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§ 70.19 Fees for listing.
?。╝） 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.
?。╞） 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（e） If a petition proposing the issuance of a regulation is withdrawn before it is finally accepted for filing, the deposit, less a $600.00 fee for clerical handling and administrative and technical review, shall be returned to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（f） If a petition proposing the issuance of a regulation is withdrawn within 30 days after filing, the deposit, less $1,800.00 if the petition is covered by paragraph （a） or （b） of this section, and less $1,600.00, if the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.
?。╣） When a petition is withdrawn after filing and resubmitted within 6 months, it shall be accompanied by a deposit of $1,800.00 for a petition filed under paragraph （a） or （b） of this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（h） When the resubmission pertains to a petition that had been withdrawn before acceptance for filing, a new advance deposit shall be made in full as prescribed in paragraph （a）, （b）, or （c） of this section.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.
?。╦） 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.
?。╨） 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.
?。╬） 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.”
?。╭） 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.
?。╮） 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 列入名單的費用
?。╝）如申請書是要將著色劑列入用于或用在食品、藥品和化妝品的名單中，則每一種著色劑列入名單的申請應預付定金3000美元。
?。╞）如該項申請只是將著色劑列入用于或用在食品的名單中，應預付定金3000美元。
?。╟）如該項申請是將著色劑列入用于或用在藥品和?或化妝品的名單中，應預付定金2600美元。
?。╠）提案中對該著色劑的使用無論有或沒有容許使用量、限度或其它限制條件，本節(jié)（a）、（b）和（c）的條款均應被接受。
?。╡）如果提交的一項頒布著色劑規(guī)定的申請書在其最終接受存檔之前被退回，則所預付的定金在扣除文書處理、管理工作和技術(shù)綜合所需的費用600美元后，余款退還給申請人。
（f）如果提交的一項頒布著色劑規(guī)定的申請書在其被存檔后30d內(nèi)撤回，則所預付的定金在申請包含本節(jié)（a）或（b）的內(nèi)容時，扣除1800美元；在申請包含本節(jié)（c）的內(nèi)容時，扣除1600美元，余款退還給申請人。
（g）如果提交的一項頒布著色劑規(guī)定的申請書在存檔后撤回，并在6個月內(nèi)又重新提交，則若存檔申請包含本節(jié)（a）和（b）的內(nèi)容時，應預付定金1800美元；若存檔申請包含本節(jié)（c）的內(nèi)容時，應預付定金1600美元。如果一項申請在6個月后重新提交，即使其內(nèi)容與第一次提交的相同，也應預付定金。
?。╤）在重新提交的提案從屬于以前已受理并存檔但又撤回的申請，應當按照本節(jié)（a）、（b）或（c）段的內(nèi)容要求另預付新的定金。
（i）在一種著色劑已經(jīng)被列入名單后，任何修訂或追加容許量內(nèi)容的請求，均應按照本節(jié)（a）和（b）的內(nèi)容預付1800美元，或按照本節(jié)（c）的規(guī)定預付1600美元的定金。
?。╦）在§80.35內(nèi)容中供著色劑混合物使用的稀釋劑列入名單的服務費是250美元。
?。╧）根據(jù)本法規(guī)721（d）節(jié)或公法（Pub.L.86-618）的203（d）（2）（c）節(jié)內(nèi)容，反對（某提案）并請求公開聽證的應當付250美元存檔費。
（l）在本節(jié)內(nèi)容下的一項申請?zhí)峤唤o咨詢委員會論證的情況下，所有發(fā)生的相關(guān)費用（包括委員會成員的個人報酬、旅行費用以及其它費用）應當由請求論證的個人或組織承擔，這類費用的數(shù)額估價依據(jù)政府提供的費用標準。其中的報酬應當包括咨詢委員會成員個人的報酬，以每天每人不超過75美元計算。
?。╩）在向咨詢委員會請求論證的情況下，應預付一筆數(shù)額為2500美元的專門定金。在必要的情況下，還要應食品與藥物專員的要求再預付一筆2500美元的定金。所付全部定金若超過實際支出的費用，則超出部分應返還支付定金的人。
?。╪）所有提出有關(guān)進行藥理或其它科學研究請求的，要預付定金5000美元，另外的預付款要根據(jù)食品與藥品專員的要求支付，以防出現(xiàn)這筆費用透支。所有超出實際費用的預付定金，均要返還給定金支付人。
?。╫）對法規(guī)721（d）中某項條款要求做出評審性意見的人，應該為該項條款的記錄制作正式文本支付費用。
（p）所有由本節(jié)規(guī)定所要求的定金和費用應當以匯票、銀行轉(zhuǎn)賬或支票支付給食品與藥物管理局，在華盛頓特區(qū)以等面值收款。所有的定金和付費應寄往：
單位：the Center for Food Safety and Applied Nutrition （HFS-200） Food and Drug Administration
地址：5100 Paint Branck Pkwy., College Park, MD 20740.
在收到款項再做出適當記錄后，它們將被轉(zhuǎn)到財政部的專用存款賬號：
Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration
?。╭）食品與藥物專員在他判定此項舉措將會改進公眾利益時，可以全額或部分免除或返還有關(guān)費用。
?。╮）任何認為自己難以支付有關(guān)費用的申請人，可向食品與藥物專員提出免除或返還有關(guān)費用。
