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Notice

Proposed Data Collections Submitted for Public Comment and Recommendations

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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 Start Printed Page 78415use 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

RespondentsNumber of respondentsNumber of responses per respondentAverage burden per response (in hours)Total burden (in hours)
HTC medical directors and coagulation technicians325120/60108
Total108
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Dated: December 23, 2004.

Joseph E. Salter,

Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.

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[FR Doc. 04-28610 Filed 12-29-04; 8:45 am]

BILLING CODE 4163-18-P]