Document ID: FDA-2011-N-0915-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
Posted Date: 2018-08-15T04:00Z

[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)]
[Notices]
[Pages 40520-40522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17526]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0915]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on Postmarketing Adverse Event 
Reporting for Nonprescription Human Drug Products Marketed Without an 
Approved Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 
entitled ``Guidance for Industry on Postmarketing Adverse Event 
Reporting for Nonprescription Human Drug Products Marketed Without an 
Approved Application.''

[[Page 40521]]

DATES: Submit either electronic or written comments on the collection 
of information by October 15, 2018.

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 October 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 15, 2018. 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 the Docket No. 
FDA-2011-N-0915 for ``Guidance for Industry on Postmarketing Adverse 
Event Reporting for Nonprescription Human Drug Products Marketed 
Without an Approved Application.'' 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.
     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.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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: 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.

Guidance for Industry on Postmarketing Adverse Event Reporting for 
Nonprescription Human Drug Products Marketed Without an Approved 
Application; OMB Control Number 0910-0636--Extension

    This information collection supports Agency guidance directed to 
manufacturers, packers, and/or distributors whose names appear on the 
label of a nonprescription drug marketed in the United States under 
section 502(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 352(b)(1)). FDA is requesting public comment on 
estimates of annual submissions from these respondents, as required by 
the Dietary Supplement and Nonprescription Drug Consumer Protection Act 
(Pub. L. 109-462) and described in the guidance. The guidance document 
discusses what should be included in a serious adverse drug event 
report submitted under section 760(b)(1)

[[Page 40522]]

of the FD&C Act (21 U.S.C. 379aa(b)(1)), including followup reports 
under 760(c)(2) of the FD&C Act (21 U.S.C. 379aa(c)(2)), and how to 
submit these reports. The estimates for the annual reporting and 
recordkeeping burdens are based on FDA data on the number of adverse 
drug experience reports submitted for nonprescription drug products 
marketed without an approved application and on prior input from 
comments received from prior Federal Register publications.
    Based on FDA records, we received 194,449 total annual responses 
from approximately 283 respondents for nonprescription drugs marketed 
without an approved application. We estimate that each submission will 
take approximately 6 hours to prepare and submit.

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Reports of serious adverse drug events (21 U.S.C. 379aa((b) and                 283          687.099          194,449                6        1,166,694
 (c))..............................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Section 760(e) of the FD&C Act (21 U.S.C. 379aa(e)) also requires 
that responsible persons maintain records of nonprescription adverse 
event reports, whether or not the event is serious, for a period of 6 
years. The guidance recommends that respondents maintain records of 
efforts to obtain the minimum data elements for a report of a serious 
adverse drug event and any followup reports. We estimate that there are 
approximately 265,700 records per year maintained by approximately 300 
respondents, and that it takes approximately 8 hours to maintain each 
record.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Recordkeeping (21 U.S.C. 379aa(e)(1))..............................             300         885.6667          265,700                8        2,125,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an 
overall increase. We attribute this adjustment to an increase in the 
number of submissions we received in the last few years.

    Dated: August 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17526 Filed 8-14-18; 8:45 am]
 BILLING CODE 4164-01-P