SUPPORTING STATEMENT for

Fast-track Drug Development Programs-

Designation, Development, and Application review

[0910-0389]{.underline}

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

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

The Food and Drug Administration (FDA) is requesting an extension of OMB
approval of the information collection provisions contained in a
document entitled \"Guidance for Industry: Fast-track Drug Development
Programs - Designation, Development, and Application Review\" (Tab A).
The information collection provisions for which approval is requested
are as follows:

# Request for fast-track designation All manufacturers of drug and biological drug

(Reporting) products seeking to have a product designated

as one in a fast-track drug development

program would submit a request for fast-track

designation as an amendment to an IND or as a supplement to an
application.

# Pre-meeting Packages After the agency makes a fast-track designation a

(Reporting) sponsor or applicant may submit a pre-meeting package which
may include additional information supporting a request to participate
in certain fast-track programs.

Section 112(a) of the Food and Drug Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105-115) (Tab B) amended the Federal Food, Drug,
and Cosmetic Act (the act) by adding section 506 (21 U.S.C. 356) (Tab
C). The section authorizes FDA to take appropriate action to facilitate
the development and expedite the review of new drugs, including
biological products, intended to treat a serious or life-threatening
condition and that demonstrate a potential to address an unmet medical
need. Under section 112(b), FDA issued guidance to industry on
fast-track policies and procedures outlined in section 506 of the act.
The guidance discusses collections of information that are specified
under section 506 of the act, other sections of the Public Health
Service Act (the PHS Act), or implementing regulations. The guidance
describes three general areas involving collection of information: (1)
Fast-track designation requests, (2) pre-meeting packages, and (3)
requests to submit portions of an application. Of these, fast-track
designation requests and pre-meeting packages, in support of receiving a
fast-track program benefit, provide for additional collections of
information not covered elsewhere in statute or regulation.

Under section 506(a)(1) of the act, an applicant who seeks fast-track
designation is required to submit a request to the agency showing that
the product: (1) Is intended for a serious or life-threatening
condition; and (2) the product has the potential to address an unmet
medical need. Mostly, the agency expects that information to support a
designation request will have been gathered under existing provisions of
the act, the PHS Act, or the implementing regulations.

After the agency makes a fast-track designation, a sponsor or applicant
may submit a pre-meeting package, which may include additional
information supporting a request to participate in certain fast-track
programs. The pre-meeting package serves as background information for
the meeting and should support the intended objectives of the meeting.
As with the request for fast-track designation, the agency expects that
most sponsors or applicants will have already gathered such information
to meet existing requirements under the act, the PHS Act, or
implementing regulations.

Under section 506(c) of the act, a sponsor must submit sufficient
clinical data for the agency to determine, after preliminary evaluation,
that a fast-track product may be effective. Section 506(c) also requires
that an applicant provide a schedule for the submission of information
necessary to make the application complete before FDA can commence its
review. The guidance does not provide for any new collection of
information regarding the submission of portions of an application that
is not required under section 506(c) or any other provision of the act.
All forms referred to in the guidance have valid OMB control numbers
that include: FDA Form 1571 (OMB Control No. 0910-0014, expires January
31, 2006); FDA Form 356h (OMB Control No. 0910-0338, expires August 31,
2005); and FDA Form 3397 (OMB Control No. 0910-0297, expires December
31, 2006).

**[2. How, By Whom, Purpose of Collection]{.underline}**

FDA uses the information to determine whether a particular drug or
biological product should be designated as a drug in a fast-track drug
development program and whether a drug or biological product so
designated continues to meet the criteria for fast-track designation.

**[3. Consideration Given to Information Technology]{.underline}**

One of FDA\'s continuing objectives is to improve the speed and quality
of its review and approval programs. In order to reach a decision to
approve an application FDA must evaluate all information and data
provided by applicants that support the safety, purity, potency, and
efficacy of the proposed product. To make the review process more
efficient for industry

and FDA, CBER (Center for Biologics Evaluation and Research) and CDER
(Center for Drug Evaluation and Research) are utilizing electronic
information systems technology. CBER and CDER currently accept
electronic applications for FDA review. FDA believes the increased use
of computer assisted applications will enhance the timeliness,
effectiveness, and efficiency of the review process and reduce
burdensome, nonessential hard-copy handling and storage. FDA is not
aware of any other improved technology to reduce the burden.

**[4. Identification of Information]{.underline}**

FDA is the only agency that requires the filing of a request for
designation as a product in a fast-track drug development program. No
other component of FDA or other government agencies requires similar
information or data to be filed. This information is not available from
any other source.

**[5. Small Businesses]{.underline}**

While FDA does not believe it can apply different standards with respect
to statutory requirements, FDA does provide special help to small
businesses. The CBER, Office of Communications, Training, and
Manufacturers Assistance and the CDER, Office of Training and
Communications provide assistance to small businesses subject to FDA\'s
regulatory requirements.

**[6. Less Frequent Information Collection]{.underline}**

Sponsors and applicants may request that FDA designate a product as one
in a fast-track drug development program. Once such designation is
received, a sponsor or applicant may submit a pre-meeting package, which
may include additional information supporting a request to participate
in certain fast-track programs. Less frequent information collections
would not provide the necessary information needed by FDA to make the
appropriate determination. There are no technical obstacles to reducing
the burden.

**[7. Information Collection Circumstances]{.underline}**

> An applicant may be required to submit to FDA proprietary trade
> secrets or other confidential information when submitting a drug or
> biological product license application or supplement. FDA has
> instituted security measures to protect confidential information
> received from manufacturers and will, to the extent permitted by law,
> protect this information.

**[8. Consultation with Persons Outside FDA]{.underline}**

In accordance with 5 CFR 1320.8 (d), FDA published a notice in the
Federal Register of December 13, 2004, (69 FR 72202) (Tab D) providing
for a 60-day comment period on the information collection. FDA received
one comment, which was not related to the information collection
provisions.

**[9. Payment or Gift]{.underline}**

No payment or gift was provided to respondents.

**[10. Confidentiality Provisions]{.underline}**

The confidentiality of information received by FDA under the guidance
would be consistent with the Freedom of Information Act and the FDA\'s
regulations under 21 CFR Part 20. Manufacturers seeking to market a drug
or biological product in interstate commerce may be required to include
proprietary or trade information in an application submitted for FDA
approval. However, such proprietary or trade information is deleted from
any information released by FDA under the Freedom of Information Act and
FDA regulations.

**[11. Privacy]{.underline}**

Questions of a sensitive nature are not applicable to this information
collection.

**[12. Burden of Information Collection]{.underline}**

The estimated annual burden for this information collection is 8,720
hours.

#### 

#### Table 1 - Estimated Annual Reporting Burden

+------------------+----------+-----------+----------+--------+------+
|                  | No. of   | Annual    | Total    | Hours  | T    |
|                  |          |           |          |        | otal |
|                  | Res      | Frequency | Annual   | per    |      |
|                  | pondents | per       |          | Re     | H    |
|                  |          | Response  | R        | sponse | ours |
|                  |          |           | esponses |        |      |
+------------------+----------+-----------+----------+--------+------+
| Designation      | 56       | 1.20      | 67       | 60     | 4    |
| Request          |          |           |          |        | ,020 |
|                  | 47       | 1.00      | 47       | 100    |      |
| Pre-meeting      |          |           |          |        | 4    |
| Packages         |          |           |          |        | ,700 |
|                  |          |           |          |        |      |
| Total            |          |           |          |        | 8    |
|                  |          |           |          |        | ,720 |
+------------------+----------+-----------+----------+--------+------+

Respondents to this information collection are sponsors and applicants
who seek fast-track designation under section 506 of the act. The FDA
estimates the total annual number of respondents submitting requests for
fast-track designation to CBER and CDER will be approximately 56. To
obtain this estimate, FDA averaged the number of requests for fast-track
designation received by CBER and CDER in the three-year period of 2001
to 2003. For these three years CBER and CDER together received a yearly
average of 67 requests from 56 respondents. The rate of submissions is
not expected to change significantly in the next few years. FDA
estimates that the number of hours needed to prepare a request for
fast-track designation may generally range between 40 and 80 hours per
request, depending on the complexity of each request, with an average of
60 hours per request.

Not all requests for fast-track designation may meet the statutory
standard. Of the average 67 requests made per year, the FDA granted 47
requests for fast-track designation. For each of the granted 47
requests, FDA estimates that a pre-meeting package was submitted to the
agency. FDA estimates that the preparation hours may generally range
between 80 and 120 hours, with an average of 100 hours per package.

[Burden Costs]{.underline}:

  ----------------- ----------------- ----------------- -----------------
  Activity          No. of Hours      Cost per Hour     Total Cost

  Reporting         8,720             \$43.00           \$374,960.00
  ----------------- ----------------- ----------------- -----------------

The estimated cost to respondents is \$374,960.00. The cost estimate is
based on the hourly pay rate of \$43.00 for a regulatory affairs
specialist who is responsible for preparing the submissions. The salary
estimates include benefits but no overhead costs.

**[13. Costs to Respondents]{.underline}**

There are no capital costs or operating and maintenance and purchase
costs associated with the information collection.

**[14. Costs to Federal Government]{.underline}**

An estimate of the total cost to FDA is based on the review of New Drug
Applications, Biologics License Applications, and supplemental
applications. The estimate is based on full-time equivalents (FTE's)
associated with the review of applications and supplements to approved
applications and the average annual salaries and benefits for CBER and
CDER reviewers. The cost estimate for the review of information
submitted under existing regulations is

\$115,702,552.00. This cost is not expected to be increased by the
procedures for fast-track designation and application review described
in the guidance document.

The amount of time and expense incurred by the government is due to the
review of all material submitted with an application. This information
is essential to determine the safety and effectiveness of products as
required by FDA\'s mission to protect the public health. This
information may include clinical data, safety updates, samples submitted
for evaluation by the agency, case report tabulations, case report
forms, and patient information.

+-----------------+-----------------+-----------------+-----------------+
| Applications    | ####            | Average Annual  | Total Cost      |
| ^1^             |  Number of FTEs | Reviewer Salary |                 |
+-----------------+-----------------+-----------------+-----------------+
| NDA ^2^         | 974             | \$99,418        | \$96,833,132.00 |
+-----------------+-----------------+-----------------+-----------------+
| BLA ^3^         | 190             | \$99,418        | \$18,889,420.00 |
+-----------------+-----------------+-----------------+-----------------+
| Total Cost to   |                 |                 | \               |
| Government      |                 |                 | $115,702,552.00 |
+-----------------+-----------------+-----------------+-----------------+

^1^ Includes original applications and supplements to approved
applications.

^2^New Drug Application

^3^ Biologics License Application

**[15. Reason for Change]{.underline}**

The estimated total annual burden for this information collection
requirement was 6,480 hours in 2001. The current increase to 8,720
burden hours is due to the increase in the number of responses received
for the submission of designation requests and pre-meeting packages.

**[16. Statistical Reporting]{.underline}**

There are no tabulated results to publish for this information
collection.

**[17. Display of OMB Approval Date]{.underline}**

FDA is not seeking approval to exempt the display of the expiration date
of the OMB approval.

**[18. Explanations to "Certification for Paperwork Reduction Act
Submissions"]{.underline}**

There are no exceptions to Section 19 of OMB Form 83-I.