- The FDA is announcing that a proposed collection of information entitled: Experimental Study of Direct-to-Consumer (DTC) Promotion Directed at Adolescents has been submitted to OMB for review and clearance.
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. Sponsors for several prescription drug classes market their products directly to vulnerable groups, including adolescents. Such DTC marketing to adolescents raises a variety of potential concerns. Adolescents are a unique audience for DTC drug marketing because their cognitive abilities are different than those of adults, and they are usually dependent on adults for health insurance coverage, health care provider access, and prescription drug payment. Despite this uniqueness, research regarding how adolescents use risk and benefit information for health-related decisions is limited. If considered at all in healthcare communication research, age is typically treated as simply another segment of the audience (Ref. 1), and researchers fail to consider how information processing (how people understand information) in response to advertisement (ad) exposure might differ among adolescents versus older viewers.FR, pages 42333-42337
- The FDA is announcing that a proposed collection of information entitled: Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring--21 CFR Part 315--(OMB Control Number 0910-0409)—Extension has been submitted to OMB for review and clearance.
FDA is requesting OMB approval of the information collection requirements contained in 21 CFR 315.4, 315.5, and 315.6. These regulations require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of a new diagnostic radiopharmaceutical or of a new indication for use of an approved diagnostic radiopharmaceutical.FR, pages 42337-42338