[Federal Register Volume 77, Number 227 (Monday, November 26, 2012)]
[Notices]
[Pages 70451-70452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28608]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Report of the Evidence-Based Methodology Workshop on Polycystic 
Ovary Syndrome--Request for Comments

SUMMARY: The National Institutes of Health (NIH) will place in the 
docket for public review and comment a report resulting from the NIH 
Evidence-Based Methodology Workshop on Polycystic Ovary Syndrome, to be 
held December

[[Page 70452]]

3-5, 2012. The purpose of the report is to summarize the workshop and 
identify future research priorities. The report will be available 
online beginning December 7, 2012, at http://prevention.nih.gov/workshops/2012/pcos/default.aspx.

DATES: Comments on the report will be accepted from December 7, 2012, 
to January 4, 2013.

ADDRESSES: Written comments must be postmarked by January 4, 2013, and 
should be sent to the NIH Office of Disease Prevention, ATTN: Paris A. 
Watson, 6100 Executive Boulevard, Suite 2B03, Bethesda, Maryland 20892. 
Email comments should be sent to [email protected] by January 4, 
2013.

FOR FURTHER INFORMATION CONTACT: To request more information, please 
contact Paris A. Watson at 301-496-6615 or [email protected].

SUPPLEMENTARY INFORMATION: Polycystic ovary syndrome (PCOS) is a common 
hormone disorder that affects approximately 5 million reproductive-aged 
women in the United States. Women with PCOS have difficulty becoming 
pregnant (i.e., are infertile) due to hormone imbalances that cause or 
result from altered development of ovarian follicles. One such 
imbalance is high blood levels of androgens, which can come from both 
the ovaries and adrenal gland. Other organ systems that are affected by 
PCOS include the pancreas, liver, muscle, blood vasculature, and fat.
    In addition to fertility impairment, other common symptoms of PCOS 
include:
     Irregular or no menstrual periods (for women of 
reproductive age)
     Acne
     Weight gain
     Excess hair growth on the face and body
     Thinning scalp hair
     Ovarian cysts.
    Women with PCOS are often resistant to the biological effects of 
insulin and, as a consequence, may have high insulin levels. As such, 
women with PCOS are at risk for type 2 diabetes, high cholesterol, and 
high blood pressure. Obesity also appears to worsen the condition. 
Costs to the U.S. health care system to identify and manage PCOS are 
approximately $4 billion annually; however, this estimate does not 
include treatment of the serious conditions associated with PCOS.
    For most of the 20th century, PCOS was a poorly understood 
condition. In 1990, the NIH held a conference on PCOS to create both a 
working definition of the disorder and diagnostic criteria. The outcome 
of this conference, the NIH Criteria, served as a standard for 
researchers and clinicians for more than a decade. In 2003, a consensus 
workshop in Rotterdam developed new diagnostic criteria, the Rotterdam 
Criteria. The 2012 NIH Evidence-Based Methodology Workshop on PCOS 
seeks to clarify:
     The benefits and drawbacks of using the Rotterdam 
Criteria;
     The condition's causes, predictors, and long-term 
consequences;
     The optimal prevention and treatment strategies.
    The NIH workshop is sponsored by the Office of Disease Prevention 
and the Eunice Kennedy Shriver National Institute of Child Health and 
Human Development. A multidisciplinary steering committee developed the 
workshop agenda. The NIH Library created an extensive, descriptive 
bibliography on PCOS to facilitate workshop discussion. During the two-
and-one-half-day workshop, invited experts will discuss the body of 
evidence and attendees will have opportunities to provide comments 
during open discussion periods. After weighing the evidence, an 
unbiased, independent panel will prepare a report that summarizes the 
workshop and identifies future research priorities.
    The report will be available online beginning December 7, 2012, at 
http://prevention.nih.gov/workshops/2012/pcos/default.aspx.

    Dated: November 16, 2012.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2012-28608 Filed 11-23-12; 8:45 am]
BILLING CODE 4140-01-P