[Federal Register Volume 73, Number 165 (Monday, August 25, 2008)]
[Notices]
[Pages 50028-50030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-19626]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0259]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for 
Industry: Fast Track Drug Development Programs: Designation, 
Development, and Application Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 24, 2008.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0389. Also 
include the FDA docket number found

[[Page 50029]]

in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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: Fast Track Drug Development Programs: 
Designation, Development, and Application Review--(OMB Control Number 
0910-0389)--Extension

    Section 112(a) of the Food and Drug Administration Modernization 
Act of 1997 (FDAMA) (Public Law 105-115) amended the Federal Food, 
Drug, and Cosmetic Act (the act) by adding section 506 (21 U.S.C. 356). 
The section 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 address an unmet medical need. Under 
FDAMA section 112(b), FDA issued guidance to industry on fast track 
policies and procedures outlined in section 506 of the act. The 
guidance discusses collections of information that are specified under 
section 506 of the act, other sections of the Public Health Service Act 
(the PHS Act), or implementing regulations. The guidance describes 
three general areas involving collection of information: (1) Fast track 
designation requests, (2) premeeting packages, and (3) requests to 
submit portions of an application. Of these, fast track designation 
requests and premeeting packages, in support of receiving a fast track 
program benefit, provide for additional collections of information not 
covered 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 into the request by referring to the information rather 
than resubmitting it.
    Under section 506(a)(1) of the act, an applicant who seeks fast 
track designation is required to submit a request to the agency showing 
that the product: (1) Is intended for a serious or life-threatening 
condition; and (2) the product has the potential to address an unmet 
medical need. Mostly, 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 regulations. If such 
information has already been submitted to the agency, the information 
may be summarized in the fast track designation request. The guidance 
recommends 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 address an unmet medical need where 
an 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 supporting a request to participate in certain fast track 
programs. The premeeting package serves as background information for 
the meeting and should support the intended objectives of the meeting. 
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. These may include descriptions of clinical safety and 
efficacy trials not conducted under an investigational new drug 
application (i.e., foreign studies), and information to support a 
request for accelerated approval. If such information has already been 
submitted to FDA, the information may be summarized in the premeeting 
package. Consequently, FDA anticipates that the additional collection 
of information attributed solely to the guidance will be minimal.
    Under section 506(c) of the act, a sponsor must submit sufficient 
clinical data 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 does 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 referred to in the 
guidance have a current OMB approval: FDA Forms 1571 (OMB Control No. 
0910-0014); 356h (OMB Control No. 0910-0338); and 3397 (OMB Control No. 
0910-0297).
    Respondents to this information collection are sponsors and 
applicants who seek fast track designation under section 506 of the 
act. The agency estimates the total annual number of respondents 
submitting requests for fast track designation to the Center for 
Biologics Evaluation and Research and the Center for Drug Evaluation 
and Research is approximately 64, and the number of requests received 
is approximately 77 annually. FDA estimates that the number of hours 
needed to prepare a request for fast track designation is approximately 
60 hours per request.
    Not all requests for fast track designation may meet the statutory 
standard. Of the requests for fast track designation made per year, the 
agency granted 60 from 54 respondents, and for each of these granted 
requests a pre-meeting package was submitted to the agency. FDA 
estimates that the preparation hours are approximately 100 hours per 
pre-meeting package.
    In the Federal Register of May 6, 2008 (73 FR 25016), FDA published 
a 60-day notice requesting public comment on the information collection 
provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
   Reporting          No. of         Annual Frequency       Total Annual        Hours per
   Activity        Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Designation                    64                  1.28                 82                 60              4,915
 Request
----------------------------------------------------------------------------------------------------------------
Premeeting                     54                  1.11                 60                100              6,000
 Packages
----------------------------------------------------------------------------------------------------------------

[[Page 50030]]

 
Total                         118                  2.39                142                160            10,915
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: August 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19626 Filed 8-22-08; 8:45 am]
BILLING CODE 4160-01-S