[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49391-49393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3275]


Contents of a Complete Submission for Threshold Analyses and 
Human Factors Submissions to Drug and Biologic Applications; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Contents 
of a Complete Submission for Threshold Analyses and Human Factors 
Submissions to an IND, NDA, BLA, or ANDA.'' The draft guidance provides 
recommendations to industry and FDA staff regarding the content and 
submission procedures for use-related risk analyses, human factors 
validation study protocols and reports, threshold analyses, and 
comparative use human factors study protocols and reports.

DATES: Submit either electronic or written comments on the draft 
guidance by November 30, 2018 to ensure that the Agency considers your 
comments in this review.

ADDRESSES: You may submit comments 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

[[Page 49392]]

identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-3275 for ``Contents of a Complete Submission for Threshold 
Analyses and Human Factors Submissions to an IND, NDA, BLA or ANDA.'' 
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 to the 
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: Quynh Nhu Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 22, Rm. 4408, Silver Spring, MD 20993, 301-796-
6273, email: [email protected]; 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 draft guidance for industry 
entitled ``Contents of Threshold Analyses and Human Factors Submissions 
to an IND, NDA, BLA, or ANDA.'' This document provides guidance to 
industry on the content and submission procedures for human factors 
(HF) submissions to promote efficient Agency review.
    The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that 
drug products submitted for approval under section 505(b) be proven 
safe and demonstrate substantial evidence of effectiveness for the 
product's intended use (21 U.S.C. 355(b)). Under section 351 of the 
Public Health Service Act (42 U.S. 262), FDA licenses a biological 
product based on a demonstration that it is safe, pure, and potent, and 
that it is manufactured in a facility designed to ensure the product 
continues to be safe, pure, and potent. As part of evaluating drug and 
biologic products for safety and effectiveness, FDA will evaluate HF 
data submitted by sponsors in support of the product user interface 
when submission of such data is warranted. For products that sponsors 
intend to submit as an abbreviated new drug application (ANDA), the 
sponsor can rely on the Agency's previous finding that the listed drug 
is safe and effective so long as the sponsor can demonstrate certain 
findings. Certain products, including drug-device combination products, 
may warrant threshold analyses and additional data, such as data from 
comparative HF studies.
    This draft guidance provides recommendations to industry and FDA 
staff regarding the content and submission procedures for use-related 
risk analyses, human factors validation study protocols and reports, 
threshold analyses, and comparative use HF study protocols and reports. 
This draft guidance applies to submissions for the following types of 
products:
     Human prescription drug products, including biologics, 
that are the subject of an investigational new drug application (IND), 
a new drug application (NDA), a biologics license application (BLA), or 
an abbreviated new drug application (ANDA), and supplements to these 
applications
     Human nonprescription drug products that are the subject 
of an IND, NDA, or ANDA
    This draft guidance does not describe when threshold analyses or HF 
submissions are warranted for any particular application pathway, the 
processes or procedures associated with their review, or the methods 
used by the Agency for evaluation. Furthermore, this draft guidance 
does not describe the methods used to design, conduct, or analyze HF 
studies.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (21 CFR 10.115). The draft guidance, when finalized, 
will represent FDA's current thinking on ``Contents of a Complete 
Submission for Threshold Analyses and Human Factors Submissions to an 
IND, NDA, BLA or ANDA.'' 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 draft 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 part 312 and Form FDA 1571 have 
been approved under OMB control number 0910-0014. 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 and 
Form FDA 356h have been approved under OMB control number 0910-0338.

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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, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21243 Filed 9-28-18; 8:45 am]
 BILLING CODE 4164-01-P