[Federal Register Volume 79, Number 243 (Thursday, December 18, 2014)]
[Notices]
[Pages 75570-75572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29609]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1953]


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) is announcing the

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availability of a guidance for industry entitled ``Providing Regulatory 
Submissions in Electronic Format--Submissions Under Section 745A(a) of 
the Federal Food, Drug, and Cosmetic Act.'' The 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, beginning no earlier than 24 months 
after issuance of a final version of a guidance document specifying the 
format for such electronic submissions. This guidance describes how FDA 
interprets and plans to implement the electronic submission 
requirements and finalizes the draft guidance that was issued on 
February 6, 2014.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Avenue, 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 documents.
    Submit electronic comments on the 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. 1192, Silver Spring, MD 20993-0002, 
[email protected]; or the Office of Communication, Outreach 
and Development, Center for Biologics Evaluation and Research (CBER), 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
3128, Silver Spring, MD 20993-0002.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Submissions Under Section 745A(a) of the Federal Food, Drug, and 
Cosmetic Act.'' Section 1136 of 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'' (21 U.S.C. 379k-1). Drug 
and biological product submissions are addressed in section 745A(a) of 
the FD&C Act.
    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), 
biologics license applications (BLAs), and investigational new drug 
applications (INDs) must be in electronic format specified in FDA 
guidance. Section 745A(a)(2) of the FD&C Act states that the guidance 
issued by FDA may provide a timetable for future standards and criteria 
for waivers and exemptions. Section 745A(a)(3) of the FD&C Act provides 
that the electronic submission requirements in section 745A(a) do not 
apply to submissions under section 561 of the FD&C Act (21 
U.S.C.360bbb).
    This guidance describes FDA's interpretation of the scope of 
section 745A(a) of the FD&C Act. It announces that certain INDs will be 
exempted from the electronic submission requirements. Finally, it 
describes 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 types of 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 FDA issues a final guidance. Therefore, no 
earlier than 24 months after issuance of the final version of an 
individual guidance specifying the format for certain types of 
submissions under section 745A(a) of the FD&C Act, the Agency will 
begin requiring that the submissions under NDAs, ANDAs, certain BLAs, 
and certain INDs be submitted in the specified electronic format for 
the types of submissions described in that guidance.
    Individual guidances will be developed to specify the electronic 
formats, subject matter, and scope of applicability for certain 
submissions under section 745A(a) of the FD&C Act. Once an individual 
guidance is finalized and the timetable for implementation described in 
that guidance has passed, the guidance will have binding effect and the 
electronic format(s) specified in that guidance must be used for 
submissions to NDAs, ANDAs, certain BLAs, and certain INDs.
    In the Federal Register of February 6, 2014 (79 FR 7200), FDA 
announced a draft version of this guidance entitled ``Providing 
Regulatory Submissions in Electronic Format--Submissions Under Section 
745A(a) of the Federal Food, Drug, and Cosmetic Act.'' The comment 
period on the draft guidance ended on May 6, 2014. We reviewed all 
comments received on the draft guidance and revised several sections of 
the guidance. The updates include:
    Section III.A and III.B: Clarified that the scope of the 
requirement under section 754A(a) does not extend to certain INDs and 
certain BLAs. Also clarified that certain INDs are exempted from the 
electronic submission requirements under section 745A(a)(2). 
Specifically, we clarified that INDs and BLAs for devices that are 
regulated by CBER as biological products under Section 351 of the 
Public Health Service (PHS) Act are instead subject to the requirements 
under Section 745A(b), and that, issued in section 745A(a)(2), INDs 
that are noncommercial are exempt from the requirements under section 
745A(a). We provided examples in this regard.
    Section III.D: Clarified that the individual guidances under 
745A(a) will specify electronic formats, subject matter, and scope of 
applicability, as well as the timetable for implementation.
    Section III.F: Clarified the timetable under which revisions or 
updates to electronic submission standards will take effect.
    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 guidance contains 
binding provisions. In section 745A(a) of the FD&C Act, Congress 
granted explicit authorization to FDA to specify in guidance the format 
for the electronic submissions required under that section. 
Accordingly, this guidance explains such requirements under section 
745A(a) of the FD&C Act, indicated by the use of the words must or 
required, and therefore is not subject to the usual restrictions in 
FDA's good guidance practice regulations, such as the requirement that 
guidances not

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establish legally enforceable responsibilities. See 21 CFR 10.115(d).

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. As discussed 
in the guidance, FDA intends to develop individual guidances to specify 
the electronic formats for certain submissions under section 745A(a) of 
the FD&C Act. 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 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: December 12, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29609 Filed 12-17-14; 8:45 am]
BILLING CODE 4164-01-P