
[Federal Register Volume 78, Number 85 (Thursday, May 2, 2013)]
[Notices]
[Page 25749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10379]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0294]


Submission of New Drug Application/Abbreviated New Drug 
Application Field Alert Reports: Notice of Form FDA 3331--Automated 
Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a pilot 
program to test an XML (extensible markup language)-enabled Adobe PDF 
form, Form FDA 3331--Automated to submit new drug application (NDA) and 
abbreviated new drug application (ANDA) Field Alert Reports (FARs) as 
required by FDA regulations. This pilot program is intended to provide 
FDA with information to allow the Agency to modernize the FAR 
submission and review pathway and will permit integration with 
electronic archive filing systems.

DATES: The XML-enabled Adobe PDF form, Form FDA 3331--Automated, will 
be available for piloting between May 1, 2013, and January 1, 2014.

ADDRESSES: Electronic or written general comments regarding the pilot 
may be submitted to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. The automated form, detailed instructions for use, and 
frequently asked questions are available at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm347604.htm.
    Questions or feedback about the pilot program should be sent to 
district Drug Field Alert Monitors (contact information for each of 
these individuals is available on FDA's Web site at http://www.fda.gov/ICECI/Inspections/IOM/ucm124063.htm). FDA's Center for Drug Evaluation 
and Research (CDER) has also established an email account, CDER-FAR-XML@fda.hhs.gov, to receive feedback on participants' experiences using 
the XML-enabled Form FDA 3331--Automated.

FOR FURTHER INFORMATION CONTACT: Mark Browning, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-5342.

SUPPLEMENTARY INFORMATION: 

I. Background

    This pilot program seeks to modernize the FAR submission and review 
pathway using an XML-enabled PDF form to enable integration with 
electronic archive filing systems and simplify data integration across 
the enterprise. Under existing procedures, firms typically submit FARs 
via fax or scanned copy to their respective FDA district offices, and 
the district offices then provide them to CDER for additional review 
and analysis. Under this pilot program, participants will be able to 
send the FAR report simultaneously to the selected FDA district office 
and to CDER's Office of Compliance, allowing for improved coordination 
within the Agency as well as more efficient reporting by industry. The 
pilot program will also offer industry participants the opportunity to 
provide the Agency with feedback regarding the use of the automated 
form. FDA will take industry feedback into account when improving the 
FAR reporting process overall.
    The pilot is open to all NDA and ANDA holders. Participation in the 
pilot program is voluntary and no additional software or licenses are 
needed to use the proposed Form FDA 3331--Automated. For the period of 
the pilot program, firms that elect to participate must continue to 
submit a signed Form FDA 3331 (whether the traditional or the automated 
version) via email, along with the pilot automated form. This parallel 
process during the pilot program will ensure delivery of all field 
alert reports and allow FDA to evaluate the utility of an automated 
form.
    The pilot program will run for 8 months following the date of the 
Federal Register Notice and may be extended as needed to accrue 
sufficient reports and experience for a meaningful evaluation. After 
the pilot concludes, CDER and the Office of Regulatory Affairs will 
evaluate the forms submitted along with any direct industry feedback 
about using the automated form. If the pilot is successful, FDA would 
likely seek to adopt a more permanent, required electronic reporting 
system, which would be implemented in accordance with existing 
regulation- and guidance-making processes, as needed.
    The automated form, detailed instructions for use, and frequently 
asked questions are available on FDA's Web site at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm347604.htm.

II. Comments and Other Feedback

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written general 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.
    Participants should contact their district Drug Field Alert 
Monitors for questions or feedback about the pilot program. Contact 
information for each district Drug Field Alert Monitor is available on 
FDA's Web site at http://www.fda.gov/ICECI/Inspections/IOM/ucm124063.htm. CDER has also established an email account, CDER-FAR-XML@fda.hhs.gov, to receive feedback on participants' experiences using 
the XML-enabled Form FDA 3331--Automated.

III. The Paperwork Reduction Act of 1995

    This notice refers to previously approved 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 collection of information in Form FDA 3331 has been approved 
under OMB control number 0910-0001.

    Dated: April 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-10379 Filed 5-1-13; 8:45 am]
BILLING CODE 4160-01-P


