§ 8.3 Application for approval as an Accreditation Body.

(a) Eligibility. Private nonprofit organizations, State or territorial governmental entities, or political subdivisions thereof, and Indian Tribes as defined by the Federally Recognized Indian Tribe List Act of 1994, that are capable of meeting the requirements of this part may apply for approval as an Accreditation Body. (b) Application for initial approval. Electronic copies of an Accreditation Body application form [SMA-163] shall be submitted to: https://dpt2.samhsa.gov/sma163/. (c) Application for renewal of approval. An Accreditation Body that intends to continue to serve as an Accreditation Body beyond its current term shall apply to the Secretary for renewal, or notify the Secretary of its intention not to apply for renewal, in accordance with the following procedures and schedule: (1) At least 9 months before the date of expiration of an Accreditation Body's term of approval, the Body shall inform the Secretary in writing of its intent to seek renewal. (2) The Secretary will notify the applicant of the relevant information, materials, and supporting documentation required under paragraph (b) of this section that the applicant shall submit as part of the renewal procedure. (3) At least 3 months before the date of expiration of the Accreditation Body's term of approval, the applicant shall send to the Secretary electronically a renewal application containing the information, materials, and supporting documentation requested by the Secretary under paragraph (c)(2) of this section. (4) An Accreditation Body that does not intend to renew its approval shall so notify the Secretary at least 9 months before the expiration of the Body's term of approval. (d) Rulings on applications for initial approval or renewal of approval. (1) The Secretary will grant an application for initial approval or an application for renewal of approval if it determines the applicant substantially meets the Accreditation Body requirements of this subpart. (2) If the Secretary determines that the applicant does not substantially meet the requirements set forth in this subpart, the Secretary will notify the applicant of the deficiencies in the application and request that the applicant resolve such deficiencies within 90 days of receipt of the notice. If the deficiencies are resolved to the satisfaction of the Secretary within the 90-day time period, the Body will be approved as an Accreditation Body. If the deficiencies have not been resolved to the satisfaction of the Secretary within the 90-day time period, the application for approval as an Accreditation Body will be denied. (3) If the Secretary does not reach a final decision on a renewal application before the expiration of an Accreditation Body's term of approval, the approval will be deemed extended until the Secretary reaches a final decision, unless an Accreditation Body does not rectify deficiencies in the application within the specified time period, as required in paragraph (d)(2) of this section. (e) Relinquishment of approval. An Accreditation Body that intends to relinquish its accreditation approval before expiration of the Body's term of approval shall submit a letter of such intent to the Secretary, at the address in paragraph (b) of this section, at least 9 months before relinquishing such approval. (f) Notification. An Accreditation Body that does not apply for renewal of approval, or is denied such approval by the Secretary, relinquishes its accreditation approval before expiration of its term of approval, or has its approval withdrawn, shall: (1) Transfer copies of records and other related information as required by the Secretary to a location, including another Accreditation Body, and according to a schedule approved by the Secretary; and (2) Notify, in a manner and time period approved by the Secretary, all OTPs accredited or seeking accreditation by the Body that the Body will no longer have approval to provide accreditation services. (g) Term of approval. An Accreditation Body's term of approval is for a period not to exceed 5 years. (h) State, territorial, or Indian Tribe Accreditation Bodies. State, territorial, and Indian Tribe entities, including political subdivisions thereof, may establish organizational units that may act as Accreditation Bodies, provided such units meet the requirements of this section, are approved by the Secretary under this section, and have taken appropriate measures to prevent actual or apparent conflicts of interest, including cases in which State or Federal funds are used to support MOUD.