[Federal Register: May 27, 2004 (Volume 69, Number 103)]
[Page 30313-30314]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0575]

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 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                                                         No. of    Frequency    Total        Hours per     Total
                        Year                          Respondents     per       Annual       Response      Hours
                                                                    Response  Responses
    2004                                              15,319           1      15,319             .02       306
    2004                                               1,000           1      1,000              .32       320
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    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

[[Page 30314]]

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.

    Dated: May 21, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11949 Filed 5-26-04; 8:45 am]