32172 Federal Register / Vol. 87, No. 103 / Friday, May 27, 2022 / Notices 

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 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. Send one self-addressed 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: 

Elaine Chang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 2169, 

Silver Spring, MD 20993–0002, 240– 

402–2628. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Advanced Prostate Cancer: Developing 

Gonadotropin-Releasing Hormone 

Analogues.’’ This guidance describes 

FDA’s current recommendations 

regarding the overall development 

program and clinical trial designs for 

developing GnRH analogues to treat 

advanced prostate cancer. 

This guidance finalizes the draft 

guidance of the same title issued on July 

18, 2019 (84 FR 34400). FDA considered 

comments received on the draft 

guidance as the guidance was finalized. 

Changes from the draft to the final 

guidance included clarifying the scope 

of the guidance in the introduction 

section, adding recommendations on 

safety monitoring, and broadening 

recommendations on the appropriate 

trial population to include metastatic as 

well as biochemically recurrent disease 

rather than only metastatic. 

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 ‘‘Advanced Prostate 

Cancer: Developing GonadotropinReleasing Hormone Analogues.’’ 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 the 

OMB under the PRA. The collections of 

information in 21 CFR part 210 and 211, 

21 CFR part 314, and 21 CFR part 601 

have been approved under OMB control 

numbers 0910–0139, 0910–0001, and 

0910–0338, respectively. The 

collections of information in 21 CFR 

part 312 have been approved under 

OMB control number 0910–0014. The 

collections of information in 21 CFR 

201.56 and 201.57 for the content and 

format of labeling for human 

prescription drug and biological 

products have been approved under 

OMB control number 0910–0572. The 

collections of information in 21 CFR 

part 58 for good laboratory practice have 

been approved under OMB control 

number 0910–0119. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: May 23, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11410 Filed 5–26–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0589] 

General and Plastic Surgery Devices 

Panel of the Medical Devices 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 General and Plastic 

Surgery Devices Panel of the Medical 

Devices Advisory 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 

virtually on July 28, 2022, from 9 a.m. 

to 5:45 p.m. Eastern Time and July 29, 

2022, from 9 a.m. to 4 p.m. Eastern 

Time. 

ADDRESSES: Please note that due to the 

impact of the COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions, 

including information regarding special 

accommodations due to a disability, 

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–2022–N–0589. 

The docket will close on August 29, 

2022. Submit either electronic or 

written comments on this public 

meeting by August 29, 2022. Please note 

that late, untimely filed comments will 

not be considered. Electronic comments 

must be submitted on or before August 

29, 2022. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

August 29, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Comments received on or before July 

11, 2022, 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 


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Federal Register / Vol. 87, No. 103 / Friday, May 27, 2022 / Notices 32173 

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– 

2022–N–0589 for ‘‘General and Plastic 

Surgery Devices Panel of the Medical 

Devices 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: 

Candace Nalls, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5216, Silver Spring, 

MD 20993–0002, 301–636–0510, 

Candace.Nalls@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 the 

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: On July 28, 2022, the 

committee will discuss the topic of skin 

lesion analyzer technology and its 

application to detecting skin cancers in 

various patient care settings. The skin 

lesion analyzer devices on which the 

discussion is focused at this meeting are 

algorithm-based devices for adjunctive 

detection of various skin lesions, 

including skin cancers. We will refer to 

these computer algorithm-aided devices 

for adjunctive detection of lesions 

suspicious for skin cancers as Skin 

Lesion Analyzers (SLAs). In recent 

years, FDA has seen an increased 

interest in the development of skin 

lesion analyzers that employ artificial 

intelligence and machine learning. 

These devices include a range of 

technologies and intended user 

populations. FDA is interested in the 

committee members’ perspectives on 

approaches for evaluating the 

performance of SLA devices given the 

heterogeneity of technologies and 

indications. 

FDA is convening this committee to 

promote an open public discussion of, 

and seek expert opinion on, currently 

available scientific and clinical data 

pertaining to the diagnosing standard 

also known as ground truth, 

performance criteria, and patient 

population in future studies assisting 

medical providers in properly 

identifying skin lesions by a computer 

algorithm-aided device. The committee 

will be asked to discuss and provide 

recommendations regarding: 

• The diagnosing standard, or ground 

truth, based on factual data that should 

be used as a comparison for the 

performance of diagnostic devices 

including, but not limited to, histology, 

consensus opinion of a panel of 

dermatologists, opinion of a single 

dermatologist, or other means. 

• Acceptable thresholds for 

sensitivity and specificity based on the 

target diagnosis (melanoma, basal cell 

carcinoma (BCC), squamous cell 

carcinoma (SCC)), or on the intended 

user (dermatologist, primary care 

physician, lay user) if assessed for 

standalone performance. 

• Patient characteristics, including 

lower or higher incidence populations, 

that should be tested before marketing. 

• Balance of increased access with 

risk mitigation measures that are 

appropriate when the devices are used 

by lay people, by populations with very 

high or very low incidence of 

melanoma, by populations with low 

incidence, but high mortality associated 

with melanoma, or by the target 

diagnosis/lesion type (melanoma, BCC, 

SCC) 

On July 29, 2022, the committee will 

discuss the possible reclassification of 

approved computer-aided melanoma 

detection class III devices: (1) MelaFind, 

a device that uses multispectral imaging 

and was approved in 2012 (P090012; 

https://www.accessdata.fda.gov/scripts/ 

cdrh/cfdocs/cfpma/ 

pma.cfm?id=p090012), and (2) 

Nevisense, a device that measures 

impedance and was approved in 2017 

(P150046; https://

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfpma/pma.cfm?id=P150046). 


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32174 Federal Register / Vol. 87, No. 103 / Friday, May 27, 2022 / Notices 

Both Melafind and Nevisense devices 

are intended for use on cutaneous 

lesions suspicious for melanoma when 

a dermatologist chooses to obtain 

additional information when 

considering biopsy. The committee will 

discuss if there is sufficient information 

to reclassify computer-aided devices for 

adjunctive diagnostic information of 

lesions suspicious for melanoma from 

class III to class II, and what special 

controls may be appropriate to provide 

reasonable assurance of safety and 

effectiveness for these devices if they 

are reclassified as class II devices. 

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 after the meeting. Background 

material is 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 

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, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

July 11, 2022, will be provided to the 

panel. Oral presentations from the 

public will be scheduled on July 28, 

2022, between approximately 1 p.m. 

and 2 p.m. Eastern Time, and on July 

29, 2022, between approximately 1 p.m. 

and 2 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 June 28, 2022. 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 June 29, 2022. 

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 Artair Mallett, 

at Artair.Mallett@fda.hhs.gov or 301– 

796–9638, 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. app. 2). 

Dated: May 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11420 Filed 5–26–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Establishment of the Advanced 

Research Projects Agency for Health 

AGENCY: National Institutes of Health, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The National Institutes of 

Health (NIH) has modified its structure. 

This notice announces the 

establishment of the Advanced Research 

Projects Agency for Health (or ARPA– 

H). 

DATES: This reorganization was 

approved by the Secretary of Health and 

Human Services and takes effect May 

24, 2022. 

SUPPLEMENTARY INFORMATION: Part N, 

National Institutes of Health, of the 

Statement of Organization, Functions, 

and Delegations of Authority for the 

Department of Health and Human 

Services (HHS) (May 27, 1975 at 40 FR 

22859, as amended most recently on 

November 3, 2004 at 69 FR 64081, and 

redesignated from Part HN as Part N on 

November 9, 1995 at 60 FR 56605, is 

amended as set forth below to 

implement ARPA–H. 

Section N, Organization and 

Functions is amended as follows: 

(1) Under Grants Management Branch 

(NW83, formerly HNW83) insert the 

following: 

Advanced Research Projects Agency 

for Health (NY, formerly HNY). (1) 

Provides leadership for high-risk, highreward biomedical and health research 

to speed application and 

implementation of health breakthroughs 

equitably. (2) Creates, supports, and 

manages programs to catalyze the 

development of transformative, 

evidenced-based, use-driven 

capabilities, platforms, and technologies 

in a range of biomedical and health 

research areas. (3) Facilitates 

partnerships and collaboration among 

government, academia, industry, and 

other sectors to accelerate the 

translation of innovation into 

meaningful and measurable benefits for 

the nation. (4) Converts use-driven 

research into tangible, sustainable 

solutions for patients. 

Acquisition and Contracting Office 

(NY2, formerly HNY2). (1) Advises the 

ARPA–H Director and staff on 

acquisition and contract and grant 

financial advisory services. (2) 

Develops/implements ARPA–H policies, 

provides oversight, and manages the 

operational components in the areas of 

acquisition and contracts management, 

including other transactions. (3) 

Manages and conducts a comprehensive 

program of all research and 

development contracting, non-research 

and development contracting, ARPA–H 

support contracting, and commercial 

item acquisitions using simplified 

acquisition procedures, GSA Federal 

Supply Schedule acquisitions and 

simplified acquisitions. (4) Provides 

advice and assistance regarding all 

phases of the acquisition cycle from 

planning to closeout with the purpose of 

accomplishing all acquisitions needed 

for the scientific mission and all related 

acquisitions required by its customers. 

Comptroller’s Office (NY3, formerly 

HNY3). (1) Directs ARPA–H-wide 

budget policy, planning, analysis, 

formulation, and presentation, in 

collaboration with HHS Office of the 

Assistant Secretary for Financial 

Resources and NIH Office of Budget. (2) 

Manages the ARPA–H appropriated 

budget, including reprogramming and 

coordination of the use of the Director’s 

Discretionary Fund and transfer 

authority. (3) Advises the ARPA–H 

Director and staff and provides 

leadership and direction for budgetary 

matters and financial management 

activities. (4) Develops policies and 

instructions for central services budget 

preparation and presentation. (5) 

Administers allocation of funds and 

manages a system of fund and budgetary 

controls. (6) Provides an ARPA–H 

manpower resource control system 

designed to allocate resources. (7) 

Provides, develops, and maintains an 

ARPA–H Management Account 


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