[Federal Register Volume 66, Number 4 (Friday, January 5, 2001)]
[Notices]
[Pages 1143-1144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-265]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1534]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Year 2000 Continuation of the National Surveys 
of Prescription Drug Information Provided to Patients

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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.

DATES: Submit written comments on the collection of information by 
February 5, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, 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 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Year 2000 Continuation of the National Surveys 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 2000 goals and now 
for Healthy People 2010 goals for the receipt of medication information 
by patients.

[[Page 1144]]

    Surveys of consumers about their receipt of Rx drug information 
were carried out in 1982, 1984, 1992, 1994, 1996, and 1998. This notice 
is in regard to conducting the survey in 2000.
    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 oral and written information were 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 patient information and counseling 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 
(nonrefill) prescription at a pharmacy for themselves or a member of 
their household in the last 4 weeks. This survey may be seen online at 
http://www.fda.gov/cder/ddmac/y2ktitle.htm.
    In the Federal Register of October 6, 2000 (65 FR 59849), FDA 
invited comments on the proposed information collection. No significant 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                            Table 1.--Estimated Annual Reporting Burden\1\: Screener
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                                                                 Total
     Year          No. of Respondents       Annual Frequency     Annual    Hours per Response      Total Hours
                                              per Response     Responses
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2000                               9,643                   1      9,643                   .03               289
                  Total........                                                                             289
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information


                                  Table 2.--Annual Reporting Burden\1\: Survey
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                                                                 Total
     Year          No. of Respondents       Annual Frequency     Annual    Hours per Response      Total Hours
                                              per Response     Responses
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2000                               1,000                   1      1,000                   .32               320
                  Total........                                                                             320
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information

    This total estimate of 609 total annual burden hours is based on 
the 1998 survey administration, in which 9,643 potential respondents 
were contacted to obtain 1,000 interviews.

    Dated: December 27, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-265 Filed 1-4-01; 8:45 am]
BILLING CODE: 4160-01-S