[Federal Register Volume 69, Number 250 (Thursday, December 30, 2004)]
[Notices]
[Pages 78414-78416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28610]


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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 [email protected].
    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....................................
                                                 -----------------
    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