Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 5763 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Shannon Hoste, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2531, Silver Spring, 

MD 20993–0002, 240–402–3747 or 

Shannon.hoste@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

To understand use-related hazards, it 

is necessary to have an accurate and 

complete understanding of how a device 

will be used. Understanding and 

optimizing how people interact with 

technology is the subject of human 

factors engineering (HFE) and usability 

engineering (UE). HFE/UE 

considerations in the development of 

medical devices include the three major 

components of the device user system: 

(1) Device users; (2) device use 

environments; and (3) device user 

interfaces. 

For safety-critical technologies such 

as medical devices, the process of 

eliminating or reducing design-related 

use problems that contribute to or cause 

unsafe or ineffective medical treatment 

is part of a process for controlling 

overall risk. For devices where harm 

could result from ‘‘use errors,’’ the 

dynamics of user interaction should be 

included in risk analysis and risk 

management. By incorporating these 

considerations into the device 

development process, manufacturers 

can reduce the overall risk level posed 

by their devices, thus decreasing 

adverse events associated with the 

device and avoiding potential device 

recalls. 

In the Federal Register of June 22, 

2011 (76 FR 36543), FDA announced the 

availability of the draft guidance 

document. Interested persons were 

invited to comment by September 19, 

2011. FDA received over 600 comments, 

which were generally supportive of the 

draft guidance document, but requested 

clarification in a number of areas. The 

most frequent types of comments 

requested revisions to the language or 

structure of the document, or 

clarification on risk mitigation and 

human factors testing methods, user 

populations for testing, training of test 

participants, determining the 

appropriate sample size in human 

factors testing, reporting of testing 

results in premarket submissions, and 

collecting human factors data as part of 

a clinical study. In response to these 

comments, FDA revised the guidance 

document to clarify the points identified 

and restructured the information for 

better readability and comprehension. 

This guidance supersedes the guidance 

entitled ‘‘Medical Device Use-Safety: 

Incorporating Human Factors 

Engineering into Risk Management’’ 

dated July 18, 2000, which will be 

withdrawn. 

II. Significance of Guidance 

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 ‘‘Applying Human 

Factors and Usability Engineering to 

Medical Devices.’’ 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 interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Applying Human Factors and 

Usability Engineering to Medical 

Devices’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 1747 

to identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations and guidance. 

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 820 are 

approved under OMB control number 

0910–0073; the collections of 

information in 21 CFR part 812 are 

approved under OMB control number 

0910–0078; the collections of 

information in 21 CFR part 807, subpart 

E are approved under OMB control 

number 0910–0120; the collections of 

information in 21 CFR part 814, 

subparts A through E are approved 

under OMB control number 0910–0231; 

the collections of information in 21 CFR 

part 814, subpart H are approved under 

OMB control number 0910–0332; the 

collections of information in 21 CFR 

parts 801 and 809 are approved under 

OMB control number 0910–0485; and 

the collections of information in the 

guidance document entitled ‘‘Requests 

for Feedback on Medical Device 

Submissions: The Pre-Submission 

Program and Meetings with Food and 

Drug Administration Staff’’ are 

approved under OMB control number 

0910–0756. 

Dated: January 28, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01887 Filed 2–2–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0194] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Biosimilar User Fee Cover Sheet; Form 

FDA 3792 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Biosimilar User Fee Cover Sheet; Form 

FDA 3792’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On June 

23, 2015, the Agency submitted a 

proposed collection of information 

entitled ‘‘Biosimilar User Fee Cover 

Sheet; Form FDA 3792’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0718. The approval expires on 

December 31, 2018. A copy of the 

supporting statement for this 

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5764 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: January 28, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01883 Filed 2–2–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0253] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Postmarketing Adverse Drug 

Experience Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Postmarketing Adverse Drug 

Experience Reporting’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On July 1, 

2015, the Agency submitted a proposed 

collection of information entitled 

‘‘Postmarketing Adverse Drug 

Experience Reporting’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0230. The approval expires on 

December 31, 2018. A copy of the 

supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: January 27, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01884 Filed 2–2–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0915] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry on 

Postmarketing Adverse Event 

Reporting for Nonprescription Human 

Drug Products Marketed Without an 

Approved Application 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry on 

Postmarketing Adverse Event Reporting 

for Nonprescription Human Drug 

Products Marketed Without an 

Approved Application’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On July 2, 

2015, the Agency submitted a proposed 

collection of information entitled 

‘‘Guidance for Industry on 

Postmarketing Adverse Event Reporting 

for Nonprescription Human Drug 

Products Marketed Without an 

Approved Application’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0636. The approval expires on 

December 31, 2018. A copy of the 

supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/

public/do/PRAMain. 

Dated: January 28, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01885 Filed 2–2–16; 8:45 am] 

BILLING CODE 4164–01–P 

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. 

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: 

• 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. 

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