Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-08AL]

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 404-639-5960 and send comments to 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 use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

The Natural History of Spina Bifida in Children Pilot Project—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

Spina Bifida (SB) is one of the most common birth defects, affecting approximately 2 per 10,000 live births in the United States annually. To date, there are no U.S. population-based cohort studies or programs on the natural history of SB. This is of importance because persons with SB often experience condition-specific difficulties and secondary conditions that detrimentally affect several aspects of their lives. The long-term purpose of this project is to increase the knowledge about the natural history of Spina Bifida

by prospectively studying children who were born with this potentially disabling condition. We estimate to enroll approximately 40 parents with a child with Spina Bifida ages 3-, 4-, or 5-years of age, and 20 of the children of these forty parents. The data to be collected will relate to medical concerns prevalent among individuals with Spina Bifida in the areas of neurology/neurosurgery, urology, and orthopedics; development and learning; nutrition and physical growth; mobility and functioning; general health; and family demographics. Families interested in participating can choose between participating in a phone survey (no more than 40 minutes) or an in-person assessment (no more than 2 hrs). For families who participate in the in-person assessment, (estimated to be twenty of the forty families); the child will also be invited to participate in a child-appropriate assessment. Data will also be collected on the actual recruitment process. Results from the project will be evaluated and disseminated to provide guidance for states that are interested in following children with Spina Bifida prospectively. The proposed project is the initial step to document the development, the health status, and the onset of complications among children with SB in order that effective interventions may be identified that will ameliorate the course of this complex, multi-system condition. Long-term results will help determine if it would be beneficial to systematically screen children with Spina Bifida for certain health related, educational and developmental problems that these children are at an increased risk of experiencing and at what age such a screening should be performed.

There will be no cost to the respondents other than their time.

Estimate of Annualized Burden Hours

Respondents

Number of

respondents

Number of

responses per respondent

Average

burden per

response

(in minutes)

Total burden hours

Parents (phone survey)

20

1

40/60

13

Parents (in-person assessment)

20

1

2

40

Child (in-person assessment)

20

1

1

20

Total

73

Dated: January 25, 2008.

Maryam I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.

[FR Doc. E8-1993 Filed 2-4-08; 8:45 am]

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