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§ 4.86 Disclosure in administrative or court proceedings.

Data and information otherwise exempt from public disclosure may be revealed in Food and Drug Administration administrative proceedings pursuant to Part 2 of this chapter or court proceedings, where the data or information are relevant. The Food and Drug Administration will take appropriate measures, or request that appropriate measures be taken, to reduce disclosure to the minimum necessary under the circumstances.

6. In § 4.100 by revising paragraph (c) (6), to correct the cross-reference to read as follows:

§ 4.100 Applicability; cross-reference to other regulations.

(c)

(6) Information on thermal processing of low-acid foods packaged in hermetically sealed containers, in §90.20 (1) of this chapter.

7. In § 4.109 by redesignating the existing text as § 4.109 (a) and adding a new paragraph (b); as revised, § 4.109 reads as follows:

§ 4.109 Data and information obtained by contract.

(a) All data and information obtained by the Food and Drug Administration by contract, including all progress reports pursuant to a contract, are available for public disclosure when accepted by the responsible agency official except to the extent that they remain subject to an exemption established in Subpart D of this part, e.g., they relate to law enforcement matters as provided in § 4.88 (b). (b) Upon the awarding of a contract by the Food and Drug Administration, the technical proposal submitted by the successful offeror will be available for public disclosure. All cost proposals and the technical proposals of unsuccessful offerors submitted in response to a request for proposals are exempt from disclosure as confidential commercial or financial information pursuant to § 4.61. 8. In § 4.111 by revising paragraph (c) (3) (vi) to read as follows:

§ 4.111 Data and information submitted voluntarily to the Food and Drug Administration.

(c) (3) *

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(vi) If a person requests a copy of any such record relating to a specific individual or a specific incident, such request will be denied unless accompanied by the written consent to such disclosure of the person who submitted the report to the Food and Drug Administration and the individual who is the subject of the report. The record will be disclosed to the individual who is the subject of the report upon request.

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9. In § 314.14 by revising paragraph (a), to correct the reference, to read as follows:

§ 314.14 Confidentiality of data and information in a new drug application (NDA) file.

(a) For purposes of this section the "NDA file" includes all data and information submitted with or incorporated by reference in the NDA, IND's incorporated into the NDA, supplemental NDA's; reports under §§ 310.300 and 310.301 of this chapter, master files, and other related submissions. The availability for public disclosure of any record in the NDA file shall be handled in accordance with the provisions of this section.

PART 514-NEW ANIMAL DRUG APPLICATIONS

10. In § 514.11 by revising the introductory text of paragraph (f) to read as follows:

§ 514.11 Confidentiality of data and information in a new animal drug application file.

(f) All safety and effectiveness data and information not previously disclosed to the public are available for public disclosure at the time any one of the following events occurs unless extraordinary circumstances are known:

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Effective date: This regulation shall be effective February 14, 1977.

[Exhibit 27]

FTC CONFIDENTIALITY PROCEDURES

FEDERAL TRADE COMMISSION,

Washington, D.C.

[Staff Bulletin 77-1]

Subject: Form letter Granting Confidentiality and Advance Notice.

In accordance with Commission minute of September 29, 1976, the form letter granting confidentiality and advance notice contained in Staff Bulletin 76-17 has been modified. The final paragraph has been revised to include judicial proceedings in addition to administrative complaint issuances. The revised format is attached.

The staff is directed to adopt this format in all pending and future requests for confidentiality respecting subpeonas, special reports, etc., in lieu of Illustrations 1 and 2 in Chapter 12 of the Operating Manual.

R. T. MCNAMAR,
Executive Director.

Attachment: Form Letter Granting Confidentiality,
Supersedes: Staff Bulletin 76–17 (7/12/76).

Distribution: Professional Staff Headquarters and Field.

FEDERAL TRADE COMMISSION,
OFFICE OF THE SECRETARY,

Washington, D.C.

DEAR This is in response to your request on behalf of (company name) for an assurance of confidential treatment and adequate notice before disclosure by the Commission of the documents submitted by (company name) in response to (give specifics, e.g., questions/specifications 4, 7e, etc.) of the Commission's (letter of inquiry/subpoena duces tecum, etc.) dated (date) in connection with Commission (case no.).

In addition to the protection afforded by Section 10 of the Federal Trade Commission Act (15 U.S.C. § 50) and Rule 4.10 (c) of the Commission's Rules of Practice and Procedure, the Commission has determined that, subject to the exceptions set out below, it will not disclose any of the above-described documents to any person outside the employ of the Federal Trade Commission, without first giving (company name) ten days' notice of its intention to do so.

This procedure will not apply to the Commission's furnishing information in response to an official request from a committee or subcommittee of Congress or to a court in response to compulsory process. In the event of such release, the Congressional committee or subcommittee or the court will be advised that the company considers the material to be confidential; and (company name) will be provided ten days' prior notice where possible, and in any event as much advance notice as can reasonably be given.

The Commission further exempts from the advance notice procedure its furnishing the documents to an outside consultant retained by the Commission. However, only a consultant who has agreed not to release the documents may be given access to them.

The above commitment to grant advance notice shall be effective for a period of three years from the date of this letter, at the end of which time (company name) may renew its request with justification.

The above notice provisions shall not apply to any information which (1) is now in the public domain; (2) enters the public domain from a source other than the Commission or its employees; (3) was in the Commission's possession prior to disclosure to the Commission by (company name); or (4) is supplied to the Commission or its employees by a third party lawfully in possession thereof. Nothing in the foregoing sentence, however, will constitute a waiver by (company name) of any restrictions imposed by law on the Commission's use of any such information, however obtained.

The foregoing assurances are given with the understanding that in the event of a judicial proceeding or the issuance of an administration complaint in connection with this matter, the confidential status of the specified information and the limitations on its disclosure shall be governed solely by the provisions, as applicable, of the appropriate judicial rules or the Commission's Rules of Practice, Part 3-Rules of Practice for Adjudicative Proceedings.

By direction of the Commission,

[Exhibit 28]

CHARLES A. TOBIN, Secretary.

EPA REGULATIONS ON CONFIDENTIALITY OF BUSINESS INFORMATION (FEDERAL REGISTER, SEPT. 1, 1976)

TITLE 40-PROTECTION OF ENVIRONMENT

[FRL 567-7]

Chapter I-Environmental Protection Agency

Requests for Information; Confidentiality of Business Information

On May 20, 1975, the Environmental Protection Agency (EPA) caused to be published in the FEDERAL REGISTER a document (40 FR 21987) proposing to amend 40 CFR Part 2 by adding a new Subpart B entitled "Confidentiality of Business Information." Certain corrections and revisions to that document were made by a document published in the FEDERAL REGISTER on July 9, 1975 (40 FR 28814). Interested persons were given until July 22, 1975, to submit written comments, suggestions, or objections. Some 60 comments were received; commenters included trade associations, business firms, environmental organizations, state agencies, and others. Full and careful consideration was given to all written comments received.

As promulgated below, the rule reflects a number of changes from the proposed rule. Many of these changes were suggested by comments on the proposed rule made by interested members of the public; others were found desirable in order to simplify and clarify various provisions, even though they were not specifically suggested by comments from the public. The changes do not introduce significant variations from the subject matter and issues presented in the May 20 and July 9, 1975, documents. A summary of the significant comments, the Administrator's responses to those comments, and the other changes that have been made appear as Appendix A. The Preamble to the May 20, 1975, document also discussed many of the issues presented by this rule-making proceeding.

The purpose of Subpart B is to establish and make known to the public the rules and procedures which EPA will use in handling information gathered by EPA which may be entitled confidential treatment for reasons of business confidentiality. The regulation represents EPA's attempt to devise a procedure which protects the interests of the businesses which furnish information to EPA, the interests of members of the public who request that EPA disclose such information, and the interests of EPA in carrying out it statutory missions. As stated more fully in the Preamble to the May 20 document, these various interests may from time to time be in conflict. Businesses have recently expressed concern that Federal agencies may disclose proprietary information the agencies possess and

thereby harm the businesses. On the other hand, members of the public have asserted that understanding and criticizing Government proposals or decisions is difficult or impossible if the business data upon which the Government relied are unavailable for scrutiny. EPA understands the importance of both these arguments and, in addition, is aware that the continuing flow of information from businesses needed for sound EPA decisionmaking may be affected adversely if businesses do not feel that EPA gives full and fair consideration to their confidentiality claims.

Subpart B, as promulgated below, establishes procedures and substantive rules designed to: Limit the likelihood of inadvertent disclosure of confidential business information; afford businesses a fair opportunity both to assert a confidentiality claim and to substantiate the claim prior to an EPA ruling on the claim; allow a business to seek judicial review of an EPA ruling unfavorable to it; protect the interests of members of the public who request disclosure of business information under the Freedom of Information Act, 5 U.S.C. 552; and furnish guidance to those EPA officers and employees who must deal with confidentiality claims and requests for information while carrying out other important Agency business. Subpart B consists of a series of generally applicable rules (§§ 2.201-2.213) and certain special rules which modify the general rules when necessary to implement several statutes under which EPA operates and which contain special provisions governing the treatment of business information.

A revision of Subpart A of 40 CFR Part 2 is also promulgated below. (Subpart A contains the Agency's basic regulations concerning the treatment of requests for information under 5 U.S.C. 552). Many of the changes to Subpart A are merely matters of style designed to more clearly set forth procedural rules which were stated in the earlier version of the subpart. Former § 2.107 has been redesignated as § 2.106, and a new § 2.107 has been added, dealing with the treatment of misdirected written requests and oral requests. The subpart has been revised in several places to indicate more clearly that a discretionary decision to withhold exempt documents should be based on a finding that the public interest would not be served by disclosure. Section 2.119 (b) has been revised to indicate that matters exempt under 5 U.S.C. 552 (b) (8) or (b) (9) normally will not be disclosed as a matter of policy. Section 2.120 has been extensively revised to state additional examples of search and duplication efforts for which the fee will be the actual direct cost to EPA, to indicate items for which no charge shall be made, and to clarify the procedure to be used in considering requests for reduction of waiver of fees. Former § 2.121, which recited a statutory requirement concerning an annual report to Congress, has been deleted as unnecessary. Because the changes to Subpart A consist of rules of agency organization, procedure, or practice, and because public comment on these changes is unnnecessary and would not serve the public interest, good cause is hereby found for promulgating the revision of Subpart A without use of proposed rulemaking procedure of 5 U.S.C. 553 (c). Finally, minor changes to other parts in Chapter I of 40 CFR are also being made for the purpose of conforming these parts to the newly promulgated Subpart B of Part 2.

Accordingly, Chapter I of 40 CFR is amended as set forth below.

Effective date: These regulations shall become effective on October 1, 1976. Dated: August 12, 1976.

Chapter I of 40 CFR is amended as follows:

RUSSELL E. TRAIN, Administrator.

1. Part 2 is amended by revising Subpart A and by adding a new Subpart B, so that the Part reads as follows:

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2.104

2.105

Requests to which this subpart applies.
Existing records.

2.106 Where requests for agency records shall be filed.
2.107 Misdirected written requests; oral requests.
2.108 Form a request.

21-656-78-24

2.109 Requests which do not reasonably describe records sought.
2.110 Responsibilities of Freedom of Information Officers.
2.111 Action by office responsible for responding to request.
2.112 Time allowed for issuance of initial determination.
2.113 Initial denials of requests.

2.114 Appeals from initial denials; manner of making.

2.115 Appeal determinations; by whom made.

2.116 Contents of determination denying appeal.

2.117 Time allowed for issuance of appeal determination.
2.118 Exemption categories.

Discretionary release of exempt documents.
Fees; payment; waiver.

2.119

2.120

2.121-2.200

[Reserved].

Subpart B-Confidentiality of Business Information

2.201 Definitions.

2.202 Applicability of subpart; priority where provisions conflict; records containing more than one kind of information.

2.203 Notice to be included in EPA requests, demands, and forms; method of asserting business confidentiality claim; effect of failure to assert claim at time of submission.

2.204 Initial action by EPA office.

2.205 Final confidentiality determination by EPA legal office.

2.206 Advance confidentiality determinations.

2.207 Class determinations.

2.208 Substantive criteria for use in confidentiality determinations.

2.209 Disclosure in special circumstances.

2.210 Nondisclosure for reasons other than business confidentiality or where disclosure is prohibited by other statute.

2.211 Safeguarding of business information; penalty for wrongful disclosure. 2.212 Establishment of control offices for categories of business information.

2.213 Designation by business or addressee for notices and inquiries.

2.214-2.300 [Reserved].

2.301 Special rules governing certain information obtained under the Clean Air Act.

2.302 Special rules governing certain information obtained under the Federal Water Pollution Control Act.

2.303 Special rules governing certain information obtained under the Noise Control Act of 1972.

2.304 Special rules governing certain information obtained under the Safe Drinking Water Act.

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2.307 Special rules governing certain information obtained under the Federal Insecticide, Fungicide, and Rodenticide Act.

2.308 Special rules governing certain information obtained under the Federal Food, Drug, and Cosmetic Act.

2.309 Special rules governing certain information obtained under the Marine Protection, Research and Sanctuaries Act of 1972.

AUTHORITY: 5 U.S.C. 301, 552, 553; sec. 114, 208, 301, and 307 of the Clean Air Act, as amended, 42 U.S.C. 1857c-9. 1857f-6, 1867g, 1867h-5; secs. 308, 501, and 509(a) of the Federal Water Pollution Control Act, as amended, 33 U.S.C. 1318, 1361, 1369 (a); sec. 13 of the Noise Control Act of 1972, 42 U.S.C. 4912; secs. 1445 and 1450 of the Safe Drinking Water Act, 42 U.S.C. 300j-4, 300j-9; secs. 10, 12, and 25 of the Federal Insecticide, Fungicide and Rodenticide Act, as amended. 7 U.S.C. 136h, 136j, 136v; sec. 408 (f) of the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. 346a (f); and secs. 104 (f) and 108 of the Marine Protection, Research, and Sauctuaries Act of 1972, 83 U.S.C. 1414(f), 1418.

§2.100 Definitions.

Subpart A-Requests for Information

For the purposes of this part:

(a) "EPA" means the United States Environmental Protection Agency. (b) "EPA record" or, simply, “record” means and document, writing, photograph, sound or magnetic recording, drawing, or other similar thing by which in

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