ࡱ> LNK@ r bjbj.. 72DDE,0 8  $0-< < R R R R R R [-]-]-]-]-]-]-$.R$1-R R -R R -R R [-[-R 0 Sa -"[--0-1Ov1001R   t R R R --00 4 004 10-144 DEPARTMENT OF HEALTH AND HUMAN SERVICES MAINE CENTERS FOR DISEASE CONTROL AND PREVENTION Chapter 276: RULES FOR INFLUENZA AGENT DISTRIBUTION REPORT Section I. Statement of Purpose The purpose of these rules is to identify the responsibilities of manufacturers or distributors of influenza immunizing agents to or within the State of fb88, establish the procedures by which the Department will estimate the supply and demand for influenza immunizing agents, and establish the circumstances in which information relating to the distribution of influenza immunizing agents in fb88 may be publicly disclosed. Section II. Definitions A. Manufacturer means a manufacturer of influenza vaccine sold or distributed in the State of fb88 and includes any subsidiary or affiliate of such manufacturer B. Distributor means anyone who offers for sale, sells, supplies or distributes, directly or indirectly, influenza immunizing agents to licensed health care providers and licensed health care facilities in the State of fb88. C. Influenza season means the time period from September 1st through the following May 1st. D. Department means the Department of Health and Human Services, fb88 Center for Disease Control and Prevention. E. Type means the trade name for an influenza vaccine. F. Quantity means the amount of influenza vaccine. G. Dosage means cc or ml for delivered influenza vaccine. H. Influenza immunizing agents means a vaccine, antitoxin, or other substance used to increase an individuals immunity to influenza. I. Licensed health care provider or facility means a hospital licensed pursuant to Title 22 MRSA, chapter 405 or non-hospital health care facility public or private, proprietary or non profit entity or institution providing health services licensed or certified under Title 22 MRSA, including, but not limited to, a radiological facility licensed under Chapter 160, a health care facility licensed under Chapter 405 and 405 D, an independent radiology center, a federally qualified health center, rural health clinic or rehabilitative agency, certified, recommended for certification or otherwise approved by the Department of Health and Human Services, Division of Regulatory and Licensing Services, a home health provider licensed under Chapter 419, a residential care facility licensed under Chapter 1665, a hospice provider licensed under Chapter 1681, a state institution as defined under Title 34-B MRSA, Chapter 1, a mental health facility licensed under Title 34-B MRSA Chapter 1, and a retail store drug outlet licensed under Title 32 MRSA Chapter 117. Section III. Timing and Content Each manufacturer or distributor of influenza immunizing agents sold, shipped or otherwise distributed in the State of fb88 shall report the following information to the Department in a format approved by the Department on a biweekly basis during influenza season and on a monthly basis at all other times: A. The contact name, company name, address, phone number and the email address of the manufacturer or distributor of influenza immunizing agents; B. The contact name, business type, type of provider, address, phone number and email address of the licensed healthcare provider or facility that will receive influenza immunizing agents from the manufacturer or distributor; C. The date that the manufacturer and/or distributor ships or distributes influenza immunizing agents and the date that the delivery is received by the licensed healthcare provider or licensed facility that ordered influenza immunizing agents; and D. The type, quantity, and dosage of influenza immunizing agents distributed to the licensed healthcare provider or facility. Section IV. Supply and Demand The Department shall estimate the supply and demand for influenza immunizing agents at the beginning of each influenza season by assessing past usage and aggregate orders; reviewing information disseminated by manufacturers, distributors and the United States Department of Health and Human Services, Centers for Disease Control and Prevention, identifying the number and location of high priority populations; identifying possible geographic and provider type disparities; and reviewing historical demand patterns. Section VI. Confidentiality A. Information obtained by the Department under this section is confidential and may not be disclosed by the Department except that the Department may provide information obtained under this section to a licensed health care provider or facility located in the State in order to facilitate access to influenza immunizing agents for patients of that licensed health care provider or facility that are residents of the State. B. Any licensed healthcare provider or facility which receives any influenza immunizing agent distribution information pursuant to 22 M.R.S.A. 1065 or these rules shall restrict its use of such information to facilitating access to influenza immunizing agents for those patients of that licensed healthcare provider or facility that are residents of the State. C. Subject to the provisions of Title 1 M.R.S.A. 401-521, information submitted to the Department pursuant to 22 M.R.S.A. 1065 or these rules may be designated as confidential. The designation must be clearly indicated on the reporting form. The Commissioner shall establish procedures to insure that information so designated is segregated from public records of the Department. Upon receipt of a public access request for any of the information designated by the submitter as confidential, the Commissioner shall notify the data submitter within 10 days of the request. The Department may accommodate the public access request unless the data submitter notifies the Department within 10 days of being notified of its objection to the release of the data and institutes appropriate measures to safeguard the data from public release. The burden shall be upon the data submitter to demonstrate that any data claimed as confidential is not a public record and not subject to disclosure pursuant to 1 M.R.S.A. 401-521 STATUTORY AUTHORITY: Title 22 ch. 251 1065 EFFECTIVE DATE: January 27, 2008 filing 2008-16 10-144 Chapter 276 page  PAGE 3 /0deO n p q - / 0 2     q s t v " # % V X Y [ !fgEHhi/1  ͿۮͿͮͮͮͮͮͮͮͮͮͮͮͮͮͮͮͮͮͮͮͮͮͮͮͮ hK#hK#CJOJQJ^JaJh-CJOJQJ^JaJhK#CJOJQJ^JaJ#h-hK#5CJOJQJ^JaJ#h-h-5CJOJQJ^JaJD01deo p q .  p@ 0^`0gd- p@ 0^`0gd- p@ ^gd- p@ &dPgd- p@ gdK#E q . /   r s ! 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