Iowa Administrative Code 657
657 IAC Chapter 26 PETITIONS FOR RULE MAKING
657—26.1 (17A) Petition for rule making.
Any person,
association, agency, or political subdivision may file a petition for rule making
with the board at 400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309-4688.
A petition is deemed filed when received by that office. The board shall provide
the petitioner with a file-stamped copy of the petition if the petitioner provides
the board an extra copy for this purpose. The petition must be typewritten, machine
printed, or legibly handwritten in ink and must substantially conform to the following
form:
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BOARD OF PHARMACY EXAMINERS
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Petition by (Name of Petitioner)
for the (adoption, amendment, or repeal) of rules relating to (state subject matter). |
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PETITION FOR
RULE MAKING |
The petition shall include the following information:
- A statement of the specific rule-making action sought by the petitioner including the text or a summary of the contents of the proposed rule or amendment to a rule and, if it is a petition to amend or repeal a rule, a citation and the relevant language to the particular portion or portions of the rule proposed to be amended or repealed.
- A citation to any law deemed relevant to the board’s authority to take the action urged or to the desirability of that action.
- A brief summary of petitioner’s arguments in support of the action urged in the petition.
- A brief summary of any data supporting the action urged in the petition.
- The names and addresses of other persons, or a description of any class of persons, known by petitioner to be affected by or interested in, the proposed action which is the subject of the petition.
- Any request by petitioner for a meeting provided for by rule 26.4(17A).
- Original signature of petitioner and date signed.
657—26.2 (17A) Briefs.
The petitioner may attach
a brief to the petition in support of the action urged in the petition. The board
may request a brief from the petitioner or from any other person concerning the
substance of the petition.
657—26.3 (17A) Inquiries.
Inquiries concerning
the status of a petition for rule making may be made to Executive Secretary/Director,
Iowa Board of Pharmacy Examiners, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa
50309-4688, or via electronic mail to lloyd.jessen@ibpe.state.ia.us.
657—26.4(17A) Board consideration.
26.4(1) Initial activities. Within 14 days after the filing
of a petition, the board shall submit a copy of the petition and any accompanying
brief to the administrative rules coordinator and to the administrative rules review
committee. Upon request by petitioner in the petition, the board shall schedule
a brief and informal meeting between the petitioner and the board, a member of the
board, or a member of the staff of the board to discuss the petition. The board
may request that the petitioner submit additional information or argument concerning
the petition. The board may also solicit comments from any person on the substance
of the petition. Any person may submit to the board comments on the substance of
the petition.
26.4(2) Decision issued. Within 60 days after the filing
of the petition, or within any longer period agreed to by the petitioner, the board
shall, in writing, deny the petition, and notify petitioner of its action and the
specific grounds for the denial, or grant the petition and notify petitioner that
it has instituted rule-making proceedings on the subject of the petition. Petitioner
shall be deemed notified of the denial or grant of the petition on the date when
the board mails or delivers the required notification to petitioner.
26.4(3) Denial for nonconformity. Denial of a petition
because it does not substantially conform to the required form does not preclude
the filing of a new petition on the same subject that seeks to eliminate the grounds
for the board’s rejection of the original petition.
These rules are intended to implement Iowa Code section 17A.7.
657 IAC Chapter 27 DECLARATORY ORDERS
657—27.1 (17A) Petition for declaratory order.
Any person may file a petition with the board of pharmacy examiners, hereinafter
referred to as "the board," for a declaratory order as to the applicability
to specified circumstances of a statute, rule, or order within the primary jurisdiction
of the Board of Pharmacy Examiners at 400 S.W. Eighth Street, Suite E, Des Moines,
Iowa 50309-4688. A petition is deemed filed when it is received by that office.
The board shall provide the petitioner with a file-stamped copy of the petition
if the petitioner provides the board an extra copy for this purpose. The petition
shall be typewritten or legibly handwritten in ink and shall substantially conform
to the following form:
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BOARD OF PHARMACY EXAMINERS
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Petition by (Name of Petitioner)
for a Declaratory Order on (Cite provisions of law involved). |
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PETITION FOR
DECLARATORY ORDER |
The petition shall provide the following information:
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A clear and concise statement of all relevant facts on which the order is requested.
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A citation and the relevant language of the specific statutes, rules, policies, decisions, or orders, whose applicability is questioned, and any other relevant law.
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The questions petitioner wants answered, stated clearly and concisely.
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The answers to the questions desired by the petitioner and a summary of the reasons urged by the petitioner in support of those answers.
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The reasons for requesting the declaratory order and disclosure of the petitioner's interest in the outcome.
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A statement indicating whether the petitioner is currently a party to another proceeding involving the questions at issue and whether, to the petitioner's knowledge, those questions have been decided by, are pending determination by, or are under investigation by, any governmental entity.
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The names and addresses of other persons, or a description of any class of persons, known by petitioner to be affected by, or interested in, the questions presented in the petition.
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Any request by petitioner for a meeting provided for by 657—27.7(17A).
The petition shall be dated and signed by the petitioner or the petitioner's representative.
It shall also include the name, mailing address, and telephone number of the petitioner
and petitioner's representative and a statement indicating the person to whom communications
concerning the petition should be directed.
657—27.2(17A) Notice of petition.
Within 15 days after receipt of a petition for a declaratory order, the board shall
give notice of the petition to all persons not served by the petitioner pursuant
to 657—27.6(17A) to whom notice is required by any provision of law. The board may
also give notice to any other persons.
657—27.3(17A) Intervention.
27.3(1) Persons who qualify under any applicable provision of law as an intervenor
and who file a petition for intervention within 20 days of the filing of a petition
for declaratory order shall be allowed to intervene in a proceeding for a declaratory
order.
27.3(2) Any person who files a petition for intervention at any time prior to the
issuance of an order may be allowed to intervene in a proceeding for a declaratory
order at the discretion of the board.
27.3(3) A petition for intervention shall be filed at the board office at 400 S.W.
Eighth Street, Suite E, Des Moines, Iowa 50309-4688. Such a petition is deemed filed
when it is received by that office. The board will provide the petitioner with a
file-stamped copy of the petition for intervention if the petitioner provides an
extra copy for this purpose. A petition for intervention shall be typewritten or
legibly handwritten in ink and shall substantially conform to the following form:
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BOARD OF PHARMACY EXAMINERS
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Petition by (Name of Original Petitioner)
for a Declaratory Order on (Cite provisions of law cited in original petition). |
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PETITION FOR INTERVENTION
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The petition for intervention shall provide the following information:
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Facts supporting the intervenor's standing and qualifications for intervention.
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The answers urged by the intervenor to the question or questions presented and a summary of the reasons urged in support of those answers.
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Reasons for requesting intervention and disclosure of the intervenor's interest in the outcome.
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A statement indicating whether the intervenor is currently a party to any proceeding involving the questions at issue and whether, to the intervenor's knowledge, those questions have been decided by, are pending determination by, or are under investigation by, any governmental entity.
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The names and addresses of any additional persons, or a description of any additional class of persons, known by the intervenor to be affected by, or interested in, the questions presented.
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Whether the intervenor consents to be bound by the determination of the matters presented in the declaratory order proceeding.
The petition shall be dated and signed by the intervenor or the intervenor's representative.
It shall also include the name, mailing address, and telephone number of the intervenor
and intervenor's representative, and a statement indicating the person to whom communications
should be directed.
657—27.4(17A) Briefs.
The petitioner or any intervenor may file a brief in support of the position urged.
The board may request a brief from the petitioner, any intervenor, or any other
person concerning the questions raised.
657—27.5(17A) Inquiries.
Inquiries concerning the status of a declaratory order proceeding may be made to
the Board of Pharmacy Examiners, 400 S.W. Eighth Street, Suite E, Des Moines, Iowa
50309-4688.
657—27.6(17A) Service and filing of petitions and other papers.
27.6(1) When service required. Except where otherwise provided
by law, every petition for declaratory order, petition for intervention, brief,
or other paper filed in a proceeding for a declaratory order shall be served upon
each of the parties of record to the proceeding, and on all other persons identified
in the petition for declaratory order or petition for intervention as affected by
or interested in the questions presented, simultaneously with their filing. The
party filing a document is responsible for service on all parties and other affected
or interested persons.
27.6(2) Filing — when required. All petitions for declaratory orders,
petitions for intervention, briefs, or other papers in a proceeding for a declaratory
order shall be filed with the Board of Pharmacy Examiners, 400 S.W. Eighth Street,
Suite E, Des Moines, Iowa 50309-4688. All petitions, briefs, or other papers that
are required to be served upon a party shall be filed simultaneously with the board.
27.6(3) Method of service, time of filing, and proof of mailing.
Method of service, time of filing, and proof of mailing shall be as provided by
657—35.11(17A,272C).
657—27.7(17A) Consideration.
Upon request by petitioner, the board shall schedule a brief and informal meeting
between the original petitioner, all intervenors, and the board, a member of the
board, or a member of the staff of the board, to discuss the questions raised. The
board may solicit comments from any person on the questions raised. Also, comments
on the questions raised may be submitted to the board by any person.
657—27.8(17A) Action on petition.
27.8(1) Within the time allowed by 1998 Iowa Acts, chapter 1202,
section 13(5), after receipt of a petition for a declaratory order, the executive
secretary/director or designee shall take action on the petition as required by
1998 Iowa Acts, chapter 1202, section 13(5).
27.8(2) The date of issuance of an order or of a refusal to issue
an order is as defined in 657—35.2(17A,272C).
657—27.9(17A) Refusal to issue order.
27.9(1) The board shall not issue a declaratory order where prohibited by 1998 Iowa
Acts, chapter 1202, section 13(1), and may refuse to issue a declaratory order on
some or all questions raised for the following reasons:
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The petition does not substantially comply with the required form.
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The petition does not contain facts sufficient to demonstrate that the petitioner will be aggrieved or adversely affected by the failure of the board to issue an order.
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The board does not have jurisdiction over the questions presented in the petition.
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The questions presented by the petition are also presented in a current rule making, contested case, or other board or judicial proceeding, that may definitively resolve them.
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The questions presented by the petition would more properly be resolved in a different type of proceeding or by another body with jurisdiction over the matter.
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The facts or questions presented in the petition are unclear, overbroad, insufficient, or otherwise inappropriate as a basis upon which to issue an order.
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There is no need to issue an order because the questions raised in the petition have been settled due to a change in circumstances.
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The petition is not based upon facts calculated to aid in the planning of future conduct but is, instead, based solely upon prior conduct in an effort to establish the effect of that conduct or to challenge a board decision already made.
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The petition requests a declaratory order that would necessarily determine the legal rights, duties, or responsibilities of other persons who have not joined in the petition, intervened separately, or filed a similar petition and whose position on the questions presented may fairly be presumed to be adverse to that of petitioner.
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The petitioner requests the board to determine whether a statute is unconstitutional on its face.
27.9(2) A refusal to issue a declaratory order shall indicate the specific grounds
for the refusal and constitutes final board action on the petition.
27.9(3) Refusal to issue a declaratory order pursuant to this provision does not
preclude the filing of a new petition that seeks to eliminate the grounds for the
refusal to issue an order.
657—27.10(17A) Contents of declaratory order — effective date.
In addition to the order itself, a declaratory order shall contain the date of its
issuance, the name of petitioner and all intervenors, the specific statutes, rules,
policies, decisions, or orders involved, the particular facts upon which it is based,
and the reasons for its conclusion. A declaratory order is effective on the date
of issuance.
657—27.11(17A) Copies of orders.
A copy of all orders issued in response to a petition for a declaratory order shall
be mailed promptly to the original petitioner and all intervenors.
657—27.12(17A) Effect of a declaratory order.
A declaratory order has the same status and binding effect as a final order issued
in a contested case proceeding. It is binding on the board, the petitioner, and
any intervenors and is applicable only in circumstances where the relevant facts
and the law involved are indistinguishable from those on which the order was based.
As to all other persons, a declaratory order serves only as precedent and is not
binding on the board. The issuance of a declaratory order constitutes final board
action on the petition.
These rules are intended to implement Iowa Code section 17A.9 as amended by 1998
Iowa Acts, chapter 1202, section 13.
657 IAC Chapter 28 AGENCY PROCEDURE FOR RULE MAKING
657—28.1(17A) Applicability.
Except to the extent otherwise expressly
provided by statute, all rules adopted by the board of pharmacy examiners, hereinafter
referred to as "board," are subject to the provisions of Iowa Code chapter 17A,
the Iowa administrative procedure Act, and the provisions of this chapter.
657—28.2(17A) Advice on possible rules before notice of proposed rule adoption.
In addition to seeking information by other methods, the board may, before publication
of a Notice of Intended Action under Iowa Code section 17A.4(1)"a," solicit comments
from the public on a subject matter of possible rule making by the board by causing
notice to be published in the Iowa Administrative Bulletin of the subject matter
and indicating where, when, and how persons may comment.
657—28.3(17A) Public rule-making docket.
28.3(1) Docket maintained. The board shall maintain a
current public rule-making docket.
28.3(2) Anticipated rule making. The rule-making docket
shall list each anticipated rule-making proceeding. A rule-making proceeding is
deemed "anticipated" from the time a draft of proposed rules is distributed for
internal discussion within the board. For each anticipated rule-making proceeding
the docket shall contain a listing of the precise subject matter which may be submitted
for consideration by the board for subsequent proposal under the provisions of Iowa
Code section 17A.4(1)"a," the name and address of board personnel with whom persons
may communicate with respect to the matter, and an indication of the present status
within the board of that possible rule. The board may also include in the docket
other subjects upon which public comment is desired.
28.3(3) Pending rule-making proceedings. The rule-making
docket shall list each pending rule-making proceeding. A rule-making proceeding
is pending from the time it is commenced, by publication in the Iowa Administrative
Bulletin of a Notice of Intended Action pursuant to Iowa Code section 17A.4(1)"a,"
to the time it is terminated, by publication of a Notice of Termination in the Iowa
Administrative Bulletin, or the rule becoming effective. For each rule-making proceeding,
the docket shall indicate:
- The subject matter of the proposed rule;
- A citation to all published notices relating to the proceeding;
- Where written submissions on the proposed rule may be inspected;
- The time during which written submissions may be made;
- The names of persons who have made written requests for an opportunity to make oral presentations on the proposed rule, where those requests may be inspected, and where and when oral presentations may be made;
- Whether a written request for the issuance of a regulatory analysis or a concise statement of reasons has been filed, whether such an analysis or statement or a fiscal impact statement has been issued, and where any such written request, analysis, or statement may be inspected;
- The current status of the proposed rule and any board determinations with respect thereto;
- Any known timetable for board decisions or other action in the proceeding;
- The date of the rule’s adoption;
- The date of the rule’s filing, indexing, and publication;
- The date on which the rule will become effective; and
- Where the rule-making record may be inspected.
657—28.4(17A) Notice of proposed rule making.
28.4(1) Contents. At least 35 days before the adoption
of a rule the board shall cause Notice of Intended Action to be published in the
Iowa Administrative Bulletin. The Notice of Intended Action shall include:
- A brief explanation of the purpose of the proposed rule;
- The specific legal authority for the proposed rule;
- Except to the extent impracticable, the text of the proposed rule;
- Where, when, and how persons may present their views on the proposed rule; and
- Where, when, and how persons may demand an oral proceeding on the proposed rule if the notice does not already provide for one.
Where inclusion of the complete text of a proposed rule in the Notice of Intended
Action is impracticable, the board shall include in the notice a statement fully
describing the specific subject matter of the omitted portion of the text of the
proposed rule, the specific issues to be addressed by that omitted text of the proposed
rule, and the range of possible choices being considered by the board for the resolution
of each of those issues.
28.4(2) Incorporation by reference. A proposed rule may
incorporate other materials by reference only if it complies with all of the requirements
applicable to the incorporation by reference of other materials in an adopted rule
that are contained in subrule 28.12(2) of this chapter.
28.4(3) Copies of notices. Persons desiring to receive
copies of future Notices of Intended Action by subscription shall file with the
board a written request indicating the name and address to which such notices should
be sent. Within seven days after submission of a Notice of Intended Action to the
administrative rules coordinator for publication in the Iowa Administrative Bulletin,
the board shall mail or electronically transmit a copy of that notice to subscribers
who have filed a written request for either mailing or electronic transmittal with
the board for Notices of Intended Action. The written request shall be accompanied
by payment of the subscription price which may cover the full cost of the subscription
service, including its administrative overhead and the cost of copying and mailing
the Notices of Intended Action for a period of one year.
657—28.5(17A) Public participation.
28.5(1) Written comments. For at least 20 days after publication
of the Notice of Intended Action, persons may submit argument, data, and views,
in writing, on the proposed rule. Such written submissions shall identify the proposed
rule to which they relate and shall be submitted to the Iowa Board of Pharmacy Examiners,
400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309-4688, or the person designated
in the Notice of Intended Action.
28.5(2) Oral proceedings. The board may, at any time,
schedule an oral proceeding on a proposed rule. The board shall schedule an oral
proceeding on a proposed rule if, within 20 days after the published Notice of Intended
Action, a written request for an opportunity to make oral presentations is submitted
to the board by the administrative rules review committee, a governmental subdivision,
an agency, an association having not less than 25 members, or at least 25 persons.
That request shall also contain the following additional information:
- A request by one or more individual persons shall be signed by each of them and include the address and telephone number of each of them.
- A request by an association shall be signed by an officer or designee of the association and shall contain a statement that the association has at least 25 members and the address and telephone number of the person signing that request.
- A request by an agency or governmental subdivision shall be signed by an official having authority to act on behalf of the entity and shall contain the address and telephone number of the person signing that request.
28.5(3) Conduct of oral proceedings.
- Applicability. This subrule applies only to those oral rule-making proceedings in which an opportunity to make oral presentations is authorized or required by Iowa Code section 17A.4(1)“b” as amended by 1998 Iowa Acts, chapter 1202, section 8, or subrule 28.5(2).
- Scheduling and notice. An oral proceeding on a proposed rule may be held in one or more locations and shall not be held earlier than 20 days after notice of its location and time is published in the Iowa Administrative Bulletin. That notice shall also identify the proposed rule by ARC number and citation to the Iowa Administrative Bulletin.
- Presiding officer. The board, a member of the board, or another person designated by the board who will be familiar with the substance of the proposed rule, shall preside at the oral proceeding on a proposed rule. If the board does not preside, the presiding officer shall prepare a memorandum for consideration by the board summarizing the contents of the presentations made at the oral proceeding unless the board determines that such a memorandum is unnecessary because the board will personally listen to or read the entire transcript of the oral proceeding.
- Conduct of proceeding. At an oral proceeding on a proposed rule, persons may make oral statements and make documentary and physical submissions, which may include data, views, comments or arguments concerning the proposed rule. Persons wishing to make oral presentations at such a proceeding are encouraged to notify the board at least one business day prior to the proceeding and indicate the general subject of their presentations. At the proceeding, those who participate shall indicate their names and addresses, identify any persons or organizations they may represent, and provide any other information relating to their participation deemed appropriate by the presiding officer. Oral proceedings shall be open to the public and shall be recorded by stenographic or electronic means.
- (1) At the beginning of the oral proceeding, the presiding officer shall give a brief synopsis of the proposed rule, a statement of the statutory authority for the proposed rule, and the reasons for the board decision to propose the rule. The presiding officer may place time limitations on individual oral presentations when necessary to ensure the orderly and expeditious conduct of the oral proceeding. To encourage joint oral presentations and to avoid repetition, additional time may be provided for persons whose presentations represent the views of other individuals as well as their own views.
- (2) Persons making oral presentations are encouraged to avoid restating matters which have already been submitted in writing.
- (3) To facilitate the exchange of information, the presiding officer may, where time permits, open the floor to questions or general discussion.
- (4) The presiding officer shall have the authority to take any reasonable action necessary for the orderly conduct of the meeting.
- (5) Physical and documentary submissions presented by participants in the oral proceeding shall be submitted to the presiding officer. Such submissions become the property of the board.
- (6) The oral proceeding may be continued by the presiding officer to a later time without notice other than by announcement at the hearing.
- (7) Participants in an oral proceeding shall not be required to take an oath or to submit to cross-examination. However, the presiding officer in an oral proceeding may question participants and permit the questioning of participants by other participants about any matter relating to that rule-making proceeding, including any prior written submissions made by those participants in that proceeding; but no participant shall be required to answer any question.
- (8) The presiding officer in an oral proceeding may permit rebuttal statements and request the filing of written statements subsequent to the adjournment of the oral presentations.
28.5(4) Additional information. In addition to receiving
written comments and oral presentations on a proposed rule according to the provisions
of this rule, the board may obtain information concerning a proposed rule through
any other lawful means deemed appropriate under the circumstances.
28.5(5) Accessibility. The board shall schedule oral proceedings
in rooms accessible to and functional for persons with physical disabilities. Persons
who have special requirements should contact the board of pharmacy examiners, telephone
(515)281-5944, in advance to arrange access or other needed services.
657—28.6(17A) Regulatory analysis.
28.6(1) Definition of small business. A “small business”
is defined in 1998 Iowa Acts, chapter 1202, section 10(7).
28.6(2) Mailing list. Small businesses or organizations
of small businesses may be registered on the board’s small business impact
list by making a written application addressed to the Iowa Board of Pharmacy Examiners,
400 S.W. Eighth Street, Suite E, Des Moines, Iowa 50309-4688. The application for
registration shall state:
- The name of the small business or organization of small businesses;
- Its address;
- The name of a person authorized to transact business for the applicant;
- A description of the applicant’s business or organization. An organization representing 25 or more persons who qualify as a small business shall indicate that fact.
- Whether the registrant desires copies of Notices of Intended Action at cost, or desires advance notice of the subject of all or some specific category of proposed rule making affecting small business.
The board may at any time request additional information from the applicant to determine
whether the applicant is qualified as a small business or as an organization of
25 or more small businesses. The board may periodically send a letter to each registered
small business or organization of small businesses asking whether that business
or organization wishes to remain on the registration list. The name of a small business
or organization of small businesses will be removed from the list if a negative
response is received or if no response is received within 30 days after the letter
is sent.
28.6(3) Time of mailing. Within seven days after submission
of a Notice of Intended Action to the administrative rules coordinator for publication
in the Iowa Administrative Bulletin, the board shall mail to all registered small
businesses or organizations of small businesses, in accordance with their request,
either a copy of the Notice of Intended Action or notice of the subject of that
proposed rule making. In the case of a rule that may have an impact on small business
adopted in reliance upon Iowa Code section 17A.4(2), the board shall mail notice
of the adopted rule to registered businesses or organizations prior to the time
the adopted rule is published in the Iowa Administrative Bulletin.
28.6(4) Qualified requesters for regulatory analysis— economic
impact. The board shall issue a regulatory analysis of a proposed rule
that conforms to the requirements of 1998 Iowa Acts, chapter 1202, section 10(2a),
after a proper request from:
- The administrative rules coordinator or
- The administrative rules review committee.
28.6(5) Qualified requesters for regulatory analysis— business
impact. The board shall issue a regulatory analysis of a proposed rule
that conforms to the requirements of 1998 Iowa Acts, chapter 1202, section 10(2b),
after a proper request from:
- The administrative rules review committee;
- The administrative rules coordinator;
- At least 25 or more persons who sign the request provided that each represents a different small business;
- An organization representing at least 25 small businesses. That organization shall list the name, address, and telephone number of not less than 25 small businesses it represents.
28.6(6) Time period for analysis. Upon receipt of a timely
request for a regulatory analysis the board shall adhere to the time lines described
in 1998 Iowa Acts, chapter 1202, section 10(4).
28.6(7) Contents of request. A request for a regulatory
analysis is made when it is mailed or delivered to the board. The request shall
be in writing and satisfy the requirements of 1998 Iowa Acts, chapter 1202, section
10(1).
28.6(8) Contents of concise summary. The contents of the
concise summary shall conform to the requirements of 1998 Iowa Acts, chapter 1202,
section 10(4,5).
28.6(9) Publication of a concise summary. The board shall
make available, to the maximum extent feasible, copies of the published summary
in conformance with 1998 Iowa Acts, chapter 1202, section 10(5).
28.6(10) Regulatory analysis contents—rules review committee or
rules coordinator. When a regulatory analysis is issued in response to
a written request from the administrative rules review committee or the administrative
rules coordinator, the regulatory analysis shall conform to the requirements of
1998 Iowa Acts, chapter 1202, section 10(2a), unless a written request expressly
waives one or more of the items listed in the section.
28.6(11) Regulatory analysis contents—substantial impact on small
business. When a regulatory analysis is issued in response to a written
request from the administrative rules review committee, the administrative rules
coordinator, at least 25 persons signing that request who each qualify as a small
business, or by an organization representing at least 25 small businesses, the regulatory
analysis shall conform to the requirements of 1998 Iowa Acts, chapter 1202, section
10(2b).
657—28.7(17A,25B) Fiscal impact statement.
28.7(1) A proposed rule that mandates additional combined expenditures
exceeding $100,000 by all affected political subdivisions or agencies and entities
which contract with political subdivisions to provide services shall be accompanied
by a fiscal impact statement outlining the costs associated with the rule. A fiscal
impact statement shall satisfy the requirements of Iowa Code section 25B.6.
28.7(2) If the board determines at the time it adopts a rule that
the fiscal impact statement upon which the rule is based contains errors, the board
shall, at the same time, issue a corrected fiscal impact statement and publish the
corrected fiscal impact statement in the Iowa Administrative Bulletin.
657—28.8(17A) Time and manner of rule adoption.
28.8(1) Time of adoption. The board shall not adopt a rule until
the period for making written submissions and oral presentations has expired. Within
180 days after the later of the publication of the Notice of Intended Action, or
the end of oral proceedings thereon, the board shall adopt a rule pursuant to the
rule-making proceeding or terminate the proceeding by publication of a notice to
that effect in the Iowa Administrative Bulletin.
28.8(2) Consideration of public comment. Before the adoption of
a rule, the board shall consider fully all of the written submissions and oral submissions
received in that rule-making proceeding, or any memorandum summarizing such oral
submissions, and any regulatory analysis or fiscal impact statement issued in that
rule-making proceeding.
28.8(3) Reliance on board expertise. Except as otherwise provided
by law, the board may use its own experience, technical competence, specialized
knowledge, and judgment in the adoption of a rule.
657—28.9(17A) Variance between adopted rule and published notice of proposed
rule adoption.
28.9(1) The board shall not adopt a rule that differs from the
rule proposed in the Notice of Intended Action on which the rule is based unless:
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The differences are within the scope of the subject matter announced in the Notice of Intended Action and are in character with the issues raised in that notice; and
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The differences are a logical outgrowth of the contents of that Notice of Intended Action and the comments submitted in response thereto; and
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The Notice of Intended Action provided fair warning that the outcome of that rule-making proceeding could be the rule in question.
28.9(2) In determining whether the Notice of Intended Action provided
fair warning that the outcome of that rule-making proceeding could be the rule in
question, the board shall consider the following factors:
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The extent to which persons who will be affected by the rule should have understood that the rule-making proceeding on which it is based could affect their interests;
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The extent to which the subject matter of the rule or the issues determined by the rule are different from the subject matter or issues contained in the Notice of Intended Action; and
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The extent to which the effects of the rule differ from the effects of the proposed rule contained in the Notice of Intended Action.
28.9(3) The board shall commence a rule-making proceeding within
60 days of its receipt of a petition for rule making seeking the amendment or repeal
of a rule that differs from the proposed rule contained in the Notice of Intended
Action upon which the rule is based, unless the board finds that the differences
between the adopted rule and the proposed rule are so insubstantial as to make such
a rule-making proceeding wholly unnecessary. A copy of any such finding and the
petition to which it responds shall be sent to petitioner, the administrative rules
coordinator, and the administrative rules review committee, within three days of
its issuance.
28.9(4) Concurrent rule-making proceedings. Nothing in this rule
disturbs the discretion of the board to initiate, concurrently, several different
rule-making proceedings on the same subject with several different published Notices
of Intended Action.
657—28.10(17A) Exemptions from public rule-making procedures.
28.10(1) Omission of notice and comment. To the extent the board
for good cause finds that public notice and participation are unnecessary, impracticable,
or contrary to the public interest in the process of adopting a particular rule,
the board may adopt that rule without publishing advance Notice of Intended Action
in the Iowa Administrative Bulletin and without providing for written or oral public
submissions prior to its adoption. The board shall incorporate the required finding
and a brief statement of its supporting reasons in each rule adopted in reliance
upon this subrule.
28.10(2) Categories exempt. The following narrowly tailored categories
of rules are exempted from the usual public notice and participation requirements
because those requirements are unnecessary, impracticable, or contrary to the public
interest with respect to each and every member of the defined class:
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Temporary designation of controlled substances consistent with federal Drug Enforcement Administration action to add a substance to a drug schedule or to change the schedule within which a substance is controlled under the Controlled Substances Act.
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Amend references to the Iowa Code, the Iowa Administrative Code, or the Code of Federal Regulations where such references change or are otherwise incorrect.
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Change the name, address, or telephone number of the board of pharmacy examiners or an authorized contact person.
28.10(3) Public proceedings on rules adopted without them. The board may, at any
time, commence a standard rule-making proceeding for the adoption of a rule that
is identical or similar to a rule it adopts in reliance upon subrule 28.10(1). Upon
written petition by a governmental subdivision, the administrative rules review
committee, an agency, the administrative rules coordinator, an association having
not less than 25 members, or at least 25 persons, the board shall commence a standard
rule-making proceeding for any rule specified in the petition that was adopted in
reliance upon subrule 28.10(1). Such a petition shall be filed within one year of
the publication of the specified rule in the Iowa Administrative Bulletin as an
adopted rule. The rule-making proceeding on that rule shall be commenced within
60 days of the receipt of such a petition. After a standard rule-making proceeding
commenced pursuant to this subrule, the board may either readopt the rule it adopted
without benefit of all usual procedures on the basis of subrule 28.10(1), or may
take any other lawful action, including the amendment or repeal of the rule in question,
with whatever further proceedings are appropriate.
657—28.11(17A) Concise statement of reasons.
28.11(1) General. When requested by a person, either prior to the
adoption of a rule or within 30 days after its publication in the Iowa Administrative
Bulletin as an adopted rule, the board shall issue a concise statement of reasons
for the rule. Requests for such a statement shall be in writing and be delivered
to the Board of Pharmacy Examiners, 400 S.W. Eighth Street, Suite E, Des Moines,
Iowa 50309-4688. The request shall indicate whether the statement is sought for
all or only a specified part of the rule. Requests will be considered made on the
date received.
28.11(2) Contents. The concise statement of reasons shall contain:
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The reasons for adopting the rule;
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An indication of any change between the text of the proposed rule contained in the published Notice of Intended Action and the text of the rule as finally adopted, with the reasons for any such change;
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The principal reasons urged in the rule-making proceeding for and against the rule, and the board's reasons for overruling the arguments made against the rule.
28.11(3) Time of issuance. After a proper request, the board shall
issue a concise statement of reasons by the later of the time the rule is adopted
or 35 days after receipt of the request.
657—28.12(17A) Contents, style, and form of rule.
28.12(1) Contents. Each rule adopted by the board shall contain
the text of the rule and, in addition:
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The date the board adopted the rule;
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A brief explanation of the principal reasons for the rulemaking action if such reasons are required by 1998 Iowa Acts, chapter 1202, section 8, or the board in its discretion decides to include such reasons;
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A reference to all rules repealed, amended, or suspended by the rule;
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A reference to the specific statutory or other authority authorizing adoption of the rule;
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Any findings required by any provision of law as a prerequisite to adoption or effectiveness of the rule;
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A brief explanation of the principal reasons for the failure to provide for waivers to the rule if no waiver provision is included and a brief explanation of any waiver or special exceptions provided in the rule if such reasons are required by 1998 Iowa Acts, chapter 1202, section 8, or the board in its discretion decides to include such reasons; and
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The effective date of the rule.
28.12(2) Incorporation by reference. The board may incorporate
by reference in a proposed or adopted rule, and without causing publication of the
incorporated matter in full, all or any part of a code, standard, rule, or other
matter if the board finds that the incorporation of its text in the board proposed
or adopted rule would be unduly cumbersome, expensive, or otherwise inexpedient.
The reference in the board proposed or adopted rule shall fully and precisely identify
the incorporated matter by location, title, citation, date, and edition, if any;
shall briefly indicate the precise subject and the general contents of the incorporated
matter; and shall state that the proposed or adopted rule does not include any later
amendments or editions of the incorporated matter. The board may incorporate such
matter by reference in a proposed or adopted rule only if the board makes copies
of it readily available to the public. The rule shall state how and where copies
of the incorporated matter may be obtained at cost from the board, and how and where
copies may be obtained from the agency of the United States, this state, another
state, or the organization, association, or persons, originally issuing that matter.
The board shall retain permanently a copy of any materials incorporated by reference
in a rule of the board.
If the board adopts standards by reference to another publication, it shall provide
a copy of the publication containing the standards to the administrative rules coordinator
for deposit in the state law library and may make the standards available electronically.
28.12(3) References to materials not published in full. When the
administrative code editor decides to omit the full text of a proposed or adopted
rule because publication of the full text would be unduly cumbersome, expensive,
or otherwise inexpedient, the board shall prepare and submit to the administrative
code editor for inclusion in the Iowa Administrative Bulletin and Iowa Administrative
Code a summary statement describing the specific subject matter of the omitted material.
This summary statement shall include the title and a brief description sufficient
to inform the public of the specific nature and subject matter of the proposed or
adopted rules and of significant issues involved in these rules. The summary statement
shall also describe how a copy of the full text of the proposed or adopted rule,
including any unpublished matter and any matter incorporated by reference, may be
obtained from the board. The board will provide a copy of that full text, at actual
cost upon request, and shall make copies of the full text available for review at
the state law library and may make the standards available electronically.
At the request of the administrative code editor, the board shall provide a proposed
statement explaining why publication of the full text would be unduly cumbersome,
expensive, or otherwise inexpedient.
28.12(4) Style and form. In preparing its rules, the board shall
follow the uniform numbering system, form, and style prescribed by the administrative
rules coordinator.
657—28.13(17A) Board rule-making record.
28.13(1) Requirement. The board shall maintain an official rule-making
record for each rule it proposes by publication in the Iowa Administrative Bulletin
of a Notice of Intended Action or adopts. The rule-making record and materials incorporated
by reference shall be available for public inspection.
28.13(2) Contents. The board rule-making record shall contain:
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Copies of all publications in the Iowa Administrative Bulletin with respect to the rule or the proceeding upon which the rule is based and any file-stamped copies of board submissions to the administrative rules coordinator concerning that rule or the proceeding upon which it is based:
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Copies of any portions of the board's public rule-making docket containing entries relating to the rule or the proceeding upon which the rule is based;
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All written petitions, requests, and submissions received by the board, and all other written materials of a factual nature as distinguished from opinion that are relevant to the merits of the rule and that were created or compiled by the board and considered by the board, in connection with the formulation, proposal, or adoption of the rule or the proceeding upon which the rule is based, except to the extent the board is authorized by law to keep them confidential; provided, however, that when any such materials are deleted because they are authorized by law to be kept confidential, the board shall identify in the record the particular materials deleted and state the reasons for that deletion;
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Any official transcript of oral presentations made in the proceeding upon which the rule is based or, if not transcribed, the stenographic record or electronic recording of those presentations, and any memorandum prepared by a presiding officer summarizing the contents of those presentations;
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A copy of any regulatory analysis or fiscal impact statement prepared for the proceeding upon which the rule is based;
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A copy of the rule and any concise statement of reasons prepared for that rule;
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All petitions for amendment of, or repeal or suspension of, the rule;
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A copy of any objection to the issuance of that rule without public notice and participation that was filed pursuant to Iowa Code section 17A.4(2) by the administrative rules review committee, the governor, or the attorney general;
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A copy of any objection to the rule filed by the administrative rules review committee, the governor, or the attorney general pursuant to Iowa Code section 17A.4(4), and any board response to that objection;
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A copy of any significant written criticism of the rule, including a summary of any petitions for waiver of the rule; and
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A copy of any executive order concerning the rule.
28.13(3) Effect of record. Except as otherwise required by a provision
of law, the board rule-making record required by this rule need not constitute the
exclusive basis for board action on that rule.
28.13(4) Maintenance of record. The board shall maintain the rule-making
record for a period of not less than five years from the later of the date the rule
to which it pertains became effective or the date of the Notice of Intended Action.
The board shall maintain a record of significant written criticism as described
in 28.13(2), paragraphs "g", "h", "i", or "j",
for a period of not less than five years from the date of the written criticism.
657—28.14(17A) Filing of rules.
The board shall file each rule it adopts in the office of the administrative rules
coordinator. The filing shall be executed as soon after adoption of the rule as
is practicable. At the time of filing, each rule shall have attached to it any fiscal
impact statement and any concise statement of reasons that was issued with respect
to that rule. If a fiscal impact statement or statement of reasons for that rule
was not issued until a time subsequent to the filing of that rule, the note or statement
shall be attached to the filed rule within five working days after the note or statement
is issued. In filing a rule, the board shall use the standard form prescribed by
the administrative rules coordinator.
657—28.15(17A) Effectiveness of rules prior to publication.
28.15(1) Grounds. The board may make a rule effective after its
filing at any stated time prior to 35 days after its indexing and publication in
the Iowa Administrative Bulletin if it finds that a statute so provides, the rule
confers a benefit or removes a restriction on some segment of the public, or that
the effective date of the rule is necessary to avoid imminent peril to the public
health, safety, or welfare. The board shall incorporate the required finding and
a brief statement of its supporting reasons in each rule adopted in reliance upon
this subrule.
28.15(2) Special notice. When the board makes a rule effective
prior to its indexing and publication in reliance upon the provisions of Iowa Code
section 17A.5(2)"b"(3), the board shall employ all reasonable efforts
to make its contents known to the persons who may be affected by that rule prior
to the rule's indexing and publication. The term "all reasonable efforts"
requires the board to employ the most effective and prompt means of notice rationally
calculated to inform potentially affected parties of the effectiveness of the rule
that is justified and practical under the circumstances considering the various
alternatives available for this purpose, the comparative costs to the board of utilizing
each of those alternatives, and the harm suffered by affected persons from any lack
of notice concerning the contents of the rule prior to its indexing and publication.
The means that may be used for providing notice of such rules prior to their indexing
and publication include, but are not limited to, any one or more of the following
means: radio, newspaper, television, signs, mail, telephone, personal notice, electronic
transmission, newsletter, or other timely publication.
A rule made effective prior to its indexing and publication in reliance upon the
provisions of Iowa Code section 17A.5(2)"b"(3), shall include in that
rule a statement describing the reasonable efforts that will be used to comply with
the requirements of this subrule.
657—28.16(17A) General statements of policy.
28.16(1) Compilation, indexing, public inspection. The board shall
maintain an official, current, and dated compilation that is indexed by subject
containing all of its general statements of policy within the scope of Iowa Code
section 17A.2(10), paragraphs "a", "c", "f", "g",
"h", and "k". Each addition to, change in, or deletion from
the official compilation shall also be dated, indexed, and a record maintained.
Except for those portions containing rules governed by Iowa Code section 17A.2(7)"f",
or otherwise authorized by law to be kept confidential, the compilation shall be
made available for public inspection and copying.
28.16(2) Enforcement of requirements. A general statement of policy
subject to the requirements of this rule shall not be relied on by the board to
the detriment of any person who does not have actual, timely knowledge of the contents
of the statement until the requirements of subrule 28.16(1) are satisfied. This
provision is inapplicable to the extent necessary to avoid imminent peril to the
public health, safety, or welfare.
657—28.17(17A) Review by board of rules.
28.17(1) Any interested person, association, agency, or political
subdivision may submit a written request to the administrative rules coordinator
requesting the board to conduct a formal review of a specified rule. Upon approval
of that request by the administrative rules coordinator, the board shall conduct
a formal review of a specified rule to determine whether a new rule should be adopted
or the rule should be amended or repealed. The board may refuse to conduct a review
if it has conducted such a review of the specified rule within five years prior
to the filing of the written request.
28.17(2) In conducting the formal review, the board shall prepare
within a reasonable time a written report summarizing its findings, its supporting
reasons, and any proposed course of action. The report shall include a concise statement
of the board's findings regarding the rule's effectiveness in achieving its objectives,
including a summary of any available supporting data.
These rules are intended to implement Iowa Code sections 17A.3 to 17A.7 as amended
by 1998 Iowa Acts, chapter 1202.