[Federal Register Volume 82, Number 249 (Friday, December 29, 2017)]
[Notices]
[Pages 61764-61766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28139]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6564]


Best Practices for Communication Between Investigational New Drug 
Application Sponsors and the Food and Drug Administration; Guidance for 
Industry and Review Staff; 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 guidance for industry and review staff entitled 
``Best Practices for Communication Between IND Sponsors and FDA During 
Drug Development.'' Timely, transparent, and effective communications 
between investigational new drug application (IND) sponsors and FDA at 
critical junctures in drug development facilitate earlier availability 
of safe and effective drugs to the American public. This guidance 
describes FDA's philosophy regarding timely interactive communication 
with IND sponsors as a core activity; describes the scope of 
appropriate interactions between FDA review teams and IND sponsors; 
outlines the types of advice appropriate for sponsors to seek from FDA 
in pursuing their drug development programs; describes the general 
expectations for the timing of FDA responses to IND sponsor inquiries; 
describes best practices and communication methods to facilitate 
interactions between FDA review teams and IND sponsors during drug 
development; and includes expectations on appropriate methods and 
frequency of such communications. This guidance does not apply to 
communications or inquiries from industry trade organizations, consumer 
or patient advocacy organizations, other government agencies, or other 
stakeholders not pursuing a development program under an IND. This 
guidance finalizes the draft guidance issued on December 9, 2015.

DATES: The announcement of the guidance is published in the Federal 
Register on December 29, 2017.

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

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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-6564 for ``Best Practices for Communication Between 
Investigational New Drug Application Sponsors and the Food and Drug 
Administration; Guidance for Industry and Review Staff; Availability.'' 
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, or 
Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, 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: Rachel B. Kichline, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-0319; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
review staff entitled ``Best Practices for Communication Between IND 
Sponsors and FDA During Drug Development.'' As part of the Prescription 
Drug User Fee Amendments of 2012 (PDUFA V), described in PDUFA 
Reauthorization Performance Goals and Procedures Fiscal Years 2013 
through 2017, the Center for Drug Evaluation and Research (CDER) and 
the Center for Biologics Evaluation and Research (CBER) agreed to 
publish a joint guidance for industry and review staff on best 
practices for communication between IND sponsors and FDA during drug 
development.
    To establish the best practices described in this guidance, CDER 
and CBER gathered the experiences of review staff and incorporated 
input from interested parties who responded to a notice published in 
the Federal Register of October 29, 2014 (79 FR 64397), or who provided 
input directly to CDER's Enhanced Communication Team. This guidance was 
published as a draft guidance on December 9, 2015. The following 
changes were made to the guidance:
     Biosimilar biological product development information was 
expanded and Biosimilar User Fee Act (BsUFA) meeting types were added.
     Roles and responsibilities for regulatory project managers 
were clarified.
     Language describing the formal communication plan for 
applications in PDUFA Program for Enhanced Review Transparency and 
Communication for NME NDAs \1\ and Original BLAs \2\ (also known as the 
Program) and for biologic biosimilar applications reviewed under BsUFA 
was added.
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    \1\ New Molecular Entity New Drug Applications
    \2\ Biologics License Applications
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     Meeting request parameters were revised in alignment with 
PDUFA VI.
     Additional information was added to the Resources for 
Sponsors and Additional Contacts sections.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on best practices for communication between IND 
sponsors and FDA during drug development. 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 information collection described in 21 CFR part 312 from IND 
sponsors is approved by OMB

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under control number 0910-0014. The information collection described in 
the guidance for industry entitled ``Formal Meetings Between the FDA 
and Sponsors or Applicants of PDUFA Products'' is approved by OMB under 
control number 0910-0429. The information collection described in the 
guidance for industry entitled ``Formal Dispute Resolution: Sponsor 
Appeals Above the Division Level'' (available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM343101.pdf) is approved by OMB under control number 0910-0430. The 
information collection described in the ``Evaluation of the Program for 
Enhanced Review Transparency and Communication for New Molecular Entity 
New Drug Applications and Original Biologics License Applications in 
Prescription Drug User Fee Acts'' is approved by OMB under control 
number 0910-0746. The information collection described in the guidance 
for industry entitled ``Expedited Programs for Serious Conditions--
Drugs and Biologics'' (available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf) 
is approved by OMB under control number 0910-0765. The information 
collection described in the guidance for industry entitled ``Formal 
Meetings Between the FDA and Biosimilar Biological Product Sponsors or 
Applicants'' (available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM345649.pdf) is 
approved by OMB under control number 0910-0802.

III. Electronic Access

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

    Dated: December 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28139 Filed 12-28-17; 8:45 am]
 BILLING CODE 4164-01-P