Proposed Data Collection Submitted for Public Comment and Recommendations

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Centers for Disease Control and Prevention</SUBAGY> <DEPDOC>[60-Day-25-0156; Docket No. CDC-2025-0288]</DEPDOC> <SUBJECT>Proposed Data Collection Submitted for Public Comment and Recommendations</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Notice with comment period. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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). </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> CDC must receive written comments on or before October 27, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments, identified by Docket No. CDC-2025-0288 by either of the following methods: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">www.regulations.gov.</E> Follow the instructions for submitting comments. • <E T="03">Mail:</E> Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329. <E T="03">Instructions:</E> All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to <E T="03">www.regulations.gov.</E> Please note: Submit all comments through the Federal eRulemaking portal ( <E T="03">www.regulations.gov</E> ) or by U.S. mail to the address listed above. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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: <E T="03">omb@cdc.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> 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 <E T="04">Federal Register</E> 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 T="03">e.g.,</E> permitting electronic submissions of responses; and 5. Assess information collection costs. <HD SOURCE="HD1">Proposed Project</HD> Data Management Plan (DMP) Template—New—Office of Science (OS), Centers for Disease Control and Prevention (CDC). <HD SOURCE="HD2">Background and Brief Description</HD> 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” [ <E T="03">https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf</E> ]. This memo emphasized DMPs and stated the following instructions. <EXTRACT> “(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;” </EXTRACT> <FP>In response, CDC developed a data plan, produced a public access policy, and updated its data policy.</FP> In 2022, OSTP released a follow-up memo titled, “Ensuring Free, Immediate, and Equitable Access to Federally Funded Research” [ <E T="03">https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/08/08-2022-OSTP-Public-Access-Memo.pdf</E> ]. This memo emphasized the scientific data underlying peer-reviewed publications. It included the following language. <EXTRACT> “(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: (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.” </EXTRACT> OSTP released an additional memo in 2025 titled, “Agency Guidance for Implementing Gold Standard Science in the Conduct & Management of Scientific Activities” [ <E T="03">https://www.whitehouse.gov/wp-content/uploads/2025/03/OSTP-Guidance-for-GSS-June-2025.pdf</E> ]. 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” [ <E T="03">https://www.whitehouse.gov/presidential-actions/2025/02/establishing-the-presidents-make-america-healthy-again-commission/</E> ], emphasizes transparency and open-source data in section 2 (a). <EXTRACT> <E T="03">Sec. 2.</E> <E T="03">Policy.</E> 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 e ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 13k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━