62380 Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices 

II. Nomination Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

representative of the interests of the 

tobacco manufacturing industry. Under 

part 14 (21 CFR part 14), nominations 

must include a current re ́sume ́ or 

curriculum vitae for each nominee, 

including current business address and/ 

or home address, telephone number, 

and email address if available. 

Nominations must also specify the 

advisory committee for which the 

nominee is recommended and must 

acknowledge that the nominee is aware 

of the nomination unless selfnominated. The nomination should be 

sent to the FDA Advisory Committee 

Membership Nomination Portal (see 

ADDRESSES) within 30 days of 

publication of this document (see 

DATES). FDA will forward all 

nominations to the organizations 

expressing interest in participating in 

the selection process. (Persons who 

nominate themselves as nonvoting 

industry representatives will not 

participate in the selection process.) 

III. Selection Procedure 

The Agency is also seeking names of 

organizations to participate in the 

selection of the nonvoting 

representative of the interests of the 

tobacco manufacturing industry. Any 

industry organization interested in 

participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest in participating in 

the selection group, attaching a 

complete list of all organizations 

participating in selection; and a list of 

all non-voting nominees along with 

their current re ́sume ́s. The letter will 

also state that it is the responsibility of 

the interested organizations on the 

selection group to confer with one 

another and to select a candidate and an 

alternative as backup, within 60 days 

after the receipt of the FDA letter, to 

serve as the nonvoting member to 

represent industry interests for the 

TPSAC. The interested organizations are 

not bound by the list of nominees in 

selecting a candidate. However, if no 

individual is selected within 60 days, 

the Commissioner will select the 

nonvoting member to represent industry 

interests. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.) and part 14, relating 

to advisory committees. 

Dated: September 6, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19499 Filed 9–8–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0008] 

Request for Nominations From 

Industry Organizations Interested in 

Participating in the Selection Process 

for Nonvoting Industry 

Representatives and Request for 

Nominations for Nonvoting Industry 

Representatives on the Vaccines and 

Related Biological Products Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting that any industry 

organizations interested in participating 

in the selection of nonvoting industry 

representatives to serve on the Vaccines 

and Related Biological Products 

Advisory Committee (VRBPAC) for the 

Center for Biologics Evaluation and 

Research notify FDA in writing. FDA is 

also requesting nominations for a 

nonvoting industry representative(s) to 

serve on the VRBPAC. A nominee may 

either be self-nominated or nominated 

by an organization to serve as a 

nonvoting industry representative. 

Nominations will be accepted for 

current vacancies effective with this 

notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by October 11, 2023 (see sections 

I and II of this document for further 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by October 11, 

2023. 

ADDRESSES: All statements of interest 

from industry organizations interested 

in participating in the selection process 

of nonvoting industry representative 

nominations should be sent via email to 

Sussan Paydar (see FOR FURTHER

INFORMATION CONTACT). All nominations 

for nonvoting industry representatives 

must be submitted electronically by 

accessing the FDA Advisory Committee 

Membership Nomination Portal at: 

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

FACTRSPortal/FACTRS/index.cfm. 

Information about becoming a member 

of an FDA advisory committee can also 

be obtained by visiting FDA’s website 

at: https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Sussan Paydar or Valerie Vashio, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

1333, Silver Spring, MD 20993–0002, 

202–657–8533, email: CBERVRBPAC@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency intends to add a nonvoting 

industry representative(s) to the 

following advisory committee: 

I. Vaccines and Related Biological 

Products Advisory Committee 

The Committee reviews and evaluates 

data concerning the safety, 

effectiveness, and appropriate use of 

vaccines and related biological products 

that are intended for use in the 

prevention, treatment, or diagnosis of 

human diseases, and as required, any 

other products for which the Food and 

Drug Administration has regulatory 

responsibility. The Committee also 

considers the quality and relevance of 

FDA’s research program which provides 

scientific support for the regulation of 

these products and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs (the Commissioner). 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter via email stating that interest to 

the FDA contact (see FOR FURTHER

INFORMATION CONTACT) within 30 days of 

publication of this document (see 

DATES). Within the subsequent 30 days, 

FDA will send a notification to each 

organization that has expressed an 

interest, attaching a complete list of all 

such organizations and a list of all 

nominees along with their current 

re ́sume ́s. The letter will also state that 

it is the responsibility of the interested 

organizations to confer with one another 

and to select a candidate, within 60 

days after the receipt of the FDA letter, 

to serve as the nonvoting member to 

represent industry interests for the 

committee. The interested organizations 

are not bound by the list of nominees in 

selecting a candidate. However, if no 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 174 / Monday, September 11, 2023 / Notices 62381 

individual is selected within 60 days, 

the Commissioner will select the 

nonvoting member to represent industry 

interests. 

III. Application Procedure 

Individuals may self-nominate, and/or 

an organization may nominate one or 

more individuals, to serve as a 

nonvoting industry representative. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business address and telephone number, 

email address if available, and a signed 

copy of the Acknowledgement and 

Consent form available at the FDA 

Advisory Committee Membership 

Nomination Portal (see ADDRESSES) 

within 30 days of publication of this 

document (see DATES). Nominations 

must also specify the advisory 

committee for which the nominee is 

recommended. Nominations must also 

acknowledge that the nominee is aware 

of the nomination unless selfnominated. FDA will forward all 

nominations to the organizations 

expressing interest in participating in 

the selection process for the committee. 

Persons who nominate themselves as 

nonvoting industry representatives will 

not participate in the selection process. 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and, therefore, encourages 

nominations of appropriately qualified 

candidates from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.) and 21 CFR part 14, 

relating to advisory committees. 

Dated: September 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19496 Filed 9–8–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–2396] 

Chemistry, Manufacturing, and 

Controls Development and Readiness 

Pilot Program; Program 

Announcement 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

year two opportunity for a limited 

number of applicants to participate in a 

Chemistry, Manufacturing, and Controls 

(CMC) Development and Readiness Pilot 

(CDRP) program to facilitate the 

expedited CMC development of 

products under an investigational new 

drug application (IND), where 

warranted, based on the anticipated 

clinical benefit of earlier patient access 

to the products. FDA has implemented 

this pilot program to facilitate CMC 

readiness for selected Center for 

Biologics Evaluation and Research 

(CBER)- and Center for Drug Evaluation 

and Research (CDER)-regulated products 

with accelerated clinical development 

timelines. To accelerate CMC 

development and facilitate CMC 

readiness, the pilot features increased 

communication between FDA and 

sponsors and explores the use of 

science- and risk-based regulatory 

approaches, such as those described in 

FDA guidance, as applicable. This 

notice outlines the eligibility criteria 

and process for submitting a request to 

participate in the pilot. 

DATES: Starting October 2, 2023, FDA 

will accept requests to participate in the 

CDRP program. See the ‘‘Participation’’ 

section of this document for eligibility 

criteria, instructions on how to submit 

a request to participate, and selection 

criteria and process. 

FOR FURTHER INFORMATION CONTACT: 

Tanya Clayton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4506, 

Silver Spring, MD 20993–0002, 301– 

796–0871; or Anne Taylor, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7256, Silver Spring, MD 20993–0002, 

240–402–5683. 

For general questions about the CDRP 

Program for CBER: industry.biologics@

fda.hhs.gov. 

For general questions about the CDRP 

Program for CDER: cder-opq-opro-cradinquiries@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Development programs for CBER- and 

CDER-regulated drugs and biologics 

intended to diagnose, treat, or prevent a 

serious disease or condition where there 

is an unmet medical need may have 

accelerated clinical development 

timelines. Yet, marketing applications 

for products in expedited development 

programs still need to meet FDA’s 

approval standards, including 

manufacturing facility compliance with 

current good manufacturing practice 

(CGMP). Products with accelerated 

clinical development activities may face 

challenges in expediting CMC 

development activities to align with the 

accelerated clinical timelines. 

Successfully expediting CMC readiness 

may require additional interactions with 

FDA during product development and, 

if applicable, warrant the use of scienceand risk-based regulatory approaches 

allowing streamlining of CMC 

development activities so that clinical 

benefits of earlier patient access to these 

products can be realized. 

As described in the FDA Prescription 

Drug User Fee Act (PDUFA) VII 

Commitment Letter for fiscal years (FYs) 

2023 Through 2027 (Ref. 1), FDA 

implemented the CDRP program to 

facilitate CMC readiness for selected 

CBER- and CDER-regulated products 

with accelerated clinical development 

timelines in FY 2023. To accelerate 

CMC development and facilitate CMC 

readiness, the pilot features increased 

communication between FDA and 

sponsors and explores the use of 

science- and risk-based regulatory 

approaches, such as those described in 

the FDA guidance for industry entitled 

‘‘Expedited Programs for Serious 

Conditions—Drugs and Biologics’’ (May 

2014) (Ref. 2), as applicable. 

FDA (CBER and CDER) is continuing 

to conduct a CDRP to facilitate the CMC 

development of selected products under 

INDs that have expedited clinical 

development timeframes, based on the 

anticipated clinical benefits of earlier 

patient access to the products. This 

includes products with Breakthrough 

Therapy (BT), Fast Track (FT), and 

Regenerative Medicine Advance 

Therapy (RMAT) designations. For 

sponsors participating in the pilot, FDA 

will provide product-specific CMC 

advice during product development, to 

include two additional CMC-focused 

Type B meetings, as well as a limited 

number of additional CMC-focused 

discussions, based on readiness and 

defined CMC milestones. The increased 

communication between FDA review 

staff and sponsors is intended to ensure 

a mutual understanding of approaches 

to completing CMC activities, including 

what information should be provided at 

the appropriate timepoint (i.e., at the 

time of new drug application (NDA) or 

biologics license application (BLA) 

submission, prior to the end of the 

review cycle, or post-approval) to 

ensure CMC readiness for a marketing 

application. 

II. Participation 

FDA will continuously accept 

requests to participate in the CDRP 

program. FDA will select no more than 

nine proposals per fiscal year, with 


ddrumheller on DSK120RN23PROD with NOTICES1