To require the Commissioner of Food and Drugs to report to Congress on issues with respect to small businesses.

1. Adds SEC. 11__. REPORT ON SMALL BUSINESSES at the end of title XI

   Adds a section

   In S. 3187 · Placed on Calendar Senate

   "(b) Financial Interest.--In this section, the term 'financial interest' means a financial interest under section 208(a) of title 18, United States Code.".

   Inserted: SEC. 11__. REPORT ON SMALL BUSINESSES.

   Inserted: Not later than 1 year after the date of enactment of this Act, the Commissioner of Food and Drugs shall submit a report to Congress that includes--

   Inserted: (1) a listing of and staffing levels of all small business offices at the Food and Drug Administration, including the small business liaison program;

   Inserted: (2) the status of partnership efforts between the Food and Drug Administration and the Small Business Administration;

   Inserted: (3) a summary of outreach efforts to small businesses and small business associations, including availability of toll-free telephone help lines;

   Inserted: (4) with respect to the program under the Orphan Drug Act (Public Law 97 414), the number of applications made by small businesses and number of applications approved for research grants, the amount of tax credits issued for clinical research, and the number of companies receiving protocol assistance for the development of drugs for rare diseases and disorders;

   Inserted: (5) with respect to waivers and reductions for small business under the Prescription Drug User Fee Act, the number of small businesses applying for and receiving waivers and reductions from drug user fees under subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.);

   Inserted: (6) the number of small businesses submitting applications and receiving approval for unsolicited grant applications from the Food and Drug Administration;

   Inserted: (7) the number of small businesses submitting applications and receiving approval for solicited grant applications from the Food and Drug Administration;

   Inserted: (8) barriers small businesses encounter in the drug and medical device approval process; and

   Inserted: (9) recommendations for changes in the user fee structure to help alleviate generic drug shortages.

   Original wording

   At the end of title XI, add the following:

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As printed