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
Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45859 

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: Ron 

Fitzmartin, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1115, Silver Spring, 

MD 20993–0002, 301–796–5333, email: 

CDERDataStandards@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 17, 2014, FDA 

published final guidance for industry 

‘‘Providing Regulatory Submissions in 

Electronic Format—Standardized Study 

Data’’ (eStudy Data) posted on FDA’s 

Study Data Standards Resources Web 

page at http://www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm. The eStudy Data guidance 

implements the electronic submission 

requirements of section 745A(a) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379k–1(a)) for study data 

contained in new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), biologics license 

applications (BLAs), and investigational 

new drug applications (INDs) to the 

Center for Biologics Evaluation and 

Research (CBER) or CDER by specifying 

the format for electronic submissions. 

The implementation of electronic 

submission requirements for study data 

became effective on December 17, 2016 

(24 months after issuance of final 

guidance for NDAs, BLAs, ANDAs, and 

36 months for INDs). The eStudy Data 

guidance states that a Federal Register 

notice will specify the transition date 

for all version updates (with the month 

and day for the transition date 

corresponding to March 15). 

The transition date for support of 

version 1.1 of ADaM 1G V 1.1 is March 

15, 2018. ADaM IG V.1.1 is supported 

as of this Federal Register notice and 

sponsors or applicants are encouraged 

to begin using it, the new version will 

only be required in submissions for 

studies that start after March 15, 2019. 

The Catalog will list March 15, 2019, 

which will be reflected in the Catalog, 

as the ‘‘date requirement begins.’’ When 

multiple versions of an FDA-supported 

standard are listed in the Catalog, 

sponsors or applicants can select any of 

those version to use. 

The transition date for the end of FDA 

support for ADaM IG V 1.0, is March 15, 

2018. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the referenced material at 

http://www.fda.gov/ectd. 

Dated: September 22, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21081 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–0007] 

Fee for Using a Material Threat Medical 

Countermeasure Priority Review 

Voucher in Fiscal Year 2018 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the fee rate for using a 

material threat medical countermeasure 

(MCM) priority review voucher for fiscal 

year (FY) 2018. The Federal Food, Drug, 

and Cosmetic Act (the FD&C Act), as 

amended by the 21st Century Cures Act 

(Cures Act), authorizes FDA to 

determine and collect material threat 

MCM priority review user fees for 

certain applications for review of 

human drug products when those 

applications use a material threat MCM 

priority review voucher. These vouchers 

are awarded to the sponsors of material 

threat MCM applications that meet all of 

the requirements of this program upon 

FDA approval of such applications. The 

amount of the fee for using a material 

threat MCM priority review voucher is 

determined each FY based on the 

difference between the average cost 

incurred by FDA in the review of a 

human drug application subject to 

priority review in the previous FY, and 

the average cost incurred in the review 

of an application that is not subject to 

priority review in the previous FY. This 

notice establishes the material threat 

MCM priority review fee rate for FY 

2018 and outlines the payment 

procedures for such fees. 

FOR FURTHER INFORMATION CONTACT: 

Robert J. Marcarelli, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd., 

COLE–14202F, Silver Spring, MD 

20993–0002, 301–796–7223. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 3086 of the Cures Act (Pub. L. 

114–255) added section 565A to the 

FD&C Act (21 U.S.C. 360bbb–4a). In 

section 565A of the FD&C Act, Congress 

encouraged development of material 

threat MCMs by offering additional 

incentives for obtaining FDA approval 

of such products. Under section 565A of 

the FD&C Act, the sponsor of an eligible 

material threat MCM application (as 

defined in section 565A(a)(4)) shall 

receive a priority review voucher upon 

approval of the material threat MCM 

application. The recipient of a material 

threat MCM priority review voucher 

may either use the voucher for a future 

human drug application submitted to 

FDA under section 505(b)(1) of the 

FD&C Act (21 U.S.C. 355(b)(1)) or 

section 351(a) of the Public Health 

Service Act (42 U.S.C. 262(a)), or 

transfer (including by sale) the voucher 

to another party. The voucher may be 

transferred (including by sale) 

repeatedly until it ultimately is used for 

a human drug application submitted to 

FDA under section 505(b)(1) of the 

FD&C Act or section 351(a) of the Public 

Health Service Act. A priority review is 

a review conducted with a Prescription 

Drug User Fee Act (PDUFA) goal date of 

6 months after the receipt or filing date, 

depending on the type of application. 

Information regarding PDUFA goals is 

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

downloads/forindustry/userfees/ 

prescriptiondruguserfee/ 

ucm511438.pdf. 

The applicant that uses a material 

threat MCM priority review voucher is 

entitled to a priority review of its 

eligible human drug application, but 

must pay FDA a material threat MCM 

priority review user fee in addition to 

any user fee required by PDUFA for the 

application. Information regarding the 

material threat MCM priority review 

voucher program is available at: https:// 

www.fda.gov/EmergencyPreparedness/ 

Counterterrorism/Medical

Countermeasures/MCMLegalRegulatory

andPolicyFramework/ 

ucm566498.htm#prv. 

This notice establishes the material 

threat MCM priority review fee rate for 

FY 2018 at $2,830,579 and outlines 

FDA’s procedures for payment of 

material threat MCM priority review 

user fees. This rate is effective on 

October 1, 2017, and will remain in 

effect through September 30, 2018. 


sradovich on DSK3GMQ082PROD with NOTICES