Ss-0910-0632 - 07-30-12

SS-0910-0632 - 07-30-12.doc

Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728 ( 21 U.S.C. 379j - 21)

OMB: 0910-0632

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SUPPORTING STATEMENT

Animal Generic Drug User Fees (AGDUFA)

Cover Sheet FDA Form 3728

OMB# 0910-0632


A. JUSTIFICATION


1. Circumstances Making the Collection of Information Necessary


The Federal Food, Drug, and Cosmetic Act, as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Title II of Public Law 110-316 signed by the President on August 14, 2008), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs.


This information collection is not related to the American Recovery and Reinvestment Act of 2009.


2. Purpose and Use of the Information


The types of fees that require a cover sheet are certain abbreviated new animal drug applications. The cover sheet (Form FDA 3728) is designed to provide the minimum necessary information to determine whether a fee is required, to determine the amount of the fee required, and to assure that each generic animal drug user fee payment is made appropriately. The form, when completed electronically, will result in the generation of a unique payment identification number used by FDA to track the payment. It will be used by FDA’s Center for Veterinary Medicine (CVM) and FDA’s Office of Management to initiate the administrative screening of new generic animal drug applications to determine if payment has been received.


3. Use of Improved Information Technology and Burden Reduction


CVM will accept electronic abbreviated new animal drug applications in the near future.



4. Efforts to Identify Duplication and Use of Similar Information


FDA is the only Agency that requires this information. The required information is not available from any other source.



5. Impact on Small Businesses or Other Small Entities


FDA believes that its duty requires the equal application of the regulations to all enterprises. While FDA does not believe it can apply different standards with respect to statutory requirements, FDA does provide special help to small businesses.


6. Consequences of Collecting the Information Less Frequently


If this information is not collected, the person subject to generic animal drug user fees would be required to have the application fee paid prior to FDA accepting an application for filing.


7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5


There are no special circumstances for this collection of information.


8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the

Agency


In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the FEDERAL REGISTER of October 5, 2011 (76 FR 61709). No comments were received.


9. Explanation of Any Payment or Gift to Respondents


No payment or gift was provided or will be provided to respondents.



10. Assurance of Confidentiality Provided to Respondents


The confidentiality of information received by FDA is consistent with the Freedom of Information Act (FOIA) and the Agency's published regulations of "Public Information" under 21 CFR Part 20 which prohibit FDA from releasing to the public any information that cannot be disclosed. Such information is deleted from any information released by FDA under FOIA and FDA regulations.


11. Justification for Sensitive Questions


Questions of a sensitive nature are not applicable to this information collection



12. Estimates of Annualized Burden Hours and Costs


12a.Annualized Hour Burden Estimate


Table 1. -- Estimated Annual Reporting Burden

FDA Form #

Number of Respondents

No. of Responses per Respondent

Total annual Responses

Average Burden per Response

Total Hours

FDA Form 3728 Cover Sheet

20

2

40

.08

(5 minutes)

3.2


Respondents to this collection of information are new generic animal drug applicants. Based on FDA's data base system, there are an estimated 20 sponsors of generic new animal drugs potentially subject to AGDUFA. However, not all sponsors will have any submissions in a given year and some may have multiple submissions. CVM estimates 40 annual responses.


12b. Annualized Cost Burden Estimate


Type of Respondent

Total Burden Hours

Hourly Wage Rate

Total Respondent Cost

Regulatory Affairs Specialist

3.2

$35

$112


FDA estimates that the total annual cost to respondents will be $ (3.2 hours X $35 per hour).


The cost to respondents is based on the salary of a regulatory affairs specialist, at a pay rate of $35 per hour, who is responsible for filling out, signing, and submitting the request. This salary estimate includes benefits but no overhead costs. There are no capital and start-up, or operation, maintenance and purchase costs associated with this information collection.


13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeeping Capital Costs


There are no capital, start-up, operating or maintenance costs associated with this information collection


14. Annualized Cost to the Government


FDA estimates that it will spend about .50 FTEs annually on this information collection. We estimate about 1650 hours of work is performed per FTE. We estimate a compensation cost of $94,969 per FTE (Washington Metro Area pay scale), which is the salary of a GS13/3, the average grade among the personnel involved in the review. $94,969 times .50 = $47,484.50.


15. Explanation for Program Changes or Adjustments


An adjustment in the estimate for the annual number of responses has been made


for the currently approval of 69. The new estimate for the annual number of responses

being requested is 40. Respondents to this collection of information are generic drug applicants . Based on FDAs database systen, there are an estimated 20 sponsors of new animal drugs potentially subject to AGDUFA , with the number of responses per responses averaging around

2 , hence the total annual responses being 40.




16. Plans for Tabulation and Publication and Project Time Schedule


No information will be published.


17. Reason(s) Display of OMB Expiration Date is Inappropriate


FDA is not seeking approval to exempt display of the expiration date for OMB approval.


18. Exception to Certification for Paperwork Reduction Act Submissions


There are no exceptions to the certification.


P. 4 of 4

File Typeapplication/msword
File TitleOMB INFORMATION COLLECTION
AuthorASTRID L. SZETO
Last Modified ByDPresley
File Modified2012-07-31
File Created2012-07-30

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