DHSS Proposes New Rules At N.J.A.C. 8:57-3 Governing The New Jersey Immunization Information System

Main Category: Immune System / Vaccines
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 21 Oct 2008 - 9:00 PDT

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The Communicable Disease Service of the Division of Epidemiology, Environmental and Occupational Health in the Public Health Services Branch of the Department of Health and Senior Services (Department) is proposing new rules at N.J.A.C. 8:57-3, governing the New Jersey Immunization Information System (NJIIS). The notice of proposal appears in the October 20, 2008 issue of the New Jersey Register.

On April 21, 2008 at 40 N.J.R. 1962(a) the Department proposed to recodify existing N.J.A.C. 8:57-3 into its own chapter at N.J.A.C. 8:58. Upon adoption of the April 21, 2008 rulemaking, N.J.A.C. 8:57-3 will be a reserved subchapter. The proposed new NJIIS rules would be codified at N.J.A.C. 8:57-3. The Department proposes new rules to implement the Statewide Immunization Registry Act (Act) at N.J.S.A. 26:4-131 et seq. (P.L. 2004, c. 138). The Act requires the Department to establish the framework necessary to operate and maintain the NJIIS in order to ensure that registrants obtain immunizations in a timely manner, notify registrants of overdue or upcoming immunizations, control communicable diseases, conduct surveillance of vaccine preventable outbreaks and, among other objectives, to ensure an effective response to a bio-terrorism event utilizing a potentially vaccine preventable disease. The Act requires automatic enrollment in the NJIIS of every newborn infant in New Jersey, who is born on or after January 1, 1998, immediately following birth unless the parent or legal guardian of the infant declines participation. Parents or legal guardians may voluntarily enroll a child born prior to January 1, 1998 in the NJIIS.

The proposed new rules at N.J.A.C. 8:57-3 would implement the Act by establishing the administrative structure necessary to operate the NJIIS. In particular, N.J.A.C. 8:57-3 would establish confidentiality requirements for the information contained in the NJIIS; the requirements for administration of the NJIIS; and the process for authorized user enrollment, training, access to NJIIS information and withdrawal. The proposed new rules would establish requirements for informing parents about the NJIIS; enrolling registrants; providing registrants with access to their information, the ability to request an amendment of their record, and a process for withdrawal. N.J.A.C. 8:57-3 would establish mandatory participation for health care providers administering vaccines to children less than seven years of age by January 1, 2011 and the information required for reporting to the NJIIS. The proposed new rules would also establish penalties for violation of the rules.

The Department will convene a public hearing on the proposed new rules between 10:00 A.M. and 11:00 A.M., or until completion of testimony from persons on the list of speakers, whichever is later, on Friday, November 14, 2008 at the New Jersey Department of Health and Senior Services, First Floor Auditorium, Health and Agriculture Building, 369 South Warren Street (at Market Street), Trenton, NJ 08608. Persons wishing to comment on the proposal at the public hearing who wish to be placed on the list of speakers are requested to telephone Ms. Chari Otero at 609-588-7512 by November 7, 2008 and to bring an extra written copy of their remarks for submission to the public record.

The public has until December 19, 2008 to comment on the notice of proposal. Persons wishing to comment on the proposal must submit their comments in writing through regular mail to Ruth Charbonneau, Director, Office of Legal and Regulatory Affairs, Office of the Commissioner, Department of Health and Senior Services, PO Box 360, Trenton, NJ 08625-0360. Written comments on the proposal must be postmarked on or before December 19, 2008, which is the close of the 60-day public comment period.

State of New Jersey Department of Health and Senior Services