[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42900-42902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18307]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 the Prescription Drug User Fee Cover Sheet, Form FDA 3397, 
that must be submitted along with certain drug and biological product 
applications.

DATES: Submit either electronic or written comments on the collection 
of information by October 23, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 23, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a

[[Page 42901]]

written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2005-N-0101 for ``Prescription Drug User Fee Cover Sheet; Form FDA 
3397.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: 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.

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 Food and Drug Administration 
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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 42902]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                              Number of
         FDA form             Number of     responses per   Total annual     Average burden per     Total hours
                             respondents     respondent       responses           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 (PDUFA VI), 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: August 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18307 Filed 8-23-18; 8:45 am]
 BILLING CODE 4164-01-P