They rarely involve matters of "general applicability," as that term is used in 2.20, but generally apply to internal agency business. Accordingly, neither 2.20 nor 2.18 is applicable to the pubHic availability of draft guidelines of this type. Their availability is subject only to the Freedom of Information Act and FDA public information regulations. Final staff manual guidelines are publicly available under 5 U.S.C. 552(a) (2) (C). No comments were received regarding §2.21 Participation in outside standard-setting activities (21 CFR 2.21), and it is issued as proposed.

79. Many comments addressed the requirement in proposed paragraph (b) of 2.22 Public calendars (21 CFR 2.22) to exempt meetings with the working press from listing on the retrospective public calendar. The preamble to the proposal had requested specifically that comments be submitted on this issue. Most of the comments urged that meetings with the working press be listed on the calendar. Several comments concluded that there was no basis for according special treatment to meetings with the press, particularly where, as in this instance, the press consisted largely of "expensive "insider' services" that assertedly are oriented toward industry customers and capable of exerting infiuence on the regulatory process. The failure to list meetings retrospectively, it was argued, would therefore not benefit the public generally, but only the press. One comment stated the exemption would revive the supposedly discredited practice of basing news on "undisclosed sources," and that responsible journalists should not need the anonymity that the proposed rule offered them. Another comment urged that a policy of nondisclosure of press meetings might lead to abuse and encourage damaging leaks.

Several contrary arguments were offered. One comment described the function of the press as seeking out information and reporting it, and contended that the press should be impeded as little as possible in this function. The comment argued that conscientious reporting would be frustrated if reporters had to disclose their sources. The comment argued, further, that agency employees who previously have been willing to discuss matters with reporters would be reluctant to continue doing so if they were required at the same time to disclose publicly that they had met with, the press. The comment argued also that the idea of an open calendar is to disclose contacts with government officials by persons seeking to influence actions, a category that does not include members of the press, who do not espouse a particular viewpoint. It was also argued that the listing would not necessarily provide greater protection for trade secrets, whose disclosure would be prohibited. Rather, the information whose distribution would be restricted would likely be of a type that would cause embarrassment or annoyance. Finally, the comment maintained that listing press contacts would hamper press competition, which fosters investigative journalism.

RULES AND REGULATIONS

The Commissioner has decided to retain the exception for the listing of press contacts in the retrospective calendar. He concludes that listing such contacts is not necessary to serve the purpose of listing generally, and would be unnecessarlly burdensome. He views that purpose as publicizing agency contacts with persons having a direct personal or economic interest in agency decisions. He does not believe that representatives of the press, including representatives of publications that can be characterized as "trade press," fall within this category. Moreover, the Commissioner notes that representatives of the trade press as a matter of practice visit the agency on virtually a daily basis to make routine inquiries. Consequently, their contacts with the various agency officials listed in § 2.22(b) (3) are so numerous as to make recording each contact for the public calendar impractical.

The Commissioner concludes, therefore, that it is appropriate to exclude from listing on the public calendar contacts with various segments of the working press. Consistent with the purposes stated above, however, he is limiting this exclusion to those segments of the working press not considered to be "house organs," i.e., publications published by a company that manufactures or distributes a regulated product or products, or by an industry association. Contacts with representatives of such publications will be listed on the retrospective calendar.

80. One comment urged that proposed § 2.22 (b), prescribing requirements for the retrospective public calendar, list meetings with persons outside the executive branch, rather than only those meetings with persons outside the entire Federal government. The Commissioner agrees. He believes there is valid reason to report retrospectively meetings between FDA officials and persons from the legislative or judicial branches of government that are held to discuss positions on regulatory issues pending before the agency. The final regulation has been modified accordingly.

81. Another comment urged that the prospective calendar described in 2.22 (a) be required to list "all meetings with persons outside Government." It argued that without advance notice of such meetings, consumer views would inevitably be presented primarily at separate meetings held subsequently, which would have only limited utility. Moreover, because such meetings are not transcribed or recorded, the comment argued, consumers should have the opportunity to be present at all meetings between the agency and industry representatives to represent consumer interests.

The Commissioner disagrees; the comment misunderstands the purpose of the prospective calendar, which is to list public meetings, conferences, etc., not private meetings. Section 2.15(d) of the regulations acknowledges the right of any person, whether a representative of industry or any other group, to meet privately with representatives of the agency. The Commissioner belleves the listing on the retrospective calendar of

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such meetings that occur with certain agency officials, and the filing of appropriate memoranda summarizing all such meetings in the administrative file, adequately protect the interests of persons not in attendance. Such memoranda, would, except where exempt from disclosure, be publicly available through either the Hearing Clerk or the Public Records and Documents Center. The Commissioner believes these procedures fairly balance consumer interests with the rights of any citizen to meet privately with agency officials.

82. One comment contended that it should be mandatory instead of optional to list telephone calls in the retrospective calendar. It argued that the substance of a meeting or call should determine whether it should be included on the calendar, not whether it was held in person or by telephone. The comment insisted that all telephone calls that could influence agency decisions should⚫ be recorded on the calendar.

The Commissioner agrees that it is the substance of a meeting that should determine whether it is included on the calendar. However, he believes the proposed regulation is responsive to the comment. He advises that recording of calls is made optional with agency employees to eliminate the need to list calls that do not bear upon the decisionmaking process of the agency, e.g., calls to establish a time for a meeting. The expectation is that any call affecting a matter of policy will be noted. All such calls must in any event be summarized in written memoranda for inclusion in the administrative file under 2.15, and such memoranda would be subject to disclosure under the Freedom of Information Act. Listing of telephone calls on the public calendar may, therefore, properly remain optional with individual agency employees.

83. One comment urged that the prospective public calendar be published in the FEDERAL REGISTER. The comment stated that the locations presently specified in 2.22(a) (2) for public display of the calendar will not assure sufficiently wide dissemination of the information.

The Commissioner does not agree. Publication in the FEDERAL REGISTER is not appropriate for routine matters such as a weekly calendar. The Commissioner believes the provisions made for public display of both the prospective and retrospective public calendars are adequate. Moreover, the Commissioner assures that topical items appearing in the calendar will be noted regularly in the trade press.

84. Section 2.22(b) (3) (ix) in the final regulation has been modified to include, among the agency representatives required to list their attendance at meetings on the public calendar, any representative of the Chief Counsel's office who attends or plans to attend a public meeting on behalf of the Chief Counsel. The organization of the Chief Counsel's office is such that representatives other than the Chief Counsel or Deputy Chief Counsel frequently attend meetings with

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members of the public as the designated representative of the office. The effect of the requirement will be to bring to public attention meetings that might otherwise not be reported.

85. Numerous comments on proposed §2.23 Representation by an organization (21 CFR 2.23) objected to the distinction between "organization" in paragraphs (a) and (c), and "trade association" in paragraph (b). Several comments questioned whether these terms included professional associations, consumer groups, large food cooperatives,

etc.

The Commissioner advises that the divergent references to "organization" and "trade association" were inadvertent. As proposed, the section was intended to apply to any organization, including a trade association that represents a "membership," or other clearly defined group appearing before the agency. Thus, professional and trade associations as well as consumer groups having an identifiable membership would be included.

86. A large number of comments objected to the statement in proposed § 2.23(b) that any representation by a trade association. in a petition, comment, objection, or otherwise would be treated by FDA as binding on all members except those that had excluded themselves by name. Numerous reasons were offered to support this objection. Many comments urged that the requirement was impracticable, associations, operating within existing resources and prescribed time frames, could not, it was said, determine members' individual views prior to submitting comments. The comments pointed out that associations ordinarily attempt to reflect consensus views, and that if adopted, the rule would dramatically reduce the effectiveness of associations and primarily penalize small companies that rely heavily on associations to express their views. Legal objections were also raised as well. Many comments noted that trade associations have an identity apart from their membership and do not purport to act as agents for each of their members. The comments argued that FDA could not impose an "agency" relationship by regulation.

The Commissioner is persuaded that the proposed regulation should be modifiled to eliminate the provision that representations, petitions, comments, or objections by trade associations are binding on all members who have not expressly excluded themselves. He is persuaded by the practical difficulties of eliciting the views of an association member within the customary comment period. He also agrees with those comments that contended that organizations, including trade associations, should be entitled to participate in agency proceedings in their own right. Consequently, the final provision does not assert that association views will be binding on association members and does not require exclusion by name of members who do not subscribe to the views of the organization.

87. An equally large number of comments objected to the requirement of

RULES AND REGULATIONS

proposed § 2.23 (b) (1) that any submission by a trade association (or other organization representing the views of its members) be accompanied by a current membership list or that the association have such a list on file in the Hearing Clerk's office. Several associations argued that their membership was simply too large and fluid; others contended that the requirement unlawfully infringed on the constitutional right of persons to petition their government or the right to participate in agency activities under the Administrative Procedure Act and the Federal Food, Drug, and Cosmetic Act. Several comments pointed to cases that have recognized a constitutional right against disclosure of association membership, citing NAACP v. Alabama,

357 U.S. 449 (1958), Bates v. Little Rock, 361 U.S. 516 (1960), and later cases, a

right that can only be overcome by a compelling governmental interest in disclosure, citing Gibson v. Florida Legislative Investigation Committee, 372 U.S. 539 (1963). Some associations stated, however, that they had no objection to filing membership lists with the Hearing Clerk.

The Commissioner does not accept the argument that the cited cases, dealing principally with potential restrictions on freedom of expression, preclude requiring disclosure of association membership in the context of administrative proceedings to establish regulations based on information submitted by parties having obvious interests in the outcome. However, because the Commissioner has elected not to consider the positions taken by associations as binding on all members, there is no compelling reason to insist on the submission of membership lists by such organizations, and the proposed requirement is not adopted. Section 2.23 (c) of the final regulation requests that such lists be provided on an annual basis to the Hearing Clerk for placement in a special file that will be available for public examination. The Commissioner hopes that organizations participating regularly in agency proceedings will file membership Hists for he believes that information concerning the number and identity of members of associations will facilitate his evalution of association comments.

88. Many comments also questioned the requirement in proposed § 2.23 (b) (2) that would prohibit a member of a trade association from deriving any rights individually from the filing by its association of an objection or request for hearing pursuant to §§ 2.110 through 2.112. The comments claimed it was inequitable to require members to be bound by association positions and not to provide rights commensurate with the obligation imposed. The Commissioner has retained the proposed provision (§ 2.23 (d) in the final regulation), because he no longer intends to consider association members bound by positions taken by their association. However, he has amplified the provision to make clear that association members who wish to file objections or requests for hearing must do so in their own name if they wish to derive any rights therefrom.

89. Many comments challenged the validity of proposed § 2.23 (c), in which the Commissioner announced his intention to treat any court proceeding in which an organization participates as a class action, and to assert in any related court case the doctrines of res judicata and collateral estoppel against all organization members except those excluded by name. The comments insisted that class actions must meet specific judicial requirements whose applicability can only be determined in specific proceedings. Other comments questioned the wisdom of including such statements of litigation strategy in these regulations.

The Commissioner acknowledges that

whether an organization challenge to FDA regulations or other agency action

should be adjudicated as a class action, just as the application of the doctrines of res judicata or collateral estoppel, will ultimately be determined judicially. Nonetheless, he has retained the provision (§ 2.23 (e) in the final regulation) to emphasize that the positions stated reflect the agency's posture in court.

No comments were received regarding § 2.24 Settlement proposals (21 CFR 2.24), and it is issued as proposed.

No comments were received regarding § 2.25 Waiver, suspension, or modification of procedural requirements (21 CFR 2.25) and it is issued as proposed.

The proposed regulations on administrative practices and procedures contained proposed conforming changes in numerous existing regulations of the agency. The Commissioner has promulgated some of the proposed conforming regulations at the time of finalizing Subparts B and F of Part 2. In this document, the Commissioner is issuing the remainder of the conforming regulations substantially as proposed, inasmuch as no

comments were received on them.

The changes in § 330.10 (a) (12) (21 CFR 330.10 (a) (12)) set forth in the September 3, 1975 proposal have been incorporated in a final regulation to be published in the FEDERAL REGISTER in the near future.

Section 328.30 Procedure for establishing, amending or repealing standards has been recodified as § 829.30 (recodification published in the FEDERAL REGISTER of February 13, 1976 (41 FR 6907)) and the proposed conforming amendment to the section is finalized in this document under Part 829.

Therefore, under the Federal Food, Drug, and Cosmetic Act (sec. 201 et seq., 52 Stat. 1040 (21 U.S.C. 321 et seq.)), the Public Health Service Act (sec. 1 et seq., 58 Stat. 682. as amended (42 U.S.C. 201 et seq.)), the Comprehensive Drug Abuse Prevention and Control Act of 1970 (sec. 4, 84 Stat. 1241 (42 U.S.C. 257a)), the Controlled Substances Act (sec. 301 et seq., 84 Stat. 1253 (21 U.S.C. 821 et seq.)), the Federal Meat Inspection Act (sec. 409 (b), 81 Stat. 600 (21 U.S.C. 679 (b)), the Poultry Products Inspection Act (sec. 24(b), 82 Stat. 807 (21 U.S.C. 4671(b)), the Egg Products Inspection Act (sec. 2 et seq., 84 Stat. 1620 (21 U.S.C. 1031 et seq.))., the Federal Import Milk Act (44 Stat. 1101 (21 U.S.C. 141 et seq.)), the

Tea Importation Act (21 U.S.C. 41 et seq.), the Federal Caustic Poison Act (44 Stat. 1406 (15 U.S.C. 401-411 notes)), the Fair Packaging and Labeling Act (80 Stat. 1296 (15 U.S.C. 1451 et seq.)), and all other statutory authority delegated to the Commissioner (21 CFR 5.1) (recodification published in the FEDERAL REGISTER of June 15, 1976 (24262)), Chapter I of Title 21 of the Code of Federal Regulations is amended as follows:

PART 1-REGULATIONS FOR THE ENFORCEMENT OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND THE FAIR PACKAGING AND LABELING ACT 1. By revising § 1.1a to read as follows: § 1.1a Foods, drugs, devices, and cosmetics; labeling; procedure for requesting variations and exemptions from required label statements. Section 403 (e) of the act (in this Part 1, the term "act" means the Federal Food, Drug, and Cosmetic Act) provides for the establishment by regulation of reasonable variations and exemptions for small packages from the required declaration of net quantity of contents. Section 403 (1) of the act provides for the establishment by regulation of exemptions from the required declaration of ingredients where such declaration is impracticable, or results in deception or unfair competition. Section 502(b) of the act provides for the establishment by régulation of reasonable variations and exemptions for small packages from the required declaration of net quantity of contents. Section 602(b) of the act provides for the establishment by regulation of reasonable variations and exemptions for small packages from the required declaration of net quantity of contents. Section 5(b) of the Fair Packaging and Labeling Act provides for the establishment by regulation of exemptions from certain required declarations of net quantity of contents, identity of commodity, identity and location of manufacturer, packer, or distributor, and from declaration of net quantity of servings represented, based on a finding that full compliance with such required declarations is impracticable or not necessary for the adequate protection of consumers, and a further finding that the nature, form, or quantity of the packaged consumer commodity or other good and sufficient reasons justify such exemptions. The Commissioner, on his own initiative or on petition of an interested person, may propose a variation or exemption based upon any of the foregoing statutory provisions, including proposed findings if section 5(b) of the Fair Packaging and Labeling Act applies, pursuant to Part 2 of this chapter.

2. By revising 1.8d (f) to read as follows:

§ 1.8d Food labeling; information panel.

2.23

2.24 2.25

Public calendars.

standard

Representation by an organization. Settlement proposals.

Waiver, suspension, or modification of procedural requirements. AUTHORITY: Sec. 201 et seq., Pub. L. 717, 52 Stat. 1040 as amended (21 U.S.C. 321 et seq.); sec. 1 et seq., Pub. L. 410, 58 Stat. 682 as amended (42 U.S.C. 201 et seq.); sec. 4, Pub. L. 91-513, 84 Stat. 1241 (42 U.B.C. 257a); sec. 301 et seq., Pub. L. 91-513, 84 Stat. 1253 (21 US.C. 821 et seq.): sec. 409 (b), Pub. L. 242, 81 Stat. 600 (21 U.S.C. 679 (b)); sec. 24(b), Pub. L. 85-172, 82 Stat. 807 (21 U.S.C. 4671 (b)); sec. 2 et seq., Pub. L. 91-597, 84 Stat. 1620 (21 U.S.C. 1031 et seq.); secs. 1 through

9, Pub. L. 625, 44 Stat. 1101-1103 as amended (21 U.S.C. 141-149); secs. 1 through 10, Chapter 358, 29 Stat. 604-609 as amended (21 U.S.C. 41-50); sec. 1 et seq., Pub. L. 783, 44 Stat. 1406 as amended (15 UB.C. 401 et seq.); sec. 1 et seq., Pub. L. 89-775, 80 Stat. 1296 as amended (15 U.S.C. 1451 et seq.). Subpart A-General

§ 2.1 Scope.

(a) Part 2 governs practices and procedures applicable to all petitions, hearings, and other administrative proceed

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ings and activities conducted by the Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and other laws with respect to which authority has been delegated to the Commissioner of Food and Drugs pursuant to § 5.1 of this chapter, except to the extent that specific provisions in other sections of this chapter state different requirements with respect to a particular matter.

(b) Where a specific provision in another section of this chapter states a different requirement with respect to a particular matter (e.g., the use of a form different from the one specified in 2.7 (b)), the sections in this part shall apply to the extent that they do not conflict with such other provisions (e.g., the requirements for inclusion of all data and information and for translations of foreign language in § 2.5(b) shall apply regardless of which form is used).

(a) As used in this part, the following terms shall have the meanings specified:

(1) "Act" means the Federal Food, Drug, and Cosmetic Act unless otherwise indicated.

(2) "Department" means the United States Department of Health, Education, and Welfare.

(3) "Secretary" means the Secretary of Health, Education, and Welfare.

(4) "Commissioner" means the Commissioner of Food and Drugs, Food and Drug Administration, United States Department of Health, Education, and Welfare, or his designee.

(5) "Agency" means the Food and Drug Administration.

(6) "Person" includes an individual, partnership, corporation, association, or other legal entity.

(7) "Presiding officer" means the Commissioner or his designee or an Administrative Law Judge appointed as provided in 5 U.S.C. 3105.

(8) "Hearing Clerk" means the Hearing Clerk of the Food and Drug Administration, United States Department of Health, Education, and Welfare, Rm. 465, 5600 Fishers Lane, Rockville, MD 20857.

(9) "Proceeding" and "administrative proceeding" mean any undertaking to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action.

(10) "Party" means the bureau of the Food and Drug Administration responsible for the matter involved and every person who either has exercised a right to request or has been granted the right by the Commissioner to have a formal evidentiary public hearing pursuant to Subpart B of this part or a regulatory hearing before the Commissioner pursuant to Subpart F of this part, or who has waived any such right in order to obtain the establishment of a Public Board of

Inquiry pursuant to Subpart C of this part, and as a result of whose action a formal evidentiary hearing or a regula

26-915 - 78-9

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tory hearing before the Commissioner has been granted or a Public Board of Inquiry has been established.

(11) "Participant" means any person participating in any proceeding, including each party and any other interested

person.

(12) "Interested person" or "any person who will be adversely affected" means any person who submits a petition or comment or objection or otherwise requests an opportunity to participate in any informal or formal administrative proceeding or court action.

(13) "Public Board of Inquiry" or "Board" means an administrative law tribunal constituted pursuant to the provisions of Subpart C of this part.

(14) "Public advisory committee" or "advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof, that is not composed wholly of full-time officers or employees of the Federal government and is established or utilized by the Food and Drug Administration to obtain advice or recommendations.

(15) "Formal evidentiary public hearing" means any hearing conducted pursuant to the provisions of Subpart B of this part.

(16) "Public hearing before a Public Board of Inquiry" means any hearing conducted by a Board pursuant to the provisions of Subpart C of this part.

(17) "Public hearing before a public advisory committee" means any hearing conducted by an advisory committee pursuant to the provisions of Subpart D of this part.

(18) "Public hearing before the Commissioner" means any hearing conducted by the Commissioner or his designee pursuant to the provisions of Subpart E of this part.

(19) "Regulatory hearing before the Food and Drug Administration" means any hearing conducted by an authorized employee of the Food and Drug Administration pursuant to the provisions of Subpart F of this part.

(20) "The laws administered by the Commissioner" means all the statutory provisions with respect to which authority has been delegated to the Commissioner pursuant to § 5.1 of this chapter.

(21) "Petition" means any petition, application, or other document requesting the Commissioner to establish, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action, under the laws administered by him.

(22) "Regulation" means any agency rule of general or particular applicability and future effect implementing or applying any law administered by the Commissioner or relating to administrative practices and procedures. Pursuant to § 2.20 (a), all agency regulations shall be promulgated in the FEDERAL REGISTER and codified in the Code of Federal Regulations.

(23) "Order" means any final agency disposition, other than the issuance of a

RULES AND REGULATIONS

regulation, in a proceeding concerning any matter and includes action on any new drug application, new animal drug application, or biological license.

(24) "Meeting" means any oral discus-sion, whether by telephone or in person.

(25) "Office of the Commissioner" includes the offices of the associate and assistant commissioners and excludes the bureaus, the office of the Executive Director for Regional Operations, and all regional and district offices.

(26) "Administrative action" includes every form and kind of act, including the refusal or failure to act, involved in the implementations of the laws administered by the Commissioner, except that it does not include the referral of apparent violations to United States attorneys for the institution of civil and criminal proceedings and acts preparatory or incidental thereto.

(27) "Administrative file" means the file maintained by the Food and Drug Administration, in which all documents pertaining to an administrative proceeding, including internal working memoranda and recommendations, are tained.

re

(28) "Food and Drug Administration employee" or "Food and Drug Administration representative" shall be deemed to include members of the Food and Drug Division of the office of the General Counsel of the Department of Health, Education, and Welfare.

(29) "Ex parte communication" means an oral or written communication not on the public record with respect to which reasonable prior notice to all parties is not given, but it shall not include requests for status reports on any matter or proceeding.

(b) Any term which is defined in section 201 of the Federal Food, Drug, and Cosmetic Act or Part 1 of this chapter shall have that definition.

(c) Words in the singular form shall be deemed to include the plural, words in the masculine form shall be deemed to include the feminine form, and vice versa, as the case may require.

(d) Whenever any reference is made to this part to any person in the Food and Drug Administration, e.g., the director of a bureau, such reference shall also be deemed to include all persons to whom that person has delegated the specific function involved.

except as otherwise specifically provided in any relevant FEDERAL REGISTER notice or in other sections of this chapter. The Hearing Clerk shall be the agency custodian of such documents.

(b) All such submissions shall be signed by the person making the submission, or by an attorney or other authorized representative on his behalf. Submissions by trade associations shall also be subject to the requirements of § 2.23(b).

(c) All data and information referred to or in any way relied upon in any such submissions shall be included in full and may not be incorporated by reference, unless previously submitted as part of the administrative file in the same proceeding.

(1) A copy of any article or other reference or source cited shall be included, except where the reference or source is: (i) A reported Federal court case,

(ii) A Federal law or regulation, (ii) A Food and Drug Administration document that is routinely publicly available, or

(iv) A recognized medical or scientific textbook that is readily available to the agency.

(2) If any part of the material submitted is in a foreign language, it shall be accompanied by an English translation verified under oath to be complete and accurate, together with the name, address, and a brief statement of the qualifications of the person making the translation. Translations of literature or other material in a foreign language shall be accompanied by copies of the original publication.

(3) Where relevant data or information are contained in a document also containing irrelevant matter, the irrelevant matter shall be deleted and only the relevant data or information shall be submitted.

(4) Pursuant to § 4.63 (a) and (b) of this chapter, the names and other information which would identify patients or research subjects shall be deleted from any record before it is submitted to the Hearing Clerk in order to preclude a clearly unwarranted invasion of personal privacy.

(5) Defamatory, scurrilous, or intemperate matter shall be deleted from any record before it is submitted to the Hearing Clerk.

(6) The failure to comply with the requirements of this paragraph or any other requirement in this part shall result in rejection of the submission for filing or, if it is filed, in exclusion from consideration of any portion of the submission which fails to comply. If a submission fails to meet any requirement of this section and such deficiency becomes known to the Hearing Clerk, the Hearing Clerk shall return the submission with a copy of the applicable regulations indicating those provisions not complied with in the submission. A deficient submission may be corrected or supplemented and subsequently filed. The office of the Hearing Clerk is not equipped to make decisions regarding the confidentiality of submitted documents. Persons wishing to voluntarily submit information consid

ered confidential shall do so in accordance with the presubmission review requirements of § 4.44 of this chapter. (d) The filing of a submission shall mean only that the Hearing Clerk has not determined that it fails to meet the technical requirements for filing established in this section and in any other applicable sections in this chapter, e.g., §2.7 relating to a citizen petition. The filing of a petition shall not mean or imply that it in fact meets all applicable requirements or that it contains reasonable grounds for the action requested or that the action requested is in accordance with law.

(e) All submissions to the Hearing Clerk shall be considered as submitted on the date on which they are postmarked or, if delivered in person during regular business hours, on the date on which they are so delivered, unless a provision in this part, an applicable FEDERAL REGISTER notice, or an order issued by an administrative law judge specifically states that such documents must be received by a specified date, e.g., § 2.8 (g) relating to a petition for reconsideration, in which case they shall be considered submitted on the date actually received.

(f) All such submissions shall be mailed or delivered in person to the Hearing Clerk, Food and Drug Administration, Rm. 4-65, 5600 Fishers Lane, Rockville, MD 20857, except that a submission which is required to be received by the Hearing Clerk by a specified date may be delivered in person to the Food and Drug Administration building in downtown Washington (Rm. 6819, 200 C St., SW., Washington, DC 20201) and shall be considered as received by the Hearing Clerk on the date on which it is logged in at Rm. 6819.

(g) The Food and Drug Administration ordinarily will not acknowledge or give receipt for such documents, except: (1) Documents delivered in person or submitted by certified or registered mail with a return receipt requested.

(2) Petitions for which acknowledgement of receipt of filing is provided by regulations in this chapter or by customary practice, e.g., § 2.7(c) relating to a citizen petition.

(h) Saturdays, Sundays, and Federal legal holidays shall be included in computing the time allowed for the submission of any document, except that when such time expires on a Saturday, Sunday, or Federal legal holiday, such period shall be extended to include the next following business day.

(1) All submissions to the Hearing Clerk constitute a representation that, to the best of the knowledge, information, and belief of the person making the submission, all statements made in the submission are true and accurate. All such submissions are subject to the False Reports to the Government Act, 18 U.S.C. 1001, under which a willfully false statement is a criminal offense.

(j) The availability for public examination and copying of submissions to the Hearing Clerk shall be governed by the following rules:

(1) Except to the extent provided in paragraphs (j) (2) and (3) of this sec

RULES AND REGULATIONS

tion, the following submissions, including all supporting material, shall be on public display and shall be available for public examination between the hours of 9 a.m. to 4 p.m., Monday through Friday. Requests for coples of such submissions shall be filed and handled pursuant to the provisions of Subpart C of Part 4 of this chapter.

(1) Petitions.

(11) Comments on petitions, on documents published in the FEDERAL REGISTER, and on similar public documents.

(1) Objections and requests for hearings filed pursuant to Subpart B of this part.

(iv) Material submitted at a formal evidentiary public hearing pursuant to Subpart B of this part, a public hear ing before a Public Board of Inquiry pursuant to Subpart C of this part, a public hearing before the Commissioner pursuant to Subpart E of this part, or an alternative form of hearing before a public advisory committee pursuant to 2.117(a) (2).

(v) Material placed on public display pursuant to regulations in this chapter, e.g., agency guidelines filed pursuant to §2.20(b).

(2) (1) Material prohibited from public disclosure pursuant to § 4.63 of this chapter (clearly unwarranted invasion of personal privacy) as interpreted and applied in Part 4 of this chapter and the regulations referenced therein, and, except as provided in paragraph (j) (3) of this section, material submitted with objections and requests for hearings filed pursuant to Subpart B of this part, or at a formal evidentiary public hearing pursuant to Subpart B of this part, a public hearing before a Public Board of Inquiry pursuant to Subpart C of this part, or an alternative form of public hearing before a public advisory committee or a public hearing before the Commissioner pursuant to § 2.117(a) (2) or (3), of the following types shall not be on public display, shall not be available for public examination, and shall not be available for copying or any other form of verbatim transcription unless they are otherwise available for public disclosure pursuant to the provisions of Part 4 of this chapter and the regulations referenced therein:

(a) Safety and effectiveness data and information, which include all studies and tests of an ingredient or product on animals and humans and all studies and tests on the ingredient or product for identity, stability, purity, potency, bioavailability, performance, and usefulness.

(b) A protocol for a test or study.

(c) Manufacturing methods or processes, including quality control procedures.

(d) Production, sales, distribution, and similar data and information, except any compilation of such data and information aggregated and prepared in a way that does not reveal confidential data and information.

(e) Quantitative or semiquantitative formulas.

(f) Data and information on design or construction of products.

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(11) Material submitted pursuant to the provisions of paragraph (1)(2) of this section shall be segregated from all other submitted material and clearly so marked. Any person who does not agree that such a submission is properly subject to the provisions of paragraph (j) (2) of this section may request a ruling thereon from the Assistant Commissioner for Public Affairs whose decision on the matter shall be final, subject to judicial review pursuant to § 4.46 of this chapter.

(3) Material listed in paragraph (j) (2) (i) (a) and (b) of this section may be disclosed pursuant to a protective order issued by the administrative law judge or other presiding officer at any hearing referenced in paragraph (j) (2) (i). The order shall only permit disclosure of the data in camera and only to the extent necessary for the proper conduct of the hearing. The order shall state to whom the information is to be made available (e.g., to parties or participants, or only to counsel for parties or participants), and persons not specifically permitted access to the data shall be excluded from the in camera part of the proceeding. The administrative judge or other presiding officer may impose other conditions or safeguards with the requirements of this section. The limited availability of material pursuant to this paragraph shall be deemed not to constitute prior disclosure to the public as defined in 4.81 of this chapter, and no such data and information shall be submitted to or received or considered by the Food and Drug Administration in support of a petition or other request from any other person.

law

$2.6 Initiation of administrative pro

ceedings.

An administrative proceeding under the laws administered by the Commissioner may be initiated in any of the following three ways:

(a) Any interested person may petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action, under the laws administered by him. Any such petition shall be either (1) in the form specified in other applicable sections in this chapter, e.g., the form for a food additive petition in § 121.51 of this chapter or for a new drug application in

314.1 of this chapter or for a new animal drug application in 514.1 of this chapter, or (2) in the form for a citizen petition in § 2.7.

(b) The Commissioner may on his own Initiative institute a proceeding to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action, under the laws administered by him. The Food and Drug Administration has primary jurisdiction to make the initial determination on issues within its statutory mandate, and will request a court to dismiss, or to hold in abeyance its determination of or refer to the agency for administrative determination, any such issue which has not previously been determined by the agency or which, if