[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)]
[Notices]
[Pages 14446-14448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05949]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0010; Docket No. CDC-2016-0030]


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 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

[[Page 14447]]

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.

DATES: Written comments must be received on or before May 16, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0030 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Leroy A. Richardson, Information 
Collection Review Office, Centers for Disease Control and Prevention, 
1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-
7570.

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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

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 01/31/2017)--
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 group infants are randomly selected from birth 
certificates or birth hospital records; mothers of case and control 
group 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 forty-five minutes to 
complete (the burden estimate includes both the introductory telephone 
script/consent and questionnaire). For five Centers, a maximum of 275 
interviews are planned per year per center, 200 cases and 75 controls; 
for the two Centers participating in additional stillbirth interviews, 
495 interviews are planned per center, 200 cases with birth defects, 75 
controls, and 220 stillbirths without birth defects. With seven centers 
planned, the maximum interview burden for all centers combined would be 
approximately 1,774 hours. Mothers in five of the seven BD-STEPS 
Centers will also be asked to provide consent for the study to access 
previously collected infant bloodspots. It takes approximately 15 
minutes to read, sign and return the informed consent for retrieval of 
bloodspots. For approximately one fifth of participants, some medical 
records review will be conducted. The medical records release form 
takes participants approximately 15 minutes to read, sign and return. 
In addition, it takes approximately 30 minutes for each medical record 
reviewer to conduct the review and send the medical record. The online 
questionnaire will be offered to approximately one third of 
participants who report certain occupations during the telephone 
interview; these participants will be asked to complete additional 
occupational questions via a Web site which will take approximately 20 
minutes to answer. In addition, in two Centers, mothers of stillbirths 
with and without birth defects and controls will be asked to 
participate in a supplemental telephone interview that will take 
approximately 25 minutes to complete.
    Information gathered from both the interviews and the 
Deoxyribonucleic acid specimens has been and will continue to be used 
to study independent genetic and environmental factors as well as gene-
environment

[[Page 14448]]

interactions for a broad range of carefully classified birth defects.
    This request is submitted to revise the previously estimated burden 
details and to request OMB clearance for three additional years. The 
total estimated annual burden hours are 3,034.
    There are no costs to the respondents other than their time.

                                      Estimates of Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
          Respondents               Activity        respondents    responses per   response  (in       hours
                                                                    respondent        hours)
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Mothers (interview)...........  Telephone                  2,365               1           45/60           1,774
                                 consent and BD-
                                 STEPS
                                 questionnaire.
Mothers (consent for bloodspot  Written consent            1,375               1           15/60             344
 retrieval).                     for bloodspot
                                 retrieval.
Mothers (online occupational    Online                       790               1           20/60             263
 questionnaire).                 Occupational
                                 Questionnaire.
Mothers (consent for medical    Written release              475               1           15/60             119
 records review).                for medical
                                 records review.
Records reviewers (medical      Pulling and                  475               1           30/60             238
 records review).                sending records.
Mothers of all AR/MA            Telephone                    710               1           25/60             296
 stillbirths and controls        consent and
 (supplemental telephone         supplemental
 interview).                     questionnaire.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           3,034
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-05949 Filed 3-16-16; 8:45 am]
 BILLING CODE 4163-18-P