[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Notices]
[Pages 57866-57867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0177]


Eosinophilic Esophagitis: Developing Drugs for Treatment; 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled 
``Eosinophilic Esophagitis: Developing Drugs for Treatment.'' This 
guidance is intended to describe the Agency's current thinking and 
recommended approach for the development of drugs and therapeutic 
biologics for the treatment of patients with eosinophilic esophagitis. 
This guidance finalizes the draft guidance of the same name issued 
February 6, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on September 16, 2020.

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-2019-D-0177 for ``Eosinophilic Esophagitis: Developing Drugs for 
Treatment.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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: Erica Lyons, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5373, Silver Spring, MD 20993-0002, 301-
796-8023.

SUPPLEMENTARY INFORMATION: 

[[Page 57867]]

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Eosinophilic Esophagitis: Developing Drugs for Treatment.'' 
This guidance provides FDA's current recommendations regarding clinical 
trials for drugs and therapeutic biologics for the treatment of 
eosinophilic esophagitis, including attributes of patients for 
enrollment, trial designs, efficacy considerations, safety assessments, 
and pediatric considerations.
    This guidance finalizes the draft guidance of the same name issued 
February 6, 2019 (84 FR 2237). Changes to the guidance took into 
consideration public comments received. Major changes included:
     Removal of the recommendation for the proton pump 
inhibitor trial before patient enrollment;
     removal of the recommendation for exclusion of patients 
with significant strictures;
     addition of a clarification that FDA does not recommend a 
randomized withdrawal design for trials of drugs with the potential to 
induce immunogenicity;
     addition of a recommendation to report eosinophil density 
per square millimeter (mm\2\) as well as per high-power field;
     creation of a statistical section with recommendations on 
estimands; and
     addition of a clarification on the recommendation for the 
number of adolescent patients to be included in adult trials.
    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 ``Eosinophilic Esophagitis: Developing Drugs 
for Treatment.'' 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.

II. Paperwork Reduction Act of 1995

    This final guidance contains no collection of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required.
    However, this final guidance refers to previously approved 
collections of information found in FDA regulations. These collections 
of information are subject to review by OMB under the PRA. The 
collections of information in 21 CFR part 312 (investigational new drug 
applications) have been approved under OMB control number 0910-0014. 
The collections of information in part 314 (new drug applications) have 
been approved under OMB control number 0910-0001. The collections of 
information in part 601 (biologics license applications) have been 
approved under OMB control number 0910-0338. The collections of 
information in parts 50 and 56 (protection of human subjects and 
institutional review boards) have been approved under OMB control 
number 0910-0130. The collections of information in the guidance for 
industry entitled ``Expedited Programs for Serious Conditions--Drugs 
and Biologics'' (available at https://www.fda.gov/media/86377/download) 
have been approved under OMB control number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: September 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20436 Filed 9-15-20; 8:45 am]
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