
[Federal Register Volume 79, Number 122 (Wednesday, June 25, 2014)]
[Notices]
[Pages 36070-36071]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14767]


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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 July 
25, 2014.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0688. 
Also include the FDA docket number found in brackets in the heading of 
this document.

[[Page 36071]]


FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 0910-0688)--Extension

    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). These 
regulations 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 includes 
the data and information listed in 21 CFR 330.10(a)(2), a listing of 
all serious adverse drug experiences that may have occurred, and an 
official or proposed compendial monograph. We published the Guidance 
for Industry ``Time and Extent Applications for Nonprescription Drug 
Products'' on September 29, 2011 (76 FR 60504).
    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 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 average of 
two TEAs and two submissions of safety and effectiveness data each 
year. In the same document, we stated in our estimate that 
approximately 1,525 hours are required to prepare a TEA and 
approximately 2,350 hours to prepare a safety and effectiveness 
submission. This estimate is based on a comment from a manufacturer 
that filed two TEAs that was submitted to the Agency in response to the 
60-day notice requesting public comment on this proposed collection of 
information in the Federal Register of October 8, 2010. The commenter 
included, as part of the estimated burden of safety and effectiveness 
data submission, an estimated burden to submit environmental data to 
conduct an environmental assessment as required by the National 
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.) (see 
21 CFR 25.1), or the application of any categorical exclusion that may 
be warranted (21 CFR 25.20(f)). Because the information provided in the 
submission is based on actual experience by a TEA applicant and 
included an estimated burden to comply with NEPA, we agreed with the 
submission and adjusted our estimates accordingly. Based on our 
experience since the October 2010 notice, we continue to estimate that 
we will receive two TEAs and two safety and effectiveness submissions 
each year, and that it will take approximately 1,525 hours to prepare a 
TEA and 2,350 hours to prepare a comprehensive safety and effectiveness 
submission, to include environmental data.
    In the Federal Register of March 24, 2014 (79 FR 16007), 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\
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                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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330.14(c)--Time and Extent                     2               1               2           1,525           3,050
 Application and (d) \2\--
 Submission of Information;
 Confidentiality................
330.14(f)--Request for Data and                2               1               2           2,350           4,700
 Views and (i) \3\--Compendial
 Monograph......................
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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: June 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14767 Filed 6-24-14; 8:45 am]
BILLING CODE 4164-01-P


