**SUPPORTING STATEMENT**

Guidance for Industry on Formal Meetings with Sponsors and Applicants
for PDUFA Products

(OMB Control Number 0910‑0429)

Docket \# 2005N-0395

**A. [Justification]{.underline}**

**1. [Circumstances of Information Collection]{.underline}**

This information collection approval request is for a FDA guidance on
the procedures for formal meetings between FDA and sponsors or
applicants regarding the development and review of PDUFA products. The
guidance describes procedures for requesting, scheduling, conducting,
and documenting such formal meetings. The guidance provides information
on how the agency will interpret and apply section 119(a) of the Food
and Drug Administration Modernization Act (the Modernization Act),
specific PDUFA goals for the management of meetings associated with the
review of human drug applications for PDUFA products, and provisions of
existing regulations describing certain meetings (§§ 312.47 and 312.82
(21 CFR 312.47 and 312.82)).

The guidance describes two collections of information: The

submission of a meeting request containing certain information and the
submission of an information package in advance of the formal meeting.
Agency regulations at §§ 312.47(b)(1)(ii), (b)(1)(iv), and (b)(2)
describe information that should be submitted in support of a request
for an End‑of‑Phase 2 meeting and a Pre‑NDA meeting. The information
collection provisions of § 312.47 have been approved by OMB (OMB Control
No.0910‑0014). However, the guidance provides additional recommendations
for submitting information to FDA in support of a meeting request. As a
result, FDA is submitting additional estimates for OMB approval.

A. Request for a Meeting

Under the guidance, a sponsor or applicant interested in

meeting with the Center for Drug Evaluation and Research (CDER) or the
Center for Biologics Evaluation and Research (CBER) should submit a
meeting request to the appropriate FDA component as an amendment to the
underlying application. FDA regulations (§§ 312.23, 314.50, and 601.2
(21 CFR 312.23, 314.50, and 601.2)) state that information provided to
the agency as part of an Investigational New Drug Application (IND), New
Drug Application (NDA), or Biological License Application (BLA) must be
submitted with an appropriate cover form. Form FDA 1571 must accompany
submissions under INDs and Form FDA 356h must accompany submissions
under NDAs and BLAs. Both forms have valid OMB control numbers as
follows: FDA Form 1571, OMB Control No. 0910‑0014, expires January 31,
2005; and FDA Form 356h, OMB Control No. 0910‑0338, expires August 31,
2005.

In the guidance document, CDER and CBER ask that a request for a formal
meeting be submitted as an amendment to the application for the
underlying product under the requirements of §§ 312.23, 314.50, and
601.2; therefore, requests should be submitted to the agency with the
appropriate form attached, either Form FDA 1571 or Form FDA 356h. The
agency

recommends that a request be submitted in this manner for two reasons:
(1) To ensure that each request is kept in the administrative file with
the entire underlying application, and (2) to ensure that pertinent
information about the request is entered into the appropriate tracking
databases. Use of the information in the agency\'s tracking databases
enables the agency to monitor progress on the activities attendant to

scheduling and holding a formal meeting and to ensure that appropriate
steps will be taken in a timely manner.

Under the guidance, the agency requests that sponsors and

applicants include in meeting requests certain information about the
proposed meeting. Such information includes:

-Information identifying and describing the product;

-The type of meeting being requested;

-A brief statement of the purpose of the meeting;

-A list of objectives and expected outcomes from the

meeting;

-A preliminary proposed agenda;

-A draft list of questions to be raised at the meeting;

-A list of individuals who will represent the sponsor or

applicant at the meeting;

-A list of agency staff requested to be in attendance;

-The approximate date that the information package will be

sent to the agency; and

-Suggested dates and times for the meeting.

This information will be used by the agency to determine the

utility of the meeting, to identify agency staff necessary to discuss
proposed agenda items, and to schedule the meeting.

B. Information Package

A sponsor or applicant submitting an information package to the agency
in advance of a formal meeting should provide summary

information relevant to the product and supplementary information

pertaining to any issue raised by the sponsor, applicant, or agency. The
agency recommends that information packages generally include:

-Identifying information about the underlying product;

-A brief statement of the purpose of the meeting;

-A list of objectives and expected outcomes of the meeting;

-A proposed agenda for the meeting;

-A list of specific questions to be addressed at the

meeting;

-A summary of clinical data that will be discussed (as

appropriate);

-A summary of preclinical data that will be discussed (as

appropriate); and

-Chemistry, manufacturing, and controls information that

may be discussed (as appropriate).

The purpose of the information package is to provide agency staff the
opportunity to adequately prepare for the meeting, including the review
of relevant data concerning the product. Although FDA reviews similar
information in the meeting request, the information package should
provide updated data that reflect the most current and accurate
information available to the sponsor or applicant. The agency finds that
reviewing such information is critical to achieving a productive

meeting.

The collection of information described in the guidance reflects the
current and past practice of sponsors and applicants to submit meeting
requests as amendments to INDs, NDAs, and BLAs and to submit background
information prior to a scheduled meeting. Agency regulations currently
permit such requests and recommend the submission of an information
package before an End‑of‑Phase 2 meeting (§§ 312.47(b)(1)(ii) and
(b)(1)(iv)) and a Pre‑NDA meeting (§ 312.47(b)(2)).

As stated earlier, the guidance provides information on how the agency
will interpret and apply section 119(a) of the Modernization Act,
specific PDUFA goals for the management of meetings associated with the
review of human drug applications for PDUFA products, and provisions of
existing regulations describing certain meetings (§§ 312.47 and 312.82).
The information collection provisions in § 312.47 concerning
End‑of‑Phase 2 meetings and Pre‑NDA meetings have been

approved by OMB (OMB Control No. 0910‑0014). However, the guidance
provides additional recommendations for submitting information to FDA in
support of a meeting request. As a result, FDA is submitting for OMB
approval these additional estimates.

**2. [Purpose and Use of Information]{.underline}**

The agency is recommending the above procedures for submitting a meeting
request for two reasons: (1) To ensure that each request is kept in the
administrative file with the entire underlying application, and (2) to
ensure that pertinent information about the request is entered into the
appropriate tracking data bases. Use of the information in the agency\'s
tracking data bases enables the agency to monitor progress on the
activities attendant to scheduling and holding a formal meeting and to
ensure that appropriate steps will be taken in a timely manner. This
information will be used by the agency to determine the utility of the
meeting, to identify agency staff necessary to discuss proposed agenda
items, and to schedule the meeting.

The purpose of the information package is to provide agency staff the
opportunity to adequately prepare for the meeting, including the review
of relevant data concerning the product. Although FDA reviews similar
information in the meeting request, the information package should
provide updated data that reflect the most current and accurate
information available to the sponsor or applicant. The agency finds that
reviewing such information is critical to achieving a productive

meeting.

**3. [Use of Improved Information Technology]{.underline}**

In the [Federal Register]{.underline} of December 11, 2003, FDA issued a
final rule amending FDA regulations governing the format in which
certain labeling is required to be submitted for review with NDAs,
certain BLAs, ANDAs, supplements, and annual reports. The final rule
requires the electronic submission of the content of labeling (i.e., the
content of the package insert or professional labeling, including all
text, tables, and figures) in NDAs, certain BLAs, ANDAs, supplements,
and annual reports electronically in a form that FDA can process,
review, and archive.

The following guidances for industry have been developed to improve the
use of information technology in the submission of marketing
applications for human drugs and related reports:

-   \"Providing Regulatory Submissions in Electronic

Format\--NDAs\" (January 28, 1999). This guidance provides information
on how to submit a complete archival copy of an NDA in electronic format
and applies to the submission of original NDAs as well as to the
submission of supplements and amendments to NDAs.

-   \"Providing Regulatory Submissions in Electronic

Format\--General Considerations\" (January 28, 1999). This guidance
includes a description of the types of electronic file formats that the
agency is able to accept to process, review, and archive electronic
documents. The guidance also states that documents submitted in
electronic format should enable the user to: (1) Easily view a clear and
legible copy of the information; (2) print each document page by page
while maintaining fonts, special orientations, table formats, and page
numbers; and (3) copy text and images electronically into common word
processing documents.

-   "Providing Regulatory Submissions to the Center for

Biologics Evaluation and Research (CBER) in Electronic Format" (November
12, 1999). This guidance provides information to assist applicants in
submitting documents in electronic format for review and archive
purposes as part of a BLA, product license application (PLA), or
establishment license application (ELA).

**•** \"Providing Regulatory Submissions in Electronic
Format----Prescription Drug Advertising and Promotional Labeling\"
(January 31, 2001). This draft guidance discusses issues related to the
electronic submission of advertising and promotional labeling materials
for prescription drug and biological products.

**•** \"Providing Regulatory Submissions in Electronic Format----ANDAs\"
(June 27, 2002). This guidance discusses issues related to the
electronic submission of ANDAs and supplements and amendments to those
applications.

**•** \"Providing Regulatory Submissions in Electronic Format----Annual
reports for NDAs and ANDAs\" (August 2003). This guidance discusses
issues related to the electronic submission of annual reports for NDAs
and ANDAs.

**•** \"Providing Regulatory Submissions in Electronic
Format----Postmarketing Periodic Adverse Drug Experience Reports\" (June
2003). This guidance discusses general issues related the electronic
submission of postmarketing periodic adverse drug experience reports for
NDAs, ANDAs, and BLAs.

**•** \"Providing Regulatory Submissions in Electronic Format----Human
Pharmaceutical Product Applications and Related Submissions\" (August,
2003). This draft guidance discusses issues related to the electronic
submission of ANDAs, BLAs, INDs, NDAs, master files, advertising
material, and promotional material.

**•** \"Providing Regulatory Submissions in Electronic Format----General
Considerations\" (October 2003). This draft guidance discusses general
issues common to all types of electronic regulatory submissions.

**•** \"Providing Regulatory Submissions in Electronic Format----Content
of Labeling\" (February 2004). This draft guidance discusses issues
related to the submission of the content of labeling in electronic
format for marketing applications for human drug and biological
products.

These guidance documents are available at FDA\'s web

> site <http://www.fda.gov/cder/guidance/index.htm>[.]{.underline}

**4. [Efforts to Identify Duplication]{.underline}**

The information collection requested under the guidance does not
duplicate any other information collection.

**5. [Involvement of Small Entities]{.underline}**

Although new drug development is typically an activity completed by
large multinational drug firms, the information collection requested
under the guidance applies to small as well as large companies. Under
the Regulatory Flexibility Act, FDA regularly analyzes regulatory
options that would minimize any significant impact on small entities.
FDA also assists small businesses in complying with regulatory
requirements.

**6. [Consequences If Information Collected Less
Frequently]{.underline}**

As explained above, use of the meeting request information in the
agency\'s tracking data bases enables the agency to monitor progress on
the activities attendant to scheduling and holding a formal meeting and
to ensure that appropriate steps will be taken in a timely manner. This
information will be used by the agency to determine the utility of the
meeting, to identify agency staff necessary to discuss proposed agenda
items, and to schedule the meeting. The information package will provide
agency staff with the opportunity to adequately prepare for the meeting,
including the review of relevant data concerning the product. Although
FDA reviews similar information in the meeting request, the information
package should provide updated data that reflect the most current and
accurate information available to the sponsor or applicant. The agency
finds that reviewing such information is critical to achieving a
productive meeting.

**7. [Consistency with the Guidelines in 5 CFR
1320.5(d)(2)]{.underline}**

There is no inconsistency with the guidelines.

**8. [Consultation Outside the Agency]{.underline}**

A 60-day notice was published in the [Federal Register]{.underline} of
October 24, 2005 (70 FR 61445) requesting comments on this information
collection. No comments were received.

**9. [Remuneration of Respondents]{.underline}**

FDA has not provided and has no intention to provide any payment or gift
to respondents under these requirements.

**10. [Assurance of Confidentiality]{.underline}**

Confidentiality of the information submitted under this guidance is
protected under 21 CFR 314.430 and under 21 CFR part 20. The
unauthorized use or disclosure of trade secrets required in applications
is specifically prohibited under Section 310(j) of the Act.

**11. [Questions of a Sensitive Nature]{.underline}**

There are no questions of a sensitive nature.

**12. [Estimates of Annualized Hour Burden]{.underline}**

*Burden Estimate*: Provided below is an estimate of the annual reporting
burden for the submission of meeting requests and information packages
under the guidance.

A. Request For a Formal Meeting

Based on data collected from the review divisions and offices within
CDER and CBER, FDA estimates that approximately 713 sponsors and
applicants (respondents) request approximately 1,783 formal meetings
with CDER annually and approximately 164 respondents request
approximately 286 formal meetings with CBER annually regarding the
development and review of a PDUFA product. The hours per response, which
is the estimated number of hours that a respondent would spend preparing
the information to be submitted with a meeting request in accordance
with the guidance, is estimated to be approximately 10 hours. Based on
FDA\'s experience, the agency expects it will take respondents this
amount of time to gather and copy brief statements about the product and
a description of the purpose and details of the meeting.

B. Information Package

Based on data collected from the review divisions and offices within
CDER and CBER, FDA estimates that approximately 615 respondents
submitted approximately 1,365 information packages to CDER annually and
approximately 132 respondents submitted approximately 208 information
packages to CBER annually prior to a formal meeting regarding the
development and review of a PDUFA product. The hours per response, which
is the estimated number of hours that a respondent would spend preparing
the information package in accordance with the guidance, is estimated to
be approximately 18 hours. Based on FDA\'s experience, the agency
expects it will take respondents this amount of time to gather and copy
brief statements about the product, a description of the details for the
anticipated meeting, and data and information that generally would
already have been compiled for submission to the agency.

As stated earlier, the guidance provides information on how the agency
will interpret and apply section 119(a) of the Modernization Act,
specific PDUFA goals for the management of meetings associated with the
review of human drug applications for PDUFA products, and provisions of
existing regulations describing certain meetings (§§ 312.47 and 312.82).
The information collection provisions in § 312.47 concerning
End‑of‑Phase 2 meetings and Pre‑NDA meetings have been

approved by OMB (OMB Control No. 0910‑0014). However, the guidance
provides additional recommendations for submitting information to FDA in
support of a meeting request. As a result, FDA is submitting for OMB
approval these additional estimates.

**Estimated Annual Reporting Burden**

+----------------+-----------+----------+----------+---------+-------+
| **Meeting      | **Number  | **Number | **Total  | **Hours | **To  |
| Requests and   | of        | of       | Annual   | Per     | tal** |
| Information    | Resp      | R        | Res      | Res     |       |
| Packages**     | ondents** | esponses | ponses** | ponse** | **Ho  |
|                |           | Per      |          |         | urs** |
|                |           | Resp     |          |         |       |
|                |           | ondent** |          |         |       |
+----------------+-----------+----------+----------+---------+-------+
| Meeting        |           |          |          |         |       |
| Requests       |           |          |          |         |       |
+----------------+-----------+----------+----------+---------+-------+
| CDER           | 713       | 2.50     | 1,783    | 10      | 1     |
|                |           |          |          |         | 7,830 |
+----------------+-----------+----------+----------+---------+-------+
| CBER           | 164       | 1.74     | 286      | 10      | 2,860 |
+----------------+-----------+----------+----------+---------+-------+
| Total          |           |          |          |         | 2     |
|                |           |          |          |         | 0,690 |
+----------------+-----------+----------+----------+---------+-------+
| Information    |           |          |          |         |       |
| Packages       |           |          |          |         |       |
+----------------+-----------+----------+----------+---------+-------+
| CDER           | 615       | 2.22     | 1,365    | 18      | 2     |
|                |           |          |          |         | 4,570 |
+----------------+-----------+----------+----------+---------+-------+
| CBER           | 132       | 1.58     | 208      | 18      | 3,744 |
+----------------+-----------+----------+----------+---------+-------+
| Total          |           |          |          |         | 2     |
|                |           |          |          |         | 8,314 |
+----------------+-----------+----------+----------+---------+-------+
| Grand Total    |           |          |          |         | 4     |
|                |           |          |          |         | 9,004 |
+----------------+-----------+----------+----------+---------+-------+

**13. [Estimates of Annualized Cost Burden to Respondents]{.underline}**

FDA\'s Economics Staff estimates an average industry wage rate of
\$50.00 per hour for preparing and submitting the information requested
under the guidance. This figure is an average of the following wage
rates (based on the percentage of time required for each type of
employee): Upper management at \$70.00 per hour; middle management at
\$35.00 per hour; and clerical assistance at \$23.00 per hour. Using the
averaged wage rate of \$50.00 per hour, and multiplied times the total
hour burden estimated above, the total cost burden to respondents is
\$2,450,200.

**14. [Estimates of Annualized Cost Burden to the
Government]{.underline}**

FDA estimates that there will be no additional costs associated with the
receipt/review by FDA of the information submitted under the guidance.

**15. [Changes In Burden]{.underline}**

The change in burden is the result of a re-calculation of and an
increase in the number of submissions received under the guidance.

**16. [Time Schedule, Publication, and Analysis Plans]{.underline}**

There are no publications.

**17. [Displaying of OMB Expiration Date]{.underline}**

The agency is not seeking to not display the expiration date for OMB
approval of the information collection.

**18. [Exception to the Certification Statement - Item 19]{.underline}**

There are no exceptions to the certification statement identified in
Item 19, \"Certification for Paperwork Reduction Act Submission,\" of
OMB Form 83-I.

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