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 Department of Health and Human Services Health Resources and Services Administration
 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, Pub. L. 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, e-mail 
                    *paperwork@hrsa.gov*
                     or call the HRSA Reports Clearance Officer at (301) 443-1129. *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.
                    ( print page 52534) Proposed Project: Sickle Cell Disease and Other Hemoglobinopathies Program Evaluation—[NEW] *Background:*
                     In response to the growing need for resources devoted to sickle cell disease and other hemoglobinopathies, Congress, under Section 501(a)2 of the Social Security Act (2000), authorized the appropriation of funds for enabling the Secretary to provide for special projects of regional and national significance, research and training with respect to maternal and child health and children with special health care needs the following: Genetic disease testing, counseling and information development and dissemination programs, for grants relating to hemophilia without regard to age, and for the screening of newborns for sickle cell anemia and other genetic disorders, and follow-up services. As stated in House Report No. 107-229 regarding the Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill 2002, the purpose of the Sickle Cell Disease and Newborn Screening Program (SCDNBSP) is “to enhance the sickle cell disease newborn screening program and its locally based outreach and counseling efforts.” In addition, the American Jobs Creation Act of 2004, Public Law 108-357, states that “* * * the Bureau of Primary Health Care and the Maternal and Child Health Bureau, shall conduct a demonstration program by making grants for up to 40 eligible entities, for each fiscal year in which the program is conducted under this section, for the purpose of developing and establishing systemic mechanisms to improve the prevention and treatment of Sickle Cell Disease.” (
                    *See*42 U.S.C. 300b-1). *Purpose:*
                     HRSA's activities under the legislative authorities relative to the Sickle Cell Disease and Newborn Screening Program (SCDNBSP) have been delegated to the Maternal and Child Health Bureau (MCHB), Genetic Services Branch (GSB). The MCHB's GSB supports seventeen community based organizations and the National Coordinating and Evaluation Center for the Sickle Cell Disease and Newborn Screening Program (SCDNBS) in addition to nine cooperative agreements and a National Coordinating Center for the Sickle Cell Disease Treatment Demonstration Program (SCDTDP). An evaluation will be conducted to assess the service delivery processes and quality of the system of care delivered by grantees under the Newborn Screening Program to individuals affected by Sickle Cell disease who present at their sites for care. The Centers for Disease Control and Prevention defines Hemoglobinopathies as “a group of disorders affecting red blood cells. SCD and Thalassemia are included in this group.” (
                    *See http://www.cdc.gov/​ncbddd/​sicklecell/​RuSH_​FAQs.html*). The information from the evaluation will be used to evaluate the grantees' performance in achieving the objectives of the hemoglobinopathies program during the grant period, assess the breadth of grantees' outreach to emerging populations affected by hemoglobinopathies and the needs of those populations attempting to access services. Data collection tools for which OMB approval is being requested are as follows: (1) The Minimum Database Project Sickle Cell Disease (MDP SCD) Questionnaire, (2) the Minimum Database Project Sickle Cell Trait/Carrier (MDP SCT) Questionnaire, and (3) the MDP Hemoglobinopathies Emerging Populations Questionnaire. Respondents: The MDP SCD and the MDP SCT Questionnaires will be administered by grantees to clients or caregivers when they present for services. At the time of enrollment, SCDNBSP participants will be informed about the data collection and clients will be asked to participate in either the SCD questionnaire or the SCT questionnaire depending on their disease or carrier status. The program will enroll participants on a rolling basis such that new patients will be added to the program as they present for services and provide consent. Data will be collected at two points annually for the SCD Questionnaire, the first, when clients and caregivers are enrolled into the SCDNBS Program and the second, at follow-up after enrollment. Data will be collected once annually for the SCT Questionnaire. The Hemoglobinopathies Emerging Populations Form serves as a stand alone form for the other HRSA hemoglobinopathies programs, with its content. These questions are also embedded in the MDT SCD and MDP SCT questionnaires. The HRSA hemoglobinopathies programs also plan to use this questionnaire in developing educational materials, prioritizing outreach activities and informing decisions for future funding requests. The annual estimate of burden is as follows: Questionnaires
Number of 
                             respondents
Responses per 
                             respondent
Total 
                             responses
Average hours per response
Total hour burden
Wage rate
Total hour costMDP SCD Questionnaire
140
2
280
.45
126
$20.90
$2,633.40MDP SCT Questionnaire
1,400
1
1,400
.30
420
20.90
8,778.00Hemoglobinopathies Emerging Populations Form
*1,125
2
*2,250
.20
450
20.90
9,405.00Total
2,665

3,930

996

20,816.40
 E-mail comments to 
                    *paperwork@hrsa.gov*
                     or mail the 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: August 19, 2010. Sahira Rafiullah, Director, Division of Policy and Information Coordination.


[FR Doc. 2010-21220 Filed 8-25-10; 8:45 am] BILLING CODE 4165-15-P