responsibility for records of the Office of the Secretary in his region. The Regional Information Center Officer in each region shall be the Assistant to the Regional Director (for Information). (c) The Information Center Officer for each of the operating agency infor Consumer Protection and Environmental Health Serviões. Health Services and Mental Health Administration. National Institutes of Health___. Social Security Administration_. Social and Rehabilitation Service___. [33 F.R. 18030, Dec. 4, 1968] § 5.33 Duty hours. The Information Centers shall be open to the public on regular work days during the regular duty hours of the installation where located. § 5.34 Material in the information cen ters. (a) The Central Information Center shall contain or shall have available, as a minimum, the following: (1) FEDERAL REGISTER, Code of Federal Regulations, and regulations of the Department contained therein; (2) Precedent final opinions and orders in the adjudication of cases issued subsequent to July 4, 1967; (3) Administrative staff manuals which affect members of the public; (4) Administrative program manuals which affect members of the public. (5) Those statements of policy and interpretations issued or adopted after July 4, 1967, and used or relied upon as precedents not otherwise published; (6) Current indices of the foregoing materials issued, adopted or promulgated after July 4, 1967. (b) Each Regional Office Information Center shall contain the records required by paragraph (a) of this section and in addition such records appertaining to the activities of that Regional Office as may be determined by the Regional Information Center Officer. (c) The Information Centers of the operating agencies shall contain or shall provide for the availability of the material appertaining to the activities of the respective operating agency. [32 F.R. 9315, June 30, 1967, as amended at 32 F.R. 14895, Oct. 27, 1967] (a) A request for any information or record may be made at (1) the Department's Central Information Center, (2) any Regional Office Information Center, or (3) any subsidiary Information Center of an operating agency. A request may also be made at any appropriate office of the Department or of any operating agency. (b) Requests made at the Central or a Regional Office Information Center for information or records not located there shall, if reduced to writing by the requester, be forwarded to the proper office. If a request is made at any other Center or office of the Department or any operating agency and the information or record is not located where the request is made, the requester shall be referred to the proper Center or office, or if the request is put in writing it may be forwarded to the proper office. (c) A request should identify the requested record by brief description, containing the name, number or date as applicable, sufficient to enable the record to be identified and located. A reasonable time should be allowed for records to be located, reproduced, and mailed. (d) The request should include the fee or request determination of the fee. § 5.52 Copies of records. Copies of available records shall be produced as promptly as possible upon receipt of the fee therefor. Copying service shall be limited to not more than two copies of any single page, except that ad ditional copies may be made where administrative considerations permit. Records which are published or available for sale need not be copied. § 5.53 Denial of requests for records. Written requests for inspection or copying of records shall be denied only by the Department's Information Center Officer, the appropriate Information Center Officer of the region or the operating agency, or other duly authorized officer of the operating agency. Denials of written requests shall be in writing. Oral requests may be dealt with orally, but if the requester is dissatisfied with the disposition of such a request he shall be asked to put the request in writing. Subpart E-Fees § 5.60 Policy on fees. It is the policy of the Department to provide routine information to the general public without charge. Special information services involving a benefit that does not accrue to the general public shall be subject to the payment of fees, which shall be fixed in such amounts as to recover the cost to the Government of providing such services. Fees will be charged for the following special services: (a) Reproduction, copying of records; duplication, or (b) Certification or authentication of records; (c) Searches of or for records. § 5.61 Fee schedules. Since the cost of such services may vary between operating agencies of the Department due to variations in the way in which records are organized and maintained, in copying equipment, or for other reasons, each operating unit of the Department providing such services shall establish and publish schedules of fees for the above services and on the basis described below. New or modified fee schedules may be published from time to time in recognition of changes in costs to the Government or changing circumstances. No fee shall be charged for searching for records which are contained in the Department Information Centers designated in or in accordance with § 5.31. § 5.62 Publication of fee schedules. Fee schedules shall be published in the FEDERAL REGISTER by the Assistant Secretary for Administration for the Office Fees for copy or duplicating services shall be set on a per page basis. The fee shall be maintained as a predetermined standard rate. § 5.65 Certification or authentication. A fee for certification or authentication of records shall be set on a per document basis. The fee shall be on the basis of a predetermined standard rate. Where the request includes making a copy of the record to be certified, the applicable fee for copying will also be charged. Where the requester furnishes a copy of the document to be authenticated or certified which requires comparison with the record on file, a comparing fee based upon predetermined hourly rates will be applicable. Subpart F-Exemptions § 5.70 Exemptions. No record duly requested shall be withheld from disclosure unless it comes within one of the following classes of records exempted by the Act. Appendix A to this part contains some examples of the kinds of materials which fall within one or more classes exempt from all requirements of the Act. Disclosure of particular items of such kinds will nevertheless be made when this can be done consistently with obligations of confidentiality and administrative necessity as determined by the official considering the request. [32 F.R. 9315, June 30, 1967, as amended at 32 F.R. 14895, Oct. 27, 1967] § 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 F.R. 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 attorney-client, tiality; and information which is privileged under any of the following privileges: Doctor-patient, lender-borrower, 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. § 5.81 Time for initiation of request for review. 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 FR. 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. (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. 8. Records of pharmaceutical and related information concerning investigational drugs, revealed to the Department by private sources. 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 files; 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 files 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 files maintained by Social Security Administration. 6.3 Licensing of Government-owned patents. 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] It is the general policy of the Department that the results of Department research should be made widely, promptly and freely available to other research workers and to the public. This availability can generally be adequately preserved by the dedication of a Government-owned invention to the public. Determinations to file a domestic patent application on inventions in which the Department has an interest will be made where the circumstances indicate that this is desirable in the public interest, and if it is practicable to do so. ment determinations not to apply for a domestic patent on employee inventions are subject to review and approval by the Commissioner of Patents. Except where deemed necessary for protecting the patent claim, the fact that a patent application has been or may be filed will Depart |