
[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31024-31025]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12589]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 June 
25, 2012.

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 0910-0636. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
juanmanuel.vilela@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) 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 Public Law 109-462 and described 
in the guidance. This guidance document discusses what should be 
included in a serious adverse drug event report submitted under section 
760(b)(1) of the FD&C Act, including follow-up reports under 760(c)(2) 
of the FD&C Act, and how to submit these reports. The estimates for 
annual reporting burden and recordkeeping are based on FDA's knowledge 
of adverse drug experience reports historically submitted per year for 
prescription drug products and for nonprescription drug products 
marketed under an approved application, including knowledge about the 
time needed to prepare the reports and to maintain records.
    FDA receives approximately 2,500 serious adverse event reports for 
nonprescription drug products marketed under approved applications, 
which comprise approximately 20 percent of the overall nonprescription 
drug market. Based on this experience, we estimate between 10,000 and 
15,000 (i.e., 12,500) total annual responses for nonprescription drugs 
marketed without an approved application.
    In the Federal Register of December 27, 2011 (76 FR 80946), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments on the information 
collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
                                     Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Reports of serious adverse drug               50             250          12,500               2          25,000
 events (21 U.S.C. 379aa((b) and
 (c))...........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          25,000
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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 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 responsible persons maintain records of 
efforts to obtain the minimum data elements for a report of a serious 
adverse drug event and any followup reports. Although the guidance does 
not provide recommendations on recordkeeping activities generally under 
section 760(e) of the FD&C Act, FDA is providing an estimate for the 
burden of this collection. Historically, serious adverse event reports 
comprise approximately two-thirds and nonserious adverse event reports 
comprise approximately one-third of the total number of postmarketing 
adverse event reports associated with drugs and biologic therapeutics 
(except vaccines) received by FDA. Based on this generalization, FDA 
estimates the total annual records to be approximately 20,000 records 
per year. FDA estimates that it takes 5 hours to maintain each record 
and the recordkeeping burden as follows:

[[Page 31025]]



                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                        Average
                                     Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Recordkeeping (21 U.S.C.                     200             100          20,000               5         100,000
 379aa(e)(1))...................
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    Total.......................  ..............  ..............  ..............  ..............         100,000
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\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: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12589 Filed 5-23-12; 8:45 am]
BILLING CODE 4160-01-P


