[Federal Register Volume 64, Number 17 (Wednesday, January 27, 1999)]
[Notices]
[Pages 4110-4112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1797]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Guidance for Industry: Designation, Development, and 
Application Review for Products in Fast-track Drug Development Programs

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 
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 submissions by sponsors of investigational new 
drugs and applicants for new drug approvals or biological licenses that 
request fast-track designation and the guidance for industry on fast-
track drug development programs.

DATES: Submit written comments on the collection of information by 
March 29, 1999.

ADDRESSES: 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 of the 
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 
listed as follows.
    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 (OMB 
Control Number 0910-0389)--Extension

    Section 112(a) of the Food and Drug Administration Modernization 
Act of 1997 (FDAMA) (Pub. L. 105-115) amends the Federal Food, Drug, 
and Cosmetic Act (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 (the 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, premeeting packages, and requests to submit portions of an 
application. Of these, designation requests, and premeeting 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 
than by resubmission. In some instances, a summary of data and 
information may be submitted in support of fast-track designation or 
fast-

[[Page 4111]]

track program benefits. Therefore, FDA anticipates that the PRA 
reporting burden under the guidance will be minimal.
    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.
    After the agency makes a fast-track designation, a sponsor or 
applicant may submit a premeeting 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 premeeting package may be summarized. Consequently, FDA 
anticipates that the additional collection of information attributed 
solely to the guidance will be minimal.
    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.
    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). Respondents to this information 
collection are sponsors and applicants that seek fast-track designation 
under section 506 of the act.
    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 
premeeting package and that a premeeting 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. FDA 
estimates the burden of this collection of information as follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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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
Premeeting Packages                    54               1              54             100           5,400
Totals                                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.



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    Dated: January 20, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-1797 Filed 1-26-99; 8:45 am]
BILLING CODE 4160-01-F