[Federal Register: December 13, 2004 (Volume 69, Number 238)]
[Notices]
[Page 72202-72204]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de04-63]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0526]
Agency Information Collection Activities; Proposed Collection;
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 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 for fast track designation by sponsors
of investigational new drugs (INDs) and applicants for new drug
approvals or biological licenses 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 February 11, 2005.
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.fda.gov/dockets/ecomments. 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: JonnaLynn P. Capezzuto, Office of
Management Programs (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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
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
[[Page 72203]]
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) (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 the potential to address an unmet medical need. Under
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 collections of information: (1) Fast track
designation requests, (2) pre-meeting packages, and (3) requests to
submit portions of an application. Of these, fast track designation
requests and pre-meeting 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 meets the statutory standard for designation, i.e.,
that: (1) The product 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 pre-meeting package which may include additional
information supporting a request to participate in certain fast track
programs. 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 IND (i.e., foreign
studies), and information to support a request for accelerated
approval. The discussion of such information in a pre-meeting package
may be summarized if it has already been previously submitted to FDA
under an OMB approved collection of information. Consequently, FDA
anticipates that the additional collection of information solely
attributed 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) or any other
provision of the act. All forms referred to in the guidance have a
current OMB approval: FDA Forms 1571 (OMB control number 0910-0014,
expires September 30, 2002); 356h (OMB control number 0910-0338,
expires March 31, 2003); and 3397 (OMB control number 0910-0297,
expires February 29, 2004).
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 (CBER) and the Center for Drug
Evaluation and Research (CDER) will be approximately 45. To obtain this
estimate, FDA averaged the number of requests for fast track
designation received by CBER and CDER in the 3-year period of 1998 to
2000. For these 3 years, CBER and CDER together received a yearly
average of 53 requests from 45 respondents. The rate of submissions is
not expected to change significantly in the next few years. FDA
estimates that the number of hours needed to prepare a request for fast
track designation may range between 40 and 80 hours per request,
depending on the complexity of each request, with an average of 60
hours per request, as indicated in table 1 of this document.
Not all requests for fast track designation may meet the statutory
standard. Of the average 53 requests made per year, the agency granted
33 requests for fast track designation. For each of the 33 granted
requests, FDA estimates that a pre-meeting package was submitted to the
agency. FDA estimates that a pre-meeting package needs more preparation
time than needed for a designation request because the issues may be
more complex and the data may need to be more developed. FDA estimates
that the preparation hours for a pre-meeting package may range between
80 and 120 hours per package, with an average of 100 hours per package,
as indicated in table 1 of this document.
FDA estimates the burden of this collection of information as
follows:
[[Page 72204]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Designation 45 1.18 53 60 3,180
Request
----------------------------------------------------------------------------------------------------------------
Pre-meeting 33 1.00 33 100 3,300
Packages
----------------------------------------------------------------------------------------------------------------
Total 6,480
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 6, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-27198 Filed 12-10-04; 8:45 am]
BILLING CODE 4160-01-S