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Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to Form FDA 3397, User Fee Cover Sheet, that must be submitted along with certain drug and biologic product applications and supplements.


Submit either electronic or written comments on the collection of information by June 15, 2015.


Submit electronic comments on the collection of information to Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

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FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,

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Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comment on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

User Fee Cover Sheet; Form FDA 3397 (OMB Control Number 0910-0297)—Extension

Under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (sections 735 and 736 (21 U.S.C. 379g and 379h)), as amended, FDA has the authority to assess and collect user fees for certain drug and biologics license applications (BLAs) and supplements to those applications. Under this authority, pharmaceutical companies pay a fee for certain new human drug applications (NDAs), BLAs, or supplements submitted to the Agency for review. Because the submission of user fees concurrently with applications and supplements is required, review of an application by FDA cannot begin until the fee is submitted. The Prescription Drug User Fee Cover Sheet, Form FDA 3397, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. The form provides a cross-reference of the fee submitted for an application by using a unique number tracking system. The information collected is used by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of NDAs, BLAs, and/or, supplemental applications to those applications.

Respondents to this collection of information are new drug and biologics manufacturers. Based on FDA's database system for fiscal year (FY) 2014, there are an estimated 290 manufacturers of products subject to the Prescription Drug User Fee Act (Pub. L. 105-115). The total number of annual responses is based on the number of submissions received by FDA in FY 2014. CDER received 3,005 annual responses that include the following submissions: 128 NDAs; 7 BLAs; 1,586 manufacturing supplements; 1,081 labeling supplements; and 203 efficacy supplements. CBER received 705 annual responses that include the following submissions: 11 BLAs; 611 manufacturing supplements; 64 labeling supplements; and 19 efficacy supplements. The estimated hours per response are based on past FDA experience with the various submissions.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden 1

FDA formNumber of respondentsNumber of responses per respondentTotal annual responsesAverage burden per responseTotal hours
FDA 339729012.793,7100.5 (30 min.)1,855
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
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Dated: March 8, 2015.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2015-08618 Filed 4-14-15; 8:45 am]