Notice: Agency Information Collection Activities: Proposed Collection; 
Comment Request; Guidance for Industry: Fast Track Drug Development 
Programs: Designation, Development, and Application Review

Federal Register: May 6, 2008 (Volume 73, Number 88)              
                  Page 25016-25018

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
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 requests by sponsors of investigational new 
drugs and applicants for new drug approvals or biologics licenses for 
fast track designation as provided in the guidance for industry on fast 
track drug development programs.

DATES: Submit written or electronic comments on the collection of 
information by July 7, 2008.

ADDRESSES: Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 
Submit written comments on the 
collection of information to the Division of Dockets Management (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: Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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 or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR

[[Page 25017]]

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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comment on these topics: (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: 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) (Pub. L. 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) 
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 premeeting package was submitted to the agency. FDA 
estimates that the preparation hours are approximately 100 hours per 
premeeting package.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 25018]]



                                 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                 77                 60              4,620
 Request
----------------------------------------------------------------------------------------------------------------
Premeeting                        54               1.11                 60                100              6,000
 Packages
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................             10,620
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.

    Dated: April 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9882 Filed 5-5-08; 8:45 am]

BILLING CODE 4160-01-S