§ 88.16 Addition of health conditions to the List of WTC-Related Health Conditions.

(a) Any interested party may submit a request to the Administrator of the WTC Health Program to add a condition to the List of WTC-Related Health Conditions in § 88.15. The Administrator will evaluate the submission to decide whether it is a valid petition.

(1) Each valid petition must include the following:

(i) An explicit statement of an intent to petition the Administrator to add a health condition to the List of WTC-Related Health Conditions;

(ii) Name, contact information, and signature of the interested party petitioning for the addition;

(iii) Name and/or description of the condition(s) to be added;

(iv) Reasons for adding the condition(s), including the medical basis for the association between the September 11, 2001, terrorist attacks and the condition(s) to be added.

(2) Not later than 90 calendar days after the receipt of a valid petition, the Administrator will take one of the following actions:

(i) Request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee;

Federal Register(ii) Publish in the a proposed rule to add such health condition;

Federal Register(iii) Publish in the the Administrator's decision not to publish a proposed rule and the basis for that decision; or

Federal Register(iv) Publish in the a decision that insufficient evidence exists to take action under paragraph (a)(2)(i) through (iii) of this section.

(3) The 90-day time period will not include any days during which the Administrator is consulting with the interested party to clarify the submission.

Federal Register(4) The Administrator may consider more than one petition simultaneously when the petitions propose the addition of the same health condition. Scientific/Technical Advisory Committee recommendations and notices initiated by the Administrator pursuant to paragraph (a)(2) of this section may respond to more than one petition.

i.e.,Federal RegisterFederal Register(5) The Administrator will be required to consider a submission for a health condition previously reviewed by the Administrator and found not to qualify for addition to the List of WTC-Related Health Conditions as a valid new petition only if the submission presents a new medical basis ( a basis not previously reviewed) for the association between the September 11, 2001, terrorist attacks and the condition to be added. A submission that provides no new medical basis and is received after the publication of a response in the to a petition requesting the addition of the same health condition will not be considered a valid petition and will not be answered in a notice pursuant to paragraph (a)(2), above. The interested party will be informed of the WTC Health Program's decision in writing.

Federal Register(b) The Administrator may propose to add a condition to the List of WTC-Related Health Conditions in § 88.15 of this part by publishing a proposed rule in the and providing interested parties a period of 30 calendar days to submit written comments. The Administrator may extend the comment period for good cause.

Federal Register(1) If the Administrator requests a recommendation from the WTC Health Program Scientific/Technical Advisory Committee, the Advisory Committee will submit its recommendation to the Administrator no later than 90 calendar days after the date of the transmission of the request or no later than a date specified by the Administrator (but not more than 180 calendar days after the request). The Administrator will publish a proposed rule or a decision not to publish a proposed rule in the no later than 90 calendar days after the date of transmission of the Advisory Committee recommendation.

(2) Before issuing a final rule to add a health condition to the List of WTC-Related Health Conditions, the Administrator will provide for an independent peer review of the scientific and technical evidence that would be the basis for issuing such final rule.