Supporting Statement A
Request for Clearance: Existing Collection in Use Without an OMB Control Number
Division of Vital Statistics Proposal for Access to Restricted-Use Vital Statistics Data
for the
National Center for Health Statistics
OMB No. 0920-XXXX
Contact Information
Andrés A. Berruti
Division of Vital Statistics
National Center for Health Statistics
3311 Toledo Road, Room 5303
Hyattsville, MD 20782
404-825-3605
Ilq9@cdc.gov
February 20, 2025
Table of Contents
1. Circumstances Making the Collection of Information Necessary 3
2. Purpose and Use of the Information Collection 5
3. Use of Improved Information Technology and Burden Reduction 5
4. Efforts to Identify Duplication and Use of Similar Information 6
5. Impact on Small Businesses or Other Small Entities 6
6. Consequences of Collecting the Information Less Frequently 6
7. Specific Circumstances Relating to the Guidelines of 5 CFR 1320.5 6
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency 6
9. Explanation of Any Payment or Gift to Respondents 6
10. Protection of the Privacy and Confidentiality of Information Provided by Respondents …...7
11. Institutional Review Board (IRB) and Justification for Sensitive Questions 7
12. Estimates of Annualized Burden Hours and Costs 8
13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers 8
14. Annualized Cost to the Federal Government 8
15. Explanation for Program Changes or Adjustments 9
16. Plans for Tabulation and Publication and Project Time Schedule 9
17. Reason(s) Display of OMB Expiration Date is Inappropriate 9
18. Exceptions to Certification for Paperwork Reduction Act Submissions 9
List of Attachments
A. Authorizing Legislation
B. 60-Day Federal Register Notice
B.1. Comment
C. Division of Vital Statistics for Access to Confidential Data
D. IRB Memo
Supporting Statement A
Division of Vital Statistics Proposal for Access to Restricted-Use Vital Statistics Data
Goal of
the proposal: to collect information about a researcher’s
proposed use of restricted-use vital statistics data to facilitate
review of the proposal and help determine whether the proposal
meets the requirements of access.
Intended use of the resulting data: review proposal information to
adjudicate whether the research proposed can be approved so
researcher can access restricted-use vital statistics data.
Methods to be used to collect information: proposal template.
The subpopulation to be studied: any bona fide researcher in the
United States whether private and/or government.
How data will be analyzed: the resulting information from the
proposal is for NCHS internal use only.
National Center for Health Statistics
This is a request for clearance of the Division of Vital Statistics (DVS) Proposal for Access to Restricted-Use Vital Statistics Data for the National Center for Health Statistics (OMB No. 0920-XXXX, Existing Collection in Use Without an OMB Control Number). A three-year clearance is requested. The DVS Proposal has been in use since 1998. Recently, as part of the Evidence Act work to develop and implement a federal government-wide Standard Application Process (see 44 U.S.C. 3583) and through OMB consultation, the NCHS DVS became aware that the DVS proposal was in fact an information collection initiative. The NCHS DVS recognizes this now and is therefore submitting this OMB clearance package to correct this oversight and obtain OMB approval.
The National Center for Health Statistics anticipates it will receive about 600 proposals annually. The total annual burden for the Division of Vital Statistics Proposal for Access to Confidential Data is 600 hours per year; 1,800 hours for the three-year period.
A. Justification
1. Circumstances Making the Collection of Information Necessary
As part of a comprehensive data dissemination program, the Division of Vital Statistics (DVS), National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention, requires prospective researchers who need access to restricted-use, namely individual-level geographic (state and/or county-level) data to complete a research project. Researchers self-select whether they need access to restricted-use vital statistics data to answer their research questions. The DVS requires the researcher to complete a research proposal so NCHS understands the research proposed, whether restricted-use vital statistics are appropriate for the research questions, how the data will be used, and what data outputs the researcher needs to satisfy their project. The completed proposal is sent to NCHS for adjudication on whether the proposed research is possible under the conditions agreed upon by the owners of the data: U.S. states and territories; (Attachment C). NCHS’ ability to grant access to vital statistics data is dependent upon meeting the conditions established by the jurisdictions (50 states, 5 territories, the District of Columbia, and New York City) that provide data to NCHS.
NCHS requests a three-year approval from OMB for the DVS proposal. NCHS is authorized to receive requests for furnishing statistics (data) to the public (see Section 306(b)(4) of the Public Health Service Act [42 USC 242k(b)(4)]; Attachment A). Receipt of public requests for restricted-use vital statistics data is implemented through the DVS proposal. Federal statistical agencies may receive requests for access to confidential data through applications (i.e., proposal) (Attachment A).
2. Purpose and Use of the Information
NCHS is the Nation’s principal health statistics agency and compiles statistical information to guide actions and policies to improve the health of the U.S. population. The data systems administered by NCHS are a unique public resource for health information, a critical element of public health and health policy. Making these data available to the public upon request is an essential mission of NCHS.
Since 1991, the NCHS DVS has sought to make restricted-use NCHS vital statistics data available to authorized researchers in a secure manner that protects the data from unauthorized disclosure.
The DVS proposal (Attachment C) collects information that is used by NCHS to assess and adjudicate researcher projects to determine whether access to restricted-use vital statistics data should be granted under the conditions established by the jurisdictions.
3. Use of Information Technology and Burden Reduction
The DVS proposal is provided to researchers online at the NCHS DVS website. Researchers complete and submit their proposals online at the NCHS DVS website.
4. Efforts to Identify Duplication and Use of Similar Information
The information collected proposed will not duplicate any existing information being collected by NCHS or its partners who collect information on behalf of NCHS. This proposal is specifically for access to restricted-use vital statistics data, and not other confidential NCHS data requested through the NCHS Research Data Center. The restricted-use vital statistics proposal follows a different process due to the unique arrangement between NCHS and the 57 jurisdictions.
5. Impact on Small Businesses or Other Small Entities
From the history of previously submitted proposals, there are very few persons representing small business who submit proposals and per the agreement with the jurisdictions these data cannot be used for purposes that involve commercial or resale purposes. Impact on small businesses is very low. Individual persons complete the proposal.
6. Consequences of Collecting the Information Less Frequently
Each individual project must be reviewed and approved separately due to the singular uniqueness of each research proposal. The DVS accepts proposals from researchers on a flow basis and the researcher determines when they submit their proposal to the DVS. Researchers self-select whether they will author and submit the proposal and when the proposal is submitted.
7. Specific Circumstances Relating to the Guidelines of 5 CFR 1320.5
This request will fully comply with the regulation 5 CFR 1320.5.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside Agency
Federal Register Notice
The 60-day notice was published in the Federal Register, on 06/16/2025, Volume 90, No. 114, pp. 25275 (see Attachment B1). Two non-substantive comments were received from this Notice (see Attachment B2).
9. Explanation of Any Payment or Gift to Respondents
The collection of information proposed does not involve any payment or gift to researchers.
10. Protection of the Privacy and Confidentiality of Information Provided By Respondents
Data will be kept private to the extent allowed by law.
The Privacy Act does apply to this information collection; direct personally identifying information will be collected.
The DVS proposal will include the following Privacy Act Statement:
The information you provide will be used by staff at the National Center for Health Statistics (NCHS) Division of Vital Statistics (DVS) to determine your eligibility for access to restricted-use NCHS data and for other administrative purposes to better coordinate internal resources according to the volume of requests (i.e., number of applications by month and time taken for the DVS team to review each application).. Your information will be protected in accordance with the Privacy Act of 1974 as amended (5 U.S.C. 552a); details about routine uses can be found in the system of records notice, CDC/NCHS – 09-20-0169, Users of Health Statistics; HHS/CDC/NCHS (51 FR 42371). Providing the information on this form is voluntary; however, the NCHS DVS will not be able to grant access to restricted-use NCHS data without this information. The information provided will be used to determine whether access can be granted to restricted-use data and used in data use agreements (see 44 U.S.C. 3583). The NCHS DVS is authorized to request the information contained in this proposal under Title 42, United States Code, Section 242k(b)(4).
11. Institutional Review Board (IRB) and Justification for Sensitive Questions
There are no sensitive questions in this application proposal.
12. Estimates of Annualized Burden Hours and Costs
Table 1 presents the annualized estimate of number of respondents and burden hours for the DVS proposal. It is estimated that 600 proposals are submitted each year on average. This equates to about 1,200 proposals received in a three-year period. The estimated time it takes to complete the proposal is about 1 hour. Other a three-year period with an estimated 1,800 proposals submitted, the estimated burden hours are 1,800.
Table 1. Annualized Burden Hour Estimate for DVS Proposal
Collect Instrument |
Number of Respondents |
Number of responses/ respondent |
Average Burden/ response (in hours) |
Response Burden (in hours) |
DVS Proposal |
600 |
1 |
1 |
600 |
Total |
600 |
......... |
........ |
600 |
Table 2. Annual Estimate of Respondent Cost for DVS Proposal
Collect Instrument |
Number of Respondents |
Number of responses/ respondent |
Average Burden (in hours) |
Total Annual Burden (in hours) |
Hourly Rate* |
Monetized Value of Respondent Time |
DVS Proposal |
600 |
1 |
1 |
600 |
$31.48 |
$18,888.00 |
Total |
600 |
......... |
........ |
600 |
|
$18,888.00 |
* Hourly Rate is based on the federal mean wage for all occupations of $31.48 per hour as given at: https://www.bls.gov/oes/current/oes_nat.htm#00-0000.
13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers
There are no additional costs to the respondents other than their time to fill out the proposal.
14. Annualized Cost to the Federal Government
While actual annualized costs will vary dependent on the number of proposals received in one year and the complexity of the research described in the proposal, it is anticipated that the costs related to staff salaries for receipt and review of the proposals might average $120,000.
15. Explanation for Program Changes or Adjustments
Existing Collection in Use without an OMB Control Number.
16. Plans for Tabulation and Publication and Project Time Schedule
The information collected in the DVS proposal will be reviewed and adjudicated to decide on whether access to restricted-use vital statistics data should be granted. This information as described in the DVS proposal is for internal NCHS use only. There are no tabulation or publication plans.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB expiration date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
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