[Federal Register Volume 72, Number 22 (Friday, February 2, 2007)]
[Notices]
[Pages 5056-5057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1674]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0036]


Agency Emergency Processing Under Office of Management and Budget 
Review; Toll-Free Number for Reporting Adverse Events on Labeling for 
Human Drug Products; Labeling Comprehension Study

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns an experimental study to test labeling statement 
alternatives for certain prescription and over-the-counter (OTC) drug 
product labeling.

DATES: Fax written comments on the collection of information by March 
5, 2007.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-6974. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. This information is needed 
prior to the expiration of the normal time periods for OMB clearance 
under the PRA regulations (5 CFR part 1320) and is essential to the 
agency's mission to protect the public health and safety. Section 17 of 
the Best Pharmaceuticals for Children Act (the BPCA) (Public Law 107-
109) requires FDA to issue a final rule mandating the addition of a 
statement to the labeling of each drug product for which an application 
is approved under section 505 of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 355). Under the BPCA, the labeling statement 
is required to include: (1) A toll-free number for consumers to use to 
report drug product side effects and (2) a statement that the number is 
to be used only for reporting side effects and is not intended to seek 
or obtain medical advice (the side effects statement). The use of 
normal clearance procedures would further delay FDA's issuance of a 
final rule to comply with this congressional mandate.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

Toll-Free Number for Reporting Adverse Events on Labeling for Human 
Drug Products; Labeling Comprehension Study

    On April 22, 2004 (69 FR 21778), FDA published a proposed rule with 
a proposed side effects statement for certain prescription drug product 
labeling and a proposed side effects statement for certain OTC drug 
product labeling. In the proposed rule, FDA solicited comments on the 
wording of these side effects statements. We received 12 comments 
suggesting changes to the specific wording of the proposed side effects 
statements. We also received several comments suggesting that FDA 
engage in research to study consumer comprehension of the wording of 
the proposed side effects statements. Among the reasons cited for 
testing the statements were: (1) To determine the best and most precise 
wording for the statements, (2) to evaluate consumer comprehension of 
the proposed statements, and (3) to address concerns that consumers who 
read the statement will mistakenly call FDA in search of medical 
advice. In addition, during the clearance process for the proposed 
rule, both the Office of Information and Regulatory Affairs of OMB and 
the Office of the Assistant Secretary for Planning and Evaluation of 
the Department of Health and Human Services suggested that FDA conduct 
consumer studies on the wording of the side effects statements. After 
the publication of the proposed rule and based on the comments 
received, FDA decided to conduct research to study the wording of the 
proposed side effects statements before issuing a final rule.
    FDA conducted two focus groups (OMB Control No. 0910-0497) to 
narrow the field of potential statement alternatives. Based on the 
findings from the focus groups, FDA has selected several statements for 
quantitative testing in an experimental study of consumer 
comprehension. The experimental study will test several ways of stating 
the required information for maximum comprehension of factual 
information and necessary action. The experimental study will provide 
quantitative data to inform FDA's selection of the side effects 
statements to fulfill the requirements of the BPCA. Each participant 
will be exposed to only one side effects statement, in a ``between-
subjects'' or ``monadic'' design. Participants initially will see one 
statement in the context of either a prescription drug bottle or an OTC 
Drug Facts label, depending on which condition they are in, and will 
all answer the same series of questions. For the remainder of the 
study, each participant will see the statement as they answer questions 
specifically about the statement. The experimental study data will be 
collected via the Internet from members of a consumer panel maintained 
by an external research organization. Panel members are recruited by a 
variety of means designed to reflect all segments of the population. 
They are required to have a computer with Internet access. Studies 
begin with an e-mailed invitation to the sampled

[[Page 5057]]

respondents. Each panel member has provided demographic data for their 
household that allows for the selection of samples that resemble 
closely the distribution of the U.S. population on age, gender, 
education, and race/ethnicity. A participant recruitment questionnaire 
(screener) will be used to ensure recruitment criteria are met. 
Conventional statistical techniques for experimental data (such as 
descriptive statistics, analysis of variance, and regression models) 
will be used to analyze the data. This proposed data collection will be 
one-time only. No successive related data collections are planned. 
Testing the statements experimentally will provide valuable information 
on the comprehension, usefulness, and selection of the side effect 
statements to be included in the final rule.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                       No. of         Annual Frequency per     Total Annual        Hours per
    Activity         Respondents            Response             Responses          Response       Total Hours
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Administration               1,684                      1               1,684             0.01               17
 of Participant
 Screener
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Administration               1,600                      1               1,600             0.15              240
 of Participant
 Questionnaire
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Total            ..................  .....................  ..................  ...............             257
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: January 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-1674 Filed 2-1-07; 8:45 am]
BILLING CODE 4160-01-S