[Federal Register: January 20, 2006 (Volume 71, Number 13)]
[Notices]
[Page 3305-3306]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ja06-65]
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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 omb@cdc.gov. 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