601.51 Confidentiality of data and information in applications for establishment and product licenses. AUTHORITY: Pub. L. 90-23, 81 Stat. 54-56, as amended by 88 Stat. 1561-1564 (5 U.S.C. 552). SUBPART F-CONFIDENTIALITY OF INFORMATION § 601.50 Confidentiality of data and information in an investigational new drug notice for a biological product. (a) The existence of an IND notice for a biological product will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged. (b) The availability for public disclosure of all data and information in an IND file for a biological product shall be handled in accordance with the provisions established in § 601.51. (c) Notwithstanding the provisions of § 601.51, the Food and Drug Administration shall disclose upon request to an individual on whom an investigational biological product has been used a copy of any adverse reaction report relating to such use. § 601.51 Confidentiality of data and information in applications for establishment and product licenses. (a) For purposes of this section the "biological product file" includes all data and information submitted with or incorporated by reference in any application for an establishment or product license, IND's incorporated into any such application, master files, and other related submissions. The availability for public disclosure of any record in the biological product file shall be handled in accordance with the provisions of this section. (b) The existence of a biological product file will not be disclosed by the Food and Drug Administration before a product license has been sent to the applicant, unless it has previously been publicly disclosed or acknowledged. The Director of the Bureau of Biologics will maintain a list available for public disclosure of biological products for which a license has been issued. (c) If the existence of a biological product file has not been publicly disclosed or acknowledged, no data or information in the biological product file is available for public disclosure. (d) If the existence of a biological product file has been publicly disclosed or acknowledged before a license has been issued, no data or information contained in the file is available for public disclosure before such license is issued, but the Commissioner may, in his discretion, disclose a summary of such selected portions of the safety and effectiveness data as are appropriate for public consideration of a specific pending issue, e.g., at an open session of a Food and Drug Administration advisory committee or pursuant to an exchange of important regulatory information with a foreign government. (e) After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown: (1) All safety and effectiveness data and information. (2) A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial or financial information in § 4.61 of this chapter. (3) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of: (i) Names and any information that would identify the person using the product. (ii) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution. (4) A list of all active ingredients and any inactive ingredients previously disclosed to the public, as defined in § 4.81 of this chapter. (5) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and it is shown to fall within the exemption established in § 4.61 of this chapter. (6) All correspondence and written summaries of oral discussions relating to the biological product file, in accordance with the provisions of Part 4 of this chapter. (7) All records showing the manufacturer's testing of a particular lot, after deletion of data or information that would show the volume of the drug produced, manufacturing procedures and controls, yield from raw materials, costs, or other material falling within § 4.61 of this chapter. (8) All records showing the testing of and action on a particular lot by the Food and Drug Administration. (f) The following data and information in a biological product file are not available for public disclosure unless they have been previously disclosed to the public as defined in § 4.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in § 4.61 of this chapter: (1) Manufacturing methods or processes, including quality control procedures. (2) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure. (3) Quantitative or semiquantitative formulas. (g) For purposes of this regulation, safety and effectiveness data include all studies and tests of a biological product on animals and humans and all studies and tests on the drug for identity, stability, purity, potency, and bioavailability. SUBCHAPTER G-COSMETICS PART 720-VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT AND COSMETIC RAW MATERIAL COMPOSITION STATEMENTS 14. In Part 720, by revising § 720.8 to read as follows: § 720.8 Confidentiality of statements. (a) The availability for public disclosure of all data and information contained in, attached to, or included with, Forms FD-2512, 2513, 2514, and amendments thereto, shall be handled in accordance with the provisions established in Part 4 of this chapter. All such data and information are submitted voluntarily to the Food and Drug Administration and are thus subject to the specific provisions for the presubmission review of a request for confidentiality of voluntarily submitted data under § 4.44 of this chapter, and to the provisions concerning data and information submitted voluntarily to the Food and Drug Administration under § 4.111 of this chapter, as well as to the exemptions in Subpart D of Part 4 of this chapter and the limitations on exemptions in Subpart E of Part 4 of this chapter. (b) A determination pursuant to § 4.44 of this chapter that an ingredient or ingredients is not a trade secret or confidential commercial information under § 4.61 of this chapter constitutes final agency action that is subject to judicial review pursuant to 5 U.S.C. chapter 7. If suit is brought within 10 days after such a determination, the Food and Drug Administration will not disclose the records involved or require that the disputed ingredient or ingredients be disclosed in labeling until the matter is finally determined in the courts. PART 730-VOLUNTARY FILING OF COSMETIC PRODUCT EXPERIENCES 15. In Part 730, by revising § 730.7 to read as follows: § 730.7 Confidentiality of reports. The availability for public disclosure of all data and information contained in, attached to, or included with Forms FD-2704, 2705, 2706, and amendments thereto, shall be handled in accordance with the provisions established in Part 4 of this chapter. All such data and information are submitted voluntarily to the Food and Drug Administration and are thus subject to the specific provisions concerning data and information submitted voluntarily to the Food and Drug Administration in § 4.111 of this chapter, as well as to the exemptions in Subpart D of Part 4 of this chapter and the limitations on exemptions in Subpart E of Part 4 of this chapter. [Exhibit 26] EXCERPTS FROM NEW FDA INFORMATION REGULATIONS (21 CFR Parts 4, 314, 514) (Federal Register, Feb. 14, 1977) PART 4-PUBLIC INFORMATION 1. In § 4.40 by revising paragraphs (a) and (c) to read as follows: § 4.40 Filing a request for records. (a) All requests for Food and Drug Administration records shall be filed in writing by mailing the request or delivering it to the Public Records and Documents Center (HFC-18), Food and Drug Administration, Rm. 4-62, 5600 Fishers Lane, Rockville, Maryland 20857. Requests should state in a prominent place on the envelope containing the request, if any, and on the request itself, "FOI request." (c) Upon receipt of a request for records, the Public Records and Documents Center shall enter it in a public log. The log shall state the date received, the name of the person making the request, the nature of the records requested, the action taken on the request, the date of the determination letter sent pursuant to § 441 (b) and the date (s) any records are subsequently furnished. 2. In § 4.42 by revising paragraphs (a) (4) and (5) to read as follows: § 4.42 Fees. (a) *** (4) Clerical searches. $3.00 for each hour spent by clerical personnel searching for and producing a requested record, including time spent copying any record. (5) Nonclerical searches. $3.00 for each hour spent by professional or managerial personnel searching for and producing a requested record, including time spent copying any record. 3. In § 4.47 by revising paragraph (d) to read as follows: § 4.47 Denial of request for records. (d) Minor delections of nondisclosable data and information from disclosable records shall not be deemed to be a denial of a request for records. 4. By revising § 4.53 to read as follows: § 4.53 Indexing trade secrets and confidential commercial or financial information. Whenever the Food and Drug Administration denies a request for a record or portion thereof on the grounds that the record or portion thereof is exempt from public disclosure as trade secret or confidential commercial or financial data and information under § 4.61, and the person requesting the record subsequently contests the denial in the courts, the Food and Drug Administration will so inform the person affected, i.e., the person who submitted the record, and will require that such person intervene to defend the exempt status of the record. If a court requires the Food and Drug Administration to itemize and index such records, the Food and Drug Administration will so inform the person affected and will require that such person undertake the itemization and indexing of the records. The failure of the affected person to intervene to defend the exempt status of the records and to itemize and index the disputed records will constitute a waiver by such person of such exemption, and the Food and Drug Administration will promptly make them available for public disclosure. 5. By revising § 4.86 to read as follows: § 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. (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. (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. * PART 314-NEW DRUG APPLICATIONS 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: 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, Attachment: Form Letter Granting Confidentiality, Distribution: Professional Staff Headquarters and Field. FEDERAL TRADE COMMISSION, 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. |