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Full Text of this Amendment

SA 282. Ms. COLLINS submitted an amendment intended to be proposed by her to the bill S. 493, to reauthorize and improve the SBIR and STTR programs, and for other purposes; which was ordered to lie on the table; as follows:

At the end, add the following:
(a) Definitions.--In this section--
(1) the term "Administrator" means the Administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget;
(2) the term "agency" has the same meaning as in section 3502(1) of title 44, United States Code;
(3) the term "economically significant guidance document" means a significant guidance document that may reasonably be anticipated to lead to an annual effect on the economy of $ 100,000,000 or more or adversely affect in a material way the economy or a sector of the economy, except that economically significant guidance documents do not include guidance documents on Federal expenditures and receipts;
(4) the term "disseminated"--
(A) means prepared by an agency and distributed to the public or regulated entities; and
(B) does not include--
(i) distribution limited to Federal Government employees;
(ii) intra- or interagency use or sharing of Federal Government information; and
(iii) responses to requests for agency records under section 552 of title 5, United States Code (commonly referred to as the "Freedom of Information Act"), section 552a of title 5, United States Code, (commonly referred to as the "Privacy Act"), the Federal Advisory Committee Act (5 U.S.C. App.), or other similar laws;
(5) the term "guidance document" means an agency statement of general applicability and future effect, other than a regulatory action, that sets forth a policy on a statutory, regulatory or technical issue or an interpretation of a statutory or regulatory issue;
(6) the term "regulation" means an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency;
(7) the term "regulatory action" means any substantive action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking; and
(8) the term "significant guidance document"--
(A) means a guidance document disseminated to regulated entities or the general public that may reasonably be anticipated to--
(i) lead to an annual effect on the economy of $ 100,000,000 or more or affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;
(ii) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(iii) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(iv) raise novel legal or policy issues arising out of legal mandates and the priorities, principles, and provisions of this section; and
(B) does not include--
(i) legal advisory opinions for internal Executive Branch use and not for release (such as Department of Justice Office of Legal Counsel opinions);
(ii) briefs and other positions taken by agencies in investigations, pre-litigation, litigation, or other enforcement proceedings;
(iii) speeches;
(iv) editorials;
(v) media interviews;
(vi) press materials;
(vii) congressional correspondence;
(viii) guidance documents that pertain to a military or foreign affairs function of the United States (other than guidance on procurement or the import or export of non-defense articles and services);
(ix) grant solicitations;
(x) warning letters;
(xi) case or investigatory letters responding to complaints involving fact-specific determinations;
(xii) purely internal agency policies;
(xiii) guidance documents that pertain to the use, operation or control of a government facility;
(xiv) internal guidance documents directed solely to other agencies; and
(xv) any other category of significant guidance documents exempted by an agency head in consultation with the Administrator.
(b) Agency Good Guidance Practices.--
(i) IN GENERAL.--Each agency shall develop or have written procedures for the approval of significant guidance documents, which shall ensure that the issuance of significant guidance documents is approved by appropriate senior agency officials.
(ii) REQUIREMENT.--Employees of an agency may not depart from significant guidance documents without appropriate justification and supervisory concurrence.
(B) STANDARD ELEMENTS.--Each significant guidance document--
(i) shall--
(I) include the term "guidance" or its functional equivalent;
(II) identify the agency or office issuing the document;
(III) identify the activity to which and the persons to whom the significant guidance document applies;
(IV) include the date of issuance;
(V) note if the significant guidance document is a revision to a previously issued guidance document and, if so, identify the document that the significant guidance document replaces;
(VI) provide the title of the document and a document identification number; and
(VII) include the citation to the statutory provision or regulation (in Code of Federal Regulations format) which the significant guidance document applies to or interprets; and
(ii) shall not include mandatory terms such as "shall", "must", "required", or "requirement" unless--
(I) the agency is using those terms to describe a statutory or regulatory requirement; or
(II) the terminology is addressed to agency staff and will not foreclose agency consideration of positions advanced by affected private parties.
(i) IN GENERAL.--Each agency shall--
(I) maintain on the website for the agency, or as a link on the website of the agency to the electronic list posted on a website of a component of the agency a list of the significant guidance documents in effect of the agency, including a link to the text of each significant guidance document that is in effect; and
(II) not later than 30 days after the date on which a significant guidance document is issued, update the list described in clause (i).
(ii) LIST REQUIREMENTS.--The list described in subparagraph (A)(i) shall--
(I) include the name of each--
(aa) significant guidance document;
(bb) document identification number; and
(cc) issuance and revision dates; and
(II) identify significant guidance documents that have been added, revised, or withdrawn in the preceding year.
(i) IN GENERAL.--Each agency shall establish and clearly advertise on the website for the agency a means for the public to electronically submit--
(I) comments on significant guidance documents; and
(II) a request for issuance, reconsideration, modification, or rescission of significant guidance documents.
(ii) AGENCY RESPONSE.--Any comments or requests submitted under subparagraph (A)--
(I) are for the benefit of the agency; and
(II) shall not require a formal response from the agency.
(I) IN GENERAL.--Each agency shall designate an office to receive and address complaints from the public relating to--
(aa) the failure of the agency to follow the procedures described in this section; or
(bb) the improper treatment of a significant guidance document as a binding requirement.
(II) WEBSITE.--The agency shall provide, on the website of the agency, the name and contact information for the office designated under clause (i).
(A) IN GENERAL.--Except as provided in paragraph (2), in preparing a draft of an economically significant guidance document, and before issuance of the final significant guidance document, each agency shall--
(i) publish a notice in the Federal Register announcing that the draft document is available;
(ii) post the draft document on the Internet and make a tangible copy of that document publicly available (or notify the public how the public can review the guidance document if the document is not in a format that permits such electronic posting with reasonable efforts);
(iii) invite public comment on the draft document; and
(iv) prepare and post on the website of the agency a document with responses of the agency to public comments.
(B) EXCEPTIONS.--In consultation with the Administrator, an agency head may identify a particular economically significant guidance document or category of such documents for which the procedures of this subsection are not feasible or appropriate.
(A) IN GENERAL.--In emergency situations or when an agency is obligated by law to act more quickly than normal review procedures allow, the agency shall notify the Administrator as soon as possible and, to the extent practicable, comply with this subsection.
(B) SIGNIFICANT GUIDANCE DOCUMENTS SUBJECT TO STATUTORY OR COURT-IMPOSED DEADLINE.--For a significant guidance document that is governed by a statutory or court-imposed deadline, the agency shall, to the extent practicable, schedule the proceedings of the agency to permit sufficient time to comply with this subsection.
(5) EFFECTIVE DATE.--This section shall take effect 60 days after the date of enactment of this Act.
(As printed in the Congressional Record for the Senate on Mar 31, 2011.)