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Agency Forms Undergoing Paperwork Reduction Act Review

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The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639-4766 or send an e-mail to Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395-6974. Written comments should be received within 30 days of this notice.

Proposed Project

Hemophilia Treatment Center Laboratory Survey—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Start Printed Page 3306

Background and Brief Description

Up to 2 million women in the United States may have an inherited bleeding disorder and not know it. Many women learn to live with the problems their bleeding causes, such as heavy periods, and do not realize that they may have a bleeding disorder. Other women may have more serious bleeding problems such as hemorrhages after childbirth or surgery, and some have hysterectomies to end their heavy periods. With proper diagnosis, women with bleeding disorders could avoid these complications and surgeries. Management of bleeding in these women can decrease heavy periods and can improve quality of life.

The most common bleeding disorder is called Von Willebrand disease (VWD). VWD is caused by a deficiency or defect in the body's ability to make a protein, Von Willebrand factor, which helps blood clot. The symptoms of VWD can range in severity; however, 90 percent of people who have this disease have the mild form. VWD occurs in men and women equally, but women are more likely to notice the symptoms of VWD due to heavy or abnormal bleeding during their menstrual periods and after childbirth. There are many gynecological and physical causes for heavy periods, such as endometriosis, thyroid problems and cancer; however, the cause is not identified in half the cases. A CDC-Emory University survey found that gynecologists rarely considered bleeding disorders as a cause of heavy menstrual bleeding. However, recent research from Europe and CDC has shown that 15-20% of women with heavy periods have inherited bleeding disorders. Women with VWD interviewed by CDC reported an average of 16 years between the onset of bleeding symptoms and diagnosis of a bleeding disorder. CDC and the National Hemophilia Foundation have been working to encourage gynecologists to consider bleeding disorders in women who have heavy menstrual bleeding, also called menorrhagia. As a result, the American College of Obstetricians and Gynecologists has recently recommended screening for VWD in these women.

An important part of increasing the awareness among physicians and their patients with heavy periods who may have an underlying bleeding disorder is referral for appropriate diagnosis. Federally funded Hemophilia Treatment Centers (HTCs) are thought to be the best source for appropriate laboratory diagnosis, however, the following concerns have been raised: (1) Anecdotal reports from HTC providers describe reduced capacity of in-house laboratory support and access to specialty coagulation laboratory tests that are essential for appropriate diagnosis of bleeding disorders; (2) A CDC Public Health Practice Program Office (PHPPO) study demonstrated reduced capacity to perform specific coagulation tests through their survey of hospital laboratories; but it is impossible to know if HTCs have higher capacity than the hospitals studied; (3) HTCs report that changes in third party payer policies, especially health maintenance organizations, are dictating the source of laboratory testing requiring shipment of laboratory specimens to sites away from the hospital that reduce the quality of the sample and affect the reliability of the results. It is important to assess the HTCs and determine their capabilities and barriers to delivering comprehensive care to patients with bleeding disorders.

The setting for the proposed study is the 135 federally funded HTCs, and the Directors and Lab Directors of these 135 HTCs will be the potential respondents. A survey will be distributed to the above personnel to ascertain their perceptions of lab capabilities and procedures.

The data received from this survey will allow CDC to evaluate the functional status of HTC labs, describe the services available, and make programmatic decisions that will best serve the medical needs of this population.

There will be no cost to the respondents other than their time. The total estimated annualized burden hours are 90.

Estimated Annualized Burden Table

Type of respondentsNumber of respondentsResponse per respondentBurden per response (in hours)
HTC Directors135120/60
Lab Directors135120/60
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Dated: January 11, 2006.

Betsey S. Dunaway,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.

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[FR Doc. E6-617 Filed 1-19-06; 8:45 am]