Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee Rates for Fiscal Year 2013, 3900-3901 [2013-00851]

Download as PDF pmangrum on DSK3VPTVN1PROD with 3900 Federal Register / Vol. 78, No. 12 / Thursday, January 17, 2013 / Notices a form that can help them make the most of their benefits and options The activities under this clearance involve social marketing and consumer research using samples of self-selected customers, as well as convenience samples, and quota samples, with respondents selected either to cover a broad range of customers or to include specific characteristics related to certain products or services. All collection of information under this clearance will utilize a subset of items drawn from a core collection of customizable items referred to as the Social Marketing and Consumer Testing Item Bank. This item bank is designed to establish a set of pre-approved generic question that can be drawn upon to allow for the rapid turn-around consumer testing required for CMS to communicate more effectively with its audiences. The questions in the item bank are divided into two major categories. One set focuses on characteristics of individuals and is intended primarily for participant screening and for use in structured quantitative on-line or telephone surveys. The other set is less structured and is designed for use in qualitative one-on-one and small group discussions or collecting information related to subjective impressions of test materials. A Study Initiation Request Form detailing each specific study (description, methodology, estimated burden) conducted under this clearance will be submitted before any testing is initialed. Results will be compiled and disseminated so that future communication can be informed by the testing results. We will use the findings to create the greatest possible public benefit. Form Number: CMS–10437 (OCN: 0938–New); Frequency: Yearly; Affected Public: Individuals. Number of Respondents: 41,592. Number of Responses: 28,800. Total Annual Hours: 21,488. (For policy questions regarding this collection contact Chris Koepke at 410–786–5877. For all other issues call 410–786–1326.) To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web Site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must VerDate Mar<15>2010 14:19 Jan 16, 2013 Jkt 229001 be submitted in one of the following ways by March 18, 2013: 1. Electronically. You may submit your comments electronically to http:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ___, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: January 11, 2013. Martique Jones, Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2013–00860 Filed 1–16–13; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0007] Generic Drug User Fee—Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee Rates for Fiscal Year 2013 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the rate for the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), enacted the Food and Drug Administration Safety and Innovation Act, as further amended by the FDA User Fee Corrections Act of 2012, authorizes FDA to assess and collect user fees for certain applications and supplements associated with human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on Type II API drug master files (DMF) to be made available for reference. GDUFA directs FDA to establish each year the generic drug user fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate SUMMARY: PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the fiscal year. This document establishes the FY 2013 rate for API and FDF facility fees. These fees are due on March 4, 2013. FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial Management (HFA–100), Food and Drug Administration, 1350 Piccard Dr., PI50, Rm. 210J, Rockville, MD 20850, 301– 796–7103. SUPPLEMENTARY INFORMATION: I. Background Sections 744A and 744B of the FD&C Act, as added by GDUFA (21 U.S.C. 379j–41 and 379j–42), establish user fees associated with human generic drug products. Fees are assessed on: (1) Certain applications in the backlog as of October 1, 2012; (2) certain types of applications and supplements associated with human generic drug products; (3) certain facilities where human generic drug APIs and FDFs are produced; and (4) certain Type II API DMFs associated with human generic drug products. This notice focuses on the API and FDF facility fees. II. Fee Revenue Amount for FY 2013 The total fee revenue amount for FY 2013 is $299,000,000, as set in the statute. GDUFA directs FDA to use the yearly revenue amount as a starting point to set the fees. GDUFA states that the backlog fee will make up $50,000,000 of the total revenue collected for FY 2013. Therefore, the rest of the fees will make up a percentage of the remaining $249,000,000 of the total fee revenue. For more information about GDUFA, please refer to the FDA Web site (http://www.fda.gov/gdufa). The API and FDF facility fee calculations for FY 2013 are described in this document. III. Foreign 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 2013 FDA has determined that the differential for foreign facilities will be $15,000. The differential may be adjusted in future years. E:\FR\FM\17JAN1.SGM 17JAN1 Federal Register / Vol. 78, No. 12 / Thursday, January 17, 2013 / Notices IV. 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 the human generic drug. These fees are due no later than 45 days after the publication of this notice. Section 744B(b)(2)(C) of the FD&C Act specifies that the FDF facility fee revenue will make up 56 percent of the remaining $249,000,000, which is $139,440,000. In order to calculate the FDF fee, FDA has used the data submitted by generic drug facilities through the selfidentification process mandated in the GDUFA statute and specified in a Notice of Requirement published on October 2, 2012. The total number of FDF facilities identified through self-identification was 758. Of the total facilities identified as FDF, there were 325 domestic facilities and 433 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 (433) 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 $6,495,000 of the total FDF fee revenue. Subtracting the foreign facility differential fee revenue ($6,495,000) from the total FDF facility target revenue ($139,440,000) results in a remaining fee revenue balance of $132,945,000. To determine the domestic FDF facility fee, we divide the $132,945,000 by the total number of facilities (758) which gives us a domestic FDF facility fee of $175,389. The foreign FDF facility fee is $15,000 more than the domestic FDF facility fee, or $190,389. pmangrum on DSK3VPTVN1PROD with V. 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 45 days after the publication of this notice. Section 744B(b)(2)(D) of the FD&C Act specifies that the API facility fee will make up 14 VerDate Mar<15>2010 14:19 Jan 16, 2013 Jkt 229001 percent of the remaining $249,000,000 fee revenue, which is $34,860,000. In order to calculate the API fee, FDA has used the data submitted by generic drug facilities through the selfidentification process. Of the total facilities identified as API, there were 122 domestic facilities and 763 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 (763) 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 $11,445,000 of the total API fee revenue. Subtracting the foreign facility differential fee revenue ($11,445,000) from the total API facility target revenue ($34,860,000) results in a remaining balance of $23,415,000. To determine the domestic API facility fee, we divide the $23,415,000 by the total number of facilities (885) which gives us a domestic API facility fee of $26,458. The foreign API facility fee is $15,000 more than the domestic API facility fee, or $41,458. VI. Fee Payment Options and Procedures To make a payment of the facility fee, you must complete a Generic Drug User Fee Cover Sheet, available on the FDA Web site (http://www.fda.gov/gdufa) and generate a user fee payment 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 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 payment ID number. Please include the user fee payment 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 the checks to: U.S. Bank, Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 3901 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 the user fee payment 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 facility 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, 1350 Piccard Dr., Rockville, MD, 20850. The tax identification number of the Food and Drug Administration is 53– 0196965. Dated: January 11, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–00851 Filed 1–16–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Program Project Meeting II. Date: February 4–5, 2013. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Majed M. Hamawy, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, E:\FR\FM\17JAN1.SGM 17JAN1

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[Federal Register Volume 78, Number 12 (Thursday, January 17, 2013)]
[Notices]
[Pages 3900-3901]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0007]


Generic Drug User Fee--Active Pharmaceutical Ingredient and 
Finished Dosage Form Facility Fee Rates for Fiscal Year 2013

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the rate 
for the generic drug active pharmaceutical ingredient (API) and 
finished dosage form (FDF) facilities user fees for fiscal year (FY) 
2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as 
amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), 
enacted the Food and Drug Administration Safety and Innovation Act, as 
further amended by the FDA User Fee Corrections Act of 2012, authorizes 
FDA to assess and collect user fees for certain applications and 
supplements associated with human generic drug products, on 
applications in the backlog as of October 1, 2012, on finished dosage 
form (FDF) and active pharmaceutical ingredient (API) facilities, and 
on Type II API drug master files (DMF) to be made available for 
reference. GDUFA directs FDA to establish each year the generic drug 
user fee rates for the upcoming year. In the first year of GDUFA (FY 
2013), some rates will be published in separate Federal Register 
notices because of the timing specified in the statute. Each year 
thereafter the GDUFA fee rates will be published 60 days before the 
start of the fiscal year. This document establishes the FY 2013 rate 
for API and FDF facility fees. These fees are due on March 4, 2013.

FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial 
Management (HFA-100), Food and Drug Administration, 1350 Piccard Dr., 
PI50, Rm. 210J, Rockville, MD 20850, 301-796-7103.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744A and 744B of the FD&C Act, as added by GDUFA (21 
U.S.C. 379j-41 and 379j-42), establish user fees associated with human 
generic drug products. Fees are assessed on: (1) Certain applications 
in the backlog as of October 1, 2012; (2) certain types of applications 
and supplements associated with human generic drug products; (3) 
certain facilities where human generic drug APIs and FDFs are produced; 
and (4) certain Type II API DMFs associated with human generic drug 
products. This notice focuses on the API and FDF facility fees.

II. Fee Revenue Amount for FY 2013

    The total fee revenue amount for FY 2013 is $299,000,000, as set in 
the statute. GDUFA directs FDA to use the yearly revenue amount as a 
starting point to set the fees. GDUFA states that the backlog fee will 
make up $50,000,000 of the total revenue collected for FY 2013. 
Therefore, the rest of the fees will make up a percentage of the 
remaining $249,000,000 of the total fee revenue. For more information 
about GDUFA, please refer to the FDA Web site (http://www.fda.gov/gdufa). The API and FDF facility fee calculations for FY 2013 are 
described in this document.

III. Foreign 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 
2013 FDA has determined that the differential for foreign facilities 
will be $15,000. The differential may be adjusted in future years.

[[Page 3901]]

IV. 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 the human generic drug. 
These fees are due no later than 45 days after the publication of this 
notice. Section 744B(b)(2)(C) of the FD&C Act specifies that the FDF 
facility fee revenue will make up 56 percent of the remaining 
$249,000,000, which is $139,440,000.
    In order to calculate the FDF fee, FDA has used the 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 FDF facilities 
identified through self-identification was 758. Of the total facilities 
identified as FDF, there were 325 domestic facilities and 433 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 (433) 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 
$6,495,000 of the total FDF fee revenue. Subtracting the foreign 
facility differential fee revenue ($6,495,000) from the total FDF 
facility target revenue ($139,440,000) results in a remaining fee 
revenue balance of $132,945,000. To determine the domestic FDF facility 
fee, we divide the $132,945,000 by the total number of facilities (758) 
which gives us a domestic FDF facility fee of $175,389. The foreign FDF 
facility fee is $15,000 more than the domestic FDF facility fee, or 
$190,389.

V. 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 45 days after the publication of this notice. 
Section 744B(b)(2)(D) of the FD&C Act specifies that the API facility 
fee will make up 14 percent of the remaining $249,000,000 fee revenue, 
which is $34,860,000.
    In order to calculate the API fee, FDA has used the data submitted 
by generic drug facilities through the self-identification process. Of 
the total facilities identified as API, there were 122 domestic 
facilities and 763 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 (763) 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 $11,445,000 of the total API 
fee revenue. Subtracting the foreign facility differential fee revenue 
($11,445,000) from the total API facility target revenue ($34,860,000) 
results in a remaining balance of $23,415,000. To determine the 
domestic API facility fee, we divide the $23,415,000 by the total 
number of facilities (885) which gives us a domestic API facility fee 
of $26,458. The foreign API facility fee is $15,000 more than the 
domestic API facility fee, or $41,458.

VI. Fee Payment Options and Procedures

    To make a payment of the facility fee, you must complete a Generic 
Drug User Fee Cover Sheet, available on the FDA Web site (http://www.fda.gov/gdufa) and generate a user fee payment 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 
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 payment ID number.
    Please include the user fee payment 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 the 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 the user fee payment 
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 facility 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, 1350 Piccard Dr., Rockville, MD, 20850. The tax 
identification number of the Food and Drug Administration is 53-
0196965.

    Dated: January 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00851 Filed 1-16-13; 8:45 am]
BILLING CODE 4160-01-P