82 FR 49210 - Electronic Study Data Submission; Data Standards; Support for Version Update of World Health Organization Drug Global
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 204 (October 24, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 204 (October 24, 2017)
| Page Range | 49210-49211 | |
| FR Document | 2017-23029 |
[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)] [Notices] [Pages 49210-49211] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23029] ======================================================================= ----------------------------------------------------------------------- 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.thefederalregister.org/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: [email protected]; 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: [[Page 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
![49210 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices
B. Annual Reporting Burden Catalog (Catalog) for study data submitted as ‘‘Confidential
Respondents: 347,239. provided in new drug applications Submissions,’’ publicly viewable at
Responses per Respondent: 1. (NDAs), abbreviated new drug https://www.regulations.gov or at the
Total Responses: 347,239. applications (ANDAs), biologics license Dockets Management Staff between 9
Hours per Response: 40. applications (BLAs), and certain a.m. and 4 p.m., Monday through
Total Burden Hours: 138,896. investigational new drug applications Friday.
(INDs) to the Center for Biologics • Confidential Submissions—To
C. Public Comments Evaluation and Research (CBER) and the submit a comment with confidential
Public comments are particularly Center for Drug Evaluation and Research information that you do not wish to be
invited on: Whether this collection of (CDER). made publicly available, submit your
information is necessary, whether it will ADDRESSES: You may submit either comments only as a written/paper
have practical utility; whether our electronic or written comments at any submission. You should submit two
estimate of the public burden of this time as follows: copies total. One copy will include the
collection of information is accurate, Electronic Submissions information you claim to be confidential
and based on valid assumptions and with a heading or cover note that states
methodology; ways to enhance the Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
quality, utility, and clarity of the following way: CONFIDENTIAL INFORMATION.’’ The
information to be collected; and ways in • Federal eRulemaking Portal:
Agency will review this copy, including
which we can minimize the burden of https://www.regulations.gov. Follow the
the claimed confidential information, in
the collection of information on those instructions for submitting comments.
its consideration of comments. The
who are to respond, through the use of Comments submitted electronically,
second copy, which will have the
appropriate technological collection including attachments, to https://
claimed confidential information
techniques or other forms of information www.regulations.gov will be posted to
redacted/blacked out, will be available
technology. the docket unchanged. Because your
for public viewing and posted on
Obtaining Copies of Proposals: comment will be made public, you are
https://www.regulations.gov. Submit
Requesters may obtain a copy of the solely responsible for ensuring that your
both copies to the Dockets Management
information collection documents from comment does not include any
Staff. If you do not wish your name and
the General Services Administration, confidential information that you or a
contact information to be made publicly
Regulatory Secretariat Division (MVCB), third party may not wish to be posted,
available, you can provide this
1800 F Street, Washington, DC 20405, such as medical information, your or
information on the cover sheet and not
telephone 202–501–4755. anyone else’s Social Security number, or
in the body of your comments and you
Please cite OMB Control No. 3090– confidential business information, such
must identify this information as
0163, Information Specific to a Contract as a manufacturing process. Please note
‘‘confidential.’’ Any information marked
or Contracting Action (Not Required by that if you include your name, contact
as ‘‘confidential’’ will not be disclosed
Regulation), in all correspondence. information, or other information that
except in accordance with 21 CFR 10.20
identifies you in the body of your
Jeffrey A. Koses, and other applicable disclosure law. For
comments, that information will be
Senior Procurement Executive, Office of
more information about FDA’s posting
posted on https://www.regulations.gov.
Acquisition Policy, Office of Government- • If you want to submit a comment of comments to public dockets, see 80
wide Policy. with confidential information that you FR 56469, September 18, 2015, or access
[FR Doc. 2017–23027 Filed 10–23–17; 8:45 am] do not wish to be made available to the the information at: https://www.gpo.gov/
BILLING CODE 6820–61–P public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submission and in the 23389.pdf.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). read background documents or the
HUMAN SERVICES electronic and written/paper comments
Written/Paper Submissions received, go to https://
Food and Drug Administration Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
[Docket No. FDA–2017–N–5436] • Mail/Hand delivery/Courier (for heading of this document, into the
Electronic Study Data Submission; written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Data Standards; Support for Version Management Staff (HFA–305), Food and and/or go to the Dockets Management
Update of World Health Organization Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Drug Global Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
• For written/paper comments
FOR FURTHER INFORMATION CONTACT: Ron
AGENCY: Food and Drug Administration, submitted to the Dockets Management
Fitzmartin, Center for Drug Evaluation
HHS. Staff, FDA will post your comment, as
and Research, Food and Drug
ACTION: Notice. well as any attachments, except for
Administration, 10903 New Hampshire
information submitted, marked and
SUMMARY: The Food and Drug Ave., Bldg. 51, Rm. 1115, Silver Spring,
identified, as confidential, if submitted
MD 20993–0002, 301–796–5333, email:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Administration (FDA or Agency) is as detailed in ‘‘Instructions.’’
announcing support for the most current Instructions: All submissions received cderdatastandards@fda.hhs.gov; or
B3-format annual version of the World must include the Docket No. FDA– Stephen Ripley, Center for Biologics
Health Organization (WHO) Drug Global 2017–N–5436 for ‘‘Electronic Study Evaluation and Research, Food and
(WHODG) (formerly named WHO Drug Data Submission; Data Standards; Drug Administration, 10903 New
Dictionary) (available at https:// Support for Version Update of World Hampshire Ave., Bldg. 71, Rm. 7301,
www.who-umc.org), end of support for Health Organization Drug Global.’’ Silver Spring, MD 20993–0002, 240–
earlier versions of WHODG, and an Received comments will be placed in 402–7911.
update to the FDA Data Standards the docket and, except for those SUPPLEMENTARY INFORMATION:
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![Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices 49211
I. Background be updated to list March 15, 2019, as the solely responsible for ensuring that your
On December 17, 2014, FDA ‘‘date support ends.’’ Studies that start application does not include any
published a final guidance for industry after March 15, 2019, will be required to confidential information that you or a
entitled ‘‘Providing Regulatory use the most current B3-format annual third party may not wish to be posted,
Submissions in Electronic Format— version of WHODG. such as medical information, your or
Standardized Study Data’’ (eStudy Data Dated: October 18, 2017. anyone else’s Social Security number, or
Guidance), posted on FDA’s Study Data confidential business information, such
Leslie Kux,
Standards Resources Web page at as a manufacturing process. Please note
Associate Commissioner for Policy.
https://www.fda.gov/forindustry/ that if you include your name, contact
[FR Doc. 2017–23029 Filed 10–23–17; 8:45 am] information, or other information that
datastandards/studydatastandards/
default.htm. The eStudy Data Guidance
BILLING CODE 4164–01–P identifies you in the body of your
implements the electronic submission application, that information will be
posted on https://www.regulations.gov.
requirements of section 745A(a) of the DEPARTMENT OF HEALTH AND • If you want to submit an
Federal Food, Drug, and Cosmetic Act HUMAN SERVICES application with confidential
for study data contained in NDAs, information that you do not wish to be
ANDAs, BLAs, and certain INDs to Food and Drug Administration made available to the public, submit the
CBER or CDER by specifying the format [Docket No. FDA–2011–N–0278] application as a written/paper
for electronic submissions. The initial submission and in the manner detailed
timetable for the implementation of Trand Doan Nguyen; Denial of Hearing; (see ‘‘Written/Paper Submissions’’ and
electronic submission requirements for Final Debarment Order ‘‘Instructions’’).
study data was December 17, 2016 (24
months after issuance of final guidance AGENCY: Food and Drug Administration, Written/Paper Submissions
for NDAs, BLAs, ANDAs, and 36 HHS. Submit written/paper submissions as
months for INDs). The eStudy Data ACTION: Notice. follows:
guidance states that a Federal Register • Mail/Hand delivery/Courier (for
notice will specify the transition date SUMMARY: The Food and Drug written/paper submissions): Dockets
for all version updates (with the month Administration (FDA) is denying Trang Management Staff (HFA–305), Food and
and day for the transition date Doan Nguyen’s (Nguyen’s) request for a Drug Administration, 5630 Fishers
corresponding to March 15). hearing and is issuing an order under Lane, Rm. 1061, Rockville, MD 20852.
FDA currently supports the use of the Federal Food, Drug, and Cosmetic • For a written/paper application
WHODG for the coding of concomitant Act (the FD&C Act) debarring Nguyen submitted to the Dockets Management
medications in studies submitted to for 5 years from providing services in Staff, FDA will post your application, as
CBER or CDER in NDAs, ANDAs, BLAs, any capacity to a person that has an well as any attachments, except for
and certain INDs in the electronic approved or pending drug product information submitted, marked and
common technical document format. application. FDA bases this order on a identified, as confidential, if submitted
Generally, the studies included in a finding that Nguyen was convicted of a as detailed in ‘‘Instructions.’’
submission are conducted over many misdemeanor under Federal law for Instructions: Your application must
years and may have used different conduct relating to the development or include the Docket No. FDA–2011–N–
WHODG versions to code concomitant approval of a drug product or otherwise 0278. An application will be placed in
medications. The expectation is that relating the regulation of a drug product the docket and, unless submitted as
sponsors and applicants will use the under the FD&C Act and that the type ‘‘Confidential Submissions,’’ publicly
most current B3-format annual version of conduct underlying the conviction viewable at https://www.regulations.gov
of WHODG at the time of study start. undermines the process for the or at the Dockets Management Staff
However, there is no requirement to regulation of drugs. In determining the between 9 a.m. and 4 p.m., Monday
recode earlier studies. The transition appropriateness and period of Nguyen’s through Friday.
date for support of the most current B3- debarment, FDA has considered the • Confidential Submissions—To
format annual version of WHODG is relevant factors listed in the FD&C Act. submit an application with confidential
March 15, 2018. Although the use of the Nguyen has failed to file with the information that you do not wish to be
current B3-format annual version of Agency information and analyses made publicly available, submit your
WHODG is supported as of this Federal sufficient to create a basis for a hearing application only as a written/paper
Register notice and sponsors or concerning this action. submission. You should submit two
applicants are encouraged to begin DATES: The order is effective October 24, copies total. One copy will include the
using it, the use of the most current B3- 2017. information you claim to be confidential
format annual version will only be ADDRESSES: Any application by Nguyen with a heading or cover note that states
required in submissions for studies that for special termination of debarment ‘‘THIS DOCUMENT CONTAINS
start after March 15, 2019. The Catalog under section 306(d) of the FD&C Act CONFIDENTIAL INFORMATION.’’ The
will list March 15, 2019, as the ‘‘date (application) may be submitted as Agency will review this copy, including
requirement begins.’’ The Study Data follows: the claimed confidential information, in
Technical Conformance Guide provides its consideration of your application.
Electronic Submissions
asabaliauskas on DSKBBXCHB2PROD with NOTICES
addition information and The second copy, which will have the
recommendations on the coding of • Federal eRulemaking Portal: claimed confidential information
concomitant medications (https:// https://www.regulations.gov. Follow the redacted/blacked out, will be available
www.fda.gov/downloads/forindustry/ instructions for submitting comments. for public viewing and posted on
datastandards/studydatastandards/ An application submitted electronically, https://www.regulations.gov. Submit
ucm384744.pdf). including attachments, to https:// both copies to the Dockets Management
FDA support for earlier versions of www.regulations.gov will be posted to Staff. If you do not wish your name and
WHODG will end for studies that start the docket unchanged. Because your contact information to be made publicly
after March 15, 2019. The Catalog will application will be made public, you are available, you can provide this
VerDate Sep<11>2014 17:47 Oct 23, 2017 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\24OCN1.SGM 24OCN1](https://thefederalregister.org/doc/82_FR_49414/page/2.svg)
Document Created: 2018-10-25 10:08:02
Document Modified: 2018-10-25 10:08:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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: [email protected]; 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. | |
| FR Citation | 82 FR 49210 |
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