
[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3608-3609]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01111]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 FDA guidance for industry 
on ``Postmarketing Adverse Event Reporting for Nonprescription Human 
Drug Products Marketed Without an Approved Application.'' This guidance 
document provides recommendations on postmarketing serious adverse 
event reporting for nonprescription (over-the-counter) human drugs 
marketed without an approved application. It provides recommendations 
on the minimum data elements that should be included in a serious 
adverse event report, the label that should be included with the 
report, reporting formats for paper and electronic submissions, and how 
and where to submit the reports.

DATES: Submit either electronic or written comments on the collection 
of information by March 24, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA 
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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 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

    Respondents to this collection of information are manufacturers, 
packers, and distributors whose name (under section 502(b)(1) (21 
U.S.C. 352(b)(1)) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act)) appears on the label of a nonprescription drug marketed in the 
United States. 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) (21 U.S.C. 379aa(b)(1)) of the FD&C 
Act, including follow-up reports under 760(c)(2) (21 U.S.C. 
379aa(c)(2)) of the FD&C Act, 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, including FDA's knowledge about the time needed to prepare 
the reports and to maintain records.
    Based on FDA data, we estimate between 10,000 and 15,000 (i.e., 
approximately 12,500) total annual responses from approximately 50 
respondents for nonprescription drugs marketed without an approved 
application, and we also estimate that each submission will take 
approximately 2 hours to prepare and submit.

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports of serious adverse drug events (21 U.S.C. 379aa((b) and                  50              250           12,500                2           25,000
 (c))..............................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 3609]]

    Section 760(e) (21 U.S.C. 379aa(e) of the FD&C Act 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 document recommends that respondents maintain 
records of efforts to obtain the minimum data elements for a report of 
a serious adverse drug event and any follow-up reports. We estimate 
that there are approximately 20,000 records per year maintained by 
approximately 200 respondents, and that it takes approximately 5 hours 
to maintain each record.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                      Average  burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping (21 U.S.C. 379aa(e)(1))..............................             200              100           20,000                5          100,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Therefore, the estimated annual reporting burden for this 
information is 25,000 hours and the estimated annual recordkeeping 
burden is 100,000 hours.

    Dated: January 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01111 Filed 1-22-15; 8:45 am]
BILLING CODE 4164-01-P


