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Maine – Proposed Reporting RequirementsNotice of Proposed Rule: Reporting Requirements for Pharmaceutical Manufacturers and Labelers
Office of Attorney General
6 State House Station
TO: Interested Parties FROM: Anthony Marple, Director, Office of MaineCare Services; and Linda J. Conti, Assistant Attorney General SUBJECT: Proposed Rule: Department of Health and Human Services, 10-144, Chapter 275-Reporting Requirements for Pharmaceutical Manufacturers and Labelers; Office of the Attorney General, 26-239, Chapter 111, Reporting Requirements for Pharmaceutical Manufacturers and Labelers. DATE: June 9, 2009This letter gives notice of a proposed rule: Department of Health and Human Services, 10-144, Chapter 275-Reporting Requirements for Pharmaceutical Manufacturers and labelers; Office of the Attorney General, 26-239, Chapter 111, Reporting Requirements for Pharmaceutical Manufacturers and Labelers. This rulemaking clarifies Maine requirements for clinical trial registration and results reporting, compatible with Federal reporting requirements and with the capabilities of the publicly funded website, www.ClinicalTrials.gov. It requires posting of past reports on the publicly funded website. The rule modifies the scope of the trials required to be registered and reported, and it clarifies the requirements of reporting post hoc analysis trial results and of updating trial results. It also extends the time anticipated for posting of submissions of results to the publicly funded website. This rulemaking provide contact information and clarifies the application of penalty for violations. The Department proposes other minor technical, grammatical and structural changes within this rulemaking. This rule change is not anticipated to have any adverse impact on small business.
Rules and related rulemaking documents may be reviewed and printed from the Office of MaineCare Services website at http://www.maine.gov/dhhs/oms/rules/provider_rules_policies.html or for a fee, interested parties may request a paper copy of rules by calling 207-287-9368. For those who are deaf or hard of hearing and have a TTY machine, the TTY number is 1-800-423-4331.
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