Notice of NIH Consensus Development Conference: Diagnosing Gestational Diabetes Mellitus, 38844-38845 [2012-15992]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES 38844 Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Notices institutions; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: University administrators and principal investigators. The annual reporting burden is as follows: Total Estimated Number of Respondents: 112,986. Estimated Number of Responses per Respondent: 1. Average Burden Hours per Response: 5.6. Estimated Total Annual Burden Hours Requested: 640,677. The annualized cost to respondents is estimated to be $22,423,709. 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VerDate Mar<15>2010 16:52 Jun 28, 2012 Jkt 226001 Date: June 25, 2012. Lawrence A. Tabak, Deputy Director, National Institutes of Health. [FR Doc. 2012–15929 Filed 6–28–12; 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 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 October 29–31, 2012, 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 that 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), caesarean 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, PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 hypoglycemia (low blood sugar), and jaundice. Up to one-half of 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 ‘‘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 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 E:\FR\FM\29JNN1.SGM 29JNN1 Federal Register / Vol. 77, No. 126 / Friday, June 29, 2012 / Notices 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? 7. What are the key research gaps in the diagnostic approach of gestational diabetes mellitus? An evidence report on GDM will be prepared through the Agency for Healthcare Research and Quality’s Evidence-based Practice Centers program, and a Consensus Development Conference will be held on October 29– 31, 2012. 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 measures to ensure the safety of NIH 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: June 21, 2012. Francis S. Collins, Director, National Institutes of Health. [FR Doc. 2012–15992 Filed 6–28–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; 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 VerDate Mar<15>2010 16:52 Jun 28, 2012 Jkt 226001 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: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel, 2013–01 SBIR Review. Date: September 24, 2012. Time: 10:00 a.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Ruixia Zhou, Ph.D., Scientific Review Officer, 6707 Democracy Boulevard, Democracy Two Building, Suite 957, Bethesda, MD 20892, 301–496–4773, zhour@mail.nih.gov. Dated: June 22, 2012. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2012–16075 Filed 6–28–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Scientific Management Review Board. The NIH Reform Act of 2006 (Public Law 109–482) provides organizational authorities to HHS and NIH officials to: (1) Establish or abolish national research institutes; (2) reorganize the offices within the Office of the Director, NIH including adding, removing, or transferring the functions of such offices or establishing or terminating such offices; and (3) reorganize, divisions, centers, or other administrative units within an NIH national research institute or national center including adding, removing, or transferring the functions of such units, or establishing or terminating such units. The purpose of the Scientific Management Review Board (also referred to as SMRB or Board) is to advise appropriate HHS and NIH officials on the use of these organizational authorities and identify PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 38845 the reasons underlying the recommendations. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: Scientific Management Review Board. Date: July 11, 2012. Time: 08:00 a.m. to 4:30 p.m. Agenda: The focus of this meeting will be on the deliberations of the SMRB’s NIH Small Business Innovation Research/Small Business Technology Transfer Program Working Group and its first stakeholder consultation. Presentation and discussion will include, but is not limited to, representatives from NIH Institutes and Centers and other government agencies with Small Business Innovation Research and Small Business Technology Transfer Programs. The Board will also discuss next steps regarding future SMRB activities. Time will be allotted on the agenda for public comment. Sign up for public comments will begin approximately at 7:30 a.m. on July 11, 2012 and will be restricted to one sign-in per person. In the event that time does not allow for all those interested to present oral comments, any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Place: National Institutes of Health, Building 31, 6th Floor, Conference Room 6, 31 Center Drive, Bethesda, MD 20892. Contact Person: Lyric Jorgenson, Ph.D., Office of Science Policy, Office of the Director, NIH, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, smrb@mail.nih.gov, (301) 496– 6837. This meeting is being published less than 15 days prior to the meeting due to scheduling conflicts of the Members. The meeting will also be webcast. The draft meeting agenda and other information about SMRB, including information about access to the webcast, will be available at https:// smrb.od.nih.gov. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxis, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research E:\FR\FM\29JNN1.SGM 29JNN1

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[Federal Register Volume 77, Number 126 (Friday, June 29, 2012)]
[Notices]
[Pages 38844-38845]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15992]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice of NIH Consensus Development Conference: Diagnosing 
Gestational Diabetes Mellitus

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 October 29-31, 2012, 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 that 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), 
caesarean 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 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 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

[[Page 38845]]

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?
    7. What are the key research gaps in the diagnostic approach of 
gestational diabetes mellitus?
    An evidence report on GDM will be prepared through the Agency for 
Healthcare Research and Quality's Evidence-based Practice Centers 
program, and a Consensus Development Conference will be held on October 
29-31, 2012.
    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 measures to ensure the safety of NIH 
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: June 21, 2012.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2012-15992 Filed 6-28-12; 8:45 am]
BILLING CODE 4140-01-P
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