Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format, 32392-32394 [2013-12825]

Download as PDF 32392 Federal Register / Vol. 78, No. 104 / Thursday, May 30, 2013 / Notices attending, and if participating via webcast or in-person. Webcast Public Participation: After pre-registration, individuals participating by webcast will receive webcast access information via email. In-Person Public Participation and Building Access: For in-person participants, the meetings are within the National Institutes of Health (NIH) Clinical Center (Building 10) as noted above in the Addresses section. Details regarding registration capacity and directions will be posted on www.DietaryGuidelines.gov. For inperson participants, check-in at the registration desk onsite at the meeting is required and will begin at 7:30 a.m. each day. Public Comments and Meeting Documents: Written comments from the public will be accepted throughout the Committee’s deliberative process; opportunities to present oral comments to the Committee will be provided at a future meeting. Written public comments can be submitted and/or viewed at www.DietaryGuidelines.gov using the ‘‘Submit Comments’’ and ‘‘Read Comments’’ links, respectively. Written comments received by June 5, 2013 will ensure transmission to the Committee prior to this meeting. Documents pertaining to Committee deliberations, including meeting agendas, summaries, and transcripts will be available on www.DietaryGuidelines.gov under ‘‘Meetings’’ and meeting materials will be available for public viewing at the meeting. Meeting information, thereafter, will continue to be accessible online, at the NIH Library, and upon request at the Office of Disease Prevention and Health Promotion, OASH/HHS; 1101 Wootton Parkway, Suite LL100 Tower Building; Rockville, MD 20852: Telephone (240) 453–8280; Fax: (240) 453–8281. Dated: May 24, 2013. Richard Olson, Designated Federal Officer, Director, Division of Prevention Science, Office of Disease Prevention and Health Promotion, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services. TKELLEY on DSK3SPTVN1PROD with NOTICES [FR Doc. 2013–12859 Filed 5–24–13; 4:15 pm] BILLING CODE 4150–32–P VerDate Mar<15>2010 16:25 May 29, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Health Resources and Services Administration CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) announce the following meeting of the aforementioned committee: Times and Dates: 8:00 a.m.–5:30 p.m., June 18, 2013; 8:00 a.m.–2:30 p.m., June 19, 2013. Place: CDC Corporate Square, Building 8, Conference Room 1–ABC, 8 Corporate Boulevard, Atlanta, Georgia 30329, Telephone: (404) 639–8317. Status: Open to the public, limited only by the space available. The meeting room will accommodate approximately 100 people. This meeting is also accessible by teleconference. Toll-free +1 (866) 718–4584, Participant code: 8484551. Status: Open to the public, limited only by the space available. The meeting room will accommodate approximately 100 people. Purpose: This Committee is charged with advising the Director, CDC and the Administrator, HRSA, regarding activities related to prevention and control of HIV/ AIDS, Viral Hepatitis and other STDs, the support of health care services to persons living with HIV/AIDS, and education of health professionals and the public about HIV/AIDS, Viral Hepatitis and other STDs. Matters To Be Discussed: Agenda items include: (1) STD clinical preventive services in primary care setting and integrating STD screening and treatment services in HIV care settings); (2) The test and cure era for hepatitis C: The public health response to rising hepatitis C mortality; The impact of new therapies on health outcomes; and Building care capacity to increase access to hepatitis C virus (HCV) therapy; (3) HIV Medical Monitoring Project: follow up on Institute of Medicine (IOM) report and other Affordable Care Act (ACA) issues; (4) Recommendations for new HIV diagnostic laboratory testing algorithms; and (5) CHAC Workgroups Update. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Margie Scott-Cseh, Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, 1600 Clifton Road NE., Mailstop E–07, Atlanta, Georgia 30333, Telephone (404) 639–8317. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register Notices pertaining to announcements of meetings and PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2013–12857 Filed 5–29–13; 8:45 am] BILLING CODE 4163–18–P 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. 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 https:// 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, Ila.mizrachi@fda.hhs.gov. SUMMARY: E:\FR\FM\30MYN1.SGM 30MYN1 Federal Register / Vol. 78, No. 104 / Thursday, May 30, 2013 / Notices 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. SUPPLEMENTARY INFORMATION: TKELLEY on DSK3SPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 16:25 May 29, 2013 Jkt 229001 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 wellformed 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 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 32393 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: E:\FR\FM\30MYN1.SGM 30MYN1 32394 Federal Register / Vol. 78, No. 104 / Thursday, May 30, 2013 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 1 There Average burden per response Total hours 11.50 5,750 1.25 7,187.50 In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. BILLING CODE 4160–01–P Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats and Declaration of Amount of Added Sugars—(OMB Control Number 0910– New) DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0495] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Consumer Responses to Nutrition Facts Labels With Various Footnote Formats and Declaration of Amount of Added Sugars Food and Drug Administration, HHS. Notice. 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 July 1, 2013. 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 emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–New and title ‘‘Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats and Declaration of Amount of Added Sugars.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400T, Rockville, MD 20850, domini.bean@fda.hhs.gov. SUMMARY: TKELLEY on DSK3SPTVN1PROD with NOTICES Total annual responses SUPPLEMENTARY INFORMATION: [FR Doc. 2013–12825 Filed 5–29–13; 8:45 am] ACTION: Number of responses per response 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. AGENCY: Number of respondents 500 Content of labeling submissions in NDAs, ANDAs, supplemental NDAs and ANDAs, and annual reports VerDate Mar<15>2010 16:25 May 29, 2013 Jkt 229001 I. Background Under the Nutrition Labeling and Education Act of 1990 (Pub. L. 101– 535), the Nutrition Facts label is required on most packaged foods and this information must be provided in a specific format in accordance with the provisions of § 101.9 (21 CFR 101.9). When FDA was determining which Nutrition Facts label format to require, the Agency undertook consumer research to evaluate alternatives (Refs. 1 to 3). More recently, FDA conducted qualitative consumer research on the format of the Nutrition Facts label on behalf of the Agency’s Obesity Working Group (Ref. 4), which was formed in 2003 and tasked with outlining a plan to help confront the problem of obesity in the United States (Ref. 5). In addition to conducting consumer research, in the Federal Register of November 2, 2007 (72 FR 62149), FDA issued an Advance Notice of Proposed Rulemaking (ANPRM) entitled, ‘‘Food Labeling: Revision of Reference Values and Mandatory Nutrients’’ (the 2007 ANPRM), which requested comments on a variety of topics related to a future proposed rule to update the presentation of nutrients and content of nutrient values on food labels. In the 2007 ANPRM, the Agency included a request for comments on how consumers use the percent Daily Value in the Nutrition Facts label when evaluating the nutritional content of food items and making purchases. Research has suggested that consumers use the Nutrition Facts label in various ways, including, but not limited to, using the Nutrition Facts label to determine if products are high or low in a specific nutrient and to compare products (Ref. 6). One component of the Nutrition Facts label that serves as an aid in these uses is the PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 percent Daily Value. Early consumer research indicated that the percent Daily Value format improved consumers’ abilities to make correct dietary judgments about a food in the context of a total daily diet (Ref. 3), which led FDA to require both quantitative and percentage declarations of nutrient Daily Values in the Nutrition Facts label in the 1993 Nutrition Labeling final rule (58 FR 2079, January 6, 1993). Research in subsequent years, however, suggested that consumers’ understanding and use of percent Daily Value may be somewhat inconsistent (Refs. 7 and 8). Additionally, FDA has received several public comments suggesting that further research on percent Daily Values may be warranted, along with research on other modifications to the Nutrition Facts label. Suggested research on potential modifications includes research on: (1) The removal of the statements, ‘‘Percent Daily Values are based on a 2,000 calorie diet. Your Daily Values may be higher or lower depending on your calorie needs’’; (2) the removal of the table in the footnote that lists the Daily Values for total fat, saturated fat, cholesterol, sodium, total carbohydrate, and dietary fiber based on 2,000 and 2,500 calorie diets as described in § 101.9(d)(9); and (3) changes to the presentation of and amount of information provided in the Nutrition Facts label. Therefore, the FDA, as part of its effort to promote public health, proposes to use this study to explore consumer responses to various food label formats for the footnote area of the Nutrition Facts label, including those that exhibit information such as a description of percent Daily Value, a succinct statement about daily caloric intake, a general guideline for interpreting percent Daily Values, or a footnote about nutrients whose daily intake should be limited. This study will also explore how declaring the added sugars content of foods might affect consumers’ attention to and understanding of the sugars and calorie contents and other information on the Nutrition Facts label. FDA received numerous comments regarding the declaration of added sugars in response to the 2007 ANPRM even though the Agency did not ask any E:\FR\FM\30MYN1.SGM 30MYN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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, Ila.mizrachi@fda.hhs.gov.

[[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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                500            11.50            5,750             1.25         7,187.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
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