[Federal Register Volume 59, Number 137 (Tuesday, July 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17482]
[[Page Unknown]]
[Federal Register: July 19, 1994]
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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]
BILLING CODE 4160-17-M
