[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45261-45262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19138]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0157]


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.

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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 review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
29, 2011.

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: 202-395-7285, 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 in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
[email protected].

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) (Pub. L. 105-115) amended the Federal Food, Drug, 
and Cosmetic Act (the FD&C 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 
section 112(b) of FDAMA, FDA issued guidance to industry on fast track 
policies and procedures outlined in section 506 of the FD&C Act. The 
guidance discusses collections of information that are specified under 
section 506 of the FD&C 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 FD&C 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) 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 FD&C 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 that 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 FD&C 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 FD&C 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 are not required under section 506(c) of the FD&C Act 
or any other provision of the FD&C Act. All forms referred to in the 
guidance have current OMB approval: FDA Forms 1571 (OMB control number 
0910-0014), 356h (OMB control number 0910-0338), and 3397 (OMB control 
number 0910-0297).
    Respondents to this information collection are sponsors and 
applicants who seek fast track designation under section 506 of the 
FD&C Act. The Agency estimates the total annual number of respondents 
submitting

[[Page 45262]]

requests for fast track designation to the Center for Biologics 
Evaluation and Research and the Center for Drug Evaluation and Research 
is approximately 97, and the number of requests received is 
approximately 118 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 77 requests from 64 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.
    In the Federal Register of April 13, 2011 (76 FR 20679), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      No. of                          Average
       Reporting activity             No. of       responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Designation Requests............              97            1.22             118              60           7,080
Premeeting Packages.............              64            1.20              77             100           7,700
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    Total.......................  ..............  ..............  ..............  ..............          14,780
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: July 19, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19138 Filed 7-27-11; 8:45 am]
BILLING CODE 4160-01-P