[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
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......................
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
    Total.......................  ..............  ..............  ..............  ..............           7,750
----------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-P