CHAPTER 8

`INFORMATION DISCLOSURE

CONTENTS

SUBCHAPTER - EXPERT WITNESS



Purpose..............................................315

Responsibility.......................................315

Criteria.............................................315

Assurance............................................315

List of Experts......................................316







SUBCHAPTER - TESTIMONY



Purpose..............................................316

Responsibilities.....................................316

Procedures...........................................317

Testimony Requests Covered By Other Guidance.........318





SUBCHAPTER - FREEDOM OF INFORMATION (FOI)



Purpose and Scope....................................318

Authority............................................318

Definitions..........................................319

General..............................................319

Exhibits.............................................328

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SUBCHAPTER

EXPERT WITNESS

PURPOSE

To set forth a procedure that will assure the availability of scientific support in the event of a contested case.

RESPONSIBLITY

Centers have primary responsibility for such assurance. The center compliance office should determine whether expert scientific or medical support will be needed to support the case. If it is determined that medical or scientific experts will be needed, the center will assure, by means of its medical or scientific review staffs, that the center's position represents the prevailing consensus of informed medical or scientific opinions and that expert witnesses, either within the agency or outside the agency, can be obtained to support the government's case. No case should go forward unless this assurance is provided.

CRITERIA FOR DETERMINING DEPTH OF ASSURANCE

Precedent-setting cases for which FDA does not have in-house expertise will always require contact with outside experts in order to adequately assess the prevailing consensus. If in-house FDA experts are available, it will be necessary to contact them to make a determination as to whether or not outside experts need to also be contacted.

Complex cases involving state-of-the-art and/or current good manufacturing practice will usually have to be reviewed to determine the need for concurrence by the experts.

Cases that are sufficiently similar to previous cases require only limited additional or independent scientific support, except where a recent court decision, new regulation, or new policy has sufficiently changed the situation to require a reassessment.

Cases that are identical to previous cases will only require referent to such recent cases.

ASSURANCE

Assurance shall be documented in a separate memorandum addressed to the Agency's Counsel. This memorandum is to summarize the center's efforts to provide assurance and to flag any significant problems with the proposed action. Factors to reference should include; prior and pending court cases, testimony or affidavits developed during a recent court or rule making proceeding or advisory committee meeting, literature searches which support the consensus of opinion, memoranda of conversations with experts, etc.

LIST OF EXPERTS

Whenever experts are contacted, they should always be requested to provide the names of other scientists who share their views so that corroborative witnesses will be available in the event of a contest. Each center should develop and maintain a list of expert witnesses. Anyone may provide the names of prospective expert witnesses. However, in considering a proposed regulatory action, the centers are responsible for the evaluation of the adequacy of scientific support.

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SUBCHAPTER

TESTIMONY

PURPOSE

This subchapter describes the procedures for handling the requests for the testimony of FDA personnel in non-FDA proceedings, including judicial, administrative, and legislative proceedings:

Testimony means testimony by written statement, by declaration under penalty of perjury, by affidavit, by deposition, interrogatory, or by appearance at the proceeding. Affidavits that identify documents for purposes of certifying records for Freedom of Information Act requests are not considered testimony for purposes of this subchapter. Questions regarding whether a particular affidavit is subject to these instructions should be referred to the Division of Compliance Policy (HFC-230).

Request means any written request, invitation, notice of deposition, letter rogatory, court order, or subpoena, except for subpoenas intended solely for the production of records.

RESPONSIBILITIES

FDA's policy regarding testimony by FDA employees is expressed in 21 CFR 20.1; and a more detailed discussion is found in Staff Manual Guide 2127.2.

The Director, Office of Enforcement (HFC-200) is responsible for authorizing approval or providing disapproval for the testimony of FDA personnel in non-FDA proceedings. (The Associate Commissioner for Regulatory Affairs, pursuant to 21 CFR 5.20(b) and 20.1(c), has designated the Director, Office of Enforcement to perform these functions.)

Division of Compliance Policy, Office of Enforcement (HFC-230) is responsible for staff work regarding testimony requests from other Federal government agencies and from private parties and for coordinating with the Division of Federal-State Relations regarding testimony requests from state and local officials.

Division of Federal-State Relations, Office of Regional Operations (HFC-150) is responsible for staff work regarding testimony requests from state and local government agencies and state and local legislative bodies.

Freedom of Information Staff (HFI-35) is responsible for handling subpoenas intended solely for the production of records and for assisting the Division of Compliance Policy and the Division of Federal-State Relations by providing records responsive to a subpoena duces tecum (21 CFR 20.2) or other requested records related to testimony requests.

Other headquarters and field offices are responsible for assisting the Division of Compliance Policy and the Division of Federal-State Relations in evaluating requests regarding testimony by their employees and testimony pertinent to their respective responsibilities. When appropriate, they are responsible for identifying suitable individuals) to testify and for drafting the authorized testimony.

Office of General Counsel (GCF-1) is responsible for providing guidance and assistance in legal aspects of handling testimony requests, including review and preclearance of affidavits and other types of testimony in written form, assistance in witness preparation, and assistance during the testimony, as requested. FDA employees who receive verbal or written requests for testimony are responsible for advising the requester of the requirements of 21 CFR 20.1 for testimony requests to be submitted to the agency in writing and for employees to obtain authorization from the Commissioner, prior to providing testimony. A copy of any memorandum of telephone conversation or letter documenting such communication should be forwarded to the Division of Compliance Policy. Alternatively, FDA employees may refer the requester to the Division of Compliance Policy. FDA employees should not indicate any commitment regarding availability or willingness to testify in any particular case, prior to an agency determination that authorization for testimony will be granted.

The office of any FDA employee who is authorized to Provide testimony generally is responsible for funding travel and other expenses associated with providing the testimony. If the office lacks sufficient funds for the authorized testimony, it should contact the appropriate administrative officer to request funding assistance.

PROCEDURES

Testimony requests should be submitted in writing well in advance of the desired testimony date in order to allow time for evaluating and processing the requests. Requests should include the following information: hearing body, date, location, and purpose of the proceeding; the nature and scope of the testimony FDA is being asked to provide and the use to which it will be put; the name(s) of the FDA employees, if known, being asked to testify; the requester's interest in the matter sought to be disclosed; and a discussion of the requester's rationale for considering that the testimony is in the public interest and will promote the objectives of FDA and the laws it enforces. Oral testimony requests will not be honored unless they are reduced to writing in compliance with 21 CFR 20.1.

FDA headquarters and field offices that receive written testimony requests should alert the Division of compliance Policy (HFC-230) by telephone, upon receipt of the request, and should forward the request by FAX or other expeditious means to that office.

Written requests for testimony should be sent to:

The staff work to be performed by the Division of Compliance Policy and the Division of Federal-State Relations in processing testimony requests includes:

1. Evaluating the request, in consultation with other agency components, the Office of General Counsel, and/or other government agencies, as appropriate, and
2. Preparing a response to the testimony request for issuance by the Director, Office of Enforcement.

The Division of Federal-State Relations will forward the recommended response to the Director, Office of Enforcement through the Director, Office of Regional Operations.

Employees authorized to present testimony should seek legal guidance from the Office of General Counsel and technical guidance from appropriate FDA unit(s), prior to presenting the testimony. Affidavits and other testimony in written form should be reviewed by the Office of General Counsel except for affidavits attesting only to the absence of records or when the testimony authorization memo provides otherwise. Subsequent to presenting the testimony, the employee should submit a summary or copy of their testimony or a transcript of the testimony to the Division of Compliance Policy. This office will review the summary and distribute copies within the agency, as appropriate. If the testimony is authorized at any hearing before a state or local legislative body, the summary memo should address not only the individuals testimony, but also any other portions of the hearing attended.

Ordinarily, FDA will first determine if agency records are available that will provide the requester with the information that is being sought. If records are available, FDA ordinarily will offer to provide the requester with certified copies of the records, in lieu of testimony. This may be done either by the Division of Compliance Policy, the office receiving the request, or the Office of General Counsel, as determined on a case- by-case basis.

If the requester will accept copies of FDA records in lieu of testimony, the request may be processed as a Freedom of Information Act (FOIA) request. (If the testimony request is not specific enough for FOIA purposes, the requester should be told to submit a separate FOIA request. Alternatively, a memorandum of telecon clarifying the request may be prepared and forwarded with the testimony request to the Freedom of Information Staff.) The Division of Compliance Policy will forward the testimony request, together with an explanatory memorandum or note, to the Freedom of Information Staff (HFI-35) for logging and assignment. The Division of Compliance Policy will notify the component FOIA officer(s) about the FOIA request and about any special processing instruction, such as the need for certified copies of records or the time frames for processing. If a subpoena for an FDA employee to provide testimony is to be denied, the Division of Compliance Policy will consult with the office of General Counsel to determine if a motion to quash or other legal step is appropriate. If appropriate, the Office of General Counsel and/or the Division of Compliance Policy will work with the U. S. Attorney's office in the jurisdiction of the court.

A subpoena duces tecum (or similar request for an FDA employee both to appear and to provide agency records) shall be handled both as a testimony request (21 CFR 20.1) and as a FOIA request (21 CFR 20.2.)

TESTIMONY REQUESTS COVERED BY OTHER GUIDANCE

DHHS Inspector General and Office of Equal Employment Opportunity - This guide does not cover requests from the DHHS Inspector General or from the DHHS Office of Equal Employment Opportunity for affidavits or other statements.

The DHHS Standards of, Conduct require all employees to "assist the [DHHS] Inspector General and other investigative officials in the performance of their duties or functions. This requirement includes the giving of statements or evidence to investigators of the Inspector General's office or other DHHS investigators authorized to conduct investigations into potential violations." (45 CFR 73.735-302(d)).

Employees who receive such requests from the DHHS Inspector General may contact the Division of Ethics and Program Integrity (HFA-20). Employees who receive such requests from the DHHS Office of Equal Employment Opportunity may contact the FDA Office of Equal Employment Opportunity and Civil Rights (HF-15).

FDA's own proceedings - Testimony in judicial or administrative proceedings to which FDA is a party (either directly or indirectly because DHHS is a party) is considered part of one's official duties and special authorization is not required. Employees who receive a testimony request from one of the other parties to the proceeding should notify the assigned FDA or DHHS attorney as soon as possible, as well as supervisors and others in the chain of command with a need to know.

Congressional testimony requests See Staff Manual Guide FDA 2127.1.

Subpoenas intended solely for the production of records - Such subpoenas are handled as FOIA requests in accordance with 21 CFR 20.2 and Staff Manual Guide 2460.7.

Testimony as a Private Citizen - Some testimony as a "private citizen" may raise special concerns such as possible conflict of interest or may require approval as an outside activity. Employees should refer to the Standards of Ethical Conduct for Employees of the Executive Branch 5 CFR Part 2635.805. For further guidance, contact the Division of Ethics and Program Integrity (HFA-20) for guidance.

Former FDA employees - Requests for the testimony of former FDA employees are not covered by 21 CFR 20.1. However, FDA may assist former employees with respect to testimony requests. Former employees are encouraged to contact either the Division of Compliance Policy or the Division of Federal- State Relations, as appropriate, if they receive a request or subpoena to provide testimony regarding FDA- related matters. Former employees must be aware that there may be other restrictions on their ability to provide the requested testimony, including possible conflict of interest concerns and statutory and regulatory restrictions on the release of trade secrets and other kinds of confidential information.

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SUBCHAPTER

FREEDOM OF INFORMATION (FOI)

PURPOSE AND SCOPE

The purpose of this subchapter is to provide both general and specific procedures for overall FDA implementation of the Freedom of Information Act (FOIA). These procedures apply to every FDA employee and all FDA organizational elements. This subchapter is intended to supplement HHS' and FDA's FOIA preambles and regulations. For greater detail, consult 45 CFR, Part 5, and the FDA preambles which are available in reprints or the preamble compilation book and 21 CFR, particularly Part 20, and regulations referenced in 20.100. This subchapter has been adapted from the Staff Manual Guide 2460.07.

AUTHORITY

DEFINITIONS

Freedom of Information Act (FOIA): Section 552 of Title 5, United States Code, as amended by Public Law 99-750.

Records: Identifiable records not normally prepared for distribution to the public, in existence, and in the possession or control of the Food and Drug Administration. "Records" means any handwritten, typed, or printed documents (such as memoranda, books, brochures, studies, writings, drafts, letters, transcripts, and minutes) and documentary material in other forms (such as punchcards; magnetic tapes, cards, or discs; paper tapes; audio or video recordings; maps; photographs; slides; microfilm; and motion pictures). It does not include objects or articles such as exhibits, models, equipment, and duplication machines or audiovisual processing materials. Nor does it include, books, magazines, pamphlets, or other reference material in formally organized and officially designated HHS libraries, where such materials are available under the rules of the particular library.

Freedom of Information Request: Any request for existing records not prepared for routine distribution to the public. Requests must only "reasonably" describe the requested records. Documents must be described, but they do not need to be specifically identified. Requests made orally may be honored at the discretion of the FDA employee. However, if an oral request is honored, it must be put into writing before a response is made.

Component FOI Officers: Designated Freedom of Information Officers within each major organizational element in FDA, including each Center, District, and Office of Associate Commissioner who is the responsible individual for all FOI activities within the component.

FOI Officers: Any responsible FDA employee whose experience and training enable him/her to process FOI requests.

Letter of Determination: A letter responding to an FOI request stating the requested record will be disclosed. This letter ends the statutory time requirement. (Attachment B.)

Acknowledgement Letter: A letter which notifies the requester the request has been received and gives the FOI control number. This letter does not end the statutory time requirement. This letter should only be used when a determination has not been made to release or deny the record within ten days. (Attachment C.)

Denial Letter: A letter responding to an FOI request by partially or wholly denying access to, or copies of requested record(s). The letter must be signed by the Associate Commissioner for Public Affairs, and it must cite the appropriate sections of the Act and regulations to support exemption from disclosure.

Appeal: Any requester has the right to appeal a denial of records to higher authority. The appeal authority for FDA is the Assistant Secretary for Health, DHHS (Surgeon General, Public Health Service).

Appeal Justification Memorandum: Upon notification that a denial has been appealed to the Department, the Component FOI Officer will be asked to prepare a memo to the FOI Staff providing sufficient explanation and justification to convince the Department that our denial should be upheld. The memo should be accompanied by copies of the denied information for Department review if needed.

GENERAL

The Food and Drug Administration will make the fullest possible disclosure of records to the public, consistent with the rights of individuals to privacy, the property rights of persons in regard to trade secrets, and the need for the Agency to promote frank internal policy deliberations, and to pursue its regulatory activities without disruption. This policy includes disclosure of records where it would be in the public interest to do so, even though they might otherwise be withheld under strict interpretation of the FOIA.

All requests for Agency records shall be sent in writing to the Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. FOI requests which are addressed to other FDA organizational components should be immediately sent by messenger or faxed to the FOI Staff for logging.

A request for testimony by Food and Drug employees pursuant to 21 CFR 20.1 should immediately be directed to the Associate Commissioner for Regulatory Affairs, Office of Enforcement, Division of Compliance Policy, HFC-230.

FOI requests will be responded to within ten working days from the date of receipt by the FOI Staff.

Freedom of Information activities do not include records which are normally prepared for public distribution, such as press releases, FDA Fact Sheets, information brochures ("We Want You To Know About FDA"), speeches, Congressional testimony, etc. Such records will be provided promptly to any requester, without reference to the FOI Act, without referral to the FOI Staff, and without collecting any fees.

The Freedom of Information Act does not require the creation of new records to respond to a request. Therefore, a request for information only is not to be considered as an FOI activity. Such inquires shall, however, be responded to promptly, without referral to the FOI Staff, as part of FDA's general effort to be responsive to the public.

The Freedom of Information Act does not require a determination of disclosure to be given in response to a request for a record not in the possession of FDA or not yet in existence at the time the request is received. The Agency will, however, respond as fully as reasonably possible to such requests. In response to a request for a record which is not yet completed, indicate that the record is not complete and offer (if possible) an estimate of when the record will be completed, so that it can be requested at that time. Do not offer to provide the record when it is completed.

Requests that specific records be automatically and regularly sent as they are created will not be fulfilled.

If any document or information is disclosed in an authorized manner to any member of the public, it must be made available to all members of the public, except as provided for in 21 CFR 20.21(a) and (b).

The authority and responsibility for granting most FOI requests is vested in the FOI Officer of the organizational component maintaining the records. Discretionary disclosure (21 CFR 20.82) and disclosures to other Federal government departments and agencies (21 CFR 20.85) can only be made by Associate and Deputy Associate Commissioners as authorized by 21 CFR 5.23.

The authority and responsibility for refusing an FOI request and in granting a request for waiver or reduction of fees is vested only in the Associate Commissioner for Public Affairs or his or her designee.

Some Freedom of Information requests may also be considered Privacy Act requests. If an individual requests access to a record concerning himself contained in a designated Privacy Act System of Records, the FDA employee receiving the request should mark the request "Privacy Act Request" and refer it to the Privacy Act Coordinator (HFI-30), unless the requester is a present or former FDA employee requesting a personnel record. All employee requests for personnel records should be referred to the Director, Division of Human Resources Management (HFA-400).

If a requester requests a record concerning an individual other than himself, and it is contained in a designated Privacy Act System of Records, the request constitutes a Freedom of Information request rather than a Privacy Act request, and the appropriate Freedom of Information regulations should be consulted to determine whether the record may be disclosed. If a clearly unwarranted invasion of privacy would occur through disclosure of the record, the request should be denied. (See "Operating Procedures," RPM page 326, (1)(j) and page 327, (2)(h) - procedures for denial of request.)

Certain requesters specify "any available information" or "all disclosable information," with the understanding that a denial is not necessary even when there are no records that can be disclosed on the requested subject. It is important that the requester understands the use of these terms. If there are no disclosable records on a requested subject, the requester should be so informed if the requester has used "disclosable" and understands the meaning of it.

If a record is disclosable but a legible copy of the record cannot be made, do not attempt to reconstruct the record. Instead, the requester should be sent the best copy that can be made, and its poor quality should be noted in the response.

If the requested records are partially releasable, the clearly disclosable records should be sent to the requester and the requester informed that further response will be made by another office. A denial recommendation with copies of the nondisclosable records and copies of the records released should be sent to the component FOI Officer for transmittal to the FOI Staff.

The following FOI requests for records are processed outside the general procedures established:

1. Requests from a Congressional Committee, Subcommittee or the General Accounting Office are controlled and responded to by the Office of the Associate Commissioner for Legislative Affairs.
2. Requests from a Federal department or agency or from a State or local government or agency who perform counterpart functions to the FDA at the State and local level are controlled and responded to by the Division of Federal-State Relations, Associate Commissioner for Regulatory Affairs.
3. Requests from a foreign government are controlled and responded to by the International Affairs Staff, Associate Commissioner for Health Affairs.
4. Requests from a Federal court are controlled and responded to by the Office of the Associate Commissioner for Regulatory Affairs in coordination with the Office of General Counsel, Food and Drug Division.

If the assigned action office for the requests listed above is not sure whether the material can be released, the FOI Staff should be contacted immediately.

RESPONSIBILITIES

The Freedom of Information Staff in the Office of Public Affairs is responsible for:
1. Providing advice and guidance of Freedom of Information policies and procedures to Agency staff and members of the public.
2. Serving as the Agency focal point for the receipt, control, coordination, and processing of all FOI requests. Preparing for release of requested records maintained by the FOI Staff.
3. Assigning FOI requests to the appropriate FDA office for action and ensuring that the requests are properly responded to within ten working days from date of receipt by the FOI Staff.
4. Referring requests and records to the PHS or HHS FOI Officer when the requests involve both FDA records and records in another operating division of the Department.
5. Coordinating requests that involve records from a foreign country; contacting the appropriate Foreign Government FOI Liaison Office to inform them of the request; and preparing the response to such requests.
6. Maintaining staff manuals, indexes, regulatory letters, computer printouts, and other records which are to be on display for public review. (See Attachment D - Records Which Are Available to the Public - RPM pages 333-334.)
7. Maintaining files of all FOI requests and responses (including copies of records sent).
8. Compiling and preparing reports on FOI activity in FDA.
9. Preparing denial letters and processing these letters for the signature of the Associate Commissioner for Public Affairs (ACPA) or his or her designee. Obtaining the concurrence of General Counsel.
10. Processing appeals by serving as liaison between FDA and PHS and coordinating total Agency response to an appeal.

Each major organizational component is responsible for:
1. Designating a Component FOI Officer and an alternate to act in his or her absence.
2. Ensuring that all employees within the Component are made aware of FOI policy and procedures.

Each Component FOI Officer is responsible for:
1. Providing internal direction and guidance to the Component on Freedom of Information polices and procedures.
2. Directing the search, review, determination regarding disclosure, and the preparation of release or denial of requested records.
3. Responding in a timely manner to the FOI Staff's requests for information.
4. Preparing predisclosure notification letters and monitoring and processing the responses.
5. Recommending denial of records or portions of records, accompanied by an explanation of the circumstances and citation of the appropriate exemptions.
6. Forwarding records responsive to requests to the FOI Staff when the requests involve both FDA records and records in another operating division of the Department or records involving a foreign country.
7. Providing additional justification in response to the appeal of a denial, accompanied by clearly identified and indexed copies of the records in question when necessary.
8. Assisting the Office of General Counsel in the event an Agency decision to deny records results in litigation by preparing documentation necessary to defend such actions.

The Division of Financial Management is responsible for:
1. Receiving all payments submitted in relation to Freedom of Information requests.
2. Promptly notifying the office originating the invoice of receipt of such payment.

The Associate Commissioner for Public Affairs is responsible for:
1. Making determinations to waive or reduce fees.
2. Making determinations of confidentiality in response to a request for presubmission review of records voluntarily submitted to FDA.
3. If appropriate, signing a denial of a request for a record.

All FDA employees are responsible for:

Promptly referring FOI requests to their Component FOI Officers for referral to the Freedom of Information Staff. In the event, however, that a responsible FDA official receives a request for a record that is clearly disclosable and readily available, the FDA official may release the record to the requester. A copy of the request and the response must be sent to the Freedom of Information Staff.

ADMINISTRATIVE POLICIES

Time Frame for Response

FOI requests must be responded to within ten working days from the date received by the Freedom of Information Staff. This requirement may be met by sending either the record, a Denial Letter, or a Letter of Determination concerning disclosure of the record (See Attachment B - RPM page 331).

In unusual circumstances, the time for sending the Letter of Determination may be extended an additional ten working days. Only the Freedom of Information Staff can make the decision to utilize the option of the ten-day extension.

Requests that Involve Both FDA Records and Records in Another Operating Division of the Department
1. When an FOI request is received anywhere in the Department that includes records of the Office of the Secretary or records of another operating division within the Department, the request and all records pertaining to the request must be forwarded to the HHS FOI Officer, who will be responsible for the Department's
reply.
2. When an FOI request involves more than one agency of the Public Health Service, the Public Health Service FOI Officer will be responsible for coordinating the response among the health agencies and will be responsible for the reply.
3. Since the requests described above require coordination outside of FDA, the standard procedures for responding to them are as follows:

Obviously, exceptions will occur with some requests, and these will have to be handled on a case-by-case basis.

Requests that Involve Records from a Foreign Country
1. When an FOI request is received that includes records obtained from individuals employed by, or a foreign Government, or for records that contain information received from a foreign country that has been reduced to written form by FDA, the Agency's FOI Staff will be responsible for coordinating the response among the Component FOI Offices and will be responsible for the reply.
2. The procedures for responding to the above-described requests will be the same as set forth in item (3) in the paragraph above.

Deletions (Purging, Redacting)
1. Certain material, with two exceptions listed in (2) below, must always be deleted from any record that is disclosed. It is the responsibility of the FOI Officer to delete the following information:

2. The two occasions when an FOI Officer is not required to purge records are:

"As you will note, the enclosed records contain certain business or personal information which is disclosable only to you or your firm. Copies of these records will be disclosed to other requesters only after thorough review and deletion of those portions which are not disclosable to the general public."

After disclosing the record, the FOI Officer should not send to the FOI Staff an unpurged copy of the record because confidential information is not to be included in the FOI Staff's files. Nor should the FOI Officer go through the exercise of purging the record and sending a purged copy to the FOI Staff just so the FOI staff can have a purged copy of the records in its files. The FOI Officer should instead send to the FOI Staff (either by a note attached to a copy of the request or in some other appropriate way) a description of the records disclosed plus a statement explaining why the copy is not attached. The FOI Officer should not purge the record unless it is requested by a third party (i.e., someone other than the subject of the record). If a third-party request is received, the FOI Staff will send it to the Component FOI Officer who will then process it as a new request.

3. If a record containing both disclosable and nondisclosable information requires only minor deletions of information (relatively isolated deletions of information clearly exempt from disclosure), the nondisclosable information will be deleted and the remaining record disclosed. The letter accompanying the record sent to the requester must contain the following paragraph:

"In order to help reduce processing time and costs, certain material has been deleted from the record(s) furnished to you because a preliminary review of the record(s) indicated that the deleted information is not required to be publicly disclosed. If, however, you desire to review the deleted material, please make an additional request at the following address:

Should the Agency then deny this information, you would have the right to appeal such denial. Any letter of denial will explain how to make this appeal."

4. A formal denial should be issued if the disclosable and nondisclosable information in a record are so inextricably intertwined that it is not feasible to separate them, or if release of the disclosable information would compromise or impinge upon the nondisclosable portion of the record, or is substantial deletions are required.

FDA FOI preambles and regulations provide detailed information on exempted material.

Predisclosure Notification (P.N.)

Executive Order (E.O.) 12600 of June 23, 1987, requires notification to submitters of records containing business information prior to disclosure of that information in response to an FOIA request, (1) if the submitter designates in writing part or all of the information in the records as exempt from disclosure under Exemption 4 (any such designation expires ten years after the records are submitted to the Government), or (2) if we have substantial reason to believe that information in non-designated records could reasonably be considered exempt under Exemption 4.

This E.O. pertains only to records submitted to the Agency; it does not include records created by the Agency.

In this case, however, a submitter may still designate records which may require the predisclosure notification procedures.

Predisclosure Notification Procedures
1. When a request is received for records which require P.N., the FOI Officer must bring this to the Component FOI Officer's attention.
2. The Component FOI Officer must send a letter (See Attachment E - RPM page 335) to the submitter to inform him/her about the P.N. procedures and time limits for submission and consideration of objections to disclosure. This letter must include a copy of the request and copies of the records which require the P.N. The submitter has five working days from receipt of the notice to object to disclosure of any part of the records and to state all bases for objections. A copy of this letter must be sent to the requester by the Component FOI Officer and to the Freedom of Information Staff (HFI-35).
3. The Component FOI Officer will give consideration to all objections to disclosure. If he/she agrees with the submitter's objections, the records should be routinely processed, i.e., either send the record with deletions or prepare a denial recommendation.
If the Component FOI Officer does not agree with the submitter's objections, a letter should be drafted (See Attachment F - RPM page 336) for the signature of the FOI Staff Director (HFI-30) notifying the person who submitted or provided the records in writing of the Agency's final determination to disclose and the reason(s) for disclosure. The letter provides five days from receipt of notification within which to institute suit in a United States District Court to prevent disclosure. The Office of Chief Counsel will be consulted prior to issuance of the letter, and a copy of this letter will be sent to the requester. If suit is brought, the record(s) will not be disclosed until the matter is determined in the courts. If suit is not brought, the record(s) will be disclosed.
4. If no objections are claimed in response to the P.N. letter (Attachment E - See RPM page 335), or if a response has not been received within five working days after receipt of the P.N. letter, the records are to be disclosed and a memorandum written to document the release.

Fees
1. Categories of Requesters (The FOI Staff will make this classification at the time a request is logged).

If the requester is not the kind described by paragraphs (a) and (b), fees will be charged only for search and duplication, except that there is no charge for the first 2 hours of search and the first 100 pages of duplication.

2. Schedule

Waiver of Fees
1. A waiver or reduction of fees should not be considered unless asked for by the requester.
2. If a waiver or reduction of fees is requested, no charge will be made for records requested if disclosure is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government, and it is not primarily in the commercial interest of the requester. Further guidance is provided in 45 CFR Part 5.45 and in fee waiver guidance issued by the Department of Justice on April 2, 1987.
A request for a waiver or reduction of fees can only be granted by the Associate Commissioner for Public Affairs (ACPA).
3. When a request for waiver is received and the charges to respond to the request are under $250, send the material and include the following statement in the response letter:
"Your request for waiver of fees will be considered by the Associate Commissioner for Public Affairs."
The FOI Staff will then consider the waiver request, and either contact the requester if more information is needed in considering the waiver request, draft a waiver response letter for the ACPA, or ask the action office who sent the records for a recommendation.
4. When a request for waiver is received and the charge to respond are over $250, the FOI Officer should send a memorandum to the Component FOI Office which includes the estimated charges and a waiver recommendation. If the Component FOI Officer agrees with the recommendation, it should be sent to the FOI Staff who will follow the procedures outlined in (3) above.

Billing

Regulations provide for aggregating the costs for requests made by the same person or organization or related persons or organizations on a periodic basis. This is done in order that such persons or organizations may appropriately bear the costs. The FOI Staff will aggregate charges and bill the requesters if the monthly total is more than $10.

Prepayment is necessary if: (1) charges will exceed $250; (2) the fee is over the limit specified by the requester; and/or (3) the requester has failed to pay previous bills.

The billing procedures are as follows when it has been determined that it is necessary to request prepayment:

The billing procedures are as follows when it has been determined that it is not necessary to request prepayment:

"The following charges may be included in a monthly invoice:

         Reproduction    _____



         Search          _____



         Review          _____



         Other           _____



         Total:        $ 

The above total may not reflect final charges for this request. Please do not send payment unless you receive an invoice for the total monthly fee."

Checks

Payment should be by check or money order payable to the Food and Drug Administration and sent directly to the Accounting Branch (HFA-120), 5600 Fishers Lane, Rockville, MD 20857. An exception to the general rule of direct payment by the requester to HFA-120 may be made when incidental FOI requests are misdirected to a Field Component prior to receipt by the FOI Staff. When such requests are clearly disclosable, readily available, and may most expeditiously be handled by the Field Component, the FOI Officer may have the requester send the check to the Field FOI Officer for forwarding (through the Field Fiscal Officer) to HFA-120.

Receipt of Prepayment

The Division of Financial Management will notify the organization who originated the invoice of receipt of prepayment. In the event that the individual cancels the request, the FOI Staff will notify the Component FOI Officer and the Division of Financial Management accordingly.

If prepayment is not received within forty-five (45) days from the date of the invoice, assume the requester is no longer interested in purchasing the records. The FOI Staff will notify the Component FOI Officer and the Division of Financial Management accordingly.

Certification of Documents

Requests for certification of documents will be forwarded to the FOI Staff or to the appropriate official authorized to certify documents in accordance with the Component's procedure, such as Center, District or Regional Offices. If such a request is initially received by a Component FOI Officer, the records may be forwarded with the request to the FOI Staff. If the request is initially received by the FOI Staff, the appropriate Component FOI Officer may be asked to forward the records for certification.

OPERATING PROCEDURES

FOI Requests Received Initially by the FOI Staff

1. FOI Staff will:

2. The Component FOI Officer to whom the request is referred will:

FOI Requests Received Initially by an FDA Component Other than FOI Staff

All FOI requests should be addressed to FOI Staff. Should an FOI request be misdirected to a District or Center, prior to being received and logged by the FOI Staff, the request is to be referred at once to the FOI Component.

Field FOI Officers who receive such requests for records which are disclosable, readily available, prepayment is not necessary, and which may be handled expeditiously by the Field Component, may respond directly to the requesters and send copies to the FOI Staff for simultaneous logging and closing.

In the event that a responsible FDA official in a Field or Headquarters Component receives an oral or written request for a record that is clearly disclosable, readily available, and prepayment is not necessary, the FDA official may release the records to the requester. An oral request must be reduced to writing and a copy of the request and the response to FOI Staff. The copy of the response sent to FOI Staff must always include the name and address of the requester.

The FOI Officer will:

1. Refer request for records which either originated in another Government agency or are primarily concerned with the internal matters of another Government agency and inform the requester accordingly.

2. Refer requests for FDA records which are not in the possession of the component to FOI Staff, and indicated where the records can most likely be found. DO NOT RESPOND TO THE REQUESTER. FOI Officers should also refer requests for FDA records which are located in more than one component to FOI Staff, with a statement indication where the records can most likely be found. FOI Staff will then coordinate the preparation of a multiple-component response by either gathering the necessary records itself or by designating one or more appropriate Component FOI Officers to do so.

3. In other instances when FOI Staff receives a request forwarded by a Component FOI Officer, proceed as though the request had been received initially by FOI Staff.

Requests for Presubmission Review for Confidentiality of Voluntarily Submitted Data or Information (21 CFR 20.44)

Requests for Presubmission Review for Confidentiality may be addressed to either the Center Director involved or the Associate Commissioner for Regulatory Affairs (HFC-1). If initially received by the latter, the request should be forwarded to the appropriate Center.

2. The Associate Commissioner for Public Affairs (ACPA) will:

EXHIBITS