[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7200-7201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02553]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0085]
Draft Guidance for Industry on Providing Regulatory Submissions
in Electronic Format--Submissions Under Section 745A(a) of the Federal
Food, Drug, and Cosmetic Act; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Submissions
Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act.''
The draft guidance announced in this notice sets forth FDA's
interpretation of 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 the Public Health Service Act be submitted in electronic
format specified by FDA, beginning no earlier than 24 months after
publication of a final version of the draft guidance. This guidance
describes how FDA interprets and plans to implement the electronic
submission requirements.
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draft guidance before it begins work on the
[[Page 7201]]
final version of the guidance, submit either electronic or written
comments on the draft guidance by May 7, 2014.
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Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Ron Fitzmartin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 1160, Silver Spring, MD 20993,
[email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Submissions Under Section 745A(a) of the Federal Food, Drug, and
Cosmetic Act.'' FDASIA (Pub. L. 112-144), signed by the President on
July 9, 2012, amended the FD&C Act to add section 745A entitled
``Electronic Format for Submissions.'' Drug and biologic submissions
are addressed in section 745A(a).
Section 745A(a)(1) of the FD&C Act describes the general scope of
section 745A(a) and provides that submissions under new drug
applications (NDAs), abbreviated new drug applications (ANDAs),
biological license applications (BLAs), and investigational new drug
applications (INDs) must be in electronic format specified in FDA
guidance. Section 745A(a)(2) states that the guidance issued by FDA may
provide a timetable for future standards and criteria for waivers and
exemptions. Section 745A(a)(3) provides that submissions under section
561 are exempt from the requirements of section 745A(a).
This guidance describes the scope of section 745A(a), the waivers
of and exemptions from the electronic submission requirements, and the
process and timetable that FDA will use to implement the electronic
submission requirements. As described in the guidance, FDA will develop
individual guidances to specify the electronic formats for certain
submissions under section 745A(a). Under section 745A(a)(1) of the FD&C
Act, electronic submissions can be required no earlier than 24 months
after a final guidance is issued. Therefore, no earlier than 24 months
after issuance of the final version of an individual guidance
specifying the format for certain submissions under section 745A(a),
the Agency will begin requiring that the submissions under NDAs, ANDAs,
BLAs, or INDs be submitted in the specified electronic format.
The required format(s) for specific submissions and corresponding
timetable(s) for implementation will be specified in individual
guidances. Once an individual guidance is finalized and the timetable
for implementation described in that guidance has passed, the guidance
is considered to have binding effect and the electronic format(s)
specified in that guidance must be used for submissions under certain
NDAs, ANDAs, BLAs, or INDs.
In section 745A(a) of the FD&C Act, Congress granted explicit
statutory authorization to FDA to specify in guidance the format for
the electronic submissions required under this section. Accordingly, to
the extent that this draft guidance provides such requirements under
section 745A(a) of the FD&C Act, indicated by the use of the words
``must'' or ``required'', this document 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). FDA guidances ordinarily
contain standard language explaining that guidances should be viewed
only as recommendations unless specific regulatory or statutory
requirements are cited. FDA is not including this standard language in
this guidance because this draft guidance contains binding provisions.
The draft guidance, when finalized, will represent the Agency's current
thinking on providing regulatory submissions in electronic format, as
required under section 745A(a) of the FD&C Act.
II. Paperwork Reduction Act of 1995
This draft guidance contains no collection of information. As
discussed in the draft guidance, FDA intends to develop individual
draft guidances to specify the electronic formats for certain
submissions under section 745A(a). We will discuss any information
collection subject to clearance by OMB under the Paperwork Reduction
Act in each Federal Register notice announcing the availability of the
individual draft guidances that specify the required electronic
formats.
III. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments 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
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.
Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02553 Filed 2-5-14; 8:45 am]
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