[Federal Register: December 13, 2004 (Volume 69, Number 238)]
[Page 72202-72204]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0526]

Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the proposed collection of 
information concerning requests for fast track designation by sponsors 
of investigational new drugs (INDs) and applicants for new drug 
approvals or biological licenses as provided in the guidance for 
industry on fast track drug development programs.

DATES: Submit written or electronic comments on the collection of 
information by February 11, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on the 

collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information including 
each proposed extension of an

[[Page 72203]]

existing collection of information, before submitting the collection to 
OMB for approval. To comply with this requirement, FDA is publishing 
notice of the proposed collection of information set forth in this 
    With respect to the following collection of information, FDA 
invites comment on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    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 the 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 collections 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. 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 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. 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. 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 pre-meeting package which may include additional 
information supporting 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. These may include descriptions of clinical 
safety and efficacy trials not conducted under an IND (i.e., foreign 
studies), and information to support a request for accelerated 
approval. The discussion of such information in a pre-meeting package 
may be summarized if it has already been previously submitted to FDA 
under an OMB approved collection of information. Consequently, FDA 
anticipates that the additional collection of information solely 
attributed to the guidance will be minimal.
    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 a 
current OMB approval: FDA Forms 1571 (OMB control number 0910-0014, 
expires September 30, 2002); 356h (OMB control number 0910-0338, 
expires March 31, 2003); and 3397 (OMB control number 0910-0297, 
expires February 29, 2004).
    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 45. To obtain this 
estimate, FDA averaged the number of requests for fast track 
designation received by CBER and CDER in the 3-year period of 1998 to 
2000. For these 3 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 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 53 requests made per year, the agency granted 
33 requests for fast track designation. For each of the 33 granted 
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 for a pre-meeting package may range between 
80 and 120 hours per package, with an average of 100 hours per package, 
as indicated in table 1 of this document.
    FDA estimates the burden of this collection of information as 

[[Page 72204]]

                                 Table 1.--Estimated Annual Reporting Burden\1\
                        No. of        Annual Frequency      Total Annual        Hours per
                     Respondents        per Response         Responses           Response         Total Hours
Designation                      45                1.18                 53                 60              3,180
Pre-meeting                      33                1.00                 33                100              3,300
Total                                                                                                      6,480
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: December 6, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-27198 Filed 12-10-04; 8:45 am]