[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Notices]
[Pages 4411-4412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01163]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-12RP]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to [email protected]. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC 
20503 or by fax to (202) 395-5806. Written comments should be received 
within 30 days of this notice.

Proposed Project

    Assessment of the Psychosocial Impact of Newborn Screening for 
Congenital Cytomegalovirus (CMV) Infection--New--National Center for 
Immunization and Respiratory Diseases (NCIRD) and National Center on 
Birth Defects and Developmental Disabilities (NCBDDD), Centers for 
Disease Control and Prevention (CDC).

[[Page 4412]]

Background and Brief Description

    Each year in the United States, more than 30,000 children are born 
with congenital CMV infection. Approximately 80% develop normally, 
while the remaining 20% are born with or subsequently develop 
disabilities such as hearing loss or mental retardation. A similar 
number of children are affected by serious CMV-related disabilities 
than by several better-known childhood conditions, including Down 
Syndrome and Spina Bifida.
    The birth prevalence of congenital CMV infection is several times 
higher than the combined birth prevalence of all metabolic or endocrine 
disorders in the core U.S. newborn screening panel. Because newborn CMV 
screening is rarely performed, and because a definitive diagnosis of 
congenital CMV requires access to urine, saliva, or blood collected 
soon after birth, most infected children are never diagnosed. Newborn 
CMV screening offers some clear potential benefits, but few studies 
have assessed the potential for harm (e.g., increased parental anxiety, 
``fragile child syndrome'').
    CDC is requesting OMB approval for one year to collect information 
about newborn CMV screening. The purpose of this information collection 
is to understand the psychosocial impact of newborn screening on 
parents whose infants underwent CMV screening as part of a routine 
infant CMV screening program in Houston, Texas. The potential study 
population includes approximately 70 CMV-infected children who were 
symptomatic at birth, 100 CMV-infected children who were asymptomatic 
at birth (20 of whom developed sequelae), and 50 controls that were 
CMV-uninfected. The goals of this information collection are to: (1) 
Document the positive and negative psychosocial impacts of newborn CMV 
screening on parents and their children; (2) identify modifiable 
factors that might increase positive psychosocial impacts and decrease 
negative psychosocial impacts of newborn CMV screening; (3) use what is 
learned about psychosocial impacts to identify key messages that 
parents need relative to newborn CMV screening and follow-up; and (4) 
to learn what challenges are associated with obtaining a congenital CMV 
diagnosis in the absence of CMV newborn screening.
    Much of the potential study population is unique in that their 
children experienced newborn CMV screening as part of a previous 
research study. Universal CMV screening has not been recommended by 
medical associations or state or federal governments and as a result 
newborn CMV screening is not typically performed. The parents' 
experience with CMV screening and follow-up will help inform decisions 
about whether newborn CMV screening would be good public health policy. 
This study represents the first assessment of the experiences of 
parents whose children were screened for CMV at birth.
    Respondents fall into four categories depending on the past 
experiences of their child who was screened for CMV:
     Parent Group 1 (PG1)--Child screened positive for 
congenital CMV at birth, asymptomatic at birth, but did not develop 
sequelae
     Parent Group 2 (PG2)--Child screened positive for 
congenital CMV at birth, asymptomatic at birth, but did subsequently 
develop sequelae (e.g., hearing loss)
     Parent Group 3 (PG3)--Child was diagnosed with congenital 
CMV and had symptoms at birth
     Parent Group 4 (PG4)--Child screened negative for 
congenital CMV at birth
    Information will be collected from PG1 via focus groups, from PG2 
and PG3 via interviews, and from all four parent groups via a mail 
survey. The focus group, interview and survey respondents will be asked 
to participate only once. It is estimated that 71 parents will 
participate in either individual interviews or focus groups and that 
230 will participate in the mail survey. The interviews are planned to 
take 60 minutes while the focus groups will be held for 90 minutes. The 
survey is estimated to take 10 minutes per respondent to complete and 
mail based on previous administrations reported in the literature. 
Reading and responding to the focus group and interview recruitment 
letters is estimated to take 5 minutes each. There is no cost to 
respondents other than their time. The annualized estimated burden 
hours are 135.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                  Average burden
          Type of respondent                    Form name            Number of     Responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Parent Group 1........................  Focus Group Guide.......              36               1             1.5
                                        Focus group recruitment               50               1            5/60
                                         letter.
Parent Groups 2 and 3.................  Interviewer guide.......              35               1               1
                                        Interview recruitment                 50               1            5/60
                                         letter.
Parent Groups 1,2,3, and 4............  Survey..................             230               1           10/60
----------------------------------------------------------------------------------------------------------------


    Dated: January 14, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2013-01163 Filed 1-18-13; 8:45 am]
BILLING CODE P