61600 Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 

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 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19284 Filed 9–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2607] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the award 

of the priority review voucher. FDA has 

determined that SOHONOS 

(palovarotene), manufactured by Ipsen 

Biopharmaceuticals, Inc., meets the 

criteria for a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394, email: Cathryn.Lee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that SOHONOS (palovarotene), 

approved on August 16, 2023, and 

manufactured by Ipsen 

Biopharmaceuticals, Inc., meets the 

criteria for a priority review voucher. 

SOHONOS (palovarotene) capsules are 

indicated for reduction in volume of 

new heterotopic ossification in adults 

and pediatric patients (aged 8 years and 

older for females and 10 years and older 

for males) with fibrodysplasia ossificans 

progressiva. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to http://www.fda.gov/ForIndustry/ 

Developing

ProductsforRareDiseasesConditions/ 

RarePediatricDisease

PriorityVoucherProgram/default.htm. 

For further information about 

SOHONOS (palovarotene), go to the 

‘‘Drugs@FDA’’ website at http://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: September 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19289 Filed 9–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2023–D–3132, FDA– 

2023–D–3133, and FDA–2023–D–3134] 

Modernizing the Food and Drug 

Administration’s Premarket 

Notification Program; Draft Guidances 

for Industry and Food and Drug 

Administration 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 three 

draft guidances entitled ‘‘Evidentiary 

Expectations for 510(k) Implant 

Devices,’’ ‘‘Recommendations for the 

Use of Clinical Data in Premarket 

Notification [510(k)] Submissions,’’ and 

‘‘Best Practices for Selecting a Predicate 

Device to Support a Premarket 

Notification [510(k)] Submission.’’ FDA 

is issuing these guidances to improve 

the predictability, consistency, and 

transparency of the 510(k) premarket 

review process. The draft guidances are 

not final nor are they for 

implementation at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 6, 2023 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 Docket No. FDA–2023–D– 

3132 for ‘‘Evidentiary Expectations for 

510(k) Implant Devices,’’ Docket No. 

FDA–2023–D–3133 for 

‘‘Recommendations for the Use of 

Clinical Data in Premarket Notification 

[510(k)] Submissions,’’ or Docket No. 

FDA–2023–D–3134 for ‘‘Best Practices 

for Selecting a Predicate Device to 

Support a Premarket Notification 

[510(k)] Submission.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 61601 

1Available at https://www.fda.gov/about-fda/ 

cdrh-reports/medical-device-safety-action-planprotecting-patients-promoting-public-health. 

2Available at https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/510kprogram-evaluating-substantial-equivalencepremarket-notifications-510k. 

3Available at https://wayback.archive-it.org/ 

7993/20190206202131/https://www.fda.gov/ 

AboutFDA/CentersOffices/OfficeofMedical

ProductsandTobacco/CDRH/CDRHReports/ 

ucm604500.htm. Public comments submitted can 

be searched under the docket FDA–2018–N–4751, 

available at https://www.regulations.gov/docket/ 

FDA-2018-N-4751. 

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)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Evidentiary 

Expectations for 510(k) Implant 

Devices,’’ ‘‘Recommendations for the 

Use of Clinical Data in Premarket 

Notification [510(k)] Submissions,’’ or 

‘‘Best Practices for Selecting a Predicate 

Device to Support a Premarket 

Notification [510(k)] Submission’’ to the 

Office of Policy, 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: 

Angela DeMarco, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2436, Silver Spring, 

MD 20993–0002, 301–796–4471; or 

Anne Taylor, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7242, 

Silver Spring, MD 20993, 240–402– 

8113. 

SUPPLEMENTARY INFORMATION: 

I. Background 

As part of FDA’s Medical Device 

Safety Action Plan: Protecting Patients, 

Promoting Public Health,1 FDA 

committed to strengthen and modernize 

the premarket notification (510(k)) 

Program. FDA is issuing these three 

draft guidances to enhance the 

transparency, consistency, and 

predictability of the 510(k) premarket 

review process. 

In ‘‘Evidentiary Expectations for 

510(k) Implant Devices,’’ FDA discusses 

considerations that are generally 

relevant to all types of implants subject 

to 510(k) requirements. This draft 

guidance is intended to serve as a 

primary resource, used in conjunction 

with other guidances, to provide clarity 

and facilitate discussions regarding 

expectations for performance data that 

may be necessary to establish 

substantial equivalence for implanted 

medical devices. However, the type and 

quantity of performance data needed to 

support a substantial equivalence 

determination for a particular device 

will vary depending on the device and/ 

or device type and on the differences 

from the predicate device. 

In ‘‘Recommendations for the Use of 

Clinical Data in Premarket Notification 

[510(k)] Submissions,’’ FDA clarifies 

and provides additional context for 

situations when clinical data may be 

necessary to demonstrate substantial 

equivalence, as initially described in the 

final guidance ‘‘The 510(k) Program: 

Evaluating Substantial Equivalence in 

Premarket Notifications [510(k)]’’ 2

(‘‘510(k) Program Guidance’’). This draft 

guidance expands on the scenarios 

described in the 510(k) Program 

Guidance, describes another scenario, 

and provides additional examples to 

illustrate when clinical data may or may 

not be necessary to include in a 510(k) 

submission to demonstrate substantial 

equivalence. 

Finally, in ‘‘Best Practices for 

Selecting a Predicate Device to Support 

a Premarket Notification [510(k)] 

Submission,’’ FDA proposes four best 

practices for choosing a predicate device 

used to support a 510(k) submission. 

Initially, FDA considered making public 

on its website those cleared devices that 

demonstrated substantial equivalence to 

older predicate devices. FDA also 

considered focusing on predicates that 

were more than 10 years old as a 

starting point. FDA issued a public 

notice on its website that requested 

public comment on this proposal.3 After 

considering the docket comments, FDA 

believes use of best practices that 

encourage the use of predicate devices 

with certain characteristics, rather than 

focusing on the age of the predicate, will 

support modernization of the 510(k) 

Program with respect to the use of 

predicate devices and encourage the 

evolution of safer and more effective 

medical devices. 

These draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidances, when 

finalized, will represent the current 

thinking of FDA on the topics discussed 

in ‘‘Evidentiary Expectations for 510(k) 

Implant Devices,’’ ‘‘Recommendations 

for the Use of Clinical Data in Premarket 

Notification [510(k)] Submissions,’’ and 

‘‘Best Practices for Selecting a Predicate 

Device to Support a Premarket 

Notification [510(k)] Submission.’’ 

These draft guidances do not establish 

any rights for any person and are 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. Electronic Access 

Persons interested in obtaining copies 

of these draft guidances may do so by 

downloading electronic copies from the 

internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveVerDate Sep<11>2014 19:19 Sep 06, 2023 Jkt 259001 PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 E:\FR\FM\07SEN1.SGM 07SEN1

ddrumheller on DSK120RN23PROD with NOTICES1
61602 Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 

regulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. These 

guidance documents are also available 

at https://www.regulations.gov, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. 

Persons unable to download an 

electronic copy of ‘‘Evidentiary 

Expectations for 510(k) Implant 

Devices’’ (document number 

GUI00020017), ‘‘Recommendations for 

the Use of Clinical Data in Premarket 

Notification [510(k)] Submissions’’ 

(document number GUI00020016), or 

‘‘Best Practices for Selecting a Predicate 

Device to Support a Premarket 

Notification [510(k)] Submission’’ 

(document number GUI00020006) may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number and complete 

title to identify the guidance you are 

requesting. 

III. Paperwork Reduction Act of 1995 

While these guidances contain no 

new collection of information, they do 

refer to previously approved FDA 

collections of information. The 

previously approved collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521). The collections of information in 

the following table have been approved 

by OMB: 

21 CFR part; guidance; or FDA form Topic OMB control 

No. 

807, subpart E .......................................... Premarket notification .................................................................................................. 0910–0120 

‘‘Requests for Feedback and Meetings for 

Medical Device Submissions: The QSubmission Program’’.

Q-Submissions and Early Payor Feedback Request Programs for Medical Devices 0910–0756 

800, 801, 809, and 830 ............................ Medical Device Labeling Regulations; Unique Device Identification ........................... 0910–0485 

803 ............................................................ Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor reporting.0910–0437 

810 ............................................................ Medical Device Recalls ................................................................................................ 0910–0432 

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

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

Forms FDA 3500 and FDA 3500A ........... Medical device adverse event reporting—MedWatch ................................................. 0910–0291 

58 .............................................................. Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies ..... 0910–0119 

Dated: September 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19283 Filed 9–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Public Comment Request; 

Information Collection Request Title: 

Health Professions Student Loan 

Program, Loans for Disadvantaged 

Students Program, Primary Care Loan 

Program, and Nursing Student Loan 

Program Administrative Requirements, 

OMB No. 0915–0047—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for the opportunity for 

public comment on proposed data 

collection projects of the Paperwork 

Reduction Act of 1995, HRSA 

announces plans to submit an 

Information Collection Request (ICR), 

described below, to the Office of 

Management and Budget (OMB). Prior 

to submitting the ICR to OMB, HRSA 

seeks comments from the public 

regarding the burden estimate below; or 

any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than November 6, 

2023. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at 301–443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Health Professions Student Loan (HPSL) 

Program, Loans for Disadvantaged 

Students (LDS) Program, Primary Care 

Loan (PCL) Program, and Nursing 

Student (Loan (NSL) Program 

Administrative Requirements, OMB No. 

0915–0047—Revision. 

Abstract: This clearance request is for 

approval of the HPSL Program, LDS 

Program, PCL Program, and NSL 

Program Administrative Requirements. 

The HPSL Program, authorized by 

Public Health Service (PHS) Act 

sections 721–722 and 725–735, is a 

grant program where recipients provide 

long-term, low-interest loans to students 

attending schools of medicine, 

osteopathic medicine, dentistry, 

veterinary medicine, optometry, 

podiatric medicine, and pharmacy. The 

LDS Program, authorized by PHS Act 

sections 721–722 and 724–735, is a 

grant program where recipients provide 

long-term, low interest loans to certain 

students attending schools of allopathic 

medicine, osteopathic medicine, 

podiatric medicine, dentistry, 

optometry, pharmacy, and veterinary 

medicine. The PCL Program, authorized 

by PHS Act sections 721–723 and 725– 

735, is a grant program where recipients 

provide long-term, low interest loans to 

students attending schools of allopathic 

medicine and osteopathic medicine to 

practice primary health care. The NSL 

Program, authorized by PHS Act 

sections 835–842, is a grant program 

where recipients provide long-term, 

low-interest loans to students who 

attend eligible schools of nursing in 

programs leading to a diploma degree, 

an associate degree, a baccalaureate 

degree, or a graduate degree in nursing. 

These programs also have a number of 

recordkeeping and reporting 

requirements for academic institutions 

and loan applicants. The applicable 

program regulations are found in 42 

CFR 57.201–218 and 57.301–318. HRSA 

proposes revisions to the Annual 


ddrumheller on DSK120RN23PROD with NOTICES1