
[Federal Register Volume 84, Number 25 (Wednesday, February 6, 2019)]
[Notices]
[Pages 2235-2236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-N-0101]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Prescription Drug 
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 March 
8, 2019.

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: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
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.

Prescription Drug 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 (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). Under this authority, pharmaceutical companies pay a fee for 
certain new human drug applications (NDAs) and BLAs submitted to the 
Agency for review. Because the submission of prescription drug user 
fees concurrently with applications 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 and BLAs.
    Respondents to this collection of information are drug and 
biologics manufacturers that submit NDAs and BLAs. Based on FDA's 
database system for fiscal year (FY) 2017, there are an estimated 155 
manufacturers of products subject to the Prescription Drug User Fee Act 
(Pub. L. 105-115), as amended by the FDA Reauthorization Act of 2017 
(Pub. L. 115-52.)
    The total number of annual responses is based on the number of 
application submissions received by FDA in FY 2017. CDER received 250 
annual responses that included the following submissions: 218 NDAs and 
32 BLAs. CBER received 12 BLAs. The estimated hours per response are 
based on past FDA experience with the various submissions.
    In the Federal Register of August 24, 2018 (83 FR 42900), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

[[Page 2236]]



                                 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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3397..........................             155          1.6903             262  0.5 (30 minutes)             131
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an 
overall decrease of 1,724 hours and a corresponding decrease of 3,448 
responses. We attribute this program change to the restructuring of the 
Prescription Drug Use Fee Program fees. The FD&C Act, as amended by the 
Prescription Drug User Fee Amendments of 2017, authorizes FDA to 
collect application fees for certain applications for the review of 
human drug and biological products and discontinued the supplement fee. 
This resulted in the removal of supplements from the Prescription Drug 
User Fee Cover Sheet, therefore reducing the burden for this collection 
of information.

    Dated: February 1, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01249 Filed 2-5-19; 8:45 am]
 BILLING CODE 4164-01-P


