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Part I: PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET

Please completely fill out the applicable areas and submit with your Information Collection Request
(ICR) to CDC’s Information Collection Review Office (ICRO). This information must match the
information in your Supporting Statement.

BRIEF
Agency (Select one)
CDC
ATSDR
Office of Management and Budget (OMB) Control Number: 0920-0010
Agency ICR Tracking Number (CDC ID #): 0920-15ZT
ICR Title: Birth Defects Study to Evaluate Pregnancy ExposureS (BD-STEPS)
Type of Information Collection (check one)
New collection (Request for a new OMB Control Number
Extension without change of a currently approved collection
Revision of a currently approved collection
Reinstatement without change of a previously approved collection
Reinstatement with change of a previously approved collection
Existing collection in use without an OMB Control Number
Type of Review Requested (check one)
Regular
Emergency – Approval requested by: __________
Delegated
If Emergency, please attach justification.
Requested Expiration Date (check one)
Three years from approval date
Six months from approval date (Maximum for Emergency reviews)
Other – Specify: _________
1/31/2017 (mm/yyyy) or Number of Months from Approval Date
Does this ICR contain surveys, census, or employ statistical methods?
Yes
No
(Attach Supporting Statement Part B if yes)
Note: Although statistical methods may not be used, a separate Supporting Statement Part B should
always be included to describe the data collection procedures.
Does the Supporting Statement serve as a Joint ICR and Privacy Impact Assessment per OMB
Memorandum 03-22, Section ID?
Yes
No
Is this ICR related to the Affordable Care Act (PPACA, P.L. 111-148 &111-152)?

Yes

No

Is this ICR related to the Dodd-Frank Act [Dodd-Frank Wall Street Reform and Consumer Protection Act,
P.L. 111-203]?
Yes
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Yes
No
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CDC 0.1496 (E), October 2014, CDC Adobe Acrobat 10.1, S508 Electronic Version, October 2014

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ABSTRACT (Briefly state in 3 or 4 sentences)
The NCBDDD Division of Birth Defects and Developmental Disabilities (DBDDD) seeks to fund a
collaborative project for a multi-site case control study of a select number of major birth defects.
The purpose of the Birth Defects Case Control Collaborative is to identify causes of birth defects
using epidemiologic and genetic research methods and provide information that will be translated
into public health prevention messages and to promote health and quality of life by preventing and
controlling disease, injury and disability.

LEGAL STATUTES
Authorizing Statute(s):
Section 317C of the Public Health Service Act (42 U.S.C. 247b-4)

Note: Authorizing Statutes include applicable Public Law, U.S. Code, Executive Orders, and Statutes.

RULEMAKING
Associated Rulemaking Information:
RIN:

Yes

No

Stage of Rulemaking (check one)
Proposed Rule
Interim Final or Final Rule
Not Associated with Rulemaking
Other Documents for OIRA Review
For Proposed Rule, OMB will not consider an ICR complete until the Notice of Proposed Rulemaking has
been published. For ICRs associated with Interim Final rules that are not significant under EO, please
include a draft of the Federal Register notice as a Supplementary Document.

FR NOTICES / COMMENTS
Federal Register Notices & Comments
60-day Notice: Federal Register Citation: Volume: ____
Publication Date: __________
81 Page #: _____
52
02/25/2016
Did the Agency receive public comments on this ICR?
Yes
No
30-day Notice: Federal Register Citation: Volume: ____ Page #: _____ Publication Date: __________
Unless submitted as an Emergency or Associated with Rulemaking, OMB will not consider an ICR
complete until the 30-day notices has been published.
Annual Cost to Federal Government: $30,340.00

PROGRAM CHANGES OR ADJUSTMENTS REPORTING
Short Statement: Explain the reasons for any program changes or adjustments reported; that is, provide
a short statement of how the reduction in burden was achieved or why the increase in burden occurred.
This information should correspond with the ICR’s Supporting Statement (Section A.15).

This revision is for 2 center's addition of stillbirth without defects to the study population and the
implementation of a supplemental telephone interview for the 2 centers' stillbirths & controls.
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CDC 0.1496 (E), October 2014, CDC Adobe Acrobat 10.1, S508 Electronic Version, October 2014

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