
[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Pages 24723-24725]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11008]



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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 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 July 31, 2017. Late, untimely filed comments will not 
be considered. Electronic comments must be submitted on or before July 
31, 2017. The https://www.regulations.gov electronic filing system will 
accept comments until midnight Eastern Time at the end of July 31, 
2017. 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.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 the 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.'' Received 
comments, those received in a timely manner (see DATES), will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     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 Division of Dockets Management. 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.gpo.gov/fdsys/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 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

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

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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--Revision

    FDA regulations at 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 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 includes the data and information listed in Sec.  
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 that it will take 
approximately 1,525 hours to prepare a TEA and 2,350 hours to prepare a 
comprehensive safety and effectiveness submission. This information is 
reflected in rows 1 and 2 of table 1.
    Recently FDA revised its regulations at 21 CFR part 330 (81 FR 
84465, November 23, 2016), thus adding 6 hours to FDA's 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 FDA's 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 
FDA refuses to file the safety and effectiveness data submission. Under 
Sec.  330.14(j)(3), if FDA refuses to file the submission, the Agency 
will notify the sponsor in writing, state the reason(s) for the 
refusal, and provide the sponsor with 30 days in which to submit a 
written request for an informal conference with the Agency about 
whether the Agency should file the submission. We estimate that 
approximately one respondent will annually submit a request for an 
informal conference, and that preparing and submitting each request 
will take approximately 1 hour. This is reflected in row 3 of table 1.
    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 approximately two 
respondents annually will submit such signed statements, and that 
preparing and submitting each signed statement will take approximately 
1 hour. This is reflected in row 4 of table 1.
    Under Sec.  330.14(k)(1), FDA, 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 submitted 
under Sec.  330.14(f). We estimate that approximately one respondent 
will annually submit such a request, and that preparing and submitting 
the request will take approximately 1 hour. This is reflected in row 5 
of table 1.
    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 annually submit such a 
request, and that preparing and submitting the request will take 
approximately 2 hours. This is reflected in row 6 of table 1.
    Accordingly, FDA estimates the burden of this collection of 
information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
    21 CFR part 330; activity        Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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330.14(c) and (d); Time and                    2               1               2           1,525           3,050
 extent application and
 submission of information......
330.14(f) and (i); Safety and                  2               1               2           2,350           4,700
 effectiveness data.............
330.14(j)(3); sponsor request                  1               1               1               1               1
 for informal conference........
330.14(j)(4); sponsor signed                   2               1               2               1               2
 statement that submission is
 complete.......................
330.14(k)(l); sponsor request                  1               1               1               1               1
 for FDA withdraw of TEA
 consideration..................
330.14(k)(2); sponsor request                  1               1               1               2               2
 for FDA to not deem submission
 withdrawn......................
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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.



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    Dated: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11008 Filed 5-26-17; 8:45 am]
BILLING CODE 4164-01-P


