E7-25603. Agency Information Collection Activities: Proposed Collection: Comment Request

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on [phone].

Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the agency; (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.

Proposed Project: Sickle Cell Disease Treatment Demonstration Program (SCDTDP), Health Resources and Services Administration (HRSA): NEW

In 2004 Congress enacted and the President signed into law Pub. L. 108-357, the American Jobs Creation Act of 2004. Section 712 of Pub. L. 108-357 authorized a demonstration program for the prevention and treatment of Sickle Cell Disease. The legislation was enacted to (1) create an optional medical assistance program for individuals with Sickle Cell Diseases for treatment and education, genetic counseling and other services to prevent mortality and decrease morbidity from Sickle Cell Disease, and (2) create a demonstration program, the SCDTDP, under HRSA. The SCDTDP provides grants to federally-qualified and nonprofit health care providers to establish geographically distributed regional networks that will work with comprehensive Sickle Cell Disease centers and community-based support organizations to provide coordinated, comprehensive, culturally competent, and family-centered care to families with Sickle Cell Disease. In fiscal year 2006, HRSA awarded four, 4-year grants to the Illinois Sickle Cell Association Network, Alabama Network for Sickle Cell Care, Access, Prevention, and Education, Carolina Partnership for Sickle Cell Treatment Continuum of Care, and the Cincinnati Sickle Cell Network.

Under the authorizing legislation, a National Coordinating Center (NCC) was established to (1) collect, coordinate, monitor, and distribute data, best practices and findings regarding the activities of the demonstration program; (2) identify a model protocol for eligible entities with respect to the prevention and treatment of Sickle Cell Disease; (3) identify educational materials regarding the prevention and treatment of Sickle Cell Disease; and (4) prepare a final report on the efficacy of the demonstration program based on evaluation findings.

As part of the evaluation, pre- and post-utilization and satisfaction data and quality of life assessments will be collected from the demonstration clients during various phases of their participation. These data will be collected through medical record abstractions and self-report using hard copy questionnaires and submitted to the NCC for processing and analysis. The total burden estimate per participant is shown below:

Type of respondent	Form name	Number of respondents	Responses per respondent	Hours per response	Total burden hours
Sickle Cell Disease clients or caregivers	Utilization Questionnaire (pre-demonstration)	400	1	.75	300 hours.
Sickle Cell Disease clients or caregivers	Utilization Questionnaire (post-demonstration)	400	1	.50 hours	200 hours.
Sickle Cell Disease clients or caregivers	SF-36 Health Survey for adults over 18 years of age; PedsQL for children/adolescents 18 years or younger (Quality of Life)	400	2	.25 hours	200 hours.
Sickle Cell Disease clients or caregivers	The Medical Home Family Index (Health Care Satisfaction)	400	2	.25 hours	200 hours.

The total burden is 900 hours or 2.25 hours per participant. This would be the maximum level of burden since some of the demonstration networks will be able to abstract medical records for some of the data collected on the Utilization Questionnaire.

Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice.

Dated: December 27, 2007.

Alexandra Huttinger,

Acting Director, Division of Policy Review and Coordination.