82 FR 41416 - Electronic Study Data Submission; Data Standards; Support for Version Update of the Medical Dictionary for Regulatory Activities
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 168 (August 31, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 168 (August 31, 2017)
| Page Range | 41416-41417 | |
| FR Document | 2017-18471 |
[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)] [Notices] [Pages 41416-41417] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18471] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4565] Electronic Study Data Submission; Data Standards; Support for Version Update of the Medical Dictionary for Regulatory Activities AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing support for the most current version of Medical Dictionary for Regulatory Activities (MedDRA), end of support for earlier versions of MedDRA, 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 investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). DATES: Submit either electronic or written comments on this document at any time. ADDRESSES: You may submit comments as follows: Electronic Submission 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-4565 for ``Electronic Study Data Submission; Data Standards; Support for Version Update of the Medical Dictionary for Regulatory Activities.'' 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 protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911, [email protected]. SUPPLEMENTARY INFORMATION: 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 https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data guidance [[Page 41417]] 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 NDAs, ANDAs, BLAs, and INDs to CBER or CDER by specifying the format for electronic submissions. This provision required that the electronic format for submission of applications be specified in guidance and effective no sooner than 24 months after issuance of the final guidance. The initial timetable for the implementation of electronic submission requirements for study data is 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 and requires MedDRA for the coding of adverse events in studies submitted to FDA's CBER or CDER in NDAs, ANDAs, BLAs, and INDs in the electronic common technical document (eCTD) format. However, the requirement to code adverse events using MedDRA in the most current version (available at https://www.meddra.org) does not apply to postmarketing studies that are submitted in eCTD sections 5.3.5.4 and 5.3.6 (https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163175.pdf). Generally, the studies included in a submission are conducted over many years and may have used different MedDRA versions to code adverse events. The expectation is that sponsors or applicants will use the most current version of MedDRA at the time of study start. However, there is no requirement to recode earlier studies. The transition date for support and requirement to use the most current version of MedDRA is March 15, 2018. Although the use of the most current version is supported as of this Federal Register notice and sponsors or applicants are encouraged to begin using it, the use of the most current 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 additional information and recommendations on the coding of adverse events (https://www.fda.gov/downloads/forindustry/datastandards/studydatastandards/ucm384744.pdf). FDA will no longer support version 8 or earlier of MedDRA. FDA support for earlier versions of MedDRA will end for studies that start after March 15, 2019. The FDA Data Standards 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 version of MedDRA. Dated: August 28, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-18471 Filed 8-30-17; 8:45 am] BILLING CODE 4164-01-P
![41416 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Total number Average
Number of of responses burden per
Type of respondent Form name respondents per response
respondent (in hours)
Public Agencies .............................................. Retrieving and refile records .......................... 56 1,223 30/60
Leroy A. Richardson, confidential information that you or a Agency will review this copy, including
Chief, Information Collection Review Office, third party may not wish to be posted, the claimed confidential information, in
Office of Scientific Integrity, Office of the such as medical information, your or its consideration of comments. The
Associate Director for Science, Office of the anyone else’s Social Security number, or second copy, which will have the
Director, Centers for Disease Control and confidential business information, such claimed confidential information
Prevention. redacted/blacked out, will be available
as a manufacturing process. Please note
[FR Doc. 2017–18512 Filed 8–30–17; 8:45 am] that if you include your name, contact for public viewing and posted on
BILLING CODE 4163–18–P information, or other information that https://www.regulations.gov. Submit
identifies you in the body of your both copies to the Dockets Management
comments, that information will be Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND posted on https://www.regulations.gov. contact information to be made publicly
HUMAN SERVICES • If you want to submit a comment available, you can provide this
with confidential information that you information on the cover sheet and not
Food and Drug Administration
do not wish to be made available to the in the body of your comments and you
[Docket No. FDA–2017–N–4565] public, submit the comment as a must identify this information as
written/paper submission and in the ‘‘confidential.’’ Any information marked
Electronic Study Data Submission; manner detailed (see ‘‘Written/Paper as ‘‘confidential’’ will not be disclosed
Data Standards; Support for Version Submissions’’ and ‘‘Instructions’’). except in accordance with 21 CFR 10.20
Update of the Medical Dictionary for and other applicable disclosure law. For
Regulatory Activities Written/Paper Submissions more information about FDA’s posting
AGENCY: Food and Drug Administration, Submit written/paper submissions as of comments to public dockets, see 80
HHS. follows: FR 56469, September 18, 2015, or access
ACTION: Notice. • Mail/Hand delivery/Courier (for the information at: https://www.gpo.gov/
written/paper submissions): Dockets fdsys/pkg/FR-2015-09-18/pdf/2015-
SUMMARY: The Food and Drug Management Staff (HFA–305), Food and 23389.pdf.
Administration (FDA or Agency) is Drug Administration, 5630 Fishers Docket: For access to the docket to
announcing support for the most current Lane, Rm. 1061, Rockville, MD 20852. read background documents or the
version of Medical Dictionary for • For written/paper comments electronic and written/paper comments
Regulatory Activities (MedDRA), end of submitted to the Dockets Management received, go to https://
support for earlier versions of MedDRA, Staff, FDA will post your comment, as www.regulations.gov and insert the
and an update to the FDA Data well as any attachments, except for docket number, found in brackets in the
Standards Catalog (Catalog) for study information submitted, marked and heading of this document, into the
data provided in new drug applications identified, as confidential, if submitted ‘‘Search’’ box and follow the prompts
(NDAs), abbreviated new drug as detailed in ‘‘Instructions.’’ and/or go to the Dockets Management
applications (ANDAs), biologics license Instructions: All submissions received Staff, 5630 Fishers Lane, Rm. 1061,
applications (BLAs), and investigational must include the Docket No. FDA– Rockville, MD 20852.
new drug applications (INDs) to the 2017–N–4565 for ‘‘Electronic Study FOR FURTHER INFORMATION CONTACT: Ron
Center for Biologics Evaluation and Data Submission; Data Standards; Fitzmartin, Center for Drug Evaluation
Research (CBER) and the Center for Support for Version Update of the and Research, Food and Drug
Drug Evaluation and Research (CDER). Medical Dictionary for Regulatory Administration, 10903 New Hampshire
DATES: Submit either electronic or Activities.’’ Received comments will be Ave., Bldg. 51, Rm. 1115, Silver Spring,
written comments on this document at placed in the docket and, except for MD 20993–0002, 301–796–5333,
any time. those submitted as ‘‘Confidential cderdatastandards@fda.hhs.gov; or
ADDRESSES: You may submit comments Submissions,’’ publicly viewable at Stephen Ripley, Center for Biologics
as follows: https://www.regulations.gov or at the Evaluation and Research, Food and
Dockets Management Staff between 9 Drug Administration, 10903 New
Electronic Submission a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 71, Rm. 7268,
Submit electronic comments in the Friday. Silver Spring, MD 20993–0002, 240–
following way: • Confidential Submissions—To 402–7911, stephen.ripley@fda.hhs.gov.
• Federal eRulemaking Portal: submit a comment with confidential SUPPLEMENTARY INFORMATION: On
https://www.regulations.gov. Follow the information that you do not wish to be December 17, 2014, FDA published final
instructions for submitting comments. made publicly available, submit your guidance for industry ‘‘Providing
sradovich on DSK3GMQ082PROD with NOTICES
Comments submitted electronically, comments only as a written/paper Regulatory Submissions in Electronic
including attachments, to https:// submission. You should submit two Format—Standardized Study Data’’
www.regulations.gov will be posted to copies total. One copy will include the (eStudy Data) posted on FDA’s Study
the docket unchanged. Because your information you claim to be confidential Data Standards Resources Web page at
comment will be made public, you are with a heading or cover note that states https://www.fda.gov/forindustry/
solely responsible for ensuring that your ‘‘THIS DOCUMENT CONTAINS datastandards/studydatastandards/
comment does not include any CONFIDENTIAL INFORMATION.’’ The default.htm. The eStudy Data guidance
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![Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 41417
implements the electronic submission earlier versions of MedDRA will end for • Federal eRulemaking Portal:
requirements of section 745A(a) of the studies that start after March 15, 2019. https://www.regulations.gov. Follow the
Federal Food, Drug, and Cosmetic Act The FDA Data Standards Catalog will be instructions for submitting comments.
(21 U.S.C. 379k–1(a)) for study data updated to list March 15, 2019, as the Comments submitted electronically,
contained in NDAs, ANDAs, BLAs, and ‘‘date support ends.’’ Studies that start including attachments, to https://
INDs to CBER or CDER by specifying the after March 15, 2019, will be required to www.regulations.gov will be posted to
format for electronic submissions. This use the most current version of the docket unchanged. Because your
provision required that the electronic MedDRA. comment will be made public, you are
format for submission of applications be Dated: August 28, 2017. solely responsible for ensuring that your
specified in guidance and effective no comment does not include any
Leslie Kux,
sooner than 24 months after issuance of confidential information that you or a
the final guidance. The initial timetable Associate Commissioner for Policy. third party may not wish to be posted,
for the implementation of electronic [FR Doc. 2017–18471 Filed 8–30–17; 8:45 am] such as medical information, your or
submission requirements for study data BILLING CODE 4164–01–P anyone else’s Social Security number, or
is December 17, 2016 (24 months after confidential business information, such
issuance of final guidance for NDAs, as a manufacturing process. Please note
BLAs, ANDAs, and 36 months for INDs). DEPARTMENT OF HEALTH AND that if you include your name, contact
The eStudy Data guidance states that a HUMAN SERVICES information, or other information that
Federal Register notice will specify the identifies you in the body of your
Food and Drug Administration
transition date for all version updates comments, that information will be
(with the month and day for the posted on https://www.regulations.gov.
[Docket No. FDA–2017–D–4764] • If you want to submit a comment
transition date corresponding to March
15). with confidential information that you
Policy Clarification and Premarket
FDA currently supports and requires do not wish to be made available to the
Notification (510(k)) Submissions for
MedDRA for the coding of adverse public, submit the comment as a
Ultrasonic Diathermy Devices; Draft
events in studies submitted to FDA’s written/paper submission and in the
Guidance for Industry and Food and
CBER or CDER in NDAs, ANDAs, BLAs, manner detailed (see ‘‘Written/Paper
Drug Administration Staff; Availability
and INDs in the electronic common Submissions’’ and ‘‘Instructions’’).
technical document (eCTD) format. AGENCY: Food and Drug Administration,
However, the requirement to code Written/Paper Submissions
HHS.
adverse events using MedDRA in the Submit written/paper submissions as
ACTION: Notice of availability.
most current version (available at follows:
https://www.meddra.org) does not apply SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
to postmarketing studies that are Administration (FDA or Agency) is written/paper submissions): Dockets
submitted in eCTD sections 5.3.5.4 and announcing the availability of the draft Management Staff (HFA–305), Food and
5.3.6 (https://www.fda.gov/downloads/ guidance entitled ‘‘Policy Clarification Drug Administration, 5630 Fishers
Drugs/DevelopmentApprovalProcess/ and Premarket Notification [510(k)] Lane, Rm. 1061, Rockville, MD 20852.
FormsSubmissionRequirements/ Submissions for Ultrasonic Diathermy • For written/paper comments
ElectronicSubmissions/ Devices—Draft Guidance for Industry submitted to the Dockets Management
UCM163175.pdf). and Food and Drug Administration Staff, FDA will post your comment, as
Generally, the studies included in a Staff.’’ When final, this draft guidance well as any attachments, except for
submission are conducted over many will clarify FDA’s policy related to information submitted, marked and
years and may have used different compliance with applicable identified, as confidential, if submitted
MedDRA versions to code adverse performance standards and as detailed in ‘‘Instructions.’’
events. The expectation is that sponsors conformance to International Instructions: All submissions received
or applicants will use the most current Electrotechnical Commission (IEC) must include the Docket No. FDA–
version of MedDRA at the time of study consensus standards for ultrasonic 2017–D–4764 for ‘‘Policy Clarification
start. However, there is no requirement diathermy devices. This draft guidance and Premarket Notification [510(k)]
to recode earlier studies. The transition will also provide recommendations for Submissions for Ultrasonic Diathermy
date for support and requirement to use information to provide in 510(k) Devices—Draft Guidance for Industry
the most current version of MedDRA is submissions for ultrasonic diathermy and Food and Drug Administration.’’
March 15, 2018. Although the use of the devices. This draft guidance is not final Received comments will be placed in
most current version is supported as of nor is it in effect at this time. the docket and, except for those
this Federal Register notice and submitted as ‘‘Confidential
DATES: Although you can comment on
sponsors or applicants are encouraged Submissions,’’ publicly viewable at
to begin using it, the use of the most any guidance at any time (see 21 CFR https://www.regulations.gov or at the
current version will only be required in 10.115(g)(5)), to ensure that the Agency Dockets Management Staff Office
submissions for studies that start after considers your comment of this draft between 9 a.m. and 4 p.m., Monday
March 15, 2019. The Catalog will list guidance before it begins work on the through Friday.
March 15, 2019, as the ‘‘date final version of the guidance, submit • Confidential Submissions—To
requirement begins.’’ The Study Data either electronic or written comments submit a comment with confidential
on the draft guidance by October 30, information that you do not wish to be
sradovich on DSK3GMQ082PROD with NOTICES
Technical Conformance Guide provides
additional information and 2017. made publicly available, submit your
recommendations on the coding of ADDRESSES: You may submit comments comments only as a written/paper
adverse events (https://www.fda.gov/ as follows: submission. You should submit two
downloads/forindustry/datastandards/ copies total. One copy will include the
Electronic Submissions information you claim to be confidential
studydatastandards/ucm384744.pdf).
FDA will no longer support version 8 Submit electronic comments in the with a heading or cover note that states
or earlier of MedDRA. FDA support for following way: ‘‘THIS DOCUMENT CONTAINS
VerDate Sep<11>2014 20:54 Aug 30, 2017 Jkt 241001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\31AUN1.SGM 31AUN1](https://thefederalregister.org/doc/82_FR_41584/page/2.svg)
Document Created: 2017-09-23 10:08:29
Document Modified: 2017-09-23 10:08:29
| 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. | |
| Dates | Submit either electronic or written comments on this document at any time. | |
| 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 protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911, [email protected] | |
| FR Citation | 82 FR 41416 |
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