83 FR 48430 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 186 (September 25, 2018)

Page Range		48430-48431
FR Document		2018-20765

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 collection of information using Form FDA 3794, entitled ``Generic Drug User Fee Cover Sheet.''

Federal Register, Volume 83 Issue 186 (Tuesday, September 25, 2018)

[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48430-48431]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-20765]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3404]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Drug User Fee Cover Sheet

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 collection of information using Form FDA
3794, entitled ``Generic Drug User Fee Cover Sheet.''

DATES: Submit either electronic or written comments on the collection
of information by November 26, 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 November 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 26, 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 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-2018-N-3404 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Generic Drug User Fee Cover
Sheet.'' 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

[[Page 48431]]

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.thefederalregister.org/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: 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: 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 comments 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.

Generic Drug User Fee Coversheet

OMB Control Number 0910-0727--Extension

On July 9, 2012, the President signed the Generic Drug User Fee
Amendments (GDUFA) (Pub. L. 112-144, Title 111) into law. GDUFA is
designed to speed the delivery of safe and effective generic drugs to
the public and reduce costs to the industry. Section 744B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f, et seq.), as
added by GDUFA, authorized FDA to assess and collect the fees related
to generic drugs, beginning fiscal year (FY) 2013 and expiring at the
close of FY 2017, on September 30, 2017. GDUFA was reauthorized on
August 18, 2017 (GDUFA II) and is effective beginning October 1, 2017,
through September 30, 2022. GDUFA II enables FDA to assess industry
user fees to bring greater predictability and timeliness to the review
of generic drug applications.
Form FDA 3794, the Generic Drug User Fee Cover Sheet available at
https://www.ipqpubs.com/wp-content/uploads/2012/09/GDUFA-cover-sheet.pdf, requests the minimum necessary information from applicants
to account for and track user fees and to determine the amount of the
fee required. Applicants complete the cover sheets to accompany
payments. While applicants may submit payment through multiple means,
all cover sheets are prepared using FDA's web-based electronic User Fee
System. Upon submitting the completed cover sheet, the User Fee System
generates a user fee identification number, which is provided to
applicants at the bottom of the cover sheet. It also notes the correct
FY user fee assessment that is due for the submission/program. FDA
requests that applicants submit a copy of this completed cover sheet
along with the abbreviated new drug application, and other GDUFA fees,
so FDA can verify that the applicant has paid the correct user fee.
Respondents to this proposed collection of information would be
potential or actual generic drug application holders or related Active
Pharmaceutical Ingredient and Finished Dosage Form manufacturers.
Companies with multiple user fee obligations will submit a cover sheet
for each user fee obligation.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Form Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA 3794.................................... 500 7.616 3,808 0.5 (30 minutes).......................... 1,904
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated burden for the information collection reflects an
increase since last OMB approval. This adjustment corresponds with an
increase in submissions received by the Agency.

Dated: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20765 Filed 9-24-18; 8:45 am]
BILLING CODE 4164-01-P

Document Created: 2018-09-25 00:22:34
Document Modified: 2018-09-25 00:22:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by November 26, 2018.
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, [email protected]
FR Citation		83 FR 48430

83 FR 48430 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 186 (September 25, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration