[Federal Register Volume 64, Number 87 (Thursday, May 6, 1999)]
[Notices]
[Pages 24406-24407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11311]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0811]
Agency Information Collection Activities; Submission for OMB
Review; 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 that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by June
7, 1999.
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.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 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, in some cases, may 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-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
[[Page 24407]]
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) 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 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) of the act 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 Frequency per Total Annual
No. of Respondents Response Responses Hours per Response Total Hours
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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.
Dated: April 29, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-11311 Filed 5-5-99; 8:45 am]
BILLING CODE 4160-01-F
