[Federal Register: December 30, 2004 (Volume 69, Number 250)]
[Notices]
[Page 78414-78416]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de04-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-05AV]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-371-5973 or
send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the
[[Page 78415]]
use of automated collection techniques or other forms of information
technology. Written comments should be received within 60 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).
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 not realize
that they could 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 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 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; and (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 effect 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 are federally funded HTCs. The
study participants are composed of medical directors, adult
hematologists, pediatric hematologists, and coagulation laboratory
technicians. A survey will be distributed to the above personnel to
ascertain their perceptions of lab capabilities and procedures.
Research questions of interest include the following:
(1) What tests can be performed?
(2) How timely can results be obtained?
(3) Which HTCs have an in-house coagulation laboratory?
(4) What percentage of tests must be sent to outside laboratories?
(5) What is the perceived quality of results obtained from an
outside laboratory?
A stamped, self-addressed envelope will be attached to each survey,
along with a cover letter explaining the survey. After a specified
period of time, non-responders will receive a phone call reminder and
sent another copy of the survey if needed. There will be no cost to the
respondents except their time to complete the survey.
Annualized Burden Table
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Number of Average burden
Respondents Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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HTC medical directors and coagulation 325 1 20/60 108
technicians....................................
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Total....................................... .............. .............. .............. 108
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[[Page 78416]]
Dated: December 23, 2004.
Joseph E. Salter,
Acting Director, Management Analysis and Services Office, Centers for
Disease Control and Prevention.
[FR Doc. 04-28610 Filed 12-29-04; 8:45 am]
BILLING CODE 4163-18-P