[Federal Register Volume 86, Number 231 (Monday, December 6, 2021)]
[Notices]
[Pages 69055-69057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26400]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-22BC; Docket No. CDC-2021-0128]


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 Enhancing Data-drive Disease 
Detection in Newborns (ED3N). CDC is developing this new national 
newborn screening (NBS) data platform to serve 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 February 4, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0128 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     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: 404-639-7118; Email: 
[email protected].

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;

[[Page 69056]]

    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)--New--
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) 
clearance for Enhancing Data-driven Disease Detection in Newborns 
(ED3N), a new national 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 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 United States. 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.

[[Page 69057]]



                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent        (in hr)         (in hr)
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Newborn Screening Programs....  Set-up and                    53               1              14             742
                                 initial
                                 submission of
                                 ED3N Data
                                 Elements.
                                Ongoing transfer              53             364            1/60             322
                                 of ED3N Data
                                 Elements.
                                                 ---------------------------------------------------------------
    Total.....................  ................              53  ..............  ..............           1,064
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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. 2021-26400 Filed 12-3-21; 8:45 am]
BILLING CODE 4163-18-P