[Federal Register Volume 71, Number 13 (Friday, January 20, 2006)]
[Notices]
[Pages 3305-3306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-06-05AV]


Agency Forms Undergoing Paperwork Reduction Act Review

    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 [email protected]. 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).

[[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
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                                                                                                    Burden per
                      Type of  respondents                           Number of     Response per    response (in
                                                                    respondents     respondent        hours)
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HTC Directors...................................................             135               1           20/60
Lab Directors...................................................             135               1           20/60
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    Dated: January 11, 2006.
Betsey S. Dunaway,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E6-617 Filed 1-19-06; 8:45 am]
BILLING CODE 4163-18-P