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
Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices 62095 

Answers to commonly asked 

questions about FDA advisory 

committee meetings may be accessed at: 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2023–N–0984. 

The docket will close on November 16, 

2023. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 16, 2023. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

Comments received on or before 

November 2, 2023, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

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 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–N–0984 for ‘‘Pulmonary-Allergy 

Drugs Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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.’’ FDA 

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 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 the 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. 

FOR FURTHER INFORMATION CONTACT: 

Takyiah Stevenson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 240– 

402–2507, email: PADAC@fda.hhs.gov, 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area). A notice in the Federal Register 

about last-minute modifications that 

impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check FDA’s website at 

https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing and/or video 

conferencing platform. The Committee 

will discuss new drug application 

215010, for gefapixant oral tablets, 

submitted by Merck Sharp & Dohme 

Corp., for the proposed indication of 

treatment of adults with refractory or 

unexplained chronic cough. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at https://

www.fda.gov/AdvisoryCommittees/ 

Calendar/default.htm. Scroll down to 

the appropriate advisory committee 

meeting link. The meeting will include 

slide presentations with audio and 

video components to allow the 

presentation of materials in a manner 

that most closely resembles an in-person 

advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 


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62096 Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before November 2, 

2023, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled between 

approximately 1:30 p.m. and 2:30 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before October 

25, 2023. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 26, 2023. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Takyiah 

Stevenson (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

No participant will be prejudiced by 

this waiver, and that the ends of justice 

will be served by allowing for this 

modification to FDA’s advisory 

committee meeting procedures. 

Dated: September 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19407 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–3137] 

Endpoints and Trial Designs To 

Advance Drug Development in Kidney 

Transplantation; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the following public 

meeting on ‘‘Endpoints and Trial 

Designs To Advance Drug Development 

in Kidney Transplantation.’’ 

DATES: The public meeting will be held 

on November 9, 2023, from 8 a.m. to 

4:30 p.m. Eastern Time. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/about-fda/visitorinformation. 

FOR FURTHER INFORMATION CONTACT: 

Ozlem Belen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave, Bldg. 22, Rm. 6118, 

Silver Spring, MD 20993–0002, 301– 

796–0676. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The goal of this public meeting is to 

facilitate discussion among FDA, 

academicians, and industry 

representatives on endpoint and trial 

designs to promote drug development in 

kidney transplantation. The last drug 

FDA approved for use in prophylaxis of 

organ rejection in kidney transplant was 

belatacept in 2011. It is well established 

that kidney transplantation offers a clear 

survival and quality-of-life advantage to 

patients with end-stage kidney disease. 

The current treatment options have 

resulted in excellent short-term graft 

and patient survival but not without 

long-term side effects. FDA recognizes 

the importance of offering safe and 

effective drugs with a tolerable adverse 

effect profile to preserve kidney 

allografts for patients. This public 

meeting aims to discuss current and 

future potential endpoints and trial 

designs that can promote development 

in this area of unmet need. 

II. Topics for Discussion at the Public 

Meeting 

The topics of discussion include: 

• Efficacy endpoints for prophylaxis 

of kidney transplant rejection trials: 

current state of primary endpoints and 

future potential endpoints. 

• Biopsy proven acute rejection 

efficacy failure: long-term impact, 

impact of treatment, and grade of 

rejection. 

• Noninferiority trials: identifying 

clinically important noninferiority 

margin, safety, and secondary efficacy 

endpoints. 

• Enrichment as a tool in trial design: 

identifying target populations. 

III. Attending the Public Meeting 

Registration: If you wish to attend the 

public meeting (either in person or via 

Zoom), please register by October 26, 

2023, at 4 p.m. Eastern Time. Visit the 

registration page here: https://kidneytransplantationworkshop.eventbrite.com. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. If time and space permit, 

onsite registration on the day of the 

public meeting will be provided 

beginning at 7:30 a.m. Eastern Time. We 

will let registrants know if registration 

closes before the day of the public 

meeting/public workshop. 

If you need special accommodations 

due to a disability, please contact 

ONDPublicMTGSupport@fda.hhs.gov 

no later than October 18, 2023. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be virtual via Zoom. Zoom links will be 

sent using the email provided by 

persons who register. We will post a 

link to the archived recording on http:// 

wcms-internet.fda.gov/drugs/newsevents-human-drugs/endpoints-andtrial-designs-advance-drugdevelopment-kidney-transplantation11092023?check_logged_in=1 


lotter on DSK11XQN23PROD with NOTICES1