1 4 SEC. 4. Orders of the Secretary with respect to a denial 2 of application or revocation or annulment of a certificate 3 shall be served (1) in person by any officer or employee 4 of the Department of Agriculture designated by the Secre5 tary or (2) by mailing the order by registered mail ad6 dressed to the applicant or respondent at his last known 7 address in the records of the Secretary. 8 SEC. 5. An appeal may be taken from an order of the 9 Secretary by an applicant for a certificate whose application 10 is denied or by the holder of a certificate which has been 11 revoked or annulled. Such appeal shall be taken by filing 12 in the circuit court of appeals of the United States within 13 any circuit wherein such applicant or holder resides or has 14 his principal place of business, or in the United States Court 15 of Appeals for the District of Columbia, within sixty days 16 after the entry of such order, a written petition praying that the order of the Secretary be set aside. A copy of such 18 petition shall be forthwith served upon the Secretary, or 17 19 upon any officer designated by him for that purpose, and 20 thereupon the Secretary shall certify and file in the court a 21 transcript of the record upon which the order complained 22 of was entered. Upon the filing of such transcript such 23 court shall have exclusive jurisdiction to affirm or set aside 24 such order. No objection to the order of the Secretary shall 25 be considered by the court unless such objection shall have 5 1 been urged before the Secretary or unless there were rea2 sonable grounds for failure so to do. The finding of the 3 Secretary as to the facts, if supported by evidence, shall be 4 conclusive. If any person shall apply to the court for leave 5 to adduce additional evidence, and shall show to the satis6 faction of the court that such additional evidence is material 7 and that there were reasonable grounds for failure to adduce 8 such evidence in the proceeding before the Secretary, the 9 court may order such additional evidence to be taken before 10 the Secretary and to be adduced upon the hearing in such manner and upon such terms and conditions as to the court 12 may seem proper. The Secretary may modify his findings 11 13 as to the facts by reason of the additional evidence so taken, 14 and he shall file with the court such modified findings which, 15 if supported by evidence, shall be conclusive, and his recom16 mendation, if any, for the setting aside of the original order. 17 The judgment and decree of the court affirming or setting 18 aside any such order of the Secretary shall be final, subject 19 to review by the Supreme Court of the United States upon 20 certiorari or certification as provided in sections 239 and 21 240 of the Judicial Code, as amended (U. S. C., 1934 edi22 tion, title 28, secs. 346 and 347). The commencement of 23 proceedings under this section shall not, unless specifically 24 ordered by the court to the contrary, operate as a stay of 25 the Secretary's orders of revocation or annulment. 2 1 gested in the labeling thereof, unless such person holds a 2 certificate issued by the Secretary of Agriculture showing 3 that such drug has been tested and has not been found to be 4 unsafe for use under such conditions. 5 SEC. 2. A person making application for the issuance 6 of such a certificate with respect to any drug subject to 7 the provisions of section 1 shall submit to the Secretary (1) 8 full reports of investigations which have been made to show 9 whether or not such drug is safe for use; (2) a full list 10 of the articles used as components of such drug; (3) a 11 full description of the methods used in, and the facilities and 12 controls used for, the manufacture, processing, and packing 13 of such drug; (4) a full statement of the composition of such 14 drug; (5) such samples of such drug and of the articles 15 used as components thereof as the Secretary may require; 16 and (6) specimens of the labeling proposed to be used for 17 such drug. If the Secretary finds that (1) such investiga18 tions include tests by all methods reasonably applicable to 19 show whether or not such drug is safe for use under the 20 conditions prescribed, recommended, or suggested in the 21 proposed labeling thereof; (2) the results of such tests do 22 not show that such drug is unsafe for use under such con23 ditions; (3) the methods used in, and the facilities and con24 trols used for, the manufacture, processing, and packing of 25 such drug are adequate to preserve its identity, strength, 3 1 quality, and purity; and (4) such drug otherwise complies 2 with the provisions of the Federal food and drug laws, now 3 or hereafter in force, he shall issue to the applicant a cer4 tificate showing that such drug has been tested and has not 5 been found to be unsafe for use under such conditions. If 6 the Secretary has reason to believe that the applicant is not 7 entitled to such certificate he shall notify the applicant and, 8 upon request, afford the applicant due notice and oppor9 tunity for hearing on the application. If the Secretary, 10 after affording such notice and opportunity for hearing, finds 11 that the applicant is not entitled to such certificate the Sec12 retary shall by order deny the application, stating the find13 ings which are the basis for his order. 14 SEC. 3. A certificate issued by the Secretary with re15 spect to any drug shall by order of the Secretary, after due notice and opportunity for hearing to the person to whom it was issued, (1) be revoked if the Secretary finds that clinical experience, tests by new methods, or tests by 16 17 18 19 20 21 22 23 24 25 methods not deemed reasonably applicable when such certificate was issued show that such drug is unsafe for use under the conditions of use upon the basis of which the certificate was issued; or (2) be annulled if the Secretary finds that such certificate was procured through fraud, or misrepre sentation, or concealment of material fact. The order shall state the findings which are the basis for the order. 1 4 SEC. 4. Orders of the Secretary with respect to a denial 2 of application or revocation or annulment of a certificate 3 shall be served (1) in person by any officer or employee 4 of the Department of Agriculture designated by the Secre5 tary or (2) by mailing the order by registered mail ad6 dressed to the applicant or respondent at his last known 7 address in the records of the Secretary. 8 13 SEC. 5. An appeal may be taken from an order of the 9 Secretary by an applicant for a certificate whose application 10 is denied or by the holder of a certificate which has been 11 revoked or annulled. Such appeal shall be taken by filing 12 in the circuit court of appeals of the United States within any circuit wherein such applicant or holder resides or has 14 his principal place of business, or in the United States Court 15 of Appeals for the District of Columbia, within sixty days 16 after the entry of such order, a written petition praying 17 that the order of the Secretary be set aside. A copy of such 18 petition shall be forthwith served upon the Secretary, or upon any officer designated by him for that purpose, and 20 thereupon the Secretary shall certify and file in the court a 21 transcript of the record upon which the order complained 22 of was entered. Upon the filing of such transcript such 23 court shall have exclusive jurisdiction to affirm or set aside 24 such order. No objection to the order of the Secretary shall 25 be considered by the court unless such objection shall have 19 |