Maryland Department of Health

The Secretary of Health and Mental Hygiene proposes to amend Regulation .04 under COMAR 10.50.01 Tissue Banks.

Statement of Purpose

The purpose of this action is to amend and update the edition of the following incorporated by reference documents:

(1) Standards for Tissue Banking; and (2) Standards for Blood Banks and Transfusion Services Comparison to Federal Standards There is no corresponding federal standard to this proposed action. Estimate of Economic Impact The proposed action has no economic impact. 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 Phinney, Director, Office of Regulation and Policy Coordination, Department of Health and Mental Hygiene, West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through July 11, 2016. A public hearing has not been scheduled.

Editor’s Note on Incorporation by Reference

Pursuant to State Government Article, §7-207, Annotated Code of Maryland, (1) Standards for Tissue Banking (American Association of Tissue Banks, 13th Edition), Sections C, D, E, F, G, H, J, K, L, and M1-8 only and (2) Standards for Blood Banks and Transfusion Services (American Association of Blood Banks, 29th Edition) have been declared documents generally available to the public and appropriate for incorporation by reference. For this reason, they will not be printed in the Maryland Register or the Code of Maryland Regulations (COMAR). Copies of these documents are filed in special public depositories located throughout the State. A list of these depositories was published in 43:1 Md. R. 10 (January 8, 2016), and is available online at www.dsd.state.md.us. These documents may also be inspected at the office of the Division of State Documents, 16 Francis Street, Annapolis, Maryland 21401.

.04 Incorporation by Reference. A. (text unchanged) B. Documents Incorporated.

(1) Standards for Tissue Banking (American Association of Tissue Banks, [2002] 13th Edition), Sections C, D, E, F, G, H, J, K, L, and M1-8 only;

(2) Standards for Blood Banks and Transfusion Services (American Association of Blood Banks, [2003] 29th Edition);