81 FR 81774 - Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 223 (November 18, 2016)

Page Range		81774-81776
FR Document		2016-27761

The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry entitled ``Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments.'' This guidance provides updated answers to common questions from the generic drug industry and other interested parties involved in the development and/or testing of generic drug products regarding GDUFA user fees and finalizes the revised version of the guidance.

Federal Register, Volume 81 Issue 223 (Friday, November 18, 2016)

[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81774-81776]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27761]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Generic Drug User Fee Amendments of 2012: Questions and Answers 
Related to User Fee Assessments; 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 guidance for industry entitled ``Generic Drug User 
Fee Amendments of 2012: Questions and Answers Related to User Fee 
Assessments.'' This guidance provides updated answers to common 
questions from the generic drug industry and other interested parties 
involved in the development and/or testing of generic drug products 
regarding GDUFA user fees and finalizes the revised version of the 
guidance.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments as follows:

[[Page 81775]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``Generic Drug User Fee Amendments of 2012: 
Questions and Answers Related to User Fee Assessments.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Mehrban Iranshad, Division of User Fee 
Management and Budget Formulation staff, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Bldg., Rm. 4145, Silver Spring, MD 20993, 301-796-7900, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Generic Drug User Fee Amendments of 2012: Questions and 
Answers Related to User Fee Assessments.'' GDUFA (Pub. L. 112-144, 
Title III) was signed into law by the President on July 9, 2012. GDUFA 
is designed to speed the delivery of safe and effective generic drugs 
to the public and improve upon the predictability of the review 
process. GDUFA enables FDA to assess user fees to support critical and 
measurable enhancements to FDA's generic drugs program. GDUFA 
establishes fees for abbreviated new drug applications (ANDAs), prior 
approval supplements (PASs) to ANDAs, and drug master files (DMFs), 
annual facility fees, and a one-time fee for original ANDAs pending 
with FDA on October 1, 2012 (backlog fees). Fees are incurred for ANDAs 
and PASs submitted on or after October 1, 2012. An application fee is 
also incurred the first time a DMF is referenced in an ANDA or PAS 
submitted on or after October 1, 2012.
    FDA previously announced GDUFA fees for fiscal year 2017 in the 
Federal Register. ANDA, PAS, DMF, and facility fees were published on 
July 27, 2016 (81 FR 49225), and the backlog fee was published on 
October 25, 2012 (77 FR 65199). On August 27, 2012, FDA announced the 
availability of a draft guidance for industry entitled ``Generic Drug 
User Fee Amendments of 2012: Questions and Answers'' (77 FR 51814). In 
response to comments received in the docket and to address additional 
questions that have arisen since the launch of the GDUFA program, FDA 
revised the draft guidance and re-issued it as ``Draft Guidance for 
Industry on Generic Drug User Fee Amendments of 2012: Questions and 
Answers (Revision 1)'' on September 10, 2013 (78 FR 55261). The 
guidance announced in this notice finalizes the section of Revision 1 
relating to user fees, updating and clarifying the responses in some 
cases and adding questions and answers based on comments received from 
the public. Questions and answers related to GDUFA's self-
identification, review of generic drug submissions, and inspections and 
compliance provisions that appeared in draft versions of this guidance 
will appear in updated form in a separately issued final guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on ``Generic Drug User Fee Amendments of 
2012: Questions and Answers Related to User Fee Assessments.'' 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

[[Page 81776]]

requirements of the applicable statutes and regulations.

II. Electronic Access

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

    Dated: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27761 Filed 11-17-16; 8:45 am]
 BILLING CODE 4164-01-P

81774 Federal Register / Vol. 81, No. 223 / Friday, November 18, 2016 / Notices

device exemption (HDE), petition for the 510(k) as required by § 807.92 submissions including premarket
Evaluation of Automatic Class III (510(k) summary) or a statement notifications or other requirements. FDA
Designation (de novo), or be reclassified certifying that the submitter will make has published and updated the list of
into class I or class II before being available upon request the information recognized standards regularly since
marketed. FDA makes the final decision in the 510(k) with certain exceptions as enactment of FDAMA and has allowed
of whether a device is substantially per § 807.93 (510(k) statement). If the 510(k) submitters to certify conformance
equivalent or not equivalent. 510(k) submitter includes a 510(k) to recognized standards to meet the
Section 807.81 states when a statement in the 510(k) submission, requirements of § 807.87. Form FDA
premarket notification is required. A § 807.93 requires that the official 3654, the 510(k) Standards Data Form,
premarket notification is required to be correspondent of the firm make standardizes the format for submitting
submitted by a person who is: (1) available within 30 days of a request all information on consensus standards that
Introducing a device to the market for information included in the submitted a 510(k) submitter chooses to use as a
the first time; (2) introducing a device premarket notification on safety and portion of their premarket notification
into commercial distribution for the first effectiveness. This information will be submission (Form FDA 3654 is not for
time by a person who is required to provided to any person within 30 days declarations of conformance to a
register; and (3) introducing or of a request if the device described in recognized standard). FDA believes that
reintroducing a device which is the 510(k) submission is determined to use of this form will simplify the 510(k)
significantly changed or modified in be substantially equivalent. The preparation and review process for
design, components, method of information provided will be a 510(k).
manufacturer, or the intended use that duplicate of the 510(k) submission Under § 807.90, submitters may
could affect the safety and effectiveness including any safety and effectiveness request information on their 510(k)
of the device. information, but excluding all patient review status 90 days after the initial
Form FDA 3514, a summary cover identifiers and trade secret and login date of the 510(k). Thereafter, the
sheet form, assists respondents in commercial confidential information. submitter may request status reports
categorizing administrative 510(k) Section 204 of the Food and Drug every 30 days following the initial status
information for submission to FDA. This Administration Modernization Act request. To obtain a 510(k) status report,
form also assists respondents in (FDAMA) (Pub. L. 105–115) amended the submitter should complete the
categorizing information for other FDA section 514 of the FD&C Act (21 U.S.C. status request form, Form FDA 3541,
medical device programs such as PMAs, 360d). Amended section 514 allows and fax it to the Center for Devices and
investigational device exemptions, and FDA to recognize consensus standards Radiological Health office identified on
HDEs. Under § 807.87(h), each 510(k) developed by international and national the form.
submitter must include in the 510(k) organizations for use in satisfying FDA estimates the burden of this
either a summary of the information in portions of device premarket review collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of Average
Number of Total annual Total
Activity and 21 CFR Part/Section Form No. responses per burden per
respondents responses hours
respondent response

510(k) submission (807 subpart ........................ 3,900 1 3,900 79 .............................. 308,100
E).
Summary cover sheet (807.87) ... FDA 3514 ...... 1,956 1 1,956 0.5 (30 minutes) ........ 978
Status request (807.90(a)(3)) ...... FDA 3541 ...... 218 1 218 0.25 (15 minutes) ...... 55
Standards (807.87(d) and (f)) ...... FDA 3654 ...... 2,700 1 2,700 10 .............................. 27,000
510(k) statement (807.93) ........... ........................ 225 10 2,250 10 .............................. 22,500

Total ...................................... ........................ ........................ ........................ ........................ .................................... 358,633
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: November 15, 2016. DEPARTMENT OF HEALTH AND Fee Amendments of 2012: Questions
Leslie Kux, HUMAN SERVICES and Answers Related to User Fee
Associate Commissioner for Policy. Assessments.’’ This guidance provides
Food and Drug Administration updated answers to common questions
[FR Doc. 2016–27851 Filed 11–17–16; 8:45 am]
BILLING CODE 4164–01–P [Docket No. FDA–2012–D–0880] from the generic drug industry and
other interested parties involved in the
Generic Drug User Fee Amendments of development and/or testing of generic
2012: Questions and Answers Related drug products regarding GDUFA user
to User Fee Assessments; Guidance fees and finalizes the revised version of
for Industry; Availability the guidance.
Food and Drug Administration,
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AGENCY: DATES: Submit either electronic or
HHS. written comments on Agency guidances
ACTION: Notice of availability. at any time.
SUMMARY: The Food and Drug ADDRESSES: You may submit comments
Administration (FDA or Agency) is as follows:
announcing the availability of guidance
for industry entitled ‘‘Generic Drug User

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Document Created: 2018-02-14 08:32:13
Document Modified: 2018-02-14 08:32:13

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 Agency guidances at any time.
Contact		Mehrban Iranshad, Division of User Fee Management and Budget Formulation staff, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., Rm. 4145, Silver Spring, MD 20993, 301-796-7900, [email protected]
FR Citation		81 FR 81774

81 FR 81774 - Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 223 (November 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration