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

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.

Table of Figures

Dates:

Submit either electronic or written comments on the collection of information by February 27, 2012.

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:

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:

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 (undersection 502(b)(1) (21 U.S.C. 352(b)(1)) of the Federal Food, Drug, and Cosmetic Act (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 (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) (21 U.S.C. 379aa(b)(1)) of the FD&C Act, including followup 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 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.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden1
ActivityNumber ofrespondents Number ofresponses per respondent Total annual responsesAverageburden per response (in hours) Total hours
¹ There are no capital costs or operating and maintenance costs associated with this collection of information.
Reports of Serious Adverse Drug Events (21 U.S.C. 379aa(b) and (c)) 50 250 12,500 2 25,000
Total 25,000

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 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:

Table 2—Estimated Annual Recordkeeping Burden1
ActivityNumber of recordkeepersNumber ofrecords per recordkeeper Total annual recordsAverageburden per recordkeeping (in hours) Total hours
1There are no capital costs or operating and maintenance costs associated with this collection of information.
Recordkeeping (21 U.S.C. 379aa(e)(1)) 200 100 20,000 5 100,000
Total 100,000

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

Dated: December 19, 2011. Leslie Kux,

Acting Assistant Commissioner for Policy.

References

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