Notice2025-16331
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
August 26, 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 proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Data Management Plan (DMP) Template. The proposed data collection will allow CDC to have a consistent and unified approach for CDC Programs to develop their own Data Management Plans (DMPs).
Full Text
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<title>Federal Register, Volume 90 Issue 163 (Tuesday, August 26, 2025)</title>
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[Federal Register Volume 90, Number 163 (Tuesday, August 26, 2025)]
[Notices]
[Pages 41564-41565]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16331]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-25-0156; Docket No. CDC-2025-0288]
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 information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Data Management Plan (DMP) Template. The proposed data
collection will allow CDC to have a consistent and unified approach for
CDC Programs to develop their own Data Management Plans (DMPs).
DATES: CDC must receive written comments on or before October 27, 2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0288 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#1a7577785a797e79347d756c"><span class="__cf_email__" data-cfemail="c0afada280a3a4a3eea7afb6">[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
Data Management Plan (DMP) Template--New--Office of Science (OS),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC), Office of
Science (OS) is requesting approval of a New Information Collection
Request (ICR) for a period of three years under the project titled,
Data Management Plan (DMP) Template. OS operates within CDC, and works
to collaborate with the agency's Centers, Institutes, and Offices
(CIOs). Multiple CIOs have their own DMPs, and a deep dive into these
DMPs showed some common elements. There is a need to have a consistent
and unified approach whereby CDC could meet obligations of calls to
action.
The White House Office of Science Technology and Policy (OSTP)
released a memo in 2013 titled, ``Increasing Access to the Results of
Federally Funded Scientific Research'' [<a href="https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf">https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf</a>]. This memo emphasized DMPs and stated
the following instructions.
``(b) Ensure that all extramural researchers receiving Federal
grants and contracts for scientific research and intramural
researchers develop data management plans, as appropriate,
describing how they will provide for long-term preservation of, and
access to, scientific data in digital formats resulting from
federally funded research, or explaining why long-term preservation
and access cannot be justified;
(c) Allow the inclusion of appropriate costs for data management
and access in proposals for Federal funding for scientific research;
(d) Ensure appropriate evaluation of the merits of submitted
data management plans;
(e) Include mechanisms to ensure that intramural and extramural
researchers comply with data management plans and policies;''
In response, CDC developed a data plan, produced a public access
policy, and updated its data policy.
In 2022, OSTP released a follow-up memo titled, ``Ensuring Free,
Immediate, and Equitable Access to Federally Funded Research'' [<a href="https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf">https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf</a>]. This memo emphasized the scientific data
underlying peer-reviewed publications. It included the following
language.
``(b) Scientific Data
i. Scientific data underlying peer-reviewed scholarly
publications resulting from federally funded research should be made
freely available and publicly accessible by default at the time of
publication, unless subject to limitations as described in Section
3(c)(i) and should be subject to federal agency guidelines for
researcher responsibilities regarding data management and sharing
plans, consistent with Section 3(c) of this memorandum.
(c) Public access plans should outline the policies that federal
agencies will use to establish researcher responsibilities on how
federally funded scientific data will be managed and shared,
including:
[[Page 41565]]
(i) Details describing any potential legal, privacy, ethical,
technical, intellectual property, or security limitations, and/or
any other potential restrictions or limitations on data access, use,
and disclosure, including those defined in terms and conditions of
funding agreement or award or that convey from a data use agreement
or stipulations of an Institutional Review Board;
(ii) Plans to maximize appropriate sharing of the federally
funded scientific data identified in Section 3(a) of this
memorandum, such as providing risk-mitigated opportunities for
limited data access; and,
(iii) The specific online digital repository or repositories
where the researcher expects to deposit their relevant data,
consistent with the federal agency's guidelines.''
OSTP released an additional memo in 2025 titled, ``Agency Guidance
for Implementing Gold Standard Science in the Conduct & Management of
Scientific Activities'' [<a href="https://www.whitehouse.gov/wp-content/uploads/2025/03/OSTP-Guidance-for-GSS-June-2025.pdf">https://www.whitehouse.gov/wp-content/uploads/2025/03/OSTP-Guidance-for-GSS-June-2025.pdf</a>]. As defined in the E.O.,
Gold Standard Science refers to science conducted in a manner that
abides by nine key tenets. (i) reproducible; (ii) transparent; (iii)
communicative of error and uncertainty; (iv) collaborative and
interdisciplinary; (v) skeptical of its findings and assumptions; (vi)
structured for falsifiability of hypotheses; (vii) subject to unbiased
peer review; (viii) accepting of negative results as positive outcomes;
and (ix) without conflicts of interest.
The Executive Order (E.O.), ``Establishing the President's Make
America Healthy Again Commission'' [<a href="https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/">https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/</a>], emphasizes transparency and open-source
data in section 2 (a).
Sec. 2. Policy. It shall be the policy of the Federal Government
to aggressively combat the critical health challenges facing our
citizens, including the rising rates of mental health disorders,
obesity, diabetes, and other chronic diseases. To do so, executive
departments and agencies (agencies) that address health or
healthcare must focus on reversing chronic disease. Under this
policy:
(a) all federally funded health research should empower
Americans through transparency and open-source data, and should
avoid or eliminate conflicts of interest that skew outcomes and
perpetuate distrust;
(b) the National Institutes of Health and other health-related
research funded by the Federal Government should prioritize gold-
standard research on the root causes of why Americans are getting
sick;
(c) agencies shall work with farmers to ensure that United
States food is the healthiest, most abundant, and most affordable in
the world; and
(d) agencies shall ensure the availability of expanded treatment
options and the flexibility for health insurance coverage to provide
benefits that support beneficial lifestyle changes and disease
prevention.
This project addresses and responds to these memos and Executive Orders
by collecting data using a unified DMP. The DMP Template was created to
capture information consistent with CDC Grants Notice of Funding
Opportunity (NOFO) Additional Requirement 25: Data Management and
Access [<a href="https://www.cdc.gov/grants/additional-requirements/ar-25.html">https://www.cdc.gov/grants/additional-requirements/ar-25.html</a>],
and is meant to be broadly applicable across CDC. The implementation of
a unified DMP is expected to reduce researcher burden when applying for
funding and when updating DMPs. This project will also reduce CDC staff
burden, reduce cognitive load on DMP reviewers, and make it explicit
which DMP elements have no responses. The project will reduce CDC staff
time spent on DMP reviews by making each DMP element atomic and
specific.
Use of the DMP Template will allow CDC to understand the number and
types of datasets that are being released and shared alongside
publications. The proposed new metadata elements for a unified DMP will
also help guide CDC-funded researchers towards greater collaborations
through fostering data reuse; improve reproducibility by encouraging
greater data documentation; and improve accessibility by making CDC
data more open and reusable to researchers and the public.
Respondents are expected to complete the DMP Template with as much
information as known at the time. The document is a living document and
may be updated when additional information is known and during
reporting periods. Expected respondents include any researcher
responding to Notice of Funding Opportunity (NOFO) announcements. CDC
requests OMB approval for an estimated 2,877 total burden hours with an
estimated annual burden of 959 hours. There is no cost to respondents
other than their time to participate.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total
Type of respondents Form name respondents responses per response burden (in
respondent (in hours) hours)
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Notice of Funding Opportunity Data Management Plan 548 1 1.5 822
(NOFO) Applicants. (DMP) Template.
Notice of Funding Opportunity Data Management Plan 548 1 15/60 137
(NOFO) Applicants (Update). (DMP) Template.
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Total......................... .................... ............ .............. ........... 959
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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. 2025-16331 Filed 8-25-25; 8:45 am]
BILLING CODE 4163-18-P
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