Privacy Act; Exempt System

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 5b

RIN: 0925-AD31

Privacy Act; Exempt System

AGENCY: Office of the Secretary, HHS.

ACTION: Final rule.

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SUMMARY: The Department of Health and Human Services (HHS) is exempting

a proposed system of records, 09-37-0021, ``Public Health Service

Records Related to Investigations of Scientific Misconduct, HHS/OASH/

ORI,'' from certain requirements of the Privacy Act to protect records

compiled during investigations of scientific misconduct and other

related decision records leading to the investigation and to protect

the identity of confidential sources in such investigations.

EFFECTIVE DATE: August 18, 1994.

FOR FURTHER INFORMATION CONTACT:

Barbara Bullman, J.D. (301) 443-5300.

SUPPLEMENTARY INFORMATION: In 1989, the Public Health Service (PHS)

established two offices, the Office of Scientific Integrity Review

(OSIR) and the Office of Scientific Integrity (OSI), to address matters

relating to scientific misconduct in the course of research funded by

the Public Health Service (54 FR 11080, March 16, 1989). The OSIR and

OSI were abolished recently and their functions transferred to the

Office of Research Integrity (ORI) (57 FR 24262-3, June 8, 1992).

The records in the ORI contain information obtained prior to,

during, and following investigations of scientific misconduct. The

records are located in the ORI, in the PHS Agency Misconduct Program

Officers' files and in PHS Agency senior intramural research managers'

offices. The system also contains records that were transferred to ORI

from the other offices which had primary responsibility for misconduct

functions prior to ORI's establishment. The PHS is preparing to

organize and operate these records as a ``system of records'' as

defined by the Privacy Act. This system will be published so that the

system becomes final on or after the date this rule becomes final.

Section 552a(k)(2) of the Privacy Act provides that an agency head

may exempt a system of records from certain provisions of the Act, if

the system of records contains investigatory material compiled for law

enforcement purposes. If the records result in a denial of any right,

privilege, or benefit to an individual, that individual would be

entitled by Federal law to access the file, except for that information

which would reveal a confidential source who was provided information

under an express promise of confidentiality. Further, section

552a(k)(5) permits an agency to exempt a system of records which is

comprised of investigatory material for use in determining suitability,

eligibility, or qualifications for Federal civilian employment or

financial assistance, but only to the extent that the exemption is

required to prevent revealing a confidential source.

On June 12, 1992, the Secretary published a proposed rule in the

Federal Register to exempt the ORI-related system of records from

certain provisions of the Privacy Act (57 FR 25005). The comment period

was open through July 13, 1992. Three responses were received that

addressed the exemptions. The comments were from one institutional

representative and two representatives of professional associations.

PHS has also considered comments received from members of the PHS

Advisory Committee on Scientific Integrity.

In general, these comments opposed withholding from the respondent

the identity of individuals who provide information on allegations of

misconduct under an express promise of confidentiality pursuant to

exemptions (k)(5) and (k)(2). The comments indicated that the accused

had a right to know the identity and source of the accusations and that

this right outweighed the need to protect the identity of the

individuals providing such information. In addition, one of the

commenters believed that the subject of an investigation should have

access to all the records in the file prior to a determination of

misconduct.

After considering the comments, PHS believes that the exemptions

are necessary to carry out its responsibilities effectively. It is

essential to the credibility and effectiveness of the ORI that ORI be

able to maintain the confidentiality of individuals providing

information pertinent to scientific misconduct cases. In certain

instances, sources of information necessary for a thorough

investigation may be reluctant to provide sensitive information unless

they can be assured that their identities will not be revealed. In

addition, the exemptions are necessary to prevent premature disclosure

of records which may impede the investigation. In practice, the

respondent during the course of the investigation has an opportunity to

be interviewed by ORI on matters related to the alleged or apparent

incidents of research misconduct. The interviews are transcribed and a

copy provided to the respondent. In addition, the respondent may have

(1) Reasonable access to copies of any research data under review and

(2) an opportunity to submit information and evidence and obtain a copy

of the draft investigative report to comment on.

Other Federal agencies that conduct investigations into violations

of law or regulations have established systems that are exempt from the

access, amendment and certain other provisions permitted by the

exemption provisions of the Privacy Act. PHS believes that the (k)(2)

and (k)(5) exemptions are essential to assure that the investigative

files will not be disclosed inappropriately. Except for information

that would reveal the identity of a confidential source, the exemptions

will not prohibit a respondent from having a reasonable opportunity of

obtaining access to his or her file in those cases in which a finding

of scientific misconduct has become final and an administrative action

has been imposed.

There is no substantive difference between the proposed rule and

the final rule. Accordingly, the Department is exempting this system

under paragraphs (k)(2) and (k)(5) of the Privacy Act from the

notification, access, correction, and amendment provisions of the

Privacy Act (paragraphs (c)(3), (d), (e)(4) (G) and (H), and (f)).

However, consideration will be given on a case-by-case basis to

requests for access, notification, and corrections which are addressed

to the system manager.

Impact Analyses

The Department has determined that the amendment to exempt a system

of records from certain requirements of the Privacy Act is not a major

rule within the meaning of Executive Order 12291 and it will not have a

significant economic impact on a substantial number of small entities

under the Regulatory Flexibility Act. The rule affects only a small

number of research grants funded by the PHS as compared to the total

number awarded annually. Finally, this rule does not impose any new

information collection requirement under the Paperwork Reduction Act.

List of Subjects in 45 CFR Part 5b

Privacy.

For the reasons set out in the preamble, title 45, part 5b is

amended as set forth below:

Dated: June 30, 1994.

Philip R. Lee,

Assistant Secretary for Health.

Approved: July 5, 1994.

Donna E. Shalala,

Secretary, Health and Human Services.

PART 5b--PRIVACY ACT REGULATIONS

1. The authority citation for part 5b is unchanged and reads as

follows:

Authority: 5 U.S.C. 301, 5 U.S.C. 552a.

2. In part 5b, Sec. 5b.11 is amended by adding paragraph

(b)(2)(vii) as follows:

Sec. 5b.11 Exempt systems.

* * * * *

(b) * * *

(2) * * *

(vii) Pursuant to subsections (k)(2) and (k)(5) of the Act:

Public Health Service Records Related to Investigations of

Scientific Misconduct, HHS/OASH/ORI.

[FR Doc. 94-17482 Filed 7-18-94; 8:45 am]

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