Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77523 

related to cessation and should address 

the following questions: 

1. How can researchers increase 

enrollment for traditionally 

underrepresented populations in 

clinical trials (e.g., racial and ethnic 

minority populations, LGBTQ+ 

populations, rural populations)? 

2. Would there be interest in an 

externally led Patient Focused Drug 

Development (PFDD) meeting to better 

understand the challenges and barriers 

to smoking cessation from individuals 

trying to quit and what additional 

endpoints can be evaluated in smoking 

cessation clinical trials? 

3. What are some novel targets that 

could facilitate cigarette cessation 

product development? 

4. What challenges are researchers 

and/or drug developers facing in their 

efforts to identify novel targets for 

smoking cessation therapies? 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 

website to register: https://advancing

smokingcessation.eventbrite.com. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone number. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public meeting in person 

must register by October 15, 2024, 11:59 

p.m. Eastern Time. Persons interested in 

attending this public meeting virtually 

must register by October 21, 2024, 9 

a.m. Eastern Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. Registrants will receive 

confirmation when they have been 

accepted. 

For special accommodations due to a 

disability, please visit the registration 

website: https://advancingsmoking

cessation.eventbrite.com. Please submit 

special accommodation requests no later 

than October 7, 2024. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during 

the public comment session. We will do 

our best to accommodate requests to 

make public comments. 

Oral presentations from the public 

will be scheduled between 

approximately 3:15 p.m. and 4:15 p.m. 

Eastern Time on October 21, 2024. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person (see FOR FURTHER

INFORMATION CONTACT) and submit a 

brief statement describing the general 

nature of the evidence or arguments 

they wish to present and the names and 

email addresses of proposed 

participants, on or before October 1, 

2024, by 5 p.m. Eastern Time. Topics 

should address the questions listed in 

II., Section 6. Individuals making formal 

oral presentations will not have the 

capacity to present slides during the 

public comment session. Individuals 

may submit presentation materials to 

the docket on or before November 21, 

2024. 

Time allotted for each presentation 

may be limited. If the number of 

registrants requesting to speak is greater 

than can be reasonably accommodated 

during the scheduled open public 

hearing session, FDA may conduct a 

lottery to determine the speakers for the 

scheduled open public hearing session. 

Similarly, room for interested persons to 

participate in person may be limited. If 

the number of registrants requesting to 

speak in person during the open public 

hearing is greater than can be reasonably 

accommodated in the venue for the inperson portion of the meeting, FDA may 

conduct a lottery to determine the 

speakers who will be invited to 

participate in person. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the focused sessions. Following the 

close of registration, we will determine 

the amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin and 

will select and notify participants as 

soon as possible to provide speakers 

with adequate time to prepare. No 

commercial or promotional material 

will be permitted to be presented or 

distributed at the public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. Please visit the following 

website for more information: https://

advancingsmokingcessation.

eventbrite.com. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). 

(Notice of this meeting is given 

pursuant to 21 CFR 10.65.) 

Dated: September 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21678 Filed 9–20–24; 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 or Agency) is 

announcing year three of the Chemistry, 

Manufacturing, and Controls (CMC) 

Development and Readiness Pilot 

(CDRP). This program facilitates the 

expedited CMC development of 

products under an investigational new 

drug application (IND) based on the 

anticipated clinical benefit of earlier 

patient access to the products. FDA has 

implemented this pilot program to assist 

with CMC readiness for products 

regulated by both the Center for 

Biologics Evaluation and Research 

(CBER) and the Center for Drug 

Evaluation and Research (CDER) that 

have 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, as applicable. This notice 

outlines the eligibility criteria and 

process for submitting a request to 

participate in the pilot. 

DATES: Starting October 1, 2024, FDA 

will accept requests to participate in 

year three of 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 James Myers, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

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. 


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77524 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

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 to 

streamline 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 administer the CDRP to facilitate the 

CMC development of selected products 

under INDs which have expedited 

clinical development timeframes, based 

on the anticipated clinical benefits of 

earlier patient access to the products. 

For sponsors participating in the pilot, 

FDA will provide product-specific CMC 

advice during product development, 

including two additional CMC-focused 

Type B meetings, as well as additional 

CMC-focused discussions. To support 

these interactions, once a sponsor is 

admitted to the pilot, FDA will expand 

the IND quality assessment team so as 

to ensure it has representation from the 

full complement of relevant disciplines. 

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 accept requests to 

participate in the CDRP program 

continuously throughout the fiscal year. 

FDA will select no more than nine 

proposals per fiscal year, with 

approximately two-thirds being CBERregulated products and one-third CDERregulated products. FDA will renew the 

CDRP program each fiscal year and 

announce the opening of the pilot 

program in the Federal Register for the 

remainder of this PDUFA VII period 

(until the end of FY 2027). However, 

once enrolled in the pilot a participating 

firm will continue to be enrolled in the 

program until their marketing 

application is filed. 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, FDA will 

hold a public workshop and issue a 

strategy document focused on CMC 

aspects of expedited development 

incorporating lessons from the CDRP. At 

the workshop, sponsors may be asked to 

present lessons learned from the pilot. 

FDA may also present summary lessons 

and case studies. Generally, FDA does 

not anticipate that the case studies will 

need to include information, such as the 

sponsor’s name, that can identify a 

unique product or product-specific 

manufacturing process information. 

Case studies will focus on FDA-sponsor 

interactions and problem solving, and 

address scientific and technical issues 

only in general terms. However, as 

described in the FDA PDUFA VII 

Commitment Letter for FYs 2023 

Through 2027, to be eligible for the 

pilot, the sponsor must reach agreement 

with FDA on the information that could 

be publicly disclosed. 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 definition of 

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

drugs/cder-small-business-industryassistance-sbia/research-investigationalnew-drug-applications-what-you-needknow). 

• 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)) 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, there should be enough 

time remaining before submission of the 

marketing application to allow the pilot 

to have an impact on CMC readiness. 

• 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’’ in section II.B of 

this document 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 Breakthrough Therapy 

(BT) or Regenerative Medicine Advance 

Therapy 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 


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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77525 

product under section 351(a) of the PHS 

Act. 

• IND has an expedited clinical 

timeframe warranted based on 

anticipated clinical benefits of earlier 

patient access. This would include INDs 

with BT or Fast Track designations as 

well as other INDs that meet this 

criterion, with 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. 

CMC Development Plan 

To focus pilot resources where they 

will 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 

brief description of their CMC 

development plan, with a prospective 

timeline for CMC development that 

would align with when the clinical 

development program is expected to be 

complete: 

• The plan should list the remaining 

CMC tasks and activities anticipated to 

be necessary, with estimated 

timeframes. This part of the plan should 

cover the following CMC-related areas: 

Æ Currently available product 

characterization and preliminary 

identification of critical quality 

attributes. 

Æ Summary of the current drug 

substance and drug product 

manufacturing process and control 

strategy (including assays, noting any 

that are still under development). 

Æ A brief description of the proposed 

commercial scale manufacturing and 

control strategy, including any 

necessary microbial control strategy— 

focusing on important differences from 

clinical scale. 

Æ Identification of potential 

commercial manufacturing facilities, 

including any contract facilities, or, at 

least, the type (in house, contract 

manufacturing organization) of facilities 

anticipated. 

Æ Plans for ensuring product 

availability at approval. 

Æ Drug substance and drug product 

stability assessment plan. 

Æ Strategy for process validation (see 

FDA’s guidance for industry entitled 

‘‘Process Validation: General Principles 

and Practices’’ (Ref. 4)). 

• Given the expedited clinical 

timeframe, mapping out a plan for 

manufacturing readiness within the 

same overall timespan may reveal 

potential challenges in accomplishing 

CMC readiness. The plan should 

highlight any anticipated CMC 

challenges—whether related to the 

bullets above or otherwise. This will 

facilitate FDA engagement and 

collaboration. 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). 

• The CMC Development Plan should 

include proposed timing (i.e., month 

and year) for the first CMC-specific 

Type B meeting afforded by the pilot. 

C. Selection Criteria and Process 

FDA intends to select CBER and 

CDER INDs based on the criteria 

outlined below. Requests will be 

acknowledged and reviewed when 

received. FDA intends to issue a 

Proceed to Disclosure Agreement letter, 

if selected into the pilot, or deny letter 

within 90 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, and (4) anticipated CMC 

challenges. Overall, FDA intends to seek 

balance and diversity in product types 

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 have the ability to discuss their 

product development strategies and 

goals with FDA review staff during the 

two dedicated Type B meetings, as well 

as in additional CMC-focused 

discussions. Besides additional 

interactions and collaboration with 

FDA, for those INDs in the pilot, FDA 

will assemble a team to support the 

CMC development and readiness of the 

IND, e.g., participating in the meetings 

and other discussions under the pilot. 

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’’ (September 2023) (Ref. 6), 

CDER MAPP 6025.6: ‘‘Good Review 

Practice: Management of Breakthrough 

Therapy-Designated Drugs and 

Biologics’’ (Rev. 1) (February 2024) (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. Although FDA 

verified the website addresses in this 

document, please note that websites are 

subject to change over time. 


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77526 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

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’’ (Rev. 7) (February 

2020): https://www.fda.gov/media/ 

135373/download. 

4. FDA guidance for industry ‘‘Process 

Validation: General Principles and 

Practices’’ (Rev. 1) (January 2011): 

https://www.fda.gov/files/drugs/ 

published/Process-Validation-GeneralPrinciples-and-Practices.pdf. 

5. CDER MAPP 5015.13: ‘‘Quality 

Assessment for Products in Expedited 

Programs’’ (December 2022): 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’’ (Rev. 1) (September 2023): 

https://www.fda.gov/media/172311/ 

download. 

7. CDER MAPP 6025.6: ‘‘Good Review 

Practice: Management of Breakthrough 

Therapy-Designated Drugs and 

Biologics’’ (Rev. 1) (February 2024): 

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 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21674 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–3805] 

The Accreditation Scheme for 

Conformity Assessment Program; 

Draft Guidances for Industry, 

Accreditation Bodies, Testing 

Laboratories, 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 guidance documents for the 

Accreditation Scheme for Conformity 

Assessment Program entitled ‘‘The 

Accreditation Scheme for Conformity 

Assessment (ASCA) Program; Guidance 

for Industry, Accreditation Bodies, 

Testing Laboratories, and FDA Staff;’’ 

‘‘Basic Safety and Essential Performance 

of Medical Electrical Equipment, 

Medical Electrical Systems, and 

Laboratory Medical Equipment— 

Standards Specific Information for the 

Accreditation Scheme for Conformity 

Assessment (ASCA) Program: Guidance 

for Industry, Accreditation Bodies, 

Testing Laboratories, and FDA Staff;’’ 

and ‘‘Biocompatibility Testing of 

Medical Devices—Standards Specific 

Information for the Accreditation 

Scheme for Conformity Assessment 

(ASCA) Program: Guidance for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff.’’ In 

accordance with amendments made by 

the FDA User Fee Reauthorization Act 

of 2022 (FUFRA), part of the Medical 

Device User Fee Amendments of 2022 

(MDUFA V), FDA was directed to 

conclude the Pilot Accreditation 

Scheme for Conformity Assessment 

Program by the end of fiscal year 2023 

and continue to operate the program 

(hereafter referred to as the ASCA 

Program) consistent with the amended 

FD&C Act. FDA is publishing these draft 

guidance documents which, when 

finalized, are intended to provide 

updates to improve the ASCA Program. 

These draft guidance documents are not 

final nor for implementation at this 

time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 22, 2024 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 the Docket No. FDA– 

2019–D–3805 for ‘‘The Accreditation 

Scheme for Conformity Assessment 

(ASCA) Program; Guidance for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff;’’ ‘‘Basic 

Safety and Essential Performance of 

Medical Electrical Equipment, Medical 

Electrical Systems, and Laboratory 

Medical Equipment—Standards Specific 

Information for the Accreditation 

Scheme for Conformity Assessment 

(ASCA) Program: Guidance for Industry, 

Accreditation Bodies, Testing 

Laboratories, and FDA Staff;’’ and 

‘‘Biocompatibility Testing of Medical 

Devices—Standards Specific 

Information for the Accreditation 


khammond on DSKJM1Z7X2PROD with NOTICES