107148 Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices 

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: 

Kunal Naik, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 240– 

402–8717. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 25, 

2024 (89 FR 60436), FDA requested 

information and comments. Interested 

persons were originally given until 

September 23, 2024, to comment on 

evaluating and mitigating the 

immunogenicity risk of host cell 

proteins. 

Following publication of the July 25, 

2024, notice, FDA received a request to 

allow interested persons additional time 

to comment. The requester asserted that 

the time period of 60 days was 

insufficient to respond fully to FDA’s 

specific requests for comments and to 

allow potential respondents to 

thoroughly evaluate and address 

pertinent issues. 

II. Electronic Access 

Persons with access to the internet 

may obtain relevant guidance at https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

clinical-pharmacology-considerationspeptide-drug-products. 

Dated: December 23, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31365 Filed 12–30–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5830] 

Advisory Committee; Dermatologic 

and Ophthalmic Drugs Advisory 

Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the renewal of the 

Dermatologic and Ophthalmic Drugs 

Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Dermatologic and 

Ophthalmic Drugs Advisory Committee 

for an additional 2 years beyond the 

charter expiration date. The new charter 

will be in effect until the October 7, 

2026, expiration date. 

DATES: Authority for the Dermatologic 

and Ophthalmic Drugs Advisory 

Committee will expire on October 7, 

2026, unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

LaToya Bonner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002, 301– 

796–2855, DODAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Dermatologic and 

Ophthalmic Drugs Advisory Committee 

(the Committee). The Committee is a 

discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. The Committee 

advises the Commissioner or designee 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

available data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the treatment of dermatologic and 

ophthalmic disorders and makes 

appropriate recommendations to the 

Commissioner of Food and Drugs. 

Pursuant to its charter, the Committee 

shall consist of a core of 12 voting 

members including 2 Chairpersons. 

Members and the Chairpersons are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

dermatology, ophthalmology, dentistry, 

immunology, epidemiology or statistics, 

and other related professions. Members 

will be invited to serve for overlapping 

terms of up to 4 years. Non-Federal 

members of this committee will serve as 

Special Government Employees or 

representatives. Federal members will 

serve as Regular Government Employees 

or Ex-Officios. The core of voting 

members may include one technically 

qualified member, selected by the 

Commissioner or designee, who is 

identified with consumer interests and 

is recommended by either a consortium 

of consumer-oriented organizations or 

other interested persons. In addition to 

the voting members, the Committee may 

include one non-voting representative 

member who is identified with industry 

interests. There may also be an alternate 

industry representative. 

The Commissioner or designee shall 

have the authority to select members of 

other scientific and technical FDA 

advisory committees (normally not to 

exceed 10 members) to serve 

temporarily as voting members and to 

designate consultants to serve 

temporarily as voting members when: 

(1) expertise is required that is not 

available among current voting standing 

members of the Committee (when 

additional voting members are added to 

the Committee to provide needed 

expertise, a quorum will be based on the 

combined total of regular and added 

members), or (2) to comprise a quorum 

when, because of unforeseen 

circumstances, a quorum is or will be 

lacking. Because of the size of the 

Committee and the variety in the types 

of issues that it will consider, FDA may, 

in connection with a particular 

committee meeting, specify a quorum 

that is less than a majority of the current 

voting members. The Agency’s 

regulations (21 CFR 14.22(d)) authorize 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 250 / Tuesday, December 31, 2024 / Notices 107149 

a committee charter to specify quorum 

requirements. 

If functioning as a medical device 

panel, an additional non-voting 

representative member of consumer 

interests and an additional non-voting 

representative member of industry 

interests will be included in addition to 

the voting members. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

dermatologic-and-ophthalmic-drugsadvisory-committee/dermatologic-andophthalmic-drugs-advisory-committeecharter or by contacting the Designated 

Federal Officer (see FOR FURTHER

INFORMATION CONTACT). In light of the 

fact that no change has been made to the 

committee name or description of 

duties, no amendment will be made to 

21 CFR 14.100. 

This notice is issued under the 

Federal Advisory Committee Act as 

amended (5 U.S.C. 1001 et seq.). For 

general information related to FDA 

advisory committees, please visit us at 

http://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: December 23, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31363 Filed 12–30–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Advanced Research Projects 

Agency for Health, Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This document announces 

that the Establishment of the Advanced 

Research Projects Agency for Health 

(ARPA–H) is being amended to reflect a 

revised organizational structure for 

ARPA–H that aligns with current 

statutory requirements. See 42 U.S.C. 

290c(a)(2). 

SUPPLEMENTARY INFORMATION: The 

Establishment of the Advanced 

Research Projects Agency for Health 

(ARPA–H) (May 24, 2022, at 87 FR 

32174) should now read as follows: 

Section I. Mission 

The mission of ARPA–H is to (1) 

expand technical possibilities for the 

future of health, (2) forge a resilient 

health ecosystem to ensure optimal 

well-being for all, (3) drive scalable 

solutions to improve health care access 

and affordability, (4) build proactive 

health capacity to keep people from 

becoming patients, (5) foster data-driven 

innovation across the health ecosystem, 

and (6) increase the probability of 

successful transition. 

Section II. Organization 

ARPA–H consists of the following 

offices and personnel: 

The ARPA–H Office of the Director 

The ARPA–H Office of the Director 

(Director’s Office (DIRO)) is comprised 

of: 

1. The ARPA–H Director 

2. Deputy Director 

3. Chief of Staff 

4. Such other staff as necessary to 

support the Office of the Director. 

The ARPA–H Director is appointed by 

the President (42 U.S.C. 290c (1)) and 

reports directly to the Secretary of 

Health and Human Services. 42 U.S.C. 

290c (3). The Secretary has delegated all 

determinations regarding ARPA–H 

programs and operations to be in the 

sole authority and discretion of the 

Director. Consistent with 42 U.S.C. 

290c(c)(4)(B), this includes all decisions 

regarding the approval, termination and 

funding of all ARPA–H projects and 

programs. 

DIRO’s functions and responsibilities 

are as follows: (1) Oversee the creation 

of agency technical strategy, program 

approval, prioritization and 

implementation (2) Lead all aspects of 

internal Director’s Office operations, 

including ongoing management of the 

agency’s communications, legislative, 

governmental, legal, international, and 

mission office activities (3) Serve as the 

primary liaison for all Executive and 

Legislative functions of the 

organization, and fulfills principal level 

duties across HHS, including 

engagement with the Secretary and 

counselors (4) Serve as the primary 

liaison to Technical Staff, including 

program managers and their teams, and 

the Director’s Advisory staff to ensure 

consistent and effective coordination 

and communication. 

The Health Science Futures Office 

The Health Science Futures Office 

(HSFO) is comprised of: 

1. Director 

2. Deputy Director 

3. Such other staff as necessary to 

support the HSF Director. 

The HSFO’s functions and 

responsibilities are as follows: (1) 

Remove scientific and technological 

limitations that stymie our nation’s 

progress toward new solutions for the 

health care of the future. (2) Cultivate 

novel, agile tools that will facilitate 

revolutionary advances in medical care. 

(3) Leverage the latest scientific 

breakthroughs and invests in the 

development of platforms and 

technologies that do not yet exist. (4) 

Propose agency-sponsored research 

programs to the ARPA–H Director, 

ensuring they align with strategic 

objectives. 

The Resilient Systems Office 

The Resilient Systems Office (RSO) is 

comprised of is comprised of: 

1. Director 

2. Deputy Director 

3. Such other staff as necessary to 

support the RSO 

RSO’s mission and responsibilities are 

as follows: (1) Drive advances in health 

systems to improve their resilience, 

robustness, and interoperability, as well 

as their ability to adapt to unforeseen 

events, such as cyber-attacks, hospital 

closures, staffing shortages, emerging 

pathogens, and natural disasters. (2) 

Improve the continuity of care during 

regional and national emergencies, 

provides time savings to healthcare 

workforces, enhances quality of care 

across geographies, improves the 

robustness of clinical artificial 

intelligence (AI) applications, makes it 

easier for patients and clinicians to 

make informed decisions, and reduces 

gaps between advanced research and 

clinical care (3) Develop, implement, 

and manage novel, innovative scientific 

and technical programs aimed at 

improving health outcomes. (4) Propose 

agency-sponsored research programs to 

the ARPA–H Director, ensuring they 

align with strategic objectives. 

The Scalable Solutions Office 

The Scalable Solutions Office (SSO) is 

comprised of: 

1. Director 

2. Deputy Director 

3. Such other staff as necessary to 

support the SSO. 

SSO’s functions and responsibilities 

are as follows: (1) Aim to improve 

health care access and affordability for 

all Americans by working with partners 

to streamline manufacturing processes, 

optimize distribution networks, and 

develop innovative delivery methods to 

bring critical health technologies and 

treatments to underserved communities 

and remote areas. (2) Focus on 

advancing research and development to 

create scalable health solutions, 

expanding the reach of proven 

technologies, and accelerating their 

integration into the healthcare system. 


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