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Draft Guidance for Industry and Reviewers on Structured Product Labeling Standard for Content of Labeling Technical Questions and Answers, Revision; Availability

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 This draft guidance is intended to assist sponsors who submit the content of their product labeling to the Center for Drug Evaluation and Research (CDER) and Center for Biologics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 The draft guidance also provides information to CDER and CBER staff who review and manage that product information using electronic systems. This draft guidance is being revised to reflect technological changes and changes resulting from the requirement in the Food and Drug Administration Amendments Act of 2007 to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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by December 28, 2009.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Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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 Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.

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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.

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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 Start Printed Page 55563any 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:Start Printed Page 55564

Table 1.—Estimated Reporting Burden1

GuidanceNo. of RespondentsFrequency per ResponseTotal ResponsesHours per ResponseTotal Hours
Draft Guidance for Industry and Reviewers on SPL Standard for Content of Labeling Technical Qs & As, Revision45011.115,0001.256,250
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.

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Dated: October 23, 2009.

David Horowitz,

Assistant Commissioner for Policy.

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[FR Doc. E9-25940 Filed 10-27-09; 8:45 am]

BILLING CODE 4160-01-S