[Federal Register Volume 63, Number 162 (Friday, August 21, 1998)]
[Notices]
[Pages 44942-44944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22463]


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SOCIAL SECURITY ADMINISTRATION


Announcement of Service to Epidemiological Researchers to Provide 
Vital Status Data on Subjects of Health Research

AGENCY: Social Security Administration.

ACTION: Notice.

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SUMMARY: Section 311 of the Social Security Independence and Program 
Improvements Act of 1994 directed the Social Security Administration 
(SSA) to provide support to health researchers involved in 
epidemiological research. Specifically, when a study is determined to 
contribute to a national health interest SSA will furnish information 
regarding whether a study subject is shown on the SSA administrative 
records as being alive or deceased (vital status).

DATES: This service is available as of this date by contacting the 
Associate Commissioner for Research, Evaluation and Statistics. The 
mailing address is Social Security Administration, Office of Research, 
Evaluation and Statistics, 4-C-15 Operations Building, 6401 Security 
Building, Baltimore MD 21235. The fax number for the Associate 
Commissioner is 410-965-3308.

FOR FURTHER INFORMATION CONTACT: Ms. Cheryl Williams, Office of 
Research, Evaluation and Statistics, 4-C-15

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Operations Building, 6401 Security Boulevard, Baltimore MD 21235; 
telephone 410-965-5540.

SUPPLEMENTARY INFORMATION:

A. Background

    Historically, SSA had made disclosures of vital status data under 
the provisions of the Freedom of Information Act (FOIA, 5 U.S.C. 
552(a)(3)). However, as a result of the Supreme Court decision in 
United States Department of Justice v. Reporters Committee for Freedom 
of the Press 489 U.S. 749 (1989), SSA discontinued the process of 
providing such data. The enactment of Section 311 of the Social 
Security Independence and Program Improvements Act of 1994 established 
the legal authority for SSA to release vital status data except for 
death data obtained from a State under section 205(r) of the Social 
Security Act, which data may only be released for statistical and 
research purposes to State and Federal agencies at the discretion of 
the Commissioner of Social Security. Accordingly, when the research in 
question has been determined to contribute to a national health 
interest SSA will furnish vital status data on study subjects. The 
researcher must submit the study subject's Social Security Number, full 
name (first, last and middle name), date of birth (month, day, century 
and year) and sex. SSA, in-turn, will furnish one of the following 
vital status determinations for each study subject so long as the 
researcher has provided adequate assurances that information relating 
to presumed living will be kept confidential:
     Death information (except information obtained under 
section 205(r)) (the date of death and State where a claim was filed, 
or the State of residence at the time of death) if available;
     Presumption that the individual is living (There is 
sufficient information in SSA administrative records to support this 
determination);
     Status unknown (SSA has no record of death, nor sufficient 
information within the SSA administrative records to support a 
determination that the subject is alive);
     Social Security Number (SSN) verification failed (the SSN 
and name furnished to SSA did not match or the date of birth furnished 
for an SSN/name did not match the information in the SSA administrative 
records); or
     The SSN was impossible or had never been issued.
    A companion change to the Internal Revenue Code (26 U.S.C. section 
6103) permits SSA to release ``presumption of living'' data based on 
reports of earnings obtained from the IRS.

B. Application Process

    Please submit requests for this service in memorandum format 
addressed to the Associate Commissioner for Research, Evaluation and 
Statistics, Social Security Administration. For each request for 
services, the following specific areas must be covered in separately 
numbered paragraphs:
    1. The name, address and phone number of the study's Principal 
Investigator. Also include the name and phone number of another person 
who can be contacted if SSA has questions about the request.
    2. The title of the study or project.
    3. Attach a one page summary of the study protocol or the project 
activities. Include specific purpose(s) of the research to be 
undertaken and the outcomes expected.
    4. The organization or institution supporting the research and the 
specific person who will sign agreements to reimburse SSA for expenses 
incurred in supplying data.
    5. An explanation of how data provided by SSA will be used. That 
is, will the data only be used to determine the subjects' vital status 
or will it also be used to obtain death certificates to determine the 
causes of death or to obtain additional information from next-of-kin, 
physicians, or hospitals.
    6. A specific statement that vital status data obtained from SSA 
under the category, ``presumed living'' will only be used for the 
purposes described in the request and will not be used for 
administrative or legal purposes.
    7. Procedures to ensure the confidentiality of the vital status 
data supplied by SSA under the category, ``presumed living''.
    8. Plans to publish or release the research results including 
whether any supporting documentation will be made available in 
identifiable form under the category, ``presumed living''.
    9. Final disposition of SSA data to include the location of files 
and full disclosure of who will have access to the identifying data 
under the category, ``presumed living'' and for how long.
    10. In addition to the staff of the requesting organization, 
identify, ``other parties'' receiving (or have contractual or other 
rights to) vital status information provided by SSA under the category 
``presumed living''. ``Other parties'' would include consultants, 
collaborators, nosologist, contractors, subcontractors, and sponsoring 
or participating agencies or organizations.

    Note: If the applicant indicates that other organizations or 
individuals will receive identifying SSA vital status data under the 
category ``presumed living'', that organization must also be a party 
(signatory) to the applicant's memorandum or must submit a separate 
supporting memorandum. In this supporting documentation each third 
party must indicate (1) their role in the study and the activities 
they will perform, (2) how they will store and maintain 
confidentiality of the identifying data under the category 
``presumed living'', and (3) how and when the identifying data on 
the ``presumed living'' will be destroyed.

    An evaluation team comprised of staff members from SSA's Office of 
Research, Evaluation and Statistics and the National Center for Health 
Statistics (NCHS) will review each application for services. The team 
will not attempt to determine the scientific merit of the study. It is 
understood that the merit of the study has been (or will be) determined 
by the sponsoring agency and/or the organization performing the study. 
The team's purpose will be to reach a consensus that the results of the 
study could be expected to advance the public's knowledge in a health 
area of importance to a segment of the United States population.
    If such a determination is made and the Associate Commissioner for 
Research, Evaluation and Statistics concurs, the applicant will be 
notified, in writing, of the methods that may be used to submit data on 
study subjects, the exact format to be used in submitting this data and 
the cost for developing and transmitting the vital status data from SSA 
records. The applicant will be required to sign a memorandum of 
understanding which will delineate his/her responsibilities in the use 
of the requested vital status data. The applicant will also be required 
to sign a contractual agreement to facilitate payment for the service.

C. Service Costs

    The service is currently available at a cost of $.16 per record 
(data supplied to identify one study subject) up to 25,000 records. 
Additional records will be processed at a cost of $.012 per record. 
Form SSA-1234-U5 ``Agreement Covering Reimbursable Services'' will be 
signed by the applicant and an appropriate SSA representative to 
formalize the payment process. As authorized by Pub. L. 97-35, SSA 
requires federal agency requestors to provide an advance payment equal 
to 50 percent of the SSA costs for this service. Non-federal requestors 
are required to provide an advance payment of 100 percent of the SSA 
costs for this service.

D. Criteria Used to Approve Requests

    The SSA/NCHS team will use the following criteria in formulating 
their

[[Page 44944]]

recommendations for the Associate Commissioner for Research, Evaluation 
and Statistics:

Use of Data for Statistical Purposes

    The request for services should clearly state that the vital status 
data supplied will be used to support statistical calculations and/or 
study findings. Furthermore, the request must indicate those situations 
in which the death data furnished will be used to identify state death 
records. A request will be disapproved if it proposes to use the vital 
status data or state death data obtained from the vital status data for 
administrative, law enforcement or other nonstatistical purposes. The 
team can suggest that the applicant be given the opportunity to revise 
the application to eliminate any nonstatistical uses of the vital 
status data.

Disease Registries

    Requests from individuals and or groups working with disease 
registries will be accepted. (Disease registry is a roster of persons 
diagnosed and/or treated for a particular disease and maintained for 
the purpose of morbidity and/or mortality surveillance without any 
specific hypotheses to be examined.) Registries usually employ a 
standardized methodology, are subject to informal and sometimes formal 
controls, and may rely on other methods for follow-up of a majority of 
the roster. Such registries deserve special considerations. Applicants 
who propose to submit a roster of names deriving from such a registry 
should specify the date the registry was founded, the purposes of the 
registry, the eligibility criteria for including persons in the 
registry, the provisions for internal and external approval of the 
registry's quality and methods (including human subject 
considerations), and the dates of the last documented internal and/or 
external reviews.
    SSA will generally approve these submissions provided the requests 
give adequate documentation of the registries' activities.
    Furthermore, registries will not be required to submit separate 
applications for each study. Multiple uses of SSA vital status data are 
permitted, provided that: (1) each study is solely used for statistical 
purposes in medical and health research, (2) adequate assurances are 
given confidentiality of the identifying vital status data under the 
``presumed living'' category will be maintained, and (3) vital status 
data under the ``presumed living'' category will be kept separate from 
any administrative records.

Mortality Follow-Up on Non-Disease Cohorts

    Most applicants are required to submit separate requests for 
specific studies. However, some organizations conduct mortality 
surveillance studies on ``non disease'' cohorts such as industrial 
workers, population samples, and members of particular families. Vital 
status data on such individuals may be used for multiple 
epidemiological studies. Such organizations, in essence, are 
maintaining exposure or other non-disease ``registries'' which 
facilitate epidemiological studies of groups with particular 
experiences. Such organizations will not be required to submit separate 
applications to SSA for each study, although they will be required to 
describe expected protocols and give specific, current or future 
examples.
    Multiple uses of vital status data obtained from SSA under the 
``presumed living'' category are permitted, provided that (1) each 
study is used solely for statistical purposes in medical or health 
research, (2) adequate assurances are given the confidentiality of 
identifying vital status data under the ``presumed living'' category 
will be maintained, and (3) vital status data under the ``presumed 
living'' category will be kept separate from any administrative 
records.

Use of Data by a Third Party

    If the applicant indicates that another organization will receive 
identifying SSA vital status data under the ``presumed living'' 
category, that organization must be a party to the original submittal 
or submit a supporting memorandum. In this supporting documentation, 
the third party must indicate (1) how they will store data and maintain 
the confidentiality of data under the ``presumed living'' category and 
(2) how and when data under the ``presumed living'' category will be 
destroyed.

Final Disposition of Data

    The applicant must indicate if, how and when identifiable data 
under the ``presumed living'' category furnished in support of a 
request, will be destroyed. If there is no indication that the 
identifiable data under the ``presumed living'' category will be 
destroyed, then the individual requesting the vital status data must 
explain, in some detail, why the data needs to be maintained.

E. Repeated Use of the Service

    Once an applicant is approved to obtain vital status data for a 
specific study or project, the approval is valid as long as there are 
no major changes in the project. Additional records may be submitted 
under the approved contract for services. If however, the project 
specifications change, the applicant must submit a new request for 
services. The following is a list of possible occurrences which would 
require the submission of a new request for services:
     The project will be supported by a new organization,
     A new organization will be receiving the vital status 
data,
     Confidentiality provisions under the ``presumed living'' 
category have changed,
     Provisions for disposing of data under the ``presumed 
living'' category obtained from this request have changed,
     Vital status data under the ``presumed living'' category 
will be used for legal, administrative or other actions which could 
directly affect particular living individuals or establishments,
     Changes have been made in the project's research 
objectives.

(Catalog of Federal Domestic Assistance Program Number 96.007, 
Social Security--Research and Demonstration)

    Dated: May 1, 1998.
Jane L. Ross,
Deputy Commissioner for Policy.
[FR Doc. 98-22463 Filed 8-20-98; 8:45 am]
BILLING CODE 4190-29-P