[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
[Notices]
[Pages 11442-11444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04191]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-0010; Docket No. CDC-2022-0030]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: 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 the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Birth Defects Study To Evaluate 
Pregnancy exposureS (BD-STEPS). Data from BD-STEPS will play an 
important part in the decision-making process that determines federal 
research agendas, birth defect prevention activities, and the direction 
of funding programs such as cooperative agreements.

DATES: CDC must receive written comments on or before May 2, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0030 by either of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS H21-8, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS H21-8, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected;
    4. 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 
submissions of responses; and
    5. Assess information collection costs.

Proposed Project

    Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS) (OMB 
Control No. 0920-0010, Exp. 2/28/2023)--Extension--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. However, 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 practices, 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

[[Page 11443]]

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. 
The 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.
    BD-STEPS is made up of a number of information collection 
activities. The interview is estimated to take approximately 55 minutes 
and is titled ``Birth Defects Prevention Study: Computer Assisted 
Telephone Interview.'' For the five Centers not participating in the 
stillbirth component of the study, a maximum of 370 interviews are 
planned per year per center, 270 cases and 100 controls; for the two 
Centers participating in additional stillbirth interviews, 590 
interviews are planned per Center, 270 cases with birth defects, 100 
controls, and 220 stillbirths without birth defects. With seven Centers 
and a maximum of 3,030 interviews, the maximum interview burden for all 
Centers combined would be 2,778 hours per year. The 55-minute burden 
includes the time for the telephone consent script which is reviewed 
with the mother at the beginning of the call to collect the information 
via the computer assisted telephone interview (CATI).
    Five of the seven BD-STEPS Centers request consent for retrieval of 
leftover newborn bloodspots. If a maximum of 2,590 interviews would be 
expected for seven Centers (not including interviews of stillbirths 
without birth defects), a maximum of 1,850 would be expected for five 
Centers requesting consent for retrieval of leftover newborn bloodspots 
(excluding stillbirths, for which newborn bloodspots are not 
available). A maximum of 15 minutes would be expected for the 
participant to read the bloodspot retrieval consent request and sign 
the consent form. The anticipated maximum burden for bloodspot consent 
would be 463 hours annually.
    With a maximum of 2,590 interviews planned annually (not including 
interviews of stillbirths without birth defects since they are not 
eligible for the online questionnaire), and approximately one-third of 
the respondents eligible for the online questionnaire (selected based 
on reporting occupations queried in the questionnaire), a maximum of 
830 women would receive the online questionnaire. Completion of the 
online questionnaire is estimated to take 20 minutes including reading 
introductory communication. The anticipated maximum burden for the 
online questionnaire is 277 hours annually.
    CDC requests the release of reportable infectious diseases 
information from all women who complete the CATI except for women who 
experienced a stillbirth without a birth defect. A maximum of 2,590 
women would receive the infectious disease information request. Based 
on experience with consent forms, we expect the review, signing and 
mailing of the release of reportable infectious diseases information to 
take a maximum of 15 minutes for participants. The anticipated maximum 
burden for the reportable infectious diseases information is 648 hours 
annually.
    In the two Centers participating in the supplemental interview, 
mothers of infants with or without birth defects that are stillborn and 
controls are asked to participate in a supplemental telephone 
interview. The 25-minute supplemental interview includes the time for 
informed consent. Based on a maximum of 640 women to be interviewed 
with the supplemental questionnaire, the maximum burden time would be 
267 hours annually.
    Although participation rates may vary, the total estimates of 
annual burden hours for all activities, all individuals, and all 
Centers is 4,433 hours. There is no cost to respondents other than 
their time to participate.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Mother's Interview............  Telephone                  3,030               1           55/60           2,778
                                 Consent Script/
                                 BD-STEPS
                                 Computer
                                 Assisted
                                 Telephone
                                 Interview.
Mother's Consent for Bloodspot  Consent for                1,850               1           15/60             463
 Retrieval.                      bloodspot
                                 retrieval.
Mother's Online Occupational    Online                       830               1           20/60             277
 Questionnaire.                  Occupational
                                 Questionnaire.
Mothers Infectious Disease      Infectious                 2,590               1           15/60             648
 Release Review.                 Disease Request
                                 Form.
Mothers of AR/MA Stillbirths    Telephone                    640               1           25/60             267
 and Controls (Supplemental      Consent and
 Telephone Interview).           Supplemental
                                 Interview.
                                                 ---------------------------------------------------------------
      Total...................  ................  ..............  ..............  ..............           4,433
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[[Page 11444]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-04191 Filed 2-28-22; 8:45 am]
BILLING CODE 4163-18-P