Document ID: FDA-2011-N-0915-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Submission for Office of Management and Budget Review; Guidance for
Industry on Postmarketing Adverse Event Reporting for Nonprescription
Human Drug Products Marketed Without an Approved Application
Posted Date: 2015-06-25T04:00Z

[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Notices]
[Pages 36543-36545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15638]

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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; 
Submission for Office of Management and Budget Review; 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) 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 July 
27, 2015.

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_

[[Page 36544]]

submission@omb.eop.gov. All comments should be identified with the OMB 
control number 0910-0636. Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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.
    In the Federal Register of January 23, 2015 (80 FR 3608), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment. The comment 
requested that we increase the reporting burden estimates from 2 hours 
to 6 hours and the recordkeeping burden estimates from 5 hours to 8 
hours. The comment said although there may be circumstances where FDA's 
estimates for reporting and recordkeeping may be accurate, the comment 
contended that, in its experience, the approximations are 
underestimated. The comment said that as many as 6 hours may be 
required to complete a single serious adverse event report, especially 
when the sponsor's medical and quality review teams are involved, and 
that as many as 8 hours may be required to maintain all relevant 
records for a single adverse event report as stipulated by statute.
    FDA Response: We have reconsidered our estimates, and agree with 
the comment that there may be circumstances where 6 hours would be 
needed to prepare and submit a report to us and 8 hours may be needed 
for recordkeeping. We have revised our reporting and recordkeeping 
burden estimates accordingly.
    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 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                  50              250           12,500                6           75,000
 (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) (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 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))..............................             200              100           20,000                8          160,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 36545]]

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

    Dated: June 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15638 Filed 6-24-15; 8:45 am]
 BILLING CODE 4164-01-P