2014-30907. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 (the PRA).

DATES:

Fax written comments on the collection of information by February 5, 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: [phone], or emailed to [e-mail]. All comments should be identified with the OMB control number 0910-0701. 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, [e-mail].

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 Medical Products and Dietary Supplements During an Influenza Pandemic; Availability (OMB Control Number 0910-0701)—Extension

The guidance includes recommendations for planning, notification, and documentation for firms that report postmarketing adverse events. The guidance recommends that each firm's pandemic influenza continuity of operations plan (COOP) include instructions for reporting adverse events, including a plan for the submission of stored reports that were not submitted within regulatory timeframes. The guidance explains that firms that are unable to fulfill normal adverse event reporting requirements during an influenza pandemic should: (1) Maintain documentation of the conditions that prevent them from meeting normal reporting requirements; (2) notify the appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions exist and when the reporting process is restored; and (3) maintain records to identify what reports have been stored.

Based on the number of manufacturers that would be covered by the guidance, we estimate that approximately 5,000 firms will add the following to their COOP: (1) Instructions for reporting adverse events; and (2) a plan for submitting stored reports that were not submitted within regulatory timeframes. We estimate that each firm will take approximately 50 hours to prepare the adverse event reporting plan for its COOP.

We estimate that approximately 500 firms will be unable to fulfill normal adverse event reporting requirements because of conditions caused by an influenza pandemic and that these firms will notify the appropriate FDA organizational unit responsible for adverse event reporting compliance when the conditions exist. Although we do not anticipate such pandemic influenza conditions to occur every year, for purposes of the PRA, we estimate that each of these firms will notify FDA approximately once each year, and that each notification will take approximately 8 hours to prepare and submit.

Concerning the recommendation in the guidance that firms unable to fulfill normal adverse event reporting requirements maintain documentation of the conditions that prevent them from meeting these requirements, maintaining records to identify what adverse event reports have been stored, and when the reporting process is restored. We estimate that approximately 500 firms will each need approximately 8 hours to maintain the documentation and approximately 500 firms will each need approximately 8 hours to maintain the records. Therefore, the total recordkeeping burden that would result from the guidance would be 258,000 hours.

The guidance also refers to previously approved collections of information found in FDA's adverse event reporting requirements in 21 CFR 310.305, 314.80, 314.98, 600.80, 606.170, 640.73, 1271.350, and part 803. These regulations contain collections of information that are subject to review by OMB under the PRA (44 U.S.C. 3501-3520) and are approved under OMB control numbers 0910-0116, 0910-0291, 0910-0230, 0910-0308, 0910-0437, and 0910-0543. In addition, the guidance also refers to adverse event reports for nonprescription human drug products marketed without an approved application and dietary supplements required under sections 760 and 761 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379aa and 379aa-1), which include collections of information approved under OMB control numbers 0910-0636 and 0910-0635.

In the Federal Register of August 11, 2014 (79 FR 46839), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received one comment. The comment said that during an influenza pandemic, FDA should not put forth a policy of reduced reporting, especially for newly approved drugs and vaccines. The comment recommended that FDA ask companies to modify their contingency plans by either leveraging the company's remote call center locations not affected by the pandemic or by outsourcing their safety reporting to such locations. The comment stated that at minimum, FDA should require weekly reporting or establish a threshold number of reports that a company must report to FDA. The comment added that FDA should specifically require reporting on newly approved drugs or vaccines for which there is little safety information.

FDA response: The Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic does not describe an approach of reduced reporting during an influenza pandemic. Rather, the guidance states that “normal adverse event reporting processes should be maintained to the maximum extent possible” (see section III.C.1, page 3). FDA also provides recommendations on how to prioritize reporting when regulatory timelines cannot be met due to limited resources during a pandemic, so that FDA continues to receive critical safety information in a timely manner. For example, table 1 of the guidance outlines how companies should prioritize their submission of postmarketing safety reports during an influenza pandemic if normal processes of mandatory adverse event reporting are not feasible because of high employee absenteeism: Reports for pandemic influenza vaccines, drugs and biological products labeled for the treatment of influenza, drugs and biologics approved for less than three years, and products with special concerns as specified by FDA. The list includes reporting on newly approved products as the comment recommended. The guidance provides resources for companies establishing a COOP plan, but specifying the content of the COOP plans as suggested by the comment is beyond the scope of the guidance. Instead, the guidance provides the more general recommendation that “each firm's pandemic influenza COOP plan should include instructions for reporting adverse events and the submission of any stored reports not submitted in the regulatory timeframes” (see section III.B, page 2).

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

Table 1—Estimated Annual Reporting Burden ¹

Type of reporting	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Notify FDA when normal reporting is not feasible	500	1	500	8	4,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2—Estimated Annual Recordkeeping Burden ¹

Type of recordkeeping	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeper	Total hours
Add adverse event reporting plan to COOP	5,000	1	5,000	50	250,000
Maintain documentation of influenza pandemic conditions and resultant high absenteeism	500	1	500	8	4,000
Maintain records to identify what reports have been stored and when the reporting process was restored	500	1	500	8	4,000
Total					258,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: December 30, 2014.

Leslie Kux,

Associate Commissioner for Policy.