Att2_FRN_60d_ACHS II

58394

Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices

individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Agenda items for these meetings are
subject to change as priorities dictate.
Dated: September 6, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012–23164 Filed 9–19–12; 8:45 am]
BILLING CODE 4160–90–M

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
Anniston Community Health Survey:
Follow-up and Dioxin Analyses (ACHS–
II)—New—Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (DHHS) Centers for Disease
Control and Prevention (CDC).

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-12–12RO]

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 and
send comments to Kimberly S. Lane,
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

Background and Brief Description
In the past, polychlorinated biphenyls
(PCBs) were used as coolants and
lubricants in electrical equipment. They
didn’t burn easily and were good
insulators. PCBs are no longer made in
the U.S. They were banned in 1977
because they persist in the environment.
Concerns grew about harm to health.
The City of Anniston, AL, was the site
of the former Monsanto facility. PCBs
were made there from 1929 to 1971. For
decades, PCBs were released into the
local air, soil, and surface water. In
1996, residents found out they were
exposed. Concerns grew and led to
litigation. In 2003, a settlement in favor
of the residents was reached in state and
federal courts.
The Anniston Environmental Health
Research Consortium (AEHRC) was
funded by the Agency for Toxic
Substances and Disease Registry
(ATSDR). The AEHRC conducted the
Anniston Community Health Survey
(ACHS) from 2005 to 2007. Serum PCB
levels in 766 Anniston adults were

found to be three to seven times higher
than in U.S. adults. Also, higher PCB
levels were found in Anniston adults
who had high blood pressure and
diabetes.
The ATSDR and the National
Institutes of Health (NIH) plan to
continue the work of the first ACHS.
These agencies will conduct a follow-up
study called the ACHS–II. It will be a
repeated cross-sectional study. Data
collection will be managed by the
University of Alabama at Birmingham
(UAB) and the Calhoun County Health
Department (CCHD).
A sample of 500 adults will be
selected from the first ACHS cohort.
After informed consent, clinical
assessments will be done. These will be
for blood pressure, height, weight, and
body girth. A questionnaire will be
answered by computer-assisted personal
interviews (CAPIs). Questions will be
asked for health, demographic, diet, and
lifestyle factors. The self-reported
responses will be compared to
laboratory analytes. For these, blood
samples will be drawn and analyzed.
The ACHS–II will measure the same
serum PCBs as in the first Anniston
survey. In this way, changes in PCB
levels can be studied. The ACHS–II will
also include serum analytes for dioxins,
furans, dioxin-like PCBs, and other
similar chemicals. Additional analytes
include blood measures of heavy metals.
Clinical biomarkers will include
measures for thyroid, diabetes, lipids,
and immune function. This will give a
more complete profile of human
exposures and health in Anniston, AL.
The ATSDR is requesting a two-year
approval for this information collection.
There are no costs to respondents
other than their time. In total, they will
spend 2 hours in the study.

mstockstill on DSK4VPTVN1PROD with NOTICES

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Avg. burden
per response
(in hrs)

Total burden
hours

Type of respondents

Form name

Adults who took part in first Anniston Community
Health Survey.

Telephone Recruitment
Script.
Survey for Refusals ......
Informed Consent .........
Update Contact Information Form.
Medications Form .........
Blood Draw Form .........
Questionnaire ...............

333

1

2/60

11

165
250
250

1
1
1

1/60
1/60
1/60

3
4
4

250
250
250

1
1
1

3/60
2/60
45/60

12
8
188

.......................................

........................

........................

........................

230

Total ...............................................................

VerDate Mar<15>2010

16:11 Sep 19, 2012

Jkt 226001

PO 00000

Frm 00041

Fmt 4703

Sfmt 4703

E:\FR\FM\20SEN1.SGM

20SEN1

Federal Register / Vol. 77, No. 183 / Thursday, September 20, 2012 / Notices
Dated: September 14, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.

Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control
and Prevention (CDC).

[FR Doc. 2012–23203 Filed 9–19–12; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-12–12RP]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

mstockstill on DSK4VPTVN1PROD with NOTICES

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

VerDate Mar<15>2010

16:11 Sep 19, 2012

Jkt 226001

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 CMVrelated 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

PO 00000

Frm 00042

Fmt 4703

Sfmt 4703

58395

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.

E:\FR\FM\20SEN1.SGM

20SEN1