DHMH PROCEDURE:  02.10.01.P1

Cross-Reference: Operations-Regulations

TITLE: PROCEDURE FOR THE ADOPTION OF OR AMENDMENT TO REGULATIONS AFFECTING THE PUBLIC

SHORT TITLE: PROCEDURE FOR REGULATIONS

 

ACTOR

ACTION REQUIRED

 
Proposing Unit 1. With its Deputy Secretary's approval, NOTIFIES Regulations Coordinator and, when appropriate, Deputy Secretaries and Program Directors of intent to amend, propose or repeal regulations through the Notice of Regulations Development Form (DHMH 2098).

 
Regulations Coordinator 2. SPECIFIES required style of language, format and codification system to the Proposing Unit in accordance with guidelines of the administrator of the Division of State Documents. Also REQUESTS the involvement of the appropriate Assistant Attorney General, if necessary, as well as involvement of interested members of the public and/or industry, and REMINDS the Proposing Unit that the draft regulations should be sent to the appropriate advisory council or board.

3. SETS target date for first draft. If date passes with no first draft, ESTABLISHES new target date. ISSUES a memorandum if second target date is missed to learn reason for delay, with copies to the appropriate Deputy Secretary and appropriate Program Director.

 
Proposing Unit 4. PREPARES the following regulations package:

a. Regulation Background Information Form (DHMH 2099) completely filled out;

b. Notice of Proposed Action statement;

c. Statement of Purpose paragraphs;

d. Comparison to Federal Standards paragraphs;

e. Economic Impact Statements (Parts, A, B & C);

f. Opportunity for Public Comment statement; and,

g. Proposed regulations.

 
5. OBTAINS approval of the regulations package by obtaining the following signatures on a Regulations Signature Sheet (DHMH 2105):

a. Drafter of regulations;

b. Drafter's supervisor or head of unit;

c. Director of Unit, if not same as (b) above; and,

d. Deputy Secretary for Proposed Unit.

 
6. FORWARDS original Signature Sheet and the original regulations package to the Regulations Coordinator.

 
Regulations Coordinator 7. APPROVES draft regulations for style and format. If changes are necessary, RETURNS draft to Proposing Unit for corrections. REQUESTS the appropriate number of copies of the approved and/or corrected proposed regulations package be forwarded to Regulations Coordinator.

 
Proposing Unit 8. MAKES changes recommended by Regulations Coordinator, if any, and SUBMITS requested number of copies to the Regulations Coordinator.

 
Regulations Coordinator 9. SENDS copy of proposed regulations package to all personnel on the Regulation Coordinator's intra-departmental mailing list; including but not limited to, the Office of Planning and Capital Financing, Office of Governmental Affairs, Assistant Attorney General's Office, and the Governor's Office, and REQUESTS comments. Comments on the proposed regulations are due to Regulations Coordinator in the time frame specified in the covering memo.

 
Proposing Unit 10. RESPONDS to comments. In coordination with person commenting and the appropriate Assistant Attorney General, MAKES changes which were accepted. If changes were substantive, RETURNS to Step #4, otherwise proceeds to Step #11.

 
Regulations Coordinator 11. SENDS proposed regulations and Regulation Signature Sheet (DHMH 2105) to the Director, Office of Planning and Capital Financing for approval as to fiscal impact.

 
Director, Budget 12. DETERMINES if fiscal impact of proposed Management Office regulation would result in expenditures in excess of the State budget and therefore require special approval as outlined in State Finance and Procurement Article, §7-235(b). INFORMS Regulations Coordinator. If fiscal impact does not result in expenditures in excess of the State budget, APPROVES and RETURNS signed signature sheet to the Regulations Coordinator.

 
Regulations Coordinator 13. If proposed regulations will increase expenditures beyond budgetary limitations, NOTIFIES the appropriate Deputy Secretary and Proposing Unit.

 
Appropriate Deputy 14. INFORMS Regulations Coordinator and Proposing Secretary Unit whether or not to abandon proposed regulations pending resolution of the problem of expenditures beyond budgetary limitations.

 
Regulations Coordinator 15. If Proposing Unit is permitted to proceed, SENDS proposed regulations to the Assistant Attorney General that has been assigned the primary responsibility of advising the Proposing Unit.

 
Assistant Attorney General 16. In consultation with the Proposing Unit, MODIFIES proposed regulations to meet legal requirements (Return to #4) or APPROVES for legal sufficiency and RETURNS signed proposed regulations to Regulations Coordinator.

 
Regulations Coordinator 17. SENDS proposed regulations package (See #4) to the Secretary's Office for approval.

 
Secretary of Health 18. REVIEWS proposed regulations. MAY REQUEST a public hearing be scheduled in conjunction with the mandatory 30-day public comment period.

a. If disapproves proposed regulations, RETURNS regulation package and INDICATES changes that need to be made by the Proposing Unit. (Return to #4)

b. If approves proposed regulations, RETURNS signed proposed regulations to the Regulations Coordinator.

 
Regulations Coordinator 19. If Secretary approves proposed regulations, but deems a public hearing is necessary, ADVISES the Proposing Unit that they need to conduct a public hearing. SETS the hearing date in conjunction with Proposing Unit and MODIFIES Opportunity for Public Comment statement to reflect hearing date.

20. If Secretary approves proposed regulations, but deems a public hearing is not necessary, DETERMINES the expiration date of the mandatory 30-day comment period.

21. If regulations do not have corresponding federal standards PROCEEDS to #25.

22. If regulations do have corresponding federal standards, SUBMITS proposal to the Department of Business and Economic Development (DBED).

 
DBED SENDS approval letter to Regulations Coordinator or FORWARDS the regulations to the Governor's office if DBED's review determines regulations are more stringent or restrictive then the federal standard.

 
Governor's Office 24. If necessary, APPROVES or DISAPPROVES the Department's proposal in writing.

 
Regulations Coordinator 25. Pursuant to State Government Article, §10-110, SUBMITS regulations to the Joint Committee on Administrative, Executive, and Legislative Review (AELR) for pre-review of regulations at least 16 days before the regulations are filed with the Administrator of the Division of State Documents for publication in the Maryland Register.

26. At least 16 days after AELR Committee receives the regulations package, FILES copies with the Administrator of the Division of State Documents. When proposed regulations are published in the Maryland Register, DISTRIBUTES copies to appropriate parties.

 
Proposing Unit 27. If a hearing was determined to be necessary, CONDUCTS a public hearing. EXPLAINS proposal in specific terms, RECEIVES oral and written comments and MAY MAKE an announcement that written comments will be accepted until a specific date.

28. If comments are received by the Regulations Coordinator or the Unit during the comment period or as a result of a public hearing, RESPONDS in writing to all comments received within the prescribed comment period. At the end of the comment period, SUMMARIZES comments in a memo to the Regulations Coordinator. RECOMMENDS specific language changes to the proposal or RECOMMENDS proposal be adopted as printed. VERIFIES approval of the recommendation by obtaining the signatures outlined in #5. FORWARDS original Signature Sheet and recommendation to the Regulations Coordinator.

If a public hearing was held, also FORWARDS a transcript of the hearing, all comments submitted at the hearing and the attendance sheet to the Regulations Coordinator. (Proceed to Step 31) or

 
Regulations Coordinator 29. If no comments were received during the comment period, PREPARES Notice of Final Action indicating proposal will be adopted as printed. REQUESTS Proposing Unit verify approval of the Notice of Final Action by obtaining the signatures outlined in #5.

 
Proposing Unit 30. If no comments were received, OBTAINS signatures as requested in #5, and RETURNS Notice of Final Action to Regulations Coordinator.

 
Regulations Coordinator 31. FORWARDS the final regulation package to the appropriate Assistant Attorney General to review as to legality. This package includes:

a. Completed Regulations Signature Sheet;

b. Proposing Unit's recommendation or a memo from Regulations Coordinator's office advising that no comments were received;

c. Any comments that were received and the Proposing Unit's responses;

d. Form memo "Re: Assistant Attorney General's Review and Response to Comments Regarding COMAR 10. . ," if applicable;

e. Final Transmittal Sheets, if applicable;

f. Notice of Final Action, if applicable; and,

g. Copy of the proposed regulations.

 
Assistant Attorney General 32. If comments were received, REVIEWS any changes recommended by Proposing Unit. COMPLETES the AG's Review and Response to Comments form memo. DETERMINES that the proposed regulations:

a. Do not need to be amended, SIGNS the Final Transmittal Sheet and ADVISES the Regulation Coordinator to continue the process. (Proceed to #34.)

b. Do need to be amended and the changes are substantive in nature, which requires republication, and ADVISES Proposing Unit to begin the Reproposal process through the Regulations Coordinator immediately. (Return to #4.)

c. Do need to be amended and the changes are substantive in nature, but after consultation with the Proposing Unit, AGREES that it is in the best interest of the Department to adopt the regulations as proposed, SIGNS the Final Transmittal Sheet, but ADVISES the Proposing Unit to submit the recommended amendments to the Regulations Coordinator as a new proposal immediately. (Proceed to #13 and Proposing Unit starts a new proposed regulation that will amend original regulation. See Step 1.)

d. Do need to be amended, but DETERMINES the changes are not substantive. ADVISES the Proposing Unit to incorporate the changes into the Notice of Final Action in accordance with State Government Article, §10-113, and CERTIFIES that the changes are not substantive, describing the nature of each change and the basis for the conclusion. REQUESTS the Proposing Unit to submit the amended Notice of Final Action to the Regulations Coordinator as soon as possible. Regulations Coordinator has amended Notice of Final Action signed by the Assistant Attorney General. (Proceed to #34.)

33. If no comments were received, if the AAG agrees with the Proposing Unit's recommendation that no changes need to be made, or if the Notice of Final Action includes non-substantive changes which the AAG has previously reviewed, APPROVES for legal sufficiency and RETURNS signed Final Transmittal Sheets approved and Notice of Final Action to Regulations Coordinator.

 
Regulations Coordinator 34. SENDS final regulation package (See #31) with the Regulation Signature Sheet (DHMH 2105) to the Secretary of Health and Mental Hygiene.

 
Secretary of Health 35. ACCEPTS, REJECTS, or MODIFIES regulation and FORWARDS decision and regulations to Regulations Coordinator.

 
Regulations Coordinator 36.  If regulations are rejected or modified, ADVISES Proposing Unit, appropriate AAG, and the appropriate Deputy Secretary, of Secretary's decision.

37. If regulations were accepted, FILES Final Transmittal Sheets and Notice of Final Action with the Administrator of the Division of State Documents per State Government Article, §§7-201 -- 7-222. When Notice of Final Action is published, DISTRIBUTES copies to appropriate parties.


APPROVED:  Georges C. Benjamin, M.D.

Secretary

Signature on File     Effective Date:  March 24, 2000