Re: Generic Drug Study-FTC File No. V000014

Dear Sir or Madam,

Attached are comments by the Center for Regulatory Effectiveness on the FTC's Proposed Collection of Information regarding the Hatch-Waxman Act, 65 Fed. Reg. 61334 (October 17, 2000). CRE's comments address a number of issues, but we wish to emphasize one important pont in this cover letter.

In order for the public to exercise its right to comment on whether the information is necessary for the proper performance of the FTC's functions, the Paperwork Reduction Act ("PRA") requires that the public be provided with the Commission's planned methodology for using the requested information to achieve the Commission's "proper functions." Furthermore, the Commission is required by the PRA to have a plan for the use of the data. 44 U.S.C. §§ 3506(c)(3)(H); 506(c)(1)(A)(vi).

The Federal Register notice for this proposed collection of information does not provide the FTC's planned methodology or plan for using the requested information. Nowhere does it explain with any specificity how the FTC will use the information to determine whether anti-competitive activity is occurring. In order to comply with the PRA, the FTC must explain what its enforcement standard is in this context, and how the sought information will be used to determine compliance with that standard. Otherwise, the public will be denied its right guaranteed by the PRA to comment on these issues.

This statutorily required information is not provided by the FTC's current Federal Register notice. Consequently, in order to comply with the PRA, it must be included in the package that the FTC sends to OMB for review and approval under the PRA. In order to comply with the PRA, the FTC's submission to OMB must include a specific discussion of how the FTC will use the requested information to determine whether the agreements at issue are illegal, even if they comply with the Hatch-Waxman Act and the FDA's implementing rules. And the public has the right to notice of and an opportunity to comment on the FTC's submission to OMB. 44 U.S.C. § 3507 (a)(1)(D); 5 C.F.R. §§ 1320.8(d)(1); 1320.11(a).