Sec. 1128. REPORT ON SMALL BUSINESSES

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## SEC. 1128 REPORT ON SMALL BUSINESSES 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— ####

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

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

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

(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 and the number of companies receiving protocol assistance for the development of drugs for rare diseases and disorders; ####

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

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

(7)barriers small businesses encounter in the drug and medical device approval process.

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Pub. L. 97-414

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Sec. 1128

REPORT ON SMALL BUSINESSES

Pub. L.Pub. L. 97-414

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