Page:United States Statutes at Large Volume 124.djvu/834

 124 STAT. 808 PUBLIC LAW 111–148—MAR. 23, 2010 in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device, or strength; or ‘‘(II) a modification to the structure of the biological product that does not result in a change in safety, purity, or potency. ‘‘(8) GUIDANCE DOCUMENTS.— ‘‘(A) IN GENERAL.—The Secretary may, after oppor- tunity for public comment, issue guidance in accordance, except as provided in subparagraph (B)(i), with section 701(h) of the Federal Food, Drug, and Cosmetic Act with respect to the licensure of a biological product under this subsection. Any such guidance may be general or specific. ‘‘(B) PUBLIC COMMENT.— ‘‘(i) IN GENERAL.—The Secretary shall provide the public an opportunity to comment on any proposed guidance issued under subparagraph (A) before issuing final guidance. ‘‘(ii) INPUT REGARDING MOST VALUABLE GUID- ANCE.—The Secretary shall establish a process through which the public may provide the Secretary with input regarding priorities for issuing guidance. ‘‘(C) NO REQUIREMENT FOR APPLICATION CONSIDER- ATION.—The issuance (or non-issuance) of guidance under subparagraph (A) shall not preclude the review of, or action on, an application submitted under this subsection. ‘‘(D) REQUIREMENT FOR PRODUCT CLASS-SPECIFIC GUID- ANCE.—If the Secretary issues product class-specific guid- ance under subparagraph (A), such guidance shall include a description of— ‘‘(i) the criteria that the Secretary will use to deter- mine whether a biological product is highly similar to a reference product in such product class; and ‘‘(ii) the criteria, if available, that the Secretary will use to determine whether a biological product meets the standards described in paragraph (4). ‘‘(E) CERTAIN PRODUCT CLASSES.— ‘‘(i) GUIDANCE.—The Secretary may indicate in a guidance document that the science and experience, as of the date of such guidance, with respect to a product or product class (not including any recom- binant protein) does not allow approval of an applica- tion for a license as provided under this subsection for such product or product class. ‘‘(ii) MODIFICATION OR REVERSAL.—The Secretary may issue a subsequent guidance document under subparagraph (A) to modify or reverse a guidance docu- ment under clause (i). ‘‘(iii) NO EFFECT ON ABILITY TO DENY LICENSE.— Clause (i) shall not be construed to require the Sec- retary to approve a product with respect to which the Secretary has not indicated in a guidance document that the science and experience, as described in clause (i), does not allow approval of such an application. ‘‘(l) PATENTS.— ‘‘(1) CONFIDENTIAL ACCESS TO SUBSECTION (k) APPLICA- TION.— Criteria.