[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
