[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Draft Guidance for Industry on Providing Regulatory Submissions 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announcing the availability of a draft guidance for industry entitled 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The draft guidance announced in this notice sets forth FDA's 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publication of a final version of the draft guidance.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draft guidance before it begins work on the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comments on the draft guidance by May 7, 2014.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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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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