
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC356b]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 356b. Reports of postmarketing studies


(a) Submission

                           (1) In general

        A sponsor of a drug that has entered into an agreement with the 
    Secretary to conduct a postmarketing study of a drug shall submit to 
    the Secretary, within 1 year after the approval of such drug and 
    annually thereafter until the study is completed or terminated, a 
    report of the progress of the study or the reasons for the failure 
    of the sponsor to conduct the study. The report shall be submitted 
    in such form as is prescribed by the Secretary in regulations issued 
    by the Secretary.

               (2) Agreements prior to effective date

        Any agreement entered into between the Secretary and a sponsor 
    of a drug, prior to November 21, 1997, to conduct a postmarketing 
    study of a drug shall be subject to the requirements of paragraph 
    (1). An initial report for such an agreement shall be submitted 
    within 6 months after the date of the issuance of the regulations 
    under paragraph (1).

(b) Consideration of information as public information

    Any information pertaining to a report described in subsection (a) 
of this section shall be considered to be public information to the 
extent that the information is necessary--
        (1) to identify the sponsor; and
        (2) to establish the status of a study described in subsection 
    (a) of this section and the reasons, if any, for any failure to 
    carry out the study.

(c) Status of studies and reports

    The Secretary shall annually develop and publish in the Federal 
Register a report that provides information on the status of the 
postmarketing studies--
        (1) that sponsors have entered into agreements to conduct; and
        (2) for which reports have been submitted under subsection 
    (a)(1) of this section.

(June 25, 1938, ch. 675, Sec. 506B, as added Pub. L. 105-115, title I, 
Sec. 130(a), Nov. 21, 1997, 111 Stat. 2331.)


                             Effective Date

    Section effective 90 days after Nov. 21, 1997, except as otherwise 
provided, see section 501 of Pub. L. 105-115, set out as an Effective 
Date of 1997 Amendment note under section 321 of this title.


                   Report to Congressional Committees

    Section 130(b) of Pub. L. 105-115 provided that: ``Not later than 
October 1, 2001, the Secretary shall prepare and submit to the Committee 
on Labor and Human Resources of the Senate and the Committee on Commerce 
[now Committee on Energy and Commerce] of the House of Representatives a 
report containing--
        ``(1) a summary of the reports submitted under section 506B of 
    the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356b];
        ``(2) an evaluation of--
            ``(A) the performance of the sponsors referred to in such 
        section in fulfilling the agreements with respect to the conduct 
        of postmarketing studies described in such section of such Act; 
        and
            ``(B) the timeliness of the Secretary's review of the 
        postmarketing studies; and
        ``(3) any legislative recommendations respecting the 
    postmarketing studies.''
