Electronic Study Data Submission; Data Standards; Support for Version Update of the Medical Dictionary for Regulatory Activities, 41416-41417 [2017-18471]
Download as PDF
41416
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Form name
Number of
respondents
Total number
of responses
per
respondent
Average
burden per
response
(in hours)
Public Agencies ..............................................
Retrieving and refile records ..........................
56
1,223
30/60
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2017–18512 Filed 8–30–17; 8:45 am]
BILLING CODE 4163–18–P
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:
Written/Paper Submissions
Food and Drug Administration,
HHS.
ACTION:
Notice.
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:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
20:54 Aug 30, 2017
Jkt 241001
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’’).
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
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
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/201523389.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,
cderdatastandards@fda.hhs.gov; 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, stephen.ripley@fda.hhs.gov.
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
E:\FR\FM\31AUN1.SGM
31AUN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
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
VerDate Sep<11>2014
20:54 Aug 30, 2017
Jkt 241001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–4764]
Policy Clarification and Premarket
Notification (510(k)) Submissions for
Ultrasonic Diathermy Devices; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Policy Clarification
and Premarket Notification [510(k)]
Submissions for Ultrasonic Diathermy
Devices—Draft Guidance for Industry
and Food and Drug Administration
Staff.’’ When final, this draft guidance
will clarify FDA’s policy related to
compliance with applicable
performance standards and
conformance to International
Electrotechnical Commission (IEC)
consensus standards for ultrasonic
diathermy devices. This draft guidance
will also provide recommendations for
information to provide in 510(k)
submissions for ultrasonic diathermy
devices. This draft guidance is not final
nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 30,
2017.
SUMMARY:
ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
41417
• 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–D–4764 for ‘‘Policy Clarification
and Premarket Notification [510(k)]
Submissions for Ultrasonic Diathermy
Devices—Draft Guidance for Industry
and Food and Drug Administration.’’
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 Office
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
E:\FR\FM\31AUN1.SGM
31AUN1
Agencies
[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)]
[Notices]
[Pages 41416-41417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.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, cderdatastandards@fda.hhs.gov; 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, stephen.ripley@fda.hhs.gov.
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