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and Welfare Records Management Food and Drug Administration Federal Manual).
Office Building No. 8, 200 C Street SW.,
Washington, D.C. 20204.
The Department's Central Information
Center serves as the information center Requests for records which originated in or concern matters which originated
for the following: in another Department or Government Office of the Secretary and the Social and agency may be forwarded to the Depart Rehabilitation Service. ment or agency primarily concerned and Saint Elizabeths Hospital, National Institute the requester so notified.
of Mental Health, Public Health Service,
maintains a subsidiary Information Center Subpart C—Where Information
as to records of Saint Elizabeths Hospital at Centers Are Located
the following address: Administration & 5.31 Information centers or facilities.
Building, Saint Elizabeths Hospital, Nich
ols Avenue beyond Anacostia Avenue SE., (a) The Department maintains its
Washington, D.C. 20032. Central Information Center at the following location:
(d) The operating agencies may estab
lish such other information centers as Department of Health, Education, and Welfare, North Building, 330 Independence
they may hereafter determine. Upon the Avenue SW., Washington, D.C. 20201. establishment of such additional cenThis Center shall include a records ref
ter(s) the operating agency shall puberence and copying service, and shall
lish in the FEDERAL REGISTER a notice have as its primary goal the provision, thereof, containing the address thereof, as far as practicable, of information materials to be maintained therein, and service covering the programs and ac the official who has a like responsibility tivities of the Department.
to that of the Information Center Offi(b) The Department maintains an cers provided for in $ 5.32 or $ 5.53. Information Center or information
132 F.R. 9315, June 30, 1967, as amended at facilities in each of its Regional Offices
32 F.R. 14895, Oct. 27, 1967) as follows:
$ 5.32 Information center officers. Region I—John F. Kennedy Federal Building, Boston, Mass. 02203.
(a) (1) The Central Information CenRegion II—42 Broadway, New York, N.Y.
ter Officer shall be responsible for deter10004. Region III—220 Seventh Street NE., Char
mining whether records of the Office of lottesville, Va. 22901.
the Secretary must be withheld from Region IV–50 Seventh Street NE., Atlanta, disclosure.
(2) The Public Information Officer, West Van Buren Street, Chicago, Ill.
Social and Rehabilitation Service, shall 60607.
be responsible for denying requests made Region VI-601 East 12th Street, Kansas
at or through the Central Information City, Mo. 64106. Region VII—1114 Commerce Street, Dallas,
Center for the Social and Rehabilitation Tex. 75202.
Service. Region VIII—Federal Office Building, 19th (b) The Regional Information Center and Stout Streets, Denver, Colo. 80202.
Officer in each region shall have a like Region IX-Federal Office Building, 50 Fulton Street, San Francisco, Calif. 94102. responsibility for records of the Office
of the Secretary in his region. The Re(c) The following operating agencies of the Department maintain subsidiary
gional Information Center Officer in centers at the following locations:
each region shall be the Assistant to the
Regional Director (for Information). Public Health Service-HEW South Building, 330 C Street SW., Washington, D.C. 20201.
(c) The Information Center Officer Office of Education--Federal Office Building for each of the operating agency infor
No. 6, 400 Maryland Avenue SW., Washing mation centers shall have, concurrently ton, D.C. 20202.
with other duly authorized officers, a like Social Security Administration-Social Secu
rity Building, 6401 Security Boulevard, responsibility for the records of his opBaltimore, Md. 21235.
erating agency. The Information Center
Officers for the respective operating Subpart D-Procedures for Requestagencies shall be as follows:
ing Access to Records Public Health Service: Assistant to the
$ 5.51 Procedure. Surgeon General and Director of Information.
(a) A request for any information or Office of Education: Information Center record may be made at (1) the DepartOfficer.
ment's Central Information Center, (2) Social Security Administration: Information
any Regional Office Information Center, Officer.
or (3) any subsidiary Information CenFood and Drug Administration: Information Center Officer.
ter of an operating agency. A request Saint Elizabeths Hospital, NIMH, PHS (as to may also be made at any appropriate
records of Saint Elizabeths Hospital) : office of the Department or of any opPublic Information Officer.
erating agency. (32 F.R. 9315, June 30, 1967, as amended at (b) Requests made at the Central or 32 F.R. 14895, Oct. 27, 1967]
a Regional Office Information Center for
information or records not located there $ 5.33 Duty hours.
shall, if reduced to writing by the reThe Information Centers shall be open quester, be forwarded to the proper ofto the public on regular work days dur fice. If a request is made at any other ing the regular duty hours of the in
Center or office of the Department or any stallation where located.
operating agency and the information or $ 5.34 Material in the information cen
record is not located where the request ters.
is made, the requester shall be referred
to the proper Center or office, or if the re(a) The Central Information Center
quest is put in writing it may be forshall contain or shall have available, as
warded to the proper office. a minimum, the following:
(c) A request should identify the re(1) FEDERAL REGISTER, Code of Feder
quested record by brief description, conal Regulations, and regulations of the
taining the name, number or date as apDepartment contained therein;
plicable, sufficient to enable the record (2) Precedent final opinions and or
to be identified and located. A reasonders in the adjudication of cases is
able time should be allowed for records to sued subsequent to July 4, 1967;
be located, reproduced, and mailed. (3) Administrative staff manuals
(d) The request should include the which affect members of the public;
fee or request determination of the fee. (4) Administrative program manuals which affect members of the public.
$ 5.52 Copies of records. (5) Those statements of policy and in Copies of available records shall be terpretations issued or adopted after
produced as promptly as possible upon July 4, 1967, and used or relied upon as
receipt of the fee therefor. Copying serv
ice shall be limited to not more than two precedents not otherwise published; (6) Current indices of the foregoing
copies of any single page, except that ad
ditional copies may be made where admaterials issued, adopted or promulgated
ministrative considerations permit. Recafter July 4, 1967.
ords which are published or available for (b) Each Regional Office Information sale need not be copied. Center shall contain the records required by paragraph (a) of this section
$ 5.53 Denial of requests for records. and in addition such records appertain
Written requests for inspection or ing to the activities of that Regional Of
copying of records shall be denied only fice as may be determined by the Re
by the Department's Information Cengional Information Center Officer.
ter Officer, the appropriate Information
Center Officer of the region or the oper(c) The Information Centers of the
ating agency, or other duly authorized operating agencies shall contain or shall
officer of the operating agency. Denials provide for the availability of the ma
of written requests shall be in writing. terial appertaining to the activities of Oral requests may be dealt with orally, the respective operating agency.
but if the requester is dissatisfied with (32 F.R. 9315, June 30, 1967, as amended at the disposition of such a request he shall 32 F.R. 14895, Oct. 27, 1967)
be asked to put the request in writing.
Subpart 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 Govern. ment of providing such services. Fees will be charged for the following special services:
(a) Reproduction, duplication, or copying of records;
(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 of the Secretary and by the agency head for his operating agency. Schedules shall also be posted at the Information Centers and made available to the public when information is requested in writing. (32 F.R. 9315, June 30, 1967, as amended at 32 F.R. 14895, Oct. 27, 1967) § 5.63 Searching records.
Fees for searching shall be computed as follows:
(a) A predetermined standard hourly rate for labor and personal services of employees of the Department. Such hourly rates shall be published in advance.
(b) Actual cost to the Government of materials, postage and other direct costs, plus indirect costs to the Government. Such costs shall be determined for each request, at the time of the request, allowing a reasonable period for the development of the estimate. $ 5.64 Copying.
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 8 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 de
classified 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 in
ternal 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. 132 F.R. 9315, June 30, 1967, as amended at 32 F.R. 14895, Oct. 27, 1967] 85.73 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 confi
dential. 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 confidentiality; 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 mem
orandums 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 unwar
ranted 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 pri.
vate party. This exemption covers all matters, including sources of information or complaints, in investigative files and reports compiled for law enforcement or regulatory activities of the Department, or relating to matters in litigation. 8 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 infor provided in subsection (a) (3) of the
mation and data (including maps) Act. concerning wells.
APPENDIX A-EXAMPLES OF KINDS OF EXEMPT Subpart G-Administrative Review
This appendix sets forth examples of kinds $ 5.80 Review of denial of a record.
of materials which are exempt from mandaThis subpart provides for the review tory disclosure pursuant to one or more of of a denial, pursuant to $ 5.53, of a writ
the exemptions in subsection (b) of the
Act and Subpart F of this part. ten request for inspection or copying of
1. Grant applications or research proposals a record.
which reveal research investigators' proto$ 5.81 Time for initiation of request for
cols or research designs. review.
2. Records of interim progress or incom
plete development of Department-supported A person whose request has been
or Department-conducted studies or research denied may initiate a review by filing a projects, including notes, notebooks, and rerequest for review within 30 days of the cordings compiled in the course of unfindate of the denial of the request.
3. Records containing information which § 5.82 By whom review is made.
is privileged through custom and usage in
the same line of endeavor, or which is approReview shall be made by the Assistant
priately given to an agency in confidence and Secretary for Administration, or his
has been obtained from members of the designee, in respect to records of the
public through questionnaires, surveys, and Office of the Secretary, or by the head of other inquiries. an operating agency, or his designee, in 4. Records of deliberations, discussions, respect to records of that operating comments, evaluations, and notes of memagency. Requests for review by the As bers of advisory committees, study or review sistant Secretary shall be addressed to
panels, task forces, or work groups. him at 330 Independence Avenue SW.,
5. Grant or loan applications which con
tain information exempt (e.g., under $ 5.74 Washington, D.C. 20201. Requests for re
or $ 5.76) from mandatory disclosure. view by an erating agency head shall
NOTE: Any of the records or materials in be addressed to the head of the agency. the examples noted in paragraphs 1-5 above 8 5.83 Contents of request for review.
may, however, be available for disclosure
if the person requesting the record obtains The request for review shall include the consent of the person who submitted the a copy of the written request and the material or whose right of personal privacy denial.
is involved in its disclosure.
6. Manuals, guidelines, instructions, and 5.84 Consideration on review.
other materials which are for guidance of Review shall be considered on the
employees in evaluating applications, in es
tablishing or carrying out audit or inspecbasis of the written record including
tion procedures, allowable tolerances, or any written argument submitted by the
quantums of proof, or in selection or hanrequester.
dling of cases in litigation, and materials of
similar kinds which cannot be disclosed to § 5.85 Decisions on review.
the public without defeating their purpose. (a) Decisions on review shall be in 7. Patients' hospital, clinical, and medical writing. If the decision is in favor of the records including related correspondence; requester, the decision shall order rec
medical histories, and supporting material; ords made available to the requester as
financial and property records and reports
pertaining to patients in hospitals or clinics. provided in the decision.
8. Records of pharmaceutical and re(b) The decision, if adverse to the lated information concerning investigational requester, shall briefly state the reasons drugs, revealed to the Department by private for the decision, and shall be promptly sources. communicated to the requester, and 9. Procurement and disposal plans which shall constitute final action of the
if prematurely released would give aid to Department.
speculators. (c) All such decisions constituting
10. Records of correspondence between
Federal and State or local officials, privileged precedents shall be indexed and available through custom and usage or where disfor inspection and copying in the same closure might prejudice negotiations in manner as final orders and opinions
progress. subject to subsection (a) (2) of the Act.
11. Respecting Food and Drug Administra
tion regulatory activities: Trade secrets or (d) Adverse decisions pursuant to this commercial or confidential information volsubpart may be reviewed by the courts as untarily revealed in requests for opinions,