83 FR 48432 - Abbreviated New Drug Application Submissions-Content and Format; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDA Submissions--Content and Format.'' This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under the Federal Food, Drug and Cosmetic Act (the FD&C Act).

[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Notices]
[Pages 48432-48433]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20790]



[[Page 48432]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0725]


Abbreviated New Drug Application Submissions--Content and Format; 
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 final guidance for industry entitled ``ANDA 
Submissions--Content and Format.'' This guidance is intended to assist 
applicants in preparing abbreviated new drug applications (ANDAs) for 
submission to FDA under the Federal Food, Drug and Cosmetic Act (the 
FD&C Act).

DATES: The announcement of the guidance is published in the Federal 
Register on September 25, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-2014-D-0725 for ``ANDA Submissions--Content and Format.'' 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 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.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 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: Elizabeth Giaquinto Friedman, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993, 240-402-7930.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``ANDA Submissions--Content and Format of Abbreviated New Drug 
Applications.'' This guidance is intended to assist applicants in 
preparing ANDAs for submission to FDA under section 505(j) of the FD&C 
Act (21 U.S.C. 355(j)). This guidance details the information that 
should be provided in each section of the common technical document 
format for human pharmaceutical product applications and identifies 
supporting guidance documents and recommendations issued by FDA to 
assist applicants in preparing their ANDA submission.
    This guidance identifies the information an applicant should 
include to ensure that a complete, high-quality application is 
submitted to FDA. FDA has previously published guidance documents on 
the filing process, including the guidances for industry about refuse-
to-receive standards and common, recurring deficiencies, which should 
be reviewed thoroughly prior to submission of an ANDA.
    In the Federal Register of June 12, 2014 (79 FR 33758), FDA issued 
the draft guidance for industry ``ANDA Submissions--Content and Format 
of Abbreviated New Drug Applications.'' FDA carefully considered the 
comments received on the draft guidance, and, where possible, has 
incorporated into the final guidance additional detailed discussion of 
our current thinking on the content and format of ANDAs submitted to 
FDA for review.
    This guidance is being issued consistent with FDA's good guidance

[[Page 48433]]

practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on the content and format of ANDA submissions. 
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 refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 314 (including subpart C) related 
to the content and format of ANDAs submitted by applicants and approved 
by FDA is approved under OMB control number 0910-0001. Applicant 
submission of controlled correspondence related to generic drug 
development and FDA approval is approved under OMB control number 0910-
0797.
    The collection of information for Form FDA 356h (NDA and ANDA cover 
sheet) has been approved under OMB control number 0910-0338. The 
collection of information for Form FDA 3674 (application certification) 
has been approved under OMB control number 0910-0616. The collection of 
information for Form FDA 3794 (GDUFA cover sheet) has been approved 
under OMB control number 0910-0727. The collection of information for 
Form FDA 3454 and Form FDA 3455 (clinical investigator financial 
interest) has been approved under control number 0910-0396.
    The submission of petitions under 21 CFR part 10 (Administrative 
Practices and Procedures) has been approved under OMB control number 
0910-0191. The collection information in 21 CFR part 11 (electronic 
records) has been approved under OMB control number 0910-0303. 
Information about the manufacture of the drug product under 21 CFR part 
211 has been approved under OMB control number 0910-0139.

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: September 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20790 Filed 9-24-18; 8:45 am]
 BILLING CODE 4164-01-P