[Federal Register Volume 79, Number 26 (Friday, February 7, 2014)]
[Notices]
[Pages 7463-7464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02654]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0077 (formerly 2007D-0213)]


Guidance for Industry; Providing Regulatory Submissions in 
Electronic Format--Receipt Date; 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 a guidance for industry entitled ``Providing Regulatory 
Submissions in Electronic Format--Receipt Date.'' This guidance 
describes how FDA will assign receipt dates to certain submissions 
provided in electronic format to the Center for Drug Evaluation and 
Research (CDER) and the Center for Biologics Evaluation and Research 
(CBER). This document finalizes the guidance of the same name, which 
was issued in June 2007.

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 (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 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: Edward Hallissey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 1139, Silver Spring, MD 20993, 301-796-
0420; or Stephen Ripley, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 5515 Security Lane, Rm. 5130, Rockville, 
MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Receipt Date.'' This guidance describes how FDA will assign receipt 
dates to certain submissions provided in electronic format or in 
physical media to CDER and CBER.
    When CDER or CBER receives a submission, the receipt date may be 
used to determine important regulatory milestones, such as FDA's 30-day 
safety review cycle for an investigative new drug (IND) application. 
The guidance provides clarity regarding when items submitted 
electronically are deemed received by FDA for purposes of such 
milestones. Prior to issuance of this final guidance, certain 
submissions received through the electronic submission gateway (ESG) 
after 4:30 p.m. were deemed to be received on the following business 
day. With this final guidance, we are generally eliminating this 4:30 
p.m. cut-off for submissions received through the ESG Monday through 
Friday. However, certain submissions received through the ESG on a 
weekend, Federal holiday, or on a day when the FDA office that will 
review the submission is otherwise not open for business, will be 
assigned a receipt date corresponding to the next business day.
    Occasionally, submissions in electronic format have technical 
deficiencies that prevent FDA from opening, processing, or archiving 
the submission. The guidance explains that FDA considers a technically 
deficient electronic submission to be not received (i.e., not present 
at the Agency and not under review) until all technical deficiencies 
are resolved.
    On June 5, 2007 (72 FR 31079), FDA announced the availability of 
the draft version of this guidance. The public comment period closed on 
August 6, 2007. Several comments were received from the public, all of 
which the Agency considered carefully as it finalized the guidance and 
made appropriate changes. Those changes clarified the draft guidance 
and updated the document to reflect legislative provisions adopted 
since the draft was issued. More specifically, the final guidance 
generally eliminates the 4:30 p.m. cut-off for submissions received 
through the ESG Monday through Friday. It also provides guidance on 
FDA's interpretation of a provision in the Generic Drug User Fee 
Amendments of 2012 (GDUFA) concerning the date of submission for Type 
II drug master files, Abbreviated New Drug Applications (ANDAs), and 
amendments and supplements to ANDAs.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on determining the receipt date for certain 
submissions in electronic format or in physical media. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Paperwork Reduction Act of 1995

    The 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, 44 U.S.C. 3501-3520. The guidance 
pertains to sponsors and applicants making regulatory

[[Page 7464]]

submissions to FDA in electronic format for INDs, pre-market 
applications, including new drug applications (NDAs), ANDAs, biologics 
license applications (BLAs), and amendments and supplements to these 
applications, master files (MFs), postapproval studies (whether 
submitted as supplements to approved applications or otherwise), 
submissions related to products marketed without an approved 
application, and adverse event reports. The information collection 
discussed in the 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.

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.

    Dated: February 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02654 Filed 2-6-14; 8:45 am]
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