50 N.J.R. 1932(a)
VOLUME 50, ISSUE 17, SEPTEMBER 4, 2018
50 N.J.R. 1932(a)
NJ - New Jersey Register >
SEPTEMBER 4, 2018 >
RULE PROPOSALS >
LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS
Interested Persons Statement
Interested persons may submit comments, information or arguments concerning any of the rule proposals in this issue until the date indicated in the proposal. Submissions and any inquiries about submissions should be addressed to the agency officer specified for a particular proposal.
The required minimum period for comment concerning a proposal is 30 days. A proposing agency may extend the 30-day comment period to accommodate public hearings or to elicit greater public response to a proposed new rule or amendment. Most notices of proposal include a 60-day comment period, in order to qualify the notice for an exception to the rulemaking calendar requirements of N.J.S.A. 52:14B-3. An extended comment deadline will be noted in the heading of a proposal or appear in a subsequent notice in the Register.
At the close of the period for comments, the proposing agency may thereafter adopt a proposal, without change, or with changes not in violation of the rulemaking procedures at N.J.A.C. 1:30-6.3. The adoption becomes effective upon publication in the Register of a notice of adoption, unless otherwise indicated in the adoption notice. Promulgation in the New Jersey Register establishes a new or amended rule as an official part of the New Jersey Administrative Code.
LAW AND PUBLIC SAFETY > DIVISION OF CONSUMER AFFAIRS
Administrative Code Citation
Proposed Amendment: N.J.A.C. 13:45H-1.1
Controlled Dangerous Substances
Authorized By: Division of Consumer Affairs, Sharon M. Joyce, Acting Director.
Authority: N.J.S.A. 24:21-9.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Submit written comments by
November 3, 2018, to:
Sharon M. Joyce, Acting Director
Division of Consumer Affairs
124 Halsey Street
PO Box 45027
Newark, New Jersey 07101
or electronically at:
The agency proposal follows:
The Director of the Division of Consumer Affairs (Division) is authorized by N.J.S.A. 24:21-9 to promulgate rules relating to the registration and control of the manufacture, distribution, and dispensing (including prescribing) of controlled dangerous substances (CDS). Such authority was transferred from the Commissioner of Health to the Director pursuant to P.L. 2007, c. 244 (Act), the same legislation that created the Prescription Monitoring Program (PMP).
The Division proposes to amend N.J.A.C. 13:45H-1.1 to increase CDS registration fees. CDS registration fees were established by the Commissioner of Health when CDS registration and control was vested in the Commissioner and have not been increased since before 1997.
CDS registration fees support the Division's Drug Control Unit, which is responsible for the administration and enforcement of the Controlled Dangerous Substances Act (N.J.S.A. 24:21-1 et seq.). Administration of the Act includes registration of manufacturers, distributors, and dispensers of CDS; handling requests for and supervising the destruction and disposal of CDS; and management of the New Jersey Prescription Blank Program (NJPB). Enforcement of CDS laws include investigation into lost or stolen CDS and NJPBs, possible diversion of CDS by professional board licensees, and indiscriminate prescribing or dispensing of CDS.
In light of the epidemic of prescription drug abuse, the Drug Control Unit augmented its staff to intensify its enforcement responsibilities. The PMP is an extremely important tool for the Drug Control Unit, as was anticipated during passage of the Act. The Unit has taken a more active role in drug diversion cases, aiding investigations and prosecution of licensees with information from the PMP. In addition, the PMP is an [page=1932] important tool for prescribers to make informed decisions concerning patient treatment.
The Drug Control Unit expects an increase in expenses for necessary technological system upgrades and expansion to increase the PMP's ability to process search requests by prescribers, professional licensing boards, and law enforcement. Increased capacity of the PMP is also necessary to continue the State's ability to be interoperable with other states, including neighboring states.
As contemplated in the Fiscal Estimate prepared in connection with the bill that established the PMP, investigation and initial implementation of the PMP was funded by grants. It was anticipated that funding for future years would be dependent on fees set by the Director of the Division to offset monitoring services, as well as fines and penalties collected for noncompliance. Sustaining the program can no longer be funded with grant money. Current fees are not sufficient to fund the administrative and enforcement activities of the Drug Control Unit and the PMP. The proposed increase in CDS registration fees is largely to fund PMP operations.
The Acting Director has determined that the comment period for this notice of proposal shall be 60 days. Therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this notice is excepted from the rulemaking calendar requirement.
The abuse of prescription drugs has reached epidemic proportions in New Jersey. The increasing demand for CDS prescription drugs for non-medical use makes the work of the Division's Drug Control Unit extremely important to the health, welfare, and safety of the public. The PMP enables prescribers to make informed treatment decisions by identifying concerning patterns of "prescriber shopping" and "pharmacy shopping," which is indicative of drug diversion and abuse. The public will benefit from the proposed fee increases that will provide funding for the Division's Drug Control Unit, including the PMP.
The proposed increase in CDS registration fees will have an economic impact on the 51,294 CDS registrants. The Acting Director has determined that the proposed fee increases are essential to raise the revenue necessary to continue the activities of the Drug Control Unit and PMP. The CDS registration fees have not been increased in at least 20 years. Although the amount of the increase is large, the respective fees are small; the Division believes that the impact on registrants will be minimal as will the impact on the public.
Federal Standards Statement
A Federal standards analysis is not required because the proposed amendments are not subject to any Federal standards or requirements.
The Division does not anticipate that the proposed amendments will increase or decrease jobs in the State.
Agriculture Industry Impact
The proposed amendments will have no impact on the agriculture industry in the State.
Regulatory Flexibility Analysis
If, for the purposes of the Act, the approximately 69 manufacturers, 65 distributors, 36 animal shelters, and 51,294 CDS registrants are considered "small businesses," then the following analysis applies.
The costs imposed by the proposed amendments are the same for all registrants in a category. The Board does not believe that CDS registrants will need to employ any professional services to comply with the requirements of the proposed amendments. The proposed amendments impose no reporting or recordkeeping requirements, but impose compliance requirements upon CDS registrants who will be required to pay the increased fee.
The proposed fee increase is set at a level sufficient to meet the ongoing costs associated with the activities of the Drug Control Unit. Therefore, no differing compliance requirements are provided for any registrant based on size.
Housing Affordability Impact Analysis
The proposed amendments will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the proposed amendments would evoke a change in the average costs associated with housing because the proposed amendments concern fee increases for CDS registrations.
Smart Growth Development Impact Analysis
The proposed amendments will have an insignificant impact on smart growth and there is an extreme unlikelihood that the proposed amendments would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed amendments concern fee increases for CDS registrations.
Racial and Ethnic Community Criminal Justice and Public Safety Impact
The Division has evaluated this rulemaking and determined that it will not have an impact on pretrial detention, sentencing, probation, or parole policies concerning adults and juveniles in the State. Accordingly, no further analysis is required.
Full text of the proposal follows (additions indicated in boldface
thus; deletions indicated in brackets [thus]):
SUBCHAPTER 1. GENERAL PROVISIONS; REGISTRATION
13:45H-1.1 Registration fees
(a) Manufacturers of controlled dangerous substances shall pay an annual fee of [$ 200.00] $ 400.00 at the time of application for registration or for renewal of registration.
(b) Distributors and reverse distributors of controlled dangerous substances shall pay an annual fee of [$ 100.00]
$ 200.00 at the time of application for registration or for renewal of registration.
(c) Dispensers of controlled dangerous substances or practitioners registered to conduct research with controlled dangerous substances shall pay an annual fee of [$ 20.00]
$ 40.00 at the time of application for registration or for renewal of registration.
(d) Incorporated humane societies or licensed animal control facilities registered to purchase and administer sodium pentobarbital for the purpose of animal euthanasia shall pay an annual fee of [$ 20.00]
$ 40.00 for registration or renewal of registration as a Dispenser in the category of hospital/clinic.
(e)-(g) (No change.)
In order to ensure your comments are received, please send your comments concerning any rule proposals via email to DCAProposal@dca.lps.state.nj.us.
Please include the following in your email:
Email Subject Line: Rule Proposal Subject
Email Body: Comments to the Rule Proposal, Name, Affiliation and Contact Information (email address and telephone number)