[Federal Register Volume 85, Number 205 (Thursday, October 22, 2020)]
[Notices]
[Pages 67352-67353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23357]


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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--Time and Extent 
Applications for Nonprescription Drug Products

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: Submit written comments (including recommendations) on the 
collection of information by November 23, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0688. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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--Time and Extent Applications for Nonprescription Drug 
Products (21 CFR 330.14)

OMB Control Number 0910-0688--Extension

    This information collection supports Agency regulations and 
associated guidance. Specifically, FDA regulations in Sec.  330.14 (21 
CFR 330.14) establish additional criteria and procedures for 
classifying over-the-counter (OTC) drugs as generally recognized as 
safe and effective and not misbranded. These regulations state that OTC 
drug products introduced into the U.S. market after the OTC drug review 
began in 1972 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 the regulations. 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 the 
data and information listed in 21 CFR 330.10(a)(2), a listing of all 
serious adverse drug experiences that may have occurred (Sec.  
330.14(f)(2)), and an official or proposed compendial monograph (Sec.  
330.14(i)).
    Based on our experience with submissions we have received under 
Sec.  330.14, we estimate that we will receive two TEAs and two safety 
and effectiveness submissions each year and assume that it will take 
1,525 hours to prepare a TEA and 2,350 hours to prepare a comprehensive 
safety and effectiveness submission.
    We revised our regulations in part 330 (21 CFR part 330) (81 FR 
84465, November 23, 2016), thus adding 6 hours to our estimated annual 
reporting burden for the information collection. Specifically, Sec.  
330.14(j) clarifies the requirements on content and format criteria for 
a safety and effectiveness data submission and provides procedures for 
our review of the submissions and determination of whether a submission 
is sufficiently complete to permit a substantive review.
    Section 330.14(j)(3) describes the process for cases in which we 
refuse to file the safety and effectiveness data submission. Under 
Sec.  330.14(j)(3), if we refuse to file the submission, we will notify 
the sponsor in writing, state the reason(s) for the refusal, and allow 
the sponsor 30 days to submit a written request for an informal 
conference with us about whether we should file the submission. We 
estimate one respondent will submit a request for an informal 
conference each year and assume that preparing and submitting each 
request will take 1 hour.
    Under Sec.  330.14(j)(4)(iii), the safety and effectiveness data 
submission must contain a signed statement that the submission 
represents a complete safety and effectiveness data submission and that 
the submission includes all the safety and effectiveness data and 
information available to the sponsor at the time of the submission, 
whether positive or negative. We estimate that two respondents will 
submit such signed statements each year and assume that preparing and 
submitting each signed statement takes 1 hour.
    Under Sec.  330.14(k)(1), we, in response to a written request from 
a sponsor, may withdraw consideration of a TEA submitted under Sec.  
330.14(c) or a safety and effectiveness data submission under Sec.  
330.14(f). We estimate that one respondent will submit such a request 
each year and assume that preparing and submitting the request takes 1 
hour.
    Under Sec.  330.14(k)(2), a sponsor may request that FDA not 
withdraw consideration of a TEA or safety and effectiveness data 
submission. We estimate one respondent will submit such a request each 
year and assume that preparing and submitting the request takes 2 
hours.
    To assist respondents with the information collection, we developed 
the guidance document entitled ``Time and Extent Applications for 
Nonprescription Drug Products'' (available from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/time-and-extent-applications-nonprescription-drug-products) issued 
consistent with our good guidance practice regulations at 21 CFR 
10.115, which provide for comment at any time. The guidance explains 
what information an applicant should submit to FDA to

[[Page 67353]]

request that a drug product be included in the OTC drug monograph 
system and describes the process for submitting that information.
    In the Federal Register of July 30, 2020 (85 FR 45892), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      No. of
    21 CFR part and activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Time and extent application and                2               1               2           1,525           3,050
 submission of information (Sec.
   330.14(c) and (d))...........
Safety and effectiveness data                  2               1               2           2,350           4,700
 (Sec.   330.14(f) and (i)).....
Sponsor request for an informal                1               1               1               1               1
 conference (Sec.
 330.14(j)(3))..................
Sponsor signed statement that                  2               1               2               1               2
 submission is complete (Sec.
 330.14(j)(4))..................
Sponsor request for FDA to                     1               1               1               1               1
 withdraw TEA consideration
 (Sec.   330.14(k)(1))..........
Sponsor request for FDA not to                 1               1               1               2               2
 deem the submission withdrawn
 (Sec.   330.14(k)(2))..........
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    Total.......................  ..............  ..............  ..............  ..............           7,756
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: October 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23357 Filed 10-21-20; 8:45 am]
BILLING CODE 4164-01-P