[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Notices]
[Pages 38658-38663]
[FR Doc No: 2011-16552]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0417]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study of
Format Variations in the Brief Summary of Direct-to-Consumer Print
Advertisements

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 review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August
1, 2011.

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:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-New and
title, ``Experimental Study of Format Variations in the Brief Summary
of Direct-to-Consumer Print Advertisements.'' Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Experimental Study of Format Variations in the Brief Summary of Direct-
to-Consumer Print Advertisements--(OMB Control Number 0910-New)

    Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352(n)) specifies that ads for prescription drugs and biological
products must provide a true statement of information ``in brief
summary''

about the advertised product's ``side effects, contraindications, and
effectiveness.'' The prescription drug advertising regulations (Sec.
202.1(e)(3)(iii) (21 CFR 202.1(e)(3)(iii))) specify that the
information about risks must include each specific side effect and
contraindication from the advertised drug's FDA-approved labeling,
including the Warnings, Precautions, Adverse Reactions, and other
relevant sections. Some of the current approaches to fulfilling the
brief summary requirement, while adequate from a regulatory
perspective, result in ads that may be difficult to read and understand
when used in consumer-directed promotion.
    In recent years, FDA has become concerned about the adequacy of the
brief summary in direct-to-consumer (DTC) print advertisements for
prescription drugs. Because the regulations do not specify how to
address each risk, sponsors can use discretion in fulfilling the brief
summary requirement under Sec.  202.1(e)(3)(iii). Frequently, sponsors
print in small type, verbatim, the risk-related sections of the
approved product labeling (also called the package insert, professional
labeling, prescribing information, and direction circular). This
labeling is written for health professionals, using medical
terminology. While adequate to fulfill the brief summary requirement
for print advertisements, this method may not be the most ideal.
Research has shown that while many consumers will make the effort to
read the brief summary in prescription drug print advertisements if
they are especially interested in the drug, as a general rule consumers
typically read little or none of the brief summary information (Ref.
1). Health practitioners themselves have indicated they often have
difficulty finding information they actively seek in package inserts
(see 65 FR 81082, December 22, 2000, for a discussion of studies
supporting the use of a highlights section in physician labeling).
There may be other ways to fulfill this requirement that improve
consumers' ability to find and comprehend the information in this
important document.
    There is evidence suggesting that both information content and the
format in which it is presented will impact comprehension. For
instance, research with the format of over-the-counter (OTC) drug
labels (Refs. 2 and 3), the nutrition facts label (Ref. 4), and other
information formats (Refs. 5 to 7) 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.
    Research conducted by FDA and others has examined the content and
format of the brief summary specifically. For instance, FDA conducted a
series of relevant studies (OMB control numbers 0910-0591 and 0910-
0611). Schwartz, Woloshin, and Welch have compared one format for
adding quantitative and qualitative benefit and risk information to the
brief summary (Ref. 8). Specifically, Schwartz et al. designed a
prescription drug facts box similar in format to the nutrition facts
panel and OTC drug facts panel. The box contains a number of elements,
including qualitative and quantitative (both absolute frequency and
absolute difference) information about benefits and risks. This study
showed that consumers who were provided efficacy information in a
prescription drug facts box were more likely to correctly choose the
product with the higher efficacy than consumers who saw the brief
summary using medical language from the prescribing information.
However, it is unclear which elements of the drug facts box are
necessary to improve consumer understanding. For instance, it is not
known whether simply adding efficacy rate information to a consumer-
friendly brief summary would be sufficient to enable consumers to
understand a product's efficacy or whether qualitative summations are
necessary as well.
    The current study will add to previous research by systematically
examining these different elements to determine whether and how to add
qualitative and quantitative benefit and risk information to the brief
summary. The results of this study will inform FDA of the usefulness
and parameters of various format and content options for the brief
summary.
    Design Overview: This study will be conducted in two concurrent
parts; one examining variations on the benefit information presented in
DTC print advertisements and the other examining variations on the risk
information presented in DTC print advertisements. The factors studied
will be the type of information (i.e., the addition of quantitative and
qualitative information in a box format) and the level of efficacy or
risk. We will vary the level of efficacy and risk such that the largest
effect is noticeably different from the placebo, whereas the smallest
effect is minimally different from the placebo. These factors will be
combined in a factorial design as follows:

                                                           Table 1--Proposed Design (4x5 + 2)
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                                                                                Efficacy level
          Information type          --------------------------------------------------------------------------------------------------------------------
                                        Smallest  effect         Smaller effect         Mid-size  effect        Larger effect          Largest effect
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Absolute Frequency.................  81% vs. 82%...........  61% vs. 82%...........  41% vs. 82%..........  21% vs. 82%..........  1% vs. 82%.
Absolute Frequency + Qualitative     Fewer 81% vs. 82%.....  Fewer 61% vs. 82%.....  Fewer 41% vs. 82%....  Fewer 21% vs. 82%....  Fewer 1% vs. 82%.
 Label.
Absolute Difference + Qualitative    Fewer (1%)............  Fewer (21%)...........  Fewer (41%)..........  Fewer (61%)..........  Fewer (81%).
 Label.
Absolute Frequency + Absolute        Fewer (1%) 81% vs. 82%  Fewer (21%) 61% vs.     Fewer (41%) 41% vs.    Fewer (61%) 21% vs.    Fewer (81%) 1% vs.
 Difference + Qualitative Label.                              82%.                    82%.                   82%.                   82%.
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Note: Two other cells will be tested: (1) No information and (2) Qualitative label only (fewer). This design (22 cells) will also be used to test risk
  information (for a total of 44 cells). The specific numbers in the table are placeholders only. Qualitative label example: ``Fewer people taking drug
  X had disease/symptom Y.''

    The test product will be for the treatment of a high prevalence
medical condition and modeled on an actual drug used to treat that
condition. Participants will be consumers who have been diagnosed with
the medical condition of interest. They will be randomly assigned to
read one ad version. After reading the ad, participants will answer a
series of questions about the drug. We will test how the information
type affects

perceived efficacy, perceived risk, behavioral intention, and accurate
understanding of the benefit and risk information.
    Interviews are expected to last no more than 20 minutes. A total of
11,750 participants will be involved in the study. This will be a one-
time (rather than annual) collection of information.
    In the Federal Register of August 31, 2010 (75 FR 53312), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Four responses were received, each of which
included several comments.

I. Study Design

    (Comment 1) Several suggestions related to participant
demographics, measuring health literacy, and determining what our
primary research questions are. One question related to the test DTC
advertisements to be used in the study.
    (Response) We agree that the study design should include the
variables of age, education, ethnicity, and race; these are included in
the questionnaire. We will ask whether participants can read,
understand, and speak English.
    We will measure subjective health literacy and the related concept
of numeracy, which is relevant for this research as we are studying the
comprehension of quantitative information. To clarify, we will not
limit our sample to those who are currently being treated with a
prescription drug for the condition being assessed; however, the
questionnaire includes questions about prescription drug use.
    Regarding the primary research questions, as stated in the 60-day
notice, the current study will add to previous research by
systematically examining the different elements in the drug facts box
tested in previous research (Ref. 8) to determine whether and how to
add qualitative and quantitative benefit and risk information to the
brief summary. Specifically, we will test whether the inclusion of a
qualitative label and/or the inclusion of quantitative information
affects consumers' understanding of the information and their
perceptions of the product.
    We have contracted with an organization that produces realistic ads
and stimuli to ensure that we will show respondents realistic
materials.
    (Comment 2) This comment states that there was not enough detail in
the 60-day Federal Register notice, such as no description of the
criteria for determining the amount and type of risk and benefit
information to provide in the box format. Another question noted that
qualitative terms depend on many factors. This comment also recommends
that we consider implementing a cross-over study design to address
interpatient variability. This comment suggested considering caregivers
and consumers who do not have the medical condition treated by the
drug. The final question in this comment asked how the tools were
qualified or validated for their intended use.
    (Response) The questionnaire, which has information about how
questions will be asked and how behavioral intention will be assessed,
was available upon request during the first comment period and will
continue to be available during the second comment period. Information
about how risk information will be portrayed, what statistical analyses
will be performed, subject recruitment, and pretest content is
addressed in this document.
    We agree that a major challenge of the drug facts box format is
deciding the amount and content of risk information to include;
however, this type of study cannot address this issue. To replicate and
extend past research, we will use the drug facts box from a previous
study (Ref. 8) with slight modifications to the risk information (e.g.,
the addition of a serious risk, different rates of side effects in the
placebo and active drug groups).
    We agree that qualitative terms depend on many factors; however,
this study does not address the feasibility of creating qualitative
terms but rather tests whether qualitative terms affect consumer
comprehension. As requested, we will note this in our conclusions.
    Conducting a cross-over design would significantly increase study
length, and repeated exposure to the same stimuli with minor changes
may affect participants' responses. We have conducted power analyses
and believe we can find interpretable results without conducting a
cross-over design.
    To ensure that our participants are motivated to consider the
information presented in the study and to conserve resources, we will
limit our sample to people who have the medical condition of interest.
    Cognitive testing will be used to test questionnaire items prior to
their use, and similar items have been used in our previous studies.
The items have face validity, and several are drawn from well-tested
items used in the psychology literature (for example, behavioral
intentions; Ref. 9). Finally, we will pretest the study manipulations.
    (Comment 3) This comment included three statements about the
details of the proposed study. First, the comment questioned why we
chose to test percents and frequencies and not relative differences in
this study. Second, this comment pointed out that the differences in
the stimuli should be stated as percentage points, not as percentages.
Third, the comment asks whether the risk and benefit information will
be presented in the same mathematical expression and whether they will
be presented independently.
    (Response) We focus on percents and frequencies because we are
replicating and extending previous research on a drug facts box (Ref.
8), which included percents and frequencies but not relative
differences. The study found that the drug facts box outperformed a
traditional brief summary. The drug facts box tested had several
elements that differed from the traditional brief summary, including
percents, frequencies (i.e., XX/100), and qualitative labels. From
these results, it is not possible to tell which elements of the drug
facts box were responsible for the effects found. This study aims to
test systematically the elements of the drug facts box to determine
which, if any, improves consumer comprehension.
    We will change percentages to percentage points in our stimuli.
    To clarify, when participants see benefit information in a certain
information type (or mathematical expression, for example, percents),
they will also see risk information in that same information type (for
example, percents). However, the efficacy level (from smallest to
largest effect) will be manipulated in one design, and the risk level
(from smallest to largest effect) will be manipulated in a separate
design.
    (Comment 4) The comment suggested that we redesign the study such
that participants would view the study materials and then answer
questions about the materials only after consulting with a physician.
This comment lists a number of practical issues surrounding how to
create drug facts boxes and notes that this study will provide limited
practical information on how to format the brief summary for drugs with
multiple indication, multiple studies, or multiple outcomes. Another
recommendation from the comment is to include conditions that test
relative difference. The comment suggests eliminating the ``largest
effect'' cells.
    (Response) We cannot ask participants to incur the financial and
personal (time) cost of visiting a doctor to discuss a treatment for
the purposes of research. This is not feasible or ethical. We cannot
ethically ask them to go to their doctor to discuss a fictitious drug
(nor would the doctor be able to discuss a fictitious drug with them),
and

we cannot ethically recommend a real product for them to discuss with
their doctor. Aside from the feasibility and ethical issues, this is an
unnecessary step to answer our research questions about participants'
comprehension of a widely disseminated written form of information.
Moreover, the assumption behind this recommendation, that physician
consultations are the ``context in which prescription drug
advertisements are actually used,'' is questionable. DTC advertising
does not exist solely in the confines of a doctor's office; rather, DTC
advertising targets consumers outside of a doctor's office, with the
goal of prompting consumers to ask their physicians about the product.
Therefore, clear communication of risks and benefits is needed for
consumers before a consultation with a physician.
    We agree that there are several practical issues surrounding the
utility of the drug facts box; however, these issues are outside the
scope of the proposed study. This study does not address how
information would be chosen for inclusion in drug facts boxes but
rather whether and how consumers can understand the information
presented. As stated in the response to comment 7, our first step will
be to study a simple version of the drug facts box, with one
indication.
    We agree that relative difference is an interesting way to present
quantitative information and are currently studying this presentation
in another study (Refs. 10 and 11). However, as noted in the response
to comment 3, in this study we are systematically testing the elements
of the drug facts box presented in past research (Ref. 8) to determine
which, if any, improves consumer comprehension.
    We agree that these ``largest effect'' cells may be unrealistic and
plan to use pretests to determine the number of levels and the content
of the levels (e.g., the differences used) to be included in the main
study.

II. Publication of the Study

    (Comment 5) This comment requested that FDA provide clarity on the
timing and strategy for the conduct of this study with respect to other
planned studies.
    The comment recommends that FDA publish findings from this study
and previous studies on the Division of Drug Marketing, Advertising,
and Communications (DDMAC) Web page (Ref. 12).
    (Response) To clarify, this study will begin after two related
studies (Refs. 10 and 11) have been conducted. The results from these
studies may inform the execution of this study. The study will not be
superseded by related research results, as none of the other research
examines the drug facts box format for the brief summary.
    We agree and have taken steps to publish reports from our previous
research on the DDMAC Web page (Ref. 12). When the current project is
concluded, we will post the findings on the DDMAC Web page as well.
    (Comment 6) Much of this comment focused on previous research.
First, this comment requests that we disclose the results of previous
research. Second, this comment recommends that we wait to begin new
studies until results of previous research have been publicly reported.
    (Response) As stated in the response to comment 5, we agree and
have taken steps to publish findings from our previous research on the
DDMAC Web page (ref. 12). Unfortunately, the lengthy research process
does not allow us to comply with the second request. To continue having
an active research program, we must submit new proposals while previous
projects are ongoing. As stated in response to comment 5, as research
projects develop, we will take results of previous research in account.

III. Product Labeling

    (Comment 7) A comment noted that product labeling is multifaceted
and recommended that conclusions should be flexible to address these
wide variations in product attributes. Another suggestion was to
consider a label format that includes multiple endpoints.
    (Response) We agree that product labeling is multifaceted and will
tailor our conclusions to acknowledge that we tested one simple version
of the drug facts box.
    As a first step, we plan to study a simple version of the drug
facts box, with one indication. If consumers cannot understand the
information in a drug facts box with one indication, they are not
likely to understand the information in the drug facts box with
multiple indications. In addition, testing an ad with one endpoint is
realistic as drug ads often promote only one indication even if a drug
has multiple indications.
    (Comment 8) Another comment suggested that, along with testing the
qualitative label, ``fewer people taking Drug X had symptom Y,'' we
should also test the qualitative label, ``more people taking Drug X
received effective relief from symptom Y.''
    (Response) Unfortunately, we do not have the resources to test
multiple qualitative labels in this study; however, we will test the
qualitative label suggested by the comment in place of our original
language.

IV. Revised Study Design

    This study will be conducted in two concurrent parts; one examining
variations on the benefit information presented in DTC print
advertisements and the other examining variations on the risk
information presented in DTC print advertisements. The factors studied
will be the type of information (i.e., the addition of quantitative and
qualitative information in a box format) and the level of efficacy or
risk. We will vary the level of efficacy and risk such that the largest
effect is noticeably different from the placebo, whereas the smallest
effect is minimally different from the placebo. We plan to use pretests
to determine the number of levels and the content of the levels (e.g.,
the differences used) to be included in the main study. We will also
pretest whether participants should have access to the ad while
completing the questionnaire. The following design includes the maximum
number of levels we would include. These factors will be combined in a
factorial design as follows:

                                                           Table 2--Benefit Design (4 x 5 + 2)
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                                                                                Efficacy level
          Information type          --------------------------------------------------------------------------------------------------------------------
                                         Smallest effect         Smaller effect         Mid-size effect         Larger effect          Largest effect
--------------------------------------------------------------------------------------------------------------------------------------------------------
(1) Absolute Frequency.............  19% vs. 18%...........  39% vs. 18%...........  59% vs. 18%..........  79% vs. 18%..........  99% vs. 18%.
(2) Absolute Frequency +             More 19% vs. 18%......  More 39% vs. 18%......  More 59% vs. 18%.....  More 79% vs. 18%.....  More 99% vs. 18%.
 Qualitative Label.

(3) Absolute Difference +            More (1 percentage      More (21 percentage     More (41 percentage    More (61 percentage    More (81 percentage
 Qualitative Label.                   point).                 points).                points).               points).               points).
(4) Absolute Frequency + Absolute    More (1 percentage      More (21 percentage     More (41 percentage    More (61 percentage    More (81 percentage
 Difference + Qualitative Label.      point) 19% vs. 18%.     points) 39% vs. 18%.    points) 59% vs. 18%.   points) 79% vs. 18%.   points) 99% vs. 18%.
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Note: Qualitative label example: ``More people taking drug X had heartburn relief.'' There are two additional conditions: a no information condition and
  a qualitative label only (More) condition.

                                                            Table 3--Risk Design (4 x 5 + 2)
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                                                                                Risk level
          Information type          --------------------------------------------------------------------------------------------------------------------
                                         Smallest effect         Smaller effect         Mid-size effect         Larger effect          Largest effect
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(1) Absolute Frequency.............  3% vs. 2%.............  23% vs. 2%............  43% vs. 2%...........  63% vs. 2%...........  83% vs. 2%.
(2) Absolute Frequency +             More 3% vs. 2%........  More 23% vs. 2%.......  More 43% vs. 2%......  More 63% vs. 2%......  More 83% vs. 2%.
 Qualitative Label.
(3) Absolute Difference +            More (1 percentage      More (21 percentage     More (41 percentage    More (61 percentage    More (81 percentage
 Qualitative Label.                   point).                 points).                points).               points).               points).
(4) Absolute Frequency + Absolute    More (1 percentage      More (21 percentage     More (41 percentage    More (61 percentage    More (81 percentage
 Difference + Qualitative Label.      point) 3% vs. 2%.       points) 23% vs. 2%.     points) 43% vs. 2%.    points) 63% vs. 2%.    points) 83% vs. 2%.
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Note: Qualitative label example: ``More people taking drug X had side effect Y.'' There are two additional conditions: a no information condition and a
  qualitative label only (More) condition.

    In the benefit design, we will use the mid-size effect for the risk
information in all conditions and vary the information type to match
the benefit information type (e.g., participants who see absolute
frequency benefit information will also see absolute frequency risk
information). Similarly, in the risk design, we will use the mid-size
effect for the benefit information in all conditions and vary the
information type to match the risk information type.
    The test product will be for the treatment of gastroesophageal
reflux disease and modeled on an actual drug used to treat this
condition. Participants will be consumers who have heartburn or acid
reflux disease. They will be randomly assigned to read one ad version.
After reading the ad, participants will answer a series of questions
about the drug. We will test how the information type affects perceived
efficacy, perceived risk, behavioral intention, and accurate
understanding of the benefit and risk information. The questionnaires
for the risk and benefit designs will have identical questions;
however, the order will differ. In the risk design, questions about
risk will appear before questions about benefits; in the benefit design
questions about benefits will appear before questions about risks.
    Data will be collected using an Internet protocol. Consumers who
have heartburn or acid reflux disease will be recruited for the study.
Because the task presumes basic reading abilities, all selected
participants must speak and read English fluently. Participants must be
18 years or older. We will use Levene's test of homogeneity of
variances, analysis of variances, and regressions to test hypotheses.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 4--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                      hours) \2\
----------------------------------------------------------------------------------------------------------------
Screener........................          30,000               1          30,000            2/60           1,000
Pretest.........................             750               1             750           20/60             250
Main Study......................          11,000               1          11,000           20/60           3,667
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,917
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60.''

V. References

    FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.

1. Aikin, K.J., J.L. Swasy, and A.C. Braman, ``Patient and Physician
Attitudes and Behaviors Associated With DTC Promotion of
Prescription Drugs--

Summary of FDA Survey Research Results, Final Report, November 19,
2004,'' accessed online at http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertisingandCommunicationsResearch/UCM152860.pdf.
2. Aikin, K.J., ``Consumer Comprehension and Preference for
Variations in the Proposed Over-the-Counter Drug Labeling Format,
Final Report,'' 1998.
3. Vigilante, W.J. and M.S. Wogalter, ``The Preferred Order of Over-
the-Counter (OTC) Pharmaceutical Label Components,'' Drug
Information Journal, vol. 31, pp. 973-988, 1997.
4. Levy, A.S., S.B. Fein, and R.E. Schucker, ``More Effective
Nutrition Label Formats Are Not Necessarily More Preferred, ''
Journal of the American Dietetic Association, vol. 92, pp. 1230-
1234, 1992.
5. Lorch, R. and E. Lorch, ``Effects of Organizational Signals on
Text-Processing Strategies,'' Journal of Educational Psychology,
vol. 87, pp. 537-544, 1995.
6. Lorch, R. and E. Lorch, ``Effects of Organizational Signals on
Free Recall of Expository Text,'' Journal of Educational Psychology,
vol. 88, pp. 38-48, 1996.
7. Lorch, R., E. Lorch, and W. Inman, ``Effects of Signaling Topic
Structure on Text Recall,'' Journal of Educational Psychology, vol.
85, pp. 281-290, 1993.
8. Schwartz, L.M., S. Woloshin, and H.G. Welch, ``Using a Drug Facts
Box to Communicate Drug Benefits and Harms: Two Randomized Trials,''
Annals of Internal Medicine, vol. 150, pp. 516-527, 2009, accessed
online at http://www.annals.org/cgi/content/full/0000605-200904210-00106v1.
9. Webb, T.L. and P. Sheeran, ``Does Changing Behavioral Intentions
Engender Behavior Change? A Meta-Analysis of the Experimental
Evidence,'' Psychological Bulletin, vol. 132, pp. 249-268, 2006.
10. ``Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request;
Experimental Study: Presentation of Quantitative Effectiveness
Information to Consumers in Direct-to-Consumer (DTC) Television and
Print Advertisements for Prescription Drugs,'' Federal Register,
vol. 75, pp. 373-379, January 5, 2010.
11. ``Agency Information Collection Activities; Proposed Collection;
Comment Request; Study of Clinical Efficacy Information in
Professional Labeling and Direct-to-Consumer Print Advertisements
for Prescription Drugs,'' Federal Register, vol. 75, pp. 34142-
34146, June 16, 2010.
12. FDA, About the Center for Drug Evaluation and Research Page,
DDMAC Research, (http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090276.htm).

    Dated: June 27, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16552 Filed 6-30-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15191-15192]
[FR Doc No: 2020-05443]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3474]

Zhang Xiao Dong: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Zhang Xiao Dong for a period of 5 years from importing articles of food
(including dietary supplements) or offering such articles for
importation into the United States. FDA bases this order on a finding
that Mr. Dong was convicted, as defined in the FD&C Act, of a felony
count under Federal law for conduct relating to the importation into
the United States of an article of food. Mr. Dong was given notice of
the proposed permanent debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. As of November
19, 2019 (30 days after receipt of the notice), Mr. Dong has not
responded. Mr. Dong's failure to respond and request a hearing
constitutes a waiver of his right to a hearing concerning this matter.

DATES: This order is applicable March 17, 2020.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857, or at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article for import into the United States if FDA
finds, as required by section 306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a felony for conduct relating to the
importation into the United States of any food.
    On December 20, 2018, Mr. Dong was convicted as defined in section

306(l)(1)(A) of the FD&C Act, in the United States District Court for
the Northern District of Texas Dallas Division, when the court entered
judgment against him for the offense of Mail Fraud in violation of 18
U.S.C. 1343.
    FDA's finding that the debarment is appropriate is based on the
felony conviction referenced herein. The factual basis for this
conviction is as follows: As contained in the Factual Resume in his
case, filed on March 12, 2018, Mr. Dong, along with other employees of
his employer Genabolix USA, Inc. and Shanghai Yongyi Biotechnology Co.,
Ltd. (Genabolix), did in or around February 2017, agree to sell
synthetic stimulant ingredients, including 1,4 Dimethylamylamine (1,4-
DMAA), to a purported dietary supplement manufacturer. That
manufacturer told Mr. Dong that the ingredients supplied by Mr. Dong
would not be accurately listed on the labels of the finished dietary
supplements produced with those ingredients. As Mr. Dong knew, the
synthetic stimulant ingredients would be omitted from the ingredient
label of the dietary supplements so that American retailers would sell
the product. Mr. Dong then sent unlabeled shipments of these
ingredients to a third party in the United States. Subsequently, on
June 8, 2017, Mr. Dong (along with others) caused 50kg of 1,3
Dimethylamylamine (1,3-DMAA) to be shipped via commercial carrier in
interstate commerce in the United States.
    As a result of this conviction, FDA sent Mr. Dong, by certified
mail on October 18, 2019, a notice proposing to debar him for a period
of 5 years from importing articles of food or offering such articles
for import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Mr. Dong's felony
conviction for Mail Fraud in violation of 18 U.S.C. 1343, constitutes
conduct relating to the importation into the United States of an
article of food because Mr. Dong unlawfully imported synthetic
stimulant ingredients which Mr. Dong then caused to be shipped in
interstate commerce and ultimately used in dietary supplements that did
not list the synthetic stimulants as an ingredient.
    The proposal was also based on a determination, after consideration
of the relevant factors set forth in section 306(c)(3) of the FD&C Act,
that Mr. Dong should be subject to a 5-year period of debarment. The
proposal also offered Mr. Dong an opportunity to request a hearing,
providing him 30 days from the date of receipt of the letter in which
to file the request, and advised him that failure to request a hearing
constituted a waiver of the opportunity for a hearing and of any
contentions concerning this action. Mr. Dong failed to respond within
the timeframe prescribed by regulation and has, therefore, waived his
opportunity for a hearing and waived any contentions concerning his
debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(1)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr. Dong
has been convicted of a felony count under Federal law for conduct
relating to the importation into the United States of an article of
food and that he is subject to a 5-year period of debarment.
    As a result of the foregoing finding, Mr. Dong is debarred for a
period of 5 years from importing articles of food or offering such
articles for import into the United States, effective (see DATES).
Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the United States of an article
of food by, with the assistance of, or at the direction of Mr. Dong is
a prohibited act.
    Any application by Mr. Dong for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2019-N-3474 and sent to the Dockets Management Staff (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20.
    Publicly available submissions will be placed in the docket and
will be viewable at http://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05443 Filed 3-16-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 157 (Tuesday, August 16, 2022)]
[Proposed Rules]
[Pages 50280-50282]
[FR Doc No: 2022-17517]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2022-0370; FRL-9950-01-R5]

Air Plan Approval; Wisconsin; 2015 Ozone Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve rules submitted by the Wisconsin Department of Natural
Resources (WDNR) as a revision to its State Implementation Plan (SIP).
The submitted rules incorporate the 2015 primary and secondary National
Ambient Air Quality Standards (NAAQS) for ozone. In addition, WDNR
included several updates to ensure implementation of the ozone NAAQS,
in areas currently or formerly designated as nonattainment for any
ozone standard, in a manner consistent with Clean Air Act (CAA)
requirements.

DATES: Comments must be received on or before September 15, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2022-0370 at https://www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Charles Hatten, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER>, [email protected]. The
EPA Region 5 office is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding Federal holidays and facility closures due to COVID-
19.

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. When and why did the State make this submittal?
II. What are the State rule revisions?
III. What is EPA's analysis of the revisions?
IV. What action is EPA taking?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. When and why did the State make this submittal?

    Section 109 of the CAA requires EPA to establish national primary
(protective of human health) and secondary (protective of human
welfare) air quality standards for pollutants for which air quality
criteria have been issued under section 108 of the CAA (the criteria
pollutants \1\). Section 109(d)(1) of the CAA requires EPA to review,
and if necessary, based on accumulated health and welfare data, to
revise each NAAQS every five years. If a NAAQS is revised, states whose
rules include state air quality standards may revise their rules to
address the revised NAAQS and associated monitoring requirements, and
submit them to EPA as SIP revision requests. See, e.g., 415 ILCS 5/
10(H).
---------------------------------------------------------------------------

    \1\ The criteria pollutants are ozone (O3), nitrogen
oxides (represented by nitrogen dioxide (NO2)), sulfur
oxides (represented by sulfur dioxide (SO2)), carbon
monoxide (CO), particulate matter (represented by total suspended
particulates (TSP), particulates (PM10), and fine
particulates (PM2.5)), and lead (Pb).
---------------------------------------------------------------------------

    On October 26, 2015 (80 FR 65291), EPA revised the primary and
secondary ozone NAAQS from 0.075 to 0.070 parts per million (ppm),
daily maximum 8-hour concentration, codified at 40 CFR 50.19. The ozone
NAAQS continues to use an 8-hour averaging time, calculated as the
fourth-highest daily maximum averaged across three consecutive years.
EPA also revised the monitoring requirements for ozone, which are
codified at 40 CFR part 50.
    As part of the implementation rule for the 2015 standard, EPA did
not address any revocation of the 2008 ozone NAAQS. Thus, currently
there are two ozone NAAQS in effect and being implemented: the 2015
ozone NAAQS and the 2008 ozone NAAQS. Several elements of this rule
will apply to areas currently or formerly designated as nonattainment
for any ozone standard, including these two ozone NAAQS.
    On April 8, 2022, WDNR submitted rules to update chapters NR 404
and 484 of Wisconsin's ambient air quality rule to include the 2015
primary and secondary NAAQS for ozone and its incorporation by
reference rule to add EPA-promulgated monitoring requirements related
to the NAAQS. WDNR revised sections of chapters NR

407 (Operation permits), 408 (Construction permits for direct major
sources in nonattainment areas) and 428 (nitrogen oxides
(NOX) reasonably available control technologies (RACT)) to
ensure implementation of the ozone NAAQS in a manner consistent with
Federal regulations. As there are currently two ozone NAAQS in effect,
the revisions to NR 407, NR 408, and NR 428 clarify which major source
emissions thresholds apply in areas subject to more than one ozone
nonattainment classifications.
    WDNR provided opportunities to comment on the rule during the
public comment period from March 1, 2021, through April 15, 2021, and
at a public hearing held on April 8, 2021, in accordance with chapter
227 of the Wisconsin Statutes and 40 CFR 51.102. No comments were
received.

II. What are the State rule revisions?

Chapter NR 404--Ambient Air Quality and NR 484--Incorporation by
Reference Rules

    WDNR updated and amended its ambient air quality rule in chapter NR
404 by adding both the primary and secondary ozone standards for ozone
to be consistent with EPA's 2015 NAAQS and codified that revision into
section NR 404.04(5)(c). Also, WDNR revised its incorporation by
reference rule in chapter NR 484 to add a reference to the monitoring
requirements at 40 CFR part 50, appendix U, Interpretation of the
National Ambient Air Quality Standards for Ozone, and codified that
revision into NR 484.04, Table 2, row 7(s) relating to the
incorporation of the 2015 NAAQS for ozone.

Chapter NR 407--Operation Permits and Chapter NR 408--Construction
Permits for Direct Major Sources in Nonattainment Areas

    NR 407 applies to all stationary sources required to obtain an
operation permit. A ``major source'' is a stationary source whose
emissions exceed a specified threshold. Major source thresholds are
defined in part D of title I of the CAA (42 U.S.C. 7501 to 7515) based
on an area's ozone nonattainment classifications (100 tons per year
(tpy) in areas classified as ``moderate,'' 50 tpy in areas classified
as ``serious,'' 25 tpy in areas classified as ``severe,'' and 10 tpy in
areas classified as ``extreme'' nonattainment). This definition is
currently incorporated in Wisconsin's rule at subsection NR
407.02(4)(c)(1)(a).
    WDNR is updating the definition of major stationary source at NR
407.20(4)(c) to clarify which major source emissions threshold applies
in an area classified as nonattainment for more than one NAAQS. WDNR
revised NR 407.20(4)(c) by adding subsection (1)(b). NR
407.20(4)(c)(1)(b) explains that the classification with the lowest
emission threshold under subsection NR 407.02(4)(c)(1)(a) determines
the major source threshold in an area classified as nonattainment for
more than one ozone NAAQS, until the area is redesignated to attainment
for a current standard or a redesignation substitute for a revoked
standard has been approved by the EPA for the standard with the lowest
emission threshold.

Chapter NR 408--Construction Permits for Direct Major Sources in
Nonattainment Areas

    NR 408 applies to all new major sources and all major modifications
located in areas designated as ozone nonattainment by EPA. A ``major
modification'' refers to a modification project, including construction
of new emission units and modification of existing units, at an
existing source that results in the source's potential to emit
exceeding the CAA-specified major source threshold. New major sources
and major modifications are subject to nonattainment New Source Review
permitting requirements. As such, WDNR updated its definition of
``nonattainment'' at subsection NR 408.02(24) to identify which major
source or major modification emissions thresholds apply in an area
classified nonattainment for more than one NAAQS.
    WDNR is revising subsection NR 408.02(24) by adding subsection (c).
As subsection NR 408.02(24)(c) explains, the classification with the
lowest emission threshold under section NR 407.02 (4)(c)(1)(a)
determines the major source or major modification threshold in an area
classified as nonattainment for more than one ozone NAAQS, until the
area is redesignated to attainment for a current standard or a
redesignation substitute for a revoked standard has been approved by
the EPA for the standard with the lowest emission threshold.
    WDNR also makes a minor change to update the definition of
``significant'' at subsection NR 408.02(32)(a) to correct an oversight
to include NOX as an ozone precursor. WDNR amended
subsection NR 408.02(32)(a)(6) by adding emissions of NOX in
reference to determination of a significant net emissions increase or
the potential of a source to emit that would equal or exceed a
pollutant rate of 40 tpy of NOX.

Chapter NR 428--Control of Nitrogen Compounds

    In subchapter IV of NR 428, to meet the requirements of sections
172(c) and 182 (f) of the CAA, section NR 428.20 includes
NOX RACT standards for NOX emission units in
areas that are classified moderate nonattainment for ozone. Currently,
in subsection NR 428.20(a)(1)(a), NOX RACT requirements
apply to sources with maximum theoretical NOX emissions
equal to or greater than 100 tpy in Kenosha, Milwaukee, Ozaukee,
Racine, Sheboygan, Washington, or Waukesha Counties that are or had
been previously classified as ``moderate'' ozone nonattainment areas.
WDNR is updating the NOX RACT requirements to expand its
applicability to any area that is classified as moderate and above for
ozone nonattainment to be consistent with section 182 of the CAA. WDNR
revised the applicability of NOX RACT requirements at
subsection NR 428.20(1)(a) by adding subsection (2). Subsection NR
428.20(1)(a)(2) includes all the major source emissions thresholds
associated with current (and former) ozone nonattainment classification
of the area (i.e., 100 tpy in areas classified as ``moderate,'' 50 tpy
in areas classified as ``serious,'' 25 tpy in areas classified as
``severe,'' and 10 tpy in areas classified as ``extreme''
nonattainment). Thus, the revision to the NOX RACT
applicability threshold provisions in NR 428 will include other
counties that may be classified as moderate in the future or for
counties whose ozone nonattainment classifications may be changed from
moderate to a more stringent classification and, as a result, have
major source thresholds below 100 tpy under the CAA.
    In addition, WDNR updated the NOX RACT requirements to
clarify which emissions threshold is applicable to the same area due to
different ozone standards or a change in nonattainment classification.
WDNR amended section NR 428 by adding subsection 428.20(1)(a)(3)(b),
which explains that if more than one emission threshold is applicable
to the same area due to different ozone standards or a change in
nonattainment classification, the lowest applicable emission threshold
applies. To ensure implementation of the ozone NAAQS under
NOX RACT, WDNR amended NR 428.20 by adding subsection NR
428.20(1)(a)(3)(c), which states, ``The requirements of this subchapter
remain applicable to each affected unit regardless of any subsequent
decrease in maximum theoretical emissions of NOX at the

source to a level below the applicable emission thresholds.''
    Subsection NR 428.21(3), ``Other Regulated Units,'' provides an
exemption for certain NOX emission units. WDNR amended NR
428.21(3), to ensure that the existing 75 tpy exemption threshold
continues to apply in areas with a 100 tpy major source emission
threshold, by adding subsections NR 428.21(3)(b) and (c). The changes
clarify that the exemption applies--if the emissions unit is located in
a facility subject to the applicability thresholds specified under
section NR 428.20 (1)(a)1, 2(a), or 3(a), and if the emission unit is
subject to and meeting an emission limitation in Wisconsin's SIP under
section NR 428.04(2) or NR 428.05(3).
    Last, WDNR updated NR 428 to create a section that describes the
compliance schedule for a facility that has NOX emission
units affected by the updated NOX RACT thresholds in NR
428.20, by adding subsection NR 428.255 to include information on
compliance schedules. The changes to NR 428 will only have the
potential to impact sources whose emissions exceed the NOX
RACT major source applicability.

III. What is EPA's analysis of the revisions?

    CAA Section 110(l) prohibits EPA from approving a SIP revision if
that revision would interfere with any applicable requirement
concerning attainment, reasonable further progress, or any other CAA
requirement. EPA concurs with WDNR's 110(l) analysis that the revision
to Wisconsin's rules does not interfere with any applicable requirement
concerning attainment or any other applicable requirement of the CAA.
The revisions to rules NR 404, NR 407, NR 408, NR 428, and NR 484 have
no impact on emissions, ensures implementation of the ozone NAAQS in
areas designated nonattainment and are consistent with the requirements
of the CAA.

IV. What action is EPA taking?

    EPA is proposing to approve revisions to chapters NR 404, 407, 408,
428, and 484, as submitted on April 8, 2022, into the Wisconsin SIP.
The revision to chapters NR 404 and 484 update Wisconsin's ambient air
quality rule to incorporate the 2015 ozone NAAQS and the incorporation
by reference rule with the monitoring requirements related to the NAAQS
make Wisconsin's rules consistent with the Federal regulations.
Additionally, the clarifications and updates to sections of chapters NR
407, 408 and 428, ensure implementation of the ozone NAAQS in areas
designated nonattainment and are consistent with the CAA.

V. Incorporation by Reference

    In this proposed rule, EPA is proposing to include in a final EPA
rule regulatory text that includes incorporation by reference. In
accordance with requirements of 1 CFR 51.5, EPA is proposing to
incorporate by reference revisions to Wisconsin Administrative Code
rules NR 404, NR 407, NR 408, NR 428, and NR 484 as published in the
Wisconsin Register #794 on February 28, 2022, effective March 1, 2022,
discussed in section II of this preamble. EPA has made, and will
continue to make, these documents generally available through
www.regulations.gov and at the EPA Region 5 Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements.

    Dated: August 9, 2022.
Debra Shore,
Regional Administrator, Region 5.
[FR Doc. 2022-17517 Filed 8-15-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 6, 2010 (Volume 75, Number 3)]
[Notices]
[Page 875-876]
[DOCID:fr06ja10-43]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0525]

Guidance for Industry on New Contrast Imaging Indication
Considerations for Devices and Approved Drug and Biological Products;
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``New Contrast Imaging
Indication Considerations for Devices and Approved Drug and Biological
Products,'' dated December 2009. As part of the Medical Device User Fee
Amendments of 2007 (MDUFA) Commitment for the Performance Goals and
Procedures commitment letter, FDA agreed to publish guidance for
medical imaging devices for use with imaging contrast agents or
radiopharmaceuticals. FDA intends this guidance to assist developers of
medical imaging devices and imaging drug/biological products that
provide image contrast enhancement. The final guidance announced in
this document fulfills FDA's commitment to issue guidance called for by
the commitment letter. The guidance supercedes the draft guidance of
the same title dated September 30, 2008.

DATES:  Submit written or electronic comments on agency guidances at
any time.

ADDRESSES:  Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:  Patricia Y. Love, Office of
Combination Products (HFG-3), Office of the Commissioner, Food and Drug
Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 301-427-
1934.

SUPPLEMENTARY INFORMATION:

I. Background

    As part of the Medical Device User Fee Amendments of 2007 (MDUFA)
Commitment for the Performance Goals and Procedures, Item I.N of the
September 27, 2007, commitment letter, FDA agreed to publish draft
guidance by September 30, 2008, for medical imaging devices for use
with imaging contrast agents or radiopharmaceuticals. Further, the
agreement stated that the ``draft guidance will be published by the end
of FY 2008, and will be subject to a 90-day comment period. FDA will
issue a final guidance within one year of the close of the public
comment period.'' The draft guidance was dated September 30, 2008 (73
FR 58604, October 7, 2008); the comment period closed on January 5,
2009. FDA held meetings with imaging industry stakeholders in July 2008
and August 2009. The final guidance announced in this document fulfills
FDA's commitment to issue final guidance called for by the commitment
letter. The guidance supercedes the draft guidance of the same title
dated September 30, 2008.
    FDA is announcing the availability of guidance for industry
entitled ``New Contrast Imaging Indication Considerations for Devices
and Approved Drug and Biological Products.'' FDA intends this guidance
to assist developers of medical imaging devices and imaging drug/
biological products that provide image contrast enhancement.
Particularly, this guidance focuses on the following topics: (1) When
the imaging device developers may add certain new imaging contrast
indications to their device for use with already approved imaging drugs
without a need for a modification of the drug labeling, (2) when the
imaging drug developers may add certain new imaging contrast
indications to their drug for use with already approved imaging devices
without a need for a modification of the device labeling, and (3) what
type of marketing submission(s) imaging drug or imaging device
developers should submit to FDA to request approval/clearance to add a
new imaging contrast indication. FDA intends for the recommendations in
this guidance to promote timely and effective review of, and consistent
and appropriate regulation and labeling for imaging drugs and devices.
    FDA notes that during the comment period, certain topics identified
in the docket were beyond the scope of the guidance document. These
comments included requests for guidance on developing specific medical
imaging indications (e.g., myocardial perfusion or breast cancer
imaging) and offered suggestions for the type of acceptable data. FDA
will consider whether separate guidance would be appropriate.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on ``New Contrast Imaging Indication
Considerations for Devices and Approved Drug and Biological Products''.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 807 have been approved under

OMB control number 0910-0120. The collections of information in 21 CFR
814 have been approved under OMB control number 0910-0231. The
collections of information in 21 CFR 314 have been approved under OMB
control number 0910-0001.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm
or http://www.regulations.gov.

    Dated: December 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-31307 Filed 1-5-10; 8:45 am]

BILLING CODE 4160-01-S