Document ID: FDA-2017-D-6554-0001
Agency: fda
Document Type: Notice
Title: Guidance: Refuse to File-New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research
Posted Date: 2017-12-13T05:00Z

[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58615-58617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26791]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6554]

Refuse To File: New Drug Application and Biologics License 
Application Submissions to the Center for Drug Evaluation and Research; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Refuse to 
File: NDA and BLA Submissions to CDER.'' The purpose of this guidance 
is to clarify certain circumstances under which FDA's Center for Drug 
Evaluation and Research (CDER) may refuse to file a new drug 
application (NDA) or

[[Page 58616]]

supplemental NDA, or a biologics license application (BLA) or 
supplemental BLA submitted to CDER, and to underscore the importance of 
submitting a complete application to minimize the chance of a refuse-
to-file (RTF) action by FDA.

DATES: Submit either electronic or written comments on the draft 
guidance by February 12, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the 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-2017-D-6554 for ``Refuse to File: New Drug Application and 
Biologics License Application Submissions to the Center for Drug 
Evaluation and Research; Draft Guidance for Industry.'' 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.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.
    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: Amalia Himaya, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301-
796-0700.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Refuse to File: NDA and BLA Submissions to CDER.'' The 
purpose of this guidance is to clarify certain circumstances under 
which CDER may refuse to file an NDA or supplemental NDA, or a BLA or 
supplemental BLA submitted to CDER, and to underscore the importance of 
submitting a complete application to minimize the chance of an RTF 
action by FDA. Since the early 1990s, in conjunction with the 
Prescription Drug User Fee Act, FDA's processes and timelines for 
reviewing newly submitted applications have substantially evolved. The 
administrative complexity of applications, with corresponding 
determinations of completeness, has become more challenging. The 
overall goal is to efficiently and effectively review applications, and 
thus it is critical to avoid use of resources to review an application 
when necessary components are so deficient as to render the application 
incomplete. FDA exercises its RTF authority for incomplete applications 
to optimize the use of both the applicant's and FDA's resources.
    Incomplete applications, including applications for which minor 
components not received within 30 calendar days after receipt of the 
original application, as may have been agreed upon at a presubmission 
meeting, may be refused for filing.
    This guidance focuses on FDA's policy for refusing to file an NDA 
under 21 CFR 314.101(d)(3) because the NDA is incomplete because it 
does not on its face contain information required under section 505(b) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and 21 
CFR 314.50. FDA considers incompleteness to be a basis for refusal to 
file for BLAs as well (21 CFR 601.2(a)).
    On May 19, 2017, FDA withdrew its previously published guidance for 
industry entitled ``Refusal to File'' (issued July 12, 1993). FDA is 
issuing this guidance to update and clarify CDER's procedures for 
determining whether an application should be

[[Page 58617]]

refused for filing because it is incomplete. This guidance includes 
procedures for certain BLAs and supplemental BLAs, given that CDER has 
regulatory responsibility for certain therapeutic biological products 
subject to licensing under the Public Health Service Act.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on refusal to 
file NDA and BLA submissions to CDER. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information 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-
3520). The collections of information in 21 CFR part 314 have been 
approved under OMB control number 0910-0001. The collections of 
information in 21 CFR part 601 have been approved under OMB control 
number 0910-0338.

III. Electronic Access

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

    Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26791 Filed 12-12-17; 8:45 am]
 BILLING CODE 4164-01-P