[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7374-7375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03772]



[[Page 7374]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-19-0010; Docket No. CDC-2019-0005]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the Birth Defects 
Study To Evaluate Pregnancy exposureS (BD-STEPS). The purpose of BD-
STEPS is to identify modifiable maternal exposures in pregnancy that 
may increase the risk for having a pregnancy affected by certain major, 
structural birth defects. This revision proposes to add stillbirths 
without defects to the study population for two Centers and implement a 
supplemental telephone interview for these two Centers' stillbirths 
(with and without birth defects) and their controls.

DATES: Written comments must be received on or before May 3, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2019-
0005 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Lead, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, 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-D74, 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; and
    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.
    5. Assess information collection costs.

Proposed Project

    Birth Defects Study To Evaluate Pregnancy exposures (BD-STEPS) 
(formerly titled The National Birth Defects Prevention Study (NBDPS)), 
(OMB Control No. 0920-0010, Expiration 02/29/2020)--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 55 minutes to complete 
and is 10 minutes longer than the previously OMB-approved interview 
(the burden estimate includes both the introductory telephone script/
consent and questionnaire). 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 3,040 interviews, the maximum interview burden for all 
centers combined would be 2,787 hours per

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year over three years. 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 CATI 
interview.
    Five of the seven BD-STEPS Centers request consent for retrieval of 
leftover newborn bloodspots. If a maximum of 2,600 interviews would be 
expected for seven Centers, a maximum of 1,850 would be expected for 
five Centers (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 to read 
and sign the consent form. The anticipated maximum burden for bloodspot 
consent would be 463 hours annually.
    With a maximum of 2,600 interviews planned annually, 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.
    We will request the release of reportable infectious diseases 
information from all women who complete the CATI. Of the 2,600 
interviews planned annually, a maximum of 2,600 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 650 hours annually.
    In the two Centers participating in the supplemental interview, 
mothers of infants with or without birth defects that are stillborn and 
controls will be asked to participate in a supplemental telephone 
interview. The 25 minute supplemental interview will include the time 
for informed consent (Attachment Z). Based on a maximum of 640 women to 
be interviewed with the supplemental questionnaire, the maximum burden 
time would be 267 hours annually.
    The total estimates of annual burden hours for all activities for 
all individuals for all Centers is 4,443 hours. The estimates of 
annualized burden hours represent the total population however due to 
lower participation rates (no more than 60%, the actual burden will be 
lower as well. There are no costs to the respondents other than their 
time.

                                      Estimates of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
          Respondents               Form name        Number of     responses per   per response    Total burden
                                                   respondents *    respondent      (In hours)         hours
----------------------------------------------------------------------------------------------------------------
Mothers (interview)...........  Telephone                  3,040               1           55/60           2,787
                                 Consent Script
                                 (Attachment S1/
                                 S2)/BD-STEPS
                                 Computer
                                 Assisted
                                 Telephone
                                 Interview
                                 (Attachment C1/
                                 C2).
Mothers (consent for bloodspot  Written consent            1,850               1           15/60             463
 retrieval).                     for bloodspot
                                 retrieval
                                 (Attachment T1/
                                 T2 and U1/U2).
Mothers (online occupational    Online                       830               1           20/60             277
 questionnaire).                 Occupational
                                 Questionnaire
                                 (Attachment M1-
                                 8).
Mothers (infectious disease     Infectious                 2,600               1           15/60             650
 release review).                Disease Request
                                 Form
                                 (Attachment D1/
                                 D2).
Mothers of all AR/MA            Telephone                    640               1           25/60             267
 stillbirths and controls        consent and
 (supplemental telephone         supplemental
 interview).                     interview
                                 (Attachment N1/
                                 N2).
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           4,443
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-03772 Filed 3-1-19; 8:45 am]
BILLING CODE 4163-18-P