(As amended by Article 1 of Executive Decree No. 39617 of March 17, 2016)
(As amended by Article 1 of Executive Decree No. 40387 of February 27, 2017)
Sworn Declaration on compliance with the procedure requirements for the Application of Positive Silence (Silencio Positivo) I ____________________________________________in my capacity as filer of the procedure for ____________________________________, declare under oath the following:
FIRST: That on the ______ day of _____ of 20___ I filed the application for: (permit, license, or authorization) called:_______________________________________, before the (Department/Unit/Region): _____________________________________ of the Institution____________________________________________________; as evidenced in the document of receipt of my application.
SECOND: That the application indicated in the preceding article fully complies with all the requirements required by (decree/regulation or law) No. _______, published in La Gaceta No. ___________; since, in accordance with Article 4 of the Law for the Protection of the Citizen from the Excess of Requirements and Administrative Procedures, Law No. 8220, these are the only requirements with which I must comply; which are as follows:
1- ____________________________________________________________________ 2- ____________________________________________________________________ 3- ____________________________________________________________________ 4- ____________________________________________________________________ THIRD: That on the past _____ of ____ of 20_____ the legal period for the institution to resolve the aforementioned application elapsed. In this sense and in compliance with the provisions of Articles 7 of Law 8220 and 42 of the regulation to said Law, I request that proceedings be carried out accordingly, so that Positive Silence is applied.
FOURTH: That I am aware of the legal consequences with which the crimes of false testimony and perjury are punished, in cases of not telling the truth, the foregoing in accordance with the provisions of the current Penal Code (Código Penal).
FIFTH: I designate the following electronic mail address for receiving notifications: ________________________________________________________________________ Signature ID No.
Authenticates
Complaint for non-compliance with the Law for the Protection of the Citizen from the Excess of Requirements and Administrative Procedures, No. 8220 (N° 8220) I, _(first name and both last names)__, identity card number ____________________, hereby file a formal complaint against the official _(first name and last names of the official)____________________________________________________, who works in (Department/Unit/Region) __________________________ of the institution (Name of the institution)______________________________________________________.
The complaint is due to the fact that the indicated official, as the person responsible for the procedure of: (permit, license, or authorization): (Name of Procedure)___, which I filed, failed to comply with Article 10 of the Law for the Protection of the Citizen from the Excess of Requirements and Administrative Procedures, Law No. 8220, in the following respects:
□ Not accepting the single presentation of documents or demanding more requirements than those established in the law, executive decrees, or regulations as established by law.
□ Not respecting competences.
□ Not publicizing procedures or complying with the law.
□ Not informing interested parties clearly and completely about the procedure.
□ Not resolving or qualifying those petitions, proceedings, applications, and other documents within the period established for each of those procedures in the General Law of Public Administration or in a special law.
□ Breaching the positive silence procedure.
□ Breaching the institutional and inter-institutional coordination procedure.
□ Disrespecting the procedure before a single administrative instance.
□ Rejecting documents validly issued by other bodies, entities, or institutions of the State in the exercise of their own competence.
□ Not performing the cost-benefit assessment of the regulation, when applicable.
□ Not abiding by the binding criteria issued by the Ministry of Economy, Industry, and Commerce, through the Directorate of Regulatory Improvement, in compliance with the obligations established in this law and the principles of regulatory improvement.
Details: (Detail of the reported acts or omissions, with an indication of the persons and bodies involved in the complaint -you may add/enable additional sheets) ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ ______________________________________________________________________________ A proof of receipt or reference for the service performed before the cited Department is attached.
A place is designated for attending notifications at:___________________________________________________________________________ _____________________________________________________________________________________________________________ Signature of the complainant _________________________________ Signature of the official receiving the complaint
| SECTION 1: PRIOR CONTROL FOR REGULATORY IMPROVEMENT (CONTROL PREVIO DE MEJORA REGULATORIA) | |
|---|
| Institution: Click here to enter text | Regulation title: Click here to enter text |
| Contact point: Name: Click here to enter text Telephone: Click here to enter text Email: Click here to enter text | Date of receipt: Click here to enter a date |
| 1.- DESCRIPTION OF THE REGULATION |
|---|
| 1. Briefly explain what the proposed regulation consists of. Click here to enter text |
| SECTION 2: MANIFESTATION OF REGULATORY IMPACT |
|---|
| 1.- DEFINITION OF THE PROBLEM AND GENERAL OBJECTIVES OF THE REGULATION |
| Identify and describe the problem or situation that the proposed regulation seeks to resolve Click here to enter text |
| Describe the general objectives of the regulation Click here to enter text |
| Cite the legal basis that grants you the authority to issue the proposed regulation. Indicate if there are other regulations in force on the matter that are insufficient to address the identified problem, or that generate duplications or contradictions. (In the latter case, you must carry out an express reform repealing the non-applicable legislation) Click here to enter text |
| II. ALTERNATIVES CONSIDERED TO THE REGULATION | |
|---|
| Indicate and compare all regulatory and non-regulatory alternatives that were evaluated with which the problem could be resolved, including the option of not issuing the regulation. For each of the alternatives considered, describe their costs and benefits qualitatively. | |
| Selections | Clear description of the alternatives, as well as their costs and benefits |
| Do not issue regulation Regulatory: Government Regulation Performance-based Regulation Co-Regulation Non-Regulatory: Market Instruments Quasi-regulation Self-Regulation Information Campaigns | Click here to enter text |
| Justify the reasons why the proposed regulation is considered the best option to address the indicated problem over the alternatives mentioned in the preceding question Click here to enter text | |
| III. IMPACT OF THE REGULATION Does the proposed regulation create or modify procedures that imply new requirements for the citizens? | | |
|---|
| Select | Name of the procedure Click here to enter text | Resolution Period (working or calendar days) Click here to enter text |
| CREATES MODIFIES NA | Validity of the procedure Click here to enter text | Positive Silence Applies Yes No |
| Requirements it Creates or modifies Click here to enter text | Legal basis (Art. of law, decree, or regulation) Click here to enter text | Justification of why it is ESSENTIAL to resolve the administrative act and to fulfill the objectives of the regulation (technical-scientific basis if applicable) Click here to enter text |
Does the proposed regulation request requirements that are obtained in another department of the same institution or in another institution?
(*)
(*)(Thus added by means of Errata published in La Gaceta No. 114 of June 14, 2016, page No. 52)
| Select | Requirement | Justification of why COORDINATION does not apply |
|---|
| Establishes period Increases period NA | Click here to enter text | Click here to enter text |
10. Does the proposed regulation reduce the validity of a procedure? (Example: permit, license, or authorization)
| Select | Name of the Procedure Click here to enter text | Change in validity Click here to enter text | Justification (legal and/or technical) Click here to enter text |
|---|
| Yes NO | | |
11. Does the proposed regulation establish or increase fees, tariffs, or charges for services?
| Select | Amount Click here to enter text | Justification and setting parameters (attach calculations for setting) Click here to enter text | Legal basis Click here to enter text | Adjustment mechanism Click here to enter text |
|---|
| Fee Tariff Charge for Services NA | | | |
12. Does the proposed regulation regulate or restrict any activity that was not previously regulated/restricted? Explain the additional conditions established and justify why.
Click here to enter text 13. Provide the quantitative estimate of the costs and benefits that the regulation entails for each particular or group of particulars.
Remember to include in the costs box: the estimated number of procedures expected to be granted in one year; as well as the costs incurred by users; and in the benefits box: the number of agents benefiting and the monetary amount of said benefit; a time range in which the benefits of the regulatory or non-regulatory measure are expected must be specified.
| COSTS | Groups or industries impacted by the regulation Click here to enter text |
|---|
| Describe and estimate the costs Click here to enter text | |
| BENEFITS | Groups or industries benefiting from the regulation Click here to enter text |
| Describe and estimate the benefits Click here to enter text | |
14. Justify that the benefits of the regulation are superior to its costs.
Click here to enter text
IV. COMPLIANCE AND APPLICATION OF THE PROPOSAL
15. Describe the form and/or the mechanisms through which the regulation will be implemented (include monetary and in-kind public resources).
Click here to enter text 16. Describe the monitoring and verification schemes that will ensure compliance with the regulation.
Click here to enter text
V. EVALUATION OF THE PROPOSAL
17. Describe the form and the means through which the achievement of the objectives of the regulation will be evaluated. Also mention the indicators and goals that will be used to evaluate the success of the regulation.
Click here to enter text
VI. CITIZEN PARTICIPATION
18. Were the interested parties and/or groups consulted for the drafting of the regulation?
| Select | Group consulted Click here to enter text | Comments given during the public consultation Click here to enter text | Comments that were included in the regulation Click here to enter text |
|---|
| Inter-institutional Consultation. Formation of a working group/technical committee for the joint drafting of the draft bill. Circulation of the draft to interested groups or persons and receipt of comments. Presentation of the proposal at a conference by invitation (and closed) Presentation of the proposal at a conference open to the public. Consultation with international bodies or authorities. Others. | | |
VII. ANNEXES
19. Attach the proposed regulation and the documents consulted or prepared to design the regulation.
Click here to enter text
VII. RESULT OF THE COST-BENEFIT ASSESSMENT
I, Click here to enter text, in my capacity as Click here to enter text, hereby attest that based on the cost-benefit assessment and the analysis of the detailed information therein, the proposed regulation must be issued because the benefits it generates are greater than the costs of applying it.
Signature of the Procedure Simplification Officer (Oficial de Simplificación de Trámite) ____________________________ Seal: Date:
(As amended by Article 1 of Executive Decree No. 39726 of May 24, 2016)
| SECTION 1: PRIOR CONTROL OF TECHNICAL REGULATIONS (CONTROL PREVIO DE REGLAMENTOS TÉCNICOS) | |
|---|
| Institution: | Title of the regulation: |
| Proposing Institutional Department: Name of the responsible technician: Telephone: Email: | Date: |
| 2. Indicate which of the following Prior Control Regulatory Actions apply to the proposed regulation. | Prior Control Regulatory Actions | Select (yes/no) | | |
|---|
| a. | Contains or modifies the technical characteristics of a product or the related production processes and methods, including the applicable administrative provisions, and whose observance is mandatory. | YES | |
| b. | Includes or modifies prescriptions regarding terminology, symbols, packaging, marking, or labeling applicable to them, or deals exclusively with them. | YES | |
| c. | Establishes or modifies definitions, classifications, formulas, criteria, characterizations, or any other technical term that, by itself or jointly with another regulation, affects the rights, obligations, services, or procedures of the regulated parties. | YES | |
| d. | Creates or modifies conformity assessment procedures. | YES | |
| e. | Creates or modifies procedures that regulated parties must comply with. | YES | |
| f. | Creates or modifies requirements or obligations for regulated parties, or makes existing requirements or obligations stricter. | YES | |
| g. | Establishes or increases the resolution period for a procedure. | YES | |
| h. | Regulates an activity that was not previously regulated or makes the regulation more restrictive. | YES | |
| i. | Makes compliance with a procedure or requirement more complex. | YES | |
A. Legality Analysis.
8. Briefly describe the conclusions of the legality analysis carried out for the issuance of the Technical Regulation.
Click here to enter text.
8.1 Please indicate if the draft Technical Regulation is derived from or based on one or more international standard(s) or a current national technical standard. If so, indicate the name of the standard, the issuing body, date of issuance, and the articles or sections that are considered in the Regulation, in whole or in part.
Click here to enter text.
8.2 Cite the legal basis that grants you the authority to issue the proposed regulation.
Click here to enter text.
8.3 Indicate whether there are other current regulations on the matter that are insufficient to address the identified problem, or that generate duplications or contradictions. In the latter case, indicate whether, as a result of the issuance of the Technical Regulation, any related legislation must be repealed or abrogated.
Click here to enter text.
B. Technical-Scientific Analysis.
9. Determine the technical and scientific basis of the matter to be regulated in order to justify the technical regulation. For this purpose, cite the scientific or technical documents supporting the proposed Technical Regulation and, if possible, attach the cited studies.
Click here to enter text.
10. Does the proposed regulation create or modify procedures or formalities for the regulated parties?
Yes / No 11. If affirmative, identify all the procedures or formalities that are created or modified in the proposed Technical Regulation. For each procedure or formality, indicate the following:
| Select | Name of the procedure Click here to enter text. | Resolution period (business or calendar days) Click here to enter text. |
|---|
| Creates | Validity of the procedure | Applies Positive Silence No |
| Requirements it creates or modifies | Legal basis (Art. of law, decree, or regulation) | Justification of why it is ESSENTIAL for resolving the administrative act and for fulfilling the objectives of the regulation (technical-scientific basis, if applicable) |
| Click here to enter text. | Click here to enter text. | Click here to enter text. |
| Click here to enter text. | Click here to enter text. | Click here to enter text. |
| Click here to enter text. | Click here to enter text. | Click here to enter text. |
12. Does the proposed regulation request requirements that are obtained from another office of the same institution or from another institution?
| Select | Requirement | Justification for why INSTITUTIONAL OR INTER-INSTITUTIONAL COORDINATION does not apply |
|---|
| Creates | | |
13. Does the proposed regulation create new requirements or obligations for the regulated parties, or make existing ones stricter? (Example: establishes inspections that previously did not exist)
| Select | Applicable Article | Justification |
|---|
| Creates Requirement | | |
| Select | Applicable Article | Justification |
|---|
| Creates Requirement | | |
14. Does the proposed regulation establish or increase the resolution period for a procedure?
| Select | Name of the Procedure | Period or change in the period (in business or calendar days) | Justification for the resolution period (legal and/or technical) |
|---|
| N/A | | | |
15. Does the proposed regulation reduce the validity of a procedure? (Example: permit, license, or authorization)
| Select | Name of the Procedure | Change in validity | Justification (legal and/or technical) |
|---|
| No | | | |
17. Indicate whether the proposed Technical Regulation carries out one or more of the following situations, taking into account that every Technical Regulation limits free competition in the markets. If affirmative, justify your response and indicate in which provision of the Technical Regulation it is determined.
17.1 Does it establish procedures for obtaining licenses, permits, or authorizations as a requirement to start operations, or to begin an additional activity? Yes ( ) No ( ) 17.2 Does it establish technical, administrative, or economic-type requirements for agents to participate in the market(s)? Yes ( ) No ( ) 17.3 Does it establish conditions or delimit areas or geographical zones for offering goods? Yes ( ) No ( ) 17.4 Does it establish quality standards or rules for products? Yes ( ) No ( ) 17.5 Does it determine the mandatory use of a particular standard, model, platform, or technology, or of any product protected by intellectual property rights? Yes ( ) No ( ) 17.6 Does it establish or substantially influence the determination of maximum prices, minimum prices, tariffs, or in general, any other price control mechanism and/or quantity of goods? Yes ( ) No ( ) 17.7 Does it modify or reduce the information available so that consumers can make an informed consumption decision? Yes ( ) No ( ) 17.8 Does it create preferential schemes in Government procurement in order to promote or benefit some agents? Yes ( ) No ( ) If affirmative, indicate if the implementation of the Technical Regulation affects the Micro, Small, and Medium Enterprise (MSME) sector. Justify your response, quantifying the impact on the sector (Indicate the number of MSMEs affected).
18. Given that risk mitigation represents the benefits (Cost-Benefit Matrix for Technical Regulations), mention the way in which the regulatory actions included in the Technical Regulation mitigate the risks, demonstrating the degree of reduction or elimination thereof (amount, units, or percentage) and include the conclusions of said analysis.
Click here to enter text.
19. Once the risk analysis has been carried out, estimate the quantification of the benefits generated by the application of the Technical Regulation (mention the assumptions and other elements considered to monetarily determine the benefits included in the Cost-Benefit Matrix for Technical Regulations).
Click here to enter text.
20. From the information included in the Cost-Benefit Matrix for Technical Regulations, indicate the assumptions and calculations made to determine each of the direct financial costs (such as fees, tariffs, or charges for procedures) generated by the Technical Regulation and justify their inclusion.
Click here to enter text.
21. From the information included in the Cost-Benefit Matrix for Technical Regulations, indicate the assumptions and calculations made to determine each of the regulatory costs generated by the Technical Regulation.
21.1. Indirect costs (compliance costs for the regulated parties) 21.2. Indirect costs (technical specification costs for the regulated parties) 21.3. Indirect costs (Conformity Assessment Procedure costs) 21.4. Indirect costs (administrative burdens for carrying out procedures) 21.5. Opportunity costs.
22. Identify and quantify the costs that the Administration will incur for the implementation of the Technical Regulation (include monetary and in-kind public resources).
Click here to enter text.
23. Indicate the proportion of the direct and indirect financial costs with respect to the total costs of the regulation.
Click here to enter text.
24. Considering the information included in the "Cost-Benefit Matrix for Technical Regulations," indicate and demonstrate whether the gross benefits are greater than the costs generated by the Technical Regulation to determine its viability.
Click here to enter text.
25. According to Executive Decree No. 37662-MEIC-H-MICIT, Procedure for the demonstration of the conformity assessment of Technical Regulations, indicate which of the following methods is established in the Draft Technical Regulation to assess conformity with it:
- a)Model 1: Type testing.
- b)Model 2: Type testing followed by verification through testing of samples withdrawn from commerce.
- c)Model 3: Type testing followed by verification through testing of samples withdrawn from the manufacturer's facilities.
- d)Model 4: Type testing followed by verification through testing of samples withdrawn from commerce and from the manufacturer's facilities.
- e)Model 5: Type testing, evaluation and approval, through audits of the manufacturer's quality management system and testing on samples withdrawn from commerce and from the manufacturer's facilities.
- f)Model 6: Evaluation and approval of the manufacturer's quality management system.
- g)Model 7: Lot testing.
- h)Model 8: 100% testing.
- i)Model 9: Specific systems or schemes established in the respective technical regulation.
26. If Model 9 was chosen, please duly justify and remember that this must be stated in the Costa Rican Technical Regulation:
Click here to enter text.
27.2 What will be the procedure to follow to assess conformity with the Technical Regulation? Will it be ex officio or at the request of a party?
Click here to enter text.
27.3 How long after publication in the Official Gazette will the Technical Regulation enter into force?
Click here to enter text.
28. Indicate the indicators with which the administration will monitor compliance with the provisions contained in the technical regulation; for each indicator you design, indicate whether the institution already has prior records, or whether new administrative records must be generated to obtain the indicators. If it already has prior records, indicate the precise data available for the indicator at the time the regulatory proposal is analyzed.
Click here to enter text.
| Compliance Indicators | | | | |
|---|
| Name of the Indicator | Description | Mathematical Formula | Does it have administrative records? Y/N, indicate the area that maintains them. | Initial Status (if applicable) |
29. Describe the form and means through which the achievement of the regulation's objectives will be evaluated. Indicate if the Technical Regulation has a regulation review clause and/or a regulation sunset clause, and describe what they consist of. If the Technical Regulation does not have these clauses, justify why it is not considered appropriate to include them.
Click here to enter text.
30. Indicate the indicators with which the institution will conduct the performance evaluation of the provisions contained in the technical regulation; for each indicator you design, indicate whether the institution already has prior records, or whether new administrative records must be generated to obtain the indicators. If it already has prior records, indicate the precise data available for the indicator at the time the regulatory proposal is analyzed. In this case, indicate the targets that will be used to evaluate the success of the regulation. (Ex-post Evaluation)
| Performance Evaluation Indicators for the Technical Regulation | | | | | | |
|---|
| Name of the Indicator | Description | Mathematical Formula | Does it have administrative records? Y/N, indicate the area that maintains them. | Initial Status (if applicable) | Target | Objective of the Technical Regulation it relates to (see question 7) |
31. Indicate whether a Technical Committee was formed:
31.1 If your answer is no, justify:
Click here to enter text.
31.2 Was consensus reached on the Draft?
Click here to enter text.
31.3 What were the main contributions of the Technical Committee to the development of the Costa Rican Technical Regulation?
Click here to enter text.
31.4 Was any other type of prior consultation carried out? If so, indicate which one, who participated, and what elements were modified or added to the Costa Rican Technical Regulation.
Click here to enter text.
32. Indicate the final result of the Cost-Benefit evaluation (To obtain the final result, it must be taken into account that the costs considered are associated with the risks to be mitigated through the regulatory actions and the technical specifications included in the Technical Regulation. For example, mitigating a risk may generate a financial cost, a compliance cost, and a technical specification cost; therefore, these three costs must be reflected and the risk recorded with its value for each cost).
Excel Worksheet Cost-Benefit Matrix for Technical Regulations Sheet No. 1. Risk Analysis
| Identification and behavior of Risks prior to the implementation of the Technical Regulation (TR) | | | | | | | | |
|---|
| No. | Identify and describe the risk(s) to mitigate | Identify the geographical area of the risk | Identify the population, group, or industry potentially affected | Identify the number of events per unit of time that have occurred 1 | Probability of occurrence | Magnitude of the damage and possibilities of recovery (whether for objects or subjects) 2 | Impact of the risk | Level of Risk without regulation |
1 You must include in the Form statistical data, scientific studies, global alerts, news, that allowed you to select the suggested parameters.
2 The selected option must be justified in the Form, indicating the population and area affected, for example: Fluoride in dentifrices, in children under 5 years of age, or iodized salt and water in the Agua Caliente area of Cartago.
| Risk Management with the implementation of the TR | | | | |
|---|
| Indicate the Legitimate Objective it aims to guarantee | Indicate the regulatory action within the technical regulation that will mitigate the risk | Indicate the numeral containing the provision | Indicate the expected level of reduction or elimination of the risk with the application of the TR | Justify how the regulatory action mitigates the risk and indicate the amount, units, or percentage of reduction thereof |
Sheet No. 2. Benefits
| Quantification of the benefits generated by the Technical Regulation by mitigating risks | | | | |
|---|
| Indicate the benefits generated by the proposed regulation (potential incidents sought to be reduced or eliminated) | Indicate the number of potential incidents expected to be reduced with the issuance of the Technical Regulation (number of incidents without regulation - number of incidents with regulation) | Indicate the current unit cost of addressing the potential incident | Total benefit generated by mitigating the risk with the TR | Net Present Value (NPV) 1 |
| 1 If the regulator wishes to evaluate the Technical Regulation over a specific period of time | Total regulatory benefits | | | |
| (for example, 5 years), they may use the net present value (NPV) technique for both benefits and costs. | | | | |
Sheet No. 3. Regulatory Costs
| Analysis of costs with the implementation of the Technical Regulation | | | | | | |
|---|
| Regulatory action within the Technical Regulation that generates the cost | Type of cost | Description of the cost | Identify the number of regulated subjects that must comply with the provision | Indicate the unit cost of complying with the provision | Total Costs (Column D * Column E) | Net Present Value (NPV) |
| Total regulatory costs | | | | | |
Sheet No. 4. Cost-Benefit Analysis
(Thus added by Article 1 of Executive Decree No. 40923 of November 13, 2017)