RDC Proposal - PRA SS-Part A 01182022

Supporting Statement A

Research Data Center Proposal for Access to Confidential Data

for the

National Center for Health Statistics

Existing Collection in Use Without an OMB Control Number

OMB No. 0920-XXXX

Contact Information

J. Neil Russell

Research Data Center

National Center for Health Statistics

3311 Toledo Road, Room 5583

Hyattsville, MD 20782

301-458-4394

[email protected]

January 18, 2022

                                       

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. Research Data Center Proposal for Access to Confidential Data

D. Authority to Operate

E. IRB Memo

Supporting Statement A

Research Data Center Proposal for Access to Confidential Data

• Goal of the proposal: to collect information about a researcher’s research study to facilitate review of the research and help determine whether the research requires access to confidential data

• Intended use of the resulting data: review proposal information to adjudicate whether the research proposed can be approved so researcher can access confidential 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, commercial, 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 Research Data Center (RDC) Proposal for Access to Confidential 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 RDC 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 RDC became aware that the RDC proposal was in fact an information collection initiative. The NCHS RDC 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 110 proposals annually. The total annual burden for the Research Data Center Proposal for Access to Confidential Data is 330 hours per year; 990 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 Research Data Center (RDC), National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention, requires prospective researchers who need access to confidential data to complete a research proposal. Researchers self-select whether they need access to confidential data to answer their research questions. The RDC requires the researcher to complete a research proposal so NCHS understands the research proposed, whether confidential data is available to address the research questions, how the confidential 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 (Attachment C).

NCHS requests a three-year approval from OMB for the RDC 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 confidential statistics is implemented through the RDC proposal. Federal statistical agencies may receive requests for access to confidential data through applications (i.e., proposal) as authorized by the Confidential Information Protection and Statistical Efficiency Act of 2018 (see 44 U.S.C. 3583(a); 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 national surveys and 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. NCHS endeavors to disseminate its data widely in accordance with the requirements of the Evidence Act (see 44 U.S.C. 3582).

Since 1998, the NCHS RDC mission is to make confidential NCHS data available to authorized researchers in a secure manner that protects the data from unauthorized disclosure.

The RDC proposal collects information that is used by NCHS to assess and adjudicate researcher projects to determine whether access to confidential data should be granted.

3. Use of Information Technology and Burden Reduction

The RDC proposal is provided to researchers via the NCHS RDC website. The RDC proposal is available in both Word and Acrobat typeable (*.pdf) files. Researchers may choice which file format is most convenient. Researchers submit their completed proposal to the NCHS RDC via email.

4. Efforts to Identify Duplication and Use of Similar Information

The information collected through the RDC proposal will not duplicate any existing information being collected by NCHS or its partners who collect information on behalf of NCHS.

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. 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 RDC accepts proposals from researchers on a flow basis and the researcher determines when they submit their proposal to the RDC. 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

1. Federal Register Notice

The 60-day notice was published in the Federal Register, on October 25, 2021, Volume 86, No. 203, pp. 58912 (see Attachment B). One non-substantive comment was received from this Notice (see Attachment B.1).

2. Consultation

NCHS RDC staff are members of the committees charged with writing the regulation for the Evidence Act Standard Application Process (44 U.S.C. 3583) and a member of the committee implementing this process in practice. The current RDC proposal conforms to the committee’s current version of the Standard Application.

9. Explanation of Any Payment or Gift to Respondents

The collection of information via the RDC proposal does not involve any payment or gift to researchers.

10. Protection of the Privacy and Confidentiality of Information Provided By Respondents

The Privacy Act does apply to this information collection; direct personally identifying information will be collected.

The RDC 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) Research Data Center (RDC) to determine your eligibility for access to restricted-use NCHS data and for other administrative purposes. 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 RDC 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, which upon full execution may become public records (see 44 U.S.C. 3583). The NCHS RDC is authorized to request the information contained in this proposal under Title 42, United States Code, Section 242k(b)(4).

The appropriate system security stewards have issued Authority to Operate this system (Attachment D).

11. Institutional Review Board (IRB) and Justification for Sensitive Questions

There are no sensitive questions in the RDC proposal. IRB approval is not required for NCHS collection of the RDC Proposal (Attachment E).

12. Estimates of Annualized Burden Hours and Costs

Table 1 presents the annualized estimate of number of respondents and burden hours for the RDC proposal. It is estimated that 110 proposals are submitted each year on average. This equates to about 330 proposals received in a three-year period. The estimated time it takes to complete the proposal is about 3 hours. Other a three-year period with an estimated 330 proposals submitted, the estimated burden hours is 990.

Table 1. Annualized Burden Hour Estimate for RDC Proposal

Collect Instrument	Number of Respondents	Number of responses/ respondent	Average Burden/ response (in hours)	Response Burden (in hours)
RDC Proposal	110	1	3	330
Total	110	.........	........	330

Table 2. Annual Estimate of Respondent Cost for RDC 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
RDC Proposal	110	1	3	330	$27.07	$8,933.10
Total	110	.........	........	330		$8,933.10

* Hourly Rate is based on the federal mean wage for all occupations of $27.07 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 $100,000.

15. Explanation for Program Changes or Adjustments

This is a new data collection; Existing Collection in Use without an OMB Control Number.

16. Plans for Tabulation and Publication and Project Time Schedule

The information collected in the RDC proposal will be reviewed and adjudicated to decide on whether access to confidential NCHS data should be granted. This information as described in the RDC 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.