[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.
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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]
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