[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Pages 5764-5766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01888]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4848]


Human Factors Studies and Related Clinical Study Considerations 
in Combination Product Design and Development; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry and FDA staff 
entitled ``Human Factors Studies and Related Clinical Study 
Considerations in Combination Product Design and Development.'' This 
document provides guidance to industry and FDA staff on the underlying 
principles of human factors (HF) studies during the development of 
combination products. Combination products are comprised of any 
combination of a drug and a device; a device and a biological product; 
a biological product and a drug; or a drug, a device, and a biological 
product.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 3, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://www.regulations.gov.

[[Page 5765]]

    <bullet> 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:
    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-D-4848 for ``Human Factors Studies and Related Clinical Study 
Considerations in Combination Product Design and Development.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
    <bullet> 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Combination Products, Food and Drug Administration, Bldg. 
32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. 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: Patricia Love, Deputy Director, Office 
of Combination Products, Office of Special Medical Programs, Office of 
Medical Products and Tobacco, Office of the Commissioner, Food and Drug 
Administration, at <a href="/cdn-cgi/l/email-protection#5121302523383238307f3d3e2734113735307f3939227f363e27"><span class="__cf_email__" data-cfemail="32425346405b515b531c5e5d4457725456531c5a5a411c555d44">[email protected]</span></a> or 301-796-8933.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Human Factors Studies and Related Clinical 
Study Considerations in Combination Product Design and Development.'' 
This document provides guidance to industry and FDA staff on the 
underlying principles of HF studies during the development of 
combination products as defined under 21 CFR part 3. This draft 
guidance describes Agency recommendations regarding HF information in a 
combination product investigational or marketing application. It 
clarifies the different types of HF studies, offers recommendations for 
timing and sequencing of HF studies, and discusses how HF studies 
contribute to assuring that combination products are safe and effective 
for the intended users, uses and environments. The draft guidance also 
addresses process considerations for HF information in investigational 
or marketing applications to promote development and timely review of 
safe and effective combination products. In addition, the draft 
guidance describes how HF studies relate to other clinical studies.
    This draft guidance refers to two existing guidance documents that 
provide related information on HF considerations. These are Guidance 
for Industry and FDA Staff, ``Applying Human Factors and Usability 
Engineering to Optimize Medical Device Design,'' accessible at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259760.pdf and Draft Guidance ``Safety 
Considerations for Product Design to Minimize Medication Errors,'' 
accessible at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM331810.pdf.
    This draft guidance provides examples of the use of HF studies for 
different types of combination products in different clinical settings. 
FDA welcomes comments to the docket on other examples of combination 
products and why they may or may not need HF studies. Additionally FDA 
seeks comments on what challenges and development risks may arise 
depending upon whether HF studies are conducted before, in parallel to, 
or after major clinical studies.

II. Significance of Guidance

    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 ``Human 
Factors Studies and Related Clinical Study Considerations in 
Combination Product Design and 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm, 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently 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

[[Page 5766]]

21 CFR part 314 for NDAs and ANDAs have been approved under OMB control 
number 0910-0001. The collections of information in 21 CFR part 601 for 
BLAs have been approved under OMB control number 0910-0338. The 
collections of information in 21 CFR part 814, subparts B and E, for 
PMAs have been approved under OMB control number 0910-0231. The 
collections of information in 21 CFR part 814, subpart H, for 
humanitarian device exemption applications have been approved under OMB 
control number 0910-0332. The collections of information in 21 CFR part 
807, subpart E, for 510(k) notifications have been approved under OMB 
control number 0901-0120. The collections of information in 21 CFR part 
312 for INDs have been approved under OMB control number 0910-0014. The 
collections of information in 21 CFR part 812 for IDEs have been 
approved under OMB control number 0910-0078. The collections of 
information in 21 CFR part 820 for the quality system regulation have 
been approved under OMB control number 0910-0073.

    Dated: January 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01888 Filed 2-2-16; 8:45 am]
 BILLING CODE 4161-01-P


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