[Federal Register Volume 79, Number 56 (Monday, March 24, 2014)]
[Notices]
[Pages 16007-16008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06365]
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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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
associated with the criteria and procedures for classifying over-the-
counter (OTC) drugs as generally recognized as safe and effective and
not misbranded, in accordance with regulations and discussed in the
Guidance for Industry ``Time and Extent Applications for
Nonprescription Drug Products.''
DATES: Submit either electronic or written comments on the collection
of information by May 23, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, [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, including
each proposed extension of an existing 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 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--21 CFR
330.14 (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 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'' in September 2011.
In the Federal Register of February 8, 2011 (76 FR 6801), 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 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, (75 FR 62404). The commenter
included, as part of the estimated burden of safety and effectiveness
data submission, an estimate 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
February 8, 2011, Federal Register notice, we continue to estimate that
we will receive two TEAs and two safety and effectiveness submissions
each year, and that it will take
[[Page 16008]]
approximately 1,525 hours to prepare a TEA and 2,350 hours to prepare a
comprehensive safety and effectiveness submission, to include
environmental data.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
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Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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330.14(c)--Time & 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......................
���������������������������������
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: March 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06365 Filed 3-21-14; 8:45 am]
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