
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: 21USC397]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                      SUBCHAPTER IX--MISCELLANEOUS
 
Sec. 397. Contracts for expert review


(a) In general

                            (1) Authority

        The Secretary may enter into a contract with any organization or 
    any individual (who is not an employee of the Department) with 
    relevant expertise, to review and evaluate, for the purpose of 
    making recommendations to the Secretary on, part or all of any 
    application or submission (including a petition, notification, and 
    any other similar form of request) made under this chapter for the 
    approval or classification of an article or made under section 
    351(a) of the Public Health Service Act (42 U.S.C. 262(a)) with 
    respect to a biological product. Any such contract shall be subject 
    to the requirements of section 379 of this title relating to the 
    confidentiality of information.

      (2) Increased efficiency and expertise through contracts

        The Secretary may use the authority granted in paragraph (1) 
    whenever the Secretary determines that use of a contract described 
    in paragraph (1) will improve the timeliness of the review of an 
    application or submission described in paragraph (1), unless using 
    such authority would reduce the quality, or unduly increase the 
    cost, of such review. The Secretary may use such authority whenever 
    the Secretary determines that use of such a contract will improve 
    the quality of the review of an application or submission described 
    in paragraph (1), unless using such authority would unduly increase 
    the cost of such review. Such improvement in timeliness or quality 
    may include providing the Secretary increased scientific or 
    technical expertise that is necessary to review or evaluate new 
    therapies and technologies.

(b) Review of expert review

                           (1) In general

        Subject to paragraph (2), the official of the Food and Drug 
    Administration responsible for any matter for which expert review is 
    used pursuant to subsection (a) of this section shall review the 
    recommendations of the organization or individual who conducted the 
    expert review and shall make a final decision regarding the matter 
    in a timely manner.

                           (2) Limitation

        A final decision by the Secretary on any such application or 
    submission shall be made within the applicable prescribed time 
    period for review of the matter as set forth in this chapter or in 
    the Public Health Service Act (42 U.S.C. 201 et seq.).

(June 25, 1938, ch. 675, Sec. 907, as added Pub. L. 105-115, title IV, 
Sec. 415, Nov. 21, 1997, 111 Stat. 2377.)

                       References in Text

    The Public Health Service Act, referred to in subsec. (b)(2), is act 
July 1, 1944, ch. 373, 58 Stat. 682, as amended, which is classified 
generally to chapter 6A (Sec. 201 et seq.) of Title 42, The Public 
Health and Welfare. For complete classification of this Act to the Code, 
see Short Title note set out under section 201 of Title 42 and Tables.


                             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.
