Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 2004 National Tracking Survey of Prescription Drug Information

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by June 28, 2004.

ADDRESSES:

OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

2004 National Tracking Survey of Prescription Drug Information—(OMB Control Number 0910-0279)—Extension

2004 National Tracking Survey of Prescription Drug Information Provided to Patients

FDA implements the provisions of the Federal Food, Drug, and Cosmetic Act (the act) designed to assure the adequate labeling of prescription (Rx) drugs. Under section 502(a) of the act (21 U.S.C. 352(a)), a drug product is misbranded if its labeling is false or misleading in any particular, and under section 201(n) of the act (21 U.S.C. 321(n)), a drug's labeling is misleading if its labeling or advertising fails to reveal material facts. FDA also has the authority to collect this information under Title VI of Public Law 104-180 (Related Agencies and Food and Drug Administration) section 601 (Effective Medication Guides), which directs the development of “a mechanism to assess periodically * * * the frequency with which the [oral and written prescription] information is provided to consumers.”

To assure that Rx drugs are not misbranded, FDA has historically asserted that adequate labeling requires certain information be provided to patients. In 1982, when FDA revoked a planned initiative to require mandatory patient package inserts for all Rx drugs in favor of private sector initiatives, the agency indicated that it will periodically conduct surveys to evaluate the availability of adequate patient information on a nationwide basis. In addition, FDA has been responsible for setting and tracking Healthy People 2010 goals for the receipt of medication information by patients.

Surveys of consumers about their receipt of Rx drug information were carried out in 1992, 1994, 1996, 1998, and 2001. This notice is in regard to conducting the survey in 2004.

The survey is conducted by telephone on a national random sample of adults who received a new prescription for themselves or a household member within the past 4 weeks. The interview assesses the extent to which information was received from the doctor, the pharmacist, and other sources. Survey respondents are also asked attitudinal questions, and demographic and other background characteristics are obtained. The survey enables FDA to determine the frequency with which such information is provided to consumers. Without this information, the agency would be unable to assess the degree to which adequate oral patient information about Rx drugs is provided.

Respondents to this collection of information are adults (18 years or older) in the continental United States who have obtained a new (non-refill) prescription at a pharmacy for themselves or a member of their household in the last 4 weeks.

FDA estimates the burden of this collection of information as follows:

This total estimate of 626 total annual burden hours is based on the 2001 survey administration, in which 15,319 potential respondents were contacted to obtain 1,000 interviews.

In the Federal Register of January 27, 2004 (69 FR 3921), FDA published a 60-day notice requesting public comment on the information collection provisions. One comment was received.

The comment was received from the National Council on Patient Information and Education, which is a consortium of organizations, public agencies, and consumer groups seeking to promote adequate patient information about medications. The comment from the National Council on Patient Information and Education states the Council's support for FDA to conduct this survey, citing usefulness of the results to the Council's goals.