Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices 62093 

21 CFR part or guidance Topic OMB control 

No. 

803 .............................................................................................. Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor 

reporting.

0910–0437 

822 .............................................................................................. Postmarket Surveillance of Medical Devices ............................ 0910–0449 

820 .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.0910–0073 

58 ................................................................................................ Good Laboratory Practice (GLP) Regulations for Nonclinical 

Laboratory Studies.

0910–0119 

Dated: September 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19402 Filed 9–7–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–4848] 

Application of Human Factors 

Engineering Principles for 

Combination Products: Questions and 

Answers; Guidance for Industry and 

FDA Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry and FDA staff 

entitled ‘‘Application of Human Factors 

Engineering Principles for Combination 

Products: Questions and Answers.’’ This 

document provides questions and 

answers for industry and FDA staff on 

the application of human factors 

engineering (HFE) principles to the 

development of combination products 

as defined under the regulations. The 

guidance clarifies how the unique 

aspects of a combination product 

influence the considerations within the 

HFE process. This guidance is intended 

to facilitate the development of 

combination products. This guidance 

finalizes the draft guidance entitled 

‘‘Human Factors Studies and Related 

Clinical Study Considerations in 

Combination Product Design and 

Development’’ issued on February 3, 

2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 8, 2023. 

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– 

2015–D–4848 for ‘‘Application of 

Human Factors Engineering Principles 

for Combination Products: Questions 

and Answers.’’ 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 Office of 


lotter on DSK11XQN23PROD with NOTICES1
62094 Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices 

Combination Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5129, Silver Spring, 

MD 20993–0002. Send one selfaddressed 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: 

Patricia Love, Office of Combination 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, Bldg. 32, Rm. 5129, Silver 

Spring, MD 20993, 301–796–8930, 

Patricia.Love@fda.hhs.gov or 

combination@fda.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry and FDA staff 

entitled ‘‘Application of Human Factors 

Engineering Principles for Combination 

Products: Questions and Answers.’’ This 

guidance provides questions and 

answers for industry and FDA staff on 

the application of HFE principles to the 

development of combination products 

as defined under 21 CFR part 3. This 

guidance should be used in conjunction 

with the guidance for industry and FDA 

staff ‘‘Applying Human Factors and 

Usability Engineering to Medical 

Devices’’ (available at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

applying-human-factors-and-usabilityengineering-medical-devices) and with 

the guidance for industry ‘‘Safety 

Considerations for Product Design to 

Minimize Medication Errors’’ (available 

at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/safety-considerationsproduct-design-minimize-medicationerrors-guidance-industry). 

This guidance focuses on 

considerations for the application of 

HFE principles to combination products 

comprised of a medical device 

combined with a drug or a biological 

product submitted for review in the 

Center for Biologics Evaluation and 

Research, the Center for Devices and 

Radiological Health, or the Center for 

Drug Evaluation and Research. This 

guidance discusses, among other things, 

the definition of a combination product 

critical task, considerations for 

combination products due to the use of 

a drug or biological product constituent 

part together with a device constituent 

part, training as part of the user 

interface, and human factors (HF) 

validation data to support the 

combination product user interface that 

may be included in a premarket 

submission. 

This guidance finalizes the draft 

guidance entitled ‘‘Human Factors 

Studies and Related Clinical Study 

Considerations in Combination Product 

Design and Development’’ issued on 

February 3, 2016 (81 FR 5764). FDA 

considered comments received on the 

draft guidance as the guidance was 

finalized. Changes from the draft to the 

final guidance include: change in format 

to a questions and answers format, 

deletion of HF information that is 

redundant with other FDA guidance 

documents and focusing the guidance 

on combination product specific issues, 

providing additional information in 

response to comments, clarification of 

the combination product critical task 

definition, further explanation of 

considerations to help identify 

combination product critical tasks, and 

replacement of an appendix of examples 

of user task failures with examples that 

provide a contextual discussion of 

combination product critical task 

considerations. In addition, editorial 

changes were made to improve clarity. 

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 ‘‘Application of 

Human Factors Engineering Principles 

for Combination Products: Questions 

and Answers.’’ 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 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections 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 for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information for 21 CFR part 312 for 

investigational new drug applications 

have been approved under OMB control 

number 0910–0014 and the collections 

of information for 21 CFR part 812 for 

investigational device exemptions have 

been approved under OMB control 

number 0910–0078. The collections of 

information in 21 CFR part 314 for new 

drug applications have been approved 

under OMB control number 0910–0001 

and the collections of information in 21 

CFR part 601 for biologics license 

applications have been approved under 

OMB control number 0910–0338. The 

collections of information in 21 CFR 

part 814, subparts A through E for 

premarket approval applications have 

been approved under OMB control 

number 0910–0231. The collections of 

information in 21 CFR part 807, subpart 

E for premarket notifications have been 

approved under OMB control number 

0910–0120 and the collections of 

information in 21 CFR 860, subpart D 

for De Novo classifications have been 

approved under OMB control number 

0910–0844. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/combination-products/ 

guidance-regulatory-information/ 

combination-products-guidancedocuments, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: September 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19404 Filed 9–7–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0984] 

Pulmonary-Allergy Drugs Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Pulmonary-Allergy Drugs 

Advisory Committee (the Committee). 

The general function of the Committee 

is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

November 17, 2023, from 9 a.m. to 5 

p.m. Eastern Time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 


lotter on DSK11XQN23PROD with NOTICES1