Document ID: FDA-2012-N-0471-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397
Posted Date: 2015-10-19T04:00Z

[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Page 63227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26435]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0471]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; User Fee Cover Sheet; 
Form FDA 3397

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 18, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0297. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 (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.
    In the Federal Register of April 15, 2015 (80 FR 20232), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                              FDA Form                                  Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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FDA 3397...........................................................             290            12.79            3,710    0.5 (30 min.)            1,855
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26435 Filed 10-16-15; 8:45 am]
BILLING CODE 4164-01-P