This is a sample Written Request template which the Agency is using to
develop its Written Request for pediatric studies the Agency believes
will provide a meaningful health benefit to the pediatric population. An
actual Written Request may differ from this sample depending upon the
nature of the specific drug product and any other indications for which
it is used. To receive a formal Written Request for pediatric studies
under section 505A of the Federal Food, Drug, and Cosmetic Act for a
particular drug, please submit a proposed pediatric study request to the
appropriate Division. The proposed pediatric study request should
incorporate the material in this sample and include descriptions of any
other studies necessary to provide a meaningful health benefit to
pediatric populations. Please refer to the outline in the \"Guidance For
Industry - Qualifying for Pediatric Exclusivity Under Section 505A of
the Federal Food, Drug, and Cosmetic Act,\" for additional information.

IND/NDA APPLICATION NUMBER(S)

**WRITTEN REQUEST**

SPONSOR

Attention: CONTACT, TITLE

ADDRESS

Dear CONTACT:

Reference is made to your INSERT DATE Proposed Pediatric Study Request
submitted to APPLICATION NUMBER(S) for DRUG PRODUCT(S).

To obtain needed pediatric information on ACTIVE MOIETY, the Food and
Drug Administration (FDA) is hereby making a formal Written Request,
pursuant to Section 505A of the Federal Food, Drug, and Cosmetic Act
(the Act), that you submit information from the following STUDY/STUDIES:

# COMPLETE AND INCLUDE ALL APPROPRIATE SECTIONS

-   *Type of study(ies)*: (e.g., double-blind, randomized, parallel
    group, safety, and/or pk)

-   *Indication(s) to be studied (i.e., objective of each study):*

-   *Age group in which study(ies) will be performed*: INDICATE SPECIFIC
    AGE RANGE

-   *Study endpoints*

-   *Drug information*

-   *dosage form*

-   *route of administration*

-   *regimen:*

-   Use an age-appropriate formulation in the study(ies) described
    above. If the studies you conduct in response to this Written
    Request demonstrate this drug will benefit children, then an
    age-appropriate dosage form must be made available for children.
    This requirement can be fulfilled by developing and testing a new
    dosage form for which you will seek approval for commercial
    marketing. If you demonstrate that reasonable attempts to develop a
    commercially marketable formulation have failed, you must develop
    and test an age appropriate formulation that can be compounded by a
    licensed pharmacist, in a licensed pharmacy, from commercially
    available ingredients.

> Development of a commercially-marketable formulation is preferable.
> Any new commercially marketable formulation you develop for use in
> children must meet agency standards for marketing approval.
>
> If you cannot develop a commercially marketable age-appropriate
> formulation, you must provide the Agency with documentation of your
> attempts to develop such a formulation and the reasons such attempts
> failed. If we agree that you have valid reasons for not developing a
> commercially marketable, age-appropriate formulation, then you must
> submit instructions for compounding an age-appropriate formulation
> from commercially available ingredients that are acceptable to the
> Agency. If you conduct the requested studies using a compounded
> formulation, the following information must be provided and will
> appear in the product label upon approval: active ingredients,
> diluents, suspending and sweetening agents; detailed step-by-step
> compounding instructions; packaging and storage requirements; and
> formulation stability information.
>
> Bioavailability of any formulation used in the studies should be
> characterized, and as needed, a relative bioavailability study
> comparing the approved drug to the age appropriate formulation may be
> conducted in adults.

-   *Drug specific safety concerns*:

-   *Statistical information, including power of study and statistical
    assessments:*

-   *Labeling that may result from the study(ies)*: Appropriate sections
    of the label may be changed to incorporate the findings of the
    studies.

-   *Format of reports to be submitted*: Full study reports not
    previously submitted to the Agency addressing the issues outlined in
    this request with full analysis, assessment, and interpretation. In
    addition, the reports are to include information on the
    representation of pediatric patients of ethnic and racial
    minorities. All pediatric patients enrolled in the study(ies) should
    be categorized using one of the following designations for race:
    American Indian or Alaska Native, Asian, Black or African American,
    Native Hawaiian or other Pacific Islander or White. For ethnicity
    one of the following designations should be used: Hispanic/Latino or
    Not Hispanic/Latino. INCLUDE OTHER INFORMATION AS APPROPRIATE

-   *Timeframe for submitting reports of the study(ies):* Reports of the
    above studies must be submitted to the Agency on or before INSERT
    DATE. Please keep in mind that pediatric exclusivity attaches only
    to existing patent protection or exclusivity that has not expired at
    the time you submit your reports of the studies in response to this
    Written Request.

-   *Response to Written Request:* As per the Best Pharmaceuticals for
    Children Act, section 4(A), within 180 days of receipt of this
    Written Request you must notify the Agency as to your intention to
    act on the Written Request. If you agree to the request then you
    must indicate when the pediatric studies will be initiated.

Please submit protocols for the above studies to an investigational new
drug application (IND) and clearly mark your submission \"PEDIATRIC
PROTOCOL SUBMITTED FOR PEDIATRIC EXCLUSIVITY STUDY\" in large font,
bolded type at the beginning of the cover letter of the submission.
Notify us as soon as possible if you wish to enter into a written
agreement by submitting a proposed written agreement. Clearly mark your
submission \"PROPOSED WRITTEN AGREEMENT FOR PEDIATRIC STUDIES\" in large
font, bolded type at the beginning of the cover letter of the
submission.

Reports of the studies should be submitted as a New Drug Application
(NDA) or as a supplement to your approved NDA with the proposed labeling
changes you believe would be warranted based on the data derived from
these studies. When submitting the reports, please clearly mark your
submission \"**SUBMISSION OF PEDIATRIC STUDY REPORTS - PEDIATRIC
EXCLUSIVITY DETERMINATION REQUESTED**\" in large font, bolded type at
the beginning of the cover letter of the submission and include a copy
of this letter. Please also send a copy of the cover letter of your
submission, via fax (301-594-0183) or messenger to the Director, Office
of Generic Drugs, HFD-600, Metro Park North II, 7500 Standish Place,
Rockville, MD 20855-2773.

In accordance with section 9 of the Best Pharmaceuticals for Children
Act, *Dissemination of Pediatric Information*, if a pediatric supplement
is submitted in response to a Written Request and filed by FDA, FDA will
make public a summary of the medical and clinical pharmacology reviews
of pediatric studies conducted. This disclosure, which will occur within
180 days of supplement submission, will apply to all supplements
submitted in response to a Written Request and filed by FDA, regardless
of the following circumstances:

1.  the type of response to the Written Request (complete or partial);

2.  the status of the supplement (withdrawn after the supplement has
    been filed or pending);

3.  the action taken (i.e. approval, approvable, not approvable); or

4.  the exclusivity determination (i.e. granted or denied).

FDA will post the medical and clinical pharmacology review summaries on
the FDA website at
[http://www.fda.gov/cder/pediatric/Summaryreview.htm](http://cdsml1.cder.fda.gov/cder/pediatric/Summaryreview.htm)
and publish in the *Federal Register* a notification of availability.

If you wish to discuss any amendments to this Written Request, submit
proposed changes and the reasons for the proposed changes to your
application. Submissions of proposed changes to this request should be
clearly marked \"**PROPOSED** **CHANGES IN WRITTEN REQUEST FOR PEDIATRIC
STUDIES\"** in large font, bolded type at the beginning of the cover
letter of the submission. You will be notified in writing if any changes
to this Written Request are agreed upon by the Agency.

As a reminder, you are responsible for compliance with section 113 of
the Food and Drug Administration Modernization Act of 1997 and section
15 of the Best Pharmaceuticals for Children Act of 2002 by registering
certain clinical trials in the Clinical Trials Data Bank
([\<<http://clinicaltrials.gov/>\>)
\<\<]{.underline}[[http://prsinfo.clinicaltrials.gov/)]{.underline}](http://prsinfo.clinicaltrials.gov/) )
[\>\>]{.underline}. If your drug is for the treatment of a serious or
life-threatening disease or condition and you are conducting trials to
test its effectiveness, then you must register the trials. Although not
required, we encourage you to register trials for non-serious diseases.
For additional information on registering your clinical trials,
including the required and optional data elements, refer to the Protocol
Registration System (PRS) Information Site
([\<\<[http://prsinfo.clinicaltrials.gov](http://prsinfo.clinicaltrials.gov/)\>\>]{.underline})
and FDA\'s Guidances for Industry entitled \"*Information Program on
Clinical Trials for Serious or Life-Threatening Diseases and
Conditions*\" (March 2002; revised draft January 2004).

If you have any questions, call NAME, Project Manager, at PHONE NUMBER.

> Sincerely,
>
> OFFICE DIRECTORS SIGNATURE BLOCK