[Federal Register Volume 74, Number 214 (Friday, November 6, 2009)]
[Notices]
[Pages 57491-57493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26760]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities: Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995, 
Federal agencies are required to publish notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on the reporting requirements contained in the 
requirements for submission of labeling for human prescription drugs 
and biologics in electronic format.

[[Page 57492]]


DATES: Submit written or electronic comments on the collection of 
information by January 5, 2010.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. All comments should be identified with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, [email protected], 301-
796-3792

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA), 44 U.S.C. 3501-3520, 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, including each proposed 
extension of an existing collection of information, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (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.

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, 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. The comments said that 
the burden estimate in 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

[[Page 57493]]

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.
    FDA estimates the burden of this collection of information as 
follows:

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


    Dated: October 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26760 Filed 11-5-09; 8:45 am]
BILLING CODE 4160-01-S