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###### Department of Health and Human Services

###### Office of the Secretary

          - 45 CFR Part 5b
          - RIN 0925-AA23

# AGENCY:

Office of the Secretary, HHS.

# ACTION:

 Final rule.

# SUMMARY:

The Department of Health and Human Services is exempting a new system of records, 09-25-0213, “Administration: Investigative Records, HHS/NIH/OM/OA/OMA,” from certain requirements of the Privacy Act to protect records compiled in the course of an inquiry and/or investigation and to protect the identity of confidential sources who furnish information to the Government under an express promise that the identity of such source would be held in confidence.

# DATES:

This final rule is effective on July 14, 2000.

# FOR FURTHER INFORMATION CONTACT:

NIH Privacy Act Officer, 6011 Executive Boulevard, Room 601, Rockville, MD 20852, 301-496-2832 (this is not a toll free number).

# SUPPLEMENTARY INFORMATION:

The Office of Management Assessment (OMA) assumes the lead responsibility on cases received through the DHHS Office of Inspector General (OIG) hotline that are referred to NIH for action. OMA serves as NIH's central liaison on matters involving the Office of Audit Services, OIG; General Accounting Office; Federal Bureau of Investigation; congressional staff members; etc., related to management controls and audits. OMA also has overall responsibility for all matters related to management controls to prevent fraud, waste, abuse, and conflict of interest or the appearance of these, including the development and implementation of policy and the Annual Management Control Plan and the development of management oversight activity that focuses on early identification and prevention of such occurrences.

To perform these responsibilities, OMA compiles and maintains administrative and investigative records related to alleged or suspected violations of statutes, regulations, and policies governing the conduct of Federal employees, recipients of Federal funding, and others who transact, or seek to transact business with the NIH.

These records contain information related to complaints of incidents, inquiries and investigative findings, administrative and other matters involving complainants, suspects and witnesses, and court dispositions.

The administrative and investigation records are located in the OMA and constitute a “system of records” as defined by the Privacy Act.

Under the Privacy Act, individuals have a right of access to information pertaining to them which is contained in a system of records. At the same time, the Act permits certain types of systems to be exempt from some of the Privacy Act requirements. Subsection (k)(2) allows agency heads to exempt a system of records containing investigatory material compiled for enforcement purposes. This exemption is qualified in that if the material results in denial of any right, privilege, or benefit to an individual to which that individual would be entitled by Federal law, the individual must be granted access to the material, unless the access would reveal the identity of a source who furnished information to the Government under an express promise of confidentiality. In addition, paragraph (k)(5) permits an agency to exempt material from the individual access, notification, and correction and amendment provisions of the Act where investigatory material is compiled for the purpose of determining suitability, eligibility, or qualification for federal employment or federal contracts if release of the material would cause the identity of a confidential source to be revealed.

Because the administrative and investigative records are compiled by a distinct component of the agency whose principal function is investigations which compile material for law enforcement purposes, the specific exemption (k)(2) requirements are met and the exemption is justified. Investigatory materials are compiled for the purpose of determining suitability, eligibility, or qualification for federal employment or federal contracts in the course of investigations that result from a direct allegation or from suspected violations of statutes, regulations and policies uncovered during an administrative management control review or audit. Investigatory material compiled for the purpose of determining whether applicants are suitable, eligible or qualified justifies the need to invoke the paragraph (k)(5) exemption.

The system contains sensitive investigative records. The release of these records to the subject of the investigation could have a chilling effect on the willingness of informants to provide information freely, not only because of fear of retribution, but because they might hesitate to provide any information other than that of which they are entirely certain. Disclosure could impede ongoing investigations and violate the privacy rights of individuals other than the subject of the investigation, thereby diminishing the ability of OMA to conduct a thorough and accurate investigation. Disclosure of information from these records might also reveal to the subjects of the investigation that their actions are being scrutinized, allowing them the opportunity to prevent detection of illegal activities. Finally, disclosure of information from the records might reveal investigative techniques and thereby jeopardize the integrity of the investigation.

Sources may be reluctant to provide sensitive information unless they can be assured that their identities will not be revealed. These exemptions ensure that: (1) Efforts to obtain accurate and objective information will not be hindered; (2) investigative records will not be disclosed inappropriately; and (3) identities of confidential sources and OMA investigators will be protected. Accordingly, NIH in collaboration with 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)(1)-(4), (e)(4)(G) and (H) and (f)].

                    The Department of Health and Human Services announced its intentions to exempt this system in a notice of proposed rulemaking (NPRM) published in the                     **Federal Register**                     on July 9, 1999 (64 FR 37081). No comments were received. Consequently the amendment is the same as that proposed in the NPRM.                          ( print page 37289)    

## Regulatory Impact Statement

Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, requires the Department to prepare an analysis for any rule that meets one of the E.O. 12866 criteria for a significant regulatory action; that is, that may—

Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; 

Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866.

In addition, the Department prepares a regulatory flexibility analysis, in accordance with the Regulatory Flexibility Act (5 U.S.C. chapter 6), if the rule is expected to have a significant impact on a substantial number of small entities.

Because the amendment affects only NIH OMA investigatory records, a small subset of Agency records, we do not believe this rule is economically significant nor do we believe that it will have a significant impact on a substantial number of small entities. The rule is not expected to have any significant impact on OMA operations and does not impose any new information collection requirements under the Paperwork Reduction Act. In addition, this rule is not inconsistent with the actions of any other agency.

For these same reasons, the Secretary certifies this rule will not have a significant economic impact on a substantial number of small entities, and that a Regulatory Flexibility Analysis, as defined under the Regulatory Flexibility Act, is not required.

# List of Subjects in 45 CFR Part 5b

      - Privacy

Dated: December 27, 1999.

Harold Varmus,

Director, National Institutes of Health.

Donna E. Shalala,

Secretary.

For the reasons set out in the preamble, 45 CFR Part 5b is proposed to be amended as set forth below:

# PART 5b—PRIVACY ACT REGULATIONS

1. The authority citation for part 5b continues to read: 

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

2. Section 5b.11 is amended in paragraph (b)(2)(vii) by designating the undesignated paragraph after the colon as paragraph (b)(2)(vii)(A) and republishing it and by adding paragraph (b)(2)(vii)(B) to read as follows: 

§ 5b.11

* * * * *

(b) * * *

(2) * * *

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

(A) Public Health Service Records Related to Investigations of Scientific Misconduct, HHS/OASH/ORI.

(B) Administration: Investigative Records, HHS/NIH/OM/OA/OMA.

* * * * *

[FR Doc. 00-14800  Filed 6-13-00; 8:45 am]

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