[Federal Register Volume 76, Number 26 (Tuesday, February 8, 2011)]
[Notices]
[Pages 6801-6802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-2692]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 March 
10, 2011.

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 [email protected]. All 
comments should be identified with the OMB control number 0910--New and 
title ``Additional Criteria and Procedures for Classifying Over-the-
Counter Drugs as Generally Recognized as Safe and Effective and Not 
Misbranded.'' 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, 301-796-3792, 
[email protected].

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.

Additional Criteria and Procedures for Classifying Over-the-Counter 
Drugs as Generally Recognized as Safe and Effective and Not 
Misbranded--(OMB Control Number 0910--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 over-the-counter 
(OTC) drugs as generally recognized as safe and effective and not 
misbranded (2002 time and extent application (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 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 Federal Register of October 8, 2010 (75 FR 62404), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. In that notice, we stated that we considered 
our estimate, in the 2002 TEA final rule, of 480 hours to prepare a TEA 
and 800 hours to prepare and submit safety and effectiveness data to 
continue to be valid (75 FR 62404 at 62405). In the same document, we 
stated that, based on the number of submissions we had received in the 
8 years following publication of the TEA final rule, we expected to 
receive an

[[Page 6802]]

average of two TEAs and two submissions of safety and effectiveness 
data each year. Therefore, we estimated the total annual reporting 
burden to be 2,560 hours. This number included 960 hours for preparing 
TEAs (two TEAs per year times 480 hours per TEA) and 1,600 hours (two 
submissions of safety and effectiveness data times 800 hours per 
submission).
    We received a submission from a manufacturer that filed two TEAs 
stating that our estimates in the 60-day notice were too low. The 
submission noted that the time spent on ``gathering, compiling, 
evaluating and preparing'' the TEA and safety and effectiveness 
submissions was ``significantly greater'' than what FDA had estimated 
in the 2002 TEA final rule and the more recent 60-day notice. The 
submission estimates that approximately 1,526 hours are required to 
prepare a TEA and approximately 2,348 hours to prepare a safety and 
effectiveness submission.
    Because the information provided in the submission is based on 
actual experience by a TEA applicant, we agree with the submission and 
are adjusting our estimates in this document accordingly. We continue 
to estimate that we will receive two TEAs and two safety and 
effectiveness submissions each year. We now estimate that it will take 
approximately 1,525 hours to prepare a TEA and 2,350 hours to prepare a 
comprehensive safety and effectiveness submission.
    The submission included, as part of the estimated burden of safety 
and effectiveness data submission, an estimated burden to submit 
environmental data. We agree with the submission and are including the 
environmental data in our estimated burden of safety and effectiveness 
data submission. In February 2010, we published a call-for-data to 
request data on the environmental impact of amending OTC drug 
monographs to include any of 13 active ingredients that were found 
eligible for potential inclusion in an OTC monograph through the TEA 
process (75 FR 7606, February 22, 2010). In that document, we explain 
that a proposed rule that would add an ingredient to an OTC drug 
monograph would be subject to the National Environmental Policy Act of 
1969 (NEPA) (see 21 CFR 25.1). In order to comply with NEPA, an 
environmental assessment of such an Agency action is required, unless 
we determine that a categorical exclusion is warranted (21 CFR 
25.20(f)). Therefore, in this document, the estimated burden of 
collection for safety and effectiveness data submission includes the 
burden to collect environmental data to support the application of any 
categorical exclusion or to conduct an environmental assessment, if 
necessary.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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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) \2\...........               2               1               2           1,525           3,050
330.14(f) and (i) \3\...........               2               1               2           2,350           4,700
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    Total.......................  ..............  ..............  ..............  ..............           7,750
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ TEA.
\3\ Safety and effectiveness submission, including environmental data in accordance with 21 CFR 25.1.


    Dated: February 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2692 Filed 2-7-11; 8:45 am]
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