82 FR 50142 - Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 208 (October 30, 2017)

Page Range		50142-50144
FR Document		2017-23526

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.'' This draft guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application.

Federal Register, Volume 82 Issue 208 (Monday, October 30, 2017)

[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Notices]
[Pages 50142-50144]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23526]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0880]


Assessing User Fees Under the Generic Drug User Fee Amendments of 
2017; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft

[[Page 50143]]

guidance for industry entitled ``Assessing User Fees Under the Generic 
Drug User Fee Amendments of 2017.'' This draft guidance provides 
stakeholders information regarding the implementation of the Generic 
Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures 
surrounding its application.

DATES: Submit either electronic or written comments on the guidance 
December 29, 2017 to ensure that the Agency considers your comment on 
this draft guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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-2012-D-0880 for ``Assessing User Fees Under the Generic Drug User 
Fee Amendments of 2017.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Division of 
Dockets Management 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.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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Mehrban Iranshad, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Rm. 4145, Silver Spring, MD 20993, 301-796-7900, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Assessing User Fees Under the Generic Drug User Fee 
Amendments of 2017.'' GDUFA II (Pub. L. 115-52, Title III) was signed 
into law by the President on August 18, 2017. GDUFA II continues FDA's 
and industry's goal to improve the public's access to safe and 
effective generic drugs and to improve upon the predictability of the 
review process. GDUFA II extends FDA's authority to collect user fees 
from fiscal year (FY) 2018 to FY 2022 and introduces a number of 
technical revisions that affect what fees are collected and how some 
fees are collected. GDUFA II authorizes fees for abbreviated new drug 
applications (ANDAs), drug master files (DMFs), annual facility fees, a 
one-time fee for original ANDAs pending with FDA on October 1, 2012 
(backlog fees), and the Generic Drug Applicant Program Fee (GDUFA 
Program Fee).
    The draft guidance announced in this notice addresses changes in 
user fee assessments from GDUFA I, user fees incurred by industry under 
GDUFA II, payment procedures, reconsideration and appeals, and other 
additional information to assist industry in complying with GDUFA II. 
FDA will issue separate guidance documents regarding GDUFA II non-user 
fee requirements and processes.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance, when finalized, 
will represent the Agency's current thinking on ``Assessing User Fees 
Under the Generic Drug User Fee Amendments of 2017.'' It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-

[[Page 50144]]

3520). The guidance refers to collections of information for filling 
out and submitting Form FDA 3913 (User Fee Payment Refund Request), 
previously approved under OMB control number 0910-0805, and Form FDA 
3914 (User Fee Payment Transfer Request), previously approved under OMB 
control number 0910-0805.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: October 25, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23526 Filed 10-27-17; 8:45 am]
BILLING CODE 4164-01-P

50142 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices

existing collection of information, Postmarketing Safety Reports for safety reports to the Agency (§§ 310.305,
before submitting the collection to OMB Human Drug and Biological Products: 314.80, 314.98, and 600.80);
for approval. To comply with this Waivers From Electronic Submission • manufacturers, packers, or
requirement, FDA is publishing notice Requirements—OMB Control Number distributors whose name appears on the
of the proposed collection of 0910–0770—Extension label of nonprescription human drug
information set forth in this document. This information collection supports products marketed without an approved
With respect to the following FDA regulations. In the Federal Register application must report serious adverse
collection of information, FDA invites of June 10, 2014 (79 FR 33072), FDA events associated with their products
comments on these topics: (1) Whether published a final rule entitled (section 760 of the Federal Food, Drug,
the proposed collection of information ‘‘Postmarketing Safety Reports for and Cosmetic Act (the FD&C Act) (21
Human Drug and Biological Products: U.S.C. 379aa)); and
is necessary for the proper performance
Electronic Submission Requirements.’’ • applicants with approved BLAs
of FDA’s functions, including whether
The final rule amended FDA’s must submit biological lot distribution
the information will have practical postmarketing safety reporting
utility; (2) the accuracy of FDA’s reports to the Agency (§ 600.81).
regulations for human drug and
estimate of the burden of the proposed biological products under 21 CFR parts Under §§ 310.305(e)(2), 314.80(g)(2),
collection of information, including the 310, 314, and 600 and added part 329 329.100(c)(2), 600.80(h)(2), and
validity of the methodology and to require that persons subject to 600.81(b)(2), those who are subject to
assumptions used; (3) ways to enhance mandatory reporting requirements these postmarketing safety reporting
the quality, utility, and clarity of the submit safety reports in an electronic requirements may request a waiver from
information to be collected; and (4) format that FDA can process, review, the electronic format requirement.
ways to minimize the burden of the and archive. Specifically, this includes: While FDA currently has OMB approval
collection of information on • manufacturers; packers; for the collection of postmarketing
respondents, including through the use distributors; applicants with approved safety reports,1 this information
of automated collection techniques, new drug applications, abbreviated new collection supports respondents seeking
when appropriate, and other forms of drug applications, and biologics waivers from submitting those reports in
licensing applications (BLAs); and those electronic format as required by the
information technology.
that market prescription drugs for regulations.
human use without an approved FDA estimates the burden of this
application must submit postmarketing collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

310.305(e)(2) ....................................................................... 1 1 1 1 1
314.80(g)(2) ......................................................................... 5 1 5 1 5
329.100(c)(2) ........................................................................ 1 1 1 1 1
600.80(h)(2) ......................................................................... 5 1 5 1 5
600.81(b)(2) ......................................................................... 1 1 1 1 1

Total .............................................................................. ........................ ........................ ........................ ........................ 13
1 There are no capital or operating and maintenance costs associated with this collection of information.

In table 1 of this document, we Dated: October 24, 2017. DEPARTMENT OF HEALTH AND
estimate the burden associated with the Lauren Silvis, HUMAN SERVICES
submission of waiver requests for Chief of Staff.
postmarketing safety reports in Food and Drug Administration
[FR Doc. 2017–23518 Filed 10–27–17; 8:45 am]
electronic format under §§ 310.305(e)(2), BILLING CODE 4164–01–P
314.80(g)(2), 329.100(c)(2), 600.80(h)(2), [Docket No. FDA–2012–D–0880]
and 600.81(b)(2). We expect few waiver
Assessing User Fees Under the
requests. We estimate that Generic Drug User Fee Amendments of
approximately one manufacturer will 2017; Draft Guidance for Industry;
request a waiver annually under Availability
§§ 310.305(e)(2), 329.100(c)(2), and
600.81(b)(2), and approximately five AGENCY: Food and Drug Administration,
manufacturers will request a waiver HHS.
annually under §§ 314.80(g)(2) and ACTION: Notice of availability.
600.80(h)(2). We estimate that each
sradovich on DSK3GMQ082PROD with NOTICES

waiver request will take approximately SUMMARY: The Food and Drug
1 hour to prepare and submit. Administration (FDA or Agency) is
announcing the availability of a draft
1 FDA currently has OMB approval for control numbers 0910–0291 and 0910–0230. The FD&C Act have been approved under OMB control
submission of postmarketing safety reports under information collection for part 600 is approved number 0910–0636.
parts 310, 314, and 600. The information collection under OMB control numbers 0910–0291 and 0910–
for parts 310 and 314 is approved under OMB 0308. Submissions required by section 760 of the

VerDate Sep<11>2014 17:59 Oct 27, 2017 Jkt 244001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1

Document Created: 2017-10-28 00:28:38
Document Modified: 2017-10-28 00:28:38

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 of availability.
Dates		Submit either electronic or written comments on the guidance December 29, 2017 to ensure that the Agency considers your comment on this draft guidance.
Contact		Mehrban Iranshad, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 4145, Silver Spring, MD 20993, 301-796-7900, [email protected]
FR Citation		82 FR 50142

82 FR 50142 - Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 208 (October 30, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration