§70.19 着色剂列入名单的费用(Fees for listing)

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   　　§ 70.19   Fees for listing.

　　（a） Each petition for the listing of a color additive shall be accompanied by a deposit of $3,000.00 if the proposal is for listing the color additive for use generally in or on foods, in or on drugs, and in or on cosmetics.

　　（b） If the petition for the listing is for use in or on foods only, the deposit shall be $3,000.00.

　　（c） If the petition for the listing is for use in or on drugs and/or cosmetics only, the deposit shall be $2,600.00.

　　（d） The provisions of paragraphs （a）, （b）, and （c） of this section shall be applicable, whether or not the proposal contemplates any tolerances, limitations, or other restrictions placed upon the use of the color additive.

　　（e） If a petition proposing the issuance of a regulation is withdrawn before it is finally accepted for filing, the deposit, less a $600.00 fee for clerical handling and administrative and technical review, shall be returned to the petitioner.

　　（f） If a petition proposing the issuance of a regulation is withdrawn within 30 days after filing, the deposit, less $1,800.00 if the petition is covered by paragraph （a） or （b） of this section, and less $1,600.00, if the petition is covered by paragraph （c） of this section, shall be returned to the petitioner.

　　（g） When a petition is withdrawn after filing and resubmitted within 6 months, it shall be accompanied by a deposit of $1,800.00 for a petition filed under paragraph （a） or （b） of this section, and $1,600.00 for a petition filed under paragraph （c） of this section. If a petition is resubmitted after 6 months, it shall be accompanied by the deposit that would be required if it were being submitted for the first time.

　　（h） When the resubmission pertains to a petition that had been withdrawn before acceptance for filing, a new advance deposit shall be made in full as prescribed in paragraph （a）, （b）, or （c） of this section.

　　（i） After a color additive has been listed, any request for an amendment or additional tolerance shall be accompanied by a deposit of $1,800.00 for use in the items specified in paragraphs （a） and （b） of this section, or $1,600.00 for use in items specified in paragraph （c） of this section.

　　（j） The fee for services in listing a diluent under §80.35 for use in color additive mixtures shall be $250.00.

　　（k） Objections and request for public hearing under section 721（d） of the act or section 203（d）（2）（C） of Pub. L. 86–618 （74 Stat. 404; 21 U.S.C. 379e, note） shall be accompanied by a filing fee of $250.00.

　　（l） In the event of a referral of a petition under this section to an advisory committee, all costs related thereto （including personal compensation of committee members, travel materials, and other costs） shall be borne by the person or organization requesting the referral, such costs to be assessed on the basis of actual cost to the Government: Provided, That the compensation of such costs shall include personal compensation of advisory committee members at a rate not to exceed $75.00 per member per day.

　　（m） In the case of requests of referrals to advisory committees, a special advance deposit shall be made in the amount of $2,500.00. Where required, further advance in increments of $2,500.00 each shall be made upon request of the Commissioner of Food and Drugs. All deposits for referrals to advisory committees in excess of actual expenses shall be refunded to the depositor.

　　（n） All requests for pharmacological or other scientific studies shall be accompanied by an advance deposit of $5,000.00. Further advance deposits shall be made upon request of the Commissioner of Food and Drugs when necessary to prevent arrears in such cost. Any deposits in excess of actual expenses will be refunded to the depositor. If a request is denied the advance deposit will be refunded less such costs as are incurred for review of the request.

　　（o） The person who files a petition for judicial review of an order under section 721（d） of the act shall pay the costs of preparing a transcript of the record on which the order is based.

　　（p） All deposits and fees required by the regulations in this section shall be paid by money order, bank draft or certified check drawn to the order of the Food and Drug Administration, collectable at par at Washington, DC All deposits and fees shall be forwarded to the Center for Food Safety and Applied Nutrition （HFS–200）, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, whereupon after making appropriate record thereof they will be transmitted to the Treasurer of the United States for deposit in the special account “Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration.”

　　（q） The Commissioner of Food and Drugs may waive or refund such fees in whole or in part when in his judgment such action will promote the public interest.

　　（r） Any person who believes that payment of these fees will work a hardship on him may petition the Commissioner of Food and Drugs to waive or refund the fees.

　　[42 FR 15636, Mar. 22, 1977, as amended at 54 FR 24890, June 12, 1989; 61 FR 14478, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]

　　§70.19　列入名单的费用

　　（a）如申请书是要将着色剂列入用于或用在食品、药品和化妆品的名单中，则每一种着色剂列入名单的申请应预付定金3000美元。

　　（b）如该项申请只是将着色剂列入用于或用在食品的名单中，应预付定金3000美元。

　　（c）如该项申请是将着色剂列入用于或用在药品和?或化妆品的名单中，应预付定金2600美元。

　　（d）提案中对该着色剂的使用无论有或没有容许使用量、限度或其它限制条件，本节（a）、（b）和（c）的条款均应被接受。

　　（e）如果提交的一项颁布着色剂规定的申请书在其最终接受存档之前被退回，则所预付的定金在扣除文书处理、管理工作和技术综合所需的费用600美元后，余款退还给申请人。

　　（f）如果提交的一项颁布着色剂规定的申请书在其被存档后30d内撤回，则所预付的定金在申请包含本节（a）或（b）的内容时，扣除1800美元；在申请包含本节（c）的内容时，扣除1600美元，余款退还给申请人。

　　（g）如果提交的一项颁布着色剂规定的申请书在存档后撤回，并在6个月内又重新提交，则若存档申请包含本节（a）和（b）的内容时，应预付定金1800美元；若存档申请包含本节（c）的内容时，应预付定金1600美元。如果一项申请在6个月后重新提交，即使其内容与第一次提交的相同，也应预付定金。

　　（h）在重新提交的提案从属于以前已受理并存档但又撤回的申请，应当按照本节（a）、（b）或（c）段的内容要求另预付新的定金。

　　（i）在一种着色剂已经被列入名单后，任何修订或追加容许量内容的请求，均应按照本节（a）和（b）的内容预付1800美元，或按照本节（c）的规定预付1600美元的定金。

　　（j）在§80.35内容中供着色剂混合物使用的稀释剂列入名单的服务费是250美元。

　　（k）根据本法规721（d）节或公法（Pub.L.86-618）的203（d）（2）（c）节内容，反对（某提案）并请求公开听证的应当付250美元存档费。

　　（l）在本节内容下的一项申请提交给咨询委员会论证的情况下，所有发生的相关费用（包括委员会成员的个人报酬、旅行费用以及其它费用）应当由请求论证的个人或组织承担，这类费用的数额估价依据政府提供的费用标准。其中的报酬应当包括咨询委员会成员个人的报酬，以每天每人不超过75美元计算。

　　（m）在向咨询委员会请求论证的情况下，应预付一笔数额为2500美元的专门定金。在必要的情况下，还要应食品与药物专员的要求再预付一笔2500美元的定金。所付全部定金若超过实际支出的费用，则超出部分应返还支付定金的人。

　　（n）所有提出有关进行药理或其它科学研究请求的，要预付定金5000美元，另外的预付款要根据食品与药品专员的要求支付，以防出现这笔费用透支。所有超出实际费用的预付定金，均要返还给定金支付人。

　　（o）对法规721（d）中某项条款要求做出评审性意见的人，应该为该项条款的记录制作正式文本支付费用。

　　（p）所有由本节规定所要求的定金和费用应当以汇票、银行转账或支票支付给食品与药物管理局，在华盛顿特区以等面值收款。所有的定金和付费应寄往：

　　单位：the Center for Food Safety and Applied Nutrition （HFS-200） Food and Drug Administration

　　地址：5100 Paint Branck Pkwy., College Park, MD 20740.

　　在收到款项再做出适当记录后，它们将被转到财政部的专用存款账号：

　　Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration

　　（q）食品与药物专员在他判定此项举措将会改进公众利益时，可以全额或部分免除或返还有关费用。

　　（r）任何认为自己难以支付有关费用的申请人，可向食品与药物专员提出免除或返还有关费用。