Submission of OMB Review; Comment Request (30-Day FRN):, 11209-11210 [2013-03571]
Download as PDF
<![CDATA[
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices
preclude the expected benefit from
correction of the mitral regurgitation.
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: 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 March 13, 2013.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on March 20, 2013.
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 March 1, 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 March 4, 2013.
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 James Clark,
Conference Management Staff, at
James.Clark@fda.hhs.gov or 301–796–
5293, at least 7 days in advance of the
meeting.
VerDate Mar<15>2010
19:09 Feb 14, 2013
Jkt 229001
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: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–03488 Filed 2–14–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission of OMB Review; Comment
Request (30-Day FRN):
Drug Accountability Report Form and
Investigator Registration Procedure in
the Conduct of Investigational Trials for
the Treatment of Cancer (NCI)
SUMMARY: In compliance with the
requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collected below. This proposed
information collection was previously
published in the Federal Register on
September 20, 2012 (77 FR 58401) 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 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 March 1, 2011, unless it
displays a valid OMB control number.
Written comments or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response times, should be directed to
the Attention: NIH Desk Officer, Office
of Management and Budget, at
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
11209
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Charles
L. Hall, Jr., Chief, Pharmaceutical
Management Branch, Cancer Therapy
Evaluation Program, Division of the
Cancer Treatment and Diagnosis, and
Centers, National Cancer Institute,
Executive Plaza North, Room 7148, 9000
Rockville Pike, Bethesda, MD 20892 or
call non-toll-free number 301–496–5725
or Email your request, including your
address to: Hallch@mail.nih.gov.
Comments regarding this information
collection are best assured of having
their full effect if received within 30
days following the date of this
publication.
Proposed Collection: Drug
Accountability Report Form and
Investigator Registration Procedure in
the Conduct of Investigational Trials for
the Treatment of Cancer (NCI), OMB
No.0925–0613, Expiration Date: 2/28/
2013, Revision, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The U.S. Food and Drug
Administration (FDA) holds the
National Cancer Institute (NCI)
responsible, as a sponsor of
investigational drug trials, for the
collection of information about the
clinical investigators who participate in
these trials and to assure the FDA that
systems for accountability are being
maintained by investigators in its
clinical trials program. The information
collected is used to identify qualified
investigators and to facilitate the
submission and distribution of
important information relative to the
investigational drug and the response of
the patient to that drug. Investigators are
physicians who specialize in the
treatment of patients with cancer. Data
obtained from the Drug Accountability
Record is used to track the dispensing
of investigational anticancer agents from
receipt from the NCI to dispensing or
administration to patients. NCI and/or
its auditors use this information for
compliance purposes.
OMB approval is requested for 3
years. There are no costs to the
respondents other than their time. The
total estimated annualized burden hours
are 14,328.
E:\FR\FM\15FEN1.SGM
15FEN1
11210
Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices
ESTIMATES OF ANNUAL BURDEN
Number of
respondents
Number of
responses per
respondent
Average time
per response
(in Hours)
Total annual
burden hour
Type of respondents
Form name
Investigators and Designee for Investigator Registration and DARF.
Statement of Investigator .................
20,220
1
15/60
5,050
Supplemental Investigator ...............
Financial Disclosure .........................
Electronic Curriculum Vitae .............
Drug Accountability Record Form
(DARF and DARF-Oral).
20,112
20,800
100
3,907
1
1
1
16
10/60
5/60
15/60
4/60
3,352
1,733
25
4,168
..........................................................
........................
........................
........................
14,328
Totals ..........................................
Dated: February 11, 2013.
Vivian Horovitch-Kelley,
National Cancer Institute Project Clearance
Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2013–03571 Filed 2–14–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of NIH Consensus Development
Conference: Diagnosing Gestational
Diabetes Mellitus
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Institutes of
Health (NIH) is holding a conference,
titled ‘‘Consensus Development
Conference: Diagnosing Gestational
Diabetes Mellitus.’’ The conference will
be open to the public.
DATES: The conference will be held on
March 4–6, 2013, in the NIH Natcher
Conference Center, 45 Center Drive,
Bethesda, Maryland 20892.
FOR FURTHER INFORMATION CONTACT:
Advance information about the
conference and conference registration
materials may be obtained from the NIH
Consensus Development Program
Information Center by calling 888–644–
2667 or by sending an email to
Prevention@mail.nih.gov. The
Information Center’s mailing address is
P.O. Box 2577, Kensington, Maryland
20891. Registration and conference
information are also available on the
NIH Consensus Development Program
Web site at https://prevention.nih.gov/
cdp/.
SUPPLEMENTARY INFORMATION:
Gestational diabetes mellitus (GDM) is a
condition in which women without
previously diagnosed diabetes exhibit
high blood glucose levels during
pregnancy (especially during the third
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:09 Feb 14, 2013
Jkt 229001
trimester of pregnancy). It is defined as
carbohydrate intolerance, which is the
inability of the body to adequately
process carbohydrates (sugars and
starches) into energy for the body, and
develops or is first recognized during
pregnancy. GDM is estimated to occur
in 1–14 percent of U.S. pregnancies,
affecting more than 200,000 women
annually. It is one of the most common
disorders in pregnancy and is associated
with an increased risk of complications
for the mother and child. Potential
complications during pregnancy and
delivery include preeclampsia (high
blood pressure and excess protein in the
urine), cesarean delivery, macrosomia
(large birth weight), shoulder dystocia
(when a baby’s shoulders become
lodged during delivery), and birth
injuries. For the neonate, complications
include difficulty breathing at birth,
hypoglycemia (low blood sugar), and
jaundice. Up to one-half of the women
who have GDM during pregnancy will
develop type 2 diabetes later in life.
Although the U.S. Preventive Services
Task Force found in 2008 that the
evidence was insufficient to assess the
balance between the benefits and harms
of screening women for GDM, the
American College of Obstetricians and
Gynecologists recommends universal
screening for gestational diabetes using
patient history, risk factors, or
laboratory testing, such as with a
glucose challenge test (GCT). Different
approaches are used internationally for
screening and diagnosis of GDM. The
standard method in the United States
begins with a GCT, which involves
drinking a sweetened liquid containing
50 grams of sugar (glucose). A blood
sample is taken after 1 hour, which
measures the glucose level. If high, a
diagnostic test is administered using a
larger dose of glucose, and several blood
tests are performed over 3 hours.
Depending on the test used and the
chosen blood glucose levels that are
used to diagnose GDM, the number of
women who will receive the diagnosis
will vary. Debate continues regarding
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
the choice of tests and the effectiveness
of treatment, especially in women with
mild to moderate glucose intolerance.
Potential harms of screening for GDM
include anxiety for patients and the
potentially adverse effects of a ‘‘highrisk’’ label in pregnancy. In addition,
women diagnosed with GDM face
stressors, including dietary constraints;
a need to add or increase exercise;
frequent self-monitoring of blood
glucose levels; and, for some, selfadministration of insulin, which will
require adjustments of insulin doses.
To better understand the benefits and
risks of various GDM screening and
diagnostic approaches, the NIH has
engaged in a rigorous assessment of the
available scientific evidence. This
process is sponsored by the Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
and the NIH Office of Disease
Prevention. A multidisciplinary
planning committee developed the
following key questions:
1. What are the current screening and
diagnostic approaches for gestational
diabetes mellitus, what are the glycemic
thresholds for each approach, and how
were these thresholds chosen?
2. What are the effects of various
gestational diabetes mellitus screening/
diagnostic approaches for patients,
providers, and U.S. health care systems?
3. In the absence of treatment, how do
health outcomes of mothers who meet
various criteria for gestational diabetes
mellitus and their offspring compare
with those who do not?
4. Does treatment modify the health
outcomes of mothers who meet various
criteria for gestational diabetes mellitus
and their offspring?
5. What are the harms of treating
gestational diabetes mellitus, and do
they vary by diagnostic approach?
6. Given all of the above, what
diagnostic approach(es) for gestational
diabetes mellitus should be
recommended, if any?
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11209-11210]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03571]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission of OMB Review; Comment Request (30-Day FRN):
Drug Accountability Report Form and Investigator Registration
Procedure in the Conduct of Investigational Trials for the Treatment of
Cancer (NCI)
SUMMARY: In compliance with the requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NIH) has submitted to the Office of Management and Budget (OMB) a
request for review and approval of the information collected below.
This proposed information collection was previously published in the
Federal Register on September 20, 2012 (77 FR 58401) 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 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 March 1,
2011, unless it displays a valid OMB control number.
Written comments or suggestions regarding the item(s) contained in
this notice, especially regarding the estimated public burden and
associated response times, should be directed to the Attention: NIH
Desk Officer, Office of Management and Budget, at OIRA_submission@omb.eop.gov or by fax to 202-395-6974. To request more
information on the proposed project or to obtain a copy of the data
collection plans and instruments, contact Charles L. Hall, Jr., Chief,
Pharmaceutical Management Branch, Cancer Therapy Evaluation Program,
Division of the Cancer Treatment and Diagnosis, and Centers, National
Cancer Institute, Executive Plaza North, Room 7148, 9000 Rockville
Pike, Bethesda, MD 20892 or call non-toll-free number 301-496-5725 or
Email your request, including your address to: Hallch@mail.nih.gov.
Comments regarding this information collection are best assured of
having their full effect if received within 30 days following the date
of this publication.
Proposed Collection: Drug Accountability Report Form and
Investigator Registration Procedure in the Conduct of Investigational
Trials for the Treatment of Cancer (NCI), OMB No.0925-0613, Expiration
Date: 2/28/2013, Revision, National Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information Collection: The U.S. Food and Drug
Administration (FDA) holds the National Cancer Institute (NCI)
responsible, as a sponsor of investigational drug trials, for the
collection of information about the clinical investigators who
participate in these trials and to assure the FDA that systems for
accountability are being maintained by investigators in its clinical
trials program. The information collected is used to identify qualified
investigators and to facilitate the submission and distribution of
important information relative to the investigational drug and the
response of the patient to that drug. Investigators are physicians who
specialize in the treatment of patients with cancer. Data obtained from
the Drug Accountability Record is used to track the dispensing of
investigational anticancer agents from receipt from the NCI to
dispensing or administration to patients. NCI and/or its auditors use
this information for compliance purposes.
OMB approval is requested for 3 years. There are no costs to the
respondents other than their time. The total estimated annualized
burden hours are 14,328.
[[Page 11210]]
Estimates of Annual Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondents Form name Number of responses per per response Total annual
respondents respondent (in Hours) burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigators and Designee for Investigator Statement of Investigator.............. 20,220 1 15/60 5,050
Registration and DARF.
Supplemental Investigator.............. 20,112 1 10/60 3,352
Financial Disclosure................... 20,800 1 5/60 1,733
Electronic Curriculum Vitae............ 100 1 15/60 25
Drug Accountability Record Form (DARF 3,907 16 4/60 4,168
and DARF-Oral).
---------------------------------------------------------------
Totals..................................... ....................................... .............. .............. .............. 14,328
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: February 11, 2013.
Vivian Horovitch-Kelley,
National Cancer Institute Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2013-03571 Filed 2-14-13; 8:45 am]
BILLING CODE 4140-01-P
