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Appendix 2.c.

Office of Sustainable Fisheries
National Marine Fisheries Service
Silver Spring, Maryland 20910

Revised April 15, 1998


Table of Contents


1. Purpose 2
2. Scope 2
3. Policy Requirements for Rules 3
4. Responsibilities of Agency Officials 4
5. Regulatory Impact Policies and Procedures 5
6. Public Participation in Informal Rulemaking 10
7. Notice of Proposed Rulemaking 11
8. Final Rule 13
9. Special Rulemaking Situations 14
10. Administrative Record 15
11. Transmittal and Clearance Procedures 17
12. Preparation of Regulatory Agenda 18
13. Review of Existing Rules 19
14. Petition to Undertake Rulemaking 20


1. Purpose

This provides guidelines of general application for conducting "informal" or "notice-and-comment" rulemaking governed by 5 U.S.C. 553, and in issuing other "rules" subject to Executive Order (E.O.) 12866, Regulatory Planning and Review, 58 FR 51735 (1993). Procedures are specified for complying with the Regulatory Flexibility Act, 5 U.S.C. 601-612, and the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. chapter 35.

2. Scope

a. These guidelines apply to all regulations of the National Marine Fisheries Service published in the FederalRegister, repeal of regulations, and to the statements of agency policy or procedure, except as follows:

(1) Regulations issued in accordance with the formal rulemaking provisions of the Administrative Procedure Act (5 U.S.C. 556, 557);

(2) Regulations issued with respect to a military or foreign affairs function of the United States; or

(3) Regulations or statements related to agency organization, management, or personnel.

The terms "regulation" and "rule" mean 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 general practice requirement of an agency (section 3(d), E.O. 12866).

b. The procedures set forth in this directive should be complied with whenever the public may be affected by the subject matter of a rulemaking, if practicable, despite the exceptions listed in section 6(a)(3)(D), E.O. 12866.

c. Regulations containing a collection-of-information requirement are subject to this directive, and to the clearance procedures set forth in NOAA Administrative Order 216-8. Regulations subject to the National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq., are also covered by NAO 216-6.

d. In the case of regulations that NMFS plans to promulgate jointly with one or more other agencies, the program officials involved in the rulemaking, in coordination with the Department of Commerce Office of the General Counsel (OGC), will designate one agency as lead agency for the purpose of determining the rulemaking procedures to be utilized.

3. Policy Requirements for Rules

a. General. The Administration and Congress have established policy requirements for rules issued by Federal agencies. The Administration's policy is E.O. 12866, while Congressional policy is expressed in the Regulatory Flexibility Act and the Paperwork Reduction Act. NMFS intends that regulatory decisions be based on adequate information concerning the need for and consequences of government action.

b. E.O. 12866. This guidance applies to the promulgation of new rules and the review of existing rules. NMFS interprets the general policy requirements of the Order to mean the following:

(1) Regulatory objectives and priorities should be established with the aim of maximizing net benefits to the United States, taking into account the condition of particular industries, state, and local or tribal governments, and consumers affected by the rule;

(2) Rules should be developed within a cost/benefit framework when possible;

(3) The chosen regulatory approach or alternative should be the one with the least net cost to society, if practicable; and

(4) Regulatory actions should not be undertaken unless the potential benefits outweigh the potential costs to society.

c. Regulatory Flexibility Act. The RFA establishes the principle that Federal rulemaking activities should fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to the regulation. To implement this principle, NMFS will solicit and consider proposals from small entities and explain the rationale for its actions to assure that such proposals are given serious consideration. NMFS will also examine the impact of proposed rules on small entities and review the continued need for existing rules.

d. Paperwork Reduction Act. Government agencies must collect information to enforce laws and to develop sound policies. In doing so, a burden is imposed on the private sector and State and local governments. The Paperwork Reduction Act establishes the principle that agencies should minimize paperwork and reporting burdens. In keeping with the general policy of this Act, NMFS will ensure that its rules contain the minimum information collection requirements needed to administer its programs.

4. Responsibilities of Agency Officials

a. Unless the Under Secretary for Oceans and Atmosphere, NOAA, has retained a specific rulemaking function, the Assistant Administrator for Fisheries, NOAA, (AA) has the authority to:

(1) Approve proposed and final regulations (paragraphs 7 and 8), subject to any reservations of authority in NOAA Administrative Order 205-11.

(2) Determine whether a rule is significant or not significant under E.0. 12866 (paragraph 5. b).

(3) Issue guidance specifying the form, appropriate methodologies, and level of detail of analytical documentation necessary to support a finding that a regulation meets the requirements of E.O. 12866 and the RFA.

(4) Determine whether a rule will have a significant economic impact on a substantial number of small entities and, if it will, prepare the regulatory flexibility analysis (RFA analysis) (paragraph 5.c (1)); however, the Assistant General Counsel for Legislation and Regulations (AGC-L&R), Department of Commerce, retains the authority to certify that a rule will not have a significant impact on a substantial number of small entities.

(5) Determine whether to delay or waive certain provisions of this directive in special rulemaking situations (see paragraph 9).

(6) Approve a Regulatory Agenda (see paragraph 12).

(7) Determine reasonable public comment periods on proposed regulations, subject to the requirements of enabling statutes (see paragraph 6(1)).

(8) Transmit a Regulatory Clearance Package to NOAA for processing and DOC review (see paragraph 11).

(9) Approve a NMFS submission of an Information Collection Budget.

(10) Delegate any of the functions in paragraph 4.a (1-9).

b. The Under Secretary retains the authority to:

(1) Approve the consolidated Regulatory Agenda transmitted to DOC (see paragraph 12);

(2) Transmit a Regulatory Clearance Package to DOC (see paragraph 11); and

(3) Review on a case-by-case basis any determination or approval of the AA made in accordance with paragraph 4.a.

c. The determinations and approvals made under paragraphs 4.a. and 4.b. may be subject to further review, consistent with Department Organization Orders.

5. Regulatory Impact Policies and Procedures

a. Policy. NOAA requires that the agency developing rules or policy initiatives consider the benefits and costs to the affected groups unless specifically directed otherwise by an enabling statute.

(1) Every rule is required to be supported by a review that considers regulatory impacts. This review should be undertaken by the officials or bodies making initial policy decisions on the regulations. The review will enable the agency to determine that a regulation satisfies the policy objectives of E.O. 12866 and the RFA, and to decide whether further analytical documents (e.g., RFA analysis) should be prepared. The AA may issue more detailed guidance consistent with this section on the form, appropriate methodologies, and level of detail of this review.

(2) Generally accepted principles of economic or policy analysis should be followed in assessing the implications of the rule or policy. A technically proficient analysis will improve the final decision and make it more defensible in the rulemaking process. A substantive analysis also will allow senior officials and decision makers the means of rapidly assessing the rule's implications and assuring them that all important issues have been considered. Any analysis should be of sufficient quality to convince an objective reviewer that the regulation is needed and that the alternative chosen will maximize net benefits.

b. Determination of "significant" under E.O. 12866

(1) E.O. 12866 provides broad criteria for determining whether a proposed regulation is "significant." A regulation is deemed to be significant if it is likely to result in:

(a) An annual effect on the economy of $100 million or more or adversely 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;

(b) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(c) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(d) Raise novel legal or policy issues arising out of legal mandates, the Presidents's priorities, or the principles set forth in this Executive Order. In addition, if an action is likely to generate significant controversy or attention, it is probably the kind of action the Office of Management and Budget (OMB) will want to review.

(2) NMFS interprets the first criterion to mean that a regulation is significant if it has an annual incremental effect on the economy of $100 million or more in direct or indirect enforcement and compliance costs, or benefits. The determination that a rule is likely to result in "significant" increases in costs or prices depends on the economic circumstances of the affected class, the consequences of the cost or price increase to a typical member of that class, and the ability of that class to carry or pass along such increases as a normal function of its operations. The term "significant" has no precise meaning, but should be judged within the particular circumstances of those affected by the rule. Similarly, the first criterion, which is triggered if a rule is a likely to "adversely affect in a material way the economy..." involves a judgment by the decision maker; no absolute standard can be applied to this determination. Whether an adverse impact is "significant" depends on the situation of the individual or business before and after the rule is issued relative to the factors listed in the criterion. Impacts that affect persons or entities outside the United States, with minimal rebound effects on the U.S. economy, may be disregarded in deciding whether a rule is "significant."

(3) E.O. 12866 established a system that requires an agency periodically to submit a list of all planned regulatory actions to OMB. The list indicates which regulations the agency believes are "significant" or "not significant" within the meaning of the Order. NMFS lists on a monthly basis all upcoming regulations not previously listed. The Office of the Assistant General Counsel for Legislation and Regulatory Affairs, DOC, is responsible for listing all rules with OMB and providing NMFS with the determination of OMB regarding the status of each rule.
c. Determination of whether an analysis is required under the Regulatory Flexibility Act

(1) Requirements. The RFA requires the Federal rulemaker to examine the impacts of proposed and existing rules on small businesses, small organizations, and small governmental jurisdictions. In reviewing the potential impacts of proposed regulations, the agency head must either certify that the proposed rule "will not, if promulgated, have a significant economic impact on a substantial number of small entities," or prepare an RFA analysis.
(2) Defining a small entity. The RFA allows each agency to use the definition of "small entity" in the RFA or to develop its own definition.

(a) The RFA recognizes and defines three kinds of small entities: Small businesses, small organizations, and small governmental jurisdiction as follows.

(i) Small business. The RFA adopts as a default definition of "small business," the definition of "small business" under the Small Business Act. Under that act, a small business concern is one that is independently owned and operated and not dominant in its field of operation. The Small Business Administration (SBA), which establishes criteria for determining the size of small businesses in a variety of industries has adopted a standard that a fish-harvesting enterprise shall be deemed a small business if it has annual receipts not in excess of $3,000,000. Size standards for related industries involved in canned and cured fish and seafood or preparing fresh or frozen fish and seafoods are--500 employees or less, and for the wholesale industry--100 employees or less.

(ii) Small organization. This is any not-for-profit enterprise that is independently owned and operated and is not dominant in its field.

(iii) Small governmental jurisdiction. This is a governmental jurisdiction with a population of less than
50 thousand.

(b) Foreign businesses, organizations, and governmental jurisdictions are not counted as "small entities," because the RFA was intended to protect small entities of the United States.

(c) If a NOAA Line Office decides to develop a different definition of a "small business" for the office or for a particular program, it must:

(i) Obtain the concurrence of the Under Secretary and the OGC; and

(ii) Consult with the Office of Advocacy at the SBA.

(3) Determining "significant economic impact." NMFS has determined that if any of the following criteria apply, then there is a "significant economic impact":

(a) The regulations are likely to result in more than a 5 percent decrease in annual gross revenues;

(b) Annual compliance costs (e.g., annualized capital, operating, reporting) increase total costs of production by more than 5 percent;

(c) Compliance costs as a percent of sales are 10 or more percent higher for small entities than compliance costs for large entities;

(d) Capital costs of compliance represent a significant portion of capital available to small entities, considering internal cash flow and external financial capabilities; and

(e) The requirements of the regulation are likely to result in 2 or more percent of the small entities affected being forced to cease business.

(4) Determining "substantial number." The following factors may be used to determine what is a "substantial number of small entities." In general, NMFS considers a "substantial number" of small entities to be more than 20 percent of those entities in the class. This percentage is calculated by dividing the number of small entities affected by the regulations by the total number of small entities in a particular industry or segment of that industry. If the effects fall primarily on a distinct segment, or portion thereof, of the industry (e.g., user group, gear type, geographical area) that segment would be considered the class for purposes of this determination. The
20 percent criterion represents a general guide; there may be instances when, in order to satisfy the intent of the RFA, an initial RFA analysis (IRFA) should be prepared even though fewer than 20 percent of the small entities in an industry are affected.

Note that these criteria all deal with adverse or negative impacts. NMFS and certain other Federal agencies interpret the RFA as requiring the preparation of an IRFA only for proposed actions expected to have significant adverse economic impacts over the long term. Thus, if any action has short term significant adverse impacts on a substantial number of small entities, even though it will benefit small entities in the long term, an IRFA must be prepared.

(5) Other factors. The list of factors to determine "significant economic impact" and "substantial number" is not all-inclusive. Some other factors may be more appropriate, or some of the listed factors may not apply. While discretion is involved, the determination must be based on the analysis or reasoned judgment in the documents supporting the rulemaking initiative. (See Guidelines on Regulatory Analysis of Fishery Management Actions, Appendix 2.d.)

(6) RFA. If an RFA analysis is prepared, it must contain the legal basis for the rule, a description and estimate of the number of small entities to which the rule will apply, a description of any projected reporting and recordkeeping requirements, and an identification of relevant Federal rules that may duplicate or conflict with the proposed rule.

If an RFA analysis indicates that the proposed action, if adopted, would have a significant economic impact on a substantial number of small entities, an IRFA must be prepared. If the proposed action is implemented, an FRFA must be prepared. The two documents contain much of the same information but the FRFA must include requirements that are different from the IRFA, for example, a summary of significant issues raised by the public in response to the IRFA, the agency's response, and a statement of changes made to the action as a result of the comments.

If the proposed action is determined not to have a significant economic impact on a significant number of small entities, an IRFA is not prepared. A summary providing the factual basis for the determination must be provided in the Classification section of the proposed rule and a memorandum must be sent from the
AGC-L&R to the Chief Counsel for Advocacy, SBA, stating why the action is not significant.

d. Public comment.

(1) The AA must make the regulatory impact review and associated explanatory documents available for public comment when the proposed rule or policy initiative is significant under E.O. 12866; if an IRFA and/or FRFA are prepared, they must be made available to the public.

(2) Open conferences or meetings may be held at which interested persons are afforded the opportunity to exchange views with the rulemaker and with each other on desirable approaches to problems that the contemplated rulemaking would address.

(3) Notices of the intention to develop regulations may be sent to publications likely to be read by those affected.

(4) Interested parties may be notified directly.

(5) More than one cycle of public comments may be provided.

6. Public Participation in Informal Rulemaking.

a. Public comment on regulations

(1) Notice of proposed rulemaking. The agency will provide a public comment period on proposed regulations (but see paragraph 9.d). The length of the period is either:

(a) That required by the relevant statute or regulations; or

(b) Where no other statute or rule applies, a "reasonable" time as required under the Administrative Procedure Act. A "reasonable time" is normally at least 30 days (but may be 15 days or shorter if justified), depending on consideration of factors including:

(i) Significance of the rule;

(ii) Complexity of the rule;

(iii) Difficulties potential commenters may have in submitting views (for example, Regional Fishery Management Councils may meet only bimonthly);

(iv) Immediacy of the need for a final rule;

(v) Amount of public participation preceding the notice of proposed rulemaking; and

(vi) Extent to which the affected public is notified by means other than Federal Register publication.

(2) Interpretive rules. Interpretive rules and statements of agency policy and procedure are not subject to a requirement for notice and comment, see 5 U.S.C. § 553(b)(A).

b. Public meetings. The agency may hold public meetings as a means, supplemental to notice published in the FederalRegister, of obtaining the views of interested persons on a proposed rule and related documents. At least a summary record of the meeting should be placed in the rulemaking record.

(1) Circumstances. Meetings might be held when a proposed rule is controversial or would have special impact in specific geographic areas. The program official should also consider special difficulties that interested persons might encounter if the submission of written comments were the only available method of public participation in the rulemaking.

(2) Reasons. A meeting might be held for one or more of several different reasons, including:

(a) The desire to clarify the meaning of a proposed rule and related documents, and to offer the public information that will be useful in the preparation of written comments;

(b) The desire to receive from interested persons oral statements supplementing written comments; or

(c) The desire to clarify issues of fact through the give and take of a public meeting.

c. Other actions. If necessary for fair and sound decisionmaking, the agency should extend the comment period specified in the notice of proposed rulemaking, establish an additional comment period, or schedule additional meetings on the proposed rule and related documents. The program official should be especially sensitive to the possible necessity of such actions when a comment, meeting summary, record of communication, amendment to the notice of proposed rulemaking, or other item placed in the record file raises new issues that many persons interested in the rulemaking may find difficult to address within the original comment period and hearing schedule. The program official should also adhere to the guidelines provided in NOAA Directive 21-24, "Comments Received by the Agency During Post-Comment Period of Informal Rulemaking."

7. Notice of Proposed Rulemaking

a. Contents. Every notice of proposed rulemaking (NPR) will include, to the extent appropriate:

(1) The text of the proposed rule (as a new regulation or amendment to existing regulations), or a description of the proposed action;

(2) A statement of the time, place, and nature of any public rulemaking proceedings if not otherwise publicized;

(3) Reference to the legal authority under which the rule is proposed;

(4) A discussion of the background, major issues, and alternatives to the proposed action;

(5) A summary of the agency's current attitudes toward the issues and alternatives, a description of the data and information on which the agency relies, and the place where the record may be inspected;

(6) A reference to any related environmental documents prepared under the National Environmental Policy Act;

(7) If any part of a required comment period is waived, the reasons for the waiver;

(8) The name and telephone number of a NMFS employee who may be contacted for additional information about the proposed rule; and

(9) Any other information required by the Federal Register to be contained in the preamble pursuant to 1 CFR 18.12.

b. E.O. 12866.

(1) For rules determined to be "significant," the NPR will include a statement that "This proposed rule has been determined to be significant for purposes of E.O. 12866."

(2) For rules determined not to be "significant," the NPR will include a statement that "This proposed rule has been determined to be not significant for purposes of E.O. 12866."

(3) For actions exempted from E.O. 12866, the NPR will include a statement that the action is "exempt from review under E.O. 12866."

c. Regulatory Flexibility Act.

(1) For rules that "have a significant economic impact on a substantial number of small entities" under the RFA, the NPR will state that the SBA has been notified. The NPR must also include a summary of the IRFA.

(2) For rules certified not to have a significant economic impact on a substantial number of small entities, the NPR will include the factual basis for that certification.

(3) For rules to which the RFA does not apply (see 5 U.S.C. 601(2)), the NPR will contain a statement to that effect.

d. Paperwork Reduction Act. For rules containing a collection-of-information requirement, the NPR will include an explanation of why the collection is necessary for proper performance of NMFS' functions, and a statement that the regulations have been forwarded to the Director of OMB for review. If the collection of information has not previously been issued an OMB control number, the NPR must also request public comments on a variety of questions, including whether the proposed collection of information is necessary, practical, whether the estimate of the time burden is accurate, how the quality and utility of the information to be collected can be enhanced; and how the reporting burden could be minimized. If an OMB control number has been issued, it should appear in the NPR. In addition, any NPR that included a paperwork requirement must include a statement that no person is required to comply with any collection-of-information requirement that does not display a valid OMB control number.

e. Emergency, under the Magnuson-Stevens Act.

For rules issued in response to an emergency, the preamble will describe the emergency, state the reasons why the RFA does not apply (see 5 U.S.C. 603(a)), and state whether it has been determined to be significant/not significant for purposes of
E.O. 12866.

f. Statutory or judicial deadline. For regulations governed by statutory or judicial deadlines, NMFS will, to the extent practicable, comply with section 6(a)(3)(B) and (C) of E.O. 12866. However, NMFS is still required to notify OMB.

8. Final Rule

a. Contents. Every final rulemaking will contain, to the extent appropriate:

(1) A summary and the text of the final rule or action;

(2) Reference to the NPR and other related documents or notices published in the Federal Register during rulemaking;

(3) A summary of public comments on the proposed rulemaking, the proposed FMP/amendment, and the responses thereto;

(4) A discussion of the changes from the proposed rule and the reasons that one alternative has been selected over another;

(5) The date on which the final rule will go into effect (which generally is no sooner than 30 days after publication,
see paragraph 9.d);

(6) The name and telephone number of a NMFS employee who may be contacted for additional information about the final rule; and

(7) Any other information required by the Office of the Federal Register to be contained in the preamble pursuant to 1 CFR part 18.

b. E.O. 12866. For "significant" rules, the final rulemaking will contain the statement that the action has been determined to be significant for purposes of E.O. 12866. Describe any additional analysis of economic significance done since publication of the proposed rule.

c. Regulatory Flexibility Act. For rules that have a "significant economic impact on a significant number of small entities," the final rulemaking will indicate where a copy of the FRFA may be obtained. Also, any rule for which a FRFA was required must be accompanied with an compliance guide. In addition, the final rule must include either a copy of or a summary of the FRFA.

d. Paperwork Reduction Act. For rules containing a collection-of-information requirement, the final rulemaking will explain how the final rule responds to any comments received from the Director of OMB or the public, and will specify the OMB control number. Also, if it is a new collection of information, it must request comments on a variety of questions (see 7. d.) and add the OMB approval number to 15 CFR part 902.

e. Administrative Procedure Act. For rules issued with no comment period or with an effective date less that 30 days after publication, the final rulemaking will explain the reasons therefor (see paragraph 9.d).

f. No NPR. For final rules published without an NPR, the preamble will comply with the requirements of paragraph 9.d.

g. Emergency. For rules issued in response to an emergency, the preamble will describe the emergency and, if such is the case, state the reasons why it is impracticable for the agency to comply with any applicable provisions of the Administrative Procedure Act (see 5 U.S.C. 553), E.O. 12866 (see section 6(a)(3)(D)), and the corresponding requirements of this directive.

h. Statutory or judicial deadlines. For regulations exempt from section 6(a)(3)(D) of E.O. 12866 because of statutory or judicial deadlines, the preamble will contain a statement of reasons why it is impracticable for the agency to comply with the provisions of the Executive Order and the corresponding requirements of this directive.

i. Withdrawal of proposed rule. If a decision is made not to issue a final rule after publication of a proposed rule, a notice of withdrawal of the proposed rule will be published in the Federal Register. The notice should contain an explanation of why the proposed rule is being withdrawn.

9. Special Rulemaking Situations

a. E.O. 12866. For regulations responding to an emergency situation or to a judicial or statutory deadline, the AA, after complying with DOC clearance procedures and making a good faith effort to meet the requirements of the Order, may:

(1) Publish the regulations before complying with requirement for a review by OMB of a significant regulation or any other analytical requirement.

(2) Notify OMB as soon as possible and, to the extent practicable, comply with the requirements in section 6(a)(3)(D) of the Executive Order.

b. Regulatory Flexibility Act. For regulations that are promulgated in response to an emergency, the RFA is not applicable because there is no requirement to publish a notice of proposed rulemaking.

c. Paperwork Reduction Act. The AA, with the concurrence of the OGC, may request the Director of OMB to authorize an information collection prior to the expiration of the 60-day review period, if the collection is needed before the end of the period and is essential to NMFS' mission.

d. Administrative Procedure Act

(1) There is no requirement for a comment period under 5 U.S.C. 553(b), if a good cause finding is made that public participation in the rulemaking is either impracticable, unnecessary, or contrary to the public interest.

(2) The AA may decide to make a substantive rule effective less than 30 days after its publication if:

(a) The rule grants or recognizes an exemption or relieves a restriction; or

(b) There is a finding of good cause not to delay the effective date 30 days after publication.

(3) Interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice are not subject to the requirement for notice and an opportunity to comment. Interpretive rules and statements of policy may be made effective immediately.

10. Administrative Record

a. Contents. The Assistant Administrator will maintain an administrative rulemaking record, which includes:

(1) A copy of the notice of proposed rulemaking;

(2) When applicable, a copy of the FMP or FMP amendment;

(3) When applicable, a copy of the draft Environmental Impact Statement or the Environmental Assessment;

(4) When applicable, a copy of the various draft regulatory analyses (Regulatory Impact Analysis, Regulatory Flexibility Analysis or other analytical document);

(5) All written comments timely submitted by interested persons in response to the NPR;

(6) When applicable, all written comments timely submitted by interested persons in response to an environmental impact statement or other documents prepared in connection with the NPR;

(7) Record of any meeting with individuals outside NMFS held in connection with the development of a proposed rule;

(8) Material submitted for inclusion in the administrative record by a program official involved in developing the rule, such as technical materials, work sheets, and memoranda;

(9) Copies of written communications and written summaries of all communications relating to the merits of the proposed rule, and copies or written summaries of all responses to such communications for purposes of communications, ANPRMs shall be treated as proposed rules;

(10) Copies of any other written communications relating to the merits of the proposed rule, and copies or written summaries of all responses to such communications; and

(11) The final rulemaking document and, where applicable, the final Environmental Impact Statement and other final analyses, or the notice of withdrawal of the notice of proposed rulemaking.

b. Public accessibility. All documents contained in the record must be accessible to the public, except those documents exempted from disclosure under the Freedom of Information Act,
5 U.S.C. 552. The agency will make the record available for public inspection and copying during normal business hours. Copying charges will be determined in accordance with Departmental regulations and NOAA Directive 21-25.

c. Treatment as comment. Any communication received by a NMFS employee involved in a rulemaking from outside DOC that relates to the merits of a proposed rule will be treated as a comment, whether or not it is so designated by the commenter.

d. Additional meetings. Unless NMFS is prohibited by law from having meetings or face-to-face discussions with persons outside of the agency during informal rulemaking, officials or employees involved in a rulemaking may participate in meetings with the public, representatives of industry, Members of Congress, or the White House and its staff following the close of the general comment period. However, a summary of any such meeting should be placed in the administrative record, particularly if the meeting disclosed significant new information or information of central relevance to the rulemaking. If significant new information is disclosed to NMFS during any such meeting, the agency may need to reopen the comment period and give the general public an opportunity to comment on the new information.

e. Secretarial review period. Written comments received and meetings held during the Secretarial review period for fishery management plans and amendments should be treated as in paragraph 10.d. If these communications provide significant information not previously in the administrative record, the Assistant General Counsel for Fisheries should be consulted for advice on the appropriate response.

11. Transmittal and Clearance Procedures

a. Scope. This section describes procedures for clearing all rules and policy statements, except for notices excepted from section 4(a) of Department Organization Order 10-6. Those notices may be transmitted by the AA, or designee, directly to the Office of the Federal Register.

b. Regulatory Transmittal and Clearance Package (RTCP).

(1) An RTCP shall contain, as appropriate:

(a) A decision memorandum that requests action by the Under Secretary, or information memorandum that advises the Under Secretary/Assistant Secretary of a contemplated action by the AA, or transmits a rule to AGC-L&R that contains determinations required by E.O. 12866 and other applicable laws, and states that the appropriate analyses have been prepared and are of satisfactory quality for decisionmaking.

(b) Copies of any analytical document required by paragraph 5.a (1).

(c) For proposed rules that will not have a "significant economic impact" on a "substantial number of small entities" for purposes of the RFA, a letter from the AGC-L&R to the Chief Counsel for Advocacy at the Small Business Administration certifying that the rule would not, if adopted, have a significant economic impact on a substantial number of small entities under the RFA.

(d) Copies of the proposed or final rule, or policy statement.

(e) A decision or information memorandum for the Secretary, if necessary.

(f) Any other documents useful as background material.

(2) Since NOAA guidelines on the clearance procedures for rules and policy statements may change, NMFS, in cooperation with the NOAA Executive Secretariat, will determine for each type of regulatory action:

(a) The necessary rulemaking documents;

(b) The number of copies of each rulemaking document for the NOAA and DOC reviews; and

(c) The procedures for transmitting the rule to DOC, OMB, and the Office of the Federal Register.

c. Information Collection Requests.

(1) Some rules or programs call for the collection of information from the public. Each information-collection request subject to the Paperwork Reduction Act must be approved by OMB (see NOAA Administrative Order 216-8). OMB is allowed 60 days to review the request.

(2) The agency initiating an information-collection request through a proposed rule should allow sufficient time for OMB review so that the rule does not go into effect before OMB approves the request. Otherwise, the effectiveness of the information collection provision of the rule will have to be delayed.

12. Preparation of Regulatory Agendas

The NMFS Office of Sustainable Fisheries, Regulatory Services Division, is responsible for coordinating the preparation of the Regulatory Agenda as required by E.O. 12866 and the RFA. NMFS will submit the NMFS agenda to OMB on a timely basis to allow preparation of the Agenda.

13. Review of Existing Rules

a. The AA is responsible for a periodic selection of existing regulations for review and possible revocation or revision.

b. In selecting regulations to be reviewed and establishing priorities, the AA will select those regulations:

(1) For which there is no continued need;

(2) Which have been the subject of a significant number of complaints or suggestions;

(3) Which impose heavy burdens on those directly or indirectly affected by the regulation;

(4) Which need to be clarified or simplified;

(5) Which overlap and duplicate other regulations; or

(6) Which have not undergone evaluation for a period of 3 or more years.

c. Any existing regulation selected for review will remain in full effect until such time as it may be revised or revoked.

d. The review of existing regulations will, at a minimum, contain the following procedural steps:

(1) Inclusion of notice of review in the Regulatory Agenda;

(2) An analysis of the regulation and the impacts of revoking or revising it;

(3) If the regulation or the revocation of it would have a significant economic impact on a substantial number of small entities, preparation of an RFA on the regulation and on the impacts of revising or revoking it; and

(4) Analysis of the need to continue any collection-of- information requirement contained in the regulation.

e. If the review results in a determination that the regulation should be revoked or revised, the rulemaking to accomplish the change will comply with the procedures of this directive.

14. Petition to Undertake Rulemaking

a. Any person may petition NMFS, pursuant to 5 U.S.C. 553(e), to issue, amend, or repeal a rule.

(1) Each petition filed under this section should:

(a) Set forth the test or substance of the rule or amendment proposed, or specify the rule that the petitioner wants to have repealed or modified;

(b) Explain the interest of the petitioner in the action requested;

(c) Indicate the size of the population affected;

(d) Explain the importance of the regulation to promoting established NOAA priorities and policies;

(e) State the resources necessary to develop the proposed regulations; and

(f) Indicate the public interest in the proposed regulation.

(2) The AA shall determine whether the petition contains enough information to enable NMFS to consider the substance of the petition. If appropriate, the AA shall also determine if the petition contains enough new information to merit reconsideration of an earlier decision. If the AA determines not to proceed further, the petitioner shall be notified in writing of the reasons for the determination.

(3) If the AA decides to proceed, NMFS shall publish a notice in the Federal Register announcing its receipt, the name of the petitioner, and a concise statement of the petitioner's request.

(4) If NMFS decides to proceed with development of a rulemaking suggested by a petitioner, it will follow the procedures set forth herein.

(a) NMFS will notify the petitioner of its decision to proceed with the rulemaking suggested by the petition within
120 days of the receipt of the petition.

(b) If NMFS determines not to open a rulemaking proceeding, NMFS will so notify the petitioner, and will provide the petitioner with a brief statement of grounds for its decision.

(c) Upon determining whether to open a rulemaking proceeding suggested by a petitioner, the AA shall publish a notice of the decision or action in the Federal Register.

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Regulatory Streamlining - Operational Guidelines