60dy Federal Register Notice

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Federal Register / Vol. 90, No. 136 / Friday, July 18, 2025 / Notices
prevention measures and improve
awareness of risks associated with
medical tourism. State and local health
departments will conduct surveys and

send them electronically to CDC. Data
will be stored in an electronic database
and extracted for further analysis.

CDC requests OMB approval for an
estimated 438 annual burden hours.
There is no cost to respondents other
than their time to participate.

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents

Form name

State/Local Health department staff .................

Form 1 Medical Tourism Case Intake Form
(Part B—Medical Chart Abstraction).
Form 1 Medical Tourism Case Intake Form
(Part A—Interviews).
Form 2 Medical Tourism Enhanced Surveillance Form.

Ill persons who have experienced an adverse
health outcome related to medical tourism.
Ill persons who have experienced an adverse
health outcome related to medical tourism.

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. 2025–13509 Filed 7–17–25; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-25–1381; Docket No. CDC–2025–
0123]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 extension to a
previously approved information
collection project titled Formative
Respirator and Personal Protective
Clothing Laboratory Testing. NIOSH
proposes using questionnaires,
physiological monitoring/
measurements, anthropometric
measurements, respirator fit
measurements, self-perception data, and
biomechanical measurements to assess
gaps in respirator and personal
protective clothing use among the
Unites States working population.

SUMMARY:

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Number of
respondents

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CDC must receive written
comments on or before September 16,
2025.

DATES:

You may submit comments,
identified by Docket No. CDC–2022–
0123 by either of the following methods:
• Federal eRulemaking Portal:
www.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
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.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;
Telephone: 404–639–7570; Email: omb@
cdc.gov.
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
ADDRESSES:

PO 00000

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Number of
responses per
respondent

Average
burden
per response
(in hours)

50

15

5/60

750

1

10/60

500

1

0.5

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
Formative Respirator and Protective
Clothing Laboratory Testing (OMB
Control No. 0920–1381, Exp. 1/31/
2026)—Extension—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Institute for
Occupational Safety and Health
(NIOSH), is requesting approval of a
three-year Extension to a previously
approved Generic information

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33960

Federal Register / Vol. 90, No. 136 / Friday, July 18, 2025 / Notices

collection request (ICR) titled Formative
Respirator and Personal Protective
Clothing Laboratory Testing.
The National Personal Protective
Technology Laboratory (NPPTL) is a
division of NIOSH, which operates
within the CDC. NIOSH is the federal
institute specifically dedicated to
generating new knowledge in the field
of occupational safety and health and is
responsible for transferring that
knowledge into practice for the
betterment of workers.
NPPTL was established in 2001, at the
request of Congress, with the mission of
preventing disease, injury, and death for
the millions of working men and
women relying on personal protective
technology (PPT). PPT plays an
important role in keeping many workers
within various industries safe while
performing their professional duties. To
achieve their mission, NPPTL conducts
scientific research, develops guidance
and authoritative recommendations,
disseminates information, and responds
to requests for workplace health hazard
evaluations. The development of NPPTL
filled a need for improved PPT and
focused research into PPT.
Respiratory protection is the
cornerstone of NPPTL’s efforts. One of
the primary responsibilities of NPPTL is
to test and approve respirators used in

U.S. occupational settings. This
function ensures a standard level of
quality and filtration efficiency for all
respirators used within a U.S.
workplace setting. The NPPTL
Respirator Approval Program exists to
increase the level of worker protection
from airborne particulates, chemicals,
and vapors.
In addition to respirators, NPPTL
conducts research on other types of
PPT, including chemical-resistant
clothing, hearing protection, gloves, eye
and face protective devices, hard hats,
sensors to detect hazardous substances,
and communication devices used for
safe deployment of emergency workers.
The NPPTL’s PPT research examines
exposure to inhalation hazards, dermal
hazards, and any other hazardous
environmental threats within an
occupational setting.
PPT performance requirements and
test methods are specified within: (1)
federal regulations by NIOSH, the Food
and Drug Administration (FDA), and the
Mine Safety and Health Administration
(MSHA); and (2) voluntary consensus
standards published by organizations
such as the American National
Standards Institute (ANSI), American
Society for Testing and Materials
(ASTM) International, and International

Organization for Standardization (ISO).
Thus, the information collected from
human subjects in a laboratory setting is
generally consistent across NPPTL
studies with only the boundary
conditions changing (e.g.,
environmental conditions such as heat
or humidity, human subject activity
such as simulated surgery or climbing a
ladder, and distance between two
subjects communicating by spoken
word). Additionally, novel PPT designs
may be examined or compared to
commercially available products under
similar boundary conditions to examine
adherence to regulations and/or
standards. NPPTL requests an Extension
of the Generic ICR package for
laboratory-collected information for
testing respirators and personal
protective clothing.
NIOSH estimates that up to 1,500
individuals could be burdened per year.
Recruitment for all laboratory studies
includes individuals from the general
population rather than specific
industries or working status. These
individuals are all adults between the
ages of 18 and 65 years. CDC requests
OMB approval for an estimated 11,903
annual burden hours. There is no cost
to respondents other than their time to
participate.

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents

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Members of the general
public.

Total .................................

VerDate Sep<11>2014

Number of
respondents

Form name

Number of
responses
per respondent

Average
burden
per
response
(in hours)

Total
burden
(in hours)

Informed Consent .....................................................

470

1

30/60

235

Health Screening Questionnaire ...............................
Demographics Questionnaire ...................................
Job-related Data: occupational Tasks, postures
used, duration of exposure.
Physiological Measurements: chest-worn heart rate
monitor strap, COSMED Kb5, SQ2020–1F8 temperature logger, TOSCA 500 pulse oximeter,
koken breathing waveform recording mask.
Biological Measurements: cortisol (stress) levels,
pregnancy tests, hydration status, lipids, inflammatory markers, heat shock proteins.
Anthropometric
Measurements:
calipers/digital
measuring of facial and body dimensions.
Respirator Fit Measurements: filter cassettes with
air pumps, fit-testing equipment, QLFT/sodium
saccharin solution.
Self-Perception Data: level of exertion, perceived
comfort level, heat sensation, fatigue.
Biomechanics Measurements: force plate, stopwatch, accelerometers.

470
470
470

6
1
1

1
30/60
15/60

2820
235
118

200

6

1.5

1800

100

6

15/60

150

500

1

15/60

125

225

100

15/60

5,625

500

6

15/60

750

30

3

30/60

45

...................................................................................

......................

..........................

....................

11,903

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Federal Register / Vol. 90, No. 136 / Friday, July 18, 2025 / Notices
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. 2025–13511 Filed 7–17–25; 8:45 am]
BILLING CODE 4163–18–P

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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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 Datadriven 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:
• Federal eRulemaking Portal:
www.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
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.regulations.gov) or by U.S. mail to
the address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the

khammond on DSK9W7S144PROD with NOTICES

SUMMARY:

VerDate Sep<11>2014

18:22 Jul 17, 2025

Jkt 265001

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: omb@
cdc.gov.
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

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33961

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-theart 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

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