Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format, 23779-23781 [2010-10361]

Download as PDF 23779 Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 21 CFR Section Annual Frequency per Recordkeeping No. of Recordkeepers Total Annual Records Hours per Record Total Hours Total 29,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3.—THIRD PARTY DISCLOSURE REQUIREMENTS1 21 CFR Section No. of Respondents 21 CFR 107.10(a) and 107.20 mstockstill on DSKH9S0YB1PROD with NOTICES 1 There Annual Frequency of Disclosure 5 Total Annual Disclosures 13 Hours per Disclosure 65 Total Hours 8 520 are no capital costs or operating and maintenance costs associated with this collection of information In compiling these estimates, FDA consulted its records of the number of infant formula submissions received in the past. All infant formula submissions to FDA may be provided in electronic format. The hours per response reporting estimates are based on FDA’s experience with similar programs and information received from industry. FDA estimates that it will receive 13 reports from 5 manufacturers annually under section 412(d) of the act, for a total annual response of 65 reports. Each report is estimated to take 10 hours per response for a total of 650 hours. FDA also estimates that it will receive one notification under § 106.120(b). The notification is expected to take 4 hours per response, for a total of 4 hours. For exempt infant formula, FDA estimates that it will receive two reports from three manufacturers annually under § 107.50(b)(3) and (b)(4), for a total annual response of six reports. Each report is estimated to take 4 hours per response for a total of 24 hours. FDA also estimates that it will receive one notification under § 107.50(e)(2). The notification is expected to take 4 hours per response, for a total of 4 hours. FDA estimates that 5 firms will expend approximately 20,000 hours per year to fully satisfy the record keeping requirements in § 106.100. It is estimated that 3 firms will expend approximately 9,000 hours per year to fully satisfy the record keeping requirements in § 107.50(c)(3). FDA estimates that compliance with the labeling requirements of §§ 107.10(a) and 107.20 will require 520 hours annually by 5 manufacturers. Dated: April 28, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–10360 Filed 5–3–10; 8:45 am] BILLING CODE 4160–01–S VerDate Mar<15>2010 18:58 May 03, 2010 Jkt 220001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0507] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 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 June 3, 2010. 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 e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0530. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, Elizabeth.Berbakos@fda.hhs.gov, 301– 796–3792. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA PO 00000 Frm 00116 Fmt 4703 Sfmt 4703 has submitted the following proposed collection of information to OMB for review and clearance. 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, E:\FR\FM\04MYN1.SGM 04MYN1 23780 Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 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 (portable document format). The comments said that the burden estimate in the 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 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. In the Federal Register of November 6, 2009 (74 FR 57491), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 mstockstill on DSKH9S0YB1PROD with NOTICES Content of labeling submissions in NDAs, ANDAs, supplemental NDAs and ANDAs, and annual reports Number of Respondents Annual Frequency per Response 450 1 There 11.11 Total Annual Responses Hours per Response 5,000 1.25 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Mar<15>2010 18:58 May 03, 2010 Jkt 220001 PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM Total Hours 04MYN1 6,250 Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices Dated: April 28, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–10361 Filed 5–3–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0199] Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1988 Categorization 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 administrative procedures for the Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization. DATES: Submit written or electronic comments on the collection of information by July 6, 2010. 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: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov. 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 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 23781 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. Administrative Procedures for CLIA Categorization—42 CFR 493.17 (OMB Control Number 0910–0607–Extension) A guidance document entitled ‘‘Guidance for Administrative Procedures for CLIA Categorization’’ was released on May 7, 2008. The document describes procedures FDA will use to assign the complexity category to a device. Typically, FDA assigns complexity categorizations to devices at the time of clearance or approval of the device. In this way, no additional burden is incurred by the manufacturer since the labeling (including operating instructions) is included in the 510(k) or PMA. In some cases, however, a manufacturer may request CLIA categorization even if FDA is not simultaneously reviewing a 510(k) or PMA. One example is when a manufacturer requests that FDA assign CLIA categorization to a previously cleared device that has changed names since the original CLIA categorization. Another example is when a device is exempt from premarket review. In such cases, the guidance recommends that manufacturers provide FDA with a copy of the package insert for the device and a cover letter indicating why the manufacturer is requesting a categorization (e.g. name change, exempt from 510(k) review). The guidance recommends that in the correspondence to FDA the manufacturer should identify the product code and classification as well as reference to the original 510(k) when this is available. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 CFR Section No. of Respondents 42 CFR 493.17 mstockstill on DSKH9S0YB1PROD with NOTICES 1 There Annual Frequency per Response 60 Total Annual Responses 15 Hours per Responses 900 Total Hours 1 hr 900 hr Total Operating & Maintenance Costs $46,800 are no capital costs associated with this collection of information. The number of respondents is approximately 60. On average, each respondent will request categorizations (independent of a 510(k) or PMA) 15 times per year. The cost, not including personnel, is estimated at $52 per hour (52 x 900) totaling $46,800. This includes the cost of copying and mailing VerDate Mar<15>2010 18:58 May 03, 2010 Jkt 220001 copies of package inserts and a cover letter, which includes a statement of the reason for the request and reference to the original 510(k) numbers, including regulation numbers and product codes. The burden hours are based on FDA familiarity with the types of documentation typically included in a PO 00000 Frm 00118 Fmt 4703 Sfmt 4703 sponsor’s categorization requests, and costs for basic office supplies (e.g. paper). The costs have been updated based on the Bureau of Labor Statistics estimates of inflation. E:\FR\FM\04MYN1.SGM 04MYN1

Agencies

[Federal Register Volume 75, Number 85 (Tuesday, May 4, 2010)]
[Notices]
[Pages 23779-23781]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10361]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 June 
3, 2010.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0530. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, Elizabeth.Berbakos@fda.hhs.gov, 301-
796-3792.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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,

[[Page 23780]]

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 
(portable document format). The comments said that the burden estimate 
in the 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 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.
    In the Federal Register of November 6, 2009 (74 FR 57491), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

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



[[Page 23781]]

    Dated: April 28, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10361 Filed 5-3-10; 8:45 am]
BILLING CODE 4160-01-S

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