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,
(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
(3) The chosen regulatory approach or alternative should
be the one with the least net cost to society, if practicable;
(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
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
(1) Approve proposed and final regulations (paragraphs 7
and 8), subject to any reservations of authority in NOAA Administrative
(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
(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
(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
(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
(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
(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
(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
(c) Compliance costs as a percent of sales are 10 or more
percent higher for small entities than compliance costs for
(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
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
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
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;
(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
(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
(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
(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
(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
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
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
(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
(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
(2) Notify OMB as soon as possible and, to the extent practicable,
comply with the requirements in section 6(a)(3)(D) of the
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
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
(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
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
(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,
(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
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
(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
(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
(4) If NMFS decides to proceed with development of a rulemaking
suggested by a petitioner, it will follow the procedures set
(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.