A bill to amend the Federal Food, Drug, and Cosmetic Act to establish a nanotechnology regulatory science program.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Nanotechnology Regulatory Science 
Act of 2011''.

SEC. 2. NANOTECHNOLOGY PROGRAM.

    Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.) is amended by adding at the end the following:

``SEC. 1013. NANOTECHNOLOGY REGULATORY SCIENCE PROGRAM.

    ``(a) In General.--Not later than 180 days after the date of 
enactment of the Nanotechnology Regulatory Science Act of 2011, the 
Secretary, in consultation with the Secretary of Agriculture, shall 
establish within the Food and Drug Administration a program for the 
scientific investigation of nanomaterials included or intended for 
inclusion in products regulated under this Act, to address the 
potential toxicology of such materials, the effects of such materials 
on biological systems, and interaction of such materials with 
biological systems.
    ``(b) Program Purposes.--The purposes of the program established 
under subsection (a) shall be to--
            ``(1) assess scientific literature and data on general 
        nanomaterials interactions with biological systems and on 
        specific nanomaterials of concern to Food and Drug 
        Administration;
            ``(2) in cooperation with other Federal agencies, develop 
        and organize information using databases and models that will 
        facilitate the identification of generalized principles and 
        characteristics regarding the behavior of classes of 
        nanomaterials with biological systems;
            ``(3) promote intramural Food and Drug Administration 
        programs and participate in collaborative efforts, to further 
        the understanding of the science of novel properties at the 
        nanoscale that might contribute to toxicity;
            ``(4) promote and participate in collaborative efforts to 
        further the understanding of measurement and detection methods 
        for nanomaterials;
            ``(5) collect, synthesize, interpret, and disseminate 
        scientific information and data related to the interactions of 
        nanomaterials with biological systems;
            ``(6) build scientific expertise on nanomaterials within 
        such Administration, including field and laboratory expertise, 
        for monitoring the production and presence of nanomaterials in 
        domestic and imported products regulated under this Act;
            ``(7) ensure ongoing training, as well as dissemination of 
        new information within the centers of such Administration, and 
        more broadly across such Administration, to ensure timely, 
        informed consideration of the most current science;
            ``(8) encourage such Administration to participate in 
        international and national consensus standards activities; and
            ``(9) carry out other activities that the Secretary 
        determines are necessary and consistent with the purposes 
        described in paragraphs (1) through (8).
    ``(c) Program Administration.--
            ``(1) Program manager.--In carrying out the program under 
        this section, the Secretary, acting through the Commissioner of 
        Food and Drugs, shall designate a program manager who shall 
        supervise the planning, management, and coordination of the 
        program.
            ``(2) Duties.--The program manager shall--
                    ``(A) develop a detailed strategic plan for 
                achieving specific short- and long-term technical goals 
                for the program;
                    ``(B) coordinate and integrate the strategic plan 
                with activities by the Food and Drug Administration and 
                other departments and agencies participating in the 
                National Nanotechnology Initiative; and
                    ``(C) develop intramural Food and Drug 
                Administration programs, contracts, memoranda of 
                agreement, joint funding agreements, and other 
                cooperative arrangements necessary for meeting the 
                long-term challenges and achieving the specific 
                technical goals of the program.
    ``(d) Reports.--Not later than March 15, 2014, the Secretary shall 
submit to Congress a report on the program carried out under this 
section. Such report shall include--
            ``(1) a review of the specific short- and long-term goals 
        of the program;
            ``(2) an assessment of current and proposed funding levels 
        for the program, including an assessment of the adequacy of 
        such funding levels to support program activities; and
            ``(3) a review of the coordination of activities under the 
        program with other departments and agencies participating in 
        the National Nanotechnology Initiative.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $15,000,000 for fiscal year 
2013, $16,000,000 for fiscal year 2014, and $17,000,000 for fiscal year 
2015. Amounts appropriated pursuant to this subsection shall remain 
available until expended.''.

Summary: Nanotechnology Regulatory Science Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Secretary of Health and Human Services (HHS) to establish within the Food and Drug Administration (FDA) a program for the scientific investigation of nanomaterials included or intended for inclusion in products regulated under the FFDCA to address: (1) the potential toxicology of such materials; (2) the effects of such materials on biological systems; and (3) the interaction of such materials with biological systems.