[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