[Federal Register Volume 62, Number 238 (Thursday, December 11, 1997)]
[Notices]
[Pages 65273-65274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32460]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0488]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on continuation of national
surveys of prescription drug information provided to patients.
DATES: Submit written comments on the collection of information by
February 9, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information listed below.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Years 1998 and 2000 Continuation of National Surveys of
Prescription Drug Information Provided to Patients--(OMB Control
Number 0910-0279--Extension)
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
[[Page 65274]]
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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
Year No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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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
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Reporting Burden1
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Annual
Year No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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1998 1,000 1 1,000 .323 20
1999 0 0 0 0 0
2000 1,000 1 1,000 .32 320
Annual average 667 667 213
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\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: December 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32460 Filed 12-10-97; 8:45 am]
BILLING CODE 4160-01-F
