60 Day FRN

Att 2 60d FRN published.pdf

[OS] CDC/ATSDR Formative Research and Tool Development

60 Day FRN

OMB: 0920-1154

Document [pdf]
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31206

Federal Register / Vol. 90, No. 132 / Monday, July 14, 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. 2025–13102 Filed 7–11–25; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–25–1154; Docket No. CDC–2025–
0058]

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 Generic
Clearance for CDC/ATSDR Formative
Research and Tool Development. This
information collection request is
designed to allow CDC to conduct
formative research information
collection activities used to inform
aspects of surveillance,
communications, health promotion, and
research project development.
DATES: Written comments must be
received on or before September 12,
2025.
SUMMARY:

You may submit comments,
identified by Docket No. CDC–2025–
0058 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

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ADDRESSES:

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(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.
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 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
respond, including through the use of
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 costs.

SUPPLEMENTARY INFORMATION:

Proposed Project
Generic Clearance for CDC/ATSDR
Formative Research and Tool
Development (OMB Control No. 0920–
1154, Exp. 3/31/2026)—Extension—
Office of Science (OS), Centers for
Disease Control and Prevention (CDC).

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Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) requests approval for
an Extension of a Generic Clearance for
CDC/ATSDR Formative Research and
Tool Development. This information
collection request is designed to allow
CDC to conduct formative research
information collection activities used to
inform many aspects of surveillance,
communications, health promotion, and
research project development at CDC.
Formative research is the basis for
developing effective strategies including
communication channels, for
influencing behavior change. It helps
researchers identify and understand the
characteristics, interests, behaviors and
needs of target populations that
influence their decisions and actions.
Formative research is integral in
developing programs, as well as
improving existing and ongoing
programs. Formative research looks at
the community in which a public health
intervention is being or will be
implemented and helps the project staff
understand the interests, attributes and
needs of different populations and
persons in that community. Formative
research occurs before a program is
designed and implemented, or while a
program is being conducted.
At CDC, formative research is
necessary for developing new programs
or adapting programs that deal with the
complexity of behaviors, social context,
cultural identities, and health care that
underlie the epidemiology of diseases
and conditions in the U.S. CDC
conducts formative research to develop
public-sensitive communication
messages and user-friendly tools prior to
developing or recommending
interventions, or care. Sometimes these
studies are entirely behavioral but most
often they are cycles of interviews and
focus groups designed to inform the
development of a product.
Products from these formative
research studies will be used for
prevention of disease. Findings from
these studies may also be presented as
evidence to disease-specific National
Advisory Committees, to support
revisions to recommended prevention
and intervention methods, as well as
new recommendations.
Much of CDC’s health communication
takes place within campaigns that have
fairly lengthy planning periods and/or
timeframes that accommodate the
standard federal process for approving
data collections. Short-term qualitative
interviewing and cognitive research
techniques have previously proven
invaluable in the development of
scientifically valid and population-

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Federal Register / Vol. 90, No. 132 / Monday, July 14, 2025 / Notices
appropriate methods, interventions, and
instruments.
This request includes studies
investigating the utility and
acceptability of proposed sampling and
recruitment methods, intervention
contents and delivery, questionnaire
domains, individual questions, and
interactions with project staff or
electronic data collection equipment.
These activities will also provide
information about how respondents
answer questions and ways in which
question response bias and error can be
reduced.
This request also includes collection
of information from public health
programs to assess needs related to
initiation of a new program activity or
expansion or changes in scope or
implementation of existing program
activities to adapt them to current
needs. The information collected will be

investigation of mental models for
health decision-making to inform health
communication messages; and (7)
organizational needs assessments to
support development of capacity.
Respondents who will participate in
individual and group interviews
(qualitative, cognitive, and computer
assisted development activities) are
selected purposively from those who
respond to recruitment advertisements.
In addition to utilizing advertisements
for recruitment, respondents who will
participate in research on survey
methods may be selected purposively or
systematically from within an ongoing
surveillance or research project.
Participation of respondents is
voluntary. CDC requests OMB approval
for an estimated 20,000 annual burden
hours. There is no cost to participants
other than their time to participate.
Estimated Annualized Burden Hours

Number of
respondents

Number of
responses per
respondent

Average hours
per response
(in hours)

Screener ....................................
Interview ....................................
Focus Group Interview ..............
Survey .......................................

10,000
5,000
5,000
5,000

1
1
1
1

15/60
1
2
30/60

2,500
5,000
10,000
2,500

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

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

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

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

20,000

Type of respondent

Form name

General public and health care providers ...........

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. 2025–13105 Filed 7–11–25; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–P–0015A and
CMS–10599]

Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:

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used to advise programs and provide
capacity-building assistance tailored to
identify needs.
Overall, these development activities
are intended to provide information that
will increase the success of the
surveillance or research projects
through increasing response rates and
decreasing response error, thereby
decreasing future data collection burden
to the public. The studies that will be
covered under this request will include
one or more of the following
investigational modalities: (1) structured
and qualitative interviewing for
surveillance, research, interventions and
material development; (2) cognitive
interviewing for development of specific
data collection instruments; (3)
methodological research; (4) usability
testing of technology-based instruments
and materials; (5) field testing of new
methodologies and materials; (6)

The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995

SUMMARY:

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(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
September 12, 2025.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to http://

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Total
burden
hours

www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:

William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:

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