; and (ii) not later than 1 year after the close of the comment period for the draft guidance, issue final guidance. (B) Response to request The Secretary shall respond to a request for accreditation or reaccreditation within 60 calendar days of the receipt of the request. The Secretary’s response may be to accredit or reaccredit the person, to deny accreditation, or to request additional information in support of the request. If the Secretary requests additional information, the Secretary shall respond within 60 calendar days of receipt of such additional information to accredit or deny the accreditation. (C) Type of accreditation The accreditation or reaccreditation of a person shall specify the particular activity or activities under subsection (a) for which such person is accredited, and shall include any limitation to certain eligible in vitro clinical tests. (D) Audit The Secretary may audit the performance of persons accredited under this section for purposes of ensuring that such persons continue to meet the published criteria for accreditation, and may modify the scope or particular activities for which a person is accredited if the Secretary determines that such person fails to meet one or more criteria for accreditation. (E) Suspension or withdrawal The Secretary may suspend or withdraw accreditation of any person accredited under this section, after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the requirements of this section or the published criteria for accreditation, or poses a threat to public health, or fails to act in a manner that is consistent with the purposes of this section. (F) Reaccreditation Accredited persons may be initially accredited for up to 4 years. After expiration of such initial period, persons may be reaccredited for unlimited additional 4-year periods, as determined by the Secretary. (c) Qualifications of accredited Persons (1) Eligibility An accredited person, at a minimum, shall— (A) not be an employee