[Federal Register Volume 75, Number 165 (Thursday, August 26, 2010)]
[Notices]
[Pages 52533-52534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21220]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


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, 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 <a href="/cdn-cgi/l/email-protection#235342534651544c5148634b5150420d444c55"><span class="__cf_email__" data-cfemail="413120312433362e332a01293332206f262e37">[email protected]</span></a> 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.

[[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:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Number of     Responses per       Total       Average hours   Total hour                Total hour
                  Questionnaires                     respondents     respondent       responses     per response      burden     Wage rate       cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDP SCD Questionnaire............................             140               2             280             .45          126       $20.90    $2,633.40
MDP SCT Questionnaire............................           1,400               1           1,400             .30          420        20.90     8,778.00
Hemoglobinopathies Emerging Populations Form.....          *1,125               2          *2,250             .20          450        20.90     9,405.00
                                                  ------------------------------------------------------------------------------------------------------
    Total........................................           2,665  ..............           3,930  ..............          996  ...........    20,816.40
--------------------------------------------------------------------------------------------------------------------------------------------------------

    E-mail comments to <a href="/cdn-cgi/l/email-protection#037362736671746c7168436b7170622d646c75"><span class="__cf_email__" data-cfemail="ccbcadbca9bebba3bea78ca4bebfade2aba3ba">[email protected]</span></a> 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


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>