90-day limit for the purposes of section 706(d)(1) of the act shall be moved forward 1 day for each day, after mailing date of the request, taken by the petitioner to submit the information and sample. If the information or sample is requested a reasonable time in advance of the 180 days, but is not submitted within such 180 days after filing of the petition, the petition will be considered withdrawn without prejudice. § 8.8 Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice. (a) Extension of time for studying petitions. If the Commissioner determines that additional time is needed to study and investigate the petition, he shall by written notice to the petitioner extend the 90-day period for not more than 180 days after the filing of the petition. (b) Substantive amendments. After a petition has been filed, the petitioner may submit additional information or data in support thereof. In such cases, if the Commissioner determines that the additional information or data amounts to a substantive amendment, the petition as amended will be given a new filing date, and the time limitation will begin to run anew. (c) Withdrawal of petitions without prejudice. (1) In some cases the Commissioner may notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or the regulation requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal will be without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew from the date of refiling. (2) At any time before the order provided for in § 8.6 has been forwarded to the FEDERAL REGISTER for publication the petitioner may withdraw the petition without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew. and not revealed, unless it is necessary to do so in the record of an administrative hearing preliminary to possible judicial proceedings under section 706 of the act Data in the petition will not be revealed to persons other than the petitioner and persons engaged in the enforcement of the act beyond that which is necessary to comply with section 706(d) (1) (notice of the regulation proposed) and 706(b) (1) (order acting on the petition). § 8.10 Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regula tion has issued. The Commissioner shall refuse to issue a regulation listing a color additive, if in his judgement the data before him show that such proposed use would promote deception of the consumer or would result in misbranding or adulteration within the meaning of the act. Such a finding shall be by order published in the FEDERAL REGISTER subject to the filing of objections and a request for a hearing by adversely affected parties. The issuance of a regulation for a color additive authorizing its use generally in or on a food, drug, or cosmetic shall not be construed as authorization to use the color additive in a manner that may promote deception or conceal damage or inferiority. The use of a color additive to promote deception or conceal damage or inferiority shall be considered as the use of a color additive for which no regulation has issued pursuant to section 706(b) of the act, even though the regulation is effective for other uses. § 8.11 Allocation of color additives. Whenever, in the consideration of a petition or a proposal to list a color additive or to alter an existing listing, the data before the Commissioner fail to show that it would be safe to list the color additive for all the uses proposed or at the levels proposed, the Commissioner will notify the petitioner and other interested persons by publication in the FEDERAL REGISTER that it is necessary to allocate the safe tolerance for the straight color in the color additive among the competing needs. This notice shall call for the presentation of data by all interested persons on which the allocation can be made in accordance with section 706 (b) (8) of the act. The time for acting upon the petition shall be stayed until such data are presented, whereupon the time limits shall begin to run anew. As promptly as possible after presentation of the data, the Commissioner will, by order, announce the allocation and the colerance limitations. 8.12 Advisory committee on the application of the cancer clause. (a) Any person who will be adversely affected by any action or proposed action applying the cancer clause may at any ime, before or within 30 days after the publication of the Commissioner's order aking such action, request the referral of the matter to an advisory committee or a report and recommendations. Such request shall be made in writing to the Commissioner and shall be accompanied by an advance deposit for fees prescribed by § 8.50. (b) The Commissioner may, at any ime, upon his own initiative refer any uch matter to an advisory committee or a report and recommendations. In case the Commissioner on his own iniiative deems it necessary to refer a proposal to an advisory committee, he shall, n writing, so inform the person filing he petition, if any there be. 8.13 Appointment of advisory com mittee. (a) Whenever the referral of a petiion or proposal to an advisory commitee is requested, or the Commissioner therwise deems such referral necessary, he Commissioner will request the Naional Academy of Sciences to select [ualified experts willing to serve on the dvisory committee. All such experts hall have had sufficient training and Experience in biology, medicine, physilogy, toxicology, pharmacology, veteriary medicine, or other appropriate cience to qualify them on the subject natter to be referred to them. The Commissioner will request the National Academy of Sciences, when it furnishes he names of such experts, to supply a iographical sketch showing the backround of their experience and their connection, if any, with academic and commercial institutions. (b) Each advisory committee shall consist of not less than three experts qualified in the subject matter to be referred to the committee and of adequately diversified professional background. The Commissioner may specify a larger number to serve. He shall appoint one member of the committee as chairman, and the chairman shall be the spokesman of the committee for re ceiving and forwarding reports and other functions of the committee. (c) The Commissioner shall appoint the experts so selected and fix their compensation at not to exceed $75.00 a day for each day or part thereof spent in committee meetings and in traveling to and from committee meetings held outside the city of their residence, plus necessary traveling and subsistence expenses while the experts are serving away from their places of residence. Subsistence expenses shall not exceed $25.00 per day. § 8.14 Procedure for advisory com mittee. (a) The Commissioner shall submit to the chairman of the committee the petition, if any there be; all pertinent data on which he based the issuance, amendment, or repeal of any regulation in question; and other such relevant information as is available. When the Commissioner submits a proposal to an advisory committee, he shall inform the petitioner, if any there be, and furnish him with copies of material other than the petition that is furnished the committee. The chairman of the committee shall acknowledge receipt of the information and readiness of the committee to act. The date of receipt of such information shall be considered the beginning of the period allowed for consideration by the committee. Copy of this acknowledgment shall be forwarded to the petitioner, if any there be, by the chairman of the committee. (b) A secretariat to the advisory committees will be established by the Commissioner. The secretariat shall furnish members of the committee with copies of the proposal or petition and any data received by the chairman. If the chairman of the committee believes that a meeting of the committee is necessary before making a recommendation, he shall so advise the Commissioner. Such meetings shall be held in Washington, D.C., or at such other place as the Commissioner shall furnish a suitable meeting place for the committee. If a meeting is held, the secretariat shall keep the minutes and provide clerical assistance. (c) As soon as practicable, the advisory committee shall make an independent study of the data, and not later than 60 days after receipt of the proposal or petition (unless the time has been extended as provided in paragraph (d) of this section), the chairman shall certify to the Commissioner the report and recommendations of the committee, including any minority report, together with all underlying data and a statement of the reasons or basis for the recommendations, and shall return the petition or proposal. The report will include copies of all material considered by the committee, except that in the case of scientific literature readily available in scientific libraries proper reference may be made to it instead of furnishing actual copies. A copy of the report of the advisory committee will be supplied to any person who has filed a petition or requested the referral to the advisory committee. (d) If at any time within 60 days the chairman believes that the advisory committee needs more time, he shall so inform the Commissioner in writing, in which case he shall make the certification contemplated by section 706(b) (5) (C) (ii) of the act within the additional 30 days. The Commissioner shall in turn notify the petitioner. (e) Within 30 days after receipt of the committee report, the Commissioner shall confirm or modify any order theretofore issued by him or shall issue an order acting on the proposal if no order has been issued. (f) The chairman of the committee, after consultation with the committee members, will inform the National Academy of Sciences of the committee's opinion as to the member who may best represent the committee at a hearing, if one occurs. (g) More than one petition or proposal may be handled by a committee concurrently. (h) A person who has filed a petition or who has requested the referral of a proposal to the advisory committee in accordance with the provisions of this section, as well as representatives of the Department of Health, Education, and Welfare, shall have a right to consult with the committee in connection with the petition or proposal. Such persons shall notify the chairman and if practicable make appointments through him. The report of the committee shall show the names of persons other than committee members discussing proposals or petitions with the committee. Except for discussions with authorized persons the committee shall not disclose data originating with a petitioner prior to publication of a regulation. § 8.15 Condition for certification. (a) When the Commissioner cannot conclude from the information before him that there is a basis for exempting a color additive from the requirement of batch certification, he will so order by appropriate listing in Subpart C, E, or G of this part. The Commissioner's order shall state in detail the specifications that shall be met by the color additive. (b) Each order shall state a period of time after which use of a color additive subject to batch certification but not from a batch certified by procedure prescribed in this section would result in adulteration of the product in which it is used. § 8.16 Revocation of exemption from certification. If information becomes available to the Commissioner that a color additive that has been granted exemption from certification should not, for the protec tion of the public health, be so exempted, such exemption will be canceled by a notice published in the FEDERAL REGISTER. § 8.17 Listing and exemption from cer tification on the Commissioner's initiative. Where a petition for a regulation to list a color additive has not been received and the Commissioner has available facts which demonstrate that a color additive should be listed and/or that certification procedure is not necessary in order to protect the public health, he may list such color additive by appropriate regulation and listing in Subpart C, D, E, F, G, or H of this part. § 8.18 Request for exemption from cer tification. A manufacturer, packer, or distributor of a color additive or color additive mix. ture that has not been exempted from the certification procedure by order of the Commissioner may make formal objections and request an order providing such exemption. Such a request shall be accompanied by full facts on which such a request is based. The request shall furnish reasonable grounds for the desired finding including specifically why such certification is not necessary for the protection of the public health. § 8.19 Procedure for filing objections to regulations. (a) Objections under section 706(d) of the act and section 203 (d) (2) (C) of 'ublic Law 86-618 (74 Stat. 404; 21 U.S.C. 76, note) shall be submitted in quinuplicate to the Hearing Clerk of the Deartment and shall be accompanied by a ling fee as specified in § 8.50. Each bjection to a provision of the regulation hall be separately numbered. (b) A statement of objections shall not e accepted for filing if: (1) It is received for filing more than 0 days after the date of publication of he order in the FEDERAL REGISTER; or (2) It fails to establish that the obector is adversely affected by the reguation; or (3) It does not specify with particuarity the provisions of the regulation o which objection is taken; or (4) It does not state reasonable rounds for each objection raised. rounds which it is reasonable to conlude are capable of being established by eliable evidence at the hearing and which if proved would call for changing he provisions specified in the objections vill be deemed reasonable grounds. (5) The fee is not submitted. (c) If the statement of objections nay not be filed, the Commissioner shall nform the objector of the reasons. 8.20 Notice of public hearing. If the objections and statement filed by any person, when they are considered with the record in the proceeding (including any reply to the objections that che petitioner may have filed), show that che person filing the objections will be adversely affected and that the grounds stated in support of the objections are reasonable, the Commissioner shall cause to be published in the FEDERAL REGISTER a notice reciting the objections and announcing a public hearing to receive evidence on them. The notice shall designate the place where the hearing will be held, specify the time within which appearances must be filed, and specify the time (not earlier than 30 days after the date of the notice) when the hearing will start. The hearing shall convene at the place and time announced in the notice, but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without other notice than announcement thereof by the presiding officer at the hearing. § 8.21 Hearing procedure. Public hearings will be conducted in accordance with the rules provided in Subpart F of Part 2 of this chapter. [31 F.R. 3008, Feb. 22, 1966] § 8.22 Request for certification. A request for certification of a batch of color additive shall: (a) Be addressed to the Commissioner of Food and Drugs. (b) Be prepared in the manner set forth in paragraph (j) of this section. (c) Be submitted in duplicate. (d) Be signed by a responsible officer of the person requesting certification of the batch. In the case of a foreign manufacturer, the request for certification must be signed by a responsible officer of such firm, and, by his agent who resides in the United States. (e) Show the name and post office address of the actual manufacturer in case such manufacturer is not the person requesting certification of the batch. (f) Be accompanied by the fee prescribed in § 8.51 unless the person has established with the Food and Drug Administration an advance deposit to be used for prepayment of such fees. In no case shall the Commissioner consider a request for certification of a batch of color additive if the fee accompanying such request is less than that required by § 8.51 or if such fee exceeds the amount held in the advance deposit account of the manufacturer submitting such request for certification. (g) Be accompanied by the sample prescribed in § 8.23 consisting of: (1) Four ounces in the case of straight colors and lakes. (2) Two ounces in the case of repacks and mixtures. A sample accompanying a request for certification must be submitted under separate cover and should be addressed to the Color Certification Branch. (h) The name of a color additive shall be given in the following manner: (1) The name of a straight color shall be the name of the color as listed in Subpart C, E, or G of this part. (2) The name of a lake shall be the name derived in the manner described in Subpart B of this part. (3) The name of a mixture shall be the name given to such mixture by the person requesting certification. (4) The name of a repack shall be the name described in subparagraph (1), (2), or (3) of this paragraph, whichever is applicable. (i) The information and samples enumerated in paragraphs (a) to (h), inclusive, of this section are the minimum required. Additional information and samples shall be submitted at the request of the Food and Drug Administration when such additional information and samples are necessary to determine compliance with the requirements of § 8.27 for the issuance of a certificate. (j) The form for submission of the application shall be one of the following, depending upon whether the color additive is a straight color, a lake, a repack of a previously certified color additive, or a color additive mixture. (1) Request for certification of a batch of straight color additive. Batch manufactured by at pounds (Name and address of actual manufacturer) How stored pending certification (State conditions of storage, with kind and size of containers, location, etc.) Certification requested of this color for use in (State proposed uses) Required fee, $--- (drawn to the order of Food and Drug Administration). The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 8.23 and is accurately representative thereof. (Signed) By (Name and address of actual manufacturer) How stored pending certification (State conditions of storage, with kind and size of containers, location, etc.) Certification requested of this color for use in (State proposed uses) Required fee, $------ (drawn to the order of Food and Drug Administration). The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 8.23 and is accurately representative thereof. (Signed) By (Title) (2) Request for certification of a batch of color additive lake. (Title) (3) Request for certification of a repack of a batch of certified color additive. Date Commissioner of Food and Drugs, Washington 25, D.C. |