[Federal Register Volume 78, Number 104 (Thursday, May 30, 2013)]
[Notices]
[Pages 32392-32394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12825]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0577]


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 
(the PRA), 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 information collection 
contained in the requirements for the submission of labeling for human 
prescription drugs and biologics in electronic format.

DATES: Submit either electronic or written comments on the collection 
of information by July 29, 2013.

ADDRESSES: 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 (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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B, 
Rockville, MD 20850, 301-796-7726, [email protected].

[[Page 32393]]


SUPPLEMENTARY INFORMATION: Under the 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 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.

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 BLAs, 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.
    We estimate that it should take applicants approximately 1.25 hours 
to convert the content of labeling from Word or PDF to structured 
labeling format (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 the past few years, we estimate that approximately 5,750 content 
of labeling submissions are made annually with original NDAs, ANDAs, 
supplemental NDAs and ANDAs, and annual reports by approximately 500 
applicants. Therefore, the total annual hours to convert the content of 
labeling from Word or PDF to SPL format would be approximately 7,187.50 
hours.
    Concerning costs, we 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 32394]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
 Content of labeling submissions in NDAs, ANDAs, supplemental NDAs      Number of      responses per     Total annual    Average burden    Total hours
                   and ANDAs, and annual reports                       respondents        response        responses       per response
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                                                                                500            11.50            5,750             1.25         7,187.50
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: May 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12825 Filed 5-29-13; 8:45 am]
BILLING CODE 4160-01-P