Supporting Statement A for Request for Clearance:
Application Form and Related Forms for the
Operation of the National Death Index
Extension
OMB No.0920-0215
(Expires 11/30/2013)
Contact Information:
Lillian Ingster, Ph.D.
Director, National Death Index
Division of Vital Statistics
National Center for Health Statistics
3311 Toledo Road, Room 7316
Hyattsville, Maryland 20782
Phone: 301-458-4286
Email: [email protected]
August 22, 2013
Table of Contents
A. Justification............................................................................................................................ 3
1. Circumstances Making The Collection Of Information Necessary............................... 3
2. Purpose And Use Of The Information Collection.......................................................... 6
3. Use Of Improved Information Technology And Burden Reduction............................ 8
4. Efforts To Identify Duplication And Use Of Similar Information................................ 8
5. Impact On Small Businesses Or Other Small Entities.................................................. 8
6. Consequences Of Collecting The Information Less Frequently................................... 8
7. Special Circumstances Relating To The Guidelines For 5CFR1320.5.......................... 8
8. Comments In Response To The Federal Register Notice And Efforts To
Consult Outside The Agency ................................................................................. 9
9. Explanation Of Any Payment Or Gifts To Respondents............................................... 9
10. Assurance Of Confidentiality Provided To Respondents............................................. 9
11. Justifications For Sensitive Questions........................................................................... 10
12. Estimates of Annualized Burden Hours and Costs........................................................ 11 |
13. Estimate Of Other Total Annual Cost Burden To Respondents Or Record Keepers… 11 |
14. Annualized Cost To The Federal Government............................................................... 12 |
15. Explanation For Program Changes Or Adjustments...................................................... 12 |
16. Plans For Tabulation And Publication And Project Time Schedule............................. 12 |
17. Reason(s) Display Of OMB Expiration Is Inappropriate.................................... 12 |
18. Exceptions to Certification for Paperwork Reduction Act Submissions....................... 11 |
ATTACHMENTS TO SUPPORTING STATEMENT FOR OMB CLEARANCE REQUEST
A - Section 306 of the Public Health Service Act 42 USC 243k.
B - National Death Index Application Form
C - Request for a Repeat NDI File Search
D - NDI User Data Transmittal Form
E1 - 60-Day Federal Register Notice
E2- Comment to 60 Day Federal Register Notice
F - National Death Index Advisers
G – NCHS ERB letter
This is a request for a three-year extension of the three administrative forms used in the operation of the National Death Index (NDI) program which was fully implemented by the National Center for Health Statistics (NCHS) in the fall of 1981. The OMB Number for this data collection is 0920-0215 (exp. November 30, 2013).
The forms to be reviewed for this clearance request are presented as Attachments B through D. There have been no changes to these three forms since the last clearance.
A. Justification
1.
Circumstances Making the of Collection Information Necessary
The National Death Index (NDI) and the services it provides are authorized under 42 USC
242k (Section 306 of the Public Health Service Act) which mandates that NCHS collect
mortality data and which permits NCHS to support epidemiological research and to furnish
mortality information (see Attachment A).
The NDI is a central, computerized index of death record information designed to assist in
the mortality ascertainment activities of investigators conducting prospective and
retrospective studies in health and medical research. The NDI contains identifying
information on all U.S. decedents since 1979 and is compiled from magnetic tapes
submitted to NCHS by the state vital statistics offices via contractual agreements.
Investigators use the NDI to determine whether persons in their studies may have died. If
so, the NDI user is provided with the corresponding names of states in which the deaths
occurred and the related death certificate numbers. The NDI user then arranges to procure
copies of the death certificates from the state vital statistics offices in order to obtain such
statistical information as cause of death. NDI users can avoid procuring copies of certificates
if they opt for the NDI Plus service, which provides users with the cause of death
information in coded form.
The NDI Application Form (Attachment B) is provided to all investigators who express an interest in the NDI. The Application Form is completed and submitted only by those
investigators who actually decide to apply for use of the NDI services. The remaining forms (Attachments C-D) are sent to the investigators after their Application Forms are approved.
The NDI Application Form and the other related NDI forms are used to ensure that NCHS maintains the confidentiality of the state death record information and that such information is used only for the purposes described in the states’ contracts with NCHS. NCHS is bound to maintain the confidentiality of the identifying death record information it obtains from the state vital statistics offices. This is required under Section 308(d) of the Public Health Service Act (42 USC 242k) which states that "no information may be used for any purpose other than the purpose for which it was supplied...” Consequently, release by NCHS of data on decedents contained in the NDI file is restricted under Section 308(d) by the purpose for which the information was supplied to NCHS by the state vital statistics office. In the case of the NDI, the purpose for which the death record information is supplied is clearly specified in the contracts between NCHS and each state office. Each contract contains provisions restricting the use of the NDI to "statistical purposes in medical and health research and prohibiting use of the NDI as a basis for legal, administrative, or other actions, which may directly affect particular individuals or establishments."
The services provided by the NDI are authorized under 42 USC 243k (Section 306 of the
Public Health Service Act) which mandates that NCHS collect mortality data and which permits NCHS to support epidemiological research and to furnish mortality information.
Additional information on the NDI can be found at its website http://www.cdc.gov/nchs/ndi.htm .
Privacy Impact Assessment
The information required for the Privacy Impact Assessment is presented in the sections below.
Overview of the Data Collection System
The National Death Index (NDI) contains all deaths in the United States since 1979. As of 2010 the NDI has obtained over 67 million death records from the state vital statistics offices, covering deaths from 1979 through 2008. The death records are obtained via a contract with each state vital statistics office. The purpose of the NDI is to assist health researchers in determining whether their study subjects have died and if so provides the researchers with the state of death, date of death, death certificate number and the causes of death (as reported on the state’s death certificates). The death records are maintained in the ADABAS data management system located on the CDC mainframe. The NDI has served over 1,600 researchers over the period 1982-2010. The research studies or projects varied greatly and included: clinical trials, disease registries, occupational health studies, non-disease or population registries, and effectiveness of specific therapies for different diseases.
Items of Information Collected from the State’s Death Certificates
In order to assist health researchers determine if there subjects have died, a computer match must be performed using the following items of identifying information as part of the matching criteria:
First name, last name, and middle initial
Father’s surname (especially for females)
Social Security Number
Date of birth
Sex
Other data items obtained from the state death records are:
Race
Marital status
State of birth
State of death
State of residence
Death certificate number
Date of death
Causes of death
Information in Identifiable Form (IIF) – Data Submitted on the Researcher’s Study Subjects
For the NDI to be able to serve the health research community, it is essential that the NDI maintain the above data elements, most of which are Protected Health Information (PHI). To use the NDI a researcher must complete a detailed application describing his/her study and how confidentiality will be maintained. The application form must be accompanied by the researchers Institutional Review Board approval for the study that is being performed. Once an NDI review group recommends approval of the application, the researcher is able to submit records of study subjects who have been lost to follow up (or who have died) in order to find out their subjects dates and causes of death. The researcher is encouraged to provide as many of the following IIF data elements as possible in order to maximize the NDI’s matching effectiveness:
First name, last name, and middle initial
Father’s surname (especially for females)
Social Security Number
Date of Birth
The other NDI data items like sex, race, marital status, state of birth and state of residence should also be provided by the researcher to assist him/her in assessing the match results and confirming which possible matches are in fact true matches.
Administrative Information Collected from Health Researchers (about themselves)
When health researchers submit their requests for use of our NDI services, they must complete several administrative forms at various points in the NDI process. The following administrative forms are required: NDI Application Form, NDI Transmittal Form, and NDI Repeat Request Form. Each of these forms requires the researcher to submit the following identifying information about themselves:
Name and address of Principal Investigator
Name of organization
Assigned NDI number
Name and phone number of the person to contact for more information about the application or about the data submitted to the NDI by the researcher
Name and address of person that will receive the NDI results via FedEx
The administrative forms also collect information about each researcher’s study:
Summary of the study protocol
Name of study sponsor(s)
How data confidentiality will be maintained
Documentation of a current IRB approval
The number of study subjects’ records to be submitted for an NDI match
The years of death to be searched
When identifiable data obtained from the NDI will be disposed
Signed NDI Confidentiality Agreements
All of these data items have been collected and approved in previous submissions.
Identification of Website(s) and Website Content Directed at Children Under 13 Years of Age
There is no website directed at children under 13 years of age.
2. Purpose and Use of Information Collection
The forms being proposed for extension of OMB clearance have been used solely for the
administration of the NDI program. The three forms are submitted by NDI users (health
investigators) when applying for use of the NDI and then when actually using the service.
(Attachment B through D).
The National Death Index Application Form (Attachment B) is the first form. No changes have been made to this form. This application form is completed by organizations and agencies who are conducting health and medical research and who would like to be approved for use of the NDI. NDI applications are reviewed by NCHS staff and advisers to the NDI program (Attachment F). The advisers review the applications by mail approximately every six weeks. The NDI program receives approximately 70 new applications each year.
The application form is used by NCHS staff and advisers to determine (1) whether each
proposed use of the NDI conforms with the criteria agreed upon between NCHS and the
state vital statistics offices; (2) how the applicant and any other participating organization(s)
will maintain the confidentiality of the identifying death record information; and (3)
whether the NDI applicant will be able to submit data on persons in the study in a manner
which meets NCHS technical specifications. The last three pages of the form are used to
obtain assurances from the NDI applicant (and other organizations participating in or sponsoring the study) that the identifiable data obtained from the NDI will be used only for "statistical purposes in medical and health research" and will be used only for the study or purpose proposed in the application form.
Furthermore, the assurances specify that identifiable data obtained via the NDI will not be
released in any form which would identify a particular individual or establishment and will
not be used as a basis for legal, administrative or other actions which may directly affect individuals or establishments identified as a result of the NDI.
The second form is the Request for a Repeat NDI File Search (Attachment C). No changes have been made to this form. At the beginning of the NDI program, users were instructed to submit updated application forms each time they wanted to conduct a subsequent NDI file search for additional years of death. Each resubmitted application would have to be reviewed by the NDI advisers. The advisers soon realized that, because of the increasing number of users, this requirement would be burdensome to the NCHS staff, the advisers, and NDI users. This very abbreviated application form for repeat requests (first approved by OMB in 1986) provides adequate assurances that there have been no significant changes in the study protocol and confidentiality provisions specified in the user’s initial application form. Furthermore, NCHS staff has been able to expedite the approval of most "repeat" requests for file searches (within one week of receipt) without holding up such requests until the next review of NDI applications by the advisers.
The third from is the User Data Transmittal Form (Attachment D). No changes have been made to this form. This form is to accompany the diskettes or CD-ROMS submitted to NCHS by NDI users. Information provided on this form is intended to clearly identify the user and to provide NCHS data processing staff with information needed to process the user’s data. The form permits users to request that their NDI output be sent to them on diskette or CD-ROM. The form is also used to show the total cost of the NDI services and how payment will be made.
Privacy Impact Assessment
The three administrative forms are completed by health researchers in government,
universities, and private industry in order to apply for NDI services and to submit
records of study subjects for computer matching against the NDI file. The administrative data collected on these forms is protected by the Privacy Act. Moreover, data provided on persons in the research study are statistical information and are covered under NCHS confidentiality provisions as described in A. 10. None of the forms request information of a sensitive nature. Furthermore, because the NDI does not involve information on human subjects, it has been determined that the NDI does not require IRB approval and was dropped from the NCHS continuing IRB review list in 1999.
3. Use of Improved Information Technology and Burden Reduction
Respondent burden in this collection is held to a minimum. There are no technical or legal
obstacles to burden reduction and improved information technology would not reduce
burden; however, an electronic version of the NDI Application Form (Attachment B) was
implemented in January 2003. It is a word document that can be downloaded from the NDI
website http://www.cdc.gov/nchs/ndi.htm.
Efforts to Identify Duplication and Use of Similar Information
The NDI is the only central computerized index to death records on file in the state vital
statistics offices. Consequently, the NDI Application Form and related administrative
forms used by health investigators to obtain use of the NDI service are unique to this
program. Information obtained from NDI applicants pertains only to use of the NDI.
Similar information is not available from other sources.
The type of administrative information collected by the NDI forms applies equally to
large and small organizations. Use of the NDI is not affected by an organization’s size.
Questions on the forms have been held to the absolute minimum required for the intended
use of the information.
6. Consequences of Collecting the Information Less Frequently
An NDI applicant must only submit one NDI Application Form (Attachment B) to
initiate use of the NDI for a particular study. The other NDI forms (Attachments C-D)
come into play each time the NDI applicant wishes to submit data for a search of the
NDI. About 40% of the NDI users only make one data submission. The remaining
60% of the users will submit data every one, two or three years as more years of deaths
are added to the NDI file. These short forms are used primarily to ensure that there have
been no significant changes in the initial NDI application and to identify the user’s
records.
The project is in full compliance with all the guidelines in 5 CFR 1320.5.
8. Comments in Response to
the Federal Register Notice and Efforts to Consult Outside the
Agency
A. As
required by 5 CFR 1320.8(d), the 60-day notice soliciting comments on
this
information collection appeared in the Federal Register on April 22, 2013. See a copy of the notice in Attachment E1. One non-substantive comment was received (Attachment E2) to which CDC sent a standard response.
B. Advisers to the NDI program meet periodically to review the NDI’s operations and
its procedures for reviewing and approving NDI applications. The last meeting of
the advisers was in May 2013. They were satisfied with the availability of the
requested information, the frequency of collection, the clarity of the instructions
and the items of information being requested. A list of the NDI advisers, their
telephone numbers, and the organizations they represent is presented in Attachment
F. Please note that the four advisers employed by state health departments
(Richard Genovese, Elizabeth Saadi, John Senner, Jane Purtill) also
represent the National Association for Public Health Statistics and Information
Systems.
9. Explanation of Any Payment or Gift to Respondents
There are no payments
or gifts to respondents.
10.
Assurances of Confidentiality Provided to Respondents
The administrative data collected on these forms is protected by the Privacy Act. Moreover, data provided on persons in the research study are statistical information and are covered under NCHS confidentiality provisions as described below.
An assurance of confidentiality is provided to all research subjects according to section 308(d) of the Public Health Service Act (42 USC 242m) which states:
"No information, if an establishment or person supplying the information or described in
it is identifiable, obtained in the course of activities undertaken or supported under
section...306,...may be used for any purpose other than the purpose for which it was
supplied unless such establishment or person has consented (as determined under
regulations of the Secretary) to its use for such other purpose and (1) in the case of
information obtained in the course of health statistical or epidemiological activities
under section...306, such information may not be published or released in other form if
the particular establishment or person supplying the information or described in it is
identifiable unless such establishment or person has consented (as determined under
regulations of the Secretary) to its publication or release in other form..."
In addition, legislation covering confidentiality for the research subjects is provided according to section 513 of the Confidential Information Protection and Statistical Efficiency Act (PL 107-347) which states:
“Whoever, being an officer, employee, or agent of an agency acquiring information for exclusively statistical purposes, having taken and subscribed the oath of office, or having sworn to observe the limitations imposed by section 512, comes into possession of such information by reason of his or her being an officer, employee, or agent and, knowing that the disclosure of the specific information is prohibited under the provisions of this title, willfully discloses the information in any manner to a person or agency not entitled to receive it, shall be guilty of a class E felony and imprisoned for not more than 5 years, or fined not more than $250,000, or both.”
Privacy Impact Assessment Information
This submission has been reviewed for Privacy Act applicability and it has been
determined that the Privacy Act applies under Systems of Record Notice 09-20-0166:
Vital Statistics for Births, Deaths, Fetal Deaths, Marriages and Divorces Occurring in the
United States During Each Year.
An assurance of confidentiality will be on each NDI form:
“All information which would permit identification of an individual, a practice, or
an establishment will be held confidential, will be used only by NCHS staff,
contractors, and agents only when required and with necessary controls, and will not
be disclosed or released to other persons without the consent of the individual or
establishment in accordance with section 308(d) of the Public Health Service Act
(42 USC 242m) and the Confidential Information Protection and Statistical Efficiency
Act (PL-107-347).”
The application forms are kept in locked files indefinitely as researchers often apply several times for data.
11. Justification for Sensitive Questions
None of the forms request information of a sensitive nature. Furthermore, because the
NDI does not involve information on human subjects, it has been determined that
the NDI does not require IRB approval and was dropped from the NCHS continuing IRB
review list in 1999 (See Attachment G).
12. Estimate of Annualized
Burden Hours and Cost
A.
Estimates of Annualized
Burden Hours
Form Type |
Number of Respondents |
Number of Responses per Respondent |
Average Burden per Response (in hours.) |
Total Burden (in hours)
|
Application Form Repeat Request Form Transmittal Form
Total |
50 70 120
|
1 1 1
|
2 .5 18/60 18/60
|
125 21 36
182
|
B. Estimates of Annualized Costs to Respondents
The three administrative forms are completed by health researchers in government,
universities, and private industry in order to apply for NDI services and to submit
records of study subjects for computer matching against the NDI file.
The mean hourly earnings of "management, professional, and related personnel" (as of May 2012) was $38.98 based on estimates of the U.S. Bureau of Labor Statistics as sited in the following publication: National Compensation Survey: Occupational Wages in the United States, 2012, U.S. Department of Labor, U.S. Bureau of Labor Statistics, May 2012 (Summary 07-03, Table 1, page 3.). The BLS website for this document is:
http://www.bls.gov/ncs/ocs/sp/ncbl0910.pdf..
The total cost to respondents is estimated at $7,095.
Total Annual Cost Burden
Type of forms |
Total Burden (in hours) |
Avg. Hourly Wage Rate |
Total Respondent Costs |
All forms |
182.0 |
$38.98 |
$7,095 |
13. Estimates of Other Total Annual Cost Burden to Respondent or Record Keepers
There is no respondent cost burden associated with capital or maintenance costs.
No change.
Not applicable. The NDI is an ongoing service with none of the information collected via the
forms being intended for statistical use. The forms are used for administrative purposes in
operating the program.
later. The main application form (Attachment B) is now available online. That document does show the current expiration date and will be updated when new approval is received.
As described in A. 17, we again request approval to not display the expiration date for OMB approval. The main application form (Attachment B) is now available online. That document does show the current expiration date and will be updated when new approval is received.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | SUPPORTING STATEMENT FOR OMB CLEARANCE REQUEST |
| Author | Michelle Goodier |
| File Modified | 0000-00-00 |
| File Created | 2021-01-28 |