Citizen Petitions

1
Citizen Petitions

• The Secretary shall not delay approval of a
  505(b)(2) or (j) application because of any
  request relating to the application, unless
• (i) the request is a citizen petition and
• (ii) the Secretary determines that a delay is
  necessary to protect the public health.

2
Notification

• If the Secretary determines that a delay is
  necessary, the Secretary shall provide the
  following to the applicant, not later than 30
  days after making such determination
• (i) Notification of the fact that a determination
  has been made.
• (ii) Any clarification or additional data that
  the applicant should submit to allow the
  Secretary to review the petition promptly.
• (iii) A brief summary of the specific substantive
  issues raised in the petition which form the
  basis of the determination.

3
Format and Disclosure

• The information shall be conveyed via either
• (i) a document or
• (ii) a meeting with the applicant involved.
• Any information conveyed by the Secretary shall
  be considered part of the application and shall
  be subject to the disclosure requirements
  applicable to information in such application.

4
Denial Based on Intent to Delay

• If the Secretary determines that a petition or a
  supplement was submitted with the primary purpose
  of delaying the approval of an application and
  the petition does not on its face raise valid
  scientific or regulatory issues, the Secretary
  may deny the petition.
• The Secretary may issue guidance to describe the
  factors that will be used to make such a
  determination.

5
Final Agency Action

• The Secretary shall take final agency action on a
  petition not later than 180 days after the date
  on which the petition is submitted.
• The Secretary shall not extend such period for
  any reason, including--
• (i) a determination to delay approval of a
  505(b)(2) or (j) application because of matters
  raised in a petition that are necessary to
  protect the public health
• (ii) the submission of comments or supplemental
  information relating to the petition or
• (iii) the consent of the petitioner.

6
Extension of the 30-Month Period

• If the filing of an application resulted in
  first-applicant status and approval of the
  application was delayed because of a petition,
  the 30-month period is deemed to be extended as
  long as the petition was pending before the
  agency -- without regard to whether the Secretary
  grants or denies the petition.

7
Certification

• A party submitting a citizen petition must
  certify that
• The petition includes all information upon which
  it relies
• The petition includes representative information
  known to the petitioner that are unfavorable to
  the petition and
• The party has taken reasonable steps to ensure
  that unfavorable information was disclosed to
  them.
• The petition must include
• The date on which the information in the petition
  first became known to the party
• Any payments or other consideration received and
  the entities involved

8
Verification

• A party submitting supplemental information or
  comments on a petition must verify that they have
  not intentionally delayed submission of the
  document.
• The verification must specify
• The date the information in the document first
  became known to the party and
• Any payments or other consideration received and
  the entities involved.

9
Final Agency Action

• The Secretary shall be considered to have taken
  final agency action on a petition if--
• (i) the Secretary makes a final decision in 180
  days or
• (ii) such period expires without the Secretary
  having made a final decision.

10
Dismissal of Actions

• If a civil action is filed against the Secretary
  with respect to any issue raised in the petition
  before the Secretary has taken final agency
  action, the court shall dismiss the action for
  failure to exhaust administrative remedies.

11
Administrative Record

• For judicial review purposes, the administrative
  record regarding any issue raised by the petition
  shall include--
• (i) the petition, supplements, and comments
  thereto
• (ii) the Secretary's response, if issued and
• (iii) other related information, as designated by
  the Secretary, as long as the information was
  considered prior to final agency action
  days, regardless of whether the Secretary
  responded to the petition before the approval of
  the application at issue.

12
Reports to Congress

• The Secretary shall annually submit to the
  Congress a report that specifies--
• (A) the number of applications that were approved
  during the preceding 12-month period
• (B) the number of such applications whose
  effective dates were delayed by petitions
• (C) the number of days by which such applications
  were delayed and
• (D) the number of such petitions that were
  submitted during such period.
• Within a year, the Secretary shall submit a
  report on ways to encourage the early submission
  of petitions.