§ 431.53 - Fees.

(a) Fees for the services rendered under the regulations in this chapter shall be such as are necessary to provide, equip, and maintain an adequate certification service.

(b) The fee for such services with respect to each batch of a drug, certification of which is provided by the regulations in this chapter, shall be $114 for each batch submitted, plus the sum of the fees for all individual tests required for certification of each batch. The minimum tests for each batch shall be those prescribed in the section relating specifically to such drug.

(1) The fee schedule for specific tests required for antibiotic drug certification is as follows:

Chargeable Fee Per TestArquad content $20Benzylpenicilloyl content 32Bleomycin 1,291Butanol content 52Candicidin potency (special turbidimetric) 85Capreomycin 1 content 121Color identity 8Column chromatography 130Column chromatographic isomer content 65Copper content 22Crystallinity 4Cycloserine color assay 27Daunorubicin potency (special turbidimetric) 19Depressor substance test 40Disc potency 52Dissolution test 107Doxycycline purity (paper chromatography) 130Free chloride 54Frozen antibiotic test panel 32Gas chromatography 32Gentamicin C 165Heavy metals test 14High pressure liquid chromatography (HPLC) 54Infrared identity 19Infrared quantitative 19Iodochlorhydroxyquin content 22Isoniazid content 22Karl Fischer moisture 8LD50toxicity185Loss on drying 12Lysine content 161Melting range 8Metal particles (ophthalmic ointments) 22Microbiological assay, plate 50Microbiological assay, turbidimetric 29 Microorganism count 68Nonaqueous titrations (and compleximetric) 22Paper chromatographic identity 43Penicillenate and penamaldate content 30Penicillin chemical assay 15Penicillin contamination 39Penicillin G content 32pH 4Polarographic assay 33Potency (special plate) 91Probenecid content 32Procaine colorimetric 8Pyrogens test: 3 rabbits 72Pyrogens test: 8 rabbits 144Quantitative thin layer chromatography 80Residual streptomycin 8Residue on ignition 26Solubility identification 54Specific rotation 22Specific rotation (potency quantitative) 44Specific surface area 22Sterility test 68Sulfate content 8Tablet disintegration 5Thin layer chromatographic identity 43Total Chlorine 54Ultraviolet absorptivity 32Ultraviolet identity 32Ultraviolet potency 32Vancomycin identity (bioautograph) 117Zinc titration 11

(2) The fee for a supplemental request submitted pursuant to the provisions of § 433.12 of this chapter shall be $50.

(3) [Reserved]

(4) In the case of persons using the certification services and whose manufacturing facilities are not located in the United States or the Commonwealth of Puerto Rico, such persons shall be required to deposit each year sufficient funds to cover costs encountered when their facilities are inspected pursuant to the provisions of section 704 of the act.

(c) When the Commissioner considers it necessary to make investigations of a new product containing a certifiable antibiotic drug on which a request has been submitted in accordance with § 431.17, the fee for such service shall be the cost thereof. In such case the request shall be followed by an advance deposit in such amount as the Commissioner specifies, and thereafter such additional advance deposits shall be made as the Commissioner estimates may be necessary to prevent arrears in the payment of such fee.

(d) A person requiring continuing certification services may maintain an advance deposit of the estimated cost of such services for a two-month period. Such deposit shall be debited with fees for services rendered, but shall not be debited for any fee the amount of which is not definitely specified in the regulations in this chapter unless the depositor has previously requested the performance of the services to be covered by such fee. A monthly statement for each such advance deposit shall be rendered.

(e) The fees for the services rendered with respect to each batch certified under the regulations in this chapter shall accompany the request for certification, or the request for check tests and assays, unless such fee is covered by an advance deposit maintained in accordance with paragraph (d) of this section. Also, if the Commissioner considers that investigations other than examination of such samples are necessary to determine whether or not such batch complies with the requirements of § 431.10 for the issuance of a certificate, the fee shall include the cost of such investigations.

(f) The unearned portion of any advance deposit shall be refunded to the depositor upon his application.

(g) Whenever in the judgment of the Commissioner the ratio between fees collected (which are based upon experience and the best estimate of costs and the best estimate of earnings) and the costs of providing the service during an elapsed period of time, in the light of all circumstances and contingencies, warrants a refund from the fund collected during such period, he shall make ratable refunds to those persons to whom the services were rendered and charged, except for those services described under § 433.12 of this chapter.

(h) All deposits and fees required by the regulations in this chapter, shall be paid by money order, bank draft, or certified check drawn to the order of the Food and Drug Administration, collectible at par at Washington, DC. All such deposits and fees shall be forwarded to the Food and Drug Administration, Department of Health and Human Services, Accounting Branch (HFA-120), 5600 Fishers Lane, Rockville, MD 20857, whereupon after making appropriate records thereof they will be transmitted to the Chief Disbursing Officer, Division of Disbursement, Treasurer of the United States, for deposit to the special account “Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration.”