[Federal Register: June 13, 2003 (Volume 68, Number 114)]
[Notices]
[Page 35417-35418]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn03-86]
-----------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Average
Number of Number burden per Total burden
Respondents respondents responses per response (in (in hrs.)
respondent hrs.)
----------------------------------------------------------------------------------------------------------------
HTC medical directors & coagulation technicians. 325 1 20/60 108
-----------------
Total....................................... .............. .............. .............. 108
----------------------------------------------------------------------------------------------------------------
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