Revised Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications; Availability, 43494-43496 [2014-17588]
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43494
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of survey
Number of
respondents
Annual
frequency per
response
Average
burden per
response
Total hours
Mail, telephone, Web-based ............................................................................
50,000
1
2 0.25
12,500
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Fifteen (15) minutes.
Dated: July 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Dated: July 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–17590 Filed 7–24–14; 8:45 am]
[FR Doc. 2014–17481 Filed 7–24–14; 8:45 am]
BILLING CODE 4164–01–P
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2014–N–1006]
[Docket No. FDA–2007–N–0220]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry—
Pharmacogenomic Data Submissions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry—
Pharmacogenomic Data Submissions’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On May 9,
2014, the Agency submitted a proposed
collection of information entitled
‘‘Guidance for Industry—
Pharmacogenomic Data Submissions’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0557. The
approval expires on July 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
18:34 Jul 24, 2014
Food and Drug Administration,
HHS.
Notice.
SUMMARY:
emcdonald on DSK67QTVN1PROD with NOTICES
Revised Draft Guidance for Industry on
Providing Regulatory Submissions in
Electronic Format—Certain Human
Pharmaceutical Product Applications
and Related Submissions Using the
Electronic Common Technical
Document Specifications; Availability
Jkt 232001
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a revised
draft guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Certain Human
Pharmaceutical Product Applications
and Related Submissions Using the
eCTD Specifications.’’ The draft
guidance announced in this notice is
being issued in accordance with the
Food and Drug Administration Safety
and Innovation Act (FDASIA), which
amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) to require that
certain submissions under the FD&C Act
and Public Health Service Act (PHS Act)
be submitted in electronic format,
beginning no earlier than 24 months
after issuance of the final version of the
guidance on that topic. The draft
guidance outlines Electronic Common
Technical Document (eCTD)
specification requirements for certain
submissions to new drug applications
(NDAs), abbreviated new drug
applications (ANDAs), biologics license
applications (BLAs), and investigational
new drug applications (INDs) and is
being issued for public comment. This
draft guidance revises and replaces a
previous draft guidance entitled
‘‘Providing Regulatory Submissions in
SUMMARY:
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
Electronic Format—Certain Human
Pharmaceutical Product Applications
and Related Submissions Using the
eCTD Specifications’’ that was issued in
January 2013 (2013 draft guidance on
eCTD Specifications). When finalized,
this revised draft guidance will
supersede the guidance for industry
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Human Pharmaceutical Product
Applications and Related Submissions
Using the eCTD Specifications’’ that was
issued in June 2008.
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 on 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 September 23,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002, or the
Office of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Virginia Hussong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1161,
Silver Spring, MD 20993, email:
virginia.hussong@fda.hhs.gov; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
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Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
emcdonald on DSK67QTVN1PROD with NOTICES
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Certain Human
Pharmaceutical Product Applications
and Related Submissions Using the
eCTD Specifications.’’ FDASIA (Public
Law 112–144), signed by the President
on July 9, 2012, amended the FD&C Act
to add section 745A (21 U.S.C.379k–1)
entitled ‘‘Electronic Format for
Submissions.’’ Section 745A(a)(1) of the
FD&C Act requires that submissions
under section 505(b), (i), or (j) of the
FD&C Act (21 U.S.C 355(b), (i), or (j)),
and submissions under section 351(a) or
(k) of the PHS Act (42 U.S.C. 262(a) or
(k)), be submitted to FDA in electronic
format no earlier than 24 months after
FDA issues final guidance on that topic.
In accordance with section 745A(a)(1)
of the FD&C Act, FDA is issuing this
draft guidance, announcing its
determination that submission types
identified in this draft guidance must be
submitted electronically (except for
submissions that are exempted), in the
format specified in this guidance.
This guidance (and the technical
specification documents it incorporates
by reference) describes how
submissions under section 745A(a) of
the FD&C Act 1 must be organized and
submitted in electronic format using
eCTD specifications version 3.2.2. The
eCTD is an International Conference on
Harmonization (ICH) format based on
specifications developed by ICH and its
member parties. FDA’s Center for Drug
Evaluation and Research (CDER) and
Center for Biologics Evaluation and
Research (CBER) have been receiving
submissions in the eCTD format since
2003, and eCTD has been the
recommended format for electronic
submissions to CDER and CBER since
January 1, 2008. The majority of new
electronic submissions are now received
in eCTD format.
This guidance revises and replaces
the previous 2013 draft guidance on
eCTD specifications. This revised
version of the draft guidance, when
finalized, will supersede the guidance
for industry titled ‘‘Providing
1 For more information concerning how the FDA
interprets section 745(a), see the draft guidance for
industry ‘‘Providing Regulatory Submissions in
Electronic Format—Submissions Under Section
745A(a) of the Federal Food, Drug, and Cosmetic
Act’’ (available at https://www.fda.gov/drugs/
guidancecomplianceregulatoryinformation/
guidances/default.htm).
VerDate Mar<15>2010
18:34 Jul 24, 2014
Jkt 232001
Regulatory Submissions in Electronic
Format—Human Pharmaceutical
Product Applications and Related
Submissions Using the eCTD
Specifications’’ that was issued in June
2008. This revised draft guidance, when
finalized, will be applicable to all
submissions within the scope of section
745A(a) of the FD&C Act, i.e., certain
NDAs, ANDAs, BLAs, and INDs and all
subsequent submissions, including
amendments, supplements, and reports,
to these submission types.2
In general, this revised draft guidance
contains the following changes from the
previous 2013 draft guidance on eCTD
specifications:
• It is now explicit that certain master
files are within the scope of section
745A(a) of the FD&C Act.
• Similarly, it is now explicit that
advertising and promotional labeling
materials are also within the scope of
section 745A(a) of the FD&C Act.
• Use of the FDA Electronic
Submissions Gateway (ESG) will be
required.
• Use of FDA fillable forms will be
required with all eCTD submissions.
• Specified file formats and software
versions will be required for
submissions filed with the FDA.
After publication of the Federal
Register notice of availability of the
final version of the guidance, all
submissions with a filing date 24
months after the Federal Register notice
must use the appropriate FDAsupported eCTD specifications for
certain NDA, ANDA, and BLA
submissions. IND submissions must use
the FDA-supported eCTD specifications
for electronic submissions filed 36
months after the Federal Register notice
of availability is published.
In section 745A(a) of the FD&C Act,
Congress granted explicit authorization
to FDA to implement the statutory
electronic submission requirements by
specifying in a guidance document the
format for the submissions.
Accordingly, to the extent that this draft
guidance provides the requirements
under section 745A(a) of the FD&C Act,
indicated by the use of the words must
or required, it is not subject to the usual
restrictions in FDA’s good guidance
practice regulations, such as the
requirement that guidances not establish
legally enforceable responsibilities (see
21 CFR 10.115(d)).
II. Paperwork Reduction Act of 1995
The draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
PO 00000
2 See
id.
Frm 00108
Fmt 4703
Sfmt 4703
43495
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
draft guidance pertains to sponsors and
applicants making regulatory
submissions to FDA in electronic format
for NDAs, ANDAs, BLAs, INDs, master
files, and advertising and promotional
labeling. The information collection
discussed in the draft guidance is
contained in our IND regulations (21
CFR part 312) and approved under OMB
control number 0910–0014, our NDA
regulations (including ANDAs) (21 CFR
part 314) and approved under OMB
control number 0910–0001, and our
BLA regulations (21 CFR part 601) and
approved under OMB control number
0910–0338.
Sponsors and applicants have been
submitting NDAs, ANDAs, BLAs, INDs,
and master files electronically since
2003, and the majority of these
submissions are already received in
electronic format. Under section
745A(a) of the FD&C Act, sponsors and
applicants are required to file most of
these submissions electronically. These
requirements will be phased in over 2and 3-year periods after the issuance of
the final version of the guidance.
For some sponsors and applicants,
there may be new costs, including
capital costs or operating and
maintenance costs, which would result
from the requirements under FDASIA
and the final version of the guidance,
because some sponsors and applicants
may have to upgrade eCTD
specifications and/or change their
method of submitting information to the
FDA. FDA estimates that for some
sponsors and applicants the costs may
be as follows:
• eCTD Publishing Software: $25,000
to $150,000;
• Publishing Operations Support:
$50,000 to $1,000,000; and
• Training: $5,000 to $50,000.
III. Comments
Interested persons may submit either
electronic comments to https://
www.regulations.gov or written
comments regarding this document to
the Division of Dockets Management
(see ADDRESSES). It is only necessary to
send one set of comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
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Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Notices
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: July 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–17588 Filed 7–24–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Clinical Investigator Training Course
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK67QTVN1PROD with NOTICES
ACTION:
Notice.
The Food and Drug Administration’s
(FDA’s) Center for Drug Evaluation and
Research/Office of Medical Policy and
the Duke University Office of
Continuing Medical Education are
cosponsoring a 3-day training course for
clinical investigators on scientific,
ethical, and regulatory aspects of
clinical trials. This training course is
intended to provide clinical
investigators with expertise in the
design, conduct, and analysis of clinical
trials; improve the quality of clinical
trials; and enhance the safety of trial
participants. Senior FDA staff will
communicate directly with clinical
investigators on issues of greatest
importance for successful clinical
research.
Date and Time: The training course
will be held on November 4 and 5, 2014,
from 8 a.m. to 5 p.m., and on November
6, 2014, from 8 a.m. to 3:30 p.m.
Location: The course will be held at
the Holiday Inn College Park, 10000
Baltimore Ave., College Park, MD
20740.
Contact Person: Tomeka Arnett,
Office of Medical Policy, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6355,
Silver Spring, MD 20993, 301–796–
8486.
Registration: Register by October 17,
2014. The registration fee is $150 per
person. The fee includes course
materials and onsite lunch. Early
registration is recommended because
seating is limited. There will be no
onsite registration.
VerDate Mar<15>2010
18:34 Jul 24, 2014
Jkt 232001
Register online for the training course
at the registration Web site https://
continuingeducation.dcri.duke.edu/citc
or download a full-size copy of the
registration form from the registration
site and mail a check and completed
form to Duke Clinical Research Institute
(DCRI), Attention—Duke CME/CEE, 300
West Morgan St., Suite 800, Durham,
NC 27701. You will receive an email
that confirms your registration. (FDA
has verified the Web site address, but
FDA is not responsible for subsequent
changes to the Web site after this
document publishes in the Federal
Register.)
Attendees are responsible for their
own accommodations. A block of rooms
has been reserved under ‘‘FDA Clinical
Investigator Course’’ at the Holiday Inn
College Park at a reduced conference
rate. Reservations for these
accommodations can be made online
using the course registration Web site
mentioned previously. Click on
‘‘registration form.’’ You will see a
direct link to the hotel.
Registration materials, payment
procedures, accommodation
information, and a detailed description
of the course can be found at the
registration/information Web site
mentioned previously.
If you need special accommodations
due to a disability, please contact
Tomeka Arnett (see Contact Person) at
least 7 days in advance. Persons
attending the course are advised that
FDA is not responsible for providing
access to electrical outlets.
SUPPLEMENTARY INFORMATION:
I. Background
Clinical trial investigators play a
critical role in the development of
medical products. They bear the
responsibility for ensuring the safe and
ethical treatment of study subjects and
for acquiring adequate and reliable data
to support regulatory decisions. This
course is intended to assist clinical
investigators in understanding what
preclinical and clinical information is
needed to support the investigational
use of medical products, as well as the
scientific, regulatory, and ethical
considerations involved in the conduct
of clinical trials. The course will cover
a wide variety of key topics, including
material on novel safety concerns,
adverse event monitoring, compliance
with the legal and ethical obligations of
clinical research, and acceptable
scientific and analytic standards in the
design and conduct of clinical studies.
The faculty will include a diverse
representation of senior FDA staff,
enabling FDA to communicate directly
with clinical investigators on issues of
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Fmt 4703
Sfmt 4703
greatest importance for successful
clinical research.
II. Description of the Training Course
A. Purpose
The training course is designed to
provide clinical investigators with an
overview of the following information:
• The essential toxicological,
pharmacological, and manufacturing
data to support investigational use in
humans;
• fundamental issues in the design
and conduct of clinical trials;
• statistical and analytic
considerations in the interpretation of
trial data;
• appropriate safety evaluation
during studies; and
• the ethical considerations and
regulatory requirements for clinical
trials.
In addition, the course should
accomplish the following:
• Foster a cadre of clinical
investigators with knowledge,
experience, and commitment to
investigational medicine;
• promote communication between
clinical investigators and FDA;
• enhance investigators’
understanding of FDA’s role in
experimental medicine; and
• improve the quality of data while
enhancing subject protection in the
performance of clinical trials.
B. Proposed Agenda
The course will be conducted over 3
days and comprises approximately 26
lectures, each lasting between 30 and 45
minutes. The course will be presented
mainly by senior FDA staff, with guest
lecturers presenting selected topics.
The course will address FDA’s role in
clinical studies and regulatory
considerations for clinical trials and
will include a review of the material
generally appearing in an ‘‘investigator’s
brochure,’’ i.e., the preclinical
information (toxicology, animal studies,
and chemistry/manufacturing
information) that supports initial
clinical trials in humans. Presenters will
discuss the role of clinical
pharmacology in early clinical studies
and how this information is used in the
design of subsequent studies. The
course will also include discussions of
scientific, statistical, ethical, and
regulatory aspects of clinical studies. On
November 6, 2014, participants will
choose among three breakout sessions
that will explain how to put together an
application to FDA for drugs, biologics,
or devices.
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]]>Agencies
[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Notices]
[Pages 43494-43496]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17588]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1006]
Revised Draft Guidance for Industry on Providing Regulatory
Submissions in Electronic Format--Certain Human Pharmaceutical Product
Applications and Related Submissions Using the Electronic Common
Technical Document Specifications; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Certain Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications.'' The draft guidance announced in this notice is
being issued in accordance with the Food and Drug Administration Safety
and Innovation Act (FDASIA), which amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) to require that certain submissions under the
FD&C Act and Public Health Service Act (PHS Act) be submitted in
electronic format, beginning no earlier than 24 months after issuance
of the final version of the guidance on that topic. The draft guidance
outlines Electronic Common Technical Document (eCTD) specification
requirements for certain submissions to new drug applications (NDAs),
abbreviated new drug applications (ANDAs), biologics license
applications (BLAs), and investigational new drug applications (INDs)
and is being issued for public comment. This draft guidance revises and
replaces a previous draft guidance entitled ``Providing Regulatory
Submissions in Electronic Format--Certain Human Pharmaceutical Product
Applications and Related Submissions Using the eCTD Specifications''
that was issued in January 2013 (2013 draft guidance on eCTD
Specifications). When finalized, this revised draft guidance will
supersede the guidance for industry entitled ``Providing Regulatory
Submissions in Electronic Format--Human Pharmaceutical Product
Applications and Related Submissions Using the eCTD Specifications''
that was issued in June 2008.
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 on 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 September 23, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Virginia Hussong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1161, Silver Spring, MD 20993, email:
virginia.hussong@fda.hhs.gov; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
[[Page 43495]]
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Certain Human Pharmaceutical Product Applications and Related
Submissions Using the eCTD Specifications.'' FDASIA (Public Law 112-
144), signed by the President on July 9, 2012, amended the FD&C Act to
add section 745A (21 U.S.C.379k-1) entitled ``Electronic Format for
Submissions.'' Section 745A(a)(1) of the FD&C Act requires that
submissions under section 505(b), (i), or (j) of the FD&C Act (21 U.S.C
355(b), (i), or (j)), and submissions under section 351(a) or (k) of
the PHS Act (42 U.S.C. 262(a) or (k)), be submitted to FDA in
electronic format no earlier than 24 months after FDA issues final
guidance on that topic.
In accordance with section 745A(a)(1) of the FD&C Act, FDA is
issuing this draft guidance, announcing its determination that
submission types identified in this draft guidance must be submitted
electronically (except for submissions that are exempted), in the
format specified in this guidance.
This guidance (and the technical specification documents it
incorporates by reference) describes how submissions under section
745A(a) of the FD&C Act \1\ must be organized and submitted in
electronic format using eCTD specifications version 3.2.2. The eCTD is
an International Conference on Harmonization (ICH) format based on
specifications developed by ICH and its member parties. FDA's Center
for Drug Evaluation and Research (CDER) and Center for Biologics
Evaluation and Research (CBER) have been receiving submissions in the
eCTD format since 2003, and eCTD has been the recommended format for
electronic submissions to CDER and CBER since January 1, 2008. The
majority of new electronic submissions are now received in eCTD format.
---------------------------------------------------------------------------
\1\ For more information concerning how the FDA interprets
section 745(a), see the draft guidance for industry ``Providing
Regulatory Submissions in Electronic Format--Submissions Under
Section 745A(a) of the Federal Food, Drug, and Cosmetic Act''
(available at https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/default.htm).
---------------------------------------------------------------------------
This guidance revises and replaces the previous 2013 draft guidance
on eCTD specifications. This revised version of the draft guidance,
when finalized, will supersede the guidance for industry titled
``Providing Regulatory Submissions in Electronic Format--Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications'' that was issued in June 2008. This revised draft
guidance, when finalized, will be applicable to all submissions within
the scope of section 745A(a) of the FD&C Act, i.e., certain NDAs,
ANDAs, BLAs, and INDs and all subsequent submissions, including
amendments, supplements, and reports, to these submission types.\2\
---------------------------------------------------------------------------
\2\ See id.
---------------------------------------------------------------------------
In general, this revised draft guidance contains the following
changes from the previous 2013 draft guidance on eCTD specifications:
It is now explicit that certain master files are within
the scope of section 745A(a) of the FD&C Act.
Similarly, it is now explicit that advertising and
promotional labeling materials are also within the scope of section
745A(a) of the FD&C Act.
Use of the FDA Electronic Submissions Gateway (ESG) will
be required.
Use of FDA fillable forms will be required with all eCTD
submissions.
Specified file formats and software versions will be
required for submissions filed with the FDA.
After publication of the Federal Register notice of availability of
the final version of the guidance, all submissions with a filing date
24 months after the Federal Register notice must use the appropriate
FDA-supported eCTD specifications for certain NDA, ANDA, and BLA
submissions. IND submissions must use the FDA-supported eCTD
specifications for electronic submissions filed 36 months after the
Federal Register notice of availability is published.
In section 745A(a) of the FD&C Act, Congress granted explicit
authorization to FDA to implement the statutory electronic submission
requirements by specifying in a guidance document the format for the
submissions. Accordingly, to the extent that this draft guidance
provides the requirements under section 745A(a) of the FD&C Act,
indicated by the use of the words must or required, it is not subject
to the usual restrictions in FDA's good guidance practice regulations,
such as the requirement that guidances not establish legally
enforceable responsibilities (see 21 CFR 10.115(d)).
II. Paperwork Reduction Act of 1995
The draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The draft guidance pertains to sponsors and applicants making
regulatory submissions to FDA in electronic format for NDAs, ANDAs,
BLAs, INDs, master files, and advertising and promotional labeling. The
information collection discussed in the draft guidance is contained in
our IND regulations (21 CFR part 312) and approved under OMB control
number 0910-0014, our NDA regulations (including ANDAs) (21 CFR part
314) and approved under OMB control number 0910-0001, and our BLA
regulations (21 CFR part 601) and approved under OMB control number
0910-0338.
Sponsors and applicants have been submitting NDAs, ANDAs, BLAs,
INDs, and master files electronically since 2003, and the majority of
these submissions are already received in electronic format. Under
section 745A(a) of the FD&C Act, sponsors and applicants are required
to file most of these submissions electronically. These requirements
will be phased in over 2- and 3-year periods after the issuance of the
final version of the guidance.
For some sponsors and applicants, there may be new costs, including
capital costs or operating and maintenance costs, which would result
from the requirements under FDASIA and the final version of the
guidance, because some sponsors and applicants may have to upgrade eCTD
specifications and/or change their method of submitting information to
the FDA. FDA estimates that for some sponsors and applicants the costs
may be as follows:
eCTD Publishing Software: $25,000 to $150,000;
Publishing Operations Support: $50,000 to $1,000,000; and
Training: $5,000 to $50,000.
III. Comments
Interested persons may submit either electronic comments to https://www.regulations.gov or written comments regarding this document to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
https://
[[Page 43496]]
www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: July 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17588 Filed 7-24-14; 8:45 am]
BILLING CODE 4164-01-P
