Document ID: FDA-2010-N-0493-0009
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2017-08-23T04:00Z

[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Pages 40006-40007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17842]

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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

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: Fax written comments on the collection of information by 
September 22, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 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, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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--21 CFR 330.14, OMB Control Number 0910-0688--Revision

    This information collection supports Agency regulations. 
Specifically, FDA regulations at 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

[[Page 40007]]

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.
    In the Federal Register of May 30, 2017 (82 FR 24723), we published 
a 60-day notice requesting public comment on the proposed extension of 
this collection of information. No comments were received.
    We therefore estimate 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 part 330; activity        Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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.

    Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17842 Filed 8-22-17; 8:45 am]
BILLING CODE 4164-01-P