TREASURY DIRECTIVE: 28-01

Date: July 17, 1989

Sunset Review: TBD

Expiration Date: TBD

SUBJECT: Preparation and Review of Regulations

1. PURPOSE. This Directive establishes procedures that govern the issuance of regulations and the preparation of regulatory analyses, programs and agendas.

2. BACKGROUND. The issuance of regulations, the review of existing regulations, and the publication of regulatory agendas and programs are governed by the Administrative Procedure Act, the Paperwork Reduction Act of 1980, the Regulatory Flexibility Act, the Tax Reform Act of 1986, Executive Order (E.O.) 12291, E.O. 12498, E.O. 12612, E.O. 12630, and 5 CFR Part 1320. The purpose of this Directive is to provide offices and bureaus with the information necessary to comply with these authorities and to obtain timely Departmental review of regulatory documents.

3. DEFINITIONS.

a. For purposes of this Directive, and except as provided in paragraph 3.b., the term regulation means:

(1) any advance notice of proposed rulemaking, notice of proposed rulemaking (proposed regulation), temporary (interim) regulation, final regulation or Treasury Decision published in the Federal Register;

(2) any other publicly-issued document of general applicability and future effect designed to implement, interpret, or prescribe law or policy, or describing the procedure or practice requirements of an office or bureau;

(3) any document that withdraws or substantively amends a previously issued regulation;

(4) any document published in the Notice section of the Federal Register that:

(a) requires or authorizes any action on the part of any person to participate in a program, avoid a penalty, or obtain a benefit;

(b) contains a reporting or recordkeeping requirement;

(c) establishes or revises policy;

(d) could limit the policymaking discretion of States; or

(e) could infringe upon a constitutionally protected property right; and

(5) any other document or category of documents to the extent determined by a bureau or office head, policy official, the General Counsel, or the Executive Secretary.

b. The term regulation does not include:

(1) documents making nonsubstantive technical corrections to a previously issued regulation;

(2) notices in the Internal Revenue Bulletin and amendments to the Internal Revenue Service Statement of Procedural Rules (26 CFR Part 601) that are not subject to the provisions of the Paperwork Reduction Act of 1980, the Regulatory Flexibility Act or E.O.s 12291, 12612 or 12630;

(3) revenue rulings, revenue procedures, decisions, legal determinations, or other similar rulings documents issued by the Internal Revenue Service, the United States Customs Service, or the Bureau of Alcohol, Tobacco and Firearms; and

(4) other documents specifically designated by the Executive Secretary in consultation with the General Counsel.

c. The term policy official means an official in the Departmental Offices at the level of a Deputy Assistant Secretary or above, and for purposes of paragraph 5.c., the Comptroller of the Currency.

d. The term LLR means the Associate General Counsel (Legislation, Litigation, and Regulation) in the Office of the General Counsel.

4. OPPORTUNITY FOR PUBLIC PARTICIPATION. Consistent with applicable law and the circumstances of a regulatory action, each bureau and office shall give the public an early and meaningful opportunity to participate in the regulatory process.

a. Special Requirements.

(1) Bureaus and offices should allow 60 days for public comment on proposed regulations that are major (see Part I), are likely to have a significant economic impact on a substantial number of small entities (see Part II), or contain a requirement for the collection of information (see Part III).

(2) For regulations to be issued without opportunity for notice and public comment, refer to Part VI.

b. Congressional Comments. Bureaus and offices shall promptly provide LLR with a copy of any written comment from a member of Congress or Senator that criticizes or opposes a proposed regulation. If a bureau or office prepares a substantive response to any such comment, a copy of the response also shall be provided to LLR.

5. DEPARTMENTAL REVIEW OF REGULATIONS.

a. Document Identification.

(1) The bureau or office originating any regulation subject to this Directive shall assign to such regulation a unique identifier not to exceed nine (9) characters (including spaces). The same identifier shall be assigned to all rulemaking stages of the regulation (e.g., a proposed regulation and subsequent final regulation must be assigned the same identifier).

(2) The identifier shall be displayed on the regulation and on all memoranda and related documents (e.g., transmittals to the Office of Management and Budget (OMB) and correspondence referenced in paragraph 4.b.) submitted to the Department with respect to such regulation. Inquiries concerning the status of review should be directed to LLR and reference the unique identifier.

b. Review Required. No bureau or office may publish or otherwise issue a regulation subject to this Directive until Departmental review has been completed.

c. Departmental Review Procedures.

(1) Regulations Issued by, or Subject to Review or Approval of, a Policy Official.

Regulations issued by, or subject to review or approval of, a policy of ficial shall be reviewed by appropriate counsel, signed by the policy official or bureau head, and transmitted to the Executive Secretary. Review shall be requested by a memorandum from the policy official (or from an office or bureau official through the policy official) to the Executive Secretary. The memorandum shall, at a minimum, fully, clearly, and succinctly:

(a) describe the regulation;

(b) explain the reason it is being issued;

(c) indicate whether any political or media interest has been expressed in the subject matter of the regulation; and

(d) list any correspondence received concerning the regulation.

Each transmittal shall include the materials and documentation described in Appendix A.

(2) Other Regulations. Regulations not issued by, or subject to review or approval of, a policy official shall be reviewed by appropriate counsel, signed by the appropriate office or bureau official, and transmitted to LLR.

d. Special Procedures.

(1) Paperwork Reduction Act. If a regulation is subject to review by OMB pursuant to the Paperwork Reduction Act (see Part III), the regulation and all required documentation shall be reviewed by the appropriate office or bureau reports management office. Five copies shall be transmitted to the Office of Information Resources Management in the Office of the Assistant Secretary of the Treasury (Management) for review and coordination with LLR.

(2) E.O. 12291. If a regulation is subject to review by OMB pursuant to E.O. 12291 (see Part I), the originating bureau or office shall provide five copies of the regulation and all required documentation directly to LLR.

6. AUTHORITIES.

a. "Administrative Procedure Act," 5 U.S.C. 553 (see 26 U.S.C. 7805(e) for special limitation on certain Internal Revenue Service and Bureau of Alcohol, Tobacco and Firearms regulations).

b. "Regulatory Flexibility Act," 5 U.S.C. 601 et seq. (see 26 U.S.C 7805(f) for special related requirement for certain Internal Revenue Service and Bureau of Alcohol, Tobacco and Firearms regulations).

c. "Paperwork Reduction Act of 1980," 44 U.S.C. 3501 et seq., as amended.

d. E.O. 12291, "Federal Regulation," dated February 17, 1981 (46 FR 13193).

e. E.O. 12498, "Regulatory Planning Process," dated January 4, 1985 (50 FR 1036).

f. E.O. 12612, "Federalism," dated October 26, 1987 (52 FR 41685).

g. E.O. 12630, "Governmental Actions and Interference with Constitutionally Protected Property Rights," dated March 15, 1988 (53 FR 8859).

h. 5 CFR 1320, "Controlling Paperwork Burdens on the Public," revised May 10, 1988 (53 FR 16618).

i. Treasury Order 113-01, "Redesignation of the Assistant Secretary for Policy Development as theAssistant Secretary for Policy Management," dated March 30, 1989.

7. SEMIANNUAL AGENDAS AND REGULATORY PROGRAMS. Pursuant to the Regulatory Flexibility Act and E.O. 12291, the Department of the Treasury will publish in the Federal Register a combined semiannual Regulatory Agenda during April and October of each year. Pursuant to E.O. 12498, the Department of the Treasury annually will prepare a regulatory program. Bureaus and offices will prepare and transmit the semiannual agendas and regulatory programs as directed by LLR.

8. OFFICES OF PRIMARY INTEREST. Associate General Counsel (Legislation, Litigation, and Regulation), Office of the General Counsel; and the Executive Secretary, Office of the Assistant Secretary of the Treasury (Policy Management).

Emily L. Walker

Executive Secretary

Attachments

Attachment

1. Nonapplicability. The provisions of this Part, other than paragraph 3., do not apply to:

a. administrative actions governed by the provisions of sections 556 and 557 of title 5, United States Code;

b. regulations issued with respect to a military or foreign affairs function of the United States;

c. regulations related to agency organization, management, or personnel;

d. regulations issued by the Bureau of the Public Debt that implement, through the exercise of the general borrowing power, the fiscal policies of the United States;

e. major regulations to be issued in response to an emergency situation or a short-term deadline imposed by statute or judicial order, to the extent provided in Part VI;

f. advance notices of proposed rulemaking issued by the Internal Revenue Service, the U.S Customs Service, or the Bureau of Alcohol, Tobacco and Firearms, providing that such documents contain no regulatory text;

g. regulations making nonsubstantive technical corrections to previously published regulations;

h. Regulations of the Internal Revenue Service, the United States Customs Service, and the Bureau of Alcohol, Tobacco and Firearms that are not reviewed or approved by an Assistant Secretary prior to issuance; and

i. regulations of the Bureau of Alcohol, Tobacco and Firearms concerning the establishment or designation of viticultural areas.

2. Major Regulations.

a. Definition. Except as provided in paragraphs 1. and 4.b.(2), a regulation shall be deemed a major regulation, and shall require a Regulatory Impact Analysis, if the appropriate bureau head or policy official, the General Counsel or the Executive Secretary determines it is likely to result in one or more of the following:

(1) an annual effect (positive, negative or a combination thereof) on the economy of $100 million or more;

(2) a major increase in costs or prices for consumers, individual industries, Federal, State or local government agencies, geographic regions; or

(3) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic or foreign markets.

A regulation shall not be deemed major if the economic or other consequences are a direct result of the implementation of a statute, international agreement or court decision.

b. Regulatory Impact Analyses.

(1) Preliminary Regulatory Impact Analysis (PRIA). In the case of a notice of proposed rulemaking determined to be a major regulation, the originating bureau or office shall prepare a PRIA prior to, or at the time of, the actual drafting of the notice of proposed rulemaking. If appropriate, such analysis may be combined with an Initial Regulatory Flexibility Analysis if such analysis is required by Part II. The PRIA shall accompany the notice of proposed rulemaking through all review levels and shall comply with the requirements of section 3(d) of E.O. 12291.

(2) Final Regulatory Impact Analysis (FRIA). In the case of a final or temporary (interim) regulation determined to be a major regulation, the originating bureau or office shall prepare a FRIA using the same criteria as with the PRIA. Such analysis may be combined with a Final Regulatory Flexibility Analysis if such analysis is required by Part II. The FRIA shall accompany the final regulation through all review levels.

(3) Availability. If the PRIA or FRIA is not published with the regulation, the bureau or office shall include in the preamble of, or as an appendix to, the regulation:

(a) a brief summary of the analysis; and

(b) a statement advising the public how copies of the analysis may be obtained.

3. Federal Register Statements. Whenever an office or a bureau publishes a regulation in the Federal Register, it shall include in the preamble a statement substantially similar to one of the following, as appropriate:

a. "This document is not subject to the requirements of E.O. 12291. [Brief explanation of basis for determination]. "

b. "It has been determined that this document is not a major regulation as defined in E.O. 12291 and a regulatory impact analysis is not required. [Brief explanation of basis for determination]."

c. "It has been determined that this document is a major regulation as defined in E.O. 12291. Accordingly, a [preliminary/final] regulatory impact analysis has been prepared." In addition, the bureau or office shall include a brief statement that the regulation is within the authority delegated by law and consistent with congressional intent.

4. Required Submissions to OMB.

a. General. Except with respect to regulations described in paragraph 1., all regulations, required transmittal forms, and applicable regulatory impact analyses shall be submitted to OMB, through LLR, for review pursuant to E.O. 12291.

b. Special Procedures for the Internal Revenue Service, the U.S. Customs Service, and the Bureau of Alcohol, Tobacco and Firearms.

(1) Major Legislative Regulations. All legislative regulations that are major, required transmittal forms, and accompanying regulatory impact analyses shall be submitted to OMB, through LLR, for review pursuant to E.O. 12291

(2) Other Regulations (including major nonlegislative regulations). With respect to all other regulations (except those described in paragraph 1.) there shall be submitted to OMB, through LLR, at least 14 days prior to the anticipated publication of a regulation, four (4) copies of a "Four-Point Memorandum" containing the following information:

(a) the title of the regulation and the unique identification number assigned to the regulation;

(b) the stage of rulemaking;

(c) a brief description of what the regulation will require and an identification of any significant policy changes proposed or resulting from the regulation; and

(d) the basis for determining that the regulation is not a major regulation or, in the case of an interpretative regulation, an explanation of why the regulation is considered interpretative.

c. OMB Review. The standard OMB review period for:

(1) regulations submitted for review under E.O. 12291 is:

(a) 10 calendar days for nonmajor regulations,

(b) 30 calendar days for major notices of proposed rulemaking and subsequent final regulations; and

(c) 60 calendar days for major temporary (interim) and final regulations not preceded by a notice of proposed rulemaking.

Offices and bureaus are advised to incorporate review periods into publication schedules and that OMB may extend the review period for any regulation.

(2) "Four-Point Memoranda" is 10 calendar days. Bureaus are advised that OMB may, during this review period, elect to review the economic impact of any regulation under the terms of E.O. 12291.

d. Coordination with E.O. 12630. Refer to Part V, paragraphs 2.b. and 2.d., for required submissions concerning E.O. 12630.

1. In General. The Regulatory Flexibility Act applies to all regulations except as provided in paragraph 2. The Regulatory Flexibility Act requires each bureau or office that is required by 5 U.S.C. 553, or any other law to publish a notice of proposed rulemaking or proposed regulation, to consider the impact of the regulation on small entities as defined in the Regulatory Flexibility Act (5 U.S.C. 601(6)).

2. Nonapplicability. Except as may be otherwise required by law, the provisions of this Part (other than paragraphs 3.b. and c.) do not apply to:

a. advance notices of proposed rulemaking, provided that they do not contain regulatory text;

b. regulations not required to be issued with notice and opportunity for public comment pursuant to 5 U.S.C. 553, or any other law, even if a notice of proposed rulemaking is published at the discretion of an office or bureau;

c. final regulations where the prior notice of proposed rulemaking was published before January 1, 1982;

d. regulations of particular applicability relating to rates, wages, corporate or financial structures, or reorganization thereof, prices, facilities, appliances, services, or allowances therefor, or to valuations, costs or accounting, or practices related to such rates, wages, structures, prices, appliances, services or allowances; and

e. to the extent provided in Part VI, regulations that will have a significant economic impact on a substantial number of small entities that are issued in response to an emergency situation or a short-term deadline imposed by statute or judicial order.

3. Certification or Statement of Nonapplicability.

a. General.

(1) The Regulatory Flexibility Act provides that an agency may exempt a regulation from the requirement to prepare regulatory flexibility analyses upon certification that the regulation will not have a significant economic impact on a substantial number of small entities. In other instances (see paragraph 2.) the Act may not apply to a regulation.

(2) Withdrawal of Certification. Notwithstanding certification that a notice of proposed rulemaking will not have a significant economic impact on a substantial number of small entities, if a bureau or office, at any time prior to issuing a final regulation, finds that the regulation is likely to have such an impact, the bureau or office shall notify LLR. Bureaus and offices are advised that preparation of an analysis may be required.

b. Federal Register Statement. Bureaus and offices shall include in the preamble to each notice of proposed rulemaking, temporary (interim), and final regulation, a statement as follows:

(1) Regulations Subject to the Act and Not Having a Significant Economic Impact on a Substantial Number of Small Entities. In the case of a regulation subject to the Act that:

(a) will not have a significant economic impact on a substantial number of small entities, or

(b) implements a statute or other legal authority that imposes a significant economic impact on a substantial number of small entities, to the extent such impact flows directly from such statute or authority and is intended or necessarily anticipated thereby,

a certification substantially identical to the following must be included: "It is hereby certified that this regulation will not have a significant economic impact on a substantial number of small entities. Accordingly, a regulatory flexibility analysis is not required." This statement must be followed by a brief explanation of the basis for the certification.

(2) Regulations Not Subject to the Act. In the case of a regulation not subject to the Regulatory Flexibility Act (see paragraph 2.), a statement explaining why the Act does not apply is required (see paragraph 3.c.(3) for special requirements for certain Internal Revenue Service and Bureau of Alcohol, Tobacco and Firearms regulations).

(3) Regulations Having a Significant Economic Impact on a Substantial Number of Small Entities. In the case of regulations subject to the analysis requirements of the Regulatory Flexibility Act, refer to paragraphs 4.b. or 5.b. (statement concerning public availability of analyses). Refer to Part VI, paragraph 4., if the regulation is being issued in response to an emergency situation or a statutory or judicial deadline.

c. Special Requirements for the Internal Revenue Service and the Bureau of Alcohol, Tobacco and Firearms.

(1) In General.

(a) Section 7805(f) of title 26, United States Code, prescribes special requirements for Internal Revenue Service and Bureau of Alcohol, Tobacco and Firearms notices of proposed rulemaking and final regulations that do not supersede a notice of proposed rulemaking. Section 7805(f) applies if any such regulation is:

(i) issued pursuant to authority contained in title 26, United States Code; and

(ii) not subject to the Regulatory Flexibility Act (see paragraph 2.).

(b) Section 7805(f) does not apply to a temporary (interim) regulation or to a final regulation superseding a notice of proposed rulemaking.

(2) Submission to Small Business Administration. With respect to any regulation described in paragraph 3.c.(1)(a), the Internal Revenue Service and the Bureau of Alcohol, Tobacco and Firearms shall submit a copy of such regulation to the Administrator of the Small Business Administration, as follows:

(a) with respect to a notice of proposed rulemaking, immediately following publication.

(b) with respect to a final regulation that does not supersede a notice of proposed rulemaking, at least four weeks prior to the publication.

Note: Section 7805(f) provides that the Administrator shall have four weeks from the date of submission to submit comments concerning the impact of the regulation on small business.

(3) Federal Register Statement. With respect to a regulation submitted to the Administrator of the Small Business Administration pursuant to paragraph 3.c.(2), the preamble to such regulation shall contain a statement that the regulation is not subject to the Regulatory Flexibility Act and that a copy of the regulation has been submitted to the Administrator of the Small Business Administration for comment on the impact of such regulation on small business pursuant to section 7805(f).

4. Initial Regulatory Flexibility Analysis (IRFA).

a. Content. In the case of a notice of proposed rulemaking that is likely to have a significant economic impact on a substantial number of small entities, the initiating office or bureau shall prepare an IRFA. This analysis may be combined with a Preliminary Regulatory Impact Analysis (see Part I). Such analysis shall be approved by the bureau or office head and shall accompany the regulation through all review levels. The IRFA shall comply with the requirements of the Regulatory Flexibility Act (5 U.S.C. 603(b) and (c)).

b. Public Availability. At the option of the initiating bureau or office, the IRFA may be published in the preamble of, or as an appendix to, the notice of proposed rulemaking, or prepared as a separate document. If the analysis is prepared as a separate document, a summary shall be published in the preamble of, or as an appendix to, the notice of proposed rulemaking and the preamble shall advise the public how copies of the analysis may be obtained.

c. Transmittal to Small Business Administration. A copy of each approved IRFA shall be transmitted by LLR to the Chief Counsel for Advocacy of the Small Business Administration.

5. Final Regulatory Flexibility Analysis (FRFA).

a. Content. In the case of a final regulation for which an IRFA was prepared or for which a FPFA is otherwise required, the originating office or bureau shall prepare a FRFA. Such analysis shall be approved by the office or bureau head and shall accompany the regulation through all review levels. Such analysis may be combined with a Final Regulatory Impact Analysis (see Part I). The final analysis shall comply with the requirements of the Regulatory Flexibility Act (5 U.S.C. 604(a)).

b. Public Availability. The originating office or bureau shall make copies of the final analysis available to the public and shall include in the preamble to the final regulation a statement describing how copies may be obtained. Alternatively, the originating bureau or office may publish the complete final analysis in the preamble of, or as an appendix to, the final regulation.

1. Notices of Proposed Rulemaking and Subsequent Final Regulations. Any notice of proposed rulemaking that contains a reporting or recordkeeping requirement, and any final regulation issued pursuant to such notice of proposed rulemaking, is subject to 44 U.S.C. 3504(h) and to such related rules, regulations and procedures as may be promulgated by OMB (see 5 CFR 1320.13, 1320.15(a), and 1320.21).

2. All Other Documents. Any document (including nonregulatory documents) not described in paragraph 1. that contains a reporting or recordkeeping requirement is subject to clearance by OMB prior to publication pursuant to 44 U.S.C. 3507 and to such related rules, regulations and procedures as may be promulgated by the OMB (see generally 5 CFR 1320.12, 1320.15(a) and 1320.21). Offices and bureaus are advised to ensure that required submissions are made at least 30 days prior to date of anticipated publication or issuance.

3. Definitions. For purposes of this Part:

a. Reporting requirement means a requirement, whether mandatory or voluntary, that persons provide information to an entity of the Federal Government. A requirement that a person obtain or compile information for the purpose of disclosure to one or more persons, or to the public at large, constitutes a reporting requirement whenever the same requirement would be subject to the Act if the information were provided directly to an agency of the Federal Government. A form codified in a regulation constitutes a reporting requirement.

b. Recordkeeping requirement means a requirement that persons maintain specified information, whether or not the information ultimately is provided to an entity of the Federal Government.

4. Nonapplicability. This Part does not apply to:

a. Regulations that do not contain a reporting or recordkeeping requirement.

b. Regulations that contain a reporting or recordkeeping requirement, if:

(1) such information is required only of agencies, instrumentalities or employees of the United States and is not collected for general statistical purposes; or

(2) the requirement in the regulation is not self-executing (i.e., the regulation does not specify the information to be reported or maintained and instead requires the submission on a form, or pursuant to instructions not codified in the regulation).

c. Regulations that contain a reporting or recordkeeping requirement for a purpose specifically described in 44 U.S.C. 3518(c)(1).

d. Collections of information specifically designated in 5 CFR 1320.7(j).

5. Required Submissions to OMB.

a. Except as provided in paragraph 4., originating offices and bureaus shall prepare required submissions to OMB for regulations that contain a collection of information as directed by the Office of the Assistant Secretary of the Treasury (Management). Such submissions shall be reviewed and approved by the appropriate bureau or office reports management officer and forwarded to the Office of Information Resources Management in the Office of the Assistant Secretary of the Treasury (Management) for coordination with LLR.

b. OMB Review.

(1) Notices of Proposed Rulemaking. Prepublication approval by OMB is not required. Submissions must be made to OMB not later than the date of publication in the Federal Register. The OMB review period is 60 days from the date the regulation is published, during which time OMB must submit comments or approve the collection of information.

(2) Final and Temporary (Interim) Regulations Issued Subsequent to a Notice of Proposed Rulemaking. Prepublication review and approval by OMB is required only if any information collection contained in the temporary or final regulation:

(a) was not contained in the prior notice of proposed rulemaking;

(b) is materially different from that contained in the prior notice of proposed rulemaking; or

(c) was commented upon by OMB in connection with its review of the prior notice of proposed rulemaking (Offices and Bureaus shall consult with LLR in such circumstances).

The OMB review period is 60 days. Offices and bureaus are advised to incorporate this review period into publication schedules and that OMB may extend the review period for an additional 30 days. If the required submission cannot be made to OMB at least 30 days prior to anticipated publication, offices and bureaus shall consult with LLR.

(3) Temporary (Interim) and Final Regulations Issued Without a Prior Notice of Proposed Rulemaking. Prepublication approval by OMB is required. The OMB review period is 60 days. Offices and bureaus are advised to incorporate this review period into publication schedules and that OMB may extend the review period for an additional 30 days. If the required submission cannot be made to OMB at least 30 days prior to anticipated publication, offices and bureaus shall consult with LLR.

6. Federal Register Statements.

a. Notices of Proposed Rulemaking. The preamble to a notice of proposed rulemaking that contains a reporting or recordkeeping requirement shall include, at a minimum, a statement substantially similar to the following and containing all the information elements specified:

The collection[s] of information contained in this notice of proposed rulemaking has/have been submitted to the Office of Management and Budget for review in accordance with the Paperwork Reduction Act of 1980 (44 U.S.C. 3504(h)). Comments on the collection[s] of information should be sent to the Office of Management and Budget, Paperwork Reduction Project (XXXX-YYYY*), Washington, D.C., 20503, with copies to the [name of office or bureau] at the address previously specified.

* XXXX = Agency Code; YYYY = OMB Control Number, if known

The collection[s] of information in this proposed regulation [is/are] in section[s] [list CFR section(s) containing the collections of information]. This information is required by [name of office or bureau] to [brief description of purpose of reporting/recordkeeping requirement]. This information will be used to [brief description of how collected information will be used]. The likely [respondents and/or recordkeepers] are [use one or more of the following terms, as appropriate: individuals or households, State or local governments, Federal agencies or employees, non-profit institutions, and/or small businesses or organizations].

Estimated total annual reporting and/or recordkeeping burden: _____hours.

[Estimated average annual burden hours per respondent and/or recordkeeper: _____hours/minutes] OR [The estimated annual burden per respondent/recordkeeper varies from _____to _____hours/minutes, depending on individual circumstances, with an estimated average of _____hours/minutes].

Estimated number of respondents and/or recordkeepers: _____.

Estimated annual frequency of responses: _____. [For reporting requirements only]

b. Final Regulations Issued Pursuant to a Notice of Proposed Rulemaking.

(1) General. A final regulation that is issued pursuant to a notice of proposed rulemaking and that contains a reporting or recordkeeping requirement shall, at a minimum, include in the preamble a statement substantially similar to one of the following, as appropriate. and containing all the information elements specified:

(a)

The collection[s] of information contained in this final regulation has/have been reviewed and approved by the Office of Management and Budget in accordance with the requirements of the Paperwork Reduction Act (44 U.S.C. 3504(h)) under control number XXXX-YYYY*. [The estimated average burden associated with the collection[s] of information in this final rule is _____hours/minutes per respondent or recordkeeper] OR [The estimated annual burden per respondent/recordkeeper varies from _____to _____hours/minutes, depending on individual circumstances, with an estimated average of _____hours/minutes].

Comments concerning the accuracy of this burden estimate and suggestions for reducing this burden should be directed to [name and address of bureau/office reports management office] and to the Office of Management and Budget, Paperwork Reduction Project (XXXX-YYYY*), Washington, D.C. 20503.

* Insert 8-digit OMB Control Number.

(b)

The collection of information requirements contained in this final regulation have been submitted to the Office of Management and Budget (OMB) in accordance with the requirements of the Paperwork Reduction Act (44 U.S.C. 3 504(h)). [The estimated average burden associated with the collection[s] of information in this final rule is _____hours/minutes per respondent or recordkeeper] OR [The estimated annual burden per respondent/recordkeeper varies from _____to _____hours/minutes depending on individual circumstances, with an estimated average of _____hours/minutes]. Final action by OMB with respect to these requirements is pending. The [name of bureau or office] will publish notification of OMB's final action in the Federal Register.

Comments concerning the accuracy of this burden estimate and suggestions for reducing this burden should be directed to [name and address of bureau/office reports management office] and to the Office of Management and Budget, Paperwork Reduction Project (XXXX-YYYY*), Washington, D.C. 20503.


*XXXX = Agency Code

YYYY = OMB Control Number, if known

Note: In addition, the effective date provision of the final rule shall specify that the collection of information shall not become effective until further notification is published in the Federal Register.

(2) Special Requirements.

(a) In the case of a final rule, to be issued pursuant to a prior notice of proposed rulemaking, that contains a reporting or recordkeeping requirement, the office or bureau shall include in the preamble an explanation of how any reporting or recordkeeping requirements contained in the final regulation respond to the comments, if any, filed by OMB or the public. or an explanation of why it rejected those comments.

(b) If the final regulation rejects comments filed by OMB, the originating bureau or office shall consult with LLR.

c. Final Regulations Issued Pursuant to a Prior Temporary (Interim) Regulation. A final regulation that is issued pursuant to a temporary (interim) regulation and that contains a reporting or recordkeeping requirement shall, at a minimum, include in the preamble a statement substantially similar to one of the following, as appropriate, and containing all the information elements specified:

The collection[s] of information contained in this final regulation has/have been reviewed and approved by the Office of Management and Budget in accordance with the requirements of the Paperwork Reduction Act (44 U.S.C. 3507) under control number XXXX-YYYY*. [The estimated average burden associated with the collection[s] of information in this final rule is _____hours/minutes per respondent or recordkeeper] OR [The estimated annual burden per respondent/recordkeeper varies from _____to _____hours/minutes, depending on individual circumstances, with an estimated average of _____hours/minutes].

Comments concerning the accuracy of this burden estimate and suggestions for reducing this burden should be directed to [name and address of bureau/office reports management office] and to the Office of Management and Budget, Paperwork Reduction Project (XXXX-YYYY*), Washington, D.C. 20503.

* Insert 8-digit OMB Control Number.

d. Temporary (Interim) and Final Regulations Issued Without a Prior Notice of Proposed Rulemaking. A temporary (interim) or final regulation that is issued without a prior notice of proposed rulemaking and that contains a reporting or recordkeeping requirement shall, at a minimum, include in the preamble one of the following statements, as appropriate, and containing all the information elements specified:

(1) Regulations Not Issued With a Separate and Contemporaneous Cross-Reference Notice of Proposed Rulemaking.

This regulation is being issued without prior notice and public procedure pursuant to the Administrative Procedure Act (5 U.S.C. 553). For this reason, the collection[s] of information contained in this regulations [has/have] been reviewed and, pending receipt and evaluation of public comments, approved by the Office of Management and Budget (OMB) under control number XXXX-YYYY*. Comments concerning the collection[s] of information and the accuracy of estimated average annual burden, and suggestions for reducing this burden should be directed to the Office of Management and Budget, Paperwork Reduction Project (XXXX-YYYY*), Washington, D.C., 20503, with copies to the [name and address of office/bureau reports management office]. Any such comments should be submitted not later than [60 days from publication].

* Insert 8-digit OMB Control Number.

The collection[s] of information in this regulation [is/are] in section[s] [list CFR section(s) containing the collections of information]. This information is required by [name of office or bureau] to [brief description of purpose of reporting/recordkeeping requirement]. This information will be used to [brief description of how collected information will be used]. The likely [respondents and/or recordkeepers] are [use one or more of the following terms, as appropriate: individuals or households, State or local governments, Federal agencies or employees, non-profit institutions, and/or small businesses or organizations].

Estimated total annual reporting and/or recordkeeping burden: _____hours.

[Estimated average annual burden hours per respondent and/or recordkeeper: _____hours/minutes] OR [The estimated annual burden per respondent/recordkeeper varies from _____to _____hours/minutes, depending on individual circumstances, with an estimated average of _____hours/minutes].

Estimated number of respondents and/or recordkeepers: _____.

Estimated annual frequency of responses: _____. [For reporting requirements only]

(2) Regulations Issued With A Separate and Contemporaneous Notice of Proposed Rulemaking.

This regulation is being issued without prior notice and public procedure pursuant to the Administrative Procedure Act (5 U.S.C. 553). For this reason, the collection[s] of information contained in this regulation [has/have] been reviewed and, pending receipt and evaluation of public comments, approved by the Office of Management and Budget (OMB) under control number XXXX-YYYY*. [The estimated average annual burden associated with the collection[s] of information in this regulation is _____hours/ minutes per respondent or recordkeeper] OR [The estimated annual burden per respondent/recordkeeper varies from _____to _____hours/minutes, depending on individual circumstances, with an estimated average of _____hours/minutes.]

For further information concerning this collection of information, and where to submit comments on the collection[s] of information and the accuracy of the estimated burden, and suggestions for reducing this burden, refer to the preamble to the cross-reference notice of proposed rulemaking published elsewhere in this issue of the Federal Register.

* Insert 8-digit OMB Control Number.

7. Control Numbers. Bureaus and offices shall ensure that control numbers assigned by the Office of Management and Budget to reporting and recordkeeping requirements contained in any final or temporary (interim) regulation are published in the Federal Register, and the Code of Federal Regulations if such regulation will be codified therein.

8. Review of Previously Approved Regulations. Bureaus and offices shall submit regulations previously approved by OMB 44 U.S.C. 3504(h) or 3507 in accordance with procedures prescribed by the Assistant Secretary of the Treasury (Management).

1. Introduction. Offices and bureaus shall review proposed regulatory actions to ensure that they are consistent with the principles of E.O. 12612.

2. Federalism Assessment.

a. General. A Federalism Assessment shall be prepared with respect to any regulatory action that raises significant federalism implications, or when otherwise directed by the General Counsel. In any case where a Federalism Assessment is required, such assessment shall be approved by the office or bureau head and shall accompany the regulation through all review levels. Bureaus and offices are advised that all Federalism Assessments will be provided to the OMB in conjunction with any submission that otherwise is required to be made pursuant to E.O. 12291.

b. Content. Each Federalism Assessment shall:

(1) contain a certification of the General Counsel that the regulation has been assessed in light of the principles, criteria, and requirements stated in sections 2 through 4 of E.O. 12612;

(2) identify any provision or element of the regulatory policy that is inconsistent with the principles, criteria, or requirements stated in sections 2 through 4 of E.O. 12612;

(3) identify the extent to which the regulatory policy imposes additional costs or burdens on the States, including the likely source of funding for the States and the ability of the States to fulfill the purposes of the regulatory policy; and

(4) identify the extent to which the policy would affect the State's ability to discharge traditional State governmental functions, or other aspects of State sovereignty.

3. Federal Register Statement. A bureau head policy official, or the General Counsel may determine that a regulatory policy raises federalism concerns that should be addressed in the preamble to an advance notice of proposed rulemaking, a notice of proposed rulemaking, or other document for which public comments are solicited.

1. Applicability.

a. Except as provided in paragraph l.b, this Part applies to any regulation that affects or may affect the use or value of private property.

b. This Part does not apply to regulations:

(1) that do not affect the use or value of private property;

(2) that reduce federal restrictions on the use or value of private property;

(3) concerning property held in trust by the United States or held with respect to treaty negotiations with foreign countries;

(4) concerning agency plans and studies;

(5) concerning military property;

(6) exercising the power of eminent domain;

(7) issued pursuant to 5 U.S.C. 553(a)(1) with respect to a military or foreign affairs function of the United States;

(8) issued in furtherance of pending or imminent litigation, whether judicial or administrative;

(9) issued by the Office of the Inspector General and bureau offices performing functions similar to those prescribed by the Inspector General Act of 1978, as amended; or

(10) concerning activities specifically identified in supplemental guidelines as may be issued by the Attorney General.

2. Identification of Takings: Required Documentation.

a. General. Offices and bureaus shall review proposed regulatory actions to ensure that they are consistent with the principles of E.O. 12630 and implementing Guidelines issued by the Attorney General. LLR shall be consulted in any case where a bureau or office believes that a regulatory action may raise takings implications.

b. Takings Implication Assessment. Except with respect to regulatory actions for the protection of public health and safety (see paragraph 2.c.) where a proposed regulatory action affects or may affect the use or value of private property under prevailing case law or guidelines promulgated by the Attorney General, the initiating office or bureau shall prepare a Takings Implications Assessment (TIA). Each TIA shall be approved by the office or bureau head, accompany the regulation through all review stages, and include the following information:

(1) an assessment of the likelihood that the regulation may effect a taking for which compensation is due in light of the principles referenced in E.O. 12630, applicable guidelines promulgated by the Attorney General, and applicable case law;

(2) an identification and discussion of alternatives, if any, to the regulation, that would achieve the desired result in a manner that would reduce intrusion on the use or value of private property; and

(3) to the extent it is determined that the regulation effects or may effect a taking for which compensation is due, an estimate, based on available data, of the potential financial exposure to the Government should a court find the regulation to be a taking.

Offices and bureaus are advised that these documents will be provided to OMB upon request if the regulation is subject to E.O. 12291.

c. Regulations for the Protection of Public Health and Safety. If a regulation would regulate private property for the protection of public health or safety (see Part VI if the regulatory action responds to an emergency situation), the originating office or bureau shall prepare a document, that shall be approved by the office or bureau head and shall accompany the regulation through all review levels, that:

(1) identifies clearly, with as much specificity as possible, the public health or safety risk created by the private property use that is the subject of the regulatory action;

(2) establishes that such proposed action substantially advances the purpose of protecting public health and safety against the specifically identified risk;

(3) establishes to the extent possible that the restrictions imposed on the private property are not disproportionate to the extent to which the use contributes to the overall risk; and

(4) estimates, to the extent possible, the potential cost to the government in the event that a court later determines that the action constituted a taking.

Offices and bureaus are advised that these documents will be provided to OMB upon request if the regulation is subject to E.O. 12291.

d. Coordination With E.O. 12291.

(1) Submission Required. If a regulation is subject to OMB review pursuant to E.O. 12291 (see Part I) and the regulation (a) is a major regulation, or (b) poses a substantial risk that a taking of private property may result or insufficient information as to facts or law exists to enable an accurate assessment of substantial risk, the originating bureau or office shall prepare a submission for OMB, that shall be approved by the office or bureau head and accompany the regulation through all review levels.

(2) Content. Any required submission shall summarize any identified takings implications of the regulation and address the merits of the regulation in light of those implications.

1. General. If a bureau or office determines, because of an emergency situation, or statutory or judicial deadline, to issue any regulation that is subject to E.O. 12291, an analysis requirement of the Regulatory Flexibility Act, the Paperwork Reduction Act, a Federalism Assessment, or a Takings Impact Analysis, the bureau or office shall immediately consult with LLR. No bureau or office shall issue any such regulation or rule without review by the General Counsel and the Executive Secretary in accordance with this Directive.

2. Special Requirements for Regulations Not Issued for Public Comment or to Become Effective in Less than 30 Days from Publication. The preamble to a regulation that is issued without opportunity for notice and public comment, or is effective less than 30 days from the date of publication, shall contain a specific statement explaining, and a citation to the provisions of 5 U.S.C. 553 that authorize, such action.

3. Effect on E.O. 12291 Review. When a regulation would otherwise be subject to review by OMB under E.O. 12291, the following procedures apply and LLR should be consulted immediately:

a. Emergencies. When a regulation that responds to an emergency situation is published in the Federal Register or otherwise issued without prior review by OMB under E.O. 12291, the initiating bureau or office shall include in the preamble a statement of the reasons why it is impracticable for the bureau or office to comply with the review provisions of E.0 12291. If the regulation is major and a Regulatory Impact Analysis normally would be required pursuant to Part I, the bureau or office shall prepare an analysis as directed by LLR.

b. Statutory or Judicial Deadlines. When a regulation that responds to a statutory or judicial deadline is published in the Federal Register or otherwise issued without prior review by OMB under E.O. 12291, the bureau or office shall include in the preamble a statement of the reasons why it is impracticable for the bureau or office to comply with the review provisions of E.O. 12291. In the case of a major regulation, bureaus and offices are advised that the preparation of a Regulatory Impact Analysis may be required by OMB.

4. Effect on Regulatory Flexibility Analyses.

a. Initial Regulatory Flexibility Analysis (IRFA). When a notice of proposed rulemaking responds to an emergency situation or statutory or judicial deadline, and if such notice otherwise would be subject to the analysis requirements of Part II, the bureau or office head, with the concurrence of the appropriate policy official and LLR, may determine that the preparation of an IRFA is impracticable. In such case the transmittal memorandum to the Executive Secretary shall explain why preparation of the analysis is impractical. The bureau or office shall publish in the preamble to the notice of proposed rulemaking a finding and explanation that the notice is being issued in response to an emergency or statutory or judicial deadline and that compliance with the requirements of the Regulatory Flexibility Act concerning preparation of an IRFA is impracticable.

b. Final Regulatory Flexibility Arialysis (FRFA).

(1) When a final or temporary (interim) regulation responds to an emergency situation or statutory or judicial deadline, and if such regulation otherwise would be subject to the analysis requirements of Part II, the bureau or agency head may, with the concurrence of the appropriate policy official and LLR, delay preparation of the FRFA. In such case the transmittal memorandum to the Executive Secretary shall explain the need to delay preparation of the analysis.

(2) The originating bureau or office may delay publication of the final analysis for a period of not more than 180 days after the date of publication of the regulation in the Federal Register. Upon publication of the regulation in the Federal Register, the bureau or office shall include a statement that the regulation is being issued in response to an emergency, or statutory or judicial deadline, which makes timely compliance with the requirement of a FRFA impracticable.

(3) The bureau or office shall prepare and transmit a FRFA to LLR not later than 150 days after publication of the regulation. Bureaus and offices are advised that the Regulatory Flexibility Act provides that failure to publish the FRFA (or advise the public how copies may be obtained) within 180 days after publication of the regulation will cause the regulation to lapse and have no effect (5 U.S.C. 608(b)).

5. Effect on Paperwork Reduction Act Review.

a. Notices of Proposed Rulemaking. Notices of proposed rulemaking that respond to an emergency or a statutory or judicial deadline that contain a reporting or recordkeeping requirement remain subject to the submission requirements of 44 U.S.C. 3504(h) and applicable regulations promulgated by OMB (see Part III).

b. Final or Temporary (Interim) Regulations. Final or temporary (interim) regulations that respond to emergency situations or to statutory or judicial deadlines and contain a reporting or recordkeeping requirement generally are subject to review by OMB prior to issuance pursuant to 44 U.S.C. 3507 and applicable regulations promulgated by OMB (see Part III). Bureaus and offices proposing issuance of such regulations or rules should promptly consult with LLR.

6. Effect on Federalism Assessment. Where a Federalism Assessment (see Part IV) is required for any regulation that responds to an emergency situation or statutory or judicial deadline, and such regulation would otherwise be subject to review by OMB pursuant to E.O. 12291 (see Part I), the procedures of paragraph 3. apply. Offices and bureaus shall promptly consult with LLR if the regulation is not otherwise subject to review by OMB pursuant to E.O. 12291.

7. Effect on Takings Analysis Where Regulatory Action is Taken For the Protection of Public Health or Safety. In any instance in which there is an immediate threat to health and safety that constitutes an emergency requiring immediate response, the Takings Analysis required by Part V may be performed upon completion of the emergency action.

8. Special Limitation on Temporary or Interim Regulations Issued by the Internal Revenue Service or the Bureau of Alcohol, Tobacco and Firearms. Pursuant to 26 U.S.C. 7805(e), any temporary (interim) regulation issued pursuant to authority contained in title 26, United States Code, shall expire not later than three years after the date of issuance of such regulation.

1. General. Bureaus and offices shall assign a unique identifier to each regulation that shall be displayed on the regulation, transmittal memorandum, and any other submissions or documents prepared with respect to such regulation.

2. Folders. Each transmittal must be in a folder, with the Clearance Sheet prescribed by the Executive Secretary on the outside cover.

a. The RIGHT side of the folder must contain ONLY the following materials in the order stated below:

(1) Original transmittal memorandum from the policy official to the Executive Secretary (or from a bureau or office head through the policy official to the Executive Secretary).

(2) One copy of the regulation.

(3) One copy of the Regulatory Impact Analysis (if applicable and not contained in the regulatory document in full).


(4) One copy of the Regulatory Flexibility Analysis (if applicable and not contained in the regulatory document in full).

(5) One copy of the Federalism Assessment (if applicable).

(6) One copy of the Takings Impact Analysis and/or OMB submission (if applicable).

(7) Background information (optional).

b. The LEFT side of the folder must contain ONLY the following materials in the order stated:

(1) Five copies of the transmittal memorandum to the Executive Secretary (with no attachments).

(2) A completed "Regulatory Profile," Treasury Department Form (TD F) 50-04.1, (Appendix B) for each regulation in the folder, with the following attachments:

(a) Documents Subject to OMB Review under E.O. 12291: One copy of the SF-83 (parts I and II completed).

Note: Separately provide LLR with four SF-83's (parts I and II completed), each attached to a copy of the regulation and, unless contained in the regulation in full, any required Regulatory Impact Analysis, Regulatory Flexibility Analysis, Federalism Assessment, and Takings Impact Submission (not Takings Assessment) attached.

(b) Regulations Subject to the Paperwork Reduction Act. One copy of the SF-83 (parts I and III completed).

(c) Regulations Subject to Regulatory Flexibility Act Analysis Requirements.

(i) If the analysis is contained in full in the regulation, provide one additional copy of the regulation; OR

(ii) If the analysis is not contained in full in the regulation, provide one additional copy of the regulation and the analysis.

(3) Two copies of the transmittal memorandum, each with copy of the regulation and, unless contained in the regulatory document in full, any required Regulatory Impact Analysis, Regulatory Flexibility Analysis, Federalism Assessment, and Takings Impact Analysis and/or Submission attached.

_______________________________

Office/Bureau and Unique Identifying Number

1. Type of Document

2. If a FINAL RULE or TEMPORARY (INTERIM) RULE, is the effective date less than 30 days from date of publication? ____ Yes ____ No

3. Is issuance of the document subject to a statutory or judicial deadline, or does the document respond to an emergency situation? ____ No ____ Yes

4. a. Is the document subject to review by OMB under Executive Order 12291?

____ Yes (attach SF-83 and answer b. below) ____ No

b. If "Yes" to a., is the document a Major Rule? ____ Yes ____ No

c. USCS, ATF and IRS only: Is a "Four-Point Memorandum" required?

____ No ____ Yes. If yes, was it submitted to LLR? ____ Yes ____ No

5. a. Does the document limit or preempt the policymaking discretion of the States?

____ No ____ Yes (answer b. below)

b. If "yes" to a., has a Federalism Assessment been prepared? ____ Yes ____ No

6. a. Does or could the document affect constitutionally protected property rights?

____ No ____ Yes (answer b. below)

b. If "Yes" to a., has a Takings Assessment/OMB Submission been prepared?

____ Yes ____ No

7. a. Is the document likely to have a significant economic impact on a substantial number of small businesses or other small entities? ____ No ____ Yes (answer b. below)

b. If "Yes" to a., has a Regulatory Flexibility Analysis been prepared? ____ Yes ____ No

8. If a ANPRM, NPRM or FINAL/TEMPORARY REGULATION WITHOUT PRIOR NPRM, does the document contain a reporting or recordkeeping requirement subject to the Paperwork Reduction Act? ____ No ____ Yes (attach SF-83)

9. If a FINAL/TEMPORARY REGULATION WITH PRIOR NPRM and the document contains a reporting or recordkeeping requirement:

a. Was the NPRM submitted to OMB under the Paperwork Reduction Act?

b. If "Yes" to a., did OMB approve the information collection in the NPRM?

____ Yes (OMB # _________; answer c. below) ____ No (answer d. below)

c. If "Yes" to b., is the collection of information materially different from that contained in the NPRM?

____ No ____ Yes

d. If "No" to b.: