB
clearance documents (73 FR 58972, Oct.
8, 2008), and feedback from respondents
who have submitted results to
ClinicalTrials.gov, we have increased
our estimate of the average response
time to 25 hours from the 10 hour
estimate included in the previous OMB
clearance request. We estimate that
updates take 8 hours, an increase over
the 5 hour estimate included in the
previous OMB clearance request for
adverse event information. In addition,
we estimate that 3,655 trials per year
will submit certifications to
ClinicalTrials.gov indicating that they
qualify for delayed results submission,
and another 200 trials will request
extensions to the submission deadline
for good cause, as permitted by FDAAA.
We expect that it would take no more
than 30 minutes for a responsible party
to determine that a certification is
required and to submit the necessary
information through ClinicalTrials.gov.
For extension requests, we estimate that
the time to prepare a request and submit
it to ClinicalTrials.gov would be no
VerDate Mar<15>2010
14:39 Apr 13, 2012
Jkt 226001
more than 2 hours. Using these figures,
we estimate the annualized hourly
burden for submitting results
information, certifications, and
extension requests to be 77,872.5 hours.
There are no capital costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate 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) Evaluate 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) Enhance 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.
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: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: David
Sharlip, National Library of Medicine,
Building 38A, Room B2N12, 8600
Rockville Pike, Bethesda, MD 20894, or
call non-toll free number 301–402–9680
or email your request to
sharlipd@mail.nih.gov.
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.
Dated: April 10, 2012.
David H. Sharlip,
NLM Project Clearance Liaison, National
Library of Medicine, National Institutes of
Health.
[FR Doc. 2012–9083 Filed 4–13–12; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
22579
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
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 USC,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel ETechnology Tools for Extending the Reach of
Prevention Interventions in Rural and
Remote Locations (5567)
Date: April 30, 2012.
Time: 1:30 p.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Nadine Rogers, Ph.D.,
Scientific Review Officer,
Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, 6001 Executive Blvd., Room 4229,
MSC 9550, Bethesda, MD 20892–9550, 301–
402–2105, rogersn2@nida.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel Rapid
Portable Devices to Measure Drug Use (1206).
Date: May 1, 2012.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Lyle Furr, Contract Review
Specialist, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 4227, MSC 9550, 6001
Executive Boulevard, Bethesda, MD 20892–
9550, (301) 435–1439, lf33c.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: April 10, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–9055 Filed 4–13–12; 8:45 am]
BILLING CODE 4140–01–P
Frm 00023
Fmt 4703
Sfmt 9990
E:\FR\FM\16APN1.SGM
16APN1
]]>Agencies
[Federal Register Volume 77, Number 73 (Monday, April 16, 2012)]
[Notices]
[Page 22579]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9055]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
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
USC, as amended. The contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable materials, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel E-Technology Tools for Extending the Reach of
Prevention Interventions in Rural and Remote Locations (5567)
Date: April 30, 2012.
Time: 1:30 p.m. to 5 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Nadine Rogers, Ph.D.,
Scientific Review Officer,
Office of Extramural Affairs,
National Institute on Drug Abuse, NIH, DHHS, 6001 Executive
Blvd., Room 4229, MSC 9550, Bethesda, MD 20892-9550, 301-402-2105,
rogersn2@nida.nih.gov.
Name of Committee: National Institute on Drug Abuse Special
Emphasis Panel Rapid Portable Devices to Measure Drug Use (1206).
Date: May 1, 2012.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Lyle Furr, Contract Review Specialist, Office of
Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS,
Room 4227, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892-
9550, (301) 435-1439, lf33c.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug
Abuse and Addiction Research Programs, National Institutes of
Health, HHS)
Dated: April 10, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-9055 Filed 4-13-12; 8:45 am]
BILLING CODE 4140-01-P
