Agency Information Collection Activities: Proposed Collection; Comment Request

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

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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