[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR8.26]



[Page 71-72]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 8_CERTIFICATION OF OPIOID TREATMENT PROGRAMS--Table of Contents

 

Subpart C_Procedures for Review of Suspension or Proposed Revocation of 

    OTP Certification, and of Adverse Action Regarding Withdrawal of 

                    Approval of an Accreditation Body

 

Sec.  8.26  Preparation of the review file and written arguments.



    The appellant and the respondent each participate in developing the 

file for the reviewing official and in submitting written arguments. The 

procedures for development of the review



[[Page 72]]



file and submission of written argument are:

    (a) Appellant's documents and brief. Within 30 days after receiving 

the acknowledgment of the request for review, the appellant shall submit 

to the reviewing official the following (with a copy to the respondent):

    (1) A review file containing the documents supporting appellant's 

argument, tabbed and organized chronologically, and accompanied by an 

index identifying each document. Only essential documents should be 

submitted to the reviewing official.

    (2) A written statement, not to exceed 20 double-spaced pages, 

explaining why respondent's decision to suspend or propose revocation of 

appellant's certification or to take adverse action regarding withdrawal 

of approval of the accreditation body is incorrect (appellant's brief).

    (b) Respondent's documents and brief. Within 30 days after receiving 

a copy of the acknowledgment of the request for review, the respondent 

shall submit to the reviewing official the following (with a copy to the 

appellant):

    (1) A review file containing documents supporting respondent's 

decision to suspend or revoke appellant's certification, or approval as 

an accreditation body, tabbed and organized chronologically, and 

accompanied by an index identifying each document. Only essential 

documents should be submitted to the reviewing official.

    (2) A written statement, not exceeding 20 double-spaced pages in 

length, explaining the basis for suspension, proposed revocation, or 

adverse action (respondent's brief).

    (c) Reply briefs. Within 10 days after receiving the opposing 

party's submission, or 20 days after receiving acknowledgment of the 

request for review, whichever is later, each party may submit a short 

reply not to exceed 10 double-spaced pages.

    (d) Cooperative efforts. Whenever feasible, the parties should 

attempt to develop a joint review file.

    (e) Excessive documentation. The reviewing official may take any 

appropriate steps to reduce excessive documentation, including the 

return of or refusal to consider documentation found to be irrelevant, 

redundant, or unnecessary.

    (f) Discovery. The use of interrogatories, depositions, and other 

forms of discovery shall not be allowed.