[Federal Register Volume 68, Number 114 (Friday, June 13, 2003)]
[Notices]
[Pages 35417-35418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14912]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-03-77]


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 the CDC Reports 
Clearance Officer on (404) 498-1210.
    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 use of automated collection techniques or other 
forms of information technology. Send comments to Anne O'Connor, CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. Written comments should be received within 60 days 
of this notice.
    Proposed Project: Hemophilia Treatment Center Laboratory Survey--
New--National Center for Infectious Diseases (NCID), Centers for 
Disease Control and Prevention (CDC). Up to two 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,

[[Page 35418]]

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 percent 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, 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 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 proposed study will involve the 135 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. There 
will be no cost to respondents.

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                                                                                      Average
                                                     Number of        Number        burden per     Total burden
                   Respondents                      respondents    responses per   response (in      (in hrs.)
                                                                    respondent         hrs.)
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HTC medical directors & coagulation technicians.             325               1           20/60             108
                                                 -----------------
    Total.......................................  ..............  ..............  ..............             108
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    Dated: June 9, 2003.
Thomas A. Bartenfeld,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 03-14912 Filed 6-12-03; 8:45 am]
BILLING CODE 4163-18-P