[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52436-52438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18746]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-0010]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the
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proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information will have practical utility; (b) Evaluate the accuracy of
the agencies estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (c) Enhance the quality, utility, and clarity of the information
to be collected; (d) Minimize the burden of the collection of
information on those who are to respond, including through the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses; and (e) Assess
information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: 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
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 case-control studies of major birth
defects that utilize existing birth defect surveillance registries
(including 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 case-control 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 an
addition to the study population for two BD-STEPS Centers.
Specifically, in these two Centers mothers of stillbirths without major
birth defects will be added to the study population for BD-STEPS and
mothers of all stillbirths (with and without birth defects) and all
controls in these two Centers will be asked to participate in a
supplemental telephone interview.
The BD-STEPS interview takes approximately forty-five minutes to
complete (burden estimate includes both the introductory telephone
script/consent and questionnaire). For five Centers, a maximum of 275
interviews are planned per year per center, 200 cases and 75 controls;
for the two Centers participating in additional stillbirth interviews,
495 interviews are planned per center, 200 cases with birth defects, 75
controls, and 220 stillbirths without birth defects. With seven centers
planned, the maximum interview burden for all centers combined would be
approximately 1,774 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. For approximately one fifth of participants, some medical
records review will be conducted. The medical records release form
takes participants approximately 15 minutes to read, sign and return.
In addition, it takes approximately 30 minutes for each medical record
reviewer to conduct the review and send the medical record. The 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 20
minutes to answer. In addition, in two Centers, mothers of stillbirths
with and without birth defects and controls will be asked to
participate in a supplemental telephone interview that will take
approximately 25 minutes to complete.
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 3,034. There are no costs to
the respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Respondents Activity Number of responses per per response
respondents respondent (in hours)
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Mothers (interview)................... Telephone consent and BD- 2,365 1 45/60
STEPS questionnaire.
Mothers (consent for bloodspot Written consent for 1,375 1 15/60
retrieval). bloodspot retrieval.
Mothers (online occupational Online Occupational 790 1 20/60
questionnaire). Questionnaire.
Mothers (consent for medical records Written release for 475 1 15/60
review). medical records review.
Records reviewers (medical records Pulling and sending 475 1 30/60
review). records.
Mothers of all AR/MA stillbirths and Telephone consent and 710 1 25/60
controls (supplemental telephone supplemental
interview). questionnaire.
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Jeffrey M. Zirger,
Health Scientist, Acting 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. 2016-18746 Filed 8-5-16; 8:45 am]
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