[Federal Register: August 25, 2008 (Volume 73, Number 165)]
[Notices]
[Page 50028-50030]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au08-57]
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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.
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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
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 baguilar@omb.eop.gov. 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\
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Reporting No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
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Designation 64 1.28 82 60 4,915
Request
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Premeeting 54 1.11 60 100 6,000
Packages
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[[Page 50030]]
Total 118 2.39 142 160 10,915
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\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