N.J. Admin. Code § 17:30A-7A.8

Current through Register Vol. 56, No. 23, December 2, 2024

Section 17:30A-7A.8 - Clinical registrant permit renewals

(a) A clinical registrant permit shall be valid for one year.

(b) The Commission may renew a clinical registrant permit subject to the conditions set forth in this subchapter.

(c) A clinical registrant permit holder shall submit a renewal application and the annual permitting fee pursuant to N.J.A.C. 17:30A- 7A.9 no later than 90 days prior to the expiration of the current clinical registrant permit. Submission within 90 days of expiration of the current clinical registrant permit may result in a lapse in the clinical registrant's permitting and subject the clinical registrant to enforcement action.

(d) The following may be grounds for denial of a clinical registrant permit renewal application:

1. Failure to provide truthful, correct, and current information;

2. Failure to maintain compliance with the Act or this chapter;

3. The inclusion of a person or entity not deemed qualified to hold a permit pursuant to N.J.A.C. 17:30A-7A.5; or

4. The commission of three or more violations within the preceding 12 months.

(e) Renewal materials submitted to the Commission pursuant to N.J.S.A. 24:6I-7.3 or this section shall not be considered a public record pursuant to N.J.S.A. 47:1A-1 et seq., or the common law concerning access to government records.

1. The information in this subsection shall include a clinical registrant's or an academic medical center's research contract and research study description, patient information, and intellectual property.

(f) If a permit renewal application is denied, the Commission shall provide notice of the renewal denial to the applicant, in writing, which shall include:

1. The specific reason for the renewal denial; and

2. The opportunity to request an administrative hearing within 45 days after the date of the renewal denial.

(g) An administrative hearing pursuant to (f) above shall take place in the Office of Administrative Law in accordance with the Administrative Procedures Act, N.J.S.A. 52:14B-1 et seq., and 52:14F-1 et seq., and the Uniform Administrative Procedure Rules, N.J.A.C. 1:1.

(h) The decision to affirm the denial after an administrative hearing shall be considered a final agency decision, subject to judicial review by, and of which jurisdiction and venue for such review are vested in, the Appellate Division of the Superior Court.

N.J. Admin. Code § 17:30A-7A.8

Adopted by 56 N.J.R. 1728(b), effective 8/19/2024