Notice2022-04191
Proposed Data Collection Submitted for Public Comment and Recommendations
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
March 1, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Birth Defects Study To Evaluate Pregnancy exposureS (BD-STEPS). Data from BD-STEPS will play an important part in the decision-making process that determines federal research agendas, birth defect prevention activities, and the direction of funding programs such as cooperative agreements.
Full Text
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<title>Federal Register, Volume 87 Issue 40 (Tuesday, March 1, 2022)</title>
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[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
[Notices]
[Pages 11442-11444]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04191]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-22-0010; Docket No. CDC-2022-0030]
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 effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Birth Defects Study To Evaluate
Pregnancy exposureS (BD-STEPS). Data from BD-STEPS will play an
important part in the decision-making process that determines federal
research agendas, birth defect prevention activities, and the direction
of funding programs such as cooperative agreements.
DATES: CDC must receive written comments on or before May 2, 2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0030 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, 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 H21-8, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
<a href="/cdn-cgi/l/email-protection#a1ceccc3e1c2c5c28fc6ced7"><span class="__cf_email__" data-cfemail="d3bcbeb193b0b7b0fdb4bca5">[email protected]</span></a>.
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;
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; and
5. Assess information collection costs.
Proposed Project
Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS) (OMB
Control No. 0920-0010, Exp. 2/28/2023)--Extension--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. However, 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 practices, 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
[[Page 11443]]
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.
The 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.
BD-STEPS is made up of a number of information collection
activities. The interview is estimated to take approximately 55 minutes
and is titled ``Birth Defects Prevention Study: Computer Assisted
Telephone Interview.'' 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 3,030 interviews, the maximum interview burden for all
Centers combined would be 2,778 hours per year. 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 computer assisted telephone interview (CATI).
Five of the seven BD-STEPS Centers request consent for retrieval of
leftover newborn bloodspots. If a maximum of 2,590 interviews would be
expected for seven Centers (not including interviews of stillbirths
without birth defects), a maximum of 1,850 would be expected for five
Centers requesting consent for retrieval of leftover newborn bloodspots
(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 sign
the consent form. The anticipated maximum burden for bloodspot consent
would be 463 hours annually.
With a maximum of 2,590 interviews planned annually (not including
interviews of stillbirths without birth defects since they are not
eligible for the online questionnaire), 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.
CDC requests the release of reportable infectious diseases
information from all women who complete the CATI except for women who
experienced a stillbirth without a birth defect. A maximum of 2,590
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 648 hours
annually.
In the two Centers participating in the supplemental interview,
mothers of infants with or without birth defects that are stillborn and
controls are asked to participate in a supplemental telephone
interview. The 25-minute supplemental interview includes the time for
informed consent. Based on a maximum of 640 women to be interviewed
with the supplemental questionnaire, the maximum burden time would be
267 hours annually.
Although participation rates may vary, the total estimates of
annual burden hours for all activities, all individuals, and all
Centers is 4,433 hours. There is no cost to respondents other than
their time to participate.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Mother's Interview............ Telephone 3,030 1 55/60 2,778
Consent Script/
BD-STEPS
Computer
Assisted
Telephone
Interview.
Mother's Consent for Bloodspot Consent for 1,850 1 15/60 463
Retrieval. bloodspot
retrieval.
Mother's Online Occupational Online 830 1 20/60 277
Questionnaire. Occupational
Questionnaire.
Mothers Infectious Disease Infectious 2,590 1 15/60 648
Release Review. Disease Request
Form.
Mothers of AR/MA Stillbirths Telephone 640 1 25/60 267
and Controls (Supplemental Consent and
Telephone Interview). Supplemental
Interview.
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Total................... ................ .............. .............. .............. 4,433
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[[Page 11444]]
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-04191 Filed 2-28-22; 8:45 am]
BILLING CODE 4163-18-P
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