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 


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approximately two-thirds being CBERregulated products and one-third CDERregulated products. Taking into 

consideration lessons learned from the 

prior year, FDA will publish in the 

Federal Register a notice to announce 

pilot programs for each of the remaining 

FYs of the CDRP program. Sponsors 

who are interested in participating in 

the pilot program should submit a 

request to participate in the pilot as an 

amendment to their IND. The cover 

letter should state ‘‘Request to 

participate in the CMC Development 

and Readiness Pilot.’’ 

To promote innovation and 

understanding in this area, lessons 

learned through the pilot may be 

presented by FDA (e.g., in a public 

workshop) as case studies, including 

when the product studied in the pilot 

has not yet been approved by FDA. FDA 

intends to conduct a public workshop 

and issue a strategy document focused 

on CMC aspects of expedited 

development incorporating lessons from 

the CDRP. To be eligible for the pilot, 

the sponsor and FDA will reach an 

agreement on the information to be 

publicly disclosed. Generally, FDA does 

not anticipate that the case studies will 

need to include information, such as the 

sponsor’s name or product information, 

that can specifically identify a unique 

product. 

Participation in the pilot program, 

including such agreement on 

information disclosure, is voluntary and 

at the discretion of the sponsor. Where 

feasible, FDA will notify a sponsor in 

advance when it plans to include some 

aspect of their experience in the 

program in a public discussion (e.g., a 

slide presentation, a white paper). 

A. Eligibility Criteria 

To be considered for the pilot 

program, participants must meet the 

following eligibility criteria: 

1. Joint CBER and CDER Eligibility 

Criteria 

• Participant must have an active 

commercial IND (see the definitions of 

commercial INDs at https://

www.fda.gov/drugs/cder-smallbusiness-industry-assistance-sbia/ 

research-investigational-new-drugapplications-what-you-need-know). 

• IND has been submitted in, or 

converted to, Electronic Common 

Technical Document (eCTD) format, 

unless the IND is of a type granted a 

waiver from eCTD format as per FDA’s 

guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Certain Human 

Pharmaceutical Product Applications 

and Related Submissions Using the 

eCTD Specifications’’ (February 2020) 

(Ref. 3). 

• INDs for combination products (21 

CFR 3.2(e)(1)) are eligible; products that 

require significant cross-Center 

interactions (e.g., complex combination 

products) may be less likely to be 

selected for the pilot. 

• In general, at the time of application 

to the pilot, the IND clinical program 

has not yet reached the end of Phase 2 

to allow the pilot to have sufficient time 

to have an impact on CMC readiness 

(e.g., 2 years from anticipated marketing 

application submission). However, in 

extenuating circumstances, requests for 

exceptions may be considered, where 

the development programs would still 

benefit from the pilot—examples of 

what could constitute such 

circumstances include: 

Æ Cases where the clinical 

development is following an innovative 

trial design 

Æ The product is intended to treat a 

rare disease 

• CMC-related information is 

provided to demonstrate a commitment 

to pursue a CMC development plan that 

aligns with the expedited clinical 

development program (see ‘‘CMC 

Development Plan’’ under What To 

Submit in a Request To Participate in 

the Pilot for details). 

Due to the differences in product 

complexity between CBER- and CDERregulated products, the following 

eligibility and selection criteria differ 

between the Centers. 

2. CBER-Specific Eligibility Criteria 

• IND is an existing, CBER-regulated 

IND intended for submission as an 

application for licensure of a biological 

product under section 351(a) of the 

Public Health Service Act (PHS Act) (42 

U.S.C. 262(a)) for cellular therapies, 

gene therapies, and other products 

regulated by the Office of Therapeutic 

Products/CBER or vaccines regulated by 

the Office of Vaccines Research and 

Review/CBER. 

• IND has a BT or RMAT designation. 

3. CDER-Specific Eligibility Criteria 

• IND is an existing, CDER-regulated 

IND for a product intended for 

submission as an application for (1) 

approval of a new drug submitted under 

section 505(b) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

355(b)), or (2) licensure of a biological 

product under section 351(a) of the PHS 

Act. 

• IND has an expedited clinical 

timeframe warranted based on the 

anticipated clinical benefits of earlier 

patient access. This would include INDs 

for products with a BT or FT 

designation; IND sponsors of other 

products that meet this criterion may 

also apply to the pilot, with their 

eligibility to be determined by FDA. 

B. What To Submit in a Request To 

Participate in the Pilot 

To participate in the CDRP, sponsors 

should submit a written request as an 

amendment to the IND. In addition to 

providing a point of contact and noting 

any expedited program designations the 

IND has received to date, the request 

should include the following 

information. 

1. CMC Development Plan 

To focus pilot resources where they 

should be most useful and have an 

impact on the timeliness with which 

CMC readiness is achieved, prospective 

applicants to the pilot program should 

include in their Request to Participate a 

description of their CMC development 

plan that includes a timeline for CMC 

development aligned with when the 

clinical development program is 

expected to be complete: 

(1) The plan should describe the 

current state of CMC development, 

including any ongoing activities not 

already included in the IND. 

(2) The plan should include a 

projected timeline for product 

development that aligns with the 

anticipated clinical development 

timeline, showing the CMC tasks and 

activities intended to yield complete 

CMC data and information to be 

included in the marketing application. 

This part of the plan should cover the 

following CMC-related areas: 

• Available product characterization 

and preliminary identification of critical 

quality attributes. 

• Description of the current drug 

substance and drug product 

manufacturing process and control 

strategy (including identification and 

development of assays), and a 

description of and plan for the proposed 

commercial scale manufacturing and 

control strategy, including any 

necessary microbial control strategy. 

• Identification of manufacturing 

facilities, including any contract 

facilities, along with the facilities’ 

recent inspection history (including 

foreign regulatory inspections, where 

applicable). 

• Plans for ensuring product 

availability for commercial launch. 

• Drug substance and drug product 

stability assessment plan. 

• Overall plan for process validation 

(e.g., stage 1 and stage 2 as described in 

FDA’s guidance for industry entitled 

‘‘Process Validation: General Principles 

and Practices’’ (Ref. 4)). 


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(3) Given the expedited clinical 

timeframe, mapping out a plan for 

manufacturing readiness within the 

same overall timespan may reveal 

potential challenges in accomplishing 

CMC activities within the allotted time 

that is typically needed during CMC 

development to prepare a marketing 

application that can support approval. 

The plan should highlight these areas 

(exemplified in the bulleted list above, 

and any additional CMC challenges that 

may require FDA input), to facilitate 

FDA engagement regarding the types of 

supportive data and information that 

might be used to address these 

challenges. Participants in the pilot 

should plan to discuss these challenges 

with FDA during the pilot (for CDERregulated products, see MAPP 5015.13, 

Quality Assessment for Products in 

Expedited Programs (Ref. 5)). 

2. Proposed Plan and Timing for 

Meetings With FDA 

The CMC Development Plan should 

include proposed timing (i.e., month 

and year) for the two additional CMCspecific Type B meetings afforded by 

the pilot, as well as any other meetings 

and discussions foreseen. 

C. Selection Criteria and Process 

FDA intends to select participant 

CBER and CDER INDs based on the 

criteria outlined below. Review of 

requests is planned to occur quarterly, 

or as needed, depending on the requests 

to participate in the pilot that are 

received during the period. FDA intends 

to issue a letter to notify each sponsor 

of FDA’s decision on their request to 

participate within 180 days of receipt. 

In selecting INDs for the pilot 

program, FDA intends to consider 

factors such as (1) anticipated clinical 

benefits of facilitating earlier patient 

access to the product, (2) novelty of the 

product, (3) complexity of the product 

or its manufacturing process, including 

technology, (4) sponsor’s overall 

manufacturing experience, and (5) 

sponsor’s experience with the particular 

product type, class, or the type of 

manufacturing process. FDA may give 

additional consideration to lessexperienced sponsors. Overall, FDA 

intends to seek balance and diversity in 

product types, sponsors, and 

therapeutic indications to obtain a 

variety of relevant experience and 

learnings from the pilot. 

D. FDA-Sponsor Interactions During the 

Pilot 

During this CDRP program, sponsors 

will be able to discuss their product 

development strategies and goals with 

FDA review staff during predesignated 

Type B meetings and a limited number 

of additional CMC-focused discussions. 

As part of the CMC readiness pilot, two 

dedicated CMC meetings will be 

granted, and sponsors will have an 

opportunity for followup discussions to 

address questions arising from the 

meeting or meeting minutes, or if 

additional clarifications are needed. 

In preparation for a meeting, sponsors 

should submit written questions along 

with a background information package 

clearly marked as a ‘‘PDUFA VII CDRP 

meeting’’ as part of the cover letter to 

enable FDA review staff to address the 

questions. The briefing package should 

be submitted to the corresponding IND. 

Meetings associated with the pilot 

should be requested by sponsors. For 

additional information on meetings and 

other communications between the 

sponsors and FDA, see the FDA draft 

guidance for industry entitled ‘‘Formal 

Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products’’ (December 2017) (Ref. 6), 

CDER MAPP 6025.6: Good Review 

Practice: Management of Breakthrough 

Therapy-Designated Drugs and Biologics 

(July 2014) (Ref. 7), CBER SOPP 8101.1: 

Regulatory Meetings with Sponsors and 

Applicants for Drugs and Biological 

Products (March 2023) (Ref. 8), and 

CBER SOPP 8212: Breakthrough 

Therapy Products—Designation and 

Management (August 2023) (Ref. 9). 

III. Paperwork Reduction Act of 1995 

Collections of information from fewer 

than 10 respondents within any 12- 

month period are not subject to the 

Paperwork Reduction Act of 1995 (PRA) 

(5 CFR 1320.3(c)(4)). To the extent this 

information collection involves 10 or 

more respondents within any 12-month 

period, the collections of information 

are subject to the PRA. These collections 

of information are subject to review by 

the Office of Management and Budget 

(OMB) under the PRA (44 U.S.C. 3501– 

3521). The collections of information for 

NDAs, formal meetings with sponsors 

and applicants for PDUFA products, 

and the PDUFA VII Commitment Letter 

have been approved under OMB control 

number 0910–0001. The collections of 

information for INDs have been 

approved under OMB control number 

0910–0014. The collections of 

information for BLAs have been 

approved under OMB control number 

0910–0338. The collections of 

information pertaining to CGMP 

requirements have been approved under 

OMB control number 0910–0139. The 

collections of information pertaining to 

expedited programs for serious 

conditions for drugs and biologics and 

breakthrough therapy-designation for 

drugs and biologics have been approved 

under OMB control number 0910–0765. 

IV. References 

The following references are on 

display at the Dockets Management Staff 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, and are available for viewing by 

interested persons between 9 a.m. and 4 

p.m., Monday through Friday; they are 

also available electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. PDUFA Reauthorization Performance 

Goals and Procedures Fiscal Years 2023 

Through 2027 at https://www.fda.gov/ 

media/151712/download. 

2. FDA guidance for industry ‘‘Expedited 

Programs for Serious Conditions—Drugs 

and Biologics’’ (May 2014): https://

www.fda.gov/media/86377/download. 

3. FDA guidance for industry ‘‘Providing 

Regulatory Submissions in Electronic 

Format—Certain Human Pharmaceutical 

Product Applications and Related 

Submissions Using the eCTD 

Specifications’’ (February 2020): https:// 

www.fda.gov/media/135373/download. 

4. FDA guidance for industry ‘‘Process 

Validation: General Principles and 

Practices’’ (January 2011): https://

www.fda.gov/files/drugs/published/ 

Process-Validation--General-Principlesand-Practices.pdf. 

5. CDER MAPP 5015.13: Quality Assessment 

for Products in Expedited Programs: 

https://www.fda.gov/media/162786/ 

download?attachment. 

6. FDA draft guidance for industry ‘‘Formal 

Meetings Between the FDA and Sponsors 

or Applicants of PDUFA Products’’ 

(December 2017): https://www.fda.gov/ 

media/109951/download. 

7. CDER MAPP 6025.6: Good Review 

Practice: Management of Breakthrough 

Therapy-Designated Drugs and Biologics 

(July 2014): https://www.fda.gov/media/ 

89155/download. 

8. CBER SOPP 8101.1: Regulatory Meetings 

with Sponsors and Applicants for Drugs 

and Biological Products (March 2023). 

9. CBER SOPP 8212: Breakthrough Therapy 

Products—Designation and Management 

(August 2023). 

Dated: September 6, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19502 Filed 9–8–23; 8:45 am] 

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