[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Human Factors Submissions to Drug and Biologic Applications; Draft
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Contents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 The draft guidance provides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DATES: Submit either electronic or written comments on the draft
guidance by November 30, 2018 to ensure that the Agency considers your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.
[[Page 49393]]
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]
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