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                              40 FR 47406 and 40 FR 41140
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40 FR 47406 (FINAL RULE - EXCERPT)  and 40 FR 41140 (NPRM - EXCERPT)  SORNS 09-10-0010, 09-10-0002, 09-10-0013








  
  
    

  
      



40 FR 47406 (FINAL RULE - EXCERPT) SORNS 09-10-0010, 09-10-0002, 09-10-0013

**Federal Register**

Rules and Regulations

Title 45--Public Welfare
Subtitle A—Department of Health, Education, and Welfare, General Administration

Part 5b—Privacy Act Regulation

**Date:** October 8, 1975**Summary**: A notice of proposed rulemaking to implement Section 3 of the Privacy Act of 1974, 5 U.S.C. 552a (hereinafter referred to as the Act) was published in the FEDERAL REGISTER on August 14, 1975 (40 FR 34129). The notice proposed procedures whereby individuals could avail themselves of the provisions of the Act which, among other things

(1) permit an individual to determine what records pertaining to him are maintained in a system of records by the Department;

(2) permit an individual to gain access to records pertaining to him in such systems of records and to have copies made of any or all such records; and,

(3) permit an individual to correct or amend a record pertaining to him in a system of records.

The notice also proposed procedures under which the Department would operate to comply with the provisions of the Act mentioned above as well as other provisions of the Act which impose requirements on federal agencies with respect to the manner in which they collect, use, disseminate and otherwise maintain records which pertain to specific individuals.

Pursuant to the provisions of subsections (j)(2) and (k)(4) of the Act, exemptions from certain provisions of the Act were proposed for four systems of records maintained by the Department.

On September 5, 1975 an additional notice of proposed rulemaking was published in the FEDERAL REGISTER (40 FR 41140) which proposed exemptions pursuant to subsections (j)(2), (k)(2), (k)(4), and (k)(5) for 10 other systems of records.

Five comments were received on the August 14, 1975 proposal. These comments are from an intermediary and a carrier which perform functions under contracts and agreements entered into under §§ 1816 and 1842 of the Social Security Act, 42 U.S.C. 1395h and 1395u, a medical specialty association representing general and family practitioners, a public interest group, and a health statistics consultant. The comments address the proposed inclusion of intermediaries and carriers as a part of the Department, the proposed special procedures for medical records, the prohibition on blanket consents, and the scope of the proposed exemption of systems of records required by statute to be maintained and used solely as statistical records.

No comments were received on those additional exemptions proposed on September 5, 1975.

The comments and recommendations, and the Secretary’s conclusion in light of them, are detailed below.

Interaction between the Freedom of Information Act and the Privacy Act
[text omitted]

General Policy and Format
[text omitted]

Definitions
[text omitted]

Maintenance of Records
[text omitted]

Notification of or Access to Records
[text omitted]

Special Procedures for Medical Records
[text omitted]

Correction or Amendment of Records
[text omitted]

Disclosure of Records
[text omitted]

**Exempt Systems**

The four exemptions which were proposed in section 5b.9 of the proposed regulation published in the FEDERAL REGISTER on August 14, 1975 and the ten other exemptions which were proposed in a notice published in the FEDERAL REGISTER on September 5, 1975 are included as final exemptions in section 5b.11 of this regulation. As was noted in the preambles of these two proposals, the exemptions are necessary to assure: continued and uninterrupted activity in the area of health services statistical research and the continued cooperation of the sources of such statistical information; the orderly and unbiased conduct of law enforcement investigations, and that efforts by the Department to obtain accurate and objective information relating to an individual’s suitability and eligibility for Department employment will not be prejudiced (40 FR 34130-34131, 40 FR 41141).

Two substantive changes have been made. As proposed the fourteen systems of records were exempted from all of those requirements of the Act authorized by subsections (j) and (k). The Department has determined, however, that it is necessary to exempt these systems of records only from the notification and access and correction and amendment provisions of the Act and this regulation. It was also determined that criminal law enforcement systems of records exempt under subsection (j)(2) of the Act need only be additionally exempted from subsection (e)(3) of the Act (requiring agencies to inform individuals whom it asks to provide a record, including the authority for providing the record, whether providing the record is mandatory or voluntary, the principal purpose for maintaining the record, etc.) to the extent that subsection (e)(3) requirements would prejudice the conduct of a criminal investigation.

A provision was also added in the final regulation to...[text omitted]

It is also noted that the Food and Drug Administration system of records, “employee, consultant, contractor security and investigative records,” proposed to be exempted in the September 5 notice is divided into two separate systems of records in section 5b.11 of this regulation These systems are entitled: the “Employee Conduct Investigative Records, HEW/FDA,” and the “Service Contractor Employee Investigative Records, HEW/FDA,” and are divided to indicate more clearly the specific types of records included in systems of records maintained by the Food and Drug Administration.

Appendix A

[text omitted]

*Effective date*. This regulation is effective immediately on October 3, 1975.

Dated: September 30, 1975.

DAVID MATHEWS,*Secretary*.

Sec.

5b.1 Definitions.

5b.2 Purpose and Scope.

5b.3 Policy.

5b.4 Maintenance of records.

5b.5 Notification of or access to records.

5b.6 Special procedures for notification of or access to medical records.

5b.7 Procedures for correction and amendment of records.

5b.8 Appeals of refusals to correct or amend records.

5b.9 Disclosure of records.

5b.10 Parents and Guardians

5b.11 Exempt systems.

5b.12 Contractors.

5b.13 Fees.

Appendix A Employee standards of conduct.

Appendix B Routine uses for multiple systems of records.

Appendix C Delegations of Authority.

**Authority:**(5 U.S.C. 301, 5 U.S.C. 552a)

[text omitted]

§ 5b.11 Exempt systems.

(a) *General policy*. The Act permits certain types of specific systems of records to be exempt from some of its requirements. It is the policy of the Department to exercise authority to exempt systems of records only in compelling cases.

(b) *Specific systems of records exempted*. (1) Those systems of records listed in paragraph (b)(2) of this section are exempt from the following provisions of the Act and this Part:

(i) 5 U.S.C. 552a(c)(3) and paragraph (c)(2) of § 5b.9 of this part which require a subject individual to be granted access to an accounting of disclosures of a record.

(ii) 5 U.S.C. 552a(d)(1) through (4) and (f) and §§ 5b.6, 5b.7, and 5b.8 of this part relating to notification of or access to records and correction or amendment of records.

(iii) 5 U.S.C. 552a(e)(4)(G) and (H) which require inclusion of information about Department procedures for notification, access, and correction or amendment of records in the notice for the system of records.

(iv) 5 U.S.C. 552a(e)(3) and paragraph (a)(3) of § 5b.4 of this Part which require that an individual asked to provide a record to the Department be informed of the authority for providing the record (including whether the providing of the record is mandatory or voluntary, the principal purposes for maintaining the record, the routine uses for the record, and what effect his refusal to provide the record may have on him), and if the record is not required by statute or Executive Order to be provided by the individual, he agrees to provide the record. This exemption applies only to an investigatory record compiled by the Department for criminal law enforcement purposes in a system of records exempt under subsection (j)(2) of the Act to the extent that these requirements would prejudice the conduct of the investigation.

(2) The following systems of records are exempt from those provisions of the Act and this part listed in paragraph (b)(1) of this section.

(i) Pursuant to subsection (j)(2) of the Act: [text omitted]

(ii) Pursuant to subsection (k)(2) of the Act: [text omitted]

(iii) Pursuant to subsection (k)(4) of the Act: [text omitted]

(iv) Pursuant to subsection (k)(5) of the Act: [text omitted]

(v) Pursuant to subsections (j)(2), (k)(2), and (k)(5) of the Act:

(A) the Clinical Investigatory Records, HEW/FDA;

(B) the Regulated Industry Employee Enforcement Records, HEW/FDA;

(C) the Employee Conduct Investigative Records, HEW/FDA; and,

(D) [text omitted].

(c) *Notification of or access*...[text omitted]

(d) *Discretionary actions*...[text omitted]

§ 5b.12 Contractors.
[text omitted]

§ 5b.13 Fees.
[text omitted]

Appendix A
Employee Standards of Conduct
[text omitted]



Appendix B
Routine Uses Applicable to More Than One System of Records Maintained by Hew
[text omitted]

Appendix C
Delegations of Authority [Reserved]

[FR Doc. 75-26924 Filed 10-2-75; 4:23 pm]

40 FR 41140 (NPRM - EXCERPT) SORNS 09-10-0010, 09-10-0002, 09-10-0013

**Federal Register**

Proposed Rules

Department of Health, Education, and Welfare
Office of the Secretary
45 CFR Part 5b

Privacy Act
Notice of Proposed Exemptions

**Date:** September 5, 1975**Summary:** Notice is hereby given that the Secretary proposes exemptions as provided under subsections (j) and (k) of the Privacy Act, Public Law 93-579, 5 U.S.C. 552a. These exemptions are proposed in addition to those exemptions proposed in § 5b.9(b) of the Secretary's proposed regulations, implementing the Privacy Act, published in the FEDERAL REGISTER on August 14, 1975 (40 FR 34129).

The “Maryland Psychiatric...[text omitted]

The “Investigatory Material...[text omitted]

The “General Criminal...[text omitted]

Also proposed to be exempted from subsections (c)(3), (d), (e)(1), (e)(4)(G), (H) and (I), and (f) of the Act are the “Investigatory Material...[text omitted]

As provided in subsections (j)(2), (k)(2) and (5) of the Act, the “Clinical Investigator Records, HEW/FDA,” the “Regulated Industry Employee Enforcement Records, HEW/FDA,” and the “employee, consultant, contractor security and investigative records,” systems of records maintained by the Food and Drug Administration, are proposed to be exempted from subsections (c)(3), (d)(1) through (4) and (f), (e)(4)(G) and (H), and (e)(3) of the Act. The Commissioner of Food and Drugs is proposing regulations to implement the Privacy Act as it will affect systems of records maintained by the Food and Drug Administration. Also included in these proposed regulations are those systems of records maintained by the Food and Drug Administration proposed to be exempted in this notice. The proposed Food and Drug Administration regulations should be consulted for a full statement of the rationale and justification for the exemptions.

Interested persons and organizations are invited to submit written comments on these proposed exemptions to the Director, Fair Information Practices Staff, Department of Health, Education, and Welfare, 330 Independence Avenue, S.W., Washington, D.C. 20201.

All comments received on or before September 17, 1975 will be considered by the Secretary before taking action on the proposed exemptions, and will be available for public inspection in Room 4513, at the above address.

These exemptions are proposed under the authority of subsections (j) and (k) of 5 U.S.C. § 552a and 5 U.S.C. § 301.

In consideration of the foregoing, it is proposed to amend part 5b of 45 CFR Subtitle A (40 FR 34129) as follows:

Part 5b—Privacy Act Regulation

1. By adding paragraphs (b)(2)(iv), (3), (4), (5), (6) and (c) as follows:

§ 5b.9 Exemptions.

(b) * * *

(2) * * *

[text omitted]

(3) As provided in subsection (j)(2) of the Act...[text omitted]

(4) As provided in subsection (k)(2) of the Act...[text omitted

(5) As provided in subsection (k)(5) of the Act...[text omitted]

(6) As provided in subsections (j)(2), (k)(2), and (5) of the Act, the “Clinical Investigator Records, HEW/FDA,” the “Regulated Industry Employee Enforcement Records, HEW/FDA,” and the “employee, consultant, and contractor security and investigative records,” systems of records maintained by the Food and Drug Administration, are exempt from the following provisions of the Act:

(i) 552a(c)(3) requiring that an individual be provided with the accounting of disclosures of records about himself; and

(ii) 552a(d)(1) through (4) and (f) requiring procedures for individuals to be given notification of and access to records about themselves, and to be allowed to challenge the accuracy, relevance, timeliness, and completeness of such records except where access is required under subsection (k)(2) of the Act and to the extent that access is required under subsection (k)(5) of the Act, and paragraph (c)(2) of this section; and,

(iii) 552a(e)(4)(G) and (H) regarding the inclusion in the notice for the system of information about agency procedures for notification, access, and contest; and,

(iv) 552a(e)(3) requiring that individuals asked to supply information be provided a form outlining the authority for the request, the purposes for which the information will be used, the routine uses in the notice of a Food and Drug Administration record system notice, and the consequences to the individual of not providing the information, but only with respect to information compiled by the Food and Drug Administration in a criminal law enforcement investigation where the conduct of the investigation would be prejudiced by such procedures.

(c) *Access*...[text omitted]

Dated: August 29, 1975.

DAVID MATHEWS,*Secretary*

[FR Doc 75-23621 Filed 9-4-75; 8:45am]

                    
  


Content created by Freedom of Information Act (FOIA) Division Content last reviewed November 27, 2017 Back to top
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