[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70830-70831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25243]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-23-0010]


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 1, 2022 to obtain comments from the public and affected agencies. 
CDC received two 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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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) 395-5806. Provide written comments within 30 days of notice 
publication.

Proposed Project

    Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS) (OMB 
Control No. 0920-0010, Exp. 2/28/2023)--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. Birth defects contributed to more than one million 
hospital stays in the U.S. in 2013, resulting in $22.9 billion in 
hospital costs. Birth defects 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.
    For most birth defects, the causes are not known, making prevention 
efforts challenging to develop. To date, primary preventive measures 
are available for only a few birth defects. 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.
    This continued burden justifies reasonable attempts to reduce the 
prevalence of birth defects. To help reduce birth defects among U.S. 
babies, in 1996 Congress directed the CDC to establish Centers of 
Excellence for Birth Defects Research and Prevention. The mandate was 
formalized with passage of the Birth Defects Prevention Act of 1998. 
This Act amended Section 317C of the Public Health Service Act (42 
U.S.C. 247b-4) and authorized CDC to: (1) collect, analyze, and make 
available data on birth defects; (2) operate regional centers that will 
conduct applied epidemiological research for the prevention of birth 
defects; and (3) provide the public with information on preventing 
birth defects.
    In response to this mandate, the Division of Birth Defects and 
Infant Disorders (DBDID) obtained OMB clearance for data collection 
that is carried out by the Centers for Birth Defects Research and 
Prevention (CBDRP). The CBDRP's first research effort was the National 
Birth Defects Prevention Study (NBDPS), which began data collection in 
1997 and ended in 2013. The CBDRPs transitioned from NBDPS to the Birth 
Defects Study To Evaluate Pregnancy exposureS (BD-STEPS), which began 
data collection in 2014. One of the main activities for each Center is 
to conduct BD-STEPS in their state, and the purpose of BD-STEPS is to 
evaluate factors associated with the occurrence of birth defects and 
stillbirths, and ultimately to work to prevent major birth defects and 
stillbirths associated with maternal risk factors.
    CDC requests OMB approval for an estimated 4,473 annual burden 
hours. There is no cost to respondents other than their time to 
participate.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                Number of
       Type of respondents              Form name            Number of        responses per   Average burden per
                                                            respondents        respondent    response (in hours)
----------------------------------------------------------------------------------------------------------------
Mothers (Interview)..............  Core Computer        3,030..............               1  55/60
                                    Assisted Telephone
                                    Interview.

[[Page 70831]]

 
Mothers (Consent)................  Linkage to           2,590..............               1  15/60
                                    Reportable
                                    Infectious Disease
                                    Consent.
Mothers (Consent for Residual      Residual Newborn     1,850..............               1  15/60
 Newborn Bloodspot Retrieval).      Bloodspot Consent.
Mothers (Online Questionnaire)...  Online Occupational  830................               1  20/60
                                    Questionnaire.
Mothers of AR/MA Stillbirths and   Supplemental         640................               1  25/60
 Controls (Interview).              Computer Assisted
                                    Telephone
                                    Interview.
Mothers of AR/MA Stillbirths with  Authorization Form   157................               1  15/60
 Specimens available for Testing.   for Stillbirth
                                    COVID-19 Sub-Study.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-25243 Filed 11-18-22; 8:45 am]
BILLING CODE 4163-18-P