[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
----------------------------------------------------------------------------------------------------------------
                                                                                     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