Issue Date: January 24, 2014
Volume 41 • Issue 2 • Pages 131—133
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
Subtitle 14 CANCER CONTROL
10.14.07 Cord Blood Transplant Center Support Fund
Authority: Health-General Article, §§13-3001—13-3004, Annotated Code of Maryland
Notice of Proposed Action
The Secretary of Health and Mental Hygiene proposes to adopt new Regulations .01—.10 under a new chapter, COMAR 10.14.07 Cord Blood Transplant Center Support Fund.
Statement of Purpose
The purpose of this action is to establish operational procedures for the Maryland Cord Blood Transplant Center Support Fund.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
I. Summary of Economic Impact. The FY 2014 budget appropriates $100,000 in general funds for initial capitalization of the Cord Blood Transplant Program. These funds will be transferred to the Cord Blood Transplant Center Support Fund as required by the enabling legislation. The Department intends to consider awarding the entire amount of $100,000 to at least one qualified medical institution.
II. Types of Economic Impact.
A. On issuing agency:
(1) General funds
(2) Special funds
(3) Special funds
B. On other State agencies:
C. On local governments:
D. On regulated industries or trade groups:
E. On other industries or trade groups:
F. Direct and indirect effects on public:
III. Assumptions. (Identified by Impact Letter and Number from Section II.)
A. General funds in the amount of $100,000 are appropriated in FY 2014 to provide initial capitalization of the Cord Blood Transplant Program. These general funds will be transferred to the Cord Blood Transplant Center Support Fund as required by the enabling legislation. The Department anticipates that general funds in this amount will be appropriated annually.
D. The Department intends to consider awarding the entire amount of $100,000 to at least one qualified medical institution.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michele A. Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to email@example.com, or fax to 410-767-6483. Comments will be accepted through February 24, 2014. A public hearing has not been scheduled.
.01 Purpose and Scope.
A. Defines the Cord Blood Transplant Program and Cord Blood Transplant Center Support Fund;
B. Describes how funds may be allocated to the Cord Blood Transplant Center Support Fund;
C. Sets forth the responsibilities of the Department of Health and Mental Hygiene and the Comptroller with respect to the Cord Blood Transplant Program and Cord Blood Transplant Center Support Fund;
D. Outlines the grant application process for the Cord Blood Transplant Center Support Fund; and
E. Outlines grantee reporting requirements.
A. In this chapter, the following terms have the meanings indicated.
B. Terms Defined.
(1) "Comptroller" means the Comptroller of the Treasury.
(2) “Cord Blood Transplant Center” means a medical facility that:
(a) Uses cells obtained from a human umbilical cord or placenta to treat pediatric or adult patients afflicted with a disease or injury; and
(b) Is a member of the National Marrow Donor Program.
(3) "Department" means the Department of Health and Mental Hygiene.
(4) "Fund" means the Cord Blood Transplant Center Support Fund.
(a) "Grant" means financial assistance from the State to support an applicant's activities related to cord blood transplantation.
(b) "Grant" does not mean a contract.
(6) “Program” means the Cord Blood Transplant Program.
(7) “Qualified medical institution” means a medical institution that:
(a) Is accredited by the Joint Commission on Accreditation of Health Care Organizations;
(b) Is located in the State;
(c) Has an established hematologic malignancies research program; and
(d) Meets all requirements established in the request for proposals issued by the Cord Blood Transplant Program.
(8) "Secretary" means the Secretary of Health and Mental Hygiene.
.03 Cord Blood Transplant Program.
A. There is a Cord Blood Transplant Program in the Department.
B. The purpose of the Program is to provide funding to qualified medical institutions to establish or maintain a cord blood transplant center.
C. The Program administers the Fund to provide grants, subject to the limitations of the State budget, to qualified medical institutions to establish or maintain a cord blood transplant center.
.04 Cord Blood Transplant Center Support Fund.
A. The purpose of the Fund is to promote economic development by supporting cord blood transplant centers at qualified medical institutions with a goal of being recognized as a regional center of excellence in the area of cord blood transplantation.
B. The Fund is:
(1) A nonlapsing, special fund pursuant to Health-General Article, §13-3001, Annotated Code of Maryland; and
(2) Not subject to the State Finance and Procurement Article, §7-302, Annotated Code of Maryland.
C. The Fund consists of any:
(1) Money appropriated in the State budget to the Fund; and
(2) Other money from any other source accepted for the benefit of the Fund.
D. The Department may only expend funds in accordance with an appropriation approved by the General Assembly in the annual State budget.
E. The Department may only make grant awards under the Fund for the establishment of or support for a cord blood transplant center at a qualified medical institution.
F. Any unspent portions of the Fund shall remain in the Fund and may not revert or be credited to the general fund of the State, nor any other special fund of the State.
.05 Responsibilities of the Department.
The Department shall:
A. Administer the Program and perform related administration activities, including:
(1) Develop and release an annual request for proposals;
(2) Convene an expert panel to review applications and select grantees; and
(3) Ensure that grantees remain in compliance with request for proposals requirements;
B. Administer the Fund;
C. Provide a grant or grants in each fiscal year, in accordance with the State budget, to qualified medical institutions; and
D. Maintain records of grantee activities supported by the Fund.
.06 Allowable Use of the Fund.
A grantee may use awarded funds to establish or maintain a cord blood transplant center, which includes support of:
A. Individuals engaged in the establishment or maintenance of a cord blood transplant center;
B. Equipment necessary for the establishment or maintenance of a cord blood transplant center.
.07 Unallowable Use of the Fund.
A grantee may not use awarded funds to pay for activities not provided for in the approved grant application.
.08 Application Process for Cord Blood Transplant Center Grants.
An applicant for a cord blood transplant center grant shall:
A. Submit a completed application to the Department by the due date listed in the annual request for proposals; and
B. Include in the application packet the following information as specified in the annual request for proposals:
(1) Executive summary;
(2) Statement of the need for funding;
(3) Proposed work plan for the grant period;
(4) Brief professional resume or curriculum vitae of key staff involved in the grant activities;
(5) Description of how the requested funding will further the institution’s goal of being recognized as a cord blood transplantation regional center of excellence;
(6) Timeline detailing the expected start and completion dates for each activity to be conducted under the grant;
(7) Organizational chart indicating where the work under the grant will be located within the institution;
(8) Statement that the grant money will not be used to supplant any existing funding;
(9) Line item budget for the grant; and
(10) Written budget justification.
.09 Grant Application Review, Selection of Grantees, and Grant Extensions.
A. The Department shall determine the amount of money available for grants under the Cord Blood Transplant Center Support Fund annually.
B. Each year the Program shall consider awarding a grant to at least one qualified medical institution.
C. The Program shall convene a grant evaluation committee to review the grant applications.
D. Members of the evaluation committee may include one or more external individuals with expertise in cord blood transplantation.
E. The evaluation committee shall review grant applications based on criteria stated in the Request for Proposals.
F. The Program shall recommend a grant application to the Secretary for approval based on:
(1) The evaluation committee's recommendations for awarding the grants; and
(2) The availability of funds.
G. The Secretary shall:
(1) Consider the grant award recommendations of the Program; and
(2) Make the final determination on which grant applications to approve.
H. A grant period expires 1 year from the date of award of the grant.
.10 Payments, Terms and Conditions of Grant Awards, and Terminations.
A. Payments Under the Grant.
(1) The Department may not make more than quarterly payments during the grant period to a grantee awarded a grant under this chapter.
(2) Before the first payment under the grant, at the request of the grantee in their submitted grant application, the Department may approve an advanced payment for the grant based on financial need.
(3) If a financial or progress report required in §B or C of this regulation is overdue, the Department may withhold payment until the report is submitted.
B. Financial Reports and Records.
(1) A grantee shall:
(a) Establish a separate account to track expenditures under the grant;
(b) Maintain accurate records, including documentation of each transaction pertaining to the grant; and
(c) Submit to the Department quarterly invoices for payment and an annual financial expenditure report containing the signature of the financial officer of the entity affiliated with the grant award.
(2) The Department may audit the accounts referenced in §B(1) of this regulation at any time.
(3) Within 90 days after the date the grant period ends, a grantee shall submit to the Department:
(a) A final financial expenditure report; and
(b) A refund of any unexpended funds.
(4) A grantee shall retain all records pertaining to a grant award for 3 years from the date the final financial expenditure report is submitted under §B(3) of this regulation.
(5) In the case of an audit or litigation, the Department may extend the time period under §B(3) or (4) of this regulation until the completion of the audit or litigation.
C. Progress Reports.
(1) A grantee shall submit to the Program one electronic copy of:
(a) An interim report describing the progress of the grant:
(i) 6 months after the date of award of the grant; and
(ii) Every 6 months until the end of the grant; and
(b) Not later than 60 days after the date the grant period ends, a comprehensive final report, that provides a summary of all of the activity conducted under the grant.
(2) The Department shall keep research results confidential as required by Health-General Article, §§4-101—4-103, Annotated Code of Maryland.
(1) A grantee who publishes results from activities supported by a grant approved by the Secretary under this chapter shall include in the publication the following acknowledgement: "Supported in part with funds from the Cord Blood Transplant Center Support Fund of the Maryland Department of Health and Mental Hygiene."
(2) A grantee shall provide the Department with one electronic copy of any published article pertaining to the activities conducted under the grant.
E. Ownership of Equipment. A grantee:
(1) Shall ensure that equipment purchased under a grant under this chapter is used for the sole purpose of the grant;
(2) Shall keep an inventory of all equipment purchased; and
(3) May not transfer the equipment to another entity without the written permission of the Department.
(1) The Secretary may terminate a grant:
(a) If a grantee fails to comply with:
(i) The requirements of this chapter; or
(ii) State, federal, and municipal laws applicable to the performance of research under the grant;
(b) If a grantee fails to carry out the purposes for which the grant was awarded;
(c) In compliance with a court order; or
(d) At the request of the grantee.
(2) The Department and the State are not responsible for any expenses incurred by a grantee after cancellation of a grant.
(3) The grantee shall return all unexpended funds to the Department within 60 days of termination of a grant.
G. Compliance with Existing Laws. A grantee shall ensure that an activity conducted in the performance of the grant is in compliance with all State, federal, and local laws.
(1) A grantee is solely responsible for the institution's actions relating to the grant-making process or pertaining to activities conducted under a grant award.
(2) The State and the Department are not liable for any claims, losses, liabilities, expenses, or damages arising from activities relating to the grant-making process or conducted under a grant awarded under this chapter.
I. Grant Agreements. A grantee shall enter into a grant agreement with the Department.
JOSHUA M. SHARFSTEIN, M.D.
Secretary of Health and Mental Hygiene