Document ID: FDA-2010-N-0493-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
Posted Date: 2010-10-08T04:00Z

[Federal Register: October 8, 2010 (Volume 75, Number 195)]
[Notices]               
[Page 62404-62405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08oc10-49]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0493]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Additional Criteria and Procedures for Classifying 
Over-the-Counter Drugs as Generally Recognized as Safe and Effective 
and Not Misbranded

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 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.

DATES: Submit either electronic or written comments on the collection 
of information by December 7, 2010.

ADDRESSES: 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.

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.

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 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

[[Page 62405]]

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.

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 Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  330.14(f). Safety and effectiveness data include not 
only the data and information listed in 21 CFR 330.10(a)(2) (Sec.  
330.14(f)(1)) but also a listing of all serious adverse drug 
experiences that may have occurred (Sec.  330.14(f)(2)) as well as an 
official or proposed compendial monograph (Sec.  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:

                                   Table 1--Estimated Annual Reporting Burden
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                                                      Annual
         21 CFR Section              Number of    frequency  per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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330.14(c) and (d) \1\...........               2               1               2             480             960
330.14(f) and (i) \2\...........               2               1               2             800           1,600
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    Total.......................  ..............  ..............  ..............  ..............           2,560
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\1\ TEA.
\2\ Safety and effectiveness submission, including adverse events and compendial monograph.

    Dated: October 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25375 Filed 10-7-10; 8:45 am]
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