45856 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 

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 807, 

subpart E, have been approved under 

OMB control number 0910–0120, the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073, and 

the collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485. The 

collections of information in 21 CFR 

parts 1002 and 1010 are approved under 

OMB control number 0910–0025. 

V. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) 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 Web site address, as of the date this 

document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. FDA Guidance, ‘‘Information for 

Manufacturers Seeking Marketing Clearance 

of Diagnostic Ultrasound Systems and 

Transducers.’’ Available at: https://

www.fda.gov/downloads/UCM070911.pdf. 

2. FDA, ‘‘Information for Industry.’’ 

Available at: https://www.fda.gov/ 

RadiationEmittingProducts/Radiation

EmittingProductsandProcedures/Medical

Imaging/ucm115357.htm 

Dated: September 22, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21077 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5776] 

Equivalence of Complex Products; 

Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Demonstrating 

Equivalence of Generic Complex Drug 

Substances and Formulations: Advances 

in Characterization and In Vitro 

Testing.’’ The purpose of the workshop 

is to share FDA’s current experiences on 

the evaluation and characterization of 

critical quality attributes for complex 

drug substances (e.g. polymeric and 

naturally derived substances and 

peptides) and formulations (e.g. 

liposomes, emulsions, suspensions, and 

polymeric inserts); discuss current and 

future innovative approaches for the 

development and regulatory review of 

equivalent complex drug products; 

obtain input from various stakeholders 

on how to conduct and assess critical 

quality attribute measurements to 

demonstrate equivalence of complex 

drug products; and request comments 

on these topics. 

DATES: The public workshop will be 

held on October 6, 2017, from 8:30 a.m. 

to 4:30 p.m. Submit either electronic or 

written comments on this public 

workshop by November 10, 2017. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public workshop will 

be held at FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503 B+C), Silver Spring, MD 20993– 

0002. Entrance for the public workshop 

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/Working

atFDA/BuildingsandFacilities/WhiteOak

CampusInformation/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 10, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of November 10, 2017. 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. 

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– 

2017–N–5776 for ‘‘Demonstrating 

Equivalence of Generic Complex Drug 

Substances and Formulations: Advances 

in Characterization and In Vitro 

Testing.’’ 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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45857 

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 

‘‘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: 

Xiaohui Jiang, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4716, 

Silver Spring, MD 20993, 240–402– 

4468, Xiaohui.Jiang@fda.hhs.gov; or 

Darby Kozak, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4710, Silver Spring, 

MD 20993, 240–402–2647, 

Darby.Kozak@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In July 2012, Congress passed the 

Generic Drug User Fee Amendments 

(GDUFA) (Title III of the Food and Drug 

Administration Safety and Innovation 

Act (Pub. L. 112–144)). GDUFA is 

designed to enhance public access to 

safe, high-quality generic drugs and 

reduce costs to industry. To support this 

goal, FDA agreed in the GDUFA 

commitment letter to work with 

industry and interested stakeholders on 

identifying regulatory science research 

priorities specific to generic drugs for 

each fiscal year covered by GDUFA. The 

commitment letter outlines FDA’s 

performance goals and procedures 

under the GDUFA program for the years 

2012 to 2017. The commitment letter 

can be found at https://www.fda.gov/ 

downloads/ForIndustry/UserFees/ 

GenericDrugUserFees/UCM282505.pdf. 

In the Regulatory Science section of 

the GDUFA Commitment Letter, FDA 

outlined its plans to advance regulatory 

science, including research to support 

the development of guidance and policy 

that clarifies the ANDA pathway for 

complex drug products. This regulatory 

science research includes but is not 

limited to: (1) Assessing innovative 

analytical methods and procedures for 

characterizing the active ingredient 

sameness and pharmaceutical 

equivalence of complex drug 

substances, such as peptides and 

naturally derived substances, and (2) 

developing and evaluating new 

techniques to measure the critical 

quality attributes of complex 

formulations, such as liposomes, 

emulsions, suspensions, and polymeric 

inserts, with the goal of providing 

robust in vitro alternatives to in vivo 

bioequivalence studies, and (3) 

developing and evaluating critical 

quality attributes for complex drugdevice combination products. To 

facilitate communication of recent 

advances in this regulatory science, 

including those supported by GDUFA 

funds, FDA plans to hold a public 

workshop on new analytical methods 

and assessment criteria for 

demonstrating the equivalence of 

complex drug substances and 

formulations. 

II. Topics for Discussion at the Public 

Workshop 

The purposes of the workshop are to: 

1. Share FDA’s current experiences on 

the evaluation and characterization of 

critical quality attributes for complex 

drug substances (e.g. polymeric and 

naturally derived substances and 

peptides) and formulations (e.g. 

liposomes, emulsions, suspensions, and 

polymeric inserts); 

2. Discuss current and future 

innovative approaches for the 

development and regulatory review of 

equivalent complex drug products; 

3. Obtain input from various 

stakeholders on how to conduct and 

assess critical quality attribute 

measurements to demonstrate 

equivalence of complex drug products; 

and 

4. Request comments on these topics. 

The scope of the workshop covers the 

current status, from an academic, 

industry, and regulatory perspective, of 

methods for assessing the 

pharmaceutical equivalence of complex 

drug substances and the bioequivalence 

of complex generic drug product 

formulations. 

Complex drug substances and 

formulations present unique 

development and regulatory challenges 

for generic drugs as establishing 

equivalence may not be straightforward 

by conventional practices. New and 

innovative analytical and statistical 

approaches may overcome these hurdles 

and thereby reduce product 

development time and cost, and inform 

regulatory decisions. For example, new 

high resolution analytical methods and 

advanced statistical models can provide 

better understanding of the complex 

structure, and greater confidence of 

structural sameness, needed for 

demonstrating the pharmaceutical 

equivalence of a generic peptide, 

carbohydrate, or other naturally-sourced 

complex drug substance. In the same 

fashion, new and innovative in vitro 

characterization methods can provide 

an accurate measure of the critical 

quality attributes of generic liposomal, 

emulsion, suspension, or polymeric 

matrix drug products. These in vitro 

tests can often be used to support a 

demonstration of bioequivalence, in lieu 

of in vivo studies, depending, among 

other factors, on the sensitivity, 

robustness and/or correlation of these in 

vitro tests to the product performance. 

The focus of this public workshop is on 

the evaluation of new analytical and 

statistical methods for demonstrating 

equivalence of complex products, 

including discussing the areas in which 

these methods can contribute 

significantly, how and when the 

methods should be conducted and 

evaluated, and inherent scientific 

challenges. 

Public input will improve FDA’s 

current understanding of present and 

future methods available for evaluating 

complex product equivalence. The 

knowledge gained from, and consensus 

reached, through this workshop will be 

summarized and disseminated to the 

scientific community by publication(s). 

FDA seeks input from the public on 

when, where, and how to utilize new 

methods for development of equivalent 

complex drug products and in the 

regulatory review of pharmaceutical 

equivalence and bioequivalence. 

Specific topics to be addressed include: 

1. Identifying the areas in which new 

in vitro analytical and statistical 

methods can contribute to the 

development of equivalent complex 

products and regulatory evaluation of 

pharmaceutical equivalence and 

bioequivalence; 

2. Discussing how in vitro testing for 

demonstrating complex product 

equivalence should be conducted and 

evaluated; and 

3. Addressing the scientific challenges 

in assessing critical quality attributes of 

complex products and in developing 

new analytical methods for 

demonstrating complex product 

equivalence. 


sradovich on DSK3GMQ082PROD with NOTICES
45858 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 

III. Participating in the Public 

Workshop 

Registration: Persons interested in 

attending this public workshop must 

register online at https://

survey.co1.qualtrics.com/jfe/form/SV_

6X23XS8WXHtfWAJ. 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 workshop must 

register by October 2, 2017, midnight, 

Eastern Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. 

If you need special accommodations 

due to a disability, please contact 

Xiaohui Jiang (see FOR FURTHER

INFORMATION CONTACT) no later than 

October 2, 2017. 

Streaming Webcast of the public 

workshop: This public workshop will 

also be webcast. A live webcast of this 

workshop will be viewable at https://

collaboration.fda.gov/complex

genericdrugs/ on the day of the 

workshop. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the Web site addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

Web sites are subject to change over 

time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). A link to the transcript will 

also be available on the Internet at 

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

ucm552461.htm. 

Dated: September 26, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21018 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–2837] 

Electronic Study Data Submission; 

Data Standards; Support for Analysis 

Data Model Implementation Guide 

Version 1.1 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) Center for Drug 

Evaluation and Research (CDER) is 

announcing support for version 1.1 of 

Clinical Data Interchange Standards 

Consortium (CDISC), Analysis Data 

Model Implementation Guide (ADaM IG 

V1.1), an update to the FDA Data 

Standards Catalog (Catalog). (See http:// 

www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm). ADaM IG V1.1 has been 

available from CDISC (www.cdisc.org) 

since February 12, 2016. FDA is 

encouraging sponsors and applicants to 

use ADaM IG V1.1 in investigational 

study data provided in regulatory 

submissions to CDER. 

DATES: Submit either electronic or 

written comments at any time. 

ADDRESSES: You may submit comments 

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– 

2017–N–2837 for ‘‘Electronic Study 

Data Submission; Data Standards; 

Support for Analysis Data Model 

Implementation Guide Version 1.1.’’ 

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 Division of Dockets 

Management. 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 ‘‘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 


sradovich on DSK3GMQ082PROD with NOTICES