[Federal Register Volume 78, Number 2 (Thursday, January 3, 2013)]
[Notices]
[Pages 310-311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31577]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-1256]
Draft Revision of 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.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of draft guidance for industry entitled ``Providing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 The draft guidance announced in this notice is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 (the 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 2 years after publication
of the final version of the draft guidance. The draft guidance
describes how FDA plans to implement the requirements for the
electronic submission of applications for certain human pharmaceutical
products and is being issued for public comment. In its final form,
this document will also supersede the guidance titled ``Guidance for
Industry Providing Regulatory Submissions in Electronic Format--Human
Pharmaceutical Product Applications and Related Submissions Using the
eCTD Specifications'' that was issued in October 2005 and revised in
April 2006 and 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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 4, 2013.
ADDRESSES: Submit written requests for single copies of the documents
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 (HFM-40), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852-1448. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
documents.
Submit electronic comments on the draft guidance to http://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: [email protected];
or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
The electronic Common Technical Document (eCTD) is an International
Conference on Harmonisation (ICH) standard based on specifications
[[Page 311]]
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 the 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.
FDASIA (Pub. L. 112-144, 126 Stat. 993 (2012)), signed by the
President on July 9, 2012, amended the FD&C Act to add section 745A,
titled ``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, and submissions under sections 351(a) or (k) of the PHS
Act, be submitted to FDA in electronic format no earlier than 24 months
after FDA issues the final guidance described in this section.
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 a format
that FDA can process, review, and archive. Currently, the Agency can
process, review, and archive electronic submissions made using the eCTD
version 3.2.2 specifications. Requirements for electronic submission
will be phased in according to the following schedule: (1) 24 months
after publication of the final version of this draft revised guidance,
the requirements will apply to new drug application (NDA), abbreviated
new drug application (ANDA), and biologics license application (BLA)
submissions and (2) 36 months after publication of the final guidance,
the requirements will apply to investigational new drug application
(IND) submissions. Section 745A(a) of the FD&C Act does not apply to
master files and advertising and promotional labeling submissions.
However, FDA accepts and strongly encourages the submission of master
files and advertising and promotional labeling materials
electronically, as described in the draft guidance.
In Section 745A(a), Congress granted explicit authorization to FDA
to implement the statutory electronic submission requirements by
specifying the format for such submissions in guidance. To the extent
that the draft guidance provides such 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 (GGP) regulations, such as the requirement that
guidances not establish legally enforceable responsibilities. See 21
CFR 10.115(d).
At the same time, the draft guidance also provides guidance on
FDA's interpretation of the statutory electronic submission requirement
and the Agency's current thinking on the best means for implementing
other aspects of the electronic submission program. Therefore, to the
extent that the draft guidance includes provisions that are not part of
the requirements under section 745A(a), it is being issued in
accordance with FDA's GGP regulation (21 CFR 10.115). Such parts of the
draft guidance, when finalized, will represent the Agency's current
thinking on this topic, and do not create or confer any rights for or
on any person and do not operate to bind FDA or the public. You can use
an alternative approach for these recommendations if such an approach
would satisfy the requirements of the applicable statutes and
regulations. The use of the word should in the draft guidance means
that something is suggested or recommended, but not required.
Accordingly, the final guidance will contain both binding and
nonbinding provisions.
II. Paperwork Reduction Act of 1995
The draft guidance refers to collections of information that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (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, and
INDs electronically since 2003, and the majority of these submissions
are already received in electronic format. Under FDASIA, sponsors and
applicants will be required to make all of these submissions
electronically. These requirements will be phased in over 2 and 3 year
periods after the issuance of the final guidance.
There may be new costs, including capital costs or operating and
maintenance costs, which would result from the requirements under
FDASIA and the final guidance, because some sponsors and applicants
would have to convert from paper-based submissions to electronic
submissions. In accordance with the PRA, prior to publication of the
final guidance document, FDA intends to solicit public comment and
obtain OMB approval for any costs that are new or that would represent
material modifications to these previously approved collections of
information found in FDA regulations.
III. Comments
Interested persons may submit either electronic comments to http://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 http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm, http://www.regulations.gov, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm, http://www.regulations.gov, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Dated: December 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31577 Filed 12-31-12; 8:45 am]
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