[Federal Register Volume 75, Number 195 (Friday, October 8, 2010)]
[Notices]
[Pages 62404-62405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25375]
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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,
[email protected].
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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