The ICR Process is Broken: At Least Procedurally
Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA-2010-N-0646—Paper Work Reduction Act Comments on Tobacco Products, Exemptions from Substantial Equivalence Requirements.
RIN: 0910-AG39
Dear Sir or Madam:
The Center for Regulatory Effectiveness (CRE) is pleased to submit these comments regarding the Food and Drug Administration’s (FDA) proposed rule for Exemptions from Substantial Equivalence Requirements for Tobacco Products. CRE will not be commenting on the substance of the rule, but rather will discuss: (1) how the government has conducted FDA’s Information Collection Request (ICR); (2) CRE’s interactive public docket for TPSAC; and (3) the comments CRE submitted on the FDA’s ICR.
I. ICR Policies are Unacceptable
On January 6, 2011, the FDA issued a proposed rule accompanied with an ICR. The ICR stated that the rule would impose an estimated annual collection burden of 20,000 hours on manufacturers, however, the FDA failed to provide an objective basis for the estimated burden. On January 15, 2011, CRE contacted the FDA requesting additional information on how FDA arrived at their estimated burden. At this time, FDA provided no additional information. In the proposed rule, the FDA stated that the comments on the information collection were due to the Office of Information and Regulatory Affairs (OIRA) on February 7, 2011. CRE submitted comments on the ICR on February 7, 2011, via fax and email to OIRA pursuant to the submission criteria contained in the rule.
CRE contacted OIRA and the FDA approximately ten times requesting to view the comments received by OIRA. FDA and OIRA stated that no comments were submitted for the ICR and that CRE’s comments had not been received. CRE submitted the fax and email confirmation for its comments and resubmitted its comments to the FDA desk officer on February 21, 2011. As of March 16, 2011, OIRA has not provided CRE with access to the comments it has received, despite CRE’s many attempts.
II. TPSAC IPD
CRE has established an Interactive Public Docket (IPD) to cover developments of the Tobacco Scientific Advisory Committee (TPSAC). CRE encourages the public to participate on the IPD, which is available at http://www.thecre.com/scur/?p=414
An IPD is a mechanism that allows the public to communicate with regulators on a 24 hour, 7 days a week basis. An IPD continues throughout the life of a proceeding, and allows the public the opportunity to provide meaningful comments beyond the formal public comment period. The IPD provides an invaluable resource of analysis and comment for the FDA to continue to draw from as developments occur beyond the public comment period. The IPD provides the public with the opportunity to question TPSAC, present differing views, and offer relevant analysis on a continuous basis. The IPD will be a particularly useful tool, because there are a substantial number of parties, across government and private sector lines, which will be affected by the findings of TPSAC. The IPD will function to keep all parties apprised of developments, while also providing a collective resource of information for FDA to make a well-informed decision regarding tobacco products.
III. CRE’s ICR Comments
The CRE has attached its comments submitted for the ICR. In its comments, CRE highlighted the deficiencies in the FDA’s ICR concerning the substantial equivalence exemption process. CRE requested that the FDA cure the defects by providing a detailed basis of its estimated burden, outlining the practical utility of the information collected, and creating a plan for the effective use of the information. On March 6, 2011, nearly a month after the closing of the comment period for the ICR, the FDA provided a supporting statement for the ICR. However, the subsequent data provided by FDA neither ameliorates CRE’s concerns nor provide the public with a meaningful opportunity to comment.
If you need further information regarding any issue discussed in this comment letter, please do not hesitate to contact me at secretary1@mbsdc.com or (202) 265-2383.
Respectfully submitted,
Jim Tozzi
Member, Board of Advisors
N. B. CRE Comments on the ICR attached.
