(a)    (1)    A Program may be established by a local health department or a community–based organization, subject to the provisions of this subtitle.

(2)    (i)    A county may cooperate with another county to establish a Program.

(ii)    A community–based organization may establish a multicounty Program.

(3)    This subtitle does not apply to the AIDS Prevention Sterile Needle and Syringe Exchange Pilot Program established under Subtitle 8 of this title.

(b)    (1)    (i)    A local health department or community–based organization shall apply to the Department and a local health officer for authorization to operate a Program.

(ii)    A local health department or community–based organization may apply at any time for authorization to operate a Program under subparagraph (i) of this paragraph.

(2)    The Department and a local health officer jointly shall issue an authorization determination based on the ability of a Program to meet the requirements of this subtitle.

(3)    The Department and a local health officer shall:

(i)    Approve or deny an application for authorization to operate a Program within 60 days after receiving a complete application; and

(ii)    Provide to the applicant a written explanation of the decision of the Department and local health officer.

(4)    (i)    A local health department or community–based organization may appeal an adverse decision by the Department and a local health officer to the Deputy Secretary for Public Health Services.

(ii)    The Deputy Secretary shall:

1.    Grant or deny an appeal within 60 days after receiving an appeal; and

2.    Provide a written explanation of the Deputy Secretary’s decision to the local health department or community–based organization.

(c)    If established under subsection (a) of this section, a Program shall:

(1)    Provide for substance use outreach, education, and linkage to treatment services to participants, including distribution and collection of hypodermic needles and syringes; and

(2)    Operate in accordance with:

(i)    The technical assistance of the Standing Advisory Committee; and

(ii)    The procedures, plans, and protocols approved by:

1.    The local health officer for each county in which a Program is established; and

2.    The Department.