01-13908. Agency Information Collection Activities; Proposed Collections; Reopening of Comment Period; Direct-to-Consumer Promotion of Prescription Drugs

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; Reopening of comment period.

SUMMARY:

The Food and Drug Administration (FDA) is reopening the comment period to June 5, 2001, the comment period for the two proposed collections of certain information by the agency. This notice reopens the comment period on surveys of physicians and patients to examine the impact of direct-to-consumer (DTC) promotion of prescription drugs. The purpose of the proposed information collection is to followup on the agency’s 1999 patient survey and expand information collection to include physicians.

DATES:

Submit written or electronic comments on the collection of information by June 5, 2001.

ADDRESSES:

Submit electronic comments on the collection of information to: http://www.accessdata.fda.gov/​scripts/​oc/​dockets/​edockethome.cfm. Submit written comments by June 5, 2001, on the collection of information to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION:

FDA needs information from physicians and patients about their reactions to, and behaviors that stem from, DTC prescription drug advertising in order to develop policy on appropriate requirements for regulating drug product promotional materials. The agency is reopening the comment period for the proposed collections due to technical problems encountered on the electronic comment submission site during the previous comment period.

Dated: May 29, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.