[Federal Register: June 7, 2005 (Volume 70, Number 108)]
[Page 33177-33179]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0526]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for 
Industry: Fast Track Drug Development Programs--Designation, 
Development, and Application Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the

[[Page 33178]]

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 July 7, 

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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.

Guidance for Industry: Fast Track Drug Development Programs--
Designation, Development, and Application Review--(OMB Control Number 

    Section 112(a) of the Food and Drug Administration Modernization 
Act of 1997 (FDAMA) (Public Law 105-115) amended the Federal Food, 
Drug, and Cosmetic Act (the act) by adding section 506 (21 U.S.C. 356). 
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 
FDAMA 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 the following collection of information: 
(1) Fast track designation requests, (2) premeeting packages, and (3) 
requests to submit portions of an application. Of these, fast track 
designation requests and premeeting packages, in support of receiving a 
fast track program benefit, provide for additional collections of 
information not covered elsewhere in statute or regulation. Information 
in support of fast track designation or fast track program benefits 
that has previously been submitted to the agency, may, in some cases, 
be incorporated into the request by referring to the information rather 
than resubmitting it.
    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 may do the following: (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 implementing 
regulations. If such information has already been submitted to the 
agency, the information may be summarized in the fast track designation 
request. The guidance recommends that a designation request include, 
where applicable, additional information not specified elsewhere by 
statute or regulation. For example, additional information may be 
needed to show that a product has the potential to address an unmet 
medical need where an approved therapy exists for the serious or life-
threatening condition to be treated. Such information 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 it 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 premeeting package, which may include additional 
information supporting a request to participate in certain fast track 
programs. The premeeting 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. These may include descriptions of clinical 
safety and efficacy trials not conducted under an investigational new 
drug application (IND) (i.e., foreign studies), and information to 
support a request for accelerated approval. If such information has 
already been submitted to FDA the information may be summarized in the 
premeeting package. Consequently, FDA anticipates that the additional 
collection of information attributed solely to the guidance will be 
    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) of the act or any 
other provision of the act. All forms referred to in the guidance have 
a current OMB approval: FDA Forms 1571 (OMB control number 0910-0014, 
expires January 31, 2006); 356h (OMB control number 0910-0338, expires 
August 31, 2005); and 3397 (OMB control number 0910-0297, expires 
December 31, 2006).
    Respondents to this information collection are sponsors and 
applicants who seek fast track designation under section 506 of the 
act. The agency estimates the total annual number of respondents 
submitting requests for fast track designation to the Center for 
Biologics Evaluation and Research (CBER) and the Center for Drug 
Evaluation and Research (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 3-year period from 2001 to 
2003. For these 3 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 range between 40 and 80 hours per request, 
depending on the complexity of each request, with an average of 60 
hours per request, as indicated in table 1 of this document.
    Not all requests for fast track designation may meet the statutory 
standard. Of the average 67 requests made per year, the agency granted 
47 requests for fast track designation. For each of the 47 granted 
requests, FDA estimates that a premeeting 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, as 
indicated in table 1 of this document.
    In the Federal Register of December 13, 2004 (69 FR 72202), FDA 
published a 60-day notice requesting public comment on the information 

[[Page 33179]]

provisions. One comment was received but was not related to the 
information collection.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                          Annual Frequency per       Total Annual      Hours per
             Reporting Activity                 Number of Respondents           Response              Responses       Respondent        Total Hours
Designation Request                                                56                      1.20                 67            60                  4,020
Premeeting Packages                                                47                      1.00                 47           100                  4,700
Total                                         ........................  ........................  .................  ............                 8,720
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: May 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11206 Filed 6-6-05; 8:45 am]