[Federal Register Volume 63, Number 203 (Wednesday, October 21, 1998)]
[Notices]
[Pages 56195-56197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28305]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0811]


Agency Emergency Processing Request Under OMB Review

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns the submission by sponsors of investigational new 
drugs and applicants for new drug approvals or biological licenses 
under the Federal Food, Drug, and Cosmetic Act (the act) and the 
guidance for industry on fast track drug development programs.

DATES:  Submit written comments on the collection of information by 
November 5, 1998.

ADDRESSES:  Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA. 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:

I. Guidance for Industry

    FDA is preparing a guidance entitled ``Guidance for Industry: 
Designation, Development, and Application Review for Products in Fast 
Track Drug Development Programs.'' The guidance will provide the 
agency's interpretation of terms central to FDA's fast track programs 
and the agency's views on information that should accompany fast track 
program submissions.
     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: Designation, Development, and Application 
Review for Products in Fast Track Drug Development Programs

     Section 112(a) of the Food and Drug Administration Modernization 
Act of 1997 (FDAMA) (Pub. L. 105-115) amends the act by adding section 
506 (21 U.S.C. 356) and 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 meet an unmet 
medical need. The issuance of the guidance will be under section 112(b) 
of FDAMA, which requires the agency to issue guidance regarding fast 
track policies and procedures within 1 year of the date of enactment of 
FDAMA, November 21, 1997. The guidance will discuss collections of 
information that are expressly specified under section 506 of the act, 
other sections of the Public Health Service Act (PHS Act), or 
implementing regulations. For example, under section 506 of the act, an 
applicant who seeks fast track designation must submit a request to 
FDA. Some of the support for such a request may be required under 
regulations, such as parts 312, 314, and 601 (21 CFR parts 312, 314, 
and 601), which specify the types and format of information and data 
that should be submitted to FDA for evaluation of the safety and 
effectiveness of investigational new drug applications (IND's) (part 
312), new drug applications (part 314), or biological license 
applications (part 601). The guidance will describe three general areas 
involving collection of information: Designation requests, pre-meeting 
packages, and requests to submit portions of an application. Of these, 
designation requests, and pre-meeting packages in support of obtaining 
a fast track program benefit will provide for additional collections of 
information not provided 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 by referring to them rather

[[Page 56196]]

than by resubmission. In some instances, a summary of data and 
information may be submitted in support of fast track designation or 
fast track program benefits. Therefore, FDA anticipates that the PRA 
reporting burden under the guidance will be minimal.

II. Fast Track Designation Request

    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 under existing 
provisions of the act, the PHS Act, or the implementing regulation. 
Such information, if already submitted to the agency, may be summarized 
in a fast track designation request. The guidance will also recommend 
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 meet an unmet medical need where 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.

A. Pre-Meeting Packages

    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, such as 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. If information has been previously submitted to FDA under an 
OMB approved collection of information, the discussion of such 
information in a fast track pre-meeting package may be summarized. 
Consequently, FDA anticipates that the additional collection of 
information attributed solely to the guidance will be minimal.

B. Request to Submit Portions of an Application

     Section 506(c) of the act requires a collection of information 
before an applicant may be permitted to submit to FDA portions of an 
application for review. Under this provision of the fast track statute, 
a sponsor must submit clinical data sufficient 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 
will 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.
    1.FDA Forms Referred to in the Guidance
    All forms that will be referred to in the guidance have valid OMB 
control numbers. These forms include: FDA Form 1571 (OMB Control No. 
0910-0104, expires December 31, 1999); FDA Form 356h (OMB Control No. 
0910-0338, expires April 30, 2000); and FDA Form 3397 (OMB Control No. 
0910-0297, expires April 30, 2001).
    2. Description of Respondents
    Sponsors and applicants that seek fast track designation under 
section 506 of the act.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
                                      No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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Designation request                    60               1              60              60           3,600
Pre-meeting packages                   54               1              54             100           5,400
Total                                 114                             114                           9,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The agency estimates that the aggregate 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 60. To obtain 
this estimate, FDA extrapolated from the number of requests for fast 
track designation actually received by CBER and CDER in a 6-month 
period since November 21, 1997, the date of enactment of FDAMA. Within 
this time period, CBER received 9 requests, and CDER received 20 
requests. 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, as indicated in Table 1 of this 
document.
    Not all requests for fast track designation may meet the statutory 
standard. The agency estimates that approximately 90 percent of all 
annual requests, approximately 54 respondents, for fast track 
designation would be granted. Of those respondents who receive fast 
track designation for a product, FDA expects that all will submit a 
pre-meeting package and that a pre-meeting package would generally need 
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.

[[Page 56197]]

    FDA has requested emergency processing of this proposed collection 
of information under section 3507(j) of the PRA and 5 CFR 1320.13. The 
information is needed immediately to implement section 506 of the act, 
which requires the agency to facilitate development and expedite the 
review of new drug products, including biological products, intended to 
treat a life-threatening or serious condition and that demonstrate a 
potential to meet an unmet medical need. The use of normal information 
clearance procedures would be likely to result in the prevention or 
disruption of this collection of information because section 112(b) of 
FDAMA requires FDA to issue guidance on fast track policies and 
procedures no later than November 21, 1998, i.e., within 1 year of the 
date of enactment of FDAMA.

    Dated: October 14, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-28305 Filed 10-20-98; 8:45 am]
BILLING CODE 4160-01-F