Document ID: FDA-2010-N-0493-0011
Agency: fda
Document Type: Notice
Title: 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—Time and Extent Applications for Nonprescription Drug Products
Posted Date: 2020-07-30T04:00Z

[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45892-45894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16528]

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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--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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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.

DATES: Submit either electronic or written comments on the collection 
of information by September 28, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 28, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 28, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include Docket No. FDA-
2010-N-0493 for ``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; Guidance for Industry--Time and Extent 
Applications for Nonprescription Drug Product.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments

[[Page 45893]]

received, go to https://www.regulations.gov and insert the docket 
number, found in brackets in the heading of this document, into the 
``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 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 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 2 TEAs and 2 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,'' issued consistent with our Good 
Guidance Practice regulations at 21 CFR 10.115 which provide for 
comment at any time, and available from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/time-and-extent-applications-nonprescription-drug-products. The guidance 
explains what information an applicant should submit to FDA to request 
that a drug product be included in the OTC drug monograph system and 
describes the process for submitting that information.
    We estimate the burden of this collection of information as 
follows:

[[Page 45894]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number 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))..........
                                 -------------------------------------------------------------------------------
    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: July 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16528 Filed 7-29-20; 8:45 am]
BILLING CODE 4164-01-P