[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Notices]
[Pages 55562-55564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25940]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0355]


Draft Guidance for Industry and Reviewers on Structured Product 
Labeling Standard for Content of Labeling Technical Questions and 
Answers, Revision; 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 draft revised guidance for industry and reviewers 
entitled ``SPL Standard for Content of Labeling Technical Qs & As.'' 
This draft guidance is intended to assist sponsors who submit the 
content of their product labeling to the Center for Drug Evaluation and 
Research (CDER) and Center for Biologics Evaluation and Research (CBER) 
using the Structured Product Labeling standard (SPL) in extensible 
markup language (XML). The draft guidance also provides information to 
CDER and CBER staff who review and manage that product information 
using electronic systems. This draft guidance is being revised to 
reflect technological changes and changes resulting from the 
requirement in the Food and Drug Administration Amendments Act of 2007 
to submit drug establishment registration and drug listing information 
electronically.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit electronic or written comments on the draft guidance 
by December 28, 2009. Submit electronic or written comments on the 
collection of information by December 28, 2009.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments on the collection of information to http://www.regulations.gov. Submit written comments on the collection of 
information to the Division of Dockets Management. All comments should 
be identified with the docket number found in brackets in the heading 
of this document. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:  Lonnie Smith, Center for Drug 
Evaluation and Research (HFD-001), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-0011.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 11, 2003 (68 FR 69009), FDA 
published final regulations requiring that the content of labeling be 
submitted to FDA electronically for new drug applications (NDAs), 
abbreviated new drug applications (ANDAs), certain biologics license 
applications (BLAs), and annual reports (see 21 CFR 314.50(l), 
314.94(d), 601.14(b), and 314.81(b), respectively) (the December 2003 
regulations). The December 2003 regulations state that the content of 
labeling must be submitted to FDA electronically and ``in a form that 
FDA can process, review, and archive.''
    Initially, CDER accepted electronic submissions of content of 
labeling in portable document format (PDF). Then, in September 2004, 
CDER announced that it would accept content of labeling in both PDF and 
SPL formats until the autumn of 2005. On October 21, 2005, CDER 
announced that effective October 31, 2005, CDER would no longer accept 
content of labeling submissions in PDF format and that applicants 
should use the SPL standard when submitting content of labeling to FDA 
in XML with original submissions, supplements, and annual reports. CBER 
made a similar announcement on July 11, 2008, which went into effect on 
October 15, 2008. On July 10, 2008, CDER, CBER, and the Center for 
Veterinary Medicine announced their intention to begin using the SPL 
standard for electronic drug establishment registration and drug 
product listing.
    Since FDA began accepting content of labeling in SPL format for 
application submissions, we have received numerous questions about SPL 
submission requirements. Based on preliminary questions, and in an 
effort to provide easy access to common questions that were being 
raised, in December 2005 we published a final guidance for industry 
entitled ``SPL Standard for Content of Labeling Technical Qs and As.'' 
As a result of initial experience using the SPL format and as a result 
of changes to the system for receiving registration and listing 
information, FDA is revising its SPL Qs & As guidance to provide 
recommendations in response to additional technical questions. Because 
of the number of questions that have arisen as a result of the actions 
described in this section of the document, FDA is issuing this guidance 
as a draft to solicit input from the public on the recommendations.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on submitting 
content of labeling in the SPL format. It does not create or confer

[[Page 55563]]

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

    Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) 
(PRA), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, we are publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Draft Guidance for Industry and Reviewers on SPL Standard for Content 
of Labeling Technical Qs & As, Revision

    In the December 2003 regulations, FDA calculated the burden hours 
(see section V ``Paperwork Reduction Act of 1995'') and the costs (see 
section VIII ``Analysis of Economic Impacts'') resulting from the final 
regulations requiring that the content of labeling be submitted to FDA 
electronically for NDAs, ANDAs, certain BLAs, and annual reports. The 
information collection resulting from the final rule is approved by OMB 
under Control Number 0910-0530. The burden hours and costs that were 
calculated in the final rule were based on the submission of the 
content of labeling in PDF. As discussed in section I of this notice 
and in the Background section of the draft guidance, CDER and CBER no 
longer accept content of labeling submissions in PDF and applicants 
should now use the SPL standard when submitting content of labeling in 
XML with original submissions, supplements, and annual reports. The 
burden hours and costs associated with making these submissions using 
the SPL standard are discussed in this section of the document.
    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 that 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 with original submissions, 
supplements, 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. We 
note that in the future, applicants will not need to convert their 
content of labeling from Word or PDF to SPL, but will be able to 
prepare their content of labeling in SPL format.
    Concerning costs, we have concluded 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 May 2009 guidance). The 
May 2009 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) (the January 2009 notice), has 
been approved by OMB under Control Number 0910-0045. As discussed in 
the January 2009 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 entitled ``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 2009 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 the draft guidance 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 55564]]



                                                         Table 1.--Estimated Reporting Burden\1\
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                                                              No. of           Frequency per                            Hours per
                       Guidance                            Respondents           Response         Total  Responses       Response         Total Hours
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Draft Guidance for Industry and Reviewers on SPL                      450                 11.11              5,000               1.25              6,250
 Standard for Content of Labeling Technical Qs & As,
 Revision
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.regulations.gov.

    Dated: October 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25940 Filed 10-27-09; 8:45 am]
BILLING CODE 4160-01-S