
[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR13]

[Page 69-71]
 
                        TITLE 45--PUBLIC WELFARE
 
                    SUBTITLE A--DEPARTMENT OF HEALTH
                           AND HUMAN SERVICES
 
PART 13--IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY PROCEEDING
S--Table of Contents
 
Subpart C--Procedures for Considering Applications

Sec. 13.21  Filing and service of pleadings.

    All pleadings, including applications for an award of fees, answers, 
comments, and other pleadings related to the applications, shall be 
filed in the same manner as other pleadings in the proceeding and served 
on all other parties and participants, except as provided in 
Sec. 13.11(b) of this part concerning confidential financial 
information.

Sec. 13.22  When an application may be filed.

    (a) The applicant must file and serve its application no later than 
30 calendar days after the Department's final disposition of the 
proceeding which makes the applicant a prevailing party.
    (b) For purposes of this rule, final disposition means the later of 
(1) the date on which an initial decision or other recommended 
disposition of the merits of the proceeding by an adjudicative officer 
or intermediate review board becomes administratively final; (2) 
issuance of an order disposing of any petitions for reconsideration of 
the Department's final order in the proceeding; (3) if no petition for 
reconsideration is filed, the last date on which such a petition could 
have been filed; or (4) issuance of a final order or any other final 
resolution of a proceeding, such as a settlement or voluntary dismissal, 
which is not subject to a petition for reconsideration.
    (c) For purposes of this rule, an applicant has prevailed when the 
agency has made a final disposition favorable to the applicant with 
respect to any matter which could have been heard as a separate 
proceeding, regardless of whether it was joined with other matters for 
hearing.
    (d) If review or reconsideration is sought or taken of a decision as 
to which an applicant believes it has prevailed, proceedings for the 
award of fees shall be stayed pending final disposition of the 
underlying controversy.

Sec. 13.23  Responsive pleadings.

    (a) Within 30 calendar days after service of the application, the 
agency's

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litigating party shall file an answer either consenting to the award or 
explaining in detail any objections to the award requested, and 
identifying the facts relied on in support of its position. The 
adjudicative officer may for good cause grant an extension of time for 
filing an answer.
    (b) Within 15 calendar days after service of an answer, the 
applicant may file a reply. If the reply is based on any alleged facts 
not already in the record of the proceeding, the applicant shall include 
with the reply either supporting affidavits or a request for further 
proceedings under Sec. 13.25.
    (c) Any party to or participant in a proceeding may file comments on 
an application within 30 calendar days, or on an answer within 15 
calendar days after service of the application or answer.

Sec. 13.24  Settlements.

    The applicant and the agency's litigating party may agree on a 
proposed settlement of the award at any time prior to final action on 
the application. If the parties agree on a proposed settlement of an 
award before an application has been filed, the application shall be 
filed with the proposed settlement. All settlements must be approved by 
the adjudicative officer and the head of the agency or office or his or 
her designee before becoming final.

Sec. 13.25  Further proceedings.

    (a) Ordinarily, a decision on an application will be made on the 
basis of the hearing record and pleadings related to the application. 
However, at the request of either the applicant or the agency's 
litigating party, or on his or her own initiative, the adjudicative 
officer may order further proceedings, including an informal conference, 
oral argument, additional written submissions, or an evidentiary 
hearing. Such further proceedings shall be held only when necessary for 
full and fair resolution of the issues arising from the application, and 
shall be conducted as promptly as possible.
    (b) A request that the adjudicative officer order additional written 
submissions or oral testimony shall identify the information sought and 
shall explain why the information is necessary to decide the issues.
    (c) The adjudicative officer may impose sanctions on any party for 
failure to comply with his or her order to file pleadings, produce 
documents, or present witnesses for oral examination. These sanctions 
may include but are not limited to granting the application partly or 
completely, dismissing the application, and diminishing the award 
granted.

Sec. 13.26  Decisions.

    The adjudicative officer shall issue an initial decision on the 
application as promptly as possible after the filing of the last 
document or conclusion of the hearing. The decision must include written 
findings and conclusions on the applicant's eligibility and status as a 
prevailing party, including a finding on the net worth of the applicant. 
Where the adjudicative officer has determined under Sec. 13.11(b) that 
the applicant's net worth information is exempted from disclosure under 
the Freedom of Information Act, the finding on net worth shall be kept 
confidential. The decision shall also include, if at issue, findings on 
whether the agency's position was substantially justified, whether the 
applicant unduly protracted the proceedings, an explanation of any 
difference between the amount requested and the amount awarded, and 
whether any special circumstances make the award unjust.

Sec. 13.27  Agency review.

    (a) The head of the agency or office, or his or her designee, shall 
review any award granted under this part whether or not the parties 
request such review, and issue a final decision. No award shall be made 
under this subpart without approval of the head of the agency or office 
or his or her designee.
    (b) If either the applicant or the agency's litigating party seeks 
review of the adjudicative officer's decision on the fee application, it 
shall file and serve exceptions within 30 days after issuance of the 
initial decision. The head of the agency or office or his or her 
designee shall issue a final decision on the application as soon as 
possible or remand the application to the adjudicative officer for 
further proceedings.

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Any party that does not file and serve exceptions within the stated time 
limit loses the opportunity to do so.

Sec. 13.28  Judicial review.

    Judicial review of final agency decisions on awards may be obtained 
as provided in 5 U.S.C. 504(c)(2).

Sec. 13.29  Payment of award.

    The notification to an applicant of a final decision that an award 
will be made shall contain the name and address of the appropriate 
Departmental finance office that will pay the award. An applicant 
seeking payment of an award shall submit to that finance officer a copy 
of the final decision granting the award, accompanied by a statement 
that the applicant will not seek review of the decision in the United 
States courts. The Department will pay the amount awarded to the 
applicant within 60 days, unless judicial review of the award or of the 
underlying decision of the adversary adjudication has been sought by the 
applicant or any other party to the proceedings.

Sec. 13.30  Designation of adjudicative officer.

    Upon the filing of an application pursuant to Sec. 13.11(a), the 
officer who presided over the taking of evidence in the proceeding which 
gave rise to the application will, if available, be automatically 
designated as the adjudicative officer for the handling of the 
application.
                          Appendix A to Part 13

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                 Proceedings covered                        Statutory authority
         Applicable regulations
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           Office of the Inspector General

Proceeding to impose civil monetary penalties or       42 U.S.C. 1320a-7a......
....  ...........................
 assessments for fraudulent claims under Medicare,
 Medicaid, and Title V.

         Health Care Financing Administration

Proceedings to suspend or revoke licenses of clinical  42 U.S.C. 263a(e), (g)..
....  ...........................
 laboratories.
Proceedings provided to a fiscal intermediary before   42 U.S.C. 1395h.........
....  ...........................
 assigning or reassigning Medicare providers to a
 different fiscal intermediary.
Proceedings before the Provider Reimbursement Review   42 U.S.C. 1395oo........
....  42 CFR Part 405, Subpart R.
 Board when CMS acts as fiscal intermediary.

             Food and Drug Administration

Proceedings to withdraw approval of new drug           21 U.S.C. 355(d), (e)...
....  21 CFR Part 12, 21 CFR
 applications.                                                                 
       314.200.
Proceedings to withdraw approval of new animal drug    21 U.S.C. 360b(d), (e), 
(m).  21 CFR Part 12, 21 CFR Part
 applications and medicated feed applications.                                 
       514, Subpart B.
Proceedings to withdraw approval of medical device     21 U.S.C. 306e(d), (e), 
(g).  21 CFR Part 12.
 premarket approval applications.

                Office of Civil Rights

Proceedings to enforce Title VI of the Civil Rights    42 U.S.C. 200d-1........
....  45 CFR 80.9.
 Act of 1964, which prohibits descrimination on the
 basis of race, color or national origin by
 recipients of Federal financial assistance.
Proceedings to enforce Section 504 of the              29 U.S.C. 794...........
....  45 CFR 84.61.
 Rehabilitation Act of 1973, which prohibits
 discrimination on the basis of handicap by
 recipients of Federal financial assistance.
Proceedings to enforce the Age Discrimination Act of   42 U.S.C. 6101, 6104(a).
....  45 CFR 90.47.
 1975, which prohibits discrimination on the basis of
 age by recipients of Federal financial assistance.
Proceedings to enforce Title IX of the Education       20 U.S.C. 1681, 1682....
....  45 CFR 86.71.
 Amendments of 1972, which prohibits discrimination
 on the basis of sex in certain education programs by
 recipients of Federal financial assistance.
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