42506 Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 

supplemental award is a key strategy for 

ORR to be prepared to meet its 

responsibility to provide shelter for 

Unaccompanied Children referred to its 

care by DHS and so that the U.S. Border 

Patrol can continue its vital national 

security mission to prevent illegal 

migration, trafficking, and protect the 

borders of the United States. 

Statutory Authority: This program is 

authorized by— 

(A) Section 462 of the Homeland 

Security Act of 2002, which in March 

2003, transferred responsibility for the 

care and custody of Unaccompanied 

Alien Children from the Commissioner 

of the former Immigration and 

Naturalization Service (INS) to the 

Director of ORR of the Department of 

Health and Human Services (HHS). 

(B) The Flores Settlement Agreement, 

Case No. CV85–4544RJK (C. D. Cal. 

1996), as well as the William 

Wilberforce Trafficking Victims 

Protection Reauthorization Act of 2008 

(Pub. L. 110–457), which authorizes 

post release services under certain 

conditions to eligible children. All 

programs must comply with the Flores 

Settlement Agreement, Case No. CV85– 

4544–RJK (C.D. Cal. 1996), pertinent 

regulations and ORR policies and 

procedures. 

Elizabeth Leo, 

Grants Policy Specialist, Division of Grants 

Policy, Office of Administration. 

[FR Doc. 2018–18152 Filed 8–21–18; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2608] 

Standardized Data for Pharmaceutical 

Quality/Chemistry Manufacturing and 

Control; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the following public 

meeting entitled ‘‘Standardized Data for 

Pharmaceutical Quality/Chemistry 

Manufacturing and Control (PQ/CMC).’’ 

This public meeting is intended to 

provide members of the pharmaceutical 

industry and other interested 

stakeholders an opportunity to discuss 

with FDA, and provide input on, topics 

and issues related to standardized data 

for electronic submission of PQ/CMC 

data, as detailed in the 2017 Federal 

Register notice (FRN), ‘‘Draft 

Standardization of Pharmaceutical 

Quality/Chemistry Manufacturing and 

Control Data Elements and 

Terminologies.’’ FDA will use the 

information from the public meeting to 

improve the usability of the proposed 

data standards. 

DATES: The public meeting will be held 

on October 19, 2018, from 9 a.m. to 4 

p.m. Submit either electronic or written 

comments on this public meeting by 

November 16, 2018. 

ADDRESSES: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503, Section A), Silver Spring, MD 

20993–0002. Entrance for the public 

meeting participants (non-FDA 

employees) is through Building 1, where 

routine security check procedures will 

be performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before November 16, 2018. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of November 16, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. Docket comments previously 

submitted to the FRN (Docket No. FDA– 

2017–N–2166, https://

www.federalregister.gov/a/2017-14456) 

noted in the SUMMARY section, should 

not be resubmitted, as these are already 

under consideration. 

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–N–2608 for ‘‘Standardized Data 

for Pharmaceutical Quality/Chemistry 

Manufacturing and Control; Public 

Meeting.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), 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 

in the body of your comments and you 

must identify this information as 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 163 / Wednesday, August 22, 2018 / Notices 42507 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Bryan Spells, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1117, Silver Spring, 

MD 20993–0002, Bryan.Spells@

fda.hhs.gov, 240–402–6511; Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911; Norman Gregory, Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl. 

(HFV–143), Rockville, MD 20855, 

Norman.Gregory@fda.hhs.gov, 240– 

402–0684; or Michael Kerrigan, Center 

for Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl. 

(HFV–143), Rockville, MD 20855, 240– 

402–0644, Michael.Kerrigan@

fda.hhs.gov. Alternatively, send 

questions to the PQ–CMC mailbox: PQCMC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

PQ/CMC is a term used to describe 

manufacturing and quality control 

information submitted to FDA in 

support of submissions. PQ/CMC plays 

an integral part in the regulatory review 

process and life cycle management of 

pharmaceutical products. This 

information is primarily submitted in 

Module 3 of the Electronic Common 

Technical Document. The 

standardization of PQ/CMC data 

elements and terminologies will 

facilitate the Agency’s transition to a 

streamlined electronic review 

environment. 

FDA intends to identify and 

standardize data elements and 

terminologies for information 

commonly used and submitted in 

support of drug product applications. 

The impetus for this standardization 

effort was the provisions from the Food 

and Drug Administration Safety and 

Innovation Act (21 U.S.C. 301 note) 

(Pub. L. 112–144), which authorized the 

Agency to require certain submissions 

to be submitted in a specified electronic 

format. The development of a structured 

format for PQ/CMC data will enable 

consistency in the content and format of 

PQ/CMC data submitted, thus providing 

a consistent look and feel for every 

application, and, in general, 

contributing to a more efficient and 

effective regulatory decision-making 

process by creating standardized data 

dictionaries. 

As part of this effort, in 2017, FDA 

released a FRN presenting a ‘‘Draft 

Standardization of Pharmaceutical 

Quality/Chemistry Manufacturing and 

Control Data Elements and 

Terminologies’’ for public comment 

(https://www.federalregister.gov/a/2017- 

14456). FDA has subsequently utilized 

the comments received to revise and 

improve the data elements, 

terminologies, and definitions for PQ/ 

CMC standardization. FDA intends to 

continue public engagement regarding 

PQ/CMC data standards development by 

holding the public meeting announced 

in this notice. After the public meeting, 

the Agency intends to issue a draft 

guidance on the standardization of PQ/ 

CMC data elements and terminologies 

for electronic submissions. 

II. Purpose of the Public Meeting 

The purpose of the October 19, 2018, 

public meeting is to provide members of 

the pharmaceutical industry and other 

interested stakeholders an opportunity 

to discuss with FDA, and provide input 

on, topics and issues related to 

standardized data for electronic 

submission of PQ/CMC data, as detailed 

in the FRN, ‘‘Draft Standardization of 

Pharmaceutical Quality/Chemistry 

Manufacturing and Control Data 

Elements and Terminologies,’’ released 

in 2017 for public comment (https://

www.federalregister.gov/a/2017-14456). 

FDA will use the information from the 

public meeting to improve the usability 

of the proposed data standards. The 

public meeting will focus on the current 

state of PQ/CMC standardization and its 

future development, to which the 

output and comments from this meeting 

will contribute. Topics of discussion 

may include: 

• Ongoing development of PQ/CMC 

data elements and terminologies, 

including revisions informed by public 

response to the ‘‘Draft Standardization’’ 

FRN, developing the technical 

specifications for PQ/CMC data 

submissions, and upcoming 

development and testing of PQ/CMC 

data exchange mechanisms. 

• Ongoing efforts to maximize 

harmonization of PQ/CMC 

standardization with other national and 

international data standardization 

activities sharing the same domain 

space as PQ/CMC (e.g., International 

Organization for Standardization 

Identification of Medicinal Products 

(ISO IDMP) standards development, the 

European Medicines Agency’s 

Substance, Product, Organisation and 

Referential (SPOR) Master Data 

initiative). 

• An understanding of industry 

business practices regarding submission 

of PQ/CMC data which will help to 

inform development of PQ/CMC 

standardization. 

FDA will consider all comments made 

at this meeting or received through the 

docket (see ADDRESSES). 

III. Participating in the Public Meeting 

Registration: To register to attend 

‘‘Standardized Data for Pharmaceutical 

Quality/Chemistry Manufacturing and 

Control; Public Meeting’’ please register 

at: https://www.eventbrite.com/e/ 

standardized-data-for-pqcmc-publicmeeting-registration-47224509780 by 

September 21, 2018. Please provide 

complete contact information for each 

attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public meeting must 

register by September 21, 2018, 

midnight 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. 

If you need special accommodations 

due to a disability, please contact Bryan 

Spells, 240–402–6511, email 

Bryan.Spells@fda.hhs.gov at least 7 days 

before the meeting. 

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). 

Dated: August 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–18080 Filed 8–21–18; 8:45 am] 

BILLING CODE 4164–01–P 


amozie on DSK3GDR082PROD with NOTICES1