Regulatory Focus™ > News Articles > Legislation Would Subject FDA Information Inquiries to Performance Standards

Legislation Would Subject FDA Information Inquiries to Performance Standards

Posted 01 August 2012 | By Alexander Gaffney, RAC 

Under a new piece of bipartisan legislation introduced in the Senate, all federal agencies, including the US Food and Drug Administration (FDA), would be subject to new standards intended establish performance measures and standards.

The Government Customer Service Improvement Act of 2012, sponsored by Sens. Mark Warner (D-VA) and Ron Johnson (R-WI), was introduced in the Senate on 31 July 2012.

Under the proposed legislation, the Office of Management and Budget (OMB) would first be tasked with developing standards to determine whether agencies are serving the public with "high-quality, timely customer service and improving service delivery to customers of the agencies." In addition, OMB would develop milestones, performance targets and target response times for each agency to adopt per the legislation's goals.

Each agency would then be responsible for implementing OMB's performance measures and collecting information regarding their ability to meet expectations. On an annual basis, each agency would also be audited by OMB, which would be tasked with determining the extent to which each agency met standards.

Would FDA be Affected?

FDA could be better prepared for such changes than most agencies thanks to the response standards already built into the FDA Safety and Innovation Act (FDASIA) and other previous pieces of user fee legislation. Still, the agency-and others-might need to revamp messaging systems in order to assess the response times of requests submitted. The bill notes each agency should set publicly available targets for call wait times, target response times for correspondence by both mail and email,  and making sure government contractors and subcontractors apply to the same standards.

Agencies not meeting OMB's standards would be subject to-at least initially-a pilot program set to be formed by OMB to work with agencies to help them make process improvements.

The law notes, "No additional funds should be appropriated," to carry out the provisions of the law, potentially making it a costly undertaking for FDA if it is required to revamp its internal processes to comply.

Read more:

(h/t The Hill) - Senators propose customer service standards for federal agencies

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