
[Federal Register Volume 79, Number 243 (Thursday, December 18, 2014)]
[Notices]
[Pages 75564-75565]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29607]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0996]


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 January 
20, 2015.

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 emailed to oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 the 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 drug product: (1) Is intended for a serious or life-
threatening condition and (2) has the potential to address an

[[Page 75565]]

unmet medical need. 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: 
Forms FDA 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 requests for fast track designation to the Center for 
Biologics Evaluation and Research and the Center for Drug Evaluation 
and Research is approximately 81, and the number of requests received 
is approximately 115 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 approximately 100 requests from 81 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 August 1, 2014 (79 FR 44780), 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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   Guidance for industry: Fast
     track drug development                          Number of                        Average
     programs: Designation,          Number of     responses per   Total annual     burden per      Total hours
  development, and  application     respondents     respondent       responses       response
             review
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Designation Requests............              81            1.42             115              60           6,900
 
Premeeting Packages.............              81            1.09              88             100           8,800
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    Total.......................  ..............  ..............  ..............  ..............          15,700
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 12, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29607 Filed 12-17-14; 8:45 am]
BILLING CODE 4164-01-P


