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
30752 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 

The Quality Metrics Site Visit 

Program does not supplement or replace 

a regulatory inspection (e.g., a 

preapproval inspection, pre-license 

inspection, or a surveillance 

inspection). 

III. Site Selection 

Selection of potential facilities will be 

based on the priorities developed for 

CDER and CBER staff training, the 

facility’s current compliance status with 

FDA, and in consultation with the 

appropriate FDA district office. All 

travel expenses associated with this 

program will be the responsibility of 

FDA; therefore, selection will be based 

on the availability of funds and 

resources for the fiscal year. FDA will 

not provide financial compensation to 

the pharmaceutical site as part of this 

program. 

IV. Proposals for Participation 

Companies interested in offering a site 

visit or learning more about this site 

visit program should respond by 

submitting a proposal directly to Tara 

Gooen Bizjak or Stephen Ripley (see FOR

FURTHER INFORMATION CONTACT). To aid 

in FDA’s site selection and planning, 

your proposal should include the 

following information: 

• A contact person; 

• site visit location(s); 

• Facility Establishment Identifier 

and Data Universal Numbering System 

numbers, as applicable; 

• maximum number of FDA staff that 

can be accommodated during a site visit 

(maximum of 10), 

• a description of the development, 

history, and ongoing management of the 

quality metrics program; 

• a sample agenda outlining the 

proposed learning objectives and 

associated activities for the site visit; 

and 

• preferred dates for a quality metrics 

site visit. 

Proposals submitted without this 

minimum information will not be 

considered. 

Dated: June 25, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14006 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–D–1772] 

Oncology Therapeutic 

Radiopharmaceuticals: Nonclinical 

Studies and Labeling 

Recommendations; Draft Guidance for 

Industry; 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 a draft 

guidance for industry entitled 

‘‘Oncology Therapeutic 

Radiopharmaceuticals: Nonclinical 

Studies and Labeling 

Recommendations.’’ The purpose of this 

draft guidance is to assist sponsors in 

designing appropriate nonclinical 

studies before initiation of first-inhuman (FIH) trials and through product 

approval. In addition, this draft 

guidance provides recommendations for 

product labeling, such as duration of 

contraception to minimize potential risk 

to a developing embryo/fetus and 

recommendations for lactating women 

to minimize potential risk to a nursing 

infant. This draft guidance intends to 

provide recommendations for 

nonclinical programs in a unique and 

challenging area of product 

development, provide a more consistent 

approach in nonclinical studies and 

product labeling, and reduce the 

conduct of nonclinical studies that are 

not informative for product use. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 28, 2018 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– 

2018–D–1772 for ‘‘Oncology 

Therapeutic Radiopharmaceuticals: 

Nonclinical Studies and Labeling 

Recommendations; Draft Guidance for 

Industry; Availability.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 


sradovich on DSK3GMQ082PROD with NOTICES