N.Y. Comp. Codes R. & Regs. tit. 5 § 260.11

Current through Register Vol. 46, No. 45, November 2, 2024

Section 260.11 - Appeal process

(a) This section shall apply to all appeals taken as a result of a life sciences research and development company's application being denied by the department pursuant to section 260.5(c) of this Title.

(b) A life sciences research and development company that received a denial of their application pursuant to section 260.5(c) of this Title may send a written notice (notice of appeal) to the commissioner appealing the denial by no later than 30 days from the date of the mailing of the notice. Failure by a company to appeal the commissioner's denial of certification within the aforementioned 30 day period will be deemed a waiver of the life sciences research and development company's right to an appeal.

(c) The notice of appeal must contain specific factual information and documentation supporting the basis for the appeal and all legal arguments that are the basis for the life sciences research and development company's challenge to the denial.

(d) Counsel to the department may file a response to the notice of appeal with the appeal officer. Any response should address the factual and legal allegations contained in the notice of appeal. A copy of the response shall be sent to the life sciences research and development company, or to the attorney representing the life sciences research and development company.

(e) The commissioner may designate any impartial person or persons to act as an appeal officer. The appeal officer shall evaluate the merits of the appeal and any response from counsel to the department. Where the appeal officer deems it appropriate, the appeal officer may require the life sciences research and development company or counsel to the department to address additional issues and/or submit additional information regarding the appeal. If the appeal officer requires submission of additional documents by either life sciences research and development company or counsel to the department, both parties shall receive copies of all submissions. Nothing herein shall preclude the appeal officer from obtaining information from any outside source, as he or she deems appropriate. The appeal officer shall determine whether he or she deems it necessary to conduct a fact-finding hearing, and the level of formality of any hearing conducted.

(f) The appeal officer shall prepare a report and make recommendations to the commissioner. The recommendations may be in the form of a proposed decision which will contain findings of fact and conclusions of law. This report, along with the entire record, shall be transmitted to the commissioner, the counsel to the department, and the business entity that filed the appeal.

(g) After receipt of the appeal officer's report, the commissioner will issue a final determination within 60 days and serve a copy on the life sciences research and development company or its representative. If the commissioner issues a final determination that includes findings of fact or conclusions of law that conflict with the recommendations of the appeal officer, the determination shall set forth the reasons therefore.

N.Y. Comp. Codes R. & Regs. Tit. 5 § 260.11