Notice2022-25243
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 21, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 87 Issue 223 (Monday, November 21, 2022)</title>
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[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70830-70831]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-25243]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-23-0010]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``Birth Defects Study To Evaluate Pregnancy
exposureS (BD-STEPS)'' to the Office of Management and Budget (OMB) for
review and approval. CDC previously published a ``Proposed Data
Collection Submitted for Public Comment and Recommendations'' notice on
March 1, 2022 to obtain comments from the public and affected agencies.
CDC received two comments related to the previous notice. This notice
serves to allow an additional 30 days for public and affected agency
comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street, NW, Washington, DC 20503 or by fax to
(202) 395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS) (OMB
Control No. 0920-0010, Exp. 2/28/2023)--Revision--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. 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 practice, 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
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.
This 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, and the purpose of BD-STEPS is to
evaluate factors associated with the occurrence of birth defects and
stillbirths, and ultimately to work to prevent major birth defects and
stillbirths associated with maternal risk factors.
CDC requests OMB approval for an estimated 4,473 annual burden
hours. There is no cost to respondents other than their time to
participate.
Estimated Annualized Burden Hours
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Number of
Type of respondents Form name Number of responses per Average burden per
respondents respondent response (in hours)
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Mothers (Interview).............. Core Computer 3,030.............. 1 55/60
Assisted Telephone
Interview.
[[Page 70831]]
Mothers (Consent)................ Linkage to 2,590.............. 1 15/60
Reportable
Infectious Disease
Consent.
Mothers (Consent for Residual Residual Newborn 1,850.............. 1 15/60
Newborn Bloodspot Retrieval). Bloodspot Consent.
Mothers (Online Questionnaire)... Online Occupational 830................ 1 20/60
Questionnaire.
Mothers of AR/MA Stillbirths and Supplemental 640................ 1 25/60
Controls (Interview). Computer Assisted
Telephone
Interview.
Mothers of AR/MA Stillbirths with Authorization Form 157................ 1 15/60
Specimens available for Testing. for Stillbirth
COVID-19 Sub-Study.
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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. 2022-25243 Filed 11-18-22; 8:45 am]
BILLING CODE 4163-18-P
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