[Federal Register Volume 66, Number 205 (Tuesday, October 23, 2001)]
[Notices]
[Pages 53612-53614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26575]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0458]


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.

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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

[[Page 53613]]

investigational new drugs 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 Decmeber 24, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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 
Information Resources Management (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 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 document.
    With respect to the following collection of information, FDA 
invites comment on: (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 0910-0389)--Extension

    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 demonstrates a potential to address an unmet medical need. Under 
section 112(b) of FDAMA, 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) 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 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 premeeting 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 investigational new 
drug application (IND) (i.e., foreign studies), and information to 
support a request for accelerated approval. The discussion of such 
information in a premeeting 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 attributed solely 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) 
of the act 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 No. 
0910-0014, expires September 30, 2002); 356h (OMB Control No. 0910-
0338, expires March 31, 2003); and 3397 (OMB Control No. 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

[[Page 53614]]

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 premeeting package was submitted to the 
agency. FDA estimates that a premeeting 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 table 
1 of this document.
    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. FDA 
estimates the burden of this collection of information as follows:

                                                     Table1.--Estimated Annual Reporting Burden \1\
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                                                                         Annual Frequency      Total Annual
                  21 CFR Section                    No. of Respondents     per Response          Responses      Hours per Response       Total Hours
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Designation request                                        45                   1.18               53                  60                3,180
Premeeting packages                                        33                   1.00               33                 100                3,300
Total                                                                                                                                    6,480
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: October 12, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-26575 Filed 10-22-01; 8:45 am]
BILLING CODE 4160-01-S