[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR5b.11]



[Page 39-41]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 5b_PRIVACY ACT REGULATIONS--Table of Contents

 

Sec.  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 Sec.  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 Sec. Sec.  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 systems of 

records.



[[Page 40]]



    (iv) 5 U.S.C. 552(e)(3) and paragraph (a)(3) of Sec.  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:

    (A) The Saint Elizabeths Hospital's Court-Ordered Forensic 

Investigatory Materials Files; and

    (B) The Investigatory Material Compiled for Law Enforcement Purposes 

System, HHS.

    (ii) Pursuant to subsection (k)(2) of the Act:

    (A) The General Criminal Investigation Files, HHS/SSA;

    (B) The Criminal Investigations File, HHS/SSA; and,

    (C) The Program Integrity Case Files, HHS/SSA.

    (D) Civil and Administrative Investigative Files of the Inspector 

General, HHS/OS/OIG.

    (E) Complaint Files and Log. HHS/OS/OCR.

    (F) Investigative materials compiled for law enforcement purposes 

for the Healthcare Integrity and Protection Data Bank (HIPDB), of the 

Office of Inspector General. (See Sec.  61.15 of this title for access 

and correction rights under the HIPDB by subjects of the Data Bank.)

    (G) Investigative materials compiled for law enforcement purposes 

for the Program Information Management System, HHS/OS/OCR.

    (iii) Pursuant to subsection (k)(4) of the Act:

    (A) The Health and Demographic Surveys Conduct in Random Samples of 

the U.S. Population;

    (B) The Health Manpower Inventories and Surveys;

    (C) The Vital Statistics for Births, Deaths, Fetal Deaths, Marriages 

and Divorces Occurring in the U.S. during Each Year; and,

    (D) The Maryland Psychiatric Case Register.

    (E) The Health Resources Utilization Statistics, DHHS/OASH/NCHS.

    (F) National Medical Expenditure Survey Records. HHS/OASH/NCHSR.

    (iv) Pursuant to subsection (k)(5) of the Act:

    (A) The Investigatory Material Compiled for Security and Suitability 

Purposes System, HHS; and,

    (B) The Suitability for Employment Records, HHS.

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

    (A) The Clinical Investigatory Records, HHS/FDA;

    (B) The Regulated Industry Employee Enforcement Records, HHS/FDA;

    (C) The Employee Conduct Investigative Records, HHS/FDA; and,

    (D) The Service Contractor Employee Investigative Records, HHS/FDA.

    (vi) Pursuant to subsection (k)(6) of the Act:

    (A) The Personnel Research and Merit Promotion Test Records, HHS/

SSA/OMA.

    (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.

    (c) Notification of or access to records in exempt systems of 

records. (1) Where a system of records is exempt as provided in 

paragraph (b) of this section, any individual may nonetheless request 

notification of or access to a record in that system. An individual 

shall make requests for notification of or access to a record in an 

exempt system of records in accordance with the procedures of Sec. Sec.  

5b.5 and 5b.6 of this part.



[[Page 41]]



    (2) An individual will be granted notification of or access to a 

record in an exempt system but only to the extent such notification or 

access would not reveal the identity of a source who furnished the 

record to the Department under an express promise, and prior to 

September 27, 1975 an implied promise, that his identity would be held 

in confidence, if:

    (i) The record is in a system of records which is exempt under 

subsection (k)(2) of the Act and the individual has been, as a result of 

the maintenance of the record, denied a right, privilege, or benefit to 

which he would otherwise be eligible; or,

    (ii) The record is in a system of records which is exempt under 

subsection (k)(5) of the Act.

    (3) If an individual is not granted notification of or access to a 

record in a system of records exempt under subsections (k) (2) and (5) 

of the Act in accordance with this paragraph, he will be informed that 

the identity of a confidential source would be revealed if notification 

of or access to the record were granted to him.

    (d) Discretionary actions by the responsible Department official. 

Unless disclosure of a record to the general public is otherwise 

prohibited by law, the responsible Department official may in his 

discretion grant notification of or access to a record in a system of 

records which is exempt under paragraph (b) of this section. 

Discretionary notification of or access to a record in accordance with 

this paragraph will not be a precedent for discretionary notification of 

or access to a similar or related record and will not obligate the 

responsible Department official to exercise his discretion to grant 

notification of or access to any other record in a system of records 

which is exempt under paragraph (b) of this section.



[40 FR 47409, Oct. 8, 1975, as amended at 43 FR 40229, Sept. 11, 1978; 

47 FR 57040, Dec. 22, 1982; 49 FR 14108, Apr. 10, 1984; 51 FR 41352, 

Nov. 14, 1986; 59 FR 36717, July 19, 1994; 65 FR 34988, June 1, 2000; 65 

FR 37289, June 14, 2000; 68 FR 62751, Nov. 6, 2003]