[Federal Register Volume 75, Number 85 (Tuesday, May 4, 2010)]
[Notices]
[Pages 23779-23781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-10361]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0507]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Requirements for 
Submission of Labeling for Human Prescription Drugs and Biologics in 
Electronic Format

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES:  Fax written comments on the collection of information by June 
3, 2010.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0530. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, [email protected], 301-
796-3792.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Requirements for Submission of Labeling for Human Prescription Drugs 
and Biologics in Electronic Format--OMB Control Number 0910-0530--
Extension

    FDA is requesting that OMB extend approval under the Paperwork 
Reduction Act (44 USC 3501-3520) for the information collection 
resulting from the requirement that the content of labeling for 
prescription drug products be submitted to FDA electronically in a form 
that FDA can process, review, and archive. This requirement was set 
forth in the final rule entitled ``Requirements for Submission of 
Labeling for Human Prescription Drugs and Biologics in Electronic 
Format'' (December 11, 2003; 68 FR 69009), which amended FDA 
regulations governing the format in which certain labeling is required 
to be submitted for FDA review with new drug applications (NDAs) (21 
CFR 314.50(l)(1)(i)), including supplemental NDAs, abbreviated new drug 
applications (ANDAs) (21 CFR 314.94(d)(1)(ii)), including supplemental 
ANDAs, and annual reports (21 CFR 314.81(b)(2)(iii)(b)) (the final rule 
also applied to certain Biologics License Applications, but the 
information collection for these requirements is not part of this OMB 
approval request).
    This OMB approval request is only for the burden associated with 
the electronic submission of the content of labeling. The burden for 
submitting labeling as part of NDAs, ANDAs, supplemental NDAs and 
ANDAs, and annual reports, has been approved by OMB under Control 
Number 0910-0001.
    When we last requested that OMB extend approval for this 
information collection (see the Federal Register of March 29, 2006 (71 
FR 15752)), we received several comments. Generally,

[[Page 23780]]

the comments said that, unlike FDA's December 11, 2003, final rule, the 
agency has now identified Extensible Markup Language (XML) as the 
required file format for Structured Product Label documents (SPL), and 
that the burden hours and costs that were calculated in the final rule 
were based on the submission of the content of labeling in PDF 
(portable document format). The comments said that the burden estimate 
in the March 29, 2006, Federal Register notice does not take into 
account the amount of time required to obtain, install, and update the 
program required to create the electronic files in the new format, and 
that SPL is a relatively new format requiring an initial investment in 
software, training, and process change that cannot simply be converted 
from the Word or PDF version of labeling. The comments said that the 
process for creating the SPL labeling includes significant effort in 
mapping, coding, recreation of the file, and quality control.
    In the December 13, 2006, Federal Register (71 FR 74924), we said 
that we will respond to the comments as soon as we have gathered 
sufficient information to address the costs specified in the comments, 
and that the public will have an opportunity to comment on the response 
at that time. The burden hours and costs associated with making these 
submissions using the SPL standard are discussed here.
    We estimate that it should take applicants approximately 1.25 hours 
to convert the content of labeling from Word or PDF to SPL format. The 
main task involved in this conversion is copying the content from one 
document (Word or PDF) to another (SPL). Over the past few years, 
several enhancements have been made to SPL authoring software which 
significantly reduces the burden and time needed to generate well-
formed SPL documents. SPL authors may now copy a paragraph from a Word 
or PDF document and paste the text into the appropriate section of an 
SPL document. In those cases where an SPL author needs to create a 
table, the table text may be copied from the Word or PDF document and 
pasted into each table cell in the SPL document, eliminating the need 
to retype any information. Enhancements have also been made to the 
software for conversion vendors. Conversion software vendors have 
designed tools which will import the Word version of the content of 
labeling and, within minutes, automatically generate the SPL document 
(a few formatting edits may have to be made).
    Based on the number of content of labeling submissions received 
during 2006, 2007, and 2008, we estimate that approximately 5,000 
content of labeling submissions are made annually with original NDAs, 
ANDAs, supplemental NDAs and ANDAs, and annual reports by approximately 
450 applicants. Therefore, the total annual hours to convert the 
content of labeling from Word or PDF to SPL format would be 
approximately 6,250 hours.
    Concerning costs, we continue to conclude that there are no capital 
costs or operating and maintenance costs associated with this 
collection of information. In May 2009, FDA issued a guidance for 
industry entitled ``Providing Regulatory Submissions in Electronic 
Format--Drug Establishment Registration and Listing.'' The guidance 
describes how to electronically create and submit SPL files using 
defined code sets and codes for establishment registration and drug 
listing information, including labeling. The information collection 
resulting from this guidance, discussed in the Federal Register of 
January 8, 2009 (74 FR 816), has been approved by OMB under Control 
Number 0910-0045. As discussed in the January 8, 2009, Federal Register 
notice, to create an SPL file and submit it to FDA, a registrant would 
need the following tools: A computer, appropriate software, access to 
the Internet, knowledge of terminology and standards, and access to 
FDA's electronic submission gateway (ESG). Registrants (and most 
individuals) have computers and Internet access available for their 
use. If a business does not have an available computer or access to the 
Internet, free use of computers and the Internet are usually available 
at public facilities, e.g., a community library. In addition, there 
should be no additional costs associated with obtaining the appropriate 
software. In 2008, FDA collaborated with GlobalSubmit to make available 
free SPL authoring software that SPL authors may utilize to create new 
SPL documents or edit previous versions. (Information on obtaining this 
software is explained in section IV.A of the guidance ``Providing 
Regulatory Submissions in Electronic Format--Drug Establishment 
Registration and Listing.'') In addition to the software, FDA also 
provides technical assistance and other resources, code sets and codes, 
and data standards regarding SPL files.
    After the SPL file is created, the registrant would upload the file 
through the ESG, as explained in the January 8, 2009, Federal Register 
notice. A digital certificate is needed to use the ESG. The digital 
certificate binds together the owner's name and a pair of electronic 
keys (a public key and a private key) that can be used to encrypt and 
sign documents. A fee of up to $20.00 is charged for the digital 
certificate and the registrant may need to renew the certificate not 
less than annually. We are not calculating this fee as a cost for this 
extension because all applicants who submit content of labeling are 
also subject to the drug establishment registration and listing 
requirements and would have already acquired the digital certificate as 
a result of the May 2009 guidance on drug establishment registration 
and listing.
    In the Federal Register of November 6, 2009 (74 FR 57491), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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   Content of labeling submissions in NDAs, ANDAs,         Number of       Annual Frequency      Total Annual          Hours per
   supplemental NDAs and ANDAs, and annual reports        Respondents        per Response          Responses           Response           Total Hours
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                                                                     450               11.11               5,000                1.25               6,250
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 23781]]

    Dated: April 28, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10361 Filed 5-3-10; 8:45 am]
BILLING CODE 4160-01-S