82612 Federal Register / Vol. 89, No. 198 / Friday, October 11, 2024 / Notices 

SUMMARY: Notice is hereby given of the 

appointment of new members to the 

GSA Senior Executive Service 

Performance Review Board. The 

Performance Review Board assures 

consistency, stability, and objectivity in 

the performance appraisal process. 

DATES: Applicable: October 11, 2024. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Nathaniel Williams, Acting Director, 

Executive Resources Division, Office of 

Human Resources Management, GSA, 

1800 F Street NW, Washington, DC 

20405, or via telephone at (571) 513– 

9451. 

SUPPLEMENTARY INFORMATION: Section 

4314(c)(1) through (5) of title 5 U.S.C 

requires each agency to establish, in 

accordance with regulation prescribed 

by the Office of Personnel Management, 

one or more SES performance review 

board(s). The board is responsible for 

making recommendations to the 

appointing and awarding authority on 

the performance appraisal ratings and 

performance awards for employees in 

the Senior Executive Service. 

The following have been designated 

as members of the Performance Review 

Board of GSA: 

• Katy Kale, Deputy Administrator— 

PRB Chair. 

• Christopher Bennethum, Assistant 

Commissioner for Assisted Acquisition 

Services, Federal Acquisition Service. 

• Lesley Briante, Associate Chief 

Information Officer of Digital 

Management, Office of GSA IT. 

• Aluanda Drain, Associate 

Administrator for Civil Rights, Office of 

Civil Rights. 

• Andrew Heller, Deputy 

Commissioner for Enterprise Strategy, 

Public Buildings Service. 

• Arron Helm, Chief Human Capital 

Officer, Office of Human Resources 

Management. 

• Dena McLaughlin, Executive 

Director, Catalog and Solicitation 

Management Program Management 

Office, Federal Acquisition Service. 

• Tanisha Palermo, Regional 

Commissioner, Public Buildings 

Service, Rocky Mountain Region. 

• Flavio Peres, Assistant 

Commissioner for Real Property 

Disposition, Public Buildings Service. 

• Camille Sabbakhan, Deputy General 

Counsel, Office of the General Counsel. 

Robin Carnahan, 

Administrator, General Services 

Administration. 

[FR Doc. 2024–23586 Filed 10–10–24; 8:45 am] 

BILLING CODE 6820–FM–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1262] 

Notice of Approval of Product Under 

Voucher: Rare Pediatric Disease 

Priority Review Voucher; TREMFYA 

(guselkumab) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of approval of a product 

redeeming a priority review voucher. 

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 issuance of priority 

review vouchers as well as the approval 

of products redeeming a priority review 

voucher. FDA has determined that the 

supplemental application for TREMFYA 

(guselkumab), approved September 11, 

2024, meets the criteria for redeeming 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 approval of a product 

redeeming a rare pediatric disease 

priority review voucher. Under section 

529 of the FD&C Act (21 U.S.C. 360ff), 

FDA will report the issuance of rare 

pediatric disease priority review 

vouchers and the approval of products 

for which a voucher was redeemed. 

FDA has determined that the 

supplemental application for TREMFYA 

(guselkumab) meets the redemption 

criteria. 

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 https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about TREMFYA 

(guselkumab), go to the ‘‘Drugs@FDA’’ 

website at https://www.accessdata.

fda.gov/scripts/cder/daf/. 

Dated: October 8, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–23629 Filed 10–10–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–1021] 

Notice to Public of Website Location of 

Center for Devices and Radiological 

Health Fiscal Year 2025 Proposed 

Guidance Development 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the website location where 

the Agency will post two lists of 

guidance documents that the Center for 

Devices and Radiological Health (CDRH) 

intends to publish in fiscal year (FY) 

2025. In addition, FDA has established 

a docket where interested parties may 

comment on the priority of topics for 

guidance, provide comments and/or 

propose draft language for those topics, 

suggest topics for new or different 

guidance documents, comment on the 

applicability of guidance documents 

that have issued previously, and 

provide any other comments that could 

benefit the CDRH guidance program and 

its engagement with interested parties. 

This feedback is critical to the CDRH 

guidance program to ensure that we 

meet the needs of interested parties. 

DATES: Either electronic or written 

comments on the notice must be 

submitted by December 10, 2024. 

ADDRESSES: You may submit comments 

as follows. 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 

December 10, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 198 / Friday, October 11, 2024 / Notices 82613 

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– 

2012–N–1021 for ‘‘Notice to Public of 

website Location of CDRH Fiscal Year 

2025 Proposed Guidance Development.’’ 

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.’’ 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. 

FOR FURTHER INFORMATION CONTACT: 

Erica Takai, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5456, Silver Spring, 

MD 20993–0002, 301–796–6353. 

SUPPLEMENTARY INFORMATION: 

I. Background 

During negotiations on the Medical 

Device User Fee Amendments of 2012, 

title II, Food and Drug Administration 

Safety and Innovation Act (Pub. L. 112– 

144), FDA agreed to meet a variety of 

quantitative and qualitative goals 

intended to help get safe and effective 

medical devices to market more quickly. 

Among these commitments included: 

• Annually posting a list of priority 

medical device guidance documents 

that the Agency intends to publish 

within 12 months of the date this list is 

published each fiscal year (the ‘‘A-list’’), 

and 

• Annually posting a list of device 

guidance documents that the Agency 

intends to publish, as the Agency’s 

guidance-development resources permit 

each fiscal year (the ‘‘B-list’’). 

The Medical Device User Fee 

Amendments of 2017 (MDUFA IV), Title 

II, FDA Reauthorization Act of 2017 

(Pub. L. 115–52), maintained these 

commitments. 

In addition, to ensure that final 

guidance documents continue to 

provide interested parties with the 

Agency’s current thinking, CDRH 

annually conducts a staged review of 

previously issued final guidances in 

collaboration with interested parties. 

CDRH intends to annually provide lists 

of previously issued final guidances that 

are subject to review in 10-year 

increments to facilitate a continuous 

and systematic assessment of the 

applicability of existing guidances. For 

instance, in FY 2025, CDRH is providing 

a list of the final guidance documents 

that issued in 2015, 2005, 1995, and 

1985; in FY 2026 we expect to provide 

a list of the final guidance documents 

that issued in 2016, 2006, 1996, and 

1986, and so on. Consistent with the 

Good Guidance Practices regulation at 

21 CFR 10.115(f)(4), CDRH would 

appreciate suggestions that CDRH revise 

or withdraw an already existing 

guidance document. We request that the 

suggestion clearly explain why the 

guidance document should be revised or 

withdrawn and, if applicable, how it 

should be revised. While we are 

requesting feedback on the list of 

previously issued final guidances 

located in the annual agenda website, 

feedback on any guidance is appreciated 

and will be considered. 

FDA welcomes comments on any or 

all of the guidance documents on the 

lists as explained in 21 CFR 10.115(f)(5). 

FDA has established Docket No. FDA– 

2012–N–1021 where comments on the 

FY 2025 lists, draft language for 

guidance documents on those topics, 

suggestions for new or different 

guidances, and relative priority of 

guidance documents may be submitted 

and shared with the public (see 

ADDRESSES). FDA believes this docket is 

a valuable tool for receiving information 

from interested parties. FDA anticipates 

that feedback from interested parties 

will allow CDRH to better prioritize and 

more efficiently draft guidances to meet 

the needs of the Agency and interested 

parties. 

In addition to posting the lists of 

prioritized device guidance documents, 

CDRH has identified as a priority, and 

has devoted resources to, finalization of 

draft guidance documents. To ensure 

the timely completion or reissuance of 

draft guidances, in FY 2015 CDRH 

committed to performance goals for 

current and future draft guidance 

documents. For draft guidance 

documents issued after October 1, 2014, 

CDRH committed to finalize, withdraw, 

reopen the comment period, or issue 

new draft guidance on the topic for 80 

percent of the documents within 3 years 

of the close of the comment period and 

for the remaining 20 percent, within 5 

years. As part of MDUFA IV 

commitments, FDA reaffirmed this 

commitment, as resources permit. 


ddrumheller on DSK120RN23PROD with NOTICES1
82614 Federal Register / Vol. 89, No. 198 / Friday, October 11, 2024 / Notices 

Fulfillment of these commitments 

will be reflected through the issuance of 

updated guidance on existing topics, 

withdrawal of guidances that no longer 

reflect FDA’s current thinking on a 

particular topic, and annual updates to 

the A-list and B-list announced in this 

notice. 

II. Website Location of Guidance Lists 

This notice announces the website 

location of the document that provides 

the A- and B-lists of guidance 

documents, which CDRH is intending to 

publish during FY 2025. To access these 

two lists, visit FDA’s website at https:/ 

www.fda.gov/medical-devices/guidancedocuments-medical-devices-andradiation-emitting-products/cdrhproposed-guidance-development. We 

note that the topics on these lists may 

be removed or modified based on 

current priorities, as well as comments 

received regarding these lists. 

Furthermore, FDA and CDRH priorities 

are subject to change at any time (e.g., 

newly identified safety issues). The 

Agency is not required to publish every 

guidance on either list if the resources 

needed would be to the detriment of 

meeting quantitative review timelines 

and statutory obligations. In addition, 

the Agency is not precluded from 

issuing guidance documents that are not 

on either list. 

Dated: October 7, 2024. 

Eric Flamm, 

Acting Associate Commissioner for Policy. 

[FR Doc. 2024–23544 Filed 10–10–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Advisory Committee on 

Minority Health 

AGENCY: Office of Minority Health, 

Office of the Secretary, U.S. Department 

of Health and Human Services. 

ACTION: Notice of meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the Advisory Committee on 

Minority Health (ACMH) will hold a 

meeting. This meeting will be open to 

the public. Preregistration is required 

for the public to attend the meeting, 

provide comments, and/or distribute 

printed material(s) to ACMH members. 

Information about the meeting is 

available from the designated contact 

person and will be posted on the HHS 

Office of Minority Health (OMH) 

website: www.minorityhealth.hhs.gov. 

Information about ACMH activities can 

be found on the OMH website under the 

heading About OMH, Committees and 

Working Groups. 

DATES: The ACMH meeting will be held 

on November 14–15, 2024 from 8:30 

a.m. to 5:30 p.m. EST each day. If the 

Committee completes its work before 

5:30 p.m., the meeting will adjourn 

early. 

ADDRESSES: The meeting will be held at 

the Tower Building at 1101 Wootton 

Parkway, Lower-Level Conference 

Room, Rockville, Maryland 20852 and 

will be accessible by webcast. Members 

of the public must register for the 

meeting by 5:00 p.m. EST on October 

29, 2024. Registered webcast 

participants will receive webcast access 

information prior to the meeting. 

FOR FURTHER INFORMATION CONTACT: 

Violet Woo, Designated Federal Officer, 

Advisory Committee on Minority 

Health, OMH, HHS, Tower Building, 

1101 Wootton Parkway, Suite 100, 

Rockville, Maryland 20852. Phone: 240– 

453–6816; email: OMH-ACMH@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Establishment of the ACMH is 

mandated under section 1707(c) of the 

PHS Act (42 U.S.C 300u–6(c) to provide 

advice to the Deputy Assistant Secretary 

for Minority Health on the development 

of goals and program activities related to 

OMH’s duties. 

The topic to be discussed during the 

meeting is the implementation of the 

updated Office of Management and 

Budget (OMB) federal race and ethnicity 

data collection standards. The focus will 

be opportunities for engagement with 

racial, ethnic, and tribal communitylevel organizations to support increased 

awareness of the race and ethnicity data 

collection standards and their intended 

goals within their communities. The 

recommendations will be given to the 

Deputy Assistant Secretary for Minority 

Health to inform efforts related to 

implementation of the revised OMB 

standards. Information on OMB’s 

updated federal race and ethnicity data 

collection standards can be found on 

this website: spd15revision.gov. 

The meeting is open to the public. 

Any individual who wishes to attend 

the meeting must register by sending an 

email to OMH-ACMH@hhs.gov by 5:00 

p.m. EST on October 29, 2024. Each 

registrant should provide their name, 

affiliation, email address, days 

attending, if planning to provide public 

verbal comments or printed statement, 

and if participation is in-person or via 

webcast. Registrants will receive 

webcast access information via email. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

contact OMH-ACMH@hhs.gov and 

reference this meeting. Requests for 

special accommodation should be made 

during registration or at least ten (10) 

business days prior to the meeting. 

Registered members of the public will 

have an opportunity to provide 

comments at the meeting. Public 

comments will be limited to two 

minutes per registered speaker during 

the time allotted. Individuals of the 

public may also submit and distribute 

electronic or printed statements or 

material(s) related to this meeting’s 

topic. Written statements or material(s) 

should be double-spaced with one-inch 

margins and not exceed two pages in 

length. Any content beyond the twopage limit will not be presented to the 

Committee. Individuals planning to 

submit electronic or printed material 

should email the material to OMHACMH@hhs.gov at least ten (10) 

business days prior to the meeting. 

Violet Woo, 

Designated Federal Officer, Advisory 

Committee on Minority Health. 

[FR Doc. 2024–23582 Filed 10–10–24; 8:45 am] 

BILLING CODE 4150–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group; Neural Basis of Psychopathology, 

Addictions and Sleep Disorders Study 

Section. 

Date: November 7–8, 2024. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: Hyatt Place Georgetown, 2121 M 

Street, Washington, DC 20037. 

Meeting Format: In Person. 


ddrumheller on DSK120RN23PROD with NOTICES1