Rule-Making Notices (Hearing Notices)

Iowa: In Iowa an applicant is eligible for nurse licensure by examination if the applicant graduated from high school or the equivalent, completes an application, pays the fee, graduated from an approved program and passes NCLEX. If the person has a criminal conviction history or prior disciplinary action, the applicant must receive Board approval. If educated outside of the United States, the education is to be evaluated by the Commission on Graduates of Foreign Nursing Schools. A nurse from a compact state shall submit a completed application, pay the fee, declare Iowa as the primary state. A nurse is eligible for licensure by endorsement from a non-compact state if the applicant completes an application, pays a fee, has verification of original licensure and nursing program transcripts and submits a criminal background check. If educated outside of the United States, the education is to be evaluated by the Commission on Graduates of Foreign Nursing Schools. If the person has a criminal conviction history or prior disciplinary action, the applicant must receive Board approval.

Michigan: In Michigan an applicant is eligible for nurse licensure by examination if the applicant completed an application, pays the fees, completed approved nursing education program and passes NCLEX. If educated outside of the United States, the education is to be evaluated by the Commission on Graduates of Foreign Nursing Schools. A nurse is eligible for licensure by endorsement if the applicant completes an application, pays the fee, graduated from an approved school of nursing and was first licensed in another state pursuant to passage of NCLEX.

Minnesota: In Minnesota a nurse is eligible for licensure by examination if the applicant completes an application, pays the fee, graduated from an approved school and passes NCLEX. If educated outside of the United States, the education is to be evaluated by the Commission on Graduates of Foreign Nursing Schools. A nurse is eligible for licensure by endorsement if the applicant completes an application, pays the fee, shows verification of licensure in another jurisdiction, has passed an examination acceptable to the board and answers questions related to any prior disciplinary actions. If the applicant has not engaged in acceptable nursing practice within the 2 years of application, the applicant must complete one contact hour of continuing education for each month that the applicant was not engaged in acceptable practice for a maximum of 60 hours and if the person has not practiced for more than 5 years, the applicant must compete a nurse refresher course. Minnesota does issue privilege to practice nursing in Minnesota licenses to border state applicants upon meeting certain requirements.

Summary of factual data and analytical methodologies

The Board reviewed the National Council of State Board of Nursing's model rules and the licensing requirements in our neighboring states.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis

The rule was posted for economic comments for a period of 14 days and none were received. This rule is related to an individual's eligibility for licensure and does not effect small business.

Fiscal Estimate and Economic Impact Analysis

The Fiscal Estimate and Economic Impact Analysis is attached.

Initial Regulatory Flexibility Analysis or Summary

These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats.

Agency Contact Person

Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone [phone]; email at [e-mail].

STATE OF WISCONSIN DEPARTMENT OF ADMINISTRATION DOA-2049 (R03/2012)	Division of Executive Budget and Finance 101 East Wilson Street, 10th Floor P.O. Box 7864 Madison, WI 53707-7864 FAX: [phone]
ADMINISTRATIVE RULES Fiscal Estimate & Economic Impact Analysis

1. Type of Estimate and Analysis
X Original   ⍽ Updated   ⍽ Corrected
2. Administrative Rule Chapter, Title and Number
N 2, 3
3. Subject
Nurse Licensure
4. Fund Sources Affected			5. Chapter 20, Stats. Appropriations Affected
⍽ GPR   ⍽ FED   X PRO   ⍽ PRS   ⍽ SEG   ⍽ SEG-S			20.165(1)(g)
6. Fiscal Effect of Implementing the Rule
⍽ No Fiscal Effect ⍽ Indeterminate	⍽ Increase Existing Revenues ⍽ Decrease Existing Revenues		X Increase Costs X Could Absorb Within Agency's Budget ⍽ Decrease Cost
7. The Rule Will Impact the Following (Check All That Apply)
⍽ State's Economy ⍽ Local Government Units		⍽ Specific Businesses/Sectors ⍽ Public Utility Rate Payers ⍽ Small Businesses (if checked, complete Attachment A)
8. Would Implementation and Compliance Costs Be Greater Than $20 million? ⍽ Yes   X No
9. Policy Problem Addressed by the Rule
This rule updates and creates clarity regarding the process of obtaining a nurse license. There has not been a review of these chapters since 1984.
10. Summary of the businesses, business sectors, associations representing business, local governmental units, and individuals that may be affected by the proposed rule that were contacted for comments.
This rule was posted for economic comments for a period of 14 days and no comments were received.
11. Identify the local governmental units that participated in the development of this EIA.
None.
12. Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)
None.
13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
The benefit is to create clarity and bring the process in line with current technologies.
14. Long Range Implications of Implementing the Rule
The long range implication is an updated licensure procedure.
15. Compare With Approaches Being Used by Federal Government
None
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota)
Our neighboring states require graduation from an approved school and passage of the NCLEX. Both Illinois and Iowa require fingerprint criminal background checks. All of the neighboring states require a person educated outside of the U.S. to have their education evaluated by the Commission on Graduates of Foreign Nursing Schools. The endorsement requirements of our neighboring states include verification of licensure in the other jurisdiction(s) and consideration of past disciplinary actions. Illinois and Iowa require fingerprint criminal background checks. Minnesota requires nursing practice within 2 years of the application.
17. Contact Name				18. Contact Phone Number
Sharon Henes				[phone]

This document can be made available in alternate formats to individuals with disabilities upon request.

Notice of Hearing

Safety and Professional Services —
Board of Nursing

rulemaking_notices CR 14-004 CR 14-004

NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Board of Nursing in ss.15.08 (5) (b) and 441.01 (3), Wis. Stats., and interpreting ss. 441.01 (3) and (4) and 441.12, Wis. Stats., the Board of Nursing will hold a public hearing at the time and place indicated below to consider an order to repeal and recreate Chapter N 1, relating to school approval.

Hearing Information

Date:   Thursday, February 13, 2014
Time:   8:00 a.m.
Location:   1400 East Washington Avenue
  Room 121A
  Madison, Wisconsin

Appearances at the Hearing

Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to the Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708. Written comments must be received at or before the public hearing to be included in the record of rule-making proceedings.

Place where Comments are to be Submitted and Deadline for Submission

Comments may be submitted to Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, WI 53708-8935, or by email to [e-mail]. Comments must be received at or before the public hearing to be held on February 13, 2014 to be included in the record of rule-making proceedings.

Copies of Rule

Copies of this proposed rule are available upon request to Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, P.O. Box 8366, Madison, Wisconsin 53708, or by email at [e-mail].

Analysis prepared by the Department of Safety and Professional Services

Statutes interpreted

Sections 441.01 (3) and (4) and 441.12, Wis. Stats.

Statutory authority

Sections 15.08 (5) (b) and 441.01 (3), Wis. Stats.

Explanation of agency authority

The board shall promulgate rules for its own guidance and for the guidance of the profession to which it pertains.

Specifically, the board may establish minimum standards for schools for professional nurses and schools for licensed practical nurses, including all related clinical units and facilities, and make and provide periodic surveys and consultations to such schools. It may also establish rules to prevent unauthorized persons from practicing professional nursing. It shall approve all rules for the administration of chapter 441, Wis. Stats.

Related statute or rule

Sections 441.01 (3) and (4) and 441.12, Wis. Stats.

Plain language analysis

The proposed rule repeals and recreates the nursing school approval process chapter. The chapter has not been updated since 1989 and the school approval process has evolved since that time.

There are three stages to the approval process. The first stage is the authorization to plan a school of nursing. The institution will provide to the board the name and address of the controlling institution, accreditation status, statement of intent including the academic and licensure levels; evidence of the availability of clinical facilities, plan to recruit an educational administrator and faculty and the proposed timeline. The board will review the application and make a decision within two months of the completed application. The second stage is the authorization to admit students. The school of nursing will provide to the board verification of employment of an educational administrator, evidence of faculty, the school's philosophy and objectives, an overview of the curriculum, verification of student policies, the ability for the students to acquire clinical skills and an updated timeline. The board will review the materials and make a decision with two months. The last stage is approval of the school of nursing. A school may apply for approval upon graduation of the first class, but no later than graduation of the third class (class is defined as a 12 month period). The board may conduct a site survey. The decision on the application will occur within two months of the completed site survey or the completed application whichever is later. The board may grant approval, conditional approval or deny approval. If the board grants conditional approval, the board will state the basis and the school of nursing may not admit any new students into the school until the board meets the standard and receives full approval. If the school of nursing is denied approval, the school will receive a notice of denial and will take steps to close the school. The school may request a hearing and the closure of the school may be postponed during the appeals process.

Out of state schools operating in the state of Wisconsin will be approve and continual to be approved if the school is approved by the board of the state where the school is located and the school has approved nursing accreditation.

A school of nursing must receive national nursing accreditation within 3 years of school approval and all schools which already have approval as of July 1, 2014, must have accreditation by July 1, 2017. Failure to maintain nursing accreditation will result in loss of school approval.

School of nursing standards include:

•   The institution shall have legal responsibility for overall conduct of the school of nursing.

•   The educational administrator will have a license or privilege to practice nursing in Wisconsin, a graduate degree with a major in nursing, knowledge of learning principles for adult education or 2 years experience as an instructor in a nursing education program within the last 5 years and current knowledge of nursing practice.

•   Faculty will have a license or privilege to practice nursing in Wisconsin. Professional nursing faculty members will have a graduate degree with a major in nursing; practical nursing faculty members will have a baccalaureate degree with a major in nursing.

•   If a school of nursing is unable to have faculty whom meeting the standards, the school may apply to the board for a faculty exception.

•   Curriculum will enable to student to develop the knowledge, skills and abilities necessary for competent nursing practice expected at the level of licensure. It will be revised as necessary to reflect advances in health care and its delivery.

•   There will be clinical learning experiences in a variety of clinical or simulated settings.

•   Preceptors will be approved by the faculty of the school of nursing and have clear roles and responsibilities. The preceptors will have an unencumbered license or privilege to practice in Wisconsin.

•   The school of nursing will implement a plan for ongoing evaluation.

The national council licensure exam (NCLEX) pass rate standards for the school is one of the following

•   A minimum of 80% of first time test takers within 6 months of graduation

•   A minimum of 80% of all students taking the NCLEX and a plan to meet the first time test taker standard.

Failure to meet the standard will result in a warning letter and school of nursing to submit an institutional plan for improvement of the NCLEX pass rate. The school of nursing will submit progress reports until the standard is met.

A school of nursing will submit annual self-evaluation reports, all documents submitted to or received from nursing accreditation agencies and notify the board if there is a change in accreditation status. Failure to maintain nursing accreditation will result in loss of school approval. The board may review the school of nursing to determine whether the standards are being met in the following situations:

•   Change in accreditation status

•   Nursing accreditation reports indicate accreditation standards are not being met

•   Complaints received regarding the school

•   Failure to meet NCLEX pass rate standard for more than 2 consecutive years

•   Violation of any rules under this chapter.

The review of the school may include a site survey, self-study report or a progress report. If standards are not being met, the school of nursing shall submit a plan and progress reports as requested. The board may withdraw board approval if the school continues to not meet standards.

Closure of a school of nursing involves providing a placement for students and indicating where the academic records and transcripts will be stored and how access to those records will be maintained.

Nurse refresher courses are designed for nurses who have been out of practice for more than five years. The course will contain theory, skills labs and clinical experience. The board will review nurse the curriculum for inclusion on a listing of approved courses. The student who participates in a non-approved course may submit curriculum for approval.

Summary of, and comparison with, existing or proposed federal regulation

None

Comparison with rules in adjacent states

Illinois: Illinois program approval process includes: a letter of intent, a feasibility study, hiring of a nurse administrator, submission of a curriculum proposal, and a site survey. Continued approval is based upon annual evaluation reports, full routine site visits and maintaining a NCLEX pass rate of 75% of first time test takers. Major and minor curricular changes are reported to the board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications (allows for variances to faculty standards) and student standards.

Iowa: Iowa program approval process includes: first step involves an application with information regarding the controlling institution and needs assessment; second step involves verification of employment of the head of program, submission of program's philosophy and objectives, curriculum plan, letter of intent from clinical facilities, evidence of provision of faculty, proposed budget and timeframe for implementation; next step is interim approval based upon program proposal and site visit; final approval is upon graduation of first class and NCLEX pass rate results. Provisional approval may be granted to program until standards are met. Change of controlling institution and changes in administrative personnel in the program. The program shall submit annual reports. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications, student standards and evaluation of the program. NCLEX pass rate standard is a minimum of 95% of the national passing percentage based upon first time test takers within 6 months of graduation.

Michigan: Michigan program approval process includes: the first step requires submission of a letter of intent, evidence of funding and other support, copy of Michigan Department of Career Development approval (if necessary), evidence of availability of clinical experiences, proposed number of students, proposed first date of admission, plans for recruiting director of the program and faculty and a site visit; initial approval involves a self-student report and annual progress reports; full approval is after the graduation of the 2nd class, but no later than graduation of the 4th class (a class for each 12 month period) and requires submission of a self-study report and a site visit. Every 4 years the school shall submit a self-study report and accredited schools shall follow the schedule of the accrediting agency. Program changes shall be submitted to the board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications (allows for variances to faculty standards), student standards, and evaluation of the program. NCLEX pass rate standard is 75% of first time test takers.

Minnesota: Minnesota program approval process includes: Phase 1 requires letter of intent including institution information, timetable for development and implementation, documentation of availability of academic facilities, impact on nursing programs in the area; Phase II involves a site visit and documentation of compliance with educational standards in order to be granted initial approval; Phase III is full approval and continual approval based upon meeting the minimum first time NCLEX success rate and acquiring national nursing education accreditation. Minnesota requires surveys of all schools on a periodic basis to maintain approval. NCLEX pass rate standard is 75% of first time test takers. All schools must be accredited by 2016. Annual reports shall be submitted to the Board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, clinical standards, nurse administrator and faculty qualifications, student standards, and evaluation of the program. The curriculum standard is the program must provide diverse learning activities that are consistent with program outcomes. Minnesota has an approval process for schools applying for innovative approaches which may require exemption from certain rules.

Summary of factual data and analytical methodologies

The Board considered the National Council of State Boards of Nursing's model practice rules and the rules and processes of our neighboring states.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis

The rule was posted for 14 days for economic impact comments and none were received.

Fiscal Estimate and Economic Impact Analysis

The Fiscal Estimate and Economic Impact Analysis is attached.

Initial Regulatory Flexibility Analysis or Summary

These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats.

Agency Contact Person

Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Board Services, 1400 East Washington Avenue, Room 151, P.O. Box 8366, Madison, Wisconsin 53708; telephone [phone]; email at [e-mail].

STATE OF WISCONSIN DEPARTMENT OF ADMINISTRATION DOA-2049 (R03/2012)	Division of Executive Budget and Finance 101 East Wilson Street, 10th Floor P.O. Box 7864 Madison, WI 53707-7864 FAX: [phone]
ADMINISTRATIVE RULES Fiscal Estimate & Economic Impact Analysis

1. Type of Estimate and Analysis
X Original   ⍽ Updated   ⍽ Corrected
2. Administrative Rule Chapter, Title and Number
N 1
3. Subject
School of Nursing Approval
4. Fund Sources Affected			5. Chapter 20, Stats. Appropriations Affected
⍽ GPR   ⍽ FED   ⍽ PRO   ⍽ PRS   ⍽ SEG   ⍽ SEG-S			20.165(1)(g)
6. Fiscal Effect of Implementing the Rule
⍽ No Fiscal Effect ⍽ Indeterminate	⍽ Increase Existing Revenues ⍽ Decrease Existing Revenues		X Increase Costs X Could Absorb Within Agency's Budget ⍽ Decrease Cost
7. The Rule Will Impact the Following (Check All That Apply)
⍽ State's Economy ⍽ Local Government Units		⍽ Specific Businesses/Sectors ⍽ Public Utility Rate Payers ⍽ Small Businesses (if checked, complete Attachment A)
8. Would Implementation and Compliance Costs Be Greater Than $20 million? ⍽ Yes   ⍽ No
9. Policy Problem Addressed by the Rule
This rule updates the school of nursing approval process. The current rules have been in place since 1985 and are not adequately addressing the changes in education.
10. Summary of the businesses, business sectors, associations representing business, local governmental units, and individuals that may be affected by the proposed rule that were contacted for comments.
This rule was posted for economic comments for a period of 14 days and no comments were received.
11. Identify the local governmental units that participated in the development of this EIA.
None
12. Summary of Rule's Economic and Fiscal Impact on Specific Businesses, Business Sectors, Public Utility Rate Payers, Local Governmental Units and the State's Economy as a Whole (Include Implementation and Compliance Costs Expected to be Incurred)
This rule will not have an economic or fiscal impact on specific businesses, business sectors, public utility rate payers, local governmental units or the state's economy as a whole.
13. Benefits of Implementing the Rule and Alternative(s) to Implementing the Rule
The benefit is to provide clarity and updates to the school of nursing approval process. The proposed rules also decrease the duplication between approval and national nursing school accreditation.
14. Long Range Implications of Implementing the Rule
The benefit is to provide clarity and updates to the school of nursing approval process. The proposed rules also decrease the duplication between approval and national nursing school accreditation.
15. Compare With Approaches Being Used by Federal Government
None
16. Compare With Approaches Being Used by Neighboring States (Illinois, Iowa, Michigan and Minnesota)
Illinois: Illinois program approval process includes: a letter of intent, a feasibility study, hiring of a nurse administrator, submission of a curriculum proposal, and a site survey. Continued approval is based upon annual evaluation reports, full routine site visits and maintaining a NCLEX pass rate of 75% of first time test takers. Major and minor curricular changes are reported to the board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications (allows for variances to faculty standards) and student standards.
Iowa: Iowa program approval process includes: first step involves an application with information regarding the controlling institution and needs assessment; second step involves verification of employment of the head of program, submission of program's philosophy and objectives, curriculum plan, letter of intent from clinical facilities, evidence of provision of faculty, proposed budget and timeframe for implementation; next step is interim approval based upon program proposal and site visit; final approval is upon graduation of first class and NCLEX pass rate results. Provisional approval may be granted to program until standards are met. Change of controlling institution and changes in administrative personnel in the program. The program shall submit annual reports. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications, student standards and evaluation of the program. NCLEX pass rate standard is a minimum of 95% of the national passing percentage based upon first time test takers within 6 months of graduation. Michigan: Michigan program approval process includes: the first step requires submission of a letter of intent, evidence of funding and other support, copy of Michigan Department of Career Development approval (if necessary), evidence of availability of clinical experiences, proposed number of students, proposed first date of admission, plans for recruiting director of the program and faculty and a site visit; initial approval involves a self-student report and annual progress reports; full approval is after the graduation of the 2nd class, but no later than graduation of the 4th class (a class for each 12 month period) and requires submission of a self-study report and a site visit. Every 4 years the school shall submit a self-study report and accredited schools shall follow the schedule of the accrediting agency. Program changes shall be submitted to the board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, curriculum standards, clinical standards, nurse administrator and faculty qualifications (allows for variances to faculty standards), student standards, and evaluation of the program. NCLEX pass rate standard is 75% of first time test takers Minnesota: Minnesota program approval process includes: Phase 1 requires letter of intent including institution information, timetable for development and implementation, documentation of availability of academic facilities, impact on nursing programs in the area; Phase II involves a site visit and documentation of compliance with educational standards in order to be granted initial approval; Phase III is full approval and continual approval based upon meeting the minimum first time NCLEX success rate and acquiring national nursing education accreditation. Minnesota requires surveys of all schools on a periodic basis to maintain approval. NCLEX pass rate standard is 75% of first time test takers. All schools must be accredited by 2016. Annual reports shall be submitted to the Board. Closure of the school involves responsibility for assisting students in transferring and notification of location of records storage. The standards for the school include institutional requirements, clinical standards, nurse administrator and faculty qualifications, student standards, and evaluation of the program. The curriculum standard is the program must provide diverse learning activities that are consistent with program outcomes. Minnesota has an approval process for schools applying for innovative approaches which may require exemption from certain rules.
17. Contact Name				18. Contact Phone Number
Sharon Henes				[phone]

This document can be made available in alternate formats to individuals with disabilities upon request.

Notice of Hearing

Safety and Professional Services —
Pharmacy Examining Board

rulemaking_notices CR 14-003 CR 14-003

NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Pharmacy Examining Board in s.15.08 (5) (b), 450.19 (2), and 961.31, Wis. Stats., and interpreting s. 450.19, Wis. Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to repeal sections Phar 18.04 (3) (intro), 18.04 (3) (k), 18.11 (3), 18.11 (4), 18.11 (9) (a), 18.11 (9) (b), and 18.11 (9) (c); to renumber and amend section Phar 18.04 (2); to amend sections Phar 18.02 (8) (a), 18.02 (9), 18.02 (15) (intro), 18.02 (17), 18.04 (title), 18.04 (3) (L), 18.04 (3) (m), 18.04 (3) (n), 18.04 (4), 18.05 (1), (1) (note), (2) (note), (3) (b) (note), and (4), 18.06 (2), (3) (b) (note), (6) (b) (note), and (8), 18.07, 18.08 (1) (a) and (b) (note), 18.09, 18.10 (1) (intro), (2) (intro.) and (b), (3), (6), and (7), 18.11 (6) (intro) and (10) (c) (note), 18.12 (4), and 18.14 (1) (intro); and to create sections Phar 18.02 (11m), (15g), and (15r), 18.04 (2) (gg) and (gr), relating to the prescription drug monitoring program.

Hearing Information

Date:   Wednesday, February 12, 2014
Time:   9:00 a.m.
Location:   1400 East Washington Avenue
  Room 121A
  Madison, Wisconsin

Appearances at the Hearing

Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to the Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708. Written comments must be received at or before the public hearing to be included in the record of rule-making proceedings.