[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58395-58396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23197]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-12-12RP]
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 404-639-7570 or
send comments to Kimberly S. Lane, at 1600 Clifton Road, MS D74,
Atlanta, GA 30333 or send an email to [email protected].
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
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).
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.
[[Page 58396]]
Estimates of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Parent category Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Parent Group 1................ Focus Group 36 1 1.5 54
Guide.
Focus group 50 1 5/60 4
recruitment
letter.
Parent Groups 2 and 3......... Interviewer 35 1 1 35
guide.
Interview 50 1 5/60 4
recruitment
letter.
Parent Groups 1, 2, 3, and 4.. Survey.......... 230 1 10/60 38
---------------------------------------------------------------
Total Burden Hours........ ................ .............. .............. .............. 135
----------------------------------------------------------------------------------------------------------------
Dated: September 14, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2012-23197 Filed 9-19-12; 8:45 am]
BILLING CODE 4163-18-P