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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

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 January 12, 2007.

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: 202-395-6974.

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FOR FURTHER INFORMATION CONTACT:

Elizabeth Berbakos, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

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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 PRA for the information collection contained in the final rule entitled “Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format” (68 FR 69009, December 11, 2003) (the 2003 final rule). The 2003 final rule amended FDA regulations governing the format in which certain labeling is required to be submitted for FDA review with new drug applications (NDAs), certain biological license applications (BLAs), Start Printed Page 74925abbreviated new drug applications (ANDAs), supplements, and annual reports. The 2003 final rule required that the content of labeling for prescription drug and biological products required under 21 CFR 201.100(d)(3) be submitted to FDA electronically in a form that FDA can process, review, and archive. Copies of product labeling have been required to be submitted to FDA for review in NDAs, certain BLAs, ANDAs, certain supplements, and annual reports under §§ 314.50, 314.70, 314.81, 314.94, 314.97, 314.98, 601.2, and 601.12 (21 CFR 314.50, 314.70, 314.81, 314.94, 314.97, 314.98, 601.2, and 601.12). Under these regulations, copies of labeling may be submitted electronically or on paper. The 2003 final rule added the requirement to submit the content of labeling in electronic format to simplify the drug labeling review process and speed up the approval of labeling changes. The reporting burden for submitting labeling under §§ 314.50, 314.70, 314.81, 314.94, 314.97, and 314.98 has been estimated by FDA and the collection of information has been approved by OMB under OMB control number 0910-0001, most recently until May 31, 2008. The reporting burden associated with current §§ 601.2 and 601.12 has also been estimated and that collection of information has been approved by OMB under OMB control number 0910-0338, most recently until September 30, 2008. We are not re-estimating these approved burdens in this action. Only the additional reoccurring reporting burdens associated with the electronic submission of the content of labeling in the 2003 final rule are estimated in this action.

New NDAs (§ 314.50), ANDAs (§ 314.94), and BLAs (§ 601.2): Based on the number of submissions during 2005 under the approved collections of information for §§ 314.50, 314.94, and 601.2, we estimate that approximately 75 NDA applicants, 160 ANDA applicants, and 6 BLA applicants (respondents) submit applications to us annually. We estimate that these applicants (respondents) submit approximately 111 NDAs, 766 ANDAs, and 21 BLAs each year that are subject to the requirements of the 2003 final rule. As explained in section V of the 2003 final rule, we estimate that the hours per response, i.e., the additional time necessary for submission of the content of labeling in electronic format for these applications, will be less than 15 minutes.

Supplements to NDAs (§ 314.70), ANDAs (§ 314.97), and BLAs (§ 601.12(f)(1) and (f)(2)): Based on the number of submissions during 2005 under the approved collections of information for § 314.70, § 314.97, and § 601.12(f)(1) and (f)(2), we estimate that approximately 272 NDA applicants, 189 ANDA applicants, and 35 BLA applicants (respondents) submit supplements to approved applications to us annually. We estimate that these applicants (respondents) submit approximately 1,839 NDA supplements, 3,208 ANDA supplements, and 82 BLA supplements each year that are subject to the requirements of the 2003 final rule. As explained in section V of the 2003 final rule, we estimate that the hours per response, i.e., the additional time necessary for submission of the content of labeling in electronic format for these applications, will be less than 15 minutes.

Annual Reports for NDAs (§ 314.81), ANDAs (§ 314.98), and BLAs (§ 601.12(f)(3)): Based on the number of submissions during 2005 under the approved collections of information for §§ 314.81, 314.98, and 601.12(f)(3), we estimate that approximately 306 NDA applicants, 333 ANDA applicants, and 4 BLA applicants (respondents) submit annual reports to us annually. We estimate that NDA applicants submit to us approximately 2,617 annual reports, ANDA applicants submit approximately 6,054 annual reports, and BLA applicants submit approximately 16 annual reports each year that are subject to the requirements of the final rule. As explained in section V of the 2003 final rule, we estimate that the hours per response, i.e., the additional time necessary for submission of the content of labeling in electronic format for these submissions, will be less than 15 minutes.

In the Federal Register of March 29, 2006 (71 FR 15752), FDA published a 60-day notice requesting comments on the information collection provisions. FDA gave interested parties an opportunity to comment on the information collection during the process requesting that OMB extend approval of the collection. We received several comments. Generally, the comments said that, unlike FDA's 2003 final rule, the agency has now identified Extensible Markup Language (XML) as the required file format for Structured Product Label documents (SPL). The comments said that 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.

We appreciate the comments and believe they raise important issues. We will respond to the comments and amend this collection as soon as we have gathered sufficient information to address the costs specified in the comments. The public will have an opportunity to comment on our response at that time.

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

Table 1.—Estimated Annual Reporting Burden1

21 CFR SectionNo. of RespondentsNo. of Responses per RespondentTotal Annual ResponsesHours per ResponseTotal Hours
New Applications
751.48111.2527.75
314.941604.79766.25191.50
601.14263.5021.255.25
Supplements
314.702726.761,839.25459.75
314.9718916.983,208.25802
601.143352.3482.2520.5
Annual Reports
314.813068.552,617.25654.25
314.9833318.186,054.251,513.50
601.1444416.254
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Total Reporting Burden Hours3,678.50
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Applications submitted under § 601.2.
3 Supplements submitted under § 601.12(f)(1) and (f)(2).
4 Annual reports submitted under § 601.12(f)(3).
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Dated: December 6, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E6-21132 Filed 12-12-06; 8:45 am]

BILLING CODE 4160-01-S