Agency Information Collection Activities; Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0488]

Agency Information Collection Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that the

proposed collection of information listed below has been submitted to

the Office of Management and Budget (OMB) for review and clearance

under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by

April 22, 1998.

ADDRESSES: Submit written comments on the collection of information to

Office of Information and Regulatory Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235, Washington, DC, 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information

Resources Management (HFA-250), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA

(44 U.S.C. 3507), FDA has submitted the following proposed collection

of information to OMB for review and clearance.

Year 1998 and 2000 Continuation of National Surveys of Prescription

Drug Information Provided to Patients--(OMB Control Number 0910-

0279--Reinstatement)

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 Pub. L. 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 in this area, the agency indicated that it

will periodically conduct surveys to evaluate the availability of

adequate patient information on a nationwide basis. Surveys of

consumers about their receipt of Rx drug information were carried out

in 1982, 1984, 1992, 1994, and 1996. This notice is in regard to

continuing the survey in years 1998 and 2000.

The survey is conducted by telephone on a national random sample of

adults age 18 and over who received a new prescription for themselves

or a household member within the past 4 weeks. The interview assesses

the extent to which oral and written 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 also 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 assure that

adequate Rx labeling and information is provided.

Respondents to this collection of information are adults (18 years

or older), in the continental United States who have obtained one or

more new (nonrefill) prescriptions at a pharmacy for themselves or a

member of their household in the last 4 weeks.

In the Federal Register of December 11, 1997 (62 FR 65273), the

agency invited comments on the collections of information. No

significant comments were received.

FDA estimates the burden of this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden: Screener1

----------------------------------------------------------------------------------------------------------------

Annual

Year No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

----------------------------------------------------------------------------------------------------------------

1998 11,044 1 11,044 .03 331

1999 0 0 0 0 0

2000 11,044 1 11,044 .03 331

Annual average 7,363 7,363 221

----------------------------------------------------------------------------------------------------------------

\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

[[Page 13866]]

Table 2.--Annual Reporting Burden: Survey1

----------------------------------------------------------------------------------------------------------------

Annual

Year No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

----------------------------------------------------------------------------------------------------------------

1998 1,000 1 1,000 .32 320

1999 0 0 0 0 0

2000 1,000 1 1,000 .32 320

Annual average 667 667 213

----------------------------------------------------------------------------------------------------------------

\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

This estimate of 434 total annual burden hours is based on the 1996

survey administration, in which 11,044 potential respondents were

contacted to obtain 1,000 interviews.

Dated: March 16, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-7475 Filed 3-20-98; 8:45 am]

BILLING CODE 4160-01-F