1802.1 Each manufacturer or labeler subject to reporting under the Act, shall submit the required annual report to the Department in an electronic format that is satisfactory to the Director.

1802.2 For each gift which was provided during the reporting period, that meets the requirements for mandated reporting, the manufacturer or labeler shall provide the following information:

1. (a) Name of manufacturer or labeler;
2. (b) Date of payment or gift;
3. (c) Name of recipient;
4. (d) Type of recipient (e.g., clinic, doctor, hospital, pharmacist, university, other prescriber, benefits manager, health plan, nursing facility, psychiatric hospital, other healthcare provider);
5. (e) Credentials of recipient, if applicable (e.g., APRN, DDS, MD, DO, DPM, DVM);
6. (f) Nature of payment (e.g., book, cash or check, donation, food, grant, lodging, transportation, samples);
7. (g) Primary purpose of payment (e.g., consulting, professional education, charitable grant, speaker fee or payment); and
8. (h) Monetary value of payment.

1802.3 For each advertising, marketing, or direct promotion activity which occurred during the reporting period, that meets the requirements for mandated reporting, the manufacturer or labeler shall provide the following information:

1. (a) Name of manufacturer or labeler;
2. (b) Date(s) of activity;
3. (c) Type of activity (e.g., advertising, marketing, direct promotion, market research survey, patient education including materials such as disease management information; materials/consulting to promote new uses of drugs);
4. (d) Medium (e.g., radio, television, magazines, newspapers, direct mail, telephone);
5. (e) Name of medium, if applicable (e.g., television or radio station, newspaper,

magazine);

(f) Product marketed (e.g., name of drug, general brand/company awareness);

(g) Target audience (e.g., general public, prescribers); and

(h) Cost of activity.

1802.4 For all employees and/or contractors of the manufacturer or labelers that that meets the requirements for mandated reporting, the manufacturer or labeler shall provide the aggregate costs, including all forms of payment, for these services as determined using GAAP.

SOURCE: Notice of Final Rulemaking published at 54 DCR 5287 (May 25, 2007).