80 FR 46015 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 148 (August 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 148 (August 3, 2015)
| Page Range | 46015-46019 | |
| FR Document | 2015-18915 |
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)] [Notices] [Pages 46015-46019] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-18915] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0007] Generic Drug User Fee--Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2016 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), [[Page 46016]] generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. This document establishes the fee rates for FY 2016. FOR FURTHER INFORMATION CONTACT: Rachel Richter, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14216, Silver Spring, MD 20993-0002, 301-796-7111. SUPPLEMENTARY INFORMATION: I. Background Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j- 42) establish fees associated with human generic drug products. Fees are assessed on: (1) Certain applications in the backlog as of October 1, 2012 (only applicable to FY 2013); (2) certain types of applications and supplements for human generic drug products; (3) certain facilities where APIs and FDFs are produced; and (4) certain DMFs associated with human generic drug products (see section 744B(a)(1)-(4) of the FD&C Act). For FY 2016, the generic drug fee rates are: ANDA ($76,030), PAS ($38,020), DMF ($42,170), domestic API facility ($40,867), foreign API facility ($55,867), domestic FDF facility ($243,905), and foreign FDF facility ($258,905). These fees are effective on October 1, 2015, and will remain in effect through September 30, 2016. Fees for ANDA, PAS, and DMF will increase in FY 2016 over the corresponding fees in FY 2015 due to a drop in the number of submissions in each of those three categories over the course of FY 2015. The fees for all types of facilities will decrease in FY 2016 over the corresponding fees in FY 2015 due to an increase in the number of facilities that self-identified for FY 2016. II. Fee Revenue Amount for FY 2016 The base revenue amount for FY 2016 is $299 million, as set in the statute prior to the inflation adjustment. GDUFA directs FDA to use the yearly revenue amount as a starting point to set the fee rates for each fee type. For more information about GDUFA, please refer to the FDA Web site (http://www.fda.gov/gdufa). The ANDA, PAS, DMF, API facility, and FDF facility fee calculations for FY 2016 are described in this document. Inflation Adjustment GDUFA specifies that the $299 million is to be adjusted for inflation increases for FY 2016 using two separate adjustments--one for personnel compensation and benefits (PC&B) and one for non-PC&B costs (see section 744B(c)(1) of the FD&C Act). The component of the inflation adjustment for PC&B costs shall be one plus the average annual percent change in the cost of all PC&B paid per full-time equivalent position (FTE) at FDA for the first three of the four preceding fiscal years, multiplied by the proportion of PC&B costs to total FDA costs of the review of human generic drug activities for the first three of the preceding four fiscal years (see section 744B(c)(1)(A)-(B) of the FD&C Act). Table 1 summarizes the actual cost and total FTE for the specified fiscal years, and provides the percent change from the previous fiscal year and the average percent change over the first three of the four fiscal years preceding FY 2016. The 3-year average is 2.2328 percent. Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change -------------------------------------------------------------------------------------------------------------------------------------------------------- Fiscal year 2012 2013 2014 3-Year average -------------------------------------------------------------------------------------------------------------------------------------------------------- Total PC&B.......................................... $1,824,703,000 $1,927,703,000 $2,054,937,000 Total FTE........................................... 13,382 13,974 14,555 PC&B per FTE........................................ $136,355 $137,949 $141,184 % Change from Previous Year......................... 3.1843% 1.1690% 2.3451% 2.2328% -------------------------------------------------------------------------------------------------------------------------------------------------------- The statute specifies that this 2.2328 percent should be multiplied by the proportion of PC&B expended for human generic drug activities for the first three of the preceding four fiscal years. When FDA set fees in FY 2014, the 3-year average of PC&B costs for the entire Agency was used because information for GDUFA was not available. Now that the first 2 years of GDUFA have been completed, FDA will use the data from FY 2013 and FY 2014 to calculate the PC&B and non-PC&B proportions. Table 2 shows the amount of PC&B and the total amount obligated for human generic drug activities in FY 2013 and FY 2014. Table 2--PC&B as a Percent of Fee Revenues Spent on the Process of Human Generic Drug Applications Over the Last 3 Years -------------------------------------------------------------------------------------------------------------------------------------------------------- Fiscal year 2012 2013 2014 3-Year Average -------------------------------------------------------------------------------------------------------------------------------------------------------- PC&B........................................ NA............................. $117,576,760 $171,612,147 Non-PC&B.................................... NA............................. $149,307,336 $215,469,133 Total Costs................................. NA............................. $266,884,096 $387,081,279 PC&B percent................................ ............................... 44.0554% 44.3349% 44.1952% Non-PC&B percent............................ ............................... 55.9446% 55.6651% 55.8048% -------------------------------------------------------------------------------------------------------------------------------------------------------- The payroll adjustment is 2.2328 percent multiplied by 44.1952 percent (or 0.9868 percent). The statute specifies that the portion of the inflation adjustment for non-PC&B costs for FY 2016 is the average annual percent change that occurred in the Consumer Price Index (CPI) for urban consumers (Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items; annual [[Page 46017]] index) for the first three of the preceding four years of available data multiplied by the proportion of all costs other than PC&B costs to total costs of human generic drug activities (see section 744B(c)(1)(C) of the FD&C Act). Table 3 provides the summary data for the percent change in the specified CPI for the Baltimore-Washington area. The data are published by the Bureau of Labor Statistics and can be found on their Web site at http://data.bls.gov/cgi-bin/surveymost?cu by checking the box marked ``Washington-Baltimore All Items, November 1996=100-- CUURA311SA0'' and then clicking on the ``Retrieve Data'' button. Table 3--Annual and 3-Year Average Percent Change in CPI for Baltimore-Washington Area -------------------------------------------------------------------------------------------------------------------------------------------------------- Year 2012 2013 2014 3-Year average -------------------------------------------------------------------------------------------------------------------------------------------------------- Annual CPI.......................................... 150.212 152.500 154.847 ....................... Annual Percent Change............................... 2.2024% 1.5232% 1.5390% 1.754867% -------------------------------------------------------------------------------------------------------------------------------------------------------- To calculate the inflation adjustment for non-pay costs, we multiply the 3-year average percent change in the CPI (1.7549 percent) by the proportion of all costs other than PC&B to total costs of human generic drug activities obligated. Since 44.1952 percent was obligated for PC&B as shown in table 2, 55.8048 percent is the portion of costs other than PC&B. The non-pay adjustment is 1.7549 percent times 55.8048 percent, or 0.9793 percent. To complete the inflation adjustment for FY 2016, we add the PC&B component (0.9868 percent) to the non-PC&B component (0.9793 percent) for a total inflation adjustment of 1.9661 percent (rounded) for FY 2016. GDUFA provides for this inflation adjustment to be compounded after FY 2013 (see section 744B(c)(1) of the FD& C Act). This factor for FY 2016 (1.9661 percent) is compounded by adding one to it, and then multiplying it by the compounded inflation adjustment factor for FY 2015 (1.044228), as published in the Federal Register of August 1, 2014 (79 FR 44797). The result of this multiplication of the inflation factors for the 3 years since FY 2013 (1.019661 times 1.044228 percent) becomes the inflation adjustment for FY 2016. For FY 2016, the inflation adjustment is 6.4759 percent (rounded). We then add one, making 1.064759. Finally, we multiply the FY 2016 base revenue amount ($299 million) by 1.064759, yielding inflation-adjusted target revenue of $318,363,000 (rounded to the nearest thousand dollars). III. ANDA and PAS Fees Under GDUFA, the FY 2016 ANDA and PAS fees are owed by each applicant that submits an ANDA or a PAS, on or after October 1, 2015. These fees are due on the receipt date of the ANDA or PAS. Section 744B(b)(2)(B) specifies that the ANDA and PAS fees will make up 24 percent of the $318,363,000, which is $76,407,000 (rounded to the nearest thousand dollars), and further specifies that the PAS fee is equal to half the ANDA fee. In order to calculate the ANDA fee, FDA estimated the number of full application equivalents (FAEs) that will be submitted in FY 2016. This is done by assuming ANDAs count as one FAE and PASs (supplements) count as one-half an FAE since the fee for a PAS is one half of the fee for an ANDA. GDUFA also requires, however, that 75 percent of the fee paid for an ANDA or PAS filing fee be refunded if the ANDA or PAS is refused due to issues other than failure to pay fees (section 744B(a)(3)(D) of the FD&C Act). Therefore, an ANDA or PAS that is considered not to have been received by the Secretary due to reasons other than failure to pay fees counts as one-fourth of an FAE if the applicant initially paid a full application fee, or one-eighth of an FAE if the applicant paid the supplement fee (one half of the full application fee amount). FDA utilized data from ANDAs and PASs submitted from October 1, 2012, to May 31, 2015, to estimate the number of new original ANDAs and PASs that will incur filing fees in FY 2016. For FY 2016, the Agency estimates that approximately 801 new original ANDAs and 421 PASs will be submitted and incur filing fees. Not all of the new original ANDAs and PASs will be received by the Agency, and some of those not received will be resubmitted in the same fiscal year. Therefore, the Agency expects that the FAE count for ANDAs and PASs will be 1,005 for FY 2016. The FY 2016 application fee is estimated by dividing the number of FAEs that will pay the fee in FY 2016 (1,005) into the fee revenue amount to be derived from application fees in FY 2016 ($76,407,000). The result, rounded to the nearest $10, is a fee of $76,030 per ANDA. The PAS fee is one-half that amount, or $38,020, rounded to the nearest $10. The statute provides that those ANDAs that include information about the production of active pharmaceutical ingredients other than by reference to a DMF will pay an additional fee that is based on the number of such active pharmaceutical ingredients and the number of facilities proposed to produce those ingredients (see section 744B(a)(3)(F) of the FD&C Act). FDA considers that this additional fee is unlikely to be assessed often; therefore, FDA has not included projections concerning the amount of this fee in calculating the fees for ANDAs and PASs. IV. DMF Fee Under GDUFA, the DMF fee is owed by each person that owns a type II active pharmaceutical ingredient DMF that is referenced, on or after October 1, 2012, in a generic drug submission by an initial letter of authorization. This is a one-time fee for each individual DMF. This fee is due no later than the date on which the first generic drug submission is submitted that references the associated DMF. Under section 744B(a)(2)(D)(iii) of the FD&C Act, if a DMF has successfully undergone an initial completeness assessment and the fee is paid, the DMF will be placed on a publicly available list documenting DMFs available for reference. Thus, some DMF holders may choose to pay the fee prior to the date that it would otherwise be due in order to have the DMF placed on that list. In order to calculate the DMF fee, FDA assessed the volume of DMF submissions over time. The statistical forecasting methodology of power regression analysis was selected because this model showed a very good fit to the distribution of DMF submissions over time. Based on data representing the total paid DMFs from October 2012 to May 2015 and projecting a 5-year timeline (October 2012 to September 2017), FDA is estimating 453 fee-paying DMFs for FY 2016. The FY 2016 DMF fee is determined by dividing the DMF target revenue by the estimated number of fee-paying DMFs in FY 2016. Section 744B(b)(2)(A) specifies that the DMF fees will make up 6 percent of the $318,363,000, which is $19,102,000 (rounded up to the [[Page 46018]] nearest thousand dollars). Dividing the DMF revenue amount ($19,102,000) by the estimated fee-paying DMFs (453), and rounding to the nearest $10, yields a DMF fee of $42,170 for FY 2016. V. Foreign Facility Fee Differential Under GDUFA, the fee for a facility located outside the United States and its territories and possessions shall be not less than $15,000 and not more than $30,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions, as determined by the Secretary. The basis for this differential is the extra cost incurred by conducting an inspection outside the United States and its territories and possessions. For FY 2016, FDA has determined that the differential for foreign facilities will be $15,000. The differential may be adjusted in future years. VI. FDF Facility Fee Under GDUFA, the annual FDF facility fee is owed by each person that owns a facility which is identified, or intended to be identified, in at least one generic drug submission that is pending or approved to produce one or more finished dosage forms of a human generic drug. These fees are due no later than the first business day on or after October 1 of each such year. Section 744B(b)(2)(C) of the FD&C Act specifies that the FDF facility fee revenue will make up 56 percent of $318,363,000, which is $178,283,000 (rounded to the nearest thousand dollars). In order to calculate the FDF fee, FDA used data submitted by generic drug facilities through the self-identification process mandated in the GDUFA statute and specified in a Notice of Requirement published on October 2, 2012 (77 FR 60125). The total number of FDF facilities identified through self-identification was 705. Of the total facilities identified as FDF, there were 283 domestic facilities and 422 foreign facilities. The foreign facility fee differential is $15,000. In order to calculate the fee for domestic facilities, we must first subtract the fee revenue that will result from the foreign facility fee differential. We take the foreign facility differential ($15,000) and multiply it by the number of foreign facilities (422) to determine the total fees that will result from the foreign facility differential. As a result of that calculation the foreign fee differential will make up $6,330,000 of the total FDF fee revenue. Subtracting the foreign facility differential fee revenue ($6,330,000), from the total FDF facility target revenue ($178,283,000) results in a remaining fee revenue balance of $171,953,000. To determine the domestic FDF facility fee, we divide the $171,953,000 by the total number of facilities (705) which gives us a domestic FDF facility fee of $243,905. The foreign FDF facility fee is $15,000 more than the domestic FDF facility fee, or $258,905. VII. API Facility Fee Under GDUFA, the annual API facility fee is owed by each person that owns a facility which produces, or which is pending review to produce, one or more active pharmaceutical ingredients identified, or intended to be identified, in at least one generic drug submission that is pending or approved or in a Type II active pharmaceutical ingredient drug master file referenced in such generic drug submission. These fees are due no later than the first business day on or after October 1 of each such year. Section 744B(b)(2)(D) of the FD&C Act specifies that the API facility fee will make up 14 percent of $318,363,000 in fee revenue, which is $44,571,000 (rounded to the nearest thousand dollars). In order to calculate the API fee, FDA used data submitted by generic drug facilities through the self-identification process mandated in the GDUFA statute and specified in a Notice of Requirement published on October 2, 2012. The total number of API facilities identified through self-identification was 826. Of the total facilities identified as API facilities, there were 105 domestic facilities and 721 foreign facilities. The foreign facility differential is $15,000. In order to calculate the fee for domestic facilities, we must first subtract the fee revenue that will result from the foreign facility fee differential. We take the foreign facility differential ($15,000) and multiply it by the number of foreign facilities (721) to determine the total fees that will result from the foreign facility differential. As a result of that calculation, the foreign fee differential will make up $10,815,000 of the total API fee revenue. Subtracting the foreign facility differential fee revenue ($10,815,000) from the total API facility target revenue ($44,571,000) results in a remaining balance of $33,756,000. To determine the domestic API facility fee, we divide the $33,756,000 by the total number of facilities (826) which gives us a domestic API facility fee of $40,867. The foreign API facility fee is $15,000 more than the domestic API facility fee, or $55,867. VIII. Fee Schedule for FY 2016 The fee rates for FY 2016 are set out in table 4. Table 4--Fee Schedule for FY 2016 ------------------------------------------------------------------------ Fee rates for FY Fee category 2016 ------------------------------------------------------------------------ Applications: Abbreviated New Drug Application (ANDA).......... $76,030 Prior Approval Supplement (PAS) to an ANDA....... 38,020 Drug Master File (DMF)............................... 42,170 Facilities: Active Pharmaceutical Ingredient (API)--Domestic. 40,867 API--Foreign..................................... 55,867 Finished Dosage Form (FDF)--Domestic............. 243,905 FDF--Foreign..................................... 258,905 ------------------------------------------------------------------------ IX. Fee Payment Options and Procedures The new fee rates are effective October 1, 2015. To pay the ANDA, PAS, DMF, API facility, and FDF facility fee, you must complete a Generic Drug User Fee Cover Sheet, available at http://www.fda.gov/gdufa, and generate a user fee identification (ID) number. Payment must be made in U.S. currency drawn on a U.S. bank by electronic check, check, bank draft, U.S. postal money order, or wire transfer. FDA has partnered with the U.S. Department of the Treasury to utilize Pay.gov, a Web-based payment application, for online electronic [[Page 46019]] payment. The Pay.gov feature is available on the FDA Web site after completing the Generic Drug User Fee Cover Sheet and generating the user fee ID number. Please include the user fee ID number on your check, bank draft, or postal money order and make payable to the order of the Food and Drug Administration. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks are to be sent by a courier that requests a street address, the courier can deliver checks to: U.S. Bank, Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only.) Please make sure that the FDA post office box number (P.O. Box 979108) is written on the check, bank draft, or postal money order. If paying by wire transfer, please reference your unique user fee ID number when completing your transfer. The originating financial institution may charge a wire transfer fee. Please ask your financial institution about the wire transfer fee and include it with your payment to ensure that your fee is fully paid. The account information is as follows: New York Federal Reserve Bank, U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, account number: 75060099, routing number: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., Silver Spring, MD 20993-0002. The tax identification number of FDA is 53-0196965. Dated: July 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-18915 Filed 7-31-15; 8:45 am] BILLING CODE 4164-01-P
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TABLE 2—FY 2016 FEE RATES—Continued
Fee rate for
Generic new animal drug user fee category FY 2016
Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) ........................................... 116,650
Generic New Animal Drug Product Fee .............................................................................................................................................. 8,705
100 Percent Generic New Animal Drug Sponsor Fee 1 ...................................................................................................................... 83,800
75 Percent Generic New Animal Drug Sponsor Fee 1 ........................................................................................................................ 62,850
50 Percent Generic New Animal Drug Sponsor Fee 1 ........................................................................................................................ 41,900
1 An animal drug sponsor is subject to only one fee each fiscal year.
VII. Procedures for Paying FY 2016 address is for courier delivery only. If it electronically to FDA and you will be
Generic New Animal Drug User Fees you have any questions concerning able to print a copy of your cover sheet
courier delivery contact the U.S. Bank at showing your unique Payment
A. Abbreviated Application Fees and
314–418–4013. This phone number is Identification Number.
Payment Instructions
only for questions about courier Step Three—Send the payment for
The FY 2016 fee established in the delivery.) your application as described in Section
new fee schedule must be paid for an The tax identification number of FDA VII.A of this document.
abbreviated new animal drug is 53–0196965. (Note: In no case should Step Four—Please submit your
application subject to fees under the payment for the fee be submitted to application and a copy of the completed
AGDUFA that is submitted on or after FDA with the application.) Animal Generic Drug User Fee Cover
October 1, 2015. Payment must be made It is helpful if the fee arrives at the Sheet to the following address: Food
in U.S. currency from a U.S. bank by bank at least a day or two before the and Drug Administration, Center for
check, bank draft, or U.S. postal money abbreviated application arrives at FDA’s Veterinary Medicine, Document Control
order payable to the order of the Food Center for Veterinary Medicine (CVM). Unit (HFV–199), 7500 Standish Pl.,
and Drug Administration, by wire FDA records the official abbreviated Rockville, MD 20855.
transfer, or by automatic clearing house application receipt date as the later of
C. Product and Sponsor Fees
using Pay.gov. (The Pay.gov payment the following: The date the application
option is available to you after you was received by CVM, or the date U.S. By December 31, 2015, FDA will issue
submit a cover sheet. Click the ‘‘Pay Bank notifies FDA that your payment in invoices and payment instructions for
Now’’ button). On your check, bank the full amount has been received, or product and sponsor fees for FY 2016
draft, U.S. or postal money order, please when the U.S. Department of the using this fee schedule. Fees will be due
write your application’s unique Treasury notifies FDA of payment. U.S. by January 31, 2016. FDA will issue
Payment Identification Number, Bank and the United States Treasury are invoices in November 2016 for any
beginning with the letters ‘‘AG’’, from required to notify FDA within 1 working products and sponsors subject to fees for
the upper right-hand corner of your day, using the Payment Identification FY 2016 that qualify for fees after the
completed Animal Generic Drug User Number described previously. December 2015 billing.
Fee Cover Sheet. Also write the FDA Dated: July 28, 2015.
post office box number (P.O. Box B. Application Cover Sheet Procedures
Leslie Kux,
953877) on the enclosed check, bank Step One—Create a user account and
Associate Commissioner for Policy.
draft, or money order. Your payment password. Log onto the AGDUFA Web
[FR Doc. 2015–18909 Filed 7–31–15; 8:45 am]
and a copy of the completed Animal site at http://www.fda.gov/ForIndustry/
BILLING CODE 4164–01–P
Generic Drug User Fee Cover Sheet can UserFees/AnimalGenericDrugUserFee
be mailed to: Food and Drug ActAGDUFA/ucm137049.htm and scroll
Administration, P.O. Box 979033, St. down the page until you find the link
DEPARTMENT OF HEALTH AND
Louis, MO 63197–9000. ‘‘Create AGDUFA User Fee Cover
HUMAN SERVICES
If payment is made via wire transfer, Sheet.’’ Click on that link and follow the
send payment to U. S. Department of the directions. For security reasons, each Food and Drug Administration
Treasury, TREAS NYC, 33 Liberty St., firm submitting an application will be
New York, NY 10045, Account Name: assigned an organization identification [Docket No. FDA–2015–N–0007]
Food and Drug Administration, Account number, and each user will also be
Generic Drug User Fee—Abbreviated
No.: 75060099, Routing No.: 021030004, required to set up a user account and
New Drug Application, Prior Approval
Swift No.: FRNYUS33, Beneficiary: password the first time you use this site.
Supplement, Drug Master File, Final
FDA, 8455 Colesville Rd., Silver Spring, Online instructions will walk you
Dosage Form Facility, and Active
MD 20993–0002. You are responsible through this process.
Pharmaceutical Ingredient Facility Fee
for any administrative costs associated Step Two—Create an Animal Generic
Rates for Fiscal Year 2016
with the processing of a wire transfer. Drug User Fee Cover Sheet, transmit it
Contact your bank or financial to FDA, and print a copy. After logging AGENCY: Food and Drug Administration,
institution about the fee and add it to into your account with your user name HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
your payment to ensure that your fee is and password, complete the steps ACTION: Notice.
fully paid. required to create an Animal Generic
If you prefer to send a check by a Drug User Fee Cover Sheet. One cover SUMMARY: The Food and Drug
courier, the courier may deliver the sheet is needed for each abbreviated Administration (FDA) is announcing the
check and printed copy of the cover animal drug application. Once you are rates for abbreviated new drug
sheet to: U.S. Bank, Attn: Government satisfied that the data on the cover sheet applications (ANDAs), prior approval
Lockbox 979033, 1005 Convention is accurate and you have finalized the supplements to an approved ANDA
Plaza, St. Louis, MO 63101. (Note: This cover sheet, you will be able to transmit (PASs), drug master files (DMFs),
VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1](https://thefederalregister.org/doc/80_FR_46163/page/1.svg)
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payment. The Pay.gov feature is guidance for industry entitled I. Background
available on the FDA Web site after ‘‘Dissolution Testing and Specification FDA is announcing the availability of
completing the Generic Drug User Fee Criteria for Immediate-Release Solid a draft guidance for industry entitled
Cover Sheet and generating the user fee Oral Dosage Forms Containing ‘‘Dissolution Testing and Specification
ID number. Biopharmaceutics Classification System Criteria for Immediate-Release Solid
Please include the user fee ID number Class 1 and 3 Drugs.’’ This draft Oral Dosage Forms Containing
on your check, bank draft, or postal guidance has been developed to provide Biopharmaceutics Classification System
money order and make payable to the manufacturers with recommendations Class 1 and 3 Drugs.’’ Drug absorption
order of the Food and Drug for submission of new drug applications from a solid dosage form after oral
Administration. Your payment can be (NDAs), investigational new drug administration depends on the release
mailed to: Food and Drug applications (INDs), and/or abbreviated of the drug substance from the drug
Administration, P.O. Box 979108, St. new drug applications (ANDAs), as product, the dissolution or
Louis, MO 63197–9000. If checks are to appropriate, for immediate-release (IR) solubilization of the drug under
be sent by a courier that requests a street tablets and capsules that contain highly physiological conditions, and the
address, the courier can deliver checks soluble drug substances. The draft permeation across the gastrointestinal
to: U.S. Bank, Attention: Government guidance is intended to define when a membrane. NDAs and ANDAs
Lockbox 979108, 1005 Convention standard release test and criteria may be submitted to FDA contain
Plaza, St. Louis, MO 63101. (Note: This used in lieu of extensive method bioavailability (BA) or bioequivalence
U.S. Bank address is for courier delivery development and specification-setting (BE) data and in vitro dissolution data
only.) Please make sure that the FDA exercises. When final, this guidance will that, together with chemistry,
post office box number (P.O. Box supersede the guidance for industry on manufacturing, and controls (CMC)
979108) is written on the check, bank ‘‘Dissolution Testing of Immediate data, characterize the quality and
draft, or postal money order. Release Solid Oral Dosage Forms’’ performance of the drug product. In
If paying by wire transfer, please (August 1997) for biopharmaceutics vitro dissolution data are generally
reference your unique user fee ID classification system (BCS) class 1 and obtained from batches that have been
number when completing your transfer. 3 drug substances that meet the criteria used in pivotal clinical and/or
The originating financial institution in this draft guidance. For class 2 and bioavailability studies and from other
may charge a wire transfer fee. Please 4 drug substances, applicants should human studies conducted during
ask your financial institution about the still refer to the August 1997 guidance product development. Knowledge about
wire transfer fee and include it with mentioned previously. the solubility, permeability, dissolution,
your payment to ensure that your fee is
DATES: Although you can comment on and pharmacokinetics of a drug product
fully paid. The account information is
any guidance at any time (see 21 CFR is considered when defining dissolution
as follows: New York Federal Reserve
10.115(g)(5)), to ensure that the Agency test specifications for the drug approval
Bank, U.S. Department of Treasury,
considers your comment on this draft process.
TREAS NYC, 33 Liberty St., New York,
guidance before it begins work on the The BCS is a scientific framework for
NY 10045, account number: 75060099,
final version of the guidance, submit classifying drug substances based on
routing number: 021030004, SWIFT:
either electronic or written comments their aqueous solubility and intestinal
FRNYUS33, Beneficiary: FDA, 8455
on the draft guidance by October 2, permeability. The definitions of high
Colesville Rd., Silver Spring, MD
2015. and low solubility and high and low
20993–0002. The tax identification
permeability are used as described in
number of FDA is 53–0196965.
ADDRESSES: Submit written requests for FDA’s Biopharmaceutics Classification
Dated: July 28, 2015. single copies of the draft guidance to the System (BCS) Guidance. The different
Leslie Kux, Division of Drug Information, Center for classifications are:
Associate Commissioner for Policy. Drug Evaluation and Research, Food Class 1: High Solubility—High
[FR Doc. 2015–18915 Filed 7–31–15; 8:45 am] and Drug Administration, 10001 New Permeability Drugs
BILLING CODE 4164–01–P Hampshire Ave., Hillandale Building, Class 2: Low Solubility—High
4th Floor, Silver Spring, MD 20993– Permeability Drugs
0002. Send one self-addressed adhesive Class 3: High Solubility—Low
DEPARTMENT OF HEALTH AND label to assist that office in processing Permeability Drugs
HUMAN SERVICES your requests. See the SUPPLEMENTARY Class 4: Low Solubility—Low
INFORMATION section for electronic Permeability Drugs
Food and Drug Administration access to the draft guidance document.
This classification can be used as a
[Docket No. FDA–1997–D–0187] Submit electronic comments on the basis for determining when in vivo
draft guidance to http:// bioavailability and bioequivalence
Dissolution Testing and Specification www.regulations.gov. Submit written studies are needed and can be used to
Criteria for Immediate-Release Solid comments to the Division of Dockets determine when a successful in vivo-in
Oral Dosage Forms Containing Management (HFA–305), Food and Drug vitro correlation (IVIVC) is likely. The
Biopharmaceutics Classification Administration, 5630 Fishers Lane, Rm. BCS suggests that, for certain high
System Class 1 and 3 Drugs; Draft 1061, Rockville, MD 20852. solubility drugs, dissolution testing can
Guidance for Industry; Availability
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
be standardized or may not be needed.
AGENCY: Food and Drug Administration, Richard Lostritto, Center for Drug Owing to their high solubility, BCS class
HHS. 1 and 3 drugs are considered to be
Evaluation and Research, Food and
ACTION: Notice. relatively low risk regarding the impact
Drug Administration, 10903 New
of dissolution on performance, provided
Hampshire Avenue, Silver Spring, MD
SUMMARY: The Food and Drug the in vitro performance meets or
20993, 301–796–1667.
Administration (FDA or Agency) is exceeds the recommendations discussed
announcing the availability of a draft SUPPLEMENTARY INFORMATION: in the guidance.
VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1](https://thefederalregister.org/doc/80_FR_46163/page/5.svg)
Document Created: 2018-02-23 10:51:49
Document Modified: 2018-02-23 10:51:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Rachel Richter, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14216, Silver Spring, MD 20993-0002, 301-796-7111. | |
| FR Citation | 80 FR 46015 |
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