OMB INFORMATION COLLECTION

SUPPORTING STATEMENT

[0910-0389]{.underline}

Guidance for Industry: Fast Track Drug Development Programs -
Designation, Development,

and Application Review

**[JUSTIFICATION]{.underline}**

**[1. Circumstances Making the Information Collection
Necessary]{.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 supplement\
to an application.

# Additional reports Additional reports would only be needed

(Reporting) after designation as a drug in a fast track drug\
development program was received. Submission of\
several of the reports would depend on which fast track programs
benefits a sponsor or applicant would seek to access.

The guidance is designed to facilitate the development and expedite the
review of new drugs intended to treat serious or life-threatening
conditions and that demonstrate the potential to address unmet medical
needs for the condition. The guidance also describes how a product may
be designated as one in a fast track drug development program and the
benefits that may be accessed by sponsors or applicants under FDA\'s
fast track program. Under section 506(a)(1) of the act, an applicant who
seeks fast track designation is required to submit a request to the
agency. In order to receive a fast track designation, the requester must
establish that the product meets the statutory standard for designation,
i.e., that: (1) The product is intended for a serious or
life-threatening condition; and (2) the product has the potential to
address an unmet medical need. In most cases, the agency expects that
information to support a designation request will have been gathered
pursuant to existing provisions of the act, the PHS Act, or the
implementing regulation and such information, if already submitted to
the agency, may be summarized in a fast

track designation request. The guidance also recommends that a
designation request include, where applicable, additional information
not specified elsewhere by statute or regulation, which

may include, clinical data, published reports, summaries of data and
reports, and a list of references. The amount of information and
discussion in a designation request need not be voluminous but should be
sufficient to permit a reviewer to assess whether the criteria for fast
track designation have been met. After the Agency makes a fast track
designation, a sponsor or applicant may submit a pre-meeting package,
which may include additional information to support a request to
participate in certain fast track programs. As with the request for fast
track designation, the agency expects that most sponsors or applicants
will have gathered such information to meet existing requirements under
the act, the PHS Act, or implementing regulations.

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 Clearance No. 0910-0014, expires September
30, 2002); FDA Form 356h (OMB Clearance No. 0910-0338, expires March 31,
2003); and FDA Form 3397 (OMB Clearance No. 0910-0297, expires February
29, 2004).

The guidance describes how FDA plans to work together with sponsors and
applicants to achieve expedited development and rapid review of new
therapies that will advance the care of patients with serious
life-threatening illnesses. The guidance is also intended to meet the
requirements of Section 112 of the Food and Drug Administration
Modernization Act of 1997 (P.L. 105-115) (Tab B), which amends the
Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 351 et seq.)
by adding new section 506 (Fast Track Products) (Tab C). Section 506
directs FDA to facilitate the development and expedite the review of
drug products that are intended to treat unmet medical needs and directs
FDA to issue guidance describing its policies and procedures pertaining
to such products.

**[2. Purpose and Use of Information]{.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 drug so designated
continues to meet the criteria for fast track designation.

**[3. Use of Information Technology and Burden Reduction]{.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 the agency 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. Efforts to Identify Duplication and Use of Similar
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 the agency or other government agencies requires
similar information or data to be filed. This information is not
available from any other source.

**[5. Impact on Small Businesses or Other Entities]{.underline}**

FDA believes that its duty requires the equal application of the
regulations to all enterprises. 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. Consequences of Collecting the Information Less
Frequently]{.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 only need submit information as
necessary to access other benefits of fast track designation. 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. Special Information Relating to the Guideline of 5 CFR
1320.5]{.underline}**

> An applicant may be required to submit to FDA proprietary trade
> secrets or other confidential information when submitting a 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. Comments in Response to the Federal Register Notice and Efforts to
Consult Outside the Agency]{.underline}**

In accordance with 5 CFR 1320.8 (d), FDA published a notice in the
Federal Register of October 23, 2001, (66 FR 53612) (Tab D) providing
for a 60-day comment period on the information collection. We received
one comment regarding the proposed collection of information. The
comment declared, without any explanation or supporting information,
that the proposed collection of information was unnecessary. The comment
also attempted to reserve judgment as to whether our estimated
information collection burden was accurate. The comment seemed to object
to fast track drug development programs and stated in part that "for our
Congress to even think about letting it happen is playing games with the
existing laws."

FDA disagrees with the comment. Section 506 of the Federal Food, Drug,
and Cosmetic Act requires sponsors to submit sufficient clinical data
for FDA to determine, after preliminary evaluation, whether a fast track
product may be effective. To obtain that clinical data as described in
the guidance document, FDA must have an approved collection of
information. Failure to obtain OMB approval for the proposed collection
of information would undermine the guidance document's value (because
FDA might not receive information that would help the review or receive
unnecessary or confusing information) and ultimately undermine the
efficiency of the review under a fast track drug development program.

Additionally, the notice which appeared in the Federal Register on
October 23, 2001 (66 FR 53612) provided sufficient information and
opportunity for public comment on the information collection burden
estimates given in the notice. The comment received did not provide any
figures or explanations that would cause us to change our burden
estimates, so FDA has no reason to revise the collection burden
estimates.

As for the comment's remarks regarding fast track drug development
programs and Congress, such matters are outside the scope of this
notice. We do, however, regard the statute as providing sufficient
safeguards to prevent unsafe or ineffective drugs from reaching the
public.

**[9. Explanation of Any Payment or Gift to Respondents]{.underline}**

No payment or gift was provided to respondents.

**[10. Assurance of Confidentiality Provided to
Respondents]{.underline}**

The confidentiality of information received by FDA under the proposed
rule would be consistent with the Freedom of Information Act and the
agency\'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. Justification for Sensitive Questions]{.underline}**

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

**[12. Estimate of Hour Burden Including Annualized Hourly
Costs]{.underline}**

The estimated annual burden for this information collection is 6,480
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      | 45       | 1.18      | 53       | 60     | 3    |
| Request          |          |           |          |        | ,180 |
|                  | 33       | 1.00      | 33       | 100    |      |
| Premeeting       |          |           |          |        | 3    |
| Packages         |          |           |          |        | ,300 |
|                  |          |           |          |        |      |
| Total            |          |           |          |        | 6    |
|                  |          |           |          |        | ,480 |
+------------------+----------+-----------+----------+--------+------+

Respondents to this information collection are sponsors and applicants
who seek fast track desigation under section 506 of the act. The agency
estimates the total annual number of respondents submitting requests for
fast track designation to CBER and CDER will be approximately 45. 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 1998
to 2000. For these three years CBER and CDER together received a yearly
average of 53 requests from 45 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 53 requests made per year,
the agency granted 33 requests for fast track designation. For each of
the granted 33 requests, FDA estimates that a pre-meeting package was
submitted to the agency. FDA estimates that a pre-meeting package needs
more preparation time than needed for a designation request because the
issues may be more complex and the data may need to be more developed.
FDA estimates that the preparation hours may generally range between 80
and 120 hours, with an average of 100 hours per package as indicated in
the chart above. The hour burden estimates contained in table 1 of this
document are for information collections requests in the guidance only
and do not include burden estimates for statutory requirements
specifically mandated by the act, the PHS Act, or implementing
regulations.

Cost to Respondents

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

  Reporting         6,480             \$38.00           \$246,240.00
  ----------------- ----------------- ----------------- -----------------

The cost estimate is based on the hourly pay rate of \$38.00 for a
regulatory affairs specialist who

is responsible for preparing the reports. The salary estimates include
benefits but no overhead costs.

**[13. Estimate of Other Total Annual Cost Burden to Respondents or
Recordkeepers]{.underline}**

There are no capital and start-up, and operation, maintenance and
purchase costs associated with the information collection.

**[14. Annualized Cost to the Federal Government]{.underline}**

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

\$34,109,598.00. 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 ^1^  Number of FTE's   Average Annual    Total Cost
                                      Reviewer Salary   

  NDA ^2^           327               \$70,834.00       \$23,162,718.00

  BLA ^3^           168               \$65,160.00       \$10,946,880.00

  Total Cost to                                         \$34,109,598.00
  Government                                            
  ----------------- ----------------- ----------------- -----------------

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

^2^New Drug Application

^3^ Biologics License Application

**[15. Explanation of Program Changes or Adjustments]{.underline}**

The estimated total annual burden for this information collection
requirement was 9,000 hours in 1999. The current decrease to 6,480
burden hours resulted from the difference in the actual number of
responses received and the original number that was estimated to be
received.

**[16. Plans for Tabulation and Publication and Program Time
Schedule]{.underline}**

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

**[17. Reason(s) Display of OMB Approval Date is
Inappropriate]{.underline}**

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

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

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