Notice of NIH Consensus Development Conference: Diagnosing Gestational Diabetes Mellitus, 11210-11211 [2013-03574]
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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
Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices
7. What are the key research gaps in
the diagnostic approach for gestational
diabetes mellitus?
An evidence report on GDM was
prepared through the Agency for
Healthcare Research and Quality’s
Evidence-based Practice Centers
program and this Consensus
Development Conference will be held
on March 4–6, 2013.
During the conference, invited
experts, including the authors of the
evidence report, will present scientific
data. Attendees will have opportunities
to ask questions and provide comments
during open discussion periods. After
weighing the evidence, an unbiased,
independent panel will prepare and
present a consensus statement
addressing the key questions. The
statement will be widely disseminated
to practitioners, policymakers, patients,
researchers, the general public, and the
media.
Please Note: As part of the NIH’s
measures to ensure the safety of
employees and property, all visitors
must be prepared to show a photo ID
upon request. Visitors may be required
to pass through a metal detector and
have bags, backpacks, or purses
inspected or x-rayed as they enter NIH
buildings. For more information about
the security measures at NIH, please
visit the Web site at https://www.nih.gov/
about/visitorsecurity.htm.
Dated: February 8, 2013.
Francis S. Collins,
Director, National Institutes of Health.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with NOTICES
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
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 meeting.
The meeting 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.
19:09 Feb 14, 2013
Jkt 229001
Dated: February 11, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–03525 Filed 2–14–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
[FR Doc. 2013–03574 Filed 2–14–13; 8:45 am]
VerDate Mar<15>2010
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Program Project on
Intestinal Transport.
Date: April 5, 2013.
Time: 12:00 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: Maria E. Davila-Bloom,
Ph.D., Scientific Review Officer, Review
Branch, DEA, NIDDK, National Institutes Of
Health, Room 758, 6707 Democracy
Boulevard, Bethesda, MD 20892–5452, (301)
594–7637, davila-bloomm@extra.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)
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: Center for Scientific
Review Special Emphasis Panel; Research
Service Awards for Individual Predoctoral
Fellows.
Date: March 7, 2013.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Michael Micklin, Ph.D.,
Scientific Review Officer, Center for
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Fmt 4703
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11211
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3136,
MSC 7759, Bethesda, MD 20892, (301) 435–
1258, micklinm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Genomics,
Molecular Evolution and Biochemical
Genetics.
Date: March 7, 2013.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: David J. Remondini, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2210,
MSC 7890, Bethesda, MD 20892, 301–435–
1038, remondid@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business Grant Applications: Immunology.
Date: March 8, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Mayflower Park Hotel, 405 Olive
Way, Seattle, WA 98101.
Contact Person: Stephen M. Nigida, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4212,
MSC 7812, Bethesda, MD 20892, 301–435–
1222, nigidas@csr.nih.gov.
Name of Committee: AIDS and Related
Research Integrated Review Group; HIV/
AIDS Vaccines Study Section.
Date: March 8, 2013
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 033 M Street NW.,
Washington, DC 20036.
Contact Person: Mary Clare Walker, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5208,
MSC 7852, Bethesda, MD 20892, (301) 435–
1165, walkermc@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Biological Chemistry, Biophysics
and Drug Discovery.
Date: March 8, 2013.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Palomar, 2121 P Street, NW,
Washington, DC 20037.
Contact Person: Vonda K Smith, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6188,
MSC 7892, Bethesda, MD 20892, 301–435–
1789, smithvo@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Cardiovascular and Surgical
Devices
Date: March 8, 2013.
Time: 10:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Pages 11210-11211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03574]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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
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 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
``high-risk'' 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, self-administration 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?
[[Page 11211]]
7. What are the key research gaps in the diagnostic approach for
gestational diabetes mellitus?
An evidence report on GDM was prepared through the Agency for
Healthcare Research and Quality's Evidence-based Practice Centers
program and this Consensus Development Conference will be held on March
4-6, 2013.
During the conference, invited experts, including the authors of
the evidence report, will present scientific data. Attendees will have
opportunities to ask questions and provide comments during open
discussion periods. After weighing the evidence, an unbiased,
independent panel will prepare and present a consensus statement
addressing the key questions. The statement will be widely disseminated
to practitioners, policymakers, patients, researchers, the general
public, and the media.
Please Note: As part of the NIH's measures to ensure the safety of
employees and property, all visitors must be prepared to show a photo
ID upon request. Visitors may be required to pass through a metal
detector and have bags, backpacks, or purses inspected or x-rayed as
they enter NIH buildings. For more information about the security
measures at NIH, please visit the Web site at https://www.nih.gov/about/visitorsecurity.htm.
Dated: February 8, 2013.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2013-03574 Filed 2-14-13; 8:45 am]
BILLING CODE 4140-01-P
