Notice2025-13510
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
July 18, 2025
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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Enhancing Data-driven Disease Detection in Newborns (ED3N). This national newborn screening (NBS) data platform serves as a secure, central, and national data sharing resource for the U.S. state and territorial NBS community.
Full Text
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<title>Federal Register, Volume 90 Issue 136 (Friday, July 18, 2025)</title>
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[Federal Register Volume 90, Number 136 (Friday, July 18, 2025)]
[Notices]
[Pages 33961-33962]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13510]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-1391; Docket No. CDC-2025-0156]
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 continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Enhancing Data-driven Disease Detection in Newborns (ED3N). This
national newborn screening (NBS) data platform serves as a secure,
central, and national data sharing resource for the U.S. state and
territorial NBS community.
DATES: CDC must receive written comments on or before September 16,
2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0156 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#d6b9bbb496b5b2b5f8b1b9a0"><span class="__cf_email__" data-cfemail="c6a9aba486a5a2a5e8a1a9b0">[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
Enhancing Data-Driven Disease Detection in Newborns (ED3N) (OMB
Control No. 0920-1391, Exp. 4/30/2026)--Revision--National Center for
Environmental Health (NCEH), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The Newborn Screening and Molecular Biology Branch (NSMBB), in the
National Center for Environmental Health (NCEH) Division of Laboratory
Science (DLS), has the only laboratory in the world devoted to ensuring
the accuracy of newborn screening (NBS) tests in every state and more
than 78 countries. NSMBB supports NBS programs by conducting research,
developing methods, and performing analyses by using complex, state-of-
the-art molecular and biochemical techniques for identifying risk
factors for diseases of public health importance.
Both NSMBB and state NBS programs are experiencing increased data
analytic challenges associated with continued expansion of the number
of newborn screening diseases, increased complexity of disease
detection, and difficulties in correlating disease markers with disease
risk. Further, the addition of late-onset diseases to NBS panels
necessitates a better way to routinely capture clinical information and
outcomes so that NBS programs can fully appreciate the spectrum of
disease they are detecting.
The NSMBB is requesting a three-year Paperwork Reduction Act (PRA)
Extension for Enhancing Data-driven Disease Detection in Newborns
(ED3N), the NBS data platform, that will address these analytic and
post-analytic challenges and promote sharing of molecular, biochemical,
and clinical information amongst NBS partners. The information shared
will help NSMBB and newborn screening partners be better equipped to
assess disease risk and will help harmonize approaches for disease
detection in newborns. Given the rarity of newborn screening diseases,
it is imperative that data be collected and analyzed at a national
level in order to glean useful insights and to analyze trends. The
NSMBB is best suited to oversee this work given its role in providing
technical assistance to NBS programs nationally.
Numerous studies along with presentations by NBS programs suggest
that gaps in programmatic resources and expertise are hampering the
ability to perform more complex data analytics resulting in low
positive predictive values for a number of conditions (which
subsequently results in higher false positive and negative rates and
downstream burden to families and the medical system). Smaller-scale
work on the use of post-analytical tools such as machine learning
algorithms have shown that incorporation of these elements into newborn
screening can improve detection rates, while reducing false positives.
These studies, however, have been limited to single sites and have not
been integrated into the daily workflow of high-throughput NBS
programs. Without this project, NBS
[[Page 33962]]
programs will continue to be unable to keep up with the increasing
complexity and future demands of screening, perpetuating inequities in
screening across the nation.
The estimated annualized burden hours were determined as follows.
There are 53 domestic NBS programs in the U.S. A ``respondent'' refers
to a single NBS program. Given that data submission will ultimately be
accomplished through automatic electronic data transfer, each
respondent's burden hours were split into two estimates: (1) the one-
time need to set-up, test, and implement the electronic data transfer
mechanism; and (2) the ongoing automatic electronic data transfer
occurring after initial set-up. Initial set-up time burden was
estimated based on analysis of similar data transfer projects embarked
upon by NBS programs as well as brief discussions with NBS Program
Laboratory Information Management System vendors. The one-time burden
to set up the data transfer interface was estimated to be 40 hours
total, annualized to 14 hours per year. Ongoing daily data submission
burden for NBS programs was estimated assuming one minute per automatic
transfer thereafter. CDC has estimated the total annualized burden for
this project to be 1,064 hours per year.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total
Type of respondent Form name respondents responses per response burden
respondent (in hr) (in hr)
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Newborn Screening Programs......... Set-up and initial 53 1 14 742
submission of ED3N
Data Elements.
Ongoing transfer of 53 364 1/60 322
ED3N Data Elements.
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Total.......................... ...................... 53 ............... ........... 1,064
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2025-13510 Filed 7-17-25; 8:45 am]
BILLING CODE 4163-18-P
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