Food and Drug Administration, HHS.
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the additional criteria and procedures for classifying over-the-counter (OTC) drugs as generally recognized as safe and effective and not misbranded.
Submit either electronic or written comments on the collection of information by December 7, 2010.
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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3792, Elizabeth.Berbakos@fda.hhs.gov.End Further Info End Preamble Start Supplemental 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 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 Start Printed Page 62405is 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.
Additional Criteria and Procedures for Classifying OTC Drugs as Generally Recognized as Safe and Effective and Not Misbranded—New
In the Federal Register of January 23, 2002 (67 FR 3060), we established regulations in § 330.14 (21 CFR 330.14) providing additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded (2002 TEA final rule). The regulations in § 330.14 state that OTC drug products introduced into the U.S. market after the OTC drug review began and OTC drug products without any marketing experience in the United States can be evaluated under the monograph process if the conditions (e.g., active ingredients) meet certain “time and extent” criteria outlined in § 330.14(b). The regulations allow a “time and extent” application (TEA) to be submitted to us by any party for our consideration to include new conditions in the OTC drug monograph system. TEAs must provide evidence described in § 330.14(c) demonstrating that the condition is eligible for inclusion in the monograph system. (Section 330.14(d) specifies the number of copies and address for submission of a TEA.) If a condition is found eligible, any interested parties can submit safety and effectiveness information as explained in § 330.14(f). Safety and effectiveness data include not only the data and information listed in 21 CFR 330.10(a)(2) (§ 330.14(f)(1)) but also a listing of all serious adverse drug experiences that may have occurred (§ 330.14(f)(2)) as well as an official or proposed compendial monograph (§ 330.14(i)).
In the 2002 TEA final rule, we estimated that 50 TEAs would be submitted to us annually by approximately 25 respondents (67 FR 3060 at 3073). We also estimated that the time required for preparing and submitting each TEA would be approximately 480 hours. We continue to believe that a respondent will spend approximately 480 hours preparing a TEA, but we no longer expect to receive 50 TEAs annually. Since 2003, we have received a total of 16 TEAs from 12 respondents. This is equivalent to 2.3 TEAs annually from 1.7 respondents. We now estimate that we will receive 2 TEAs annually from 2 respondents (see table 1 of this document).
We also estimated in the 2002 TEA final rule that we would receive three safety and effectiveness submissions for each condition found eligible for further consideration under a TEA (67 FR 3060 at 3072). We estimated that we would receive 90 submissions of safety and effectiveness data annually. And, we estimated that it would take approximately 800 hours to prepare and submit each safety and effectiveness submission. We believe that each submission, including serious adverse drug experiences and a compendial monograph, will take approximately 800 hours to complete (see table 1 of this document). However, we do not believe the estimated number of submissions is accurate. During the 8 years that have elapsed since publication of the 2002 TEA final rule, we have found 14 ingredients eligible under the TEA process and have received 16 submissions of safety and effectiveness data from 9 respondents. Therefore, we now estimate that we will receive two submissions of safety and effectiveness data annually from two respondents.
FDA estimates the burden of this collection of information as follows:
|21 CFR Section||Number of respondents||Annual frequency per response||Total annual responses||Hours per response||Total hours|
|330.14(c) and (d) 1||2||1||2||480||960|
|330.14(f) and (i) 2||2||1||2||800||1,600|
|2 Safety and effectiveness submission, including adverse events and compendial monograph.|
Dated: October 3, 2010.
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25375 Filed 10-7-10; 8:45 am]
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