30748 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

1See ‘‘FDA Pharmaceutical Quality Oversight: 

One Quality Voice’’ at https://www.fda.gov/ 

downloads/AboutFDA/CentersOffices/Officeof

MedicalProductsandTobacco/CDER/ 

UCM442666.pdf. 

submit payments. The draft guidance 

also explains how respondents can 

request discontinuation from the BPD 

program as well as how respondents can 

request to move products to the 

discontinued section of the biosimilar 

list. Finally, the draft guidance provides 

information on the consequences of 

failing to pay BsUFA II fees, as well as 

processes for submitting reconsideration 

and appeal requests. The draft guidance 

is available on our website at https://

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM584984.pdf. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Information collection title Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response 

(hours) 

Total hours 

Biosimilar User Fee Cover Sheet; Form FDA 3792 35 1 35 0.5 (30 minutes) ........ 17.5 

Annual Survey .......................................................... 35 1 35 1 ................................ 35 

Request for discontinuation from BPD program ...... 2 1 2 1 ................................ 2 

Request to move products to discontinued section 

of the biosimilar list.

5 1 5 0.5 (30 minutes) ........ 2.5 

Total .................................................................. ........................ ........................ ........................ .................................... 57 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We have increased our estimate by an 

additional 15 respondents since last 

OMB approval of the information 

collection. This estimated increase is 

based on our expectation that 

participation in the BPD program will 

continue to grow, consistent with our 

experience since establishment of the 

information collection in 2012. 

Dated: June 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14057 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1903] 

Modernizing Pharmaceutical Quality 

Systems; Studying Quality Metrics and 

Quality Culture; Quality Metrics 

Feedback Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

Center for Drug Evaluation and Research 

(CDER) is announcing two new efforts to 

gather feedback on the use of quality 

metrics to modernize pharmaceutical 

quality systems and advance innovation 

based on stakeholder feedback. These 

efforts include Type C formal meeting 

requests and pre-abbreviated new drug 

application (pre-ANDA) meeting 

requests, and a pilot study to gain 

feedback from those establishments for 

which Type C formal meetings or preANDA meetings do not apply (e.g., 

active pharmaceutical ingredients (API) 

establishments, contract manufacturing 

organizations, over-the-counter (OTC) 

monograph products establishments, or 

marketed unapproved finished drug 

products establishments). Participation 

in either of these efforts is voluntary and 

the programs are intended to foster the 

joint efforts of FDA and stakeholders to 

further develop an FDA Quality Metrics 

Program. The FDA Quality Metrics 

Program aims to evaluate a new 

approach for regulatory oversight of 

pharmaceutical products through the 

collection of certain quality information 

developed and maintained in the course 

of manufacturing drugs under current 

good manufacturing practices. FDA 

intends to use quality metrics data to 

further develop the Agency’s risk-based 

inspection scheduling (e.g., decreased 

surveillance inspection frequency for 

certain establishments) to improve the 

efficiency and effectiveness of 

establishment inspections, improve 

FDA’s evaluation of drug manufacturing 

and control operations, and identify 

situations in which there may be a risk 

for drug supply disruption. 

DATES: Submit a written request to 

participate in the program by July 29, 

2019. See sections II and III.B of this 

notice for information to include in 

such requests. FDA will start accepting 

requests beginning July 30, 2018. 

FOR FURTHER INFORMATION CONTACT: Tara 

Gooen Bizjak, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2109, 

Silver Spring, MD 20993, 301–796– 

3257, Tara.Gooen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

More than a decade ago, FDA 

launched an initiative to encourage the 

implementation of a modern, risk-based 

pharmaceutical quality assessment 

system. As part of this initiative, and in 

recognition of the increasing complexity 

of pharmaceutical manufacturing, FDA 

developed a 21st century vision for 

manufacturing and quality with input 

from academia and industry. The 

desired state was described as follows: 

‘‘A maximally efficient, agile, flexible 

pharmaceutical manufacturing sector 

that reliably produces high-quality drug 

products without extensive regulatory 

oversight.’’ 1

There has been significant progress 

toward this vision in the intervening 

years, as evidenced by programs and 

guidance from FDA around major 

initiatives such as pharmaceutical 

development and quality by design, 

quality risk management and 

pharmaceutical quality systems, process 

validation, and process analytical 

technology, among other initiatives. 

These programs and guidances are 

intended to promote effective use of the 

most current pharmaceutical science 

and engineering principles and 

knowledge throughout the life cycle of 

a product. 

While much progress has been made, 

we have not fully realized our 21st 

century vision for manufacturing and 

quality. Rather than focusing on use of 

science- and risk-based principles as 

described in current good 

manufacturing practices, many 

establishments continue to focus on 

minimum requirements (e.g., check-box 

approach). Recalls and drug shortages, 

which are often indications of serious 

product quality defects caused by drug 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30749 

2Refer to https://www.fda.gov/Drugs/DrugSafety/ 

DrugRecalls/default.htm for more information on 

drug recalls. 

3 In 2012, for example, based on information 

collected from manufacturers, FDA determined that 

66 percent of disruptions in drug manufacturing 

were the result of either efforts to address productspecific quality failures or broader efforts to 

remediate or improve an unsafe manufacturing 

facility. FDA’s ‘‘Strategic Plan for Preventing and 

Mitigating Drug Shortages,’’ see figure 2, at https:// 

www.fda.gov/downloads/drugs/drugsafety/drug

shortages/ucm372566.pdf. 

4We update guidances periodically. To make sure 

you have the most recent version of a guidance, 

check the FDA Drugs guidance web page at https:// 

www.fda.gov/Drugs/Guidancecompliance

RegulatoryInformation/Guidances/default.htm. 

manufacturing issues, continue to 

occur.2 3 The Agency has found that 

most drug shortages stem from quality 

issues (e.g., substandard manufacturing 

facilities or processes, or significant 

quality defects are identified in the 

finished product). These situations 

necessitate remediation efforts to fix the 

issue, which in turn may interrupt 

production and cause a shortage of 

drugs. Taking action to reduce drug 

shortages remains a top priority for 

FDA. 

FDA sought input from industry on 

the establishment of an FDA Quality 

Metrics Program as another mechanism 

to promote continual improvement in 

manufacturing quality. FDA has also 

consulted with other stakeholders to 

identify mutually useful and objective 

quality metrics. The Agency learned 

that it should perform further studies of 

the FDA Quality Metrics Program 

through a pilot program and additional 

discussions with stakeholders. Based on 

this input, FDA is initiating this Quality 

Metrics Feedback Program to assist the 

Agency in the development of a Quality 

Metrics Program. Stakeholders are 

encouraged to participate in these 

efforts by using the two feedback 

procedures described below. Additional 

references may be found at the FDA web 

page, Quality Metrics for Drug 

Manufacturing, https://www.fda.gov/ 

Drugs/DevelopmentApprovalProcess/ 

Manufacturing/ucm526869.htm. 

Based on stakeholder feedback, FDA 

is presenting two new methods for 

engaging industry. The approaches 

announced in this notice provide 

industry stakeholders with an 

opportunity to provide information to 

further the development of the Quality 

Metrics Program. CDER will also 

continue to engage with trade 

associations to gather feedback for 

industry subsectors. 

FDA does not intend to publicly 

disclose information submitted to the 

Agency as part of this Quality Metrics 

Feedback Program that is exempt from 

disclosure under disclosure laws and 

regulations. The following types of 

information may be exempt from public 

disclosure if not made public by the 

owner: (1) Commercial relationships; (2) 

production and sales volume; (3) 

business plans; and (4) unapproved 

applications. 

II. Type C Formal Meetings and PreANDA Meetings 

Applicants who have an interest in 

participating in this method of the FDA 

Quality Metrics Feedback Program 

should submit a written request. New 

drug application (NDA) applicants or 

sponsors should follow the procedures 

for submitting Type C meeting requests 

as described in the draft guidance for 

industry entitled ‘‘Formal Meetings 

Between the FDA and Sponsors or 

Applicants of PDUFA Products 

(December 2017).’’ 4 The requests 

should be labeled as ‘‘Type C Meeting— 

Request to Participate in the Quality 

Metrics Feedback Program.’’ Pre-ANDA 

applicants or sponsors planning to 

submit an original or supplemental preANDA should submit a pre-ANDA 

meeting request to OPQ-OS-Quality 

Metrics@fda.hhs.gov and label it as 

‘‘Pre-ANDA Meeting—Request to 

Participate in the Quality Metrics 

Feedback Program.’’ 

In addition to the procedures and 

items outlined in the referenced 

guidances, a request for a meeting 

should include the following items: 

1. A description of the quality metrics 

currently used for the product and 

process in the facility(ies) that are 

specific to the risks of the facility(ies), 

products, manufacturing processes, 

supply chain, and current business 

decisions (e.g., amount of product held 

in inventory or days on hand). That is, 

the metrics which have been 

determined by the applicant to be most 

meaningful to product quality and for 

patient impact. 

2. A statement on whether the 

following quality metrics are measured 

using consistent definitions: Lot 

acceptance rate per product or rejection 

rate, invalidated out-of-specification 

rate per product, product quality 

complaint rate, process performance 

and process capability per product, 

corrective action and preventive action 

effectiveness, quality system timeliness, 

and on-time-in-full fulfillment of orders. 

3. A statement that suitably detailed 

technical definitions for the quality 

metrics data elements in the previously 

mentioned items (1) and (2) are 

established to enable consistent 

measurement and comparison. 

4. A description of the routine 

assessment and management oversight 

of quality culture. This assessment 

should include all levels of staff, from 

senior management to base level 

employees, to gauge and shape the 

behaviors, beliefs, values, morals, 

conventions, goals, and practices that 

characterize or are associated with 

manufacturing at the facility(ies). 

5. A description of the ongoing site 

management and senior management 

review of the quality metrics program, 

including identification of areas for 

continual improvement. 

To maximize the benefits of an inperson meeting, FDA prefers that the 

applicant or sponsor provide a 

statement of willingness for one or more 

of the following: (1) To provide access 

to certain current and historical 

product-specific measures and the data 

supporting the measures, including lot 

acceptance rate or rejection rate, 

product quality complaint rate, and 

invalidated out-of-specification rate; (2) 

to share available information 

supporting the categories (product 

specific measurements), where 

applicable, of process performance and 

process capability (product specific), 

corrective and preventive actions 

(CAPA) effectiveness, quality culture, 

quality system metrics (e.g., periodic 

product report on-time rate), and ontime-in-full fulfillment of orders 

(product specific); and (3) to discuss 

details of their quality metrics program, 

including quality metrics data 

definitions and methods of analyzing 

available data. 

We intend to accept as many meeting 

requests as Agency resources allow and 

to focus on establishments that show an 

interest in engaging in robust 

discussions regarding their quality 

metrics programs. FDA expects to notify 

companies in writing of its decision 

regarding meeting acceptance within 60 

days of receipt of their requests. 

Although incomplete and/or unclear 

requests will generally be denied, FDA 

may contact the applicant to request 

additional information. Once a meeting 

is granted, the participant can engage 

with the Quality Metrics Program team 

in accordance with existing meeting 

procedures and guidance(s). FDA 

anticipates that discussions with 

stakeholders will help to further 

develop the Quality Metrics Program 

and will provide the Agency with 

information on existing industry 

practices using modern pharmaceutical 

quality systems. 

III. Pilot Program 

A. Participation 

Establishments eligible to participate 

in this voluntary Quality Metrics Pilot 


sradovich on DSK3GMQ082PROD with NOTICES
30750 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

Program are limited to nine or fewer 

firms that follow the procedures set 

forth in section III.B and meet the 

following selection criteria: 

1. The company must be a covered 

establishment. A covered establishment 

is an owner or operator of an 

establishment that is engaged in the 

manufacture, preparation, propagation, 

compounding, or processing of a 

covered drug product, or an API used in 

the manufacture of a covered drug 

product. A covered drug product is: (1) 

Subject to an approved application 

under section 505 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 355) 

or under section 351 of the Public 

Health Service Act (42 U.S.C. 262); (2) 

marketed pursuant to an OTC 

monograph; or (3) a marketed 

unapproved finished drug product. A 

covered establishment does not need to 

be involved in the physical 

manipulation of a drug. 

2. The company must have a quality 

metrics program that has been 

developed and implemented by the 

quality unit and that is used to support 

product and process quality 

improvement. The established quality 

metrics program must include productspecific measurements and include at a 

minimum: (1) Lot acceptance rate or 

rejection rate, (2) invalidated out-ofspecification rate, and (3) product 

quality complaint rate. If a product is 

manufactured at more than one location, 

these product specific metrics could be 

limited to operations at the participating 

covered establishment. To provide 

feedback on recommended changes in 

the metrics definitions, send an email to 

OPQ-OS-QualityMetrics@fda.hhs.gov. 

The ideal participant in the Quality 

Metrics Pilot Program will have the 

following elements in their quality 

metrics program: 

1. Quantitative measurement of 

quality metrics for the products and 

processes in the facility(ies) that are 

specific to the risks of the facility(ies), 

products, manufacturing processes, 

supply chain, and current business 

decisions (e.g., amount of product held 

in inventory or days on hand); 

2. Certain quality metrics measured, 

such as lot acceptance rate or rejection 

rate per product, invalidated out-ofspecification rate per product, product 

quality complaint rate, process 

performance and process capability per 

product, CAPA effectiveness, quality 

system timeliness, and on-time-in-full 

fulfillment of orders; 

3. Suitably detailed technical 

definitions for the quality metrics data 

elements to enable consistent 

measurement and comparison; 

4. routine assessment and 

management oversight of quality culture 

at multiple levels of staff, such as senior 

management to base level employees, to 

assess and shape the behaviors, beliefs, 

values, morals, conventions, goals, and 

practices that characterize or are 

associated with manufacturing at the 

facility(ies); and 

5. Ongoing site management and 

senior management review of the 

quality metrics with identification of 

areas for continual improvement. 

The establishments that will likely 

benefit most from the Quality Metrics 

Pilot Program and discussions with FDA 

are those that are able to: (1) Provide 

access to certain current and historical 

product-specific measures and the data 

supporting the measures, including lot 

acceptance rate or rejection rate, 

product quality complaint rate, and 

invalidated out-of-specification rate; (2) 

share available information supporting 

the following categories (product 

specific measurements), where 

applicable, of process performance and 

process capability (product specific), 

CAPA effectiveness, quality culture, 

quality system metrics (e.g., periodic 

product report on-time rate), and ontime-in-full fulfillment of orders 

(product-specific); (3) discuss details of 

their quality metrics program, including 

quality metrics data definitions and 

methods of analyzing available data (for 

comparison purposes, we are interested 

in establishments that are willing to 

provide data based on definitions in the 

draft guidance as well as their preferred 

definitions); (4) be available for realtime consultations with FDA; (5) 

provide information about the firm’s 

quality management system related to 

the quality metrics program; and (6) 

comment on and discuss their 

experiences with this Quality Metrics 

Pilot process. 

B. Procedures 

To be considered for the voluntary 

Quality Metrics Pilot Program, a 

company should submit a statement of 

interest for participation to OPQ-OSQualityMetrics@fda.hhs.gov. The 

statement of interest should include 

agreement to the selection qualities 

listed in section III.A. 

The following captures the proposed 

process for the Quality Metrics Pilot 

Program selection: 

1. FDA will collect statements of 

interest for participation in the pilot 

program beginning July 30, 2018. 

2. FDA will select the first nine 

participants that submit a statement of 

interest in participation meeting the 

selection criteria in the first paragraph 

of section III.A. While any covered 

establishment meeting the criteria may 

request inclusion in the pilot program 

per the first paragraph of section III.A, 

FDA would prefer that establishments 

for which Type C formal meetings and 

pre-ANDA meetings are not applicable 

use this approach. Additionally, FDA is 

seeking participants that represent 

different sectors of the pharmaceutical 

industry, including companies that 

manufacture the following types of 

products: Brand, generics, 

biotechnology, APIs, and nonapplication products marketed under 

the OTC monograph system. 

Furthermore, we are looking for 

representation from contract 

development and manufacturing 

organizations, establishments with 

small and large portfolios, and 

establishments with past or current 

product availability issues (e.g., history 

of a drug supply issue or recall). 

3. Lessons learned from the initial 

participants in the pilot program 

(maximum of nine participants) will 

help inform FDA’s thinking as it refines 

the Quality Metrics Program. 

IV. Beginning Date of the Quality 

Metrics Pilot Program and Type C 

Formal Meetings and Pre-ANDA 

Meetings 

FDA intends to accept requests for 

participation in the voluntary Quality 

Metrics Pilot Program and Type C 

formal meetings and Pre-ANDA 

meetings beginning July 30, 2018. The 

pilot program will begin July 30, 2018 

and will close July 29, 2019. The Type 

C formal meetings and pre-ANDA 

meetings will be granted based on the 

schedules described in the associated 

guidance documents. 

V. Paperwork Reduction Act of 1995 

This notice refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 505 have been approved 

under OMB control number 0910–0001 

and the collections of information in 21 

CFR parts 210 and 211 have been 

approved under OMB control number 

0910–0139. 

The collections of information to be 

included in a meeting request for a 

product submitted in an NDA is 

approved under OMB control number 

0910–0429. The collections of 

information to be included in a meeting 

request for a product submitted in an 

ANDA is approved under OMB control 

number 0910–0797. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30751 

1See ‘‘FDA Pharmaceutical Quality Oversight: 

One Quality Voice’’ at https://www.fda.gov/ 

downloads/AboutFDA/CentersOffices/Officeof

MedicalProductsandTobacco/CDER/ 

UCM442666.pdf. 

Dated: June 25, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14005 Filed 6–28–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1896] 

Quality Metrics Site Visit Program for 

Center for Drug Evaluation and 

Research and Center for Biologics 

Evaluation and Research Staff; 

Information Available to Industry 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Center for Drug 

Evaluation and Research (CDER) and the 

Center for Biologics Evaluation and 

Research (CBER) in the Food and Drug 

Administration (FDA or Agency) are 

announcing a 2018 CDER and CBER 

staff experiential learning site visit 

program specific to FDA’s Quality 

Metrics Program. FDA is proposing this 

program, in part, in response to input 

from a variety of stakeholders over the 

past couple of years. The purpose of this 

2018 Quality Metrics Site Visit Program 

is to provide experiential and firsthand 

learning opportunities to FDA staff 

involved in the development of the FDA 

Quality Metrics Program and to provide 

stakeholders with an opportunity to 

explain the advantages and challenges 

associated with implementing and 

managing a robust Quality Metrics 

Program. This notice invites 

pharmaceutical companies interested in 

participating in this program to submit 

a Quality Metrics Site Visit proposal. 

DATES: Submit either an electronic or 

written proposal to participate in this 

program by August 28, 2018. See section 

IV of this notice for information on what 

to include in such proposals. 

FOR FURTHER INFORMATION CONTACT: Tara 

Gooen Bizjak, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2109, 

Silver Spring, MD 20993–0002, 301– 

796–3257, email: Tara.Gooen@

fda.hhs.gov or Stephen Ripley, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7268, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

More than a decade ago, FDA 

launched an initiative to encourage the 

implementation of a modern, risk-based 

pharmaceutical quality assessment 

system. As part of this initiative, and in 

recognition of the increasing complexity 

of pharmaceutical manufacturing, FDA 

developed a 21st century vision for 

manufacturing and quality with input 

from academia and industry. The 

desired state was described as follows: 

‘‘A maximally efficient, agile, flexible 

pharmaceutical manufacturing sector 

that reliably produces high-quality drug 

products without extensive regulatory 

oversight.’’ 1

There has been significant progress 

toward this vision in the intervening 

years as evidenced by programs and 

guidances from FDA around major 

initiatives such as pharmaceutical 

development and quality by design, 

quality risk management and 

pharmaceutical quality systems, process 

validation, and emerging technology, 

among others. These programs and 

guidances are intended to promote 

effective use of the modern 

pharmaceutical science and engineering 

principles and knowledge throughout 

the life cycle of a product. 

FDA sought input from industry on 

the establishment of an FDA Quality 

Metrics Program as another mechanism 

to promote continual improvement in 

manufacturing quality. FDA has also 

consulted with other stakeholders to 

identify mutually useful and objective 

quality metrics. The Agency heard that 

it should perform further studies of 

existing quality metrics programs and 

conduct additional discussions with 

stakeholders. Based on this input, CDER 

and CBER are initiating this 2018 

Quality Metrics Site Visit Program to 

assist the Agency in understanding 

existing programs. This voluntary site 

visit program is designed to offer 

experiential and firsthand learning 

opportunities to CDER and CBER staff 

involved in the development of FDA’s 

Quality Metrics Program and to provide 

stakeholders with an opportunity to 

explain the advantages and challenges 

associated with implementing and 

managing a robust quality metrics 

program. One goal of these visits is to 

provide CDER and CBER staff exposure 

to existing quality metrics programs 

through onsite visits, tour of operations, 

and discussions with establishments to 

assist staff in further developing FDA’s 

Quality Metrics Program. Another goal 

is to provide a forum for industry to 

engage in the process and provide 

additional feedback into improving the 

FDA Quality Metrics Program. 

II. The Site Visit Program 

During a quality metrics site visit, 

CDER and CBER staff will observe how 

quality metrics data are gathered, 

collected, and reported to management. 

We anticipate 5 to 10 FDA 

representatives (involved in the 

development of FDA’s Quality Metrics 

Program) would participate in a site 

visit taking place over a 1- to 2-day 

period. To facilitate the learning 

process, the host establishment may 

present overviews of the development 

and management of their quality metrics 

program. The presentation(s) will allow 

the participating establishments an 

opportunity to showcase technologies 

that support their program. 

CDER and CBER encourage covered 

establishments, including 

establishments that do not perform 

physical manipulation of drugs, 

engaging in the development and 

manufacturing of both active 

pharmaceutical ingredients (small and 

large molecules) and drug products to 

submit quality metrics site visit 

proposals. A covered establishment is 

an owner or operator of an 

establishment that is engaged in the 

manufacture, preparation, propagation, 

compounding, or processing of a 

covered drug product, or an active 

pharmaceutical ingredient (API) used in 

the manufacture of a covered drug 

product. CDER and CBER staff 

participating in this program will 

benefit by gaining a better 

understanding of current industry 

practices, processes, and procedures for 

quality metrics programs. 

CDER and CBER identified a number 

of establishment types that are of 

particular interest to their staff. The 

following list identifies some examples 

of these establishments but is not 

intended to be exhaustive, mutually 

exclusive, or to limit industry response 

to the notice: 

• Manufacturer of brand, generic, 

biotechnology, APIs, and nonapplication product(s) marketed under 

the over-the-counter (OTC) monograph 

system, and any combination of these 

products; 

• contract development and 

manufacturing organizations; 

• establishments with small and large 

portfolios; and 

• establishments with past or current 

product availability issues (e.g., history 

of a drug supply issue, recall). 


sradovich on DSK3GMQ082PROD with NOTICES