Page:United States Statutes at Large Volume 122.djvu/3536

 12 2 STA T .35 13 PUBLIC LA W 11 0– 31 6— AU G .1 4, 200 8‘ ‘ (C)providea period o f30 da ys af t ert h ep ubl i cm eeti ng to obtain w ritten comments from the public suggesting changes to this part and ‘‘( D ) publish the comments on the F ood and Drug A dministration ’ s I nternet W eb site . ‘‘(3) PERIOD I C CO NSULTA TION. —N ot less fre q uently than once every 4 months during negotiations with the regulated industry , the S ecretary shall hold discussions with representa - tives of veterinary, patient, and consumer advocacy groups to continue discussions of their views on the reauthori z ation and their suggestions for changes to this part as e x pressed under paragraph ( 2 ). ‘‘(4) PU B LIC RE V IE W O F RECO M MENDATIONS.—After negotia- tions with the regulated industry, the Secretary shall— ‘‘(A) present the recommendations developed under paragraph ( 1 ) to the Congressional committees specified in such paragraph; ‘‘( B ) publish such recommendations in the Federal R eg- ister; ‘‘(C) provide for a period of 30 days for the public to provide written comments on such recommendations; ‘‘(D) hold a meeting at which the public may present its views on such recommendations; and ‘‘( E ) after consideration of such public views and com- ments, revise such recommendations as necessary. ‘‘( 5 ) T RANSMITTAL OF RECOMMENDATIONS.—Not later than J anuary 15, 2013, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments. ‘‘( 6 ) M INUTES OF NE G OTIATION MEETINGS.— ‘‘(A) PUBLIC AVAILABILIT Y .—Before presenting the rec- ommendations developed under paragraphs (1) through (5) to the Congress, the Secretary shall ma k e publicly avail- able, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings con- ducted under this subsection between the Food and Drug Administration and the regulated industry. ‘‘(B) CONTENT.—The minutes described under subpara- graph (A) shall summarize any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotia- tions and their resolution.’’. SEC.105 . ANTIM IC ROB IA L ANIMAL D R UG DISTRIBUTION RE P ORTS. (a) RE P ORTS.—Section 512(l) (21 U .S.C. 360b(l)) is amended by adding at the end the following

‘‘(3)(A) In the case of each new animal drug described in para- graph (1) that contains an antimicrobial active ingredient, the sponsor of the drug shall submit an annual report to the Secretary on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. ‘‘(B) Each report under this paragraph shall specify the amount of each antimicrobial active ingredient— ‘‘(i) by container size, strength, and dosage form; Websit e .D e adl i n e. Com ments. F ede r al R e g ister ,pu bli c ation. Deadlines. Web site.

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