[Federal Register Volume 84, Number 164 (Friday, August 23, 2019)]
[Notices]
[Pages 44314-44316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18207]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-0010]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Birth Defects Study To Evaluate Pregnancy
exposureS (BD-STEPS) to the Office of Management and Budget (OMB) for
review and approval. CDC previously published a ``Proposed Data
Collection Submitted for Public Comment and Recommendations'' notice on
March 4, 2019 to obtain comments from the public and affected agencies.
CDC did not receive comments related to the previous notice. This
notice serves to allow an additional 30 days for public and affected
agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the 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, 725 17th
Street NW, Washington, DC 20503 or by fax to (202)
[[Page 44315]]
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Birth Defects Study To Evaluate Pregnancy exposureS (OMB Control
No. 0920-0010, Exp. 02/29/2020)--Revision--National Center on Birth
Defects and Developmental Disabilities (NCBDDD), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Birth defects are associated with substantial morbidity and
mortality in the United States. About one in every 33 babies is born
with a birth defect, which are the leading cause of infant mortality
and the fifth leading cause of loss of potential years of life before
age 65. One in five infant deaths is due to birth defects.
CDC's National Center on Birth Defects and Development Disabilities
(NCBDDD) works to identify causes of birth defects, improve the health
of those living with birth defects, and find and promote opportunities
for prevention. For example, vaccination programs have reduced the
incidence of congenital rubella syndrome, Rh hemolytic disease of the
newborn can be prevented by appropriate medical practice, and genetic
counseling can provide parents with information about the increased
risk of Down syndrome associated with advanced maternal age. Perhaps
most importantly, folic acid intake before and during pregnancy can
prevent many cases of fatal or permanently disabling neural tube
defects, such as anencephaly and spina bifida.
For most birth defects, however, the causes are not known, making
prevention efforts challenging to develop. To improve understanding of
the causes of birth defects, CDC initiated active surveillance of birth
defects in the wake of the thalidomide tragedy. The system has been in
continuous operation since 1967 and is the longest running active
surveillance system in the world. Over this period CDC adapted the
system to both utilize and contribute to new findings about the
epidemiology and causes of birth defects. Previous related efforts
include the ``Metropolitan Atlanta Congenital Defects Program'' (MACDP)
and the ``National Birth Defects Prevention Study'' (NBDPS).
In its current form, CDC conducts birth defects surveillance
through the Birth Defects Study To Evaluate Pregnancy exposureS (BD-
STEPS, OMB No. 0920-0010). BD-STEPS is a CDC-funded collaborative
effort involving six CDC-funded, state-based Centers for Birth Defects
Research and Prevention (CBDRP) that have legislative authority to
collect population-based information on infants with major congenital
malformations (Arkansas, California, Iowa, Massachusetts, New York, and
North Carolina). CDC serves as an additional site on behalf of Georgia.
Information collection for BD-STEPS is based on a case-control design
that builds upon information obtained from state-based vital records
and birth defects tracking systems. At all CBDRP sites, mothers who
have given birth to infants with birth defects are invited to
participate in a computer-assisted telephone interview (CATI) to
discuss their medical history, pregnancies, environmental exposures,
and medications. In addition, interviews are conducted with mothers of
control-infants from each CBDRP, selected randomly from live-born
infants without a major birth defect. Controls are identified either
from vital records (birth certificates) or from hospitals of birth, and
represent the birth population from which the case infants were
identified. Two CBDRP sites (Arkansas and Massachusetts) also conduct
interviews with mothers of infants who are stillborn without major
birth defects, and controls. In states that allow retrieval of blood
spots, BD-STEPS participants are asked for permission to share a
portion of the newborn blood spot for the child who is part of the
study, and for mothers of multiples, the co-siblings of this child.
Finally, the interviews identify mothers who work in one of eight
occupational categories of interest. These respondents are asked to
complete a supplemental online questionnaire designed to assess the
impact of the workplace on reproductive outcomes.
During the next OMB approval period, CDC plans to implement a
number of changes, many reflecting increased emphasis on birth defects
with established or suspected association with maternal infection. Five
new birth defect case groups will be added. In addition, the maternal
interviews will include new questions on infections, travel history,
and marijuana use during pregnancy. The new case groups and questions
will increase the estimated burden per interview from 45 minutes to 55
minutes. CBDRPs will also begin asking mothers for permission to access
information on reportable infectious diseases from their state health
departments. The estimated burden per response is 15 minutes. CDC will
discontinue plans for a medical records review that was previously
approved but never implemented.
Additional changes will also affect burden estimates. The estimated
number of case interviews per site will increase from 200 to 270, and
the number of control interviews per site will increase from 75 to 100.
The number of interviews with mothers who gave birth to a stillborn
infant will remain constant (220 interviews per site for the two CBDRP
sites participating in this information collection activity, plus 100
control interviews per site). The number of respondents who complete
the online occupational questionnaire will increase but there is no
change to the estimated burden per response of 20 minutes. The number
of mothers who are asked to provide permission for bloodspot retrieval
will also increase, but the burden per response will not change.
CDC will use BD-STEPS data to identify modifiable maternal risk
factors and to apply findings to prevention programs for birth defects
and stillbirths. Data will also be used to examine hypotheses for gene-
environment interactions involved in the etiology of birth defects.
OMB approval is requested for three years. Participation is
voluntary and there are no costs to respondents other than their time.
The total estimated annualized burden will increase from 3,034 hours to
4,433 hours.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Mothers of birth defects cases and Telephone Consent Script 3,030 1 55/60
controls. and BD-STEPS Computer
Assisted Telephone
Interview.
Mothers of birth defects cases and Consent for bloodspot 1,850 1 15/60
controls. retrieval.
[[Page 44316]]
Mothers of birth defects cases and Online Occupational 830 1 20/60
controls. Questionnaire.
Mothers of birth defects cases and Infectious Disease 2,590 1 15/60
controls. Request Form.
Mothers of stillbirths and controls... Telephone consent and 640 1 25/60
supplemental interview.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2019-18207 Filed 8-22-19; 8:45 am]
BILLING CODE 4163-18-P