[Federal Register Volume 75, Number 85 (Tuesday, May 4, 2010)]
[Notices]
[Pages 23779-23781]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10361]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 oira_submission@omb.eop.gov. 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, Elizabeth.Berbakos@fda.hhs.gov, 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
450 11.11 5,000 1.25 6,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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