49210 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices 

B. Annual Reporting Burden 

Respondents: 347,239. 

Responses per Respondent: 1. 

Total Responses: 347,239. 

Hours per Response: 40. 

Total Burden Hours: 138,896. 

C. Public Comments 

Public comments are particularly 

invited on: Whether this collection of 

information is necessary, whether it will 

have practical utility; whether our 

estimate of the public burden of this 

collection of information is accurate, 

and based on valid assumptions and 

methodology; ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and ways in 

which we can minimize the burden of 

the collection of information on those 

who are to respond, through the use of 

appropriate technological collection 

techniques or other forms of information 

technology. 

Obtaining Copies of Proposals: 

Requesters may obtain a copy of the 

information collection documents from 

the General Services Administration, 

Regulatory Secretariat Division (MVCB), 

1800 F Street, Washington, DC 20405, 

telephone 202–501–4755. 

Please cite OMB Control No. 3090– 

0163, Information Specific to a Contract 

or Contracting Action (Not Required by 

Regulation), in all correspondence. 

Jeffrey A. Koses, 

Senior Procurement Executive, Office of 

Acquisition Policy, Office of Governmentwide Policy. 

[FR Doc. 2017–23027 Filed 10–23–17; 8:45 am] 

BILLING CODE 6820–61–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5436] 

Electronic Study Data Submission; 

Data Standards; Support for Version 

Update of World Health Organization 

Drug Global 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing support for the most current 

B3-format annual version of the World 

Health Organization (WHO) Drug Global 

(WHODG) (formerly named WHO Drug 

Dictionary) (available at https://

www.who-umc.org), end of support for 

earlier versions of WHODG, and an 

update to the FDA Data Standards 

Catalog (Catalog) for study data 

provided in new drug applications 

(NDAs), abbreviated new drug 

applications (ANDAs), biologics license 

applications (BLAs), and certain 

investigational new drug applications 

(INDs) to the Center for Biologics 

Evaluation and Research (CBER) and the 

Center for Drug Evaluation and Research 

(CDER). 

ADDRESSES: You may submit either 

electronic or written comments 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– 

2017–N–5436 for ‘‘Electronic Study 

Data Submission; Data Standards; 

Support for Version Update of World 

Health Organization Drug Global.’’ 

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 

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: 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; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices 49211 

I. Background 

On December 17, 2014, FDA 

published a final guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Standardized Study Data’’ (eStudy Data 

Guidance), posted on FDA’s Study Data 

Standards Resources Web page at 

https://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 

for study data contained in NDAs, 

ANDAs, BLAs, and certain INDs to 

CBER or CDER by specifying the format 

for electronic submissions. The initial 

timetable for the implementation of 

electronic submission requirements for 

study data was 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). 

FDA currently supports the use of 

WHODG for the coding of concomitant 

medications in studies submitted to 

CBER or CDER in NDAs, ANDAs, BLAs, 

and certain INDs in the electronic 

common technical document format. 

Generally, the studies included in a 

submission are conducted over many 

years and may have used different 

WHODG versions to code concomitant 

medications. The expectation is that 

sponsors and applicants will use the 

most current B3-format annual version 

of WHODG at the time of study start. 

However, there is no requirement to 

recode earlier studies. The transition 

date for support of the most current B3- 

format annual version of WHODG is 

March 15, 2018. Although the use of the 

current B3-format annual version of 

WHODG is supported as of this Federal 

Register notice and sponsors or 

applicants are encouraged to begin 

using it, the use of the most current B3- 

format annual version will only be 

required in submissions for studies that 

start after March 15, 2019. The Catalog 

will list March 15, 2019, as the ‘‘date 

requirement begins.’’ The Study Data 

Technical Conformance Guide provides 

addition information and 

recommendations on the coding of 

concomitant medications (https://

www.fda.gov/downloads/forindustry/ 

datastandards/studydatastandards/ 

ucm384744.pdf). 

FDA support for earlier versions of 

WHODG will end for studies that start 

after March 15, 2019. The Catalog will 

be updated to list March 15, 2019, as the 

‘‘date support ends.’’ Studies that start 

after March 15, 2019, will be required to 

use the most current B3-format annual 

version of WHODG. 

Dated: October 18, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23029 Filed 10–23–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0278] 

Trand Doan Nguyen; Denial of Hearing; 

Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying Trang 

Doan Nguyen’s (Nguyen’s) request for a 

hearing and is issuing an order under 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) debarring Nguyen 

for 5 years from providing services in 

any capacity to a person that has an 

approved or pending drug product 

application. FDA bases this order on a 

finding that Nguyen was convicted of a 

misdemeanor under Federal law for 

conduct relating to the development or 

approval of a drug product or otherwise 

relating the regulation of a drug product 

under the FD&C Act and that the type 

of conduct underlying the conviction 

undermines the process for the 

regulation of drugs. In determining the 

appropriateness and period of Nguyen’s 

debarment, FDA has considered the 

relevant factors listed in the FD&C Act. 

Nguyen has failed to file with the 

Agency information and analyses 

sufficient to create a basis for a hearing 

concerning this action. 

DATES: The order is effective October 24, 

2017. 

ADDRESSES: Any application by Nguyen 

for special termination of debarment 

under section 306(d) of the FD&C Act 

(application) may be submitted as 

follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application 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 

application, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an 

application with confidential 

information that you do not wish to be 

made available to the public, submit the 

application 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 a written/paper application 

submitted to the Dockets Management 

Staff, FDA will post your application, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: Your application must 

include the Docket No. FDA–2011–N– 

0278. An application will be placed in 

the docket and, unless 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 an application with confidential 

information that you do not wish to be 

made publicly available, submit your 

application 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 your application. 

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 


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