[Federal Register: December 21, 2007 (Volume 72, Number 245)]
[Notices]
[Page 72710-72713]
[DOCID:fr21de07-80]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-1019; FRL-8341-8]

Nicotine, 4-Aminopyridine, and Fenoxycarb; Notice of Receipt of
Requests to Voluntarily Cancel Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing this
notice of receipt of requests by the registrants to voluntarily cancel
their registrations of certain products containing the pesticides
nicotine, 4-aminopyridine, and fenoxycarb. The requests from Bonide,
Inc. would terminate nicotine use in or on lawns and outdoor
ornamentals; this request would not cancel the last nicotine product
registered for use in the United States. The requests from Avitrol
Corporation would terminate 4-aminopyridine products formulated as
powder; this request would not cancel the last 4-aminopyridine product
registered for use in the United States. The requests from SC Johnson &
Son, Inc. would terminate fenoxycarb use in indoor residential areas;
this request would not cancel the last fenoxycarb product registered
for use in the United States. The requests from Syngenta would
terminate fenoxycarb use by residential handlers; this request would
not cancel the last fenoxycarb product registered for use in the United
States. EPA intends to grant these requests at the close of the comment
period for this announcement unless the Agency receives substantive
comments within the comment period that would merit its further review
of the requests, or unless the registrants withdraw their requests
within this period. Upon acceptance of these requests, any sale,
distribution, or use of products listed in this notice will be
permitted only if such sale, distribution, or use is consistent with
the terms as described in the final order.

DATES: Comments must be received on or before January 22, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID)

number EPA-HQ-OPP-2007-1019, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-1019. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Search for Dockets.'' Insert the

docket ID number where indicated and select the ``Submit'' button.
Follow the instructions on the regulations.gov website to view the
docket index or access available documents. Although listed in the
index, some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  Jill Bloom or Katie Weyrauch, Special
Review and Reregistration Division (7508P), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. For information on the nicotine requests,
please contact: Jill Bloom, telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>For information on the 4-aminopyridine and
fenoxycarb requests, please contact: Katie Weyrauch, telephone number:
(703) 308-0166; e-mail address<EMAIL_ADDRESS>The fax number
for both contacts is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

     1.  Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
     iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
     viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background on the Receipt of Requests to Cancel Registration

    This notice announces receipt by EPA of requests from Bonide
Products, Inc. to cancel two nicotine product registrations. Nicotine
is derived from the tobacco plant and is used to kill insect pests of
ornamental plants, and as part of a formulation used to repel dogs and
rabbits from yard and garden areas. In separate letters dated September
18, 2007, Bonide requested that EPA cancel the two nicotine product
registrations identified in this notice (see Table 1). Specifically,
Bonide has made these requests in light of preliminary indications of
toxicological and ecotoxicological concerns, coupled with a lack of
applicable data and the likely requirement to fill these data gaps.

Bonide has not produced the insecticide product (EPA registration
 4-340) for a number of years, and has not requested time for
the sale of existing stocks. For the repellent product (EPA
registration  4-465), Bonide has requested a 24-month interval
after the cancellation order is issued in which to sell existing
stocks. This action on the registrant's requests will not terminate the
last nicotine product registered in the United States; it will
terminate the registration of the last nicotine products registered in
the United States for use on and around lawns and outdoor ornamentals.
    This notice also announces receipt by EPA of requests from Avitrol
Corporation, to cancel five 4-aminopyridine product registrations. 4-
aminopyridine is an avicide with flock-alarming properties. 4-
aminopyridine products are used around structures and in feedlots for
the control of pigeons, starlings, some species of grackles, sparrows,
crows, and some species of blackbirds. In letters dated May 30, 2007,
September 30, 2007, and October 5, 2007, Avitrol Corporation requested
that EPA cancel affected product registrations identified in this
notice (see Table 1). Specifically, Avitrol Corporation has made these
requests in light of preliminary indications of toxicological and
ecotoxicological concerns and the possibility of airborne transmission
of the powders. The registrant has requested to be able to sell these
4-aminopyridine products through December 31, 2007. This action on the
registrant's requests will terminate the last 4-aminopyridine products
formulated as powders in the United States. In addition, this action on
the registrant's requests will terminate the last 4-aminopyridine
products registered in the United States for use on gulls; in grape
vineyards in California; on sprouting crops in California; and on the
Greater Antillean grackle in Puerto Rico.
    This notice also announces receipt by EPA of requests from S.C.
Johnson & Son, Inc. to cancel two fenoxycarb product registrations.
Fenoxycarb is an O-ester carbamate derivative insecticide/miticide/
insect growth regulator. Fenoxycarb is used on turf, non-bearing
orchards, and on ornamentals to control insects, including fire ants.
In a letter dated July 20, 2007, S.C. Johnson & Son, Inc. requested
that EPA cancel affected product registrations identified in this
notice (see Table 1). Specifically, S.C. Johnson & Son, Inc. has made
this request because the fenoxycarb technical label no longer includes
indoor residential uses of fenoxycarb. S.C. Johnson & Son, Inc. has not
produced the insecticide products (EPA registrations 4822-292
and 4822-442) for a number of years, and has not requested
time for the sale of existing stocks. This action on the registrant's
request will terminate the last fenoxycarb end-use products registered
in the United States with use in indoor residential settings.
    This notice also announces receipt by EPA of requests from Syngenta
to cancel four fenoxycarb product registrations. In a letter dated
November 6, 2007, Syngenta requested that EPA cancel affected product
registrations identified in this notice (see Table 1). Specifically,
Syngenta has made this request because these registrations have not
been produced for some time. Syngenta has not produced the insecticide
products (EPA registrations  100-725,  100-746,
 100-750, and  100-753) for a number of years, and
has not requested time for the sale of existing stocks. This action on
the registrant's requests will not terminate the last fenoxycarb
product registered in the United States.

III. What Action is the Agency Taking?

    This notice announces receipt by EPA of requests from registrants
to cancel certain nicotine, 4-aminopyridine, and fenoxycarb product
registrations. The affected products and the registrants making the
requests are identified in Tables 1 and 2 of this unit.
    Under section 6(f)(1)(A) of FIFRA, registrants may request, at any
time, that their pesticide registrations be canceled or amended to
terminate one or more pesticide uses. Section 6(f)(1)(B) of FIFRA
requires that before acting on a request for voluntary cancellation,
EPA must provide a 30-day public comment period on the request for
voluntary cancellation or use termination. In addition, section
6(f)(1)(C) of FIFRA requires that EPA provide a 180-day comment period
on a request for voluntary cancellation or termination of any minor
agricultural use before granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The Administrator determines that continued use of the pesticide
would pose an unreasonable adverse effect on the environment.
    The nicotine and fenoxycarb products are not agricultural use
products and are not subject to section 6(f)(1)(C) of FIFRA. EPA will
provide a 30-day comment period on the proposed requests for the
nicotine and fenoxycarb products. The 4-aminopyridine registrant has
requested that EPA waive the 180-day comment period. EPA will provide a
30-day comment period on the proposed request.
    Unless a request is withdrawn by the registrant within 30 days of
publication of this notice, or if the Agency determines that there are
substantive comments that warrant further review of this request, an
order will be issued canceling the affected registrations.

 Table 1.--Product Registrations with Pending Requests for Cancellation
------------------------------------------------------------------------
       Registration Number           Product Name           Company
------------------------------------------------------------------------
4-340                             Bonide Tobacco      Bonide Products,
                                   Dust                Inc.
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4-465                             Bonide Rabbit &     Bonide Products,
                                   Dog Chaser          Inc.
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100-725                           Logic Fire Ant      Syngenta Crop
                                   Killer              Protection, Inc.
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100-746                           Fenoxycarb 1% Bait  Syngenta Crop
                                                       Protection, Inc.
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100-750                           Precision 25 WP     Syngenta Crop
                                                       Protection, Inc.
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100-753                           Fenoxycarb 25 WP    Syngenta Crop
                                                       Protection, Inc.
------------------------------------------------------------------------
11649-10                          Avitrol             Avitrol
                                   Concentrate         Corporation
------------------------------------------------------------------------
11649-11                          Avitrol Powder Mix  Avitrol
                                                       Corporation
------------------------------------------------------------------------

CA780131                          Avitrol Mixed       Avitrol
                                   Grains - Special    Corporation
                                   Local Need
------------------------------------------------------------------------
CA780132                          Avitrol Mixed       Avitrol
                                   Grains - Special    Corporation
                                   Local Need
------------------------------------------------------------------------
PR020001                          Avitrol Powder Mix  Avitrol
                                   - Special Local     Corporation
                                   Need
------------------------------------------------------------------------
4822-292                          Raid Flea Kill IV   S.C. Johnson &
                                   Plus                Son, Inc.
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4822-442                          Raid DOB            S.C. Johnson &
                                                       Son, Inc.
------------------------------------------------------------------------

    Table 2 of this unit includes the names and addresses of record for
the registrants of the products listed in Table 1 of this unit.

         Table 2--Registrants Requesting Voluntary Cancellation
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            EPA Company Number                Company Name and Address
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4                                           Bonide Products, Inc.
                                            6301 Sutliff Road
                                            Oriskany, NY 13424
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100                                         Syngenta Crop Protection,
                                             Inc.
                                            P.O. Box 18300
                                            410 Swing Road
                                            Greensboro, NC 27419
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11649                                       Avitrol Corporation
                                            7644 East 46th Street
                                            Tulsa, OK 74145
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4822                                        S.C. Johnson & Son, Inc.
                                            1525 Howe Street
                                            Racine, WI 53403
------------------------------------------------------------------------

IV. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the Administrator may approve such
a request.

V. Procedures for Withdrawal of Requests

    Registrants who choose to withdraw a request for cancellation must
submit such withdrawal in writing to the person listed under FOR
FURTHER INFORMATION CONTACT, postmarked before [30 days after date of
publication in the Federal Register]. This written withdrawal of any
request for cancellation will apply only to the applicable FIFRA
section 6(f)(1) requests listed in this notice. If the products have
been subject to a previous cancellation action, the effective date of
cancellation and all other provisions of any earlier cancellation
action are controlling.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action.
     In any order issued in response to these requests for amendments
to terminate uses, the Agency proposes to include the following
provisions for the treatment of any existing stocks of the products
identified or referenced in Table 1 in Unit III:
     For EPA registration  4-340, no sale by the registrant of
existing stocks. Bonide has not manufactured this product for 3-4 years
and there are no stocks in its possession.
    For EPA registration  4-465, sale by the registrant of
existing stocks will be allowed for a period of 24 months, counted from
the date of the cancellation order associated with this notice.
    For 4-aminopyridine products (EPA registrations  11649-10,
 11649-11,  CA780131,  CA780132, and
 PR020001), sale by the registrant of existing stocks will be
permitted through December 31, 2007. From January 1, 2008 on, sale by
the registrant of existing stocks will be prohibited.
    For fenoxycarb products (EPA registrations  100-725,
 100-746,  100-750,  100-753,
4822-292, and  4822-442), no sale by the registrant of
existing stocks. Syngenta Crop Protection, Inc. has not manufactured
their products for several years and there are no stocks in its
possession. S.C. Johnson & Son, Inc. has not manufactured their
products for several years and there are no stocks in its possession.
    If the requests for voluntary cancellation are granted as discussed
in this unit, the Agency intends to issue a cancellation order that
will allow persons other than the registrant to continue to sell and/or
use existing stocks of cancelled products until such stocks are
exhausted, provided that such use is consistent with the terms of the
previously approved labeling on, or that accompanied, the cancelled
product. The order will specifically prohibit any use of existing
stocks that is not consistent with such previously approved labeling.
If, as the Agency currently intends, the final cancellation orders
contain the existing stocks provisions just described, the order will
be sent only to the affected registrants of the cancelled products. If
the Agency determines that any of the final cancellation orders should
contain existing stocks provisions different than the ones just
described, the Agency will publish the cancellation order in the
Federal Register.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: December 13, 2007.
Peter Caulkins.
Acting Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E7-24903 Filed 12-20-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: May 4, 2010 (Volume 75, Number 85)]
[Notices]
[Page 23775-23777]
[DOCID:fr04my10-91]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0184]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study of Patient Information Prototypes

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,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments for research entitled ``Experimental Study of
Patient Information Prototypes.'' This study is designed to determine
based on different prototype testing whether consumers are able to
comprehend serious warnings, directions for use, drug indications and
uses, contraindications, and side effects in the material that is
presented.

DATES:  Submit written or electronic comments on the collection of
information by July 6, 2010.

ADDRESSES:  Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. 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
Management Programs (HFA-250), Food and Drug Administration, 1350
Piccard Dr., PI50-400B, Rockville, MD 20850<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    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 before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
    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.

Experimental Study of Patient Information Prototypes--New

    In order to make informed decisions about health care and to use
their medications correctly, consumers need easy access to up-to-date
and accurate information about the risks, benefits and safe use of
their prescription drugs. Consumers currently receive multiple pieces
of paper with their prescription drugs from the pharmacy, containing
information that is developed and distributed through various sources.
Written prescription drug information is provided through a voluntary
effort (Consumer Medication Information)\1\ as well as through FDA
mandated use of Medication Guides\2\ and Patient Package Inserts
(PPI).\3\ Patients describe a wide range of experiences and varying
degrees of satisfaction with information currently provided at the time
medicines are received at the pharmacy. In some cases, the written
documents are difficult to read and understand, duplicative and
overlapping, incomplete or contradictory. FDA has held multiple public
meetings to solicit feedback on providing balanced, comprehensive and
up-to-date prescription drug information to consumers.
---------------------------------------------------------------------------

    \1\ Public Law 104-180, August 6, 1996, Title VI. Effective
Medication Guides.
    \2\ 21 CFR part 208.
    \3\ 21 CFR 310.501 and 310.515.
---------------------------------------------------------------------------

    Since 1968, FDA regulations have required that PPIs written
specifically for patients be distributed when certain prescription
drugs or classes of prescription drugs are dispensed. PPIs are required
for estrogens and oral contraceptives, are considered part of the
product labeling, and are to be dispensed to the patient with the
product. In the 1970s, FDA began evaluating the general usefulness of
patient labeling for prescription drugs resulting in a series of
regulatory steps to help ensure the availability of useful written
consumer information. Other

PPIs are submitted to FDA voluntarily by manufacturers and approved by
FDA, but their distribution is not mandated by regulation. In the
Federal Register of July 6, 1979 (44 FR 40016), FDA proposed
regulations that would have required written patient information for
all prescription drugs. In the Federal Register of September 12, 1980
(45 FR 60754), FDA finalized those regulations. In the Federal Register
of September 7, 1982 (47 FR 39147), the regulations were revoked based,
in part, on assurances that the effort could be handled more
efficiently within the private sector.
    In the Federal Register of August 24, 1995 (60 FR 44182), FDA
proposed the Prescription Drug Product Labeling: Medication Guide
Requirements, designed to set specific distribution and quality goals
and timeframes for distributing written information to patients. In the
Federal Register of December 1, 1998 (63 FR 66378 at 66396), the agency
published a final rule that established a program under which
Medication Guides would be required for a small number of drugs
considered to pose a serious and significant public health concern (21
CFR 208.20).
    Evidence suggests that both the content (e.g., organization) and
format (e.g., white space) of a document will impact the comprehension
of patient information. Research on reading behavior and document
simplification suggests that the use of less complex terminology
presented in shorter sentences with a more organized, or chunked,
structure should improve consumer processing for at least three
reasons. First, it should decrease the cognitive load engendered by the
current physician-directed format. Second, a more structured and
organized patient information document should present a less imposing
processing demand, increasing consumers' willingness and self-perceived
ability to read and understand the presented material. Research with
the format of over-the-counter (OTC) drug labels,\4\ the nutrition
facts label,\5\ and other information formats\6\ demonstrates that
information presented with section headings, graphics (such as
bullets), and other design elements is more easily read than
information presented in paragraph format. Consumers are more likely to
engage in behavior they believe they can successfully complete.\7\
Third, a patient information document that provides readers with
clearer ``signals'' regarding the most important information should
help readers prioritize the importance of the presented information.
This should increase the probability that the set of information
identified as important is subjected to more complete mental
processing, thereby increasing the communication of that
information.\8\
---------------------------------------------------------------------------

    \4\ Aikin, K.J., ``Consumer Comprehension and Preference for
Variations in the Proposed Over-The-Counter Drug Labeling Format,
Final Report'' (1998); Vigilante, W.J., M.S. Wogalter, ``The
Preferred Order of Over-the-Counter (OTC) Pharmaceutical Label
Components,'' Drug Information Journal, 31, 973-988, 1997.
    \5\ Levy, A.S., S.B. Fein, R.E. Schucker. ``More Effective
Nutrition Label Formats Are Not Necessarily More Preferred.''
Journal of the American Dietetic Association, 92(10), 1230-1234,
1992.
    \6\ Lorch, R., E. Lorch, ``Effects of Organizational Signals on
Text-Processing Strategies,'' Journal of Educational Psychology,
87(4), 537-544, 1995; Lorch, R., E. Lorch, ``Effects of
Organizational Signals on Free Recall of Expository Text,'' Journal
of Educational Psychology, 88(1), 38-48, 1996; Lorch, R., E. Lorch,
W. Inman, ``Effects of Signaling Topic Structure on Text Recall,''
Journal of Educational Psychology, 85(2), 281-290, 1993.
    \7\ Wood, R., A. Bandura, ``Impact of Conceptions of Ability on
Self-regulatory Mechanisms and Complex Decision Making.'' Journal of
Personality and Social Psychology, 56(3), 407-415, 1989.
    \8\ Lorch, R., E. Lorch, ``Effects of Organizational Signals on
Text-processing Strategies, '' Journal of Educational Psychology,
87(4), 537-544, 1995; Lorch, R., E. Lorch, ``Effects of
Organizational Signals on Free Recall of Expository Text,'' Journal
of Educational Psychology, 88(1), 38-48, 1996; Lorch, R., E. Lorch,
W. Inman, ``Effects of Signaling Topic Structure on Text Recall,''
Journal of Educational Psychology, 85(2), 281-290, 1993.
---------------------------------------------------------------------------

    As part of FDA's efforts to improve the patient information
received with prescription drugs, a Risk Communications Advisory
Committee meeting was held on February 26 and 27, 2009. At this
meeting, committee members discussed issues such as the ones described
previously in this document and listened to stakeholder problems
regarding the design and distribution of patient information. Following
the advisory committee meeting, the working group created four
prototypes to aid discussion at a public workshop to be held later in
the year.
    This public workshop was held on September 24 and 25, 2009. During
the workshop stakeholders from industry, consumer advocacy, and
academia converged to discuss desirable features for a single-document
patient leaflet, if that were to be developed, consumer tested and
distributed. Participants were divided into six groups to address the
pros and cons of the four prototypes with the goal of deciding which
features participants appreciated and did not appreciate. Additional
information on the September 24 and 25, 2009, public workshop, is
available at http://www.fda.gov/Drugs/NewsEvents/ucm168106.htm.
    Given the information obtained from workshop participants, the
working group refined several prototypes and designed a study to
investigate the usefulness of three possible patient information
formats from a user perspective. The results of this study will inform
FDA as to the usefulness and parameters of various format options for
the patient information documents.

II. Description of the Project

    This project is designed to test different ways of presenting
information about prescription drugs to patients who have obtained a
prescription. The information used will be based on a fictitious
medication for the treatment of rheumatoid arthritis, ankylosing
spondylitis, and plaque psoriasis. Data collection will occur via
computer at training and testing facilities with orientation and
debriefing conducted by interviewers. Participants will include adults
who have been diagnosed with one of the conditions the fictitious drug
treats. Participants will be prescreened to obtain a reasonable
representation of health literacy, including those who score at the
lower end of the scale. Questionnaire measures will include open- and
closed-ended questions. Extensive pretesting of materials and stimuli
will be conducted to refine the experimental stimuli and dependent
measures and to ensure the stimuli meet minimum communication
requirements and are delivering expected messages.

Proposed Study Design and Protocol

    The study is experimental and will have two independent variables
in a 3 x 2 design. The independent variables are Format (3 levels: Drug
Facts, Minimal Column, and Column Plus) and Order (2 levels: Warning
first and Indication first).

                                                     Format
----------------------------------------------------------------------------------------------------------------
          Order                     Drug Facts                 Minimal Column                Column Plus
----------------------------------------------------------------------------------------------------------------
Warning first              ...........................  ...........................  ...........................
----------------------------------------------------------------------------------------------------------------
Indication first           ...........................  ...........................  ...........................
----------------------------------------------------------------------------------------------------------------

    The Order manipulation will vary the primacy of the boxed warning
information versus the paragraph about the uses to the drug. In terms
of Format, the Drug Facts format will follow the conventions of the
existing OTC labeling. The Minimal Column condition will contain
information in two columns with only basic information in the sections
regarding information patients should tell their doctors. The Column
Plus condition will also present information in two columns, but will
include additional contextual information in the sections about what
information patients should report to their doctors.
    Participants with relevant medical conditions will be randomly
assigned to one of the six experimental conditions and each participant
will see only one version of the patient information. Participants will
be prescreened to represent a range of health literacy levels,
including a portion with low literacy. Thus, all participants in the
study will have been diagnosed with rheumatoid arthritis, ankylosing
spondylitis, or plaque psoriasis and at least 30 percent of the sample
will fall in the lower range of literacy. Because the average reading
level in the United States is estimated to be 8th grade\9\ and it is
recommended that consumer medication information be written at a 5th
grade reading level,\10\ the low literate cohort will consist of
consumers who have 5th to 8th grade reading skills. Education level is
not a reliable substitute for literacy testing. At screening, the
participants will be assessed for literacy level using a validated
instrument.
---------------------------------------------------------------------------

    \9\ Cotunga N., C.E. Vickery, K.M. Carpenter-Haefele,
``Evaluation of Literacy Level of Patient Education Pages in Health-
Related Journals,'' Journal of Community Health, 30(3), 213-219,
2005.
    \10\ Andrus, M.R., M.T. Roth, ``Health Literacy: A Review,''
Pharmacotherapy, 22(3), 282-302, 2002.
---------------------------------------------------------------------------

    An additional small study will be conducted via the Internet to
determine whether electronic prototype presentation alters the
processing of the information in any way. Two-hundred individuals with
the same characteristics of the original sample (e.g., medical
condition and literacy levels) will be recruited over the Internet and
will complete the same questionnaire as original participants.
    FDA is undertaking this study because it does not yet have
sufficient evidence-based research relating to patient needs, or
whether those needs are being effectively met. Research related to the
functionality and effectiveness of written patient information
consistently identifies the importance of performance-based testing as
well as content based testing, which enables the evaluation of
materials in order to assure their utility and identify issues in
content format, or design. Development of new prescription drug patient
materials must be based on consumer testing that focuses on utility to
the patient and comprehension of material in the broadest audience
possible. FDA has developed three prototypes in order to user test
prescription drug information with consumers in order to achieve this
goal. For further information, contact Elizabeth Berbakos (see FOR
FURTHER INFORMATION CONTACT).
    The burden table reflects up to three pretests of 180 individuals
each, 900 participants in the main study, and 200 participants in the
followup study involving electronic administration.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
   21 CFR                          Annual Frequency      Total Annual          Hours per
   Section    No. of Respondents     per Response          Responses           Response           Total Hours
----------------------------------------------------------------------------------------------------------------
                             540                   1                 540               20/60                 178
----------------------------------------------------------------------------------------------------------------
                             900                   1                 900               25/60                 369
----------------------------------------------------------------------------------------------------------------
                             200                   1                 200               25/60                  82
----------------------------------------------------------------------------------------------------------------
Total                                                                                629
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: April 28, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.

[FR Doc. 2010-10359 Filed 5-3-10; 8:45 am]
BILLING CODE 4160-01-S