B - 60 day FRN

AttB_60-day_Fed_Registry_Notice_Feb18_2015.pdf

Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)

B - 60 day FRN

OMB: 0920-0010

Document [pdf]
Download: pdf | pdf
8655

Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices
basic education and increase awareness
of HIV/AIDS among the general public,
and others will be targeted to specific
subgroups or communities at greatest
risk of infection. The current study
addresses the need to assess the
effectiveness of these social marketing
messages aimed at increasing HIV
awareness and delivering HIV
prevention and testing messages among
at-risk populations.
This extension of an ongoing study
will evaluate the Act Against AIDS
(AAA) social marketing campaign aimed
at increasing HIV/AIDS awareness,
increasing prevention behaviors, and
improving HIV testing rates among
consumers. A total of 36,000
respondents were originally approved
for this 3-year data collection. Since the

original approval date, 4,250
respondents have participated in the
surveys. The number of remaining
respondents for the 3-year period is
31,750. We anticipate screening
approximately 52,915 individuals
annually to achieve 10,583 respondents
annually. The information collected
from each of the data collections were
used to evaluate specific AAA campaign
phases. We are requesting additional
time to continue to survey other AAA
target audiences and campaign phases
and measuring exposure to each phase
of the campaign and interventions
implemented under AAA.
Depending on the target audience for
the campaign phase, the study screener
will vary. The study screener may
address one or more of the following

items: race/ethnicity, sexual behavior,
and sexual orientation. Each survey will
have a core set of items asked in all
rounds, as well as a module of questions
relating to specific AAA activities and
communication initiatives.
Survey respondents will be selected
from a combination of sources,
including a national opt-in email list
sample and respondent lists generated
by partnership organizations (e.g., the
National Urban League, the National
Medical Association). Participants will
self-administer the survey at home on
personal computers. There is no cost to
the respondents other than their time.
The total number of estimated annual
burden hours is 7,056.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hours)

Form name

Individuals (male and female) aged 18 years
and older/Study Screener.
Individuals (male and female) aged 18 years
and older.

Study Screener ..............................................

52,915

1

2/60

Survey ............................................................

10,583

1

30/60

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–03246 Filed 2–17–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–0010]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

emcdonald on DSK67QTVN1PROD with NOTICES

Number of
respondents

Respondents

The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. To request more
information on the below proposed
project or to obtain a copy of the
information collection plan and
instruments, call 404–639–7570 or send

VerDate Sep<11>2014

19:32 Feb 17, 2015

Jkt 235001

comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. 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; (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; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and

PO 00000

Frm 00067

Fmt 4703

Sfmt 4703

maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Proposed Project
Birth Defects Study To Evaluate
Pregnancy exposures (BD–STEPS)
(formerly titled The National Birth
Defects Prevention Study (NBDPS)),
(OMB 0920–0010, Expiration 01/31/
2017)—Revision—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC has been monitoring the
occurrence of serious birth defects and
genetic diseases in Atlanta since 1967
through the Metropolitan Atlanta
Congenital Defects Program (MACDP).
The MACDP is a population-based
surveillance system for birth defects
currently covering three counties in
Metropolitan Atlanta.
Since 1997, CDC has funded casecontrol studies of major birth defects
that utilize existing birth defect
surveillance registries (including

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8656

Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices

MACDP) to identify cases and study
birth defects causes in participating
states/municipalities across the United
States.
The current study, BD–STEPS, is a
case-control study that is similar to the
previous CDC-funded birth defects casecontrol study, NBDPS, which stopped
interviewing participants in 2013. As
with NBDPS, BD–STEPS control infants
are randomly selected from birth
certificates or birth hospital records;
mothers of case and control infants are
interviewed using a computer-assisted
telephone interview.
The results from NBDPS have
improved understanding of the causes
of birth defects. Over 200 articles have
been written in professional journals
using the data from NBDPS, and BD–
STEPS data will soon be added to
NBDPS data for analysis. The current
BD–STEPS revision is a change in
proposed data collection. Specifically,

the study will not ask BD–STEPS
participants to participate in saliva
collection as originally planned, but we
will add an opportunity for some
participants to respond to an online
questionnaire, and we will also ask
some participants for permission to
retrieve newborn bloodspots.
The BD–STEPS interview takes
approximately forty-five minutes to
complete. A maximum of 275
interviews are planned per year per
center, 200 cases and 75 controls. With
seven centers planned, the maximum
interview burden for all centers
combined would be approximately
1,444 hours. Mothers in five of the
seven BD–STEPS Centers will also be
asked to provide consent for the study
to access previously collected infant
bloodspots. It takes approximately 15
minutes to read, sign and return the
informed consent for retrieval of
bloodspots. Finally, the newly planned

online questionnaire will be offered to
approximately one third of participants
who report certain occupations during
the telephone interview; these
participants will be asked to complete
additional occupational questions via a
Web site which will take approximately
15 minutes to answer.
Information gathered from both the
interviews and the Deoxyribonucleic
acid specimens has been and will
continue to be used to study
independent genetic and environmental
factors as well as gene-environment
interactions for a broad range of
carefully classified birth defects.
This request is submitted to revise the
previously estimated burden details and
to request OMB clearance for three
additional years. The total estimated
annual burden hours are 1,949.
There are no costs to the respondents
other than their time.

ESTIMATES OF ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden
per response
(In hours)

Total burden
hours

Activity

Mothers (interview) ...........................

Telephone consent and BD–STEPS
questionnaire.
Written consent for bloodspot retrieval.
Online Occupational Questionnaire

1,925

1

45/60

1,444

1,375

1

15/60

344

642

1

15/60

161

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

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

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

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

1,949

Mothers (consent for bloodspot retrieval).
Mothers (online occupational questionnaire).
TOTAL .......................................

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–03245 Filed 2–17–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–15NS]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
emcdonald on DSK67QTVN1PROD with NOTICES

Number of
respondents

Respondents

The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or

VerDate Sep<11>2014

20:47 Feb 17, 2015

Jkt 235001

continuing information collections, as
required by the Paperwork Reduction
Act of 1995. To request more
information on the below proposed
project or to obtain a copy of the
information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. 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; (d) ways to
minimize the burden of the collection of
information on respondents, including
through the use of automated collection

PO 00000

Frm 00068

Fmt 4703

Sfmt 4703

techniques or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.

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