Electronic Study Data Submission; Data Standards; Timetable for Updates to the Food and Drug Administration Data Standards Catalog for Study Data Submitted Electronically Under the Federal Food, Drug, and Cosmetic Act, 3161-3163 [2018-01119]
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Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
MRTPA (section 911(d) of FD&C Act) ................................
Environmental analysis (21 CFR 25.15) ..............................
Request for a meeting prior to submitting a MRTPA ..........
All activities related to postmarket surveillance studies, including submission of protocols, conduct of studies, and
annual reporting (section 911(g)(2)(C)(ii), 911(i)(1) and
(2)) ....................................................................................
Requests for renewal (section 911(g)(2)(C)(i) and
911(h)(4)) ..........................................................................
sradovich on DSK3GMQ082PROD with NOTICES
Average
burden per
response
Total annual
responses
Total hours
3
3
8
1
1
1
3
3
8
10,000
320
40
30,000
960
320
5
1
5
5,000
25,000
1
1
1
1,000
1,000
........................
Total Hours ...................................................................
1 There
Number of
responses
per
respondent
Number of
respondents
Activity
........................
........................
........................
57,280
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 describes the annual reporting
burden as a result of submitting a
MRTPA. FDA estimates that it will
receive three MPRTAs annually and that
it will take the applicant 10,000 hours
per response to conduct studies and
collect the information needed to
support an MRTPA. FDA is also
including an estimation of the burden
associated with preparing
environmental analyses. FDA estimates
that it will take an additional 320 hours
to prepare any environmental analyses.
FDA encourages persons considering
developing a MRTPA to meet with the
Center for Tobacco Products to discuss
MRTPA submission and investigational
requirements. FDA anticipates that eight
respondents considering developing
MRTPAs may request meetings with
FDA. FDA estimates it will take 40
hours per response to prepare a meeting
request, including background
information.
Section 911 of the FD&C Act requires
applicants to whom FDA issues orders
to conduct postmarket surveillance and
studies and submit relevant information
to FDA on an annual basis. Applicants
must submit and receive FDA approval
of surveillance protocols. FDA estimates
that it will take 5,000 hours per
response to collect and submit the
protocol information to FDA, conduct
the postmarket surveillance and studies
and to submit results of postmarket
surveillance and studies to FDA
annually. FDA expects five respondents
to carry out postmarket surveillance and
studies annually.
Because orders issued under section
911(g) of the FD&C Act are valid for
only a set number of years, FDA expects
applicants will submit requests for
renewal. Because the dates on which
orders are issued and the length of the
period for which the order is valid will
vary, FDA expects one request for
renewal annually. FDA estimates that it
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will take 1,000 hours to prepare the
request for renewal.
The estimated total burden hours for
this collection of information is
estimated to be 57,280. These burden
estimates were computed using FDA
staff expertise and by reviewing
comments received from recent FDA
information collections for other
tobacco-related initiatives. In addition,
FDA notes that due to the many
similarities between the content
requirements of sections 910(b)(1) (from
PMTAs) and 911(d) (for MRTPAs) of the
FD&C Act, and the likelihood that many
respondents will submit joint PMTAs
and MRTPAs, or cross-reference the
applications, that part of the collection
of information burden for respondents
submitting an MRTPA will be captured
in the preparation of the PMTA.
Dated: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–01121 Filed 1–22–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6879]
Electronic Study Data Submission;
Data Standards; Timetable for Updates
to the Food and Drug Administration
Data Standards Catalog for Study Data
Submitted Electronically Under the
Federal Food, Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the timetable for updates to
the FDA Data Standards Catalog for
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
study data submitted electronically 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). The
initial implementation timetable for
submitting standardized study data in
electronic format was 24 months for
NDAs, ANDAs, and applications, and 36
months for certain INDs after
publication of the final guidance
‘‘Providing Regulatory Submissions in
Electronic Format—Standardized
Study’’ in December 2014. When future
updates to study data standards listed in
the FDA Data Standards Catalog
(Catalog) occur, these updated standards
will be required in studies with a start
date no earlier than 12 months after a
Federal Register notice announcing
such updates is published. When future
new study data standards are listed in
the Catalog, these new standards will be
required in studies with a start date no
earlier than 24 months after a Federal
Register notice announcing such new
standards is published.
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,
E:\FR\FM\23JAN1.SGM
23JAN1
3162
Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices
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–6879 for ‘‘Electronic Study
Data Submission; Data Standards;
Timetable for Updates to the FDA Data
Standards Catalog for Electronic
Submissions of Study Data.’’ 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/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. 7301,
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 entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Standardized Study
Data’’ posted on FDA’s Study Data
Standards Resources web page at
https://www.fda.gov/forindustry/
datastandards/studydatastandards/
default.htm. The guidance implemented
the electronic submission requirements
of section 745A(a) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 379k–1) for study data contained
in NDAs, ANDAs, applications under
subsection (a) or (k) of section 351 of the
Public Health Service Act (PHS Act) (42
U.S.C. 262), and certain INDs. The
initial implementation date for the
electronic submission requirement for
standardized study data was 24 months
after final guidance for NDAs, ANDAs,
and applications under subsection (a) or
(k) of section 351 of the PHS Act
(December 17, 2016) and 36 months
after final guidance for INDs (December
17, 2017). To provide a consistent
timetable for announcing FDA’s support
and requirement for future version
updates and new study data standards,
the guidance states that a Federal
Register notice will specify a transition
date with a specific month and day for
the transition date. When a Federal
Register notice is published after March
15 of the current calendar year, the
transition date will be March 15 of the
next calendar year.
When future version updates to
supported study data standards and new
study data standards are announced in
the Federal Register, they will be
required in studies that have a start date
no earlier than 12 months after the
transition date for version updates and
no earlier than 24 months after the
transition date for new study data
standards. Table 1 presents an example
of timetables for the requirement to use
future version updates and new study
data standards after publication of
Federal Register notices. In the
example, a new study data transport
format standard and a version update to
the Study Data Tabulation Model
Implementation Guide (SDTMIG) each
have a single date listed when the
standard will be required. The new
study data transport format is supported
as of the date of the Federal Register
notice, but will only be required in
studies that start 24 months after the
transition date of March 15, 2019. The
SDTMIG version update is supported as
of the date of the Federal Register
notice, but will only be required in
studies that start 12 months after the
transition date of March 15, 2019.
sradovich on DSK3GMQ082PROD with NOTICES
TABLE 1—EXAMPLE OF TIMETABLES FOR REQUIRED STUDY DATA STANDARDS
Federal
Register
notice of FDA
support
(yyyy–mm–dd)
FDA data standards catalog
New Study Data Transport ..............................................................................................
SDTMIG Version Update .................................................................................................
VerDate Sep<11>2014
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Sfmt 4703
Transition date
(yyyy–mm–dd)
2019–02–20
2018–09–05
E:\FR\FM\23JAN1.SGM
23JAN1
2019–03–15
2019–03–15
Date
requirement
begins
(yyyy–mm–dd)
2021–03–15
2020–03–15
Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Notices
Dated: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
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’’).
[FR Doc. 2018–01119 Filed 1–22–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2343]
Hazard Analysis and Risk-Based
Preventive Controls for Food for
Animals; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing the availability of a draft
guidance for industry #245 entitled
‘‘Hazard Analysis and Risk-Based
Preventive Controls for Food for
Animals.’’ This draft guidance
document, when finalized, will help
animal food facilities comply with the
requirements for hazard analysis and
risk-based preventive controls under our
regulation ‘‘Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals.’’
DATES: Submit either electronic or
written comments on the draft guidance
by July 23, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
17:59 Jan 22, 2018
Jkt 244001
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–
2016–D–2343 for ‘‘Hazard Analysis and
Risk-Based Preventive Controls for Food
for Animals.’’ 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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
3163
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Jenny Murphy, Center for Veterinary
Medicine (HFV–200), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–6246,
jenny.murphy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) enables
FDA to better protect public (human
and animal) health by helping to ensure
the safety and security of the food
supply. FSMA enables FDA to focus
more on preventing animal food safety
problems rather than relying primarily
on reacting to problems after they occur.
Section 103 of FSMA amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), by adding section 418 (21
U.S.C. 350g) with requirements for
hazard analysis and risk-based
preventive controls for establishments
that are required to register as food
facilities under our regulations in 21
CFR part 1, subpart H, in accordance
with section 415 of the FD&C Act (21
U.S.C. 350d). We have established
regulations to implement the hazard
analysis and risk-based preventive
controls requirements within part 507
(21 CFR part 507).
We are announcing the availability of
a draft guidance for industry #245
entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Food for
Animals.’’ This multi-chapter draft
guidance for industry is intended to
E:\FR\FM\23JAN1.SGM
23JAN1
]]>Agencies
[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3161-3163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01119]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6879]
Electronic Study Data Submission; Data Standards; Timetable for
Updates to the Food and Drug Administration Data Standards Catalog for
Study Data Submitted Electronically Under the Federal Food, Drug, and
Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the timetable for updates to the FDA Data Standards Catalog for study
data submitted electronically 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). The initial
implementation timetable for submitting standardized study data in
electronic format was 24 months for NDAs, ANDAs, and applications, and
36 months for certain INDs after publication of the final guidance
``Providing Regulatory Submissions in Electronic Format--Standardized
Study'' in December 2014. When future updates to study data standards
listed in the FDA Data Standards Catalog (Catalog) occur, these updated
standards will be required in studies with a start date no earlier than
12 months after a Federal Register notice announcing such updates is
published. When future new study data standards are listed in the
Catalog, these new standards will be required in studies with a start
date no earlier than 24 months after a Federal Register notice
announcing such new standards is published.
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,
[[Page 3162]]
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-6879 for ``Electronic Study Data Submission; Data Standards;
Timetable for Updates to the FDA Data Standards Catalog for Electronic
Submissions of Study Data.'' 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 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, [email protected].
SUPPLEMENTARY INFORMATION: On December 17, 2014, FDA published final
guidance for industry entitled ``Providing Regulatory Submissions in
Electronic Format--Standardized Study Data'' posted on FDA's Study Data
Standards Resources web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The guidance implemented
the electronic submission requirements of section 745A(a) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1) for
study data contained in NDAs, ANDAs, applications under subsection (a)
or (k) of section 351 of the Public Health Service Act (PHS Act) (42
U.S.C. 262), and certain INDs. The initial implementation date for the
electronic submission requirement for standardized study data was 24
months after final guidance for NDAs, ANDAs, and applications under
subsection (a) or (k) of section 351 of the PHS Act (December 17, 2016)
and 36 months after final guidance for INDs (December 17, 2017). To
provide a consistent timetable for announcing FDA's support and
requirement for future version updates and new study data standards,
the guidance states that a Federal Register notice will specify a
transition date with a specific month and day for the transition date.
When a Federal Register notice is published after March 15 of the
current calendar year, the transition date will be March 15 of the next
calendar year.
When future version updates to supported study data standards and
new study data standards are announced in the Federal Register, they
will be required in studies that have a start date no earlier than 12
months after the transition date for version updates and no earlier
than 24 months after the transition date for new study data standards.
Table 1 presents an example of timetables for the requirement to use
future version updates and new study data standards after publication
of Federal Register notices. In the example, a new study data transport
format standard and a version update to the Study Data Tabulation Model
Implementation Guide (SDTMIG) each have a single date listed when the
standard will be required. The new study data transport format is
supported as of the date of the Federal Register notice, but will only
be required in studies that start 24 months after the transition date
of March 15, 2019. The SDTMIG version update is supported as of the
date of the Federal Register notice, but will only be required in
studies that start 12 months after the transition date of March 15,
2019.
Table 1--Example of Timetables for Required Study Data Standards
----------------------------------------------------------------------------------------------------------------
Federal Register
notice of FDA Transition date Date requirement
FDA data standards catalog support (yyyy-mm- (yyyy-mm-dd) begins (yyyy-mm-
dd) dd)
----------------------------------------------------------------------------------------------------------------
New Study Data Transport.................................. 2019-02-20 2019-03-15 2021-03-15
SDTMIG Version Update..................................... 2018-09-05 2019-03-15 2020-03-15
----------------------------------------------------------------------------------------------------------------
[[Page 3163]]
Dated: January 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01119 Filed 1-22-18; 8:45 am]
BILLING CODE 4164-01-P
