§ 5.71 Records specifically required by Executive order to be kept secret in the interest of the national defense or foreign policy.

No record shall be withheld from disclosure on the ground that the national defense or foreign policy so requires, unless it has been classified pursuant to the criteria and procedures prescribed by Executive Order, such as Executive Order 10501, as amended, and has not been declassified in accordance with applicable procedures.

[32 F.R. 9315, June 30, 1967, as amended at 32 F.R. 14895, Oct. 27, 1967]

$5.72

Records relating solely to the internal personnel rules and practices of the Department.

This exemption covers only those internal rules or instructions to personnel relating to how employees carry out their assigned functions and activities for which the Department has responsibility. Thus, materials which provide guidelines or instructions to employees relating to tolerances, selection of cases, quantums of proof, and the like, are within this exemption. However, materials having only management significance, such as rules relating to work hours, leave, promotion plans, while relating to personnel, may be disclosed.

[32 FR. 9315, June 30, 1967, as amended at 32 F.R. 14895, Oct. 27, 1967]

§ 5.73 Records specifically exempted from disclosure by statute.

This exemption preserves the full force and effect of statutes which restrict public access to specific Government records. Several such statutes apply to records and information of the Department.

§ 5.74 Trade secrets and commercial or financial information obtained from any person and privileged or confidential.

This exemption protects generally against disclosure of information which the person furnishing it customarily would not release to the public or which is submitted by him in reliance upon the Department's assurance that it will not be disclosed. It includes records which fall in any one of such categories as: Trade secrets; technical, commercial, or financial information which is privileged through general custom and usage in the same line of endeavor; information which is obtained from any person under explicit or implicit pledge of confiden

tiality; and information which is privileged under any of the following privileges: Doctor-patient, lender-borrower, attorney-client, or Governmentinformer privileges. It also includes data and views of scientists, scholars, or consultants submitting or making judgments on research designs in applications for grant or other support.

§ 5.75 Interagency or intraagency memorandums or letters which would not be available by law to a private party in litigation with the agency.

This exemption preserves the existing freedom of Government officials and employees to engage in full and frank communication with each other; whether such expression relates, for example, to a recommendation for legislation, to the evaluation of a grant application, or to the recommendation to select one or another case for the enforcement of a law or regulation. Thus, proposed budgets which have not been transmitted to the Congress, the recommendations of an expert or consultant or advisory committee whose advice was sought by the agency, an opinion relating to liability of the Department in a medical malpractice lawsuit are not, except to the same extent routinely available to a party in litigation with the agency, available for inspection and copying. This exemption includes internal memorandums, opinions and recommendations, correspondence and documents, as well as notations, route slips, and working papers; materials received or generated by the Department before the transaction to which they relate has been completed. § 5.76 Personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. This exemption covers all personal, private, financial, or business information contained in any files which, if disclosed to the public, would constitute a clearly unwarranted invasion of the privacy of any person. This exemption includes such matters as names of unsuccessful applicants as well as other data which invades personal privacy. § 5.77 Investigatory files compiled for law enforcement purposes except to the extent available by law to a private party.

This exemption covers all matters, including sources of information or com

plaints, in investigative files and reports compiled for law enforcement or regulatory activities of the Department, or relating to matters in litigation.

§ 5.78

Records contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of the Department or any operating agency responsible for the regulation or supervision of financial institutions.

§ 5.79 Geological and geophysical information and data (including maps) concerning wells.

Subpart G-Administrative Review § 5.80 Review of denial of a record.

This subpart provides for the review of a denial, pursuant to § 5.53, of a written request for inspection or copying of a record.

A person whose request has been denied may initiate a review by filing a request for review within 30 days of the date of the denial of the request. § 5.82 By whom review is made.

Review shall be made by the Assistant Secretary for Administration, or his designee, in respect to records of the Office of the Secretary, by the Assistant Secretary for Health and Scientific Affairs, or his designee, as to records of the three operating agencies comprising the Public Health Service, and, as to the records of other operating agencies, by the head of that operating agency, or his designee. Requests for review shall be addressed to the officers.

[33 F.R. 18030, Dec. 4, 1968]

§ 5.83 Contents of request for review.

The request for review shall include a copy of the written request and the denial.

§ 5.84 Consideration on review.

Review shall be considered on the basis of the written record including any written argument submitted by the requester.

§ 5.85 Decisions on review.

(a) Decisions on review shall be in writing. If the decision is in favor of the requester, the decision shall order records made available to the requester as provided in the decision.

(b) The decision, if adverse to the requester, shall briefly state the reasons for the decision, and shall be promptly communicated to the requester, and shall constitute final action of the Department.

(c) All such decisions constituting precedents shall be indexed and available for inspection and copying in the same manner as final orders and opinions subject to subsection (a) (2) of the Act. (d) Adverse decisions pursuant to this subpart may be reviewed by the courts as provided in subsection (a)(3) of the Act.

APPENDIX A-EXAMPLES OF KINDS OF EXEMPT RECORDS

This appendix sets forth examples of kinds of materials which are exempt from mandatory disclosure pursuant to one or more of the exemptions in subsection (b) of the Act and Subpart F of this part.

1. Grant applications or research proposals which reveal research investigators' protocols or research designs.

2. Records of interim progress or incomplete development of Department-supported or Department-conducted studies or research projects, including notes, notebooks, and recordings compiled in the course of unfinished research.

3. Records containing information which is privileged through custom and usage in the same line of endeavor, or which is appropriately given to an agency in confidence and has been obtained from members of the public through questionnaires, surveys, and other inquiries.

4. Records of deliberations, discussions, comments, evaluations, and notes of members of advisory committees, study or review panels, task forces, or work groups.

5. Grant or loan applications which contain information exempt (e.g., under § 5.74 or § 5.76) from mandatory disclosure.

NOTE: Any of the records or materials in the examples noted in paragraphs 1-5 above may, however, be available for disclosure if the person requesting the record obtains the consent of the person who submitted the material or whose right of personal privacy is involved in its disclosure.

6. Manuals, guidelines, instructions, and other materials which are for guidance of employees in evaluating applications, in establishing or carrying out audit or inspection procedures, allowable tolerances, or quantums of proof, or in selection or handling of cases in litigation, and materials of similar kinds which cannot be disclosed to the public without defeating their purpose.

7. Patients' hospital, clinical, and medical records including related correspondence; medical histories, and supporting material; financial and property records and reports pertaining to patients in hospitals or clinics.

9. Procurement and disposal plans which if prematurely released would give aid to speculators.

10. Records of correspondence between Federal and State or local officials, privileged through custom and usage or where disclosure might prejudice negotiations in progress.

11. Respecting Food and Drug Administration regulatory activities: Trade secrets or commercial or confidential information voluntarily revealed in requests for opinions, and opinions and related records indicating that a person, firm, or product is or is not in compliance with the law; records relating to factory inspections, sample collections, seafood inspection, and other examinations and investigations by the Food and Drug Administration; Investigational New Drug filles; New Drug Applications and master files, other than final printed labeling; reports and records relating to individual adverse drug reaction(s); data in support of petitions relating to pesticide chemicals, food standards, food additives, and color additives, and master files relating thereto; files relating to certification of insulin, antibiotics, and color additives, and master filles relating thereto; notices of hearing issued to individuals and firms under 21 U.S.C. 335 and records relating thereto; records relating to research in support of actions to further the law enforcement or regulatory activities of the Food and Drug Administration.

NOTE: Certain documents in some of the above files may be available upon request identifying the particular documents.

12. Budget and legislative proposals and all materials related thereto, other than those presented to Congress.

13. Opinions of the Office of General Counsel

14. Records revealing names of persons considered but not appointed to public advisory committees, unsuccessful job applicants; records reflecting the identity of experts, consultants, or other persons from whom opinions, judgments, evaluations, or other data were obtained.

15. Records to the extent they reveal names of complainants, drug abusers, or informers; audit, civil rights, disciplinary, grievance, security, and other investigation files, including reports of interviews, signed or sworn statements or other reports and related material.

16. Official personnel folders and related files including grievance and disciplinary files; confidential statement of employment and financial interest; performance evaluations and test scores; internal mailing keys. 17. Earnings record and claim filles maintained by Social Security Administration.

Publication or patenting of inventions.
General Responsibility.

6.3 Licensing of Government-owned pat

ents.

6.4 Central records; confidentiality.

AUTHORITY: The provisions of this Part 6 issued under Reorg. Plan No. 1 of 1953, 18 F.R. 2053; 3 CFR, 1953 Supp. E.O. 10096, 15 F.R. 391; 3 CFR, 1950 Supp.

§ 6.0 General policy.

Inventions developed through the resources and activities of the Department are a potential resource of great value to the public health and welfare. It is the policy of the Department:

(a) To safeguard the public interest in inventions developed by Department employees, contractors and grantees with the aid of public funds and facilities;

(b) To encourage and recognize individual and cooperative achievement in research and investigations; and

(c) To establish a procedure, consistent with pertinent statutes, Executive orders and general Government regulations, for the determination of rights and obligations relating to the patenting of inventions.

[20 F.R. 6747, Sept. 14, 1965. Redesignated at 31 F.R. 12842, Oct. 1, 1966]

§ 6.1

not require any departure from normal policy regarding the dissemination of the results of Department research. [28 F.R. 2990, Mar. 27, 1963. Redesignated at 31 F.R. 12842, Oct. 1, 1966]

§ 6.2

General Responsibility.

The Assistant Secretary (Health and Scientific Affairs) is responsible for the administration of the invention and patent program of the Department and the determination of rights in inventions and patents in which the Department has an interest.

[31 F.R. 12842, Oct. 1, 1966]

§ 6.3 Licensing of Government-owned patents.

Licenses to practice inventions covered by patents and pending patent applications owned by the U.S. Government as represented by this Department will generally be royalty free, revocable and nonexclusive. They will normally be issued to all applicants and will generally contain no limitations or standards relating to the quality or testing of the products to be manufactured, sold, or distributed thereunder.

Where it appears however that the public interest will be served under the circumstances of the particular case by licenses which impose conditions, such as those relating to quality or testing of products, requirement of payment of royalties to the Government, etc., or by the issuance of limited exclusive licenses by the Assistant Secretary for Health and Scientific Affairs after notice and opportunity for hearing thereon, such licenses may be issued.

[34 F.R. 15560, Oct. 7, 1969]

§ 6.4 Central records; confidentiality.

Central files and records shall be maintained of all inventions, patents, and licenses in which the Department has an interest, together with a record of all licenses issued by the Department under such patents. Invention reports required from employees or others for the purpose of obtaining determinations of ownership, and documents and information obtained for the purpose of prosecuting patent applications shall be confidential and shall be disclosed only as required for official purposes or with the consent of the inventor.

[20 F.R. 6747, Sept. 14, 1965]

PART 7-EMPLOYEE INVENTIONS

Sec.

7.0 Who are employees.

7.1

7.3

Duty of employee to report inventions. Determination as to domestic rights. 7.4 Option to acquire foreign rights. 7.7 Notice to employee of determination. 7.8 Employee's right of appeal.

AUTHORITY: The provisions of this Part 7 issued under Reorg. Plan No. 1 of 1953, 18 F.R. 2053; 3 CFR, 1953 Supp. E.O. 10096, 15 F.R. 391; 3 CFR, 1950 Supp. and E.O. 10930, 26 F.R. 2583; 3 CFR 1961 Supp.

SOURCE: The provisions of this Part 7 appear at 27 F.R. 7986, Aug. 10, 1962, unless otherwise noted.

As used in this part, the term "Government employee" means any officer or employee, civilian or military, except such part-time employees or part-time consultants as may be excluded therefrom by a determination made in writing by the head of the employee's office or constituent organization, pursuant to an exemption approved by the Commissioner of Patents that to include him or them would be impracticable or inequitable, given the reasons therefor. A person shall not be considered to be a part-time employee or part-time consultant for this purpose unless the terms of his employment contemplate that he shall work for less than the minimum number of hours per day, or less than a minimum number of days per week, or less than the minimum number of weeks per year, regularly required of full-time employees of his class.

§ 7.1 Duty of employee to report inventions.

Every Department employee is required to report to the Assistant Secretary (Health and Scientific Affairs) in accordance with the procedures established therefor, every invention made by him (whether or not jointly with others) which bears any relation to his official duties or which was made in whole or in any part during working hours, or with any contribution of Government facilities, equipment, material, funds, or information, or of time or services of other Government employees on official duty. [31 F.R. 12842, Oct. 1, 1966] § 7.3

Determination as to domestic

rights.

The determination of the ownership of the domestic right, title, and inter

est in and to an invention which is or may be patentable, made by a Government employee while under the administrative jurisdiction of the Department, shall be made in writing by the Assistant Secretary (Health and Scientific Affairs), in accordance with the provisions of Executive Order 10096 and Governmentwide regulations issued thereunder by the Commissioner of Patents as follows:

(a) The Government as represented by the Assistant Secretary (Health and Scientific Affairs) shall obtain the entire domestic right, title and interest in and to all inventions made by any Government employee (1) during working hours, or (2) with a contribution by the Government of facilities, equipment, materials, funds, or information, or of time or services of other Government employees on official duty, or (3) which bear a direct relation to or are made in consequence of the official duties of the inventor.

(b) In any case where the contribution of the Government, as measured by any one or more of the criteria set forth in paragraph (a) of this section, to the invention is insufficient equitably to justify a requirement of assignment to the Government of the entire domestic right, title and interest in and to such invention, or in any case where the Government has insufficient interest in an invention to obtain the entire domestic right, title, and interest therein (although the Government could obtain same under paragraph (a) of this section, the Department, subject to the approval of the Commissioner, shall leave title to such invention in the employee, subject, however, to the reservation to the Government of a nonexclusive, irrevocable, royalty-free license in the invention with power to grant licenses for all governmental purposes, such reservation to appear, where practicable, in any patent, domestic or foreign, which may issue on such invention.

(c) In applying the provisions of paragraphs (a) and (b) of this section, to the facts and circumstances relating to the making of any particular invention, it shall be presumed that an invention made by an employee who is employed or assigned (1) to invent or improve or perfect any art, machine, manufacture, or composition of matter, (2) to conduct or perform research, development work, or both, (3) to supervise, direct, coordinate, or review Government financed or conducted research, development work,

or both, or (4) to act in a liaison capacity among governmental or nongovernmental agencies or individuals engaged in such work, falls within the provisions of paragraph (a) of this section, and it shall be presumed that any invention made by any other employee falls within the provisions of paragraph. (b) of this section. Either presumption may be rebutted by a showing of the facts and circumstances and shall not preclude a determination that these facts and circumstances justify leaving the entire right, title and interest in and to the invention in the Government employee, subject to law.

(d) In any case wherein the Government neither (1) obtains the entire domestic right, title and interest in and to an invention pursuant to the provisions of paragraph (a) of this section, nor (2) reserves a nonexclusive, irrevocable, royalty-free license in the invention, with power to grant licenses for all governmental purposes, pursuant to the provisions of paragraph (b) of this section. the Government shall leave the entire right, title and interest in and to the invention in the Government employee, subject to law.

[27 F.R. 7986, Aug. 10, 1962, as amended at 31 F.R. 12842, Nov. 1, 1966] § 7.4

Option to acquire foreign rights.

In any case where it is determined that all domestic rights should be assigned to the Government, it shall further be determined, pursuant to Executive Order 9865 and Government-wide regulations issued thereunder, that the Government shall reserve an option to require the assignment of such rights in all or in any specified foreign countries. In case where the inventor is not required to assign the patent rights in any foreign country or countries to the Government or the Government fails to exercise its option within such period of time as may be provided by regulations issued by the Commissioner of Patents, any application for a patent which may be filed in such country or countries by the inventor or his assignee shall nevertheless be subject to a nonexclusive, irrevocable, royalty-free license to the Government for all governmental purposes, including the power to issue sublicenses for use in behalf of the Government and/or in furtherance of the foreign policies of the Government.