Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review, 20679-20680 [2011-8818]
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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
21 CFR 314.81(b)(2)(ii)(b)
Number of
reponses per
respondent
Total annual
respondents
Average
burden per
response
(in hours)
Total hours
The submission of a copy of that portion of each annual
report containing authorized generic drug information ....
60
6.7
400
3/60
20
Total ..............................................................................
........................
........................
........................
........................
520
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8820 Filed 4–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0157]
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.
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 either electronic or
written comments on the collection of
information by June 13, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:37 Apr 12, 2011
Jkt 223001
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
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
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
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
comments 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,
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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 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
E:\FR\FM\13APN1.SGM
13APN1
20680
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices
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 lifethreatening 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 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 (IND) (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 a
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
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 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Reporting activity
Designation Request ............................................................
Premeeting Packages ..........................................................
Annual
frequency per
response
97
64
Total annual
responses
1.22
1.20
118
77
Total ..............................................................................
1 There
60
100
Total hours
7,080
7,700
14,780
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: April 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DATES:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Application for
Food and Drug Administration
Approval To Market a New Drug
BILLING CODE 4160–01–P
Food and Drug Administration
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
[Docket No. FDA–2010–N–0627]
[FR Doc. 2011–8818 Filed 4–12–11; 8:45 am]
mstockstill on DSKH9S0YB1PROD with NOTICES
Hours
per response
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
VerDate Mar<15>2010
18:37 Apr 12, 2011
Jkt 223001
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Fax written comments on the
collection of information by May 13,
2011.
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
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0001. Also
include the FDA docket number found
E:\FR\FM\13APN1.SGM
13APN1
]]>Agencies
[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20679-20680]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8818]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0157]
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 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 either electronic or written comments on the collection
of information by June 13, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://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
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
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 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 comments 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 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
[[Page 20680]]
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 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 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 (IND) (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 a 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 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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
Reporting activity Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
Designation Request............. 97 1.22 118 60 7,080
Premeeting Packages............. 64 1.20 77 100 7,700
-------------------------------------------------------------------------------
Total....................... 14,780
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8818 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P
