Gamete Bank, Fertility Clinic, and Gamete Agency ClinicApplication for Licensure

Gamete Bank, Fertility Clinic, and Gamete Agency Clinic

Application for Licensure

Colorado Department of Public Health and Environment

Introduction

Please read through the application thoroughly and complete all items. Incomplete applications will not be processed.

Initial applications must be submitted by April 1, 2025 to ensure applications are reviewed and inspections scheduled prior to the July 1, 2025 deadline. Licenses must be renewed annually. Renewal applications must be submitted between ninety (90) and sixty (60) calendar days prior to the expiration date of the current license.

Application Process

Step 1 - Pay licensing fee*

Enter the online payment portal.
Complete all required fields in the payment portal and select each applicable category of service provided by the entity.
A $500 fee is applied for each category listed on the license.
Submit payment and retain a copy of the receipt.

*Application fees are waived for non-profit organizations. This may be noted on the application.

Step 2 - Gather supporting documentation

The following documents must be submitted with the application. These documents should be complete and readily available prior to starting the application:

Copy of license fee receipt
Self-inspection checklist
Written plan for bankruptcy, dissolution, or insolvency
Attestation of legal history, signed by an owner or chief administrator
Manual of policies and procedures, including staff training procedures
Organizational chart
Additional partners and corporate officers (for partnerships and corporations only)

Step 3 - Complete application

Complete the application in its entirety and submit. Upon submission, a signature page will be sent to the signee’s email address as indicated on the application form.

Step 4 - Digital signature

After submitting the application form, a signature page will be sent to the email address of the primary owner indicated on the application. The corporate officer, general partner, or sole proprietor must sign and submit the form using the instructions provided. The primary owner and entity administrator will receive a confirmation email upon signature completion.

Please allow 10 business days for the Program to review and process the application. The Program will notify the entity by email if additional information is required. When review of the application is complete, an inspection will be conducted to ensure adherence to 5 CCR 1005-6.

Information on application requirements, along with required forms and guidance documents, can be found on the Gamete Bank and Fertility Clinic Program website.

General Information

Entity Name*

DBA (If applicable)

Renewal?

Check the box if this application is for renewal of existing licensure.

License Number*

Entity Contact Information

Physical Address

Physical Location*

Select or enter value

Street*

City*

State*

Select

Zip Code*

Country*

Phone Number*

Fax Number

Website*

EIN Tax ID*

FDA FEI number (if applicable)

Physical address and mailing address are the same

Mailing Address

Mailing Address - Street*

Mailing Address - City*

Mailing Address - State

Select

Mailing Address - Zip Code

Mailing Address - Country*

Fee Payment

Entity Type*

Type of Entity Requested for Licensure (check all that apply):

Note that the application fee is $500 for EACH selection. Entities may pay up to $1500 in application fees, depending on the services provided. This category is determined based on the services provided by your entity, and not the general industry label for your business. If you perform any of the below services at all, you must apply for that relevant category.

Fertility Clinic: entity or organization that:

Performs assisted reproduction medical procedures and receives donor gametes for a recipient and the recipient and gamete donor are unknown to each other at the time of donation.

Gamete Agency: oocyte or sperm donor matching agency that:

Matches gamete donors with recipients; and
Matches the potential recipients and gamete donors who are unknown to each other at the time of donation; and (I) Is located within Colorado; or (II) Is located outside of Colorado and matches intended recipients located in Colorado during the matching process with gamete donors.

Gamete Bank: entity or organization that:

Collects gametes from a donor or receives embryos; and
Provides gametes or embryos to a recipient parent or parents or the recipient parent’s medical provider when the recipient and donor are unknown to each other at time of donation, and (I) is located within Colorado or (II) provides gametes or embryos to a recipient parent or parents located in Colorado.

Fertility Clinic

Gamete Agency

Gamete Bank

Is the applicant a nonprofit organization and thus exempt from the application fee?*

Yes

Date fee was submitted*

Ownership and Business Information

Ownership type*

Sole proprietor

Partnership

Corporation

Entities that are a partnership or corporation must attach a list of all corporate officers or partners who have at least 10% ownership in the company in the Supporting Documentation section below. The attachment must include the names, addresses, and phone numbers of all individuals listed. Entities may fill out and submit this template or submit one of their own formatting.

Entities must submit a business organizational chart in the Supporting Documentation section below. The organizational chart must include the name, address, and website of any parent company.

Corporate Officer/General Partner/Sole Proprietor

The following fields must contain the contact information of either the corporate officer, general partner, or sole proprietor. The named individual will receive an application signature page via email upon submitting this application. The signature page must be returned for the application to be considered complete.

Primary Owner - Name*

Primary Owner - Title*

Primary Owner - Email address*

Primary Owner - Phone number*

Primary Owner - Street*

Primary Owner - City*

Primary Owner - State

Select

Primary Owner - Zip code

Primary Owner - Country*

Entity Administrator

Contact person for application questions

Administrator - Name*

Administrator - Title*

Administrator - Email Address*

Administrator - Phone Number*

Insurance

Insurance Attestation*

By checking this box, I attest that the named applicant entity carries all types of insurance coverage required by Colorado law and industry best practices for the specific facility.

Initials*

Print Name*

Supporting Documentation

The following documents must be submitted with the application:

Copy of license fee payment receipt
Self-inspection checklist
Written plan for bankruptcy, dissolution, or insolvency
Attestation of legal history
Manual of policies and procedures, including staff training procedures
Organizational chart
Complete list of all partners and corporate officers (for partnerships and corporations only)
Educational materials (if out-of-state and not using the materials provided by the Program)

Please clearly label all uploaded files. Supporting documentation may be submitted through the following options:

1) Drag and drop files into the box below (preferred)

Compressed (zip or rar) files may be used to consolidate documents into fewer separate files.

2) Provide a link in the box below to a cloud-based storage drive (such as Dropbox or Google Drive) containing the required documents.

Be sure you have granted the Gamete Bank Program (cdphe_dcphr_gametebankprogram@state.co.us) permission to view the drive and its documents before submitting the application and that access remains active throughout the entirety of the licensing process.

Out-of-state entities

Entities located outside of Colorado are not required to use the educational materials provided by the Department. If you choose to use your own educational materials, they must be uploaded and submitted with this application.

Storage drive link(s)

File Upload

Up to 10 files may be uploaded to this form with a file size limit of 30 mb per file.

Drag and drop files here or

Signature and Completion

After submitting the online application, a signature page will be sent to the email address of the corporate officer, general partner, or sole proprietor as was indicated above. The signature page will be sent from the Program’s Smartsheet account. Please make note of this and adjust spam filters as needed.

You can review the instructional video for how to locate and complete the signature form.

The corporate officer, general partner, or sole proprietor must sign the provided signature page. The application will not be considered complete until the signature has been received by the Program.

Required fields are complete*

Required documents are attached*

Ready for the signature*

Application Complete*

The online application form is complete.

If you wish to retain a copy of this application for your records or for the signee to review prior to adding their signature, select the following box and add your email addresses.

Send me a copy of my responses

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